BABIES, BATHWATER AND MEDICINES

Modern life is a risky business--and medicine is no different. We accept peril on a daily basis without even thinking about it. For the convenience of being able to zip from place to place, we drive possibly dangerous, gasoline-guzzling contraptions called cars. In return for the gift of flight, we accept not only the danger of plane crashes but also a potential heightened risk of cancer for frequent flyers, who spend more time close to the sun and its gene-mutating radiation.

Then there's the tremendous risk you take every time you swallow a pill--and the tough job facing a panel of academics called by the U.S. Food And Drug Administration to examine the safety of popular pain pills.

Medicines are chemicals that alter the way the body works. "Give me a drug without a side effect," a drug researcher once said, "and I'll show you a drug that doesn't work." This is true for most life-saving medicines. Chemotherapy kills cancer, but sometimes it will also kill the patient, perhaps by lowering white blood cell counts so much that infection is a risk. Cholesterol drugs such as Pfizer's Lipitor or Merck's Zocor cut the odds of heart attack or stroke in high-risk patients by a third, but they also can cause side effects that destroy muscle tissue and, eventually, the liver.

Coumadin, a Bristol-Myers Squibb blood thinner, prevents strokes but also increases the risk of bleeding and interacts with everything from other drugs to broccoli and spinach. The allergy pill Allegra, from Aventis, might stop your runny nose but it can also give you a backache.

Patients are often more than willing to take big risks. Amgen faced a chorus of protest from patients and doctors after it stopped developing a medicine for Parkinson's disease because of its onerous side effects. When GlaxoSmithKline recalled an irritable bowel syndrome drug, patient groups made such a clamor that the medicine went back on the market. (Heavy restrictions were placed on its use.)

What we need is a way of balancing risk against benefit better, because for some medicines, the dangers will never justify the gains. Vioxx, for instance, got on the market with one proven advantage--it reduced the risk of ulcers. For the vast majority of patients, a heart attack risk might very well outweigh any benefit from the drug.

Now, many are increasingly convinced that Celebrex and Bextra have similar risks, especially after the publication last night of the full studies implicating the drugs, and two blistering editorials, in The New England Journal of Medicine.

Australia's medical regulators have already slapped warnings on both drugs. By Friday, the panel of academics will give its opinion, and the FDA is likely to follow its recommendations as to whether the drugs stay on the market--and in what form.

But an even more difficult task lies ahead. The FDA needs to be fixed. But how do we avoid throwing out the baby with the bathwater? It's estimated that 100,000 Americans die each year because of adverse drug reactions, but that's no reason to dump the medicine box down the toilet. Some 100,000 U.S. patients also die each year from medical errors, but we keep doctors and nurses around for the simple reason that, as a society, we're better off with them than without them.

The same is true of medicines--at least by and large. Like everything else in life, pill popping is an odds game. The challenge is to make sure that the odds are in our favor.

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation.

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