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FDA Breaks its Own Rules in Considering Merck Painkiller

April 12, 2007 | 19,069 views

An FDA advisory panel is meeting to review the arthritis medication Arcoxia and vote on whether it is safe and effective.

However, the panel includes three doctors with financial ties to the drug industry, even though it is meeting less than a month after the FDA proposed a stricter conflict-of-interest policy for outside experts.

The panel is not bound by the tougher rules because they have not been officially adopted yet, but many have criticized the FDA's actions and say that the rules should have been followed anyway.

Arcoxia, a medication developed by Merck as a replacement for the withdrawn and discredited Vioxx, may be just as risky for your heart as the older drug. Concerns about cardiovascular safety forced Merck to stop selling Vioxx in September 2004.

Arcoxia has been marketed as a safer compound, but critics point out that Merck's largest trial of Arcoxia simply showed that it has the same heart risks as a drug called diclofenac. Some research indicates that diclofenac may be as risky to the heart as the lower marketed dose of Vioxx.

Drug trials comparing Arcoxia with naproxen found a 60 percent to 70 percent higher risk of cardiovascular events with Arcoxia.

Los Angeles Times April 12, 2007

USA Today April 9, 2007


Dr. Mercola's Comment:

You might remember that this is history repeating itself as two years ago  Vioxx was reapproved by the FDA advisory committe that was loaded with panel members with drug company ties. It should become obvious to you by now that massive conflict of interest is the rule, not the exception, at the FDA.

Now pressure has been mounting at the FDA to reconsider Arcoxia, based on growing concerns by some medical experts who have dubbed it the son of Vioxx.

But in one more case of stacking the deck in favor of the drug company cartel, the FDA has allowed doctors with conflicts of interest to serve on the advisory committee, something expressly forbidden in new rules levied by the agency itself.

Although these rules are not technically in effect yet, this move demonstrates the agency's insincerity in passing them in the first place. This shows, once again, how the agency still protects the industry it regulates.

It's also somewhat ironic that it was the massive conflicts of interest involved in an advisory committee's voting on Vioxx, Bextra and Celebrex more than two years ago that led to these new rules being proposed in the first place. So far, at least, little has apparently changed, and you shouldn't lower your guard one tiny bit when it comes to trusting the purported safety of a drug.

Another reminder, you don't need a toxic drug to treat your pain when there are many alternatives that are just as effective and safer for your health.

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