NEW HARRIS POLL ON PUBLIC PERCEPTION OF FDA SHOWS THAT PEOPLE UNDERSTAND SYSTEMIC PROBLEMS AT DRUG AGENCY

PRESS RELEASE

May 24, 2006

Statement of Sidney M. Wolfe, M.D.
Director, Public Citizen’s Health Research Group

A Harris poll released today found that 58 percent of 2,371 people surveyed last week thought that the Food and Drug Administration (FDA) does only a fair or poor job ensuring the safety and efficacy of new prescription drugs, a significantly worse assessment than as recently as two years ago. This shows that the public has caught on to the systemic problems at the FDA - problems that jeopardize the health of millions of prescription drug users in this country.

The recent cascade of prescription drug disasters involving revelations of potentially deadly effects caused by new blockbuster drugs such as the painkillers Vioxx and Bextra, along with news stories about the dual political influences on the FDA by the religious right (as with Plan B) and the drug industry (which paid the FDA more than $250 million this year to review drugs, as called for by the 1992 Prescription Drug User Fee Act (PDUFA)) have worsened public opinion about the agency. This is likely why 82 percent of those polled thought FDA decisions were to a great extent or some extent influenced by politics rather than medical science.

Adverse drug reactions cause 100,000 deaths and 1.5 million hospitalizations annually, making this one of the five leading causes of death in the United States. Many of these deaths and serious injuries could be prevented if patients were given prescriptions for safer but equally effective drugs.

These results come because drug companies cannot be trusted to provide accurate information to patients or doctors, and the FDA is now heavily funded directly by the drug industry and is therefore much less vigilant than it used to be. The survey also found that 76 percent of people were somewhat or very concerned about the FDA’s ability to effectively communicate safety concerns about prescription drugs to doctors and the public. Thus, there is a need for other, more accurate sources of information about prescription drugs.

That is why we created the Web site www.WorstPills.org. We aim to guide patients and their doctors away from the worst pills - the 185 drugs that consumers should not use - and instead recommend other, safer drugs. These "Do Not Use" drugs represent one-fourth of the top 200 selling drugs in the country.

Rather than the FDA looking out for consumers, it was Public Citizen who warned people not to use each of the last nine prescription drugs taken off the market. Our warnings came as much as three years before these drugs were removed. Two-thirds of the 28 prescription drugs we have formally asked the FDA to ban have been taken off the market.

For example, we warned our readers not to use Vioxx in early 2001, more than three years before it was pulled from the market. We have recently warned people not to use the weight reduction drug orlistat because it causes pre-cancerous lesions in the intestine of animals given the drug. Despite this, the FDA recently sent GlaxoSmithKline, which is seeking approval for over-the-counter use of the drug, an "approvable" letter, often a signal that the drug will soon be approved. Once again, the FDA is falling down on the job.

Two things should be done: First, PDUFA must be repealed so the drug industry no longer pays the agency that regulates it. Second, congressional oversight of the agency must be significantly boosted.

Only by taking these steps can the FDA begin to fulfill one of its most important duties, which is to protect the public from dangerous drugs.