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When The Cure May Make You Sicker




The Hidden Dangers in Your Medicine Cabinet

By Thomas J. Moore

Simon & Schuster 271pp $25

Of the 50 top-selling prescription drugs, only four are "safe," says Thomas J. Moore, a medical writer and senior fellow in health policy at George Washington University Medical Center. Numerous others, he claims, can cause addiction, cancer, or heart problems. And the number of Americans killed by pharmaceuticals is quadruple the number of people who are murdered and double the number who die in car crashes. Moore says at least a million each year are "severely injured" by their medications. An additional 2 million are harmed by drugs administered during hospital stays.

Moore, the author of three previous books critical of medical practice, makes all of the above claims in Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet. The claims are backed up with references to studies conducted by the U.S. Food & Drug Administration and others. Moore's goal is to make the public less complacent about prescriptions--and less eager to embrace the cult of the magic bullet. Prescription for Disaster does make a compelling case that medications ranging from heart drugs to antipsychotics and pain relievers can do as much harm as good. But Moore neglects a serious discussion of how much risk is acceptable when people are ill and the medicine in question might help them. How many of the people injured by drugs would have died otherwise? Moore sometimes uses figures disingenuously to make his points. But he raises important issues about drug safety.

A key problem, according to Moore, is that there is no effective oversight of drugs already on the market. "To monitor the safety of 3,200 approved drugs...the Food & Drug Administration has a staff of just 54," he writes. This effort receives just 4% of the FDA budget for drug evaluation--less than $5 million. Doctors are supposed to report deaths or serious injuries caused by prescription drugs. But Moore notes that only about 1% of serious events are reported, according to former FDA Commissioner David A. Kessler. Moreover, Moore says, the pharmaceutical industry has a strong motive for keeping the public in the dark: Public worries about drug dangers "might interfere with the relentless drive to sell ever larger numbers of drugs."

Moore also takes aim at doctors who don't tell patients about side effects or who prescribe drugs merely because patients demand them. An FDA survey found that 70% of patients studied were not told about side effects. Injuries can occur when pharmacists don't notice harmful drug combinations or when they fail to provide labeling information. And finally, Moore assigns blame to patients who don't ask about the drugs they are taking or who use them inappropriately.

Moore notes that drugs have benefits, too. Few people think of chemotherapy drugs as safe; yet their beneficial effects against cancer make the risk acceptable. The same is true of drugs for AIDS or serious bacterial infections. Moore's arguments are strongest when the advantages of long-term use are either very small or unclear.

Because so many people take prescription drugs, a small risk of dangerous side effects can translate into tens of thousands of injuries. Citing FDA calculations, Moore says that Eli Lilly & Co.'s Prozac, for example, "was associated with more hospitalizations, deaths, or other serious adverse reactions reported to the FDA than any other drug in America."

Drugs may win approval following clinical trials of a few months involving controlled populations of several hundred people. But later, surprises do occur. To detect these problems, the FDA relies on doctors' voluntary reports, a seriously deficient approach, writes Moore. As an example, he cites a study of doctors in Rhode Island: The doctors' files show 26,000 adverse reactions to drugs, but only 11 of these were reported to the FDA.

Even when the government issues warnings, doctors don't always heed them, says Moore. Problems with the sleeping pill Halcion, including aggressive behavior and psychosis, prompted the FDA to request that the drug not be prescribed for longer than 7 to 10 days. But a 1996 FDA report found that 85% of prescriptions were for longer periods. The FDA could do nothing; once a drug is approved, doctors are allowed to use it as they see fit.

It's hard to argue that society hasn't profited greatly from modern medicine, but it's also clear the system needs help. To that end, Moore offers several worthy proposals, although they may be difficult to enact when Congress is looking to cut taxes and regulations, not expand them. First, he calls for a beefed-up FDA surveillance system. Drugs should be reevaluated every five years, and the reporting of adverse effects by doctors should be mandatory. Companies should be required to do long-term studies of some drugs, using money from a tax on companies that market highly profitable drugs.

Other suggestions include a standard rating system for drug toxicity and, employing the resources of managed-care companies, better oversight of doctors' prescriptions. Finally, there's a primer on how to read drug labels and how best to make informed decisions--in concert with a physician--about whether a drug is necessary. From Moore's point of view, prescription drugs represent a double-edged sword. His final advice: Respect that force and use it wisely.BY NAOMI FREUNDLICHReturn to top

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