On Friday, the FDA announced that Abbott Laboratories has withdrawn its diet drug Meridia (also known as sibutramine), stating that the advantage of a small amount of weight loss does not outweigh the heightened risk of heart attack and stroke. The FDA’s request trails a study called the Sibutramine Cardiovascular Outcomes Trial, which found a 16 percent increase in “the risk of serious heart problems” (these “problems” include death).
Yet Meridia has been making appearances in the media for years. Concerns about the drug’s safety date back at least to 2002, when the nonprofit organization Public Citizen petitioned the FDA (it re-petitioned in 2009) to ban Meridia. Then in 2004, GAP client Dr. David Graham testified before a Senate Finance Committee hearing that sibutramine may be more dangerous than the conditions it was being used for. The hearing focused on the latest controversy at the FDA at the time – the FDA’s disastrous handling of the pain medication Vioxx – the horrific effects of which (tens of thousands of Americans died) were exposed by Dr. Graham.
But the hearing also provided an opportunity for Dr. Graham to speak out about additional regulatory failures, and other problematic drugs. From a November 2004 article in the NYT, which covered the hearing:
Dr. Graham, with more than 20 years of service with the Food and Drug Administration, cited the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane. Makers of each drug defended the medicines as safe.
Let’s look at the story of each of these five drugs:
In addition to Meridia, only one other drug in this list – Bextra – has been completely removed from the market. Serevent and Accutane remain available with greater restrictions and public health advisories. Crestor seems to remain both on the market and unrestricted (you can try a free trial here!), despite Dr. Graham’s warnings that the government “should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor.”
In the hearing, Dr. Graham stated that federal drug regulators were “virtually incapable of protecting America.” So take heart – perhaps the FDA isn’t totally incompetent; it’s just incompetently slow. It only took six (!) years for the agency to take action regarding Meridia, despite the abiding existence of evidence of the drug’s dangerous side effects.
How many years will it take before the FDA will be capable of responding to drug safety threats in a timely manner?
Lindsay Bigda is Communications Fellow for the Government Accountability Project, the nation's leading whistleblower advocacy organization.