Senate Investigations Spread to APA and ACCME

Both the American Psychiatric Association (APA) and the Accreditation Council for Continuing

Medical Education (ACCME) are embroiled in the widening Senate investigations of pharma’s possible influence on CME in particular and on medicine in general.

In a July 10 letter to James Scully Jr, MD (APA’s medical director and chief executive officer), Senator Charles Grassley (R, Iowa), a ranking member of the Senate Finance Committee, explained that the committee was investigating various aspects of the pharmaceutical industry, including consulting arrangements and industry funding for CME. Both he and members of the Senate committee staff, he said, have seen documentation of strong ties between pharma and nonprofit organizations.

“Specifically, it is alleged that pharmaceutical companies give money to nonprofits in an attempt to garner favor in ways that increase sales of their products,” he said. Senator Grassley then asked APA for an accounting of industry funding (eg, grants, donations, sponsorship for meetings) that pharmaceutical companies and/or the foundations established by these companies have provided to APA since January 2003. He also requested that APA describe its policies for accepting industry funding and to submit everything by July 24.

APA’s views

Commenting on Senator Grassley’s letter, APA’s president, Nada Stotland, MD, MPH, told Psychiatric Times, “The APA supports full transparency and disclosure regarding relationships between medicine and industry.”

She explained that Senator Grassley’s letter was presented to APA’s Board of Trustees at a regularly scheduled board meeting in July and they, along with the staff, agreed to “comply fully” with the Senator’s request for information. The APA asked for an extension to September 2.

“We had much of the general information at the APA office, but details of programs, such as agreements between pharmaceutical companies and us for each activity, are often archived off-site,” she said.

“We are proud of our punctiliousness in our relationships with the pharmaceutical industry and are not aware of any rules broken. Certainly, our intention is to obey all the rules and even anticipate them,” said Stotland, professor of psychiatry at Rush Medical College and also in private practice.

APA’s most recent reaccreditation (ACCME) was for 6 years-the maximum awarded any group-and APA procedures for addressing competing interest and working with industry received positive recognition.

The drug industry accounted for 29% of APA’s $62.5 million in financing in 2006 (the latest year for which numbers are available), according to data confirmed by APA’s press office. Some 15% was from advertising in APA journals and exhibits at the annual meeting. Another 8% was unrestricted funding for research fellowships and resident conferences, and 6% was from industry-supported symposia at the annual meeting. APA reported netting about $3.7 million from pharmaceutical funding.

Stotland emphasized that APA’s review of its revenues from pharma antedates Senator Grassley’s request.

People and organizations with the most integrity are always questioning their integrity, she said, noting that the aphorism definitely applies to APA. Last March, she explained, APA’s board established a Work Group on Adapting to Changes in Pharmaceutical Revenue, headed by Jeffrey Geller, MD, MPH, professor of psychiatry and director of Public Sector Psychiatry at the University of Massachusetts Medical School. The group was charged with reviewing all APA pharmaceutical revenues; sorting those revenues into categories (eg, industry-support symposia, exhibits, journal advertising and fellowships); examining all APA activities-not just the activities supported by pharma; and determining the costs related to each.

Stotland expects the working group to report its findings by October. The board will then consider whether it wants to recommend diminishing or ending pharmaceutical funding in specific categories while identifying other ways to pay for the activities they support. She anticipates decisions at the board’s March 2009 meeting.

In discussions with APA members and leaders, Stotland said that those who call for elimination of all pharma funding for APA often express very different views once the issue is “unglobalized.” For instance, she said, they do not object to pharmaceutical advertising in APA’s journals or pharma’s support for research training for minority residents.

When Stotland was asked to spec­ulate about why Senator Grassley seems to be spotlighting psychiatry [see the August issue of Psychiatric Times], she replied that because psychiatric medications are widely prescribed, the Senator may be looking at their impact on costs to Medicare and Medicaid programs over which the Senate Finance Committee has jurisdiction. The problem is that psychiatrists are not the ones prescribing most of those psychotherapeutic medications-“a fine but important distinction,” she said. She also said it may relate to the continuing stigma that surrounds psychiatry.

The relationship between medicine and the pharmaceutical industry is a challenge for the whole field of medicine, Stotland believes.

“APA has been a leader with regard to disclosure, and along with all branches of medicine, we will continue to examine and refine the rules governing disclosure,” she said.

