Results tagged “CME” from Pathophilia

Just like in 2008, total income to produce all certified continuing medical education (CME) programs dropped by another 7% last year, from about $2.37 billion in 2008 to $2.18 billion, according to the latest data from the Accreditation Council for CME. But commercial support to publishing/ educational companies, or MECCs, fell even more dramatically—by greater than 20% (which is comparable to the drop observed between 2007 and 2008). Consequently total income to MECCs (which are down from a total number of 144 in 2008 to 135) declined by about 10% (companies evidently made up some of their losses with modest increases in advertising income, money from other sources,* and a slight reduction in expenses).

Here's the cut-up year-to-year table, which provides not only cumulative data, but average total and net incomes per MECC. The cumulative net income (total income minus total expense) and the average net income per MECC in 2009 were about half of what they were in 2007. The explanations: a general reduction in support from commercial sources to all CME providers (down 30% from 2007) and a directed reduction in support to MECCs (down nearly 40% from 2007).

Year	Total Income	Total Commercial Support	Advertising and Exhibits Income	Other Income	Total Expense
2005 (N = 148)	$780,783,394	$594,864,588	$18,757,802	$167,161,004	$598,727,647
2006 (N = 154)	$818,772,623	$620,657,405	$15,431,546	$182,683,672	$607,961,083
2007 (N = 150)	$830,811,192	$594,419,878	$10,831,027	$225,560,282	$615,705,205
2008 (N = 144)	$667,419,787	$463,382,991	$10,054,745	$193,982,051	$509,811,733
2009 (N = 135)	$604,024,888	$365,315,693	$11,406,679	$227,302,516	$500,057,330

Year (No. MECCs)	Net Income	Average Total Income per MECC	Average Net Income per MECC
2005 (N = 148)	$182,055,747	$5,275,563	$1,230,106
2006 (N = 154)	$210,811,540	$5,316,705	$1,368,906
2007 (N = 150)	$215,105,987	$5,538,741	$1,434,040
2008 (N = 144)	$157,608,054	$4,634,860	$1,094,500
2009 (N = 135)	$103,967,558	$4,474,258	$770,130

MECCs = medical education-communications companies.

* Like, for example, participant registration fees and "allocations from a provider's parent organization or other internal departments." 

This week, the ACC, as an arena for impassioned conflict, didn't stand solely for the Atlantic Coast Conference. A heated confrontation also occurred at the annual meeting of the American College of Cardiology, where Duke physician Robert Harrington debated the Cleveland Clinic's attention-loving Steve Nissen on the issue of physicians' relationships with industry.

Both cardiologists acknowledged historical examples of the marketing influence that pharma and the medical-device industry have had on professional education and, potentially, medical practice. But Harrington painted a more complex picture, in which physicians and medical journal publishers have been complicit in allowing this influence to happen. While Harrington advocated that ongoing relationships with commercial entities are "critical," he urged clear "firewalls" between physicians (particularly academic physicians) and industry and full access to data from industry-funded research. Harrington also correctly stressed that potential conflicts of interest go beyond money; "scientific hubris" is also in the mix.

And speaking of hubris...

Nissen conversely argued that industry funding to sponsors of continuing medical education (CME) and professional medical societies must cease. He cited a Merck-funded CME program at the ACC's Cardiosource web site, "Optimizing Patient Outcomes in Acute Heart Failure Syndromes: Strategies to Preserve Cardiorenal Function," which was sponsored by an accredited* medical-education communications company (Med-IQ) and the ACC.** Without citing specific examples of undue industry influence in the program, Nissen argued that Merck's reason for sponsoring the program was due to the fact that the company had a novel compound, rolofylline, in development that addressed the condition in question. Nissen called the CME program a "market preparation business activity" and an ultimate "misuse of medical information," primarily because the drug died in phase 3 development. But Nissen failed to acknowledge the obvious follow-up question: How could Merck influence cardiac practice with this particular CME program if rolofylline can never be prescribed?

Using an even more tenuous example, Nissen implied that the American Heart Association had backed away from a study that linked soft-drink consumption with cardiac risk factors and an NEJM-advocated soft-drink tax, on the basis of the AHA's alleged marketing relationship with Coca-Cola. As evidence, Nissen offered up the red-dress logo for The Heart Truth educational campaign, which has been prominently displayed on cans of Diet Coke. Nissed charged that the logo comes from the AHA.

However, on this very circumstantial point, Nissen appears to be wrong in his facts. According to MedPage Today, the logo belongs to the National Heart, Lung, and Blood Institute. Moreover, both the AHA and the NHLBI deny that any money has been exchanged between Coca-Cola and their organizations to produce the campaign. The Heart Truth program is solely funded by government entities, according to an NHLBI spokesperson.

Those physicians who argue that ties between industry and medical practice should be severed may have some valid points, but Steve Nissen didn't deliver their perspective in any compelling fashion in this debate. Like in the recent b-ball champ-ship, the hands-down ACC winner here was (the guy from) Duke.

N.B.--Audio portions of the debate are provided by MedPage Today.

* Nissen called the Accreditation Council for CME, the organization that accredits other organizations to sponsor certified CME, "absolutely pathetic" and a "toothless watchdog."

** Notably the program included faculty from Duke (acknowledged by Nissen) and the Cleveland Clinic (not acknowledged by Nissen).

Image of The Heart Truth campaign logo from the NHLBI web site.

Addendum: The AHA sponsors the trademarked Go Red for Women campaign, which is supported by Macy's and Merck, according to the campaign web site. The campaign's logo (left), while incorporating a red dress, is distinct from The Heart Truth's logo. Both red-dress logos are trademarked by the DHHS.

03/19/10 addendum: Christopher Cannon, Harvard cardiologist and Cardiosource Editor-in-Chief, reviewed the Merck-sponsored CME program that was criticized by Dr. Nissen and provided a lengthy comment at MedPage Today. Among 5 talks, according to Cannon, 4 did not mention Merck's (now defunct) drug in development, rolofylline. The talks covered the pathophysiology and epidemiology of the condition in question, possible interventions, and clinical development. Last a case was presented "where the drug is not mentioned." Cannon counted 130 slides in the CME program, 8 (6%) of which concerned the funder's drug in development. Cannon concluded, "This is I believe a fair balanced program and it does not meet the charaterization [sic] stated by Dr. Nissen." 

Once again: I'll attempt to clarify the difference between participating in speakers' bureaus and delivering continuing medical education (CME).

The repeat effort to distinguish the two is prompted by today's newspaper and blog reports of physician Lawrence DuBuske, who decided to give up his academic gig at Harvard when the institution required him to make a choice between speaking for pharma and working at the Brigham and Women's Hospital.

Evidently DuBuske earned nearly $100,000 during April, May, and June of last year for giving Glaxo-paid talks to physicians and decided that the pharma gigs were just too lucrative.* In GSK's second-quarter report, "Fees Paid to US Based Healthcare Professionals for Consulting & Speaking Services," DuBuske's services are described as "speaker" and are apparently distinct from any CME honoraria that he might have received through GSK's educational grants (see, for example, "Grants & Charitable Contributions to US Based Healthcare Organizations").

A quick Google search shows that DuBuske did, in fact, also deliver certified CME programs last year (see here and here). Published disclosures through one of these CME programs reveal that DuBuske participated in the speakers' bureaus of 10 drug companies (including GSK) and received honoraria (assumed to be CME honoraria) through grants from 11 drug companies during the last 12 months (at least).

Distinction Between Speakers' Bureaus and CME

Participation in speakers' bureaus consists of giving talks that are based on slides and talking points created by the drug or medical-device company. The content of these talks must be reviewed by the company's medical-legal department and must adhere to FDA guidelines—for example, they must contain so-called fair-balance information. In essence, a healthcare professional who participates in speakers' bureaus becomes a glorified sales representative (like Daniel Carlat during his speakers' gigs for Wyeth).

