Over the past decade, the wall between doctors and the pharmaceutical industry has grown higher and wider. Concerns from the medical, governmental and public communities about prescribing bias and unethical influence have resulted in widespread re-evaluation of practices and relationships with industry.
In a 2009 position paper in the Journal of the American Medical Association (JAMA), David J. Rothman, PhD, of Columbia University, and a task force comprising former and current presidents and CEOs of professional medical associations and the JAMA editor recommended that professional medical associations “work toward a complete ban on pharmaceutical and medical device industry funding, except for income from journal advertising and exhibit hall fees.”
The AAN policy for managing relationships and conflicts of interest — delineated in a March 6 paper in Neurology — is more consistent with guidelines developed in 2010 and refined last year by the Council of Medical Specialty Societies (CMSS), an organization of 37 national medical specialty societies, including the AAN: it allows for some industry funding, as long as there is transparency and disclosure. AAN Executive Director and Chief Executive Officer Catherine M. Rydell, CAE, said she believes the AAN has been in the forefront of creating an ethical and open relationship between physicians and industry.
[Rydell, originally a member of the task force that authored the 2009 position paper in JAMA, agreed with many but not all of the principles proposed and withdrew her name from the final document with the approval of the AAN board.] “A lot of people have painted industry as the ‘evil empire’ that is trying to have undue influence, but generally I don't believe that's the case,” she said. “Pharmaceutical companies conduct critical research to find much needed treatments and cures. I would hate to see a world without their contributions to help patients. I think pharmaceutical companies are very concerned about any perception that they're trying to influence treatment or decision making. That's not in their best interest.”
There are four main strategies for addressing conflict of interest issues: avoidance, separation, disclosure, and regulation, according to the Neurology paper. The Academy has become much more strict in scrutinizing the disclosure statements of those serving on its board and committees, Rydell said. Those who speak to the media on behalf of the AAN are also evaluated and if their ties to the industry present too much of a conflict of interest, another speaker is found.
Disclosure statements are also required by all members of the board of directors and officers at the presidential level; the president, CEO/Executive Director and the editor-in-chief of the society's journal do not have direct financial relationships with industry.
Daniel Larriviere, MD, JD, is vice chair of the department of neurology at Ochsner Clinic Foundation in New Orleans and the current chair of the Ethics, Law and Humanities Committee, a combined committee of the AAN, American Neurological Association, and Child Neurology Society. He said it's a challenge for the AAN as an institution to find the appropriate balance, but that pharmaceutical funding is a reality in terms of support, whether it's journal ads or advertising at meetings.
“There are some educational advantages to having that input,” said Dr. Larriviere, one of the paper's authors who also serves on the editorial advisory board of Neurology Today. “There needs to be a way for information about products and devices to get to the membership, and that good has to be balanced against the potential to influence positions taken by the Academy and the integrity of the organization itself.”
Part of the challenge is finding a way to explain to the public how the relationship between industry and physicians work. Although Dr. Larriviere has no current industry ties, he did receive educational grants to help support his unfunded teaching time. Eventually, he found a way to do that without industry support.
Robert A. Gross, MD, PhD, professor of neurology at the University of Rochester Medical Center and editor-in-chief of Neurology, said that the field is slowly but surely moving in the right direction. When he became editor and a member of the AAN board of directors, Dr. Gross eliminated his relationships with industry.
“We don't want a world that is so clearly regulated that it means we don't have a good drug discovery pipeline,” he said. “But conflicts of interest are always present so there needs to be a highly transparent process.”
He said that it used to be common to see posters advertising dinners, or pharmaceutical representatives openly courting doctors, but no longer. There are specific roles where industry and physicians need to work together, however, with clinical trials. There would be no way for drug companies to run clinical trials without building their own hospitals and hiring their own physicians, he noted, and even then, their findings would be tainted, or at least perceived to be so.
The only way drug treatments can move forward, he said, is through the formal clinical trial process.
“The best defense against bias is a sound scientific method,” said Dr. Gross, adding that if doctors do take money for clinical trials, it should go to their institution and not for personal gain. “We require the registration of trials in advance, so outcome measures are predefined.”
Rydell pointed out that the Academy received 18 percent of its revenue from industry in 2009 and 17 percent in 2010, including journal advertising and meeting exhibit charges. The 2011 revenue is scheduled to be posted at the end of March. Information about industry revenue is publicly posted on the AAN site, underneath the membership section in Organizational Disclosure.
Information about individual physicians is not disclosed, she said. That is up to the doctor.
The AAN policy also addresses the role of industry in continuing medical education. Although the American Medical Association's Council on Ethical and Judicial Affairs suggested that zero industry involvement would be an “aspirational goal,” Rydell said compliance with the Accreditation Council for Continuing Medical Education guidelines ensures appropriate measures are taken to have transparency and prevent against undue influence.
She said that the Academy goes through many regulatory steps when requesting money for unrestricted grants for CME but that it is worth it to protect both physicians and patients.
“There cannot be a total separation, because patient care would suffer dramatically,” Rydell said. “The goal of all the disclosures is to make sure that interaction is transparent and clean.”
The neurologists interviewed agreed that, in large part, it was up to individuals to be honest on their disclosure forms.
“The journals would need to go out and hire squadrons of investigators,” said Dr. Gross. “We have no way of looking at every single form and reviewing every single conflict of interest.”
While the AAN and CMSS policies specifically addressed issues such as CME and gifting, the role of patients in the disclosure process is unclear.
Dr. Larriviere, of New Orleans, said physicians will need to come to terms with the fact that more patients will be asking them about their ties to industry as the information becomes widely disseminated. [See a related story in Neurology Today, “Industry Set to Disclose All Conflicts: How Will Patients and Their Neurologists React?”: http://bit.ly/zhh2rv]
Some physicians would not be comfortable trying to justify their relationships to their patients and will choose to preemptively divest themselves of industry ties. But he said a dialogue with patients about potential conflict-of-interest could have value in other ways.
“Patients who ask questions could change the relationship between a physician and the patient — it could make it a better relationship, but it also has the potential to end the relationship,” he said. “Many physicians receiving support from industry could demonstrate that they have a productive relationship and it's good for patients because it advances medical knowledge.”
“Patients may wish to continue the relationship with a physician who is engaged in important clinical research. Other physicians may have more difficulty explaining how their relationship with industry benefits patients and trying to so may create discomfort for both the patient and the physician. If they feel uncomfortable about explaining their relationship, maybe there's a reason to think about.”
For more on the AAN policy on pharmaceutical and device industry support, listen here for an interview with Ted Burns, MD, of the University of Virginia, and AAN Associate General Counsel John C. Hutchins, lead author of the March 6 paper in Neurology: www.aan.com/rss/index.cfm/getfile/AAN_2380.mp3