tag:blogger.com,1999:blog-35205931Wed, 13 May 2009 08:04:04 +0000A catalyst for public debatehttp://ahrp.blogspot.com/noreply@blogger.com (Vera Hassner Sharav)Blogger556125tag:blogger.com,1999:blog-35205931.post-6273940243900076159Tue, 23 Dec 2008 14:25:00 +00002008-12-23T09:26:03.772-05:00Underscoring the fact that certain prescription drugs can and do precipitate suicide, FDA acknowledges that four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did.<br /><br />Perhaps one of the last actions taken by the FDA is to require warnings about increased risks of suicide attempts ("suicidality") for a very large class of drugs originally approved for the treatment of epilepsy but whose profits come from their mostly off-label use for pain or psychiatric conditions (in which case they're called, Mood Stabilizers). [see list below]<br /><br />The FDA convened an advisory committee hearing after the agency's review of 199 clinical trials of 11 anti-epileptic drugs showed that patients prescribed these drugs doubled their risk of engaging in suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference translates into one in 500 patients taking an anti-seizure (mood stabilizer) drug is at risk of making a suicide attempt--regardless of the condition for which the drug was prescribed.<br />However, FDA only issued a half hearted warning--no Black Box Warning of suicidality as required on the labels of the SSRI antidepressants. This is strange inasmuch as anti-seizure drugs are prescribed mostly with other psychotropic drugs--such as SSRIs and antipsychotics--and these drugs ALSO increase the risk of suicide!<br /><br />One would think that a cumulative increased risk of such a serious drug-induced effect would warrant bolder warnings rather than a muted one. <br /><br />We also suggest that psychiatrists who claim that the suicide rate among American youth has increased in recent years--a matter of dispute--should check the drug cocktails that children and adolescents are being prescribed, mostly by child psychiatrists.<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>FOR IMMEDIATE RELEASE<br />Dec. 16, 2008<br />Media Inquiries:<br />Sandy Walsh, 301-796-4669</strong><br /><br />Consumer Inquiries: 888-INFO-FDA<br /><br />FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications<br /><br />The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.<br /><br />The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.<br /><br />"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. " Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."<br /><br />The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.<br /><br />The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.<br /><br />Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.<br /><br />The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.<br /><br />Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.<br /><br />The following antiepileptic drugs are required to add warnings about the risk of suicidality:<br /><br /><ul><li>Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)</li><li>Clonazepam (marketed as Klonopin)</li><li>Clorazepate (marketed as Tranxene)</li><li>Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)</li><li>Ethosuximide (marketed as Zarontin)</li><li>Ethotoin (marketed as Peganone)</li><li>Felbamate (marketed as Felbatol)</li><li>Gabapentin (marketed as Neurontin)</li><li>Lamotrigine (marketed as Lamictal)</li><li>Lacosamide (marketed as Vimpat)</li><li>Levetiracetam (marketed as Keppra)</li><li>Mephenytoin (marketed as Mesantoin)</li><li>Methosuximide (marketed as Celontin)</li><li>Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin</li><li>Suspension)</li><li>Pregabalin (marketed as Lyrica)</li><li>Primidone (marketed as Mysoline)</li><li>Tiagabine (marketed as Gabitril)</li><li>Topiramate (marketed as Topamax)</li><li>Trimethadione (marketed as Tridione)</li><li>Zonisamide (marketed as Zonegran)</li></ul><br /><br />Some of these medications are also available as generics.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/forced-electroshock-in-usa-national.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-6273940243900076159?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/fda-drug-warning-anti-seizure-mood.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-6153319792112383547Sun, 21 Dec 2008 15:07:00 +00002008-12-21T10:09:00.573-05:00Most Americans, and many in the media cannot not believe that an individual living in the community in the USA could be forced to undergo electroshock--which many patients who are subjected to it against their will view as a punishment masquerading as "treatment." Psychiatrists call it "treatment," neurologists call it brain damaging procedures. [1] [<a href="http://retina.anatomy.upenn.edu/pdfiles/Oct2002NYC.pdf" target="_blank">Link</a>] <br /><br />In an Aug. 2008, editorial, Shock and Panic, ECT proponent, David Healy, MD, dismisses critics' concerns about ECT to "psychiatry's dark past": "Some of the unease about ECT," he writes, "stems from psychiatry's dark past, when patients in many countries had fewer legal rights than prisoners. Not so long ago, physical treatments such as lobotomy and ECT could be inflicted on patients without their consent, and sometimes for punitive purposes." [<a href="http://www.mmegi.bw/index.php?sid=2&aid=161&dir=2008/August/Tuesday26" target="_blank">Link</a>]<br /><br />Well, in Minnesota, Ray Sanford, a 54 year old man living in the community, has been forced to undergo weekly seizure-producing electroshock (ECT) "treatments," since the end of May. After 12 sessions, a COURT AUTHORIZED more ECT treatments to be administered as often as every week for up to a year.<br /><br />He has already had 36 electroshock zaps administered against his will. He complains that ECT is wrecking his memory.<br /><br />Unbeknown to Ray Sanford, his complaint about memory loss is backed by a body of scientific evidence. [2]<br /><br />In the 1950s Dr. Irving Jannis (Yale ) conducted a series of small, well-designed, matched controlled follow-up studies--comparing the cognitive function of patients who underwent ECT-- before and after ECT. Their cognitive function was tested at 2-1/2, 3-1/2, and one year follow-up against a control group that had not had ECT. [3] The Jannis studies are recognized as methodologically unique in the ECT scientific literature: their importance is noted by neurologists, independent scientists, and patients. The studies confirmed that ECT caused memory loss and cognitive impairment. <br /><br />ECT's ardent proponents claim the methodology changed, and they vigorously deny the serious damage ECT continues to produce on memory and cognition. But they have refused to conduct a test that will prove them right. Why? <br /><br />As psychiatrist, David Kaiser, MD observed: "Biologic psychiatry as it exists today is a dogma that urgently needs to be unmasked. One of the surest signs that dogmatists are at work here is that they rarely question or attempt to problemitize their basic assumptions." [4]<br /><br />In 2000, the central supporting stone was pulled from ECT's house of clay by Harold Sackeim, Ph.D., a prominent ECT advocate (arguably the most prolific ECT researcher who simultaneously headed both the Columbia University and NY Cornell divisions of ECT ). Dr. Sackeim wrote an astonishingly candid editorial in the Journal of ECT, in which he explicitly validated patients' claims, acknowledging that consistent evidence exists documenting that: "virtually all patients experience some degree of persistent and likely permanent amnesia. It has also become clear that for rare patients the retrograde amnesia due to ECT can be profound, with the memory loss extending back years prior to receipt of the treatment." [5] <br /><br />Sackeim further conceded that ECT causes frontal lobe damage significantly affecting the brain's executive functions: including working memory, logical reasoning and abstraction, problem solving, planning and organizing. Dr. Sackeim was the recipient of tens of millions of dollars in NIMH research grants collecting data on its effects for two decades--so he was in possession of a body of unpublished evidence documenting cognitive harm and memory loss. In 2007, he finally published the data itself. [<a href="http://www.ect.org/wp-content/uploads/2007/01/1301180a.pdf" target="_blank">Link</a>] [2]<br /><br />In 2003, the UK National Institute for Health and Clinical Excellence (NICE) issued new guidelines recommending (1) cognitive assessment after each ECT for memory loss; (2) that treatment be stopped if adverse cognitive effects manifest; (3) the use of validated psychometric scales; (4) inclusion of user perspectives on the impact of ECT, and (5) documentation of incidence and impact of important side effects such as cognitive functioning. [<a href="http://apt.rcpsych.org/cgi/content/abstract/12/3/228" target="_blank">Link</a>] [6]<br /><br />US judges who issue court-ordered year-long involuntary ECT clearly don't have a clue about the nature of the harm produced by the treatment they order----i.e., memory loss and possibly irreversible brain damage.<br /><br />Below is a transcript from the National Public Radio broadcast (9 min.) [<a href="http://www.npr.org/templates/story/story.php?storyId=98273451" target="_blank">Link</a>] "One of the things I have problems with is certain people," Sandford said. "I can't remember their names anymore. And I should be able to remember their names, since I've known some of them a long time. I can't quite remember their names. And don't ask me to tell you their names 'cause I won't remember."<br /><br />Marilyn Sandford, his mother, told NPR: "I don't care if he forgets the birthday of his nieces and nephews -- although it's very important to him to remember that, and probably more important to him than it is to anybody else in the family. But I do care that he can remember the names and know that they're born, and remember what he did last Christmas if it was a happy memory, remember the good times. It's too bad to take away that." <br /><br />But such human considerations don't make a dent with a corps of psychiatrists whose enthusiasm for electroshock is not deflected one bit by patients' complaints. <br /><br />For much of his career, Max Fink, M.D., has been viewed as a pre-eminent researcher and advocate for electroconvulsive therapy. In a 2005 profile in Psychiatric Times, [<a href="http://www.psychiatrictimes.com/display/article/10168/52281" target="_blank">Link</a>] Dr. Fink confirmed: "There is no official count, but in 1996 the estimate was that 100,000 patients per year were being treated with ECT in the United States [Ottosson and Fink, 2004] ... If you take the 100,000 estimate per year and each patient gets an average of 10 treatments, that's about 1 million treatments in 1996," he said. Fink believes that now the numbers being treated in the United States are beyond 100,000 patients per year, and he sees a revival of ECT in Europe as well. [7]<br /><br />One has to wonder whether it's a genetic or character flaw that propels psychiatrists to apply radical damage-producing medical assault weapons on innocent children? <br /><br />Harvard's Joseph Biederman has the dubious distinction of being credited with influencing his peers to prescribe antipsychotic drugs for children, while Max Fink is on record promoting the use of ECT on children and the elderly:<br /><br />"Electroconvulsive therapy is an effective treatment for severe mental disorders, including psychotic depression, delirious mania, catatonia, postpartum depression and postpartum psychosis. Age is no barrier," according to Fink, who has explained that ECT has been used successfully in children, adolescents and the old-old (Fink, 2001). Today, Fink told Psychiatric Times, "It is reasonable for child psychiatrists who are not wedded to psychodynamic thinking to consider ECT in children and adolescents with the illnesses for which ECT is used in adults." [<a href="http://www.psychiatrictimes.com/display/article/10168/52281" target="_blank">Link</a>]<br /><br />Asked what he wants psychiatrists and others to understand about ECT, Fink responded, "Over the 70-plus years that ECT has been around, we have learned to appreciate that something magical happens in the body when we produce an epileptic fit."<br /><br />Dr. Fink acknowledged that neurologists and internists reflect the public fear of an epileptic attack. A major part of neurological practice is devoted to suppressing seizures, and this attitude influences the approach of neuroscientists to seizures, Fink said.<br /><br />"What we have learned about ECT is that nothing about the electricity, nothing about the chemicals used in anesthesia, nothing about a psychological aspect in the process is important, except producing a grand mal seizure in the brain," he said. He explained that anesthesia during ECT makes the process easier for the patient and the physician, but it is not essential to the outcome. "The only thing that is essential is the seizure...<br /><br />Dr. Fink's website continues to state that he is now working "on a book on a History of Convulsive Therapy with the Toronto (Canada) Professor of History of Medicine, Edward Shorter and the Reader in Psychopharmacology David Healy of Wales UK." <br /><br />That book, authored by Edward Shorter, PhD and David Healy MD was published under the title: Shock Therapy: A History of Electroconvulsive Treatment in Mental Illness. The book is an uncritical tribute to Max Fink whose personal foundation (SCION) provided a $33,900 grant to the authors in 2004-2005. [<a href="http://dfcm.utoronto.ca/research/pdf/grants.pdf" target="_blank">Link</a>]<br /><br />The authors baldly claim that ECT--at best a short-term respite from suicidal depression--is "the penicillin of psychiatry"--implying that it is as effective a treatment as penicillin. The proponents of ECT, much like the proponents of widespread use of antidepressants and antipsychotics--psychiatry's pharmacological failed treatments--resort to just such unsubstantiated claims in making their case. If only they could provide scientifically valid evidence--rather than consensus from like-minded believers--to support their belief that it works and it's safe.<br /><br />An essay by psychiatrist David Kaiser (1996) in Psychiatric Times is as pertinent today as when he wrote it--except for his lack of knowledge about the hazardous effects of the new drugs:<br /><br />"...It has occurred to me with forcible irony that psychiatry has quite literally lost its mind, and along with it the minds of the patients they are presumably supposed to care for. Even a cursory glance at any major psychiatric journal is enough to convince me that the field has gone far down the road into a kind of delusion, whose main tenets consist of a particularly pernicious biologic determinism and a pseudo-scientific understanding of human nature and mental illness...<br /><br />Biologic psychiatrists as a whole are unapologetic in their view that they have found the road to the truth, namely that mental illnesses for the most part are genetic in origin and should be treated with biologic manipulations, i.e., psychoactive medications, electroconvulsive treatment (which has made an astounding comeback), and in some cases psychosurgery."<br /><br />References:<br /><br /><ol><li>Sterling, P. Testimony Prepared for the Standing Committee on Mental Health of the Assembly of the State of New York. October 5, 1978. [Link] [<a href="http://www.ect.org/effects/testimony.html" target="_blank">Link</a>]</li><li>Sackeim H, Prudic J, Fuller R, Keilp J, Lavori P, Olfson M. The Cognitive Effects of Electroconvulsive Therapy in Community Settings Neuropsychopharmacology (2007) 32, 244-254. [Link] [<a href="http://www.ect.org/wp-content/uploads/2007/01/1301180a.pdf" target="_blank">Link</a>]</li><li>Janis, I. (1948) Memory loss following electric convulsive treatments. J. Personality 17:29; Janis, I. (1950a) Psychologic effects of electric convulsive treatments. I. Post-treatment amnesias. J. Nerv. & Ment. Dis 111:359-382; Janis, I. (1950b) Psychologic effects of electric convulsive treatments. II. Changes in word association reactions. J. Nerv. & Ment. Dis 111:383-397; Janis, I. and Astrachan, M. (1951) The effects of electroconvulsive treatments on memory efficiency. J. Abnormal & Soc. Psychol. 46:501</li><li>David Kaiser, M.D. Against Biologic Psychiatry. Commentary, Psychiatric Times, December 1996, Vol. XIII, Issue 12 [<a href="http://psychiatrized.org/Articles/psychTimes-KaiserCommentary.htm" target="_blank">Link</a>]</li><li>Sackeim, Harold A. Memory and ECT: From Polarization to Reconciliation. Journal of ECT. 16(2):87-96, June 2000.</li><li>NICE Guidelines [<a href="http://www.nice.org.uk/TA059" target="_blank">Link</a>]</li><li>Arline Kaplan Through the Times With Max Fink, M.D. Psychiatric Times. September 1, 2005. [<a href="http://www.psychiatrictimes.com/display/article/10168/52281" target="_blank">Link</a>]</li></ol><br />My critical review of the Shorter / Healy book: [<a href="http://ahrp.blogspot.com/2008/02/ect-penicillin-of-psychiatry-review-of.html" target="_blank">Link</a>]<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>NATIONAL PUBLIC RADIO "DAY TO DAY" - transcript<br />Minnesota man fights forced electroconvulsive therapy</strong><br /><br />by Minnesota Public Radio's Lorna Benson:<br /><br />St. Paul, Minn. -- Ray Sandford has been getting electro-convulsive treatment, also known as electroshock and ECT, since the end of May. For Ray, the process works like this. Every week or two he is taken to a hospital, where a medical technician attaches electrodes to his head and delivers electrical current into his brain. The current causes a seizure.<br /><br />For reasons that doctors still don't quite understand, some patients with severe depression or mania get better after having ECT.<br /><br />But the potential benefits don't matter to Ray. He says he dreads the shocks and wants them to stop.<br /><br />"It's scary as hell," he said.<br /><br />Ray is 54 years old, with a receding hairline and a salt-and-pepper beard. He walks with a cane and his hands shake slightly, a side effect from some of the medication he's taking, he says.<br /><br />We've met up in the basement of the small group home where he lives, so we can talk without disturbing his roommates. I'm warned by his legal guardians who are present for the interview that Ray gets tired easily, so this conversation may not last long.<br /><br />I ask him what bothers him about getting ECT. Besides being scary, he says the electroshock makes his head hurt for at least a day, and it's wrecking his memory.<br /><br />"One of the things I have problems with is certain people," Sandford said. "I can't remember their names anymore. And I should be able to remember their names, since I've known some of them a long time. I can't quite remember their names. And don't ask me to tell you their names 'cause I won't remember."<br /><br />Sandford's doctors aren't allowed to discuss his case with Minnesota Public Radio News. The courts have determined that Ray isn't competent to make decisions regarding his own welfare, according to his guardian, Lutheran Social Services. As a result, he can't give his doctors permission to discuss his private medical record.<br /><br />But in public court documents, his psychiatrists state they sought ECT only after all other treatments, including psychotropic drugs, failed. They wanted to pull Ray out of a particularly lengthy psychotic episode that began a year ago.<br /><br />His court record describes a man who was out of control for many months, urinating wherever and whenever he felt like it, smearing feces on hospital walls and even eating it.<br /><br />Ray didn't want to talk about his hospitalization. But his 80-year- old mother Marilyn was willing to fill in a few of the details.<br /><br />"Voluntary treatment is always preferable to forced treatment. The more intrusive the treatment, the higher the bar needs to be for imposing." -Pamela Hoopes, Minnesota Disability Law Center<br /><br />Sitting on a cream-colored chair in her tiny retirement community apartment, Marilyn Sandford clutched a picture frame showing Ray in happier times.<br /><br />"I put in their baby picture and then their high school graduation picture. He didn't graduate, but I've always liked that picture of him. He was a much beloved child," said Marilyn Sandford.<br /><br />Her son had a very happy childhood, Marilyn says. But by the time he turned 17, he began acting out in disturbing ways.<br /><br />"One of the things I remember him doing was getting this car and driving it. We lived on a hill where there was pasture land. [He was] driving it round and round our house in the late night. Another time he got on my tail and just kept following me, no matter where I went, with the car," she recalled.<br /><br />"And then there were many very irritating things that had to do with body excrement and all kinds of things. And just his behavior was just out of control."<br /><br />Episodes like these re-occurred like clockwork every 18 months to two years throughout her son's adult life, she said. The episodes lead to dozens of hospitalizations for a condition described in court records as schizo-affective disorder with bipolar tendencies.<br /><br />When Marilyn Sandford heard this past summer that a court had ordered involuntary ECT for her son, she thought it seemed like a reasonable option. And after a few treatments, she was convinced that it had helped.<br /><br />"What I told him is that it gave me my son back again. I hadn't seen what I call the normal Raymond for a long time," said Marilyn Sandford. "I was able to converse with him. We were able to have a normal conversation. It was wonderful and I thought, oh good, this is great."<br /><br />Marilyn assumed the ECT would stop after three or four sessions, especially since her son seemed to get better rather quickly. But after 12 sessions, the court authorized more treatments to be administered as often as every week for up to a year.<br /><br />That seemed excessive, Marilyn said, given her son's complaints that the ECT was causing memory loss.<br /><br />"I don't care if he forgets the birthday of his nieces and nephews --although it's very important to him to remember that, and probably more important to him than it is to anybody else in the family. But I do care that he can remember the names and know that they're born, and remember what he did last Christmas if it was a happy memory, remember the good times. It's too bad to take away that," said Marilyn Sandford.<br /><br />She wasn't sure what she could do about the situation, given her own health issues and her busy family life, including new twin grandchildren.<br /><br />As the summer and fall wore on, Ray continued to get his weekly ECT treatment -- all the while complaining to anyone who would listen. Then about a month ago, Ray ramped up his anti-ECT campaign.<br /><br />"He's a hero for me. He called up his local library and asked for help, and I love that," said David Oaks, director of MindFreedom International, a coalition that advocates against forced medication and involuntary ECT therapy. "I guess they did an Internet search for mental health human rights and they found MindFreedom, and so we are coming through for him."<br /><br />"Those kind of things are just so intrusive, that no means no. If an individual says no, then no, they should not get those procedures," Oaks said.<br /><br />Most of the time, ECT is given to patients who want it. University of Minnesota psychiatry professor Carl Malmquist isn't involved in Ray's case, but he says it is now well accepted that ECT does help some people.<br /><br />"If the drugs aren't doing their job, so to speak, and the patient is responding and you've tried different drugs, you've tried different dosages, then you start to think in certain cases that maybe you need to use ECT. But it's really used very sparingly compared to medication," said Malmquist.<br /><br />In cases like Ray Sandford's, the treatment can be forced upon the patient, if doctors believe it's the only way to make them well. There are no good numbers on how many people receive forced ECT in the U.S. It's up to states to track these cases and most, like Minnesota, do not.<br /><br />The advocacy group MindFreedom launched an Internet campaign on Ray's behalf, calling on Gov. Pawlenty to investigate his case and put an immediate end to the ECT. The group also filed a claim with the United Nations, saying that Ray's forced ECT treatments constitute torture.<br /><br />The lobbying attracted the attention of the Minnesota Disability Law Center which is now reviewing the case. Legal director Pamela Hoopes says the group has just begun its investigation, so she can't say much about the merits of the case. Any time someone's right to self- determination is taken away, she says, the courts need to have a good reason.<br /><br />"These are very difficult issues, and I think it would be hard to argue with the proposition that voluntary treatment is always preferable to forced treatment," said Hoopes. "And the more intrusive the treatment, the higher the bar needs to be for imposing."<br /><br />Yet there's not total agreement in the legal system on how to make a decision in someone's best interest. Attorney Eric Janus is the president and dean of William Mitchell College of Law in St. Paul. He has studied the boundaries of the state's ability to forcibly treat patients.<br /><br />There are different perspectives on how the state should make these decisions, Janus says.<br /><br />"Sometimes people say you should use the perspective of a reasonable person," said Janus. "And it's assumed that a reasonable person wants to protect him or herself against a relapse of a terrible mental illness."<br /><br />In Sandford's case, his doctors haven't said if they're using the ECT to prevent a relapse or to continue his treatment.<br /><br />Still the "reasonable person" test doesn't make sense to everyone, including even himself, Janus says.<br /><br />Janus says even greater weight should be given to what the patient wants --even if it appears their illness might be clouding their judgment. Competent or not, not everyone wants to be treated when they're sick, he says.<br /><br />"That's really what the court should be asking," said Janus. "What are this person's values? What does he want? What kind of life does he want to live? And it should be trying to make the decision in his behalf."<br /><br />Ray Sandford agrees.<br /><br />"A person should have a choice in their life what they're doing."<br /><br />Ray Sandford is undergoing an exam by court-ordered psychiatrists today. Tomorrow, he will appear before a judge in St. Paul to see if his forced ECT can be stopped.<br /><br />- end of transcript -</div><br /><br /><br /><br /><a href="http://ahrp.blogspot.com/2008/12/follow-up-fda-contract-to-improve.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-6153319792112383547?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/forced-electroshock-in-usa-national.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-6060489936440612533Sun, 21 Dec 2008 12:21:00 +00002008-12-21T07:22:26.648-05:00There is a lot more background information behind FDA's "morale improvement" contract (Bloomberg News, [<a href="http://www.bloomberg.com/apps/news?pid=20601124&sid=aOa2vsfzmbVA&refer=home#" target="_blank">Link</a>] ). As several FDA safety reviewers have described (anonymously to protect themselves from harassment), the agency's safeguarding mission has been turned on its head: "ex-industry VPs have come to FDA and implemented new processes over the past several years that will prevent the detection of serious adverse events including death, and detection is instead moving to post marketing rather than pre-marketing evaluation." <br /><br />In March 2008, the Readers Digest provided an excellent overview of what ails the FDA: <br /><br />"Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slowly to remedy them. Instead of depending on the FDA, Americans are doubting it -- and for good reason." [<a href="http://www.rd.com/national-interest/special-reports-and-surveys/problems-in-the-fda/article.html" target="_blank">Link</a>] <br /><br />The author, Alexis Jetters, noted that money alone won't solve the FDA's morale problem and that without change at the top there's no assurance that FDA officials will get tough on industry scofflaws. [<a href="http://ahrp.blogspot.com/2008/03/readers-digest-crisis-in-fda-and.html" target="_blank">Link</a>]<br /><br />On June 3, 2008, a report by the Associated Press, posted on Pharmalot under the heading Fleeing the FDA For Industry and Retirement revealed that the FDA was scrambling to recruit a new generation of regulators. Thirty percent of the regular staff are already eligible to retire and FDA hopes to hire 600 staffers by October to replace those leaving. AP reported that FDA's turnover is twice that of other agencies. FDA outsiders say the major reason for turnover is frustration with FDA culture: [<a href="http://www.pharmalot.com/2008/06/fleeing-the-fda-for-industry-and-retirement/" target="_blank">Link</a>]<br /><br />Then, another AP report (Sept. 2008) posted on Pharmalot described FDA's employee recruitment drive--excerpt below* Following that (Sept) post, a highly informative exchange of comments posted on Pharmalot includes eye opening comments by FDA safety reviewers who have an inside view of the hostile culture at the agency and its retaliatory tactics against those who point to safety problems.<br /><br />Here are two sample comments from FDA Reviewers<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">September 12th, 2008<br /><br />"Many of the hires for front line reviewers are either coming from Big Pharma where there are layoffs occurring or from academic programs with exceptionally close ties to big pharma.<br /><br />In both cases the new hires tend to be those individuals who are supportive of big pharma and the change in FDA's mission to 'promote the public health by making new drugs available'.<br /><br />Many of the new hires are foreign nationals on H1-B visa's who come from countries where corruption in government is rampant and who culturally are more compliant. This is not to say that all individuals from these countries are so and in fact a number of the best reviewers both scientifically and ethically are from these countries and came to the US in part to get away from that.<br /><br />A number of the positions that the new reviewers are filling are due to experienced reviewers (primarily native born US citizens) having been forced out due to harassment or even from reviewers being fired for raising safety issues.<br /><br />Other industry people have been hired over the last few years as reviewers and have been rapidly promoted to that they dominate the lower management ranks and there won't be anyone or anyway to change FDA back under a new administration.<br /><br />In any event ex-industry VPs have come to FDA and implemented new processes over the past several years that will prevent the detection of serious adverse events including death, and detection is instead moving to post marketing rather than pre-marketing evaluation. When detected under the new sentinel program it's likely that genetic tests will be co-marketed or other drugs will be promoted as treatments. This appears to be the rationale behind much of the Food Drug and Amendments Act of 2007, (FDAAA). In fact there were industry VPs walking freely around the restricted areas of FDA who had come to work on this act even though it nominally came from the offices of Senators Kennedy and Enzi.<br /><br />FDA has also been sending it's managers to China and India to train scientists in those countries to help get products through the FDA. Yet these scientists are performing the same types of clinical and preclinical research that was being performed in the US until the recent layoffs in Big Pharma.<br /><br />As for numbers of primary reviewers over the past couple of years only a little over 1/3 of the review staff in some areas have been actually doing reviews. The remainder are managers (in some cases 16 managers having oversight of one reviewer) or are working on projects for Big Pharma developing drug-disease models or promoting biomarkers.<br /><br />Dr. Von Eschenbach had said 90% of these 2000 new hires will only be for 2 years and are primarily for training purposes and will then have to find jobs elsewhere. Since many are on H1-B visas they will likely go back to their home countries and work there or will be used to replace the US citizens who have been laid off.<br /><br />If you look at the data FDA has on its website, over the past couple of years the number of INDs per year had doubled to nearly 400/yr whereas it had stable at 200 / year for decades. This suggests that there will soon be a rash of NDA submissions that these new reviewers will be working on. However without the experience and with the new review system being implemented (with the help of a rigged evaluation system using outside consultants including Booz Allen Hamilton and the Carlyle Group) many safety issues will likely be missed.<br /><br />Although FDA and Big Pharma like to show graphs at show that the number of NDAs approved since 1994 has been decreasing, if you look at the data from the past 3 - 4 decades (which is available on the FDA Website) the numbers are actually stable. The drop is due to a high number of approvals in 1994 /95 due to a backlog that was removed under PDUFA 1 and due to companies hurrying up submissions so they would be reviewed by inexperienced reviewers. This resulted in about 10% of these drugs being withdrawn from the market due to safety reasons within a couple of years. Thus I believe we are looking at similar situation that will occur over the next couple of years. As for approval rates and FDA being tougher, actually if you look over the past 3 - 4 decades the % of drugs approved has been steadily increasing from around 60% to 80%. In part this could mean that companies are getting better are submitting and going through the process however in my experience over the past few years the drugs being submitted are more and more dangerous and we are simply lowering our standards.<br /><br />The entire FDA has been rigged so that no matter what a new administration tries to do to undo the damage many dangerous drugs will likely soon come onto the market and with preemption and new FDA policies to try to find a way to keep dangerous drugs on the market no matter what there will be no recourse."<br /><br />Signed: An FDA Reviewer</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">September 14, 2008<br /><br />"Articles on the 2000 total new hires indicate that this is 15% of the FDA workforce. That's true but there are only 2000 people in the Center for Drugs and of these maybe a third are reviewers.<br /><br />In fact they've been intentionally starving the psych review teams for certain disciplines so that there will not be any comments made to the companies during development (INDs) when problems could be averted or FDA input could result in study designs that adequately characterize safety issues. Instead new hires are going towards drug disease state modeling of biomarkers and helping pharma develop drugs.<br /><br />Even the new hires going into postmarketing surveillence aren't going to help stop dangerous drugs before they reach the market. In fact the new risk management plans are being reviewed by the postmarketing division before the new drug reviewers have had a chance to do their reviews and find the side effects. It's all about closing the gate after the horses have gotten out and even then closing the gate veeeerrrry slllooooolllllly.<br /><br />FDA management compartmentalizes reviewers and have put people who are supposed to be doing collaborative reviews into 3 different buildings with 20 minute walks between them. There are now urveillence cameras everywhere including monitoring of computers and phone calls. Some division directors as a pilot program have even been ordering their staff to stay in their rooms and communicate entirely electronically. They can't even go and talk in person to the reviewer in the room next to them.<br /><br />There are posters up on the walls telling new reviewers that anyone who isn't happy and cheerful and going along is a problem. In meetings the new reviewers are told that anyone who is against the new way of doing things is a sabatour, and there are parties and baseball caps and special emphasis to indoctrinate these junior reviewers on the new way of doing things while at the same time senior reviewers are scheduled so they can't attend and are excluded. This also goes for meetings regarding the science of safety issues on drugs reviewers are reviewing.<br /><br />FDA management also keeps reviewers in the dark. Reviewers don't even know what other reviewers in the next room are working on, and they don't tell reviewers about adverse effects that might be class effects. Labeling changes and public safety announcements are also hush hush inside FDA. Unless you actively look yourself.<br /><br />As for the lack of keeping up with the latest science that Pharma's complaining about. That's only because FDA management has prevented reviewers from keeping up with things so they won't know about class toxicities or have qualifications to obtain a new job when they're forced out for raising safety concerns."<br /><br />Signed, Another Reviewer</div><br /><br />There are 52 comments on Pharmalot--<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.bloomberg.com/apps/news?pid=20601124&sid=aOa2vsfzmbVA&refer=home#" target="_blank">Link</a>] FDA's $1.5 Million Morale Contract Draws U.S. Lawmaker Scrutiny By Justin Blum<br /><br />Dec. 12 (Bloomberg) -- A $1.5 million contract between the U.S. Food and Drug Administration and a California firm to improve morale at the agency's drug division faces scrutiny from lawmakers who questioned whether the company's plan will work.<br /><br />The FDA awarded the two-year contract to the Center for Professional Development in Oakland, according to a statement today from Republican Representatives Joe Barton of Texas and John Shimkus of Illinois.<br /><br />One of the consultants for the center "works with the metaphor of colour, symbol, dance and story to help people give meaning to their lives and work," the lawmakers said, quoting from the group's Web site.<br /><br />The FDA announced the contract in October 2007 "to improve workplace leadership, empower staff and establish more effective business practices," according to an agency statement at the time. The FDA has been under criticism from members of Congress, who say the agency has approved unsafe drugs and hasn't done enough to protect people from tainted imports of food and drugs.<br /><br />"We are very concerned about the lack of any justifiable metrics for measuring contract success," Barton and Shimkus said in a letter to the FDA commissioner, Andrew von Eschenbach.<br /><br />Barton is the top Republican on the House Energy and Commerce Committee, which oversees the FDA, and Shimkus is the top Republican on the panel's investigative subcommittee.<br /><br />The FDA won't comment and will respond directly to the lawmakers, said Heidi Rebello, an agency spokeswoman, in an e-mail.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.pharmalot.com/2008/09/fda-touts-its-recruiting-drive-but-will-it-work/#comment-373516" target="_blank">Link</a>]<br /><br />FDA officials say about 1,000 of the new hires have already started, with another 158 due to report later this month. An additional 160 have accepted offers, and are going through background checks. Of those on the job already, more than 850 are professionals, including chemists, biologists, pharmacologists, statisticians, medical officers, microbiologists and field inspectors, the AP writes.<br /><br />Of the total 1,317 positions, 770 are new jobs and 547 are posts that were left vacant by people leaving the agency for other jobs or due to retirement, according to the AP.<br /><br />Within the FDA, the biggest number of jobs will go to the Center for Drug Evaluation and Research, with 663 new staffers. The smaller food safety program will get just 104, although that amounts to a 10 percent increase. The FDA's enforcement branch, which has lost many field inspectors in recent years, will get 245 new staffers, the AP reports.