Participation in CME requires either the development of educational content or its delivery to other healthcare professionals. In the case of industry-funded CME, funds are procured by an organization that is accredited to produce CME.** This organization—which can be a university-based CME department, a medical professional organization, or a for-profit medical education communications company (MECC)—then recruits faculty and assists them with the development of the educational content. The organization is also instrumental in deciding the format of the CME program (eg, Internet-based activity, dinner meeting) and enforcing recognized guidelines to ensure the independence of the program. Honoraria to faculty that develop or deliver content are paid by the accredited organization from the industry-supplied educational grant. Critics of industry-funded CME (eg, Daniel Carlat) argue that companies unduly influence the content of these CME programs through their indirect or direct pressure on grant recipients.

Policies of Partners Healthcare Regarding Speakers' Bureaus and CME

The newly enforced policies of Partners Healthcare, comprising Harvard's Mass General and Brigham and Women's Hospitals, "ban faculty participation in industry speakers bureaus." However, policies relating to industry funding for CME only address involvement at the institutional level; they do not explicitly prohibit Partners physicians from receiving honoraria for developing or presenting certified industry-funded CME programs.

Industry funding for "educational programs" (whether certified or not) may only be accepted after approval from Partners' newly created Educational Review Board, which requires that support for a specific CME program come from more than one company. Also Partners faculty who earn so much per year from a potential industry sponsor (eg, ≥$20,000) might be prohibited from participating in the creation or delivery of a Partners-produced CME program.

* Whether industry will still want to pay DuBuske to speak after his separation from Harvard is debated.

** In the United States, accreditation is most often bestowed by the Accreditation Council for CME.

In an apparent effort to suppress criticism of industry bias in continuing medical education (CME), Pfizer is giving Stanford $3 million to produce such programs without condition. Specifically the grant will not stipulate therapeutic areas of interest for the educational activities—a major departure from current, recognized standards for US-based CME. A full report, with soup-to-nuts opinions from physicians on Pfizer's new type of pooled CME grant to the university, is available in today's NYT.

However...however.

Decisions have apparently been made that Stanford's Pfizer-funded CME will concentrate on diabetes, cardiovascular disease, smoking cessation, and infections, reports the paper. All of these therapeutic areas are of potential interest to the monolithic company.* For example, Pfizer makes Chantix, a smoking-cessation drug; the blockbuster statin Lipitor; and Caduet, a combo calcium-channel blocker/statin.

Now whether bias is inherent in a CME grant that merely specifies a therapeutic area is up for debate. For instance, see the comments here.

And for the historical record:

1. Last year, Pfizer announced that it would no longer directly provide CME grants to medical education communications companies (MECCs), presumably because of the perception of bias in MECC-produced CME.
2. In 2004, Pfizer agreed to pay the government $430 million to settle allegations of promoting Neurontin (gabapentin) off-label. One alleged off-label outlet: Pfizer-funded CME.**

* Implying here that it might be hard to find a therapeutic area that is not of interest to Pfizer.

** Also 2 months ago, it was revealed that the protocol-defined primary endpoints in company-funded trials of Neurontin were often changed.

No. 3: The Transparency Movement Takes a Vice-Like Hold

The push to uncover every potentially relevant tie between physicians and commercial interests, every medical writer behind a figurehead author continued with a vengeance in 2009.

In December, Northwestern University became the latest medical school to voluntarily disclose the financial relationships of its faculty with drug or device companies at its web site. The Chicago-based university joined Stanford, which provided similar online information in August, and the Cleveland Clinic, which boarded the disclosure train last year.

A handful of pharma companies, perhaps in an effort to avoid legislated disclosure,* also committed to posting some of their payments to physicians. This year, Eli Lilly, Merck, and GlaxoSmithKline began revealing various forms of compensation to healthcare professionals for a variety of services, like consulting or speaking. And Pfizer promised to disclose comprehensive data (for instance, meals exceeding $25) beginning in the new year.

Caught up in the spirit of transparency—the Accreditation Council for Continuing Medical Education (ACCME), the US organization that accredits other organizations to provide certified CME—released detailed data on 729 accredited providers in August. In an impressive data dump, the ACCME revealed each provider's accreditation status and whether they received commercial support or income from advertising or exhibits (without, however, disclosing dollar amounts). The vast majority (81%) received some type of commercial support.

Peer-reviewed medical journals published at least 2 press-worthy studies that outlined the prevalence of industry ties among academic physicians (53%) and the incomplete disclosure practices of orthopedic surgeons specifically (nearly 30% of payments, some of which exceeded $1 million). An example of the exhaustive transparency to be expected in medical journals today: the author disclosures in a highly publicized, company-sponsored study in Alzheimer disease consumed roughly 3 columns of small type in the journal Neurology.

In addition to flushing out the financial ties of physician authors, journal editors launched the age of "ghostbusting." The practice and that of honorary authorship (eg, adding the name of a laboratory head to lend cachet or credibility to an article) were found to be relatively common in the most prestigious medical journals, including The New England Journal of Medicine and the Journal of the American Medical Association, according to survey results presented publicly in September.** For offenders whose work is published in PLoS Medicine, the editors recommended immediate article retraction, lifetime banning of the named author, and a report to the author's institution for investigation. Ouch.

Recently Cochrane reviewers became concerned about the actual involvement of listed authors, the possibility of ghostwriting, and the quality of the data from a 2006 analysis of 10 Roche-sponsored trials of oseltamivir (Tamiflu). The drug company received a very public comeuppance from BMJ editor Fiona Godlee this month, for resisting unconditional access to the trial data (see BMJ Editor Bitch Slaps Roche). Godlee concluded that the joint investigation by the Cochrane reviewers, BMJ editors, and a British TV news station "cast doubt not only on the effectiveness and safety of [Tamiflu] but on the system by which drugs are evaluated, regulated, and promoted." 

* Either through the proposed Physician Payments Sunshine Act or healthcare reform bills.

** Nosing in on the ghostbusting movement was Senator Chuck Grassley (IA-R), ranking minority member of the Senate Finance Committee. In November, Grassley sent a letter (personally written by the Senator?) to the deans of 10 medical schools, asking them to respond to 6 essay-type questions regarding their schools' policies on ghostwriting and plagiarism.

On Friday, the WSJ printed a story by Alicia Mundy, "Health-Bill Disclosure Rule Is Resisted," which revealed that a recently passed health-reform bill in the House would require drug companies to disclose payments made to physicians and third parties, such as medical education communications companies, or MECCs. But the idea is nothing new, and reports of such disclosures have been carried extensively by various news sources, including the WSJ and the related WSJ Health Blog.

Given the scrutiny that financial relationships between pharma and physicians have received of late (thanks largely to the Senate Special Committee on Aging and Senate Finance Committee), several drug companies (for example, Eli Lilly and GSK) have voluntarily offered readily accessible information about payments made to physicians for consultant, advisory, or speaking services, as well as educational grants given to MECCs to produce CME programs.

Resisting disclosure, Mundy reported, is John Kamp, executive director of the Coalition for Healthcare Communication. The Coalition, according to the organization's web site, "defends the right of health professionals and consumers to receive truthful information regarding pharmaceuticals and medical products, as safeguarded by the Constitution of the United States. Founded in 1991, the Coalition represents organizations, rather than individuals, dedicated to assuring the free exchange of scientific information without undue government interference." Among the member groups of the Coalition are the American Association of Advertising Agencies and the Association of Medical Media.

