Apres le Deluge: The CEJA Spin Cycle Begins

When the AMA adopted the 5^th version of the CEJA report on industry-funded CME, it seemed clear that this was an ominous and very bad sign for the future of industry-funded CME. I already posted my take on the report here (short version: say goodbye to most industry CME). Now we are beginning to see how industry supporters are responding. Basically, they are saying, or maybe just desperately hoping, "Feh! It's no big deal."

 

They were singing a different tune before the vote. As was true for the prior CEJA CME reports, MECCs (medical education communication companies) and their supporters maligned the document. The Alliance for CME, the main trade organization for MECCs, had released this statement recommending that many sentences in the recommendations be stricken—essentially any sentence that challenged the status quo.  

ACRE, a relatively new organization composed of physicians who  vigorously defend financial relationships with drug companies issued what amounted to a white paper calling for the rejection of the report. ACRE found so many things wrong with CEJA 5.0 that its critique ran three pages longer than the report itself.

A couple of weeks before the vote, Medical Meetings magazine published an editorial by columnist and MECC owner Stephen Lewis angrily attacking CEJA as being an “oxymoron” because it “seems to have forgotten the critical link that exists between ethics and evidence.”

And five days before the vote, Thomas Sullivan, the owner of the MECC Rockpointe, who writes the influential pro-industy blog Policy and Medicine, reviewed and agreed with the Alliance for CME’s position that the CEJA report be canned.

So much for the run up. Now that the report has been adopted, industry advocates appear to be quickly distancing themselves from these prior alarmist views about CEJA.

Two days after the vote, Thomas Sullivan was almost celebrating. Headlined “AMA CEJA 2011: AMA House of Delegates Approves Report – Now Emphasis on Value of CME in Patient Care,” his post was nonchalant. Far from seeing this as a threat to industry funding, Sullivan now argued that the report “merely reflects an alignment of AMA policies on CME with the ACCME, HHS OIG, and the PhRMA and AdvaMed Code of Ethics.  Commercial support of CME will still remain a valuable resource for CME providers to help keep physicians up to date on the latest breakthroughs and treatments.”

Medical Marketing & Media, a publication financially dependent on pro-industry stakeholders, published an article that appeared to be journalistic coverage of the decision but which was essentially an editorial saying "don't worry, be happy." The article emphasized that CEJA 5.0 does not call for an “all out ban” on industry funding, but instead “places the moral onus on physician presenters to disclose to learners their financial interests in the topic they are speaking about.”

Derek Warnick, an industry CME director and blogger, responded with an entertaining and thoughtful post in which he concludes that “If I had to guess (OK, I don’t HAVE to guess, but I’m going to anyway), I would say that CME providers may be asked to provide a little more documentation about faculty selection and conflict resolution processes, but I don’t anticipate any major shake-ups.” 

Meanwhile, the only person whose opinion anyone cares about has remained silent. That would be Murray Kopelow, the director of ACCME. If you email ACCME for his response (as I did) you will receive the following official statement: “We are currently reviewing the CEJA Recommendations and the Board of Directors will be deciding on any next steps.” The next board meeting is July 21 in Chicago, so we will probably not get any response until they publish their Executive Summary of that meeting, probably a month or so after it occurs. 

Meanwhile--into the void--let the spinning continue. 

AMA Votes to Discourage Commercial Support of CME

Something huge happened yesterday at the American Medical Association House of Delegates meeting in Chicago. Although the meaning of what happened will be spun throughout the blogosphere, twittersphere, and schmuckosphere, the bottom line is that the AMA just voted most commercial funding of CME out of existence.

Specifically, the delegates voted to approve a report of the AMA ethics committee that calls for a near elimination of industry support for CME. The report is entitled "Financial Relationships with Industry in Continuing Medical Education," and can be read in its entirely here.

It is a 12 page report, and CME geeks like me will want to pore over every word, but the essence is found on page 8 under "Recommendations." The third paragraph makes the intent of the AMA explicit:

"CME that is independent of funding or in-kind support from sources that have financial interests in physicians‘ recommendations promotes confidence in the independence and  integrity of professional education, as does CME in which organizers, teachers, and others  involved in educating physicians do not have financial relationships with industry that could influence their participation. When possible, CME should be provided without such support or the participation of individuals who have financial interests in the educational subject matter." (emphasis added)

What this means is that the AMA now expects that most CME courses will meet two criteria:

1. No commercial support for the activity.

2. Faculty teaching the CME should have no financial relationships (such as being on speakers' bureaus) with drug or device companies.

