Policy and Medicine

AMA CEJA 2009: Report Financial Relationships with Industry in Continuing Medical Education Referred Back to Committee for the Third Time by AMA House of Delegates

American Medical Association House of Delegates referred back to committee the Council on Judicial and Ethical Affairs report Financial Relationships with Industry in Continuing Medical Education referred to as CEJA 1.  This is the third time it has been sent back for more work by the AMA House of Delegates. 

The rejection by the House of Delegates shows a commitment to CME funding and academic freedom by the AMA membership. 

The AMA members are not willing to give up their rights to collaborate with industry and walk away from commercial support of CME especially in these tough economic times.

At the reference committee prior to the vote 25 speakers representing 24 organizations spoke against adoption of the report including two organizations (AAFP and ACOG) that had supported the previous version.  Many organizations asked the committee to reject completely as opposed to sending back to committee. 

On the pro side 10 speakers representing the Council for Judicial and Ethical Affairs and the Council of Medical Education members and four other organizations spoke in support of the measure. 

Now the details:

In favor of the proposal:

The AMA Council for Judicial and Ethical Affairs According to the council the CEJA report takes into account feedback from a number of stakeholders.  The report has five recommendations that must be taken together. 

The report ensures access to CME that would otherwise be too expensive, restores AMA to a leadership position and recognizes MD’s ethical and moral judgment.  

 The report does not ban CME. 

The council admitted there is no compelling evidence of bias but concluded that there is no evidence of CME not being bias. 

The Council brought up that "we are not lining up at the “pro” microphone to give the appearance of support".  (he was the fourth speaker).  

There is an advantage of a code that it’s what is best for patients, MD’s should control med ed, what others said (that the report was restrictive) was not true.

The AMA Council on Medical Education according to them rules on gifts to MD’s and commercial support are out of date.  

The CEJA report is giving guidance beyond CME.  

The recommendation for not accepting commercial support are ideals and inspirational but impractical to implement.  

They believe that these recommendations beneficial consistent with current practice and bring us up to date.  There is nothing in the policy that changes CME policy. 

The report follows current ACCME guidelines but acknowledged that there are plenty of good existing CME policies on file.

Medical Student Section supported the measure but went on to describe how we must continue collaborate with industry. (they left their address for contributions)….

Colorado Delegation thinks medical students are awesome and that we should listen to them (what is up with that).  We need this policy because MD’s are more ethically challenged, need guidance and is essential to the integrity of medicine. (the first CEJA Chairman to write a CME report Mark Levine is an active member of the Colorado delegation)

Michigan Delegation report allows for exceptions.   CEJA has set the bar high but not made it impossible.

Medical Residents Section CEJA fills an important gap in policy.

 

Against the proposal:

The Heart of America Caucus representing the delegations of Kansas, Missouri, Nebraska, and Iowa stated that commercial support is a fact of life and by adopting the report conflicts won’t go away.  Small CME providers are under resourced to comply with the current CME standards, they are finding it difficult to resolve all conflicts because their CME staffs are part time employees and cannot afford extensive training on the CME rules.    They concluded that physician’s judgments need extra help, disclosure and sunshine and size of conflict will contribute to determing the magnitude of the interest.

The Council for Medical Specialty Societies representing 26 medical societies on the grounds that:

• Commercial Support for CME is not unethical
• The AMA should support the ACCME Standards for Commercial Support
• The report is not evidenced based that there is no evidence of industry support impacting CME
• The only “study” cited in the report from 1986
• Commercial influence is unethical but not their support
• Recommendation number 3 was inconsistent with recommendation number 1
• The IOM did not call for the elimination of commercial support
• Under CEJA Pooled funding would be prohibited
• In kind contributions would be prohibited which is espically hard for surgical specialties that rely on access to equipment

A copy of the CMSS written statement

American Academy of Pediatrics other credentialing bodies (ACCME, AAN…) already regulate this space, what societies need is uniform regulation not more regulations.

American Academy of Family Physicians they carefully adhere to the ACCME standards of commercial support and have long endorsed proper ethical relationships between their physicians’ and industry.  The CEJA report confuses the issue of personal and organizational responsibility.    CEJA should address individual physician behavior not organizational behavior.    They believe that CME support is beneficial and not inherently bad.

Though they supported the previous version of the CEJA report, they recommend that this report not be referred back to committee and not adopted, time to move on.

Association of Clinical Researchers and Educators strongly oppose the report as not being evidenced based.  The report does not infer that the relationship between industry and physicians holds any value or does any good, and to the contrary that relationship has brought enormous benefit to patients developing new devices and updated medications adding years to patient’s lives. 

A Copy of the ACRE written statement

American Congress of Obstetricians and Gynecologists the report mixes associations, individuals and organizations.  Many groups have adopted stronger policies and the report undermines their ethical statements.   Feel that this is not the appropriate time to address the issue.   Though they supported the previous version, it is time for CEJA to move on and they recommend not adopting and not referring back to committee.

Florida Delegation  the report is too restrictive, there is too much new and information and technology and institutions would be forced to seek exceptions on a regular basis where exceptions would be more common than the rule.  The ACCME guidelines require disclosure, and that is generally being adhered to and are working fine.   Also recommended to move on.

American College of Allergy  felt that these recommendations were very restrictive and difficult for smaller societies to adhere to.

American Association of Orthopedic Surgeons came out strongly against the report, citing that medical education needs access to new technologies and these proposed policies are very restrictive towards that access.  If these restrictions are adopted it, device education would move into the hands of sales reps, and wouldn’t it be better if education stayed in the hands of MD’s.

American Academy of Physical Medicine:   The report would be restrictive and cause tremendous burdens towards small and rural hospitals where most of their members are from.