Kamp penned his objection to legislated CME disclosure in a July letter to Senator Herb "I'm Richer Than Croesus and God" Kohl (WI-D), who chairs the Special Committee on Aging. In response to an inquiry from the Committee, Kamp wrote, "Many leading drug and device companies have published all their grants for the world to see, and others are following quickly. Given this trend, the Committee should consider elimination of certified CME reporting in all versions of Health Care Reform bills because they are unneeded, redundant and needlessly expensive [boldface sic]." Mundy quoted Kamp, beginning at "should consider..."; she failed to clarify why Kamp resisted legislated disclosure—thereby misleading her readers to believe that Kamp resists disclosure altogether. 

Mundy then segued to Thomas Sullivan, president of a small Maryland-based MECC, Rockpointe, and sole blogger at Policy and Medicine. Although Sullivan reported to Mundy that he's not against legislated CME disclosure from drug companies, he has been openly critical of Senator Kohl's Committee, as well as Senator Chuck Gassley (IA-R), who is the ranking minority member of the Senate Finance Committee. In a September blog post, Sullivan described the efforts of Grassley's investigator, Paul Thacker, into physician-related conflicts of interest with pharma as "witch hunts." (It's a description that Sullivan should have heeded when considering any voluntary cooperation with Senator Kohl's Committee and its chief investigator, Jack Mitchell. But more on Mitchell in a follow-up post.) 

In a move that was off-point from her article's lede but apparently designed to shock or embarrass, Mundy then proceeded to report the amount of educational grant money that Sullivan's private company had received from drug firms during the last 3½ years. Evidently Mundy had obtained this proprietary company data through the UCSF's publicly accessible Drug Industry Document Archive, which had received the information from Kohl's Committee.

In July, the Committee had requested "an accounting of the funding received by Rockpointe Corporation from pharmaceutical, medical device and biologics companies." Why the Committee was spending taxpayer dollars investigating the 18-employee, privately owned MECC is anybody's guess.* In any event, Sullivan volunteered the information, writing, "We have discussed with your Chief of Investigations, Jack Mitchell, the business information provided is proprietary. We would appreciate your use of this information in the aggregate, and reasonable protection against this information becoming publicly available." So much for government courtesy. 

Mundy proceeded to report the cumulative amount of CME grant money that Rockpointe received from the beginning of 2006 to July 2009 (~$23 million), as well as a breakdown of funds the company received from Medtronic ($802,791 or about $100,350 per CME seminar). She added, "Rockpointe's classes typically addressed ailments that the sponsors' products treat"—an observation that should be news to, well, no one. A drug firm is not going to fund a CME program that is outside its therapeutic area of interest.

What Mundy (most egregiously) failed to do was examine (or ask an independent and knowledgeable physician to examine) Rockpointe's CME programs, to determine if any were biased toward the grantor's product. To do so would have required work, and the possible outcome (namely that Rockpointe's CME programs were not biased) would mean that Mundy wouldn't have much of a story. 

But as irresponsible as Mundy's reportage is here, it's nothing compared to the harsh writing of blogger and shrill critic of pharma-funded CME Daniel Carlat—who, curiously enough, posted his arguably libelous rant about Sullivan and his company's finances the day before Mundy's story was published. The timing suggests that Carlat is more than a mere fall-off-a-log quote source for lazy and/or agenda-driven reporters like Mundy.

* In his letter to Senator Kohl (which is available at the UCSF archive), Sullivan wrote, "It is a concern to us that this letter has been directed to Rockpointe as a result of a group meeting that we initiated with the Aging Committee staff. That initiative was intended to provide information, understanding and insight concerning CME and the proposed Physician Payment Sunshine Act. The meeting, and the required time and preparation, constituted a good faith effort to bring relevant information to the Committee. Our intent was to differentiate accredited CME from promotional marketing. Under the credo of "no good deed goes unpunished," this initiative led directly to your singling us out among the hundreds of similar CME providers to submit confidential business records. We have expended considerable time, expense and professional fees identifying, locating, reviewing and organizing nearly 4 years of business records in order to digest and prepare the accurate summary you requested. An inquiry of this nature will likely discourage other concerned "good Samaritans" from exercising their rights as involved citizens to bring issues of concern to the attention of the committee."

Image of Alicia Mundy from the New America Foundation; reproduced through a Creative Commons license.

There is a particular irritation to be found in the criticism of continuing medical education (CME) by a nonphysician. There is even more irritation to be found in the criticism of CME by a purveyor of sociology. There may be practical benefits of the so-called science, but its merits have eluded me in a life that's had its fill of academia.

In the latest issue of JAMA—a journal becoming known for its overbearing editorials—sociologist Eric Campbell, PhD, and health economist Meredith Rosenthal, PhD, condemn the current state of physician CME by applying general critiques from the landmark Flexner Report of 1910. They also advocate investment in something they call "physician human capital," a term adapted from economists to convey the medical knowledge and skills that are required to provide "high-quality, efficient, and cost-effective care."

By using the Flexner Report, Campbell and Rosenthal attempt to draw parallels between the heterogenous state of early American medical education and the quality of today's CME, which they allege is equally scattershot. The comparison is meant to empower their criticism of CME, but the comparison is invalid.

In the early twentieth century, educator Abraham Flexner visited more than 100 US medical schools at the behest of the Carnegie Foundation for the Advancement of Teaching, which conducted its survey at the behest of the AMA's Council on Medical Education. The 2 major reforms for graduate medical education that were promoted (and ultimately realized) by the AMA Council were 1) the standardization of the preliminary requirements for entry into medical school and 2) the implementation of a nationally recognized curriculum of 2 years of basic sciences and 2 years of clinical instruction in a teaching hospital.

Among Flexner's findings in 1910 was, as suspected, the fact that medical curricula varied widely from school to school. But Campbell and Rosenthal wrongly apply Flexner's observation to today's CME by maligning physicians' autonomy when selecting from the varied number of certified CME activities. They argue, "While the diversity of CME offerings provides benefits to physicians, it also deprives CME of representing the mastery of an essential core set of knowledge and competencies."

The problem with the authors' criticism is that, for practicing physicians, the foundation or "essential core" of medical education has already been established, thanks to the Flexner-inspired curriculum of accredited medical schools and postgraduate clinical-training programs. Perhaps if Campbell and Rosenthal had undergone medical education themselves, this blatant fact would not have been so stunningly overlooked. 

It is also entirely reasonable to assume that individual physicians are in the best positions to select the CME activities that may be most beneficial to their practices. Moreover, as Campbell and Rosenthal indicate, the mastery of an essential core set of knowledge and skills is already periodically reinforced by the required maintenance-of-certification examinations through the American Board of Medical Specialties (ABMS). It hardly seems necessary, or even desirable, that participation in specific CME activities should be dictated to practicing physicians beyond the state-mandated requirement of so many certified hours per year. I would be no more inclined to require that Dr. Campbell read certain sociology journals.

Flexner also lambasted the for-profit medical schools of his time, largely because of their substandard curricula. Campbell and Rosenthal proceed to make a very loose correlate between Flexner's observation and the "excessive commercialization" of current CME activities. They cite the ACCME's 2007 report, which indicated that 58% of the income of accredited CME providers came from industry. (The 2008 report indicates that about 44% of total income came from industry, a drop of nearly 25%.) However, there are no objective data to show that commercially supported CME is inferior or less effective at improving medical practice or patient outcomes than CME activities funded by other sources. In fact, Campbell and Rosenthal acknowledge, "[T]here is scant evidence that CME actually improves patient outcomes." In this statement, Campbell and Rosenthal do not distinguish between commercially and noncommercially supported CME. The inferiority of industry-funded CME is merely assumed by the authors, apparently because it has been argued or assumed by others.

Campbell and Rosenthal also maintain that CME relies too heavily on the lecture format, a criticism that Flexner threw at unregulated medical schools 100 years ago. By extension of their argument, the authors claim that CME "is not adequately focused on improving patient outcomes." However, later in their editorial, while advocating CME reform the authors anticipate a transition to CME that is provided by hospitals. But already overburdened hospitals are unlikely to pioneer innovative formats for CME activities.

