Vioxx presents larger problem

In February 2005, an FDA advisory committee made up of 32 industry experts recommended that “black box” warnings be placed on Bextra, Vioxx, and other members of the so-called “next generation” of pain relievers. However, the committee did not recommend that the FDA pull these pain relievers from the market. At that point, Vioxx had already been “voluntarily” removed by its manufacturer Merck. Pfizer's Bextra has since been pulled too, though both may be re-released. Celebrex, a sister drug of Bextra made by Pfizer, is the only one of its class still on the market.

However, the advisory committee's recommendations came with its own controversy. The New York Times and other newspapers reported that at least 10 of the 32-member committee had industry ties, and may have “swung” the vote. Of these 10, nine voted to allow the drugs to remain on the market. Had these 10 members not voted, the results would have been 12-8 that Bextra be removed from the market, and 14-8 that Vioxx not be allowed to return. The 10 panelists were identified by searching published research papers of all members. Published studies must reveal any possible conflicts of interest that the researcher may have, including connections with drug companies.

Even before these committee-industry connections came forth, the British Medical Journal underlined the fact that just because the panel found that Bextra and other drugs should not be removed from the market doesn’t mean that they are “safe”. The report quoted Dr Alastair Wood, the panel's chairman and associate dean at Vanderbilt University School of Medicine in Nashville. He compared the committee's findings to a group of airplane pilots standing at the end of a runway and “half of the pilots tell you the plane is unsafe to fly. Would you get on it?”

The controversy surrounding the committee's findings illustrates the bigger problem in the pharmaceutical industry. The researchers and other experts who review the effectiveness and safety of drugs are the same researchers that rely on the pharmaceutical companies to fund their own studies. This lack of an arm's length between industry and the academic community can lead to conflicts of interest on several levels. As a result, patient care and safety can suffer.

No matter who’s to blame for the way drugs are researched and marketed, ultimately it is the pharmaceutical companies who are responsible for the safety of their products. If you or a family member has been hurt by Bextra, Vioxx, or any other medication, it is in your best interest to seek legal advice before trying to take on the billion-dollar companies alone. Contact Jim S. Adler & Associates for a free case review. We will let you know what your rights are, and help you protect them. To contact us, click on the link below or call us directly.