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Claims in drug advertising are attracting new scrutiny

FDA has stepped up its warnings and Congress is preparing to take up curbs.

WASHINGTON - The advertisement for an athlete's foot drug depicted attacks on a giant fungus alongside the words






in bold type.

But after looking at clinical studies related to the drug, the Food and Drug Administration in August sent a letter to the distributor, Johnson & Johnson, warning that the ads "greatly overstate" claims that the prescription drug, Ertaczo, wipes out infections.

The FDA was similarly troubled by a testimonial video featuring former professional basketball star Earvin "Magic" Johnson describing his "normal life" while taking the HIV drug Kaletra. The FDA wrote to Illinois-based Abbott Laboratories, Kaletra's manufacturer, in July warning about unsubstantiated claims of long-term effectiveness.

"The personal experience of a Kaletra patient such as Magic Johnson does not constitute such evidence," the letter read.

The letters were among about 36 sent to pharmaceutical manufacturers so far this year warning of violations and ordering the ads to stop, correspondence shows. In all of 2008, the federal agency sent out just 22 warning letters, similar to the FDA's regulatory pace during much of this decade.

Stung by the recent scrutiny, major drugmakers are pushing for online advertising flexibility in hopes of launching a new wave of Internet marketing.

But Congress is watching and preparing to take up new advertising curbs, including an end to corporate tax deductions for drug promotion.

Rep. Jo Ann Emerson (R., Mo.), is one of Washington's chief critics of pharmaceutical ads.

Emerson said that she was working with Democratic cosponsors on legislation to impose advertising restrictions, including a prohibition on marketing new drugs until their safety is proved.

"It's gotten so outrageous," she said, recalling a recent television program in which she counted a half-dozen ads for prescription drugs. "All of the money spent on advertising and marketing causes us to spend much more on drugs than we need to, money that could be better spent on research and development. Better yet, it could be spent on lowering the price people pay for drugs."

Already, drug companies are spending more than $4 billion yearly on advertising, and a recent study sponsored by AARP reported that the cost of prescription drugs had jumped 9.3 percent in a recent 12-month period even as the nation suffered through recession.

The Government Accountability Office, the investigative arm of Congress, concluded in 2006 that the FDA had minimal success stopping ads that inflate the benefits of drugs and minimize their risks. Consumer groups argue that little has changed since then.

"It's like the early 1900s when they were selling snake oil," asserted William Vaughn, a health-care expert with Consumers Union, publisher of Consumer Reports. "We hope that the new energy [at the FDA] is going to make a difference, because this has been a serious ongoing issue that has not been managed well."

The pharmaceutical industry defends its promotions.

Marketing "brings patients into their doctors' offices and helps to begin important doctor-patient conversations about previously undiagnosed or untreated conditions," Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America trade association, said in response to St. Louis Post-Dispatch questions.

While the FDA's drug marketing division monitors claims of prescription drugmakers, another FDA unit has been keeping a closer eye on over-the-counter products that don't live up to their billing.

In September, the agency's compliance office gave a thumbs-down to claims by a hand-sanitizer billed as "the first line of defense in the war against the H1N1 swine flu epidemic." On at least seven occasions this year, the FDA sent letters contending that such ads themselves threaten public health by giving people a false sense of security.