ALLIANCE FOR HUMAN RESEARCH PROTECTION

Federal Judge Reverses His Preemption Ruling in Indiana Paxil Suicide Case

noreply@blogger.com (Vera Hassner Sharav) — Sun, 20 Jul 2008 10:54:00 +0000

Preemption!

Judge David F. Hamilton, Chief Judge of the United States District Court, Southern District of Indiana, reversed his preemption ruling in a Paxil suicide case, stating that in his prior ruling, he "failed to appreciate [] the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer."

In his 28 page ruling he noted that: "The FDA's current position on preemption is not 'long standing' but is in fact a '180-degree reversal' from its earlier stance." [Link]

Indeed, FDA's position on preemption-- was articulated by former FDA Chief Counsel, Porter MJ in 1997: " FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection." The 180-degree reversal occurred during the Bush Administration when (then) chief counsel, Daniel Troy, a former and current defense attorney for industry, sought to provide pharmaceutical companies (his clients) with a shield against product liability.

In his ruling on July 18, Judge Hamilton affirmed that "drug manufacturers have the authority to strengthen warnings without the advance permission of the FDA." And "failure to warn litigation can serve to reinforce the FDA's regulations, which already place the obligation to strengthen the warnings on a drug's label squarely on the shoulders of the drug's manufacturer."

A persuasive source that led Judge Hamilton to reverse his earlier ruling is a law review article by former FDA Commissioner, David Kessler, in which he articulated the need for judicial review: "The most fundamental problem is that drugs are approved on the basis of clinical testing that cannot, and is not designed to, uncover risks that are relatively rare or have long latency periods. Legislation cannot solve this problem ... Top-down surveillance is no substitute for failure to warn litigation, which provides the FDA, doctors, and patients with information about new risks that is otherwise unavailable to the agency."

The plaintiff in the case, Debra Tucker, the disabled younger sister of Father Tucker, a Catholic priest who had served as a priest for over 26 years. He had no prior history of suicidal ideation or behavior. On August 28, 2002, he was prescribed Paxil which he took for 22 days until his death on September 18, 2002.

On the morning of September 18, 2002, Father Rick celebrated St. Mary's morning mass. Sometime between the end of mass and 8 p.m. that evening (when he was found), Father Rick shot himself in the head with a .25 caliber pistol. He was 55 years old.

Attorneys for the plaintiff, Baum, Hedlund, Aristei & Goldman, PC of California, who have extensive experience litigating suicide and suicide attempt cases involving SSRI antidepressants. The firm's lead attorney in this case, Bijan Esfandiari, stated:

"Winning a motion for reconsideration is an extremely rare event - it happens in less than 15% of cases, so we are extremely gratified that Judge Hamilton had the clarity to really look at the preemption issue again and reverse his prior ruling. You have to seriously admire a judge who is willing to do this. In the prior ruling, we didn't think the court fully appreciated certain points, which resulted in an adverse decision , so we asked the court to reconsider. In granting our motion for reconsideration, Judge Hamilton held that preemption does not apply because 'drug manufacturers have the authority to strengthen warnings without the advance permission of the FDA' and that drug manufacturers (as opposed to the FDA) have 'the ongoing ability, authority, and responsibility to strengthen a label.'

Judge Hamilton's ruling ensures that injured victims will be able to seek redress against negligent drug manufacturers. This is a victory for all consumers and we hope Judge Hamilton's ruling will be used as a model by court's in other jurisdictions. When we told our client about the ruling, she cried. This is one hurdle crossed on the road to seeking redress for Father Tucker's death."

The Supreme Court is scheduled to rule on two cases invoking FDA preemption and involving Philip Morris and Wyeth. Each company argues that its product should be shielded from personal injury suits because they were approved for use by a federal agency.

The preemption argument suffers from (at least) three fundamental flaws: First, the argument presumes that FDA surveillance alone provides adequate safety and that FDA opinion is infallible. Second, it overlooks the fact that an ESSENTIAL part of the scientific process is analysis of all the evidence by independent scientists with different points of view. Third, immunity from liability is a radical departure undermining the foundation of a democracy whose citizens have the right to judicial review.

Reading

See also: Why Doctors Should Worry about Preemption by Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M. NEJM, July 3, 2008 [Link]
See also: No Court of Last Resort? FDA Preemption Removes Fear of Liability, Likely Increasing Risks of Harm by Vera Sharav, The Monitor, (pub. Association of Clinical Research Professionals), June, 2008. [copy upon request]

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Pharma "Drug Kingpins" Running Scared (Times UK)

noreply@blogger.com (Vera Hassner Sharav) — Sat, 19 Jul 2008 11:08:00 +0000

A noteworthy column by Carl Mortished, the UK Times World Business Editor (below) --if only because we have to read a UK newspaper to learn that the U.S. presidential contenders Barack Obama and John McCain "have drugs at the top of the agenda" and "the drug kingpins are running scared."

Both Senators McCain and Obama favor drug importation to save costs. Senator Obama wants to go further and grasp the nettle of Medicare pricing to open this vast program to negotiation with manufacturers. "for the first time, the political mood on both Right and Left is in favour of taking action."

The drugs that have made pharmaceutical companies rich--are NOT life-saving medicines, but rather, "lifestyle drugs and medicines to alleviate the diseases of America's affluent society." The problem is that industry's focus on marketing and blockbuster sellers--rather than research and development of improved treatments-- has resulted in a dry pipeline with no blockbusters in sight.

The obscene high cost of drugs that American taxpayers pay--both at the pharmacy and through government subsidized programs--is no longer sustainable. Industry's outworn model relied on U.S. government largesse to support extraordinary inflated U.S. prescription drug prices: Indeed, "45% of total expenditure on healthcare in America is borne by government, which is the biggest buyer in the US pharmaceutical market."

But that expenditure is unsustainable in the wake of the economic crunch, when the US government is feeling the pinch: "for the first time since President Johnson signed the original Medicare Bill in 1965, a serious discussion about socialized medicine is beginning in the United States."

The drug Industry's outworn argument, that without their excess US profits, the research that brings new medicines to market would not be possible, is refuted by industry's expenditure record:

A 2008 study published in PLoS Medicine analyzed pharmaceutical industry sales and expenditures in 2004, using industry's proprietary data bases. The Canadian authors found that the pharmaceutical industry sales in the U.S. = $235.4 billion. This industry spent $57.5 billion on drug promotion in the U.S.--which is 24.4% of U.S. sales. The percentage spent by Big Pharma on research and development was only 13.4%

The authors' conclusion that the U.S. pharmaceutical industry is marketing-driven, rather than driven by medical improvement is further corroborated by the huge increase in the number of meetings the pharmaceutical industry convened in the U.S. for promotional purposes: In 1998, the number of promotional meetings was 120,000; in 2004, the number of promotional meetings jumped to 371,000.

The non-negotiable prescription drug costs under Medicare--is finally being recognized by Americans for what it is, a give-away subsidy to drug giants: "healthcare costs are a bigger issue than Iraq for most Americans, hardly surprising given that it affects a greater number."

According to Carl Mortished, pharma bosses are alarmed to hear the Republican candidate bashing their industry, even supporting the direct importation of cheap drugs from abroad.

This industry needs a new business model--all the king's horses (sales reps and lobbyists) and all the king's men (in government and academia) can't put this Humpty Dumpty business model together again (relying as it does, on non-negotiable, anti-competitive, government subsidized price fixing) .... So, someone in the White House must impose change.

See: Gagnon MA and Lexchin J. “The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States,” appears in the January 3, 2008 issue of PLoS Medicine, an online journal published by the Public Library of Science. See also: York University (2008, January 7). Big Pharma Spends More On Advertising Than Research And Development, Study Finds. ScienceDaily. Retrieved July 18, 2008, from [Link]

[Link]The Times
July 16, 2008 Barack Obama and John McCain go to war with Big Pharma Carl Mortished: World business briefing

America has declared war on drugs, an industry that is bleeding the nation dry. The drug kingpins are running scared and, for the first time, the political mood on both Right and Left is in favour of taking action. The presidential contenders Barack Obama and John McCain have drugs at the top of the agenda and the stock prices of the drug merchants are crumbling.

These are the legitimate drug barons - Pfizer, Merck and Britain's GlaxoSmithKline (GSK). Selling lifestyle drugs and medicines to alleviate the diseases of America's affluent society made pharmaceutical companies rich.

But now the pool of available private cash is diminished - drained by the credit crunch and real estate collapse. Government is feeling the pinch and, for the first time since President Johnson signed the original Medicare Bill in 1965, a serious discussion about socialised medicine is beginning in the United States.

It is hardly surprising, because, despite what you may have heard, the US Government is already the biggest buyer in the US pharmaceutical market. Americans spend about £140 billion annually on medicine, compared with £11 billion in the UK. According to World Health Organisation statistics, American expenditure per head on healthcare is double the amount in Britain and a large part of that higher investment is related to the cost of drugs.

On average, for the same drug, an American pays twice that paid in the UK. American insurers pick up a great deal of the bill and their lack of efficiency is a big bone of contention, but the heaviest burden falls on the taxpayer because 45 per cent of total expenditure on healthcare in America is borne by government.

It's a colossal bill, but the American taxpayer doesn't get any pricing power for his dollar. In Britain, most other European countries and Canada, national agencies, such as the NHS, negotiate with the pharma giants, bully suppliers and set tariffs for a list of approved drugs.

In the US, such intervention is anathema - the US Food and Drugs Administration (FDA) approves drugs for their safety, but price and availability are market-driven and the drug barons argue that freedom leads to choice, a multiplicity of products and more rapid introduction of new medicines.

Into this jungle of corporate lobbyists, union activists and consumer firebrands, the presidential candidates are taking their first, tentative steps. Healthcare reform is dangerous territory. Hillary Clinton failed at her first attempt, but the costs have risen since - drug prices are rising at a rate of 7 per cent a year at a time when Americans are feeling poorer.

