Organ[ization] Donors and Conflicts of Interest: Investigations Broaden

While Sen. Charles Grassley (R-Iowa) broadens his conflict of interest (COI) investigations to include mental health leaders and associations, the National Institutes of Health (NIH), teaching hospitals, universities, and mental health organizations are intensifying their vigilance and taking corrective actions.

Recently, Grassley sent a letter to NIH Director Francis Collins, PhD, MD, seeking National Institute of Mental Health (NIMH) records. Grassley noted that since 2008 he has released information demonstrating that “universities are not managing their professors’ financial conflicts of interest and that change is needed at NIH.” He cited cases involving NIMH-funded psychiatrists at Emory University, Stanford University, and Harvard University.

“Because I have uncovered so many problems at NIMH, I wonder if there is something in particular about this institute that leads to so many funding problems,” Grassley said. “In one particular case, the researcher from Emory who failed to report his outside income left Emory and is now at the University of Miami and still has NIMH funding.”

As ranking member of the Senate Finance Committee, Grassley requested e-mails, phone, records, and calendar for specified time periods for NIMH Director Thomas Insel, MD, as well as all communications and/or e-mails sent or received by NIMH staff regarding Senate investigations and/or COIs from June 1, 2008, to the present.

This is not the first time that Grassley has put an NIH director in his viewfinder. In 2007, Grassley and other members of Congress explored allegations of mismanagement at the National Institute of Environmental Health Sciences (NIEHS). The then director, David Schwartz, MD, MPH, eventually stepped aside.

NIMH response
NIMH declined to detail how the agency plans to respond to Grassley’s request, explaining it is involved in a “deliberative process and is working diligently with the senator to have this all resolved.” But in his director’s blog, Insel disputed some of Grassley’s assertions. He noted that the former Emory researcher has not received NIMH support since December of 2008 and that some researchers have been removed from projects.

In the summer of 2008, Insel said, NIMH notified every principal investigator about disclosure requirements and implemented “an aggressive approach to identify and prevent potential conflicts in our portfolio.” He added that NIH is working to strengthen federal regulations on financial COI to ensure greater transparency and accountability and “to prevent the introduction of bias in federally supported research.”

Federal regulations
Sally Rockey, PhD, NIH acting deputy director of the Office of Extramural Research, said changes in regulations are “a work in progress.” In the May 8, 2009 Federal Register, NIH on behalf of HHS issued an Advance Notice on Proposed Rulemaking on the responsibility of applicants for promoting objectivity in research for which Public Health Service (PHS) funding is sought. (RIN 0925-AA53 and Docket Number NIH-2008-0002).

Individual investigators, scientific societies and associations, and institutions that receive funding, among others, were asked for their opinions by July 7 on such issues as expanding the scope of the regulation and disclosure of interest, defining what is “significant financial interest,” identification and management of conflicts by institutions, assuring institutional compliance, and defining institutional COIs.

The American Association of Medical Colleges in its response noted that covered investigators should be required to report to institutions all of their external financial interests directly or indirectly related to their research responsibilities, regardless of amount, and that institutions should be required to submit information on managed COIs that goes beyond current regulatory requirements.

NIH is currently working on the Notice of Proposed Rulemaking. Publication will be followed by a 60-day public comment period, with the final rule expected by late summer of 2010, Rockey said.

Other efforts
In an effort to manage potential COIs, some institutions have taken proactive approaches. Under new rules that took effect January 1, high-ranking physicians and executives at Partners HealthCare, which includes Massachusetts General and Brigham and Women’s hospitals, can no longer receive stock or unlimited fees for sitting on the boards of biotechnology and pharmaceutical companies. The rules limit their pay to $500 an hour or $5,000 for a typical 10-hour day attending a board meeting. Additionally, Partners new COI policy bans physicians from traveling the country as a paid member of a drug company’s “speaker’s bureau.”

In mid-January, Stanford University announced plans to develop new continuing medical education programs for physicians that seek to “improve patient care while ensuring that corporate donors do not exert influence over the curriculum”

Under this model, Stanford will use a new, $3 million, 3-year grant from Pfizer to design and implement a novel curriculum that uses a variety of advanced technologies and teaching methods, including simulated and immersive learning tools. The grant comes with no conditions, and Pfizer will not be involved in developing the curriculum.

