Dr. Adriane Fugh-Berman, director of PharmedOut (left): Dr. Graham McMahon, president and CEO of the Accreditation Council for Continuing Medical Education (right)
This story has been updated.
Even as industry funding for continuing medical education courses has fallen steeply in recent years, questions about the integrity of CME have not completely disappeared. A controversial drug approval provided the spark needed to ignite that debate once again, with the latest salvos being fired in the pages of a medical journal.
A long-standing critic of pharmaceutical marketing practices is calling for beefing up accredited continuing medical education standards, after she traded sharply worded commentaries with Dr. Graham McMahon, the Accreditation Council for Continuing Medical Education’s president and CEO, in recent issues of a BMJ ethics publication.
The critic, Dr. Adriane Fugh-Berman, director of PharmedOut, a Georgetown University project that studies how marketing affects pharmaceutical prescribing practices, in December published a letter referring to CME as “commercial medical education,” arguing that the ACCME doesn’t track reporting of in-kind support, such as the costs of equipment, hotel rooms or meeting spaces, or advertising and exhibits income.
Calling PharmedOut’s accusations “wholly inaccurate,” McMahon countered that, “Despite the authors’ rhetoric, they provide no evidence for their claims to suggest that our work to create and maintain independence in CME has been corrupted or maligned,” he said in a statement.
The dustup followed a viewpoint co-authored by Fugh-Berman that appeared in the June 29 edition of the BMJ’s Journal of Medical Ethics. Titled “Hypoactive sexual desire disorder: inventing a disease to sell low libido,” the piece examined what the authors said is one of the latest instances of “disease branding,” whereby drugmakers develop a condition while they are developing a drug for that condition.
In this case, researchers identified multiple industry-funded, accredited CME modules on hypoactive sexual desire disorder in women that took place in advance of the FDA approval in mid-2015 of the drug Addyi (flibanserin), the first prescription medication sanctioned for that condition.
The drug is now marketed by Sprout Pharmaceuticals, which acquired flibanserin from Boehringer Ingelheim in 2011. (Within days of the approval, specialty drugmaker Valeant announced plans to buy Sprout. Some analysts had predicted that Addyi would be a blockbuster, but sales have so far been a disappointment. Bloomberg Business in November reported that there were only 227 prescriptions written for Addyi in its first few weeks on the market.)
Nevertheless, the controversial approval of Addyi has raised questions in the medical community about the validity of the disorder, the design of the drug’s clinical trial and the company’s use of marketing, among other concerns.
Of the 14 accredited CME modules about hypoactive sexual desire disorder researchers studied, all disclosed funding from BI, the drug’s owner at that time, and 12 out of 14 modules had at least one author who had financial ties to BI.
“There are certainly women who are troubled by low libido, but there is no reliable scientific evidence that hypoactive sexual desire disorder is a real medical condition,” the researchers contended. “Invented diagnoses may outlive the drugs for which they were invented. Although Boehringer Ingelheim did not create hypoactive sexual desire disorder, the company apparently attempted to brand the condition through CME modules available years before the expected launch of flibanserin.”
They concluded their research by calling for serious consideration of banning industry sponsorship of CME.
It’s not the first time critics have called for an end to this industry practice. Such calls have been circulating for at least a decade. But it comes after drug and device manufacturers boosted their investment in CME by 2.4% in 2014, the first such increase since 2007, according to data released by the ACCME in July.
Legislative changes have been cited as one possible reason for the rebound. A 2014 report in Modern Healthcare had predicted that the industry could begin shifting their marketing budgets toward CME and away from branded promotional programs, due to a detail in the federal Physician Payments Sunshine Act, a provision in the Affordable Care Act, that allows them to evade disclosure as long as the sponsor is blind to the recipient.
In his October rebuttal to the June PharmedOut piece, McMahon responded that PharmedOut had made misleading and unsupported claims. “Creating awareness of newly identified diseases and facilitating the translation of new research into practice are appropriate and important functions of accredited CME,” he wrote.
The back-and-forth between McMahon and Fugh-Berman highlights a broader issue in the medical community, one that has little to do with any one particular drug. (The most recent commentary published by Fugh-Berman does not mention Addyi or hypoactive sexual desire disorder. McMahon’s commentary mentions the disorder once.)
The heightened criticism may have more to do with the implementation of the Sunshine Act and increased awareness about the prevalence of conflicts of interest in medicine.
The CMS had said it planned to eliminate the Sunshine Act reporting exemption for CME, but a measure in the 21st Century Cures Act seeks to codify the carve-out. The Act passed the House this summer.
(UPDATE: ACCME said that it does require accredited CME providers to report the type of in-kind support but that the information does not include hotel rooms or other costs related to the CME event. Its reporting rules for in-kind support were changed in 2011 after CME providers said it was not always possible to determine accurate, standardized estimates for the dollar value for in-kind support.)