PharmaGossip

US mental guidelines attacked - FT.com

2012-02-11T00:08:00.001Z

David Pilgrim, Professor of Mental Health Policy at the University of Central Lancashire, said: “It’s hard to avoid the conclusion that DSM-5 will help the interests of the drug companies and the wrong-headed belief of some mental health professionals.”

He said DSM-5, set for release in May next year, generates substantial income and reinforces the role of the American Psychiatric Association, as well as playing down “the complexity of people’s problems that are a mixture of psychological, social and biological factors”.

via ft.com

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Will Cameron be the last Tory PM ever?

2012-02-10T18:18:00.000Z

Link

Leo Pharma Sales Reps File Overtime Class Action in New York Federal Court - FiercePharma

2012-02-10T17:26:00.001Z

Complaint Filed by Sanford Wittels & Heisler, LLP Details Current and Past Federal & State Wage and Hour Violations

NEW YORK, Feb. 9, 2012 /PRNewswire via COMTEX/ -- Just weeks after winning preliminary approval of a 99 million dollar settlement on behalf of Novartis Pharmaceuticals Sales Representatives, Attorneys from Sanford Wittels & Heisler, LLP today filed a class action complaint in the U.S. District Court for the Southern District of New York on behalf of four former Sales Representatives and other similarly-situated employees at LEO Pharma Inc. The suit details the foreign pharmaceutical company's denial of the reps' basic overtime pay and other wage and hour practices that violate the U.S. Fair Labor Standards Act (FLSA) and state overtime laws in New York, California and Washington.

"LEO Pharma willfully misclassifies its sales representatives as exempt from the benefits of federal and state wage and hour laws," said Deborah Marcuse, an attorney at Sanford Wittels & Heisler, LLP (SWH) who represents the four named plaintiffs and the class. "The LEO reps worked well over 40 hours per week but have not received any overtime pay. Their misclassification deprives them of the overtime pay and other work-related benefits to which they are legally entitled. Such egregious practices allow the company to enrich its bottom line at the expense of the economic wellbeing of its sales force, which is intolerable."

Steven Wittels, Jeremy Heisler and Deborah Marcuse in SWH's New York City office and David W. Sanford, in the Firm's Washington, D.C., office represent the plaintiffs and the class.

Lori Hoel, Shuntel Blount, Lisa Borden and Mitra Mottaghian are the plaintiffs and class representatives in the matter. Each plaintiff seeks to represent all LEO Pharma sales reps in the federal collective action under the Fair Labor Standards Act, and Ms. Hoel, Ms. Blount and Ms. Mottaghian each seek to represent class members under the state laws of California, Washington and New York, respectively.

According to the complaint, LEO Pharma improperly classifies its non-exempt sales representatives as salaried exempt employees and denies them overtime pay, even though these employees regularly perform non-exempt duties. Because of the misclassification, the company does not pay these or similarly situated employees for the hours they work in excess of 40 hours of week at the required rate of time and a half.

"LEO Pharma has not made a good faith effort to comply with Fair Labor Standards Act or with the comparable state laws that protect workers' rights," said Mr Heisler. "In today's depressed economic climate, this is not only illegal, but unconscionable."

The four plaintiffs seek to represent every person who works or who has worked as a full-time Sales Representative for LEO Pharma for at least one day in any U.S. state or territory between February 7, 2009, and the present.

"These companies need to get the message that they cannot cultivate their profits at the expense of the basic rights of their workforce," explained Mr. Wittels. "At a time when working people are struggling to support their families, it becomes all the more important to stand up and insist that corporations do the right thing for their employees by paying them in accordance with federal and state laws."

LEO Pharma, which is incorporated in Pennsylvania and headquartered in Parsippany, NJ, is a wholly-owned subsidiary of Ballerup, enmark-based LEO Pharma A/S. The company specializes in dermatology and critical products for the health care industry. It reported an after-tax profit in 2010 of DKK 699.6 million.

via fiercepharma.com

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QE explained

2012-02-10T14:12:00.002Z

Hospital Pharmacy Europe - Clopidogrel with aspirin 'does not prevent strokes'

2012-02-10T13:58:00.001Z

The anti-blood clot regimen that adds the drug clopidogrel (Plavix) to aspirin treatment is unlikely to prevent recurrent strokes and may increase the risk of bleeding and death in patients with subcortical stroke, according to research presented at the American Stroke Association's International Stroke Conference 2012.

Because of these preliminary results, researchers ended the anti-clotting part of the Secondary Prevention of Small Subcortical Strokes Trial (SPS3) in August 2011.

The part of the study that examines the effect of high blood pressure treatments will continue.

via hospitalpharmacyeurope.com

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GSK malpractice case raises questions about trial standards : The Lancet

