Ethics Newsline®

WASHINGTON
The U.S. House of Representatives last week continued to hold hearings on whether drug maker Merck hid dangers when marketing its popular painkiller Vioxx, which was pulled from store shelves last year after being linked to an increased risk for heart attacks.

The House Government Reform Committee questioned the company’s aggressive pursuit of Vioxx sales despite internal concerns about the drug’s dangers.

Even after a Merck study found a fivefold increase in heart attacks and strokes for Vioxx patients compared to patients taking a competitor’s product, the company put a full-court press on physicians, instructing its sales force to use materials with less worrying figures and avoid discussions of the study, according to press reports.

More than 100 million Vioxx prescriptions pulled in $2 billion in annual sales, with the vast majority of prescriptions being written while Merck was downplaying safety concerns, reported the Los Angeles Times.

Last week, Dennis Erb, Merck’s vice president in charge of regulatory issues, defended the company’s tactics, saying its marketing materials complied with regulatory requirements.

“We believe Merck acted appropriately and responsibly to extensively study Vioxx after it was approved,” Erb told House committee members. “And we promptly disclosed the results of these studies to the FDA, physicians, the scientific community, and the media.”

Lawmakers said that while Merck indeed did disclose results to the FDA, it was less forthcoming with physicians pushed to prescribe the medicine — training sales reps to skirt discussions about Vioxx’s dangers, tucking away worrisome results in fine print, and aggregating study results to soften starker findings.

“The real question we want to know is, can we trust you?” said Rep. Mark Souder (R-Ind.), according to the New York Times.

“Merck’s sales representatives were trained to sell as if lives depended on it,” added Rep. Henry Waxman (D-Calif.). “Ultimately, their message may have cost lives.”

Merck, which voluntarily pulled Vioxx from the market last year, is considering returning the product to store shelves. Before it does so, it is trying to determine what label warnings will be required, noted the Times.

In other news, Merck chief executive Raymond Gilmartin last week stepped down ten months ahead of schedule. The company’s head of manufacturing, Richard Clark, will assume the reins following a six-month search that failed to find a better candidate from outside the company, noted the Times.