San Francisco Chronicle - Saturday, April 28, 2001
Sabin Russell, Chronicle Medical Writer

FDA marketing division chief Thomas Abrams told drugmakers in a letter that they must change their ads within 90 days.

New ads will have to carry information about the lethal nature of HIV infection and the dangers of transmitting the virus. The FDA found fault with images of buffed-up models that do not reflect the side effects many patients experience from the medication -- including redistribution of fat from the face and arms to the belly and back.

After months of deliberation, the federal agency appears to have endorsed the views of California AIDS activists and San Francisco Board of Supervisors President Tom Ammiano that the depictions of healthy, robust AIDS patients in drug advertisements are sending an overly optimistic message.

"Images that are not generally representative of patients with HIV infection are misleading because they imply greater efficacy than demonstrated by substantial evidence, or minimize the risks associated with HIV drugs," wrote Abrams, whose division regulates what drug companies can say in consumer advertisements.

Many AIDS drug advertisements, according to Abrams, "do not adequately convey that these drugs neither cure HIV infection nor reduce its transmission. " The outcry over the ads in San Francisco drew national attention to an issue that has been an irritant to AIDS patients who have complex relationships with the drugs, which simultaneously have saved their lives but make them ill with side effects and cost thousands of dollars a year.

Jeff Getty, of the organization Survive AIDS, hailed the agency's decision. "It's a major victory. It looks like this is exactly what we asked for four months ago."

Getty said that FDA officials were initially hostile to the activists' campaign but may have been persuaded by San Francisco Department of Public Health research suggesting that gay men felt the ads were affecting decisions on whether to have unsafe sex.

"They have been using sex to sell AIDS drugs," Getty said.

The pharmaceutical industry is coming under increasing criticism for its expensive "direct-to-consumer" advertising campaigns that market prescription drugs of all kinds to the general public. Since rules were relaxed in 1997 -- allowing prescription drug ads to run without the full list of side effects -- industry spending on direct-to-consumer ads in the United States has grown to a rate of $2.6 billion a year, according to IMS Health, which tracks drug company marketing.

Consumer groups and health maintenance organizations alike have criticized the prescription drug advertising as incomplete and misleading, as well as for unnecessarily driving up the cost of medical care.

"This problem has been getting out of hand, with different drugs for different diseases. It took AIDS activists to finally get the FDA to step in," said Getty.

Among the AIDS drug manufacturers notified were Merck & Co., Pfizer Inc. and GlaxoSmithKline Plc, which make a variety of drugs that inhibit the human immunodeficiency virus that causes AIDS or the various infections that exploit damage to the immune system.

Activists were particularly upset with the ad campaign of Merck for its antiviral drug Crixivan. The ads depicted healthy AIDS patients hiking on a rocky mountaintop.

"On these drugs, you don't feel like climbing a mountain," said Getty. Merck spokeswoman Kyra Lindemann said yesterday that company executives are "aware of the letter," but declined further comment. "As a rule, we don't comment on any discussions or actions taken by a regulatory agency," she said.

Daniel Dallabrida, a San Francisco consultant to both drug companies and community groups on health care issues, said there is a need for a "balanced" message on AIDS drugs. While he agreed that AIDS drug companies need to address the "treatment optimism" issue, he also said it is not a bad thing to show positive images of people with AIDS.

"There are many handsome, healthy and strong men and women who have HIV and are taking the medications," he said. "It is widely believed that hope and optimism and belief in the future are important to people with any disease."

E-mail Sabin Russell at srussell@sfchronicle.com.
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