American Academy of Allergy Asthma and Immunology   Agree with the AAFP that the measure should be defeated and not referred back to committee.   High quality CME comes through industrial support,   this will decrease the availability of CME especially to specialty societies.

American Academy of Neurosurgeons surgeons need to have access to professionals who have developed techniques (who have industry relationships), adopting this rule will make CME burdensome and counter productive.  We must have access to the experts.  With CME accredited programs industry does not have input on the content where adoption of this policy would move funding to non CME activities and pushes physicians into a corner to get a majority of their information from industry.

College of Neurosurgeons medical education is very expensive so involvement of industry is very important.  If we don’t retain control of the use of funds in CME, industry will do it (education) on their own pushing education further in the wrong direction towards branded messages.

Alliance for Continuing Medical Education the report will have negative Inpact on the quality of CME

American Academy of Psychiatry and the Law the report has impact on institutions and not just individuals which is what CEJA reports and opinions are for.  The report has potential impact on physician’s ability to be an expert trial witness’s.

American Association of Clinical Endocrinology the report is not evidenced based,  We have had industry support for years and we are OK.  We are taking care of bad actors.  The 12 months ban on speaking is ridiculous, and stifling to the distribution of knowledge.   We have sent this report back three times, no more, the majority of their membership reject the report.

American Society of Hematology there is plenty of existing guidance; we don’t need a new report that muddies the water on existing interactions.

Coalition for Health Care Communication CEJA report fails to address the current crisis in CME caused by the precipitous drop in funding for CME.   The report fails to take into account the changes that the ACCME has undertaken over the last four years to resolve conflict of interests.   The report will potentially ban a majority of physicians and researchers from presenting at CME programs.  There will be fewer CME opportunities for physicians because of this report.   Additional compliance will burden small CME providers and hinder access to CME activities.

Endocrine Society it is difficult to receive funding, fewer programs are affordable, for the most part the damage has been done as seen with industry pulling out of supporting CME activities.  The report is based on a flawed premise, there is no evidence of bias and that doesn’t mean that bias will go away when industry support goes away.  If the report is adopted CME will suffer.  She recommended that everyone read the ACRE Commentary on the CEJA Report and that the committee should consider replacing the CEJA report with something similar to the ACRE Commentary.

American Academy of Neurology great changes to treatment and education supported by industry has helped us adopt to the changing healthcare environment.  We already have working guidelines.   If the report is adopted we loose control of industry.  The council on medical specialty societies has expressed constructive ideas on collaboration.

New Jersey Delegation we must have faith in a physician’s judgment but reject the report, physicians follow good ethics.  The CEJA report will not allow medical education to move forward.

Georgia Delegation we already have house policy on this.  The problem comes in saying physicians are unethical if they don’t follow this.   This report if adopted will have chilling effects on industry funding

Neurological Association to say don’t accept support but there are “exceptions” doesn’t make sense. Congress will on focus on recommendation 1 - -not to accept commercial support, this will cause real problems. 

American Urological Association:  There is enough work following the ACCME guidelines for commercial support, we don’t need additional guidelines.

Several individuals spoke out on behalf of themselves

Against

One physician from Florida commented that the report assumes that business and physicians’ are unethical in their interactions.  We (physicians) are smart enough to know the difference.

Pro

One CEJA member is a neurosurgeon argued that one should take the argument of expenses off the table.

Another CEJA member noted that we “Must have policy”  We have outdated policy on gifts to  physicians (which this report does not address) rejecting this policy doesn’t help. (help who?)

Summary

Overall this should send a message back to CEJA that the intellectual basis of the report needs to include references and discussion that is fair and balance.    It needs to acknowledge and embrace the benefits and advances that have been achieve in medicine as a result of industry, physician and institutional collaboration.

 The recommendations should be focused on the behavior of physician’s and not manufactures and CME providers who are regulated by other entities.

The recommendations should emphasize the benefits of physicians who work with industry to develop and disseminate information on products.  Encouraging accurate disclosure of relationships and reminding physicians of their responsibility to the patient to give the best treatment, learn about those treatments and apply that education to their practices.

In June of 2010 we should see this resolution come back to the House of Delegates meeting so it may again be ground hogs day….

AMA CEJA 2009: Council of Medical Specialty Societies Recommends that CEJA Join the Process for Change

The Council of Medical Specialty Societies (CMSS) issued their comments to the reference committee on constitution and bi-laws concerning the Council on Ethical and Judicial Affairs (CEJA) of the American Medical Association (AMA) CEJA Report 1-I-09, “Financial Relationships with Industry in Continuing Medical Education.” Their response is in concurrence with the draft CMSS Code on Interactions of Specialty Societies in Relationships with Industry, which will occur November 20, 2009.

 

CMSS agreed with CEJA’s report that “medicine has an ethical obligation to ensure that the profession itself sets the agenda and defines the goals of physician education; controls what subject matter is taught; determines physicians’ educational needs; and takes steps to ensure the objectivity of educational content and of those who teach it” (p. 2, lines 27-30).”

 

They also agreed that while “there is growing concern within and outside of medicine that industry funding can have undesired effects on CME, at present there is no clear evidence to settle the question whether such concerns are borne out empirically” (p. 3, lines 42-46).” As a result, CMSS wrote that it could not support CEJA report 1-I-09 in its current form, as the report is internally inconsistent and flawed for the following reasons.

 

• In disagreeing with the CEJA report, CMSS asserted that “commercial support of CME is not unethical.” Instead, they noted that influence of commercial support “should be prohibited by CEJA, as it is by the Accreditation Council for Continuing Medical Education (ACCME), in its “Standards for Commercial Support: Standards to Ensure the Independence of CME Activities” (SCS). Specifically, content is not allowed to be controlled by commercial support of CME activities, and presently, adherence by providers to the ACCME SCS succeeds in separating industry support from influence.

