Interview with FDA Whistleblower Dr. David Graham

Dr. David Graham is the Associate Director for Science, Office of Drug Safety in the U.S. Food and Drug Administration. Dr. Graham is credited with blowing the whistle on the FDA’s failure to warn the public about the health risks associated with Vioxx. He spoke with PennPIRG about the need for better consumer protections, including public disclosure of clinical trials.

When did you learn that the painkiller Vioxx was linked to an increased risk of heart problems? How did FDA officials respond?

I first became aware of the cardiovascular risks associated with Vioxx in November 2000, when the results of a manufacturer sponsored study were published. They showed that Vioxx increased the risk of heart attack 5-fold compared to another pain reliever.

FDA’s response was silence. While FDA remained silent, the use of Vioxx skyrocketed and so did unnecessary heart attacks. Nearly two years later, FDA issued new product labeling for the drug. This labeling did not change physician prescribing behavior or use of Vioxx.

Now, fast-forward to August 2004. We had just completed our own study of heart attack risks with Vioxx and found that the drug increased heart attack risk at both high and low doses. FDA officials rejected these conclusions and insisted that there was no regulatory issue to address because they had relabeled Vioxx in 2002. FDA’s decision was based on its pro-industry bias rather than on concern for patient safety.

Was FDA’s response characteristic of its response to other safety concerns?

FDA’s response was typical of how it responds to most major safety issues. Within FDA, there are no checks and balances and no separation of power. The people responsible for the approval of new drugs are the same people deciding how to address the risks that emerge once the drug is on the market. The people with the expertise and responsibility for evaluating new safety risks have no power or authority and are typically ignored by the approval people. For the sake of patient safety, it’s essential that the safety people be separated from the approval people and given the authority to protect the public.

Can FDA reform itself or is other action needed?

FDA is utterly incapable of reforming itself because FDA is part of the problem. FDA’s denial that anything went wrong with Vioxx is just the most recent proof of this. FDA views industry as its client, its primary customer. Patients are a distant second. Under the current arrangement, FDA drags its feet and does nothing meaningful about safety while companies continue to generate huge sales and profits. This system has resulted in up to 60,000 people dying from Vioxx-associated heart attacks, a number similar to the number of U.S. soldiers killed during the Vietnam War.

In the U.S. Senate, Senators Dodd and Grassley have introduced a bill that would address the major problems with FDA and go a long way toward preventing a repeat of the Vioxx disaster. Unfortunately, Congress has failed to act because it, too, is in the grip of the pharmaceutical industry. If Congress doesn’t reform FDA and create an independent center for drug safety, many thousands more will die unnecessarily, and Congress and FDA will be responsible.

PennPIRG is supporting state legislation requiring drug companies to disclose clinical trial data. How important is it to make this information public?

I think it’s vital that clinical trials data be publicly available so that independent researchers can scrutinize the data. It’s also important that everyone be aware of what other trials a company has started that may not be completed because companies frequently bury studies that give unfavorable results to their drug.

What protections do you have as a whistleblower?

The federal government provides virtually no protection to whistleblowers, so it is extremely difficult for government workers to step forward and warn the public about waste, fraud or endangerment of public safety because of the retaliation they inevitably experience. If government scientists can’t protect themselves, how can they be expected to protect the public?