According to polls, healthcare costs are a bigger issue than Iraq for most Americans, hardly surprising given that it affects a greater number. Still, it is alarming for the pharma bosses to hear the Republican candidate bashing their industry, even supporting the direct importation of cheap drugs from abroad.

Many pensioners fly to Canada in search of cheaper prescription medicine and there is a continuing legal battle between state and federal government as state employee health benefit organisations seek to tap sources of cheap medicine north of the border.

Senator Obama also supports imports, but he wants to go further and grasp the nettle of pricing. He wants Medicare to negotiate directly with the drug giants, much as the NHS fixes drug prices in Britain.

This would be a disaster for Big Pharma - a federal agency setting discounted drug prices for senior citizens, the disabled and the poor. According to the Obama camp, it might save $30 billion (£14.9 billion) for the nation's taxpayers, a huge bite out of the industry's earnings - and it would not end there.

If Medicare patients were able to secure supplies of Lipitor, the bestselling Pfizer anti-cholesterol drug, at half-price, legions of middle-class and middle-aged taxpaying Americans would ask themselves why they were paying double.

The argument in favour of free market pricing in medicines would be shredded on the rack of fairness and a host of employee benefit organisations would combine forces and demand similar discounts. The Obama cheap drugs plan would open a crack in the foundations of Big Pharma's tower of cash and quickly bring it tumbling down.

It will happen, it is just a question of when. Monopsony power has already taken root in the healthcare markets of most OECD countries.

You can see faith undermined in the share prices of the drug giants: in the UK, AstraZeneca has lost a third of its value since October 2006, while GSK has shrunk by a quarter. Over the same period, Pfizer has tumbled by 38percent and since December Merck has shrunk by 40percent.

In vain, the drug giants argue that without their US profits, the research that brings new medicines to market would not be possible. It is true that scientific research follows the money.

A big new drug is reckoned to cost $800 million in research and development and Europe has been losing its pharmaceutical edge to US labs, which generated two thirds of the new drugs launched in the world over the past five years.

The problem is that the pipeline is thin and the blockbusters are not emerging. This industry needs a new business model and, in the absence of self-generated ideas, someone in the White House might soon impose one.

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Alabama Aims at Billion-plus in Settlements with Drug Makers

noreply@blogger.com (Vera Hassner Sharav) — Sat, 19 Jul 2008 10:59:00 +0000

Pharmaceutical companies may find that their fraudulent practices may cost them more than they had anticipated.

The Alabama Attorney General filed suit against 72 pharmaceutical companies alleging fraudulent Medicaid overcharges seeking $1 billion to help defray Medicaid costs.

Of these two went to trial with juries awarding hundreds of millions of dollars to the state: the first, against AstraZeneca resulted in the jury awarding the state $240 million (later reduced by a judge to $160 million).

67 suits remain and the lead lawyer, former Alabama Lt. Governor, Jere Beasley, who said, "We're going to give them a chance to settle and cut their litigation costs...."If we could settle them all today, we would accept the amount they cheated Alabama out of, plus interest (of 6 percent), plus 10 to 15 percent penalty." Beasley estimated total damages to the state of $1 billion. If all claims are settled out of court, Alabama could realize between $1.16 billion and $1.21 billion, less expenses and legal fees. Beasley said he and the other lawyers hired by the state would receive 14 percent of the net recovery."

Mr. Beasley said he would be willing to cut his fee to settle.

[Link] Montgomery Independent Jere Beasley aims at billion-plus in settlements with drug makers
July 15, 2008 By Bob Gambacurta

Having won multi-million-dollar awards against three large drug manufacturers, the state of Alabama is now offering 67 other pharmaceutical companies the opportunity to settle out of court and save the companies millions of dollars. At the same time, the state could add more than $1 billion to its bottom line and markedly improve funding for Medicaid which serves the poor, the elderly, children and the disabled in Alabama.

Former Alabama Lt. Gov. Jere Beasley speaks with reporters following a meeting with Democratic presidential hopeful John Edwards and fellow Alabama Democratic Party leaders at the Alabama Education Association building Thursday, May. 24, 2007, in Montgomery, Ala.

Lead attorney Jere Beasley of Montgomery says that Attorney General Troy King has sent letters to the remaining drug companies, giving them 30 days to settle all claims or face trial in Montgomery County Circuit Court. "After 30 days, we ain't going to negotiate with any of them," Beasley said.

The state initially filed suit against 72 pharmaceutical companies, alleging they had fraudulently overcharged the state Medicaid Agency more than $1 billion. The first case went to trial in Montgomery in February and a jury awarded the state $215 million against AstraZeneca PLC. Judge Charles Price later reduced the verdict to $160 million: $40 million in compensatory damages and $120 million in punitive damages.

The second trial ended last Tuesday with another $114 million verdict in favor of the state. The jury awarded Alabama $81 million against GlaxoSmithKline PLC and $33 million against Novartis AG. Both awards were for compensatory damages. No punitive damages were awarded.

Two smaller drug companies, Takeda Pharmaceuticals North America Inc. and Dey LP settled before trial for about $7 million. Trials are pending against the remaining 67 companies.

"We're going to give them a chance to settle and cut their litigation costs," Beasley said. He noted that the costs of defending themselves were astronomical. He said one defendant had paid-out $12 million for one expert witness from 2005 until today.

"It will be good for the state to settle, so the bottom line to the state is as close to full recovery as possible," Beasley said. He said settlement talks are already underway with four or five companies, but he declined to name them. "The settlements made have not slowed these companies down one bit," he said.

"If we could settle them all today, we would accept the amount they cheated Alabama out of, plus interest (of 6 percent), plus 10 to 15 percent penalty." Beasley estimated total damages to the state of $1 billion. If all claims are settled out of court, Alabama could realize between $1.16 billion and $1.21 billion, less expenses and legal fees. Beasley said he and the other lawyers hired by the state would receive 14 percent of the net recovery.

"I'd be willing to cut my fee to settle these cases," Beasley said. A number of states have hired Beasley's firm to represent them in their claims against drug manufacturers. In addition to Alabama, Beasley said he's representing Alaska, Hawaii, Mississippi, South Carolina and Utah and talks are underway with five or six other states. He said 23 states have filed suits against the defendants. Alabama is the first to go to trial.

Beasley said if the drug companies choose to go to trial, they could face more than $1 billion in compensatory damages plus, using a 3-to-1 ratio, another $3 billion in punitive damages. The next trial is scheduled for October 27 in Montgomery against Bristol-Myers Squibb Co., Sandoz Inc. a Novartis subsidiary, and Abbott Laboratories Inc.

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Crooked Academics and the Universities that Shield Them

noreply@blogger.com (Vera Hassner Sharav) — Sat, 19 Jul 2008 10:53:00 +0000

"The chief villains remain our academic institutions and medical leadership. They have colluded with and have acted as apologists for commercial scientific fraud. They have tolerated the telling of lies by senior academics. They have encouraged the prostitution of medicine. They have allowed abuse of the most fundamental safeguards of science. Most importantly, they have set terrible examples for our students." See: [Link]

The next academic psychiatrist to be caught by Senator Charles Grassley's floodlight is Martin Keller, MD of Brown University, the lead author of a fraudulent journal report about the safety and tolerability of Paxil (Seroxat), in children. See: Ed Silverman of Pharmalot: [Link]

The published report in the Journal of the American Academy of Child and Adolescent Psychiatry (2001) misrepresented the actual findings of GlaxoSmithKline's Study 329. The highly skewed report was penned by some of the leading pillars of U.S. child psychiatry as "co-authors" was ghostwritten by Scientific Therapeutics Information. [1]

Documents uncovered during Paxil litigation [Link]

Dr. Keller' sworn deposition during Paxil litigation and his explanation of his working relationship with the ghostwriters is accessible online:
[Link]

Our colleague in the UK, Dr. Aubrey Blumsohn, puts it bluntly: "It is hard to say this nicely. Based on the publicly available evidence, Professor Martin Keller is guilty of gross and obvious scientific deception and abuse of the scientific process. He has betrayed the trust of our patients. Brown University have continued to provide Keller with a shield of University respectability. Since he remains in post, we can only guess the level of scientific deception that Brown administration deem to be acceptable. [Link]

See Dr. Blumsohn's letter to Brown University's new dean, Edward J. Wing: [Link] . It remains unanswered.

The sordid story of fraud involving Dr. Keller et al-GSK-Paxil--Scientific Information--is laid out in Alison Bass' book, Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial.

The New England Journal of Medicine: "Alison Bass has put on trial in her book far more than just a bestselling antidepressant--she has used the case of Paxil to expose the unsavory and self-serving relationships among members of the pharmaceutical industry, psychiatrists, and members of the FDA. And she does it in a book that has the brio of a crime thriller...." -

Reference KELLER, MARTIN B. M.D.; RYAN, NEAL D. M.D.; STROBER, MICHAEL PH.D.; KLEIN, RACHEL G. PH.D.; KUTCHER, STAN P. M.D.; BIRMAHER, BORIS M.D.; HAGINO, OWEN R. M.D.; KOPLEWICZ, HAROLD M.D.; CARLSON, GABRIELLE A. M.D.; CLARKE, GREGORY N. PH.D.; EMSLIE, GRAHAM J. M.D.; FEINBERG, DAVID M.D.; GELLER, BARBARA M.D.; KUSUMAKAR, VIVEK M.D.; PAPATHEODOROU, GEORGE M.D.; SACK, WILLIAM H. M.D.; SWEENEY, MICHAEL PH.D.; WAGNER, KAREN DINEEN M.D., PH.D.; WELLER, ELIZABETH B. M.D.; WINTERS, NANCY C. M.D.; OAKES, ROSEMARY M.S.; MCCAFFERTY, JAMES P. B.S. Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial. Journal of the American Academy of Child & Adolescent Psychiatry. 40(7):762-772, July 2001.

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Zyprexa Litigation: Federal Judge Blasts FDA

noreply@blogger.com (Vera Hassner Sharav) — Sat, 19 Jul 2008 10:28:00 +0000

On Thursday, July 17, Judge Jack Weinstein held a hearing on his discussion-only draft certification of a third-party payer RICO class against Eli Lilly.

