Fighting the Fearmongering on Drug Safety

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  • 06/23/2006

Great piece today in the NY Post by Dr. Marc Siegel about how the fearmongering by the media and certain members of Congress is driving his patients away from taking medicines that can keep them alive. Marc has written well about how we should use science — not fear — to guide policy and medical decisions.

Here’s the entire article:


June 23, 2006 — MEDICINES are too often portrayed as either life savers or killers - a polarization of our pills that serves neither science nor health care.

Thanks to two high-profile lawsuits, my patients are now asking me if Lipitor - the cholesterol-lowering drug - is still safe. With the suits claiming that Lipitor can cause brain and nerve damage, my old comeback - “I take the drug myself” - is no longer sufficient to calm fears. One patient tells me that I’m blindly ignoring the risks of serious side effects.

In fact, Lipitor, the country’s top-selling prescription drug, has been shown to prevent the progression of coronary plaques in patients with heart disease, and is likely to be as useful in patients who are at risk for heart attack and stroke from these same plaques.

The most potent drug in the class known as statins, Lipitor has been successfully administered to millions. In very rare cases, it can trigger a severe muscle breakdown known as rhabdomyalysis. It has never been proven to cause memory loss or nerve damage, and I and most other physicians believe it to be a safe and effective drug.

So why the worry? Part of the problem is the way the drug industry hypes its products, setting them up as some kind of panacea. But if it’s sold as a magic elixir, the discovery of any flaw rings alarm bells.

Not all drugs that are victims of the pendulum swing from panacea to panic are as famous or as successful as Lipitor. This month, an FDA safety panel also cancelled a study where 4,000 children were to receive the antibiotic Ketek, an effective treatment for bronchitis and sinus infections. Why stop the study? Ketek, a new drug, has been prescribed to over 5 million people over the past two years, but 12 have sustained liver failure (in four cases, fatally), while 23 others have suffered damaged livers.

Should Ketek be restricted, labeled with ominous warnings or taken off the market entirely? Not without much better evidence of danger. At a time when few new antibiotics are being developed, drug-resistant bacteria continue to emerge, drugs like Ketek are important tools.

Unfortunately, when the media and the lawyers target a drug, they overlook the fact that the side effects are rare, and/or alternative treatments more problematic. Sober statistics-based analysis gets tossed aside. The drug-maker’s stock price and the number of prescriptions written plummet.

Decisions on drug safety should be based on real facts - a weighing of the real risks and benefits. Hysteria doesn’t belong in the drug-safety equation.

Dr. Marc K. Siegel is an internist at NYU Medical Center and associate professor at the NYU School of Medicine.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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