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Merck Tries to Move Beyond Vioxx Debacle

LINDA WERTHEIMER, host:

Merck and Company has agreed to settle tens of thousands of lawsuits involving its blockbuster drug Vioxx for $4.9 billion. Merck does not acknowledge that Vioxx caused individual heart attacks.

NPR's Richard Knox reports the impact of Vioxx will be lasting.

RICHARD KNOX: Before Merck pulled Vioxx off the market three years ago, Americans could hardly avoid the Vioxx message.

(Soundbite of commercial)

Unidentified Man: Vioxx is here, a prescription medicine for the most common type of arthritis pain.

KNOX: Merck spent more to promote Vioxx than any drug company had ever spent before. And therein lies the first lesson of the Vioxx debacle, says Doctor Catherine DeAngelis. She's editor-in-chief of the Journal of the American Medical Association.

Dr. CATHERINE DeANGELIS (Journal of the American Medical Association): What people should learn from this is you don't believe anything, not one thing, put out by a pharmaceutical company. Just don't believe it. You start from there.

KNOX: DeAngelis says Vioxx represents the height of a drug industry trend that dates back 10 or 15 years, the ascendancy of marketing over science. Because of Merck's massive marketing push, most of the people who took Vioxx didn't need it.

Dr. DeANGELIS: Probably five to 10 percent of the people who took it really should have been taking it, because Vioxx for them worked. No other drug worked for them.

KNOX: She says for the other 90 percent, the drug raised the risk of a heart attack or stroke with no significant benefit.

Dr. DeANGELIS: When you want to make money by selling products to people who don't need it rather than putting your money into developing new drugs, then you're going to get into this kind of trouble.

KNOX: In Merck's push to turn Vioxx into a blockbuster, critics say the company ignored early signs that the drug greatly increased the risk of heart attacks.

Dr. Steven Nissen of the Cleveland Clinic says the episode is a powerful illustration of the dangers in the way new drugs get approved and quickly get widely used.

Dr. STEVEN NISSEN (Chairman, Cardiovascular Medicine, Cleveland Clinic): When new drugs are approved, there are often unresolved safety questions. The number of patients studied in the trials leading to drug approval can only be two, three, four thousand patients sometimes. And that's not enough to clearly see the risks associated with drugs.

KNOX: The Food and Drug Administration is supposed to monitor problems that crop up after a drug goes on the market. But Nissen says Vioxx shows how reluctant the FDA has been to force companies to do these so-called post-marketing studies.

Dr. NISSEN: In its recent report to Congress, the FDA acknowledged that only 14 percent of those post-marketing trials were ever conducted as intended.

KNOX: On September 27th, President Bush signed a new law that gives the FDA authority to fine companies that don't do these safety studies.

Dr. BRUCE PSATY (University of Washington): We'll see, if they get used. It won't be for the lack of the authority.

KNOX: That's Dr. Bruce Psaty of the University of Washington. He says it won't take long to see if the FDA uses its new authority.

Dr. PSATY: I expect new drugs to come on the market and have adverse effects. That necessarily mean it's a problem. The question is how rapidly was it identified?

KNOX: Catherine DeAngelis, the AMA journal's editor, agrees Vioxx is not the last of the nasty surprises.

Dr. DeANGELIS: This one they got caught, and I think we just have to be very vigilant about this.

KNOX: DeAngelis says she used to be skeptical of drug companies; now she's cynical. That may be the real legacy of Vioxx.

Richard Knox, NPR News.

WERTHEIMER: You can trace the rise and fall of Vioxx at npr.org. Transcript provided by NPR, Copyright NPR.

NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.

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Since he joined NPR in 2000, Knox has covered a broad range of issues and events in public health, medicine, and science. His reports can be heard on NPR's Morning Edition, All Things Considered, Weekend Edition, Talk of the Nation, and newscasts.