2012-02-10T03:55:00.001Z

Natalia Fuertes
An ongoing legal case between GlaxoSmithKline and courts in Argentina has drawn attention to possible procedural problems in trials done in developing nations. Natalia Fuertes reports.
After GlaxoSmithKline (GSK) was fined US$92 000 by Argentinian courts for administrative irregularities in a vaccine trial, observers have questioned whether trials are done under the same strict principles all over the world.
On Dec 28, 2011, Marcelo Aguinsky, a judge in the province of Mendoza, found GSK guilty of irregularities in obtaining informed consent in a trial assessing the efficacy and safety of Synflorix—a vaccine against Streptococcus pneumoniae and acute otitis media caused by non-typeable Haemophilus influenzae. Aguinsky fined the drug company and the two main investigators, Miguel Tregnaghi and Hector Abate, a total of AR$1 million. GSK is currently appealing the decision. “GSK conducts clinical trials to the same high standards, irrespective of where in the world they are run”, the company said in a statement.
The COMPAS trial was done between 2007 and 2008 in rural areas of three provinces in the east and north of Argentina—Mendoza, Santiago del Estero, and San Juan. It involved around 400 health professionals and was originally intended to recruit 17 000 children.
Problems in the GSK trial first came to light in 2007, when paediatrician Ana Marchese reported possible irregularities to FeSProSa (Syndicate Federation of Argentinian Health Professionals) after speaking to the trial participants' families. FeSProSa investigated the accusations and filed a report to the National Administration of Drugs, Food and Medical Technology (ANMAT) in December, 2007, declaring problems surrounding informed consent. GSK stated that it was the company that had identified the irregularities through self-monitoring and reported them straight to ANMAT.
ANMAT undertook an inspection of the procedures and consent forms and found that in some of them, there was reason to believe that the parents of the participants did not fully understand what they were signing and the witnesses were not impartial. Due to these irregularities, the recruitment process was stopped in August, 2008. Roberto Lede, director of Planning and Institutional Relationships of ANMAT, states that “the intervention of the ANMAT was very opportune. The recruitment was stopped in the way it was being carried out and resumed with intensive control. It should be noted that the irregularities only affected less than 1% of the subjects.”
14 infants who were taking part in the COMPAS trial died during it. However, because they were in the placebo group, GSK and ANMAT agreed that the trial could continue. COMPAS ended successfully in 2008, with only 18% fewer subjects than originally intended, and Synflorix was approved by ANMAT.
However, as the problem regarding invalidity of some of the consent forms remained, ANMAT issued a fine to GSK and the local doctors in charge. While GSK are appealing the fine in Mendoza, in Santiago del Estero, their appeal to the Supreme Court was successful, and the ruling was dismissed. In San Juan, the local courts have yet to rule.
The ruling of the Argentinian courts marks a pivotal moment in the regulations of trials by local authorities. Luis Petri, a member of the Lower House in Mendoza presented a bill in early January, 2012, to ban clinical trials in the province. “Children of Mendoza must not be used as guinea pigs by pharmaceutical companies to try their drugs or vaccines, regardless of the consent of their parents”, he stated. The bill is still under consideration.
In 2007, about 200 trials were done in Argentina, but not all of them were officially registered. After the irregularities in the COMPAS trial were disclosed, the government decided to create a National Register of Trials. In November, 2008, ANMAT ordered drug companies throughout the country to include a warning sign in red capital letters on every consent form, clearly stating the experimental nature of the trial. However, ANMAT's Lede said that “there was no need to introduce any modifications to the law; the problem was not the law but the compliance with it”.
Brian Angus, director of the Wellcome Trust UK Centre for Clinical Tropical Medicine in Oxford, UK, states that “protection of volunteers for clinical trials is crucial. Especially overseas, where people sometimes do not have the level of education to understand the implications of a clinical trial, there is even greater need for the doctors to act in the patient's best interests. It is ultimately the doctor's responsibility. What would you do if somebody agrees to be part of a clinical trial but you do not think they really understand what it means? The answer is clear, you do not recruit them.”
GSK's fine is the largest Argentina has issued against a drug company. And while the case has led to legal changes in the country, it has also drawn attention to the need to improve ethical and procedural standards of trials done in developing regions of the world.

via thelancet.com

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E-cigarettes will get FDA oversight as tobacco products - OrlandoSentinel.com

2012-02-10T03:54:00.001Z

The Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up.
In a letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. To shore up its authority to do so, the agency will propose new regulatory language that would specifically define e-cigarettes as a tobacco product.

via orlandosentinel.com

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Can The Man From Heinz Keep Novartis On Top? - Forbes

2012-02-09T13:18:00.001Z

via forbes.com

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Oops! Anti-Obesity Drug Now In Clinical Trials May Cause Rapid Bone Loss

2012-02-09T13:15:00.001Z

An endocrine hormone used in clinical trials as an anti-obesity and anti-diabetes drug causes significant and rapid bone loss in mice, raising concerns about its safe use, UT Southwestern Medical Center researchers have shown.
The hormone, fibroblast growth factor 21 (FGF21), promotes bone loss by enhancing the activity of a protein that stimulates fat cells but inhibits bone cells, researchers report in a study available online in Proceedings of the National Academy of Sciences.
"This hormone is a very potent regulator of bone mass," said Dr. Yihong Wan, assistant professor of pharmacology and senior author of the study. "When we oversupply FGF21 in mice, it results in substantial bone loss."

via medicalnewstoday.com

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GSK emptying bank accounts to limit euro zone exposure - The Irish Times -

2012-02-08T02:31:00.001Z

ANDREW JACK in London
GLAXOSMITHKLINE is emptying out tens of millions of euro each day from its bank accounts in Europe’s more fragile countries to minimise the risk of exposure to a regional banking or financial crisis.
GSK chief executive Sir Andrew Witty said that since early last year the UK pharmaceutical group had been conducting “a daily sweep” to remove all cash from most euro zone countries and deposit it in banks “we think are robust and secure”.
He stressed that the euro zone crisis had “settled down” and that GSK’s own debts in the Mediterranean countries had fallen over the past year, but he had no plans to stop the practice “just in case”.

via irishtimes.com

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Drug Rep Fired for "Poor Performance", Awarded $880,000

2012-02-08T02:28:00.001Z

What happened. "Moore" worked for B. Braun, primarily selling pain-killing prescription drugs. Hired in October 1998, she was fired in April 2007. She was very much aware that federal law prohibits both kickback payments from drug makers to customers and promoting off-label uses—those for indications or in dosages not approved by the Federal Drug Administration—for drugs.

Moore's concerns about these practices went back to early 2000, when she sent a memo to her manager about off-label promotion. In November of that year, trainers instructed drug reps on how to promote off-label uses for one of Braun's pain killers. Again, Moore objected, but her regional manager angrily pulled her out of the session and scolded her. At a training session in 2003, a salesperson instructed reps how to funnel kickback payments to customers through a third party. At that point, she approached Braun's Compliance Department, where she continued to take her concerns.

In 2006, a hospital customer pressured her to give it what she felt was a kickback payment, and she refused. But her supervisors were increasingly unhappy about her complaints. So, they began downgrading her for failing to meet her sales quotas. Then they transferred her to a new sales territory where she found the quotas unattainable. And, she was fired.

She sued, claiming wrongful discharge in violation of public policy: Common law bars employees from being fired for refusing to break the law. A jury heard her case in federal district court and awarded her $880,000. Braun appealed the verdict to the 6th Circuit, which covers Kentucky, Michigan, Ohio, and Tennessee.

