WASHINGTON – Federal drug officials have long been criticized for failing to force drug makers to complete studies proving that their drugs work as hoped, and Congressional investigators on Monday released yet another report pointing out that some of these studies remain undone many years after being promised.
The result is that doctors and patients remain unsure whether some critical medicines used to treat illnesses like cancer and heart disease are actually beneficial.
Concerns about this situation reached such a pitch several years ago that Congress passed legislation in 2007 giving the Food and Drug Administration greater power to force drug makers to complete their promised studies and to fine companies that fail to follow through.
In a report released Monday, the Government Accountability Office said that from 1992 through Nov. 20, 2008, the food and drug agency asked drug makers to complete 144 studies associated with 90 drug applications, and that drug makers had completed just two-thirds of the requested studies. Fifteen of the 52 uncompleted studies have been pending for more than five years, and several have been pending for more than eight years, the report said.
“Since getting new powers and funding in 2007, F.D.A. has completely overhauled its system for tracking” these promised studies, said Dr. Joshua Sharfstein, the agency’s principal deputy commissioner. “This is a problem that’s being fixed.”
Senator Charles E. Grassley, Republican of Iowa, who called for the study, said, “The report should serve as an impetus for the F.D.A. to improve the postmarket surveillance of these drugs, giving patients and their doctors meaningful information and necessary safeguards.”
All 90 drug applications reviewed by the investigators were submitted to the agency under a program intended to speed drugs to patients with life-threatening conditions like H.I.V./AIDS and cancer. Under this accelerated-approval program, the agency often approves medicines even though regulators are not certain they may be beneficial. For instance, a drug might have been shown to keep cancerous tumors from growing, but investigators did not wait the years needed to ensure that the drug actually extended life.
This is a deliberate and risky trade-off between hope and speed on the one hand and certainty and deliberateness on the other. The drugs approved under this program may save thousands of lives while researchers try to prove that they are actually beneficial; or they may increase suffering and costs among the desperately ill.
Drug makers are supposed to conduct confirmatory trials after approval to ensure that their medicines are working as well as hoped, but many take years longer than expected to fulfill their promises.
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