Justinian C. Lane, Esq.
Let Justice Be Done, Though the Heavens May Fall

Justinian Lane's Blog

Justinian's Blog

Consumers: 1, Merck: 0 - FDA Panel Rejects Vioxx Successor "Arcoxia"

Remember Vioxx?  The "safe" drug that Merck yanked from the market after a few pesky deaths and heart attacks hurt the shareholders?  Merck apparently is trying to forget it; Merck has been trying to bring  "Arcoxia" to the U.S., a drug so similar to Vioxx that some have dubbed it " The Son of Vioxx."  Thankfully, the FDA panel of experts reviewing the drug have recommended by a landslide 20-1 that the FDA not approve the drug for sale:

From Reuters: "The Food and Drug Administration's panel of outside experts voted 20-1 against recommending clearance for the drug, called Arcoxia.

The agency is not required to follow panel recommendations but usually does. Merck said it expects a final FDA decision on Arcoxia by month's end.

The company had argued Arcoxia was as safe as other pain relievers on the market and would be a valuable alternative for arthritis patients who do not respond well to current options. "

Hmmmm...  Do you think they made that safety argument while Vioxx was still on the market? 

Honestly, I'm surprised that the vote was 20-1, considering three of the FDA panelists have substantial financial ties to Merck.  I wonder if the 1 who did vote for it is one of the three.

Dr. Sidney Wolfe testified before the FDA advisory committee and not only recommended that Arcoxia be banned in the U.S., but that Merck should (voluntarily) withdraw the drug the rest of the world:

From Public Citizen: "It is time to shut the door on further additions to this dangerous class of COX-2 inhibitor drugs. The idea that there may be certain patients, however unidentifiable they are, who might benefit from this drug is just not good enough as a basis for its approval...

In addition to strongly urging your committee and the FDA to reject Merck’s effort to approve etoricoxib in the U.S., I urge prompt removal of Arcoxia from the market in the 60+ countries where it is causing unacceptable risks to the hundreds of thousands of people using the drug."

Color me skeptical, but I don't think Merck is going to yank Arcoxia from the rest of the world market.  Unless of course it's not profitable.

No doubt the blogosphere will be aflame with corporate propaganda about how the FDA is keeping "much needed" and "safe" medicines from the market.  You know what I say to that?  If two out of the three doctors that are on Merck's payroll or own Merck's stock say the drug isn't safe... the drug isn't safe.