Policy and Medicine

AMA CEJA: AMA House of Delegates Passes Clarification to Align with ACCME Standards for Commercial Support

The American Medical Association (AMA), held it’s Interim Meeting, where the House of Delegates discussed, debated, and voted on several important recommendations.

Of importance to our readers and stakeholders in  continuing medical education (CME) community, the house also clarified the AMA’s ethical guidance on CME—the Council on Ethical and Judicial Affairs (CEJA) Report 1-A-11.  Specifically, CEJA recommended that Opinion E-9.011, which was last updated in 1996, be amended because “CME has evolved substantially, as have standards for the conduct of CME providers, such as those of the ACCME.”  In addition, CEJA pointed to its 1-A-11 Report, adopted in June 2011 and subsequently Opinion E-9.0115, as “developments” that led to updating E-9.011.  

The revisions to E-9.011 were made to ensure consistency among Opinions in the Code of Medical Ethics, to avoid unnecessary repetition of guidance set out in AMA policies and other standards for CME.  Revisions were developed in consultation with the Council on Medical Education.  The majority of the recommendations and changes made are consistent with the CEJA Report 1-A-11 from June 2011, and are also consistent with ACCME Standards for Commercial Support. 

The Guidelines for physician-attendees were edited for clarity, including replacing cross-references to E-8.061, “Gifts to Physicians from Industry,” with explicit guidance regarding subsidies for expenses of attending CME activities.  

Specifically, the modified position urges physicians to “decline any subsidy offered by a commercial entity other than the physician’s employer to compensate the physician for time spent or expenses of participating in a CME activity.” 

As a point of clarification this is already the practice for CME providers in certified CME.  While industry support of CME may allow physicians and health care providers to attend CME events for reduced registration costs—CME programs with commercial support are prohibited from using funds to fund a physician’s travel or expenses for a CME activity.  The Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support explicitly prohibit such activities, Specifically, Standard 3.12 states that: 

The [CME] provider may not use commercial support to pay for travel, lodging, honoraria, or personal expenses for non-teacher or non-author participants of a CME activity. The provider may use commercial support to pay for travel, lodging, honoraria, or personal expenses for bona fide employees and volunteers of the provider, joint sponsor or educational partner.  

In addition, Standard 3.9 states that “No other payment shall be given to the director of the activity, planning committee members, teachers or authors, joint sponsor, or any others involved with the supported activity.  Standard 3.10 states that “If teachers or authors are listed on the agenda as facilitating or conducting a presentation or session, but participate in the remainder of an educational event as a learner, their expenses can be reimbursed and honoraria can be paid for their teacher or author role only,”—thus their participation cannot be reimbursed.    

Industry trade codes, such as those by PhRMA and AdvaMed, as well as many professional medical associations, also have similar policies. 

Moreover, if a CME company who received support from a pharmaceutical company for an educational grant, paid for the travel or expenses to attend an activity, the federal government could view such payments as a “kickback” to the physician that induces him or her to prescribe the company’s drugs.   

What may be problematic about this newly adopted position is continuing education or training for medical devices.  As we have covered several times, the training of physicians on medical devices is highly technical and requires physicians to sometimes travel to a manufacturer to obtain the best form of education—often by the creator or innovator that invented the device.  If this newly adopted position does not provide flexibility for medical device training, the education of physicians may suffer due to the prohibitive costs that travel and lost patients may have.   

Other Recommendations  

Guidelines for faculty and sponsors were also updated to remove specific references to guidance from other entities (e.g., Accreditation Criteria, Standards for Commercial Support and related policies of the ACCME; Guidance on industry-supported educational activities from the FDA; and Code on Interactions with Healthcare Professionals of PhRMA). 

CEJA acknowledge that “Physicians should strive to further their medical education throughout their careers, to ensure that they serve patients to the best of their abilities and live up to professional standards of excellence.” 

Participating in formal CME activities is “critical to fulfilling this professional commitment to lifelong learning.”  As attendees of CME activities, physicians should: 

a)    Select activities that are of high quality and are appropriate for the physician’s educational needs.

b)    Choose activities that are carried out in keeping with ethical guidelines and applicable professional standards.

c)    Claim only the credit commensurate with the extent of participation in the CME activity.

d)    Decline any subsidy offered by a commercial entity other than the physician’s employer to compensate the physician for time spent or expenses of participating in a CME activity. 

Physicians should strive to further their medical education throughout their careers, for only by participating in CME can they continue to serve patients to the best of their abilities and live up to professional standards of excellence.  Fulfillment of mandatory state CME requirements does not necessarily fulfill the physician’s ethical obligation to maintain his or her medical expertise. 

Attendees.  

Guidelines for physicians attending a CME conference or activity are as follows: 

(1)  The physician choosing among CME activities should assess their educational value and select only those activities which that are of high quality and appropriate for the physician’s educational needs.  When selecting formal CME activities, the physician should, at a minimum, choose only those activities that

(a)  are offered by sponsors accredited by the ACCME, the American Academy of Family Physicians (AAFP), or a state medical society;

(b)   contain information on subjects relevant to the physician’s needs;

(c)  are responsibly conducted by qualified faculty;

(d)  conform to Opinion 8.061, “Gifts to Physicians from Industry.”

(2)  The educational value of the CME conference or activity must be the primary consideration in the physician’s decision to attend or participate. Though amenities unrelated to the educational purpose of the activity may play a role in the physician’s decision to participate, this role should be secondary to the educational content of the conference.

(3)  Physicians should credit commensurate with only the actual time spent attending a CME activity or in studying a CME enduring material.

(4)  Attending promotional activities put on by industry or their designees is not unethical as long as the conference conforms to Opinion 8.061, “Gifts to Physicians from Industry,” and is clearly identified as promotional to all participants. 

Faculty. 

Guidelines for physicians serving as presenters, moderators, or other faculty at a CME conference are as follows: 

(1)  Physicians serving as presenters, moderators, or other faculty at a CME conference should ensure that

(a)  research findings and therapeutic recommendations are based on scientifically accurate, up-to-date information and are presented in a balanced, objective manner;

(b)  the content of their presentation is not modified or influenced by representatives of industry or other financial contributors, and they do not employ materials whose content is shaped by industry. Faculty may, however, use scientific data generated from industry-sponsored research, and they may also accept technical assistance from industry in preparing slides or other presentation materials, as long as this assistance is of only nominal monetary value and the company has no input in the actual content of the material.

(2)  When invited to present at non-CME activities that are primarily promotional, faculty should avoid participation unless the activity is clearly identified as promotional in its program announcements and other advertising.

(3)  All conflicts of interest or biases, such as a financial connection to a particular commercial firm or product, should be disclosed by faculty members to the activity’s sponsor and to the audience. Faculty may accept reasonable honoraria and reimbursement for expenses in accordance with Opinion 8.061, “Gifts to Physicians from Industry.” 

Sponsors 

Guidelines for physicians involved in the sponsorship of CME activities are as follows: 

(1)  Physicians involved in the sponsorship of CME activities should ensure that

(a)  the program is balanced, with faculty members presenting a broad range of scientifically supportable viewpoints related to the topic at hand;

(b)  representatives of industry or other financial contributors do not exert control over the choice of moderators, presenters, or other faculty, or modify the content of faculty presentations. Funding from industry or others may be accepted in accordance with Opinion 8.061, “Gifts to Physicians from Industry.”

(2)  Sponsors should not promote CME activities in a way that encourages attendees to violate the guidelines of the Council on Ethical and Judicial Affairs, including Opinion 8.061, “Gifts to Physicians from Industry,” or the principles established for the AMA’s Physician Recognition Award. CME activities should be developed and promoted consistent with guideline 2 for Attendees.

(3)  Any non-CME activity that is primarily promotional must be identified as such to faculty and participants, both in its advertising and at the conference itself.

(4)  The entity presenting the program should not profit unfairly or charge a fee which is excessive for the content and length of the program.

(5)  The program, content, duration, and ancillary activities should be consistent with the ideals of the AMA CME program.

 

AMA CEJA 2011 – The New Myths of the CEJA Report Financial Relationships with Industry in Continuing Medical Education.

During the 22^nd Annual Conference of the National Task Force on CME Provider/Industry Collaboration, there was a presentation about the passage of the American Medical Association (AMA) Council on Ethical & Judicial Affairs (CEJA) Report 1-A-11, Financial Relationships with Industry in Continuing Medical Education, which addressed industry support of continuing medical education (CME). 

