[e-drug] FDA warning to manufacturers of AIDS drugs

[Kirsten Myhr <myhr@online.no>]

E-drug: FDA warning to manufacturers of AIDS drugs
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BMJ 2001;322:1143 ( 12 May )
http://bmj.com/cgi/content/full/322/7295/1143/b
News
FDA warning to manufacturers of AIDS drugs
Deborah Josefson , San Francisco
The US Food and Drug Administration (FDA) has issued a warning letter to 
manufacturers of AIDS drugs cautioning them to tone down the optimistic 
tenor of their antiretroviral drug advertisements.
Thomas Abrams, director of the FDA's division of drug marketing, 
advertising, and communications said that current antiretroviral 
advertisements directed at consumers are misleading as they fail to depict 
the limitations of AIDS drugs and also feature healthy looking people who 
are not representative of typical patients with AIDS. The advertisements 
therefore violate the Federal Food and Drug Act.
The FDA's letter stated that many of the advertisements "do not adequately 
convey that these drugs neither cure HIV infection nor reduce its 
transmission."
The pharmaceutical companies have 90 days to comply with the FDA's 
directive to modify their promotional advertisements.
The FDA's move was prompted by protests from AIDS activists in San 
Francisco. They were angry that billboard and magazine advertisements 
portrayed sexy and athletic models in the prime of health who were climbing 
mountains, sailing boats, and riding bikes. These are pursuits which are 
quite difficult for people with HIV infection, who have to take drugs 
several times a day that have debilitating side effects.
Many of the billboard advertisements are displayed in predominantly 
homosexual communities. The grassroots demonstrations in San Francisco 
resulted in a public hearing calling for such advertisements to be banned 
in that city and in a petition to the FDA for a review of the 
advertisements.
Tom Ammiano, head of the San Francisco Board of Supervisors and himself an 
AIDS activist, led the hearing (31 March, p 804). Among the concerns of the 
activists are that the glamorous advertisements give a false sense of 
security to people with HIV infection and may convince some to abandon safe 
sexual practices. They may think that, by popping a pill, AIDS can be 
avoided or completely managed.
Preliminary evidence supports the contention that the drug companies' 
advertisements may alter behaviour by their overly optimistic message. A 
public health survey by Dr Jeffrey Klausner, an epidemiologist in the San 
Francisco city health department, found that 61% of 422 men surveyed 
attending the city's sexually transmitted disease clinics thought that such 
advertisements indirectly encourage unsafe sex. Men who saw the 
advertisements were more likely to engage in unprotected sexual activities 
than those who did not. Results of the ongoing survey are accessible at 
www.surviveaids.org <http://www.surviveaids.org>
Moreover, Dr Klausner believes that the advertisements may have contributed 
to the dramatic rise in HIV infections in San Francisco over the past four 
years. Although the number of AIDS related deaths have declined, the number 
of new cases is rising and drug resistance is emerging. The FDA's letter 
did not target any particular advertisement or drug company but was sent to 
all manufacturers of AIDS drugs.

Kirsten Myhr, MScPharm, MPH
Head, Eastern Region Drug Information Centre
Home address:
Bygdoy alle 58B
0265 Oslo, Norway
Tel.: +47 23 01 64 11(o)   Fax: +47 23 01 64 10
+47 22 56 05 85 (h)   mobile: +47 416 38 747
myhr@online.no


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