The price of pain
You get relief. You also get some health risk. This is the deal you cut
In the past few months, David Borenstein's life and his Washington, D.C., rheumatology practice have become something of a nightmare. Most of his patients suffer chronic pain and inflammation from arthritis, back pain, or muscular-skeletal diseases. "I see over 100 patients a week," says Borenstein. "My life is about trying to keep these people functional."
And that mission is becoming an increasingly difficult challenge every day. In the past few weeks, both Celebrex and Bextra--which belong to a popular class of pain relievers known as Cox-2 inhibitors--and the widely used over-the-counter pain reliever naproxen, sold as Aleve, have been linked to an increase in heart attacks and strokes. Two large government-funded trials of these drugs to prevent colon cancer and Alzheimer's disease have been stopped, though officials admit that the heart risk revealed in these studies is preliminary and conflicts with data from other studies. The drugmaker Pfizer agreed to stop direct-to-consumer advertising of Celebrex after patients taking the drug had a 2.5-fold increased risk of major cardiovascular events. The Food and Drug Administration issued an advisory recommending that doctors limit use of the Cox-2 inhibitors and that consumers adhere to the label directions for nonprescription pain pills, taking them no longer than 10 days without physician supervision.
Nation in pain. As a result, many doctors have been deluged with calls from frightened patients. "Everybody takes these drugs," says Elizabeth Tindall, president of the American College of Rheumatology and in private practice in Portland, Ore. Indeed, pain reliever sales are estimated by Kalorama Information at more than $18.8 billion in 2004, not surprising when over 30 million Americans take a nonsteroidal anti-inflammatory drug, or NSAID, every day.
Until recently, the NSAID naproxen was thought to be mildly protective of the heart. Available over the counter for the past decade, naproxen is recommended to treat everything from the muscle soreness suffered by weekend jocks to severe joint pain among rheumatoid arthritis sufferers. Yet, a $26 million, five-year Alzheimer's trial was suspended by the National Institutes of Health last month after naproxen was linked to a 50 percent increase in cardiovascular events.
"They stopped the trial for an unclear reason," says Eric Topol of the Cleveland Clinic. "This would be the only study of its kind to show harm with naproxen. A 50 percent increase in heart attacks and strokes? Fifty percent of what?" But no additional data have been forthcoming, and NIH refused to provide any scientist to answer questions about why the trial was stopped or what it might reveal.
Topol is one of many scientists skeptical of the unconfirmed results and critical of this type of medicine by press release. "It had already been a terrible situation for patients on Vioxx," says Topol, who believes the FDA should have insisted on warnings about the drug sooner, so patients could evaluate their heart risk with their doctors. Now, he says, stopping the Aleve study has "added to the fear and panic that already exists about pain relievers."
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