Guest Column: Failures of the FDA

In May of 2000, Randy Halsey, a 38-year old resident of Mt. Prospect, Ill. died suddenly of a heart attack. His family was shocked. Just two weeks earlier, Randy’s cardiologist had said that his heart was in good condition.

Randy’s family believes that his death was connected to his taking the pain medication Vioxx. While juries have split on finding Vioxx’s manufacturer, Merck, responsible for deaths and injuries, one thing is clear—Randy and other Vioxx takers knew nothing about studies showing that it significantly increased a patient’s risk of suffering a heart attack or stroke. They didn’t know this because, according to the Food and Drug Administration’s (FDA) chief drug safety official, the agency chose to ignore the studies’ troubling evidence and approved the drug for sale in 1999. The FDA’s decision made it likely that countless families will continue to see their loved ones die unnecessarily.

The facts surrounding Vioxx’s approval highlight the sorry state of affairs at an agency whose drug safety reviewer, Dr. David Graham, said was “incapable of protecting America” from harmful drugs.Graham told the Senate Finance Committee in November 2004 that the Vioxx catastrophe “should have been largely or completely avoided. But it wasn’t, and over 100,000 Americans have paid dearly for this failure.” He said that the FDA had “let the American people down, and, sadly, betrayed a public interest.” Dr. Graham also testified that his superiors at the FDA had delayed publication of a study that connected Vioxx to heart problems and pressured him to change the report’s conclusion. The scandalous behavior of the FDA is rooted partly in its deep ties to the industry it is supposed to regulate.

In 1992 Congress passed a law that allows drug manufacturers to pay the FDA “user fees” to review their products. These “user fees,” paid to speed up the FDA’s drug review process, constitute a huge portion of the agency’s budget for regulating drugs, making the FDA financially beholden to the pharmaceutical industry.

Furthermore, researchers with ties to the pharmaceutical industry commonly serve on FDA drug review panels. According to an investigation by The New York Times, 10 of 32 panel members who recommended that Merck’s Vioxx and Pfizer’s Celebrex be kept on the market have consulted for Merck, Pfizer, or Novartis, which is applying to sell a similar pill discussed by the panel.

Given this, it isn’t surprising that the Vioxx catastrophe is not the only incident in which the FDA has failed to safeguard the public’s health. According to Graham, the FDA recently mishandled safety problems with six other widely-used drugs: Meridia, a weight-loss drug linked to higher blood pressure and strokes; Crestor, an anti-cholesterol drug associated with high rates of kidney failure; Accutane, an acne drug linked to birth defects; Bextra, a painkiller that increases the risk of heart attack and stroke; Severent, an asthma medication shown to cause death; and Mobic, an arthritis painkiller associated with an increased risk of heart attack.

The FDA’s problems also go beyond an inability to screen new hazardous drugs from the marketplace. As it stands, the FDA currently has weak authority to require drug companies to submit studies of the effects of drugs that are already on the market. The serious risks associated with this lax monitoring led to an internal FDA survey made public in December 2004 that found about two-thirds of agency scientists were less than fully confident in the agency’s monitoring of the safety of prescription drugs now being sold.

Despite new leadership at the FDA and a Government Accountability Office (GAO) report released in April of this year detailing the agency’s poor track record, there has not been any substantive change.

There is a proposal in the Senate to create an independent drug safety office within the FDA. This is a positive step. Congress needs to follow their lead and put the health of the nation before the interests of the drug companies. If we don’t reform the FDA’s grossly inadequate drug-oversight system, countless Americans like Randy Halsey will continue to be unnecessarily killed or hurt by dangerous drugs.

Fraley and Buckley are field organizers for the Center for Justice and Democracy.

From the Nov.8-14, 2006, issue

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