I think Direct-to-Consumer (DTC) ads are great. I do believe that they educate consumers and allow for greater choice and understanding. My legs aren’t restless, though I’m sure for those who have restless legs, it is a relief to know there is relief. For those who misdiagnose themselves, that is between them and their doctor. Though I do wish the evening news wasn’t filled with DTC. I can only deduce that people who watch the news have a great deal of trouble sleeping or have upset stomachs or headaches because the news we get each night is so bad…
That said, DTC marketing is going to be the subject of greater debate in the upcoming election cycle, particularly as legislation is considered to reform the FDA as evidenced by an editorial calling for greater regulation of DTC by FDA in the Christian Science Monitor. PhRMA Communications Director Ken Johnson responded with a letter to the editor that offered a defense of DTC. In it, he cited recent research showing that a substantial number of patients spoke to a physician for the first time about a condition because they had seen something in DTC that sparked the conversation. He cites the Prevention Magazine study of DTC and consumers, a study that PhRMA relied on last year in defending DTC. He also stated that "America’s pharmaceutical research companies take seriously their responsibility to patients. That is why nearly one year ago PhRMA established Guiding Principles on direct-to-consumer advertising of prescription medicines; many of these guidelines go above and beyond current legal and regulatory requirements."
The Prevention Magazine study makes a valid point, but it is no longer cutting edge and by itself, does not stand up to the rising tide of DTC criticism. And while it is true that the PhRMA DTC Guidelines program was announced in August of last year, it only took effect in January 2006 and so far, there does not appear to be much substance that has come from it. Without that substance, repeating surveys about the impact of DTC is only half the message. The other half of the message needs to be that PhRMA has seriously stepped up to the plate to increase compliance and can begin offering the track record that proves that point.
In his speech announcing the DTC Guidelines (and also contained in the PhRMA guidelines themselves) Billy Tauzin stated that "PhRMA is establishing an accountability office to take all comments from the general public and health care professionals about signatory company’s DTC ads. PhRMA will provide the comments on compliance with the principles to signatory companies and it will also periodically issue reports to the FDA and the public about these comments and how signatory companies have responded." The term "periodically" is vague and a search of the PhRMA Web site by myself did not find a report or a list of the signatory companies. A section of the site does have the Office of Accountability link, but there is little there except for press releases.
If PhRMA is going to wage a successful campaign around DTC, it needs to have more of its ducks in a row than a stack of speeches, press releases, guidelines and repeated use of statistics from aging surveys.
Last month, a company with a product that had a Black Box Warning created a reminder ad, which isn’t allowed by FDA or the guidelines. (A reminder ad states the name of the company and the product, but nothing about the condition it treats – in other words, no helpful information to the patient.) It is not possible, as far as I can determine, to see what action, if any, PhRMA took and whether or not the company involved was a signatory to their guidelines. FDA issued a Warning Letter and promptly posted it. But there as yet, appears no way to yet compare the track record of Warning Letters vis a vis the role of PhRMA in enforcing its guidelines – or at least I could not find it. Until there is a track record on the DTC Guidelines, editorializing by PhRMA has but a fraction of the necessary facts, figures and credibility behind it to be successful in its defense of DTC.