To realize their "new model of CME" and to ensure physician human capital, Campbell and Rosenthal conclude by advocating 3 lofty reforms. They might as well advocate a tilt of the Earth's axis without proving why it's really better or specifying how to bring it about. Two of their reforms require monumental changes to US medical practice: 1) physician-payment reform to motivate practice quality and efficiency (as if physicians aren't sufficiently motivated to achieve these ends at present) and 2) the use of "sophisticated health information technology" to facilitate on-the-job learning. In addition, the authors propose specialty certification as a requirement for state licensure—an admittedly nice idea that will never happen.

"Boston Ivy" from Flickr.

Medical-education communications companies (MECCs) must brace for more retrenchment.

GlaxoSmithKline announced today that it will no longer provide continuing medical education (CME) grants to MECCs, according to Reuters. The drug company's decision, which is part of a new grant policy, is effective immediately. GSK joins Pfizer, which announced its decision to cut off educational grants to MECCs more than a year ago.

GSK also reports that it will fund fewer CME programs and "invite grant applications from approximately 20 medical education providers with a documented track record of developing and delivering high quality medical education programs that have a measurable impact on improved patient health." Invited applicants are limited to unnamed, accredited academic medical centers and national physicians' organizations.

It's been argued here that the move by drug firms to deny grants to MECCs is based on the perception of bias, not actual bias, in MECC-generated CME. In any event, it's bad news for companies like CE Alliance ($225,000), Discovery Communications* ($426,500), Physicians' Education Resource Group ($363,700), Pri-Med Institute ($1,024,773), Research to Practice ($530,000), and Vindico Medical Education ($225,338), which received a total of nearly $2.8 million in grants from GSK in the first half of this year. (Values in parentheses indicate GSK funds to the individual company for the first 2 quarters of 2009.)

According to data from the ACCME, total income for "publishing and education companies" (in other words, MECCs) dropped 20% from 2007 to 2008. The income drop is largely due to the loss of grant support from pharma.

Whether CME leads to positive changes in healthcare delivery remains up for debate. A recent Cochrane review concluded that professional educational meetings, particularly when combining didactic and interactive formats, can improve healthcare delivery and patient outcomes. However, the effect is typically small and similar to that of other types of CME activities, like audit and feeback programs. The effectiveness of CME increases when serious outcomes or less complex behaviors are considered.

* Suspected to be the Discovery Institute of Medical Education.

09/23/09 addendum: According to Daniel Carlat, blanket critic of all pharma-supported CME, GSK will still provide CME grants to invited applicants that partner with MECCs. Carlat ignorantly describes the MECC-cosponsor arrangement as adding another layer to a "money laundering operation." The description, which Carlat appears to be in love with, is simply wrong.

Money laundering refers to methods by which illegally obtained income (eg, from drug trafficking, prostitution) is moved around to disguise its source. There are at least 2 very important ways in which "money laundering" fails to describe pharma-funded CME. First and foremost: Providing educational grants to MECCs or any other organization is not illegal (although on Planet Carlat, it would be). Second: The source of the funding is not hidden; the pharma grantor must be disclosed on CME materials to the program participant. This requirement is stipulated by the ACCME.

And gambling occurs in casinos.

Yesterday Gardinar Harris of the NYT revealed that Forest Laboratories, the maker of the antidepressant escitalopram (Lexapro), had a 2004 marketing plan for the drug. Harris's article,* which is made possible by government access to a previously confidential document from Forest, seems intended to generate a considerable amount of righteous indignation. But a review of the abridged plan, which is made available here, reveals nothing more than the usual strategies and tactics by pharma to achieve or maintain a drug's market share—objectives that are, in fact, a company's responsibility to its shareholders. Frankly if Forest's marketing team, circa 2003, is to be publicly chided, it should be for lack of originality.

The not-so-surprising subtext of the marketing document, which contains the expected SWOT analysis (or a version of it), is to obtain the best-of-all-possible fiscal worlds for Lexapro and Forest. One strategy or tactic for doing so (depending on how you define each term) was to "increase med ed efforts," including more sponsorships of continuing medical education (CME).** Proposed CME efforts included plans to sponsor various professional-meeting symposia, summaries of these symposia, and scientific sessions. Nothing outside of the ordinary or, more important, in violation of standards for commercial support of CME (either then or now).

The description of the proposed goal and purpose of CME is similarly banal:

[To] Sponsor the development of continuing medical education activities that will educate physicians and other healthcare providers and assist them in acquiring the most current knowledge in the diagnosis and treatment of depression and other related disorders.

Perhaps the only proposed CME tactic to raise an eyebrow is the use of reporters "from publications like CNS News [probably CNS Spectrums], Psych Times, and the Journal of Clinical Psychiatry...to cover key Lexapro data presented at important medical meetings." The report would then be included in the journal as a CME supplement.

Overt (non-CME) marketing methods in the Forest document included the use of bylined medical articles from thought leaders, some of which could be ghostwritten; the typical speakers' bureau; and drug rep-presented "Lunch and Learn" programs for doctors.

Whether any or all of Forest's 2003 marketing plan for Lexapro came to fruition is not addressed by Harris. It is presumed that at least some of it was realized; but what was and what wasn't funded is probably only known to Forest personnel—at least at present.

* One of Harris's points is to show how Forest promoted (or intended to promote) escitalopram as superior to its other antidepressant citalopram or Celexa, which was going off patent--despite the fact that Lexapro is merely an enantiomer (or chemical mirror image) of Celexa. The tactic of creating an enantiomer of a successful, but soon-to-expire, drug to maintain pharma revenue is nothing new: think omeprazole (Prilosec) and esomeprazole (Nexium), both from AstraZeneca.

** The fact that Forest included CME in its marketing plan 6 years ago may be shocking to some, but it shouldn't be. In the current climate of scrutiny, however, major pharma companies separate their proposed CME and marketing efforts.

Last Thursday the Accreditation Council for Continuing Medical Education (ACCME)—the organization that accredits other organizations to provide certified CME in the United States—released detailed data on 729 providers. In an e-mailed press release, the ACCME's Chief Executive, Murray Kopelow, stated that these data were being made public in an effort to "increase the system's transparency and accountability."

Among the accredited providers, 124 (17%) received the designation of "Accreditation with Commendation" from the ACCME; 16 received commendation under the more stringent 2006 criteria, which is intended to foster providers' participation in "institutional or system-wide initiatives" to improve the quality of healthcare (whatever that entails exactly).

An examination of the ACCME's stats, which can be downloaded from the organization's web site, identifies all accredited organizations by name and their relevant data. The 16 commended providers include 8 academic institutions, 4 medical societies, 1 medical center (Memorial Sloan-Kettering), 1 government medical institute (the FAA's Civil Aerospace Medical Institute), 1 professional-liability insurance company (Norcal Mutual), and 1 medical-education communications company, or MECC (Discovery). According to the ACCME's data, only 21% of all providers have been reviewed under the 2006 criteria.

A total of 33 providers (4.5%) are on "probation." The designation means that providers may continue to offer certified CME, but they are also required to show their plans to improve areas of noncompliance within a specified time. Contrary to popular expectations, MECCs are not disproportionately represented among the CME providers on probation. Among the warned providers that were assessed under the 2006 ACCME criteria (n = 15), there are 4 academic institutions, 4 MECCs, 3 medical societies, 3 hospitals, and 1 physician group. The 18 providers on probation that were not assessed under the 2006 criteria include 16 medical societies, 1 MECC, and 1 community-based organization.

Among all accredited providers, 81% reported receiving commercial (ie, pharmaceutical) support; 66% received income from advertising and exhibits. Of those 124 commended providers, only 14 (11%) did not receive commercial support; 4 of the 14, however, did report advertising and exhibits income.

