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May 20, 2010

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

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

    1. 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

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

    1. 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)

    1. 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

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Tom

You are right on! Multiple studies show lack of bias. Another time we see a "solution looking for a problem." Attending CME can be done at industry supported or other. People, competent, intelligent adults, can choose. What is at stake is only whether industry should fund these. The evidence points to value!

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