RECKLESS DISREGARD
Can money-in-politics kill you? A look at what has happened at the Food and Drug Administration (FDA) ever since the pharmaceutical industry started pushing to loosen the agency's process for reviewing the safety of new drugs suggests the answer is yes.
Take the drug Rezulin, produced and marketed by Warner-Lambert as a "breakthrough therapy" for the 15 million adults with diabetes. At least 28 cases of fatal liver damage have been linked to the drug's use, though the actual number of deaths is much higher since doctors and hospitals are not required to report adverse events tied to prescription drugs. The September 1999 issue of The Washington Monthly has a major article by David Willman of the Los Angeles Times examining the hasty process by which Rezulin was approved by the FDA. It makes for harrowing reading.
Lab studies of Rezulin indicated that it damaged the hearts and livers of rats, causing their premature deaths. Early clinical studies on humans showed nearly four times the rate of liver injury, up to life-threatening levels, than in patients who took placebos. Nevertheless, in January 1997 the drug was declared fit for sale, "the FDA's fastest-ever approval of a diabetes drug," Willman writes.
Why the rush? As the FDA was reviewing Warner-Lambert's application for Rezulin in the second half of 1996, "Forces hostile to strong pharmaceutical-industry regulation were in control of both the House and Senate [and] legislation with bipartisan support had moved in both houses, threatening to severely limit the FDA's drug review powers," Willman reports. As a result, "the seed of fear was sown at the FDA, undermining vigorous scrutiny of newly proposed drugs, according to government physicians."
The next year, Congress passed and President Clinton signed a bill reducing the number of clinical trials needed for new drugs (to just one), speeding up the approval process in other ways and allowing the promotion of FDA-okayed products for uses other than their original approved purpose.
According to a survey of FDA medical officers by Public Citizen's Research Group, at least 27 new drugs have been approved in the last three years despite being opposed by the medical professionals reviewing the drugs. The FDA actually withdrew a record number of approved drugs from the market last year due to their lethal side-effects. But despite the rising hazards, Congress has given no indication of imposing tougher standards to protect public health. The reason: nearly $30 million in individual, PAC and soft money contributions from the pharmaceutical sector since 1995, two-thirds to Republicans.
Though it has been banned in Britain, Rezulin is still approved for sale in the United States. Even after being told this March by the FDA's top epidemiologist that a patient is at least 1200 times more likely to suffer liver failure by going on Rezulin than staying off it, an agency advisory committee voted to keep the drug on the market.
As of this spring, Willman reports, Warner-Lambert's sales of Rezulin have exceeded $1.4 billion. The company and its executives have given $276,000 in campaign contributions since 1995. Not a bad return on investment.
