An article published in today’s issue of the Journal of the American Medical Association has me kind of freaked out.

According to a press release advancing the article, Wide Variation Found in Quality of Evidence Used By FDA For Approval of New Drugs:

“Many patients and physicians assume that the safety and effectiveness of newly approved therapeutic agents is well understood; however, the strength of the clinical trial evidence supporting approval decisions by the U.S. FDA has not been evaluated.”shutterstock_97409945

As someone who has been on not one, not two but a cocktail of  three medications – two anti-depressants and a mood stabilizer –  for more than seven years I am one of those persons who assumed that the safety and effectiveness of the drugs I take were established by the gold standard for evaluation: the randomized, double-blind study.

Apparently not. Dr. Joseph Ross and Nicholas Downing from the Yale University School of Medicine examined every FDA drug approval from 2005-2012. Their study included how many clinical trials were submitted to support the approval, how long the trials lasted, how many patients were studied and the outcomes used to define the drug’s effects and safety.

I understand there must be some flexibility in the approval process, especially for promising drugs that treat life-threatening illnesses for which there are no therapeutic alternatives or rare illnesses.

The majority of drugs they looked at came on the market after high-quality clinical trials. However, “A third of new drugs are approved on the basis of a single trial. It may have been a big trial or it may have been a very small trial,” according to Dr. Ross.

Okay, perhaps that’s appropriate for that particular drug. Here’s what I am not okay with:

  • Less than half of drugs are compared to an existing alternative that’s available on the market today at the time of approval.
  • Fewer than half the drugs specified for long-term use are studied for more than six-months.

The way I see it, drug companies really like long-term use drugs, such as the medications I am on. I have already refilled those prescriptions dozens of times and will likely do so countless more times before I either die or no longer need them.

Folks like me – on medications for a very long time – are the gravy train for drug companies. The last thing these drug companies want is the government to force them to continue costly research on long-term use medications for years – or even decades – especially after the drugs’ patents expire.

What has me even more concerned is the summary of an accompanying editorial in the same issue of the journal in which the authors, Steven N. Goodman, M.D., M.H.S., Ph.D., of Stanford University, Stanford, Calif., and Rita F. Redberg, M.D., M.Sc., of the University of California, San Francisco, and Editor, JAMA Internal Medicine, comment on three studies in this issue, including the study of Dr. Ross and Dr. Downing, that examine the FDA approval process.

“Although these reports represent important steps in improving understanding of FDA decision making, further commitment to and progress toward ensuring transparency, including reducing report redactions, is needed to help the scientific community and other interested parties answer the questions these studies raise, thereby helping the FDA in its mission to find the right balance between allowing innovation and protecting the public’s health.”

The question now is, will the FDA take any action in response to the studies?

Pill question mark available from Shutterstock.



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    Last reviewed: 22 Jan 2014

APA Reference
Stapleton, C. (2014). Worried? Quality of evidence FDA uses to approve medications varies widely. Psych Central. Retrieved on January 29, 2015, from


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