<br /><br />The FDA's budget is about $2.2 billion a year, with some $1.7 billion coming from taxpayers and the rest from industry user fees, the AP notes. About 40 percent of the total number of positions are being paid for with industry user fees, meaning that the new hires will mainly be evaluating new drugs or medical devices and, in some cases, monitoring safety issues.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/biederman-et-al-when-mainstream-presses.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-6060489936440612533?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/follow-up-fda-contract-to-improve.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-1072759134397577886Sat, 20 Dec 2008 23:47:00 +00002009-01-06T11:04:21.593-05:00On Sunday two doctors who treat children and a professor at George Washington University point out the significance of the crime against children being perpetrated by psychiatrists at prestigious institutions. Leading the pack is Harvard University's Joseph Biederman MD. Their conclusion: Never fully trust the biggest supermen in any scientific field. Or, putting it another way, "Trust but verify"-- Ronald Reagan's admonition. Never, never, simply trust "authorities" just because they're purported to be authorities by "peers" (i.e., people like themselves).<br /><br />Below, an article in Psychology Today, by pediatrician Lawrence Diller, MD, focuses on separate ongoing scandals involving two of America's top experts in children's mental health.<br /><br />The first scandal involves Joseph Biederman MD: "Some say Dr. Biederman, from his position at Harvard and supported by the drug industry, has been the most powerful child psychiatrist in the world over the last two decades. Depending on one's point of view his work is either revolutionary and pioneering or dangerous and unethical. Biederman has vigorously promoted the aggressive use of psychiatric drugs in children. He is arguably the person most responsible for the pediatric bipolar epidemic sweeping the U.S. and the concomitant use of anti-psychotic drugs (like Risperdal and Zyprexa) in children."<br /><br />The second scandal involves Melvin Levine MD, a Professor of Pediatrics at the University of North Carolina Medical School in Chapel Hill, North Carolina and so- founder of All Kinds of Minds, an institute founded to train teachers to help children with learning disabilities. He resigned from the latter after being charged in five lawsuits with sexual molestation of boys. <br /><br />"Biederman's growing conflict of interest problems highlight a systemic issue for American medical research and teaching. Thirty years ago the federal government essentially handed over to business the financing and support of medical school research and their faculties. Three decades later convincing evidence of drug and prosthesis manufacturers' influence on research threatens the very credibility and professionalism of doctors."<br /><br />Leonard Sax, MD, writes in the New York Daily News: "When I first began writing prescriptions for children 22 years ago, it was unusual for a child to be taking powerful psychiatric drugs. Today it's common. How did we get here?<br /><br />Dr. Joseph Biederman is part of the answer. He's an important guy. His title is "chief of pediatric psychopharmacology" at Massachusetts General Hospital, the main teaching hospital for Harvard Medical School. Pediatricians and family doctors look to him, and doctors like him, for guidance about what they should do with problem kids. For the past two decades, Biederman has pushed the use of medications for treating ADHD and bipolar disorder. Over the past two decades, the use of medications for treating those disorders has soared."<br />Dr. Sax' advice to parents: " what's the bottom line for parents? Buyer beware. If your doctor recommends a medication for your child, ask: What's known about the long-term risks of this medication? What's the source of that information?<br /><br />The traditional rule for good medical practice has been "First, do no harm." For parents, that translates: "When in doubt, say no." Don't let anyone push you into giving your child a drug whose long-term risks are uncertain."<br /><br />Margaret Soltan, Professor of literature, George Washington University makes some very prescient observations on her blog, University Diaries: [<a href="http://www.margaretsoltan.com/?p=6972" target="_blank">Link</a>] <br /><br />Only When The Mainstream Press like the Daily News, writes more pieces like this, will Americans begin to protect themselves against people like Joseph Biederman.<br /><br />Harvard won't help them. Harvard continues to employ Biederman. And ordinary people continue to assume that a person employed by Harvard is a legitimate physician and researcher.<br /><br />[As readers know, just as Harvard continues to shelter Biederman, George Washington University, where UD teaches, continues to shelter Goodwin.]<br /><br />We can't wait for universities to withdraw the respectability they give these people. It'd be like waiting for Yeshiva to have noticed all by itself that the head of its business school ran the biggest scam in American history. Only the press - and Charles Grassley - can expose these corrupt professors<br /><br />[One line of text deleted]<br /><br />And note that Sax pleads with Americans in the last paragraph: Please don't be gulled into ruining your kids by doctors with fancy university affiliations. He has to plead, because he knows how unfair the competition is. In fact he can plead all he likes, but until universities find the moral clarity to identify and remove cynical profiteers, ordinary people don't have a fighting chance.<br /><br />She's absolutely right. It's universities who harbor unscrupulous doctors whose aggressive promotion of toxic drugs for children harmed far more innocent children than any street pusher ever did. <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://blogs.psychologytoday.com/blog/the-last-normal-child/200812/fallen-heroes-childrens-mental-health-0" target="_blank">Link</a>]<strong>PSYCHOLOGY TODAY<br />Fallen Heroes of Children's Mental Health<br />By Lawrence Diller, M.D. <br />December 13, 2008</strong> <br /><br />About two weeks ago, new developments were reported nationally on separate ongoing scandals involving two of America's top experts in children's mental health -- making their situations appear worse. The impact is sure to cause untold damage to parents' belief in these doctors and the causes they espoused.<br /><br />I'm referring first, to the growing conflict of interest problems of Joseph Biederman, head of Harvard's Pediatric Psychopharmacology Clinic. More evidence has emerged detailing his relationship between his purported research and psychiatric drug promotion with money coming from pharmaceutical companies. The second story is less prominent, but no less upsetting to both doctors and families with children. Melvin Levine, America's preeminent child developmentalist, resigned from the organization he founded, All Minds at a Time, while under a cloud of suspicion for child sexual abuse.<br /><br />These two individuals have been so important in their respective fields that it's hard to imagine an area of children's mental health and development that won't be affected by the loss of credibility engendered by these doctors' current travails. Without a judgment of innocence or guilt, the mere facts, already reported, potentially diminish the long-term contributions both men have made in their fields.<br /><br />Biederman's work is the more controversial of the two. Some say Dr. Biederman, from his position at Harvard and supported by the drug industry, has been the most powerful child psychiatrist in the world over the last two decades. Depending on one's point of view his work is either revolutionary and pioneering or dangerous and unethical. Biederman has vigorously promoted the aggressive use of psychiatric drugs in children. He is arguably the person most responsible for the pediatric bipolar epidemic sweeping the U.S. and the concomitant use of anti-psychotic drugs (like Risperdal and Zyprexa) in children.<br /><br />Biederman's growing conflict of interest problems highlight a systemic issue for American medical research and teaching. Thirty years ago the federal government essentially handed over to business the financing and support of medical school research and their faculties. Three decades later convincing evidence of drug and prosthesis manufacturers' influence on research threatens the very credibility and professionalism of doctors.<br /><br />Biederman's star began to fall this past June when he became the first of a series of physicians "outed" by Senator Charles Grassley's physician-conflict of interest campaign for having accepted $1.6 million of unreported income from drugs companies. Biederman's defense at the time was that his interests were "solely in the advancement of medical treatment through rigorous and objective study."<br /><br />New court related emails reveal his efforts to obtain funds from the drug giant, Johnson and Johnson, to develop a pediatric drug research center at the Massachusetts General Hospital that included the goal "to move forward the commercial goals of J&J." The overt contradictions and blatant hypocrisy seem certain on the short term to further erode Biederman's credibility as an unbiased researcher. Longer-term consequences may result in disciplinary actions from Harvard University and legal problems over income and taxes with the Federal government.<br /><br />Levine's influence has been pivotal in international views on children's learning problems. Previously children were viewed as slow, lazy or both. Levine's ideas were seminal in the development of tailoring teaching to different learning styles. He's been the guru to special education teachers and pediatric developmentalists, not to mention, the parents of affected children.<br /><br />His problems, first revealed last April, involve allegations of child sexual abuse two or three decades old. Unlike the Biederman case, there are no smoking guns yet. Five adults are suing him in civil court. Their lawyer says fifty more adults-abused-as-children or their parents are ready to come forward. But it's already a tragedy. If it's true, doctors like me in the field will feel betrayed. It's the professional equivalent to the shock and despair that Catholic parishioners must feel in learning of the multiple cases of abuse by priests revealed over the past decade.<br /><br />The challenge for physicians and parents alike will be to appropriately "not throw out the baby with all the bath water." The medical profession is belatedly beginning a process of reform. There are new rules for submitting articles to professional journals. Senator Grassley has proposed a Physicians Sunshine Act that will require doctors to report payments of more than $500 from drug companies. However, much more regulation is necessary if corporate money continues to be the main source of medical research funding.<br /><br />Both Biederman and Levine have made valuable contributions to the field of pediatric mental health and development. But our trust in these two physicians has been broken. That is the saddest part, but also a continuing lesson. Never fully trust the biggest supermen in any scientific field. At some point they may be revealed to have some very human frailties and problems.<br /><br />Dr. Diller is the author of The Last Normal Child See his biography at: [<a href="http://blogs.psychologytoday.com/authors/lawrence-diller-md" target="_blank">Link</a>]</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.nydailynews.com/opinions/2008/12/14/2008-12-14_child_psychiatry_is_sick_with_hidden_con.html" target="_blank">Link</a>]<strong>THE NY DAILY NEWS <br />Child psychiatry is sick with hidden conflicts of interest<br />By Dr. Leonard Sax<br />Sunday, December 14th 2008</strong><br /><br />When I first began writing prescriptions for children 22 years ago, it was unusual for a child to be taking powerful psychiatric drugs. Today it's common. How did we get here?<br /><br />Dr. Joseph Biederman is part of the answer. He's an important guy. His title is "chief of pediatric psychopharmacology" at Massachusetts General Hospital, the main teaching hospital for Harvard Medical School. Pediatricians and family doctors look to him, and doctors like him, for guidance about what they should do with problem kids. For the past two decades, Biederman has pushed the use of medications for treating ADHD and bipolar disorder. Over the past two decades, the use of medications for treating those disorders has soared.<br /><br />Sen. Charles Grassley (R-Iowa), recognizing how much influence Biederman has in promoting these medications for children, wondered whether the doctor might be taking money from drug companies. When first asked, Biederman admitted to taking perhaps "a couple hundred thousand dollars" from pharmaceutical companies. When he was asked to take another look, it turned out that Biederman and a colleague had accepted more than $1.6 million from the drug companies. And they hadn't told anybody.<br /><br />Or consider the case of Dr. Fred Goodwin. After stepping down as director of the National Institute for Mental Health, Goodwin moved on to serve as the host of the NPR program "The Infinite Mind." Goodwin didn't think he needed to tell anybody that the drug companies were paying him $1.3 million, even as he reassured listeners on his program about the safety of powerful psychiatric medications for children. Last month, after his connections to the drug industry came to light, NPR canceled his program.<br /><br />Or consider Dr. Charles Nemeroff, who was until just a few weeks ago chairman of the psychiatry department at Emory University. Between 2000 and 2007, Nemeroff pocketed $2.8 million in payoffs from drug companies. He never told anybody about it until a Senate investigation brought the payments to light.<br /><br />Are the medications recommended by these opinion leaders risky for children? We don't know for sure. Researchers at Harvard have reported that giving medications such as Ritalin and Concerta to young laboratory animals results in those animals displaying a loss of drive when they grow up. There could be a similar phenomenon in our children.<br /><br />I've seen many young men in my own practice who took these medications as children or teenagers and are now content, as twenty somethings, to live in their parents' homes, work a few hours a week at the coffee shop, and spend most of their free time playing video games.<br /><br />So the verdict is out. Maybe the drugs are harmful to children. Maybe they aren't. Would you like to volunteer your child for the experiment?<br /><br />The Cleveland Clinic may be on the right track toward fixing this problem. The clinic has just begun exposing ties to the drug industry for every one of their doctors. Any doctor who accepts more than $5,000 per year from the drug industry, or any industry, must acknowledge that fact online. The site doesn't provide the juicy details about exactly how much money each doctor gets, just that it's more than $5,000.<br /><br />I'd like to see every other health care facility follow that example - or go further and disclose the actual dollar amount received above $5,000. Or above $500, for that matter.<br /><br />Until that happens, what's the bottom line for parents? Buyer beware. If your doctor recommends a medication for your child, ask: What's known about the long-term risks of this medication? What's the source of that information?<br /><br />The traditional rule for good medical practice has been "First, do no harm." For parents, that translates: "When in doubt, say no." Don't let anyone push you into giving your child a drug whose long-term risks are uncertain.<br /><br />Sax is the author of "Boys Adrift: The Five Factors Driving the Growing Epidemic of Unmotivated Boys and Underachieving Young Men."</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/congress-to-investigate-fda-15-million.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://scientific-misconduct.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-1072759134397577886?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/biederman-et-al-when-mainstream-presses.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-4089039706364620511Sat, 20 Dec 2008 21:46:00 +00002008-12-20T16:47:15.023-05:00FDA's response to severe criticism from members of Congress for its poor performance--as demonstrated by its approval of unsafe drugs that killed, and its failure to protect people from tainted imports of food and drugs--was to hire a firm "to improve morale at the agency's drug division" for a cost of $1.5 million.<br /><br />Demonstrating how far removed FDA administrators are from applying even rudimentary scientifically valid, measurable standards to justify their decisions, Bloomberg News reports (below) that Republican Congressmen, Joe Barton of Texas and John Shimkus of Illinois expressed concern in a letter to FDA Commissioner, Andrew von Eschenbach: "We are very concerned about the lack of any justifiable metrics for measuring contract success."<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.bloomberg.com/apps/news?pid=20601124&sid=aOa2vsfzmbVA&refer=home#" target="_blank">Link</a>]<strong>FDA's $1.5 Million Morale Contract Draws U.S. Lawmaker Scrutiny<br />By Justin Blum</strong><br /><br />Dec. 12 (Bloomberg) -- A $1.5 million contract between the U.S. Food and Drug Administration and a California firm to improve morale at the agency's drug division faces scrutiny from lawmakers who questioned whether the company's plan will work.<br /><br />The FDA awarded the two-year contract to the Center for Professional Development in Oakland, according to a statement today from Republican Representatives Joe Barton of Texas and John Shimkus of Illinois.<br /><br />One of the consultants for the center "works with the metaphor of colour, symbol, dance and story to help people give meaning to their lives and work," the lawmakers said, quoting from the group's Web site.<br /><br />The FDA announced the contract in October 2007 "to improve workplace leadership, empower staff and establish more effective business practices," according to an agency statement at the time. The FDA has been under criticism from members of Congress, who say the agency has approved unsafe drugs and hasn't done enough to protect people from tainted imports of food and drugs.<br /><br />"We are very concerned about the lack of any justifiable metrics for measuring contract success," Barton and Shimkus said in a letter to the FDA commissioner, Andrew von Eschenbach.<br /><br />Barton is the top Republican on the House Energy and Commerce Committee, which oversees the FDA, and Shimkus is the top Republican on the panel's investigative subcommittee.<br /><br />The FDA won't comment and will respond directly to the lawmakers, said Heidi Rebello, an agency spokeswoman, in an e-mail.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/wyeth-paid-ghostwriters-to-produce.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-4089039706364620511?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/congress-to-investigate-fda-15-million.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-540660602816838154Sat, 20 Dec 2008 19:27:00 +00002008-12-20T14:29:03.214-05:00Two reports about fraud will, no doubt, heighten public distrust about the integrity of America's financial market and medical research reports which are under the control of the pharmaceutical industry. One report, by award winning journalist, Duff Wilson, (Seattle Times now with the New York Times), involves medico-scientific fraud by Wyeth Pharmaceuticals and DesignWrite, a medical writing firm, whose ghostwritten journal articles--all signed by prominent gynecologists--were designed to deceive doctors about the safety of Prempro, a hormone replacement therapy for menopausal women that was found to increase the risk of breast cancer. The other news report in The Wall Street Journal, involves investor fraud by the former chairman of NASDAQ stock market.<br /><br />Both cases are staggering in their magnitude: <br /><br />Documents released on Friday by Sen. Charles Grassley provide a detailed look at the practice that has polluted the medical literature and made a mockery of science-based medicine. From the conception of ideas for journal articles through the distribution of reprints, the ghostwritten articles all involve reviews of clinical studies and other research. While such reviews are common in medical publishing, what Mr. Grassley contends happened with the Wyeth-commissioned articles is that that expert authors whose names appear on the articles became involved only after outlines or drafts of the articles were already written.<br /><br />One of the ghostwritten articles was published as an "Editors' Choice" feature in May 2003 in The American Journal of Obstetrics and Gynecology, more than a year after a big federal study called the Women's Health Initiative linked Wyeth's Prempro, a combination of estrogen and progestin, to breast cancer. The May 2003 article said there was "no definitive evidence" that progestins cause breast cancer and added that hormone users had a better chance of surviving cancer.<br /><br />The WSJ reports that Bernard L. Madoff, a former chairman of the Nasdaq Stock Market and a force in Wall Street trading for nearly 50 years, was arrested by federal agents Thursday, for running (by his own admission) "a giant Ponzi scheme" to the tune of $50 billion. [<a href="http://online.wsj.com/article/SB122910977401502369.html" target="_blank">Link</a>] <br /><br />These examples underscore the folly of leaving oversight responsibilities to the stakeholders in enterprises that affect public health and public wealth. The consequences of the outgoing Administration's disastrous policy of loosening government regulatory oversight over the financial market and the prescription drug industry, are simply staggering in their magnitude. The American taxpayer has been defrauded on a colossal scale--we have every reason to distrust the "authorities" entrusted with keeping publicly traded and taxpayer financed businesses honest. <br /><br />Bernard Madoff will likely go to prison. No pharmaceutical company executive has yet been held accountable for criminal conduct.<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.nytimes.com/2008/12/12/business/13wyeth.html?emc=eta1&pagewanted=print" target="_blank">Link</a>]<strong>THE NEW YORK TIMES<br />December 12, 2008<br />Drug Maker Said to Pay Ghostwriters for Journal Articles<br />By DUFF WILSON</strong><br /><br />Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company's involvement in medical ghostwriting. At least one article was published even after a federal study found the drug raised the risk of breast cancer.<br /><br />The letters, sent electronically Friday by Senator Charles E. Grassley, ask Wyeth and DesignWrite, a medical writing firm, to disclose payments related to the preparation of journal articles and the activities of doctors who were recruited to put their names on them for publication.<br /><br />The letters are part of a continuing investigation by Mr. Grassley, a member of the Senate Finance Committee, into drug industry influence on doctors. "Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling," Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth's chairman and chief executive, Bernard J. Poussot.<br /><br />Phone calls and e-mail messages to Wyeth and DesignWrite were not immediately returned.<br /><br />Mr. Grassley's staff on the Senate Finance Committee released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.<br /><br />One article was published as an "Editors' Choice" feature in May 2003 in The American Journal of Obstetrics and Gynecology, more than a year after a big federal study called the Women's Health Initiative linked Wyeth's Prempro, a combination of estrogen and progestin, to breast cancer. The May 2003 article said there was "no definitive evidence" that progestins cause breast cancer and added that hormone users had a better chance of surviving cancer.<br /><br />At the peak of hormone therapy, in 2001, more than 126 million prescriptions for such drugs were written for women in the United States. Sales that year, primarily by Wyeth, were $3 billion. But after the federal finding, sales of the hormone drugs plummeted. The drugs, which contain cancer warnings on the label, are still legal to treat severe symptoms of menopause, but their use is advised at only the lowest possible doses.<br /><br />The documents show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles - all without disclosing the companies' roles to journal editors or readers.<br /><br />The issue of ghostwriting for medical journals has been raised in the past, involving various companies and drugs, including the Merck painkiller Vioxx, which was withdrawn in 2004 after it was linked to heart problems, and Wyeth's diet pills, Redux and Pomdimin, withdrawn in 1997 after being linked to heart and lung problems.<br /><br />But the documents Mr. Grassley released Friday provide a detailed look at the practice - from the conception of ideas for journal articles through the distribution of reprints. The articles all involve reviews of clinical studies and other research. While such reviews are common in medical publishing, what Mr. Grassley contends happened with the Wyeth-commissioned articles is that that expert authors whose names appear on the articles became involved only after outlines or drafts of the articles were already written.<br /><br />When accusations of ghostwriting have cropped up in patient lawsuits over its hormone drugs, Wyeth executives to date have insisted that their publication practices were legitimate and that the listed authors played significant roles in journal articles.<br /><br />But the documents released Friday include a "publication plan tracking report" by Wyeth showing 10 articles in which manuscripts were completed by the company before they were sent to the putative author for review. Any revisions were subject to final approval from the company, according to the tracking report.<br /><br />Such activities would seem to run afoul of medical journal guidelines. The International Committee of Medical Journal Editors says authorship means "substantive intellectual contributions" including conception or analysis of the subject and drafting or critical revision of the document. The World Association of Medical Editors says ghost authorship - which it defines as a substantial contribution not mentioned in the manuscript - is "dishonest and unacceptable."<br /><br />Congressional investigators were given the documents about a month ago by James F. Szaller, a personal injury lawyer in Cleveland who has sued drug makers. Mr. Szaller collected the documents from court filings and made reference to some in an article he wrote last year for a law magazine, Trial. "For the last three years, I've looked at ghostwriting at Wyeth," Mr. Szaller said in a telephone interview. "There is a mammoth amount of material. The problem is that almost all of it is still under seal."<br /><br />In Friday's letter, Mr. Grassley asked Wyeth to list all scientific reports prepared for the company by DesignWrite since Jan. 1, 1995, to describe the named authors' "extent of involvement" and to disclose fees paid to DesignWrite, authors and others. He also requested "all internal and external correspondence, communications and meeting minutes regarding each of the DesignWrite-prepared studies."<br /><br />The letter to DesignWrite requested all manuscripts prepared for Wyeth since 1995, along with information on related payments and a description of the author's involvement.<br /><br />The May 2003 article supporting Prempro was signed by Dr. John Eden, an associate professor at the University of New South Wales and director of the Sydney Menopause Center in Australia. Wyeth executives suggested that Dr. Eden write such a paper in 2000, according to the documents, and had the outline and draft manuscript written for him. The Archives of Internal Medicine rejected the paper before it was published in The American Journal of Obstetrics and Gynecology - with no mention of Wyeth or DesignWrite connections. Dr. Eden did not respond to an e-mail request for comment.<br /><br />In another case, documents show, Dr. Lila E. Nachtigall, a New York University professor and director of its Women's Wellness Center, was recruited by Wyeth as author of a 1999 journal article extolling hormone treatment after the manuscript had already been drafted.<br /><br />Dr. Nachtigall, reached by telephone Friday afternoon, said she had written all of the approximately 1,000 articles and three books she has had published. Asked about the Wyeth documents, she said, "If they came up with the idea or gave me an outline or something, I don't remember that at all." Dr. Nachtigall, who is still practicing at age 75, added: "It kind of makes me laugh that with what goes on in the Senate, the senator's worried that something's ghostwritten. I mean, give me a break."<br /><br />Two months before the negative findings of the federal study were released, a May 2002 memo to DesignWrite employees said that Michael S. Dey, who was president of Wyeth's Women's Healthcare Business unit, asked a committee to increase the number of positive journal articles related to another of its hormone replacement drugs, Premarin. "Mike would like us to publish at least 1 study per month," the memo said.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/fda-panel-votes-to-ban-2-of-4-asthma.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-540660602816838154?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/wyeth-paid-ghostwriters-to-produce.htmlnoreply@blogger.com (Vera Hassner Sharav)1tag:blogger.com,1999:blog-35205931.post-4534996986811680877Sat, 20 Dec 2008 13:25:00 +00002008-12-20T08:27:09.369-05:00Trust in medicine?<br /><br />The New York Times reports (below) that an FDA advisory panel voted to ban two of the four asthma drugs that FDA drug safety officers had warned, put asthmatic patients at risk of sudden deaths. [<a href="http://www.ahrp.blogspot.com/http://www.nytimes.com/2008/12/06/health/policy/06allergy.html" target="_blank">Link</a>]<br /><br />The Wall Street Journal reports that "the panel stopped short of recommending the drugs not be used at all..." [<a href="http://blogs.wsj.com/health/2008/12/12/why-an-fda-panel-saw-asthma-drugs-differently" target="_blank">Link</a>] <br /><br />Which is it?<br /><br />The panel voted to continue marketing Advair, (GlaxoSmithKline) and Symbicort (AstraZeneca) for asthma, but not Serevent (Glaxo) and Foradil (Novartis). The panel's recommendations came after several top F.D.A. drug safety experts had recommended earlier this month that all four asthma drugs should be banned from treating asthmatic children and adults because they were linked to sudden deaths.<br /><br />Dr. Jesse Joad, a panel member and pediatrician from the University of California Davis Medical Center, said she did not "want to give a drug that is making the disease you're treating worse."<br /><br />Dr. Fernando Martinez, director of the Arizona Respiratory Center at the University of Arizona, said far too many patients whose conditions could be treated adequately with steroids alone were instead receiving Advair or Symbicort, which are riskier and more expensive. Dr. Martinez blamed heavy marketing by Glaxo of Advair instead of Flovent, which contains only a steroid. "In the last two years," he said, "I haven't seen a single ad for Flovent, but I have seen many for Advair."<br /><br />However, FDA decisions are far more influenced by the business interests of prescription drug manufacturers--whom agency officials regard as their clients--than they are by drug safety considerations affecting American citizens.<br /><br />The financial stakes are high: Through the first nine months of this year, Advair's sales were $5.66 billion, and Symbicort's were $209 million. Last year, Serevent's sales were $538 million and Foradil's were $362 million. <br /><br />Even if the agency follows the panel's advice, all four drugs will remain on the market since Serevent and Foradil are also approved to treat chronic obstructive pulmonary disorders like emphysema. So, doctors can prescribe them off-label for just about anything.<br /><br />Trust in industry-funded medical associations?<br /><br />True to form, the following professional medical associations appeared to protect their financial interests by expressing support for the continued use of all four of these medicines despite the avoidable risks of death: The American Academy of Pediatrics, American Thoracic Society, American Academy of Allergy Asthma and Immunology, and American College of Allergy Asthma and Immunology.<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.nytimes.com/2008/12/12/health/policy/12fda.html" target="_blank">Link</a>]<strong>THE NEW YORK TIMES<br />December 12, 2008<br />F.D.A. Panel Votes to Ban Asthma Drugs<br />By GARDINER HARRIS</strong><br /><br />ROCKVILLE, Md. - A panel of federal drug experts voted on Thursday that the drugs Serevent and Foradil should be banned from use in the treatment of asthma, but the experts said that Advair and Symbicort, which together are far more popular, should continue to be used.<br /><br />The experts, gathered by the Food and Drug Administration, said that too many doctors used Serevent and Foradil inappropriately and that asthmatic patients were often fooled by their own symptoms and used them incorrectly. Serevent and Foradil widen lung airways but increase the risks of death unless paired with a steroid. The drugs' labels already warn of this risk but half of patients taking the medicines do not get a steroid. Even when patients are prescribed a steroid, many fail to take it.<br /><br />GlaxoSmithKline, the maker of Serevent, and Novartis and Schering-Plough, the marketers of Foradil, argued that doctors want the freedom to mix and match these drugs with steroids. But Dr. Jesse Joad, a panel member and pediatrician from the University of California Davis Medical Center, said she did not "want to give a drug that is making the disease you're treating worse."<br /><br />Dr. John Jenkins, a top F.D.A. official, cautioned that patients should consult their doctor before stopping any asthma drug regimen. And Dr. Jenkins said the agency would consider requiring drugmakers to undertake large studies to assess the safety of Advair and Symbicort, particularly in children.<br /><br />The drugs' makers rejected the committee's decision to ban Serevent's and Foradil's use in asthma, although each said that it would cooperate with the agency.<br /><br />Last year, Serevent's sales were $538 million and Foradil's were $362 million. Through the first nine months of this year, Advair's sales were $5.66 billion, and Symbicort's were $209 million.<br /><br />Serevent and Foradil are also approved to treat chronic obstructive pulmonary disorders like emphysema. So even if the agency follows the panel's advice, the drugs will remain on the market.<br /><br />Asthma is caused when airways in the lungs spasm and swell, restricting the supply of oxygen. The two primary treatments are steroids, which reduce swelling, and beta agonists, which treat spasms. Rescue inhalers usually contain albuterol, a short-acting beta agonist.<br /><br />Serevent and Foradil are longer-acting beta agonists intended to prevent attacks. Used without a steroid, however, these drugs have been shown to increase the risks of more severe attacks. Advair and Symbicort combine longer-acting beta agonists with steroids in a single inhaler.<br /><br />The expert panel voted unanimously to ban the use of Serevent and Foradil in children, but for adults, it voted 17 to 10 to ban Serevent and 18 to 9 to ban Foradil. It voted unanimously that Advair should continue to be used in asthmatic adults and supported its use in adolescents by 23 to 3 and in children by 13 to 11. Symbicort's use in adults was supported unanimously, while its use in adolescents was supported 20 to 5. Symbicort is not approved for use in children.<br /><br />Earlier, some top F.D.A. safety experts recommended that all four drugs should be banned from treating asthma, while other agency experts said the drugs' benefits outweighed their risks.<br /><br />Like other drug-safety controversies, the debate largely pits those who treat patients against those who study populations. Since the drugs may lead to one death in somewhere from 700 to 4,000 patients, few doctors have seen drug-related deaths, so most focus on their benefits, which allow many of their patients to play sports, go to work or lead normal lives.<br /><br />Among the drugs' supporters was Anne Dorsey of Baltimore, who described when her 13-year-old son, Julian, nearly died from an asthma attack. Julian spends much of his life in the hospital and is now taking Advair.<br /><br />"I have to ask you not to let him perish" by banning the drugs, Ms. Dorsey said.<br /><br />Then Julian stepped to the microphone and in a reedy voice said that Advair had cut the time spent in the hospital in half. "Life got a lot easier," he said, "and without Advair, I don't know what I'd do."<br /><br />The American Academy of Pediatrics, American Thoracic Society, American Academy of Allergy Asthma and Immunology, and American College of Allergy Asthma and Immunology all support the continued use of the medicines.<br /><br />Some experts say that although long-acting beta agonists may make patients feel better, they have few concrete benefits that justify risking death.<br /><br />Dr. Sean P. Hennessy, a panel member from the University of Pennsylvania, called for Glaxo to start a large safety study of Advair. "Given the problems and the nearly $8 billion in revenue earned from Advair," Dr. Hennessy, "this seems imminently plausible."<br /><br />Dr. Fernando Martinez, director of the Arizona Respiratory Center at the University of Arizona, said far too many patients whose conditions could be treated adequately with steroids alone were instead receiving Advair or Symbicort, which are riskier and more expensive. Dr. Martinez blamed heavy marketing by Glaxo of Advair instead of Flovent, which contains only a steroid. "In the last two years," he said, "I haven't seen a single ad for Flovent, but I have seen many for Advair."<br /><br />Stan Hull, a Glaxo senior vice president, said, "That's absolutely not true."<br /><br />"The reason physicians use Advair over Flovent," he said, "is that Advair has been shown to be superior to Flovent in providing control over asthma."<br /><br />Doctors face difficult choices with children whose asthma remains uncontrolled with low-dose steroid treatment. If they increase the steroid dose, the risks include stunted growth, acne, greater vulnerability to infections and changes to skin, eyes and bone. If they add a long-acting beta agonist, the risk of death, although small, increases.<br /><br />The beta agonists, by relaxing bronchial spasms, treat mild symptoms and make patients feel better immediately. Feeling better, these patients may decide against taking the steroids since steroids have few immediate benefits. Indeed, patients prescribed both drugs separately get fewer refills of the steroid than of the beta agonists. Such patients leave themselves vulnerable to severe attacks and death.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>THURSDAY, Dec. 11 (HealthDay News) - The safety of four asthma medications will be weighed by a U.S. Food and Drug Administration expert panel as two days of hearings end Thursday.</strong><br /><br />The controversy over these drugs has been going on for several years, with two FDA officials recently calling for banning the use of these drugs for anyone under 17.<br /><br />One expert thinks the problem is not with the drugs, but with their misuse.<br /><br />"This is an over-interpretation of the risk without adequate consideration of benefit," said Dr. Miles Weinberger, a professor of pediatrics at the University of Iowa. "However, there has been irresponsible marketing of the products, salmeterol and formoterol, and irresponsible prescribing by many physicians."<br /><br />"Since most patients with chronic asthma can be controlled with inhaled steroids alone, using these more expensive combination formulations as first line is inappropriate but strongly encouraged by marketing practices" of drug makers, Weinberger said.