 

• CMSS strongly believes that the AMA should unequivocally support the ACCME Standards and should continue the profession’s voluntary self-regulation through the ACCME SCS. If AMA does not support the ACCME SCS, it sends the message that the profession does not support its own voluntary self-regulation, opening up the profession to the natural consequence of external regulation of CME.

 

• “CEJA report violates its own warning by justifying its concerns about the influence of commercial support by referencing literature which pre-dates the first edition in 1991 of the ACCME SCS (Bowman 1986, CEJA reference 25).” As a result, calling for an end to commercial support of CME, gives the appearance of establishing ethical guidance without the evidence necessary to draw such conclusions because there CEJA does not use up to date peer reviewed and accepted evidence that such support biases CME.

 

• The Institute of Medicine’s recent report on Conflict of Interest in Medical Research, Education and Practice (April 28. 2009) does not call for an end to commercial support of CME. The extensive, interdisciplinary IOM review of relationships between medicine and industry concluded, as does ACCME, that influence, not support, should be avoided.

 

CMSS also took issue with two CEJA recommendations because of their contradictory nature.

 

• The report calls for prohibiting pooled funding from multiple sources, and in-kind use of expensive equipment from multiple vendors. What CEJA did not realize is that pooled funding is attractive in that it separates a perceived influence of a single company on a CME activity.

 

• CEJA’s recommendations already permitted the use of expensive equipment, provided in-kind by multiple vendors for training physicians in important procedures but, then prohibited in a separate recommendation. 

 

• This type of confusion highlights the types of mistakes CEJA is making that will ultimately harm patients, and keep providers uneducated about new lifesaving treatments.    

 

Ultimately, CMSS believes that it is the profession’s responsibility to society to voluntarily regulate itself, in this case in its relationships with industry.

 

Accordingly, CMSS has invited the AMA to work with them, and the 15 national organizations of the Conjoint Committee (CCCME) on a 24 month process, called for by IOM, to convene the national dialogue leading to a system of CME support.

 

AMA CEJA: Good Ideas Using Bad Logic

In response to a third report on Continuing Medical Education (CME) issued by the Council on Ethical and Judicial Affairs (CEJA) of the American Medical Association (AMA) titled CEJA Report 1-1-09: Financial Relationships with Industry in Continuing Medical Education , Stephen Lewis President of Global Education Group and the North American Association of Medical Education and Communications Company (NAAMECC) recognized that the report had some “good ideas but used bad logic.”

 

Mr. Lewis asserts that the report includes examples of flawed logic and non-sequiter sidebars that will greatly diminish the level of agreement and support for its conclusions. The bulk of the report’s recommendations that address “conditions” that should be met when industry funding is necessary “to ensure that physicians have access to appropriate, high quality” CME are already required and addressed by ACCME Standards and policies.

 

CEJA contradicts itself by expressing “concern” about independence in Certified CME when the report acknowledges that CME follows AMA and ACCME definitions, standards, and policies. The report also makes all of its claims without any “available data to demonstrate conclusively that commercial funding unduly biases continuing professional education.”

 

Even though they call for a ban on industry funding, CEJA confusingly admits that funding may have positive results because “it is not always feasible, or necessarily desirable, for professional education to disengage from industry completely.” They even recognize that “refusing support from industry entirely could significantly undermine the profession’s capacity to ensure that physicians have access to appropriate, high quality CME.”

 

Much of the growing concern about conflicts has been over ethical infractions outside of the CME arena. To date, all evidence indicting CME stems from unethical practices: three examples stemmed from federal cases alleging illegal marketing practices of the drugs Neurontin, Vioxx, and Xyrem between 2002 and 2005.

 

Conclusion

 

The new CEJA report does specifically address the link between CME and improved physician practices. Specifically, the report states that 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.’” In addition, the report states, “CME activities that are pedagogically sound, scientifically grounded, and clinically relevant are essential to ensure that physicians can provide the high quality of care their patients deserve.”

 

As a result, the media and the CME enterprise should keep a global perspective on the costs, risks, and benefits of Certified CME compared to other fields. Why? Because $880 million was awarded in grant funding from all pharmaceutical companies to CME providers in 2008. This funding enabled the development of 100,000 educational courses that educated more than 16 million healthcare professionals.

 

Industry CME funding improves quality, because it helps support the development of an accreditation system for compliance and professional accredited providers that thrive by demonstrating quality and developing innovative education that improves professional practice. In the absence of funding, CME would not include appropriate management or development of innovative, interactive, web-based and live presentations.

 

The organization without professional resources to effectively manage a CME program is the most likely one to develop poor quality CME. Funding allows CME professionals to identify and resolve faculty conflicts of interest and clinically review educational content.

 

Eliminating industry funding would reduce CME quality and eliminate the system of checks and balances that currently ensures relevant, evidence-based education.

If current rules and guidelines require independence, then the solution would not be to add another layer of rules and recommendations from CEJA. The most effective solution should be to enforce existing rules to the fullest.

ACRE Responds to CEJA Report Financial Relationships with Industry in Continuing Medical Education

 

The Association of Clinical Researchers and Educators (ACRE), recently released their response to the AMA CEJA Report: Financial Relationships with Industry in Continuing Medical Education (1-I-09). Specifically, ACRE recommended that AMA House of Delegates reject the report or refer its recommendations back to committee.    The report which includes some light editing from the report rejected by the House of Delegates this past summer needs to be rewritten from the beginning.

Methodology and Evidence

The CEJA report itself admits that “there is no empirical evidence to support or refute the hypothesis that CME activities are biased” (p. 3 48-49), and the available data by no means demonstrate conclusively that commercial funding unduly biases continuing professional education (p. 4 11-12). The report also admits to using an “arbitrary” methodology to define criteria that would be used to eliminate industry-funded CME is even more problematic considering the evidence CEJA uses to advance its claims. 

