Do you remember Vioxx, Bextra, Baycol, Trovan, Meridia, Seldane, Hismanal, Darvon, Mylotarg, Lotronex, Propulsid, Raxar or Redux? They were all highly promoted drugs that were withdrawn for safety risks after millions used them. Sorry about that.
Big Pharma always insists it only knows about such safety risks after a wide swath of the population uses the drugs and "safety signals" emerge. But the story of the antidepressant Paxil shows otherwise.
Paxil (paroxetine) was a top selling SSRI antidepressant drug for GSK--during the "happy pill" craze that also included pills like Prozac and Zoloft. But soon after its approval, there were questions about the research published in the Journal of the American Academy of Child and Adolescent Psychiatry known as "study 329" and charges that the drug's true suicide risks in young adults had been buried.
It was also charged that the 22 doctors and researchers listed as "authors" were not authors at all and that the research was actually written by a medical communication company (MCC) that GSK hired. Such ghostwriting is disturbingly common in establishing drug safety.
"You did a superb job with this," wrote the paper's first "author," Brown University's Martin Keller to Sally Laden, a ghostwriter working for the MCC Scientific Therapeutics Information. "It is excellent. Enclosed are rather minor changes from me. In 2006, Keller, former Brown Professor Emeritus of Psychiatry, acknowledged that GSK had given him tens of thousands of dollars during and after the time the study was conducted.
Ten years later, questions from reporters, psychiatrists, researchers and professors had not died down. In 2014, two members of the American Academy of Child and Adolescent Psychiatry, Edmund Levin and George Stewart, asked the editor of the Academy's journal why the discredited paper has not been retracted. This year the British Medical Journal (BMJ) took the step of publishing a reanalysis of Paxil that amounted to a reversal of the controversial 2001 study. It showed that Paxil indeed increases risks of suicide in young people and adolescents.
The 2015 BMJ study "is a clear break from scientific custom and reflects a new era in scientific publishing, some experts said, opening the way for journals to post multiple interpretations of the same experiment," wrote the New York Times. "It comes at a time of self-examination across science -- retractions are at an all-time high; recent cases of fraud have shaken fields as diverse as anesthesia and political science; and earlier this month researchers reported that less than half of a sample of psychology papers held up."
While the New York Times acknowledges that "Over the years, thousands of people taking or withdrawing from Paxil or other psychiatric drugs have committed violent acts, including suicide," it also notes that it is "not clear" when the drugs cause and when they prevent suicide.
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