A new Yale University study revealed that clinical trials used by the U.S. Food and Drugs Administration are not very thorough for all drugs, and this brings into question the safety of various medications approved by this authority.
Consumers in the United States take it for granted that any drug approved by the FDA is safe for use. However, a new study conducted by Yale University researchers revealed that this may not always be the case. According to the study findings, the FDA uses different clinical trials to test different drugs and these trials "vary in their thoroughness."
"We found that during the study period, more than one-third of the drugs were approved on the basis of a single trial, without replication, and many other trials were small, short, and focused on lab values, or some other surrogate metric of effect, rather than clinical endpoints like death," said first author and Yale School of Medicine student, Nicholas S. Downing.
The researchers examined 188 drugs tested in 448 pivotal trials approved between 2005 and 2012, which were meant to treat 206 illnesses. Researchers noted that out of the 206 illnesses, 4 were approved for treatment with a drug on the basis of a single trial, 77 on two trials, and 50 on three or more.
"The variation in the [amount and type] of clinical trial and evidence used by the FDA to assess the efficacy of novel therapeutic agents highlights the agency's flexible standards for approval," the researchers wrote. "This flexibility - including surrogate endpoints - allows for a speedier approval process, which can be good for diseases that are in dire need of a treatment. But by speeding up approval, many drugs skip the "costly and time-consuming randomized, double-blinded, controlled trials," which are often "regarded as the gold standard for evaluation."
Before any drug is approved, it is examined by a panel of health experts. This panel is part of the FDA's Center for Drug Evaluation and Research and comprises of physicians, statisticians, chemists, pharmacologists, and other scientists. While it seems sensible to believe in these experts and the safety of FDA approved drugs, researchers recommend that people should be well informed about the drugs they use.
