CLEVELAND, Ohio — A broad conflict-of-interest overhaul at Case Western Reserve University will scrutinize industry-sponsored research and could mean the end of drug representatives picking up lunch for medical students.
It essentially requires anyone working or attending the school to report even a modicum of potential conflict related to their research. If there’s “any doubt about whether or not an activity must be reported, the individual should report the activity,” the new policy states.
The university’s new conflict of interest policy (pdf) covers its entire campus as well as, because of an affiliation agreement, students at the Cleveland Clinic Lerner College of Medicine. However, due in part to its breadth, it doesn’t touch on many issues specific to medical schools.
Also, potential conflicts are handled by a conflict of interest committee in a process that is completely private. That’s not uncommon, but it breaks with recent calls – and new policies by some institutions – to better disclose problematic ties between industries and researchers.
Schools nationwide are mulling how best to blunt interest from the commercial side of health care while still relying on sponsorships for items like continuing education classes. The Ohio State University Medical Center and Johns Hopkins University will in July enact separate policies that bar students and staff from receiving food and gifts of any value. OSU’s policy also makes it harder – though not impossible – to accept free drug samples from pharmaceutical representatives.
The University of Cincinnati changed its policy last year to, among other things, ban drug representatives from campus unless they have an appointment. The University of Minnesota recently announced a new policy that frustrated some officials for rolling back rules to phase out industry funding of continuing education.
“Some schools are completely doing away with industry funding because of its potential to bias the content – even when careful restrictions are made,” said Gabriel Silverman, the director of last year’s American Medical Student Association conflict of interest scorecard.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Case Western unveiled it’s new policy in late February. The previous rules were 28 years old, 11 paragraphs long and meant only for faculty. It’s now an 18-page, 6,700-word document that covers everyone down to students.
The new policy doesn’t explicitly prohibit anything. Instead, it requires reporting of any financial interest – from receiving a salary to potential board appointments to reimbursed travel arrangements – relating to work at the university and research.
Other potential conflicts in the policy include faculty requiring students to participate in research projects; ghostwriting on behalf of industry; taking direct outside funding – rather than through the school – for research at the university; or receiving payments for obtaining certain research results.
Accepting “reasonable meals,” income and travel expenses for government service, or “customary business amenities (such as pads and pens)” don’t have to be reported, according to the policy.
Faculty as well as students involved in university research will have to submit annual conflict of interest reports, which are due in late May or early June. The university could halt research if committee guidelines are ignored.
Conflicts are managed privately by a committee. The policy states that all information contained in reports or obtained during a review of a potential conflict of interest are strictly confidential. It’s unclear whether any conflicts would ever be publicly disclosed.
Silverman, who read CWRU’s policy, said other schools have similar privacy protections. However, he said more institutions are adopting policies similar to the Cleveland Clinic’s approach to publicly list the industry ties of its staff.
In a written response to questions about the policy, CWRU stated it wanted rules that encouraged its staff and students to “engage with the world beyond the campus” and recognize that life-changing innovations “are of little value if they never leave a laboratory.” In turn, the policy also wanted to make sure these “engagements avoid any actual or perceived conflicts.”
It added: “The new policy represents a substantial update from the standards previously applied on our campus. They adhere to best practices at other academic institutions, and reflect a collective sense among the administration and Faculty Senate regarding the most effective way to balance questions of personal privacy, reporting burdens and institutional accountability. Ultimately, the most effective policy is the one that draws the greatest compliance; that is one of many reasons why the committee and administration worked so closely with the Faculty Senate in finalizing this document.”
The school decided it needed a university-wide policy and opted not to create something specifically for the medical school. While CWRU has partnerships and affiliations with area hospitals, it does not maintain its own medical facility. However, the committee reviewing conflicts of interest will include the Cleveland Clinic, University Hospitals Case Medical Center and other affiliates.
“Based upon how this policy plays out in practice we can move forward from here and continue to address conflicts of interests in academic medicine in the most productive way possible,” said Jeff Collins, a third-year medical student who was last year’s chapter president of the American Medical Student Association. Collins was among a group of medical students who advised CWRU on the policy.
Collins thinks medical students would be violating the school’s policy if they accepted food from pharmaceutical representatives. CWRU said none of its study sessions are sponsored by pharmaceutical companies. But students have said drug representatives regularly pick up meals during informal study sessions or journal club meetings, some of which are done at the hospitals.
Medical students who reviewed the draft policy pushed for specific guidelines on drug-company access on campus and guidelines on accepting free drug samples, Collins said. Because of ommissions like that, Silverman said it’s likely AMSA wouldn’t consider CWRU’s a “model policy.”
In its written statement, the university stated it didn’t cover drug samples because “those are for the most part the province of our hospital affiliates.”
Cleveland Clinic spokeswoman Eileen Sheil said its medical school staff is reviewing the policy.
Plans are different at Ohio State, which already has a university-wide conflict of interest policy. It is creating new “vendor interaction” rules specifically for the medical school.
The plan tentatively bans speakers-bureau retainers and instead requires speakers to be paid per speech. Such talks must also take place either in an academic setting or a continuing medical education session. Also, drug representatives can also no longer provide food for staff — from “bagels during grand rounds” to “Morton’s steakhouse downtown” after hours, said Dr. Andrew Thomas, associate dean of OSU’s medical center.
“What our policy basically says is that it’s a 24-7 policy,” Thomas said. “Off campus, on campus, out of town.”
The policy will make it hard, though not impossible, to use free samples supplied by drug vendors. Instead of samples the school is supposed to ask vendors for vouchers to obtain generic medications elsewhere. When clinics do take samples they will need to fill out paperwork about what they’re stocking, who is monitoring those drugs, and whether there are any conflicts, Thomas said.
For the policy to work, the university will have to be a trusted buffer. Thomas said drug companies could, for example, donate money which could go to meals, textbooks or other items for students. But that money will go to the university and the school will do the catering so there is no interaction between people at an event and the company indirectly funding it.
The new policies come as the next American Medical Student Association conflict of interest scorecard is about to be released. Last year, CWRU received an incomplete grade because it was revising its policy, while Ohio State got an F for not responding to AMSA requests for information.
[Photos courtesy of Flickr users Charles Burkett and Mike Licht, Notionscapitol.com]
