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Healthy Skepticism Library item: 15484

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Taylor L.
Drugmakers challenge FDA over Internet search ads
Pharma Times 2009 Apr 21
http://www.pharmatimes.com/WorldNews/article.aspx?id=15711


Full text:

Including product risk information on Internet search ads, as required by warning letters sent this month by the US Food and Drug Administration (FDA) to 14 drug majors, has made the ads even more misleading, say the firms.

In early April, the FDA issued the warning letters after routine surveillance by its Division of Drug Marketing, Advertising & Communications (DDMAC) found that Internet company-sponsored links on search engines such as Google had “made representations and/or suggestions for the efficacy” of a total of 48 drugs without communicating any risk information about them, thus misleading patients. Among the medicines were 19 which carry “black box” warnings of serious side effects, and some of the ads included information on uses of the drugs which have not been approved by the FDA.

The firms set about removing the ads and revising them as soon as they received the warning letters, but they have since discovered that it is impossible to include all the required risk information in the 95 characters which are available for such ads, and that trying to do so only makes them more confusing and misleading, according to a report in the New York Times.

Moreover, companies which have tried to avoid the FDA risk disclosure rule by introducing a generic-sounding web address – referring to the condition or type of treatment without naming the brand – to redirect consumers to the brand’s website have found that this also risks confusion, as users may believe they are being directed to an independent information source rather than a sales site, the report adds.

Commenting on the agency’s actions, leading law expert Arnold Friede criticised DDMAC for violating “cardinal principles of advertising interpretation that the FDA itself has routinely adopted.”

“The whole purpose of a sponsored link is to persuade the information seeker to click on the link,” and, before receiving the warning letters, the companies had assumed that the “one-click rule” applied, says Mr Friede, a member of the health law department at Washington law firm McDermott Will & Emery. Moreover, in comments reported on the firm’s website, he warns: “if sponsored links were to disappear because of the position being taken by the FDA, “then the information seeker will be relegated to wading through a list of web sites, most of which are not even regulated by FDA and which contain all manner of information whose validity is largely unknown.”

Drugmakers and advertisers are now calling on the agency for a new set of standards which specifically address Internet search ads, or at least for clear guidelines, rather than requiring them to try to adhere to rules which were originally developed for television and magazines.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909