In stepping up COI rules, Yale takes 'rational' approach to industry
Leffell: allowing "principled" interactions
The school, acting through the Yale Medical Group, turned its elective guidelines into policy. “We made it more of a defining element of our practice world,” David Leffell, MD, deputy dean for clinical affairs for the medical school and CEO of Yale Medical Group, told MM&M. “Overall, we've taken a pretty rational approach.”
The policies are designed to promote “principled interactions” with industry. They don't restrict doctors from joining speakers' bureaus, where they give promotional talks for drug and medical device makers, as Harvard Medical School recently did, or put the brakes on accepting commercial support for CME, as the University of Michigan did. But they place limits on such areas as gifts, meals, interaction with sales reps, consulting and education.
And Yale takes a strong stand in one area in particular, ghostwriting, something few other schools currently do. Faculty are barred from being listed as authors on articles unless they make a substantive contribution to content. If industry reps, or others retained by industry, contribute to the same article, they must be listed as contributors or authors and their industry affiliation disclosed. A study appearing in PLoS Medicine this year showed that, out of 50 academic medical centers analyzed, only 10 explicitly banned ghostwriting and most had no published policies on ghostwriting or authorship.
“The ghostwriting policy is something we needed to do to protect academic integrity,” explained Leffell. “I don't know how much was going on at Yale, but as a matter of principle, [any] ghostwriting was not acceptable. I'm confident that quality papers will find their way into publication.”
“I think that Yale's [ghostwriting] policy is a great start,” commented Dr. Adriane Fugh-Berman, MD, an associate professor at Georgetown University who recently wrote a different paper for PLoS Medicine analyzing the controversial practice. “I hope that it's combined with educational efforts for their physicians.”
She said the policy still leaves open the possibility that doctors could be approached to sign onto papers by firms providing editorial assistance and not know those firms are working on behalf of drug or device companies, unless the physician asks explicitly. In addition, the policy, as written, doesn't seem to prohibit clinician researchers from affixing their names to papers drafted by outside entities, Fugh-Berman said.
Why didn't Yale expressly prohibit physicians from accepting such drafts? "The [guidelines] committee didn't address drafting because the guidelines make it clear that physicians have to be involved in the writing," said Leffell. What about the concern that, if a pharma or device maker does the draft, they will drive their own point of view? "It's irrelevant who provides the draft since manuscripts are going to change," Leffell said. "We expect authors will have intelligent and creative input into [the paper] if they will put their name on it."
As for the rest of Yale's policy, clinical personnel may not accept gifts, unless related to patient care or training, nor meals, unless served at a CME activity which adheres to ACCME Standards for Commercial Support (SCS) or under other limited circumstances. Sales reps are permitted by appointment only, and consulting deals are subject to several rules including public disclosure (the means of which have yet to be determined). As far as medical education, the policy allows physicians to take part in commercially supported CME delivered on-campus as long as it complies with the SCS, and grants must pass through Yale's CME office. Sponsored off-campus talks are OK, but must comply with a host of rules.“We were the first [medical school] in the country to create COI guidelines six or seven years ago,” Leffell added. “As people were catching up to us, we realized we needed to move these into policy form."