CLEVELAND—During the waning days of summer some 300 people representing academia, government, industry, hospitals, and the media gathered at the Cleveland Clinic for “A National Dialogue on Biomedical Conflicts of Interest and Innovation Management.”
The meeting preceded another two-day conference that about one third of the participants would also attend—the Annual Forum on Conflicts of Interest in Academe, an affiliate of the Association of American Medical Colleges.
Ethical Issues Related to Bringing Scientific Discovery to Medical Marketplace
The National Dialogue's sessions delved into dealing with the ethical issues related to bringing scientific discovery to the medical marketplace.
This was a topic not unknown to the host institution, which had its own share of ethical embarrassments during the recent past, including its CEO's relationship with a medical-device company, and the ousters of various Clinic superstars due to direct conflicts of interest, or criticism of the Clinic's conflicts.
In fact, one Cleveland Clinic official noted early on, perhaps not entirely in jest, that maybe they should have changed the name of the conference to innovation management, which he said seemed more appropriate than conflicts of interest.
Nina Totenberg, Legal Affairs Correspondent for National Public Radio, moderated the morning sessions, setting the stage for many similar discussions seen from differing points of view throughout the rest of the day.
Despite the complexity of issues surrounding conflicts of interest, Ms. Totenberg cited what she called the Washington Post rule: “Can you live with the arrangement when it is plastered across the front page of the Washington Post or New York Times?”
She raised questions about the various repercussions for academia and industry; why industry gives gifts; is mere disclosure enough; and how to manage conflicts that inevitably exist in almost all academic medical centers because their people are often the best in the field.
Philip A. Pizzo, MD, a pediatric oncologist who is Dean of Stanford School of Medicine, announced that as of October 1, Stanford would ban all free gifts and meals from industry, which he said was too close an intermingling between industry and academia, and violated the public trust.
“We want to foster an environment that encourages innovation and discovery by breaking the shackles that lead to marketing relationships.” He said that the pharmaceutical industry invests more than $20 billion in marketing, directed mainly at physicians.
He added that academic medical centers' missions have grown through NIH funding, but that managed care had decreased profits once used to subsidize medical education and training, causing institutions to look for alternatives to supplement those missions, including the establishment of technology-transfer offices that have encouraged relationships with industry.
”Lots of physicians and academic centers don't need guidelines, since they always know what to do, but they do need boundaries to set conditions to look at.”
Dr. Pizzo acknowledged that conflicts will exist between academic innovators and entrepreneurial concerns, and that the need wasn't to eliminate such conflicts but to manage them with full disclosure. He added that small gifts to physicians are part of the strategy, and with the world of technology today there is no reason that information about drugs has to come from marketing reps.
However, it was also noted that part of the problem was the reluctance of medical professors to give up lunches for students since they might not come, and the professors didn't know how to deal with it.
P. Roy Vagelos, MD, Former CEO of Merck
P. Roy Vagelos, MD, who retired in 1994 as Chairman and CEO of Merck & Co., Inc., discussed his efforts 15 years ago to get rid of the pharmaceutical giant's sales force.
“We failed,” he said. “We tried to force innovation in marketing, and tried experiments through the sales force….I am personally opposed to giving gifts; what we should do is bring together the two groups from academia and industry to find the most appropriate way to bring the groups together to teach about new products.”
Dr. Vagelos said conflicts of interest between academia and industry have existed for more than 40 years, but are now heightened.
He spoke of the stages of the innovation process with drug development generated by knowledge from universities.
“Once the product candidate is identified at the university it goes to industry, which uses academic specialists. This is crucial to the innovative process, but the safety of patients should never be compromised.”
He explained that once the product is approved by the FDA then pharmaceutical marketing and sales representatives get information about the studies to doctors.
“These reps are highly trained to teach the benefits and risks of drugs, but they are limited to what they can say by the FDA. The trick is to get enough time to see busy physicians. Companies have measured the impact of gifts or they wouldn't spend the money.”