<br /><br />The products under review are Advair (salmeterol, fluticasone), Foradil (formoterol), Serevent (salmeterol), and Symbicort (formoterol, budesonide). Advair and Symbicort are combination products containing both a long-acting beta agonist and an inhaled corticosteroid. These drugs relax airway muscles, letting asthma patients breathe more easily.<br /><br />In the panel's first day of hearings Wednesday, FDA officials themselves were split over the risks of the drugs.<br /><br />One official told the panel members that more than 14,000 people may have died since 1994 after taking the drugs, while another suggested that an even greater number might have died without them, according to The New York Times.<br /><br />Last week, two FDA officials, who work in the agency's safety division, posted an assessment on the agency Web site, saying asthma sufferers of all ages should not take the medicines. But a third FDA official concluded that Advair and Symbicort are safe for adults, but that all four drugs should no longer be used by children 17 and younger, the Times said.<br /><br />The panel is reviewing an FDA study of 110 trials that included 60,954 people and found an increase in asthma-related hospitalization, asthma-related intubation, and asthma-related death in asthmatic patients with the use of these drugs. The risk varied, however, depending on the particular drug studied.<br /><br />For example, there were 20 asthma-related deaths, 16 among people taking long-acting beta agonists compared with four patients not taking these drugs. All the deaths were in patients taking Serevent, the FDA notes.<br /><br />The increased risk was seen in three of the four drugs, Foradil, Serevent and Symbicort, but was not seen with Advair. The increased risk wasn't seen when a long-acting beta agonist was used along with an inhaled corticosteroid, the agency found.<br /><br />The greatest risk appears to be among children aged 4 to 11; women also appeared to be at greater risk than men.<br /><br />Weinberger thinks that long-acting beta agonists should be used only in combination with inhaled steroids.<br /><br />"All trials of the combination of long-acting beta agonists and an inhaled steroid demonstrate substantial additive effect for patients not fully controlled on the inhaled steroid alone," Weinberger said. "The sensible approach is to use the combination products only after inadequate control is observed with an inhaled steroid alone."<br /><br />The drug manufacturers believe there is adequate evidence that their products are safe and effective when used properly.<br /><br />"AstraZeneca believes that Symbicort exhibits a favorable benefit-risk profile in patients 6 years of age and older. Symbicort offers an important therapeutic option for asthma patients who cannot be adequately controlled on other asthma controller medications [low- to medium-dose inhaled corticosteroids] or whose disease severity clearly warrants initiation of treatment with two maintenance therapies," the company said in a statement filed with the FDA.<br /><br />GlaxoSmithKline said in its statement: "The combination of salmeterol with an inhaled corticosteroid provides unsurpassed asthma control to patients by improving lung function, preventing daytime and night-time symptoms and decreasing the use of rescue medications. For Advair, there was no evidence of increased risk for asthma-related death, asthma-related hospitalization, asthma-related intubation and all-cause death in any database. Therefore, no regulatory action is necessary for this product."<br /><br />A third company, Novartis, noted that "given the benefits associated with long-acting beta 2-agonist use in asthma, Novartis believes that the benefit-risk ratio is in favor of formoterol use as currently reflected in labeling and treatment guidelines. Long-acting beta 2-agonists, including formoterol, remain an important therapeutic option in the treatment of patients with asthma."<br /><br />In 2007, an FDA advisory panel urged that stronger label warnings focused on children be added to the packaging for Serevent and Advair.<br /><br />In 2006, after a 2005 panel investigation focused mainly on the drugs' use by adults, the FDA ordered a strong "black box" warning on both medications that they "may increase the risk of asthma-related death."</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://blogs.wsj.com/health/2008/12/12/why-an-fda-panel-saw-asthma-drugs-differently" target="_blank">Link</a>]<strong>THE WALL STREET JOURNAL December 12, 2008, 8:49 am Why an FDA Panel Saw Asthma Drugs Differently Posted by Sarah Rubenstein</strong><br /><br />An FDA advisory panel said yesterday that two drugs, Serevent and Foradil, shouldn't be used for asthma any more, and two others, Advair and Symbicort, should. So what's the difference between these drugs?<br /><br />This morning's New York Times gives quick overview of asthma by way of explanation. Asthma strikes when airways in the lungs spasm and swell, restricting the supply of oxygen. Steroid treatments reduce swelling, and beta agonists treat spasms.<br /><br />Serevent, from GlaxoSmithKline, and Foradil, from Schering-Plough and Novartis, are longer-acting beta agonists that are supposed to be used with steroids. If they're not, they can increase the risk for even worse asthma attacks. The FDA panel worried that a lot of people don't take the steroid as they should.<br /><br />Advair, also from Glaxo, and Symbicort, from AstraZeneca, combine longer-acting beta agonists and steroids. So while some doctors still had concerns about the beta agonist ingredient, the panel gave the combination drugs the nod.<br /><br />Both Glaxo and Schering-Plough rejected the committee's recommendation about Serevent and Foradil, but said they'd cooperate with the FDA, according to NYT. The FDA isn't required to follow expert panels' advice but normally does.<br /><br />Glaxo told Bloomberg it is "confident that our proposed new labeling, medication guide and risk-management plan would help physicians safely manage the appropriate use of Serevent," and that cutting the drug's asthma approval would "deny patients needed treatment for optimal care." Here are statements from AstraZeneca and Glaxo.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>THE WALL STREET JOURNAL DECEMBER 11, 2008 FDA Panel Says Some Asthma Drugs Too Risky By JENNIFER CORBETT DOOREN</strong><br /><br />WASHINGTON--A U.S. Food and Drug Administration panel said the risks of two asthma drugs outweighed the benefits of their usage by children and adults.<br /><br />The panel said the risks of GlaxoSmithKline PLC's asthma drug Serevent as well as Novartis AG's and Schering-Plough Corp.'s Foradil were greater than the benefits of the drugs as maintenance treatments. However, the panel stopped short of recommending the drugs not be used at all. Many panel members said the drugs' labels should be reworded to tell doctors to use Serevent and Foradil with an inhaled corticosteroid, as current treatment guidelines recommend.<br /><br />Another Glaxo drug, Advair, uses the active ingredient in Serevent along with an inhaled corticosteroid, and has largely replaced use of Serevent. AstraZeneca's Symbicort also includes a corticosteroid.<br /><br />The panel voted 10 to 17 on a question that asked if the benefits of Serevent outweigh the risks as a maintenance treatment in adult asthma patients, and six to 21 for adolescents ages 12 to 17. Panel votes on Foradil were 9 to 18 for adults, 6 to 21 for adolescents. The panel unanimously said the benefits didn't outweigh the risks for Serevent and Foradil in children ages 11 and younger.<br /><br />For Advair, the panel unanimously backed its use in adults, but more narrowly recommended it for children. The panel voted 23-3, with one member abstaining, for Advair's use in adolescents ages 12 to 17, and voted 13-11 for its use in children ages 4 to 11, with three members abstaining.<br /><br />The FDA has asked the panel of outside medical experts for advice on whether to allow certain drugs to continue to be marketed for the treatment of asthma in children and adults amid lingering concerns that the products increase the risk of asthma-related side effects.<br /><br />The drugs, known as long-acting beta-agonists, or LABAs, are used by about six million asthma patients whose symptoms aren't well-controlled by other drugs including inhaled corticosteroids, which are the backbone of asthma treatment, and are designed to reduce airway inflammation.<br /><br />Long-acting drugs have been the subject of a continuing FDA safety review for several years and the drugs' labels already warn they could "increase the risk of asthma-related death." The drugs are designed to prevent the tightening of muscles around the airway. About 22 million Americans, including about 6.5 million children, have asthma, a chronic condition marked by narrowing of the airways.<br /><br />The FDA's drug-safety division is recommending that the drugs not be marketed for children, and in some cases adults, while the agency's pulmonary division stated that removing the products from the market would be "extreme."<br /><br />Both the FDA and the companies presented data to the panel. The FDA's analysis of the four drugs said, as a group, that the products are linked with an increased risk of asthma-related side effects, with higher risks seen in children. It looked at whether the drugs increased a combined measure of asthma-related death, hospitalization and asthma-related intubations, or the placement of a tube in patients' noses or mouths to help them breathe. Overall, it found an additional 2.8 asthma events per 1,000 patients treated with a LABA compared with patients not receiving the drugs.<br /><br />When looking at specific drugs, the FDA said the risk was seen with Foradil, Serevent and Symbicort "but was not apparent in Advair," which is Glaxo's top-selling drug as well as the dominant drug in the class. The agency also said the increased risk was far less when using inhaled corticosteroids, which current asthma-treatment guidelines recommend.<br /><br />WASHINGTON--A U.S. Food and Drug Administration panel unanimously backed the use of GlaxoSmithKline PLC's asthma drug Advair in adults.<br /><br />The panel voted 27-0 in the affirmative to the question that asked if the benefits of the drug outweighed the risks. Advair is Glaxo's top-selling drug and had U.S. sales of $2.9 billion through the first nine months of the year. The panel voted 23-3, with one member abstaining, in saying the benefits outweighed the risks in adolescents ages 12 to 17.<br /><br />The panel more narrowly backed the use of Advair in children ages 4 to 11 with a vote of 13 to 11, with three members abstaining. Several panel members said they struggled with their decision because of a relative lack of clinical data in that age group.<br /><br />The panel is discussing the class of drugs into which Advair falls. The drugs, known as long-acting beta-agonists, or LABAs, are used by about six million asthma patients whose symptoms aren't well-controlled by other drugs, including inhaled corticosteroids, which are the backbone of asthma treatment and are designed to reduce airway inflammation. Advair contains both a long-acting ingredient and an inhaled corticosteroid.<br /><br />The FDA has asked the panel of outside medical experts for advice on whether to allow certain drugs to continue to be marketed for the treatment of asthma in children and adults amid lingering concerns that the products increase the risk of asthma-related side effects.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/dissenting-acnp-psychiatrist-re.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-4534996986811680877?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/fda-panel-votes-to-ban-2-of-4-asthma.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-8883733886191290316Fri, 19 Dec 2008 19:33:00 +00002008-12-19T14:34:42.181-05:00Our hats off to psychiatrist Douglas Bremner MD of Emory University: "We used to say that the struggles in academia were so great because the rewards were so small, but thanks to payola from Merck, Lilly, Pfizer, and friends, I guess we can't say that anymore!"<br /><br />Dr. Bremner reports from the Annual Meeting of the American College of Neuropsychopharmacology (to which he refers as the Amer. College of Narcissistic Psychiatrists). The ACNP, he writes, "continues to put its head in the sand and denies a relationship between antidepressants and suicidality"--much as it has done for years--despite the overwhelming evidence to the contrary.<br /><br />"But take a look at the people on the committee ruling on suicidality and antidepressants and you see conflicts abound with members taking speaking and consulting fees from drug companies." <br /><br />His reference to the now discredited, pillar of American psychiatry, Frederick Goodwin, MD, former host of NPR's The Infinite Mind...is priceless: "It takes an infinite reach of the imagination to believe that antidepressants making you suicidal are no big deal..."<br /><br />The ACNP comprises psychiatry's most influential academic-based heavy hitters. Their inordinate influence has misled practicing clinicians about the dangers of psychotropic drugs such as the antidepressants and the antipsychotics. Budget allocations and Medicaid / Medicare reimbursement for psychiatry's questionable drug-centered prescription guidelines rested on the false assumption that these pillars of psychiatry were scientists and their recommendations, science-based. Nothing could be further from the truth. Dr. Bremner describes ACNP members' sleazy unbecoming professional conduct and their defilement of science. <br /><br />Below, an equally devastating description of the unprofessional shenanigans by leading psychiatrists at the World Congress of Biological Psychiatry in Berlin (2002), was written by psychiatrist E. Fuller Torrey, The Going Rate on Shrinks, published by the American Prospect. It is worth revisiting--for its kinship to descriptions of the debauchery during the Last Days of the Roman Empire: [<a href="http://www.prospect.org/cs/articles?article=the_going_rate_on_shrinks" target="_blank">Link</a>]<br /><br />Dr. Bremner is the author of Before You Take that Pill: Why the Drug Industry May Be Bad for Your Health.<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.beforeyoutakethatpill.com/2008/12/acnp.html" target="_blank">Link</a>]<strong>Drug News and Health Blog<br />DECEMBER 8, 2008<br />A DISSENTING OPINION FROM THE ACNP ON ANTIDEPRESSANTS AND SUICIDALITY</strong><br /><br />This week I am in Scottsdale, Arizona, for the Annual Meeting of the American College of Narcissistic Psychiatrists (Oops! I mean Neuro-Psychopharmacology... or maybe it was Negotiators for Prostitution, since the word is that the original annual meeting was held in the 1960s and 1970s in San Juan, Puerto Rico, since the whores in San Juan were more affordable on the limited salaries of the academic psychiatrists, at least before they themselves became, well...)<br /><br />We've had some memorable moments at the annual meetings of the ACNP (of which I am a proud member, at least as of the time of the writing of this post). The narcissistic psychiatrists print out their research results on "posters" and pin them up on boards and then everyone walks around getting drunk while they pretend to read the posters while catching up on gossip. And oh, we have some great gossip to catch up on. Usually we are supposed to print the posters out from computers, but one year one of the narcissistic psychiatrists drew the title of his poster with a crayon. Although the posters are supposed to represent research, another year one of the narcissistic psychiatrists had a poster dedicated to the alleged corruption of another one of our august members. And then there are the numerous inquiries, investigations, accusations, and assorted phlegm sent to the group email list that livelies up our days. Such fun!<br /><br />We used to say that the struggles in academia were so great because the rewards were so small, but thanks to payola from Merck, Lilly, Pfizer, and friends, I guess we can't say that anymore! Cheerio!<br /><br />Anyhoo, to the point of this post, my dissenting opinion from the official position statement of the ACNP on suicidality and antidepressants. For years the ACNP has been solemnly convening a committee every year to comment on a possible association between suicidality and antidepressants. Even five years ago when I viewed their report (before the more recent uproar over the topic) I saw their list of studies showing that in almost every case the rates of suicidality were doubled. I therefore concluded that the conclusions of my august fellow members were, frankly... bullshit.<br /><br />Even now the ACNP continues to put its head in the sand and denies a relationship between antidepressants and suicidality. But take a look at the people on the committee ruling on suicidality and antidepressants and you see conflicts abound with members taking speaking and consulting fees from drug companies. And it takes an infinite reach of the imagination to believe that antidepressants making you suicidal are no big deal, as was recently argued by one of the committee members on his NPR show, since it hasn't been shown that they will make you SUCCESSFULLY kill yourself since suicide is rare and noone has ever shown that something will make you more likely to successfully kill yourself.<br /><br />Hey buddy, wanna buy some blue pills that are gonna make you think about killing yourself? Dont' worry, in the end you won't actually do it.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.prospect.org/print-friendly/print/V13/13/torrey-e.html" target="_blank">Link</a>]<strong>The American Prospect<br />Volume 13, Issue 13. July 15, 2002.<br />The Going Rate on Shrinks: Big Pharma and the Buying of Psychiatry<br />By E. Fuller Torrey</strong><br /><br />It was last summer in Berlin when I first encountered pharmaceutical funhouses. I was one of 4,000 attendees at the 7th World Congress of Biological Psychiatry. Until about a decade ago, pharmaceutical companies passed out pens or notepads with their companies' logos at such events, and most speakers presented data and opinions based upon their true scientific beliefs.<br /><br />That all changed when Big Pharma took over. At the congress, I counted 15 major displays on the way to the lunch area, including an artificial garden (Janssen-Cilag), a brook running over stones (Lundbeck), and a 40-foot rotating tower (Novartis). Almost all offered free food and drink, T-shirts, or other inducements designed to get psychiatrists to pause so that an army of smiling sales representatives could give their sales pitch.<br /><br />Eli Lilly's display included two large, walk-through tunnels set up like funhouses. One tunnel, labeled "Zyprexa," included a mirrored room with dozens of telephones dangling from the ceiling. Was Lilly trying to convince me that God was calling, telling me to prescribe Zyprexa? The sales representative said no, the phones were meant to illustrate the communication problems common in schizophrenia, which Lilly claims Zyprexa improves. The other funhouse, labeled "Prozac," featured a 10-foot mouselike creature sitting in front of a blank television screen. I asked whether Lilly was recommending Prozac for mice. The representatives said no, the creature was really a depressed man who needed Prozac.<br /><br />My favorite display, by the Dutch firm Organon, advertised Remeron, an antidepressant. It featured a small, multihued tent with purple doors and the painted head of a genie. Inside, a red-robed young woman with sprinkles in her hair was taking Polaroid pictures, one by one, of psychiatrists who had waited patiently in line for 20 minutes or more. This was no ordinary picture but rather a snapshot of one's aura, taken, as the Organon brochure noted, "with advanced biofeedback equipment." The equipment consisted of two small machines, on which I placed my hands. The result was a picture of my head peering out of a red, orange, and yellow cloud.<br /><br />According to the brochure, "the aura colors give you information about your appearance, character, talents, and future energy." After taking my picture,<br /><br />the red-robed young woman escorted me to a yellow-robed young woman with even more sprinkles in her hair. "Hi! My name is Amber," she said, and proceeded to interpret the picture of my aura as indicating intelligence and good judgment, although with some hints of skepticism.<br /><br />I privately asked the Organon sales staff if they thought it wise to associate their product with auras, magic, New Age thinking, and anti-science. They said the decision had been made at "a higher level" but pointed out that the waiting line was an ideal place for engaging psychiatrists in brief, friendly chats about the virtues of Remeron.<br /><br />This is, after all, big business. Antidepressant and antipsychotic drugs are among America's top-selling pharmaceuticals. Last year Prozac and Zyprexa accounted for almost half of Eli Lilly's total sales. Sales of antipsychotic medications have quadrupled in the past four years to more than $4billion. These drugs are a major reason why the profitability of the 11 pharmaceutical companies in the Fortune 500 "was almost four times greater" than the median for all Fortune 500 companies during the 1990s, according to a report by the Public Citizen Health Research Group.<br /><br />Not surprisingly, psychiatrists have become a prime target of pharmaceutical companies' marketing, because prescription drugs can't be sold directly to consumers. In the United States, pharmaceutical companies spend an estimated $8,000 to $13,000 per physician per year on marketing.<br /><br />At professional gatherings, of course, one must offer the attending psychiatrist more than an opportunity to view one's aura. The Berlin Congress offered 136 symposia plus workshops and lectures. Of these, 23 were clearly labeled as being sponsored by pharmaceutical companies; all focused on drugs to treat psychiatric disorders. Several other industry-sponsored talks had no disclosure of the sponsorship.<br /><br />Each brought in two to four psychiatric experts, whom the sponsoring pharmaceutical company usually gave business-class air tickets, four-star hotel accommodations, and an honorarium, typically $2,000 to $3,000. If the expert organized the symposium, the payments went as high as $5,000, and higher still if the expert presented data very favorable to that company's drug (or at least presented unfavorable data in a very favorable light). One American expert was paid $10,000 last year to fly to Europe to give a single lecture.<br /><br />Symposia and workshops on subjects not directly concerned with drug prescriptions had little, if any, industry support. The speaker at one such symposium, which was lightly attended, said he "felt like the legitimate act at a burlesque show, included only to keep the cops out."<br /><br />Honoraria and future invitations are directly dependent on how experts present their data. Emphasizing adverse effects of a drug, for example, may well cost the expert a trip to future congresses. Some of the psychiatric experts sponsored by a pharmaceutical company are also on the company's speakers bureau; many own stock and thus have a direct financial interest in the success of the company's products.<br /><br />The ultimate targets for this pharmaceutical extravaganza, of course, are the practicing psychiatrists who constitute the vast majority of attendees. Although meeting officials won't provide precise numbers, they acknowledge that pharmaceutical companies had sponsored more than half of the attendees. Sponsorship normally includes coach-class airfare, hotel accommodations, and registration fees as well as special receptions and parties, some literally with dancing girls.<br /><br />Pharmaceutical companies in many countries can now use computerized pharmacy databases (which delete the names of the patients) to track how many prescriptions any given physician writes for any given drug. So Eli Lilly could sponsor Dr. Smith from Detroit or Manchester, send him to Berlin, and then monitor his prescribing pattern following the congress. If Dr. Smith's prescriptions for Zyprexa and Prozac do not increase sufficiently, a company representative can remind him how well he was treated in Berlin. And besides, isn't he interested in going to Copenhagen next summer?<br /><br />There is clear evidence that attending conferences such as the Berlin meeting does affect the prescribing practices of physicians. In one U.S. study, 10 physicians were invited by a pharmaceutical company to attend "all-expenses paid" symposia at "popular Sunbelt vacation sites." The company tracked the physicians' prescribing patterns for two drugs, for 22 months before and 17 months after the symposia. Though the physicians had predicted that their attendance would not affect their rescribing practices, their prescriptions for one drug increased 87 percent and for the other, 272 percent. Other studies have shown that attending drug-sponsored education courses affects drug-prescribing practices, even though the physicians deny it. Indeed, if it were otherwise, why would pharmaceutical companies sponsor such activities?<br /><br />Does any of this really matter? It does, for two reasons. First, patient care suffers when physicians are misled. Psychiatrists trying to evaluate schizophrenia drugs are not told that the expert who minimizes the side effects of Zyprexa receives a $10,000 retainer from Eli Lilly and also owns substantial company stock. Or that the psychiatric expert claiming that Remeron reverses depression more rapidly in suicidal patients receives $75,000 per year from Organon to support his laboratory.<br /><br />Second, the hoopla adds to the cost of drugs. Payments to aura interpreters and dancing girls are simply passed on to patients. The pharmaceutical company costs for the Berlin congress were at least $10 million. According to a recent report, in 2000 the 11 pharmaceutical firms in the Fortune 500 "devoted nearly three times as much of their revenue to marketing and administrative costs (30 percent of revenue) as to research and development (12 percent of revenue)."<br /><br />Plainly some changes are in order. Reform should start with medical students. As one observer summarized it in The New England Journal of Medicine: "Medical training should not include acquiring a sense of entitlement to the largesse of drug companies." Pharmaceutical companies should be banned from giving gifts to medical students and residents; the free pizza from the drug representative may seem trivial, but it sets a pattern that rationalizes accepting a free trip to Berlin later on. <br /><br />Practicing psychiatrists should get their continuing education from objective sources, not from drug "detail" (marketing) persons and industry-sponsored talks. Vermont has just made a modest beginning with a law requiring disclosure of all drug-company gifts to doctors valued at more than $25. The profession's ethical standards should prohibit experts who are involved in drug trials or giving talks at symposia from owning stock in pharmaceutical companies. Unfortunately, most of the profession's organizations, such as the American Psychiatric Association, are themselves so indebted to drug companies that they are unlikely to lead reform.<br /><br />For speakers at symposia such as the Berlin meeting, the solution is simple.<br /><br />Prominently displayed next to the speaker's lectern should be a sign reading: "For this talk, Dr. Smith is being paid $3,500, business-class airfare, and four-star hotel accommodations by Eli Lilly and Company."<br /><br />E. Fuller Torrey Copyright C 2002 by The American Prospect, Inc. Preferred Citation: E. Fuller Torrey, "The Going Rate on Shrinks," The American Prospect vol. 13 no. 13, July 15, 2002.</div><br /><br /><br /><a href="http://ahrp.blogspot.com/2008/12/high-doses-of-vitamin-b-3-fights.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-8883733886191290316?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/dissenting-acnp-psychiatrist-re.htmlnoreply@blogger.com (Vera Hassner Sharav)1tag:blogger.com,1999:blog-35205931.post-6055849351615695652Wed, 17 Dec 2008 01:05:00 +00002008-12-16T20:06:36.495-05:00A (highly technical) report in the Journal of Neuroscience, by a multi-disciplinary team of scientists at the University of California (Irvine) reported that high doses of nicotinamide (vitamin B-3 or niacin): "restored cognitive deficits associated with pathology. Nicotinamide selectively reduces a specific phospho-species of tau (Thr231) that is associated with microtubule depolymerization, in a manner similar to inhibition of SirT1. Nicotinamide also dramatically increased acetylated-tubulin, a primary substrate of SirT2, and MAP2c, both of which are linked to increased microtubule stability. Reduced phosphoThr231-tau was related to a reduction of monoubiquitinconjugated tau, suggesting that this posttranslationally modified form of tau may be rapidly degraded. Overexpression of a Thr231-phospho-mimic tau in vitro increased clearance and decreased accumulation of tau compared with wild-type tau. These preclinical findings suggest that oral nicotinamide may represent a safe treatment for AD and other tauopathies, and that phosphorylation of tau at Thr231 may regulate tau stability."<br /><br />Conclusion: "...these results suggest that nicotinamide may also be effective against other tauopathies, which share many common pathological features with the tau pathology seen both in AD and in the 3xTg-AD mice. In summary, the results presented here suggest that nicotinamide has potential as a novel, safe, and inexpensive AD therapy, either alone or in combination with AB-lowering therapies."<br />Earlier, a team at Rush Institute and the Center for Disease Control conducted a large prospective study--close to 4000 people aged 65 and older, who had no Alzheimer's disease at the start of the study, were recruited. The published study (2004) in the Journal of Neurology Neurosurgery and Psychiatry examined whether dietary intake of niacin was associated with incident Alzheimer's disease (AD) and cognitive decline. The favorable results: "Dietary niacin may protect against AD and age related cognitive decline." [2] The researchers noted that previous research has indicated that niacin has an important role in DNA synthesis and repair, neural cell signaling, and acts as a potent antioxidant in brain cells. [<a href="http://www.nutraingredients.com/Research/Niacin-appears-to-protect-against-Alzheimer-s-too" target="_blank">Link</a>]<br /><br />The bottom line: There are 140,000 deaths annually attributable to properly prescribed prescription drugs. (6) And this figure is just for one year, and just for the USA. Furthermore, when overdoses, incorrect prescription, and adverse drug interactions are figured in, total drug fatalities number over a quarter of a million dead. Each year. <br /><br />Niacin's safety has been confirmed for over 50 years. Nutritional (orthomolecular) physicians have used vitamin B3 in doses as high as tens of thousands of milligrams per day. Cardiologists frequently give patients thousands of milligrams of niacin daily to lower cholesterol. Niacin is preferred because its safety margin is so very large. The American Association of Poison Control Centers' Toxic Exposure Surveillance System annual reports indicates there is not even one death per year due to niacin in any of its forms. [3] [4] <br /><br />Below, a news release from Orthomolecular Medicine, examines the media's mixed signals about the very positive efficacy findings of using vitamin B-3 for the prevention and treatment of Alzheimer's. So why, were news reports were so muted about a potentially cheap efficacious nutritional supplement treatment compared to the coverage afforded to reports about expensive pharmaceutical products?<br /><br /><strong>References:</strong><br /><ol><li>Kim N. Green, Joan S. Steffan, Hilda Martinez-Coria, Xuemin Sun, Steven S. Schreiber, Leslie Michels Thompson, and Frank M. LaFerla. Nicotinamide Restores Cognition in Alzheimer's Disease Transgenic Mice via a Mechanism Involving Sirtuin Inhibition and Selective Reduction of Thr231-Phosphotau in The Journal of Neuroscience, November 5, 2008 . 28(45):11500 -11510.</li><li>M C Morris, D A Evans, J L Bienias, P A Scherr, C C Tangney, L E Hebert, D A Bennett, R S Wilson, N Aggarwal. Dietary niacin and the risk of incident Alzheimer's disease and of cognitive decline Journal of Neurology Neurosurgery and Psychiatry 2004;75:1093-1099</li><li>Annual Reports of the American Association of Poison Control Centers' National Poisoning and Exposure Database (formerly known as the Toxic Exposure Surveillance System). AAPCC, 3201 New Mexico Avenue, Ste. 330, Washington, DC 20016. Download any report from1983-2006 at [<a href="http://www.aapcc.org/dnn/NPDS/AnnualReports/tabid/125/Default.aspx" target="_blank">Link</a>]</li><li>See also:The American Journal of Cardiology - Volume 99, Issue 6A (March 2007) [<a href="http://www.mdconsult.com/das/article/body/113408063-2/jorg=journal&source=MI&sp=19467991&sid=0/N/575177/1.html" target="_blank">Link</a>]</li></ol><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.orthomolecular.org/resources/omns/index.shtml" target="_blank">Link</a>] <br />[<a href="http://www.orthomolecular.org/resources/omns/v04n25.shtml" target="_blank">Link</a>]<b>FOR IMMEDIATE RELEASE Orthomolecular Medicine News Service, December 9, 2008</b> <br /><br />High Doses of Vitamins Fight Alzheimer's Disease Why Don't Doctors Recommend Them Now?<br /><br />(OMNS, December 9, 2008) The news media recently reported that "huge doses of an ordinary vitamin appeared to eliminate memory problems in mice with the rodent equivalent of Alzheimer's disease." They then quickly added that "scientists aren't ready to recommend that people try the vitamin on their own outside of normal doses." (1) <br /><br />In other words, extra-large amounts of a vitamin are helpful, so don't you take them! <br /><br />That does not even pass the straight-faced test. So what's the story? <br /><br />Researchers at the University of California at Irvine gave the human dose equivalent of 2,000 to 3,000 mg of vitamin B3 to mice with Alzheimer's. (2) It worked. Kim Green, one of the researchers, is quoted as saying, "Cognitively, they were cured. They performed as if they'd never developed the disease." <br /><br />Specifically, the study employed large amounts of nicotinamide, the vitamin B3 widely found in foods such as meat, poultry, fish, nuts and seeds. Nicotinamide is also the form of niacin found, in far greater quantity, in dietary supplements. It is more commonly known as niacinamide. It is inexpensive and its safety is long established. The most common side effect of niacinamide in very high doses is nausea. This can be eliminated by taking less, by using regular niacin instead, which may cause a warm flush, or choosing inositol hexaniacinate, which does not. They are all vitamin B3.<br /><br />HealthDay Reporter mentioned how cheap the vitamin is; the study authors "bought a year's supply for $30" and noted that it "appears to be safe." Even so, one author said that "I wouldn't advocate people rush out and eat grams of this stuff each day." (1) <br /><br />The BBC quoted Rebecca Wood, Chief Executive of the UK Alzheimer's Research Trust, who said, "Until the human research was completed, people should not start taking the supplement. . . . people should be wary about changing their diet or taking supplements. In high doses vitamin B3 can be toxic." (3) <br /><br />The Irish Times reiterated it: "People have been cautioned about rushing out to buy high dose vitamin B3 supplements in an attempt to prevent memory loss. . . The warnings came today one day on from the announcement . . .Vitamins in high doses can be toxic." (4) <br /><br />Their choice of words is quaint but hardly accurate. There is no wild "rush;" half of the population already takes food supplements. And as for "toxic," niacin isn't. Canadian psychiatrist Abram Hoffer, M.D., asserts that it is actually remarkably safe. "There have been no deaths from niacin supplements," Dr. Hoffer says. "The LD 50 (the dosage that would kill half of those taking it) for dogs is 5,000-6,000 milligrams per kilogram body weight. That is equivalent to almost a pound of niacin per day for a human. No human takes 375,000 milligrams of niacin a day. They would be nauseous long before reaching a harmful dose." Dr. Hoffer conducted the first double-blind, placebo-controlled clinical trials of niacin. He adds, "Niacin is not liver toxic. Niacin therapy increases liver function tests. But this elevation means that the liver is active. It does not indicate an underlying liver pathology." <br /><br />The medical literature repeatedly confirms niacin's safety. Indeed, for over 50 years, nutritional (orthomolecular) physicians have used vitamin B3 in doses as high as tens of thousands of milligrams per day. Cardiologists frequently give patients thousands of milligrams of niacin daily to lower cholesterol. Niacin is preferred because its safety margin is so very large. The American Association of Poison Control Centers' Toxic Exposure Surveillance System annual reports indicates there is not even one death per year due to niacin in any of its forms. (5) <br /><br />One the other hand, there are 140,000 deaths annually attributable to properly prescribed prescription drugs. (6) And this figure is just for one year, and just for the USA. Furthermore, when overdoses, incorrect prescription, and adverse drug interactions are figured in, total drug fatalities number over a quarter of a million dead. Each year. <br /><br />The BBC's curious mention that we should even be "wary about changing our diets" is especially odd. More and more scientists think our much-in-need-of-improvement diets are what contribute more than anything to developing Alzheimer's. "There appears to be a statistically significant link between a low dietary intake of niacin and a high risk of developing Alzheimer's disease. A study of the niacin intake of 6158 Chicago residents 65 years of age or older established that the lower the daily intake of niacin, the greater the risk of becoming an Alzheimer's disease patient." The group with the highest daily intake of niacin had a 70 percent decrease in incidence of this disease compared to the lowest group. "The most compelling evidence to date is that early memory loss can be reversed by the ascorbate (vitamin C) minerals. Greater Alzheimer's disease risk also has been linked to low dietary intake of vitamin E and of fish." (7) <br /><br />Nutrient deficiency of long standing may create a nutrient dependency. A nutrient dependency is an exaggerated need for the missing nutrient, a need not met by dietary intakes or even by low-dose supplementation. Robert P. Heaney, M.D., uses the term "long latency deficiency diseases" to describe illnesses that fit this description. He writes: "Inadequate intakes of many nutrients are now recognized as contributing to several of the major chronic diseases that affect the populations of the industrialized nations. Often taking many years to manifest themselves, these disease outcomes should be thought of as long-latency deficiency diseases. . . Because the intakes required to prevent many of the long-latency disorders are higher than those required to prevent the respective index diseases, recommendations based solely on preventing the index diseases are no longer biologically defensible." (8) Where pathology already exists, unusually large quantities of vitamins may be needed to repair damaged tissue. Thirty-five years ago, in another paper, Hoffer wrote: "The borderline between vitamin deficiency and vitamin-dependency conditions is merely a quantitative one when one considers prevention and cure." (9) <br /><br />As there is no recognized cure for Alzheimer's, prevention is vital. In their article, the Irish Times does admit that "Healthy mice fed the vitamins also outperformed mice on a normal diet" and quoted study co-author Frank LaFerla saying that "This suggests that not only is it good for Alzheimer's disease, but if normal people take it, some aspects of their memory might improve." (4) And study author Green added, "If we combine this with other things already out there, we'd probably see a large effect." <br /><br />The US Alzheimer's Association's Dr. Ralph Nixon has said that previous research has suggested that vitamins such as vitamin E, vitamin C and vitamin B12 may help people lower their risk of developing Alzheimer's disease. At their website (although you have to search for it), the Alzheimer's Association says, "Vitamins may be helpful. There is some indication that vitamins, such as vitamin E, or vitamins E and C together, vitamin B12 and folate may be important in lowering your risk of developing Alzheimer's. . . One large federally funded study (10) showed that vitamin E slightly delayed loss of ability to carry out daily activities and placement in residential care." <br /><br />But overall, at their website [<a href="http://www.alz.org/index.asp" target="_blank">Link</a>] the Alzheimer's Association has strikingly little to say about vitamins, and they hasten to tell people that "No one should use vitamin E to treat Alzheimer's disease except under the supervision of a physician." "They write as if these safe vitamins are dangerous drugs, not be used without a doctor's consent," comments Dr. Hoffer. "I have been using them for decades." <br /><br />Niacin and nerves go together. Orthomolecular physicians have found niacin and other nutrients to be an effective treatment for obsessive compulsive disorder, anxiety, bipolar disorder, depression, psychotic behavior, and schizophrenia. New research confirms that niacinamide (the same form of B3 used in the Alzheimer's research) "profoundly prevents the degeneration of demyelinated axons and improves the behavioral deficits" in animals with an illness very similar to multiple sclerosis. (11) <br /><br />A measure of journalistic caution is understandable, especially with ever-new promises for pharmaceutical products. Drugs routinely used to treat Alzheimer's Disease have had a disappointing, even dismal success rate. So when nutrition may be the better answer, foot-dragging is inexplicable, even inexcusable. Nutrients are vastly safer than drugs. Unjustified, needlessly negative opinionating is out of place. Over 5 million Americans now have Alzheimer's disease, and the number is estimated to reach 14 million by 2050. Potentially, 9 million people would benefit later from niacin now. <br /><br />"Man is a food-dependent creature," wrote University of Alabama professor of medicine Emanuel Cheraskin, M.D.. "If you don't feed him, he will die. If you feed him improperly, part of him will die." <br /><br />When that part is the brain, it is dangerous to delay the use of optimum nutrition.