She noted that APA signed a letter sent by the AMA that supported the Physician Payments Sunshine Act of 2007 (S 2029), introduced by Senators Grassley and Herb Kohl (D, Wis). The bill, according to Grassley, “would require companies to report payments that they make to doctors.” It would cover manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or the State Children’s Health Insurance Program (SCHIP).

Verifying disclosures

More of Stotland’s views on disclosure of possible conflicts of interest (COIs) and verification of those disclosures were presented in her “From the President” column in the July 18 Psychiatric News.

“If pharmaceutical companies publish information about all payments to physicians, that would be one source, but how would we know whether it is accurate? And pharmaceutical companies are not the only sources of support that pose COI questions,” she wrote. “Is it reasonable to ask APA to go through the tax returns of every DSM participant and every member of every committee, the Assembly, and the Board? Would the tax returns even be sufficient? Money often passes through CME organizations, medical schools, APA district branches, and other intermediaries between its source and its recipient.”

In addition, she discussed the COI questions surrounding selection of participants who are developing the DSM-V.

“The director of the DSM-V pro­cess gave up his pharmaceutical income for the duration. After reviewing the disclosure forms of the federal government and major universities, we developed a disclosure form that takes up to 8 hours to complete. There is no established standard; we set a limit of $10,000 a year of pharma income per participant,” she wrote.

Many of APA’s disclosure policies and monitoring procedures were described last March when then APA president Carolyn Robinowitz, MD, submitted a statement to the Institute of Medicine (IOM) Committee on Conflict of Interest in Medical Research, Education, and Practice.

For example, Robinowitz described the procedures of APA’s Committee for Commercial Support (CCS) as they pertain to APA’s annual meeting. Those procedures included having the CCS preview slides for in­dustry-supported symposia for bias before the meeting and having monitors attend the industry-supported sessions to watch for commercial bias and for compliance with APA commercial support procedures.

APA has not changed any COI procedures since the IOM statement was submitted, according to Stotland.

Despite the focus on industry funding of APA activities and psychiatrists, Stotland commented to Psychiatric Times, “We hope that this investigation will not deter people from seeking and receiving necessary mental health care nor impede the tremendous progress we have made in providing that care and alleviating suffering for millions.”

ACCME’s response

In late June, Senator Kohl requested that ACCME provide by July 7 information on “the accreditation process for CME courses; any criteria the ACCME uses, as part of the accreditation process, regarding the scientific validity of course content; any mechanisms the ACCME has in place to ensure that no undue influence by any industry is being exerted through CME courses; and any further plans the ACCME may have in place to develop such mechanisms.”

Kohl wrote Murray Kopelow, MD, MS, FRCPC, ACCME’s chief executive, that his committee was particularly concerned about “instances where drug companies use CME courses to encourage physicians to use their products for potentially controversial medical practices.”

In mid-July, ACCME submitted its response to the Senate Special Committee on Aging and posted that response on ACCME’s Web site.¹

ACCME addressed the areas requested by the committee and then discussed its plans to develop other mechanisms to ensure “no undue influence by any industry is being exerted through the courses.” Those plans included:

• Development of new capabilities for maintaining a CME activ-ity database that will provide a new source of information for ACCME’s newly emphasized oversight processes.

• Requirement that accredited pro­viders transmit to ACCME an enhanced data set of information that describes each CME activity through a Web-based portal or direct transmission of appropriately formatted spreadsheets.

• Requirement that accredited pro­viders measure for commercial bias and content validity and report their results in real-time through a Web portal.

• Closer scrutiny of approximately 100 ACCME providers that receive most of the commercial support.

• Giving due consideration to the possible elimination of commercial support of CME.

Because of the many questions raised about commercial support and its possible effects on CME, ACCME recently commissioned a review of the literature on the subject. The review, prepared by Ronald Cervero, PhD, and Jiang He, MPA, of the University of Georgia’s Department of Lifelong Education, Administration and Policy, is posted on ACCME’s Web site.² It includes abstracts of 10 studies on commercial funding and CME.

References:

References

1. Accreditation Council for Continuing Medical Education Web site.

http://www.accme.org/dir_docs_upload/6d4d0864-2f45-4185-975c-cd8954feb966_uploaddocument.pdf

. Acces­sed August 5, 2008.

2. Cervero RM, He J. The Relationship between Commercial Support and Bias in Continuing Medical Education Activities: A Review of the Literature. Published June 2008.

http://www.accme.org/dir_docs/doc_upload/aae6ecc3-ae64-40c0-99cb-4c4coc3b23ec-uploaddocument.pdf

. Accessed August 5, 2008.