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By Matthew Brown | August 6th 2008 07:41 PM | 8 comments | Print | E-mail | Track Comments
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About Matthew Brown

Matthew Brown comes to ScientificBlogging from the University of Oxford, where he received his Master of Science degree in Physiology.

His previous research has included Cardiac Allograft


... Full Bio

For years, doctors like Arnold Relman and Marcia Angell, both former editors of the New England Journal of Medicine, have been advocating drastic changes to the way the Accreditation Council for Continuing Medical Education (ACCME) deals with pharmaceutical industry funding.

The ACCME is the body responsible for accrediting the institutions and organizations that deliver continuing medical education (CME) to doctors after they have finished medical school and residency programs, but there are many doctors who view this continuing education as a “quasi-academic activity.”

Mixed in with the respected medical schools that provide CME are businesses, some of them essentially advertising agencies with no standing in the medical community until they become accredited by the ACCME.

So why do CME and pharmaceutical companies get such a bad rap? Pharmaceutical industry funding is not negative per se; the relationship between doctors and drug companies can promote awareness of treatment therapies that are underutilized, “enhance the practitioner's knowledge base, provide updates and review, and expand professional skills.”

But many doctors think that there is a strong potential for bias if pharmaceutical companies are funding the source of their continuing education—not surprising considering that since 2003, pharmaceutical companies were providing about $900 million of the $1 billion spent annually on continuing medical education in the United States.

The problem isn’t actually with pharmaceutical companies. That is, the pharmaceutical industry is a business, and they would be acting irresponsibly if they were not doing everything possible to maximize the profits of their shareholders (within the accepted standards).

Dr. Relman says that the pharmaceutical industry “is simply doing what the medical profession allows it to do. Industry has every right to market and advertise, but it supports accredited medical education only with permission (and often at the request) of medical educators.”

The problem, doctors contend, is with the programs that the ACCME allows to administer continuing medical education. Pharmaceutical companies fund their own “vendors,” or MECCs (Medical Education and Communications Companies) that are accredited to give CME credit. By paying around $12,000 and filing some paperwork, advertising agencies have spun off companies and have become accredited to give CME that counts just as much as that from the top medical schools in the country.

Just a few years ago, it was not hard to follow the ACCME’s links of accredited providers to arrive upon sites describing themselves as “Your resource for off-site events, dining, golf tournaments, guest speakers, entertainment, themed events, spouse programs, etc.” and others offering to team with “Non-accredited healthcare organizations and other entities who are interested in offering Category 1 AMA/PRA physician credit…”

It looks like the ACCME has tried to clean up the content of the links, because today it’s a little harder to find links like that, but it doesn’t take to long to track one down offering a “Free iPod Nano with CME; The Way CME Should Be!” Really? And that’s just it: this is exactly not what CME should be.

Here’s one reason why: at the University of Pennsylvania Center for Bioethics, Dana Katz and colleagues found that “When a gift or gesture of any size is bestowed, it imposes on the recipient a sense of indebtedness. The obligation to directly reciprocate, whether or not the recipient is conscious of it, tends to influence behavior…Feelings of obligation are not related to the size of the initial gift or favor.”

    BY THE NUMBERS

    • 50: percent of medical school-produced CME supported by industry
    • 3.66x: return on investment for doctor-led discussion groups calculated by Merck, versus 1.96 for a meeting with a sales representative
    • 87: percent of initial applicants that are successful in achieving ACCME accreditation
    • 40: number of states requiring physicians to supplement their practice with continuing education credits to retain their license
    • 50: hours of continuing education a Connecticut doctor must complete within 24 months to retain a license

    Since the 80’s and 90’s, professional medical organizations and journals began to establish guidelines to regulate the relationship between the pharmaceutical industry and medicine, and the ACCME continually reviews and updates its policies and practices in an attempt to deliver balanced CME.

    In 2005, the Yale University School of Medicine, in order to “ensure as much as possible that the integrity of clinical decision making is not compromised by financial or other personal relationships with industry,” developed guidelines for managing the relationships of faculty with the pharmaceutical industry. In formulating these guidelines, Yale received input not only from clinical faculty, but also representatives of the pharmaceutical industry.

    According to the abstract of the guidelines, “In contrast to existing recommendations, the Yale guidelines…ban faculty from receiving any form of gift, meal, or free drug sample (for personal use) from industry, and set more stringent standards for the disclosure and resolution of financial conflict of interest in Yale’s educational programs.”

