Showing posts with label CME. Show all posts
Showing posts with label CME. Show all posts

June 7, 2010

AMA CEJA 2010: ACRE Recommends Rejecting CEJA Report

In response to the American Medical Association Council on Judicial and Ethical Affair's (CEJA) fourth attempt to hinder physician and institution relationships with industry, the Association of Clinical Researchers and Educators (ACRE) recommended (HERE) 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,” improperly asks individual physicians and institutions of medicine to not accept industry funding to support professional educational activities.  As a result, ACRE has 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.
By ignoring ACRE’s previous response (HERE) to their third report (HERE) and ignoring recent evidence that industry support does not produce bias in CME, the most recent CEJA report is contrary to evidence-based professional ethics.  In fact, the report is a virtual replica of the previous report that was rejected on three separate occasions by the House of Delegates.  The most recent version contains the same 57 references and includes the same disclaimer that “to date, there is no empirical evidence to support or refute the hypothesis that CME activities are biased.” 

CEJA further 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 these data?  Nothing.

Ultimately, ACRE’s response reflects the organization's understanding, which is founded on experience and data, 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.

June 1, 2010

Bias Towards Medical Progress

Efforts to avoid the appearance of bias for its own sake are futile and ill-advised. This caused some headaches for the religious court that condemned Galileo for proposing that the earth revolves around the sun. Science vs. empiricism vs. pragmatism. Still a problem today.

Bias is compatible with truth and fact. My bias for disc brakes and airbags is evidence-based. Preference for specific commercial products may also be biased, objective and evidence-based.

Manufacture and promotion of products that do not yield beneficial medical outcomes, superior to the current standard of care, is the single greatest cause of corporate extinction. Think of Chrysler. They managed to collapse without paying a single fine for off-label promotion. This is economic and independent of liability. Products that do not perform or do not reduce risk do not sell.

The recent fiduciary concern by many of America's doctors for high medical costs and the self-appointed obligation to recommend generics over costlier ethical drugs is romantic but hardly reassuring. Death and "conservative management" are always the low-cost option. Generics play a valuable economic role in the life cycle of technology and the cost-effective delivery of care but to suggest that cheap drugs developed in 1960 are generally preferable to today's patented products is a menace to public health.

The biggest problem with the reports regarding industry influence on medical education is that they miss the whole point of industry-sponsored medical education: company's have an incentive and bias for medical progress. Journals are incentivized by subscriptions and advertising revenue, AMCs by research grants, tuition and billing CMS for clinical care; and professional medical societies (PMS) by tuition and fees for knowledge and advocacy.  None of these entities have an explicit progress incentive.  

Novel technology, by definition, works from an implicit evidence disadvantage. Journals and PMS guidelines are legend for dismissing the scanty data on breakthroughs, especially since few of their members have either incentive or motive to champion accompanying changes in practice. One of the authors derides industry reps for often lacking scientific training. Science only proves or disproves a hypothesis, nothing more or less. Promoting change through the continuum of accumulating evidence (often 30 years and longer) depends on more than just clinical science, to the chagrin of some. Incentives to change practice are almost always small when compared to the status quo incentive, even when outcomes are superior. In hindsight, most skeptics claim to have been early adopters and it's not impossible to remember history that way 20 years after the fact.

Right or wrong, industry drives change and progress does not occur without change

April 28, 2010

Subtle Links: Health Reform and COI


Interactions between physicians and industry come under intense scrutiny in a variety of arenas including marketing, research, and continuing medical education.  There has also been a slow creep of this debate into an increasing number of policy and political areas.  An upcoming conference being organized by the Josiah Macy Jr. Foundation (May 13, Washington DC) highlights how the 'conflict of interest' crowd is attempting to put stakes in the ground further and further from their home base, despite having little new information to offer.

The conference"Will Health Professionals Be Prepared to Meet The Demands of Health Reform?: Adapting continuing education for a new health care era," features the usual handful of organizations and individuals that are critical of physician-industry collaboration.  

The focus will be on continuing medical education (CE), and "How CE should change in an era of health reform to better prepare health professionals and debate what policymakers, providers, and licensing, certification and accrediting bodies should do to foster effective and appropriate lifelong learning."

The topics are typical for the CE-industry funding debate and there appears to be few new concepts that will be presented at the conference.  Nonetheless, it demonstrates how emerging, hot-topics such as health reform can be used to promote an issue in a new, more subtle, way.  In this case, the conflict of interest movement is being promoted through healthcare reform.  It also demonstrates that those in opposition to physician-industry interactions remain active in promoting and advancing their cause,which should reinforce the call to engage for those that see the value of collaboration.