What the court said. Judges saw that in 2004 and 2005, Moore had not met all her sales quotas but had been ranked as 3rd-best and then 10th-best out of 35 drug reps. Suddenly in 2006, she was ranked near the bottom. They believed she had been wrongly discharged and affirmed the jury's verdict. Morrison v. B. Braun Medical, U.S. Court of Appeals for the 6th Circuit, No. 10-1548 (2011).

Point to remember: High evaluations before a complaint and low ones after it can be a dead giveaway in court. Here, they seem to have convinced judges that Moore's case was a righteous one.

via hr.blr.com

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The tricks that drug companies do live after them, their patients are oft interred with their trials

2012-02-08T02:23:00.001Z

via davidhealy.org

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Go Buddy Go! Drug companies to pay $25.2 million back to Medicaid in pricing fraud cases

2012-02-07T22:30:00.001Z

via nola.com

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Merck anti-clot compound again shows bleeding risk

2012-02-07T20:51:00.001Z

TRENTON - An experimental anti-clotting drug that Merck & Co. is developing was found to increase risk of dangerous internal bleeding in a second study, meaning it's unlikely to achieve the blockbuster status once expected, if it's even approved.

Vorapaxar is part of a new generation of anti-clotting drugs meant to prevent the death and disability strokes and heart attacks cause in the millions of people at risk for them. Drugmakers have generally touted their compounds as more effective and safer than Coumadin, known chemically as warfarin, the standard treatment for decades despite the need for frequent blood tests because getting the dosage right is so tricky.

On Tuesday, Merck said top-line results from a 26,000-patient study called TRA-2P show vorapaxar, when added to standard anti-clotting therapy, significantly reduced risk of heart attack, stroke, and death from heart disease or emergency heart surgery.

But the company said there was a significant increase in bleeding, including bleeding inside the skull. That can cause a stroke, brain damage or death. Such intracranial bleeding was less common in patients who had not previously had a stroke.

A year ago, the same bleeding problem led safety monitors to halt a late-stage study of vorapaxar called Tracer. That international study included nearly 13,000 patients who had had a heart attack or severe chest pain from clogged arteries.

At the time, Merck decided to continue the TRA-2P study but to no longer give vorapaxar to about 6,000 patients in that study who had a history of stroke.

"We believe commercialization is unlikely, given the potential safety profile of the drug and negative results from Tracer," Citi analyst John Boris wrote to investors. "If vorapaxar reaches the market, we see a limited commercial" opportunity.

He still has a "Hold" rating on Merck but wrote off any chance of vorapaxar sales in January 2011.

Merck basically conceded the drug's diminished prospects when it took a $1.7 billion charge a little over a year ago to write down the value assigned to vorapaxar when it acquired the compound through its November 2009 purchase of Schering-Plough Corp.

Merck, based in Whitehouse Station, N.J., and with operations in the Philadelphia region, said it will present detailed results from TRA-2P at the March 24-27 meeting of the American College of Cardiology.

"We are pleased that TRA-2P met its primary endpoint, and we look forward to discussing the results with the scientific community," Peter Kim, president of Merck Research Laboratories, said in a statement.

Merck has said it plans to apply for approval of five different drugs between this year and next. Vorapaxar is not on the list, although Merck originally had planned to apply for approval in 2011.

Meanwhile, rival drug companies have gotten new anti-clotting drugs approved recently or expect a ruling on their drug shortly. Those are: Boehringer Ingelheim of Germany, whose Pradaxa was approved in October 2010; partners Johnson & Johnson and Bayer Healthcare, whose Xarelto was approved last July, and partners Pfizer Inc. and Bristol-Myers Squibb Co. Their Eliquis is expected to get a ruling from the Food and Drug Administration by March 28.

None of those drugs has shown such serious bleeding risks, but they are far more expensive than warfarin.

In midday trading, Merck shares were up 28 cents at $38.68.

Summary:

STRIKE TWO: A second study shows Merck's experimental anti-clotting drug vorapaxar increased risk of dangerous internal bleeding, including inside the skull. The study, called TRA-2P, did show vorapaxar lowered risk of heart attack, stroke and death.

DIM FUTURE: Merck's already taken a $1.7 billion charge over vorapaxar after it flopped in the earlier study. It's to release full results of the latest study in late March.

ANALYST VIEW: Citi's John Boris thinks approval is unlikely. If it happens, he writes, vorapaxar has "limited commercial" opportunity.

,,,

Linda A. Johnson can be followed at http://twitter.com/LindaJ,onPharma

via philly.com

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Faking It for the Dean - Brainstorm - The Chronicle of Higher Education

2012-02-07T20:50:00.001Z

via chronicle.com

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Ex-health care exec pleads guilty to fraud

2012-02-07T20:35:00.001Z

LOUISVILLE, Ky.

The one-time vice president of a health care company has pleaded guilty to charges of misbranding and altering drugs and to committing health care fraud.

via wchstv.com

A statement from the U.S. Attorney's Office says 62-year-old Johnny Perry of Mount Washington entered the plea Monday in U.S. District Court in Louisville. Perry served as an executive with National Respiratory Services.

A grand jury charged Perry in August with altering medications that were not FDA approved, but billing them as approved. Perry was also charged with submitting false claims to Medicare for the cost of FDA approved drugs. Prosecutors say Medicare paid the company $2,030,343 from November 2006 through June 2008.

Perry also faced charges of misbranding and altering inhalation drugs.

A sentencing date has not been set.

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Pharma fears it is not up to demands of 'value challenge' - EIU

2012-02-07T18:14:00.001Z

Kevin Grogan

Drugmakers realise they need to demonstrate the value of their new treatments to payers, but many are concerned about their ability to do so.

That is one of the key findings from a new report from the Economist Intelligence Unit, sponsored by Quintiles. The analysis, called 'The Value Challenge', is based on findings of a survey of 399 senior executives from the life sciences industry, and it states that the situation is "further complicated by a shift in the balance of power among industry stakeholders, each of which may require different evidence to be convinced of a product’s value".

