Conscious Choice: Fairy Tales for Grown-ups

August 2006 | Art & Soul

Fairy Tales for Grown-ups

The Government Ensures That Drugs are Safe, Right?

By Randall Fitzgerald

During the first few years of the twenty-first century, four authoritative books appeared, each written by a physician turned medical school academic, demolishing some of our fondest myths about the pharmaceutical industry and the true nature of its symbiotic relationship to modern Western medicine. Three of the physicians—Marcia Angell, Jerry Avorn and John Abramson—are associated with Harvard Medical School, while the fourth, Jay S. Cohen, serves as a professor of medicine at the University of California at San Diego.

What these medical authorities share is a conclusion that modern medicine’s dependence on synthetic chemicals manufactured by pharmaceutical companies often results in a failure to adequately protect public health. That failure begins with the relationship that evolved over the past century between the FDA and the drugmakers this agency has been tasked to regulate.

“There is a comforting shared myth that by the time the FDA approves a new drug, the product has been studied exhaustively and determined to be a worthwhile new addition, and that all its actions in the body, both good and bad, are well defined,” writes Avorn in his book, Powerful Medicines. “In fact none of these assumptions is quite correct. The FDA itself does not study any drugs prior to approval, relying on the company that makes the product to generate that information.”

Our government depends on safety data supplied by the drug manufacturers to make its approval decisions. To Angell, former editor in chief of The New England Journal of Medicine, relying on the drug companies “for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism.”

While we might hope and pray that medical tests of drug safety by pharmaceutical companies are conducted without distortion by the profit motive or competitive pressures, especially since so many lives are at stake, Abramson and Angell both suggest that widespread patterns of deception occur in these drug trials. Rigged medical studies, misrepresented research results, and “the propagandizing of physicians and the public by manipulative pharmaceutical companies,” writes Abramson in his book, Overdo$ed, “creates a corruption of medical science.” Angell is no less candid in her own book, The Truth About the Drug Companies : “Is there some way companies can rig clinical trials to make their drugs look better than they are? Unfortunately, the answer is yes. Trials can be rigged in a dozen ways and it happens all the time.”

A possible case in point occurred in late 2005 as a new diabetes drug headed to the marketplace, having had its safety endorsed by an FDA panel. Two prominent Ohio cardiologists did an independent analysis of the testing data for this drug and rushed their findings onto a website maintained by the The Journal of the American Medical Association “to head off a Vioxx-like fiasco, a public health catastrophe.” They had discovered that this treatment for type 2 diabetes called Muraglitazar, developed by Bristol-Myers Squibb and Merck & Company, causes many more instances of death from heart attacks and strokes than company test data had portrayed to the FDA. The two Cleveland cardiologists uncovered a pattern of omissions in data presented to the FDA that created an unwarranted “illusion of safety.” JAMA’ s editor in chief, Catherine DeAngelis, was scathing in her description of the FDA’s oversight failure: “It is beyond me why individuals who are supposed to be overseeing the safety of the public would take a chance [with public health] when it’s not necessary.”

If the system fails, the only effective way to judge drug safety or drug dangers is by the health effects reported among those unknowing human guinea pigs who are the first consumers of new prescription drugs. Since 1997, reported toxic health effects have resulted in the withdrawal of more drugs from the marketplace than ever before in history. Four of those withdrawn—Redux, Rezulin, Propulsid and Seldane—were prescribed to nearly twenty million people before the toxic effects began showing up.

The human costs of this ongoing experiment with drug safety have become staggeringly large. At least 106,000 people die each year just in hospitals from drug side effects, according to a study in 1998 by JAMA. That averages out to around 300 deaths a day, every day, from legal toxic drugs.

In his book Over Dose, Cohen quotes a study by three university professors in JAMA that determined that at least 51 percent of all FDA-approved drugs “have serious adverse effects not detected prior to approval.” The revelation prompted Cohen to indignantly write: “Think about this: More than half of our drugs, after being deemed ‘safe’ by the FDA and then prescribed to millions of people, are subsequently detected to have previously unrecognized, medically serious side effects. No wonder we have a side-effect epidemic.”

An investigation by Consumer Reports (January 2006) examined a dozen common types of prescription drugs sold in 140 brandname or generic versions and found a range of adverse side effects including stroke, heart attack and kidney failure. In every case these side effects “were undetected or underestimated when the FDA approved them for use.”

Blame for this “illusion of safety” was laid equally on the drug manufacturers and the FDA. “Some companies have withheld publication of studies that found serious risks, or have failed to conduct post-approval studies that they promised,” charged the magazine. For its part, the FDA “lacks the power to compel companies to complete studies after drug approval, force doctors to report adverse reactions or dictate new warning labels.”

Commenting on the public perceptions of objectivity and safety afforded by the FDA, an FDA commissioner, Herbert Lay, made this revealing statement in 1969, which still holds true today: “The thing that bugs me is that people think the FDA is protecting them. It isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day.”

Excerpted from The Hundred-Year Lie , ©2006 by Randall Fitzgerald, published by Dutton, a member of Penguin Group (USA) Inc.

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