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Are Our Drugs Safe And, If Not, What Should We Do About It?

Ask a Scientist - April 2012

B. Sant of Driggs, ID, asks “After reading your blog posts about Vioxx and the FDA’s sometimes flawed drug approval process, I’ve been wondering about the safety of my prescription medicine for high blood pressure. Are our drugs in the United States safe and, if not, what should we do about it?" and is answered by Senior Scientist and Director of the Scientific Integrity Program Francesaca Grifo, Ph.D.

Despite some examples of undue corporate or political interference, you should rest assured that our nation’s drug approval process has long been a model for the world and the overwhelming majority of drugs on the market in the United States are safe. The problem: some in Congress are pushing now to weaken the vital independence of the U.S. Food and Drug Administration (FDA) that helps safeguard the quality and efficacy of our drugs. We at the Union of Concerned Scientists are working hard to preserve and strengthen the FDA’s ability to do its job by ensuring that science—not politics—guides its decisions about the safety and efficacy of drugs and medical devices.
 
Here’s what you need to know about the current situation: In 2007, Congress passed several key improvements to the rules governing the FDA’s drug approval process by creating more transparency at the agency, granting the agency more authority to monitor drugs after they are approved, and importantly, requiring the FDA to more carefully evaluate experts for its advisory panels to prevent a reliance on experts with corporate ties that might hamper their independent judgment. Unfortunately, these conflict-of-interest reforms are now at risk of being eliminated by Congress.

The Vioxx case you mention underscores the vital importance of preventing conflicts of interest among the FDA’s scientific advisors. Tragically, the FDA’s flawed approval of Vioxx led to thousands of premature deaths and 100,000 heart attacks that could have been avoided. An analysis of the FDA process showed that no fewer than 10 of the 32 members of the advisory panel evaluating the safety of Vioxx had financial conflicts of interest. Of those, nine voted in favor of continuing to market the drug despite the scientific evidence of elevated heart attack risks.

Despite progress on this issue after Congress took action in 2007, conflicted experts still wield influence too often. In 2010, for example, the FDA convened a panel to evaluate whether the diabetes drug Avandia should be recalled due to an increased risk of heart attack—a decision with a significant impact on the drug’s maker, GlaxoSmithKline (GSK). One of the panelists, Dr. David Capuzzi, had served for several years as a paid member of GSK speaker’s bureau, earning nearly $7,000 in speaking fees from the company. Dr. Capuzzi, whose conflict was not noted by the FDA but uncovered only in a subsequent investigation by a journalist, was one of just three members of the committee who voted to keep Avandia on the market without any stronger warnings or restrictions.

Cases of financial ties to industry rightfully undermine public confidence in the FDA. They also undermine confidence among the FDA’s staff scientists. A 2011 UCS survey of FDA scientists found that, while more FDA scientists expressed confidence in the agency’s direction and leadership compared to a 2006 survey, 347 staff scientists (or 40 percent of respondents) reported that FDA decisions today are overly influenced by business interests. Strikingly, 338 different FDA scientists reported firsthand experience of inappropriate interference in their work at the agency over the past year.

These numbers remain far too high and illustrate that more work is needed to ensure the agency’s independence. Now is certainly not the time to weaken conflict of interest rules. UCS supports a total ban on the FDA’s use of experts with conflicts of interest except in those unique situations where the agency is evaluating drugs to treat rare diseases where the pool of experts is very small. Congress needs to continue the progress that has been made since 2007 by upholding and further tightening restrictions on conflicted experts and requiring even greater transparency in the FDA’s drug-approval process. Only then can we have the full confidence we all need in the safety of the medicines and devices in our drugstores and medicine cabinets.

Dr. Francesca Grifo is the senior scientist and director of the Scientific Integrity Program at UCS. She has a doctorate in botany from Cornell and a bachelor's degree in biology from Smith College. Before joining UCS she directed Columbia University's Center for Environmental Research and Conservation graduate policy workshop and ran the Science Teachers Environmental Education Program. Prior to that, she was director of the Center for Biodiversity and Conservation and a curator of the Hall of Biodiversity at the American Museum of Natural History in New York.

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