Public debate may change industry’s role in continuing medical education

Over the past few years, continuing medical education has come under public scrutiny over perceived industry bias.

Critics have charged that industry support of continuing medical education (CME) allows too much influence over the medical profession by the makers of drugs, devices and diagnostic products and others who make a profit from medicine. This influence, they claim, has allowed profit-motivated companies to drive physician decision-making, which may harm the profession and the treatment of patients.

Edward J. Holland, MD, secretary for the AAO annual meeting, addresses the questions surrounding industry relationships and potential conflicts of interest. Image: Holland EJ

The criticism has spurred a maelstrom of activity in the CME world: Congressional subcommittees held public hearings and investigations, education accrediting bodies suggested new measures to help assuage fears, medical organizations released updated ethical guidelines, industry proposed changes to the way it would interact with physicians, and education providers defended the programs they believe serve the public.

Although the debate is still ongoing, medical societies such as the American Academy of Ophthalmology have found themselves in a reactionary position and have enacted new policies in an effort to build additional transparency.

The AAO, in planning for the annual meeting, felt obligated to re-address the questions surrounding industry relationships and potential conflicts of interest, according to Edward J. Holland, MD, secretary for the AAO annual meeting.

In the planning committee’s view, disassociating with presenters who had industry relationships would be injurious to the advancement of good science and education. Instead, it was decided that complete transparency was the best possible solution for resolving the appearance of bias.

“We cannot eliminate conflict of interest, and if we were to limit ourselves to speakers without relationships, we would not be presenting the most cutting-edge information,” Dr. Holland said.

Public debate

Much of the CME debate centers on whether industry support of education creates undue influence on educational efforts. In January 2008, the Josiah Macy Jr. Foundation, a patient advocacy group, released a report claiming that industry distorted continuing education and that the current status quo places faculty in a situation in which they are paid by industry interests.

The Conflict of Interest in Medical Research, Education, and Practice Committee of the Institute of Medicine, which is funded in part by the Macy Foundation, held a series of meetings in 2007 and 2008. Among the considerations of the committee are proposals to disallow industry support of educational activities and to investigate conflict of interest issues in research as well as CME. The committee is expected to publish a report from these meetings soon.

In March 2008, the North American Association of Medical Education and Communication Companies (NAAMECC), a trade group for medical education companies, presented information on conflicts of interest and delivered oral testimony reaffirming its belief that industry support of education is beneficial to patients and physicians.

To NAAMECC and others, the knowledge gap created by advancements in science calls for increased educational opportunities, and the possibility of removing commercial support would do more harm than good.

Karen Overstreet

“Commercial support facilitates about half of the education that takes place in this country. If we just take commercial support away, there’s going to be a huge void,” Karen Overstreet, EdD, RPh, FACME, CCMEP, a past-president of NAAMECC, said in an interview.

“The government’s not likely to step in. Institutions that are already cutting budgets are not going to be able to provide more funding for their own departments. So I think there would be a huge deficit in quality education if commercial support were to go away,” Dr. Overstreet said.

In oral testimony to the Institute of Medicine, Dr. Overstreet defended the role of NAAMECC’s member companies in the CME realm, saying that “according to ACCME data, [medical education and communication companies] are the compliance leaders in this industry, exceeding the performance of medical schools and medical societies in virtually every standard of regulatory compliance.”

Standards exist

According to Dr. Overstreet, the stance of NAAMECC in the ongoing debate is based in part on a belief that standards and practices already in place are enough to manage potential conflicts of interests. In addition, those standards have not been in place long enough to bear fruit, either good or bad.

The Accreditation Council for Continuing Medical Education (ACCME) last updated its Standards for Commercial Support in 2007. The ACCME announced in December that it had just completed its accrediting reviews of the first cohort of education providers under the revised guidelines.

“Those accreditation standards and criteria have not been enacted long enough for people to evaluate the outcomes and see if they are working,” Dr. Overstreet said. “I think people are acting under the assumption that commercial support leads to bias, but there is no credible evidence to support that hypothesis.”

Despite the existence of CME standards, the Council on Ethical and Judicial Affairs of the American Medical Association introduced a report at the AMA House of Delegates’ June 2008 meeting sharply criticizing industry’s role in medical education. The report offered sweeping changes in the way education is conducted, including the expulsion of industry-supported medical education and severe limitations on marketing activities at medical schools and teaching hospitals.