The EIU report argues that the value challenge is "not just a temporary symptom of current economic conditions, but a long-term issue that is a leading concern for a majority of drug companies worldwide". Moreover, although deteriorating financial circumstances are prompting some payers —particularly governments —to focus more closely on reducing pharmaceutical spending, "the demand for proof of value has been evolving for decades".

However, many stakeholders, especially biopharma companies, "lack confidence in the industry’s ability to respond to the value challenge", the report claims. Only about one-half of survey respondents say that the pharmaceutical sector is adjusting well to increasing demands for proof of value.

All respondents are harsher about biopharmaceutical companies’ ability to demonstrate value and, among payers and regulators, only 25% are confident about the broader claims of value made by these firms. However, 68% of life sciences respondents saw the growing demand to provide value has had an important impact on their business models; 85% have made at least one change to their model for this reason, 82% to their R&D strategy, and 78% to their commercial plans.

The EIU survey also notes that biopharmaceutical companies see their market power decreasing, but others still regard them as dominant players. The report quotes Ed Pezalla, national medical director for pharmaceutical policy and strategy at US insurance major Aetna, as saying that “the industry is still making decisions about what drugs come to market and what they can charge. It is just beginning to pay attention to payer sensitivity.”

via pharmatimes.com

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NIH Clinical Research Trials and You - National Institutes of Health (NIH)

2012-02-07T11:09:00.001Z

via nih.gov

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The 11 Most Expensive Medicines in America - Medical Billing and Coding Certification

2012-02-07T10:07:00.001Z

The 11 Most Expensive Medicines in America

Posted on February 6, 2012

Think you pay way too much for your monthly prescriptions? These amazingly expensive drugs may put things into perspective. Paying $10,000 or even $30,000 in annual prescriptions might be busting many peoples’ budgets, but those price tags pale in comparison to some that come in at over $400,000 for an annual treatment.

So why isn’t someone doing something about this obvious highway robbery? How could the FDA let evil pharmaceutical companies get away with this? The truth is that these are often lifesaving drugs that would not exist if it were not for their incredible cost. To be fair, pharmaceutical companies spend an amazing amount of money to make highly specialized drugs, often in the range of hundreds of millions of dollars. As such, the FDA supports this practice with the Orphan Drug Designation program, which encourages the development of drugs for rare diseases that, without special protections and benefits, might not ever be developed. While patients may be losing their shirts to the pharmaceutical companies, they are at the same time lucky not to lose their lives thanks to these drugs. Still, it is quite interesting to marvel at the sheer cost of annual treatment, and we’ve compiled a list of 11 mind-bogglingly expensive medicines being used to treat conditions in America right now.

Soliris

Soliris has been made famous by Forbes as the world’s single most expensive drug, coming in at $409,500 a year. Soliris is used to treat paroxysmal nocturnal hemoglobinuria, a rare blood disease that affects 8,000 Americans. Soliris’ high price tag is largely due to $800 million investment and 15 years of research that Alexion Pharmaceuticals put into its development. Its 2009 sales were $295 million, and in 2010, Alexion pulled in $541 million for the drug. The high cost of Soliris is shocking, but it does seem to be worth every penny: studies show that Soliris use results in a 90% reduction in the most serious complication and cause of death from paroxysmal nocturnal hemoglobinuria.

Elaprase

Patients who suffer from Hunter syndrome, an inherited disease caused by a lack of the enzyme iduronate sulfatase can find relief in the recombinant form of this enzyme, but at an incredibly high price of $375,000 each year. Some estimates put its annual cost as high as $657,000. Each vial of the drug is reported to cost $4,215 each, and in the U.S. alone, the 500 Americans who suffer from Hunter syndrome spent a combined $353 million on Elaprase in 2009.

Naglazyme

Naglazyme is right behind Elaprase’s reported $375,000 price tag, coming in at the bargain price of just $365,000. This purified human enzyme is used to treat Maroteaux-Lamy syndrome, a rare genetic metabolic condition that typically presents itself in childhood through growth retardation in intellectually normal toddlers, and can cause tissue damage and mental retardation. The administration of the drug improves growth and joint movement, as well as range of motion and pain management.

Cinryze

Patients with hereditary angioedema suffer from severe swelling, often in the face and airways, caused by low levels or improper function of the C1 inhibitor protein. This condition is hereditary, and there’s usually a family history, but often, deaths from hereditary angioedema go undiagnosed and reported as a sudden and premature death of a family member. This makes the condition relatively rare, and the treatment is quite expensive: an estimated $350,000 per year for Cinryze, an injectable man-made protein form of complement C1 esterase inhibitor. Cinryze maker Viropharma has mapped out yearly sales of the drug ranging from $95 million to as much as $350 million.

Folotyn

Getting cancer is bad enough, but things just get even worse when the cost of treating such a severe disease begins to sink in. Patients with T-cell lymphoma typically turn to Folotyn when their cancer has not improved with treatment, or comes back. This drug works by killing cancer cells, and has a short course of treatment. Typically, patients will take the drug for about six weeks, but even in that short amount of time, the bill for this treatment is staggering — around $30,000 per month.

ACTH

If you think $30,000 per month is insane, consider this: it’s a bargain compared to the approximate $115,000 per month families pay for ACTH. This drug is used to treat infantile spasms, seizures that often affect infants 4 to 6 months of age. Daily injections of ACTH are given for a period of weeks up to several months. At $23,000 per vial, patients often use 6 to 7 vials per course, and often go through two courses, which adds up to more than $300,000 in prescription drug bills. Unfortunately, ACTH is not FDA-approved to treat infantile spasms, and that means families may have trouble getting their insurance companies to pay for this mind-boggling bill.

Myozyme

Developed by Genzyme, Myozyme costs up to $100,000 per year for child treatment, and about $300,000 per year for adults. Myozyme was created to treat a rare and often fatal disease, Pompe, which disables the heart and skeletal muscles. Often affecting infants, most of its sufferers die in the first year, and those who do survive typically need assistance like ventilators and wheelchairs. But thanks to Myozyme, some patients can do fairly well with the disease, able to speak, walk, and feed themselves. The drama behind creating such an expensive, yet lifesaving drug, was depicted in the movie Extraordinary Measures, sharing the race against time and profit motives experienced in the drug’s development.

