A recent editorial in the British Medical Journal calls on pharmaceutical companies to make all of their clinical trial data available to public scrutiny. Although drugmakers have saved countless lives with their innovations and breakthroughs, many companies continue to hide or misrepresent the safety of their drugs and medical devices. This results in significant public harm and costs caused by defective medications.
We have discussed the Food and Drug Administration's review process for drugs in several prior blog posts. The FDA recently announced that it had cleared many untested pharmaceuticals for sale because it followed a scientifically flawed "extrapolation model" of testing larger doses of already-approved drugs. The FDA wrongly assumed that powerful pharmaceuticals such as Wellbutrin XL would be safe in large dosages just because smaller doses were proven to be okay for public consumption.
After several years the FDA determined that increasing the dosage of Wellbutrin XL decreased efficacy and increased the number of serious side effects. It is unclear if the drugmaker knew of these effects beforehand because the drugmaker was not obliged to share all of its data with regulators.
It often takes years for it to become clear that a pharmaceutical company fabricated or misrepresented the efficacy of its drugs. By the time the true dangers of drugs like Actos and Avandia were known, the drugmakers had already made billions of dollars and were promoting a new class of pharmaceuticals. This three-steps-behind approach of regulatory agencies may be avoided if independent scientists are given access to all of a drugmaker's data once a drug has been approved for the market.
"Why aren't all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made?" the BMJ editorial author asked. How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose?"
Source: British Medical Journal, "Clinical trial data for all drugs in current use," Fiona Godlee, Oct. 29, 2012