Risk Management

The FDA's Deference to Drug Companies is Bad for America's Health
September 1, 2004 |
As politicians have become beholden to drugmakers' money, the FDA increasingly has promoted sales over science, serving as a de facto subsidiary of the very industry it is supposed to oversee.
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As medication becomes a way of life for more and more Americans, the U.S. Food and Drug Administration has been remodeled to fit the times. Of the 296 drugs the FDA has approved in the last decade, most have been lifestyle drugs, or copycats of already existing medicines, or both. There have been multiple obesity treatments, allergy medicines, hair-loss cures, impotence pills, and drugs for the newest "disease," irritable bowel syndrome. Despite offering consumers few additional health benefits, these drugs have proven a boon for those the FDA has identified in internal documents, since the late 1990s, as its "customers": the pharmaceutical companies that manufacture and sell the drugs. The pharmaceutical industry has done much to put itself so securely in the government's good graces. Since the Republican takeover of the House of Representatives in 1994, drug companies have spent in excess of $500 million on lobbying and political contributions, and rank among the top fifteen industries in overall giving to members of Congress.

Congress has repaid this largesse by passing several "FDA reform" bills that have made the agency more responsive to the wishes of drug companies. In addition to giving faster and more frequent drug approvals, the FDA has done little to prevent companies from promoting "off-label" uses of drugs approved only for a specific symptom or illness. It also has allowed companies to claim "proprietary trade information" to keep negative studies about their pharmaceuticals secret: the pharmaceutical giant GlaxoSmithKline, for instance, was not required to publish tests that revealed its antidepressant Paxil -- which earned the company $3 billion in revenue in 2002 -- to be little different than a placebo when used by young patients. Even more shocking is the extent to which the FDA has routinely downplayed and suppressed safety concerns expressed by its own experts and drug reviewers. Of the thirteen drugs withdrawn from the market due to health risks since 1997, at least seven are now known to have been approved over the objections of FDA safety reviewers, who either had warned of serious potential dangers or had refused to sign official approval letters. Between just 1996 and 1998, at least twenty-seven drugs were made available to the public over the objections of FDA scientists.

In its mission statement, the FDA has pledged to protect "the public health" and to ensure that the American people "get the accurate, science-based information they need." But as politicians have become beholden to drugmakers' money, the FDA increasingly has promoted sales over science, serving as a de facto subsidiary of the very industry it is supposed to oversee.

This conflict of interest has resulted in a string of cases in which the FDA has knowingly failed to safeguard the public's health. In 1996 the FDA approved the diet drug Redux -- which later had to be withdrawn, along with another weight-loss medication involved in the deadly fen-phen scandal -- after its lead reviewer warned of "severe life-threatening risk." The diet drug Meridia, which was known to raise blood pressure and is now suspected as a factor in forty-nine deaths, was allowed to reach consumers despite the protests of an FDA advisory committee. Another pharmaceutical approved over the concerns of the agency's doctors was Lotronex, a pill for irritable bowel syndrome. Although later withdrawn amid allegations that the drug caused numerous hospitalizations and deaths, Lotronex was returned to the marketplace after a successful patient "advocacy" and "education" campaign, which was funded in part by its manufacturer. In March 2003 the FDA approved Arava, a new drug for arthritis, despite the fact that FDA experts had linked it to liver toxicity. Because new guidelines at the FDA prohibit reviewers from formally stating their opinions on whether drugs should be approved, FDA scientists had to sit in silence at the public meeting at which Arava's safety was debated, even as a consumer advocate attempted to goad the doctors into sharing their judgments.

Earlier this year, when the FDA's longtime specialist in antidepressants and pediatrics, Dr. Andrew Mosholder, concluded that Paxil and most other antidepressants offered children and teens few health benefits and caused potentially dangerous side effects, the FDA attempted to suppress his findings. Weeks before a February public meeting at which Mosholder was to present his report, he was advised by superiors at the FDA to adopt "alternative language" and to issue only "an executive summary. No recommendations." His direct supervisor wrote in a memo, "Would be nice touch to acknowledge the limitations of your analysis." Even as Mosholder was conducting his scientific study, the FDA bowed to pressure from Paxil's maker and approved the drug for a large secondary market, women with premenstrual syndrome.

The FDA also has ignored its safety experts' warnings on over-the-counter medicines. If the FDA had listened to its doctors, the dietary supplement ephedra would have been withdrawn in 1995 -- almost a decade before the 2003 death of a Baltimore Orioles pitcher made the drug's dangers into headline news. In 2000, when FDA epidemiologists issued a formal recommendation to remove the chemical PPA from all over-the-counter cold medicines and diet drugs because it had been linked to strokes, the drugs' manufacturers censured the scientists. Officials at the FDA backed the drug-makers, instructing their doctors to give only the facts about PPA, not their own recommendations.

Indeed, in order to be more industry friendly, the FDA has changed its entire philosophy on how a drug's safety is evaluated. Whereas previously the agency would weigh a drug's potential risks against its proven medical benefits, the FDA now has adopted a more lenient standard of "risk management," which essentially assumes that all drugs are in some measure unsafe and leaves it up to patients and their physicians to monitor a drug's effects with frequent checkups and blood tests -- a near impossibility in this age of managed health care. Meanwhile, the FDA has undermined its Office of Drug Safety (ODS), the division whose scientific research is supposed to guide the approval and labeling of all drugs. According to one FDA employee, the deputy commissioner in the agency's drug-review center, Dr. Steven Galson, announced at a September 2003 closed meeting that ODS had to do more to "add value" to the agency's work. This past March scientists at the FDA were told that the agency's Office of New Drugs (OND), which is ultimately responsible for drug approval, would no longer be requiring their final safety recommendations in writing.

Soon after hearing of this development, Charles Grassley, a Republican senator from Iowa, launched an inquiry into the structural and procedural failings at the FDA. "The Office of Drug Safety may be nothing more than an unwanted stepchild of the Office of New Drugs," Grassley said in a recent interview. In June he appealed to the General Accounting Office to begin a formal review of the FDA's drug-approval process, writing in his request: "It appears that OND influences ODS often and dramatically, [and] that OND is frequently the last word on analyses, reviews and consults done by ODS employees

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