Why Are These Fraudulent Papers Unretracted?
According to Science Times[1], the Tuesday science section in the New York Times, scientific retractions are on the rise because of a “dysfunctional scientific climate” that has created a “winner-take-all game with perverse incentives that lead scientists to cut corners and, in some cases, commit acts of misconduct.”
But elsewhere, audacious, falsified research stands unretracted–including the work of authors who actually went to prison for fraud!
Richard Borison, MD, former psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud[2] but his 1996 US Seroquel® Study Group research is unretracted.[3] In fact, it is cited in 173 works and medical textbooks, misleading future medical professionals.[4]
Scott Reuben, MD, the “Bernie Madoff” of medicine who published research on clinical trials that never existed, was sentenced to six months in prison in 2010.[5] But his “research” on popular pain killers like Celebrex and Lyrica is unretracted.[6] If going to prison for research fraud is not enough reason for retraction, what is?
Wayne MacFadden, MD, resigned as US medical director for Seroquel in 2006, after sexual affairs with two coworker women researchers surfaced[7], but the related work is unretracted and was even part of Seroquel’s FDA approval package for bipolar disorder.[8]
More than 50 ghostwritten papers about hormone therapy (HT) written by Pfizer’s marketing firm, Designwrite, ran in medical journals, according to unsealed court documents on the University of California–San Francisco’s Drug Industry Document Archive.[9] Though the papers claimed no link between HT and breast cancer and false cardiac and cognitive benefits and were ghostwritten by marketing professionals not doctors, none has been retracted.
Pfizer/Parke-Davis placed 13 ghostwritten articles[10] in medical journals promoting Neurontin for offlabel uses, including a supplement to the Cleveland Clinic[11] but only Cochrane Database Systematic Reviews and Protocols has retracted the specious articles.[12]
Nor is the phony science just a product of “Big Pharma.” In 2008, JAMA was forced to print a correction stating that authors of an article arguing for a higher recommended dietary allowance of protein were, in fact, industry operatives. [13] Sharon L. Miller was “formerly employed by the National Cattlemen’s Beef Association,” and author Robert R. Wolfe, PhD, received money from the Egg Nutrition Center, the National Dairy Council, the National Pork Board, and the Beef Checkoff through the National Cattlemen’s Beef Association, said the clarification. Miller’s email address, in fact was smiller@beef.org, which should might have been the JAMA editors’ first tip-off.[14] The article has also not been retracted.
Martha Rosenberg’s is an investigative health reporter. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, has just been released by Prometheus books.
[1] http://www.nytimes.com/2012/04/17/science/rise-in-scientific-journal-retractions-prompts-calls-for-reform.html?_r=1&pagewanted=all
[2] Steve Stecklow and Laura Johannes, “Test Case: Drug Makers Relied on Two Researchers Who Now Await Trial,” Wall Street Journal, August 8, 1997
[3] Richard Borison et al., “ICI 204,636, an Atypical Antipsychotic: Efficacy and Safety in a Multicenter, Placebo-Controlled Trial in Patients with Schizophrenia,” Journal of Clinical Psychopharmacology 16, no. 2 (April 1996): 158–69
[4] Alan F. Schatzberg and Charles B. Nemeroff, Textbook of Psychopharmacology (New York: American Psychiatric Publishing, 2009) p. 609
[5] http://www.scientificamerican.com/article.cfm?id=a-medical-madoff-anesthestesiologist-faked-data
[6] Scott Reuben et al., “The Analgesic Efficacy of Celecoxib, read more..