We have written extensively on this issue.  This past June after four previous failed attempts, the AMA House of Delegates passed a significantly revised version of the report, with a bare majority on the first vote.  It was passed, largely to honor the outgoing chairman of CEJA and with the support of the several large medical societies including the AAFP.

The presentation at the Taskforce, moderated by Norman Kahn, MD, of the Council of Medical Specialty Societies, included the Director of Ethics Policy and Secretary of CEJA.  The discussion was entitled, “10 Myths about CEJA 1.”  While the presentation attempted to address myths, it may have created some of their own.  

First, AMA staff presentation and interpretation of CEJA 1-A-11, as discussed below, perhaps overreached in a number of areas.  AMA staff has used their own “interpretation” and “judgment,” which sometimes are contrary to the explicit language contained in the CEJA report, to suggest things that are not written anywhere in the report.  And even more troublesome, is that AMA staff plans to take their “interpretation” of CEJA 1-A-11 and have a number of Webinars in the following months, professing “What CME Providers Need to Know About CEJA Report.” 

Second, and more importantly, AMA staff comments come prematurely.  CEJA 1-A-11 has not been fully adopted yet.  In fact, CEJA recently published an Opinion (1-I-11) regarding CEJA 1-A-11, which revealed a very important procedural clarification that some may not be aware of.  As noted by CEJA: 

Opinions of the Council on Ethical and Judicial Affairs will be placed on the Consent Calendar for informational reports, but may be withdrawn from the Consent Calendar on motion of any member of the House of Delegates and referred to a Reference Committee. The members of the House may discuss an Opinion fully in Reference Committee and on the floor of the House. After concluding its discussion, the House shall file the Opinion. The House may adopt a resolution requesting the Council on Ethical and Judicial Affairs to reconsider or withdraw the Opinion. 

Accordingly, when the House of Delegates meets November 12-16, 2011 in New Orleans, there will be an opportunity for any member of the House of Delegates to make a motion to have the CEJA report sent to a reference Committee, and that Committee can then have the report reconsidered or withdrawn.  As noted by the AMA website, the CEJA Opinion 1-I-11 is a “DRAFT resolution, subject to change.” 

Consequently, AMA noted that, “final documents will be made available to the HOD on or before Friday, Oct. 21, at which time they will be numbered and assigned to reference committees.  All resolutions submitted for consideration at the 2011 Interim Meeting are subject to review by the Resolution Committee which is responsible for reviewing resolutions to determine their compliance with the meeting's focus on advocacy and legislative issues.” 

Presentation and Discussion 

The following are some of the key discussion points the AMA staff person presented at the taskforce.

Myth 1: “CEJA 1” prohibits all industry support for CME (slide 2) 

AMA staff noted that the goal of CEJA 1 is for there to be “independence from industry support.”  The slide noted that, industry support ethically is acceptable when: 

• There is a demonstrated need
• The activity requires high-cost resources
• The decision to seek/accept funding is independent, prospective
• The decision-making process is transparent 

We agree with the opening statement that it is a myth that CEJA 1-A-11 does not prohibit commercial support.  But the follow up comments state the goal of CEJA is independence from industry support.  Nowhere in CEJA 1-A-11 or in the 1-I-11 Opinion (which is identical), does it state that the goal of CEJA 1 is for there to be “independence from industry support.”  The only thing even close to this suggestion is the following: 

When possible, CME should be provided without such support or the participation of individuals who have financial interests in the educational subject matter.  (1-I-11, line 26-27). 

This language contains no suggestion that support for CME should be independent from industry.  Instead, it only suggests the need for CME providers to evaluate when it is and is not possible to provide CME support.  Accordingly, the CEJA report does not in any way stand for independence from industry support, but rather it confirms ACCME principles and other CME guidelines that call on CME providers to be transparent and document their need for and use of commercial support.  

Myth 2: “CEJA 1” prohibits participation by anyone who has financial relationships with industry (slide 3-4) 

AMA staff noted that the goal of CEJA is to have “no reliance on conflicted experts.” The slide explained that participation by conflicted expert is ethically acceptable when: 

• Dissemination of device/technique/technology will benefit patients, public, professional community
• Activity meets a demonstrated need
• Participation is central to success of activity
• Individual is uniquely qualified
• Steps are taken to mitigate potential influence
• commensurate with financial interest at stake
• including disclosure – source, nature, magnitude of interest
• Decision-making process is transparent 

We agree with the opening statement that it is a myth that CEJA 1 prohibits participation by anyone how has a financial interest.  Yet, once again, this interpretation could be considered  a stretch.  Nowhere in the entire CEJA report does it say that experts who have financial interest or even potential conflicts, should be banned from CME.  Instead, the report explicitly recognizes that:

In some circumstances, support from industry or participation by individuals who have financial interests in the subject matter may be needed to enable access to appropriate, high quality CME.  (1-I-11, line 29-31). 

Contrary to AMA staff’s explanation, the CEJA report recognizes undoubtedly that there will be instances where reliance on an expert with financial interests in the educational subject matter is necessary to enable access to appropriate, high quality CME.  And the report supports the use of experts with financial interests by reassuring physician-learners that there is no need for concern about such reliance because CME providers will make “vigorous efforts … to maintain the independence and integrity of educational activities.” (1-I-11, line 31-32). 

The CEJA report necessarily uses language to acknowledge that there will be “circumstances” when ACCME, CEJA and CME providers will recognize that reliance on support from industry or participation by individuals who have financial interests “may be needed.”  To suggest that CEJA means a complete ban on such individuals or “no reliance” is therefore an incorrect interpretation. 

It should also be noted that AMA staff perhaps overstated CEJA with respect to the new kind of reporting and disclosure that will be required if the report is adopted.  As noted above, AMA staff asserted in their slide the steps that CME providers need to take to mitigate potential influence, which included disclosure of the “magnitude of interest.”  AMA staff mentions “magnitude” twice in fact, on Slide 4 and 7.  However, this is not what CEJA adopted.  

Specifically, the CEJA report explicitly states that, only “individuals who have a substantial financial interest in the educational subject matter” are required to disclose the “magnitude of the individual’s specific financial interest.” (1-I-11, line 34-38).

Conclusion

Ultimately, the presentation by AMA staff produces  concern.  CME providers are worried that radical members of CEJA, including staff, will use the report to push their restrictive agenda on CME providers by painting a picture that the goals of the CEJA report are “independence from industry support” and “no reliance on conflicted experts,” rather than what was actually stated in the CEJA document. 

In fact, if AMA staff believes that it is the goal of the CEJA report to “articulate broad ethical principles” (slide 8).  However, nowhere in the entire CEJA report does it give CEJA the responsibility to articulate any such principles or guidance, let alone “broad” ones. However, this may be of no concern to CEJA staff, because they assert, as AMA staff did in their presentation, that implementing the report will be a matter of “judgment.” 

It is evident from CEJA’s approach during this presentation, that their “judgment” is a stark contrast to what the CEJA report actually states and what the AMA House of Delegates voted to pass.  The repeated statements that all faculty and CME providers will have to disclose the magnitude of financial support—when in fact the report states that disclosure of magnitude is for only those faculty with a “substantial financial interest”—is concerning, because it appears that CEJA staff may be using this kind of “education” as a backdoor to implement language that was in previous CEJA reports.

Had AMA Staff made this presentation at the House of Delegates meeting this past summer where CEJA 1 was adopted, with the goals of CEJA as independence from commercial support, no reliance on conflicted experts and reporting the magnitude of every relationship, it is doubtful that the House of Delegates would have passed this bill.

To avoid a floor battle over this report at next month’s AMA House of Delegates meeting in New Orleans, it is in CEJA’s and AMA’s best interest for their staff to remain true to the facts of the documents.  Otherwise, they may be fighting the CEJA CME battle for many years to come.

AMA CEJA 2011: AMA House of Delegates Approves Report – Now Emphasis on Value of CME in Patient Care

 

Earlier this week, the American Medical Association House of Delegates (AMA HOD) passed the Council on Judicial and Ethical Affairs (CEJA) 1-A-11 report entitled, “Financial Relationships with Industry in Continuing Medical Education.” 

It came down to a very close vote and worked much like a roller coaster.  Initially, the testimony was 2/3rds against the CEJA report. Though the report was conflicted in how it presented commercial support of continuing medical education (CME), the recommendations reinforce current CME practices.  

In three of the previous four versions of the CEJA report, the reference committee had recommended approval to the House of Delegates, but the delegates then pulled it out of the consent calendar and voted to refer the document back to CEJA for more revisions.  

