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John Bisnar
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Controversy over plan to sell a Vioxx-like drug

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A furor over the a new Merck painkiller that is “just like Vioxx” has spurred the U.S. Food and Drug Administration, according to an article in The Boston Globe.

The article says that some analysts are scratching their heads at Merck & Co.’s plan to sell a new painkiller that is not much different than Vioxx, the blockbuster drug it pulled from the market in 2004 after several said that it doubled the risk of heart attacks and seizures.

According to this article, members of Congress have characterized the FDA as powerless in the Vioxx issue even when Merck took its own sweet time to alert consumers about its risks and continued its aggressive marketing campaign, which led to skyrocketing sales amid growing concerns over its perils.

Pending legislation aimed at avoiding another Vioxx fiasco would make it easier to curb advertising for new drugs and to restrict the number of doctors who can prescribe such medications when safety questions flare after FDA approval, the article said.

But that’s not causing Merck to hesitate on its new painkiller, Arcoxia, already for sale in 62 countries.

“We believe Arcoxia has the potential to become a valuable treatment option for many Americans suffering from osteoarthritis,” Chris Loder , a Merck spokesman , said in a statement. “As long as people suffer from pain, either from arthritis or other chronic conditions, there will always be a need for additional treatments to combat it.”

Merck will present its case for Arcoxia’s approval during an FDA advisory meeting scheduled for April 12 .

Meanwhile, the US House of Representatives is taking a tougher stance on FDA reform. A House bill, cosponsored by Representative Edward J. Markey , Democrat of Malden , would mark brand new drugs with a symbol that warns of their uncertain safety and ban ads for new drugs for three years, compared with a two-year moratorium possible under the Senate bill.

Right now, the FDA has more power to demand action from drug makers prior to approval. But the clinical trials that guide FDA action usually involve just a few thousand patients, providing an incomplete picture of a drug’s safety. New side effects can crop up once the drug is on sale and used by millions of people — including older and sicker patients than those involved in pre-approval trials.

This information is absolutely appalling yet not surprising to me! Merck is facing hundreds, possibly thousands of lawsuits, over Vioxx and Fosamax. In fact they have won ten of the first 15 Vioxx cases to go to trial and either have or have threatened to appeal the other five.

Is this another billions making Merck fiasco waiting to happen? The FDA needs to wake up and do its job. As this article points out, the agency has control during the approval process. But it turns absolutely powerless once the approval has been granted.

They need to put companies like Merck, which have had a track record of pushing drugs into the market without adequate research or testing, under more scrutiny.