How were Celebrex and Vioxx misrepresented by the drug companies in their clinical trials outcomes, the peer-reviewed published medical jounals' articles, and the published articles in the popular press such as newspapers, magazines and drug advertisements? How do you think these misrepresentations affected physicians and patients?
Vioxx was FDA approved as a pain relief drug for arthritis and experienced immediate success, distributed to more than 30,000 pharmacies just eleven days after approval. Vioxx manufacturer has found itself in the middle of lawsuits for the life threatening side effects that have occurred. Vioxx manufacturer, Merck has been warned by the FDA to change their advertising regarding the company's misrepresentation of safety information, unsubstantiated comparative claims, the lack of fair balance, and the misrepresentation of efficacy information.
Vioxx and competitor Celebrex used marketing strategies to try to differentiate themselves from one another, emphasizing small differences until the advantages became extensive and the flaws appeared minimal. The FDA attributed the competition between Vioxx and Celebrex to insufficient warning to doctors and patients of the serious risks and adverse effects of Vioxx. Arthritis affects 40 million people in the U.S. with millions of these people relying on medications like Vioxx for relief.
When safety questions were first raised about Vioxx, Merck responded by increasing its ad campaign efforts instead of further researching safety concerns. The amount of money Merck spent on advertising Vioxx exceeded efforts by Pepsi and Budweiser.
While the advisory panel noted the role advertising played in the drug recall controversy, some people had hoped the panel would call to ban advertising of COX-2 drugs completely. The United States is one of just two countries, the other being New Zealand, that allows direct-to-consumer advertising of prescription drugs, which the advisory panel reminded is a privilege.
The use of Vioxx contributed to the death of as many as 61,000 Americans during its five-year stay on the market. The FDA panel also decided Vioxx was safe enough to rejoin Celebrex and Bextra on the market after concluding all three drugs pose some type of cardiovascular risk. Like Vioxx, Pfizer Inc. has also been criticized for its heavily marketed blockbuster drug Celebrex
Graham said he was threatened with "severe consequences" by a supervisor if the paper was published, and he asked The ...