He noted that inducements such as meals, modest gifts under $100, and continuing medical education are used, adding that Stanford's recent ban on all gifts from industry followed similar moves by Yale and the University of Pennsylvania.
Dr. Vagelos concluded by saying transparency is crucial.
“All drugs at high enough doses have complications. Early action is imperative when safety is an issue. Any mistake can destroy a company,” he said without referring specifically to recent problems experienced by his former company, which ironically had been the beginning of the end for Dr. Eric Topol's tenure at the Cleveland Clinic when the cardiologist publicly criticized Merck's handling of Vioxx.
Most Provocative Speaker: Thomas Stossel, MD
The day's most provocative speaker was Thomas P. Stossel, MD, American Cancer Society Professor in the Department of Medicine at Harvard Medical School and Co-Director of the Division of Hematology at Brigham and Women's Hospital.
Dr. Stossel disclosed that he sleeps with a drug rep, his wife, Kerry Maguire, DDS, MSPH, who is Director of Professional Advocacy for Tom's of Maine, Inc., and then tossed tubes of Tom's toothpaste to his fellow panelists—a gesture that would have been more appreciated upon check-in to the host hotel, which ran out of samples for those conference participants who traveled to the conference when toothpaste and other liquids and gels were banned from flights.
A proponent of increased and free interactions between academic researchers and private industry, Dr. Stossel said, “With excessive disclosure, the conflict-of-interest vigilantes scan for opportunities to embarrass us.”
He likened a prophylactic law such as banning corporate consulting to forbidding speeding by banning the sale of fast cars.
“I see harmony, not a conflict of interest. The accusations that they have compromised research are untrue.”
He said that trust in physicians comes from a track record, not from who pays you or how much, and that we should give practitioners more credit. He was also opposed to Stanford's ban on gifts, and later questioned if financial incentives corrupt, quipping “the plural of anecdote is not data.”
Dr. Stossel said institutions institutionalized relationships with industry following enactment of the Bayh-Dole Act in 1980.
Sponsored by Senators Birch Bayh of Indiana, and Robert Dole of Kansas, the legislation gave US universities, small businesses, and nonprofits intellectual property control over their inventions resulting from federally funded research, and allowed those institutions to elect to retain title first.
Most of the others on the panel disagreed generally with Dr. Stossel's point of view, and Ms. Totenberg noted, “Dr. Stossel seems to want to go back to a time that no longer exists.”
Keynote Speaker: Richard Thornburgh
The keynote speaker was Richard L. Thornburgh, former Governor of Pennsylvania and Attorney General of the United States, and a former Director of Elan Corp., plc, a publicly traded pharmaceutical company.
Mr. Thornburgh's take-home message was to disclose everything and to reduce relationships.
“If important research, regulatory, and clinical institutions begin to lose the public trust, we risk undermining our nation's capacity for experimentation, scientific innovation, and ultimately, excellence in patient care,” he said.
The conference focused primarily on conflicts of interest in academic medical centers, with many of the speakers representing elite institutions, and didn't really take into consideration many of the ethical considerations faced in the community or less prestigious institutions and hospitals where marketing and public relations efforts are often poor substitutes for innovation and excellence, and gifts and meals are welcome and expected.
Perhaps, a comment from one of the audience members who identified herself as an attorney with Ropes & Gray LLP, offered a more realistic, albeit cynical, perspective.
“My clients ask us what can I do, not what can't I do,” she said.
Which may just be another way of asking what can be done to circumvent current standards, regulations, and laws.
Proceedings Published in February
The Cleveland Clinic plans to publish the proceedings from the conference as a supplement to the Cleveland Clinic Journal of Medicine in February 2007.
The conference was sponsored by the Kauffman Foundation of Entrepreneurship, the American College of Radiology, and the American Society of Colon and Rectal Surgeons.