Vioxx settlement puts focus on drug ad claims

Efforts to bring more scrutiny to drug research and promotion got a boost Tuesday when Merck settled claims from 29 states and the District of Columbia that it misled consumers in advertisements for its painkiller Vioxx.

The New Jersey drug maker agreed to pay $58 million, including $1.8 million to North Carolina, and will change how it publishes clinical trial data and how it uses this data to promote its drugs to doctors and patients.

The settlement ends an investigation that began three years ago. Merck denied any wrongdoing, according to the settlement.

Merck had pulled Vioxx off the market in 2004 after a study found the blockbuster seller, which had been heavily promoted in television and magazine advertisements, doubled the risk of heart attack and stroke.

Consumer advocates who have long called for stricter regulation of drug ads, were less than enthusiastic about the settlement.

"It moves things in the right direction," said Dr. Kevin Schulman, a health policy expert at Duke University. "But it's not a sea change."

Criticism of the pharmaceutical industry and the Food and Drug Administration has become louder as problems with other prescription drugs already on the market have raised the public's concern about drug safety.

The court settlement, although it applies to only one drug maker, makes strides toward transparency in drug research, Schulman said.

It requires Merck to refrain from manipulating data for publication in peer-reviewed medical journals and promotional materials. The drug maker no longer may present favorable conclusions that are not supported by a study or attribute a publication to an author who didn't substantially contribute, according to the settlement.

But the settlement won't change Merck's direct-to-consumer advertising much, Schulman said.

Merck agreed to submit all TV drug ads to the FDA for review before they are aired. Even PhRMA, the pharmaceutical industry's trade group, acknowledged in a 2007 report that most drug makers already do that voluntarily.

Oversight of ads

The settlement also leaves unanswered concerns consumer advocates have raised about FDA oversight of direct-to-consumer drug advertisements.

In 2001, the FDA warned Merck that its promotional campaign for Vioxx failed to warn consumers that study results suggested the painkiller increased the risk of heart attack.

But the number of FDA enforcement actions to pull misleading drug advertisements has dropped sharply since then.

Drug makers quadrupled their spending on direct-to-consumer advertisements in the past decade. Meanwhile, the number of FDA warning letters about violations decreased 86 percent.

PhRMA argues that drug advertisements on TV and billboards, and in magazines and newspapers help patients become more aware of their diseases and treatment options.

Dr. Sidney Wolfe of Public Citizen, a Washington, D.C., consumer advocacy group, disagreed.

"These ads have a huge amount of misinterpretation," Wolfe said. "They are intended to get to the gut instincts. Ads are to sell drugs."