Aug. 17, 2005
FDA Denial of Public Citizen’s Petition to Ban Meridia Is Misguided
Statement of Sidney M. Wolfe, MD, Director of Public Citizen’s Health Research Group
For a drug such as Meridia to be approved or for it to stay on the market, there must be evidence that its benefits outweigh its risks. Evidence prior to its approval and more than 50 cardiovascular deaths, many in young people (see chart below), since its approval confirm that its benefits do not outweigh its risks and that it should be removed from the market despite efforts by the FDA/Abbott duo to keep the drug alive.
Although there was a 60 percent decrease in prescriptions filled for this drug in the United States between 2001 (1.7 million prescriptions filled) and 2004 (670,000 prescriptions filled), many people are still getting this dangerous but not very effective drug that we have warned people not to use since 2001 and petitioned the FDA to ban in 2002.
In one of the only independent reviews of this drug by researchers from the University of Washington, published a year ago but predictably not mentioned by either the FDA or by Abbott in their responses to our petition, the authors concluded that:
“Weight loss with sibutramine was associated with modest increases in heart rate and blood pressure. … There was no direct evidence that sibutramine reduces obesity-associated morbidity or mortality. … Thus, we conclude that there is insufficient evidence to accurately determine the risk-benefit profile for sibutramine.”
Prior to sibutramine’s approval in 1997, an FDA advisory committee voted 5-4 that the benefits of sibutramine did not outweigh the risks. The FDA medical officer who reviewed the drug wrote that “sibutramine has an unsatisfactory risk-benefit ratio and therefore this Reviewer recommends non-approval of the original submission.” The concern of both the advisory committee and the FDA medical officer was based on the fact that sibutramine significantly increases blood pressure and heart rate in many people. In the clinical trials, compared to patients receiving a placebo, an excess of 10 percent of Meridia users had a sustained increase in diastolic blood pressure of 10 mm Hg (millimeters of mercury) or more and 4 percent had a sustained increase in systolic pressure of 15 mm Hg or more at the commonly used 15 milligram dosage. When announcing its seriously mistaken approval of sibutramine in November 1997, the FDA stated that the average weight loss in obese people taking the drug for one year – beyond the weight loss in those getting a placebo – was only 6 1/2 pounds in the group taking 10 mg of the drug.
It is especially ironic that Abbott, caught hiding information about Meridia deaths by the FDA, claims that our efforts to ban Meridia are “not based on valid scientific analyses.” A 3/21/02-4/03/02 FDA inspection report of the Abbott Laboratories plant in Abbott Park, Ill., found that “[one] death associated with Meridia was not reported and several records [involving seven other deaths] reviewed showed that the adverse drug information reported to FDA was either not accurate, not supported by source data, or was missing additional information found in the source data.”
Cardiovascular deaths reported to the FDA as of 3/03 in people under the age of 50:
|Cardiac arrest; tachycardia
|Sudden death unexplained
|Myocardial Infarction; palpitations
Once again, the FDA is siding with a large drug company, much as the agency did several years ago with Merck concerning Vioxx, when it failed to demand a black box warning on that drug. How many more dangerously flawed decisions will the FDA make before the Congress repeals the Prescription Drug User Fee Act, which brings the agency ever closer to – and makes the agency less vigilant over – the companies that give it almost $200 million a year in funding?
Arch Intern Med. 2004;164:994-1003 David E. Arterburn, MD, MPH; Paul K. Crane, MD, MPH; David L. Veenstra, PharmD, PhD.