PAPER CUTS: FDA Follies

Far more dangerous than a loaded gun is the threat posed by the very agency authorized to protect us.The Food and Drug Administration, responsible for safeguarding the nation's food and drug supply, has instead become hopelessly compromised. Under ferocious pressure from pharmaceutical manufacturers to expedite the drug approval process, the FDA is becoming more of a health hazard than the NRA and Big Tobacco put together.A 1998 study in the Journal of the American Medical Association estimates that adverse reactions to medications kill 106,000 Americans each year, making prescription drugs the fourth leading cause of death in the U.S., after heart disease, cancer, and stroke.Last week, two FDA approved drugs were removed from the market. Propulsid, used to treat heartburn and gastroesophageal reflux, was recalled after 7 years, 70 deaths, and hundreds of reports of cardiac arrhythmias. Rezulin, a drug for the treatment of diabetes, is responsible the deaths of at least 63 people from liver failure, and for hundreds of cases of life threatening liver toxicity.Rezulin is the fourth of the 39 new drugs released in 1997 to be recalled by the FDA. It was approved under what many FDA physicians describe as "lowered safety standards".Posicor, Duract, Raxar, and Rezulin, four drugs approved in 1997, and now taken off the market, represent twice the number of recalls of any previous year. The antibiotic Trovan, a fifth drug approved in 1997, is now banned in Europe, and banned in the U.S. except for hospitalized and nursing home patients. Redux, approved in 1996 for weight reduction, was recalled in 1997 for often-fatal pulmonary hypertension and heart valve damage.Public Citizen reports that in many of these cases, "there was either opposition by FDA employees to approval of these drugs (Redux and Rezulin), unsuccessful urging of stronger product warnings (Duract), or inadequately-heeded opposition from FDA advisory committee members (Posicor)."In late 1998 the consumer watchdog group found 27 instances in which a drug was approved over FDA staff objections, and 14 instances in which staff were told not to present data at advisory committee meetings which might adversely affect the chance of a drug being approved.The Food and Drug Administration was established in 1938, with the responsibility for "showing new drugs to be safe before marketing". It was not until 1962, however, under provisions of the Kefauver-Harris Drug Amendments, that drug manufacturers were required to prove the efficacy of their products to the FDA before marketing.The testing procedures of the FDA remained unchanged until 1991, when the drug review process was fast tracked for life-threatening diseases. In 1997, after intense lobbying by the Pharmaceutical Research and Manufacturers of America, the FDA accelerated the drug review process for all prescription drugs.In January 1999, the Environmental Research Foundation reported that "rather than strengthening the U.S. government's drug safety programs, ...Congress has recently diminished the powers of the FDA to monitor drug safety. Congress now allows drug companies to pay fees which the FDA uses to speed up the approval process for new drugs. As a result, during 1996-1997, FDA approved new drugs for market at twice the previous rate. However, Congress specifically prohibited the FDA from using any of the new money for monitoring drug safety."As of last year, the FDA Division of Pharmacovigilance and Epidemiology, which monitors all newly marketed drugs and collects information about their side effects, had a total staff of 52 people, only 8 of whom are physicians.The New England Journal of Medicine reports that 51 percent of approved drugs have serious side effects not detected prior to approval, but "only about 1 percent of adverse drug reactions (ever) get reported."If the FDA's Division of Pharmacovigilance and Epidemiology identifies a problem with a particular drug, they pass that information along to the division of FDA which issued the original approval. The FDA will then simply request that the manufacturer develop additional information, which is most often "a change in the product disclosure label or package insert." In contrast to the full page announcements trumpeting the arrival of new drugs, these correctives are limited to tiny warnings barely visible to the naked eye.On March 22, following the recall of Rezulin, Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group, wrote to Donna Shalala, Secretary of Health and Human Services:"It is urgent for you and other leaders in Health and Human Services, and all government agencies, to re-read and strongly urge the implementation and enforcement of the 1958 Congressional Resolution entitled The Code of Ethics for Government Service which states that 'Any person in Government Service should put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department'.""These guidelines have not been followed by those FDA officials who have harassed FDA physicians in the context of the recent controversy concerning Rezulin. Rather than encouraging FDA physicians and other scientists to be vigilant and try to stop these disasters from occurring before approval, or encouraging them to speak up, ...there have been several recent incidents in which FDA medical officers have been harassed because of their concerns about drug safety."Dr. Wolfe goes on to "urge the widespread dissemination and discussion of the above Code of Ethics and obligations of public service, and for sanctions to be brought against those agency personnel who are responsible for interfering with the duty of other employees to voice their concerns about serious problems with drug safety.... Until this is done, the FDA will continue to make additional serious mistakes regarding drug safety and other issues, much to the detriment of the health of people in this country."

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