Healthy Skepticism Library item: 7405

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Levin AA.
FDA Credibility and New Information About Cox-2 Inhibitors
Center for Medical Consumers 2006 Jun
http://www.medicalconsumers.org/pages/FDACredibility.html

Full text:

Public confidence in the FDA’s ability to protect users of prescription drugs from harm is slipping, according to a recent Wall Street Journal Online/Harris Interactive poll. When asked about how well the FDA is doing to ensure that new prescription drugs are safe, almost six out of every ten people polled said it was doing only a fair or poor job. When the same question was asked in a similar 2004 poll, a majority of respondents praised the FDA’s performance.

This should come as no surprise. Over the last few years FDA has been rocked by controversy over its handling of prescription drug safety. The most notable have been: FDA’s reluctance to acknowledge that antidepressants (Paxil, Effexor and Prozac among others) might increase the risk of suicide among children and adolescents; failing to respond quickly to emerging evidence that heart attacks and strokes were linked to the popular painkillers known as COX-2s (Vioxx, Bextra and Celebrex); and most recently, an almost begrudging acceptance of a duty to warn doctors and users about serious cardiac harm from attention deficit hyperactivity disorder drugs (ADHD) Ritalin, Adderal and others.

The latest information about COX-2 and ADHD drugs safety may further tarnish the FDA’s image. Recently, experts have reviewed new data and concluded that the risk of heart attack and stroke associated with COX-2 pain relievers starts earlier and lasts longer than previously thought. As a result, previous estimates of tens of thousands of users put in harm’s way by these drugs may have to be revised upwards. And a study by the Centers for Disease Control and Prevention estimates that 3,075 people visited hospital emergency rooms in 2004 because of adverse reactions to ADHD drugs.

Arguably, it’s the FDA’s safety lapses related to COX-2 drugs that may do the most damage. In May, Merck & Company announced results from a year-long followup of participants who had been in a study designed to test whether Vioxx prevents colon polyps. This study, which compared the painkiller to a placebo, had to be stopped ahead of schedule in 2004 because safety monitors observed that Vioxx users suffered twice the number of heart attacks and strokes as those not on the drug–a finding that led Merck to withdraw Vioxx.

After the study had been stopped, the participants continued to be followed for one year. The results were recently touted in Merck press releases as good news because the people who had stopped taking Vioxx purportedly showed no increased risk of a cardiac event. But several drug safety experts looked at the same study results and came to an entirely different conclusion, according to an article in The New York Times. “What it shows us is that you can stop taking Vioxx, and based on this study, for the next year you’re still at increased risk,” said cardiologist Steven E. Nissen, MD, of the Cleveland Clinic. Bruce M. Patsy, MD, of the University of Washington called on Merck to follow the colon polyp trial participants beyond one year-until it knew with certainty whether or not Vioxx caused long-term heart damage. “That would be an honorable thing to do.”

The news gets worse. National Public Radio recently asked clinical trial expert Curt Furberg, MD, of Wake Forest University to review a confidential report from Merck to the FDA which contained yet another analysis of data from the colon polyp study. In the NPR interview, Furberg said the original 2004 safety analysis that led Merck to withdraw Vioxx purportedly showed that “it takes about 18 months [of use] to see an increase in risk.” However, after reviewing the latest data, Furberg concluded, “The risk appears to be present from the beginning, and it increases gradually over time.” Amazingly, Merck admitted its error and confirmed Furberg’s analysis, according to a May 31 New York Times article.

Concern about COX-2 toxicity will likely lead to a new round of questions about the FDA’s competence to protect the public. What must not be lost in the finger pointing is that Congress has chronically underfunded the FDA and not given it adequate regulatory muscle to do its job. Legislation to bolster the agency’s drug safety programs remains stalled in Congress. With mid-term elections this November, what better time to demand that our elected representatives finally take action to fix FDA’s safety shortcomings/