This list was compiled by Jim Edwards in his last post to BrandweekNRX, the blog associated with the venerable Brandweek print publication. Edwards is leaving to take up studying journalism at Columbia University. Surprisingly, Brandweek has hired Peter Rost — pharma’s most vehement critic — to replace Jim (see this post to Pharma Blogosphere, which broke the story yesterday).
[Peter Rost as Journalist. I am withholding my questioning of Brandweek’s wisdom to hire such an outspoken critic of the pharmaceutical industry. Although Jim Edwards wrote for both the blog and the print publication, it is not certain that Rost will do the same. Perhaps he will stick only to blogging, which I have no qualms about. It is problematic, however, for a blogger to also be a journalist (see “Journalistic Suicide or Blog Assimilation?“). Bloggers are expected to be opinionated and proud of it (see “I’m Non-Objective and Proud of It!“), whereas journalists are expected to suppress their opinion when writing articles. O well! I suppose I am being an old fuddy-duddy. When Rupert Murdock buys the Wall Street Journal, we know the writing is on the wall for unbiased journalism everywhere!]
Back to Edward’s “10 reforms,” which are:
- In TV ads for drugs, the FDA should ban disjointed imagery during side-effect warnings
- Reminder ads should be illegal
- Product placement should be illegal, paid or unpaid
- Drug company PR people should be properly trained to answer straight questions with straight answers
- Pharma companies should be required by the SEC to break out their promotional costs
- FDA should require relevant head-to-head studies for second-to-market drugs
- FDA-mandated transparency in Continuing Medical Education
- FDA-mandated transparency in grants and donations for non-profit groups
- FDA mandated transparency for payments and gifts to doctors
- FDA mandated transparency in prescription-writing habits
Whoa! FDA should do this, FDA should do that! Jim, read the law that governs the power of the FDA. It doesn’t give the FDA authority to do half the things you want it to.
Not only that, only reforms #1 and #2 (and maybe #3) on your list really are about advertising. I think you should have entitled your post “10 reforms that the drug industry needs right now.” Let’s not blame everything wrong with the industry on advertising, which is a typical ploy of those whose agenda is anti-industry and who want to misled the public on the issues.
Don’t get me wrong. I agree with a lot of what Edwards says needs to be done. I just don’t think it’s all about advertising and marketing. Therefore, it’s a mistake to put all this in FDA’s court.
Let’s look at a few of the reforms that are of interest to me.
#1: Side effect warnings in DTC ads
Edwards cites a study by Ruth Day of Duke University “showing that when drug ads listed benefits, the images on the screen matched the voiceover and moved slowly. But when side effects were listed, the images often became mis-matched to the voiceover and moved much faster or were more distracting.”
I remember that study very well, Jim. I was in the audience at the FDA hearing when she presented it. Where were you?
Day’s methodology was, to say the least, laughable, especially when she recounted an analysis of how fast the bee’s wings fluttered in the Nasonex TV ads. I have already “bitch slapped” that analysis elsewhere (see “FDA DTC Hearings: Snippets from Day 1“).
DTC ads have come a long way since Day’s study. When Pfizer came out with it’s long Celebrex TV ad that focused almost exclusively on side effects (see “Celebrex Ad: Let’s Dive Deeper“).
In any case, practically all of the FDA’s untitled and warning letters about DTC ads involve the lack of “fair balance” in ads. Some of these have even cited “disjointed imagery.” So, in effect, the FDA already has a “ban” on this practice. What more do you want Jim?
Let’s talk SERIOUS reform, shall we? The FDA, IMHO, should be given more power to sanction companies that violate its regulations — like the power to issue fines and other penalties. The only power the FDA has now is the “nuclear option,” which is to rescind a drug’s marketing approval status. Not very useful as a stick for punishing minor advertising infractions!
#2: Reminder Ads
I think the boat has already sailed on this issue. Only one company I know of currently runs reminder ads — Allergan, which runs Botox reminder ads, especially in print (see “PhRMA Intern vs. BOTOX!“). Most other companies have signed on to PhRMA’s voluntary DTC guidelines, which prohibit these ads (but only on TV).
My opinion is that in cases where voluntary industry guidelines are working, there is no need for an extra layer of new government regulations. The REAL call for reform on this issue, therefore, is to call on PhRMA to add some teeth to its guidelines (eg, public disclosure of violations, fines, etc.) and to expand them to cover Internet and print advertising.
#3: Product Placement
Now we are getting away from advertising per se and into the realm of marketing/promotion. Nevertheless, I agree that this practice has to be reigned in. I don’t believe, however, in making it illegal, which I suppose would take an act of Congress (ha!).
Drug product placements should be regulated, just like other DTC advertising is. For example, if a drug is promoted by a celebrity on a TV talk show and that celebrity has been paid to make the promotion, this fact should be revealed as the celebrity is speaking. You know, a little text notice at the bottom of the screen like car ads run when expert drivers are doing stunts in ads — just in case some dope out there attempts to do the same thing.
I could go on and comment about the remaining 7 “reforms,” but I do need to do some real work to earn a living. Besides, as I said in the beginning, these are reforms that are not specifically in the realm of advertising and are really reforms that the industry may need to make in its other activities. Many of these do not involve the FDA at all. So, calling upon the FDA to do all this reforming is really diverting attention away from the actual responsible parties.