This article from AMNews briefly outlines some of the reactions to the recently released ACCME Standards for Commercial Support.

In other AMNews news, this article makes a pretty strong case for the effectiveness of evidence-based medicine on patient outcomes. While it doesn’t mention CME, one has to assume that the recent push for evidence-based education has something to do with increased compliance with the guidelines.

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AMNews asked both President Bush and Senator Kerry what they would do to help physicians deal with today’s many healthcare-related problems. Here’s what they had to say. (Neither addressed what’s of most concern to the CME community right now, i.e., pharma influence and potential for bias in med ed.)

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Post courtesy of Anne Taylor-Vaisey:

Hoey J. “The Truth about Drug Companies: How They Deceive Us and What to Do About It” [review] New England Journal of Medicine October 7 2004;351(15):1580-1581.

Here is a new review by John Hoey of the CMAJ, of Marcia Angell’s book, The Truth about Drug Companies: How They Deceive Us and What to Do About It. 305 pp. New York, Random House, 2004. $24.95. ISBN 0-375-50846-5.

Excerpt of the review: In this book, her most recent, Marcia Angell explores pharmaceutical research, deplores the rapidly expanding involvement (and distortion of truth) of Big Pharma, and implores us all (physicians, patients, politicians) to do something about it. The dust-jacket blurb asserts that Angell, “during her two decades at [the New England Journal of Medicine] had a front-row seat on the growing corruption of the pharmaceutical industry.” Perhaps, but since leaving the Journal, she’s gone behind the curtains of Big Pharma, Big University, and Big Faculty. Drawing on her own work and on her thoughtful analysis of research, company financial statements, and investigative reports into drug development and marketing, Angell writes with the unambiguous and unyielding style that Journal readers cam! e to expect and trust.

By Angell’s account, the current slide toward the commercialization and corruption of clinical research coincided with the election of President Ronald Reagan in 1980 and the passage of the Bayh Dole Act, a new set of laws that permitted and encouraged universities and small businesses to patent discoveries from research sponsored by the National Institutes of Health (NIH). Research paid for by the public to serve the public instantly became a private, and salable, good, one that is producing drug sales of more than $200 billion a year.

…

But perhaps Angell is right. We must change the way we manage research and the development and distribution of new drugs. Not only are health and health care at risk, but so are the research enterprise and the reputations of universities and governments. The integrity of scientific research! is too important to be left to the invisible hand of the marketplace.

Full text [by subscription]

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We at Medical Meetings magazine are working now to put together the industry response to the new ACCME Standards for Commercial Support and the related guidance documents released just last week. In the meantime, for those who aren’t regular readers of our magazine, or who just want a refresher on the recent history of the evolution of the new Standards, here are some articles you might find interesting:

New Standards:

New Standards Under Fire (letter to the editor, July/August 2004)

Don’t Relax Yet (June 2004)

Support the New Standards

(June 2004)

Cheers for New Standards (June 2004)

ACCME Board of Directors Gives Thumbs-up to New Standards

(April 2004>

New Standards: The Cost of Waiting (January 2004)

Previous Draft Standards:

Gag Rules (June 2003)

Continuing Medical Education Community Critiques Proposed New Rules (May 2003)

Mission Impossible (March 2003)

ACCME Releases New Standards for Commercial Support (January 2003)

General climate:

The Party’s Over (December 2003)

CME at Risk (editorial, July 2004)

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I hesitated to read Steve Passin’s column in the latest issue of Medical Meetings on implementing the new Standards of Commercial Support, since it was written well before ACCME released them this week, along with documents explaining what the organization would and would not accept as resolutions for conflicts of interest.

But I read it, and he did a great job of explaining the steps to take–even without seeing the supporting documents. It’s good advice for any ACCME-accredited provider who’s pondering putting the new Standards into effect.

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In a post that begins, “CME has become tainted,” DB’s Medical Rants–a physician-run blog–has lots to say about the new ACCME Standards for Commercial Support:

This rule appears solid on surface review. The problem will be in finding experts without conflict of interest. In many fields, virtually all the experts receive some pharmaceutical support (often for drug trials).



I suspect that we will see a new  specialty arise in CME. Those who have no financial ties will become the truth arbiters. And again on surface review this seems logical.




I worry that these new experts will have another axe to grind. None of us is without bias. Those who accept no pharmaceutical moneys (and I am included here) may have an anti-pharmaceutical company bias. They may tend towards therapeutic nihilism (at least until the evidence is overwhelming).

This just in from ACCME: “The member organizations of the ACCME have unanimously approved the 2004 Updated ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities.”

For complete information, click here.

