Consumers Deserve Better Drug Data

The phenomenon that is Viagra is but the latest and most spectacular example of a powerful trend sweeping the drug industry--so-called lifestyle drugs that ameliorate chronic conditions from impotence to arthritis to depression. Increasingly, such drugs appeal to a wide swath of users, many of them baby boomers and many of them people seeking "off-label" use. Medical experts believe that a large part of the market for Viagra, for instance, is among normally potent men who are looking to improve their sexual performance.

These blockbuster drugs may seem like a godsend, but they bring with them a slew of problems for the medical profession, insurers, government, and consumers. Because off-label use is so prevalent, doctors need to be vigilant about the the drugs' possible side effects and their interactions with drugs patients are already taking. Look at what happened with Fen-Phen, two drugs not meant to be used in combination. Prescribed for weight loss, they led to heart-valve problems in some patients.

Evidence shows that doctors have been sloppy about monitoring drug use. In one survey, the Food & Drug Administration found that 70% of patients were not told about side effects. Meanwhile, the FDA relies on doctors' voluntary reports of problems. If the medical profession doesn't do a better job of tracking reactions to drugs, perhaps the FDA should require formal monitoring.

Of course, some drugs have effects that aren't known for years--witness breast-cancer drug Tamoxifen's possible promotion of uterine cancer a decade later. But a patient facing death today may gladly chance getting a life-threatening disease in 10 years. Not so, perhaps, with someone popping pills to counter baldness. Lifestyle drugs change every consumer's risk-benefit calculus--and require patients to assume greater responsibility. But they need more information. One way to get it is for more patients to be enrolled in clinical trials. Today, only 3% to 5% of potential users of new drugs participate; experts think 10% would yield more useful data. Insurers should help shoulder the cost of broader clinical trials. They shouldn't, however, be expected to cover the costs of off-label or "enhancement" uses of new drugs.

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