Tuesday, October 13, 2009

CEI's Critique of FDA's Paid Search Stance Should be Titled "The Little (Search) Engine that Could"

"Hey, John. This is America, after all, and everyone is entitled to their opinion—even you!," said Arnie Friede, co-author the Competitive Enterprise Institute's (CEI's) article "FDA and Advertising" (see here), in an e-mail to me. He was responding to my blog post in which I called CEI's premise --ie, "FDA's position on sponsored links could have the unintended effect of making regulated information less available to consumers while making less reliable and unsubstantiated information more available...If sponsored links for highly regulated drugs and devices become more rare, then an information seeker will be relegated to wading through a list of Web sites that contain all manner of information of dubious validity." -- "Carefully Wrought Bullshit" (see "Is FDA's Sponsored Search Advertising Policy Increasing Consumer Risk?")
"For my part," continued Friede, "the CEI paper was not offered or characterized as empirical evidence on any point. The language was carefully chosen to say that FDA’s policy “could have” the unintended effect postulated. The matter certainly deserves careful consideration and study. I would submit that your quick look at Google probably does not qualify as such an analysis. As for doing a disservice to FDA, I think that raising important arguments like these for consideration by everyone affirmatively serves FDA’s interests in having all of the arguments on all sides vetted. That is the essence of transparency."
Since Friede cites transparency, I would like to reveal the communications I have been having with the authors of this report, who have chosen not to respond in comments to my blog.

Greg Conko, the other co-author of the CEI report, also emailed me. "I was tempted to let Arnie's reply speak on my behalf as well," said Conko. "But I thought it was worth repeating Arnie's point that we, in our paper, suggest only that a diminution in paid links by pharma companies 'could' result in raising the visibility of links for unregulated products, most of which are of unknown or dubious quality. It's a simple proposition: In a world characterized by A and B, a smaller number of A without a change in the number of B implies a higher proportion of B."

Conko continues:
You twice accurately quote us as claiming this 'could' occur, but then you misleadingly write that we "claim that the void has been filled by ads of 'dubious validity'," and allege to have knocked down this strawman. The questionable validity of your test results aside, you'd think that someone who so glibly uses such phrases as "carefully wrought bullshit" and "complete disregard for facts" might be a little more careful with his own arguments.

It is, of course, your prerogative to suggest that what we wrote is unlikely, or that you are confident upon further examination it will prove to be untrue. I, however, suspect that, upon further examination, we will find a proportionately larger number of links for unregulated products as for regulated ones.
Freide ended his email in a similar vien:
As for characterization that what we have written is “Carefully Wrought BS”, both Greg and I are lawyers and, at least as to me, it is not the first time, nor will it likely be the last time, that someone has called what I have said “BS”. I am prepared to be judged on the merits of the analysis, including the analysis in CEI’s recent comments to FDA and the attached article of mine from FDLI Update titled, “Yes We Can: Time for an FDA Drug Advertising Policy”
It appears that Friede speaks for Conko and vice versa.

Unlike lawyers, my goal is not to argue in order to win my case. At least I offered evidence -- albeit flawed -- that Friede and Conko's premise was false (in a real court, I "could" win if the jury saw my "evidence" even if it had no scientific merit. Unlike the FDA, juries and the public in general are not swayed so much by science as they are by carefully wrought BS). More importantly, however, is my challenge to everyone out there to provide BETTER evidence that CEI's premise is true. Only with such evidence will the FDA be swayed to change its opinion.

It is not within my capability to provide the needed evidence. Friede & Conko should have done that instead of imagining what "could" happen. Many things can happen if suddenly there were no more pharma paid search advertising. Google stock shares "could" lose 30% of their value! Maybe I should write a report claiming that "could" happen and short sell Google! Now there's an idea worth pursuing.


  1. John,

    Are you kidding me? You chose one item of reasonable conjecture to write two articles on the CEI article? You dispute this one item of conjecture with your own conjecture and some equally anecdotal "testing."

    Its kind of pity that I don't understand what ax you have to grind sometimes, but its a disservice. In fact, your reporting, analysis or blogging (whatever you want to call it) ignores nearly the entire CEI article which is an excellent analysis of FDA's policy contradictions and clearly an excellent starting point for challenging FDA's policy based on its own precedents. The article also has a good analysis of how FDA's enforcement underestimates the cababilities of consumers to navigate the web (This coming from an agency that still makes companies submit all promotional materials to DDMAC on a paper form 2253 and won't accept electronic transmission even though the technology and most of the infrastructure has been in place for years. Don't get me started on FDA's continued reliance on FAX machines. This is then the same agency who judges consumer's technology capabilities through the telescope of its own technological deficiencies.)

    Whether or not the theory that sponsored link restrictions on prescription manufactures negatively alters the information eco system will only be evaluated by time. There are many factors that could occur in the future that could change those search results you created. Overgrowth can occur in the absence of another organism competing for a resource. That said, one solution would simply be to ensure the FTC actually regulates effectively dubious health marketing claims. Unfortunately, they'll be more like the orkin man trying to get rid of your stink bugs. A false or misleading ad is a false or misleading ad and there are instruments (and regulatory authorities and consumer protection mechanisms like the FTC) to wield these instuments. Except, at least today (and in my opinion) the FTC does a woeful job at enforcing against false and miseading advertising.

    Also, for one who has frequently portrayed FDA as inept half-witted in your blog, it is awfully ironic how senstitive you now are to the common FDA man/woman. Carelessly wrought BS indeed. Also, I'm pretty sure Arnie has some perspective on what its like to be inside FDA and getting policies challenged. So I'm pretty sure I can trust the validity of his approach, in spite of the inevitable holes.

    Nonetheless, I remain an avid reader because I know you'll post this.

    One last thing, when you post your survey results, can you post the sample size of the survey respondents? That's data transparency/reporting basics. Something DDMAC would cite you for failing to reveal material facts. Unless of course I'm missing something.

  2. When the survey is finished and I submit it ti the FDA, I will include the sample size.


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