November 18th, 2015|
Many companies engage in less-than-honest practices, but it is even more concerning when the companies that make your medications aren’t telling you the whole truth. A third of clinical trials performed by pharmaceutical companies and reviewed by the U.S. Food and Drug Administration (FDA) for approval were not made available to the public, according to the Washington Post. (How Pharma Keeps a Trove of Drug Trials out of Public View, Nov. 12, 2015).
Bioethics International, a non-profit organization funded by foundations and universities, announced they will conduct annual reviews of pharmaceutical giants; and give them a transparency report card. The hope is that the “Good Pharma Scorecard” will prompt large pharmaceutical manufacturers to be more transparent with their research. The grade is determined by the percentage of all studies made public, not just the ones that are legally required to be released.
The concern with the lack of transparency is entirely valid. The unpublished studies may be the ones that reflect unremarkable or even negative results.
The Washington Post reported on early results from the studies:
- Gilead’s HIV drug, Stribild, got a grade of 21 percent. Of 34 trials presented to the FDA, 26 were never made public.
- Bayer’s Stivarga, a colorectal cancer drug, got a grade of 42 percent. Of 12 trials presented to the FDA, 7 were never made public.
- Pfizer’s kidney cancer drug, Inlyta, got a grade of 100 percent. Results of all 28 of the trials presented to the FDA were made public.
“To me the right number is 100 percent; if you’re selling a product on the U.S. market, the public and the clinical science community has a right to be able to review the results, and has a right to know on what basis” the FDA approves the drug, said Joseph Ross, an associate professor of medicine at Yale University School of Medicine.
As a nation, we take more prescriptions than ever before, and the new drugs that come out every year often cost more than the ones they are designed to replace. Unfortunately, industry practices and medical mistakes can often cause the very drugs meant to help us cause serious injuries.
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