Ignoring Relevant Evidence

CEJA’s reliance upon the Brennan paper violates a major requirement of serious scholarship by not citing research that shows the many benefits of commercial contributions to medicine.  Instead, Brennan exercised confirmation bias by referring only to publications critical of industry influences on medicine, although others refuting these criticisms existed when the Brennan paper appeared.

CME Participation is Voluntary

Participation at industry sponsored CME is always a voluntary activity.  If doctors choose to go it’s because they find it to be of value.  They do not have to go.  And when physicians do go, they know the nature of the content being presented from the disclosure and the rules governing industry sponsored CME (through the Accreditation Council for Continuing Medical Education (“ACCME”)). 

Industry-Funded CME

With over 50% of CME being funded by industry, who is going to pick-up the bill if industry is banned? For the most part, the federal government does not see supporting CME as part of its mission and states are broke.  Insurance companies and academic medical centers have reduced funding for CME over the last ten years. If industry funding of CME is removed, physicians will lose critical access to programs that teach them how to use new medicine, treatments, devices and technology, the majority of which is created by the same industry that support such programs. 

Delayed Implementation

The CEJA recommendation on elimination of commercial support, chooses to ignore the potential for patient harm by delaying treatment if new procedures and therapies are not discussed and explored in CME activities or those activities fail to take place due to lack of support.

Rural and Inner-City Physicians benefit from CME

In these areas, it is unlikely that any outside expert would come on their own to teach other providers the management of diabetes or complex cancers without commercial support helping to cover expenses of these experts.   Also, the selection criteria of having to prove that a speaker does not have a conflict is especially burdensome on smaller CME providers

Medical Societies benefit from experts

Medical Societies will also suffer from recommendation 2, in that a vast majority of new science is presented by faculty who are currently involved in compensated relationships with a commercial entity.  The exception criteria will be tremendously burdensome on smaller societies who will be forced to dedicate resources to justify the use of the most knowledgeable speakers and presenters.

Healthcare Reform: More CME, Not Less

With healthcare reform around the corner, we need to consider that adding an additional 30–60 million patients to the system will force a need for additional training by physicians especially primary care physicians.  Reducing the sources of funding for education of physicians will only further strain the already overburdened physician healthcare providers.

CME Progress

The commercial support which helps pay for CME enhances patient care. The death rate from cardiovascular disease, for example, the number one killer, has steadily decreased and is currently half of what it was at that time.  Death rates for cancer have also decreased.

Commonality of Interests

There is no inherent “conflict” of interest in the working relationship of physicians with industry and government.  Rather, there is a commonality of interest that is healthy, desirable, and beneficial.  The collaborative and constructive relationship among physicians, government, and industry has resulted in many medical advancements and improved health outcomes.

CME and Industry Promote Variety

Industry-funded CME is merely one of many options physicians use to address the well being of patients. Since the purpose of medical "professionalism" is better patient care, positive outcomes of corporate investments in research, development, and promotion create a variety of knowledge and information to providers wishing to be competent to help with the patient's best interest in mind. 

Industry Support of Education is Not Corrupt

CEJA’s use of the Brennan Report is oddly selective because it neglects the obvious fact that academic health centers and medical journals are also "commercial," are engaged in vigorous competition with rivals, and exhibit the same promotional behavior deemed unattractive when exhibited by private companies.

Conclusion

Ultimately, ACRE asserted that there is value to physicians, medicine, medical education, and patients from the working relationship between physicians and industry, and that there is no conflict in advancing science or in providing the education that is required to do so.

By working together with industry colleagues, ACRE believes that physicians an industry 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. Finally, ACRE acknowledges that by working with industry to develop and market therapies with the highest integrity, medical education will keep physicians current on the best available evidence to provide excellent patient care.

Full ACRE Response to CEJA

CEJA Report 1-1-09: Financial Relationships with Industry in Continuing Medical Education

Disclosure:  Thomas Sullivan is a principle of Rockpointe and the Potomac Center for Medical Education a private medical education company, in addition Thomas volunteers and serves on the ACRE steering committee as a non voting member.

 

AMA CEJA: Financial Relationships with Industry In Continuing Medical Education Version 3.0

Under pressure from one member of Congress the American Medical Association (AMA) Council of Judicial and Ethical Affairs (CEJA) proposed another report CEJA Report 1-1-09: Financial Relationships with Industry in Continuing Medical Education to be voted on at the 2009 Interim Meeting of the American Medical Association House of Delegates.

The meeting is being held from Saturday, November 7 - Tuesday, November 10 at the
Houston Hilton and George R. Brown Convention Center, in Houston, Texas. Below is a summary of the report.

The report appears to be yet another attempt by CEJA to restrict speakers and CME funding.

Background

 

While their proposal is an improvement from previous CEJA Reports (June 2009, June 2008) which were rejected by the House of Delegates, the report is still built on the same extremely weak scientific structure of largely editorials, and opinion papers and little science (3 original papers out of 57 references). 

 

In fact, CEJA itself admits that the process it proposes is “arbitrary” and the “available data by no means demonstrates conclusively that commercial funding unduly biases continuing professional education.” Yet without scant evidence to support their claims, CEJA goes on to use commentary, conjecture, opinion and mostly a non-scientific framework to embellish that CME cannot be objective if industry is involved.