    But doctors like Melissa Stiles and Bruce Barrett at the University of Wisconsin still complain that they “continue to regularly receive a barrage of invitations to free dinners, offers to attend professional athletic venues, and all-expenses-paid consultant meetings at five-star hotels”—events that are sponsored by pharmaceutical companies as continuing medical education.

    Doctors allow very little input from the pharmaceutical industry when it comes to their education in medical school or in the residency program, so why do they outsource their CME to pharmaceutical companies? Dr. David Blumenthal , the Director of the Institute for Health Policy at Massachussets General Hospital, writes, “When a great profession and the forces of capitalism interact, drama is likely to result.”

    Dr. Relman goes as far as to suggest that the pharmaceutical industry’s involvement with CME is “as inappropriate as its involvement with predoctoral medical education of students, or with the graduate education of residents,” while Drs. Victor Marrow and David Heaphy of Johns Hopkins University, liken this sort of interaction to "salespersons doing surgery in the operating room." The basic problem, maintains Dr. Relman, “lies in trying to manage conflicts of interest that shouldn’t even be allowed to exist.”

    In response to arguments against industry funded CME, Dr. George Dermksian, an Internal Medicine doctor from New York, wonders if people like Dr. Relman have considered "the inherent intelligence of the physicians and their rigorous scientific and clinical training that allow them to make appropriate judgments of industry-supported CME. To think otherwise," he says, "would denigrate most physicians,” while Dr. Ton J. Cleophas, President of the American College of Angiology, responds, “we as physicians have a responsibility to estimate the possible loss of objectivity in what we hear.” The reality is, if you eliminated all the conflicts of interest, there would be no experts left in the field. He points out that unsponsored programs are “equally at risk of loss of objectivity and manipulation,” just as are pharmaceutical industry-funded CME programs.

    However, Dr. Blumenthal says, this implies that “physicians are different in fundamental ways from their fellow human beings.” In fact, this may very well be the case, considering that the professional training of a physician is meant to render him resistant or immune to the effect of bias: physicians tend to be “confident that they themselves are invulnerable to any bias inherent in educational content offered or supported by drug companies.”

    But a 2005 study published in JAMA presents a different picture: of 183 medical students surveyed who thought a gift from a drug company valued at less than $50 was inappropriate, 158 (86.3 percent) had accepted one. Another study in the American Journal of Medicine found that 61 percent of medical residents believed that they were not influenced by the marketing efforts of pharmaceutical companies, but only 16 percent were equally as confident about their colleagues.

    It looks like doctors, after all, are human.

    Frusterated with CME? Have an experience you would like to share? Add it here!

    Comments

    I liked your article about the ACCME revealing how big Pharma companies have been swaying the minds of doctors through conventions and five star hotel vacations within the context of furthering their education. It has been a truth that has been swept under the carpet for a long time. Most people never question money or gifts without thinking where they came from or what is expected in return. This is most apparent in politics. Donations are never questioned… but merely logged in as another person/company who may come knocking after you've assumed your role.

    Your article also points out how it would be stupid for Pharma companies not to market and advertise their products to maximize profits. Another great point. You already see tons of ads on TV about Viagra, Allegra, and other drugs that the next logical step would be to go after the doctors themselves. To do so in such a tricky manner however... that leaves something to be desired. This point got me wondering about how they got in to this position in the first place. How were the Pharma companies able to take hold of the ACCME if they have been blocked from most medical institutions in the past? What I have surmised is that this gap is due to lack of funding... or desire to direct existing funding elsewhere. When institutions, such as Yale or Harvard, have large budgets to play with, money is spent mainly on the CURRENT lot of students and scientific projects under investigation. To spend that money on graduates (who may or may not reciprocate the gift) seems outlandish considering that the money could be used elsewhere within the schools. I have a feeling this is due to the fact that the country as a whole seems to view education with mixed emotions. Pictures are painted in the media depicting how a child can succeed in life by becoming the next great NFL star, NBA baller, or lottery winner without even having to step foot in a university or receiving a respected degree. This easily illustrates the lack of emphasis being placed on education and why money is directed elsewhere. Back to the point. The hole in funding for the ACCME was bound to be scooped up by someone. The sad point however, is that there is no government program that can match what big Pharma can spend. Would you throw away 900 million when someone else can only come up with 200? The answer is a plain and simple no. Until someone comes to the plate with an offer that can match what the Pharma companies are willing to shell out our doctors will continue to vacation at five star hotels under the context of "continuing their education." Awareness is one of the solutions to this problem, and hopefully most doctors are smart enough to understand who is paying for this vacation and what they want in return.

