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Questions the FDA can't answer

The law says all our medicines must be safe and effective and the Food and Drug Administration is charged with ensuring that the law is enforced. The feds appear to know what they are doing, but what they don't know could be killing you.

There are a surprising number of unsettling questions the agency can't answer. The bureaucrats may wish these issues would go away, but sweeping them under the rug isn't going to solve the dilemma physicians and patients face.

The problem is balancing risks against benefits for many common medications. Perhaps the biggest controversy involves the popular products Premarin (conjugated estrogens) and Provera (synthetic progesterone). These female hormones are prescribed to millions of women to treat menopausal symptoms and reduce the risk of heart disease and osteoporosis.

What the FDA cannot tell doctors is whether these medications will increase a woman's risk of breast cancer. Preliminary studies have raised concern that some women may be more vulnerable to this common cancer if they take such drugs for long periods of time. Although these hormones have been on the market for decades, it will be years more before the FDA can tell us if there is truly a significant risk.

Another area of intense debate involves iron supplementation. For over a hundred years purveyors of tonics have touted the benefits of iron for extra energy. Doctors have often encouraged their patients to take supplements containing high doses of iron, and the FDA has permitted food processors to add iron to many products.

New data from Finland suggest that too much iron may be as dangerous as too little. The men in the study were more likely to suffer heart attacks if they had higher levels of iron. The only other factor more strongly associated with heart attack risk was smoking.

Now, although this research is inconclusive, previous questions have surfaced about the wisdom of widespread iron supplementation. An association has been reported between iron and the risk of certain cancers, but no one, not even the FDA, knows whether this represents a real danger. How long will it take for the feds to figure it out? Don't hold your breath.

Speaking of breathing, asthma victims are faced with a quandary. Canadian researchers have reported that people who use more than one canister of bronchodilator a month may run an increased risk of complications. These drugs are effective in opening constricted airways, but if they are overused they may pose unforeseen dangers.

FDA administrators can't tell asthma specialists how dangerous the situation is. Nor can they tell allergy victims whether they should worry about the hazards of nonsedating antihistamines like Seldane (terfenadine) and Hismanal (astemizole). Reports of dangerous irregular heart rhythms associated with these drugs have left millions fearful.

It sometimes seems as if drug regulators don't want to hear bad news about medicines they have approved. Questions about the safety of Prozac (fluoxetine) for depression and Halcion (triazolam) for insomnia have been downplayed.

Where does this leave physicians and patients? Doctors are often forced to make decisions with inadequate data and patients are encouraged to take medicines without always knowing the long-term risks.

The FDA needs to start planning to answer these and other troublesome questions. Wishing won't make them go away.

Joe Graedon is a pharmacologist. Teresa Graedon is a medical anthropologist and nutrition expert. Their newest book is Graedons' Best Medicine (Bantam Books). In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of: the Times, P.O. Box 1121, St. Petersburg, FL 33731-1121.