Wednesday, Dec. 22, 2004 | 8:59 a.m.
With the airwaves full of ads for prescription drugs, and with the ads creating a public demand so enormous that drug companies count their revenues by the tens of billions of dollars, the news that some of these pills are being linked to increased risk of heart problems is beyond disconcerting -- it's frightening.
On Sept. 30 Merck & Co. Inc. withdrew its worldwide inventory of Vioxx, a painkiller that had been on the market since 1999. Merck was aware as early as 2000 of evidence showing Vioxx increased the risk of heart problems. The U.S. Food and Drug Administration ordered Merck to include warnings of the risks on its labels in 2002. Earlier this year, when a study by Merck again revealed evidence of increased heart risk in consumers, the company voluntarily withdrew its blockbuster drug -- but not before an estimated 27,000 Vioxx users had developed heart problems, with many of them resulting in fatalities.
Last week another drug maker, Pfizer Inc., announced that it was pulling ads for its own blockbuster painkiller, Celebrex, after a study found evidence that the drug might be causing heart attacks when taken in high doses. Pfizer stopped short of pulling the drug off the market, because another study showed no relationship between Celebrex and heart problems. Previously, Pfizer had announced that a study of another of its pain medications, known as Bextra, had found that the drug could increase the risk of heart attacks for people who have had heart surgery. This week a study by the National Institutes of Health found that the prescription painkiller naproxen -- which is sold in its over-the-counter form as Aleve, made by Bayer -- could also lead to heart problems. In reporting on the alarming news, The New York Times quoted federal officials as saying thi s whole class of pain-relieving, anti-inflammatory drugs, which also includes Advil and Mobic, could cause "worrisome effec! ts on the heart."
What's worrisome to us is how the drugs are approved and marketed. In considering whether to approve a new drug, the FDA relies principally on tests conducted by the drug's manufacturer. A key factor in all approvals is whether the drug's benefit outweighs its risks -- and the risks are many. Yet the drug companies are allowed to advertise directly to consumers without emphasizing those risks. Incessant TV ads are dominated by celebrities engaged in joyous activities, with the name of the drug repeated often to create a positive association. When side effects are mentioned, they are overridden by imagery or sound effects, and spoken as if someone put a tape on fast forward.
The ads usually advise, "Ask your doctor." This is good advice, but the first question for the doctor should be, "How much do you really know about these pills other than what the drug makers have told you?" And a question by the FDA and Congress should be: "Should direct-to-consumer ads be outlawed?" Such ads are not allowed in most countries because of exactly what's happening here -- the downplaying of serious side effects. How can consumers understand what they are really ingesting when even the FDA is confused? Dr. Sandra Kweder, deputy director of the FDA's office of new drugs, told The New York Times, "This is a very confusing situation." She recommended that every patient have a conversation with his or her doctor about the drug's "unique risks."
As we see it, the most unique risk of all is that of a whole nation becoming dependent upon expensive, possibly unnecessary and sometimes dangerous drugs -- largely because the medicines are marketed like candy. This practice is allowed, in part, because of the overwhelming presence in Washington of lobbyists for drug manufacturers. Consumers should get only straight information about prescription drugs -- from the FDA itself, from respected medical journals or manuals, from responsible organizations and from their doctors -- and not from manufacturers' ads that portray negative side effects as inconsequential.
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