Fałszowanie badań klinicznych na leki – spowiedz Dr Scott Reuben
Influential US anaesthesia professor faked drug research over 12 years
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by the ANH team
An influential Massachusetts anaesthesia professor pleaded guilty on 22nd February 2010, to one count of federal health care fraud, after being accused of faking research for 12 years. Dr Scott Reuben’s ‘work’ on post-operative pain management using highly controversial pharmaceutical drugs such as Vioxx and Celebrex was published in scientific journals such as ‘Anesthesia & Analgesia’. Tweny-one of Reub published studies were retracted last year.
Following a plea hearing in a US District Court, Dr. Scott Reuben’s attorney confirmed that the anaesthesiologist will have to repay $361,932 in research grants and forfeit assets worth at least $50,000.
An article in the Washington Post: ‘Mass doctor pleads guilty to research fraud’ reports on this recent development, though the story broke last year. They reported that: “Prosecutors alleged the former chief of acute pain at Baystate Medical Center in Springfield sought and received research grants from pharmaceutical companies but never performed the studies. They said he fabricated patient data and submitted information to anesthesiology journals that unwittingly published it.”
See also last years Scientific American article: ‘A Medical Madoff: Anesthesiologist Faked Data in 21 Studies’
Fake pharmaceutical research influenced millions
When a doctor or scientist has reached the rank of ‘professor’, and is described as ‘prolific’, ‘influential’, and a ‘pioneer’ in their area of expertise, people generally assume that their work is of the highest quality and their research methods sound. Not so in the case of Scott S Reuben, the Massachusetts Professor of Anesthesiology and Pain Medicine.
Of course it’s a huge concern that Dr Reuben’s fabricated research ‘findings’ in the area of postoperative pain management (using pharmaceutical products) may have influenced millions of patients worldwide. So believes Steven Shafer, editor in chief of the Journal Anesthesia & Analgesia, as reported in the journal Scientific American last March. Steven Shafer retracted many of Reuben’s papers, which had been previously published in Anesthesia & Analgesia. Other journals did the same. Consequently, many hospitals and other medical institutions had to review their postoperative care programs.
Patients put at risk with dangerous, unproven drugs
Of equal concern is the reported estimation by Paul White (also an editor of Anesthesia & Analgesia) that Dr Reuben’s phony research may have encouraged the sale of billions of dollars worth of the potentially dangerous COX2 inhibitors, Pfizer’s Celebrex and Merck’s Vioxx. We are told that such use would only have been for short-term pain management, but that recovery periods may possibly have been prolonged by the unproven, off-label use of these drugs for this purpose.
Dr Reuben’s financial incentives
Between 2002 and 2007, it seems he was given five research grants by Pfizer. With so much money being handed out, why would Pfizer not have any input into, or overseen how these funds were being used? It may never be known just how much of a hand Pfizer had in influencing Reuben’s research. And how many other Prof Reuben’s have yet to be identified?
The Fanelli study: misconduct more prevalent in clinical, medical and pharmaceutical research
Last year, a study by Dr Daniele Fanelli brought to our attention that misconduct is actually more prevalent in clinical, medical and pharmaceutical research than most other fields. Given that clinical research is now seen by regulators as the ‘gold standard’ and required for approvals of new ingredients or health claims, makes this even more astonishing. An ANH feature in July 2009 by Steve Hickey PhD, ANH expert committee, and Robert Verkerk PhD, executive & scientific director, explores this further, and concluded:
“This misconduct is a consequence of the large financial interests in studies of drugs and other treatments. A minor change in the percentage of people benefiting from a treatment in a study could affect billions of dollars in future sales. We know that most of these clinical studies are reporting false and misleading results from statistical considerations alone. We need to add a specific bias from fraud and data manipulation. When deliberate deception is included, we conclude that modern „evidence-based” medicine needs a health warning”.
Rotten to the core
So while Prof Reuben has been exposed, it seems clear he has not operated on his own, and without pressure from one of the most powerful industry’s on the planet today. One also has to examine the way big business is allowed to conduct itself.
Does Big Pharma’s relationship with doctors and many others in the health care industry, (and beyond), with its ‘financial incentive and rewards’ system too easily encourage anything ranging from a slight bias in favour of certain pharmaceuticals to utter and complete fraud?
For more information, please refer to our earlier news item:
UK Guardian article: Glaxo’s handling of Avandia concerns damned by US Senate committee and
ANH-USA article: FDA Memo Blasts Diabetes Medicine Avandia
(It seems that, when a drug is lucrative, Pharma companies might not only be misrepresenting or suppressing data about harmful effects, but they might also be trying to intimidate independent scientists! And why did the FDA allow continued sales of Avandia, once they knew of the dangers?)
Good Science campaign
Komentarz MEDYCYNY TYBETAŃSKIEJ
Jeżeli nie wiadomo o co chodzi to chodzi o pieniądze. Dlaczego znany doktor przez 12 lat fałszował badania kliniczne na dopuszczenie leków do obrotu. Z tego powodu aby mieć z tego większe pieniądze. Suplementów diety i witamin nie da się patentować, a więc nie są one atrakcyjne dla wielkiego przemysłu farmaceutycznego. Stanowią jednak one wielkie zagrożenie i konkurencje dla nieskutecznych w większości leków syntetycznych. Bezpieczeństwo preparatów ziołowych zostało sprawdzone przez lata wnikliwych obserwacji i udoskonalania składów. Leki dopuszczane są na ogół jedynie w laboratoriach po dokonaniu badań klinicznych, które to mogą być fałszowane – tzw. robienie badań pod wynik. Dlatego tak ważne jest aby cały system medyczny ukierunkowany był na metody naturalne, łatwo osiągalne ze środowiska naturalnego, a w więc zioła i produkty glebowe.