Does “a wealth of data from independent studies,” show that direct-to-consumer advertising of prescription medications “has a positive impact on public health”? That’s the claim from Pfizer in its recent submission to the FDA. But their evidence ain’t much.

Our own submission, filed jointly with Prescription Access Litigation, cites a systematic review by Gilbody et al. The authors evaluated 2800 DTCA-related publications, finding only four that met strict criteria for quality of study design (most available DTCA data comes in the form of consumer and physician surveys). And none of the four studies demonstrate a public health benefit from DTCA; they in fact raise some concerns.

Pfizer references eight citations in its submission. But it turns out that four of those were consumer surveys focused mainly on awareness and perception, and two others were earlier testimony from Pfizer and PhRMA to the FDA. One was a General Accounting Office report warning (Pfizer neglected to mention this) that “DTC advertising prompts millions of consumers to ask their doctors for prescriptions for specific brand-name drugs. As a result, it is important that FDA act effectively to minimize the public’s exposure to misleading DTC advertisements.”

In the one study put forth by Pfizer from a peer-reviewed journal, patients were asked what had happened when an advertisement prompted them to ask their doctor a question.  It turns that about a quarter of these patients ended up with new diagnoses (a substantial minority of which were for “high priority” conditions). There were some methodological limitations, but the bottom line is that not even the study’s authors concluded that DTCA produces public health benefits.

There may or may not be free speech grounds for allowing DTCA. Based on this evidence, there surely isn’t a public health case.

To view the full docket, follow this link.