Vioxx approval may have been a mistake

As more details come out about how the FDA regulates the drug industry (thanks to Vioxx recall scandal), one starts to wonder if any of the drugs approved today in the United States are safe. For instance, as pointed out by Scott Hendler, "The FDA does not actually test any drugs. They only review the results of clinical trials conducted and submitted by the pharmaceutical company seeking approval for the drug." Scary; isn't it?

A very lenient process was used to approve Vioxx in 1999. The underlying data that was used to grant approval to Vioxx was not made available to the public until the end of 2000, or more than 18 months after the drug's approval. By that time there were discussions in the medical community that Vioxx had problems but the FDA did not meet to look into this until February of 2001.

In the meantime, however, Merck was happily telling the world that Vioxx was a wonderful drug that they should take for arthritis. According to Eric Topol of The New England Journal of Medicine, "Each time a study was presented or published, there was a predictable and repetitive response from Merck, which claimed that the study was flawed and that only randomized, controlled trials were suitable for determining whether there was any risk." Understandably so, these trials were never conducted by either FDA or Merck.

At the same time, Merck was also using training material for its sales and marketing staff that essentially asked them to avoid addressing the concerns about Vioxx. Many of these guides were written as those for games, e.g., "Dodge Ball Vioxx".

Recommended article: Vioxx approval process was probably faulty