This morning, while I was checking out our Google+ account, I came across an interesting article posted by Chris Kresser’s about the conflict of interest between Big Pharma and doctor support of off-label uses for drugs.
Because I’m always one for a good conspiracy, I took the bait and started reading the post, published on Dr. John Briffa’s website, entitled “It seems opinion leaders’ conflicts of interest with drug companies often go undisclosed.” Overall, I thought the article was interesting and opened my eyes to a whole new level of “shadiness” within the pharmaceutical and medical communities.
I’ve always felt we should take medical findings with a grain of salt given that I’d heard many studies receive funding/grant money either directly or indirectly from the company/companies whose very product(s) are being evaluated. Unfortunately, as Briffa’s article points out, there’s something going on that I think is a lot worse:
Not uncommonly, it seems, a drug company will encourage off-label use by doctors (it extends its market, of course). One way a drug company can do this is to partake in a bit of ‘off-label marketing’. A strategy here might be to court and then pay doctors and scientists to speak and write about off-label uses of a drug.
Ideally, if a doctor or researcher were to write in an academic journal about off-label uses of a drug, then he or she would at least declare any relevant conflicts of interest. That way, readers can better judge whether the author’s opinions might be biased (tainted) through whatever commercial arrangement they have with the drug company that makes the product they are writing about. Some new research suggests that, on the whole, reporting of conflicts of interest here leaves much to be desired .
For those of you who don’t know what “off-label” means, here’s a quick synopsis:
When a prescription drug is approved for use, it is approved for a very specific group of people and condition. This does not, however, mean this is the only reason a drug can be prescribed.
In a hypothetical example, let’s assume there is a new drug called PaleoMax that has been tested and approved for the treatment of IBS in men over the age of 40. However, PaleoMax also increases fertility in women between the ages of 24 and 38. This additional “benefit” would be an off-label benefit, and in practice, doctors would be allowed to prescribe the drug to women to help with fertility, even though it’s not what the drug was approved for.
Back to Briffa’s article, where he talks more about the referenced study:
The study in question started by identifying doctors or researchers who had been reported by other health professionals for (inappropriate) off-label activities. 39 relevant individuals were identified who had gone on to author a (whopping) total of 404 articles about relevant products (drugs with which their appeared to be a conflict of interest) over a 3-year period.
Of 404 articles, 342 (85 per cent) were deemed to lack adequate disclosure statements.
For me, here’s the disturbing part about all of this: doctors are being approached by pharmaceutical companies to speak or write about off-label uses, but when many doctors speak/write they’re not disclosing the fact they’ve been courted to do so.
Granted, this study is skewed in the sense that it was already focusing on doctors who had been flagged for inappropriate off-label activities, so I certainly don’t believe that 85% of all off-label support from doctors has a conflict of interest.
Again, I’m not trying to say that all doctors that do this are crooked and would be less than honest with their championing of additional uses for already available drugs. However, I do feel very strongly that all doctors should be forthcoming and state up front whether or not they are being “sponsored” to support these additional uses since there is an apparent conflict of interest.
What are your thoughts on this? Are we just over thinking this or is this a real problem? Leave your comments below!
1. Kesselheim AS, et al. Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures. PLoS Med 9(8): e1001280. doi:10.1371/journal.pmed.1001280