 

“to date there is no empirical evidence to support or refute the hypothesis that CME activities are biased.”(p 3 48-49) and The available data by no means demonstrate conclusively that commercial funding unduly biases continuing  professional education. (p 4 11-12)

 

The report as in other CEJA reports and recommendations are still based on the belief that “Financial and in-kind support of continuing medical education (CME) by pharmaceutical, biotechnology, and medical device companies puts that ethical obligation (to ensure objectivity) at risk by creating conditions for conflict of interest. Medicine’s ethical aspiration should be to avoid this potential.” (p 9 14-15)

 

They then go on in the very next sentence to outline that: In some circumstances, however, refusing support from industry entirely could significantly undermine the profession’s capacity to ensure that physicians have access to appropriate, high quality CME. (p 9 19-21)

 

There premise holds that:  Medicine should seek to minimize such occasions when they cannot be avoided; medicine must act vigorously to protect the interest of patients and the integrity and independence of the educational exercise. (p 9 21-23)

 

Financial Relationships with Industry in Continuing Medical Education

 

CEJA’s report is seeking to provide ethical guidance for physicians and the profession with respect to industry support for continuing medical education. After surveying various literatures, CEJA found that relationships with industry—i.e., pharmaceutical, biotechnology, and medical device companies—can offer enormous benefit to the profession and the patients it serves.

 

Contrary to this finding however, CEJA is concerned that commercial funding for professional education can pose significant ethical challenges to medicine’s ability to focus primarily on the needs of patients and ensure quality education for physicians.” As a result, CEJA stated that there should be “no direct financial interest in a physician’s clinical recommendations.” Specifically:

 

    “Those involved in CME should have no current, recent, or potential direct    financial interest in the subject matter and should not currently be or recently     have been involved in a compensated relationship with a commercial entity that     has a financial interest in the educational subject matter.” (p9 31-39 summarized)

 

Avoiding Conditions that Can Compromise the Integrity of CME

 

CEJA proposes that physicians will have to decline to accept or seek support for professional education activities from commercial funders who have significant financial interests in physicians’ clinical decisions. By totally eliminating industry, CEJA asserts that it would eliminate the administrative and resource costs that must otherwise be devoted to mitigating influence. If doctors are required by law to already disclose such information publicly, what kind of administrative cost is CEJA really eliminating? It sounds more like CEJA is eliminating of ways for doctors to learn about new treatments for patients, which will end up costing ten times as much in administrative and resource costs once patients go without proper care.

 

The report calls for CME providers to avoid financial relationships with industry by cultivating alternative sources of support; designing and conducting educational activities independently; and identifying content developers and faculty members who do not have problematic ties with industry.

 

Where exactly is CEJA going to find such people? How much is that going to cost? While the Institute of Medicine has called for development of a new system of funding CME that is free of industry influence, who is going to pay for it? For the most part the federal government does not see supporting CME as part of their mission and states are broke.  Insurance companies and academic medical centers have reduced funding for CME over the last ten years.

 

What CEJA’s plan sounds like is a waiting list for doctors to be able to talk about new medicine and research. Hypothetically, CEJA would prefer to let studies for breakthroughs in medicine and devices to wait around until a doctor who has no experience with the material reads the article. This is problematic for two reasons: first, it prevents patients and physicians from learning about lifesaving and altering technologies; and second, it harms rural communities, as CEJA notes, because they “may not always be able to obtain the services of experts who do not have problematic ties to industry” based on the local conditions.

 

Mitigating Potential Influence That Cannot Be Avoided

 

CEJA does acknowledge “that not all relationships with industry are equally problematic. For example, having once conducted sponsored research or accepted a modest honorarium for speaking on behalf of a company would not necessarily create such clear potential for bias as to preclude an individual with the appropriate expertise developing content or serving as a faculty member for a given CME activity.”

 

Who determines what ‘appropriate expertise’ is? Any physician who conducts clinical studies on a particular device or medicine successfully would certainly have more expertise then a doctor who just read the outcome. So then why is payment for such research, which represents the legal work product of physicians, such a problem?

 

If examples like cadavers and sophisticated equipment to train physicians in new surgical procedures or the use of new technologies “are not feasible without financial support from industry,” then why is CEJA trying to take such broad strokes eliminating industry funding? Perhaps CEJA would revise such claims if they read a recent scientific study from the Journal of American Medicine which found that an overwhelming majority of physicians found it appropriate to work with industry.

 

CEJA is also seeking to create additional “firewalls” between industry funders and decisions about educational goals, content, faculty, pedagogical methods and materials, and other substantive dimensions of CME activities. Ideas include using multiple, competing funders for CME programs, and creating a “blind trust” model where funders have no knowledge of which programs their grants or gifts supported, nor are CME providers, content developers, or faculty aware of which funder supported their activities;

 

Exceptional Cases: Conflicted But Essential Expertise

 

CEJA’s ethical considerations are even more confused by the fact that they support using physicians paid by industry “in the earliest stage of adoption of a new medical device, technique, or technology, because they are the only individuals truly qualified to train physicians in its use, and are often those who developed the innovation.”

 

Although CEJA feels these are the very individuals who often have the most substantial and direct interests at stake, this is irrelevant: these experts are morally and ethically obligated to teach doctors how to use such devices, techniques and technologies, and it is legal for them to do so. These breakthroughs and innovations, which require physician education, have one priority: saving lives. Whether such relationships are ongoing or through employment with manufacturers, or other direct financial interests in the adoption and dissemination of the new device, technique, or technology is of little importance compared to saving a life.