    One bizarre statement after another in the original post:

    The writer asks "So why do CME and pharmaceutical companies get such a bad rap? Pharmaceutical industry funding is not negative per se; the relationship between doctors and drug companies can promote awareness of treatment therapies that are underutilized, “enhance the practitioner's knowledge base, provide updates and review, and expand professional skills.”"

    I would agree that pharma funding of CME was not necessarily negative per se if it were (a) obtained through a mandatory tax on pharmaceuticals; (b) allocated through the medical societies with no participation or input from drug makers; and (c) did not depend on the charitable impulse or marketing savvy of the drugmakers. Until then, I think the statement that the medical profession's reliance on Big Pharma for its CME funding is, in fact, quite negative, per se and in fact.

    The writer continues: "But many doctor’s [sic] think that there is a strong potential for bias if pharmaceutical companies are funding the source of their continuing education—not surprising considering that since 2003, pharmaceutical companies were providing about $900 million of the $1 billion spent annually on continuing medical education in the United States."

    And what about non-doctors? What about every human being over the age of ten, almost all of whom understand the idea of conflict of interest and professional independence?

    The writer continues: "The problem isn’t actually with pharmaceutical companies. That is, the pharmaceutical industry is a business, and they would be acting irresponsibly if they were not doing everything possible to maximize the profits of their shareholders (within the accepted standards)."

    It seems that a self-appointed ethicist would be capable of recognizing that, just maybe, the pharmaceutical industry being "a business" that is responsible for "doing everything possible" to make shareholders richer is indeed a problem.

    adaptivecomplexity's picture
    I would agree that pharma funding of CME was not necessarily negative per se if it were (a) obtained through a mandatory tax on pharmaceuticals; (b) allocated through the medical societies with no participation or input from drug makers; and (c) did not depend on the charitable impulse or marketing savvy of the drugmakers.

    Marcia Angell, a former NEJM editor, has frequently made a similar point. The pharma companies provide many of the CME activities for free, as the article states - because they expect a return on their investment. Angell has said that if these companies were really in the business of providing education, they would charge for their services, but as it is, this "education" only improves profits by resulting in more drug sales.

    I'm also always amused when physicians make the argument that their intelligence and education makes them immune to conflict of interest problems.

    One bizarre statement after another in the original post:

    :

    In fairness to Matt, this piece is primarily reporting on the issue of CME, not making an ethical argument in favor of pharma-sponsored CME.

    Mike

    Dears Matthew..,
    I like your nice and informative blog.

    Matthew's picture
    Update: Dr. Bruce Barrett, quoted above, was kind enough to take the time to forward me an article published last month that has generated quite some controversy in the scientific community.

    Jeanne Lenzer and Shannon Brownlee have published a list of experts affirming that they have not received "any financial support in any form from pharmaceutical or medical device manufacturers during the past five years, and they don't have any other affiliations or financial involvements that would present a conflict of interest."

    The list includes both Arnold Relman and Marcia Angell, as well as two former editors of the Western Journal of Medicine, a senior editor of PLoS Medicine, advisers to the US Food and Drug Administration, and several journalists, to name a few.

    Lenzer and Brownlee quote research that found that about half of news stories either don't make an attempt to quote an independent expert, or fail to report potential conflicts of interest.

    They add that "many reporters...fail to realize that the individuals and organizations they turn to for expert commentary...often depend financially on the industry."

    So why has there been so much controversy over this list?

    Critics have accused the authors of everything from "baised, sloppy reporting to being members of the Church of Scientilogy (which is opposed to psychiatric drugs). Many of our critics--virtually all of them backed by the industry--opined that our list was undoubtedly filled with experts on the payrolls of plaintiffs' attorneys."

    The full article, "Naming names: is there an (unbiased) doctor in the house?" appears in the July 23 issue of BMJ (BMJ 2008;337:a930).

    The list of independent experts can be viewed here.

    Matthew

    Matthew's picture
    Update: Dr. Arnold Relman has also let me know that he will be further discussing these issues in the September 3rd issue of JAMA. Be sure to check back here for a review of this article.

    Matthew

    MAXIDEX WARNING

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    Matthew's picture
    FYI, the Sept. 3rd Arnold Relman Article has finally come out, and as promised I write about it here.

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