Making sense of recommendations on Vioxx, Celebrex, Bextra

The hearings of the FDA panel, while coming up with some shocking recommendations, also caused a lot of confusion. On one hand, expert after expert has argued for years that Vioxx, Celebrex, and Bextra are such dangerous drugs that they should have never been approved or recalled much earlier. On the other hand, the panel recommended that all three drugs are safe for marketing, despite their huge risks, provided a black-box warning is added. (Related article: Implications of FDA panel's recommendations on Vioxx, Celebrex, and Bextra)

So what should an arthritis patient make of it? There is plenty of research out there on all three drugs but nothing that provides a definitive answer either way. No wonder the panel members have called for more research, ban on direct-to-consumer advertising, and severe restrictions on prescriptions. (Related article: European authorities ban/restrict Cox-2 drugs)

So how will FDA respond to the recommendations? No one knows. In most cases, FDA simply accepts the advice of advisory panels though it can come up with a different decision in the case of Vioxx where the vote was a close one. If the requirement was a two-thirds or three-fourths vote, Vioxx would not have been allowed back on the market. Since the recall of Vioxx, FDA has come under strong criticism from all quarters, including politicians in Washington that generally do not criticize the FDA or the pharmaceutical companies (that are among the largest contributors to Republican lawmakers). So it would not be a surprise if FDA did reverse the panel's recommendations in the case of Vioxx, but that would pose a lot of problems for the agency considering that Merck has taken a very aggressive approach since the recall of Vioxx in September 2004. (Related article: Merck knew of Vioxx risks earlier)

While investors have generally cheered the recommendations of the panel, the analysts are still very cautious. Readers of this website may recall the Sanford Bernstein analyst, Richard Evans' estimate of Merck's Vioxx liabilities to be as high as $55 billion if Vioxx plaintiffs could prove negligence. Evans is not changing his opinion despite what is generally perceived as positive news for Merck. "Even if Vioxx returns, we don't see a change in product liability," he said in a research report. "Plaintiffs have to show two things: that they were harmed by the product and that the manufacturer failed to warn." And it is pretty obvious that Merck did fail to warn and might have even hidden damaging information about Vioxx from consumers and doctors.

By admitting that Vioxx and other drugs in the Cox-2 class like Celebrex and Bextra have similar side effects, Merck is simply trying to say that it was not the sole culprit in the crime. Indeed it makes Merck's position no better than before the panel's recommendation, but it does make the case of Vioxx victims stronger. And also, makes Pfizer subject to more lawsuits from Celebrex and Bextra patients. (Related article: Merck and Pfizer ignored drug safety; focused on profits)

Recommended article: Celebrex and Bextra to stay on market with stronger warnings