The AMA governance opted to refer the report back to the Council on Ethical and Judicial Affairs for further review, but later that same month, a different set of guidelines was adopted by the Executive Council of the Association of American Medical Colleges (AAMC).

According to the AAMC, a group that represents accredited U.S. medical schools, teaching hospitals, and academic and scientific societies, industry support of education should be filtered through a central CME office in each institution. The AAMC guidelines also discourage faculty participation in speaker’s bureaus and suggest that academic medical centers ban gift giving to physicians, students and staff.

Questioning interactions

Additional suggestions for changing the way industry interacts with education providers came from the ACCME. At its June board of directors meeting, the ACCME released three proposed policy changes for public comment: to consider banning accredited providers from receiving communication from industry on CME topics; to consider stopping all industry support of educational activities and create a new paradigm for funding; and to consider stopping physicians on speaker’s bureaus from lecturing at CME activities.

Response to the policy proposals came from all sectors. In written responses published on the AACME’s Web site, the NAAMECC called the suggestion to end commercial support “seriously flawed, and if adopted, may well cripple the ongoing viability of the CME enterprise.” In reference to the proposal for initiating a new paradigm for CME funding, the NAAMECC responded that it was “ambiguous and unworkable and, in any event, beyond the ACCME’s authority.” The trade group also suggested that the ACCME’s own standards are in their infancy and that time should be afforded before they are changed again.

The AMA separately questioned “what value the proposed policies add to the current process.” The group also held that standards and practices already in place adequately address industry interactions in CME, including AMA’s own ethics opinions on the matter.

The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents pharmaceutical research and biotechnology companies, said that “recent changes made by both the ACCME and PhRMA in our respective Standards for Commercial Support and Code on Interactions with Healthcare Professionals

further promote the independence of CME from commercial bias and that more time is needed for full implementation and assessment of their impact before further changes relating to commercial support of independent education are contemplated.”

Essentially, PhRMA echoed calls from other parts of the education industry to allow new standards to take effect before they are changed again.

“Before ACCME goes and makes what might be some significant changes in their guidelines that can have a real impact on the kinds of activities that are provided, let’s just take a breath for a minute and let our new code take effect, and let’s let ACCME’s new guidelines take effect,” PhRMA Vice President and Deputy General Counsel Ann Kaplan explained.

“Some of the changes that ACCME is proposing, including their new paradigm that would provide for maybe a government agency to determine what the educational needs are, to have specific national organizations develop curriculum, and the various kinds of aspects to that new paradigm, could reduce the kinds of CME that would be provided both with respect to the scope of offerings in connection with diseases and new developments as well as meeting all regional and local needs,” Ms. Kaplan said.

Additionally, the ACCME suggestion that industry sponsorship in and of itself creates bias stands in contrast to the available evidence, according to Ms. Kaplan.

An example of this is found in the ACCME’s own study, also released in June, finding insufficient evidence to conclude that CME activities are biased. The study conceded that activities funded by commercial interests can influence prescribing patterns, but that the evidence to reach this conclusion predates the publication of ACCME’s updated standards, does not clearly establish whether changes in behavior are negative, and is consistent with the established evidence showing that CME can change physician behavior to positively improve patient care.

Changing interactions

Another significant development in 2008 that will affect how CME is conducted is in the form of updates to guidance documents by leading industry groups on interactions with physicians. In announcing the updated code, which took effect in January, PhRMA said it was continuing efforts to ensure that pharmaceutical marketing practices comply with the highest ethical standards.

As it pertains to education, the code allows companies to provide medical textbooks, journal subscriptions and patient education items of less than $100 in value but bans gifts to physicians of non-educational practice related items or items that might have personal value “outside of his or her professional responsibilities.”

PhRMA updated its voluntary guidance to its members to state that companies should be permitted to list or report CME topics they are willing to fund, but that companies should not influence in any way the content or selection of faculty members.

“Industry has a role in supporting CME. They feel they are players in the health care arena and, as such, have an obligation to help educate physicians,” Ms. Kaplan said. In addition to funding independent CME, “there is real value to the other interactions that occur between pharmaceutical manufacturers and health care professionals in terms of information about products, the feedback that companies get on the use of the product or ideas for developing new products. There is value there, so we want them to be done in a legal and ethical way.”

Another industry group, the Advanced Medical Technology Association (AdvaMed), a group representing device and diagnostic product manufacturers and developers of health information systems, announced an update and significant expansion to its Code of Ethics on Interactions with Health Care Professionals in December. The revisions are set to take effect in July.