This time, in a parliamentary move, the reference committee report was pulled out from a list of recommendations scheduled to be voted on by unanimous consent and was quickly debated and then voted on to passed CEJA on a very close vote.  This caught many of the opponents off guard and many who spoke the previous day against the measure were not in the room to show their opposition and thus did not speak out.

Overall, those opposed to the measure based their position on the best available evidence that shows that CME is already highly regulated and the data overwhelmingly supports that commercial bias is minimal to nonexistent.  Some of the organizations who spoke against the measure included the American Association of Clinical Endocrinologist, American College of Surgeons and several states including Florida and Minnesota. 

Those in favor submitted comments that the report was much better than in previous years and other organizations have policies on commercial support and its time we do too.  Supporters of the measure included American Association of Family Physicians, American College of Physicians and the Western Mountain Caucus, the organization that this year’s Chairman of CEJA represents. 

One supporter noted that, “CEJA was finally largely focusing on individual physician's interactions with industry and not on interactions between industry and CME providers that comply with ACCME SCS, CMSS Code, etc. 

Several organizations submitted detailed comments in advance of the meeting on the report including the Alliance for Continuing Medical Education and the Association of Clinical Researchers and Educators. 

Despite what others have suggested, the AMA HOD’s adoption of the CEJA report does not mean an end to commercial support of CME.  Rather, it merely reflects an alignment of AMA policies on CME with the ACCME, HHS OIG, and the PhRMA and AdvaMed Code of Ethics.  Commercial support of CME will still remain a valuable resource for CME providers to help keep physicians up to date on the latest breakthroughs and treatments. 

Background 

This is the fifth time that CEJA brought a report on continuing education and its financial relationships with industry, and each of the previous reports has been sent back to CEJA by the AMA House of Delegates and adjusted to reflect recommendations closer to current practices.   Several notable players involved in this report include the Regina Benjamin, current U.S. Surgeon General who at the time, was chairman of CEJA for the second iteration of the report.  Dr. Benjamin was very gracious in her negotiations with CME providers on the report and hosted a meeting with CME providers in the winter of 2008. 

This version recognizes the value of commercial support, and where previous reports focused on the obligations of the CME provider, this report focuses on the obligation of the physician. 

Now that the report is approved, the report itself is filed away and the recommendations are added to the AMA ethical handbook.  The final recommendations focused on the ethical obligation of presenters to disclose to the learners their financial interests in the topic they are presenting.  

Version 5.0

Though the first half of the report goes away, CEJA explicitly recognizes that, “relationships between medicine and industry—such as pharmaceutical, biotechnology, and medical device companies—have driven innovation in patient care, contributed to the economic well-being of the community, and provided significant resources (financial and otherwise) for professional education, to the ultimate benefit of patients and the public.” 

This assertion shows CEJA’s recognition of how industry makes life saving and changing treatments, devices, and tools to help improve the health of people each day.  It also shows that CEJA is aware that through commercial research, development and discovery, companies are finding ways to diagnose, treat and prevent serious, chronic, and rare diseases at a faster rate than ever before. 

Moreover, CEJA recognizes that, “industry support helps to meet the costs of CME activities in the face of uncertain funding from other sources and may help make CME more accessible, especially for physicians in resource-poor communities.”  The report also points out that,  “industry engagement and support can be especially helpful in ensuring affordable CME when educational activities need high cost, sophisticated, rapidly evolving technology or devices.” In addition to “lower costs, industry support also encourages greater participation than would otherwise be the case by providing amenities.” 

Recommendations 

The first recommendation that CEJA proposes is that, “when possible, CME should be provided without such support or the participation of individuals who have financial interest in the educational subject matter.” 

Next, CEJA recognized that in some circumstances, support from industry or participation by individuals who have financial interest in the subject matter may be needed to enable access to appropriate high-quality CME.  As a result, they recommend that vigorous efforts be made to maintain the independence and integrity of educational activities.  What is problematic about this recommendation is that CEJA recognizes that in many cases, “high-quality CME cannot reasonably be carried out without support from sources that have a direct financial interest in physicians’ clinical recommendations, such as activities that require cadavers or high-cost, or sophisticated equipment to train physicians in new procedures or the use of new technologies.”  

CEJA also acknowledges that, “in the earliest stage of adoption of a new medical device, technique, or technology, the only individuals truly qualified to train physicians in its use are often those who developed the innovation.” 

In addition, CEJA recommends that physicians who attend CME activities should expect that commercially supported CME:

• Is transparent about financial relationships that could potentially influence educational activities
• Provides the information physician-learners need to make critical judgments about an educational activity, including: 
  • The source(s) and nature of commercial support for the activity; and/or
  • The source(s) and nature of any individual financial relationships with industry related to the subject matter of the activity; and
  • What steps have been taken to mitigate the potential influence of financial relationships 
• Protects the independence of educational activities by
  • Ensuring independent, prospective assessment of educational needs and priorities
  • Adhering to a transparent process for prospectively determining when industry support is needed
  • Giving preference in selecting faculty or content developers to similarly qualified experts who do not have financial interest in the educational subject matter
  • Ensuring a transparent process for making decisions about participation by physicians who may have a financial interest in the educational subject matter
  • Permitting individuals who have a substantial financial interest in the educational subject matter to participate in CME only when their participation is central to the success of the educational activity; the activity meets a demonstrated need in the professional community; and the source, nature, and magnitude of the individual’s specific financial interest is disclosed
  • Taking steps to mitigate potential influence commensurate with the nature of the financial interest(s) at issue, such as prospective peer review.

Conclusion

These are ethical guidelines for AMA members to follow. These recommendations serve as a guide and principles adopted by a politically motivated body, and should not be interpreted as absolute truth or given the same weight as existing guidelines.

All of these recommendations are covered in existing guidelines, including the 2005 ACCME Standards for Commercial Support, and the FDA Guidance on CME.  We do not expect there to be any immediate changes in the system. There will however, be greater emphasis on encouraging other stakeholders in the medical community including the government, insurance and health systems to provide a greater share of the support for CME. 

When recommending minimizing industry support when possible, CEJA may not have been aware of the extensive cost associated with maintenance of certification CME (MOC-CME) many of the new modes of CME such as performance improvement (PI) or quality improvement (QI) CME all require significant financial resources  to fund collection of data from electronic medical records (EMR) and EMR reminder alert systems.

As CEJA notes in their report, “competing interests are a fact of life for everyone, including but not limited to physicians.” 

Though the AMA controls the AMA PRA Category 1 system, it is not likely that this report will change much in the way the credits are awarded.  This is because this final version of the CEJA recommendations is currently covered in existing guidelines on commercial support. 

In the coming months, commercially supported CME may play a key role in the implementation of health care reform.   

In just the area of Accountable Care Organizations (ACO’s), the government will require 64 quality measures for participating facilities.  Commercially supported CME provides a unique media to train and educate America’s health care providers on strategies on how to implement and meet those measures.

Now that the report is behind us, rather than focus on amorphous topics such as “perceived bias,” we should focus our efforts on educational programs that improve patient care.  In the end, the only thing that should matter to everyone is improving patient care, a goal that CME providers and industry have shared since the beginning.  Effective and accurate education is the key, not who financially supports the education.

AMA CEJA 2011: The Alliance for Continuing Medical Education Calls for Report to be Referred Back to Committee for More Work

 
The Alliance for Continuing Medical Education (Alliance), which represents more than 2,300 professionals who strive every day to improve patient care and outcomes through the design and delivery of unbiased, evidence-based education for health care professionals, recently submitted its comments in response to the American Medical Association Council (AMA) on Judicial and Ethical Affairs (CEJA) Report 1-A-11 on “Financial Relationships with Industry in Continuing Medical Education.” 

For all certified continuing medical education (CME), Alliance members adhere to the Standards for Commercial Support promulgated by the Accreditation Council for Continuing Medical Education (ACCME), of which the AMA is a member organization

Alliance Response to CEJA 1-A-11

The Alliance strongly recommended that CEJA Report 1-A-11 be referred back to CEJA for additional consideration and modification because the report:

• Does not fully recognize the ACCME guidelines
• Is not supported by available, scholarly research and
• Would require that providers spend time and resources developing unnecessary processes.

The Alliance noted that CEJA extended its jurisdiction beyond the authority granted to it by offering opinion CME without fully recognizing that the appropriate accreditation guidelines are currently in place to govern these relationships, such as the ACCME updated Standards of Commercial Support, which are backed by serious consequences when violations are discovered.