Arcalyst

Rare genetic conditions like Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome are inflammatory disorders that cause the body to develop symptoms without a known cause, including virus and illnesses, and can affect the bones, joints, and major organs, leading to deafness, kidney impairment, and vision loss. These inherited conditions impair the immune systems of sufferers, but with Arcalyst, the symptoms associated with these syndromes can be treated and even prevented. It’s even been found to help prevent gout flares, but all of this helpful treatment comes at a very high cost: a reported $250,000 per year of treatment.

Ceredase/Cerezyme

Patients with Gaucher disease, a condition that causes lumps of fat to build up in various places in the body, including the heart, brain, and spleen, suffer from the disease due to a missing enzyme. With Ceredase, made from human placentas, that enzyme can be replaced. But placentas don’t come cheap: the price of this drug is $150,000 per year. A new version, Cerezyme, came out in 1994, made with genetically engineered hamster cells, and was expected to be cheaper, but unfortunately for Gaucher disease sufferers, the price has actually gone up to $200,000 per year for the average patient. The drug has annual sales of more than a billion dollars.

Fabrazyme

Like so many other terribly expensive drugs on this list, Fabrazyme replaces a necessary enzyme in the human body. Patients with Fabry disease suffer from the lack of or faulty enzyme that is needed to metabolize lipids. Without it, lipids are not effectively broken down, and can build to harmful levels in the nervous system, cardiovascular system, eyes, and kidneys, leading to cloudiness of the cornea, increased heart attack and stroke risk, as well as an enlarged heart and impaired kidneys. It’s not hard to understand why this condition is just downright harmful, and why it’s so important to treat. Using Fabrazyme, patients can make up for their enzyme deficiency, reducing deposits throughout the body. The treatment is reported to cost $200,000 for a year of treatment, that is, if you can get it: in 2009, Fabrazyme maker Genzyme’s plant was shut down due to contamination, and is just now resolving its manufacturing problems.

Aldurazyme

Aldurazyme is used to treat a genetic enzyme condition, a far too common and expensive issue on this list. The condition in this case is Hurler syndrome, a metabolic disorder in which the lack of an enzyme keeps the body from breaking down certain sugars and proteins properly. Like Fabry disease, sugars and proteins not broken down will build up, leading to enlarged organs, breathing issues, decreased physical abilities, and more. With Aldurazyme, breathing and walking ability can be improved, but it does cost a pretty penny: $200,000 per year. The drug is usually given on a weekly basis in a clinic or hospital setting, which may incur additional costs as well.

via medicalbillingandcoding.org

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Sloan-Kettering Chief, Celgene Sued Over Cancer Research - Businessweek

2012-02-07T01:44:00.001Z

Feb. 6 (Bloomberg) -- The head of Memorial Sloan-Kettering Cancer Center was accused along with biotechnology company Celgene Corp. of using research he helped develop at another cancer institute to start his own company.

The Leonard and Madlyn Abramson Family Cancer Research Institute at Philadelphia’s University of Pennsylvania sued Dr. Craig Thompson in federal court in Manhattan for fraudulent misrepresentation, asking a judge to decide on the ownership of intellectual property rights to the research. The institute seeks damages from Thompson of more than $1 billion, according to the complaint.

Thompson studied cancer metabolism while he was scientific director of the institute, which was created by a $100 million donation from the Abramson family foundation to the university, according to the complaint filed Dec. 13. Without telling the institute, Thompson formed Agios Pharmaceuticals Inc. to exploit the research and got funding from Summit, New Jersey-based Celgene, the institute said.

via businessweek.com

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JPMorgan Chase To Pay $110 Million To Settle Accusations Of Excessive Overdraft Fees

2012-02-07T01:26:00.001Z

By Jonathan Stempel
Feb 6 (Reuters) - JPMorgan Chase & Co has agreed to pay $110 million to settle consumer litigation accusing it of charging excessive overdraft fees.
The largest U.S. bank by assets joined Bank of America Corp and several smaller lenders in settling their portion of the nationwide litigation over the fees, which are typically assessed when customers overdraw their checking accounts.
Consumers had accused more than 30 lenders of routinely processing transactions from largest to smallest rather than in chronological order.
This can cause overdraft fees, typically $25 to $35, to pile up because account balances fall faster when larger transactions are processed first. Critics say this disproportionately burdens customers with lower incomes and balances.
JPMorgan's settlement in principle was disclosed in a filing on Friday with the U.S. district court in Miami.
The settlement requires negotiation of final documentation and approval by U.S. District Judge James Lawrence King, who oversees the nationwide litigation. It also calls for an unspecified change to JPMorgan's overdraft practices.

via huffingtonpost.com

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The Shortage of Essential Chemotherapy Drugs in the United States — NEJM

2012-02-07T01:19:00.001Z

A Correction Has Been Published
Perspective
The Shortage of Essential Chemotherapy Drugs in the United States
Mandy L. Gatesman, Pharm.D., and Thomas J. Smith, M.D.
N Engl J Med 2011; 365:1653-1655November 3, 2011
Comments open through November 9, 2011
Article
References
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For the first time in the United States, some essential chemotherapy drugs are in short supply. Most are generic drugs that have been used for years in childhood leukemia and curable cancers — vincristine, methotrexate, leucovorin, cytarabine, doxorubicin, bleomycin, and paclitaxel.1 The shortages have caused serious concerns about safety, cost, and availability of lifesaving treatments. In a survey from the Institute for Safe Medication Practices, 25% of clinicians indicated that an error had occurred at their site because of drug shortages. Many of these errors were attributed to inexperience with alternative products — for instance, incorrect administration of levoleucovorin (Fusilev) when used as a substitute for leucovorin or use of a 1000-mg vial of cytarabine instead of the usual 500-mg one, resulting in an overdose. Most cancer centers quadruple-check drugs for accuracy, and we're unaware of any documented death of a patient with cancer such as the nine deaths in Alabama attributable to the use of locally compounded liquid nutrition because the sterile product was not available. However, it is only a matter of time.

