Healthy Skepticism Library item: 9411

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Publication type: news

Mathews AW.
FDA Panel's Vote Against Arcoxia Gives Merck New Headache in Painkiller Class
The Wall Street Journal 2007 Apr 13A3
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Full text:

A Food and Drug Administration advisory committee said the agency shouldn’t approve Merck & Co.‘s arthritis drug Arcoxia, a medication from the same class as the company’s withdrawn painkiller Vioxx.

FDA MEMO

Read the FDA memo1 on the tough scrutiny the agency is applying to new painkillers like Arcoxia.
The panel’s 20-1 vote against the new painkiller is the latest sign that, with their handling of drug risks under close scrutiny from Congress, the FDA and its advisers are weighing side effects heavily as they evaluate whether medications should be on the market.

Vioxx, pulled in 2004 because it was linked to a heightened risk of heart attacks and strokes, has been a lightning rod for critics of both the agency and the drug industry’s handling of safety issues. Several of those critics told the committee yesterday that Arcoxia held cardiovascular risks similar to those of Vioxx.

‘Disappointed by Vote’
Arcoxia and Vioxx are painkillers of a type called Cox-2 inhibitors. Another Cox-2 drug, Pfizer Inc.‘s Bextra, was withdrawn from the market in 2005, leaving the company’s Celebrex as the only remaining member of the class available in the U.S. Pfizer is easing back into consumer promotion of Celebrex, which had more than $2 billion in global sales in 2006. Arcoxia is sold in 63 countries, though its use is limited.

A Merck spokeswoman said the company was “disappointed” by the vote and still believes Arcoxia can be a valuable treatment option. Merck will continue to work with the FDA, she said.
Committee members rejected Merck’s argument that Arcoxia is needed as a new option for arthritis pain and said the new drug appeared to hold no treatment advantage that outweighed concerns about cardiovascular risk. “There is nothing special about this drug that would warrant giving it to patients” and exposing them to potential heart dangers, said David Felson, a professor of medicine at Boston University.

The panelists’ comments signaled that while Arcoxia might have a risk profile similar to those of some painkillers already on the market, the panelists believed that was no longer good enough to justify approval for a new Cox-2 drug. Richard Cannon, a cardiologist from the U.S.‘s National Heart, Lung and Blood Institute, said he believed all the Cox-2s “increase cardiovascular risk” and “we don’t really have strong data that there’s a need for this drug.”

The FDA typically follows the advice of its expert committees. Robert Meyer, director of the FDA office that oversees arthritis drugs, said the panel sent a clear message that “simply having another drug on the market…didn’t seem to be sufficient reason” for approval, but he didn’t believe that would “broadly apply to all classes of drugs.”

Large Study Showed Risk
In documents prepared for the committee, the FDA said a large study had shown that Arcoxia’s cardiovascular risk was similar to another drug, diclofenac, but appeared higher than a different painkiller, naproxen.

The agency also said Arcoxia appeared similar to diclofenac in its link to serious gastrointestinal problems such as ulcers serious enough to require a blood transfusion, though the newer drug did show some advantage on less-serious problems. The agency also said Arcoxia, at least at high doses, was tied to a higher rate of hypertension than diclofenac.

The committee’s meeting drew an array of drug-safety advocates, most prominently David Graham, an FDA official who has frequently criticized his own agency’s handling of the risks of medicines. Though he was officially speaking for the agency, he faulted the FDA’s 2005 decision to endorse similar heart-risk warnings for the labels of a broad array of painkillers that includes the Cox-2 drugs. Dr. Graham told the panel that Arcoxia held major cardiovascular risks.

Write to Anna Wilde Mathews at anna.mathews@wsj.com7