In addition to accreditation standards, the Alliance also noted how the Food and Drug Administration (FDA), the Office of Inspector General (OIG), the National Institutes of Health (NIH), the United States Senate and countless regional and state agencies have investigated and issued guidance, opinion or ruling shaping these interactions.  They also recognized how an increasing number of organizations, professional societies, member groups, academic centers and healthcare organizations have developed and issued their own codes of ethics and standards for interactions with industry, as well as mechanisms to monitor and identify challenges to those policies.

Accordingly, the Alliance asserted that sets of clearly defined national standards, federal, regional and state regulation, as well as local policy and monitoring already exist to manage potential influence of CME by industry. These, coupled with a troubling lack of evidence suggesting these mechanisms, as they have been in place since 2005, are ineffective, negate the need – regardless of authority – for CEJA to issue an opinion on the matter.

In addition, the Alliance noted that there is no evidence, which shows that learner confidence in the independence and integrity of CME is promoted because of no industry support or faculty relationships related to that CME. As a result, the Alliance recommended that CEJA eliminate its contention that CME should be provided without commercial support “when possible.”

The Alliance also recommended that CEJA eliminate the language requiring physicians who “organize, teach, or have other roles in CME” to disclose to physician learners what steps have been taken to mitigate potential influence of financial relationships because such a requirement would move the AMA into the role that has been established for the ACCME.  The Alliance explained that this additional standard is not part of the current ACCME Standards for Commercial Support and that there is no current requirement that this mechanism be reported to the learners. 

The Alliance also identified that CEJA’s report is unclear as to what group(s) would make a determination of need for industry funding of CME, on what criteria decisions would be made, and what system would be used to prospectively evaluate all educational activities for industry funding.

Consequently, they also recommended that instead of limiting education funding from industry, which would result in a further decrease of education activities, appropriate organizations that support the provider communities should seek new sources of incremental funding for physician education

Finally, the Alliance asserted that CEJA’s prohibition or limitation of expert physicians who work with industry would likely reduce the quality and effectiveness of physician education.  Further, they noted how eliminating or reducing the role of physicians (with industry relationships) who excel in teaching other clinicians, and to eliminate or reduce the role of this group of educators could also negatively impact the quality and effectiveness of medical education.

Accordingly, the Alliance recognized that CEJA’s approach conflicts with the goal of advancing patient outcomes and population health by potentially limiting access to the best available scientific information delivered by those physicians who may possess the highest level of expertise.  Moreover, they noted how CEJA’s recommendation would not permit physicians, who have spent much of their professional careers researching and understanding the diseases and infections that affect patients, to serve as faculty or content developers.

This could lead to the use of faculty and developers who may not be as knowledgeable about the array of therapeutic entities, emerging therapies, barriers to care, contraindications, risk management issues, and patient adherence challenges.  

For these reasons, the Alliance recommended that 1-A-11 be referred back to CEJA.

AMA CEJA 2011: Association of Clinical Researchers and Educators Response – House of Delegates Should Reject the CME Report and End the Debate

 
In response to the American Medical Association Council (AMA) on Judicial and Ethical Affairs (CEJA) fifth attempt to hinder physician and institution relationships with industry, the Association of Clinical Researchers and Educators (ACRE) recommended that CEJA Report 1-A-11"Financial Relationships with Industry in Continuing Medical Education" be rejected by the AMA House of Delegates.

ACRE is an organization of physicians and colleagues engaged in promoting excellence in medical service, education, and innovation. Our members have records of achievement in these endeavors. 

While ACRE affirmed CEJA’s dedication to excellence in medical education, clinical research and patient care, they disagreed with the 2011 CEJA report because of its “self-defeating, misguided, and harmful strategy.  Moreover, ACRE rejected CEJA’s continued use of a framing bias that is defined by “conflicts of interest”—whether real, potential or imagined—and their fixation on subjective, ill-defined “perceptions,” because this reasoning cannot advance the goals that unite the house of medicine, namely, professionalism, excellence and a commitment to base policy on objective evidence. 

Specifically, ACRE recommended that CEJA Report 1-A-11 be rejected for the following reasons:

• Physicians overwhelmingly value industry grants to support CME and attendees overwhelmingly assert that commercially supported CME programs provide up-to-date, timely, useful, and reliable information about medications to treat particular conditions, and knowledge or skills helpful in their practice
• CME is already highly regulated to prevent undue influence from industry
• CME already has in place adequate provisions for transparency and independence
• Three very large studies conclusively show there is little bias in CME
• Commercially supported CME has been documented to improve outcomes in a number of subjects including COPD, Hypertension, ICU patients, Sepsis, and hospital acquired infections
• A large number of professional organizations and specialty groups find value in commercially supported CME
• CME is critical to educating doctors about new drugs and treatments

• The report relies on references and research that do not differentiate CME and commercial education
• The report too vaguely describes under what circumstances commercial support of CME would be acceptable by using the term “significantly undermine”
• Attempts to change CME to a system similar to continuing legal education (CLE) are unrealistic because (1) the volume of information in medicine is vastly greater than law, (2) changes to practice in medicine occur at a much faster rate than law, and (3) mistakes in medicine can lead to death, whereas mistakes in law can be corrected through other, less life threatening processes
• The best evidence of the perceived value of CME events is that doctors attend voluntarily, giving up Saturdays or evenings to do so

• Reducing resources in CME will result in less education of physicians
• With the adoption of Health Care Reform and the subsequent addition of 30 million new patients to the healthcare system, additional financial resources will be needed to educate a greater number of physicians and other healthcare providers not less
  • CME plays a vital role in promoting evidence-based medicine (EMB)
  • Failure to adopt EMB is estimated to cost hundreds of millions of dollars
  • CME is also the best means of disseminating comparative effectiveness research, the cornerstone of any sensible health policy

• Passage of the Physician Payment Sunshine Provisions in Health Care Reform eliminates the need for more detailed disclosure as recommended in the CEJA report
• There is no discussion in the CEJA report of the following issues:
  • The risk to patients because of reduced financial support of CME
  • The effects of their restrictions on rural and inner-city physicians
  • The effects on medical societies
  • The progress made by medical innovation from education
  • That diversity of funding leads to competition for better CME
  • That industry has a social responsibility to support education

Discussion

ACRE recognized that CEJA reports have consistently approached the issue of industry funded CME improperly.  First, ACRE noted that the funding of CME through commercial support is not an “ethics” matter as CEJA has repeatedly suggested over the years.  Commercial support of CME is about practical access to high quality health care education. 

The ACRE response noted that, industry makes life saving treatments, devices, and tools to help improve the health of people each day.  Through research and development, companies are finding ways to diagnose, treat and prevent serious, chronic, and rare diseases at a faster rate than ever before.  Accordingly, industry support of CME is one of the most effective ways to distribute this new information, to ensure that healthcare practitioners are aware of the benefits, risks, and uses of these new tools and treatments.  Research has shown that there is little bias in such programs.  

Consequently, the CEJA report explicitly recognizes that, “relationships between medicine and industry—such as pharmaceutical, biotechnology, and medical device companies—have driven innovation in patient care, contributed to the economic well-being of the community, and provided significant resources for professional education, to the ultimate benefit of patients and the public.”   Despite this recognition, CEJA asserts however that the “interests and obligations of medicine and industry diverge in important ways.” 

How industry’s obligation to support medical education diverges from that of medicine is unapparent, ACRE noted.  In fact, their response asserted that the opposite holds true: there is convergence of interests and obligations between industry and medicine, especially considering that the standard of care leads doctors to use the treatments and tools industry provides to them to improve the health of patients.  

Additionally, ACRE asserted that CEJA’s report clearly ignores the proven benefits and outcomes that commercially supported CME have caused in subjects including COPD, Hypertension, ICU patients, Sepsis, and hospital acquired infections.  CEJA’s report is led to a biased conclusion that does not reflect the actual data currently available on the subject.  The list of references in the CEJA report has not been updated to reflect evidence based research on this subject.  It uses similar references from previous reports to support the bias of the authors.  As a result, all CEJA’s report does is state opinions numerous times, without any evidence or factual support.

Moreover, ACRE recognized that CEJA ignores recent research that shows both Americans and physicians want industry-physician collaboration.  For example, a recent poll showed that 81 % of Americans support developing public-private partnerships between government, industry and universities to maximize resources and expertise in medical innovation and research in the U.S.

In addition, a recent survey found that 89% of physicians valued industry grants to support CME because such programs provide knowledge or skills helpful in their practice and information about medications to treat particular conditions that is up-to-date, timely, useful, and reliable.  Additionally, a large number of professional organizations and specialty groups find value in commercially supported CME.  These physicians recognize that commercially supported CME is critical to educating doctors about new drugs and treatments.