Targeting health organizations
In December of last year, Grassley asked 33 medical groups to submit accounting information dating back to January 2006, detailing grants, donations, and meeting sponsorships they received from the pharmaceutical, medical device, and insurance industries.

“These organizations have a lot of influence over public policy and people rely on their leadership,” Grassley said. “There’s a strong case for disclosure and the accountability that results.”

The list of identified groups included 7 mental health organizations: the American Psychological Association (APA), Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD), Depression and Bipolar Support Alliance (DBSA), Mental Health America (MHA), NARSAD, Screening for Mental Health Inc. (SMH), and the National Center for Mental Checkups at Columbia University (TeenScreen).

Earlier in 2009, Grassley sent letters to the National Alliance for Mental Illness’ national office and to state chapters asking them to disclose income from pharmaceutical companies. According to an October 22 New York Times article, pharmaceutical companies from 2006 to 2008 contributed nearly $23 million to NAMI. In his October 29 letter to the editor, Michael Fitzpatrick, NAMI’s executive director, said about “50 percent of NAMI’s total annual budget comes from pharmaceutical companies.”

Bob Carolla, NAMI’s director of media relations, said the organization has long had strict guidelines to govern corporate relationships and protect against COIs. Its Guidelines for Business Support Relationships are posted on its Web site.

“NAMI does not endorse any specific treatment or service,” he said, adding that the no endorsement policy is also part of NAMI’s public policy platform. With regard to corporate donors, Carolla said the organization has always made their names public.

“For competitive fundraising reasons, we did not disclose specific amounts until 2009, when we began to list corporate and foundation grants at or above $5,000 in a registry on NAMI’s Web site.”

Publication of the first quarter of 2009 contributions registry for NAMI national coincided with NAMI’s response to Grassley’s inquiry in April 2009. NAMI’s fourth quarter, 2009, listing of contributions revealed that the national organization received $1.7 million, the majority of which came from pharmaceutical companies.

In contrast to NAMI, Susan A. Craig, MPH, director of communications for the TeenScreen National Center for Mental Health Checkups at Columbia University, said the organization “has a policy of not accepting industry funding and has no affiliations with pharmaceutical companies.”

TeenScreen, she told Psychiatric Times, is funded entirely by private family foundations, individual donors and organizations committed to the early identification of mental illness in youth and the prevention of teen suicide.

In NARSAD’s December 8 response to Grassley, Benita Shobe, president and CEO, said the organization solicits industry funding for its educational programs but does not allow companies to place restrictions or provide guidance on how funding will be spent. It lists contributors of $1,000 and above in its annual report. In citing 2009 contributions from pharmaceutical, medical device corporations, and related foundations for Grassley, NARSAD said it received $134,201.

“NARSAD’s mission is to support research on mental illness.” Shobe said. “We fund research by scientists, and we do not use industry funding to support our scientists’ work.”

Steve Vetzner, spokesperson for MHA, said, “We believe in full disclosure and transparency of financial relationships between voluntary health agencies and corporate sponsors.”

MHA adheres to the transparency and disclosure guidelines of the Better Business Bureau and the National Health Council, Vetzner said, and funding sources are disclosed in its annual report posted on its Web site. Additionally, board members and top staff must disclose possible COIs.

E. Clarke Ross, DPA, CEO for CHADD, said that total pharmaceutical donation support of CHADD as of June 30, 2009 was 26.6% ($1,174,626). CHADD’s board established a ceiling of 30% from industry.

The organization was one of the first voluntary health associations to disclose revenues from pharmaceutical companies, he said, explaining that it posts IRS Form 990 (return of organization exempt from income tax) going back to 2001-2002, as well as income and expenditure reports and annual reports. In 2008, CHADD began reporting the amount and corresponding percent of all financial support from pharmaceutical companies, and in 2009 began listing the names of companies supporting specific projects.

We have a COI policy for board members and have posted ethical principles for CHADD’s acceptance of corporate and foundation support, Ross told Psychiatric Times.

A core, highly vocal minority of CHADD members believes voluntary health associations (VHAs) should not accept funds from pharmaceutical companies, according to Ross. Paradoxically, the current retrenchment of many pharmaceutical companies may support their efforts. Pharmaceutical companies, Ross said, are reducing their funding of VHAs, often with little notice, “causing stress to organizations which are trying to continue their mission of providing support and services.”