Drug companies, in a few cases, have recently started to release much more data from drug trials. Unsurprisingly, analysis of the new data by outsiders — people who have nothing to gain from positive results — has often contradicted the drug company analysis of the same data.
One example involves the flu drug Tamiflu. The new analysis suggested that “Tamiflu falls short of claims—not just that it ameliorates flu complications, but also that the drug reduces the transmission of influenza.” Another example involved Prozac. The new analysis “ended up bucking much of the published literature on antidepressants. . . . [It]found no link between Prozac and suicide risk among children and young adults . . . Prozac appeared to be more effective in youth, and antidepressants far less efficacious in the elderly, than previously thought.”
Another reason to believe in the value of this new data is the work of Lisa Bero at UCSF. She looked at the efficacy of nine drugs using unpublished FDA data. “Nineteen of the redone analyses showed a drug to be more efficacious, while 19 found a drug to be less efficacious. The one harm analysis that was reanalyzed showed more harm from the drug than had been reported.”
I hope that the FDA will eventually require that all raw data from drug trials be publicly available as a condition of approval. (The same should also be true of journal articles, as a condition of publication.) It is abundantly clear that drug company analyses are often misleading — which harms the public.