Funny timing: I just came across this article about the new standards. In part, this is what it says:

In the past, a doctor teaching such a course would disclose his or her financial relationship with any drug company, say as a paid member of the company’s speakers’ bureau or a grant recipient. Once that was out in the open, the physician might then talk glowingly about anecdotal experience with that company’s drug.



Now, a third party with no ties to the drug company would have to tell the doctor what kind of recommendations he or she could make. Anecdotal observations would be replaced by results of systematic clinical trials. Any review of journal literature would have to include negative, as well as positive, studies.




“So this whole thing about just saying ‘I’ve got a conflict of interest. And I’ve got a relationship. And I’ve got a personal opinion. And I’m probably biased. But, I’m going to tell you anyways,’ that’s not allowed,” said Murray Kopelow, chief executive of the accreditation council.

This is, of course, a little off from what the Standards actually say, which is that CME providers must identify and resolve all conflicts of interest  but leaves the decisions about how to do that up to providers. It almost seems like this reporter was looking at the previous draft Standards, which raised a huge wave of discontent because it did appear to imply that any faculty with industry ties should be disqualified from speaking. The latest proposal only says that CME providers must identify and resolve conflicts of interest–not disqualify faculty out of hand if they have ties to industry.

For the most part, CME providers I’ve spoken with seem to think the new Standards are an improvement, though some remained worried over that “resolve” part.

We’ll have to wait and see how it all shakes out now that the new version is in play.

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A guest blog from Kevin Bunnell, EdD, a CME consultant based in Boulder, Colo., and former Alliance for CME president, commenting on the opinions of attorney Jim Miles, of Miles & Peters, PC, on Stark II thatI posted recently (click here to read the original post):

A word on the $300 limit on emoluments to physicians that are exempted under Stark II. All benefits such as free meals, free parking, free golf, and so on must have their value imputed, recorded, and counted toward the $300 exemption. The CMS “enforcers” have said informally that an imputed value to a physician for a single CME activity would be $25. Hence, a CME office can offer twelve CME activities a year for medicare referring physicians–assuming they get no other emoluments that would also have to be counted toward the exemption.



I have not heard before of the idea that the total value of a CME activity to physicians is equal to the honorarium paid to the speaker. And I have not heard of imputing the value of the activity to individual physicians by dividing the amount of the honorarium by the number of physicians attending

the activity.




And as if this mess weren’t bad enough, think of the record keeping involved in keeping track of all of the emoluments received by all the referring physicians associated with a hospital.




As the CEO of a large hospital or a hospital system, I would be reluctant to take Mr. Miles’ optimistic position until the word came directly from CMS saying that they really didn’t mean that we should not help physicians to improve the way they take care of medicare patients. The fines so far have been horrendous.

Sue again: I was unable to get in touch before my deadline ran out with many of the various different organizations–AMA, AHA, CMSS etc.–that undoubtedly will be bringing pressure to bear on CMS to take CME out of the Stark II loop. If anyone knows what they’re planning to do on this one, please let me know. We’ll be following up on this one in future issues, I’m sure.

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Since I just pulled together this list of links to articles about the PhRMA Code and related regs for someone on the MIMlist, a meeting planner listserv, I thought I’d post it here as well, in case anyone wants a refresher course or a quick resource to e-mail to others who might not be on top of it:

Cracking the Code

Advamed Takes on Ethics

McGettigan’s New Web Program Tackles PhRMA Code Compliance

CME providers gear up to comply with PhRMA code

PhRMA Adopts New Marketing Code

Thumbs Up for New PhRMA Code

The Party’s Over

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Can you imagine getting a memo from your hospital s compliance officer telling you that you can t provide more than $300 per year of CME to a physician that refers Medicare/Medicaid patients to your organization, and that you have to have the commercial supporter cut the check directly to faculty?

Believe it or not, that memo did go out to an organization recently, according to Denver attorney Jim Miles, of Miles & Peters, PC. It was in reaction to the Stark II regs I wrote about last week.

Stark II, which is aimed at ridding the system of Medicare and Medicaid abuse and fraud caused by hospitals or other organizations that handle Medicare/Medicaid patients wooing their best referrers with perks, firmly places CME in the perk realm, much to the dismay and annoyance of providers I ve been speaking with. Up to $300 per year can be exempted from the rule, or so it appears in the vaguely worded document after that, you risk noncompliance. Maybe.

Miles says that it s all a tempest in a teapot and, basically, don t worry about it. Here s a boiled down version of his reasoning (some of it will make it into the article for the next issue of Medical Meetings, but there s never space to say it all, so I ll blog it instead):