In a previous blog post, I explained the FDA’s complex process for approving drugs and medical devices. However, in many cases, pressure from commercial interests has broken down this process. The approval and subsequent recall of Vioxx took its toll on thousands of Americans, including my own father.
In 2004, the pharmaceutical company Merck voluntarily recalled the drug Vioxx after four years on the market, marking the start of the end of what FDA scientist Dr. David Graham stated in testimony before the Senate was the “single greatest drug safety catastrophe in the history of this country or the history of the world.” For many, that was four years too late. Dr. Graham calculated that the drug had resulted in 55,000 premature deaths from heart attacks and strokes and caused 100,000 unnecessary heart attacks in the U.S. alone.
How did this happen? It was a combination of corporate interference and suppression of science at the FDA.
Just prior to the approval of the drug in 1999, Merck implemented aggressive marketing and public relations strategies to boost sales of the drug. The marketing strategies came in direct conflict with the science but in the interest of profits, science took a back seat.
By no means was this out of the ordinary. It has been revealed through litigation that pharmaceutical companies have used a variety of methods to shape the science and the debate to fit their needs. In the short term, this strategy worked for Merck. In 2003, alone, Vioxx sales totaled $2.5 billion.
Marketing teams at Merck played a direct role in the clinical trials. When results from a clinical trial comparing Vioxx and naproxen showed that Vioxx increased cardiovascular risk, Merck officials spun data and stated that, instead, naproxen decreased cardiovascular risk. Merck employees ghostwrote twenty scientific articles and published them under respected scientists’ names. Dr. Gurkipal Singh testified that scientists had raised concerns about the possible cardiovascular risks of the drug as early as 1996, but Merck did not officially conclude that patients on Vioxx were more than twice as likely to suffer heart attacks or strokes until September 23, 2004 – seven days before it withdrew the drug.
While Merck is largely accountable for the scandal, systemic failures at the FDA allowed Vioxx to remain on the market. Many FDA scientists were vocally critical of the FDA’s response. Scientists raising concerns about Vioxx and other similar drugs faced intimidation and threats from supervisors and were asked to change their research. Senior FDA officials called Dr. Graham’s research “junk science” and brushed off criticisms that the FDA drug review system was operating correctly. Officials retaliated against researchers for speaking publicly about their research or attempted to censor scientists from publishing research in scientific journals. The culture of abuse and lack of oversight led Dr. Graham to state that the FDA was “incapable from protecting us from another Vioxx.”
As we previously noted, the FDA has a complex mission and has come a long way since 2004. A series of reforms such as the FDA Amendments Act of 2007 and the FDA Transparency Initiative have improved the standards for drug approval and transparency at the agency. But the agency still has a ways to go and faces continued pressure to change scientific results. And this spring, members of Congress are looking to turn back many of the 2007 reforms.
In the coming days, we’ll continue to explore how the FDA can make progress in the face of threats to its independence. We must remember that going back to the way things used to happen at the FDA means going back to medicines that do not heal, but as in the case of Vioxx, kill and handicap people we love.