Drug peddlers’ ads ignore FDA
Posted by Henry Bauer on 2009/11/05
Advertising of prescription drugs direct to consumers is permitted, in the developed world, only in the United States and New Zealand (Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What To Do About It, Random House, 2004, p. 125). Anyone who watches TV or reads magazines knows how attractive these ads can make their medications seem: radiantly satisfied users are shown, and the “side” effects are hidden in the finest print in magazine ads while on TV or radio they are described in cheery, lighthearted tones and words intended to make them seem ignorable, mild inconveniences at worst. My favorite illustration of that is in the ads for sexual stimulants, where one is advised to consult one’s doctor if experiencing “changes in hearing or vision”, which doesn’t quite acknowledge the occasional cases of irreversible deafness or blindness.
The overwhelming majority of HIV-positive people who have taken antiretroviral drugs have found the “side” effects extremely debilitating. On a number of occasions I’ve cited the gruesome descriptions from the NIH Treatment Guidelines, including that people on HAART suffer more “non-AIDS” events than “AIDS” events, chiefly heart, kidney, or liver failure. A backhanded official acknowledgment of these awful “side” effects is the prominence given to the problem of ensuring “compliance” by patients to taking the pills. An actual demonstration is that in clinical trials in an orphanage, the children found the side effects of the drugs so painful that “compliance” had to be ensured by surgically implanting tubes direct into their stomachs (www.guineapigkids.com, accessed 13 May 2009) for ready insertion of the drugs. Another illustration is that AIDS clinics report a 40% drop-out rate from medication [Drug non-adherence, imaginary epidemics, and sexual nonsense, 30 August 2009].
The drug peddlers nevertheless like to illustrate their advertisements for antiretroviral drugs with photos of radiant men in the pink of condition. This has been so egregious that “In a strongly worded letter, FDA marketing division chief Thomas Abrams ordered pharmaceutical companies to create ads that are more ‘representative’ of the realities of HIV . . . . The ad for Crixivan features three athletic men and one woman who have just scaled a dramatic mountain peak, an athletic feat that many perfectly healthy people probably couldn’t do. Meanwhile, the ad for Combivir shows a muscular and attractive African-American with a towel over his shoulder, hinting that he has just completed a rugged workout. The text tells us he’s ‘living proof’ of the power of Combivir. . . . [T]he HIV drug ads . . . fail to spell out the potentially deadly kidney and liver problems, diarrhea, nausea and other side effects that are endemic to anti-retroviral treatments” (Daryl Lindsey, 8 May 2001, “The ‘Joe Camel’ ads of AIDS?”).
Despite that “strongly worded” admonishment from the FDA, 3 years later the FDA had to actually ban two advertisements by Abbott Laboratories.
Another 3 years on, and the drug pushers had still not mended their ways:
”Certain omissions in these ads do not technically violate current FDA regulations, but they do violate those regulations’ intent. . . . Current ads [fail to] . . . highlight life-threatening side effects” [Kallen et al., “Direct-to-consumer advertisements for HIV antiretroviral medications: A progress report”, Health Affairs, 26 #5 (2007): 1392-8].
Another two years on, and the apparently toothless tiger of the FDA overlooks or ignores such ads as this one, which appeared recently as a full page on the inside cover in both gay publications in Washington DC, Washington Blade and Metro Weekly.
Perhaps the FDA could insist that photos in such ads always be of people who have been compliantly on the advertised drugs for at least a year?
This entry was posted on 2009/11/05 at 11:46 am and is filed under antiretroviral drugs, Legal aspects, uncritical media. Tagged: Alexander Kallen, “Guinea Pig Kids”, “The Truth About the Drug Companies: How They Deceive Us and What To Do About It”, Daryl Lindsey, direct-to-consumer advertising of drugs, Ellen Juhl, FDA criticizes ads for antiretroviral drugs, Jennifer Shu, Lisa Schwartz, Marcia Angell, Metro Weekly, misleading ads for antiretroviral drugs, non-compliance with antiretroviral drugs, Steven Woloshin, Thomas Abrams, Washington Blade. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.