The Inside Dope On Drugs

Watchdog Web sites can tip you off to concerns that may not be on the label

First it was antidepressants. Then Vioxx. Now questions have been raised about the safety of yet another drug, the painkiller Bextra, made by Pfizer (PFE ). Is there anything you can do to prevent the unnerving situation of finding out from news reports that a drug you've taken for months or years has been flagged for safety or even been withdrawn from the market? Yes there is. Asking doctors and pharmacists the right questions and tapping into the vast medical resources on the Web can help you avoid nasty surprises. In the cases above, information was available years before the recent news splashes that would have at least thrown up caution signs. Consider Vioxx. Drugmaker Merck (MRK ) withdrew the COX-2 inhibitor-type painkiller in September in the face of mounting evidence that the drug increases the risk of heart attack and stroke. But even a cursory Internet search two years ago would have alerted you to potential cardiovascular risks associated with the drug. You would have also learned that the likelihood of the gastrointestinal side effects Vioxx was said to prevent were low for most patients. There was evidence, too, that as a painkiller, Vioxx was no more effective than over-the-counter drugs available for a third of the cost.

Still, before you hit the Net, start with your doctor. Ask how long the drug has been on the market, what its side effects are, whether it will interact with anything you are already taking, and why this drug is better than an older and probably cheaper one. Dr. Joseph Lau, a researcher at Tufts-New England Medical Center, says he would avoid prescribing new drugs for a year or two unless there are no other choices or the patient is allergic to the alternatives. Others are even more conservative. Dr. Sidney Wolfe, a physician and co-founder of advocacy group Public Citizen, believes patients shouldn't use a new drug until seven years after its introduction unless it is clearly a "breakthrough" -- meaning it is the first to treat an ailment or represents a new and clearly more effective approach.

ONLINE WITH THE FDA

Following Wolfe's advice would have kept you out of Vioxx' way. Even Lau's counsel might have protected you, since by 2000 a Merck-sponsored study had uncovered the link between Vioxx and heart problems, though it did not explain the connection. By early 2001, the Food & Drug Administration was discussing and writing about those findings, with letters and memorandums posted on its Web site, www.fda.gov. One way to look for such information is by going to the FDA's home page, clicking on the "advisory committees" link, then going to "drugs." This can turn up issues raised in advisory committee hearings, especially those held around the time of a drug's approval. You can also click the "drug information" tab, then go to the "drug safety and side effects" section to uncover other material -- in this case a warning letter from the FDA to Merck that discusses the cardiovascular findings.

One of the best ways to vet a drug is to obtain the drug's label (or Physicians' Desk Reference entry), available either from your doctor or the FDA site. Since April, 2002, Vioxx' label has referred to studies showing increased risk of heart attack and other cardiovascular problems. The label also showed that Vioxx was less likely to cause gastrointestinal problems than over-the-counter medicines. But the label adds that such problems affect only 1% of patients treated for three months to six months, or 2% to 4% of patients treated for a year. You might have concluded that the risk Vioxx was designed to prevent wasn't worth the heart attack danger.

The FDA site isn't the only place where you could have seen concerns about the drug. Wolfe's organization has a Web site, worstpills.org, which charges for some content, and a subscription newsletter, Worst Pills, Best Pills News, that warns about drugs the group considers risky. The newsletter listed Vioxx on its "Do Not Use" list in April, 2001.

Or you could have gone to a site run by the Office for Oregon Health Policy & Research that compares the safety and effectiveness of various drugs by reviewing drug research. In 2002 that site, oregonrx.org, questioned whether COX-2 inhibitors provided a significant gastrointestinal advantage. Meanwhile, heart problems were a concern. Plus, the site reported there was no evidence that the COX-2s were more effective for treating pain than over-the- counter alternatives.

WHAT ELSE ARE YOU TAKING?

In researching drugs, you should also check with your pharmacist, who might know about side effects reported in the professional literature, says Michael Maddux, executive director of the American College of Clinical Pharmacy. While this wasn't the problem that took Vioxx off the market, several drugs have gotten into trouble because of interactions with other medications. To guard against that, let your pharmacist know about all the drugs you use, including those you buy elsewhere. Be especially careful to ask about interactions when accepting samples. You can also check for interactions at www.drugdigest.org, a free site produced by Express Scripts (EXRX ), a company that manages pharmacy benefit programs.

Keep an eye on medical news sites. Articles linking Vioxx to heart failure in elderly patients appeared last spring on webmd.com. The National Library of Medicine site, pubmed.gov, offers abstracts and citations from professional articles. Type the drug you're taking into the site's search engine and see what comes up. Keep in mind, though, that some studies showing negative results may not be published.

In the end, you might have chosen to take Vioxx, despite the risk, to avoid stomach bleeding. But at least you would have made an informed decision.

By Carol Marie Cropper

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