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/following-federal-audit-600-clinical.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-6055849351615695652?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/high-doses-of-vitamin-b-3-fights.htmlnoreply@blogger.com (Vera Hassner Sharav)2tag:blogger.com,1999:blog-35205931.post-258683862288259324Wed, 17 Dec 2008 01:05:00 +00002008-12-16T20:05:48.290-05:00The Seattle Times reports (below) that all 600 human trials conducted by Washington University researchers at the veteran's hospital in Seattle have been halted following an audit by the federal Office of Human Research Protections (OHRP). Such a move is not taken lightly, it is an indication that the violations were very serious: patients' welfare and scientific integrity were likely at risk.<br /><br />According the Seattle Times, among other things, OHRP found violations of informed consent and failure by the Institutional Review Boards to properly review the protocols and "to make a formal judgment about risk levels." <br /><br />If an IRB fails to make research risk assessments--the research should be halted and the IRB disbanded.<br /><br />A letter posted on the OHRP website involves the following two projects: Research Project: Hypertonic Saline Study, Principal Investigator: Eileen Bulger, M.D. Research Project: Prehospital Resuscitation using an IMpedance valve and Early vs. Delayed analysis - ROC PRIMED Principal Investigator: Peter J. Kudenchuk, MD.<br /><br />The letter requests responses to questions about the relevant issues.<br /><br />However, all the questions have been redacted: Questions and Concerns Regarding the Hypertonic Study: All 6 questions redacted Questions and Concerns Regarding the ROC-PRIMED Study: Redacted Questions and Concerns Regarding UW's System for Protecting Human Subjects: Redacted<br /><br />Surely OHRO's practice of concealing vital safety information is NOT good public policy. <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://seattletimes.nwsource.com/html/localnews/2008488704_veteransresearch10m0.html" target="_blank">Link</a>]<strong>Seattle Times Wednesday, December 10, 2008 Audit leads to enrollment halt in research at veterans hospital<br />By Kyung M. Song ST health reporter</strong><br /><br />The veterans hospital in Seattle has halted all new enrollments in research involving human subjects after a federal audit found that patient safeguards weren't properly documented. The decision - which applies to about 600 studies being conducted at the veterans hospital and the University of Washington - could delay the work of some researchers by weeks or longer, in some cases forcing them to turn to minor but still research-related tasks to avoid running afoul of the conditions of their research grants. Researchers also will be barred from analyzing or publishing their data at the veterans hospital without a special waiver.<br /><br />Also affected are about 15 bone-marrow transplant and oncology studies at the Fred Hutchinson Cancer Research Center that were actively recruiting patients at the hospital.<br /><br />Nationally, the federal Department of Veterans Affairs has been a fertile proving ground for medical breakthroughs, including advances in artificial limbs, the CT scanner and drug trials for tuberculosis and hypertension. Locally, thousands of veterans and their dependents are enrolled in human studies. The research spans a range of conditions and treatments, including testing the effects of testosterone in men with mild cognitive impairments to studying the genetic propensity for certain diseases.<br /><br />Subjects often receive modest payment, ranging from $20 or $30 for a visit to $200 for a lumbar puncture.<br /><br />The restrictions in Seattle announced this week stem from a review completed last month by the federal department's Office of Research Oversight, which is responsible for ensuring patient safeguards.<br /><br />The oversight office found, among other things, that patient-consent forms did not conform to department regulations and that local committees in charge of approving each clinical study failed to make a formal judgment about risk levels.<br /><br />Dr. Steven Kahn, director of research and development at the VA Puget Sound Health Care System, which includes the hospital, stressed that the federal audit largely found record-keeping problems and raised no concerns with specific studies.<br /><br />Kahn said that while this is the first time the hospital here has suspended enrollment in human studies, "there has been no violation of federal regulation and no harm to patients."<br /><br />Kahn, who also is a professor of medicine at UW, said several other VA health systems - including Boise, San Diego and Palo Alto, Calif. - also have received similar findings from the federal oversight office.<br /><br />Kahn said researchers can continue collecting data, blood and other samples from people already enrolled in their studies. However, they can't add new subjects or analyze or publish the results of their research until their study protocols have been re-reviewed and cleared.<br /><br />Researchers can seek special waivers, Kahn said, if the delays would compromise patient safety or otherwise jeopardize their research.<br /><br />Vera Sharav, president of Alliance for Human Research Protection, a New York nonprofit group that promotes ethical medical research, said particular care is needed to safeguard veterans enrolled in studies.<br /><br />They "are vulnerable to being coerced into becoming guinea pigs in order to get treatment," she said.<br /><br />Kahn said the action was unrelated to recent national headlines about patient-safety issues at VA research centers elsewhere around the country.<br /><br />In August, a report by the department's inspector general's office concluded that VA researchers in central Arkansas broke rules on human experimentation multiple times since the 1980s.<br /><br />Researchers allowed people with no medical experience to collect muscle tissue, destroyed consent forms and failed to report the deaths of 105 patients who had been involved in studies at VA facilities throughout Arkansas.<br /><br />Later that month, Veterans Affairs Secretary James Peake apologized publicly to the widow of a veteran who died of a human form of mad-cow disease after being turned away from a veterans hospital in the Bronx borough in New York.<br /><br />The man's family contended he was steered into hospice care after declining to enroll in an Alzheimer's study.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/goodwin-tells-gw-student-paper-infinite.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-258683862288259324?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/following-federal-audit-600-clinical.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-4790625520430450055Wed, 17 Dec 2008 01:04:00 +00002008-12-16T20:04:57.432-05:00The George Washington University student newspaper, The GW Hatchet, reports (below) that Dr. Frederick Goodwin, under fire after his concealed pharmaceutical company financial ties were uncovered by Sen. Charles Grassley, acknowledged that "The Infinite Mind," a National Public Radio program, received "perhaps 30 to 50 percent of its funding over the years from drug companies."<br /><br />Dr. Goodwin denied any conflicts of interest, but confirmed that most psychiatrists have financial relationships to pharmaceutical companies: "like most experts in my field, I have relationships as a consultant with a number of pharmaceutical companies." His denial that financial relationships define conflicts of interest: "I've always thought that if you have multiple relationships they sort of cancel each other out." By this logic, a prostitute who earns her fees from "multiple relationships" is less of a prostitute!<br /><br />Dr. Goodwin used National Public Radio to promote a hidden agenda-such as was demonstrated in a March 2008 broadcast, "Prozac Nation Revisited." That agenda served the financial interests of SSRI antidepressant drug manufacturers, the benefactors he kept hidden from NPR listeners. [<a href="http://www.slate.com/id/2190775/" target="_blank">Link</a>] <br /><br />Dr. Goodwin mischaracterized scientific findings and used the NPR forum to gain listener support for rescinding the FDA mandated Black Box label warnings about an increased risk of suicide for youngsters prescribed SSRI antidepressants. A detailed critique of how Dr. Goodwin manipulated that broadcast is provided by Dr. Jonathan Leo (July 29, 2008). [<a href="http://chemicalimbalance.org/?p=183" target="_blank">Link</a>] <br /><br />For starters, Dr. Goodwin stacked the deck in his choice of four guests-all of who received financial support from pharmaceutical companies. For example, Peter Pitts was presented merely as a 'Former FDA official." At the time of this interview, he was employed by a PR firm which represents the major antidepressant drug manufacturers-Eli Lilly, GlaxoSmithKline, Pfizer, et al. Those financial ties were never disclosed to listeners. Much of the discussion between Pitts and Goodwin mischaracterized an epidemiological study published in the fall of 2007. The authors, Drs. John Mann and Robert Gibbons had financial ties to antidepressant drug manufacturers-JM received money from Pfizer (Zoloft) and GlaxoSmithKline (Paxil). RG served as expert witness for Wyeth (Effexor). Their claimed findings, that the Black Box Warning has led to a drop in antidepressant use in children and adolescents which may have resulted in a subsequent increase in the suicide rate, were debunked when their analysis was found to have stopped BEFORE the black box warnings went into effect. <br /><br />Of note, in an interview Pharmaceutical Executive, a drug industry trade magazine, Peter Pitts lamented the withdrawal of Vioxx, the drug that caused cardiac arrest: "The more I think about Vioxx, the more I'm convinced that it should not have been pulled from the market. Vioxx was a tremendous opportunity to put forth a responsible argument that drugs have risks as well as benefits and that the public needs to be better aware of that." [<a href="http://www.sourcewatch.org/index.php?title=Peter_Pitts" target="_blank">Link</a>]<br /><br />In other words, Peter Pitts never met a drug-even a lethal drug-whose sales he did not support.<br /><br />However, it was Dr. Goodwin who led the charge by misrepresenting the scientific evidence. He baldly claimed that there were no reports of suicides in the SSRI adult data in the FDA database: "In fact ,in the FDA database there was zero - no suicides at all in any of the antidepressant trials - 35,000 [adult] patients." Goodwin (44:27) This is a patently false statement. While suicide rates vary depending on what group of studies are examined, there have certainly been cases of suicides in trials submitted to the FDA. For example, an analysis by Arif Khan et al (2003) puts the number of completed suicides in SSRI antidepressant trials at 77. [1] And Dr. Joseph Glenmullen's report analyzing GlaxoSmithKline Paxil Safety Review is especially revealing: In 1989 a GSK internal report indicated that 42 of 2,963 patients on Paxil attempted suicide compared to only 3 of 554 patients on placebo. And of 12 patients who died on Paxil, five committed suicide. Two reported deaths of patients on placebo were listed as suicides but later were found to have occurred during the washout phase. So, the zero suicides might have applied to the placebo group. [<a href="http://media.newscientist.com/data/images/ns/av/mg19726424600D1.pdf" target="_blank">Link</a>] <br /><br />Dr. Goodwin told the student paper, The Hatchet: "My producer was actually pleased that I had connections because it helped get company funding for 'The Infinite Mind,' which was clearly disclosed." LCM president, Bill Lichtenstein, has denied that he knew about Goodwin's ties to drug companies. "There was no gray area," Lichtenstein wrote in a news release. "Fred Goodwin was legally bound to inform LCM of any conflicts of interest. And he didn't."<br /><br />Who do you believe?<br /><br /><strong>Reference:</strong> <br /><br />1. Arif Khan, M.D., Shirin Khan, Russell Kolts, Ph.D., and Walter A. Brown, M.D.Suicide Rates in Clinical Trials of SSRIs, Other Antidepressants, and Placebo: Analysis of FDA Reports, Am J Psychiatry 160:790-792, April 2003. 2. Joseph Glenmullen report: [<a href="http://media.newscientist.com/data/images/ns/av/mg19726424600D1.pdf" target="_blank">Link</a>] <br /><br />See also: [<a href="http://www.furiousseasons.com/archives/2008/05/npr_radio_show_tied_to_pharma_influence.html" target="_blank">Link</a>] [<a href="http://www.pharmalot.com/2008/12/goodwin-my-pharma-ties-have-never-been-a-secret/http://carlatpsychiatry.blogspot.com/2008/12/biederman-goodwin-greed-arrogance.html" target="_blank">Link</a>] <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://media.www.gwhatchet.com/media/storage/paper332/news/2008/12/04/News/Professor.Scrutinized.For.Alleged.Conflict.Of.Interest-3569630.shtml" target="_blank">Link</a>]<strong>THE GW HATCHET. THE INDIEPENDENT STUDENT NEWSPAPER<br />Professor scrutinized for alleged conflict of interest<br />by Lauren French 12/4/08</strong> <br /><br />A GW research professor is under scrutiny for allegedly violating another employer's conflict of interest policies by receiving at least $1.3 million from drug companies while hosting a public radio program about psychiatric drugs.<br /><br />The New York Times reported on Nov. 22 that Frederick Goodwin, a research professor of psychiatry, received millions from drug companies for participating in marketing lectures, which was discovered during an investigation conducted by Sen. Charles E. Grassley, R-Iowa. Charles Nemeroff of Emory University and Joseph Biederman of Harvard have also been accused by Grassley of similar conflicts of interest.<br /><br />Nemeroff was forced to vacate his chairmanship of the Emory psychiatry department and Biederman's department is undergoing an internal review, but Goodwin still serves as the director of the University's Psychopharmacology Research Center. The University is not reconsidering its conflict of interest policy with regards to Goodwin, University spokeswoman Tracy Schario said.<br /><br />Goodwin denied in interviews with The Hatchet this week that any conflict of interest had taken place. "I frankly do not see these things as a conflict of interest. It was my judgment," said Goodwin. "Like most experts in my field, I have relationships as a consultant with a number of pharmaceutical companies. I've always thought that if you have multiple relationships they sort of cancel each other out."<br /><br />Lichtenstein Creative Media, which produced "The Infinite Mind," Goodwin's public radio program before it was taken off the air for unrelated financial reasons, has released two statements to the press criticizing Goodwin.<br /><br />Goodwin's acceptance of money from drug companies is a "direct violation of his written contract with LCM," said Lichtenstein Creative Media President Bill Lichtenstein. Though Goodwin is a GW professor, his supposed violation is not a University issue because Goodwin is employed as an unpaid research professor, said Charles A. Garris Jr., the chairman of the Faculty Senate's committee on Professional Ethics and Academic Freedom. Research professors are similar to adjunct professors, though they are not required to disclose potential conflict of interests to GW.<br /><br />"What he does on the outside is not something the University deals with," Garris said. "He did not violate any of the University rules, whether or not he violated ethical principles is a totally different matter."<br /><br />On the University's Web site, Goodwin, who has worked for GW since May 1994, is still listed as a research professor and director of the University's Psychopharmacology Research Center. A spokeswoman for the School of Medicine and Health Sciences declined to comment.<br /><br />Goodwin said New York Times reporter Gardiner Harris misrepresented his long-standing beliefs about psychiatric drugs and involvement with drug companies. He added that a portion of the $1.3 million was a reimbursement for travel expenses. "Including all the expenses paid in the article was a distortion, because you are not earning money when you are reimbursed," said Goodwin. "It was really under a million dollars in speaking fees and the rest of it was expenses."<br /><br />Calling Goodwin's response "demonstrably false," Harris, the author of the New York Times article about Goodwin's alleged conflict of interest, said he did not misrepresent Goodwin or his failure to disclose information. "I think most people would see travel expenses to very nice places as a benefit worthy of citing," Harris said.<br /><br />Goodwin also maintains he did not violate any contracts with "The Infinite Mind" because Goodwin and Lichtenstein casually talked of Goodwin's consulting with drug companies and because it was never required for him to disclose information.<br /><br />"My producer was actually pleased that I had connections because it helped get company funding for 'The Infinite Mind,' which was clearly disclosed," Goodwin said. " 'The Infinite Mind' perhaps got 30 to 50 percent of its funding over the years from drug companies."<br /><br />LCM's president has denied that he knew about Goodwin's ties to drug companies. "There was no gray area," Lichtenstein wrote in a news release. "Fred Goodwin was legally bound to inform LCM of any conflicts of interest. And he didn't."</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/fda-safety-scientists-warn-about-deaths.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-4790625520430450055?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/goodwin-tells-gw-student-paper-infinite.htmlnoreply@blogger.com (Vera Hassner Sharav)1tag:blogger.com,1999:blog-35205931.post-5188400777107758584Mon, 08 Dec 2008 21:47:00 +00002008-12-08T16:47:54.045-05:00The New York Times reports (below) "Two federal drug officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs - Advair, Symbicort, Serevent and Foradil...."Sudden deaths among asthmatics still clutching their inhalers have fed the debate."<br /><br />No sooner was Serevent approved in 1994, than the agency began receiving reports of deaths. A letter to the New England Journal of Medicine described two elderly patients who died holding Serevent inhalers. Glaxo warned patients that the medicine, unlike albuterol, does not work instantly and should not be used during an attack.<br /><br />In 1996, Glaxo began a study of Serevent's safety, but the company refused for years to report the results until 2003 when Glaxo reported that patients given the medicine were more likely to die than those given placebo inhalers. What led FDA officials to remain silent about the lethal risk for 7 years!!! Glaxo said problems with the trial made its results impossible to interpret.<br /><br />So, what scientific evidence leads agency officials and others to disagree about the drug's safety hazard? Could the high financial stakes involved have greater persuasive power than the evidence???<br /><br />Last year, Advair sales were $6.9 billion and may approach $8 billion this year, making the medication GlaxoSmithKline's biggest seller and one of the biggest-selling drugs in the world. Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissed the conclusions of FDA's drug-safety division as "not supported by their own data." <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>Whose drug safety assessment do you trust? [<a href="http://www.nytimes.com/2008/12/06/health/policy/06allergy.html" target="_blank">Link</a>] <br />THE NEW YORK TIMES<br />December 6, 2008<br />Warning Given on Use of 4 Popular Asthma Drugs, but Debate Remains</strong><br />By GARDINER HARRIS<br /><br />WASHINGTON - Two federal drug officials have concluded that asthma sufferers risk death if they continue to use four hugely popular asthma drugs -Advair, Symbicort, Serevent and Foradil. But the officials' views are not universally shared within the government.<br /><br />The two officials, who work in the safety division of the Food and Drug Administration, wrote in an assessment on the agency's Web site on Friday that asthma sufferers of all ages should no longer take the medicines. A third drug-safety official concluded that Advair and Symbicort could be used by adults but that all four drugs should no longer be used by people age 17 and under.<br /><br />Dr. Badrul A. Chowdhury, director of the division of pulmonary and allergy products at the agency, cautioned in his own assessment that the risk of death associated with the drugs was small and that banning their use "would be an extreme approach" that could lead asthmatics to rely on other risky medications.<br /><br />Once unheard of, public disagreements among agency experts have occurred on occasion in recent years. The agency is convening a committee of experts on Wednesday and Thursday to sort out the disagreement, which has divided not only the F.D.A. but also clinicians and experts for more than a decade.<br /><br />Sudden deaths among asthmatics still clutching their inhalers have fed the debate. But trying to determine whether the deaths were caused by patients' breathing problems or the inhalers has proved difficult.<br /><br />The stakes for drug makers are high. Advair sales last year were $6.9 billion and may approach $8 billion this year, making the medication GlaxoSmithKline's biggest seller and one of the biggest-selling drugs in the world. Glaxo also sells Serevent, which had $538 million in sales last year. Symbicort is made by AstraZeneca and Foradil by Novartis.<br /><br />Whatever the committee's decision, the drugs will almost certainly remain on the market because even the agency's drug-safety officials concluded that they were useful in patients suffering from chronic obstructive pulmonary disease, nearly all of whom are elderly.<br /><br />Dr. Katharine Knobil, global clinical vice president for Glaxo, dismissed the conclusions of the agency's drug-safety division as "not supported by their own data." Dr. Knobil said that Advair was safe and that Serevent was safe when used with a steroid.<br /><br />Michele Meeker, a spokeswoman for AstraZeneca, said that the F.D.A.'s safety division improperly excluded most studies of Symbicort in its analysis, and that a review of all of the information shows that the drug does not increase the risks of death or hospitalization.<br /><br />Dr. Daniel Frattarelli, a Detroit pediatrician and member of the American Academy of Pediatrics's committee on drugs, said that he was treating children with Advair and that his committee had recently discussed the safety of the medicines.<br /><br />"Most of us felt these were pretty good drugs," Dr. Frattarelli said. "I'm really looking forward to hearing what the F.D.A. committee decides."<br /><br />About 9 percent of Advair's prescriptions go to those age 17 and under, according to Glaxo. Ms. Meeker could not provide similar figures for Symbicort.<br /><br />In 1994, Serevent was approved for sale, and the F.D.A. began receiving reports of deaths. A letter to the New England Journal of Medicine described two elderly patients who died holding Serevent inhalers. Glaxo warned patients that the medicine, unlike albuterol, does not work instantly and should not be used during an attack.<br /><br />In 1996, Glaxo began a study of Serevent's safety, but the company refused for years to report the results publicly. In 2001, the company introduced Advair, whose sales quickly cannibalized those of Serevent and then far surpassed them.<br /><br />Finally in 2003, Glaxo reported the results of its Serevent study, which showed that those given the medicine were more likely to die than those given placebo inhalers. Glaxo said problems with the trial made its results impossible to interpret.<br /><br />Asthma is caused when airways within the lungs spasm and swell, restricting the supply of oxygen. The two primary treatments are steroids, which reduce swelling, and beta agonists, which treat spasms. Rescue inhalers usually contain albuterol, which is a beta agonist with limited duration. Serevent and Foradil are both beta agonists but have a longer duration than albuterol and were intended to be taken daily to prevent attacks.<br /><br />Advair contains Serevent and a steroid. Symbicort, introduced last year, contains Foradil and a steroid. In the first nine months of this year, Symbicort had $209 million in sales.<br /><br />The problem with albuterol is that it seems to make patients' lungs more vulnerable to severe attacks, which is why asthmatics are advised to use their rescue inhalers only when needed. The long-acting beta agonists may have the same risks.<br /><br />But drug makers say this risk disappears when long-acting beta agonists are paired with steroids. The labels that accompany Serevent and Foradil instruct doctors to pair the medicines with an inhaled steroid.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/german-tv-documentary-big-pharma-ssri.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-5188400777107758584?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/fda-safety-scientists-warn-about-deaths.htmlnoreply@blogger.com (Vera Hassner Sharav)1tag:blogger.com,1999:blog-35205931.post-3126488554531666149Mon, 08 Dec 2008 15:30:00 +00002008-12-08T10:30:51.514-05:00On Tuesday, December 9, German TV ZDF will broadcast a hard hitting documentary about corrupt pharmaceutical company practices.<br /><br />One issue that will be addressed for the first time is: Why did the German drug regulatory agency (BGA) approve Prozac in 1991 after denying Eli Lilly the license to market the drug in Germany in 1984 without explicit label warnings about the increased suicide risk the drug poses ? <br /><br />May 25, 1984 Internal memorandum from Eli Lilly regarding the company's efforts to obtain a marketing license for Prozac in Germany states: "During the treatment with the preparation [fluoxetine] 16 suicide attempts were made, 2 of these with success. As patients with a risk of suicide were excluded from the studies, it is probable that this high proportion can be attributed to an action of the preparation in the sence (sic) of an deterioration of the clinical condition, which reached its lowest point." [PZ281]<br /><br />Furthermore, Lilly's own documents reveal that a 1988 review of clinical trials found that 38% of patients taking Prozac compared to 19% of patients on placebo experienced "activation," which is linked by the FDA in current labeling to violent and suicidal behavior. [PZ-477] . <br /><br />See: Eli Lilly internal documents: What do They Reveal? [<a href="http://www.ahrp.org/infomail/05/01/27.php" target="_blank">Link</a>]<br />BZ281: Lilly Memo, Keitz; Bad Homburg to Corporate Headquarters, May 25, 1984, with Comment on Clinical Documentation Fluoxetine from BGA (Germany) rejecting Prozac for marketing.<br /><br />PZ-477: Lilly Memo. Activation and Sedation in Fluoxetine Clinical Trials, 1988<br /><br />See: Lenzer, J. FDA to Review "Missing" Drug Company Documents, BMJ (formerly British Medical Journal), January 1, 2005. [<a href="http://bmj.bmjjournals.com/cgi/content/full/330/7481/7" target="_blank">Link</a>] <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>From: Lothar Schröder<br />Sent: Saturday, December 06, 2008 6:32 AM<br />To: Veracare<br />Subject: German TV-Documentary on SSRI and psychotopic Drugs</strong><br /><br />Dear Vera, <br /><br />Since the death of my wife I am trying to inform the German public about the risk and dangers of SSRI-antidepressants. My wife took ZOLOFT 3 years ago for only 11 days. Two days before her death the medication was stopped abruptly. A few months after her death the European Commission made it mandatory for European license holder of SSRI- antidepressants to include a warning about the risk of suicide for children and adolescents in the product information and package insert. Before it, the risk of suicide was not even listed in the product information and package insert.<br /><br />I have tried to press criminal charges against Pfizer but the German courts have put it down. I have also informed the media about it. Now next Tuesday (09. December 2008, 21:00 hour German time on ZDF) the German TV ZDF will broadcast a documentary about the criminal practices by the big pharmacy companies to press the SSRI antidepressant to the European market. The German regulatory agency BGA (Bundesgesundheitsamt) knew about the risk of suicide of the SSRI Prozac and refused to admit it to the German market: first in 1985 and then 3 years later in 1988. But finally Prozac was admitted to the German market in 1991. Zoloft and the other SSRI antidepressants followed. <br /><br />Last Tuesday, Frontal 21 has broadcast a 6-minute long report about Prozac and Zoloft (see: [<a href="http://frontal21.zdf.de/ZDFde/inhalt/19/0,1872,7486227,00.html" target="_blank">Link</a>] ). <br /><br />I hope that this report and the documentary will put real pressure on our politicians and on our regulatory agency. Why was Prozac approved in 1991 although the german BGA knew about the risk of suicide since 1984? Maybe you want to inform the readers of your infomail - I am one of them for many years- and in your blog about the documentary. It will be seen in all German speaking countries in Europe. Thank you very much.<br /><br />Best regards,<br /><br />Lothar Schröder</div><br /><br /><br /><a href="http://ahrp.blogspot.com/2008/12/astrazeneca-was-aware-of-seroquel-risks.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-3126488554531666149?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/german-tv-documentary-big-pharma-ssri.htmlnoreply@blogger.com (Vera Hassner Sharav)1tag:blogger.com,1999:blog-35205931.post-2285831203342193583Sun, 07 Dec 2008 23:22:00 +00002008-12-07T18:22:45.952-05:00Indisputable evidence shows that Seroquel and the other second generation neuroleptics, known as atypical antipsychotics, are associated with an increased risk of diabetes. Warnings about the risk were issued in Japan and the UK (2002)--a year before the FDA finally required drugmakers of this class of drugs to warn doctors of the risks in September 2003. <br /><br />Bloomberg News reports (below) that AstraZeneca documents shown publicly for the first time during a hearing in a federal court in Florida, AstraZeneca, manufacturer of the neuroleptic / antipsychotic, Seroquel, led plaintiff attorneys to conclude that the knew based on "reasonable evidence" documented in internal company trials and studies, that Seroquel can cause diabetes and related conditions." <br /><br />Responding to an FDA letter (January) asking AstraZeneca to provide an analysis of all its clinical trials relating to Seroquel, the company responded with an analysis showing that 2.4% of people with normal sugar levels in the blood became diabetic after 52 weeks of taking Seroquel compared with 1.4% given a placebo--that's a 70% increased risk. <br /><br />Seroquel sales last year surpassed $4 billion.<br /><br />Though AstraZeneca has had 2,243 cases dismissed or dropped, the company is currently facing 1500 claims over the drug in both state and federal courts in the U.S. The initial trial, set to begin Feb. 2, is based on a complaint filed by Linda Guinn of Palm Bay, Florida.<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.bloomberg.com/apps/news?pid=20601127&refer=law&sid=arcAPvYRDKn4#" target="_blank">Link</a>]<strong>BLOOMBERG NEWS<br />AstraZeneca Was Aware of Seroquel Risks in 2000, Records Show<br />By Joe Schneider and Margaret Cronin Fisk</strong><br /><br />Dec. 5 (Bloomberg) -- AstraZeneca Plc., facing more than 15,000 consumer claims alleging the antipsychotic drug Seroquel causes diabetes, knew about the risk as far back as 2000, according to company documents shown in federal court.<br /><br />AstraZeneca Global Safety Officer Wayne Geller concluded there was "reasonable evidence to suggest Seroquel therapy can cause" diabetes and related conditions, according to documents presented yesterday in federal court in Tampa, Florida. Geller drew his conclusions following a review of available studies and internal trials, according to the documents.<br /><br />The internal documents were shown publicly for the first time during a hearing over the qualifications of expert witnesses the plaintiffs plan to use at trial. They are to testify in a lawsuit over the drug's effects when the proceeding begins in February. While portions of the documents were shown in court, the filings remain sealed at the request of the London-based pharmaceutical company.<br /><br />Seroquel, used to treat bipolar disorder, brought in $4.03 billion last year, making it AstraZeneca's second-biggest seller after its ulcer treatment Nexium. The company is trying to broaden the medicine's use to offset revenue lost as pricing pressure in the U.S. reduces demand for Nexium.<br /><br />AstraZeneca is facing claims over the drug in state and federal courts in the U.S. The company has had an additional 2,243 cases dismissed or dropped. The initial trial, set to begin Feb. 2, is based on a complaint filed by Linda Guinn of Palm Bay, Florida.<br /><br />Developed Diabetes Guinn claimed she developed diabetes after taking Seroquel. The drug is part a class of newer antipsychotic drugs including Eli Lilly & Co.'s Zyprexa and Johnson & Johnson's Risperdal. Thousands of consumers have sued the companies claiming they hid the risks of the drugs and marketed them for unapproved purposes. Lilly has paid $1.2 billion to settle 31,000 claims by individuals.<br /><br />The U.S. Food and Drug Administration, in a Jan. 8 letter, asked AstraZeneca to provide an analysis of all its clinical trials relating to Seroquel, Paul Pennock, the plaintiffs' lawyer, told U.S. District Judge Anne Conway yesterday, showing her the letter.<br /><br />AstraZeneca responded June 26 with an analysis that showed 2.4 percent of people who began treatment with normal levels of sugar in the blood became technically diabetic after 52 weeks. Normal levels are less than 100 milligrams per 10 deciliters. Someone is labeled diabetic with a reading of 126 milligrams, said Laura Massey Plunkett, a human risk assessment specialist, who read in court from the company report.<br /><br />1.4 Percent That result, compared to 1.4 percent of patients given a placebo who showed the same increase in blood-sugar levels, Plunkett testified, makes it almost 70 percent more likely that people taking Seroquel would develop diabetes than people who weren't taking the drug. "It's clear this compound Seroquel can cause diabetes," she said. "I don't think there is any real controversy about that."<br /><br />AstraZeneca lawyer Jane Thorpe said that was just a part of the company's analysis and data showed no significant increases when all people who had a sugar reading of less than 125 milligrams were included.<br /><br />Thorpe also questioned Plunkett's conclusions, saying she relied only on studies that supported her views and ignored those that didn't show an increased tendency for people taking Seroquel to develop diabetes.<br /><br />Studies have shown that Seroquel and similar medications known as atypical antipsychotics are associated with an increased risk of diabetes. These studies prompted the FDA to require AstraZeneca and other drugmakers to warn doctors of the risks in September 2003. AstraZeneca doesn't intend to settle these lawsuits, company spokesman Tony Jewell said in an interview. "We intend to litigate these cases on the merits," he said.<br /><br />The case is In Re Seroquel Products Litigation, 06-MD- 01769, U.S. District Court, Middle District of Florida (Tampa).</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/more-evidence-for-need-of-fda-overhaul.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-2285831203342193583?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/astrazeneca-was-aware-of-seroquel-risks.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-8526311759889814376Sun, 07 Dec 2008 19:29:00 +00002008-12-07T14:30:22.122-05:00A November 26, 2008 The Washington Post reported (below) about the widespread consensus among healthcare experts and consumer groups that the FDA is in a state of crisis and in "Need of a Major Overhaul." <br /><br />"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."<br /><br />"FDA is close to being at a tipping point," said William K. Hubbard, who worked for the agency for 27 years. "If something is not done, they could become a failed institution."<br /><br />Morale within the FDA, along with its credibility outside, has plummeted as the agency has been stretched to keep pace with its responsibilities and driven by accusations of ideological bias, a tilt toward industry rather than consumers, and internal dissension.<br /><br />"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.<br /><br />The FDA has been subverted from its science-based mandate by commercial "drug utilization" considerations-i.e., maximizing sales. A glaring example of FDA's dereliction of its public responsibility is its slip shod safety review of highly toxic drugs for use in children. <br /><br />As newly uncovered Johnson & Johnson documents reveal, the "science" behind the marketing of its controversial, toxic antipsychotic, Risperdal, for children is tainted: J & J officials termed clinical trials for the drug's use is children as "growth opportunities." <br /><br />FDA officials provided J & J with the US government seal of approval for Risperdal use in children-in the knowledge J & J had withdrawn its U.K application for use of the drug in Autistic children (June 2006) after the UK Committee on Safety in Medicine conducted an expert risk/ benefit analysis. That analysis resulted in "extensive recommendations which would improve the safety of the prescribing of risperidone." [<a href="http://ahrp.blogspot.com/2007/08/fda-approval-of-risperdal-for-children.html" target="_blank">Link</a>]<br /><br />Risperdal is a highly toxic drug whose efficacy remains in doubt while its severe, even life-threatening hazards- some highlighted in Black Box label warnings-are the subject of multiple lawsuits. FDA officials approved the drug for pediatric "bipolar disorder"--a diagnosis whose validity is swirled in controversy-on the basis of ONE UNPUBLISHED study involving 169 subjects, whose findings remain secret. <br /><br />Philip Dawdy (Furious Seasons) who uncovered this short-circuit, questionable approval process, writes: "I've been writing about pharmaceutical products for years and have been told by the FDA and sources in the medical world that the FDA requires two positive trials (meaning efficacy over placebo is demonstrated) for a drug to be approved for any indication. It struck me as odd that the FDA would approve such a tricky drug--it has black box warnings and plenty of lawsuits on its tail--with only one approval study for a disorder that is the source of much controversy within psychiatry itself and which the FDA only announced this summer was a "valid diagnosis" in its estimation." [<a href="http://www.furiousseasons.com/archives/2008/11/jj_called_clinical_trials_of_psychiatric_drugs_for_kids_growth_opportunities.html" target="_blank">Link</a>] <br /><br />"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.