1 Boring Old Man

AAMC Reporter: June 2010

New Conflict of Interest Rules Help Spur Financial Disclosures Online
Association of American Medical Colleges
By Scott Harris

^{With lawmakers and the public ever more vigilant of the conflicts of interest that may occur between private industry and the clinical and research communities, more medical institutions and companies are disclosing financial relationships online. No definitive lists exist, but informal Web analysis shows that pharmaceutical companies and academic medical centers are establishing Web sites to publicize and track physician-industry relationships. Academic medical institutions with disclosure Web sites include Stanford University School of Medicine, the Partners HealthCare system, Washington University in St. Louis School of Medicine, and the University of Pittsburgh Health Sciences Center. Pharmaceutical companies Pfizer, Eli Lilly, and Merck have also created sites to disclose their payments to physicians.}

^{"Over the past 20 years, there has been a shift in the framework of how we consider, manage, and perceive our relationships with industry," said Pascal J. Goldschmidt, M.D., chief executive officer at the University of Miami Health System and dean of the university’s Leonard M. Miller School of Medicine, which unveiled its disclosure Web site in April. "A drive behind this is the respect for human rights and the need for patients to understand any conflict a doctor might have in providing care. It seems the best way to address this is to start with full transparency. That requires patients to type the name of their doctor into their computer and determine whether the doctor has any conflict of interest they should be concerned about"…}

^{According to figures provided by the National Institutes of Health (NIH), relationships between researchers and industry encompassed 53 percent of all researchers in 2007, nearly double the 28 percent who had such relationships in 1996. The federal government is putting in motion a variety of efforts that will result in more disclosure of financial relationships within health care and medical education. Emerging regulations virtually guarantee that any academic medical center receiving federal research funds from Public Health Services agencies, including the NIH, will need to create a disclosure Web site in the relatively near future. On May 21, the Department of Health of Human Services (HHS) proposed rules that would require academic medical centers to report online the "significant financial interests" (generally defined as having a value of $5,000 or more) of investigators and other key personnel, if the interest is related to the researcher’s work and the institution determines that a financial conflict of interest exists. Each Web disclosure would be required to include the recipient’s name and position within the research project, and the specific nature and approximate dollar value of the financial interest.}

^{"Institutions will now be required to develop a publicly accessible Web site to display financial interests in order for the public to have a clear pathway for determining what kinds of financial interests exist," said NIH Director Francis S. Collins, M.D., Ph.D. "This may have some burden, but we believe it is essential to tighten up this process to ensure we are maintaining the public trust." According to AAMC Chief Science Officer Ann Bonham, Ph.D., the proposals closely mirror guidelines on managing financial interests that the AAMC and the Association of American Universities made to the NIH in 2008.}

^{"We are gratified to see that many of the AAMC’s earlier suggestions to the NIH are reflected in the proposed regulations," Bonham said. "Transparency is critical to the public’s trust in the research enterprise. The proposed requirement that institutions post information on financial conflicts of interest related to NIH-funded research on public Web sites contributes to that transparency. Many medical schools and teaching hospitals are already displaying this information online, and many more plan to do so"…}

^{Leaders at the Miller School of Medicine in Miami created a search engine that allows patients to find their doctor and his or her financial relationships. Richard J. Bookman, Ph.D., the school’s executive dean for research and research training and vice provost for research at the University of Miami, said user-friendliness is an essential component.}

^{"They might have a fragment of a name or a company, and we wanted to support searching for just that fragment," said Bookman, who added that the school might also add the ability to search by medical specialty. "Some sites are not very user-friendly, and we wanted to do better. If you want to know who on our faculty has a relationship with Pfizer or Novartis, for example, you can search for Pfizer or Novartis. If you want to know the relationships of an individual neurologist or oncologist, you can search on that person’s name."}

^{Goldschmidt said faculty are required to provide updated reports on their interactions each year, with failure to do so resulting in reprimand, suspension, or even dismissal. To this point, Goldschmidt said 95 percent of faculty have complied with the request. In the future, Goldschmidt said the site will begin publishing specific compensation amounts, although Bookman noted that school leadership and faculty are "still having discussions" about specifics. "There’s a balance between privacy and transparency, and we’re working to find that balance," Bookman said. "We want this process to run an appropriate course with the faculty." Bookman said the disclosure issue should precipitate dialogue, rather than unilateral rule-setting.}

^{"We do this for the outside world, but we also do it for our internal culture," Bookman said. "It’s a sea change. It makes people uncomfortable. It shines a light into an area that has previously been private. I see an internal process lasting a number of years in which faculty and staff engage in a dialogue about transparency. That a for-profit entity might seek advice from a faculty member is not intrinsically evil. It can be a very good thing. We need to move beyond the thou-shalt-nots. But at the same time, we need a transparent and unconflicted process"…}

Nemeroff Accepts Offer at U. Miami
EmoryWheel
By Kate Borger
11/20/2009

^{Goldschmidt said he recognizes that Nemeroff “has been the epicenter of significant investigations and scandals of conflict of interest and disclosure of University income” and that UM will take steps to ensure transparency in the future. “Dr. Nemeroff has committed fully to accept the rules of the University of Miami and to therefore provide all information relative to his out of University activities which will be very carefully reviewed by experts to make sure that the activities are in the interest of medicine, patients and the advancements of mental health sciences,” Goldschmidt said…}

^{Goldschmidt said Nemeroff has called this scandal a series of “honest mistakes” due to policy confusion. “He is remorseful for it because he realizes that it has had a negative impact,” Goldschmidt said. Goldschmidt said that Nemeroff has agreed to undergo a period of moratorium in which UM will analyze his activity…}

^{“There will be particular scrutiny of his activities to protect him and the institution and to take sure there is no bias in his work,” Goldschmidt said. Goldschmidt said that the progress of medicine must be aided by the economic world and that conflicts of interests are not always made transparent. “It is very unfortunate that there were these issues of disclosure, but it doesn’t take away from the fact that [Nemeroff] is a major leader in the field and will continue to be a major leader in the field,” Goldschmidt said…}