AfterShoxx - Pharmaceutical Executive


Merck's withdrawal of blockbuster Vioxx blew a $2.5 billion hole in its revenues and stirred up a storm of suspicion and speculation accompanied by a chorus of wild laments. Some perspective, anyone?

Pharmaceutical Executive

Wofsy takes another tack: "FDA announced the problem so patients and physicians could be aware of it but didn't require the companies to do anything. They left it to further studies to clarify the issue—accidentally. There probably should have been more insistence at an early stage on looking directly at the cardiac issues posed by these drugs. There were enough clues two or three years ago to force a more thorough evaluation. Fortunately, the findings came up in a subsequent study by chance. But it would have been a good idea for Vioxx to have been systematically evaluated." Wertheimer is on the same wavelength. "For FDA there's a lesson: independent of who the company is, their reputation, or size, they have to look more carefully and communicate more forcefully," he says.

But keep in mind, Morris says, "You can't know everything about a drug before it's approved for marketing or else you could never approve any drug." Even Wofsy concedes that, "You have a dilemma, which will always exist in public health. At what point in the understanding of the long-term consequence of a new agent is it acceptable to release it to the public who might benefit from it? And at what point do you withhold a potentially valuable medication because you don't have enough long-term follow-up for possible late adverse effects?"

"People have to be realistic," says Edward Langston, MD, a member of the American Medical Association's Board of Trustees. Langston, a geriatrician and pharmacist by training, believes FDA's rigor in screening new medications is the most severe in the world. "Medications are available in Europe or Asia that aren't here," he says. "We take a very hard look at things. It's difficult and costly. Some people say it's a failed system. It's not. It's working. Everyone wants the perfect answer—the perfect drug—and it isn't out there." It's just not a simple matter to balance risks, benefits, and costs. "We're still learning," Morris says. "It wasn't until thalidomide that we understood the teratogenicity of drugs."

That's not to say improvements aren't needed. "The type of drugs developed today have a much longer-term effect on patients," Hall says. Information needed to understand long-term side effects cannot be obtained in even a multiyear trial. Hall also thinks trials may have to be more specific. Say you treat trials for broad-based indications, such as Vioxx, as more of a specialty. "Then you want to target the 65 and older population that will probably take it for chronic problems," says Hall, who believes clinical transparency should help a lot. "People will have to understand what their strategy is and where the risks are," he says. Langston suggests that "FDA needs more manpower. They have a very challenging job."

Direct Pressure "It says a lot about the power and danger of direct-to-consumer (DTC) marketing that the COX-2 inhibitors achieved a popularity in the market that far exceeded their benefit," Wofsy says. Fellow physician Langston agrees, saying, "I think there are some unreal expectations generated from advertising. Patients always put pressure on you to try something they may not totally understand." Wofsy say doctors in general are very strongly opposed to DTC marketing of new drugs, and Vioxx is a good example of why. "You have a chronic condition here—arthritis—that we can't cure," he says. "What we do for people is ameliorate their symptoms. We help them cope. You settle on a certain level of symptoms that the patient tolerates because pushing more aggressively to control them is more worrisome than the symptoms themselves. If a new agent comes along and is directly and aggressively marketed to patients, what's the physician to do? It becomes a tremendous pressure against sound medical judgement."


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