Wednesday, June 12, 2013

Guest Post: The myth of unrestricted pharmaceutical grants

A free clinical monograph from the American Academy of Family Physicians on "Diagnosis and Management of Obesity," sponsored by an educational grant from VIVUS, Inc. (manufacturer of the prescription weight-loss drug Qsymia) has stirred controversy about the financial relationships of the AAFP (which, full disclosure, pays me to provide independent editorial and consulting services for their journals American Family Physician and Family Practice Management). I received a copy of the obesity monograph and patient education materials in my clinical office but have been unable to find it online. Although this is hardly the first time that the AAFP has sought questionable commercial sponsorship for educational material (see my previous blog post about its agreement with Coca-Cola), the timing of this monograph's publication and a renewed sales push for the thus-far-disappointing diet drug is unlikely to be coincidental.

The usual defense of such medical-industry relationships goes as follows: the drug manufacturer provided an "unrestricted" educational grant and had no influence over the content, other than that it had to be about a certain topic (in this case, management of obesity). So why not accept this funding with no strings attached to produce unbiased clinical content for one's member physicians? In fact, why shouldn't a medical specialty society such as the AAFP seek funding from multiple competing drug companies to reduce the chance that its educational offerings will be biased one way or another? Dr. Jerome Hoffman strongly disagrees in his guest post below.

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It is possible that when Ford Motor Company puts out a brochure comparing mid-sized SUVs that it contains some "educational material," but this is hardly guaranteed! Same for this; it's possible they include some other stuff that is factual, in order to dress up the advertisement -- but neither is this guaranteed ... nor even relevant. Or if Ford paid Car and Driver to publish an "educational review" of auto companies, would you say, "Let's read it to see if it's fair before we presume to imagine it might be biased"? Of course if Ford assured us the funding was "an unrestricted grant," and the paid authors assured us they had no conflicts of interest -- well, OK, then I take it all back.

What if a law firm gave an unrestricted grant to a judge, to write an educational review of the firm's pending case before him? No worries, especially if the judge denies any conflicts.

I say that all those unrestricted grants corporations give to politicians (who certainly never fail to put the public interest first) don't ever buy influence, but merely "access."  When Enron gives millions to candidates on all sides, they're giving away their money merely as a generous public service ... just as the scientific monographs that they sponsor -- all written by non-conflicted authors (or ghostwriters) -- are simply attempts to educate us. Heaven forbid we prejudge them.

Excuse me, but Pharma doesn't throw away its money. There is no such thing as an unrestricted grant; if it didn't buy value in return, why would they pay for it? And if the author didn't write something they like to read, do you think he'd ever get another unrestricted grant?

Finally, I don't believe it's actually about favoring one company over another; it's about favoring them all. They may compete over certain individual drugs, but they all thrive when "Key Opinion Leaders" (and our "independent" societies, and journals, and universities) help doctors, and the public, buy into the myth about wonder drugs (for sexual performance, for weight loss, etc.) ... at a cost of many many billions to all of us. That's why their extremely active lobbying trade group (PhRMA) represents all of them together.

3 comments:

  1. First, I am no shill for pharma. No.

    Do you believe "unrestricted" can ever translate to use of funds which might produce more benefit than harm?

    By that I mean:
    Unrestricted means exactly that. Write on obesity (yes, disease awareness sells rx--no doubt), but we, Company A, wont review or ask for any retractions. Use the money as you wish and dont disclose our name. Additionally, we will deposit the same amounts for years two and three for difft projects. Again, no shackles.

    How do you respond? Can we serve the public health more with the grant than without?

    Brad

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  2. Dear Brad,

    I wrote the “guest blog," and thus would like to respond to your very reasonable comment/question of whether an unrestricted grant can be used to do more good than harm. I suggest that the answer is almost surely “no” … but more importantly, would say that the real question should be “can there really ever be such a thing as an ‘unrestricted’ grant?” There is plenty of evidence that when we enter into such a relationship (you are paying me to do something) I cannot avoid bias in how I deal with you – even though (or rather, especially because) that bias is largely unconscious. Furthermore, I have to know that the only way I’m going to continue to receive such largesse from you (or any of your colleagues) is if what I write is acceptable to you; you certainly are not giving out your money without expecting that you will benefit from so doing. The drug industry didn’t become enormously successful by giving away its money, and certainly not to people who threaten its interests; why on earth would you keep depositing the money, year after year, if what I write is anathema to you?

    If I somehow managed to be the rare exception who was able to write something honest and unbiased about your product, I might be able to do a little bit of good, with that one effort (and even though I wouldn’t get any further funding, to write more). But my impact on the larger world, even with this first unbiased monograph, is likely to be extremely small. A more powerful organization, like AAFP, surely won’t spend lots of money publicizing or distributing my piece if the sponsor is unhappy with it – as AAFP certainly needs to maintain good relations, b/c they absolutely want further funding in the future.

    I’ve been writing as if the sponsor’s product was less than perfect. But what about if the product was really an unusually good one? Couldn’t I accept the money only if I already liked the sponsor’s product … and in which case wouldn’t it be a good idea to let people know? Every one of us is less able to be unbiased in making such a judgment – one way or the other – if we have a financial COI. If I like your product, there’s nothing to keep me from writing about it ... without getting paid to do so. Once I take your money, though, I not only change my ability to think clearly about this product (subtly, unconsciously – there’s lots of evidence of this in the psychology literature), but I also forfeit any ability I might have to evaluate in an unbiased manner whatever other products you will be selling in the future.

    Jerome Hoffman, MD

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  3. I say collegially and warmly (words get misinterpreted)...

    You have not told me anything I dont know. I lecture the same themes.

    However, the empiric question, "can there be a situation/relationship where more benefit occurs than harm," remains unanswered. You speculate, and I viscerally agree, but arrangements can be firewalled, third parties can avail themselves, etc., and I can imagine a society getting money from a blind centralized trust.

    Dont say never. My question speaks to benefit over harm. You need to weigh them both carefully.

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