The report does allow for some exceptions to these criteria: "At times it may be impossible to avoid a financial interest or extraordinarily difficult or even  impossible to mitigate its potential impact on an educational activity." They cite examples such as courses involving the use of very expensive material, such as cadavers or sophisticated equipment. Also, they allow that in some remote parts of the country it may be acceptable to take industry money to fly out experts to teach doctors. However, in that same "exception section," they reiterate that: "For the most part, accepting support from a company or permitting participation by an individual when there is an irreducible financial interest would not be ethically acceptable."

What happens next? Since the AMA literally defines "AMA PRA Category 1 Credit" for the ACCME, any company that deviates from the recommendations of this report will be non-compliant with ACCME's criteria for CME. ACCME itself will have to revise its Standards for Commercial Support to clarify that in most cases, commercial support is no longer allowed.

None of this will happen overnight, of course. But you can bet that medical societies and medical education companies that are dependent on commercial support are, even as you read this, holding emergency conference calls with their attorneys to figure out what they need to do next. 

We have finally entered the era of post-deception medical education. Congratulations to the AMA.

The AMA, Going Reagan, Turns to Bean-Counting Again

It’s a “there you go again” moment for the American Medical Association.

We learn from CNN’s Elizabeth Cohen’s twitter page that the biggest standing ovation given to Obama by the AMA House of Delegates was in response to this line:

“You did not enter this profession to be bean-counters and paper-pushers. You entered this profession to be healers – and that’s what our health care system should let you be.” (Here is the entire text of the president's speech.)

It is ironic that this sentiment in particular moved the AMA so, considering that the organization’s actions at the meeting so far indicate that bean counting—that is, counting their hard-earned money—is exactly why these doctors entered the profession.

First, they announced that they would not support an optional public insurance plan, because it might mean less money for doctors (though they appear now to be trying to recant that statement). They are basing their opposition on figures showing that Medicare pays doctors 20% less than private health plans, and therefore an expanded Medicare-like public insurance program might mean less money in their bank accounts.

A pay cut? Outrageous!

Here’s a news flash: all the players in the health care industry—doctors, hospitals, and insurance companies—are going to have to accept pay cuts if we want to bring health care spending under control. The AMA’s posture of knee-jerk opposition to anything that smacks of financial sacrifice gives it the look and feel of a reactionary organization, which is how they looked when they hired Ronald Reagan for "operation coffee cup" in its ill-fated effort to defeat Medicare in 1965.

Second, the AMA, yet again, has decided that its own ethics committee just doesn't understand medical ethics, at least when it comes to the topic of industry funding of continuing medical education. This is an issue I have covered here and here. One year ago, the first time the AMA read CEJA's report on CME (CEJA being the Council on Ethical and Judicial Affairs), the delegates rejected it because it announced the bad financial news that industry funding of education for doctors represents an unresolvable conflict of interest and therefore has to go.

Now, a year later, a new CEJA, under a new chair, introduced a new report, this time saying that industry funding of CME can continue, but it is still “ethically preferable” for doctors to pay for their own education. Apparently even this watered down version of medical ethics is unacceptable to the AMA, because defining industry-free CME as "preferable" might slow down the flow of industry cash, so they rejected it, referring it back to CEJA for more extreme dilutions. You can read the particulars on the Policy and Medicine blog.

Presumably, the next report will not dare to even mention ethics and industry funding in the same breath. I predict that the entire report will be brief and to the point: “Industry funding of CME is necessary for the public health.” Now that’s the kind of sentiment any bean-counting doctor can get behind!

The AMA, Ethics, and "404 Not Found"

As I announced last week, the APA (American Psychiatric Association) has voted to phase out pharmaceutical industry funding of CME symposia at its annual meeting. The APA now has bragging rights as the first national medical organization to make this needed reform.

So what's shaking over at the AMA (American Medical Association)? Acting on a tip from Kate Peterson at The Prescription Project's blog, PostScript, I did a little investigating. As some faithful readers may recall, last fall, the AMA's Council on Ethical and Judicial Affairs (CEJA) released a report in which they recommended that doctors and medical institutions "must not accept industry funding to support professional education activities." But when the report was brought before the AMA House of Delegates in November, the representatives of for-profit MECCs (medical education and communication companies) were allowed to speak directly to the committee charged with evaluating the proposal. These MECCs, whose very existence depends on industry funding, were persuasive, and the AMA tabled the proposal (see here for details), asking CEJA to go back to the drawing board.

Since then, some unfortunate things have occurred. First, the excellent CEJA report on industry involvement in medical education has been removed from the AMA website. If you follow the original link, you get an unceremonious "404 Not Found" and "The requested document was not found on this server."