Finally, ACRE asserted that CEJA’s report fails to acknowledge that for over five years, CME has been highly regulated to prevent undue influence from industry.  CME already has in place adequate provisions for transparency and independence. 

As a result, ACRE recommended that the AMA House of Delegates reject the CEJA Report 1-A-11 to ensure that physicians continue to have access to appropriate, high-quality CME.

 

AMA CEJA 2011: Financial Relationships with Industry in Continuing Medical Education Version 5.0 – Better But Not There Yet?

 
The American Medical Association (AMA) Council on Ethical and Judicial Affairs recently released Report 1-A-11 entitled, “Financial Relationships with Industry in Continuing Medical Education.”  This is CEJA’s fifth attempt to ask individual physicians and institutions of medicine to not accept industry funding to support professional educational activities.  As we previously noted, the 2010 CEJA report was the same as the 2009 report, both of which were referred back to committee and voted down by the AMA House of Delegates.  While the 2011 Report and its recommendations have made improvements from its predecessors, the reasoning and rationale behind this report are still problematic.  

Background 

In this year’s report, as in others, CEJA explicitly recognizes that, “relationships between medicine and industry—such as pharmaceutical, biotechnology, and medical device companies—have driven innovation in patient care, contributed to the economic well-being of the community, and provided significant resources (financial and otherwise) for professional education, to the ultimate benefit of patients and the public.”  Despite this recognition, CEJA asserts however that the “interests and obligations of medicine and industry diverge in important ways.”  

Industry makes life saving and changing treatments, devices, and tools to help improve the health of people each day.  Through commercial research, development and discovery, companies are finding ways to diagnose, treat and prevent serious, chronic, and rare diseases at a faster rate than ever before.  How such an obligation diverges from that of medicine is unapparent, especially considering doctors are obligated to use the treatments and tools industry provides to them to improve the health of patients.   

Moreover, CEJA recognizes that, “industry support helps to meet the costs of CME activities in the face of uncertain funding from other sources and may help make CME more accessible, especially for physicians in resource-poor communities.”  The report also points out that,  “industry engagement and support can be especially helpful in ensuring affordable CME when educational activities need high cost, sophisticated, rapidly evolving technology or devices.” In addition to “lower costs, industry support also encourages greater participation than would otherwise be the case by providing amenities.” 

Based on these comments, CEJA clearly understands that commercial support of CME has demonstrable benefits to physicians and patients, and there is evidence to prove this.  For example, physicians who attended an industry-supported educational activity were 50% more likely to provide evidence-based care for COPD than nonparticipants.  Another program showed that the patients of physicians who attended the industry supported educational activity were 52% more likely to receive evidence-based care than those seen by health care providers who did not participate in the activity. Commercially supported CME has also improved patient outcomes in intensive care units at hospitals and has helped patients with sepsis. Industry supported CME programs also help physicians fight hospital acquired infections. 

In addition, the results of a recent study showed that “heart disease patients whose general practitioners participated in an interactive, case-based CME program had a significantly reduced risk of death over 10 years compared with those whose doctors didn't receive the education.” 

Despite this evidence and CEJA acknowledging the critical role commercial support plays in CME, the report focuses their “growing concern” for industry funding on the “potential for bias.”  Specifically, the report asserts that, “where patients’ health and public trust are concerned, the perception of bias, even if mistaken, can be as potentially damaging as the existence of actual bias.”  This statement is extremely problematic for a number of reasons. 

First, while CEJA asserts that the “perception of bias” can be as potentially damaging as the existence of actual bias, there is no evidence to support this claim.  Moreover, how can anyone identify perceived bias?  Evidence from three large studies shows there is almost no bias in commercially supported CME (Cleveland Clinic; Medscape, and UCSF).  In fact, CEJA explicitly admits that, “the available data neither support nor disprove that financial relationships influence CME.” 

Second, CEJA believes that even a “mistaken” perception of bias can be as damaging as actual bias.  Such an assertion is extremely misguided.  If a patient or physician is mistaken about a perceived bias, how can this be damaging?  The real damage would be to remove a commercially supported CME program that helps improve patient outcomes because someone mistakenly believed there as potential or perceived bias. 

Recommendations 

Consequently, although using questionable methodology, reasoning, and research, CEJA made a number of recommendations to change the landscape of commercially supported CME.  The first recommendation that CEJA proposes is that, “when possible, CME should be provided without such support or the participation of individuals who have financial interest in the educational subject matter.” 

When is it possible for CME to be provided without commercial support?  Today, and in the near future, America will demand more doctors.  We have already seen a severe shortage of primary care doctors, particularly in rural and inner city areas.  These problems will only continue to grow as provisions of the Affordable Care Act are implemented and bring an additional 30 million Americans into the health care system.  

This all means that we will not only need more doctors, but more CME to keep our doctors up to date on ways to treat, diagnose, and prevent chronic disease and illnesses.  Accordingly, we will need resources to provide CME to this expanded group of physicians.  The government largely does not fund any kind of CME or programs, and the rest is left to commercial support or doctors/organization fees.  

Moreover, a recent study found that Decreased Funding Has Significantly Affected Management of Grand Rounds, Extended CME Events, and Other Educational and Social Functions in Academic Departments.  Because of decreased support, many academic CME departments reported that they engage fewer nationally-renowned, out-of-the-geographic-area speakers for Grand Rounds and CME conferences. Departments have less or no support for meals associated with Grand Rounds and other departmental functions and have less discretionary support for varied conference expenses. 

Next, CEJA recognized that in some circumstances, support from industry or participation by individuals who have financial interest in the subject matter may be needed to enable access to appropriate high-quality CME.  As a result, they recommend that vigorous efforts be made to maintain the independence and integrity of educational activities.  What is problematic about this recommendation is that CEJA recognizes that in many cases, “high-quality CME cannot reasonably be carried out without support from sources that have a direct financial interest in physicians’ clinical recommendations, such as activities that require cadavers or high-cost, or sophisticated equipment to train physicians in new procedures or the use of new technologies.”  

If high-quality CME cannot reasonably be carried out without commercial support, why is CEJA telling stakeholders to do so, “whenever possible?”  Isn’t that a huge risk to take, not accepting commercial support, but having a low-quality CME program?  What will cause more harm: mistaken perceptions of bias, or CME that does not educate or train doctors effectively? 

CEJA also acknowledges that, “in the earliest stage of adoption of a new medical device, technique, or technology, the only individuals truly qualified to train physicians in its use are often those who developed the innovation.  These individuals may have the most substantial and direct interests at stake, whether through employment, royalties, equity interests or other direct financial interests in the adoption and dissemination of the new technology.”  When numerous individuals can fall in this category, why is CEJA recommending rules that will only make it harder for these individuals to provide meaningful CME to their colleagues?   

In addition, CEJA recommends that physicians who attend CME activities should expect that commercially supported CME:

• Is transparent about financial relationships that could potentially influence educational activities
• Provides the information physician-learners need to make critical judgments about an educational activity, including: 
• The source(s) and nature of commercial support for the activity; and/or
• The source(s) and nature of any individual financial relationships with industry related to the subject matter of the activity; and
• What steps have been taken to mitigate the potential influence of financial relationships 
• Protects the independence of educational activities by
  • Ensuring independent, prospective assessment of educational needs and priorities
  • Adhering to a transparent process for prospectively determining when industry support is needed
  • Giving preference in selecting faculty or content developers to similarly qualified experts who do not have financial interest in the educational subject matter
  • Ensuring a transparent process for making decisions about participation by physicians who may have a financial interest in the educational subject matter
  • Permitting individuals who have a substantial financial interest in the educational subject matter to participate in CME only when their participation is central to the success of the educational activity; the activity meets a demonstrated need in the professional community; and the source, nature, and magnitude of the individual’s specific financial interest is disclosed
  • Taking steps to mitigate potential influence commensurate with the nature of the financial interest(s) at issue, such as prospective peer review.

The problem with the overwhelming majority of this last set of recommendations is that they are already incorporated into the CME community through the 2005 ACCME Standards for Commercial Support, so the need for these additional rules in not necessary.  In addition to the regulations and changes noted above, CME stakeholders have also reduced and managed any potential for bias through:

• The National Faculty Education Initiative, which trains CME faculty on the difference between certified CME content and presentations and promotional/other content
• The ACCME requirement to both identify (via financial disclosures for all faculty and CME con­tent developers) conflicts and resolve them through mechanisms including elimination of the faculty member, altering the conflicted faculty member’s role, etc.
• Monitoring and enforcement of Standards for Commercial Support for CME independence from promotional influence
• The development of separate CME/IME departments within commercial interest organiza­tions, ensuring CME is managed outside of sales/marketing departments
• ACCME rules prohibiting control over faculty selection and CME content by potential/cur­rent funding organizations, ensuring independence of accredited providers that develop certi­fied CME
• Dramatic increases in the number of accredited CME providers on probation or working with the ACCME on progress reports for quality improvement
• Increased transparency of ACCME reporting on accredited provider compliance
• Increased transparency among pharmaceutical and medical device companies regarding CME grants issued

One group of recommendations dealing with faculty is particularly troubling,

Giving preference in selecting faculty or content developers to similarly qualified experts who do not have financial interest in the educational subject matter. 

