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What you don't know can nauseate you: FDA considering shorter side effect lists

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In 1997, pharmaceutical firms began advertising directly to consumers (DTC) via television ads, as a result of guidance from the FDA that required drug advertisements to provide only a "brief summary" of side effects, rather than the full list required for print advertisements. Now the FDA is considering a further reduction of the side effects required to be disclosed on television ads. The agency has announced its intention to study the risks of reducing enumerated side effects to only those deemed "serious and actionable" (docket number FDA-2014-N-0168).

Pharmaceutical advertising lobbyists are applauding the idea. John Kamp, the executive director of the Coalition for Healthcare Communication, asserts that consumers "would benefit from a focus on primary risks that does not include every possible side effect spoken at a rapid-fire pace." However, consumer advocates have long argued that the side effect (and benefit) information provided in DTC television ads should provide more detail, rather than less information. As early as June 1999, Ralph Nader stated that "the main purpose of DTC ads is to sell drugs" and argued that consumers "can't make rational, comparative decisions" on the basis of the information provided in television ads. Writing about pharmaceutical DTC ads in print media from 1985 onward -- the FDA banned DTC print ads from 1983 to 1985 -- and on television from 1997 onward, Dr. Matthew Hollon argued in a 1999 JAMA piece that DTC ads provide "information of suspect quality and thus minimal benefit."

One thing that is not debatable is that DTC advertising of pharmaceutical products is big business. In the first quarter of 2012, spending on DTC advertising totaled nearly $900 million -- and more than $640 million of that was on television. The total for 2012 on DTC advertising? Two-point-four billion dollars. Although this is a lower figure than the peak of $3.1 billion in 2007, it is equal to 1.6 percent of the total revenue of the pharmaceutical industry in 2012. No wonder the Coalition for Healthcare Communication doesn't want to see those dollars go away!

Studies by concerned physicians and researchers have found that DTC advertising provides "limited information about the causes of a disease or who may be at risk," leading many in the medical community to argue for a complete ban on DTC pharmaceutical advertising. The editor of the Annals of Family Medicine asserted in 2007 that "DTC ads distort the relationship between patients and clinicians," and that they "manipulate rather than give power to patients because they are fundamentally designed to sell drugs, not to provide the balanced information that truly empowers." The opinion of the medical community seems clear: although it may be more pleasant for television viewers not to hear lists of side effects such as headache, dizziness, and upset stomach, removing such data from the required disclosure may be a case of "what you don't know can hurt you."

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