I asked CEJA officials why the document was censored, and received a prompt response from Bette-Jane Crigger, Director of Ethics Policy, that read, in part:

Because the report was referred back and CEJA is continuing its deliberations, the document is not posted to CEJA's Web pages. This is standard practice. The document was available last spring as proposed policy in the Delegates Handbook for the 2008 Annual Meeting of the House of Delegates, not as a CEJA posting per se. So, neither censorship nor anything irregular.

Fair enough. I also asked if I could receive a copy of the report to post on my blog for posterity. The answer was not encouraging:

I rather doubt the Council would favor allowing you to post the prior version of its report, but I will raise the question at our next conference call.

Meanwhile, it appears that the eventual conclusion of the revised ethics report is in little doubt. The AMA has posted a series of "fact sheets" from their National Task Force on CME Provider/Industry Collaboration. There are three in all, plus a "Get the Facts Toolkit." For chuckles and giggles, I suggest you read these documents. They appear to have been written by a pharma-funded public relations firm. Here are some choice excerpts:

The pharmaceutical, biotechnology and medical device industries play a significant role in informing healthcare professionals about the availability, value, and proper use of medications, vaccines, and medical devices.

(Yes, and we call this "advertising").


These industries have adopted voluntary guidelines on interactions with healthcare professionals.

(That's right, with a gun to their heads called the "Physician Payments Sunshine Act").


The company then provides funding in the form of an educational grant to an educational provider, for example a medical school, organization or agency that manages the grant funds and is responsible for ensuring independence from commercial influence. In all cases, the company has no input into the faculty selection or content of the educational activity.

(Except that, if the company is displeased with the faculty or the content, they will choose a different MECC to fund--not that this incentive could possibly lead to any influence over content, of course).


The CME activities that are supported by industry must be unbiased, open to a variety of viewpoints, and must not serve as marketing or promotional vehicles for industry.

(Which is why all industry-funded CME focuses singularly on conditions for which the company markets a product--no "promotion" there).


Ethics are important for the AMA and for all of us. But when ethics comes face to face with $1.2 billion in annual industry funding for CME, we pretty much know how lopsided the battle will be.

AMA's U-Turn on Industry Funding

As reported in Medical Meetings, the AMA's Council on Ethical and Judicial Affairs (CEJA) will reverse its earlier position, and will recommend that industry support of CME be allowed to continue. Just last May, CEJA had prepared this report urging the AMA to adopt a stance against allowing commercial support of CME, concluding that:

To promote continued innovation and improvement in patient care, medicine must sustain ongoing, productive relationships with the pharmaceutical, biotechnology, and medical device companies. However, industry support of professional education has raised concerns that threaten the integrity of medicine’s educational function....Existing mechanisms to manage potential conflicts and influences are not sufficient to address these concerns. Recognizing the profession-defining importance for medicine of achieving its educational goals, the Council recommends that:
Individual physicians and institutions of medicine, such as medical schools, teaching hospitals, and professional organizations (including state and medical specialty societies) must not accept industry funding to support professional education activities.

That report was debated in an AMA reference committee (a committee which debates issues before bringing them before the full house of delegates), and after hearing from a slew of medical education companies, the committee recommended tabling the proposal for further review. Since then, Dr. Mark Levine, the chairman of the committee, ended his term and was replaced by Dr. Regina Benjamin. Apparently, one of the committee members (not Dr. Benjamin) told journalist Dave Kovaleski that while the next version of the report will not be released until next June, an interim report makes it clear that industry funding will continue in some fashion or other. That's clear enough. But in a strange twist, CEJA is now calling for comments as they prepare the final report. They've already given us the punchline, and now they want input?

At any rate, it appears that CEJA is working on this report jointly with the AMA's Committee on CME, and this may explain why CEJA has changed its mind. The ethics of the issue have not changed over the last 6 months--after all, ethics rarely change at all. The core ethics of this issue were summarized in the original report's abstract thusly:

Medicine’s autonomy and authority to regulate itself depends on its ability to ensure that current and future generations of physicians acquire, maintain, and apply the values, knowledge, skills, and judgment essential for quality patient care. To fulfill this obligation, medicine must ensure that the values and core commitments of the profession protect the integrity of professional education.

In May, this ethical core struck CEJA as being inconsistent with industry funding of medical education. What appears to have happened is that ethics (CEJA) has married expediency (the CME Committee.) The final report will therefore be a moral compromise. This does not make me proud of my profession.