 

FDA asks makers of HIV drugs to tone down ads
Last Updated: 2001-04-30 18:23:17 EDT (Reuters Health)
By Ori Twersky
WASHINGTON (Reuters Health)- The US Food and Drug Administration (FDA) has warned makers of HIV drugs not to overstate the effectiveness of their products in direct-to-consumer (DTC) ads.
In a letter sent to a number of drug firms, the federal agency said it has determined that certain ads "do not adequately convey that these drugs neither cure HIV infection nor reduce its transmission." The letter does not cite specific companies or advertisements, but instead issues a general caution to the industry.
The FDA said that the offending ads should be changed within 90 days. The letter gives companies until May 18 to respond with a list of the promotional materials that need to be changed as well as an outline of their plans for implementing the changes.
The tone of the ads is important because people on HIV drugs can still transmit the infection, noted Thomas Abrams, director of the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC).
Although today's treatment regimens essentially have transformed HIV infection to a chronic disease, the virus is still associated with significant mortality, Abrams added.
Experts on Monday applauded the FDA action.
"In my opinion, it is paramount that we portray an accurate picture," said Dr. Gregory Thompson, vice president of the International Association of Physicians in AIDS Care. "To portray that medicine is the ultimate answer is a falsehood."
HIV drugs have a number of serious side effects, Thompson explained in an interview with Reuters Health. In addition, he observed, patients have been demonstrating growing resistance to HIV treatments--although the overall number of deaths has declined.
DDMAC's Abrams has said that the FDA's review of the ads was prompted by a complaint from government officials in San Francisco. The San Francisco Board of Supervisors is considering banning certain HIV ads if they are not toned down.
In March, the San Francisco Board said the ads are potentially dangerous because they may increase the likelihood that people will have unprotected sex. Preliminary results from an ongoing survey being conducted by the city's health department showed that 61% of 422 men attending a sexually transmitted disease clinic believed the ads affected people's decisions about risky sex.
The largest makers of HIV drugs include Abbott Laboratories, Agouron Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, DuPont Pharmaceuticals, GlaxoSmithKline, Hoffmann-LaRoche and Merck.
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