Judge Weinstein refused defendant Lilly's request that he withdraw his draft opinion because two state government plaintiffs have already cited it. The judge said he kind of likes the First Amendment and the free marketplace of ideas. And he rebuffed a plaintiffs request to change the proposed class period from 2001-2005 to 1996-2005, but said that might be a good idea if there were a settlement...

Judge Weinstein's Statement is here

He then read a Statement of the Court which in effect is a sweeping indictment of the entire US federal and state protective agencies "upon which users of pharmaceuticals primarily depend to protect against overpricing and misuse, and, in particular, the FDA's lack of adequate research and control over marketing; failure of third-party payers, pharmacy benefit managers, and their consultants to exercise control over drug pricing and use; failure of what should be impartial and timely research by governmental and non-governmental organizations; inadequate steps by governmental and non-governmental organizations to promptly publicize efficacy and dangers; and, to some extent, failure of prescribing doctors and other medical personnel to limit appropriately usage and costs."

"Lilly's alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation. This congeries of conflicting considerations would tend to minimize a jury's finding of damages and preclude punitive damages."

He knocked down most of plaintiffs' arguments--even as he once again acknowledged that there is "some merit" to the claim that Eli "Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant's alleged failure to disclose its products' side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO."

Judge Weinstein undercut the arguments of FDA officials who pretended not to know about Zyprexa's hazards and the illegal off-label marketing: "Information about Zyprexa's alleged deficiencies and overpricing has been available for years. Food and drug agencies in other countries were not misled. The third-party payers, with their professional consultants and pharmacy benefit managers, arguably should not have been gulled."

He further undercut the case made by third-party payers by reminding them of their "fiduciary duty to ensure that their members were not overusing or overpaying for a medication."
Judge Weinstein makes a persuasive argument when he says: "Strong evidence that they were not defrauded is provided by the fact that most of the third-party plaintiff representatives still maintain Zyprexa on their formularies and continue to pay for the drug, as they have in the past."

"By contrast, the Veterans Health Administration in Los Angeles dropped Zyprexa as a first line drug in 1998 because of its known high costs and adverse side effects..."

He also notes that state Attorneys General, who have made overpricing and off-label claims based primarily on state Medicaid payments for Zyprexa, "[have] all already received substantial payments in the form of liens and hold-backs on personal injury settlements obtained by individuals who used Zyprexa when they were covered by Medicaid."

Indeed, the victims of Zyprexa's debilitating effects whose attorneys won $2.2 billion judgments never did get just compensation: those who survived Zyprexa-induced life-threatening effects and were awarded $50,000, never saw that money. They were made to pay the state for past care received.

Judge Weinstein' harshest criticism is directed at the U.S. Food and Drug Administration: "The federal government's claims may well be viewed by juries as especially anomalous. A large part of the legal problems attributed to Zyprexa, if they exist, are arguably due to the failure of the responsible federal agencies to prevent abuse."

"Compared to its peer agencies in other parts of the world, the United States Food and Drug Administration ("FDA") has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa."

Finally, Judge Weinstein points to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173 prohibiting the government from negotiating with drug companies over the price of pharmaceuticals as contributing to the problems.

Judge Weinstein's Statement is here

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US Government withdrew key expert thimerosal reports

noreply@blogger.com (Vera Hassner Sharav) — Mon, 14 Jul 2008 19:17:00 +0000

In a surprise move, in a June 27, 2008 Autism Omnibus Proceeding (OAP) conference, attorneys for the US Department of Health and Human Services (DHHS) announced that they were withdrawing two key written reports and any statements which relied on those reports.

The expert reports by two world-renowned toxicologists (Dr. Laszlo Magos, formerly from the Medical Research Council Laboratories, England, and Dr. Thomas Clarkson, from the University of Rochester, Rochester, NY USA), were the toxicological pillars underpinning the government's claim that Thimerosal does not cause autism.

On July 3, 2008, the three Special Masters of the Autism Omnibus Proceedings recorded that they had granted the DHHS' request to withdraw the expert reports of Drs. Magos and Clarkson. In addition, their court order stated: ". respondent would be permitted to withdraw any reliance on those two expert reports, and that we would not consider those reports at all in resolving those test cases."

See: US Court of Federal Claims, July 3, 2008: [Link]

A press release issued by CoMed, a non-profit engaged in the legal battle against the government position on mercury (Thimerosal laced vaccine) link to autism states: "Ironically, though Drs. Magos and Clarkson were expected to testify to the safety of Thimerosal in vaccines, their previous publications clearly document its significant toxicity."

The press release cites a peer-reviewed, 1977 published study co-authored by Dr. Clarkson, under a grant from the National Institutes of Environmental Health Sciences (NIEHS) which concluded: "Samples of fresh and fixed tissues from infants with exomphalos treated by Thimersal application were analysed for mercury content. The results showed that thiomersal can induce blood and organ levels of organic mercury which are well in excess of the minimum toxic level in adults and fetuses. The analysis of fresh and fixed tissues must be carefully controlled against normal tissues in order to interpret mercury levels accurately."

The authors note: "Although thiomersal is an ethyl mercury compound, it has similar toxicological properties to methyl mercury (Friberg and Vostal, 1972) and the long-term neurological sequelae produced by the ingestion of either methyl or ethyl mercury-based fungicides are indistinguishable."

Their unequivocal recommendation: "Organic mercurial antiseptics should be heavily restricted or withdrawn from hospital use, as the fact that mercury readily penetrates intact membranes and is highly toxic seems to have been forgotten. Equally effective and far less toxic broad-spectrum antifungal and antibacterial topical antiseptics are currently available."

See: Fagan DG, Pritchard JS, Clarkson TW, Greenwood MR. Organ mercury levels in infants with omphaloceles treated with organic mercurial antiseptic. Arch. Dis. in Childhood 1977; 52: 962-964. Online at: [Link]

The government request to remove the experts' reports underpinning the government's claim that Thimerosal does not cause autism, would lead one to conclude that no new scientific evidence contradicts Dr. Clarkson's published 1977 findings and recommendation.
If so, how do government health officials explain why they only now discovered the contradiction between the reports their experts submitted to the court and their published findings ?

Dr. Bernadine Healy, the former director of the National Institutes of Health, publicly broke with the government-backed medical industrial position, noting their failure to adequately study the evidence: "I think the government or certain public health officials in the government have been too quick to dismiss the concerns of these families without studying the population that got sick....too quick to dismiss the hypothesis as irrational." [Link]

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Wall Street Journal - Drugs' Links To Suicide Risk Draw Concern

noreply@blogger.com (Vera Hassner Sharav) — Mon, 14 Jul 2008 12:24:00 +0000

(Note this is a delayed posting)

Tomorrow, the FDA is convening a hearing with two advisory committees--Peripheral and Central Nervous System Drugs Advisory Committee and the Psychopharmacologic Drugs Advisory Committee--to consider adding "Black Box" warnings about the risk of suicide linked to 11 epilepsy (anti-seizure) drugs:

Carbamazepine (marketed as CARBATROL, Shire, EQUETRO, Validus, TEGRETOL,Novartis); felbamate ( FELBATOL, Meda ); gabapentin (NEURONTIN, Pfizer); lamotrigine (LAMICTAL, GlaxoSmithKline); levetiracetam ( KEPPRA, UCB) oxcarbazepine (TRILEPTAL, Novartis); pregabalin (LYRICA, Pfizer); tiagabine (GABITRIL, Cephalon); topiramate (TOPAMAX, Ortho-McNeil-Janssen); valproate (DEPAKOTE, DEPAKOTE ER, DEPAKENE, DEPACON, Abbott); and zonisamide (ZONEGRAN, Dainippon).

To gain insight into corrupt practices in the marketing of prescription drugs, examine the case of Pfizer and its acknowledged criminal marketing of Neurontin, mostly for unapproved, off-label uses. In May 2004, The Wall Street Journal reported "Neurontin was approved for limited use as a supplemental anti-seizure treatment for epilepsy, but was promoted by Lambert-Warner (now Pfizer) and a consortium of paid physicians who promoted and prescribed the drug for everything from ADHD, mental illnesses to a variety of pain conditions, including migraine headaches." Indeed, "use of Neurontin for unapproved uses - estimated to account for 90% of the $2.7 billion in sales last year - continues to rise despite stepped up prosecutorial efforts aimed at curbing the practice. At the same time, studies show that much of the unapproved use of Neurontin isn't even effective." Pfizer pleaded guilty to criminal fraud and paid $430 million dollars to settle the case. See: [Link]

In recent years, millions of U.S. children are being labeled with a previously unheard of "diagnosis" for children--i.e., bipolar disorder. The treatment prescribed include these anti-seizure drugs together with diabetes-inducing antipsychotics. Prescription of these dangerous drugs have skyrocketed: child psychiatrists in the U.S. were persuaded to prescribe these powerful psychotropic drugs widely for children who do not have epilepsy or seizures following the recommendation of influential child psychiatrists who concealed the hefty cash they received from drug manufacturers--e.g., Harvard-Massachusetts General Hospital, Joseph Biederman, MD.

The term "suicidality" needs to be clarified. Suicidality, the term preferred by drug manufacturers and FDA officials, blurs the meaning of the risk, couched as it is in vague descriptions such as "suicide ideation..." In point of fact, the term, "suicidality" refers to suicidal acts such as, deliberate self-harm resulting in admission to hospital emergency rooms or the morgue. In other words, suicidality refers to successful and serious, but unsuccessful suicide attempts.

The report in today's WSJ (below) is most informative in identifying the suicide risk that these drugs pose: the reporter does not fall into the trap of transcribing FDA's linguistic obfuscations and the scope of the number of FDA-approved drugs that pose a suicide risk.

"The FDA is expected Thursday to recommend new tough "Black-Box" warnings about suicide risk and suicide behavior for a group of 11 epilepsy drugs--adding them to about 50 other new or additional warnings for suicide risk compiled in just the past four years. In all, these warnings cover about 35 drugs."

