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November 09, 2009

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The AMA Council on Medical Education according to them rules on gifts to MD’s and commercial support are out of date.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

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