Healthy Skepticism Library item: 1504

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Appleby J.
Merck's marketing of Vioxx called misleading
USA TODAY 2005 May 6;
http://www.usatoday.com/printedition/money/20050506/vioxx06.art.htm

Full text:

Drugmaker Merck misled doctors for years about the safety of its blockbuster painkiller, Vioxx, Rep. Henry Waxman said Thursday at a congressional hearing on the drugmaker’s sales tactics.
“Health risks were viewed as ‘obstacles’ the sales force was instructed to surmount,” said Waxman, D-Calif.

A top Merck official defended the company before the largely critical House Committee on Government Reform. “I believe in the safety of Vioxx,” said Dennis Erb, Merck’s vice president of global strategic regulatory development.

Documents released by the committee showed:

.Merck in 2000 developed a “cardiovascular card” used by sales representatives to respond to doctors’ questions. It said Vioxx was eight to
11 times safer than other, similar painkillers. The data were pooled from several studies submitted to the Food and Drug Administration as part of the drug’s initial approval process. The card did not mention newer findings reflecting heart attack concerns, which had not yet been added to the drug’s label.

“As we know now, this card was inaccurate and misleading,” Waxman said.
But Erb called the cards “accurate, balanced and fair.”
Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, says the promotional material was technically legal but added, “Many physicians would say it was not inclusive enough.”

Rep. Gil Gutknecht, R-Minn., criticized the FDA for “shirking its responsibility” to better police marketing material and asked: “It may have been technically legal, but is it ethical?”

.Sales reps were instructed by Merck not to initiate discussions on the study. Sales reps told doctors who asked that they could not talk about the study because it was not yet included on the drug’s label. Waxman said there is nothing to preclude the company from discussing new safety concerns.

.Merck continued to ramp up its Vioxx marketing efforts, offering representatives bonuses of at least $2,000 for meeting sales targets. Vioxx hit the market in 1999 and quickly became one of the most widely prescribed and advertised drugs. Then, in March 2000, one of Merck’s own studies showed a fivefold increase in heart attacks among patients taking Vioxx compared with those taking the painkiller naproxen. At the time, Merck said naproxen may have provided a protective effect on the heart. Additional cardiovascular concerns about Vioxx and similar drugs were raised in an August 2001 study in The Journal of the American Medical Association.

Merck and the FDA wrangled for nearly two years on changing the drug’s label to reflect the heart attack concerns. Merck withdrew its $2.5 billion-a-year Vioxx in September after another study linked it to a twofold increase of heart attack and strokes in patients taking it for more than 18 months. Erb said there was plenty of information in the media, in The New England Journal of Medicine and other forums for doctors to learn about the Vioxx safety studies.