"Among the 20 best-selling drugs of 2007, six already carry warnings for suicidality, and one was the subject of a special FDA "alert" this year and is being further studied."

Question: How many years elapsed between these drugs' being marketed with NO warning about the suicide risk? How many people committed suicide as a result of being prescribed suicide-inducing drugs? Why aren't doctors rising up against manufacturers' failure to disclose the lethal risks of drugs they prescribe?

Although FDA officials knew --or should have known about the suicide risk of antidepressants, had they examined the evidence in FDA's possession--no action was taken to protect the public from a drug-induced suicide risk. Dr. Thomas Laughren is disingenuous in claiming "lack of systematic data on suicide risk." It was his responsibility to conduct a systematic analysis of the data in his files.

Only after the controversy surrounding the SSRI antidepressants hit the front pages of the press, and not before New York State Attorney General filed a lawsuit (2003) against GlaxoSmithKline, charging its marketing of the antidepressant, Paxil (Seroxat) was fraudulent--only then did the FDA come clean.

[Link]THE WALL STREET JOURNAL
Drugs' Links To Suicide Risk Draw Concern By ALICIA MUNDY July 9, 2008; Page D1

Federal regulators are about to expand the number of drug warnings for suicide risk, escalating worries for consumers and fueling a debate about whether the Food and Drug Administration is overreacting, or properly alerting the public of risks it ignored for too long.

The FDA is expected Thursday to recommend new tough "black-box" warnings about suicide risk and suicidal behavior for a group of 11 epilepsy drugs -- adding them to about 50 other new or additional warnings for suicide risk compiled in just the past four years. In all, these warnings cover about 35 drugs. (Some drugs' warnings were strengthened or expanded in the wake of new information or research.)

All drugs come with warnings about possible side effects. But now, some drugs designed to treat conditions ranging from depression to the compulsion to smoke cigarettes carry warnings that tell patients that they could experience "suicidality," the medical term for suicidal thoughts or behavior.

Among the 20 best-selling drugs of 2007, six already carry warnings for suicidality, and one was the subject of a special FDA "alert" this year and is being further studied.

Weighing a drug's suicide risk against its potential health benefits has become a growing concern within the FDA. On Tuesday, at the regular meeting of top FDA officials and Commissioner Andrew von Eschenbach, agency leaders discussed whether the FDA should work with the National Institutes of Health to more comprehensively address the dilemma. They want to know if new or existing research on molecular activity in the brain could better determine what chemicals are likely to stimulate suicidal ideation. This kind of analysis would help the FDA as it considers more suicide-risk warnings for different drugs.

Prior to 2000, the FDA almost never raised the issue of suicide risks. That changed in 2004, after the agency endured scathing criticism for taking more than a year to respond to studies linking suicidality among teens and children to their use of popular antidepressants. Black-box labels, the strongest warnings used, were mandated at the end of 2004 and expanded later.

The pending move by the FDA on epilepsy drugs highlights the problem now facing doctors, pharmaceutical companies and patients as more and more popular drugs are tagged with suicidality warnings.

"I think putting a black box on these drugs is terrible," says Ginny Miller -- an activist best known as "KayakMom" on the public blog on the Epilepsy Foundation of America's Web site.

Mrs. Miller of Dayville, Conn., and her teenage son Sam both suffer from epilepsy. In an interview, she says the 11 epilepsy medicines "are strong drugs, and yes, they have side effects," including mood swings. Sam has tried to kill himself twice, she says.

However, "the FDA is making a mistake in alarming patients" who have no choice but to take their epilepsy drugs to prevent seizures, Mrs. Miller adds.

For makers of the epilepsy drugs -- with sales of $8 billion last year -- the disorders go beyond just epilepsy, since the same drugs are widely used by patients with other problems.

Lyrica, an epilepsy drug made by Pfizer Inc., had $1.8 billion in sales alone and is widely used for fibromyalgia, a disorder associated with chronic pain. Pfizer did not comment for this article but earlier said that it disagrees with the FDA analysis.

Thomas Laughren, who runs the FDA's division on psychiatric treatment and drugs, says that until about 2003, the FDA didn't have systematic data on suicide risks, and that it was difficult to determine how to separate drug side effects from the disease itself.

Patients on antidepressants are already at risk for depression, mood swings, anxiety and suicidal behavior. So are epilepsy patients, according to studies that suggest a strong link between the disease and a risk of depression four times that of the general population.

The rise in suicidality warnings crosses different classes of drugs. The popular smoking-cessation drug Chantix, made by Pfizer, was also linked to a heightened risk of suicidality, and a warning was added this year to Chantix's label.

In March, the Merck & Co. allergy and asthma drug Singulair, the sixth-most-popular drug in America, according to IMS Health sales analyses, was the subject of an unexpected "early warning" by the FDA based on anecdotal data of suicidal behavior from some patients and doctors. The agency is reviewing data from earlier studies on Singulair, but has not indicated whether it will add a warning to the drug's label.

The FDA now is asking some drug makers to include studies looking for suicidality during the approval process. Columbia University Medical Center has developed a framework for looking for suicidality side effects during clinical trials, and it is being used by several companies, says Dr. Laughren.

Kelly Posner, a clinical researcher, worked with the FDA to help create Columbia's suicide-risk-assessment scale to standardize information and questions about suicidality. The problems with some of the new suicide-risk "alerts," such as that for Singulair, she says, is that they are based on spontaneous reports from patients and doctors.

Former FDA Deputy Commissioner Scott Gottlieb, who served during the Bush administration, says the agency's heightened concern about suicide will add new cost and uncertainty to drug development. It comes at a time when some big drug makers already are complaining that tougher FDA scrutiny is delaying the launch of valuable new remedies in the U.S.

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Pediatrician Lawrence Diller Chastises Child Psychiatrist Joseph Biederman

noreply@blogger.com (Vera Hassner Sharav) — Mon, 14 Jul 2008 09:38:00 +0000

An OpEd piece in the San Francisco Chronicle by pediatrician, Lawrence Diller, MD, chastises Harvard's chairman of child psychiatry, Joseph Biederman, MD for his irresponsible promotion of psychotropic drugs for children, noting that "The ambiguities of children's mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence."

"The science of children's psychiatric medications is so primitive and Biederman's influence so great that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs. This happens in the absence of a drug trial of any kind - instead, the decision is based upon word of mouth among the 7,000 child psychiatrists in America.

That's why Iowa Sen. Charles Grassley's recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic. If true, this scandal is yet one more stake in the heart of American academic medicine's credibility with frontline doctors like me -and more importantly, with the parents of the patients I deal with every day."

Joseph Biederman's irresponsible promotion of mind-altering drugs for children surpasses even Timothy Leary, another influential Harvard psychotropic drug promoter, whose drug advocacy-- "Turn On, Tune In, Drop Out" with psychedelic drugs-- derailed youthful lives.

But whereas Leary was fired from Harvard, Dr. Biederman's position is assured by the large sums in grant money that he garners.

Both will be judged by the brain damage their drug use recommendations caused America's next generation.

[Link]San Francisco Chronicle ARE OUR LEADING PEDIATRICIANS DRUG INDUSTRY SHILLS?
Lawrence Diller Sunday, July 13 2008

Most parents have never heard of him, but Joseph Biederman of Harvard may be the United States' most influential doctor when it comes to determining whether their children are normal or mentally ill.

In 1996, for example, Biederman suggested that drugs like Ritalin might serve 10 percent of American kids for Attention Deficit Hyperactivity Disorder. By 2004, one in nine 11-year-old boys was taking the drug. Biederman and his team also are more responsible than anyone for a child bipolar epidemic sweeping America (and no other country) that has 2-year-olds on three or four psychiatric drugs.

The science of children's psychiatric medications is so primitive and Biederman's influence so great that when he merely mentions a drug during a presentation, tens of thousands of children within a year or two will end up taking that drug, or combination of drugs. This happens in the absence of a drug trial of any kind - instead, the decision is based upon word of mouth among the 7,000 child psychiatrists in America.

That's why Iowa Sen. Charles Grassley's recent revelation that Biederman did not declare $1.6 million in drug company consulting fees is so important, scary and tragic. If true, this scandal is yet one more stake in the heart of American academic medicine's credibility with frontline doctors like me -and more importantly, with the parents of the patients I deal with every day.

American medicine, with psychiatry the most culpable, has fallen back to a time more than 100 years ago when doctor credibility was tantamount to the promotion of patent medicine. Subsequent reforms severed ties between medical school doctors and the drug industry - and for decades there was a much more ethical balance between the industry and physicians.

Now once again, drug company money is corrupting medical practice and the maintenance of our country's health. In a market economy, both doctors and the companies are motivated by profit. However, doctors' Hippocratic oath and their personal/professional relationships with their patients attenuate the most crass aspects of a fee-for-service system.

In contrast, drug companies owe primary responsibility to their shareholders. Of course these companies must operate within legal business and Food and Drug Administration restraints, but the drive to push such rules to the limit is implicit in any business. Such a strategy isn't always beneficial when our children's health is affected.

The Fortune 500 drug companies, by their sheer economic clout, have become the single most dominant influence in our health care system. The ambiguities of children's mental health and illness make child psychiatry the most vulnerable branch of medicine open to such influence.

In this climate, drug company research money, professional medical education and direct advertisements to parents tilt families and doctors to biologically brain-based solutions, rather than nondrug (e.g., parenting and education) approaches.

That's why we're seeing famous (or infamous) Newsweek cover boys like Max, a 10-year-old who has taken 38 psychiatric medications in his short, unhappy life.

Research funding must be directed to the needs of patients and their doctors - not to the bottom line of stockholders. Drug companies can still make money, but it's ethically immoral when stockholder profits trump children's health needs (as in the cover-up of negative studies of antidepressants in children).

More money must be directed toward head-to-head competition between existing generics and the new products, and toward more studies comparing nondrug or combination approaches to drug-only interventions for children's problems.

