The Fda's Next Target: Drugs

By ANDREW PURVIS

The report, aired on a local news program in Detroit this spring, trumpeted the success of the drug Xanax in treating panic attacks. Former Houston Oiler Earl Campbell appeared in the segment and poignantly described his battle with the psychiatric disorder. A useful little news spot? Actually, it was more of a commercial. Upjohn, which manufactures Xanax, produced the video segment, paid Campbell for his performance and sent the tape ready-made to TV stations around the U.S. as part of a campaign to peddle its product.

Traditionally, ads for prescription drugs were pitched only to doctors, primarily in medical journals. But as competition for market share intensifies, more drugmakers are doing as Upjohn did, crossing the once inviolable line and appealing directly to patients. This high-powered approach, combined with some questionable marketing practices, has provoked - the ire of FDA chief David Kessler. "Promotional practices, to be blunt, have got out of hand," he recently told drug-industry lobbyists.

To underscore the pitfalls of direct-to-consumer advertising, Kessler points to an ad for Actigall, a medication for gallstones. The ad, which ran in newspapers and magazines around the U.S., suggests that the Ciba-Geigy product is a good alternative to surgery. Kessler objects because surgery is the preferred treatment in most cases. Though many people find the drug ads helpful, doctors share Kessler's concern. "The consumer can take a little bit of information and come to the exact opposite conclusion that he should," says the American Medical Association's Dr. M. Roy Schwarz.

Physicians are leerier about another of Kessler's campaigns: restricting the promotion of drugs for purposes other than those explicitly approved by the FDA. Such "off-label" prescribing is surprisingly common in the U.S. About one-quarter of the 1.6 billion prescriptions written each year are for unapproved purposes. In the mid-1980s some drug-company salespeople began encouraging such uses, a practice Kessler views as dangerous.

In one regrettable example, drugs called calcium channel blockers were touted as a treatment for heart attacks, though they had been approved only for hypertension and angina. Later, researchers found that some heart-attack patients faced an increased death risk after taking the drug.

To counter promotional abuses, Kessler is doubling his advertising- enforcemen t staff and plans to release stricter drug-marketing guidelines by year's end. But doctors fear that a clampdown could actually impede the flow of medical information. Cancer specialists in particular rely on drug companies to help inform them about experimental uses of drugs. "The reality is that this is the way oncologists get educated," says Dr. Robert Young, director of the Fox Chase Cancer Center. "If you start denying that information to doctors, then people are going to die."

Clearly, the pharmaceutical industry is suffering from a bad case of hucksterism. But policing the complex world of drug promotion will be a tougher job for the FDA than wiping the FRESH label off a carton of orange juice.

With reporting by Anne E. West/Washington