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Panel Recommends "Black Box" Warning for COX-2 Drugs

FDA Panel Confirms Link Between Heart Problems and COX-2 Arthritis Drugs; Suggests Ban on Direct-to-Consumer Ads

WASHINGTON, D.C. -- March 4, 2005 -- Gold medal winner Dorothy Hamill effortlessly skates across the arena on our TV screens as we hear about the marvels of Vioxx®. We imagine that our aches and pains can be a thing of the past.

This popular ad helped sell the arthritis drug, Vioxx®, to nearly 2 million Americans before it was pulled from the shelves in September 2004. At that time, it became public knowledge that Vioxx® can increase the risk of heart attacks and strokes.

Last month, a panel of the Food and Drug Administration (FDA) confirmed the link between heart problems and Vioxx®, Bextra®, and Celebrex®, arthritis medicines known as COX-2 inhibitors. The group recommended that these drugs not be advertised directly to the public. Many panel members also suggested that "black box" warnings about heart attack and stroke risks were in order.

Included in the product insert and prescribing instructions, the black box is the highest alert level about health dangers. If a black box is required for a drug, then any ads must include the list of side effects (FDA Advertising, Labeling Definitions). "It would have to say the bad news," said Robert Temple, director of the FDA Center for Drug Evaluation and Research, and "... the contents of the black box are scary and unpleasant" (Wall Street Journal, February 28, 2005).

Direct-to-Consumer Drug Advertising is Big Business

Selling directly to consumers is a big part of a pharmaceutical company's budget and strategy. For example, in 2000, Merck spent $160.8 million promoting Vioxx® to the public. Vioxx® sales climbed from $329.5 million in 1999, when the drug first came out, to $1.5 billion in 2000. This was in part due to heavy advertising (Prescription Drugs and Mass Media Advertising, National Institute for Health Care Management, November, 2001). No doubt, Merck, the maker of Vioxx®, and Pfizer, the manufacturer of Bextra® and Celebrex®, would have to rethink their strategies if their direct advertising campaigns were canceled or restricted. Pfizer already pulled its Celebrex® ads in December of last year.

Dr. John Jenkins, director of the FDA Office of New Drugs, says that the agency does not have the power to stop direct-to-consumer advertising of prescription drugs. However, former FDA commissioner David Kessler believes that the agency has more power than it will admit. "I think there is no doubt that the agency could, on its own, tighten up direct-to-consumer advertising and improve requirements on that advertising..." he said. His former deputy commissioner, Mary Pendergast, agreed: "In my opinion they can bring an injunction, especially if there have been past shame-on-you warnings [about ad campaigns]" (San Francisco Chronicle, February 27, 2005).

A consumer group, Public Citizen, suggests that the FDA does not do a good job of drug oversight. According to statistics cited by Dr. Sidney Wolfe, the director of the organization's Health Research Group, the FDA asked drugmakers to pull ads only 24 times in 2004, and about 157 times in 1998 (Chicago Tribune, February 23, 2005).

FDA Panel Allows Vioxx® and other COX-2 Medicines to Stay on the Market

Vioxx® (rofecoxib), , Celebrex® (celecoxib), and Bextra® (valdecoxib) are nonsteroidal anti-inflammatory drugs (NSAIDs) that block cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. The drugs interfere with the form of cyclooxygenase known as COX-2, which is why they are referred to as COX-2 inhibitors.

Merck removed Vioxx® from the market after a study involving colon cancer patients showed that it increased the risk of heart attacks and strokes. Last December, the FDA issued a health advisory about Celebrex® and Bextra®, warning of their links to heart attacks and strokes, especially when the medications are used for long periods of time or after heart surgery.

Although the FDA panel agreed last month that the three COX-2 inhibitors posed safety issues and recommended that they not be advertised directly to consumers, it stopped short of recalling the drugs. The vote on Vioxx® was close--17 in favor of continued marketing, and 15 against. For Bextra®, the vote was 17 for continuing sales, and 13 for withdrawing the drug. For Celebrex®, the vote was 30 to 1 in favor of continued marketing.

"There's politics mixed with science mixed with consumer demand," commented Dr. Jason Theodosakis, assistant professor of the University of Arizona College of Medicine. "These drugs should only be used as the last line of therapy..." (HealthDay News, February 19, 2005).

Ten Panel Members Had Ties to Drug Companies

The Center for Science in the Public Interest (CSPI) went further in its analysis and checked the background of the 32 FDA panelists (Press Release, February 25, 2005). It found that 10 of the scientists had affiliations with Merck, Pfizer, or related companies. They received fees, honoraria, or even research support from the companies. CSPI considers this a direct violation of the Federal Advisory Committee Act, which may prohibit scientists with conflicts of interest from serving on panels offering advice to federal regulatory agencies. The group believes that the panel would have voted against keeping Bextra® and Vioxx® on the market had the scientists with conflicts of interest been excluded from the vote.

As for the value of the panel's recommendations, they are suggestions only. The panel is an advisory committee. Although the FDA usually follows the panel's lead, it is not required to do so. We will know the extent of the panel's influence in the months ahead.

Meanwhile, at Brayton Purcell, we continue to evaluate cases of heart attacks, strokes, and blood clots that are associated with COX-2 arthritis drugs. If you or a loved one has had these conditions while taking Celebrex® or shortly after discontinuing the medication, please feel free to contact us. We have been successfully handling cases on behalf of injured consumers for over 20 years, and aggressively fight to protect the legal rights of our clients.

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