Drug company funding of medical research is not going to end - nor should it entirely stop. Yet a new set of federal rules dictating the transparency and direction of such funding is desperately needed to redress a dangerously corrupt system. It's not enough to simply have doctors more explicitly report their incomes from drug companies, though it is a very useful first step.

I remember about six years ago when I read a major article by the Biederman team on the advantages of a non-Ritalin drug pathway for ADHD. On the same day, much to my dismay, I also heard him give a speech - for a Wall Street audience - promoting a new drug by Eli Lilly called Strattera.

Although Strattera turned out to be a bust both clinically and commercially for ADHD, I was still shaken that such a prominent researcher could be so brazen with his potential conflict of interest appearance.

The $1.6 million that Biederman didn't declare is only a small fraction of the full amount of research funding that his clinic receives from nearly a dozen companies that pay for not only the cost of running studies but also the salaries of the doctors involved. Virtually all doctors who receive drug company money say they are not influenced, but every independent study examining the effects of such money says they are.

The leadership of Harvard's psychiatry department is strangely silent or even defends Biederman. These are good men with solid reputations both in drug and nondrug aspects of treatment. Yet they know that their psychiatry department would not exist were it not for drug company money - considering the withdrawal of federal research dollars over the past 25 years and the meager reimbursements that psychiatrists receive for their services from insurance companies and Medi-Cal.

Sens. Grassley, a Republican, and Herbert Kohl, a Wisconsin Democrat, have introduced the Physician Payments Sunshine Act, which will require more vigorous reporting and enforcement on payments (anything more than $500) received by doctors from drug companies.

But in addition, we need laws to have the federal government, along with the major academic research centers, coordinate and direct the use of drug company money in medical research. This is not pie-in-the sky wishing. Such reform was precisely what the doctors of 100 years ago accomplished in this country.

Lawrence Diller, M.D., practices behavioral-developmental pediatrics in Walnut Creek and is on the clinical faculty of UCSF. He is the author of "The Last Normal Child" (Praeger, 2006).

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At Least 12 Babies Die in GSK Trials in Argentina

noreply@blogger.com (Vera Hassner Sharav) — Sun, 13 Jul 2008 22:37:00 +0000

Trading Markets provides news of interest to investors.

On July 10 it reported that at least 12 babies who were test subjects in a clinical trial testing GlaxSmithKline's pneumonia vaccine in Argentina died.

According to the Argentine Federation of Health Professionals, or Fesprosa, the pharmaceutical giant uses children from poor families, who are "pressured and forced into signing consent forms. This occurs without any type of state control" and "does not comply with minimum ethical requirements."

Pediatrician Ana Maria Marchese, who works at the children's hospital in the provincial capital where the studies are being conducted, was highly critical: "because they can't experiment in Europe or the United States, they come to do it in third-world countries."

Indeed, "Colombia and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria."

But one of the lead Glaxo-paid investigators, pediatrician Enrique Smith, is quoted stating:

"Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria." Since 2007, 15,000 babies have been subjects of the trial, so the death rate in the trial is 1 in 1,250.

Question is, would they have died had they not been in the trial?

(((...was it a randomized trial and if so how many died in placebo arm - no information available on this????)))

Fesprosa complained that the parents are pressured, and trial "occurs without any type of control..."

If "the trials were authorized when Enrique's brother, Juan Carlos Smith, was provincial health minister" the legitimacy of the trial is questionable, at best.

The world is bearing witness to the moral dissolution of corporate influenced medicine--a pediatrician is sanguine about the death of 12 babies in a clinical trial, claiming it is "a very low figure..."

This profit-driven culture has derailed medicine from its traditional ethical principles, rapidly converting into a ruthless commercial enterprise.

This medical tragedy is widely disseminated on internet blogs but ignored by the press--

Why ?????????????????????

[Link]Babies die during vaccine trials in Argentina Thursday
July 10, 2008

Buenos Aires, Jul 10, 2008 (EFE via COMTEX)

-- At least 12 babies who were part of a clinical study to test the effectiveness of a vaccine against pneumonia have died over the past year in Argentina, the local press reported Thursday.

The study was sponsored by global drug giant GlaxoSmithKline and uses children from poor families, who are "pressured and forced into signing consent forms," the Argentine Federation of Health Professionals, or Fesprosa, said.

"This occurs without any type of state control" and "does not comply with minimum ethical requirements," Fesprosa said.

The vaccine trial is still ongoing despite the denunciations, and those in charge of the study were cited by the Critica newspaper as saying that the procedures are being carried out in a lawful manner.

Colombian and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.

Since 2007, 15,000 children under the age of one from the Argentine provinces of Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve.

"Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria," pediatrician Enrique Smith, one of the lead investigators, said.

In Santiago del Estero, one of the country's poorest provinces, the trials were authorized when Enrique's brother, Juan Carlos Smith, was provincial health minister.

According to pediatrician Ana Maria Marchese, who works at the children's hospital in the provincial capital where the studies are being conducted, "because they can't experiment in Europe or the United States, they come to do it in third-world countries."

"A lot of people want to leave the protocol but aren't allowed; they force them to continue under the threat that if they leave they won't receive any other vaccine," said Julieta Ovejero, great aunt of one of the six babies who died in Santiago del Estero.

Fesprosa's Juan Carlos Palomares said that "in most cases these are underprivileged individuals, many of them unable to read or write, who are pressured into including their children" in the trials.

According to Fesprosa, "the laboratory pays $8,000 for each child included in the study, but none (of that money) remains in the province that lends the public facilities and the health personnel for the private research." EFE

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Cholesterol Drugs for 8-Year Olds (NYT Editorial)

noreply@blogger.com (Vera Hassner Sharav) — Sun, 13 Jul 2008 14:38:00 +0000

The recommendation by the American Academy of Pediatrics encouraging physicians to prescribe cholesterol lowering statins for children has appalled the editors of the New York Times. Even this a bastion of vocal supporters of the medical profession have come around to recognize that doctors' advice may not be backed by science or motivated by best interest of their patients.

"We were appalled when we first heard that the American Academy of Pediatrics has recommended that some children as young as 8 be given drugs to reduce their cholesterol levels - and that they could end up taking these drugs for the rest of their lives."

"The ease of popping pills should not distract parents, health professionals or policy makers from the more arduous tasks of cutting back on junk foods, promoting healthy diets and putting physical education back into the schools."

This AAP recommendation and others raise strong suspicions about the motivating factor. For example, the AAP did not hesitate to recommend vaccinating ALL 11-and 12-year-old girls with Merck's human papilomavirus vaccine (Gardasil). Indeed, AAP recommended vaccinating even girls as young as nine, if doctors "consider it necessary." What's more, the AAP expanded the recommendation to 13-26-year-olds who have not received the full vaccine series (even if they are sexually experienced). [1]

Such industry-supportive recommendations appear to be motivated by financial considerations rather than medico-scientific evidence demonstrating that the best interest of the children will be served.

1. Committee on Infectious Diseases, American Academy of Pediatrics, Prevention of human papillomavirus infection: provisional recommendations for immunization of girls and women with quadrivalent human papillomavirus vaccine, Pediatrics, 2007, 120(3):666-668. transparent financially-motivated

[Link]THE NEW YORK TIMES
July 10, 2008
Editorial Cholesterol Drugs for 8-Year-Olds

We were appalled when we first heard that the American Academy of Pediatrics has recommended that some children as young as 8 be given drugs to reduce their cholesterol levels - and that they could end up taking these drugs for the rest of their lives. After reading the academy's report, we are now more dismayed about what this recommendation says about children's health.

The academy recommended that children as young as 2 who have risk factors for heart disease or whose family medical history is not known should be screened for high cholesterol. And it proposed that children 8 or older with very high concentrations of LDL, or "bad," cholesterol - 190 milligrams per deciliter or above - be considered for drug treatment to drive levels below 160 or even much lower.

The new recommendations are based on evidence that the damage leading to heart disease begins early in life. While cholesterol levels among adolescents have remained stable, the new stance reflects concerns that childhood obesity is increasing and that the prevalence of high blood pressure may be increasing.

The recommendation has provoked furious debate among pediatricians, as Tara Parker-Pope reported in Science Times on Tuesday. Critics complain that there is no evidence that giving statins to children will prevent heart attacks later in life and that there is no data on the potential side effects of taking the drugs for decades.

Still, it can't be good for children to have very high cholesterol levels. The new recommendations apply to these high-risk youngsters, not to all children. Short-term studies indicate that the statins are safe and effective in children and adolescents, and one statin has been approved by the Food and Drug Administration for use in children as young as 8.

The academy did urge that good diets and physical exercise be tried first, but the drug recommendation has attracted the most attention. We do fear that it will open the way for drug companies to bombard anxious parents with ads promoting these and other products and increase the number of parents insisting on prescriptions for their children.

The ease of popping pills should not distract parents, health professionals or policy makers from the more arduous tasks of cutting back on junk foods, promoting healthy diets and putting physical education back into the schools.

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Grassley Probes COI at American Psychiatric Association

noreply@blogger.com (Vera Hassner Sharav) — Sun, 13 Jul 2008 10:14:00 +0000

According to The New York Times, Senator Charles Grassley "is demanding that the American Psychiatric Association give an accounting of its finances." Last year, drug manufacturers provided the APA with at least $62.5 million.

Sen. Grassley is peeling away psychiatry's layers of deception about the efficacy and safety of its treatments and its commercially influenced dubious diagnostic criteria: "I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions."

Indeed, the APA-which publishes and has control over the field's major journals and standard diagnostic manual, which are over run with drug money influence-is the voice of psychiatry's establishment. The APA lends legitimacy to psychiatry's diagnostic and prescribing practices-even when no scientific evidence supports them. Comments by former presidents of the APA-- Steven Sharfstein, MD and Paul Appelbaum, MD-reveal that they are trying to disassociate from industry influence, not so, the APA.

Dr. Sharfstein, president of Sheppard Pratt Health System, acknowledges: "With every new revelation, our credibility with patients has been damaged"

Dr. Appelbaum, director of the division of psychiatry, medicine and the law at Columbia University, is quoted stating: "I think we may be coming to a point where hospitals and medical schools have to get serious about sanctioning. You can suspend doctors' privileges, or suspend their right to treat patients; both have a huge impact on income and career. But if you're serious about these disclosure policies, you have to be willing to back them up."