This recommendation is troubling because it sets up a discrimination class i.e. somehow those work with industry are less knowledgeable and or ethical than those who do not.  Since there is no evidence of undue bias in talks by experts with financial interest than those without then perhaps this recommendation should be dropped entirely.

Conclusion

While changes in CEJA’s 2011 report are somewhat reasonable with respect to transparency and disclosure, the overall approach of the report is still problematic.  Although CEJA recognizes in multiple parts of the 2011 report that commercial support of CME is extremely valuable to physicians and patients, they contradict themselves by asking the CME community not to use commercial support “whenever possible.”  

According to Thomas Stossel, MD, Director of Translational Medicine at Harvard, "this topic is not an "ethical or judicial," rather a practical one and the underlying principles of the repeated CEJA emanations derive from opinions, not fact or sound logic." 

Besides shrinking budgets and already scarce resources, this recommendation is misguided, especially considering CEJA’s own recognition that no evidence shows that commercial support of CME introduces bias.  It is also problematic because CEJA is more concerned about perceived bias, even when mistaken, then they are about producing CME programs that will improve patient outcomes. 

As CEJA notes in their report, “competing interests are a fact of life for everyone, including but not limited to physicians.”  Instead of taking the extreme approach of not using commercial support “whenever possible,” CEJA needs to follow their own rationale and recognize that there are many instances when use of commercial support and CME faculty that have proper relationships with industry are not only desirable, but also crucial for improving patient outcomes and physician training and education.

In the coming months, commercially supported CME may play a key role in the implementation of health care reform.   

In just the area of Accountable Care Organizations (ACO’s), the government will require 64 quality measures for participating facilities.  Commercially supported CME provides a unique media to train and educate America’s health care providers on strategies on how to implement and meet those measures.

Rather than focus on amorphous topics such as “perceived bias,” we should focus our efforts on educational programs that improve patient care.  In the end, the only thing that should matter to everyone is improving patient care, a goal that CME providers and industry have shared since the beginning.  Effective and accurate education is the key, not who financially supports the education.

CEJA A-11

Financial Relationships with Industry in Continuing Medical Education

Will be heard at:

American Medical Association House of Delegates

Reference Committee on Amendments to Constitution and Bylaws

Sunday, June 19, 2011

Hyatt Regency Chicago

(Room and time to be determined)

 

AMA CEJA 2010: House of Delegate Sends Back CEJA Report on CME for 4th Time

For a fourth time in a row, the American Medical Association House of Delegates (AMA-HOD) has sent the Council on Judicial and Ethical Affairs (CEJA) 1-A-10 report on Financial Relationships with Industry in Continuing Medical Education back for more work to CEJA. Perhaps this time they will get the message.

Despite strong opposition (3-1) from those who spoke at the reference committee, the AMA HOD Reference committee recommended CEJA for passage, but on the floor debate it was apparent that the House of Delegates was not in favor of this report as shown in them sending it back for the 4^th time.

During the debate, testimony regarding 1-A-10 was divided. Testimony recognized that organizations such as ACCME and CMSS already have policies in place that address financial relationships with industry in continuing medical education (CME), and as such, the additional guidance presented in CEJA Report 1 may be unduly burdensome.

Additional testimony acknowledged a lack of compelling evidence to support the contention that industry funding of CME leads to bias in continuing medical education.

Once again this outcome reflects the overwhelming support physicians have for industry supported CME because they recognize that it brings high quality education and training to doctors.

It also shows that CEJA’s lack of evidence is concerning for many considering there is significant data showing that commercial support of CME does not result in bias. As a result, the next proposal must acknowledge this new evidence, and must support the role industry funded CME plays in educating physicians to help close gaps in care, and providing better patient care.

Other Stories on CEJA

AMA CEJA 2010: ACRE Recommends Rejecting CEJA Report Financial Relationships with Industry in Continuing Medical Education

AMA CEJA 2010: Financial Relationships with Industry in Continuing Medical Education Version 4.0 – Same Report - Same References

AMA CEJA: Strike 4 - Report Perhaps Ushered from the CME Ballpark

 

 

AMA CEJA 2010: ACRE Recommends Rejecting CEJA Report Financial Relationships with Industry in Continuing Medical Education

In response to the American Medical Association Council on Judicial and Ethical Affairs (CEJA) fourth attempt to hinder physician and institution relationships with industry, the Association of Clinical Researchers and Educators (ACRE) recommended that CEJA Report 1-A-10 and its recommendations be rejected by the AMA House of Delegates.

CEJA’s report, entitled “Financial Relationships with Industry in Continuing Medical Education,” without any significant evidence to support their proposal, improperly asks individual physicians and institutions of medicine to not accept industry funding to support professional educational activities.  As a result, ACRE called for the rejection of 1-A-10 for many reasons including:

· CME is already highly regulated to prevent undue influence from industry

· Reducing resources in CME will result in less education of physicians

· With the adoption of Health Care Reform and the subsequent addition of 30 million new patients to the healthcare system, additional financial resources will be needed to educate a greater number of physicians and other healthcare providers not less

· The CEJA report ignores 3 recently published studies, involving very large study populations, which are directly relevant to the Report's subject matter but "contra" to the report's recommendations. By an overwhelming margin, doctors who actually attend commercially sponsored CME do not perceive bias.

· Passage of the Physician Payment Sunshine Provisions in Health Care Reform eliminates the need for more detailed disclosure as recommended in the CEJA report

In ignoring ACRE’s previous response to their third report and ignoring recent evidence that industry support does not produce bias in CME, CEJA’s report is tendentious and contrary to "evidence-based professional ethics because 1-A-10 is virtually the exact same report that has been rejected three times previously by the House of Delegates.

Accordingly, CEJA must realize that CME is already highly regulated by ACCME Standards for Commercial Support and the FDA Guidance already enforce much of what CEJA considers changes and need for a code of conduct. Clearly then, there is no compelling reason or evidence to support their proposed changes.

By neglecting to use any real evidence to support their claims or underscoring health care reform legislation, CEJA’s Report 1-A-10 will only create auditing programs and ask for a magnitude of disclosure that would result in enormous undue administrative burdens on specialty societies and state accredited organizations running thousands of CME programs each year.  This ignorance is particularly problematic because their reliance on the same fifty seven (57) references that were previously rejected still leads them to admit that “to date, there is no empirical evidence to support or refute the hypothesis that CME activities are biased.”

CEJA acknowledges that presently, it “has not been clearly demonstrated to what extent the amount of a financial interest may influence perception and judgment” Instead, CEJA declares that “clear evidence is lacking” and acknowledges that most policies on “conflict of interest” at least tacitly assume that the greater the financial interest, the more problematic that interest is, but without any evidence. What evidence does exist about commercial support of CME?

This past year, three studies produced substantial data that demonstrate a lack of commercial bias in industry-sponsored CME (Cleveland Clinic; Medscape, and UCSF). So what did CEJA do with this data?  Nothing.

In choosing to pick which data CEJA wants to use to support their position and in disregarding this evidence, 1-A-10 is a complete contradiction.  Specifically, while recommending that physicians avoid industry funded CME, CEJA also recognizes that industry support is “vital to the professional community,” a clear example of how 1-A-10 uses faulty reasoning and contradictions. 

CEJA’s mistake is clear by a simple fact that they admit themselves: “in many situations, the only individuals truly qualified to train physicians in the earliest stage of adoption of a new medical device, technique, or technology, are often those who developed the innovation.” If industry support of CME should be avoided, who can teach doctors about new stents or pacemakers, when the person qualified created them?

Their ignorance is even more evident by CEJA’s recognition that there are also numerous circumstances when “access to appropriate, high-quality, independent CME may be seriously impaired if support from industry is refused,” such as when expensive equipment is needed, and accepting funds or in-kind support from multiple, competing firms might result in more independence than refusing such support.