<br /><br />Even President Bush's former FDA Commissioner, Mark McClellan, acknowledges that the FDA has lost the trust of the public: "The most important thing is overall effective leadership that leads in a way that establishes public trust."<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.washingtonpost.com/wp-dyn/content/article/2008/11/25/AR2008112502219_pf.html" target="_blank">Link</a>]<strong>Washington Post<br />Ailing FDA May Need a Major Overhaul, Officials and Groups Say<br />By Rob Stein Wednesday, November 26, 2008; A02</strong><br /><br />The Obama administration will inherit a Food and Drug Administration widely seen as struggling to protect Americans from unsafe medication, contaminated food and a flood of questionable imports from China and other countries.<br /><br />Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.<br /><br />"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."<br /><br />With nearly 11,000 employees and an annual budget of more than $2 billion, the FDA is charged with overseeing products that account for one-quarter of consumer spending in the United States, including over-the-counter and prescription medications, heart valves, stents and other medical devices, the blood supply, and food.<br /><br />But morale within the FDA, along with its credibility outside, has plummeted as the agency has been stretched to keep pace with its responsibilities and riven by accusations of ideological bias, a tilt toward industry rather than consumers, and internal dissension. "FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us," said William K. Hubbard, who worked for the agency for 27 years. "If something is not done, they could become a failed institution, and no one wants that. The FDA is not only important to protecting the public health but also to the industries it regulates."<br /><br />Alarm about the agency began to spike after a series of highly publicized incidents, including the discovery that the painkiller Vioxx caused heart attacks. That has been followed by other safety issues, including questions about the widely used diabetes medication Avandia and several psychiatric drugs. "I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.<br /><br />At the same time, there has been increasing alarm about the agency's ability to protect the food supply -- concerns highlighted by recent major outbreaks of E. coli infection in spinach and salmonella in spinach and peppers. That has prompted calls to split the agency in two -- with one dedicated to drugs and the other to food.<br /><br />"Food safety tends to get short shrift," said Christopher Waldrop of the Consumer Federation of America. "The drug side tends to get much more attention than the food side. Food is equally important and needs to get the attention it deserves." Both the food and drug parts of the FDA's responsibilities have been hobbled by its inability to adequately monitor goods pouring into the United States from around the world, including food, drugs and raw materials, many say. Such concerns were highlighted by contaminated toothpaste from China; tainted pet food that killed hundreds of dogs and cats; and the fouled blood thinner heparin, which took the lives of at least 81 Americans and caused hundreds of serious illnesses.<br /><br />"The agency is still stuck at the border," said Carl R. Nielsen, who was in charge of the FDA's import operations for the last six of his 28 years at the agency. "There has to be radical reorganization -- no doubt about that."<br /><br />Although the FDA has started opening offices overseas to try to better police safety standards at the source, experts say much more needs to be done. For starters, the agency needs to sharply boost inspections abroad, develop strict new regulatory standards, and update and integrate its computer systems, which are woefully antiquated and disjointed, Nielsen and others said.<br /><br />"It's still largely a paper-driven agency," Nielsen said. "The agency has great information pigeonholed all over the place, but it cannot be applied in real time, which is what you need today."<br /><br />The FDA has also been one of the many federal agencies where Bush administration critics say ideology has trumped science, citing the long delay in approving the over-the-counter sale of the emergency contraceptive Plan B. "The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.<br /><br />Questions have also been raised about the agency's handling of suspected toxins such as bisphenol A in baby bottles and other products. And internal dissension has erupted publicly from the usually hermetically sealed agency. Last week, the House Energy and Commerce Committee released a letter from FDA scientists complaining about "serious misconduct" by top managers who oversee medical devices.<br /><br />The turmoil comes as the FDA is facing a host of new demands, including the next wave of drugs and other products resulting from breakthroughs in genetics, nanotechnology and bioengineered foods, among others. And Congress may give the FDA the power to regulate tobacco for the first time.<br /><br />"This would be a totally new regulatory responsibility that the FDA doesn't have expertise in," said Mark B. McClellan, who led the agency in President George W. Bush's first term.<br /><br />While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.<br /><br />"There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources," McClellan said. "The most important thing is overall effective leadership that leads in a way that establishes public trust." Many hope the new administration will quickly name a new FDA commissioner --a post that has frequently been left in the hands of acting commissioners for long periods. An acting commissioner ran the agency for more than half of the past eight years.<br /><br />"The FDA can't be left to drift," said Hubbard, the former official. "There's a lack of leadership when a caretaker is in charge, and the FDA can't afford that."</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/50-of-college-age-youth-have.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-8526311759889814376?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/more-evidence-for-need-of-fda-overhaul.htmlnoreply@blogger.com (Vera Hassner Sharav)1tag:blogger.com,1999:blog-35205931.post-3682014790363228042Sun, 07 Dec 2008 12:32:00 +00002008-12-07T07:33:00.555-05:00President-Elect Barak Obama's new administration will have to guard against being taken in by industry-driven promotional spin promoting fabricated mythological mental health epidemics which would greatly expand the patient rolls and profit margins for expensive drugs. Most if not all of psychiatric "epidemics"--such as depression, pediatric bipolar disorder, anxiety disorders (SAD, GAD), personality disorders--have been shown to serve industry's commercial market expansion goals. <br /><br />The evidence analyzed by independent scientists--including a leading medical technology research and consulting firm, which completed an exhaustive evaluation of clinical evidence behind popular treatments for pediatric Bipolar Disorder, contradicts psychiatry's current harm-producing paradigm of care: <br /><br />Below an assessment by an independent medical technology research and consulting organization, Hayes, Inc, after completing an exhaustive evaluation of clinical evidence behind popular treatments for pediatric Bipolar Disorder. Their independent verdict: <br /><br />"Our findings indicate that at this time, anticonvulsants and atypical antipsychotics cannot be recommended for children diagnosed with Bipolar Disorder. We have serious concerns about the depth of clinical research that has been done to demonstrate the effectiveness of these pharmacological treatments; in addition, in many cases the potential side effects are alarming. We suggest that parents of B-D diagnosed children carefully weigh the potential benefits against the known health risks of these medications and proceed with caution when doctors recommend anticonvulsants or antipsychotics....for many medications currently being prescribed, the Hayes Rating was D ("No proven benefit and/or unsafe".)<br /><br />Because psychiatry lacks scientifically valid diagnostic tools and scientifically validated evidence of benefit from psychopharmacological therapies, psychiatric diagnoses multiply like rabbits with each new edition of the DSM (Diagnostic Statistical Manual. BTW, the DSM has no statistical basis whatsoever). <br /><br />Thus, mental health crises are announced and budgets for "treatments"--almost exclusively, pharmacologic, are increased. The latest mythological claim published in the Archives of General Psychiatry (abstract below):<br /><br />"Almost half of college-aged individuals had a psychiatric disorder in the past year." <br /><br />The study was conducted by Columbia University/ New York State Psychiatric Institute, Department of Psychiatry. The authors' conclusion: "overall fewer than 25% of individuals with a mental disorder sought treatment in the year prior to the survey. These findings underscore the importance of treatment and prevention interventions among college-aged individuals."<br /><br />An elementary question that must be asked of those who make claims about the need for expanded psychiatric treatments is: Where is the evidence to support the assertion that psychopharmacological treatments serve as "prevention interventions"????<br /><br />Underscoring the underlying commercially profitable expansive purpose of studies such as these, the Associated Press quotes the study co-author, Dr. Mark Olfson, who called "the widespread lack of treatment particularly worrisome." He said it should alert not only "students and parents, but also deans and people who run college mental health services about the need to extend access to treatment." <br /><br />Sounds like Dr. Olfson is calling for an financial bailout for the mental health drug industry.<br /><br />Of note: Dr. Mark Olfson, the senior author of the study, has received substantial research support from drug manufacturers: Bristol-Myers Squibb, Eli Lilly, and AstraZeneca; he has also worked as a consultant for McNeil Pharmaceuticals, Pfizer, Janssen, Bristol-Myers Squibb, and Eli Lilly. He has also received funding from pharmaceutical industry sponsored organizations including: American Foundation for Suicide Prevention (AFSP), and the National Association for Research on Schizophrenia and Affective Disorders (NARSAD). <br /><br />The list of psychiatrists who serve on the Scientific Council of AFSP and NARSAD reads like a Who's Who in Psychiatry. These include familiar names whose reputations have been tarnished by disclosures made by Sen. Charles Grassley and information contained in secret company documents.<br /><br />See: [<a href="http://www.afsp.org/?fuseaction=home.download&folder_file_id=0926FE30-7E90-9BD4-C247E5E05AF32C20" target="_blank">Link</a>] See: [<a href="http://www.narsad.org/about/org_profile/sc.html" target="_blank">Link</a>]<br /><br />Coming to the rescue of an incoherent financial bailout policy, Elizabeth Warren, was elected Chairwoman of a new Congressional oversight panel (Nov. 14) charged with evaluating how the $700 billion federal bailout (TARP) is being spent. She noted that so far, a coherent plan is lacking because no one has developed the right questions to ask those charged with spending the billions in bailout. By stepping out of the "consensus" box, she cuts to the chase, focusing on the core issues where the root of the trouble lies. "You can't just say, 'Credit isn't moving through the system.' You have to ask why?<br /><br />She went on to explain, if the answer is that banks don't have money to lend, it would make sense to push capital into their hands--as the Treasury has been doing. But if the answer is the banks' potential borrowers are getting less creditworthy with each passing day, "pouring money into banks isn't going to fix that problem." "Any effective policy has to start with the households. Years of flat wages, low savings and high debt have left America's households extremely vulnerable....You cannot repair this economy if you can't repair those families, and I'm not sure the people directing the bailout see that as their job." [<a href="http://www.nytimes.com/2008/12/02/business/02tarp.html?scp=1&sq=elizabeth%20warren&st=cse" target="_blank">Link</a>]<br /><br />No one among the mental health stakeholders has been asking the questions that must be answered BEFORE policies are adopted that expose children and adolescents to serious risks from treatments whose benefit is unproven. <br /><br />What is causing America's children and adolescents to be "diagnosed" in epidemic numbers as suffering from serious mental illness? Who is doing the diagnosing and how reliable are the tools? What financial ties do those who determine a diagnosis--and their institutions-- have to drug manufacturers? What evidence is there substantiating an epidemic of bipolar disorder among America's children? What is the basis for the claim that 50% of America's college-age youth suffer from mental disorder within a given year?<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.pharmalive.com/News/index.cfm?articleid=589714&categoryid=10#" target="_blank">Link</a>] <strong>Hayes Says New Treatments for Pediatric Bipolar Disorder Not Ready for Prime Time</strong><br /><br />LANSDALE, Pa.--(BUSINESS WIRE)--Dec 3, 2008 - Hayes, Inc., a leading medical technology research and consulting firm, has completed an exhaustive evaluation of clinical evidence behind popular treatments for pediatric Bipolar Disorder.<br /><br />Hayes has recently completed reviewing the clinical evidence behind a range of anticonvulsants and antipsychotics that are prescribed as treatments for pediatric BD. The results are not pretty: none of the pharmaceuticals received Hayes ratings higher than C. Hayes found that evidence regarding the safety and efficacy of anticonvulsants and antipsychotics in pediatric BD is very limited, and, at this time, no strong conclusions can be drawn regarding the safety or clinical effectiveness of these agents. Overall, clinical study designs had serious limitations, including the lack of placebo conditions, lack of randomization and blinding procedures, small sample sizes, and the financial involvement of the pharmaceutical companies whose products were being evaluated. In addition, certain classes of antipsychotics cause potentially serious side effects in children.<br /><br />Elisabeth Houtsmuller, Ph.D., Senior Analyst for Hayes says, "Our findings indicate that at this time, anticonvulsants and atypical antipsychotics cannot be recommended for children diagnosed with Bipolar Disorder. We have serious concerns about the depth of clinical research that has been done to demonstrate the effectiveness of these pharmacological treatments; in addition, in many cases the potential side effects are alarming. We suggest that parents of B-D diagnosed children carefully weigh the potential benefits against the known health risks of these medications and proceed with caution when doctors recommend anticonvulsants or antipsychotics."<br /><br />Pharmaceuticals evaluated in Hayes' review of clinical evidence for anticonvulsants were carbamazepine (Novartis' TegretolR), divalproex (Abbott Labs' DekapoteR), lamotrigine (GlaxoSmithKline's LamictalR), oxcarbazepine (Novartis' Trileptal), topiramate (Ortho's Topamax).<br /><br />Atypical antipsychotics reviewed in the study included aripiprazole (Bristol-Myers-Squibb's AbilifyR), olanzapine (Eli Lilly's ZyprexaR;), quetiapine (AstraZeneca's SeroquelR and Orion's KetipinorR), risperidone (Ortho's RisperdalR; a generic formulation is also available by Teva UK Ltd. and Patriot Pharmaceuticals), and ziprasidone (Pfizer's GeodonR).<br /><br />For both antipsychotics and anticonvulsants, no Hayes Ratings above C ("Potential but unproven benefit") were assigned as a result of Hayes' evidence-based review of clinical research, and for many medications currently being prescribed, the Rating was D ("No proven benefit and/or unsafe".)<br /><br />Dr. Houtsmuller concluded, "Healthcare payers and providers look to evidence-based medicine to make fully-informed decisions about the use of clinical technologies such as pharmaceuticals and medical devices. Unfortunately for parents who are desperate for a solution that will help children diagnosed with BD, evidence that anticonvulsants and antipsychotics are safe and effective is lacking at this time. Additional clinical research is required to clearly demonstrate effectiveness, and to alleviate concerns about potential side effects before widespread use of these drugs for children with BD can be recommended."<br /><br />About Hayes, Inc. Hayes, Inc. is an independent health technology research and consulting company dedicated to promoting better health outcomes. Hayes performs unbiased, evidence-based assessments of the safety and efficacy of new, emerging, and controversial health technologies and evaluates the impact of these technologies on healthcare quality, utilization, and cost. Hayes' worldwide clients include hospitals, healthcare systems, managed care organizations, government agencies and employers.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://archpsyc.ama-assn.org/cgi/content/short/65/12/1429" target="_blank">Link</a>]<strong>Mental Health of College Students and Their Non-College-Attending Peers Results From the National Epidemiologic Study on Alcohol and Related Conditions</strong> Carlos Blanco, MD, PhD; Mayumi Okuda, MD; Crystal Wright, BS; Deborah S. Hasin, PhD; Bridget F. Grant, PhD, PhD; Shang-Min Liu, MS; Mark Olfson, MD, MPH Arch Gen Psychiatry. 2008;65(12):1429-1437.<br /><br />Context Although young adulthood is often characterized by rapid intellectual and social development, college-aged individuals are also commonly exposed to circumstances that place them at risk for psychiatric disorders.<br /><br />Objectives To assess the 12-month prevalence of psychiatric disorders, sociodemographic correlates, and rates of treatment among individuals attending college and their non-college-attending peers in the United States.<br /><br />Design, Setting, and Participants Face-to-face interviews were conducted in the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (N = 43 093). Analyses were done for the subsample of college-aged individuals, defined as those aged 19 to 25 years who were both attending (n = 2188) and not attending (n = 2904) college in the previous year.<br /><br />Main Outcome Measures Sociodemographic correlates and prevalence of 12-month DSM-IV psychiatric disorders, substance use, and treatment seeking among college-attending individuals and their non-college-attending peers.<br /><br />Results Almost half of college-aged individuals had a psychiatric disorder in the past year. The overall rate of psychiatric disorders was not different between college-attending individuals and their non-college-attending peers. The unadjusted risk of alcohol use disorders was significantly greater for college students than for their non-college-attending peers (odds ratio = 1.25; 95% confidence interval, 1.04-1.50), although not after adjusting for background sociodemographic characteristics (adjusted odds ratio = 1.19; 95% confidence interval, 0.98-1.44). College students were significantly less likely (unadjusted and adjusted) to have a diagnosis of drug use disorder or nicotine dependence or to have used tobacco than their non-college-attending peers. Bipolar disorder was less common in individuals attending college. College students were significantly less likely to receive past-year treatment for alcohol or drug use disorders than their non-college-attending peers.<br /><br />Conclusions Psychiatric disorders, particularly alcohol use disorders, are common in the college-aged population. Although treatment rates varied across disorders, overall fewer than 25% of individuals with a mental disorder sought treatment in the year prior to the survey. These findings underscore the importance of treatment and prevention interventions among college-aged individuals.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://news.yahoo.com/s/ap/20081202/ap_on_he_me/med_mental_health_8" target="_blank">Link</a>]<strong>1 in 5 young adults has personality disorder</strong> By LINDSEY TANNER, AP Medical Writer Tue Dec 2, 2008<br />CHICAGO - Almost one in five young American adults has a personality disorder that interferes with everyday life, and even more abuse alcohol or drugs, researchers reported Monday in the most extensive study of its kind.<br /><br />The disorders include problems such as obsessive or compulsive tendencies and anti-social behavior that can sometimes lead to violence. The study also found that fewer than 25 percent of college-aged Americans with mental problems get treatment.<br /><br />One expert said personality disorders may be overdiagnosed. But others said the results were not surprising since previous, less rigorous evidence has suggested mental problems are common on college campuses and elsewhere.<br /><br />Experts praised the study's scope - face-to-face interviews about numerous disorders with more than 5,000 young people ages 19 to 25 - and said it spotlights a problem college administrators need to address.<br /><br />Study co-author Dr. Mark Olfson of Columbia University and New York State Psychiatric Institute called the widespread lack of treatment particularly worrisome. He said it should alert not only "students and parents, but also deans and people who run college mental health services about the need to extend access to treatment."<br /><br />Counting substance abuse, the study found that nearly half of young people surveyed have some sort of psychiatric condition, including students and non-students.<br /><br />Personality disorders were the second most common problem behind drug or alcohol abuse as a single category. The disorders include obsessive, anti-social and paranoid behaviors that are not mere quirks but actually interfere with ordinary functioning.<br /><br />The study authors noted that recent tragedies such as fatal shootings at Northern Illinois University and Virginia Tech have raised awareness about the prevalence of mental illness on college campuses.<br /><br />They also suggest that this age group might be particularly vulnerable.<br /><br />"For many, young adulthood is characterized by the pursuit of greater educational opportunities and employment prospects, development of personal relationships, and for some, parenthood," the authors said. These circumstances, they said, can result in stress that triggers the start or recurrence of psychiatric problems.<br /><br />The study was released Monday in Archives of General Psychiatry. It was based on interviews with 5,092 young adults in 2001 and 2002.<br /><br />Olfson said it took time to analzye the data, including weighting the results to extrapolate national numbers. But the authors said the results would probably hold true today.<br /><br />The study was funded with grants from the National Institutes of Health, the American Foundation for Suicide Prevention and the New York Psychiatric Institute.<br /><br />Dr. Sharon Hirsch, a University of Chicago psychiatrist not involved in the study, praised it for raising awareness about the problem and the high numbers of affected people who don't get help.<br /><br />Imagine if more than 75 percent of diabetic college students didn't get treatment, Hirsch said. "Just think about what would be happening on our college campuses."<br /><br />The results highlight the need for mental health services to be housed with other medical services on college campuses, to erase the stigma and make it more likely that people will seek help, she said.<br /><br />In the study, trained interviewers, but not psychiatrists, questioned participants about symptoms. They used an assessment tool similar to criteria doctors use to diagnose mental illness.<br /><br />Dr. Jerald Kay, a psychiatry professor at Wright State University and chairman of the American Psychiatric Association's college mental health committee, said the assessment tool is considered valid and more rigorous than self-reports of mental illness. He was not involved in the study. <br /><br />Personality disorders showed up in similar numbers among both students and non-students, including the most common one, obsessive compulsive personality disorder. About 8 percent of young adults in both groups had this illness, which can include an extreme preoccupation with details, rules, orderliness and perfectionism. <br /><br />Kay said the prevalence of personality disorders was higher than he would expect and questioned whether the condition might be overdiagnosed. All good students have a touch of "obsessional" personality that helps them work hard to achieve. But that's different from an obsessional disorder that makes people inflexible and controlling and interferes with their lives, he explained. <br /><br />Obsessive compulsive personality disorder differs from the better known OCD, or obsessive-compulsive disorder, which features repetitive actions such as hand-washing to avoid germs. OCD is thought to affect about 2 percent of the general population. The study didn't examine OCD separately but grouped it with all anxiety disorders, seen in about 12 percent of college-aged people in the survey. <br /><br />The overall rate of other disorders was also pretty similar among college students and non-students. <br /><br />Substance abuse, including drug addiction, alcoholism and other drinking that interferes with school or work, affected nearly one-third of those in both groups. <br /><br />Slightly more college students than non-students were problem drinkers - 20 percent versus 17 percent. And slightly more non-students had drug problems - nearly 7 percent versus 5 percent. <br /><br />In both groups, about 8 percent had phobias and 7 percent had depression. <br /><br />Bipolar disorder was slightly more common in non-students, affecting almost 5 percent versus about 3 percent of students.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/britains-nice-model-for-reforming-us.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-3682014790363228042?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/50-of-college-age-youth-have.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-7645645453753725289Sun, 07 Dec 2008 11:06:00 +00002008-12-07T06:08:01.305-05:00Today's front page report in The New York Times, British Balance Benefit vs. Cost of Latest Drugs, is part of the Times continuing series, The Evidence Gap.<br /><br />Whatever flaws the British healthcare system has in delivering high quality medical care to its citizenry--its model for reining in the exorbitant cost of new drugs and medical devices is a huge success. As Gardiner Harris reports, not only does the cost-benefit standard used by UK's National Institute for Health and Clinical Excellence (NICE) for determining whether to approve the most expensive drugs is succeeding at getting drug discounts "unavailable almost anywhere else"--which the pharmaceutical industry keeps hidden from other countries. <br /><br />The chairman of NICE, Dr. Michael Rawlins, understands how the industry works. By exercising its approval / disapproval authority, NICE has been able to a "good deal" from industry, he can's see why other countries are "so dim not to notice" the price differential. <br /><br />Whereas Britain took steps to rein in drug costs in 1995 when Viagra was approved, the US healthcare system has become unsustainable by all measures: the US spends the most per capita of any country in the world and it's getting worse healthcare for its Big Bucks. Even the US Secretary of Health and Human Services, Michael Levitt, acknowledges that US expenditure for healthcare "could potentially drag our nation into a financial crisis that makes our major subprime mortgage crisis look like a warm summer rain."<br /><br />Dr. Rawlins is fully cognizant of the drug industry's corrupt and corrupting practices: "I want them to produce new drugs for conditions we really need treatments for, but I loathe their marketing practices, which corrupt doctors in a dreadful way."<br /><br />Ironically, the Times reports that Dr. Mark McClellan who served in the Bush administration as chief of the FDA, then administrator of the Center for Medicare and Medicaid Services--an architect of the government's give-away to Big Pharma by instituting a policy prohibiting Medicare from negotiating drug prices, now acknowledges "the American government would soon have no choice" but to adopt a system akin to NICE for reigning in drug expenditures.<br /><br />Another barometer of its success is the fact that the NICE model is being adopted by more and more countries in Europe and South America--and even healthcare experts in the US are conceding that "NICE is the only workable paradigm."<br /><br />Surely President-Elect Barak Obama and his team will not be deterred by the army of Pharmaceutical industry lobbyists from bringing cost-benefit effectiveness into the equation when tackling a healthcare system that has hugely enriched an unscrupulous industry while failing its citizenry. <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.nytimes.com/2008/12/03/health/03nice.html" target="_blank">Link</a>]<strong>THE NEW YORK TIMES<br />December 3, 2008<br />The Evidence Gap<br />British Balance Gain Against the Cost of the Latest Drugs<br />By GARDINER HARRIS</strong><br /><br />RUISLIP, England — When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Mr. Hardy is British, and the British health authorities refused to buy the medicine. His wife has been distraught.<br /><br />“Everybody should be allowed to have as much life as they can,” Joy Hardy said in the couple’s modest home outside London.<br /><br />If the Hardys lived in the United States or just about any European country other than Britain, Mr. Hardy would most likely get the drug, although he might have to pay part of the cost. A clinical trial showed that the pill, called Sutent, delays cancer progression for six months at an estimated treatment cost of $54,000.<br /><br />But at that price, Mr. Hardy’s life is not worth prolonging, according to a British government agency, the National Institute for Health and Clinical Excellence. The institute, known as NICE, has decided that Britain, except in rare cases, can afford only £15,000, or about $22,750, to save six months of a citizen’s life.<br /><br />British authorities, after a storm of protest, are reconsidering their decision on the cancer drug and others.<br /><br />For years, Britain was almost alone in using evidence of cost-effectiveness to decide what to pay for. But skyrocketing prices for drugs and medical devices have led a growing number of countries to ask the hardest of questions: How much is life worth? For many, NICE has the answer.<br /><br />Top health officials in Austria, Brazil, Colombia and Thailand said in interviews that NICE now strongly influences their policies.<br /><br />“All the middle-income countries — in Eastern Europe, Central and South America, the Middle East and all over Asia — are aware of NICE and are thinking about setting up something similar,” said Dr. Andreas Seiter, a senior health specialist at the World Bank.<br /><br />Even in the United States, rising costs have led some in Congress to propose an institute that would compare the effectiveness of new medical technologies, although the proposals so far would not allow for price considerations. At the present rate of growth, medical costs will increase to 25 percent of the nation’s gross domestic product in 2025 from 16 percent, with half of the increase coming from new drugs and devices, according to the Congressional Budget Office.<br /><br />To arrest this trend, the United States needs to adopt at least some of NICE’s methods, said Dr. Mark McClellan and Dr. Sean Tunis, who served earlier in the Bush administration as, respectively, administrator and chief medical officer of the Center for Medicare and Medicaid Services. Dr. Tunis said he spent a lot of time in government “learning about NICE and trying to adopt the processes and mechanisms they used, and we just couldn’t.”<br /><br />That’s because the idea of using price to determine which drugs or devices Medicare or Medicaid provides has provoked fierce protests. But Dr. McClellan said the American government would soon have no choice.<br /><br />Drug and device makers, which once routinely denounced the British for questioning product prices, have begun quietly slashing prices in Britain to gain NICE’s coveted approval, especially because other nations are following the institute’s lead. Companies have said that they will consult with NICE to help determine which experimental compounds enter the final stage of clinical trials, so the British agency’s officials will soon influence which drugs enter the market in the United States.<br /><br />The British government created NICE a decade ago to ensure that every pound spent buys as many years of good-quality life as possible, but the agency is increasingly rejecting expensive treatments. The denials have led to debate over what is to blame: company prices or the health institute’s math.<br /><br />Dr. Michael Rawlins, chairman of NICE, blames the industry, saying that some companies raise prices “to get profits up so their executives can get better bonuses.” Dr. Karol Sikora, a prominent London oncologist, said that the institute’s math was flawed and that Dr. Rawlins had a “personal vendetta” against cancer treatments.<br /><br />Drug company executives who were interviewed uniformly promised to cooperate with NICE, but industry advocates were not so kind. Robert Goldberg, vice president of the Center for Medicine in the Public Interest, an advocacy group financed by drug makers, likened Dr. Rawlins and his institute to terrorists and said their decisions were morally indefensible.<br /><br />Developing a Method<br /><br />It all started with Viagra.<br /><br />Pfizer’s introduction of the drug in 1998 panicked British health officials, who feared it would wreck the government’s health budget. So they placed restrictions on its use. Pfizer sued, claiming the government’s decision was arbitrary. To defend itself against similar claims, the government needed a standard method of rationing. The following year, NICE opened.<br /><br />Asked whether he thought the institute would succeed, Frank Dobson, the Labor health minister at the time, famously said, “Probably not, but it’s worth a bloody good try.”<br /><br />Britain’s National Health Service provides 95 percent of the nation’s care from an annual budget, so paying for costly treatments means less money for, say, sick children. Before NICE, hospitals and clinics often came to different decisions about which drugs to buy, creating geographic disparities in care that led to outrage. (Such disparities are common in the United States, even for federal Medicare patients.)<br /><br />Now, any drug or device approved by the institute must be offered to patients. The institute has also written hundreds of treatment guidelines in hopes of improving, and making more consistent, basic medical care.<br /><br />The institute has analyzed the cost-effectiveness of surgical operations, cancer screening tests and medical devices. For example, it found that drug-coated cardiac stents were worth only $450 more than bare-metal ones. In the United States, stent price differences are often far wider.<br /><br />Five years ago, the British health institute recommended more emergency room CT scans of patients suffering from head trauma — forcing hospitals to buy more machines.<br /><br />But the decisions that get the most attention are those involving new drugs. Any drug that provides an extra six months of good-quality life for £10,000 — about $15,150 — or less is automatically approved, while those that give six months for $22,750 or less might get approved. More expensive medicines have been approved only rarely. The spending limits represent the health institute’s best guess for how much the nation can afford.<br /><br />After consulting a citizens group, the institute decided that the nation should spend the same amount saving or improving the life of a 75-year-old smoker as it would a 5-year-old.<br /><br />‘Muddling Through’<br /><br />The institute’s decision-making process involves a series of independent assessments, consultations with manufacturers, committee meetings, comment periods for outsiders and appeals that, taken together, Dr. Rawlins described as “procedural justice,” or “muddling through elegantly.” While the institute provides advice, decisions are made by one of three committees made up of doctors, nurses and economists from outside the government.<br /><br />Transparency recently became a high priority, but gaps in the idea of openness remain. At the institute’s first public decision-making appraisal meeting in September, staff members handed a reporter a stack of documents, only to snatch them back moments later. The committee’s chairman, Dr. David Barnett, was so intent on keeping the meeting brief that he told a committee member: “This must be the last question. It must be relevant. Otherwise, you will feel my wrath.”<br /><br />To analyze the value of the drug that Mr. Hardy, the kidney cancer patient, wanted, and the value of three other kidney cancer medicines, the British institute hired a university group that considered how many months the drugs delayed cancer’s progress.<br /><br />Firestorm of Protest<br /><br />The academics got drug prices and calculated the costs of administering them and treating their side effects. Not one of the drugs came close to being worth their expense, the group suggested. In a preliminary ruling in August, a committee from NICE agreed.<br /><br />The decision caused a firestorm. Twenty-six prominent British oncologists wrote a letter to The Sunday Times saying that the institute assessed cancer treatments poorly and that patients were remortgaging their homes to buy drugs freely available in other countries.<br /><br />Given that fewer than 6,000 people per year in England and Wales are diagnosed with kidney cancer, “Why put ourselves through so much heartache for very little money?” Andrew Dillon, the institute’s chief executive, asked in a September interview. “The answer is that if we don’t apply the same criteria even to small groups of patients, there’s little value to what we do at all.”<br /><br />Dr. Sikora, who helped organize the August protest, predicted in a September interview that the institute would buckle under political pressure.<br /><br />Flooded with anguished comments, the institute beat a hasty retreat. A preliminary consultation posted Nov. 5 said that the institute would instruct its appraisal committees to consider approving highly expensive life-saving drugs for terminal illnesses affecting fewer than 7,000 patients per year — a policy that seems tailor-made for Sutent and the three other kidney cancer drugs.<br /><br />Negotiations with companies on possible discounts are continuing, and a committee is scheduled on Jan. 14 to make public this nascent compromise.<br /><br />NICE has stood fast in other areas, though, rejecting Kineret for rheumatoid arthritis and Avonex for multiple sclerosis. In 2001, NICE ruled that Aricept and two other drugs used to treat Alzheimer’s disease were worth their costs only if patients’ conditions had increased from mild to moderate severity.