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Back to Sanity on Cox-2 Drugs ; Patients, Doctors Can Weigh Risk, Rewards

Posted on: Monday, 28 February 2005, 09:00 CST

If ever there were truth to the claim that one person's gain is another's pain it was in the FDA advisory panel's recent decision to allow Vioxx, Celebrex and Bextra - the easy-on- the stomach painkillers and anti-inflammatories known as Cox-2 inhibitors - to go back on the market. That is, a gain for people who need chronic pain management versus pain for the trial lawyers who'd hoped to litigate the pharmaceutical industry into oblivion.

It's about time the nation's months- long panic over Cox-2s came to an end. While the panel's decision helps restore regulatory sanity to the market for future drug development, far more important is its recognition that these drugs have huge benefits and that their risks should be weighed by doctors and patients.

There was testimony to the contrary, of course, though much of it was less than scientific. For example, Sidney Wolfe, director of the consumer health watchdog Public Citizen, went after the FDA itself, claiming the problem with Cox-2 safety was indicative of the corrupt process by which the pharmaceutical industry funds operations at the FDA to speed the drug review process. The FDA can justifiably be accused of various ineptitudes, but this was hardly the case with Cox-2s. If anything, the review process has been crippled by a less- than-balanced risk-benefit analysis that has prevented patients from getting faster access to developmental drugs.

But it was David Graham, the FDA's own drug safety officer, who tried to steal the show by urging Cox-2 inhibitors be pulled off the market. Graham charged that the use of high-dose Cox-2s was riskier than smoking, diabetes and hypertension and might provide no more benefits than older medications such as aspirin, ibuprofen and naxopren.

It's true studies have never shown Bextra, Vioxx or Celebrex to be more effective than some older pain relievers. In fact, the most complete studies to date on the risk of cardiovascular problems have shown that patients who can achieve pain relief with a safer drug should never take Vioxx. But as the panel heard from doctors who actually treat patients, Cox-2 inhibitors are the best option for certain pain sufferers. "In a perfect world, I would have endless choices, because all patients are not created equal," Atlanta rheumatologist W. Hayes Wilson told the panel.

Patients echoed those comments, testifying that however great the risks, they were an acceptable trade-off for what they considered to be life-enhancing pain relief.

Of course, it's one thing to contend, as the panel finally did, that not all Cox-2 drugs are equal when it comes to risk. But it's quite another to say, as Graham did, that "The bottom line is, there really doesn't appear to be a need for Cox-2" inhibitors. If that logic guided regulators, numerous cancer trials would end, since Cox- 2 enzymes, which cause inflammation and pain, have been found in every stage of a variety of cancers, including cancers of the esophagus, breast, stomach and colon. And as one military officer told the advisers, U.S. troops in the field would be denied reliable and often preferred pain relievers that do not cause bleeding, as aspirin can.

If there's a lesson to be learned from the FDA conference, perhaps it's that Americans must come to terms with the fact that healing is an inexact science and all drugs have side effects, especially when taken in large doses and over the long term.

Source: Rocky Mountain News

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