These contradictions clearly confuse and ignore the proposal’s own acknowledgement that “industry support for CME helps to meet the costs of programs and activities in the face of uncertain funding from other sources.” It also reduces “costs to individual attendees and makes CME more accessible, especially for physicians in resource poor communities.” Consequently, since CEJA did not address these clearly conflicting statements, the least they could do is explain how physicians can get CME credits, education and training if in some cases, as CEJA also acknowledges, “CME may not be feasible without industry support.”  They do not however, explain where 50% of the funding for CME will come from and where doctors will get their education if industry funded CME is phased out.

Ultimately, ACRE’s response reflected the organizations belief that there is value to physicians, medicine, medical education, and patients from the working relationship between physicians and industry. There is no conflict in advancing science, and there is no conflict in providing the education that is required to do so.

By working together with industry colleagues, physicians can explain to the public that the contributions of corporations to medicine are, on balance, more beneficial than harmful and that both medicine and the industries that provide it with its technologies are worthy of public support. Cooperation, instead of antagonism, can help industry develop and market therapies with the highest integrity, by keeping physicians current on the best available evidence and by providing excellent patient care.

ACRE’s Response to CEJA 1-A-10

Other articles on CEJA 1-A-10

AMA CEJA 2010: Financial Relationships with Industry in Continuing Medical Education Version 4.0 – Same Report - Same References

AMA CEJA: Strike 4 - Report Perhaps Ushered from the CME Ballpark

AMA CEJA: Strike 4 - Report Perhaps Ushered from the CME Ballpark

In its fourth attempt to soil independent CME grants provided by industry to advance competency and patient outcomes, the American Medical Association Council on Ethical and Judicial Affairs (AMA CEJA) is earning distinction for being one of the least credible sources of information in the CME enterprise.

 

In AMA CEJA Report #1, the authors confused Certified CME with promotional activities branded under the name “professional education.” Specifically, the first CEJA report stated that “professional education” included:

 

• “CME”

• “industry marketing and promotional activities”

• “personal expenses associated with attendance at meetings”

• “educational travel grants for medical students”

• “free lunches”

• “residency positions”

• “company speakers’ bureaus”

• “free or subsidized travel”

 

Unfortunately, the only thing on the list above that does qualify for physician credit and meet the definition for Certified CME is “CME.” Everything else is not Certified CME.  

 

Additional AMA CEJA reports on CME continued the confusion and borrowed misunderstood ideas from other national organizations. The AMA CEJA parroted the 2009 Institute of Medicine report that created the amorphous concept of “subtle bias” in CME: an undefined bias somehow created just by the very presence of industry grant funding, even though accreditation rules specifically require independence from any promotional influence and appropriate management of grant support.

 

The AMA CEJA took it a step further in its third (2009) report on CME. The CEJA report stated that grant funding soiled CME content by creating both “unconscious” and “subtle bias.”

 

There are two important non-sequiters plaguing these “subtle bias” arguments. First, if CME bias is so subtle that physicians can’t detect it, how is it that the authors of these reports can do so?

 

Second, the evidence cited by CEJA doesn’t hold up. The footnotes CEJA provides to support the connection between grant funding and CME bias don’t even relate to CME activities. One article is on “gifts to physicians from industry” from marketing/sales representatives. The second is a Harvard Business Review article on the 2002 Enron scandal and financial crisis addressing “Why Good Accountants Do Bad Audits” (erroneously titled by CEJA as “Why good accountants go bad”).

 

In spite mounting evidence and convincing studies showing little or no connection between bias and grant-funded CME, the AMA CEJA is back at the plate, swinging against industry education grants. The 2010 report ignores both the Medscape and comprehensive Cleveland Clinic CME studies showing that 98% of physician attendees considered CME to be free of bias, whether or not industry grant funding was provided.  In addition, the 2010 AMA CEJA report continues to erroneously cite and footnote information. Evidence based? Not AMA CEJA.

 

Ironically, a different group within the AMA appears diametrically opposed to AMA CEJA. In April, the AMA hosted National Task Force on CME Provider/Industry Collaboration produced a “Get The Facts” campaign that sets the record straight with a toolkit and series of fact sheets. This is an excellent step in clarifying what CME is and what it is not.

 

The four AMA hosted National Task Force Fact Sheets on CME address the following:

 

· CME: Providing Valid and Independent Evidence for Clinical Decisions

· Addressing Conflict of Interest through Disclosure and Resolution

· Commercial Support of CME and Compliance with Guidelines

· Appropriate Discussion of Off-Label Drug Use within CME

 

In its announcement of the Get The Facts campaign, the National Task Force plainly stated the perception problem we face in the CME enterprise:

 

“The media, state and federal law and policy makers as well as regulators and other ‘collective/consensus opinions’ frequently use and disseminate information that can lead to incorrect assumptions and false perceptions about CME. This has led to increased regulatory scrutiny and critical public opinion regarding CME practices.”

 

The more AMA CEJA pitches out reports that lead to “incorrect assumptions and false perceptions about CME,” the more the AMA Task Force and the rest of us have to field unfounded accusations and criticism.

 

After four strikes against CME without factual support, it’s time for AMA CEJA to either play by the rules of evidence or leave the ballpark. Let AMA CEJA know they are harming patients by playing games with unfounded accusations about CME support.

 

 

By Stephen M. Lewis, MA, CCMEP

AMA CEJA 2010: Financial Relationships with Industry in Continuing Medical Education Version 4.0 – Same Report - Same References

Insanity: doing the same thing over and over again and expecting different results.

Albert Einstein, (attributed)
US (German-born) physicist (1879 – 1955)

In baseball it is three strikes and you are out, at the American Medical Association (AMA) House of Delegates their Council on Ethical and Judicial Affairs (CEJA) is more like the Bill Murray Movie Ground Hog Day – Bringing the same recommendations year after year despite the fact that the membership has soundly rejected them.

The American Medical Association (AMA) Council on Ethical and Judicial Affairs (CEJA) released yet again their fourth version Report on Financial Relationships with Industry in Continuing Medical Education this week.  The report is basically a word for word copy of the Winter 2009 version of the report that the AMA House of Delegates referred back to committee .

There are basically no changes in the tone or wording throughout the document and no changes are made in the document prior to page 5.  Of the 389 lines leading up to the recommendations only 15 lines were changed.  All 57 of the references were identical in reference and order to the 2009 report.  The recommendations are basically word for word the same as the 2009 report.

The ethics report has a conformational bias and fails to mention any of the evidence that contradicts their position or that has been released since their last report.  They purposely ignored studies released by the Cleveland Clinic, University of California San Francisco and Medscape.  (We provided the committee copies of the articles)

The report is constructed to read more like a religious document than a scientific statement and reflects a bias against physician-industry collaboration.

It also states strongly held beliefs as facts.  Irrefutable truths are rare in nature yet the authors of the report express a dogma about the evils of physician-industry relationships without a trace of fallibility.  It is as if their privileged positions somehow confer wisdom and certainty.

Report

In comparing the 2010 Report to 2009, the changes begin on page 5 under the heading of “Ensuring the Independence, Objectivity & Integrity of CME.”  Specifically, the 2010 Report states that:

“Financial relationships inevitably create conditions that can give rise to conflict of interests. When they do arise, not all conflicts are equally problematic ethically; but even minor conflicts of interest can undermine confidence in the independence and objectivity of the individuals, organizations, or activities involved. In some cases, the appearance of conflict of interest can be as damaging as the existence of an actual conflict.”

Although the three options to address COI are the same (avoid, implement strategies, or both), the 2010 Report clarifies language by noting “conditions that can give rise to” conflict of interests.  The new Report also recognizes that “not all conflicts are equally problematic ethically” but notes that “even minor conflicts of interest can undermine confidence.” The 2010 Report however takes the same stance as the previous report by stating that the “the appearance of conflict of interest can be as damaging as the existence of an actual conflict.”

If a physician educator talks with someone who works with industry couldn’t that   give the appearance of conflict?  Who is going to determine and define what constitutes a “minor” conflict?  With the new reporting requirements under the Sunshine Act, will every doctor who has received $10 from industry be excluded from leading or contributing to a CME program?  If so, with 94% of physicians reporting relationships with industry, who does CEJA expect will teach CME?  This has the potential of setting up a CME police state with colleagues settling personal vendettas accusing one another of “potential conflict of interest.”

Also troublesome, is the idea that an “appearance” of conflict can be damaging.  This notion is problematic because physicians have the experience and training necessary to recognize that CME programs are funded by industry.  Allowing physicians to hear all sources of information equally allows them to determine accordingly what weight to give to each.  Suppressing these programs for what might “potentially” be bias is unnecessary, and preventing industry funded CME essentially violates First Amendment rights of free speech.  