These shortages have increased the already escalating costs of cancer care. Brand-name substitutes for generic drugs can add substantial cost. For instance, Abraxane, a protein-bound version of paclitaxel, costs 19 times as much as equally effective generic paclitaxel (see table
Average Wholesale Prices (AWPs) of Selected Oncology Drugs in Short Supply and Their Potential Alternatives.). Since 2010, health care labor costs in the United States have increased by about $216 million because of the increased time and work required to manage drug shortages.2 A gray market for essential drugs — an unofficial alternative market of drugs obtained by vendors outside the usual distribution networks — has grown rapidly, with unregulated vendors charging markups of up to 3000% for cancer drugs.

The main cause of drug shortages is economic. If manufacturers don't make enough profit, they won't make generic drugs. There have been some manufacturing problems, but manufacturers are not required to report any reasons or timetable for discontinuing a product. Contamination and shortages of raw materials probably account for less than 10% of the shortages. In addition, if a brand-name drug with a higher profit margin is available, a manufacturer may stop producing its generic. For instance, leucovorin has been available from several manufacturers since 1952. In 2008, levoleucovorin, the active l-isomer of leucovorin, was approved by the Food and Drug Administration. It was reportedly no more effective than leucovorin and 58 times as expensive, but its use grew rapidly. Eight months later, a widespread shortage of leucovorin was reported.

The second economic cause of shortages is that oncologists have less incentive to administer generics than brand-name drugs. Unlike other drugs, chemotherapeutics are bought and sold in the doctor's office — a practice that originated 40 years ago, when only oncologists would handle such toxic substances and the drugs were relatively cheap. A business model evolved in which oncologists bought low and sold high to support their practice and maximize financial margins. Oncologists buy drugs from wholesalers, mark them up, and sell them to patients (or insurers) in the office. Since medical oncology is a cognitive specialty lacking associated procedures, without drug sales, oncologists' salaries would be lower than geriatricians'. In recent decades, oncology-drug prices have skyrocketed, and today more than half the revenue of an oncology office may come from chemotherapy sales, which boost oncologists' salaries and support expanding hospital cancer centers.

Before 2003, Medicare reimbursed 95% of the average wholesale price — an unregulated price set by manufacturers — whereas oncologists paid 66 to 88% of that price and thus received $1.6 billion annually in overpayments.3 To blunt unsustainable cost increases, the Medicare Modernization Act mandated that the Centers for Medicare and Medicaid Services (CMS) set reimbursement at the average sales price plus a 6% markup to cover practice costs. This policy has reduced not only drug payments but also demand for generics. In some cases, the reimbursement is less than the cost of administration. For instance, the price of a vial of carboplatin has fallen from $125 to $3.50, making the 6% payment trivial. So some oncologists switched to higher-margin brand-name drugs.4 Why use paclitaxel (and receive 6% of $312) when you can use Abraxane (for 6% of $5,824)?

Now practices are struggling to treat their patients because of the unavailability of drugs. Short-term solutions include gray-market purchases, which more than half of surveyed hospitals say they've made, but that option introduces safety and quality-control issues. Pharmacists are intensively managing inventories and alerting prescribers to developing shortages and potential alternatives. Some centers now have a red–yellow–green system for quickly recognizing developing shortages and determining which patients get priority (usually those with curable cancers) when supply is limited.

Long-term, non–market-based solutions have been elusive. Proposed legislation would require manufacturers to give 3 to 6 months' notice before discontinuing a drug in order to allow others to pick up production. However, it is likely that gray-market vendors would buy the remaining inventory of such drugs and charge huge markups. Creating a national stockpile is impractical: Do we stockpile the drugs and then waste whatever is not used or stockpile the ingredients and make new batches as needed? A national health care plan with a single formulary and a central pharmacy stockpile is possible for Medicare or Veterans Affairs but unrealistic given oncologists' dependence on drug income and difficulties with timely, safe distribution.

Market solutions take one of two approaches: let the market work and accept short-term uncertainties or regulate the market more tightly. For instance, the CMS could reimburse at the average sales price plus 30%, but that wouldn't help if the drug price has fallen from $125 to $3.50 per vial. The government could set a floor for average sales prices to encourage the production of generic drugs, but that would increase the total cost of cancer drugs unless brand-name prices were reduced. Europe has fewer shortages for that reason: prices are set higher for generics so that companies will make them, but prices of brand-name drugs are often much lower than U.S. prices.

More far-reaching reforms of oncology practices and reimbursement are necessary if there is no national intervention or federal market regulation. One solution is adopting clinical pathways for which practices are paid disease-management fees that are not based on chemotherapy sales. For instance, one large oncology group has developed care pathways specifying preferred drug combinations and sequences — for example, allowing only a few first-line, mostly generic regimens for patients with non–small-cell lung cancer, as compared with the 16 possible drugs and many more combinations included in National Comprehensive Cancer Network pathways. This approach has been shown to result in equal or better survival, less use of chemotherapy near the end of life, and 35% lower costs than usual care.5 Another solution is to pay physicians salaries, as Kaiser Permanente, Veterans Affairs, and most academic centers do, but that would reduce oncologists' earnings at a time when a 40% workforce shortage is predicted, so the effect must be monitored.

To ensure a predictable supply of generic cancer drugs, manufacturers need reasonable markets and profits, and oncologists need incentives to use generics. Standardized clinical pathways with drug choices based only on effectiveness will enable the prediction of drug needs, practices for effective management of inventory, and planning by manufacturers for adequate production. Such pathways, disease-management fees, and physician salaries would dramatically change oncologic practice, but since drug costs will increase by 4 to 6% this year alone, they are necessary. The current system not only is unsustainable but also puts oncologists in potential ethical conflict with patients, since it hides revenue information that might influence drug choices and thus affects costs and patients' copayments.

