Monday, October 26, 2009
A new report by the Government Accountability Office (GAO
) indicates that the Food and Drug Administration has often allowed drugs to remain on the market even after follow up studies show a lack of benefit. Additionally, the investigation discovered that the FDA has never taken action to remove a drug from the market when the required follow-up studies are not conducted. An Associated Press report released this week indicates that about a third of the required follow-up studies are still pending.
began a program of "accelerated approval" in 1992 to help fast-track drugs to market based on preliminary lab data. A number of cancer and HIV drugs were among those approved in this program. A condition of that program was that manufacturers must conduct follow-up to determine if the drugs actually extend patient lives. Many drugs still on the market failed to show the clinical benefits in follow-up studies. The FDA did not require independent 3rd party studies to assess drug efficacy, so it was the manufacturers own data which showed lack of benefit in these cases. Since independent studies are less likely to show product benefits, it is likely that even more drugs on the market fail to offer any benefits for saving lives.
The FDA has no immediate plans to change its oversight and enforcement of these regulations, as agency officials indicate that the FDA has focused its limited resources on other matters. Apparently, these other matters include threatening legal action against sellers of natural remedies that claim to prevent or treat illnesses. The FDA is currently cracking down on sellers of products claimed to prevent or treat the flu, even while available data suggests that approved vaccines don't significantly reduce flu cases or prevent flu deaths
and commonly used flu drugs may also contain more hazards than benefits
. Public trust in the FDA is misplaced if the agency acts to protect the interests of pharmaceutical manufacturers rather than the interest of public health. With many studies and physicians now questioning the efficacy and safety of the vaccination paradigm, it is time to examine these topics in more depth