<br /><br />The analysis put a value on patients’ improved thinking skills, and possible savings from delayed entry into nursing homes. Instead of pills, the institute suggested more counseling.<br /><br />Advocates for patients with Alzheimer’s disease called the decision heartless.<br /><br />Dr. Rawlins said he was frustrated that his institute had been censured instead of the drug company executives who set sky-high prices. Take the case of Celgene, the maker of Revlimid, a drug for multiple myeloma, a bone-marrow cancer, that in a preliminary ruling on Oct. 28 the institute said was too costly.<br /><br />Celgene’s first big seller was thalidomide, a decades-old medicine now used as a cancer treatment, which is so cheap to manufacture that a company in Brazil sells it for pennies a pill.<br /><br />Celgene initially spent very little on research and priced each pill in 1998 at $6. As the drug’s popularity against cancer grew, the company raised the price 30-fold to about $180 per pill, or $66,000 per year. The price increases reflected the medicine’s value, company executives said.<br /><br />In 2005, the company introduced Revlimid, a derivative of thalidomide that is supposed to be less toxic, but may be no more effective. Celgene priced it at about $260 per pill, or $94,000 per year.<br /><br />Offering Discounts<br /><br />Private and public insurers in the United States must pay whatever Celgene and other makers of unique cancer medicines decide to charge, so prices are soaring. Spending on cancer drugs and other such specialty medicines rose 9 percent last year and now represents 24 percent of the nation’s drug bill, according to Health Strategies Group, a New Jersey consulting company. Drug expenses in 2006 grew faster than any other part of the nation’s health bill except home care.<br /><br />But because of the institute, Britain’s National Health Service has been among the first to balk at paying such prices, which has led many companies to offer the British discounts unavailable almost anywhere else.<br /><br />Johnson & Johnson, for instance, agreed to charge for Velcade, another drug for multiple myeloma, only if tests showed it was effective in a particular patient. Novartis agreed to give free injections of Lucentis, a drug for age-related macular degeneration, if patients needed more than 14 shots. Dr. Rawlins said these deals were constructed by drug makers to hide from other countries the discounts offered in Britain.<br /><br />“It’s a good deal for us, but I can’t see that it will work in the long run because I can’t see that others countries will be so dim as to not notice it,” Dr. Rawlins said.<br /><br />A more prudent bureaucrat would never make such a remark. Dr. Rawlins said that he delighted in controversy, “although I’ll admit that it doesn’t always work out.” He wears thick glasses and fine suits whose pockets are stuffed with nicotine gum packages that rattle as he walks. He laughs easily, plays the piano and viola, and moves effortlessly between politics and medicine.<br /><br />His criticisms of the pharmaceutical industry have sharpened.<br /><br />“I want them to produce new drugs for conditions we really need treatments for, but I loathe their marketing practices, which corrupt doctors in a dreadful way,” said Dr. Rawlins, who until recently practiced general medicine and for years was chairman of the British version of the Food and Drug Administration. “And I’m very conscious that the prices the pharmaceutical industry charges are what they think the market will bear.”<br /><br />In 10 years, the health institute’s budget has grown to $50 million from $13 million, and it is scheduled to rise to $142 million in four years. NICE has 270 employees, who include doctors, economists and pharmacists.<br /><br />Worldwide Impact<br /><br />Agencies like NICE are popping up across the globe. Dr. Leonardo Cubillos, Colombia’s national director of insurance, said that Colombia was using British methods to choose drugs for a national health insurance package.<br /><br />Membership in an international group of drug and device assessment agencies grew to 45 last year from 8 in 1992. The British institute has created a consulting group to advise foreign governments.<br /><br />Much of the reason for this proliferation of agencies is that, while prescription drugs represent just 10.3 percent of overall medical spending in the United States, that share is 17 percent on average in industrialized countries.<br /><br />As spending on drugs soared in many nations — often haphazardly — overall health often showed little improvement. So international aid agencies are advising governments to adopt British assessments and deliberations to improve their public’s health while lowering costs, and officials are listening — a trend that is likely to accelerate during the present global economic slowdown.<br /><br />The health institutes in both Britain and Germany may soon suggest prices for drugs, a strategy intended to deflect political pressure back on the companies and shorten negotiations that now often take months.<br /><br />“We have been told that the price is the price, but the worm is turning now,” Dr. Barnett said.<br /><br />Company executives acknowledge that they are increasingly acceding to British demands to slash prices.<br /><br />But the most pressing question for the industry is what influence the British institute will have in the United States. The United States already spends more than twice as much per capita on health care as the average of other industrialized nations, while getting generally poorer health outcomes.<br /><br />Michael O. Leavitt, the Bush administration’s secretary of health and human services, said in a September speech that, at its present growth rate, health care spending “could potentially drag our nation into a financial crisis that makes our major subprime mortgage crisis look like a warm summer rain.”<br /><br />And while there is fierce disagreement about how and whether to control drug and device expenses as part of a broader reform of the health system, many say some cost controls are inevitable. At a September device industry conference in Washington, a seminar on the issue was standing-room only and half of the questioners mentioned NICE.<br /><br />John R. Dwyer Jr., a Washington lawyer who represents device makers, said that many in the industry have believed that major changes to control costs in the federal Medicare program were inevitable, and “people see NICE as the only workable paradigm.”<br /><br />Meanwhile, Mr. Hardy waits. In recent weeks his growing tumor has pressed on a nerve that governs his voice. He can barely speak and is increasingly out of breath. The Hardys are hoping that in January NICE will approve the use of Sutent, allowing Mr. Hardy further treatment.<br /><br />"It’s hard to know that there is something out there that could help but they’re saying you can’t have it because of cost,” said Ms. Hardy, who now speaks for her husband of 45 years. “What price is life?”</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/ssris-not-recommended-for-youth4-000.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-7645645453753725289?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/britains-nice-model-for-reforming-us.htmlnoreply@blogger.com (Vera Hassner Sharav)2tag:blogger.com,1999:blog-35205931.post-1436492125780244892Sat, 06 Dec 2008 22:25:00 +00002008-12-06T17:26:24.731-05:00The headline news in The Australian reads: 4000 Australian children under 10 prescribed antidepressants, 48 babies. "Experts appalled" "Numbers beyond comprehension"<br /><br />SSRIs have severe adverse effects--including a two to six-fold increased risk of suicide attempts--and that risk is NOT offset by a benefit. <br /><br />CNN reports (below) that based on an analysis of individual biomarkers which predict effectiveness of drugs ("personalized medicine" or Referenced EEG), confirms the evidence from controlled clinical trials--that children and adolescents do not respond positively to SSRI antidepressants: <br /><br />"One conclusion of this analysis was that, at most, 26 percent of these patients might be expected to sustain a good response to an SSRI. Seventy-four percent would not be expected to be responders, or their response probability would be so low as to question the risk of negative response to the probability of positive response. The poster notes, 'These results question the rationalization of SSRIs as a first-line treatment without the benefit of some physiologic marker to select the appropriate child or adolescent candidate'." <br /><br />If 74% of children who are prescribed SSRIs don't benefit but are put at increased serious risk of harm, what propels doctors--mostly psychiatrists--other than financial incentives (i.e. kickbacks)--to prescribe SSRI antidepressants for children? In Australia, no antidepressant is approved for the treatment of depression in children and adolescents." <br /><br />Even as the validated scientific evidence demonstrates that psychotropic drugs are doing far more harm than good--especially when prescribed for children / adolescents whose developing brains and bodies are damaged by the serious adverse effects of drugs such as the SSRI antidepressants and so-called 'atypical' antipsychotics (i.e. neuroleptics) doctors--mostly psychiatrists--in the US and Australia disregard the warnings, disregard the perceptible drug-induced harmful effects for patients.<br /><br />The Australian Adverse Drug Reactions Advisory Committee warns doctors against prescribing any of the SSRI anti-depressant drugs to children under 18 - aside from two that are approved for obsessive compulsive disorder in children aged over six years - and points out that the drug companies themselves advise against their use for any condition. <br /><br />But, The Australian reports, "There are numerous examples in the Health Department figures that show doctors are ignoring the warnings." <br /><br />Australian doctors, it appears, are following the abusive prescribing protocol that irresponsible US psychiatrists follow. See: [<a href="http://psychrights.org/Kids/080225PharmalotNJLegislatorProbeAntipsychotics2Kids.htm" target="_blank">Link</a>]<br /><br />Gordon Parker, executive director of the Black Dog Institute, a non-profit devoted to education about depression and bipolar disorder: "At first pass, it is beyond comprehension that more than 500 Australian children - aged one to five years - have received an antidepressant drug. When the particular drugs are considered, the risk of significant side effects - let alone their efficacy - is of key concern. It strikes me that there would be wisdom in having the doctors justify such prescriptions to determine whether there are any justifiable reasons for such surprising data." <br /><br />The US and Australian pediatric SSRI drug prescribing data provides evidence for indicting physicians who prescribe these drugs for children of undermining the health of children. <br /><br />The real tragedy is that doctors who are given a government license to prescribe drugs safely for the benefit of patients, are abusing their license. They are prescribing drugs they know (or should know if they read the evidence) cause patients harm. Doctors--not drug companies--are to blame for creating a public health crisis. <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://money.cnn.com/news/newsfeeds/articles/marketwire/0451591.htm" target="_blank">Link</a>]<strong>CNN<br />CNS Response Provides Poster Review Regarding the Use of SSRIs in Children and Adolescents<br />November 12, 2008</strong><br /><br />CNS Response, Inc. (OTCBB: CNSO) reported today the results of a study presented at the U.S. Psychiatric and Mental Health Congress by Daniel Hoffman, M.D., Chief Medical Officer for CNS Response. The poster presentation, titled "First Do No Harm: Children and SSRIs," provided an analysis of the utilization of SSRIs (Selective Serotonin Reuptake Inhibitors) as a first-line treatment in children or adolescents without the benefit of a physiologic marker technology, such as CNS Response rEEGR-guided pharmacotherapy. <br /><br />"This is my second poster on how rEEG personalized medicine has helped advance our medical obligation to 'First Do No Harm,'" commented Dr. Hoffman. "Due to the FDA's warning of suicide risk, coupled with the popularity of SSRI prescriptions for children and adolescents, we reviewed the CNS Response rEEG database and associated reports, in combination with our own patient data, to look for any trends in this age range that might provide further insights in consideration of these medications. The results beg for a larger analysis, as the findings give credence to SSRIs not being the drug of choice for some children and adolescents with depression. A system, like rEEG, to better guide appropriate selection of those children and adolescents, would be of great value to all." <br /><br />Researchers had the benefit of two data sets. The first data set was the rEEG analysis of 65 unmedicated patients and their associated rEEG-guided medication report. The second data set was comprised of 15 patients whose outcomes were known after following the rEEG treatment guidance. <br /><br />Results in the 15 patients were used to estimate probable results, based on stratification of the larger group of 65 patients through their own rEEG response prediction. The rEEG database gives a predictive probability score of medication response delineated by medication class, type and specific drug, where Sensitive has an 80 percent or greater probability, Intermediate has a 35 to 85 percent probability, and Resistant has a < 35 percent probability that patients with this brainwave (QEEG) pattern will have a positive response. <br /><br />One conclusion of this analysis was that, at most, 26 percent of these patients might be expected to sustain a good response to an SSRI. Seventy-four percent would not be expected to be responders, or their response probability would be so low as to question the risk of negative response to the probability of positive response. The poster notes, "These results question the rationalization of SSRIs as a first-line treatment without the benefit of some physiologic marker to select the appropriate child or adolescent candidate." <br /><br />"While it is difficult to draw scientific conclusions from this non-statistically sampled review, the low number of cases indicating SSRI responsiveness was noteworthy, given the clinical popularity of those medications," said CNS Response Chief Executive Officer Len Brandt. "I think this is an example of the utility of rEEG's ability to extend beyond specific, personalized medication to use as an analytical tool in consideration of medical policy." <br /><br />The full poster presentation and analysis of results are available at [<a href="http://www.cnsresponse.com/ssriposterpresentation" target="_blank">Link</a>]</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.theaustralian.news.com.au/story/0,25197,24743413-23289,00.html" target="_blank">Link</a>]<strong>THE AUSTRALIAN<br />4000 Australian children under 10 prescribed antidepressants <br />Julie-Anne Davies<br />2 Dec 2008</strong> <br /><br />Unpublished figures show that nearly 4,000 children under the age of 10 were prescribed antidepressants last year, including 553 children under five and 48 babies, even though no antidepressant is approved in Australia for the treatment of depression in children and adolescents, The Australian reports.<br /><br />"At first pass, it is beyond comprehension that more than 500 Australian children - aged one to five years - have received an antidepressant drug," Gordon Parker, executive director of the Black Dog Institute, a non-profit devoted to education about depression and bipolar disorder, tells the paper. "When the particular drugs are considered, the risk of significant side effects - let alone their efficacy - is of key concern. It strikes me that there would be wisdom in having the doctors justify such prescriptions to determine whether there are any justifiable reasons for such surprising data." <br /><br />The figures are based on Pharmaceutical Benefits Schedule data that covers only people who received a subsidized prescription, according to the paper, which notes that most antidepressants are sold privately. A spokesman for the pediatric division of the Royal Australian College of Physicians was unable to explain the prescribing patterns: "The college would like to know who is prescribing these drugs to such young children and why." <br /><br />Parliamentary Secretary for Health and Ageing Jan McLucas tells the paper that the government would be "very concerned if antidepressant medications were being inappropriately prescribed and dispensed, particularly to children." And the government's Therapeutic Goods Administration issued a statement saying it was powerless to regulate the use of off-label med, but maintained there might be medical practice and medico-legal implications associated with prescribing a drug beyond approved indications. <br /><br />The Adverse Drug Reactions Advisory Committee warns doctors against prescribing any of the SSRI antidepressant drugs to children under 18 -aside from two that are approved for obsessive compulsive disorder in children aged over six years - and points out that drugmakers themselves advise against their use for any condition. <br /><br />There are numerous examples in the Health Department figures that show doctors are ignoring the warnings, according to the paper. <br /><br />Wyeth's Effexor carries this statement: "Do not give Effexor XR to children or adolescents under 18 years of age. The safety and effectiveness of Effexor XR in this age group have not been established." Yet, 3,347 children and teenagers were prescribed the drug last financial year. Eight were babies, 19 were aged two and three and another 15 were five years old. A Wyeth spokeswoman tells the paper the drug was not indicated for use in children and adolescents below 18 years of age, and it had never recommended its use in this population.<br /><br />Two SSRI antidepressants have Therapeutic Goods Administration approval to treat children as young as six years for Obsessive Compulsive Disorder; and other, older antidepressants can be prescribed by doctors to treat bedwetting. But even allowing for these conditions, Royal Australian College of Psychiatrists spokesman Peter Jenkins tells the Australian the figures were mysterious and worrying. <br /><br />The Health Department figures were obtained by the Citizens Commission on Human Rights, a Church of Scientology-backed lobby group opposed to anti-depressant therapy. <br /><br />The most comprehensive research into SSRI anti-depressants and their use in children and adolescents in 2004 led to drugmakers being forced to include a warning in product labeling, stating the drugs could increase the risk of suicidal thoughts and behaviour in children. This followed the results of an extensive analysis of clinical trial data by the FDA in the US. <br /><br />According to the Health Department figures, the most commonly prescribed antidepressant for children and adolescents aged under 18 years is Prozac, with 7833 given the drug in the past year, including 863 children aged under 10.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/expert-or-pharma-shill.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-1436492125780244892?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/ssris-not-recommended-for-youth4-000.htmlnoreply@blogger.com (Vera Hassner Sharav)1tag:blogger.com,1999:blog-35205931.post-2547503832289459488Sat, 06 Dec 2008 21:23:00 +00002008-12-06T16:24:11.166-05:00The stench of corrupt practices by psychiatry's peer anointed "experts" is now a matter of public record. So is the cover-up by elite academic institutions.<br /><br />The editors of The New York Times state: "appalling conflicts of interest throw into doubt the advice rendered and the research performed by two prominent psychiatrists who have received substantial funding from the pharmaceutical industry." <br /><br />The most recently 'outed' psychiatrists whose disgraceful professional and personal misconduct is documented in internal corporate documents: Dr. Joseph Biederman, of Harvard University, and Dr. Frederick Goodwin, former director of the National Institute of Mental Health. <br /><br />Dr. Goodwin and his long-running program, "The Infinite Mind," on National Public Radio were kicked off the air only after Sen. Grassley made public Dr. Goodwin's financial conflicts of interest. Dr. Goodwin covertly promoted psychotropic drugs: he mischaracterized the safety of antidepressants, while concealing substantial payments from GlaxoSmithKline, maker of the antidepressant, Paxil.<br /><br />Dr. Biederman continues to hold sway as the influential professor of psychiatry at Harvard Medical School, and Chief of Clinical / Research Programs in pediatric psychopharmacology at Massachusetts General Hospital. Indeed, Dr. Biederman is "credited" with a 40-fold (that's 4,000%) increase the use antipsychotics in children. He bears major responsibility for the harm these drugs have produced in children, such as 4-year old Rebecca Riley, who died of drug toxicity. [<a href="http://ahrp.blogspot.com/2007/02/4-year-old-rebecca-riley-casualty-of.html" target="_blank">Link</a>] <br /><br />Both Drs. Goodwin and Biederman are considered pillars of American psychiatry: both have been showered with awards and "honors" by their professional peers as well by industry supported "advocacy" groups--such as CHADD, NAMI, NARSAD--all of whom shill for industry.<br /><br />Dr. Biederman's biography is posted on the Harvard University website: [<a href="http://www.mgh.harvard.edu/pediatricpsych/staff/biederman.html" target="_blank">Link</a>]<br /><br />"Dr. Biederman has been the recipient of the American Psychiatric Association Blanche Ittelson Award for Excellence in Child Psychiatric Research, the American Academy of Child and Adolescent Psychiatry Charlotte Norbert Rieger Award for Scientific Achievement. He has been inducted into the CHADD "Hall of Fame". Dr Biederman has also been selected every year since its inception into the Best Doctors in America" compilation of the best physicians in the country. <br /><br />Dr. Biederman has been a mentor to more than 15 junior investigators in the field. He is on the editorial board of multiple journals, a reviewer for most of the Psychiatric journals, and has served as a grant reviewer in the Child Psychopathology and Treatment Review Committee of the NIMH. Dr. Biederman is the author and co-author of close to 600 scientific articles, 650 scientific abstracts, and 70 book chapters. <br /><br />In 2000, Dr. Biederman pioneered and established a Stanley Foundation Center at the Massachusetts General Hospital dedicated to the treatment of pediatric bipolar disorder. Dr. Biederman was the recipient of the 1998 NAMI Exemplary Psychiatrist award. He was also the recipient of the 2002 NARSAD Senior Investigator award. Since 2002 Dr. Biederman has been Associate Editor and from 2005-2006 Deputy Editor for Child Psychiatry in Biological Psychiatry, ranked as the third most impactful scientific journal in Psychiatry. In 2005 Dr. Biederman was appointed Chair of the section on ADHD at the World Psychiatric Association. He was also recently selected by the Massachusetts Psychiatric Society Awards committee as the recipient of the 2007 Outstanding Psychiatrist Award for Research. In 2007, Dr. Biederman received the Excellence in Research Award from the New England Council of Child and Adolescent Psychiatry. He was also awarded the Mentorship Award from the Department of Psychiatry at the Massachusetts General Hospital in September.<br /><br />As of March 2007, Dr. Biederman has been ranked as the second highest producer of high-impact papers in psychiatry overall throughout the world with 235 papers cited a total of 7048 times over the past 10 years as determined by the Institute for Scientific Information (ISI). The same organization ranked Dr. Biederman at #1 in terms of total citations to his papers published on ADD/ADHD in the past decade. Dr. Biederman's work is supported by multiple federal and pharmaceutical industry grants."<br /><br />Dr. Goodwin's biography, posted on Best Practice: [<a href="http://www.best-practice.net/about/leadershipteam/bio.asp?FN=frederickkgoodwin&ACPgID=12&ACPgImgID=4" target="_blank">Link</a>]<br /><br />"Dr. Goodwin is a recipient of the major research awards in his field including the Hofheimer Prize from the American Psychiatric Association, the A.E. Bennett Award from The Soc. Of Biological Psychiatry, the Psychopharmacology Research Award from the American Psychological Association, the International Anna-Monika Prize for Research in Depression, the Edward A. Strecker Award, the Falcone Prize from NARSAD, the McAlpin Research Award from the National Mental Health Association, the Distinguished Service Award from NAMI, and the Research Award from the American Foundation for Suicide Prevention and the Lifetime Achievement Award from International Review Of Bipolar Disorders He was the first recipient of the Psychiatrist of the Year from Psychiatric Times, and the Fawcett Humanitarian Award of the NDMDA, the Public Service Award from the Federation of American Societies for Experimental Biology (FASEB), and the Hope Award from the Depression and Bipolar Support Alliance (DBSA). In 1998 he was elected and served as President of the Psychiatric Research Society."<br /><br />The Times calls upon universities and professional societies "to crack down on conflicts of interest, and for Congress to pass legislation that will bring hidden conflicts into the open."<br /><br />However, the corrupting influence pharmaceutical industry money on medicine--and psychiatry's disgraced leadership in particular--will not end with generic disclosures that conceal the $$$ amounts. Drug manufacturers pay fees for services rendered--the higher the fees the more substantial the services. <br /><br />Furthermore, it is disingenuous to claim that universities and professional societies knew nothing about the financial ties of its leading psychiatrists. If we knew, how could Harvard administrators claim, they not know?<br /><br />Indeed, universities, such as Harvard, and professional societies such as the American Psychiatric Association, are themselves the recipients of substantial--multi-million dollar--financial support from the prescription drug industry. These institutions have high stakes in ensuring the profitability of that industry.<br /><br />The needed prescription for reform is not merely posting a laundry list of corporations that fund physician / scientists. What's needed is mandatory open access to ALL the research data--whether funded by taxpayers or drug manufacturers. Only when ALL of the data is independently analyzed will the integrity of science-based medicine be restored.<br /><br />To achieve transparency--which is the essential ingredient for scientific integrity--federal legislation is needed: 1. Requiring the FDA to post ALL clinical trial data submitted by manufacturers; 2. Prohibiting government agencies from awarding grants to scientists who refuse to sign a contractual obligation to make ALL their drug research data available--no matter who the sponsor is, whether the findings are positive or negative, whether published or not.<br />See J & J Risperdal documents detailing fees paid for Dr. Biederman's services and J & Js list of KOLs (key opinion leaders in psychiatry): [<a href="http://psychrights.org/Research/Digest/NLPs/Risperdal/081112Opp2BiedermanQuash-Seal.pdf" target="_blank">Link</a>] <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.nytimes.com/2008/11/30/opinion/30sun2.html" target="_blank">Link</a>]<strong>THE NEW YORK TIMES<br />November 30, 2008<br />Editorial<br />Expert or Shill?</strong><br /><br />More evidence has emerged of appalling conflicts of interest that throw into doubt the advice rendered and the research performed by two prominent psychiatrists who have received substantial funding from the pharmaceutical industry. The revelations prove, once again, the need for universities and professional societies to crack down on conflicts of interest, and for Congress to pass legislation that will bring hidden conflicts into the open.<br /><br />Earlier this year, Congressional investigators discovered that Dr. Joseph Biederman, a world-renowned child psychiatrist at Harvard Medical School and Massachusetts General Hospital, had failed to report to Harvard at least $1.4 million in income from drug companies, in violation of the university's conflict-of-interest guidelines.<br /><br />Now, internal drug company e-mail and documents that surfaced in a lawsuit have sketched out what looks like an unsavory collaboration between Dr. Biederman and Johnson & Johnson to generate and disseminate data that would support use of an antipsychotic drug, Risperdal, in children, a controversial target group.<br /><br />The various documents indicate that Dr. Biederman repeatedly asked a Johnson & Johnson subsidiary to fund a research center at Massachusetts General to focus on children and adolescents with bipolar disorders and that the company provided almost $1 million. Disturbingly, one of the center's publicly stated missions, along with improving the psychiatric care of children, was to "move forward the commercial goals of J.& J."<br /><br />The company also drafted a scientific abstract on Risperdal for Dr. Biederman to sign - as if he were the author - before it was presented at a professional meeting. And it sought his advice on how to handle the uncomfortable fact, not mentioned in the abstract, that children given placebos, not just those given Risperdal, also improved significantly.<br /><br />Dr. Biederman's work and reputation have helped fuel a huge increase in the use of powerful, risky and expensive antipsychotic medicines in young people, an upsurge that brought a warning recently from a federally appointed panel of experts. Now it is hard to know whether he has been speaking as an independent expert or a paid shill for the drug industry.<br /><br />Congressional investigators also recently reported that Frederick Goodwin, an influential psychiatrist who has been hosting a popular weekly program on public radio, earned at least $1.3 million by giving marketing lectures for drug makers who potentially stood to benefit from the recommendations he made on the program. He has rightly been removed from the air.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/fda-sets-melamine-safety-standard-for.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-2547503832289459488?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/expert-or-pharma-shill.htmlnoreply@blogger.com (Vera Hassner Sharav)2tag:blogger.com,1999:blog-35205931.post-6850402203305071983Sat, 06 Dec 2008 20:06:00 +00002008-12-06T15:07:42.972-05:00The problem of melamine-laced infant formula first surfaced in China in September when it was reported that 54,000 babies were sickened and several died. On October 3, FDA officials insisted: "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns." <br /><br />FDA scientists said then that they couldn't set an acceptable level of melamine exposure in infant formula because science hadn't had enough time to understand the chemical's effects on infants' underdeveloped kidneys. Plus, there is the complicating factor that infant formula often constitutes a newborn's entire diet.<br /><br />However, days after the Associated Press disclosed that FDA had found traces of melamine and traces of cyanuric acid had been found in different US- made baby formula, the FDA changed its position. The FDA set a safety standard that ALLOWS higher levels of melamine than those found in the US made baby products.<br /><br />Question: Was this change in FDA's position an accommodation to the business interests of US infant formula manufacturers? Ninety percent of infant formula in the US are manufactured by Abbott Laboratories, Nestle and Mead Johnson. <br /><br />FDA officials now urge parents to continue feeding their infants with whatever formula they have been using, insisting the formulas "are safe." <br /><br />The Associate Press reports (below): "Dr. Stephen Sundlof, the FDA's director of food safety, said Friday the agency was confident in the 1 part per million level for either of the chemicals alone, even though there have been no new scientific studies since October that would give regulators more safety data. He had no ready explanation for why the level was not set earlier. The standard is the same as the one public health officials have set in Canada and China, but is 20 times higher than the most stringent level in Taiwan.<br /><br />Dr. Sundlof told the AP the melamine traces found in US products "so far are in the trace range, and from a public health or infant health perspective, we consider those to be perfectly fine." That's a radical departure from FDA's Oct 3 zero tolerance statement.<br /><br />"This is a slippery slope of rationalization by FDA," said Urvashi Rangan, a senior scientist with the Consumers Union in New York. <br /><br />See, The FDA's melamine guidance: [<a href="http://www.fda.gov/oc/opacom/hottopics/melamine.html" target="_blank">Link</a>]<br /><br />FDA's rationalizations about the unsubstantiated safety of melamine in baby formula is all too reminiscent of FDA and CDC (Center for Disease Control) officials' insistence that Thimerosal-laced vaccines were absolutely "safe" and bore "absolutely" no relation to autism.<br />What is known about the development of children fed formulas containing traces of melamine?<br /><br />Was FDA's position change from zero tolerance of melamine in baby formula an accommodation to the business interests of US infant formula manufacturers?<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.fda.gov/oc/opacom/hottopics/melamine.html" target="_blank">Link</a>]<strong>ASSOCIATED PRESS<br />FDA sets melamine standard for baby formula<br />By JOAN LOWY and JUSTIN PRITCHARD</strong><br />WASHINGTON (AP) - Two months ago, federal food regulators said they were unable to set a safety threshold for the industrial chemical melamine in baby formula. Now, however, they found a way to settle on a standard that allows for higher levels than those found in U.S.-made batches of the product.<br /><br />Food and Drug Administration officials on Friday set a threshold of 1 part per million of melamine in formula, provided a related chemical is not present. They insisted the formulas are safe.<br /><br />The development comes days after The Associated Press reported that FDA tests found traces of melamine in the infant formula of one major U.S. manufacturer and cyanuric acid, a chemical relative, in the formula of a second major maker. The contaminated samples, which both measured at levels below the new standard, were analyzed several weeks ago.<br /><br />The FDA had said in early October it was unable to set a safety contamination level for melamine in infant formula.<br /><br />Dr. Stephen Sundlof, the FDA's director of food safety, said Friday the agency was confident in the 1 part per million level for either of the chemicals alone, even though there have been no new scientific studies since October that would give regulators more safety data. He had no ready explanation for why the level was not set earlier.<br /><br />The standard is the same as the one public health officials have set in Canada and China, but is 20 times higher than the most stringent level in Taiwan.<br /><br />The problem of melamine in infant formula first surfaced in China in September.<br /><br />Sundlof said the lack of dual contamination was key because studies so far show dangerous health effects only when both chemicals are present. He emphasized that neither of the two tainted samples had both contaminants.<br /><br />The agency still will not set a safety level for melamine if cyanuric acid is also present, he said.<br /><br />Both the new safety level and the amount of the chemical found in U.S.-made infant formula are far below the amounts of melamine added to infant formula in China that have been blamed for killing at least three babies and making thousands ill.<br /><br />"The levels were so low ... that they do not cause a health risk to infants," Sundlof said. "Parents using infant formula should continue using U.S.-manufactured infant formula. Switching away from one of these infant formulas to alternate diets or homemade formulas could result in infants not receiving the complete nutrition required for proper growth and development."<br /><br />A scientist for a national consumer group said it was irresponsible of FDA to assure the public that infant formula is safe based on tests of only 74 samples, especially since cyanuric acid is a byproduct of melamine, making it likely that they will be found together.<br /><br />"This is a slippery slope of rationalization by FDA," said Urvashi Rangan, a senior scientist with the Consumers Union in New York. "FDA needs to get a handle on how widespread the problem is and, most important, if both these chemicals are occurring in any products. They just haven't tested enough to know that yet."<br /><br />Earlier this week, members of Congress and the Illinois attorney general demanded a national recall, something FDA said made no sense because it had no evidence suggesting that the formula would be dangerous for babies at the levels of contamination found.<br /><br />After saying it made an error in its data, the FDA on Wednesday produced these results: Nestle's Good Start Supreme Infant Formula with Iron had two positive tests for melamine on one sample; Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron had three positive tests on one sample for cyanuric acid.<br /><br />Separately, a third major formula maker, Abbott Laboratories, told the AP that in-house tests had detected trace levels of melamine in its infant formula.<br /><br />Those three formula makers manufacture more than 90 percent of all infant formula produced in the United States.<br /><br />The agency had left the impression of a zero tolerance on Oct. 3 when it stated: "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns."<br /><br />The FDA and other experts said they believe the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally. The U.S. government quietly began testing domestically produced infant formula in September, soon after problems with melamine-spiked formula surfaced in China.<br /><br />Melamine can legally be used in some food packaging, and can rub off into food from there. It's also part of a cleaning solution used on some food processing equipment.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>FDA finds traces of melamine in US infant formula<br />By MARTHA MENDOZA and JUSTIN PRITCHARD - 3 days ago</strong><br /><br />Traces of the industrial chemical melamine have been detected in samples of top-selling U.S. infant formula, but federal regulators insist the products are safe.<br /><br />The Food and Drug Administration said last month it was unable to identify any melamine exposure level as safe for infants, but a top official said it would be a "dangerous overreaction" for parents to stop feeding infant formula to babies who depend on it.<br /><br />"The levels that we are detecting are extremely low," said Dr. Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "They should not be changing the diet. If they've been feeding a particular product, they should continue to feed that product. That's in the best interest of the baby."<br /><br />Melamine is the chemical found in Chinese infant formula - in far larger concentrations - that has been blamed for killing at least three babies and making at least 50,000 others ill.<br /><br />Previously undisclosed tests, obtained by The Associated Press under the Freedom of Information Act, show that the FDA has detected melamine in a sample of one popular formula and the presence of cyanuric acid, a chemical relative of melamine, in the formula of a second manufacturer.<br /><br />Separately, a third major formula maker told AP that in-house tests had detected trace levels of melamine in its infant formula.<br /><br />The three firms - Abbott Laboratories, Nestle and Mead Johnson - manufacture more than 90 percent of all infant formula produced in the United States.<br /><br />The FDA and other experts said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, rather than intentionally.<br /><br />The U.S. government quietly began testing domestically produced infant formula in September, soon after problems with melamine-spiked formula surfaced in China.