The only good news is that the drug shortages may catalyze a shift from a mostly market-based system to one that rewards the provision of high-quality cancer care at an affordable cost.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article (10.1056/NEJMp1109772) was published on October 31, 2011, and updated on November 2, 2011, at NEJM.org.
Source Information
From the Virginia Commonwealth University Health System, Richmond (M.L.G.); and the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore (T.J.S.).
References
1
Food and Drug Administration. Current drug shortages (http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm).
2
Kaakeh R, Sweet BV, Reilly C, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm 2011;68:1811-1819
CrossRef | Medline
3
Twombly R. Medicare cost containment strategy targets several oncology drugs. J Natl Cancer Inst 2004;96:1268-1270
CrossRef | Web of Science | Medline
4
Jacobson M, Earle CC, Price M, Newhouse JP. How Medicare's payment cuts for cancer chemotherapy drugs changed patterns of treatment. Health Aff (Millwood) 2010;29:1391-1399
CrossRef | Web of Science | Medline
5
Neubauer MA, Hoverman JR, Kolodziej M, et al. Cost effectiveness of evidence-based treatment guidelines for the treatment of non-small-cell lung cancer in the community setting. J Oncol Pract 2010;6:12-18
CrossRef
Citing Articles
1
Marc Cohen, Walter P. Jeske, Jose C. Nicolau, Gilles Montalescot, Jawed Fareed. (2012) US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins. Journal of Thrombosis and Thrombolysis
CrossRef

14 Reader's Comments

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Data by Profession and Location

DEAN TSARWHAS, MD | Physician | Disclosure: None
LIBERTYVILLE IL
November 08, 2011
Integrity among Medical Oncologists
I am writing to defend the thousands of medical oncologists in community and academic practices who do not prescribe particular chemotherapy regimens based on maximizing financial profits but based on approved treatment guidelines, pathways, and what is best for the patient. The article is truly a "slap in the face" for the hard working oncologists who provide countless hours of unreimbused time caring for some of the sickest patients in medicine. The article fails to mention that the "drug margin" primarily goes to cover the numerous under-reimbursed expenses involved with providing cancer care in the community setting. Since the advent of the MMA, the ASP+6% reimbursement is often under our acquisition cost, making it impossible to treat the patient in the cost-effective office setting, and as a result, the patients are treated at the hospital where it is costlier and often more inconvenient. Finally, many medical students and medical residents choose a career not only based upon their passion, but also upon financial considerations. To suggest that oncologists should be salaried as at the VA would exacerbate a workforce shortage that already exists.

DANIEL LANGER, MD | Physician | Disclosure: None
WINDSOR CO
November 03, 2011
Price fixing.
Economics 101. Price fixing = drug shortages.

Han Zhong | Other | Disclosure: None
Madison WI
November 03, 2011
ASP not AWP
Why does the table list the AWPs of comparable drugs when physicians are reimbursed at ASP+6%? Actual Medicare Part B drug reimbursement at ASP+6% is often significantly lower than AWP.
Just look at the CMS Medicare Part B drug pricing file https://www.cms.gov/mcrpartbdrugavgsalesprice/
Just looking at Paclitaxel vs. Abraxane, Abraxane is more expensive at ASP+6%, but it is also significantly more effective. Is it worth the difference in price? Ask a cancer patient if they want a less efficacious drug to treat their life-threatening condition.

THOMAS WAGNER | Other | Disclosure: None
SNELLVILLE GA
November 03, 2011
The faliure of economic homeopathy
Why is the answer to a market failure caused by inane regulatory action always more inane regulatory action, instead of removing the regulatory thumb from the market's windpipe? This is reminiscent of homeopathic theory, where the cure for a disease is a drug that reproduces the symptoms of the disease, without homeopathy's saving grace of dilution to extinction.

ROGER WILGUS | Other | Disclosure: None
November 02, 2011
What an Astounding Situation
I worked in the health care field for more than three decades and was unaware of the absurd situation described, wherein oncologists sell drugs to their patients at cost plus a percentage. This situation simply begs for abuse, which is clearly occurring. Only our governmet bureaucracy could countenance such a situation, after having permitted it to begin.
Whether oncologists need this windfall to obtain fair compensation for their services is beside the point. There are other ways to provide them such remuneratiion -- ways in which patients and the taxpayers aren't negatively affected. This deplorable situation should be halted at once.

GEORGE CALDWELL, MD | Physician | Disclosure: None
SINGAPORE Singapore
November 02, 2011
Benzbromarone shortage
For the treatment of Acute Gout the combination of Colchicine with Benzbromarone ("Narcaricin") is excellent.
No longer is Benzbromarone available unless someone knows of a new manufacturer.
Don't try and teach me.
Allopurinol is for defectives who will not observe careful diet.
Do they yet know that an excess of Fructose will cause a delay in the kidney's ability to excrete Uric Acid? That is, Bananas and Mangos, Dates and figs and nectarines can produce Gout just as Prawns and Squid will.
Anyone got any "Narcaricin" (Benzbromarone)?

THOMAS MONAGHAN, MBBS | Resident - Neurology | Disclosure: None
MEATH Ireland
November 02, 2011
A physician should not profit from a prescription
In our country we have strong laws that prevent any association between a prescriber and the dispenser for obvious and sensible reasons. Therefore I was somewhat horrified when I came to understand this article and that the oncologist profits from the dispensing of the drug.
Of course bringing this to its logical extension one might question the prescriber of angioplasty also being the person who may materially "profits" from it. This has of course been addressed worldwide with concerns about pay-for-procedure. Perhaps it is not that different from the concerns expressed here.
Perhaps it is therefore a cultural thing, or that I am a product of a semi-socialised system (full of it's own ills), but I remain deeply concerned about the act of profiting from prescribing a medication. We are beyond the spectrum of a few pens from a drug representative or a trip to a conference here. Maybe those geriatricians should be marking up and selling the donepezil...

ROBERT HAMILTON | Other | Disclosure: None
COLCHESTER VT
November 01, 2011
Reimbursements
Instead of reimbursing oncologists at cost plus a percentage, reimburse at cost plus a fixed fee. This removes the incentive to use more expensive drugs to maximize the percentage reimbursements.

