Unproven Drugs Allowed to Remain on Market By FDA
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We trust organizations like the FDA to keep us safe. After all, that's why they were created in the first place, right?
Well, a new report by the Government Accountability Office (GAO) suggests that the FDA has failed to pull several drugs that are currently on the market, despite studies that indicate that these drugs lack any real health benefits.
The problem started in 1992, when the FDA began a new method for approving drugs by using "surrogate endpoints". Basically, the FDA would use the results of initial tests on a drug to try and predict the long-term effects that the drug will have. This policy was implemented to shorten the time it takes to get critically-needed medications on the market, as well as to lower the costs of medication production by eliminating expensive repeated trials.
One example of this is the use of HIV-drugs, which were approved based on initial tests showing their virus-lowering capabilities.
According to the Associated Press:
The FDA approved AstraZeneca's lung cancer drug Iressa in 2003 based on early results showing it reduced the size of tumors. But later studies showed the drug did not significantly extend patient lives.
The FDA has left the drug on the market, despite hundreds of reports of a sometimes fatal pneumonia.
FDA officials explain that access to Iressa has been restricted to a small number of patients who have shown benefit. The agency recommends all other patients try two alternative drugs.
Many of the drugs that were tested with "surrogate endpoints" did end up being as successful as their initial tests predicted. Nevertheless, since 1992, the FDA has failed to pull even one drug off the market due to missing or inconclusive data, despite the fact that outside studies have determiend that many of these drugs are not beneficial to patients.
This lack of follow-through is dangerous and costly to patients who are paying for medications that may not even help them. It is a shame that the FDA, which we rely on to keep us safe in so many ways, is the organization behind this scandal.