Although the Accreditation Council for Continuing Medical Education (ACCME) reports that total income for all CME providers dropped only 7% from 2007 to 2008, total income for publishing and education companies (ie, MECCs) dropped 20%. These data are derived from the ACCME's 2008 Annual Report, which was released last week. The income drop for MECCs is largely due to loss of commercial (ie, pharma) support, which fell 22% from 2007 to 2008. Also 6 fewer MECCs reported income data to the ACCME in 2008 (from 150 in 2007).

CME Income and Expense Data for Publishing/Education Companies, 2004-2008

Net income (total income – total expense) for all reporting MECCs in 2008 was $157,608,100, compared with $215,106,000 in 2007 (percentage drop, 27%). In addition, the percentage of total CME income for MECCs (among all providers) dropped below 30% (to 28%) for the first time in at least 5 years. General sentiment in the CME-MECC biz is that last year's income drop is the beginning of a downward trend, not a one-time aberration.

MECCs = medical education communications companies.

In the National Review, conservative journalist Mary Claire Kendall questions the influence that the private Josiah Macy, Jr, Foundation has on the nonprofit Institute of Medicine (IOM). At stake, evidently, is the Foundation's interest in removing all sources of commercial funding for physicians' continuing medical education (CME)—funding which is argued (without supporting evidence) to adversely influence physician practice and, consequently, patient outcomes.

Kendall highlights the possibility that the Foundation itself, a private philanthropy established by the descendant of merchant seamen, is unduly influencing the IOM by funding various IOM committees that are concerned with medical education. The possibility that the Foundation is buying off the IOM to push its own predetermined, but unfounded, idea that commercial support of CME is bad is implicit in the Foundation's support of the IOM's Conflict of Interest Committee ($75,000) and the IOM's upcoming ad-hoc Committee on Planning a Continuing Health Care Professional Education Institute ($428,177). The ad-hoc committee, Kendall notes, will include representatives from the Association of American Medical Colleges and the Institute of Health Policy—both of which have received a cumulative $738,000 from the Macy Foundation.

"What is damning is that they [the Macy Foundation] are dedicated to pushing private industry out of CME in the name of an entirely self-serving definition of 'bias' that reaches predetermined conclusions," Kendall writes. What is also damning and, moreover, ironic is the fact that the IOM has failed to provide detailed evidence of its funding sources, despite a united call for transparency in CME to uncover possible conflicts of interest.

HT: Policy and Medicine

Invoking an endless reflection in facing mirrors, the Accreditation Council for Continuing Medical Education—the organization that accredits other organizations to produce certified CME—is currently asking for public comments on its proposed Notice and Comment Procedures. Comments on the ACCME's comment procedures, which will restrict a comment period to 30 days, will be allowed for (you guessed it) 30 days (from April 22 to May 21).

The ACCME is also soliciting comments on its proposals to provide branded designations for certain CME programs that are not funded by commercial sources (trademarked Commercial Support-Free™) or those that are not delivered by individuals with relevant commercial interests (trademarked Promotional Teacher and Author-Free™). As usual, God (or the devil) is in the details; the proposals beg a host of questions. Top of mind: What defines a relevant commercial interest? What defines a relationship with a commercial interest?*

Last, the ACCME recommends the creation of a CME Funding Entity, a source of pooled industry funds that would somehow be managed independently of the ACCME. Funds from the "entity" would be handed out to accredited organizations to develop and deliver certified CME. How the administration of such an entity would, itself, be financed is not stated.

* It also seems unfair and really just inaccurate to designate a physician who happens to have some kind of relationship with industry, be it in an advisory or consultant position, as a "promotional" teacher or author.

04/28/09 addendum: Over at The Carlat Psychiatry Blog, Daniel Carlat actually raises a good point (although we differ on the conclusion from that point**). If the ACCME is proposing commercial-free labels for qualifying CME programs—which imply that a commercial-free program is somehow superior to a commercially funded program—then why allow for the certification of commercially funded programs at all?

If the ACCME leadership were purist in thought with consistent standards, it would completely eliminate the option for certifying industry-supported CME, or it would acknowledge (and in fact, stress) that commercially funded CME is an important source of information for healthcare professionals, provided that the current standards are met.

** While Daniel Carlat champions the idea that commercial-free CME is always superior CME, I do not. Continuing education of the healthcare professional is best achieved by allowing access to as many options as possible, provided that CME activities disclose their source of funding and the faculty's potential conflicts of interest.

The popular and continuing backlash against the pharmaceutical industry and its potential influence on the practice of medicine (and the practice of academic medicine, in particular) led to a number of notable events this year.

The most tangible is legislation dictating pharma and physician conduct—specifically, the Massachusetts Health Code Bill, which bans pharma gifts and meals to Massachusetts physicians and requires them to report pharma payments for their consulting and speaking services. The legislation is in the spirit of the updated PhRMA Interaction Code, which goes into effect January 1 and bans non-educational gifts—like branded pens, notepads, and stress balls—from pharma or medical-device companies to healthcare professionals.

A prime issue informing these actions is whether pharma money biases the treatment recommendations of key opinion leaders in academia. Notable academic psychiatrists specifically* were caught in the crosshairs of anti-pharma bulldog Senator Chuck Grassley, the national press, and interested bloggers, who charged that these influential physicians failed to report the payment of hundreds of thousands of dollars from pharma.

Another important factor is whether pharma currently holds undue influence over the content of continuing medical education (CME) that it supports financially. Some pharma companies (eg, Lilly), without withdrawing CME support altogether, have agreed to publicly disclose their CME funding to outside groups in a show of conscientiousness and in response to a request from Senator Grassley. Others (ie, Pfizer) cut off direct CME grants to medical education communications companies (MECCs), a probable PR move that is based on the perception of (and not so much actual) bias in MECC-produced CME specifically.

And if academic isolation from pharma is not possible (or very smart), then transparency is next to godliness. This year, the web site of The Cleveland Clinic began disclosing information about its physicians' financial ties to industry; although specific dollar amounts and research funding from pharma are not currently provided. In addition, the University of Pennsylvania recently reported that it will create a searchable web site that discloses the industry relationships of its physicians.

Straggling behind in this anti-pharma zeitgeist is the nearly toothless Accreditation Council for CME (ACCME), the accreditor of CME providers and, like many a bureaucracy, an apparent fan of abstruse verbiage. This year, the ACCME promised to enhance its monitoring and surveillance of CME production (by increasing its fees) and proposed harsh limits on CME production that demonstrated little practical forethought.

* Namely Joseph Biederman of Harvard, Alan Schatzberg of Stanford, and Charles Nemeroff of Emory.

Way back in June, education expert Robert Cervero and graduate research assistant Jiang He, both of the University of Georgia, published their ACCME-funded examination of professional articles that addressed the relationship between industry support of CME and CME bias. Surprisingly enough, they found no directly relevant, published studies. However, they discovered exactly 2 original research articles, both of which predate the ACCME's 1992 Standards for Commercial Support, that examined the effect of commercially supported CME on physicians' prescribing practices.

In 1988, Bowman and Pearle published before-and-after prescribing patterns of 374 physicians who attended 3 industry-sponsored educational courses on beta blockers or calcium-channel blockers (CCBs). Physicians' prescription data were limited in that they were obtained by mailed self-reports, and before-and-after responses were not matched for 2 of the 3 courses. Also rates of survey returns (6-month "after" responses) were less than robust—from 40% to 60%.

Bowman and Pearle concluded that prescribing patterns generally favored the sponsoring company's drug. However, Cervero and He interpreted these results as mixed. They found that prescriptions for the CME sponsor's drug increased after course 1 (up 12%), but not as much as those for a competitor drug (up 17%). After course 2 (beta blockers), prescriptions for the sponsor's drug increased nonsignificantly, and after course 3, the sponsor's drug became the most frequently prescribed CCB (when compared with 2 other drugs).