JEFF SOURBEER, MD | Physician | Disclosure: None
November 01, 2011
The inevitable result of the attempt to fix prices.
This is an excellent analysis, except for the statement implying the need to move from a market-based solution. Such shortages and perverse incentives are the natural result of the attempt to control prices by fiat (government regulation). The failure is not that of a market system so much as it is a failure of a mis-regulated market system, with prices fixed by Medicare for both the drugs and the services. The Medicare system fails to appropriately reward oncologists for their cognitive efforts and the real costs of administration of chemotherapy, leaving them reliant upon "ancillary income" from drug sales. This is a fine illustration of the Rule of Unintended Consequences that attends bureaucratic management of a complex system. Medicare compounds the shortages of the drugs by its pricing mechanism, as is so well highlighted in the article. It creates perverse incentives for providers, such as those cited.

JAMES COWELL, PHD | Other | Disclosure: None
HOLLY SPRINGS NC
November 01, 2011
Abraxane vs paclitaxel use
The authors strongly imply that many oncologists use Abraxane over paclitaxel for their patients simply for a higher profit for their practice. I suggest that this is not a good example to draw such a conclusion, since it my understanding that there are important advantages for use of Abraxane from the standpoint of reduced adverse reactions compared to the use of paclitaxel.

PROF RAGHUNADHARAO DIGUMARTI, MD | Physician | Disclosure: None
HYDERABAD India
November 01, 2011
Cancer Drug Shortages
Cancer Drug Shortages in the US can be easily overcome by importing drugs from high quality, US FDA Certified manufacturers outside the US, especially from countries in the developing world, like India and China

ROMI SZAWLOWSKI | Other | Disclosure: None
Canada
October 31, 2011
Forecasting demand
I sense the need to reexamine customer demands and forecasting methods.

SIMON QUILTY, MD | Resident | Disclosure: None
CASUARINA NT Australia
October 31, 2011
Pharmaceutical security an international issue
This issue is of international importance, with Australia having many shortages in the last few years, most recently intravenous benzylpenicillin.
Pharmaceutical supply chain in the global economy requires governments to mandate notification of manufacturing failure, quaIity, or supply compromise and share this information globally. Individual nations need to identify "essential" medicines and specifically legislate for secure manufacture and supply of these exceptional drugs. International efforts need to focus on strategies to diversify manufacturing of such essential medicines.

JOHN WILLIAMS, MD | Physician | Disclosure: None
WESTPORT CT
October 31, 2011
Drug "shortages" and government intervention
Only the government could be responsible for such price dislocations.
The president's executive order will only make things worse.
The government should not get involved in "medicine"' and other places they don't understand! Only the government could be responsible for such price dislocations.

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via nejm.org

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Smith & Nephew to Settle Foreign Bribery Charges - WSJ.com

2012-02-06T20:37:00.001Z

BY NATHALIE TADENA
Medical-device company Smith & Nephew PLC and its U.S. unit will pay more than $22 million to settle charges that a former distributor bribed public doctors in Greece for more than a decade, the U.S. Securities and Exchange Commission said Monday.

London-based Smith & Nephew PLC will pay more than $5.4 million to settle the SEC's charges, while its U.S. subsidiary, Smith & Nephew Inc., will pay a $16.8 million fine to the U.S. Department of Justice.

via online.wsj.com

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Johnson & Johnson shuns poor people with HIV -- New Internationalist

2012-02-06T17:39:00.001Z

via newint.org

Patents held by drugs companies are a big reason why more than nine million people in the developing world are not getting the HIV medicines they need. So the creation in July 2010 of the Medicines Patent Pool – which encourages the pharmaceutical giants to loosen their grip on licences so that cheaper, better and more accessible HIV medicines can be made – was seen as a key victory for common sense.

But, hold the party poppers, there’s a massive hitch. Some of the main players, notably Johnson & Johnson, are refusing to negotiate with the Pool, putting a huge number of lives at risk.

‘It seems Johnson & Johnson have decided that their own business interests are more important than the effect of joining the Pool could have on the health of millions of people around the world,’ says Diarmaid McDonald, spokesperson for the Stop AIDS Campaign.

Johnson & Johnson holds patents on three new HIV drugs that are desperately needed in the Global South. And, as some medicines are built from several patents from different sources, the company’s refusal to play ball means some cheap drugs can’t even be made with patents that have been licensed to the Pool by others.

‘None of the companies own all the patents for the fixed-dose combinations recommended by the World Health Organization,’ says Ellen ’t Hoen, executive director of the Pool. ‘So there is an awful lot of pressure on the companies that stay out.’

And even though joining the Pool would bring down the price of some HIV treatments from around $1,000 to less than $100 per patient per year, it would have little impact on the company’s profit margins.

‘When you look at the amount of Johnson & Johnson’s profit that comes from developing countries it really is small beans,’ says Diarmaid McDonald. ‘It’s just not going to affect their bottom line.’

The importance of companies adding their licences to the pool is greater than ever as people with HIV are becoming resistant to older treatments. The urgency is compounded by evidence that shows HIV treatments are an effective way of preventing the spread of the virus.

‘Recent studies have shown that people with HIV on antiretroviral treatments are 96 per cent less likely to pass on the virus,’ says Michelle Childs, Director of Policy and Advocacy at Médecins Sans Frontières’ Access Campaign. ‘This pushes the issue right up the political agenda, especially at a time when funding for HIV medicines is under extreme pressure.’

But with companies like Johnson & Johnson showing no signs of coming to the table any time soon, the Patent Pool is on shaky ground. Around 30 children die every hour as a result of AIDS. It is deeply ironic that a company trading on a ‘No more tears’ family-friendly image is not prepared to do more to help save children’s lives.

Nick Harvey

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Lawmakers Probe Drugmakers on Generic ADD Drug Shortages

2012-02-06T16:53:00.001Z

Several Democratic lawmakers are requesting information from two brand drugmakers and the Drug Enforcement Administration (DEA) on production quotas that may limit generic attention deficit disorder (ADD) drugs. The four leading House members accuse Shire Pharmaceuticals and Novartis of “manipulating the market” by using DEA quotas that limit the amount of a particular product to flood pharmacies with more brand than generic versions of ADD drugs.
Generic Line

via fdanews.com

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