<br /><br />Sundlof said there have been no reports of human illness in the United States from melamine, which can bind with other chemicals in urine, potentially causing damaging stones in the kidney or bladder and, in extreme cases, kidney failure.<br /><br />Melamine is used in some U.S. plastic food packaging and can rub off onto what we eat; it's also contained in a cleaning solution used on some food processing equipment and can leach into the products being prepared.<br /><br />Sundlof told the AP the positive test results "so far are in the trace range, and from a public health or infant health perspective, we consider those to be perfectly fine."<br /><br />That's different from the impression of zero tolerance the agency left on Oct. 3, when it stated: "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns."<br /><br />FDA scientists said then that they couldn't set an acceptable level of melamine exposure in infant formula because science hadn't had enough time to understand the chemical's effects on infants' underdeveloped kidneys. Plus, there is the complicating factor that infant formula often constitutes a newborn's entire diet.<br /><br />The agency added, however, that its position did not mean that any exposure to a detectable level of melamine and melamine-related compounds in infant formula would result in harm to infants.<br /><br />Still, the announcement was widely interpreted by manufacturers, the news media and Congress to mean that infant formula that tested positive at any level could not be sold in the United States.<br /><br />The Grocery Manufacturers Association, for example, told its members: "FDA could not identify a safe level for melamine and related compounds in infant formula; thus it can be concluded they will not accept any detectable melamine in infant formula."<br /><br />It was not until the AP inquired about tests on domestic formula that the FDA articulated that while it couldn't set a safe exposure for infants, it would accept some melamine in formula - raising the question of whether the decision to accept very low concentrations was made only after traces were detected.<br /><br />On Sunday, Sundlof said the agency had never said, nor implied, that domestic infant formula was going to be entirely free of melamine. He said he didn't know if the agency's statements on infant formula had been misinterpreted.<br /><br />In China, melamine was intentionally dumped into watered-down milk to trick food quality tests into showing higher protein levels than actually existed. Byproducts of the milk ended up in infant formula, coffee creamers, even biscuits.<br /><br />The concentrations of melamine there were extraordinarily high, as much as 2,500 parts per million. The concentrations detected in the FDA samples were 10,000 times smaller - the equivalent of a drop in a 64-gallon trash bin.<br /><br />There would be no economic advantage to spiking U.S.-made formula at the extremely low levels found in the FDA testing. It neither raises the protein count nor saves valuable protein, said University of California, Davis chemist Michael Filigenzi, a melamine detection expert.<br /><br />According to FDA data for tests of 77 infant formula samples, a trace concentration of melamine was detected in one product - Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron. An FDA spreadsheet shows two tests were conducted on the Enfamil, with readings of 0.137 and 0.14 parts per million.<br /><br />Three tests of Nestle's Good Start Supreme Infant Formula with Iron detected an average of 0.247 parts per million of cyanuric acid, a melamine byproduct.<br /><br />The FDA said last month that the toxicity of cyanuric acid is under study, but that meanwhile it is "prudent" to assume that its potency is equal to that of melamine.<br /><br />And while the FDA said tests of 18 samples of formula made by Abbott Laboratories, including its Similac brand, did not detect melamine, spokesman Colin McBean said some company tests did find the chemical. He did not identify the specific product or the number of positive tests.<br /><br />McBean did say the detections were at levels far below the health limits set by all countries in the world, including Taiwan, where the limit is 0.05 parts per million.<br /><br />"We're talking about trace amounts right here, and you know there's a lot of scientific bodies out there that say low levels of melamine are always present in certain types of foods," said McBean.<br /><br />Mead Johnson spokeswoman Gail Wood said her company's in-house tests had not detected any melamine, and that the company had not been informed of the FDA test results, even during a confidential agency conference call Monday with infant formula makers about melamine contamination.<br /><br />The FDA tests also detected melamine in two samples of nutritional supplements for very sick children who have trouble digesting regular food. Nestle's Peptamen Junior medical food showed 0.201 and 0.206 parts per million of melamine while Nestle's Nutren Junior-Fiber showed 0.16 and 0.184 parts per million.<br /><br />The agency said that while there are no established exposure levels for infant formula, pediatric medical food - often used in feeding tubes for very sick, young children - can have 2.5 parts per million of melamine, just like food products other than infant formula.<br /><br />In a written response to questions, a Nestle spokesman denied that any of the company's products contained cyanuric acid, and said its products are safe.<br /><br />Rep. Rosa DeLauro, D-Conn., who heads a panel that oversees the FDA budget, said the agency was taking a "marketplace first, science last" approach.<br /><br />"The FDA should be insisting on a zero-tolerance policy for melamine in domestic infant formula until it is able to determine conclusively based on sound independent science that the trace levels would not pose a health risk to infants," DeLauro said.<br /><br />Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, said: "If no safe level of melamine has been established for consumption by children, then the FDA should immediately recall any formula that has tested positive for even trace amounts of the contaminant."<br /><br />Several medical experts said trace concentrations would be diluted even in an infant, and are highly unlikely to be harmful.<br /><br />"It's just a tiny amount, it's very unlikely to cause stones," said Stanford University Medical School pediatrics professor Dr. Paul Grimm.<br /><br />Dr. Jerome Paulson, an associate professor of pediatrics at Children's National Medical Center in Washington, D.C., said he didn't think the FDA's decision was unreasonable. He added, however, that the agency should research the impacts of long-term, low-dose exposure, "and not just assume it's safe, and then 15 years from now find out that it's not."</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/biederman-coi-backlash-boston-globe.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-6850402203305071983?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/fda-sets-melamine-safety-standard-for.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-6714407730717193878Mon, 01 Dec 2008 21:21:00 +00002008-12-01T16:22:29.230-05:00PBS Frontline reports: "Now the controversial Dr. Biederman is back in the headlines...." <br /><br />"Newly disclosed court documents portray Dr. Joseph Biederman, a leading Harvard child psychiatrist, as courting drug company money by promising that his work at Massachusetts General Hospital would help promote the use of antipsychotic drugs for youngsters diagnosed with bipolar disorder.<br /><br />Biederman is one of the central figures in the growing legal and political backlash against potential conflicts of interest in medicine, particularly in psychiatry." Boston Globe<br /><br />Public Broadcasting System (PBS)-Frontline provides several useful links to news coverage of (what some critics are calling) the abusive prescribing of toxic psychotropic drugs for children. <br /><br />The Boston Globe highlights the key issues confirmed by the latest evidence. As has been the pattern with most secret company documents, these were uncovered in the context of a major lawsuit.<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>PBS-Frontline<br />In the News Ask Your Doctor?<br />November 26, 2008</strong><br /><br />"All of a sudden, out of nowhere, bipolar disorder was being diagnosed left, right and center." David Shaffer, M.D., Chief, Child Psychiatry, Columbia University<br /><br />Dr. Joseph Biederman, an influential child psychiatrist, made embarrassing news last June when it was revealed that he had failed to disclose over a million dollars in fees from drug companies whose antipsychotic medications he had promoted to treat bipolar disorder in children.<br /><br />Now the controversial Dr. Biederman is back in the headlines, this time over new conflict of interest questions regarding his financial ties to pharmaceutical giant Johnson and Johnson. For the latest developments on the story, see The New York Times and The Wall Street Journal. For the full back-story, take a look at The Medicated Child, FRONTLINE's recent hour on the dramatic rise in diagnosis and drug treatment of ADHD and bipolar disorder in children. [<a href="http://www.pbs.org/wgbh/pages/frontline/medicatedchild/" target="_blank">Link</a>] <br /><br />Veteran FRONTLINE producer Marcela Gaviria tells the moving stories of families struggling to help their children cope with the pain and confusion of conditions that may, or may not, be susceptible to pharmaceutical solution. [<a href="http://www.pbs.org/wgbh/pages/frontline/medicatedchild/" target="_blank">Link</a>]<br /><br />The brief excerpt from the film on this page spotlights Dr. Biederman's seminal role in the story. [<a href="http://www.pbs.org/wgbh/pages/frontline/medicatedchild/You" target="_blank">Link</a>] can also watch the entire program, and dig deeper into the subject, on this webpage. And for deeper background still, you can see Marcela's previous FRONTLINE, Medicating Kids, broadcast in 2001, on the early days of ADHD diagnosis, and the contentious battles fought over whether and how to treat it. [<a href="http://www.pbs.org/wgbh/pages/frontline/shows/medicating/" target="_blank">Link</a>]</div><br /><br />One final source to recommend: Judith Warner has written thoughtfully in her NY Times blog on how hard it is to assess the pros and cons of antipsychotic medications for children. [Excerpt below] [<a href="http://warner.blogs.nytimes.com/2008/11/20/tough-choices-for-tough-children/" target="_blank">Link</a>]<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.boston.com/news/local/massachusetts/articles/2008/11/25/papers_reveal_push_on_drug_firm_funds/" target="_blank">Link</a>]<strong>Papers Reveal Push on Drug Firm Funds<br />Prominent doctor tied to efforts<br />By Carey Goldberg, Globe Staff <br />November 25, 2008</strong><br /><br />Newly disclosed court documents portray Dr. Joseph Biederman, a leading Harvard child psychiatrist, as courting drug company money by promising that his work at Massachusetts General Hospital would help promote the use of antipsychotic drugs for youngsters diagnosed with bipolar disorder.<br /><br />Biederman is one of the central figures in the growing legal and political backlash against potential conflicts of interest in medicine, particularly in psychiatry. He could not be reached for comment yesterday, but Massachusetts General Hospital said it would thoroughly investigate the allegations against him.<br /><br />The psychiatrist is the country's most prominent advocate of diagnosing bipolar disorder in children, even those under age 6, and using antipsychotic drugs to treat many of them, even when federal regulators have not approved the drugs for that use. Congressional investigators led by Senator Charles E. Grassley, an Iowa Republican, accused Biederman this summer of failing to disclose more than $1 million in payments from drug companies. Harvard Medical School is investigating those reporting discrepancies.<br /><br />He is now also emerging as a key witness in a huge, multistate lawsuit brought on behalf of more than 2,000 patients, including children, who claim to have been injured by psychiatric drugs known as atypical antipsychotics, including the Johnson & Johnson drug Risperdal, also known as risperidone.<br /><br />Biederman is not a defendant in the case, but the plaintiffs' lawyers submitted more than two dozen documents aiming to present him as an exam ple of how drug companies and researchers conspired to boost "off-label" prescriptions that go beyond federally approved uses of a drug.<br /><br />The plaintiffs' lawyers sought to compel Biederman to let them interview him - a legal fight they won. He is expected to be interviewed under oath by January.<br /><br />Biederman issued a statement earlier this year saying he had complied with conflict of interest rules at Mass. General and Harvard.<br /><br />It is legal for doctors to prescribe drugs for off-label purposes, but not for drug companies to actively market such uses. To get around that restriction, drug marketers recruit and pay respected "opinion leaders" like Biederman to discuss their off-label prescribing experiences with colleagues at company-sponsored "educational" talks or meetings.<br /><br />In one internal 2002 e-mail that the plaintiffs' lawyers submitted, executives of Janssen Pharmaceuticals - the Johnson & Johnson subsidiary that markets Risperdal - discuss Biederman's repeated proposals for the company to help fund a center on pediatric bipolar disorder at Massachusetts General. "The rationale of this center is to generate and disseminate data supporting the use of risperidone in this patient population," it says.<br /><br />It wasn't until five years later, in 2007, that the Food and Drug Administration approved Risperdal for children with bipolar disorder.<br /><br />Another document, the 2002 annual report of the center that was ultimately created and directed by Biederman, states that one of the center's "essential features" is its ability to conduct research that "will move forward the commercial goals of J&J" - Johnson & Johnson. An e-mail from November of that year mentions at least $700,000 in Johnson & Johnson payments to the center.<br /><br />Massachusetts General Hospital issued a statement yesterday saying that the center, the MGH-Johnson & Johnson Center for the Study of Pediatric Psychopathology, existed from 2002 to 2006 and gave many researchers "the infrastructure necessary to complete projects related to the psychiatric care of children in an efficient, expeditious, and integrated manner."<br /><br />The hospital controlled the center's programs, it said, and, "The grant agreements stated that the center was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates."<br /><br />The allegations in the Risperdal case "have raised significant questions and concerns about the implementation of those agreements," the statement said. "The MGH takes these allegations very seriously and intends to investigate these issues thoroughly."<br /><br />Attempts to reach Biederman at his office were unsuccessful.<br /><br />Some of the legal documents reflect the ticklish dealings that drug company employees had with Biederman.<br /><br />In one 1999 e-mail, a Janssen employee seeking to make sure Biederman receives $3,000 that the company owes him writes frantically to his superiors: "Dr. Biederman is not someone to jerk around. He is a very powerful national figure in child psych and has a very short fuse."<br /><br />Another document in the court case suggests that Janssen employees ghost-wrote a summary of a study, to be presented at a 2002 meeting of child psychiatrists, on which Biederman was to be listed as presenting author. They appeared to seek his help in making the results appear more positive for Risperdal. In a reply, he agreed to be named as author but it was not clear whether he provided the requested help.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://warner.blogs.nytimes.com/2008/11/20/tough-choices-for-tough-children/" target="_blank">Link</a>]<strong>THE NEW YORK TIMES BLOG<br />November 20, 2008, 9:00 pm<br />Tough Choices for Tough Children<br />By Judith Warner</strong><br /><br />EXCERPT<br /><br />It was disturbing to read in The Times this week that the "atypical" antipsychotic Risperdal, a tranquilizing whopper of a drug with serious, sometimes deadly side effects, is now being widely prescribed to children with attention deficit hyperactivity disorder.<br /><br />This despite the fact that Risperdal, which is used in children mostly to treat bipolar disorder, isn't approved for A.D.H.D., and apparently doesn't work for treating it at all. So why, according to new Food and Drug Administration data on doctors' prescribing practices, were 16 percent of the pediatric users of Risperdal over the past three years children with A.D.H.D.?<br /><br />The simple answer is to point fingers at the drug companies, whose aggressive efforts to promote off-label use of this problematic new class of drugs have resulted in a spate of lawsuits, including one recently filed by the Arkansas attorney general that accuses Risperdal's manufacturer, Johnson & Johnson, of having "engaged in a direct, illegal, nationwide program of promotion of the use of Risperdal for non-medically necessary uses" - like the treatment of A.D.H.D..<br /><br />But I think the truth is more complicated than that. I think that what's happening is that children with big problems are being given big, bad drugs because no one really knows what to do with them..... cut .....<br /><br />Many doctors, influenced by the work of Dr. Joseph Biederman at Harvard Medical School (whose ties to industry were detailed in The Times in June), say these symptoms are signs of mania, and call these children bipolar. Others label them with "extreme A.D.H.D." or Oppositional Defiant Disorder or "severe mood dysregulation," a diagnosis that's been proposed by Dr. Ellen Leibenluft, chief of the section on Bipolar Spectrum Disorders in the Mood and Anxiety Disorders Program at the National Institute of Mental Health.<br /><br />For the past five years, Dr. Leibenluft has been tracking 100 children she believes have severe mood dysregulation, studying the course of their illness and the outcome of their treatment. Sixty percent of these children were diagnosed with bipolar disorder - mistakenly, she believes - before she met them. Ninety percent of them meet the criteria for diagnoses of A.D.H.D. or O.D.D. Sixty percent suffer from serious anxiety. Twenty-five percent had an episode of major depression before they turned 12.<br /><br />"The severely mood dysregulated children are as sick as the bipolar children. They're severely impaired," she told me this week. "You can see easily why people would feel you need to use medication. But what medication? We don't have the data to see what medication because we don't yet know how to think about these children diagnostically." cut ...<br /><br />And it isn't just a matter of semantics.<br /><br />Category change could mean treatment change. Children who are diagnosed as bipolar, even if they have attention issues, anxiety or depression, often aren't treated with stimulants (the first-line treatment for A.D.H.D) or antidepressants, because some prominent child psychiatrists have argued that they make bipolar children much worse. So physicians who suspect children are bipolar instead try the much more powerful atypicals, which have much more serious side effects. But severe mood dysregulated children wouldn't necessarily have to go the atypical route. And there is also data to indicate a real role for non-drug therapy.<br /><br />In other words, thinking hard about these kids - instead of merely moralizing about them and their psychotropic drug use - may well lead to a situation in which atypical use can be greatly reduced.<br /><br />This will not satisfy the critics of today's biological psychiatry for whom no drug use is good drug use, nor the critics of today's culture of parenting who are sure that all the aggression, irritability and out-of-control behavior that psychiatrists call mental illness is actually nothing more than a state of "toddlerhood in perpetuity" caused by ineffective parenting practices, as the conservative family psychologist and writer John Rosemond and his coauthor have asserted in his new book, "The Diseasing of America's Children."<br /><br />It won't solve the problem of the drug companies' predatory marketing practices, or of thought leaders in psychiatry renting out their minds for the sake of fancy vacations and top-flight meals. But the fact that efforts are being made, in a concerted way, to figure out what lies behind the scary-sounding statistics about drugs like Risperdal argues, I think, for hope. After a period in which drug companies have had way too much power in determining how children with psychiatric issues are treated, the pendulum may be swinging back.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/evidence-gap-in-current-medical-rx.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-6714407730717193878?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/biederman-coi-backlash-boston-globe.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-5055012891028061444Mon, 01 Dec 2008 21:20:00 +00002008-12-01T16:20:58.961-05:00The New York Times revisits the story of how Pfizer scuttled the government-sponsored $130 million (ALLHAT, "antihypertensive and lipid lowering to prevent heart attack trial" ) study findings published in the 18 December issue of JAMA (2002;288;2981-97). <br /><br />The study compared incidence of heart attacks, strokes and other cardiovascular problems in 42,000 patients randomized into one of four drugs: a diuretic called chlorthalidone; an ACE inhibitor called lisinopril, which AstraZeneca sold as Zestril; a calcium channel blocker, amlodipine, sold by Pfizer as Norvasc; and an alpha blocker, doxazosin, which Pfizer sold as Cardura. <br /><br />The study was conducted by the National Heart, Lung and Blood Institute (NHLBI), after it was noticed that there was no real evidence that the newer, expensive, drugs were better than the old, cheap diuretics. Use of the more expensive pills added an estimated $3.1 billion to the nation’s medical bill over that period. <br /><br />Cardura was added only after Pfizer, which had already agreed to contribute $20 million to the trial’s costs, increased that to $40 million. However, Pfizer’s bet on Cardura proved a big mistake. The ALLHAT data showed that patients taking Cardura were nearly twice as likely as those receiving the diuretic to require hospitalization for heart failure, a condition in which the heart cannot pump blood adequately. The finding lead the NHLBI to suspend the Cardura part of the trial in 2000.<br /><br />What happened next provides insight into just how Big Pharma companies embark on aggressive marketing and large cash payments to key opinion leaders (KOLs) and authoritative professional associations--in this case, the American College of Cardiology--to drown out negative scientific findings that would diminish prescriptions.<br /><br />The saga was reported by Jeanne Lenzer in the BMJ (British Medical Journal) in 2003 [1] "Pfizer was not alone in blunting the response to ALLHAT results. The American College of Cardiology (ACC) issued an alert in March 2000 urging doctors to "discontinue use" of Cardura. However, another Pfizer memo dated 28 March 2000 and stamped "confidential" says that Pfizer was "successful in getting the ACC to agree to a clarification" of the ACC press release. The "clarification" that the ACC agreed upon replaced its initial press release on the ACC website within just hours of the original posting and changed the recommendation that Cardura be discontinued to a much milder recommendation that doctors "reassess" its use. It may have added to Pfizer's standing with the ACC that Pfizer has contributed more than $500 000 (£312 000; 474 000) annually to the college in recent years." [<a href="http://tinyurl.com/6j6tbw" target="_blank">Link</a>] <br /><br />The Times reports (below): <br /><br />"Rather than warn doctors that Cardura might not be suited for hypertension, Pfizer circulated a memo to its sales representatives suggesting scripted responses they could use to reassure doctors that Cardura was safe, according to documents released from a patients’ lawsuit against the company."<br /><br />"Tensions about industry influence reached even the study’s own steering committee. Dr. Furberg, the chairman, bluntly accused some members of the committee of being agents of the industry."<br /><br />"Dr. Richard H. Grimm Jr. of the University of Minnesota, had led an effort to remove Dr. Furberg from his position on the grounds that he had not been impartial. Dr. Grimm had been receiving tens of thousands of dollars a year from Pfizer since at least 1997, according to reports that pharmaceutical companies file in that state. In 2003, the year after the ALLHAT results were published, Dr. Grimm’s payments from Pfizer soared to more than $200,000." <br /><br />"Dr. Grimm said in a recent interview that about half those fees in 2003 came from giving about 100 Pfizer-sponsored talks to doctors about Allhat. Dr. Grimm said he gave mainly the standard Allhat-sanctioned talk. But instead of saying diuretics were outright better than the other drugs, he said they were as good or better."<br /><br />"And in an e-mail message unearthed in those same court documents, a Pfizer sales executive boasted to colleagues that company employees had diverted some European doctors attending an American cardiology conference from hearing a presentation on the Allhat results and Cardura. “The good news,” the message said, “is that they were quite brilliant in sending their key physicians to sightsee rather than hear Curt Furberg slam Pfizer once again!” <br /><br />The Food and Drug Administration waited a year before convening a meeting of outside experts to discuss Cardura’s safety. And when the FDA got around to doing so, there was sharp disagreement about the ALLHAT study conclusions. They argued that the heart failure cases might have been false readings and that an inadequate dose of Cardura had been used in the trial. The committee decided that there was no need to issue an urgent warning to doctors and patients about Cardura.<br /><br />Cardura sales held up in 2000. Pfizer’s decision to stop promoting Cardura in late 2000--after the drug lost patent protection--was the most likely primary factor resulting in the drug's sales decline. Drug comanies pull the purse strings and doctors happily march in log step: they hardly act like the "learned intermediaries" they were supposed to be.<br /><br /><strong>Reference:</strong><br /><br />Lenzer J. Spin doctors soft pedal data on antihypertensives, BMJ 2003;326:170 ( 18 January )<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>November 28, 2008<br />The Evidence Gap<br />The Minimal Impact of a Big Hypertension Study<br />By ANDREW POLLACK</strong><br /><br />The surprising news made headlines in December 2002. Generic pills for high blood pressure, which had been in use since the 1950s and cost only pennies a day, worked better than newer drugs that were up to 20 times as expensive.<br /><br />The findings, from one of the biggest clinical trials ever organized by the federal government, promised to save the nation billions of dollars in treating the tens of millions of Americans with hypertension — even if the conclusions did seem to threaten pharmaceutical giants like Pfizer that were making big money on blockbuster hypertension drugs.<br /><br />Six years later, though, the use of the inexpensive pills, called diuretics, is far smaller than some of the trial’s organizers had hoped.<br /><br />“It should have more than doubled,” said Dr. Curt D. Furberg, a public health sciences professor at Wake Forest University who was the first chairman of the steering committee for the study, which was known by the acronym Allhat. “The impact was disappointing.”<br /><br />The percentage of hypertension patients receiving a diuretic rose to around 40 percent in the year after the Allhat results were announced, up from 30 to 35 percent beforehand, according to some studies. But use of diuretics has since stayed at that plateau. And over all, use of newer hypertension drugs has grown faster than the use of diuretics since 2002, according to Medco Health Solutions, a pharmacy benefits manager.<br /><br />The Allhat experience is worth remembering now, as some policy experts and government officials call for more such studies to directly compare drugs or other treatments, as a way to stem runaway medical costs and improve care.<br /><br />The aftereffects of the study show how hard it is to change medical practice, even after a government-sanctioned trial costing $130 million produced what appeared to be solid evidence.<br /><br />A confluence of factors blunted Allhat’s impact. One was the simple difficulty of persuading doctors to change their habits. Another was scientific disagreement, as many academic medical experts criticized the trial’s design and the government’s interpretation of the results.<br /><br />Moreover, pharmaceutical companies responded by heavily marketing their own expensive hypertension drugs and, in some cases, paying speakers to publicly interpret the Allhat results in ways that made their products look better.<br /><br />“The pharmaceutical industry ganged up and attacked, discredited the findings,” Dr. Furberg said. He eventually resigned in frustration as chairman of the study’s steering committee, the expert group that continues to oversee analysis of data from the trial. One member of that committee received more than $200,000 from Pfizer, largely in speaking fees, the year after the Allhat results were released.<br /><br />There was another factor: medicine moves on. Even before Allhat was finished, and certainly since then, new drugs appeared. Others, meanwhile, became available as generics, reducing the cost advantage of the diuretics. And many doctors have shifted to using two or more drugs together, helped by pharmaceutical companies that offer combination pills containing two medicines.<br /><br />So Allhat’s main query — which drug to use first — became “an outdated question that doesn’t have huge relevance to the majority of people’s clinical practices,” said Dr. John M. Flack, the chairman of medicine at Wayne State University, who was not involved in the study and has consulted for some drug makers.<br /><br />Dr. Sean Tunis, a former chief medical officer for Medicare, remains an advocate for comparative-effectiveness studies. But, as Allhat showed, “they are hard to do, expensive to do and provoke a lot of political pushback,” said Dr. Tunis, who now runs the nonprofit Center for Medical Technology Policy, which tries to arrange such trials.<br /><br />“There’s a lot of magical thinking,” he said, “that it will all be science and won’t be politics.”<br /><br /><strong>Expensive Pills</strong><br /><br />Promising better ways to treat high blood pressure, drug companies in the 1980s introduced a variety of medications, including ones known as calcium channel blockers and ACE inhibitors.<br /><br />Although there was no real evidence the newer pills were better, diuretics fell to 27 percent of hypertension prescriptions in 1992, from 56 percent in 1982. Use of the more expensive pills added an estimated $3.1 billion to the nation’s medical bill over that period.<br /><br />So the National Heart, Lung and Blood Institute, part of the federal National Institutes of Health, decided to compare the various drugs’ ability to prevent heart attacks, strokes and other cardiovascular problems. “This was a big-bucks issue,” said Dr. Jeffrey Cutler, the Heart, Lung and Blood Institute’s project director for the study.<br /><br />Allhat — short for the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial — began enrolling patients with high blood pressure, age 55 and older, in 1994, with more than 42,000 people eventually participating. Patients were randomly assigned one of four drugs: a diuretic called chlorthalidone; an ACE inhibitor called lisinopril, which AstraZeneca sold as Zestril; a calcium channel blocker, amlodipine, sold by Pfizer as Norvasc; and an alpha blocker, doxazosin, which Pfizer sold as Cardura.<br /><br />Cardura was added only after Pfizer, which had already agreed to contribute $20 million to the trial’s costs, increased that to $40 million, Dr. Cutler said.<br /><br /><strong>Early Trouble Signs</strong><br /><br />Pfizer’s bet on Cardura proved a big mistake. As the Allhat data came in, patients taking Cardura were nearly twice as likely as those receiving the diuretic to require hospitalization for heart failure, a condition in which the heart cannot pump blood adequately. Concerned, the Heart, Lung and Blood Institute announced in March 2000 that it had stopped the Cardura part of the trial.<br /><br />What happened next provided the first signs that the Allhat evidence might not be universally embraced.<br /><br />Rather than warn doctors that Cardura might not be suited for hypertension, Pfizer circulated a memo to its sales representatives suggesting scripted responses they could use to reassure doctors that Cardura was safe, according to documents released from a patients’ lawsuit against the company.<br /><br />And in an e-mail message unearthed in those same court documents, a Pfizer sales executive boasted to colleagues that company employees had diverted some European doctors attending an American cardiology conference from hearing a presentation on the Allhat results and Cardura. “The good news,” the message said, “is that they were quite brilliant in sending their key physicians to sightsee rather than hear Curt Furberg slam Pfizer once again!”<br /><br />Pfizer declined to comment on the messages.<br /><br />The Food and Drug Administration waited a year before convening a meeting of outside experts to discuss Cardura’s safety. At that session, some of the experts sharply challenged the conclusions of the Allhat organizers. They argued that the heart failure cases might have been false readings and that an inadequate dose of Cardura had been used in the trial.<br /><br />By the end of the daylong meeting, Dr. Robert J. Temple, a senior F.D.A. official, was clearly exasperated by the experts’ varying interpretations of a supposedly definitive trial.<br /><br />“This is the largest and best attempt to compare outcomes we are ever going to see,” he said. “And people are extremely doubtful about whether it has shown anything at all.”<br /><br />The committee decided that there was no need to issue an urgent warning to doctors and patients about Cardura.<br /><br />Cardura sales held up in 2000. But the next year, worldwide sales fell to $552 million, from $795 million. Prescriptions for all alpha blockers fell 22 percent from 1999 to 2002 after having risen before then, according to one study.<br /><br />Pfizer’s decision to stop promoting Cardura in late 2000, after the drug lost patent protection, was a factor in the decline. But Allhat clearly was, too.<br /><br /><strong>Cost-Benefit Analysis</strong><br /><br />The main Allhat results were announced in December 2002 at a news conference in Washington and published in The Journal of the American Medical Association.<br /><br />In the primary target outcome of the trial — the prevention of heart attacks — the three remaining drugs were proved equal. But patients receiving the Norvasc calcium channel blocker from Pfizer had a 38 percent greater incidence of heart failure than those on the diuretic. And those receiving the ACE inhibitor from AstraZeneca had a 15 percent higher risk of strokes and a 19 percent higher risk of heart failure.<br /><br />Moreover, the diuretic cost only about $25 a year, compared with $250 for an ACE inhibitor and $500 for a calcium channel blocker. So the diuretic was declared the winner.<br /><br />But some hypertension experts accused the government of overstating the case for the diuretics, as a way to cut medical spending.<br /><br />“There was a feeling there was a political and economic agenda as much as a scientific agenda,” said Dr. Michael Weber, a professor of medicine at the Health Science Center at Brooklyn, part of the State University of New York, who had been an investigator in the study but afterward became one of its leading critics. “They pushed beyond what the data allowed them to say.”<br /><br />Critics said the rules of the trial had favored the diuretics. If the first drug did not adequately lower blood pressure — as happened in more than 60 percent of cases — a second drug could be added. But that second drug was usually a type that worked better with diuretics than with ACE inhibitors.<br /><br />There were also more new cases of diabetes among the patients who took diuretics, although experts argued over how meaningful that finding was.<br /><br />Adding fuel to the debate, an Australian study released two months after Allhat found an ACE inhibitor superior to a diuretic. The proper lesson to draw from Allhat, some critics contended, was that what matters most is how much blood pressure is lowered, not which drug is used to do it. For these and other reasons, European hypertension experts discounted Allhat.<br /><br />Allhat’s proponents discounted the Australian study as less authoritative, and they dismissed the other criticisms.<br /><br />Still, the arguments “muddied the waters,” said Dr. Randall S. Stafford of Stanford, who studied the effect of Allhat on prescriptions. “The message,” he said, “was no longer as clear to physicians.”<br /><br /><strong>Science Moves On</strong><br /><br />By the time the Allhat results were released, lisinopril, the ACE inhibitor, had become generic. That meant AstraZeneca and Merck, which sold a version of the compound as Prinivil, had less interest in defending their drugs.<br /><br />Not so Pfizer. Norvasc was the best-selling hypertension treatment in the world, with sales of $3.8 billion in 2002, and Pfizer’s second-biggest drug behind the cholesterol medication Lipitor.<br /><br />The company set out to accentuate the positive. In a news release after the Allhat results were announced, it said that Norvasc was found to be “comparable to the diuretic in fatal coronary heart disease, heart attacks and stroke.” And in a medical journal advertisement, it proclaimed “ALL HATs off” to its drug.<br /><br />Neither the news release nor the ad, however, included the 38 percent greater risk of heart failure with Norvasc in the Allhat study.<br /><br />Nor did Hank McKinnell, then Pfizer’s chief executive, mention heart failure in lauding the results during his quarterly earnings conference call with analysts a few weeks after the Allhat report was released. “Contrary to what you might have read in the press,” Mr. McKinnell said, “Allhat is extremely positive for Norvasc. It will be our job to explain that to the medical community.”<br /><br />Dr. Paul K. Whelton, president of Loyola University Health System and the current chairman of the Allhat steering committee, said that Pfizer and other drug companies “took what was in their best interest and ran with those, and conveniently didn’t mention other things.”<br /><br />Pfizer defends its actions. Dr. Michael Berelowitz, the head of Pfizer’s global medical organization, said that in the trial’s design, heart failure was merely one component of a broader measure of various cardiovascular problems. And in that broader measure, Dr. Berelowitz said, there was no difference between Norvasc and the diuretic. Also, he said, the label for Norvasc already contained a precaution about heart failure.<br /><br />“Further action regarding the heart failure finding was therefore not considered necessary,” he said in a statement in response to questions.<br /><br />Pfizer was not the only company promoting its drugs. The drug giant Novartis, for example, was spending heavily to market Diovan, a leader among a class of hypertension drugs called angiotensin receptor blockers, which were too new to have been included in Allhat. Diovan, which had more than $5 billion in sales last year, sells for $1.88 to $3.20 a pill on drugstore.com, compared with 8 to 31 cents for a diuretic.<br /><br />No company, though, was spending money to promote generic diuretics. So the federal Heart, Lung and Blood Institute recruited Allhat investigators, provided them with training and sent them to proselytize fellow physicians. In all, 147 investigators gave nearly 1,700 talks and reached more than 18,000 doctors and other health care providers.