Over at The Carlat Psychiatry Blog, Daniel Carlat—fervent critic of industry-supported CME—examined the Bowman-Peale study and, not surprisingly, maligns Cervero and He for not coming to a more emphatic conclusion that industry sponsorship of CME unduly influences prescribing patterns. Curiously enough, though, Carlat proposes that the mixed results seen after course 1—specifically an increase in prescriptions for a competitor drug—are due to the more effective CME efforts of the competitor (eg, course 3 and other CME activities).

This interesting proposal from Carlat actually supports the fact that industry-sponsored CME is not consumed in a vacuum. Carlat (perhaps unwittingly) bolsters the argument that a wide range of industry-sponsored CME, in conjunction with non-industry-sponsored CME and other countless sources of medical information, should be considered (if at all possible) when assessing influences on physicians' prescribing practices.

The other CME study cited by Cervero and He was published in 1992, and the CME activity in question featured a number of perks—for instance, an all-expenses-paid trip to a resort—that would not be compatible with the current standards of the ACCME. The study authors, by assessing hospital pharmacy data, determined that this more blatant marketing activity increased prescriptions for the sponsor's drug.

Cervero and He conclude their report by posing a number of questions to be addressed in the investigation of bias in commercially supported CME. The most important, paraphrased here, is How does the adoption of a sponsor's product (if influenced by CME) affect patient care?

ACCME = Accreditation Council for Continuing Medical Education; CME = continuing medical education. 

Over at The Carlat Psychiatry Blog, Daniel Carlat finally takes a look at the latest proposal by the ACCME to restrict those writers or physicians who engage in industry-funded promotional efforts (eg, speakers' bureaus) from also producing independent CME. While, to some, this proposal seems to encroach on First Amendment issues, Carlat pooh-poohs the argument. Quel surprise.

Among the various specious arguments I've heard against this policy, the most astonishing is the censorship argument. By forbidding doctors on company speakers bureaus from writing accredited CME, so the argument goes, ACCME is "censoring" them. At Policy and Medicine, for example, Tom Sullivan, president of the MECC Rockpointe, says that "banning certain authors from writing books and giving talks doesn't seem to accord with freedom of speech, but that is exactly what the ACCME is proposing."

Come on folks. Let's get real. ACCME is not preventing anybody from saying or writing anything they want, anywhere, at any time. They are simply witholding[sic] a lucrative seal of approval from speech that does not meet their requirements. When Good Housekeeping Magazine witholds[sic] its seal of approval from a shoddy product, they are not preventing the company from making it. The shoddy product can still be sold; the company just can't use the seal to market the product.

Similarly, ACCME is saying that medical communication produced by people who take marketing money from drug companies no longer meets its standards for high quality CME, and it will no longer accredit such communication. MECCs are still free to provide it, print it, circulate it in conferences, but it won't be accredited information. How is this "censorship?"

Here's potentially how. As I understand it (although I'm certainly not a legal scholar), freedom of speech comes into play at the juncture of government and the public. To my knowledge, all state governments require that physicians acquire so many credit hours per year of certified CME to maintain their licensure. The ACCME is the only organization (again to my knowledge) that accredits educational groups (medical associations, academic CME offices, MECCs) to provide certified CME to physicians. Therefore the ACCME is proposing limitations on who can produce or deliver government-required CME—what can be reasonably argued as a restriction on free speech.

In any event, the ACCME's proposal sure feels like it encroaches on First Amendment rights (Dr. Carlat's opinion excepted), in which case some legally informed somebody should figure out why (if the above is not accurate). Also the ACCME would be wise to seek legal counsel before proposing such restrictions.

Comments to the ACCME's latest proposal can be submitted here, through tomorrow (9/12/08).

ACCME = Accreditation Council for Continuing Medical Education; CME = continuing medical education; MECC = medical education communications company.

With tony simulation devices for graduate and postgraduate training, well-endowed university medical centers can afford to snub commercial support of traditionally produced CME.

This is the cat-bird seat specifically for Stanford University, which (as of yesterday) prohibits industry funding of any specific CME course or program that uses the Stanford name or is directed or initiated by its medical school faculty. Instead pharma companies hoping to support Stanford-sponsored CME must give their funds to Stanford's Office of CME, which will coordinate and distribute the funds for educational activities within 4 broad categories: medical, pediatric, and surgical specialties; diagnostic and imaging technologies and disciplines; health policy and disease prevention; and "other areas approved by the Office of CME."

The new policy does not outrightly prohibit Stanford medical faculty from delivering industry-funded CME that is certified by another ACCME-accredited organization (such as a MECC); although the policy implicity discourages the act. Also it is unclear how the Stanford name, in the form of a faculty member's affiliation, may be used in such a CME activity.

The new Stanford policy follows other university actions, beginning in 2006, when Stanford adopted a center-wide policy that prohibits the acceptance of any industry-supplied gifts* (including food) by medical faculty, healthcare staff, or medical students in any clinical setting. Last year, Stanford revised its annual conflict-of-interest and commitment disclosure for faculty to address personal and family ties to industry that may influence clinical practice.

While supporting CME, Stanford acknowledges that the effect of traditional programs—typically in the form of lectures or discussion groups—on healthcare improvement has not been demonstrated. The university implies that interactive education may be more effective by advising, "Future CME programs should take advantage of emerging technologies and should be more focused on the professional and technical development and education of the learner."

A press release from Phillip Pizzo, MD, the Dean of Stanford's School of Medicine, refers to novel programs available through high-tech university-based learning centers—such as the Goodman Simulation Center and the future Li Ka Shing Center for Learning and Knowledge. Funding for Stanford's educational simulation programs is unclear, although the $90-million Li Ka Shing Center has been made possible by a very generous donation from a Hong Kong entrepreneur. 

ACCME = Accreditation Council for Continuing Medical Education; CME = continuing medical education; MECC = medical-education communications company.

* It is not clear from the online policy if gifts include drug samples.

Photo: Screen of virtual procedural simulation from the Goodman Simulation Center.

Physicians have been arguing about pharma's influence on postgraduate medical education for at least 50 years, reveal Scott Podolsky, MD, and Jeremy Greene, MD, PhD, in last week's JAMA. The Harvard physicians' commentary, "A Historical Perspective on Pharmaceutical Promotion and Physician Education," is intended to provoke cautionary thought about the future of medicine, given industry's longstanding involvement in and financial support of the dissemination of drug information.

However, the fact that a 50-year argument on the subject goes on merely indicates this: There's still no tangible evidence that pharma's potential influence on continuing medical education (CME) alters physician competence or patient outcomes—for better or worse.

In the closing of their JAMA commentary, Podolsky and Greene quote advertising executive Pierre Garai from 1963: "We know what the doctors are today. What will they be tomorrow?" This originally rhetorical question cannot be answered, of course, for today's physicians; but it can be addressed for physicians who were practicing during the early 1960s.

Therefore we can ask, what untoward healthcare event has occurred during the last 45 years as a result of pharma's influence on CME?

The only event that comes to mind (to which Podolosky and Greene also allude) is the overuse or misuse of antibiotics, ostensibly as a result of pharma marketing injected into industry-funded CME. However, a search of the medical literature does not support this contention (although an exhaustive search, for the purposes of this blog post, cannot be guaranteed).

On the other hand, a survey of Georgia pediatricians, discussed in a 1999* issue of Pediatrics, indicates that the decision to prescribe antibiotics for children is influenced by 1) diagnostic uncertainty (ie, Is the illness viral or bacterial?); 2) sociocultural and economic pressures (eg, consideration for time-strapped working parents); 3) fears of malpractice litigation; and 4) parental expectations. While the surveyed physicians may have been reluctant to admit to the influence of pharma-funded CME on their prescribing behavior, it seems unlikely that this potential influence would supersede the practice considerations cited by the surveyed physicians.

