Dive Brief:
- There is an ongoing standoff between Dr. Adriane Fugh-Berman, director of PharmedOut, a Georgetown-based project, and Dr. Graham McMahon, president and CEO of the Accreditation Council for Continuing Medical Education (ACCME), according to reporting from Medical Marketing & Media.
- In June, Dr. Fugh-Berman and her co-authors published an opinion piece in the BMJ Journal of Medical Ethics—"Hypoactive sexual desire disorder: inventing a disease to sell low libido." The gist of the article was that CME is used as a vehicle to brand invented conditions during the drug development stage prior to approval. Valeant/Sprout Pharma's controversial Addyi (flibanserin) is used as an example of this practice.
- Dr. McMahon, who vigorously disagrees with Dr. Fugh-Berman, has called Dr. Fugh-Berman's contention that continuing medical education is actually "commercial" medical education "wholly inaccurate."
Dive Insight:
In order to make their point, the authors of the article published in June decrying the invention of diseases in tandem with drug development, pointed out that there were multiple, industry-funded CME programs about hypoactive sexual desire disorder (HSDD), starting several years before Addyi was approved in the summer of 2015. They suggest that pre-approval CME was a form of early DTP marketing.
In addition, they noted that Boehringer Ingleheim, which was the company developing the drug at the time (it was subsequently sold to Sprout Pharma), provided funding for all of the modules. The article also defines what an invented disorder is, citing not only HSDD as an example, but also gastro-esophageal reflux disease, premenstrual dysphoric disorder, social anxiety disorder, and erectile dysfunction.
Even as Dr. Graham defends the integrity of CME and the role that it plays in educating healthcare practitioners, there have been some red flags in recent years. For example, drug companies increased CME investments by 2.4% in 2014—a huge leap that occurred alongside the implementation of the Sunshine Act.
Notably, this act does not require that CME payments to physicians be disclosed—as long as the sponsor is blind to the recipient. This could be a coincidence, but Dr. Fugh-Berman does not think so.