 

Still, CEJA wants to make such experts wait in line with the other ‘conflicted’ physicians while the committee tries to arbitrarily define whether the:

 

-    Dissemination of the device, technique or technology will be of significant benefit to patients, and to the public and the professional community;

 

-    That the individual is uniquely qualified as an expert in the relevant body of knowledge or skills; and

 

-    That there is demonstrated, compelling need for the specific CME activity;

 

RECOMMENDATIONS

 

Accordingly, CEJA recommends that financial and in-kind support of continuing medical education (CME) by pharmaceutical, biotechnology, and medical device companies should be:

 

1.    Provided only by sources that have no direct financial interest in a physician’s clinical recommendations; and

 

2.    Individuals who develop content for or teach in CME activities should:

 

a.   Have no current, recent (within the preceding 12 months), or potential direct financial interest (e.g., royalties or ownership interest) in the educational subject matter; and

 

b.   Not currently be and not recently have been (within the preceding 12 months) involved in a compensated relationship (e.g., direct employment, service on a speakers bureau, service as a consultant or expert witness) with a commercial entity that has a financial interest in the educational subject matter.  

 

CEJA recommends that CME can be funded by industry sources if declining such support would significantly undermine the capacity to ensure that physicians have access to appropriate, high quality professional education. If such circumstances are established, then industry can fund CME if:

 

·  The educational activity is planned by the provider based on needs identified independent of and prior to solicitation or acceptance of the funding;

 

·  The CME provider can articulate compelling reason(s) to accept industry support;

 

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

 

·  The source and magnitude of support are clearly disclosed; and

 

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

 

CEJA recommends that CME providers may permit involvement of individuals with “modest financial interests” if the nature and magnitude of those interests are disclosed and steps are taken to eliminate or mitigate the potential influence of those interests.

 

CEJA recommends that CME providers may permit involvement of a uniquely qualified expert who has a direct, substantial, unavoidable financial interest if:

 

·  There is a demonstrated, compelling need for the educational activity in the professional community that cannot otherwise be met;

 

·  The CME provider demonstrates that the individual has unique expertise in the relevant body of knowledge/skills;

 

·  The CME provider takes steps to mitigate the potential influence of the unavoidable financial interest;

 

·  The nature and magnitude of the specific interest are clearly disclosed; and

 

·  CME activities that use such experts should contribute overall to the timely development a pool of qualified, independent experts in the relevant field.

 

Summary

 

The ethical considerations of CEJA’s report are at best confusing. The report itself even admits that because “there are no specific, publicly agreed on understandings of the key criteria proposed above, trying to create concrete definitions would be an essentially “arbitrary exercise.”

 

The recommendations include several italicized words (modest, uniquely qualified, direct, substantial, and unavoidable) which provide more examples of the ambiguous language surrounding this report.   And lack of definition will in the end cause even more confusion for those seeking to regulate and understand CME.

 

This report summarizes a conflict of interest on one hand CEJA clearly sees the benefit of commercial support of CME in high quality programs, on the other hand they are scared that somehow subtle bias will prevail.  “Our concern is not with egregious lapses of judgment or with corruption, but with the subtle bias that financial ties create.” (p 4 21-22)

 

Disregarding their own admission, CEJA would rather force patients to wait for a new therapy to become available, rather then let your doctor even learn about such therapies in advance of FDA approval.

 

CEJA also wants to make patients wait for new treatments to find a “uniquely qualified” expert (or one of only a very few) who has significant knowledge about or experience in treating a rare disease or who was involved in the early development or testing of a new treatment, device, or technology.” Ironically, this premise is a contradiction in itself because the only experts who could meet such expectations would have absolutely worked with industry.    

 

What this report suggest for patients is that waiting for new treatments and medicine from CEJA’s perspective is about waiting for arbitrary definitions to be created out of thin air—which is essentially what CEJA’s entire report was based on—to determine who can teach our doctors about such breakthroughs.

 

If the AMA House of Delegates allows CEJA or even Congress tell your doctor who can teach them about medicine and treatments for their patients, next time your doctor tells you something, how will you know if it’s based on education and experience?

 

Hopefully, you can ask your doctor, and they can tell you “I learned it from CME.”

 

Twice now the AMA House of Delegates has sent this report back for more work, until they build it on a framework of evidence one can only expect them to continue to do the same.

 

AMA CEJA: Senator Kohl Exerts Pressure for Further Restrictions

With healthcare reform stalled at least until September, the focus on medical organizations is gaining momentum. For example, The Wall Street Journal recently focused on the American Medical Association’s (AMA) yearlong goal of drafting a new ethics policy aimed to limit industry influence on continuing medical education for doctors.

As a result, Senator Herb Kohl (D-WI), sent a letter to the AMA for a status report of how the new legislation was progressing. The chairman of the Aging Committee specifically asked why the CEJA report on medical education was not adopted by the AMA House of Delegates.

Although the Committee acknowledged that there “is a role for valid physician industry relationships,” Senator Kohl still noted the concerns about “real and apparent conflicts of interest associated with these arrangements.” Consequently, he asked about the AMA’s Council on Ethical and Judicial Affairs’ report regarding industry involvement in medical education.

Specifically, he recognized that although CEJA initially addressed in a report that “physicians must not accept industry funding to support professional education activities,” since then that report has been rescinded. The Chairman then asked the AMA to provide a status update as to why this recommendation was removed.

In response, the AMA wrote back saying it is still at work. The organization’s House of Delegates has rejected two proposals, and its ethics committee will take up the issue again in late August, the group said.

The first proposal from the AMA’s ethics committee recommended that doctors and others “must not accept industry funding to support professional education activities.” This proposal focused on the fact that there are not strong enough “mechanisms to manage potential conflicts.” But the impact of waiting until the right guidelines are in place will be detrimental not only to industry, but to patients. Organizations and officials will only use this setback to call for additional regulations, until eventually all of industry is forced to close or invest outside of the U.S.

Drug company funding of CME quadrupled between 1998 and 2006 to $1.2 billion, almost one-half of CME’s total income, according to a 2008 article in the Journal of the American Medical Association. Yet this money represents an extremely small of total healthcare spending. More importantly, the benefit to society for investing in CME is perhaps most valuable to patients and physicians, because it keeps doctors informed, trained, and updated on new technologies, treatments, and medicine.

