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The Vioxx Panic
Why our fear of rare risks is deadly


Marc Siegel, MD
Medical Progress Today
June 30, 2005

For all the recent attention to drug safety, the public might easily lose sight of the fact that drug side effects can be far less dangerous than an untreated disease.

Arthritis is a case in point. Millions of Americans are crippled from eroding joints; though there are still several choices of drugs to ease the pain, for many the only drug that really worked well was Vioxx. Physicians and patients know all too well that an individual’s response to a particular drug is often idiosyncratic, and removing Vioxx took away an important choice from many arthritis sufferers.

The studies that led to Vioxx’s withdrawal looked at high doses of the drug taken daily for several years, and found, not that Vioxx is a killer drug, but that prolonged overuse slightly increases the risk of heart disease. This finding was irrelevant to casual users, but many of them were still afraid they would drop dead on the spot after hearing news of Vioxx’s removal.

Vioxx, consequently, became the scapegoat for public suspicions of the FDA process for prescription drug approval. But the question of whether there needs to be more attention paid to safety at drug inception, along with large scale post-approval trials, is not the same question as whether a single pill of Vioxx is safe. The question could have been solved by a warning on the drug’s label, but in today’s liability environment Merck’s executives felt they had no choice but to withdraw the drug.

Sadly, the drug’s removal and proliferation of class-action lawsuits have scared thousands of patients who have little or nothing to fear. I and other medical doctors have been bombarded by the concerns of former Vioxx users who blame every chest pain or breathing difficulty on the drug. These anxious patients pass their nervous opposites in every waiting room – those who attribute their arthritis pains to Vioxx’s absence. One of my patients was so stricken by the inability to pop an occasional Vioxx that it accelerated his decision to have both of his hips replaced, just to obtain some relief.

The Vioxx panic is symptomatic of a pervasive disease – fear. As a society, we openly distrust the same things we revere. We worship our products, especially our medications and treatments, elevating them to panaceas. When we discover the slightest risk or problem, the balloon bursts and we panic. Once heralded drugs are reviled. Vioxx, yesterday’s magic elixir, has become today’s perceived poison.

In reality, our drugs are not always lifesavers, but they are also rarely killers. They all have risks that need to be very carefully studied, but they should be seen in perspective, not as cure-alls or poisons. Without keeping risks and benefits in perspective, our national Viagra obsession becomes a dread of going blind far too easily, based on just a handful of cases. Anti-depressants, which save millions of lives and give millions more renewed hope, suffer a growing stigma because they happen to renew energy, and for a few that renewed energy translates into impulsive self-destruction. But for most, these drugs decrease the risk of suicide rather than increase it.

Statistical evaluation of drug risks is needed, but it should be taken in the context of practical application and weighed against real-world benefits. By focusing on the rare danger and broadcasting this risk via the media megaphone, we undermine the utility of some of our greatest treatments.

We doctors partly have ourselves to blame for the sudden scrutiny that we and our treatments have endured. We need to make clear to our patients the options available for each condition. If we emphasize one particular treatment over another, we risk setting that drug up for the big fall. And each time an effective treatment takes a hit, consumers become more distrustful of the whole industry.

Of course, pharmaceutical companies are profit seeking, but that doesn’t mean the products they make are automatically unsafe. Drug makers have powerful financial and reputational incentives for making safe drugs. Does that mean we should entrust the drug industry with policing its own products and techniques? Not at all. But doctors and patients need to take more responsibility for our own rampant enthusiasm for chemical cures.

In our media-driven cycle of pill-popping and cynicism, we lose sight of our true wonder drugs. Cholesterol-lowering statins are weathering the storm, as accusations of memory loss are debunked and each study reveals a more profound beneficial effect. Examining the heart, researchers discover not just lowered cholesterol, but plaque retardant, and plaque-diminishing effects. Do statins also reduce the risk of certain cancers and work to prevent Alzheimer’s? It’s possible. Will Lipitor one day be seen in the elite category of aspirin, one of our most versatile medicines? This, too, is entirely possible.

But I worry that if the wrong famous person gets inflamed muscles or even dies from a statin drug, the whole class of drugs could be instantly thrown in the trash. Where will those at great risk of heart disease and stroke be then? How many deaths might we cause erroneously in the name of promoting drug “safety”?


Marc Siegel MD is an internist and associate professor of medicine at NYU School of Medicine. His new book, False Alarm, The Truth About the Epidemic of Fear, will be published in August.

 
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