DTC without Risk Revisited

On March 31, I posted a critique of the Coalition for Health Communication's (CHC's) petition to the FDA, the aim of which I said was "the elimination of specific risk information in print and broadcast DTC" (see "DTC without the Risk"). I was not alone in this interpretation. The Associated Press picked up on this story and the following day reported that the CHC "wants to strip most of the warnings from prescription drug ads aimed at consumers" (see "Coalition wants most warnings banished from consumer drug ads").

So, we have a mainstream news source and a blogger reaching essentially the same conclusion independently (I am assuming, however, that the AP reporter didn't just read my blog without doing his own investigation). Harry Sweeney, CHC's executive committee chair and outspoken proponent of the pharmaceutical industry (see, for example, "Clash!"), said my conclusion -- and by extension, AP's conclusion as well -- was "simply wrong."

Harry was speaking at a recent Pharma Marketing Roundtable conference call that I organized. This Roundtable discussion will be published in the April 2006 issue of Pharma Marketing News due to be published next week. Subscribe Now and get it free!

After doing a search on Google for other stories and blogs related to the CHC petition, and after surveying readers of Pharma Marketing News, I found that the general reaction has not been very positive.

For example, the survey (which you can take by clicking here) results suggested that the petition's proposal may have merit, but the FDA is not likely to adopt the regulatory amendments proposed.

When asked "In your opinion, does this proposal have merit?," 50% of respondents said "Yes" and 50% said "No." However, when asked "How likely or unlikely, in your opinion, is it that the FDA will adopt such an amendment to its regulation of DTC advertising?", none said it was "very likely," only 7% said it was "somewhat likely," whereas 14% said it was "somewhat unlikely" and 71% said it was "very unlikely." (See Survey).

Some comments from survey respondents:

"Eliminating risk information from advertising will make the public trust pharma less, not more. While there are certainly problems with current risk provision, audiences feel that advertising without risk information is unbalanced. This proposal runs counter to the current trend in DTC advertising with pharmaceutical companies providing more informative advertising."

"It is absurd to require specific DTC disclosure for products that are available only through an informed intermediary. To insist that risks be disclosed directly to potential patients, is an abject lack of respect for prescribing professionals and the healthcare system."

"I hope the FDA does not yield to industry pressure to remove these warnings. Doctors do not have the time nor inclination to warn patients. Patients are being led by the nose into believing that drugs are completely safe. This proposal would make it even easier to have patients continue in their delusion. It's dishonest, unethical, and meant only to manipulate patients into demanding specific drugs from their doctors."

"Irrational thinking in today's world of moving toward patient/consumer-directed health care; if anything, health information needs are heightened to weigh risk/benefit in making informed decisions on health care matters. Balanced information applies to not only decisions about drugs -- it extends to devices, procedures, plan benefits, etc."

"One advertising network chairman said this was done to because 'great advertising' required clear messages...well, the message here is loud and clear: ad agencies involved in this are trying to re-shape the PhRMA DTC guidelines to their benefit, where the real point is to shape them to the benefit of the patient and consumer. It also is absurd to think a doctor has time to go over all the information a patient needs in their time-squeezed environment."

"Thin-slicing the petition leads me to the (albeit cynical) view that this is a transparently veiled tactic to protect the massive earnings that could potentially be lost if FDA regulation on DTC is tightened/becomes more restrictive. Why not simplify the entire proposal to an old bit of latin: caveat emptor."

I hope these opinions were based on actual reading of the CHC petition and not just my interpretation. You can find a copy of the petition here. I urge you to read it yourself and then take the survey and let me know what you think. The Coalition wants a dialog. Bring it on!