Furthermore, PhRMA asserted that any efforts to sharply restrict company funding for CME of physicians “could be problematic and could negatively impact public health.” The drug-industry group said that CME is an important tool for updating doctors on the latest medicines, additional indications, and new warnings about drugs and noted that PhRMA has revised its code of conduct to “enhance the independence” of CME.

Ultimately, the AMA needs to take a much more representative voice from the population of physicians, this meaning that instead of relying on the top administrative officials who want to get in the limelight, they need to be more focused on the doctors who treat patients day-to-day, and only have enough time to use medicines and devices that are readily available to them. Often the real conflict of interest is from payer groups (insurance companies, hospitals, and government formularies) which prescribe what drugs or devices a physician uses taking away the physicians’ power to choose what is best for their patients.

Industry brings medical advances directly to patients through their doctors, and there is no conflict in that.

AMA CEJA 2009: Referred Back to CEJA by House of Delegates

The AMA House of Delegates on Monday referred the Council for Ethical and Judicial Affairs (CEJA Report 1-A-09) Financial Relationships with Industry in Continuing Medical Education back to the committee for further revisions. 

The discussions were clear on what needs to be done to get the report passed.  With some relatively easy revisions (dropping ethically preferable and ethically permissible, and ambiguous terms such as “overly reliant” and “modest financial interest”) the report probably would have been acceptable to the House of Delegates.  

Many are uncomfortable with definitions of levels of ethics that CEJA had proposed.    

AMA CEJA and the Council on Medical Education did a good job this past February in bringing stakeholders together and receive input on the report. 

Dr. Regina Benjamin, Chairman of CEJA and Dr. Claudette Dalton, Chairman of the Council on Medical Education deserve many thanks for their tireless efforts to design reports that attempted to be fair and balanced.

Unfortunately because of last year’s draconian report there is still a level of mistrust towards CEJA on this issue by members of the house of delegates.   

With all the changes that have happened in the last few years to ensure fair balance and resolution of conflicts of interest in CME and further changes in the works, perhaps CEJA should re-consider if commercial support of CME is in fact an ethical issue and refocus their efforts on reports that address physician ethics as opposed to where the funding for continuing education comes from. 

In the near future CME funding will come from many more diverse sources including the government.  To say that one source of CME funding is more ethical than another is perhaps a decision better left to the physicians own judgment.

AMA CEJA 2009: Reference Committee

At the AMA meeting in Chicago on Sunday, the Reference on Constitution and Bi-laws heard testimony on the Council for Ethical and Judicial Affairs report (CEJA Report 1-A-09) Financial Relationships with Industry in Continuing Medical Education. 

Overall there was concern in the language even by several of those who stood in support of the measure on the use of the language used to classify CME.   The main concern was around the use of the wording ethically preferable and ethically permissible.

The Council for Medical Specialty Societies offered their support of the measure if those definitions (ethically preferable and ethically permissible) were dropped in favor of a pre-amble, and in place of ethically preferable, CME providers can take steps to virtually eliminate perceived conflicts of interest in the following manor, and in place of ethically permissible, ethical guidelines for CME providers receiving industry support…  They also pointed out that no other CEJA reports or opinions used that language.

The mix of speakers and states both for and against showed that this is still a very controversial report in the house of delegates.  

Rising in support were:

·         ACOG which outlined their strong ethical guidelines,

·         AAFP which is overall supportive of the report and emphasized that conflicts need to be managed

·         New York which wants to see CEJA pass but move on

·         California stated the train is moving so we have to jump on it.

·         Another NY Physician who stated the report is appropriate and not prescriptive

·         Several CEJA and Council on Medical Education members stood up in support their comments included:

o   CEJA report does not negate need for industry relationships

o   The language is not arbitrary and the report is good.

Rising in Opposition and to refer back to committee:

·         Pennsylvania – expressed that where one gets their CME support is business decision not an ethical one

·         American Association of Clinical Endocrinologists who stated that this report will be viewed as a standalone report and with reverence from the medical community, and that they do not believe that commercial support of CME is an ethical problem

·         American Association of Neurosurgery noted that they have strong eithical guidelines in place they also have problems with the terms “overly reliant” as vague term.  They rely on industry to help provide equipment for teaching their members on procedures.

·         Texas saw the language as vague and that it was more of an ethical procedure vs. espousing principles which could be followed.

·         The Endocrine Society stated the AMA should put forward principles not regulations

·         American Academy of Pediatrics was concerned with the language and what “modest reimbursement and overly reliant” meant.

·         Facial and Plastic Surgeons brought up that there is no gradation on ethics

·         North Carolina there is a need for industry to help with education, especially on cutting edge topics

·         ASCO the report is in conflict with the Accreditation Council for Continuing Medical Education (ACCME)

·         Florida discussed how you can’t label ethical grades

·         Alliance for CME brought up the ambiguity in the language “ethically preferable and permissible”, and the problems with the “overly reliant and modest financial interest”

·         Coalition for Healthcare Communication – offered their support if the CMSS clarifying amendments were accepted, and offered a clarifying amendment to replace “not overly reliant on funding from industry sources” to not overly reliant on a single commercial supporter or other source”

·         Society for Surgery of the Hand noted that there are already rules in place to resolve conflicts of interest in the ACCME Standards of Commercial Support and we don’t need another report.

·         One surgical society noted that they would not be able to afford access to millions of dollars in equipment provided by industry under the proposed guidelines.

Update

The AMA Reference Committee on Constitution and Bi-Laws recomended that despite strong objections from the membership that the report be adopted by House of Delegates.  On Monday when the reference committee reports were made available, the report was extracted from the consent calandar and rejected by the full house.