In sharp contrast, the APA confirmed its cynicism and unwavering vote of confidence in commercially successful psychiatrists-without any regard for the unseemly means used to achieve that "success." The APA membership elected as its new president, Dr. Alan F. Schatzberg, chairman of Psychiatry at Stanford University, who gained notoriety when he expressed his enthusiastic endorsement for the use of the abortion pill, mifepristone (better known as RU-486) to treat depression by claiming the drug "may be the equivalent of shock treatments in a pill without the side effects." Needless to say, there was no scientific evidence to support such a claim. There was, however, a very sizable financial interest. See: [Link]

Dr. Schatzberg's financial conflicts of interest were documented in The Mercury News by Paul Jacobs (2006). Dr. Schatzberg administers a $600,000-a-year federal grant from NIMH, part of which pays for ongoing research at the medical school on mifepristone, in depression. But he is the "co-founder of Corcept Therapeutics, a publicly traded company that hopes to turn mifepristone into an approved treatment for depression and other psychiatric ills. There is no clear boundary between Dr. Schatzberg's NIMH-supported research and his service to the corporation he founded, and in which he has a substantial vested interest.

Sen. Grassley's probe is uncovering both individual undisclosed financial conflicts of interest as well as institutional conflicts. Corcept had an exclusive license from Stanford for Dr. Schatzberg's discovery. Thus, the university also stood to profit from the successful marketing of a controversial abortion pill for depression. [Link]

Notwithstanding Stanford's oft-made claim that its conflict of interest standards are the most stringent.. [Link] read Stanford's statement in response to Sen. Grassley's letter pointing out that Dr. Schatzberg only reported to the university that his stock holdings in Corcept are worth "over $100,000," when, in fact, the psychiatrist's stake is worth more than $6 million.

Stanford's reply: "$100,000 is the highest dollar category on the form." See: [Link]

Clearly, neither the American Psychiatric Association nor major academic medical centers take seriously federal and university disclosure regulations. "plus ca change, plus c'est la meme chose."

THE NEW YORK TIMES July 12
2008 Psychiatric Group Faces Scrutiny Over Drug Industry Ties
By BENEDICT CAREY and GARDINER HARRIS

It seemed an ideal marriage, a scientific partnership that would attack mental illness from all sides. Psychiatrists would bring to the union their expertise and clinical experience, drug makers would provide their products and the money to run rigorous studies, and patients would get better medications, faster.

But now the profession itself is under attack in Congress, accused of allowing this relationship to become too cozy. After a series of stinging investigations of individual doctors' arrangements with drug makers, Senator Charles E. Grassley, Republican of Iowa, is demanding that the American Psychiatric Association, the field's premier professional organization, give an accounting of its financing.

The association is the voice of establishment psychiatry, publishing the field's major journals and its standard diagnostic manual. "I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions," Mr. Grassley said Thursday in a letter to the association.

In 2006, the latest year for which numbers are available, the drug industry accounted for about 30 percent of the association's $62.5 million in financing. About half of that money went to drug advertisements in psychiatric journals and exhibits at the annual meeting, and the other half to sponsor fellowships, conferences and industry symposiums at the annual meeting.

This weekend in Chicago, the psychiatry association's board will meet behind closed doors, in part to discuss how to respond to the increasingly intense scrutiny and questions about conflicts of interest. "With every new revelation, our credibility with patients has been damaged, and we have to protect that first and foremost," said Dr. Steven S. Sharfstein, a former president of the association and now president of the Sheppard Pratt Health System in Baltimore. "I think we need to review all arrangements between doctors and industry and be very clear about what constitutes a conflict of interest and what does not."

One of the doctors named by Mr. Grassley is the association's president-elect, Dr. Alan F. Schatzberg of Stanford, whose $4.8 million stock holdings in a drug development company raised the senator's concern. In a telephone interview, Dr. Schatzberg said he had fully complied with Stanford's rigorous disclosure policies and federal guidelines that pertained to his research.

Blocking or constraining researchers from trying to bring medications to market "will mean less opportunities to help patients with severe illnesses," Dr. Schatzberg said, adding, "Drugs that are helpful may not be developed by big pharmaceutical companies, for a variety of reasons, and we need some degree of communication between academia and industry" to expand options for patients.

Commercial arrangements are rampant throughout medicine. In the past two decades, drug and device makers have paid tens of thousands of doctors and researchers of all specialties. Worried that this money could taint doctors' research plans or clinical judgment, government agencies, medical journals and universities have been forced to look more closely at deal details.

In psychiatry, Mr. Grassley has found an orchard of low-hanging fruit. As a group, psychiatrists earn less in base salary than any other specialists, according to a nationwide survey by the Medical Group Management Association. In 2007, median compensation for psychiatrists was $198,653, less than half of the $464,420 earned by diagnostic radiologists and barely more than the $190,547 earned by doctors practicing internal medicine.

But many psychiatrists supplement this income with consulting arrangements with drug makers, traveling the country to give dinner talks about drugs to other doctors for fees generally ranging from $750 to $3,500 per event, for instance.

While data on industry consulting arrangements are sparse, state officials in Vermont reported that in the 2007 fiscal year, drug makers gave more money to psychiatrists than to doctors in any other specialty. Eleven psychiatrists in the state received an average of $56,944 each. Data from Minnesota, among the few other states to collect such information, show a similar trend.

In both states, individual psychiatrists are not top earners, but consulting arrangements are so common that their total tops all others. The worry is that this money may subtly alter psychiatrists' choices of which drugs to prescribe.

An analysis of Minnesota data by The New York Times last year found that on average, psychiatrists who received at least $5,000 from makers of newer-generation antipsychotic drugs appear to have written three times as many prescriptions to children for the drugs as psychiatrists who received less money or none. The drugs are not approved for most uses in children, who appear to be especially susceptible to the side effects, including rapid weight gain.

Senator Grassley's investigations have not only detailed how lucrative those arrangements can be but have also shown that some top psychiatrists failed to report all their earnings as required.

After The Times reported on such an arrangement involving Dr. Melissa P. DelBello of the University of Cincinnati, Mr. Grassley asked the university to provide her income disclosure forms and asked AstraZeneca, the maker of the antipsychotic Seroquel, to reveal how much it paid her. In scientific publications, Dr. DelBello has reported working for eight drug makers and told university officials that from 2005 to 2007 she earned about $100,000 in outside income, according to Mr. Grassley.

But AstraZeneca told Mr. Grassley it paid her more than $238,000 in that period. AstraZeneca sent some of its payments through MSZ Associates, an Ohio corporation Dr. DelBello established for "personal financial purposes."

The University of Cincinnati agreed to monitor those payments more closely.

In early June, the senator reported to Congress that Dr. Joseph Biederman, a renowned child psychiatrist at Harvard Medical School, and a colleague, Dr. Timothy E. Wilens, had reported to university officials earning several hundred thousand dollars apiece in consulting fees from drug makers from 2000 to 2007 when in fact they had earned at least $1.6 million each.

Another member of the Harvard group, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley's investigators. The Harvard psychiatrists said they took conflict-of-interest policies seriously and had abided by disclosure rules.

In late June, after Mr. Grassley singled out Dr. Schatzberg, Stanford disputed some of the numbers in the report and has denied that Dr. Schatzberg violated any research rules devised to police such conflicts.

In an interview on Wednesday, Dr. Nada L. Stotland, president of the psychiatric association, said the group had studied Mr. Grassley's letter and Stanford's response and agreed with Stanford. Dr. Schatzberg will take over as president of the association as planned, she said. "The larger issue here is that there's a revolution going on" in how medicine handles industry money, said Dr. Stotland, a psychiatrist at Rush Medical College in Chicago. "That's good, that's what we need, and I believe we've been on the cutting edge of that revolution in many ways."

Dr. Stotland said that the association began reviewing the income it received from pharmaceutical companies last March, to identify potential conflicts. Doctors and academic researchers generally worked at arm's length from industry until the early 1980s, when Congress passed the Bayh-Dole Act. This legislation encouraged closer collaboration between researchers and industry to bring products to market more quickly. The act helped foster the growth of the biotech industry, and soon professors and universities were busy obtaining patents and building relationships with industry.

Some psychiatrists have long argued that consulting with a company - to help design a rigorous drug trial, for instance - benefits patients, as long as the researcher has no financial stake in the product and is not paid to speak about the drug to other doctors, like a traveling pitchman.

Others say industry and academic researchers are now so deeply intertwined that exposing doctors' private arrangements only stokes suspicion without correcting the real problem: bias. "Having everyone stand up like a Boy Scout and make a pledge isn't going to quell suspicion," said Dr. Donald Klein, an emeritus professor at Columbia, who has consulted with drug makers himself. "The only hope to rule out bias is to have open access to all data that's produced in studies and know that there are people checking it" who are not on that company's payroll.

Studies have shown that researchers who are paid by a company are more likely to report positive findings when evaluating that company's drugs. The private deals can directly affect patient care, said Dr. William Niederhut, a psychiatrist in private practice in Denver who receives no industry money.

Dr. Niederhut said company-sponsored doctors had spread the word that new and expensive drugs were better in treating bipolar disorder than lithium, the cheaper old standby treatment.

"It's a sales pitch, and now it's looking like a whole lot of people would have done better if they'd started on lithium in the first place," Dr. Niederhut said in a telephone interview. "The profession absolutely has to come clean on these industry deals, and soon."

Tighter rules, stronger statements and more debate may not make much difference, if Mr. Grassley's findings are any guide. Universities have rules requiring that faculty members disclose their outside income so that conflicts of interest in research or patient care can be managed. But some of the psychiatrists named in the investigations apparently ignored the rules.

"I think we may be coming to a point where hospitals and medical schools have to get serious about sanctioning," said Dr. Paul S. Appelbaum, director of the division of psychiatry, medicine and the law at Columbia. "You can suspend doctors' privileges, or suspend their right to treat patients; both have a huge impact on income and career. But if you're serious about these disclosure policies, you have to be willing to back them up."

