Statement of Diana Zuckerman, Ph.D., President National Research Center for Women & Families at the FDA Advisory Committee Meeting on Meridia

September 15, 2010

I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies.  We do not accept contributions from companies that make medical products.

In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, and a board member for two nonprofit organizations that work to improve resources for the FDA: the Alliance for a Stronger FDA, and the Reagan Udall Foundation.

My perspective is as a researcher.  I was on the faculty at Yale and Vassar, was trained in epidemiology at Yale Medical School, conducted research at Harvard, and I have worked on FDA policy issues in the U.S. Congress, the Institute of Medicine, and for nonprofit organizations.

The big questions facing you is: how dangerous is Meridia; do the benefits outweigh the risks and if so, for whom; and is there any way to control its use so that those who would truly benefit from Meridia can buy it, but those who are likely to be harmed by it can’t buy it.

First, let’s face some facts.  Health problems caused by obesity kill too many Americans every year.  Unfortunately, there are no magic pills for weight loss.  Diet pills are available, but none are especially effective and all have risks.  Meridia is not saving lives and on average harms more patients than it helps.

The results for Meridia are very disappointing.  Most people taking Meridia don’t lose much weight, even in the best of circumstances, such as a clinical trial with careful monitoring that provides patients with training to improve their lifestyles to help them lose weight.  Meridia patients who are very overweight are not losing enough weight to improve their health.  There is no evidence that even moderate weight loss with Meridia reduces cardiovascular morbidity or mortality.

In contrast, the cardiovascular risks that are associated with being overweight are even more likely for people taking Meridia.

The sponsor points out that patients with cardiovascular disease are already warned not to take Meridia.  But, the problem is that many overweight people don’t know that they have cardiovascular disease.  According to the AERS analysis, 1) young people without known risk factors (aside from obesity) have died shortly after initiating Meridia therapy and 2) prescribers do not always follow the labeling recommendations for patient selection. Because cardiovascular disease is often asymptomatic or unrecognized by clinicians, labeling changes are unlikely to reliably mitigate risk.

In an ideal world, the risks of Meridia could possibly be reduced.  In an ideal world, all patients would be carefully tested for cardiovascular disease before being given a prescription for Meridia.  In addition, patients would be closely and regularly monitored for 3 months on Meridia and immediately taken off the drug if they don’t lose at least 5% of their body weight, or at the first sign of high blood pressure or other cardiovascular problems.

If FDA wants to interfere with the practice of medicine, it might be possible to restrict distribution only to specially trained physicians and specially trained patients.  By restricting which doctors could prescribe Meridia and which patients could obtain prescriptions, it might be possible to decrease the risks.  It certainly would not eliminate them.

But, we don’t live in an ideal world, we live in the real world.

  • I can go on the Internet and buy Meridia without a prescription, and that won’t change if the FDA tries to restrict which doctors can prescribe Meridia.  However, rescinding FDA approval for Meridia would have a substantial chilling effect on its use, including online purchases.
  • FDA does not like to interfere with the practice of medicine.  They don’t even like to interfere with a company’s decision to widely advertise prescription medication directly to the public, including offering free samples or coupons to patients who see an ad on TV or in a magazine.
  • Despite the current warnings, patients who have taken Meridia, even for relatively short periods of time, have died while taking Meridia.

For those reasons, it seems that warnings on labels are not working and it is unlikely that the FDA could effectively enforce restrictions on the prescribing and use of Meridia.  Restrictions and clearly worded black box warnings would be better than nothing, but rescinding approval is the better public health strategy.

All of us wish there was an effective diet pill, and many of us wonder if Meridia could be more effective than other strategies for at least a small number of patients.  However, it is impossible to justify keeping such a risky product on the market, given the modest benefits and substantial risks for the overwhelming majority of people who take it.

The EU has taken Meridia off the market.  The FDA could save lives by following in their footsteps and taking Meridia off the market in the U.S.  And you have the power to save lives by making that recommendation today.