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Lessons for Vioxx, Celebrex, Bextra controversy

The drama with Cox-2 inhibitor drugs got even more interesting last week. In a bizarre turn of events, a drug that was supposedly so dangerous that its manufacturer recalled it voluntarily, was found safe to be sold again by a panel of scientists. That is when the scientists were almost unanimous in their belief that the drugs were less safe than it was believed before the Vioxx controversy started in September 2004. (Related article: Merck's flawed Vioxx recall strategy)

Benefits to Pfizer

It gets to sell both Celebrex and Bextra (though with black-box warnings). The FDA panel did not fully agree with the company that these drugs were safe. Most experts do not expect that either Celebrex or Bextra will achieve the pre-controversy level of sales, considering all the bad news that has come out during last four months. (Related article: Pfizer's wrong strategy for Celebrex and Bextra)

Benefits to Merck

It is too early to predict how being able to sell Vioxx again will help Merck. Several law firms that have filed lawsuits against Merck have made statements that Merck's legal troubles will get worse if it were to re-launch Vioxx. While many Vioxx patients will be delighted to see it back in pharmacies, it is highly unlikely if Vioxx can gain even half its pre-recall sales. (Related article: Lessons from Vioxx controversy)

Did Pfizer and Merck pursue the right strategy?

  • It is still too early to pass a judgment since the FDA has not made a decision yet. The FDA decision to allow sales for Vioxx to resume may come with severe restrictions on prescriptions as has been done by the EMEA, TGA, and the German authorities.
  • The bad press for Vioxx, Celebrex, and Bextra means that Merck and Pfizer will need to do a lot of work in raising the confidence of consumers in these drugs. If the FDA puts restrictions on direct-to-consumer advertising for these drugs, their task will become extremely hard. (Related article: Poor risk management strategy hurts Pfizer)
  • A lot of research that shows some of the adverse side effects of these drugs has since come in public domain. In other words, both companies will still have a very difficult time in courts and the lawsuits will be major distractions for the management for years to come.

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