<br /><br />But it was a coffee-and-doughnuts operation compared with the sumptuous dinners that pharmaceutical companies used to market to doctors. Moreover, the steering committee’s outreach program did not get under way until about three years after the results were published.<br /><br />Dr. Stafford of Stanford said the outreach seemed to have had a slight effect on increasing the use of diuretics.<br /><br />The results of Pfizer’s efforts are easier to quantify. Norvasc sales continued to grow to $4.9 billion in 2006, falling only after the drug lost patent protection in the United States in 2007.<br /><br /><strong>Tangles and Strife</strong><br /><br />Tensions about industry influence reached even the study’s own steering committee. Dr. Furberg, the chairman, bluntly accused some members of the committee of being agents of the industry.<br /><br />One member, Dr. Richard H. Grimm Jr. of the University of Minnesota, had been receiving tens of thousands of dollars a year from Pfizer since at least 1997, according to reports that pharmaceutical companies file in that state.<br /><br />In 2003, the year after the Allhat results were published, Dr. Grimm’s payments from Pfizer soared to more than $200,000 — an increase that The New York Times reported in 2007.<br /><br />Dr. Grimm said in a recent interview that about half those fees in 2003 came from giving about 100 Pfizer-sponsored talks to doctors about Allhat. Dr. Grimm said he gave mainly the standard Allhat-sanctioned talk. But instead of saying diuretics were outright better than the other drugs, he said they were as good or better.<br /><br />Meanwhile, Dr. Grimm had led an effort to remove Dr. Furberg from his position on the grounds that he had not been impartial.<br /><br />“He had a vendetta against the calcium channel blockers,” Dr. Grimm said. Dr. Furberg had been publicly questioning the safety of those drugs based on some studies he did in the 1990s. The effort to oust Dr. Furberg failed in 2001. But in August 2004, Dr. Furberg resigned as chairman, contending that there had not been enough effort to disseminate the Allhat message.<br /><br />Dr. Whelton, who took over as chairman, said that the study’s message was never compromised by industry ties on the steering committee.<br /><br />“Curt is a wonderful guy who is a crusader,” said Dr. Whelton, who did not have industry ties and was not involved in the effort to unseat Dr. Furberg. “He has certainly rubbed a lot of people, even good friends, the wrong way.”<br /><br /><strong>Changing Practice</strong><br /><br />Experts see several lessons to be learned from Allhat.<br /><br />One is that “all trials have flaws” that leave the results open to interpretation, said Dr. Robert M. Califf, a cardiologist at Duke who served on the safety monitoring committee of Allhat.<br /><br />Another is that providing doctors information is “necessary, but not sufficient” to urge them to change their practices, said Dr. Carolyn M. Clancy, director of the federal Agency for Healthcare Research and Quality, which itself conducts studies comparing different medical treatments.<br /><br />And while insurers can influence practice through reimbursement policies, they did not seem to have pushed strongly for diuretics after Allhat, in part because some of the other drugs had become generic.<br /><br />Even the cost-conscious medical system at the Department of Veterans Affairs did not require diuretics, because too many doctors would probably have requested exceptions, said Dr. William C. Cushman, chief of preventive medicine at the department’s medical center in Memphis.<br /><br />Dr. Cushman, a member of the Allhat steering committee, said diuretic use in the system was still “much lower” than he thought it should be.<br /><br />Dr. Clancy said that her agency was now mainly using insurance records to judge how treatments perform. While clinical trials are the gold standard, she said, they are costly and time-consuming.<br /><br />And, she added, “You might be answering a question that by the time you are done, no longer feels quite as relevant.”</div><br /><br /><a href="http://ahrp.blogspot.com/2008/12/j-j-risperdal-documents-biederman.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-5055012891028061444?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/evidence-gap-in-current-medical-rx.htmlnoreply@blogger.com (Vera Hassner Sharav)1tag:blogger.com,1999:blog-35205931.post-7817460935821061754Mon, 01 Dec 2008 21:19:00 +00002008-12-01T16:20:12.947-05:00A group of internal emails by Johnson & Johnson officials-mostly from officials in the company's Risperdal marketing division-provide a bird's eye view of collusion between the drug giant and Harvard's leading child psychiatrist, Dr. Joseph Biederman, and one of Harvard's premier teaching hospitals, Massachusetts General Hospital. <br /><br />The New York Times reports (below) "Dr. Biederman's work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children. Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions in the world."<br /><br />An early e-mail (dated 1999) states: "Dr. Biederman is not someone to jerk around. He is a very proud national figure in child psych and has a very short fuse." <br /><br />A 2001 e-mail refers to university-based clinical trial programs as "growth opportunity" exercises similar to "money on the table" exercises.<br /><br />A Feb. 5, 2002 email related to the Johnson & Johnson Pediatric Research Center established at Harvard's Massachusetts General Hospital, states that Dr. Biederman "approached Janssen multiple times to propose the creation of the [center] to generate and disseminate data to support the use of risperidone in this patient population." "Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events."<br /><br />A 2002 annual report for the J&J funded Mass General Children's Center stated that an "essential feature" of its research is to "move forward the commercial goals of J&J." Dr. Biederman is the researcher whose "science" the FDA said it was leaning upon when it decided that pediatric bipolar disorder was a valid diagnosis back in July.<br /><br />The Wall Street Journal notes (below) that the Center's research work--as described in the annual report--appeared to focus exclusively on Risperdal. <br /><br />In 2001, Dr. Biederman began a three-year study on the use of Risperdal in 4- to 6-year-olds. That work, the WSJ reports, appears to have violated rules at Harvard and Mass General forbidding researchers from conducting clinical trials of a drug if they receive payments of more than $20,000 a year from a drug maker.<br /><br />Dr. Biederman and colleagues have published dozens of favorable studies on the drug. For example, a 2005 study concluded that "risperidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder."<br /><br />The commercial value of academic psychiatrists is acknowledged in a March 22, 2002 e-mail describing Dr. Biedeman's persuasive skills in convincing 1,000 psychiatrists about the validity of pediatric mania and the utility of Risperdal: "I think this is a clear example of the utility of partnering with a group such as MGH, who has the potential of reaching and having a significant impact upon the field of child and adolescent psychiatry with these types of professional activities in non-sponsored venues." <br /><br />The Times quotes a June 2002 e-mail from Dr. Gahan Pandina, a Johnson & Johnson executive, to Dr. Biederman which included a brief abstract of a study of Risperdal in children "diagnosed" with disruptive behavior disorder. The study was intended to be presented at the 2002 annual meeting of the American Academy of Child & Adolescent Psychiatry. <br /><br />One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly, "so, if you could, please give some thought to how to handle this issue if it occurs."<br /><br />The draft abstract that Dr. Pandina included in the e-mail, however, misrepresented the actual findings: the abstract stated that only the children given Risperdal improved, while those given placebos did not. <br /><br />According to the e-mail, when asked to sign a form listing himself as author so the company could present the study to the conference, Dr. Biederman responded: "I will review this morning. I will be happy to sign the forms if you could kindly send them to me." The documents do not make clear whether Dr. Biederman approved the final summary of the brief abstract or asked to read the longer report on the study.<br /><br />The WSJ reports that the emails suggest that the company's marketing staff were involved in creating the institute and that company officials helped to write and vet research work done by Dr. Biederman and his associates. The WSJ further reports that a Harvard spokesman, said the university is not directly involved in the child psychiatry center at Massachusetts General Hospital. <br /><br />However, the MGH website proudly states: "over the last 30 years we [psychiatry department] have been offering educational programs in Boston through Harvard Medical School's Division of Continuing Education which have drawn thousands of colleagues to learn a broad range of topics..." and "17 faculty members [of MGH psychiatry department] have achieved full professor rank at Harvard Medical School, the highest number in any department at the MGH."<br /><br />The e-mails were part of a group of documents submitted by plaintiff's attorneys seeking a judge's order to require Dr. Biederman to be deposed under oath were obtained by the Alliance for Human Research Protection after they became public. <br /><br />Dr. Biederman is scheduled to be deposed in Boston on January 30, 2009.<br /><br />These internal emails validate the view that partnerships and financial ties between drug manufacturers and academia undermine the integrity of medical research and, by extension, the practice of medicine. The absence of independent checks and balances in medicine, the absence of trustworthy government gatekeepers to guard against corrupt practices, millions of American children are being forced to ingest unsafe, toxic psychotropic drugs for unvalidated scientifically unsupportable "conditions." <br /><br />Drug manufacturers are hardly the only ones to blame--American children are being victimized by a consortium of influential psychiatrists at prestigious academic institutions--a list of about 30 KOLs (key opinion leaders in psychiatry) is contained in one of the J & J Risperdal documents; psychiatry's professional associations lend their "authoritative" support to this crime--as do a bevy of industry-financed patient "advocacy" groups. As if that were not enough, government agencies that were established to protect the public health and the scientific process have also come under the influence of industry.<br /><br />These commercially-driven stakeholders are condemning children to a life of drug dependency and drug-induced disabling chronic physical and mental illnesses.<br /><br />If the new administration is serious about healthcare reform--a suggestion to protect children from harm and save (literally) hundreds of millions of taxpayer dollars. First, Medicaid should not pay for off-label use of drugs for unvalidated non-life-threatening conditions. Secondly, doctors prescribing psychotropic drugs for children should be registered, and the prescriptions monitored for abuse by the Drug Enforcement Agency. <br /><br />See, several internal J & J documents posted on the WSJ website: Discussions about the Children's Center [<a href="http://s.wsj.net/public/resources/documents/WSJ_Risperdal46-47-112408.pdf" target="_blank">Link</a>] <br /><br />A breakdown of J & J's goals and budget for the Center research [<a href="http://s.wsj.net/public/resources/documents/WSJ_Risperdal125-127-112408.pdf" target="_blank">Link</a>] <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0"><strong>THE NEW YORK TIMES<br />November 25, 2008<br />Research Center Tied to Drug Company <br />By GARDINER HARRIS</strong><br /><br />When a Congressional investigation revealed in June that he had earned far more money from drug makers than he had reported to his university, Dr. Joseph Biederman, a world-renowned child psychiatrist, said that his "interests are solely in the advancement of medical treatment through rigorous and objective study."<br /><br />But e-mails and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to fund a research center at Massachusetts General Hospital whose goal was "to move forward the commercial goals of J&J," the documents state. The documents also show that Johnson & Johnson wrote a draft summary of a study that Dr. Biederman, of Harvard University, was said to author. <br /><br />Dr. Biederman's work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children. Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions in the world. Johnson & Johnson manufactures Risperdal, also known as risperidone, a popular antipsychotic medicine. More than a quarter of Risperdal's use is in children and adolescents. <br /><br />Last week, a panel of federal drug experts said that medicines like Risperdal are being used far too cavalierly in children and that federal drug regulators must do more to warn doctors of their substantial risks. Other popular antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify, made by Bristol-Myers Squibb.<br /><br />Thousands of parents have sued Johnson & Johnson, AstraZeneca and Eli Lilly, claiming that their children were injured after taking the medicines, whose risks the companies minimized, the parents claim. As part of the suits, plaintiffs' attorneys have demanded millions of documents from the companies. Nearly all of those documents have been provided under judicial seals, but a select few that mentioned Dr. Biederman became public after plaintiffs attorneys sought a judge's order to require Dr. Biederman to be interviewed by plaintiff attorneys under oath. <br /><br />In a motion filed two weeks ago, attorneys for the families argued that they should be allowed to interview Dr. Biederman under oath because his work has been crucial to the widespread acceptance of pediatric uses of antipsychotic medicines. To support this contention, the lawyers included more than two dozen documents, including e-mails from Johnson & Johnson that mentioned Dr. Biederman. That interview request has yet to be ruled upon. <br /><br />The documents offer an unusual glimpse into the delicate relationship that drug makers have with influential doctors. In one November 1999 e-mail, John Bruins, a Johnson & Johnson marketing executive, begs his supervisors to approve a $3,000 check to Dr. Biederman in payment for a lecture he gave at the University of Connecticut. "Dr. Biederman is not someone to jerk around," Mr. Bruins wrote. "He is a very proud national figure in child psych and has a very short fuse."<br /><br />Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made to receive a $280,000 research grant. "I have never seen someone so angry," Mr. Bruins wrote. "Since that time, our business became non-existant (sic) within his area of control." Mr. Bruins concluded that, unless Dr. Biederman received a check soon, "I am truly afraid of the consequences." A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, for which Dr. Biederman still serves as chief. <br /><br />A 2002 annual report for the center stated that its research must satisfy three criteria: improve psychiatric care for children, have high standards and "move forward the commercial goals of J&J," according to court documents. "We strongly believe that the center's systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children," the report stated. "Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events."<br /><br />A February 2002 e-mail from Georges Gharabawi, a Johnson & Johnson executive, stated that Dr. Biederman approached the company "multiple times to propose the creation" of the center. "The rationale of this center is to generate and disseminate data supporting the use of risperidone in" children and adolescents, the e-mail stated. Johnson & Johnson gave the center $700,000 in 2002 alone, documents show.<br /><br />A June 2002 e-mail from Dr. Gahan Pandina, a Johnson & Johnson executive, to Dr. Biederman included a brief abstract of a study of Risperdal in children suffering disruptive behavior disorder. The study was intended to be presented at the 2002 annual meeting of the American Academy of Child & Adolescent Psychiatry, the e-mail stated. "We have generated a review abstract, but I must review this longer abstract before passing this along," Dr. Pandina wrote. One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly, "so, if you could, please give some thought to how to handle this issue if it occurs."<br /><br />The draft abstract that Dr. Pandina included in the e-mail, however, stated that only the children given Risperdal improved, while those given placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing himself as author so the company could present the study to the conference, according to the e-mail. "I will review this morning," Dr. Biederman responded, according to the documents. "I will be happy to sign the forms if you could kindly send them to me." The documents do not make clear whether Dr. Biederman approved the final summary of the brief abstract in similar form or asked to read the longer report on the study.<br /><br />Drug makers have long hired professional writers to compose scientific papers and then recruited well-known doctors to list themselves as authors. The practice, known as ghostwriting, has come under intense criticism recently, and medical societies, schools and journals have condemned it. In June, a Congressional investigation revealed that Dr. Biederman had failed to report to Harvard at least $1.4 million in outside income from Johnson & Johnson and other makers of antipsychotic medicines. <br /><br />In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked by Senator Charles E. Grassley, a Republican of Iowa, to check again, Dr. Biederman said he received $3,500. But Johnson & Johnson told Mr. Grassley that it paid Dr. Biederman $58,169 in 2001.<br /><br />On Monday, David J. Cameron, a Harvard spokesman, said the university was still reviewing Mr. Grassley's allegations against Dr. Biederman. He added that they had not seen the drug company documents in question and that the university is not directly involved in the child psychiatry center at Massachusetts General Hospital. <br /><br />Calls to Dr. Biederman were not returned. Johnson & Johnson did not immediately comment or make executives available for comment.</div><br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://online.wsj.com/article/SB122755237429253763.html?mod=testMod" target="_blank">Link</a>]<strong>NOVEMBER 25, 2008<br />J&J Emails Raise Issues of Risperdal Promotion <br />By DAVID ARMSTRONG and ALICIA MUNDY</strong><br /><br />Johnson & Johnson planned funding for a research institute to focus on use of the antipsychotic drug Risperdal by children well before the treatment was approved for patients that young, according to internal emails produced in a lawsuit against the company.<br /><br />The 2001 and 2002 emails, which circulated in the drug maker's Janssen unit, raise issues of whether the company helped promote, through the institute, an unapproved use of Risperdal, which wasn't cleared by the Food and Drug Administration for widespread use in minors until 2007. Doctors may prescribe FDA-approved drugs as they see fit, but companies aren't permitted to market them for uses that aren't approved by the agency.<br /><br />J&J, in a statement, said it helped to fund the center in 2002 "with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children." It noted that some of those uses were later approved by the FDA, and it said the company only promotes its products for FDA-approved indications. Dr. Biederman didn't return phone calls seeking comment.<br /><br />Dr. Biederman has been a leading advocate for wider childhood and adolescent use of the drug. The emails were provided to a New Jersey court as part of an effort by patient plaintiffs to force the psychiatrist to testify in their suit against J&J over alleged harms caused by Risperdal. The company has said the drug's side effects are limited, and it has defended Risperdal's safety in previous statements.<br /><br />In a statement Monday, Massachusetts General said "the allegations related to the Johnson & Johnson Center that were described in various media reports today have raised significant questions and concerns about the implementation of those agreements. The MGH takes these allegations very seriously, and intends to investigate these issues thoroughly."<br /><br />Risperdal was being prescribed to thousands of teens and younger children before it was approved in mid-2007 for use in children and adolescents with bipolar disorder, according to data presented at an FDA panel last week. The doctors' panel convened by the FDA said that antipsychotics have been overprescribed to children and adolescents; nearly 390,000 were given Risperdal in 2007, and 200,000 of them were under the age of 12.<br /><br />The diagnoses included attention-deficit disorder, for which the drug isn't approved. Risperdal, whose chemical name is risperidone, has been linked to side effects including serious weight gain and diabetes.<br /><br />The emails in the lawsuit indicate that Dr. Biederman approached Janssen to start the institute. A spokesman for Harvard said the institute isn't affiliated with the university.<br /><br />"Dr. Biederman is the pioneer in the area of [child and adolescent] bipolar disorders," said a 2002 internal email from a Janssen researcher to others at the company. "He approached Janssen multiple times to propose the creation of a Janssen-MGH center for C&A bipolar disorders. The rationale of the center is to generate and disseminate data supporting use of risperidone in this patient population."<br /><br />In a 2002 annual report for the institute, one of the criteria listed as an "essential feature of the center" is moving "forward the commercial goals of J&J," as well as research to "improve the psychiatric care of children." The documents don't indicate if Dr. Biederman profited from the work of the center or derived any income from it. In the 2002 annual report, he was listed as director of the center.<br /><br />Internal J&J records that are part of the plaintiffs' filing indicate that Janssen paid, or was requested to make payments, of $500,000 to help start up the center in 2002, another $200,000 for operating funds in 2003 and an additional $250,000 for 2004 activities. Janssen declined to comment on those figures.<br /><br />Dr. Biederman was receiving direct compensation from J&J during those years, according to records obtained by Sen. Charles Grassley, who has been investigating drug-company payments to the Harvard researcher and others at academic medical centers. In 2001, Dr. Biederman was paid $58,169 by J&J although he reported to Harvard that he was only paid $3,500, according to Sen. Grassley. In all, Dr. Biederman received more than $1.6 million between 2000 and 2007 from drug companies while reporting to Harvard receiving only several hundred thousand, Sen. Grassley's documents show.<br /><br />Harvard declined to answer specific questions about Dr. Biederman's pay, saying there is an ongoing review of his outside compensation.<br /><br />The center's research work, according to the annual report, appeared to focus exclusively on Risperdal. Dr. Biederman and colleagues have published many favorable studies on the drug. A 2005 study, for instance, concluded that "risperidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder."<br /><br />In 2001, Dr. Biederman began a three-year study on the use of Risperdal in 4- to 6-year-olds. That work appears to have violated rules at Harvard and Mass General forbidding researchers from conducting clinical trials of a drug if they receive payments of more than $20,000 a year from a drug maker.<br /><br />The Janssen emails indicate the company was concerned about maintaining a positive relationship with Dr. Biederman, who is o chief of clinical and research programs in pediatric psychopharmacology at Mass General, which includes the Johnson & Johnson Center. "Dr. Biederman is not someone to jerk around," a company official wrote in 1999. "He is a very powerful national figure in child pysch and has a very short fuse."<br /><br />The emails also suggest that the company's marketing staff were involved in creating the institute and that company officials helped to write and vet research work done by Dr. Biederman and his associates. Dr. Biederman has been ordered to undergo a deposition as part of the New Jersey case on Jan. 10.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/11/npr-drops-infinite-mind-hosted-by-dr.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-7817460935821061754?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/12/j-j-risperdal-documents-biederman.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-3066890679268798503Sun, 30 Nov 2008 14:19:00 +00002008-11-30T09:20:31.717-05:00The latest influential academic psychiatrist whose secret financial ties to drug makers have been documented by Senator Charles E. Grassley, is Dr. Frederick K. Goodwin, a former director of the National Institute of Mental Health, who has for many years served as the host of national public radio’s influential popular program, “The Infinite Mind.” <br /><br />Sen. Grassley’s investigation reveals that Dr. Goodwin concealed the fact that he earned at least $1.3 million between 2000 and 2007 by giving marketing lectures for drug makers. Indeed, he introduced a March, 2008 broadcast titled “Prozac Nation: Revisited” by saying, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.” That same week, Dr. Goodwin earned around $20,000 from GlaxoSmithKline, the company that for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors.<br /><br />An article in SLATE (May 6, 2008) by Shannon Brownlee and Jeanne Lenzer, brought to light Dr. Goodwin’s concealed financial conflicts of interest and his duplicitous use of NPR as a marketing venue. [<a href="http://www.slate.com/id/2190775/SLATE" target="_blank">Link</a>] <br />The New York Times reports that “Margaret Low Smith, vice president of National Public Radio, said that N.P.R. will remove “The Infinite Mind” from its satellite radio service next week, the earliest possible date. Ms. Smith said that had N.P.R. been aware of Dr. Goodwin’s financial interests, it would not have aired the program.” <br /><br />Dr. Goodwin's promotion of psychotropic drugs--not for therapeutic purposes, but as a means for controlling children's behavior--goes back to 1991 when he was the federal government's highest ranking psychiatrist as director of the (now defunct) Alcohol, Drug Abuse and Mental Health Administration (ADAMHA). At that time he promoted the “Violence Initiative” which promoted a federal policy to use of psychotropic drugs to control inner city children’s behavior. At a February 11, 1992 meeting of the prestigious National Advisory Mental Health Council Dr. Goodwin compared “inner city youth to monkeys who live in a jungle, who just want to kill each other, have sex and reproduce.” His remarks set off a public storm and he was forced to resign only to be appointed director of the National Institute of Mental Health. See: [<a href="http://www.breggin.com/index.php?option=com_content&task=view&id=53" target="_blank">Link</a>] and<br /><br />[<a href="http://query.nytimes.com/gst/fullpage.html?res=9E0CE1DE1E3DF93BA35750C0A964958260&sec=&spon=&&scp=5&sq=fred" target="_blank">Link</a>] goodwin monkeys&st=cse [<a href="http://query.nytimes.com/gst/fullpage.html?res=9E0CE2D61630F93BA15751C0A964958260&scp=1&sq=fredgoodwinmonkeys&st=cse" target="_blank">Link</a>] <br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.nytimes.com/2008/11/22/health/22radio.html?em" target="_blank">Link</a>]<strong>Popular Radio Host Has Drug Company Ties<br />By GARDINER HARRIS <br />November 21, 2008</strong> <br /><br />An influential psychiatrist who served as the host of public radio’s popular “The Infinite Mind” program earned at least $1.3 million between 2000 and 2007 giving marketing lectures for drug makers, income not mentioned on the program.<br /><br />The psychiatrist and radio host, Dr. Frederick K. Goodwin, is the latest in a series of doctors and researchers whose ties to drug makers have been uncovered by Senator Charles E. Grassley, a Republican from Iowa. Dr. Goodwin, a former director of the National Institute of Mental Health, is the first media figure investigated.<br /><br />Dr. Goodwin’s radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, Dr. Goodwin warned that children with bipolar disorder who are left untreated could suffer brain damage, a controversial view. “But as we’ll be hearing today,” Dr. Goodwin reassured his audience, “modern treatments ¬ mood stabilizers in particular ¬ have been proven both safe and effective in bipolar children.”<br /><br />That very day, GlaxoSmithKline paid Dr. Goodwin $2,500 to give a promotional lecture for its mood stabilizer drug, Lamictal, at the Ritz Carlton Golf Resort in Naples, Fla. Indeed, Glaxo paid Dr. Goodwin more than $329,000 that year for promoting Lamictal, records given Congressional investigators show.<br /><br />In an interview, Dr. Goodwin said that Bill Lichtenstein, the program’s producer, knew of his consulting activities but that neither he nor Mr. Lichtenstein thought that “getting money from drug companies could be an issue. In retrospect, that should have been disclosed.” <br /><br />But Mr. Lichtenstein said that he was unaware of Dr. Goodwin’s financial ties to drug makers and that he called Dr. Goodwin earlier this year “and asked him point-blank if he was receiving funding from pharmaceutical companies, directly or indirectly, and the answer was, ‘No.’”<br /><br />“The fact that he was out on the stump for pharmaceutical companies was not something we were aware of. It would have violated our agreements,” Mr. Lichtenstein said in an interview.<br /><br />Margaret Low Smith, vice president of National Public Radio, said that N.P.R. will remove “The Infinite Mind” from its satellite radio service next week, the earliest possible date. Ms. Smith said that had N.P.R. been aware of Dr. Goodwin’s financial interests, it would not have aired the program. <br /><br />Sarah Alspach, a spokeswoman for Glaxo, said, “We continue to believe that healthcare professionals are responsible for making disclosures to their employers and other entities, in this case National Public Radio and its listeners.”<br /><br />“The Infinite Mind” is a weekly program that has won more than 60 journalism awards over 10 years and bills itself as “public radio’s most honored and listened to health and science program.” It has more than one million listeners in more than 300 radio markets. Mr. Lichtenstein said that the last original program aired in October, that reruns have been airing since and that “the show is going off the air.”<br /><br />The program has received major underwriting from the National Institutes of Health and the National Science Foundation, both of which have policies requiring grantees to disclose and manage conflicts of interest. Mr. Grassley wrote letters to both agencies asking whether disclosure rules were followed for the grants. Spokespeople for both agencies said they were cooperating with the investigation.<br /><br />Mr. Grassley is systematically asking some of the nation’s leading researchers and doctors to provide their conflict-of-interest disclosures, and Mr. Grassley is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly.<br /><br />In October, Mr. Grassley revealed that Dr. Charles B. Nemeroff of Emory University, one of the nation’s most influential psychiatric researchers, earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules. As a result, the National Institutes of Health suspended a $9.3 million research grant to Emory and placed restrictions on other grants, and Dr. Nemeroff relinquished his chairmanship of Emory’s psychiatry department.<br /><br />In June, the senator revealed that Harvard University’s Dr. Joseph Biederman, whose work has fueled an explosion in the use of powerful antipsychotic medicines in children, had earned at least $1.6 million from drug makers between 2000 and 2007, failed to report most of this income to his university, and may have violated federal and university research rules.<br /><br />Mr. Grassley’s investigation demonstrates how deeply pharmaceutical commercial interests reach into academic medicine, and it has shown that universities are all but incapable of policing these arrangements. As a result of these revelations, almost every major medical school and medical society is now reassessing its relationships with drug and device makers. <br /><br />“We know the drug companies are throwing huge amounts of money at medical researchers, and there’s no clear-cut way to know how much and exactly where,” Mr. Grassley said. “Now it looks like the same thing is happening in journalism.”<br /><br />Mr. Grassley has proposed legislation that would require drug makers to publicly post all payments of $500 or more made to doctors. Eli Lilly and Merck have promised to begin posting such payments next year. <br /><br />Dr. Goodwin has authored an influential textbook on bipolar disorder and is an adjunct professor at George Washington University. In an extensive interview, Dr. Goodwin blamed a changing ethical environment for any misunderstandings between himself and Mr. Lichtenstein about his consulting arrangements.<br /><br />“More than 10 years ago when he and I got involved in this effort, it didn’t occur to me that my doing what every other expert in the field does might be considered a conflict of interest,” Dr. Goodwin said.<br /><br />He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias.<br /><br />“These companies compete with each other and cancel each other out,” he said. This view is dismissed by industry critics, who say that experts who consult widely for drug makers tend to minimize the value of non-drug or older drug treatments.<br /><br />In the fine print of a study he authored in 2003, Dr. Goodwin reported consulting or speaking for nine drug makers. Mr. Grassley only asked for payment information from Glaxo. Dr. Goodwin said that in recent years Glaxo paid him more than other companies.<br /><br />He said that he has never given marketing lectures for antidepressant medicines like Prozac, so he saw no conflict with a program he hosted in March titled “Prozac Nation: Revisited” that he introduced by saying, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.”<br /><br />That same week, Dr. Goodwin earned around $20,000 from Glaxo, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors.<br /><br />Tom Rosenstiel, director of the Project for Excellence in Journalism, said that although concerns about media bias are growing, few people believe that journalists take money from those they cover. Disclosures like those surrounding Dr. Goodwin could change that, “so this kind of thing is very damaging,” Mr. Rosenstiel said.</div><br /><br /><a href="http://ahrp.blogspot.com/2008/11/children-and-antipsychotics-fox-news.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-3066890679268798503?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/11/npr-drops-infinite-mind-hosted-by-dr.htmlnoreply@blogger.com (Vera Hassner Sharav)0tag:blogger.com,1999:blog-35205931.post-2146890141571088783Sun, 30 Nov 2008 14:18:00 +00002008-11-30T09:19:07.682-05:00FOX News is to be congratulated for airing a hard hitting report by Douglas Kennedy who pulled no punches by shedding light on the FDA official who is most responsible for giving the green light that opened the floodgates for the prescribing of increasingly toxic psychotropic drugs for children. See: [<a href="http://www.foxnews.com/video-search/m/21485444/medication_nation.htm?q=douglas+kennedy" target="_blank">Link</a>]<br /><br />Mostly healthy American children are being forced to ingest antipsychotic drugs that alter their brain chemistry, interfere with normal development, and induce (iatrogenic) chronic diseases such as, diabetes, and metabolic syndrome. <br />An FDA advisory panel earlier in the week criticized the FDA's failure to protect children from these toxic drugs. <br /><br />Featured in the news report was Philadelphia attorney, Stephen Sheller representing children harmed by antipsychotics, including boys who grew breasts after ingesting Risperdal, hit the nail on the head: "the reason they [antipsychotics] are prescribed so much is that there are a very good profit center for the drug industry." <br /><br />How many millions of previously healthy American children will be rendered disabled by FDA-approved toxic drugs?<br /><br />Below is a transcript, but you can still catch the FOX evening News report clip at [<a href="http://tinyurl.com/69k9dz" target="_blank">Link</a>] or [<a href="http://www.foxnews.com/video-search/m/21485444/medication_nation.htm?q=douglas+kennedy" target="_blank">Link</a>]<br /><br /><div style="BORDER-RIGHT: rgb(102,102,102) 1px solid; PADDING-RIGHT: 10px; BORDER-TOP: rgb(102,102,102) 1px solid; PADDING-LEFT: 10px; PADDING-BOTTOM: 10px; BORDER-LEFT: rgb(102,102,102) 1px solid; PADDING-TOP: 10px; BORDER-BOTTOM: rgb(102,102,102) 1px solid;BACKGROUND-COLOR: #f0f0f0">[<a href="http://www.foxnews.com/video-search/m/21485444/medication_nation.htm?q=douglas+kennedy" target="_blank">Link</a>] <strong>Fox News - U.S. National 11/20/2008 5:57:15 PM: </strong><br /><br />...jon: should children be prescribed pills that treat conditions that they do not even have? how about drugs that have already killed kids nationwide? Adding to the argument of the overmedication of america's children, an issue that our guest has been falling, douglas kennedy, the first national reporter to link anti-depressant medications to childhood suicide and violence. that prompted action. <br /><br />for years, they ignored the side effects of anti- depressants, and now, it seems they're doing the same thing with antipsychotics, drugs that some say are seriously hurting our nation's youth. One young woman on youtube describing what happened to her on the drug resperdal. <br /><br />it affects my moods, makes me depressed.<br /><br />She is one of the many videographers complaining about the side effects of anti- psychotic drugs, including seroquel and zyprexa, drugs whose usage have increased fivefold in the last years, despite there is no scientific benefit to using them. <br /><br />this is a huge industry.<br /><br />Now, an independent group of doctors and scientists convened by the food and drug industry itself agrees, criticizing them for being prescribed to children. <br /><br />Stephen Sheller an attorney in Philadelphia: <<the FDA is too heavily influenced by the drug industry.>><br /><br />the reason they are prescribed so much is that there are a very good profit center for the drug industry. <br /><br />anytime you come into a doctor's office and say, ""my kid is a problem in school"" or ""he is acting out,"" they come up with the diagnoses of bipolar or attention deficit disorder or other vague diseases. Sheller represents patients damaged by anti-psychotic drugs, including these boys who had to have mastectomies because they grow breasts on rispserdol. <br /><br />He and others point the finger directly at Thomas Laughren, director of the Division of Psychiatry Products whom has been turning a blind eye to the side effects. <br /><br />He has been accused of major conflicts of interest, ghostwriting articles, supporting new diagnoses to use these drugs, and he is not protecting the public health. he is protecting the profit of the drug industry....<br /><br />The FDA said Dr. Laughren was unavailable for comment<br />See the video: [<a href="http://mms.tveyes.com/Transcript.asp?StationID=130&DateTime=11%2F20%2F2008+5%3A57%3A15+PM&LineNumber=&MediaStationID=130&playclip=True&RefPage" target="_blank">Link</a>]</div><br /><br /><a href="http://ahrp.blogspot.com/2008/11/fda-officials-have-corrupted-scientific.html">Earlier</a>|<a href="http://www.ahrp.blogspot.com">Later</a>|<a href="http://www.ahrp.blogspot.com">Main Page</a><div class="blogger-post-footer"><img width='1' height='1' src='http://res1.blogblog.com/tracker/35205931-2146890141571088783?l=ahrp.blogspot.com'/></div>http://ahrp.blogspot.com/2008/11/children-and-antipsychotics-fox-news.htmlnoreply@blogger.com (Vera Hassner Sharav)0