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Drugs have risks, but so does life, study notes

As Congress moves to improve drug safety, researchers suggest a new way to evaluate risks and benefits of some medications.

By Susan J. Landers, AMNews staff. May 28, 2007.

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Washington -- Is it riskier to take a daily aspirin, drive a car or fight fires? Turns out they all carry about the same risk -- between 10.4 and 11 fatalities per 100,000 person-years, according to a study in the May/June Health Affairs, a policy journal published by Project HOPE.

Researchers from Tufts-New England Medical Center in Boston set out to compare the risks of taking each of six drugs to the risks people face at work, while traveling on various modes of transportation and during recreational activities. They reported those risks in terms of the mortality probability associated with each "person-year" of participation.

Their findings surprised them. For example, taking Vioxx (rofecoxib), which was withdrawn from the market in 2004, or Tysabri (natalizumab) for multiple sclerosis was comparable to or exceeded the risk of dying in a car crash, working as a truck driver or rock climbing.

On the other hand, it was less risky to take either drug than it was to drive a motorcycle, work as a logger or climb the Himalayas.

Assessing the risks and benefits of a medication is a scenario that plays out many times a day in physicians' offices. And concerns about drug risks currently are receiving attention on Capitol Hill, as Congress works on legislation containing several drug safety measures.

On May 9, the Senate approved its version of the measure, while a House companion also moves toward completion. Both include provisions intended to strengthen the Food and Drug Administration's ability to monitor drugs after they are approved.

The AMA closely followed the Senate's efforts and worked with Sen. Tom Coburn, MD (R, Okla.), and others to shape the final package, said Cecil B. Wilson, MD, chair of the AMA Board of Trustees. AMA advocacy "greatly improved the drug safety bill to preserve physicians' ability to prescribe restricted-use and off-label drugs for medical care without onerous government interference and to increase FDA's capabilities to create postmarketing risk identification and communication systems."

The Tufts-New England Medical Center researchers also had physicians and their patients in mind when designing their study.

"Helping patients, health care providers and policymakers understand the magnitude of drug risks is crucial to helping them make an informed decision when evaluating the risks and benefits of treatment," said study author Peter Neumann, ScD, director of the Center for the Evaluation of Value and Risk in Health, Tufts-New England Medical Center.

Dr. Neumann and other authors of articles in Health Affairs' theme issue, "Pursuing Medical Progress: Managing Benefits and Risks," discussed their work at a May 8 briefing in Washington, D.C.

Risky business

"There are a lot of risks in daily life, and by comparing them to drug risks, we thought it would provide some context and intuition," Dr. Neumann said in a separate interview.

The study has a practical side, said David O. Meltzer, MD, PhD, associate professor of medicine at the University of Chicago. For example, it will help in thinking about the magnitude of benefits and harms. "I think the big problem is that doctors don't spend enough time talking about either of those things," said Dr. Meltzer, who served on an Institute of Medicine panel that released an influential report last fall on drug safety and was not involved in the study.

In the analysis of Vioxx, researchers found that it posed a mortality risk of 76 fatalities per 100,000 person-years, compared with a rate of 114 fatalities for loggers and 450 for motorcyclists. "I was surprised by how low the risk was," Dr. Neumann said. "Riding a motorcycle is a lot riskier than taking Vioxx, a drug that was withdrawn from the market and is seen as the poster child for drug safety problems."

Lead author Joshua T. Cohen, PhD, a research associate professor of medicine at Tufts-New England Medical Center, was surprised that the risk associated with aspirin use by a 50-year-old man to protect against heart disease and cancer was 10.4 fatalities per 100,000 person-years -- about the same as the risk for driving a car.

But in the quest for safety, a drug's benefit shouldn't be ignored, Dr. Cohen said. "The reason we put up with the risks are the benefits. We take the aspirin because it is conferring a benefit. And we drive because of the benefit of getting somewhere faster."

And don't discount the benefits of taking even risky drugs, Dr. Cohen said. "I think we are wired to think about the risk, and it's easy to focus on that. But if one does that without thinking of the benefits, you can lose out on something that is important to your health."

Surveys show that people voluntarily accept a wide range of risks under various circumstances. Many people with arthritis mourned the loss of Vioxx, for example, and said they were willing to accept the cardiovascular risk in exchange for the medication's pain-relieving benefit.

Researchers also evaluated Tysabri. After its approval in November 2004 to treat relapsing-remitting MS, the drug was withdrawn because of the risk it posed for progressive multifocal leukoencephalopathy, a disorder of the central nervous system. It was allowed to re-enter the market, although with restrictions on its use, in March 2006.

The fatality risk for using Tysabri was assessed at 65 deaths per 100,000 patient years, compared with 36 deaths for a taxi driver or a chauffeur.

Of course, all other risks pale before that faced by climbers in the Himalayas. The researchers give them a fatality rate of 13,000 deaths per 100,000 person-years. As physicians are counseling patients, they might want to discuss risks not normally mentioned, such as scaling the Himalayas or, more realistically, riding motorcycles, Dr. Neumann noted.

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