Like the PhRMA code, the AdvaMed code is voluntary and updates existing guidance to members while seeking to preserve potentially valuable physician-industry relationships.

“AdvaMed’s had a code of ethics since 1991 and a sustained commitment to compliance and to ethical interactions with physicians and health care workers since that time,” Christopher L. White, AdvaMed executive vice president, general counsel, said. “We wanted to preserve the appropriate relationships between medical device manufacturers and those who would sponsor bona fide educational activities, but we recognize that there needs to be some additional rigor provided relative to the forms of support.”

Among the measures addressed in the voluntary code are a prohibition on the distribution of branded non-educational items, such as coffee mugs and pens, and limits on the types of meals that industry sales representatives can give health care providers.

“We recognize that our industry has come under criticism for some of these token objects, as nominal as they may appear. For that reason, we thought it was important to remove any appearance of impropriety whatsoever,” Mr. White said.

The code also states that industry has a responsibility to provide product training and education. According to Mr. White, that role is particularly germane to AdvaMed’s member companies that make products with a shorter average life cycle than other industry sectors and where there is a need to train and retrain on sophisticated technologies.

“Medical device companies have an ethical obligation to provide product-related training and education, particularly for advanced technologies where surgeon technique or hands-on interaction with the technology is critical to a successful health outcome. In some cases, it’s a condition of FDA approval,” Mr. White said.

Striking a balance

According to Roger F. Steinert, MD, program chair for the American Society of Cataract and Refractive Surgery and an OSN Cornea/External Disease Section Member, increased transparency has led to positive changes in educational activities.

Roger F. Steinert

For example, ASCRS has proactively instituted a mandatory online training course for all participants in its annual meeting in San Francisco in April. The course teaches and then tests participants on the essentials of proper CME content and the avoidance of conflict of interest. “We have received many compliments and few complaints about this new requirement,” he said.

“I think most of our colleagues welcome a de-commercialization of the program activity to which they are exposed. While we have become more sophisticated at recognizing commercial influence, and in many cases we react so strongly that such tactics may backfire on a manufacturer, we prefer not to have to guess at these conflicts, nor have valuable education time taken up by poor presentations,” Dr. Steinert said.

Industry, however, will continue to play an important role in education. “Only through partnerships with industry have millions of people each year received the benefit of the many breathtaking advances that we provide each day.

“The immediate concern is that industry is reducing funding of educational activities that have been beneficial, on the balance,” he said. “How will we make this up? How much higher will meeting registrations fees have to go — and how will physicians with declining incomes be able to afford them?”

Dr. Steinert said physicians must always consider what is best for the patient, and in the end, industry relationships have helped many more patients than they have hurt.

“Has there been abuse? No question,” he said. “We must be concerned, both about abuse of relationships, which is intolerable, but also about over-regulation that impairs education and innovation.”

AAO meeting presentations

At the AAO annual meeting, ophthalmologists will notice some changes in the meeting format that reflect, in part, the ongoing debate regarding industry support of CME. According to Dr. Holland, an OSN Cornea/External Disease Section Member, the most pertinent question to the AAO board is whether the organization should allow physicians with financial relationships to participate in CME activities.

When faced with that question, Dr. Holland said, the planning committee saw three possible solutions: to ignore the question altogether, to disallow speakers with financial relationships, or to build transparency into the system and allow audience members to judge bias for themselves. The AAO opted for the most inclusive solution.

“Financial relationships should not restrict presentation or publication, provided there is disclosure of the financial relationship,” Dr. Holland said.

According to a poll conducted by the AAO, the transparency that has been built into the system has already had a positive effect. In meeting presentations, participants felt there was less bias than 3 years ago. According to Dr. Holland, the key to that change is transparency.

The AAO felt that it could not eliminate speakers with relationships and still maintain the highest educational offerings. According to another AAO analysis of all of the presentations at the 2007 annual meeting – lectures, videos, posters and papers – 51% of all senior presenters had some financial interests. Some of those interests involved participation on speaker’s bureaus or marketing activities, but also included faculty with research arrangements with industry. Eliminating speakers with relationships would exclude some potentially valuable speakers

“If someone uses a product in a clinical trial, they’re going to be the best source of information. And participation in a clinical trial is a financial relationship,” Dr. Holland said.