Monday, 4 June 2012
Journal Of Clinical Psychopharmacology-Veterans Affairs Medical Center-Medical College Of Georgia
Tuesday, 10 April 2012
Preliminary Injunction-Patent Expiration-Astrazeneca-Seroquel-Company
AstraZeneca's ($AZN) last-ditch effort to hold off generic Seroquel has failed. A U.S. judge denied the drugmaker's request for a preliminary injunction that would delay copycat rivals, saying the company didn't prove that it qualified.The company had aimed to keep the Seroquel market to itself until December. That's when exclusivity expires on safety data that, AstraZeneca argued, should be included in any generic drug label. The company sued the FDA over the labeling issue, after the agency denied its internal request.So, as the Seroquel patent expires today, generic versions will roll onto the market. Several billion in annual sales are up for grabs; Leerink Swann's Seamus Fernandez sees a dropoff of $3.9 billion in the first 9 months of generic competition. And as the Wall Street Journal points out, Seroquel's patent expiration is just the first of three biggies over the next 5 years."This is a company that is probably facing one of the worst patent cliffs in the industry," Morningstar analyst Damien Conover told the Delaware News Journal. "That, coupled with a pipeline that hasn't produced enough offsetting new products, has really put the company in a challenging spot."AstraZeneca says it's weighing its options in the FDA lawsuit. Meanwhile, it's cutting costs, pushing hard to boost sales of existing drugs, looking for strategic acquisitions and scrambling to develop new drugs, an effort that has hit some big snags recently. Despite CEO David Brennan's repeated assurances to the contrary, analysts are playing name-that-potential-AstraZeneca-buyout, tagging such companies as Shire and Amylin Pharmaceuticals as likely prospects. But spokesman Tony Jewell says AstraZeneca will succeed by sticking to the knitting it has already begun: "We knew this was coming, and we have a business strategy," Jewell told the News Journal.- read the News Journal piece
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Tuesday, 27 March 2012
'Tis The Season-David Brennan-Astrazeneca-Seroquel
'Tis the season for executive pay raises, and AstraZeneca's ($AZN) David Brennan is no exception. Last year, Brennan won an 11% increase in overall compensation to £3.37 million, from £3 million in 2010, the Financial Times reports. For those of us who think in dollars, that's $5.89 million and $4.77 million, respectively.The FT makes the point that Brennan's raise comes at a challenging time for AstraZeneca, with Seroquel's patent expiring today and three more significant expirations over the next 5 years (see our Seroquel story for more). It has also seen some R&D disappointments recently, dismaying investors who were hoping that a few late-stage drugs could jump into the patent-cliff gap.But stacking up Brennan's pay alongside his Big Pharma brethren, $5.89 million comes in toward the bottom. U.K. rival GlaxoSmithKline's ($GSK) boss got a 24% raise to £6.7 million, or $10.5 million, while Bristol-Myers Squibb ($BMY) chief Lamberto Andreotti clocked a 27% increase to almost $15 million. It can certainly be argued that these companies have better short-term prospects than AstraZeneca does, particularly Bristol-Myers, which has an impressive recent record on the R&D side. But the fact remains that Brennan is far from the highest paid pharma exec out there--and given AstraZeneca's current problems, that raise could be considered hazard pay.- read the FT story?Related Articles:
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Sunday, 11 March 2012
Antipsychotic Drug Seroquel-Astrazeneca
The FDA has officially denied AstraZeneca's petition to hold off generic versions of its antipsychotic drug Seroquel. The agency turned down AZ's ($AZN) request that it withhold final approval of any knockoff version that didn't bear the same safety warnings as the branded drug. Seroquel is expected to face generic competition after the company's pediatric exclusivity expires later this month.Credit AstraZeneca for trying: Seroquel is a multibillion-dollar drug, and watching those sales erode will be painful for the drugmaker. Indeed, the FDA's decision only underscores how needy AstraZeneca soon will be. The company has announced another big round of cost cuts, but cutting can't continue forever. Analysts are expecting the company to go on an acquisition spree, to make up for the fact that its internal pipeline has offered up several disappointments lately.And apparently, the company has the same idea. Research chief Martin Mackay told Reuters that AZ is "actively talking to a number of companies," both biotech prospects and "peer-to-peer" opportunities. "I will be disappointed if we do not do some deals this year that the market will be pleased by," Mackay said.Bernstein's Tim Anderson listed a few prospects, as the Philadelphia Inquirer reports: Amylin Pharmaceuticals ($AMLN), which recently won approval for its long-lasting version of the diabetes drug Byetta, a deal that could run $4.5 billion. Shire, the growing U.K. drugmaker, a much bigger deal at $30 billion. Or Abbott Laboratories' ($ABT) soon-to-be-split-off drug business at $52 billion. But he figures that sub-$10 billion deals are most likely.That would be Mackay's opinion, too. "We are looking at some in the low billions (of dollars) ... with deals of that size, we can do them sequentially and build that way," Mackay told Reuters. "We know one deal won't be the answer in itself." And CEO David Brennan (photo) has been unequivocal in his opposition to a major merger. A series of 5-6 deals, as investor Dan Mahoney of Polar Capital suggests to Reuters? We'll have to wait and see.- see AstraZeneca's press release
- get more from Dow Jones
- check out the Inquirer piece
- read the Reuters analysisRelated Articles:
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