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Glaxo Exec Resigns From UK Watchdog Group

noreply@blogger.com (Vera Hassner Sharav) — Fri, 11 Jul 2008 19:45:00 +0000

Amid growing controversy, GlaxoSmithKline's Vice President and Financial Comptroller, Paul Blackburn, was asked to resign from the board of UK's government education watchdog agency, Ofsted.

For background about this latest GSK-government "affair" see: [Link]

UK patient advocate-- Robert Fiddaman and colleagues--who challenged the UK government with facts about GSK's appalling corporate record of unethical conduct--including, concealing the suicide risk of its antidepressant, Paxil (Seroxat)--clearly led the Ofsted board to ask Mr. Blackburn to resign.

In a letter to Mr. Fiddaman [Link] Customer Service Advisor of Ofsted acknowledges that Mr. Blackburn's resignation "follows public concerns about the activities of his employer GSK."

Lesson to be learned: Yes, We Can Make a Difference by speaking truth to power!!!!!

From: enquiries@ofsted.gov.uk
To: fiddaman64
Sent: Wednesday, July 09, 2008 1:22 PM
Subject: Fw: Appointment of GSK Vice President to Ofsted
Dear Mr Fiddaman

Further to my email to you this morning, please be advised as follows:

Paul Blackburn resigned as a non executive member of the Ofsted Board on 5th July. His resignation follows public concerns about the activities of his employer GSK. Paul did not want any negative press interest to detract from the excellent work of Ofsted and therefore resigned. As far as Ofsted is concerned the matter is now concluded.

Should you require any further assistance please do not hesitate to contact us.

Regards,
Alan O'Neal
Customer Service Advisor
Ofsted - National Business Unit

See also Pharmalot: [Link]

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8-Year-Olds on Statins? Backlash Bites AAP

noreply@blogger.com (Vera Hassner Sharav) — Thu, 10 Jul 2008 11:16:00 +0000

New York Times reports that a backlash has erupted following the recommendation issued by the American Academy of Pediatrics encouraging physicians to prescribe statins for 8-year old children.

"To be frank, I'm embarrassed for the A.A.P. today," said Dr. Lawrence Rosen of Hackensack University Medical Center in New Jersey, vice chairman of an academy panel on traditional and alternative medicine. He added: "Treatment with medications in the absence of any clear data? I hope they're ready for the public backlash."

"It will open the door for pharmaceutical companies to heavily advertise and promote their use in 8-year-olds, when we don't know yet the long-term effect on using these drugs on prepubertal kids," said Dr. Alan Greene, a pediatrician in Danville, Calif., and the founder of the popular Web site DrGreene.com

"We're talking about potentially treating thousands and thousands of children simply to possibly prevent one heart attack," says Dr. Sanghavi, from the University of Massachusetts. "That kind of risk benefit calculation is entirely absent from the A.A.P.'s policy."

The recommendation is not backed by any scientific evidence to justify children's exposure to drugs whose known adverse effects outweigh any speculative, unsubstantiated benefit in the future.

AHRP is heartened to note that the criticisms we expressed in yesterday's infomail about the recommendation is confirmed by responsible physicians.

We repeat our assessment that this ill-considered recommendation was not free of AAP's financial considerations. Considerations for the best interest of children clearly conflict with corporate / institutional financial interests.

See AAP list of donors includes McDonald--the company whose fat and fast-food has contributed mightily to US children's obesity and cholesterol epidemic. Other contributors are pharmaceutical companies that market statins: AstraZeneca (Crestor), Sanofi-Aventis (Zocor), Merck (Mevacor, Vytorin). [Link]

One has learned to expect pharmaceutical companies to put profits ahead of children's health--but that the AAP, a professional association of physicians would throw caution to the wind and promote dubious treatments that undermine children's best interest is scandalous.

[Link]
8-Year-Olds on Statins? A New Plan Quickly Bites Back July 8, 2008 By TARA PARKER-POPE

Cholesterol drugs for 8-year-olds?

This aggressive new recommendation for warding off heart disease in some children has stirred a furious debate among pediatricians since the American Academy of Pediatrics issued it on Monday.

While some doctors applauded the idea, others were incredulous. In particular, these doctors called attention to a lack of evidence that the use of the cholesterol-lowering drugs, called statins, in children would prevent heart attacks later in life.

"What are the data that show this is helpful preventing heart attacks?" asked Dr. Darshak Sanghavi, a pediatric cardiologist and assistant professor at the University of Massachusetts Medical School. "How many heart attacks do we hope to prevent this way? There's no data regarding that."

Nor, Dr. Sanghavi added, are there data on the possible side effects of taking statins for 40 or 50 years.

Other doctors said the recommendation would distract from common-sense changes in diet and exercise, which are also part of the new guidelines. "To be frank, I'm embarrassed for the A.A.P. today," said Dr. Lawrence Rosen of Hackensack University Medical Center in New Jersey, vice chairman of an academy panel on traditional and alternative medicine. He added: "Treatment with medications in the absence of any clear data? I hope they're ready for the public backlash."

Doctors who sat on the academy's committee on nutrition, which issued the guidelines, agree there are no long-term data on statin use in children. But they say there are adequate safety data to justify the recommendations. One statin, Pravachol, has already been approved by the Food and Drug Administration for use in children as young as 8.

"We extrapolate from the information we have in adults," said a member of the panel, Dr. Nicolas Stettler, an assistant professor of pediatric epidemiology at the Children's Hospital of Philadelphia. "We know that in adults, decreasing cholesterol and giving some of those drugs decreases risk of heart disease or death. So there's really no reason to think that would be any different in children."

Some recent ultrasound studies of the carotid arteries in high-risk children also show that statin use in children does appear to slow the progression of heart disease, Dr. Stettler said.

To be sure, the statin recommendation does not apply to most children. "Among the vast majority of children, this will not even be an issue," said Dr. Daphne Hsu, a chief of pediatric cardiology at Children's Hospital at Montefiore.

But it signals a more aggressive approach to treating cardiovascular disease at a young age using drugs that have been studied primarily in adults.

Under the old guidelines, children considered at high risk for heart disease could be given statins starting at age 10. The new guidelines apply to children as young as 8 with LDL, or "bad," cholesterol of 190 milligrams per deciliter, or those with LDL of 160 and a family history of heart disease or two other risk factors. Among children with diabetes, drug treatment may begin when bad cholesterol reaches 130.

In addition, the academy recommended that children with a family history of heart disease be screened as early as the age of 2 and no later than the age of 10. And by the age of 12 months, if a doctor is concerned about future weight problems, low-fat milk may be recommended.

Although the real numbers are small, some experts worry that the new guidelines will encourage too much reliance on drug therapy rather than more difficult lifestyle changes "It will open the door for pharmaceutical companies to heavily advertise and promote their use in 8-year-olds, when we don't know yet the long-term effect on using these drugs on prepubertal kids," said Dr. Alan Greene, a pediatrician in Danville, Calif., and the founder of the popular Web site DrGreene.com [Link] .

None of the doctors on the academy's nutrition panel have disclosed any financial relationship with makers of statin drugs. (The report's lead author, Dr. Stephen Daniels, told The Associated Press that he had worked as a consultant to Abbott Laboratories and Merck, but not on their cholesterol drugs. He was not available for comment on Monday.)

Some childhood obesity experts said they understood the need for the new guidelines, but added that there needed to be more focus on public health changes to address childhood obesity.

"When you have a kid whose cholesterol looks like an overweight 65-year-old, what do you do?" said Dr. David Ludwig, director of the childhood obesity program at Children's Hospital in Boston. "The committee had to balance the risks of treating children with powerful drugs, about which there is limited long-term data, with the risks of not treating children with unprecedented cardiovascular disease risk factors."

Even so, Dr. Ludwig says he has some concerns about what the guidelines say about public health. "My concern is what this is saying about society when we are so quick to prescribe drugs for these conditions before having systematically attacked the problem from the public health perspective," he said.

Part of the concern about statin use in children stems from the fact that there is still controversy about how widespread their use should be in adults. Statins, which are the most prescribed drugs in the world, have been shown to lower risk for heart attack and death in middle-aged men with existing heart disease. But there is little evidence they prolong life in healthy men, women or people over 70. And since statins have been around only since the mid-1980s, there is no evidence to show whether giving statins to a child will lower his or her risk for heart attack in middle-age.

Side effects, particularly muscle pain and cognitive problems, also have been a concern in adults, but it is unclear whether children will experience similar problems.

"We're talking about potentially treating thousands and thousands of children simply to possibly prevent one heart attack," says Dr. Sanghavi, from the University of Massachusetts. "That kind of risk benefit calculation is entirely absent from the A.A.P.'s policy."

While most of the attention has focused on the drug therapy guidelines, far more parents may be affected by the recommendation that low-fat milk products are appropriate to give to children after the age of 12 months. Historically, low-fat milk has been discouraged for very young children because fat is essential to brain development. But the academy noted that because children were getting so much fat elsewhere in their diets, low-fat milk may be recommended by pediatricians if they are concerned about future weight problems.

"Obviously all of us want kids to really take care of their health," said Dr. Marcie Schneider, a member of the nutrition committee who is an adolescent medicine specialist in Greenwich, Conn. "We want them exercising, we want them eating well. You try the least invasive things always first, but at some point if that's not helping enough, you need to go to the next level."

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AAP Recommends Aggressive Screening and statins in Children - evidence????

noreply@blogger.com (Vera Hassner Sharav) — Thu, 10 Jul 2008 06:13:00 +0000

The American Academy of Pediatrics (AAP) is poised to issue recommendations for "wider cholesterol screening for children and more aggressive use of cholesterol-lowering drugs starting as early as the age of 8 in hopes of preventing adult heart problems."

