A Symptom of FDA Laxity
Merck & Co. said its surprise decision Thursday to withdraw the arthritis drug Vioxx -- used by about 2 million people worldwide -- was driven by recent evidence that the drug’s adverse side effects outweighed any potential benefits. But that wasn’t really news. Though the new study was more comprehensive than past research because it looked at patients over the course of three years, research since November 2000 has suggested that those who take Vioxx face a heart attack risk four to five times greater than those who take older, equally effective arthritis treatments such as ibuprofen and naproxen.
So why is Merck recalling the drug now? One can only speculate, but it may have less to do with side effects outweighing benefits than with legal liabilities outweighing profits. Merck faces several lawsuits, including a class action filed Thursday alleging the company made false and misleading statements about Vioxx’s safety. Whatever the company’s motives, its decision to withdraw Vioxx should cast scrutiny on at least two problems inherent in the nation’s system for assessing and monitoring drug safety.
The first is misleading ads. Vioxx and a similar drug from Pfizer Inc., Celebrex, have been touted as “super-aspirins” in numerous TV commercials that have downplayed their known cardiovascular risks. Such commercials show how far the Food and Drug Administration has slipped in enforcing its own rules. When the agency determines a drug company has made a misleading ad, it first issues a warning letter, then imposes a fine if the ad is not pulled. But the number of warning letters has dropped precipitously since the Bush administration took power, from 82 in 2000 to 24 in 2003.
The second problem is the nation’s almost exclusive reliance on drug companies to police the safety and efficacy of their own drugs. Although the FDA requires drug makers to demonstrate the superiority of their medications to placebos before they can release them, the agency lets drug companies monitor their own products’ dangers after they’ve reached the shelves.
The FDA could help solve these problems not only by enforcing its own rules but by requiring doctors and hospitals to report “adverse events” when patients use drugs. Big government payers such as Medicaid or Medicare could pay only for expensive new drugs that are demonstrably superior to older, cheaper ones.
The withdrawal of Vioxx caused Merck’s market value to sink by almost $27 billion. The FDA’s current hands-off approach to drug companies doesn’t just endanger consumers, it hurts investors -- who shouldn’t be caught by surprise over a drug whose dangers have long been clear.