So the debate will continue, until there is compelling evidence that pharma's influence on CME—influence that has clearly been moderated during the last several years—has caused some undeniably beneficial or untoward healthcare outcome. 

* Arguably the height of pharma's influence on CME, before the institution of stricter firewalls between pharma marketing and CME.

Photo of the pop duo Sonny & Cher, who charted with the 1967 hit "The Beat Goes On," from Wikipedia.

Addendum: Some may cite the exuberant use of off-label fen-phen in the 1990s as an example of the adverse influence of pharma-funded CME. However, the fen-phen mess doesn't seem to be easily distilled to a single factor. Nevertheless, I am certainly receptive to any evidence that Wyeth funded CME activities in which the drug combination and supportive studies were discussed. 

Good lord almighty. I'm beginning to think that the ACCME should move to Cuba.

The council that bestows accreditation on organizations to provide CME is now proposing that independent physicians or writers who are involved in the production of any kind of promotional material for pharma cannot be involved in the development of content for CME. This would arguably prohibit any non-industry physician involved on a company's advisory board or speakers' bureau from participating in the production and delivery of CME. Likewise, any independent writer who produces promotional material for a company could not be involved in the creation of CME content about the same drug class. Yeesh, what's next, ACCME? Little Mao caps?

The ACCME's new proposal is evidently based on the following:

In May 2008, the Attorney's[sic] General of thirty US states won a judgment against a commercial interest that included the stipulation that a promotional speaker for the commercial interest could not also be a CME speaker, on the same class of drugs discussed in the promotion activity, in a CME activity that received funding from the commercial interest.

As Thomas Sullivan at the Policy and Medicine blog points out, the ACCME's characterization is not exactly accurate. In May 2008, Merck actually agreed to a multistate* settlement (it was not a judgment) regarding its Vioxx ads. With respect to the funding of CME, the settlement indicated that Merck will comply with the ACCME's Standards of Commercial Support (nothing particularly earth-shattering) and that any person acting in a promotional capacity for Merck shall disclose to CME participants this promotional relationship (again, nothing particularly earth-shattering). This settlement also indicated that Merck cannot fund a CME program, if it has foreknowledge that a CME speaker has been a promotional speaker for Merck during the last 12 months (a minor tremor, given that Merck could not recommend CME speakers anyway, according to the ACCME standards).

In addition, the ACCME cites a June report from the AAMC Task Force, which urged academic medical centers to discourage their faculty from participating in industry-sponsored speakers' bureaus. But the Task Force also wrote,

To the extent that academic medical centers choose to allow participation of their faculty and staff in industry-sponsored, FDA-regulated programs, they should develop standards that define appropriate and acceptable involvement.

1. Academic medical centers should require full transparency and disclosure by their personnel to the centers and when participating in such programs; and

2. Academic medical centers should require that payments to academic personnel be only at fair market value.

So the ACCME, given the full details of the Merck settlement and the AAMC opinion, is overgeneralizing and grossly overstepping its purview, IMO, by proposing that non-industry physicians limit their communication to other physicians, depending on the setting. Moreover, the ACCME's proposal would needlessly undermine opportunities for independent medical writers to earn a living.

Or to provide another free-speech comment: Blpppht.

AAMC = Association of American Medical Colleges; ACCME = Accreditation Council for Continuing Medical Education.

* Twenty-nine states and Washington, DC.

I'm not eager to recommend therapy to another MD, but I wouldn't mind if psychiatrist and fervent CME critic Daniel Carlat took up some kind of regular relaxation technique. Perhaps, simply deep-breathing exercises—particularly before posting at his blog.

The effort might otherwise prevent hasty, arguably emotion-driven, and inaccurate assumptions about those who dare to disagree with him on the subject of industry-supported continuing medical education (CME). I am specifically referring to his post yesterday, which referred to online critical comments of a recent BusinessWeek article ("Teaching Doctors—or Selling to Them?"). One of these online comments (which can be found here) was mine, and in addition, I cited the BW author, Arlene Weintraub, at this blog for failing to distinguish between overt pharma marketing and CME and her omission of relevant information about Zimmer Holdings.

What I and other online critics of the BW article apparently failed to do, Dr. Carlat implies, is reveal every darn thing about ourselves in the comment box as a show of transparency. (Of course, Dr. Carlat's focus on the article's critics diverts attention from what is actually justified criticism of the BW article.) Some of the critics, who did provide their names, are (gasp) affiliated with the CME business—which could be easily determined by your basic fall-off-a-log Google sleuthing. With respect to my comment, Dr. Carlat wrote the following:

But wait—there's more!

B. Martin criticizes Weintraub's "inability to differentiate between outright pharma marketing and the current status of industry-funded CME." She does not disclose that she is Barbara Martin, who, on her Pathophilia website, identifies herself as a "formerly practicing board-certified neurologist" who is now a full time writer in the "intriguing world of pharmaceutical marketing and pharma-supported continuing medical education (CME)." I guess that means her job is dependent on industry support of CME.

For perspective, here's my actual comment at the BW site:

B. Martin, MD
Aug 6, 2008 5:24 PM GMT
In addition to Ms. Weintraub's inability to differentiate between outright pharma marketing and the current status of industry-funded CME, she also neglects to indicate that Zimmer's move away from funding MECC-sponsored CME is likely related to the company's Deferred Prosecution Agreement with US Attorneys: http://bmartinmd.com/2008/08/businessweek-engages-in-sloppy.html.

So what I did do was provide a link to this blog, which Dr. Carlat failed to notice or inform his blog readers. For an online comment, at least in my opinion, that's as transparent as cellophane. I would also correct Dr. Carlat's interpretation of my About page. I am indeed a formerly practicing neurologist, and I was employed, after my clinical experience, in pharma marketing and, later, in the CME business (which accounts for my knowledge of CME). Today, I am a full-time, freelance writer; however, it is inaccurate to say that my current job is "dependent on industry support of CME."

There. Deep bloody breath.

In a recent BusinessWeek article, writer Arlene Weintraub demonstrates a very poor understanding of the differences between outright pharma marketing and the current status of industry-funded, certified continuing medical education (CME). Several online comments to the article, which features the usual high dudgeon of CME critic Daniel Carlat, rightly indicate that Weintraub describes a dated version of industry-funded medical education. For example, MCM's Lew Pinsker wrote,

It's unfortunate that a reporter for a major business periodical would indict a billion-dollar industry without doing due journalistic diligence in researching her subject. As has been pointed out in previous comments, her use of the term "marketing companies" when describing accredited medical education companies ignores the significant changes which have been taking place for more than a year. Organizations which develop certified CME cannot in any way be "marketing companies".

In her article, Weintraub cites two companies, Pfizer and Zimmer Holdings, as having recently suspended their funding of CME produced by medical education communications companies (MECCs). In fact, Zimmer—an orthopedic device company—suspended funding of all CME activity, Weintraub reports, and will identify an "independent third party," like a professional medical society, to produce the CME activities that the company supports financially.

However, Weintraub fails to note that Zimmer's move away from funding CME is likely related to fallout from a Deferred Prosecution Agreement in September of last year with the US Attorney's Office in New Jersey. The Indiana company settled with federal prosecutors as a result of an investigation into the company's financial relationships with consulting orthopedic surgeons. As part of the agreement, Zimmer will pay a civil fine of $169.5 million* and agreed to an 18-month oversight by a federal monitor appointed by the DOJ and a 5-year Corporate Integrity Agreement with the Office of the Inspector General (OIG). The company, however, did not admit to any wrongdoing.

In April of this year, Zimmer announced "comprehensive changes in its corporate compliance model," which "is designed to aggressively reduce potential or perceived conflicts of interest inherent in consulting relationships between industry and healthcare professionals." The changes are intended to "meet and exceed the requirements of its September 2007 resolution agreements with the US government," the company wrote in its press release. 