This is a highly controversial recommendation that smacks of pharmaceutical company influence. Indeed this recommendation overturns the AAP position-as reported in 2002, by The Washington Post: "The American Academy of Pediatrics (AAP) worries that the FDA's February approval of Merck's Mevacor (lovastatin) -- for children with a disorder that gives them very high blood cholesterol -- could fuel more statin use when there is still little long-term safety and efficacy data in children, said John Moore, a pediatric cardiologist at Philadelphia's M.C. Hahnemann Medical Center and chairman of the AAP's cardiology section. There's also no consensus on how best to treat high cholesterol in youngsters, he said." See: [Link]

Neither reporters of the Associated Press or The New York Times questioned what scientific evidence supports the use of statins in children who do not have heart disease. Cholesterol-lowering drugs were first introduced in 1987 (Mevacor), and are currently the most prescribed drugs in the U.S.

So, why has there been no dramatic improvement in U.S. mortality rates? Why are more Americans becoming obese, diabetic--and dying of heart attacks compared to the rest of the world?

Statins have been proven effective ONLY in patients with a prior history of heart attacks-not in those deemed to be "at risk" because of high cholesterol. [Link]

To gain insight one must turn to physicians who are not on the payroll of drug manufacturers. Doctors, such as John Abramson, MD, author of Overdosed America (2004), points out that in clinical trials that included healthy but high-risk people without heart disease, statins were shown to be of no benefit. For example, for women of any age who do not have heart disease or diabetes, and for men older than 69--who do not have heart disease or diabetes-there was no benefit from ingesting statins.

For men aged 30-69 years who are at high risk of developing heart disease statins show a modest benefit: Out of 50 high-risk men taking a statin every day for five years, only one avoids a "cardiac event." In other words, of every 50 men who stay on statins for five years, 49 risk an adverse drug reaction with no benefit. [1] [Link]

Is it good medicine to expose children to risks of harm in adults are questioned?

What is the overall effect on children's health of taking a drug? Warnings and side effects listed on the drugs' label: Lipitor: [Link]

Given the potential risks of harm from statins-including cognitive impairment, liver damage, and muscle pain, weakness, rigidity, shouldn't we seek alternative ways to reduce the risk of heart disease? Life-style changes, healthy eating, no smoking, and exercise are PROVEN EFFECTIVE against cardiovascular disease-and they pose NO risk of any sort.

Why, then, does the American Academy of Pediatrics recommend a dubious course of treatment with drugs instead? One clue may be found in list of donors who include McDonald-whose fast-food has contributed mightily to US children's obesity and cholesterol epidemic-and pharmaceutical companies that market statins, such as, AstraZeneca (Crestor), Sanofi-Aventis (Zocor), Merck (Mevacor, Vytorin). [Link]

Neither the AP nor the Times informed readers about AAP's financial ties to companies with vested interests in the recommendation.

The Times quotes Jatinder Bhatia, a member of the academy's nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta. He stated: "We are in an epidemic. The risk of giving statins at a lower age is less than the benefit you're going to get out of it."

Times readers are not informed that Dr. Bhtia has extensive pharmaceutical ties as a consultant, speaker, and sits on several company advisory boards-and these may just influence his bald, unsubstantiated statements. See: [Link]

Another AAP committee member, Dr. Stephen Daniels, is quoted stating: "the new advice is based on mounting evidence showing that damage leading to heart disease, the nation's leading killer, begins early in life." AP reporter, Lindsey Tanner--but not NYT reporter, Tara Parker Pope -- informed readers that he has worked as a consultant to Abbott Laboratories and Merck & Co.

The 2008 AAP cholesterol recommendations are a crass example of how financial conflicts of interest can influence treatment recommendations by American professional medical associations.

Reference:

Wright JM and Abramson J. Are lipid-lowering guidelines evidence-based? THE LANCET Vol 369 January 20, 2007 169. [Link]

[Link]
THE NEW YORK TIMES July 7, 2008 Cholesterol Screening Is Urged for Young
By TARA PARKER-POPE

The nation's pediatricians are recommending wider cholesterol screening for children and more aggressive use of cholesterol-lowering drugs starting as early as the age of 8 in hopes of preventing adult heart problems.

The new guidelines were to be issued by the American Academy of Pediatrics on Monday.

The push to aggressively screen and medicate for high cholesterol in children is certain to create controversy amid a continuing debate about the use of prescription drugs in children as well as the best approaches to ward off heart disease in adults.

But proponents say there is growing evidence that the first signs of heart disease show up in childhood, and with 30 percent of the nation's children overweight or obese, many doctors fear that a rash of early heart attacks and diabetes is on the horizon as these children grow up.

Previously, the academy had said cholesterol drugs should be considered in children older than 10 if they fail to lose weight after a 6- to 12-month effort. The academy estimated that under the current guidelines, 30 percent to 60 percent of children with high cholesterol were being missed. And for some children, cholesterol-lowering drugs, called statins, may be their best hope of lowering their risk of early heart attack, proponents said.

"We are in an epidemic," said Dr. Jatinder Bhatia, a member of the academy's nutrition committee who is a professor and chief of neonatology at the Medical College of Georgia in Augusta. "The risk of giving statins at a lower age is less than the benefit you're going to get out of it."

Dr. Bhatia said that although there was not "a whole lot" of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children.

Surprisingly, the paper published in the medical journal Pediatrics that explains the new guidelines notes that among adolescents, average total cholesterol levels as well as LDL and HDL cholesterol have remained stable, while triglyceride levels have dropped, based on data collected from 1988 to 2000.

It is not clear how many children would be affected by the new guidelines. The recommendations call for cholesterol screening of children and adolescents, starting as early as the age of 2 and no later than the age of 10, if they come from families with a history of high cholesterol or heart attacks before 55 for men and 65 for women.

Screening is also recommended for children when family history is unknown, or if they have other risk factors, like being at or above the 85th percentile for weight, or have diabetes.

If the child's cholesterol level is normal, retesting is suggested in three to five years. Although lifestyle changes are still recommended as the first course of action, drug treatment should be considered for children 8 years and older who have bad cholesterol of 190 milligrams per deciliter and who also have a family history of early heart disease or two additional risk factors, the new recommendations say.

The guidelines give no guidance on how long a child should stay on drug treatment.

But they do say the first goal should be to lower bad cholesterol levels to less than 160 milligrams or possibly as low as 110 milligrams in children with a strong family history of heart disease or other risk factors like obesity.

Because statins have been around since only the mid-1980s, there is no evidence to show whether giving statins to a child will lower the risk for heart attack in middle age.

The academy also now recommends giving children low-fat milk after 12 months if a doctor is concerned about future weight problems. Although children need fat for brain development, the group says that because children often consume so much fat, low-fat milk is now appropriate.

[Link]THE ASSOCIATED PRESS
Cholesterol drugs recommended for some 8 - year - olds
By LINDSEY TANNER July 7, 2008

CHICAGO - For the first time, an influential doctors group is recommending that some children as young as 8 be given cholesterol-fighting drugs to ward off future heart problems.

It is the strongest guidance ever given on the issue by the American Academy of Pediatrics, which released its new guidelines Monday. The academy also recommends low-fat milk for 1-year-olds and wider cholesterol testing.

Dr. Stephen Daniels, of the academy's nutrition committee, says the new advice is based on mounting evidence showing that damage leading to heart disease, the nation's leading killer, begins early in life.

It also stems from recent research showing that cholesterol-fighting drugs are generally safe for children, Daniels said.

Several of these drugs are approved for use in children and data show that increasing numbers are using them.

"If we are more aggressive about this in childhood, I think we can have an impact on what happens later in life ... and avoid some of these heart attacks and strokes in adulthood," Daniels said. He has worked as a consultant to Abbott Laboratories and Merck & Co., but not on matters involving their cholesterol drugs.

Drug treatment would generally be targeted for kids at least 8 years old who have too much LDL, the "bad" cholesterol, along with other risky conditions, including obesity and high blood pressure.

For overweight children with too little HDL, the "good" cholesterol, the first course of action should be weight loss, more physical activity and nutritional counseling, the academy says.

Pediatricians should routinely check the cholesterol of children with a family history of inherited cholesterol disease or with parents or grandparents who developed heart disease at an early age, the recommendations say. Screening also is advised for kids whose family history isn't known and those who are overweight, obese or have other heart disease risk factors.

Screening is recommended sometime after age 2 but no later than age 10, at routine checkups.

The academy's earlier advice said cholesterol drugs should only be considered in children older than 10 after they fail to lose weight. Its previous cholesterol screening recommendations also were less specific and did not include targeted ages for beginning testing.

Because obesity is a risk factor for heart disease and often is accompanied by cholesterol problems, the academy recommendations say low-fat milk is appropriate for 1-year-olds "for whom overweight or obesity is a concern."

Daniels, a pediatrician in the Denver area, agreed that could include virtually all children. But he said doctors may choose to offer the new milk advice only to 1-year-olds who are already overweight or have a family history of heart problems.

The academy has long recommended against reduced-fat milk for children up to age 2 because saturated fats are needed for brain development.

"But now we have the obesity epidemic and people are thinking maybe this isn't such a good idea," said Dr. Frank Greer of the University of Wisconsin, co-author of the guidelines report, which appears in the July edition of Pediatrics, the group's medical journal.

Very young children are increasingly getting fats from sources other than milk and Greer said the updated advice is based on recent research showing no harm from reduced-fat milk in these youngsters.

With one-third of U.S. children overweight and about 17 percent obese, the new recommendations are important, said Dr. Jennifer Li, a Duke University children's heart specialist.

"We need to do something to stem the tide of childhood obesity," Li said.

Li said that 15 years ago most of her patients with cholesterol problems had an inherited form of cholesterol disease not connected to obesity.

"But now they're really outnumbered" by overweight kids with cholesterol problems and high blood pressure, she said.

Dr. Elena Fuentes-Afflick, a pediatrics professor at the University of California at San Francisco, also praised the new advice but said some parents think their kids will outgrow obesity and cholesterol problems, and might not take it seriously.

"It's hard for people to really understand" that those problems in childhood can lead to serious health consequences in adulthood, Fuentes-Afflick said.

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