 

AMA CEJA 2009: Alliance for CME – Refer Back to CEJA

 

The Alliance for Continuing Medical Education (The Alliance) representing over 2,500 CME professionals from medical schools, hospitals, medical specialty societies, state medical societies, medical communication companies,  pharmaceutical and medical device companies and related organizations.   Issued a statement to refer back to committee the current (CEJA Report 1-A-09) Financial Relationships with Industry in Continuing Medical Education

 

Despite the laudable objective of the CEJA report, the specific ethical guidance provided to physicians and the profession on pages 8 & 9 of the report is vague and open to multiple interpretations. The Alliance strongly recommends that this report be referred back to CEJA for reconsideration and clarification.

The Alliance offers the following comments concerning CEJA's proposed "ethical framework to guide professional practice with respect to financial relationships in the context of continuing medical education."

 

The Differentiation Between Ethically Preferable and Ethically Permissible:

 

•         The distinction presented between ethically preferable and ethically permissible implies a value judgment that educational activities with commercial support or speakers with financial relationships with industry are somehow less evidence-based or less ethical than activities with no commercial support or speakers with no financial relationships. The report from CEJA provides no current data to support this potential judgment. Indeed, the report fails to acknowledge the one current study by Cervero that found no evidence in support for or against this premise!  Further research needs to be conducted in this area before new ethical standards are established.

 

•         The delineations between ethically preferable and ethically permissible can be subjective and confusing and will be interpreted differently by physicians and the public alike. We believe there is no value in suggesting shades of gray as to whether or not a practice is ethical. Both "ethically preferable" and "ethically permissible" are, in fact, ethical.

 

•         Ethically preferable CME, as defined by this document, places undue pressure on all organizations that provide continuing medical education to eliminate commercial support. Business models may well have been established that rely upon industry support. As long as these models comply with the ACCME Essentials, Standards, and Policies there is no evidence that industry support represents an ethical issue.

 

•         There are circumstances when individuals having relationships with industry are the best potential faculty for a CME activity. This is particularly true when a new a pharmaceutical product or device is made available either in clinical trials or after FDA approval. The Alliance would argue that it is ethically preferable to have knowledgeable faculty with a financial relationship with industry in this instance rather than the CME provider selecting a "good enough" speaker simply because he/she lacks a relationship with industry.

 

•         In its effort to clarify how a program can be ethically permissible while accepting commercial support or utilizing speakers with relationships with industry, the report specifies several conditions that lack clarity. The report should:

 

o   Define what "overly reliant" means in regards to CME provider dependence on funding from industry sources.

 

o   Define "modest financial interests" with regard to individuals involved in programming for, developing content for, and teaching in CME activities. Note that the ACCME's Standards for Commercial Support require that any amount of financial interest must be disclosed and managed. Does CEJA propose that CME providers collect information on specific financial amounts? If so, CEJA should clearly state where the tipping point is between "modest financial interests" and unacceptable financial interests.

 

o   Define "demonstrably uniquely qualified" as it relates to the involvement of individuals with significant, unavoidable financial interest. This is a subjective description that would be very hard to defend or prove if the uniquely qualified expert had a "substantial" financial interest in the educational recommendations or content. Providing evidence of such a selection could become onerous. A focus on the overall process of faculty selection and evidence of the process for the CME provider's management of conflict of interest policy is more appropriate.

 

Finally, we note that the report does not recognize the value of the safeguards that are currently in place to address conflicts of interest. Accredited CME providers must uphold the ACCME's Standards for Commercial Support and already adhere to the conditions being recommended in the description of ethically permissible, so we contend that there is no ethical dilemma to be addressed.

 

Furthermore, there are no data available to suggest that the Standards for Commercial Support are not effectively mitigating potential conflicts of interest.

 

CEJA needs to take these recommendations very seriously; the Alliance represents almost everyone who works in the educational process and design of CME courses.    

 

The bottom line comes to this is commercial support or any other support (commercial, governmental, insurance, hospital paid for) CME is either ethical or not, perhaps CEJA is looking at the wrong equation, regardless of who pays for the CME it is in the patients best interest for the physician to be as well educated as possible, this is epically true when life saving medications are involved.

AMA CEJA (CEJA Report 1-A-09) Financial Relationships with Industry in Continuing Medical Education

Alliance for Continuing Medical Education:  Response to AMA CEJA Report 1-A-09

 

AMA CEJA 2009: Council of Medical Specialty Societies Responds

In a letter to the Chairman of CEJA and the Chairman of the AMA reference committee, the Council of Medical Specialty Societies (CMSS) provides input on the current CEJA recommendations.

They have several major concerns with the report as it now stands:

·         Continued inappropriate mixing of two issues:  commercial support for CME and direct gifts and payments to physicians.

·         Management and Resolution of Disclosed Conflicts of Interest

·         Ethically Preferable/Ethically Permissible

o   They question the basic assumption of the CEJA document that there is somehow an ethically ideal, bellow which “less ethical” behavior is “permissible.”

CMSS goes on to suggest that in order for CEJA and the AMA fulfill the ethical tenets of professionalism prioritizing:

·         Altruism (putting patients’ interest continually first, in process and outcomes)

·         Voluntary self regulation (Adopting implementable CEJA guidelines around gifts to physicians, while commercial support should be governed by strict adherence to the ACCME Standards for Commercial Support and Standards to Ensure Independence of CME Activities)

·         Transparency (at the level of the AMA , medical and specialty societies, CME providers and physicians)

These recommendations need to be seriously considered, by CEJA, lest they potentially face the same results as last year.

No matter what the outcome, this weeks AMA meeting with the focus on healthcare reform promises to be an exciting one to say the least.

AMA CEJA 1-A-09 CMSS comments