Public opinion of FDA sliding in Vioxx wake

Public confidence in the FDA is waning, according to an opinion poll released amid a pair of Senate committee hearings in March on the agency’s drug approval process and safety record.

"We have seen America’s confidence in the FDA decline in recent months," says Celinda Lake, president of a Washington-based survey company called Lake, Snell, Perry & Associates Inc. "An overwhelming majority of Americans want to either increase FDA’s capacity for oversight and regulation, or at least keep it at current levels."

The agency has found itself under fire with regard to drug safety after questions surrounding the COX-2 inhibitor class of pain drugs and non-steroidal anti-inflammatory products. The market withdrawal of the multiple sclerosis drug Tysabri this week, which occurred after the poll was taken, cannot have helped the FDA’s image.

Lake, the survey’s chief pollster, backed her statements with a number of results on confidence in the FDA’s ability to protect the public. The poll surveyed 1,000 people, with an error margin of +2.5%.

Overall, 14% said they had a great deal of confidence in the FDA. Two-thirds favored an independent body to conduct a full review of all of the agency’s practices and procedures, while 70% supported strengthening the FDA’s collection and reporting process on drugs and devices that have been found to cause harm after approval.

Opinions were mixed on the issue of sponsor company fees collected by the agency for its reviews, but Lake says the poll showed that by an overwhelming margin, "the industries regulated by the FDA have too much influence over the agency’s decisions."

That feeling was echoed by Arthur Levin, the director of the Center for Medical Consumers, who in commenting on the poll’s finding also referred to conflict-of-interest issues that arose following the FDA’s recent three-day hearing on COX-2 inhibitors. After the meetings, it was revealed that a number of people who sat on the agency’s advisory panel, of which Levin was a member, had consulting relationships with the pharmaceutical companies that produce the pain reliever drugs called into question.

"Whether it’s real or perceived," he says, "it’s just not a good thing for the public to see industry having too much influence over the FDA process."

Lake says the cardiovascular risks with COX-2 drugs have brought regulatory worries to the forefront of political opinion right now, concurrent with other high-publicity issues, such as Iraq and Social Security.

CAM therapies must meet standards

In a new report, the Institute of Medicine calls for conventional medical treatments and complementary and alternative medical (CAM) treatments to be held to the same standards for demonstrating clinical effectiveness to make it easier for health care providers and the public to make evidence-based decisions about CAM use.

The report says the same general research principles should be followed in evaluating both types of treatments, although innovative methods to test some therapies may have to be devised. It says randomized controlled trials are the "gold standard" for providing evidence of efficacy, but that other study designs can generate useful information on treatments that do not lend themselves to such trials.

The National Institutes of Health (NIH) and Agency for Health Care Research and Quality sponsored the study to help NIH develop research methods and set priorities for evaluating CAM products and approaches. More than a third of U.S. adults report using some form of CAM, which includes chiropractic and acupuncture to herbal remedies.