Senator Wants APA Records of Drug-Industry Interactions

The ranking Republican member of the Senate Finance Committee has asked APA to provide detailed information about its relationships with the pharmaceutical industry.

Sen. Charles Grassley (R-Iowa) last month requested in a letter addressed to APA Medical Director James H. Scully Jr., M.D., “an accounting of industry funding that pharmaceutical companies and/or the foundations established by these companies have provided” to APA, “including but not limited to grants, donations, and sponsorship for meetings or programs.”

The request covers the period from January 2003 to the present.

Grassley's request is the latest instance of the rapidly escalating public interest in—and scrutiny of—financial relationships between medicine and the pharmaceutical industry. Similar letters were sent by Grassley in January to the American College of Cardiology and the American Heart Association.

Separate from the request for information from APA, Grassley has also asked Stanford University for information on its conflict-of-interest policies and on disclosures made by APA President-elect Alan Schatzberg, M.D., about his involvement with pharmaceutical manufacturers. In a detailed response, Stanford said that all of Schatzberg's earnings have been properly disclosed, and Grassley's staff later acknowledged that at least one charge he leveled against Schatzberg about undisclosed income was in error (see Original article: Schatzberg Met Disclosure Requirements, Stanford Says).

In response to the request to APA for information, APA President Nada Stotland, M.D., M.P.H., said APA has nothing to hide.

“We intend to comply with the letter and spirit of Senator Grassley's request,” she told Psychiatric News. She added that Grassley's letter, dated July 10, had asked for the information no later than July 24—a deadline she said had been impossible to meet to collect all the information he requested. APA asked for, and received, an extension of the deadline until September 2.

Upon receipt of Grassley's letter, Stotland disseminated a memo to the APA membership. It read, in part: “[R]ecent public focus on relationships between medicine and the pharmaceutical industry is a challenge for the whole field of medicine. APA fully endorses the concept of transparency in our relationships with pharma and other entities and has been in the forefront of the disclosure process.... We are proud of what we do.”

Speaking to Psychiatric News, Stotland reiterated those points, saying that in the area of monitoring conflicts of interest, “APA is in many ways way ahead of the curve.” She especially cited the processes and policies in place for vetting potential appointees to the DSM-V Task Force and for monitoring the content of industry-supported symposia at APA meetings.

She also noted that in March the Board of Trustees empanelled a work group charged to review all APA pharmaceutical revenues, sort them into categories, and provide the Board with options for ending pharmaceutical support in each category and the implications for the activities they currently fund.

Publicity Focuses on Psychiatry

Grassley, in his letter to APA, requested that all information be produced in a table detailing pharmaceutical income by year, company name, amount of funding, and reasons the funding was provided. He also asked for a description of “policies for accepting industry funding and whether or not the APA allows companies to place restrictions or provide guidance on how funding will be spent.”

A press representative for Grassley told Psychiatric News that the senator's investigation was not solely focused on psychiatry. “His focus is on transparency in the relationship between medicine and the pharmaceutical industry,” the press officer said.

But in June, one month before Grassley's letter, the New York Times featured an article alleging that psychiatric researchers at Harvard Medical School may have failed to properly report drug-industry funding they received.

Also, an analysis by the state's attorney general of pharmaceutical monies given to doctors in Vermont found that among the 100 Vermont physicians receiving the largest amount of money from drug manufacturers, 11 were psychiatrists, and they had received a total of $626,379. That total was greater than the totals for any other group of specialists on the list, according to the attorney general's report. (In 2002, Vermont became the first state in the nation to require pharmaceutical companies to disclose their gifts and cash payments to doctors, hospitals, and other health care providers.)

But Stotland and other APA leaders who spoke with Psychiatric News pointed out that though the 11 psychiatrists who were among the top 100 recipients of pharmaceutical funds received the largest total amount of money, it should not be inferred that psychiatrists generally in Vermont or elsewhere were receiving more money than other physicians—as the New York Times seemed to report on June 27.

The paper ran a correction on July 3 in which it stated that the average dollar figure the newspaper had reported for psychiatrists receiving pharmaceutical money applied only to the 11 psychiatrists in the top 100, not to all psychiatrists in the state.

“The issues of conflict of interest and relationships with industry transcend all the specialties and are by no means limited to psychiatry,” said Paul Appelbaum, M.D., past chair of APA's Council on Psychiatry and Law and a past president of APA.

He added that for some specialties, such as cardiology and orthopedics, the issue of industry collaboration extends beyond pharmaceuticals to devices and technology. “I find it hard to believe that psychiatrists are any more prone to this kind of involvement than other specialties,” Appelbaum said.

APA Long Sensitive to Issue

APA leaders who spoke with Psychiatric News generally agreed with Stotland that the Association has been diligent about monitoring conflict of interest at the organizational level well in advance of the current intense public scrutiny and that individual problems around conflict of interest are pervasive throughout medicine. (For more information about APA's relationship with the pharmaceutical industry, see “From the President” in the July 18 issue and “APA Enforces Strict Rules to Keep Bias out of CME” in the April 4 issue.)

Michael Jibson, M.D., chair of APA's Committee on Industry Relations, which is responsible for monitoring the content of industry-supported symposia at APA meetings, said APA's efforts in this area are “pretty heroic.”

In keeping with requirements by the Accreditation Council on Continuing Medical Education, pharmaceutical companies are not allowed to determine the subjects for symposia—those are decided by the Scientific Program Committee—but can choose only from a menu of subjects if they want to sponsor a session.

Additionally, since 1998 APA has monitored the content of industry-supported symposia at the annual meeting and the Institute on Psychiatric Services through its Resident Monitoring Program. Psychiatry residents attend the symposia and, using guidelines developed by APA's Department of CME and Committee on Commercial Support, monitor the balance in each presentation, disclosure of conflicts of interest by faculty, use of generic vs. brand names, discussion of unapproved or investigational uses, and bias toward the supporting-company's products.

“[The process] is rigorous, and it's unusual to find anything that is objectionable,” Jibson told Psychiatric News. “We have everything audiotaped so that if a question is raised about someone saying something that was not supported by the general literature, we can go back and review it.”

But while APA's policies for monitoring conflict of interest at the organizational level may be advanced, Stotland and others agreed that standards and expectations around conflicts of interest in medicine are evolving as public scrutiny mounts and that further refinements of policy may be needed.

Appelbaum said that some organizations, such as the American Academy of Child and Adolescent Psychiatry, are moving toward developing conflict-of-interest guidelines for individual clinicians.

“There are two separate loci for monitoring clinicians in this area,” he said. “One is at the medical school and hospital, where there is the greatest potential for overseeing relationships. The other is at the level of professional organizations like APA, which obviously have less leverage in terms of regulation but can certainly develop guidelines for their members. It may be appropriate for APA to do that as well,” he said.

The report on Vermont physicians is posted at<www.atg.state.vt.us>.▪