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HEALTHY SKEPTICISM First in an occasional series

Where the Naproxen Story Went Wrong

When NIH Halted a Major Study, Citing Risks From a Common Painkiller, the Media Played the News Big. That Was Just Part of the Problem

By Steven Woloshin, Lisa M. Schwartz and H. Gilbert Welch
Special to The Washington Post
Tuesday, February 1, 2005; Page HE01

Medical research often becomes news. But sometimes the news is made to appear more definitive and dramatic than the research warrants. This article dissects a recent health news story to highlight some common study interpretation problems we see as physician researchers and show how the research community, medical journals and the media can do better.

Raising doubts about the safety of a widely used drug like naproxen, also known as Aleve, is big health news. Add this to recently raised concerns about other drugs in the same broad category -- nonsteroidal anti-inflammatory drugs (NSAIDs) such as Vioxx, pulled off the market this fall, and Celebrex -- and the news is big indeed.

_____Graphics_____
What Is the Chance of Having Your First Heart Attack in the Next 10 Years?
What Was the Likely Risk of Naproxen in This Study?
_____From the Post_____
Quantifying Medical Risk (The Washington Post, Feb 1, 2005)
Aleve's Maker Tries to Reassure the Public (The Washington Post, Feb 1, 2005)

So it is no surprise that the government's decision in December to halt the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) because of safety concerns about naproxen received intense media coverage. In the three days following the announcement by the National Institutes of Health (NIH), the story appeared on the front pages of all 10 top-circulation U.S. newspapers and led numerous national TV and radio newscasts.

Front-page headlines included: "Heart Risk Seen in Naproxen" (Wall Street Journal), "Tough Choice: Pain or Risk?" (USA Today), "Patients, Doctors Agonize Over Risks of Painkiller" (Los Angeles Times), "Study Links a Fourth Painkiller to an Increase in Heart Problems" (New York Times) and "Warnings About Medications' Risks Add Worry to Pain" (The Washington Post).

The headlines and the stories' prominent play overstated the nature of the evidence, inviting their audiences to believe that taking naproxen as directed for pain had been shown to be dangerous. As we explain, this may not be the case.

But the media were not the sole source of the problem. The Food and Drug Administration (FDA) and NIH played roles as well.

What Happened With the Study?

ADAPT was a large, federally funded study designed to investigate whether Celebrex or naproxen could prevent Alzheimer's disease. In January 2001 researchers began enrolling more than 2,400 healthy men and women age 70 and older who showed no signs of Alzheimer's but were considered at increased risk because of a family history of the disease.

Study participants were randomly assigned to one of three groups: One took Celebrex daily, another took naproxen, while the third took a placebo. The investigators planned to follow participants for about seven years to see how many people in each group developed Alzheimer's disease.

As in most major research studies, a committee was charged with periodically monitoring study results. It was the committee's responsibility to decide whether the study should be stopped early -- either because of the occurrence of unforeseen risks or the appearance of a dramatic treatment benefit.

This data safety monitoring committee met early in December 2004 and, according to news reports, reviewed some data raising the possibility that naproxen increased cardiovascular or cerebrovascular risk -- that is, risk of conditions involving the heart or brain and related blood vessels. But given the small size of the differences observed between the naproxen users and the placebo users and the possibility that they might be just a statistical fluke, the committee did not recommend stopping the study.


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