To increase transparency, the AAO has instituted new policies for all presenters. All speakers must disclose relationships as part of a presentation, and if they do not, the presentation will be rejected. All relationships are also listed in the meeting’s program book.

In addition, those who give oral presentations must also verbally acknowledge financial interests during the presentation.

“The attendees want to know about relationships,” Dr. Holland said. “Transparency has been well received by our members. Additionally, we try to balance presentations with other speakers so all sides of the issue are presented.”

According to Dr. Holland, the AAO believes these changes are enough to allow audience members to make up their own minds and reinforce the trust the AAO must maintain with its audience. In the end, transparency at public meetings also helps maintain the trust physicians must earn from their patients.

In the future, the AAO, like the rest of the medical education enterprise, may institute new policies regarding bias or physician relationships with industry. Those changes may be voluntary, or if lawmakers step up efforts to regulate the industry, policy edicts may be mandatory. – by Bryan Bechtel and Matt Hasson

Why should ophthalmology, and medicine in general, concern itself with questions surrounding industry-physician relationships?

References:

• Accreditation Council for Continuing Medical Education. ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities. 2007. http://www.accme.org/dir_docs/doc_upload/68b2902a-fb73-44d1-8725-80a1504e520c_uploaddocument.pdf. Accessed Jan. 8, 2009.
• Accreditation Council for Continuing Medical Education. Policy Announcements and Calls-for-Comment 06/11/08. 2008. http://www.accme.org/dir_docs/doc_upload/d6b96a50-084c-485b-b71a-6b405b9c07d8_uploaddocument.pdf. Accessed Jan. 8, 2009.
• Accreditation Council for Continuing Medical Education. Responses to the ACCME Summer 2008 Calls-for-Comment 10/20/08. 2008. http://www.accme.org/index.cfm/fa/news.detail/News/.cfm/news_id/03a0d60f-92aa-4051-ac1a-0513429f2f5a.cfm. Accessed Jan. 8, 2009.
• Advanced Medical Technologies Association. Code of Ethics on Interactions with Health Care Professionals. 2008. http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081-B219-12D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestated Effective20090701.pdf.
• Accessed Jan. 8, 2009. American Medical Association Council on Ethical and Judicial Affairs. Industry support of professional education in medicine. http://www.ama-assn.org/ama1/pub/upload/mm/471/ceja1-2.doc. Accessed Jan. 8, 2009.
• Association of American Medical Colleges. Industry funding of medical education report of an AAMC task force. 2008. https://services.aamc.org/publications/showfile.cfm?file=version114.pdf&prd_id=232&prv_id=281&pdf_id=114.
• Accessed Jan. 8, 2009. Cervero RM, He J. The relationship between commercial support and bias in continuing medical education activities: a review of the literature. 2008. http://www.accme.org/dir_docs/doc_upload/aae6ecc3-ae64-40c0-99c6-4c4c0c3b23ec_uploaddocument.pdf.
• Accessed Jan. 8, 2009. Hager M, Russell S, Fletcher SW, eds. Continuing Education in the Health Professions: Improving Healthcare through Lifelong Learning. 2008. http://www.josiahmacyfoundation.org/documents/pub_ContEd_inHealthProf.pdf.
• Accessed Jan. 8, 2009. Pharmaceutical Research and Manufacturers of America. Code on interactions with healthcare professionals. 2008. http://www.phrma.org/files/PhRMA%20Marketing%20Code%202008.pdf. Accessed Jan. 8, 2009.

• Edward J. Holland, MD, can be reached at Cincinnati Eye Institute, 580 South Loop Road, Edgewood, KY 41017; 859-331-9000; e-mail: eholland@fuse.net.
• Ann Kaplan can be reached at PhRMA, 950 F St. NW, Suite 300, Washington, DC 20004; 202-835-3400; e-mail: akaplan@phrma.org.
• Karen Overstreet, EdD, RPh, FACME, CCMEP, can be reached at Indicia Medical Education, 1120 Welsh Road, Suite 125, North Wales, PA 19454; 215-855-9090; e-mail: karen.overstreet@indiciaed.com.
• Roger F. Steinert, MD, can be reached at the Gavin Herbert Eye Institute at University of California, Irvine, 118 Med Surge I, Irvine, CA 92697-4375; 949-824-8089; e-mail: steinert@uci.edu.
• Christopher L. White can be reached at AdvaMed, 701 Pennsylvania Ave. NW, Suite 800, Washington, DC 20004; 202-783-8700; e-mail: cwhite@advamed.org.