Next, in addressing how to “Avoid Conditions that Can Compromise the Integrity of CME,” the 2010 Report states that:

“The ethical aspiration should be to avoid the potential for bias or the chance that confidence in the integrity and independence of professional education could be diminished.”

This language is different from 2009 because it adds avoiding the “potential for bias or the chance that confidence in the integrity and independence of professional education.” Everything has the potential for bias, and to suggest that avoiding this potential will protect CME is misguided.  Physicians are capable of determining when and if programs are biased, and at least three recent studies have shown physicians overwhelmingly believe that industry funded CME is not biased. The 2010 report also adds that “In their roles as” CME providers, content developers, and faculty, physicians should strive to avoid financial relationships with industry.

With regards to “Exceptional Cases,” the 2010 Report added a new section, which notes that:

“Some essential educational activities may not be feasible without financial or in-kind support from industry—for example, the provision of cadavers or high-cost, sophisticated equipment to train physicians in new surgical procedures or the use of new technologies. Such support may be vital to the professional community, but, like individual financial ties, also creates potential for bias.”

In addition, in listing criteria for determining when it is ethically justifiable to permit participation by someone who has a direct, substantial, unavoidable, and irreducible financial interest in a CME activity, the 2010 Report added that:

   

“Comparable criteria might apply when an educational activity cannot reasonably be carried out without financial or in-kind support from sources that have a direct financial interest in physicians’ clinical recommendations.”

CEJA Recommendations

The 2010 Report adds that financial and/or in-kind support of CME from sources that have a direct financial interest in physicians’:

“Creates conditions in which financial interests could influence the availability and/or content of education. Similarly, current, recent (within the preceding 12 months), or anticipated (e.g., royalties or ownership interest) financial relationships between such firms and individuals who develop content for or teach in CME create conditions in which CME content may be influenced inappropriately.”

The 2010 Report also adds the recommendation that

“When possible, CME should be provided without funding or in-kind support from sources that have a direct financial interest in physicians’ clinical recommendations, and individuals who develop content for or teach in CME should have no current, recent, or anticipated direct financial interest in the educational subject matter, since avoiding such arrangements strengthens the confidence that physicians acquire and maintain knowledge, skills, and values that are independently judged important by the profession.”

The CEJA 2010 report recommendation also notes that:

   

“In some circumstances, however, access to appropriate, high quality, independent CME may be seriously impaired if support from industry is refused. For example, when expensive equipment is needed, accepting funds or in-kind support from multiple, competing firms might result in more independence than refusing such support. When such support is needed, physicians who organize CME, teach in CME, or have other roles in continuing physician education should adhere to the guidelines below to protect the interests of patients and promote the integrity and independence of education.

As a result, the 2010 Report made these same recommendations as last year’s report:

1.    When funding or in-kind support is provided by sources with a direct financial interest in physicians’ recommendations:

1. The educational activity has been planned by the provider based on needs identified independent of and prior to solicitation or acceptance of the support; and

2. The CME provider can articulate a compelling reason(s) to accept such support for the educational activity or activities; and

3. The CME provider declines any support that is conditioned on the provider’s acceptance of advice or services concerning educational content, faculty, content developers, or other educational matters; and

4. The source and magnitude of the funding or in-kind support are clearly disclosed;

5. The CME provider mitigates the potential for influence, for 1 example, through the use of firewalls, blind trusts, having multiple rather than single sources of support, or other mechanisms; and (New requirement)

6. The CME provider routinely audits the level of industry support it receives to ensure that it maintains the independence and integrity of its educational mission and programs.

2.    When participation as a content developer or faculty member by an individual who has modest financial relationship with the commercial supporter is necessary to ensure that physicians have access to appropriate, high quality professional education:

a.    The existence and magnitude of any financial interests are clearly disclosed; and

b.    Steps are taken to eliminate or mitigate the potential influence of those interests.

3.    When participation as a content developer or faculty member by an individual who has direct, substantial, and unavoidable financial interest in the educational subject matter (e.g., as the inventor of a new device) is required because the individual is a uniquely qualified expert:

a.    there is a demonstrated, compelling need for the specific CME activity in the professional community that cannot otherwise be met; and

b.    the CME provider is able to justify its determination that the individual is uniquely qualified; and

c.    steps are taken to mitigate the potential influence of the unavoidable financial interest (e.g., using independent review of content); and

d.    the nature and magnitude of the individual’s specific financial interest in the subject matter are clearly disclosed; and

e.    the activity contributes overall to the timely development of a pool of qualified, independent experts in the relevant field.

4.    Continuing medical education that is offered for credit has adhered to all applicable professional standards for accreditation.

The change to this part of the recommendations amounted to a simple reordering of the same recommendations for instance:

-    The first guideline is the same as the third guideline from the 2009 report;

-    The second guideline is the same as the fourth guideline from the 2009 report;

-    The third guideline is the same as the fifth guideline from the 2009 report;

-    The 2010 report removes the guideline that “funding or in-kind support should be provided only by sources that have no direct financial interest in a physician’s clinical recommendations;

-    The fourth guideline in 2010 adds a new requirement that “Continuing medical education that is offered for credit has adhered to all applicable professional standards for accreditation.”

Discussion

The CEJA 2010 Report while making very minor changes, has ignored various studies over the past year, which have shown that industry funded CME does not produce bias. This is despite the fact that these studies were provided with confirmed receipt by members of the committee.

In particular, CEJA ignored:

-    A Cleveland Clinic study of almost 100,000 participants, which found no evidence that commercial support results in perceived bias in CME activities, and bias level was quite low for all types of CME activities and was not significantly higher when commercial support was present;

-    A study by Medscape, LLC, of over 1,000,000 physician CME participants, which found very little reporting of bias (less than 1%) and no difference between bias reported in commercially supported vs. non supported CME activities; and

-    A UCSF study of 213 directly sponsored live CME activities, which found that “the vast majority of CME activities were perceived by participants to be free of commercial bias.

In addition to these studies there is a body of evidence that shows that this relationship with industry is beneficial to society.  By only including the exact references from previously rejected CEJA reports and not including a single citation from thirty or more provided to the committee, it seems almost unethical for the committee to make these recommendations.  

By not including a single additional reference to the report reflects the haphazard process that the CEJA committee seems to take after receiving input from their constituencies.  It’s hard to imagine how much scholarship went into this document, given it is identical to the previous years. To save face CEJA should withdraw this report.

In failing to address this crucial evidence, CEJA has continued to make the same errors in their recommendations to limit industry interaction, involvement and funding of CME. As their report itself states, “individual physicians have an ethical obligation to dedicate themselves to continue to study, apply, and advance scientific knowledge” and to “maintain a commitment to medical education.”  This commitment is expected for physicians to “commit themselves to lifelong learning and to maintain their clinical knowledge and skills through CME and other professional development activities.”

CEJA must go back to the drawing board and start from scratch.  They must realize that “industry support for CME helps to meet the costs of programs and activities in the face of uncertain funding from other sources.” It also reduces “costs to individual attendees and makes CME more accessible, especially for physicians in resource poor communities.”

Ultimately, without industry support of CME, 50% of programs would be eliminated immediately, and physicians in rural areas would face significant difficulty finding live programs, and specialists would be left with limited options for learning about new advances in their respective fields.  These negative consequences would have a significant impact on patient outcomes and would create unnecessary burdens for physicians trying to maintain licenses and stay up-to-date with effective new treatments and technologies.

With the 2010 report continuing to cite that “to date there is no empirical evidence to support or refute the hypothesis that CME activities are biased,” CEJA’s recommendations must be changed, otherwise “access to appropriate, high quality, independent CME will be seriously impaired if support from industry is refused.”

This report is about continuing medical education.  As a medical educator, if your student was sent home with requested changes to his paper it would be highly unlikely that they would then re-submit basically the same paper the next year and unconscionably four semesters in a row and expect to eventually pass.

With four tries and little effort on CEJA’s part to correct the problem, we recommend that the report be rejected by the House of Delegates once and for all.  Perhaps we won’t have to relive “Ground Hog Day” yet again.

The CEJA Report will be discussed:

AMA House of Delegates

Location:    Hyatt Regency Chicago

Committee:   Reference Committee on Amendments to Constitution and Bi Laws

Date:  Sunday June 13, 2010

Time: 1pm – 4:00pm

Room:    Regency C

June 2010 Version:  AMA HOD - CEJA I - V.4.0 5-18-10

December 2009 Version: CEJA Report on CME 2-I-09