Harris' article points out that "the agency (FDA) rarely examines" some raw data from drug trials, which detail events occurring to individual subjects. Due to continuing conflict over the safety of Avandia, FDA's "Dr. Thomas Marciniak took an unusually close look," demanding to see these records. He discovered twelve serious cardiovascular adverse events that had been omitted from consideration, and "If given more time, he wrote, he would probably have found still more."
In my opinion, paying fines when such dishonest practices have been uncovered has done absolutely nothing to stop them. Instead, the prices of drugs have risen steeply, and the fines are considered by Pharma to be the cost of doing business. IMHO, until responsible drug company employees receive prison sentences when found guilty for making false claims about their products and hiding evidence of injuries, such practices will continue.
Excerpts from Harris' article follow. A later Harris article on this subject was published July 12.
A federal drug official on Friday dealt a severe blow to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.
The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events. Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Dr. Marciniak wrote.
The detailed report could prove crucial next week, when a panel of experts will meet to consider whether to recommend to the F.D.A. that the manufacturer, GlaxoSmithKline, withdraw Avandia from the market or restrict its sale.
An editorial in The New England Journal of Medicine on Friday accused GlaxoSmithKline of interfering with the trial and said the system for hiring trial safety experts should change.
In an interview on Friday, Dr. Jerome P. Kassirer, a former editor of The New England Journal, said the Record trial raised the question “whether the entire system is corrupt.” “To the extent that we can’t trust the data,” he added, “we are in jeopardy of giving patients the wrong drugs.”
Others within the F.D.A. say that observational studies are not good enough and that a well-controlled “prospective” study, like the one being conducted by GlaxoSmithKline, is the only sure way to answer whether Avandia is truly dangerous.
In a report released Friday, the Institute of Medicine, the nation’s leading medical advisory group, seemed to side with those who have argued that observational studies are adequate. Indeed, the group seemed to describe almost exactly a study of 227,571 Medicare patients conducted by an F.D.A. reviewer and published June 28 in The Journal of the American Medical Association concluding that Avandia increased the risks of stroke, heart failure and death compared with Actos. The institute concluded that such studies “can sometimes provide higher-quality safety evidence than randomized controlled trials.”