Bayer And Trasylol: ‘It Was A Set-Up’
Do you remember the Bayer scandal last fall? An FDA panel declared that Bayer’s Trasylol, a drug used to reduce bleeding during bypass procedures, was safe and effective, and voted unanimously to keep the med on the market.
The panel skewered research by Dennis Mangano, founder of the nonprofit Ischemia Research and Education Foundation, whose study in The New England Journal of Medicine showed that Trasylol put patients at higher risk of heart attacks, stroke and renal failure. And choosing lower-risk alternatives would save $250-million a year in health care costs and another $1 billion in dialysis.
But a few days later, the FDA was contacted by Alexander Walker of Harvard’s School of Public Health, who said Bayer hid evidence. He was hired by Bayer six months earlier to review a database of 67,000 bypass patients and compared Trasylol side effects with two other anti-bleeding drugs. His analysis matched Mangano’s: Trasylol patients seemed to be at increased risk for death, kidney failure, congestive heart failure and stroke. Bayer said it “mistakenly” neglected to mention the giant study.
In a blistering recounting of this sorry episode, The St. Petersburg Times interviews Mangano who, not surprisingly, told the paper he was shocked by the panel’s harsh reception of his work. He notes that the chairman of the panel, William Hiatt, has written papers underwritten by Bayer, and that three committee members received waivers to vote because of financial interests in drug companies.
“The whole thing was a set-up. We did not have anything to gain financially by this. We were making an observation about safety,” says Mangano, an anesthesiologist with a doctorate in math. “The system is ridiculous. It’s all pro-industry. Who’s protecting the patient?”
He proposes that any drugmaker that hides data from the FDA should be banned immediately from submitting new drug applications for three years. “The pharmaceutical industry would straighten up in a matter of seconds because you’d be hitting them in the pocketbook. If you don’t give drug companies boundaries, they’ll do anything they want. Only the end user here is the patient, and I think it’s critical for the government to assume the goal of protecting patients.”
Hank
Knowingly hiding data from the FDA is a criminal felony and should be prosecuted as such. Unfortunately (in my view), the record shows that it virtually never is, even in the most blatant cases. The recent Oxycontin story is yet another example of what we can expect from some (most?) Justice Departments vis a vis industry.
FDA also has an “integrity policy” that sometimes bans individuals or CROs from submitting data for a period of time. And I _believe_ Warner-Lambert was once put on a kind of extended probation after several cover-ups of manufacturing defects (best known involving Dilantin). That’s about as severe as it gets.
X
http://www.sptimes.com/2007/08/05/news_pf/Worldandnation/Drug_warnings_fall_fl.shtml
Simon Passanante - Researcher gets heat after reporting truth on Trasylol
[...] Pharmalot reports that not long after the advisory was posted, Alexandar Walker of Harvard’s School of Public Health came forward and claimed that Bayer hired him six months before to review a database they compiled of 67,000 bypass patients who received Trasylol. He found the same results that Dr. Mangano found in his study. Bayer neglected to mention their study to the FDA. [...]