* According to Yahoo, Zimmer's net income for 2007 was $773.2 million.

Daniel Carlat argued yesterday that Pfizer withdrew its direct commercial support of MECC-sponsored CME because MECCs―unlike other CME-producing organizations―receive most of their income from industry-funded CME. The argument is that, because MECCs are so dependent on industry for their existence, they are more likely to bias their CME to curry favor and foster continued business with the industry grantor. 

However, this explanation ignores the fact that pharma income of other CME-producing organizations, like medical societies, is not inconsequential, despite what Dr. Carlat alleges. For instance, by examining the ACCME's 2006 Annual Report (the same report that Dr. Carlat references), it is apparent that the collective, net commercial income (total commercial support – total expense) for nonprofit organizations (eg, a physician membership organization) was actually higher than that for publishing/education companies in 2006: $247,782,325 vs $210,811,540. And the average net income per nonprofit organization (n = 267) was not that far behind the net income per publishing/education company (n = 154): $928,024 vs $1,368,906.

Organization Type	2006 Net Income	Average Net Income per Organization
Government or military (n = 16)	-935,343	-58,459
Hospital/health care delivery system (n = 93)	-287,209	-3088
Insurance company/ managed care company (n = 14)	-4,308,420	-307,744
Nonprofit, other (n = 34)	26,122,848	768,319
Nonprofit (eg, MD organization) (n = 267)	247,782,325	928,024
Not classified (n = 29)	12,946,920	446,446
Publishing/education company (n = 154)	210,811,540	1,368,906
School of medicine (n = 122)	71,740,237	588,035

So while Dr. Carlat argues that loss of pharma CME income for a big-budget academic medical center would "cause barely a hiccup," this is not likely the case for a medical society operating on much smaller revenues. For instance, the 2006 expenses of the American Academy of Neurology, the flagship organization of practicing neurologists, totaled approximately $3.5 million.

Pfizer's move to cut off MECCs, I would argue, is primarily (if not solely) based on the perception of bias in MECC-generated CME, not actual bias.* Otherwise, according to Dr. Carlat's argument, Pfizer would have considered cutting off direct CME grants to medical societies as well―a questionable PR move.

ACCME = Accreditation Council for Continuing Medical Education; MECC = medical education communications company.

* And if bias did exist in Pfizer-funded CME, it's only because Pfizer expected (even demanded) bias. 

In an unprecedented move, Pfizer is immediately cutting off all CME grants given directly to medical education communications companies (MECCs), according to today's press release from the company. However, Pfizer will honor existing grant committments and will continue to provide financial support for physician-directed CME to healthcare facilities and medical societies.

The move unfairly implies that MECCs, unlike other ACCME-accredited organizations, have specifically undermined the credibility of pharma-supported CME; although Pfizer does nothing more than make the implication. Joseph Feczko, Pfizer's Chief Medical Officer, is quoted: "We understand that even the appearance of conflicts in CME is damaging and we are determined to take actions that are in the best interests of patients and physicians." It is presumed that academic centers or medical societies, unlike like MECCs, confer a desirable credibility to CME.

According to the Dow Jones Newswires, Pfizer spent approximately $80 million last year on CME, with less than half given directly to for-profit MECCs. It is unknown if other pharma companies will follow Pfizer's lead; but if MECCs are to survive the current and impending climate of ill will toward pharma-supported CME, they will need to partner up with academic CME offices or medical societies in jointly sponsored CME projects. In this event, MECCs will no longer need independent accreditation from the ACCME, which at last count accredited 155 MECCs.*

HT: WSJ Health Blog

* Not counting initial or reaccreditation ACCME fees, the loss of annual fees from these 155 accredited MECCs would amount to a yearly loss of at least $310,000 for the ACCME.

Update: On a Pfizer-related note, Derek Lowe at In the Pipeline hears rumors of autumn layoffs at Groton.

And the Congressional letters just keep on comin'.

This time the target is Murry Kopelow, MD, chief executive of the Accreditation Council for Continuing Medical Education (ACCME), the organization that bestows accreditation on MECCs, medical societies, and universities to deliver certified CME. Senator Herb Kohl (D-WI), chairman of the Senate Special Committee on Aging, sent a letter June 20 (link courtesy of Pharmalot) as part of an ongoing investigation to determine the influence that pharma has on CME. The contents of the letter indicate that Senator Kohl and the Committee have much to learn.

As the Committee continues its examination of the relationship between physicians and pharmaceutical companies, we have become concerned with reports that pharmaceutical companies are increasingly [emphases added] using continuing medical education (CME) events as a vehicle to increase the market for their products.

The opposite is true. Thanks largely to heavy fines exacted by the Office of the Inspector General (OIG) for off-label promotion,* pharma has become decreasingly involved in the development of content for industry-sponsored CME. In my MECC experience during the last several years, pharma has continued to play a decidedly hands-off role in the development of CME programs for which they provide financial support. Some companies have even gone so far as to recuse themselves entirely of reviewing the content (even for medical-legal purposes) before the program is released publicly.

According to the [ACCME] 2006 annual report, commercial support for CME activities accounted for $1.2 million, or half of the budget for CME courses in the United States.

For what it's worth, the most recent number may actually be a little higher, accounting for 60% of the US CME budget.

Of particular concern are instances where drug companies use CME courses to encourage physicians to use their products for potentially controversial medical practice. For example, it has come to the Committee's attention that one pharmaceutical company, which produces an anti-herpes drug, sponsors CME events which promote testing all pregnant women for herpes.

Senator Kohl may consider this nitpicking, but how does a CME program on pregnancy concern senior care? Couldn't the Senator or the Committee's investigators find a more relevant and objectionable CME program?

In any event, it appears that Senator Kohl is referring to GlaxoSmithKline's support of at least one Medscape-produced CME program ("Genital Herpes and Pregnancy"), which expired more than a year ago. GSK is the maker of valacyclovir (Valtrex), which is indicated for "the treatment or suppression of genital herpes [HSV] in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected individuals."

The Medscape program was delivered by Zane Brown, MD, Professor of OB-GYN at the University of Washington, and Serdar Ural, MD, then of U Penn, who (along with the accredited bodies of Medscape and the Medical Education Collaborative) are responsible for the program's content. Brown, in particular, urged HSV testing of all women during early pregnancy, which is based on (according to the program) his data published in the NEJM in 1997, JAMA in 2003, the American Journal of Obstetrics and Gynecology in 2004, and Obstetrics and Gynecology in 2005. Also Brown's experience with a newborn's death caused by congenital herpes (shown in the program) is probably enough for any doctor to mandate HSV testing for all pregnant women in his/her practice.

However, routine testing for herpes in pregnancy is not recommended by any scientific evidence or any national expert panel. In fact, the American College of Obstetricians and Gynecologists, the Centers for Disease Control and Prevention, and the United States Preventive Services Task Force all reject prenatal herpes testing due to the dearth of evidence that exists to recommend routine screening and the potential harm to many low-risk women and fetuses from the side effects of antiviral therapy.

Drs. Brown and Ural may disagree with the Committee (and again, shouldn't we be talking about conditions that affect the aging?) that "routine testing...is not recommended by any scientific evidence." And while it is true that the ACOG, the CDC, and the US Preventive Services Task Force do not recommend routine HSV testing for all pregnant women, this may be a point on which obstetricians reasonably disagree. For instance, in the Medscape program, the majority of program participants (64%) said that they do offer HSV testing to all of their pregnant patients. Dr. Brown also offers the following explanation about ACOG's recommendations to not routinely screen for HSV: "A reason that ACOG is reluctant to issue a new bulletin is because they are concerned about the medical-legal ramifications of widespread screening. On the other hand, I would just ask you to consider a woman whose baby develops a case of neonatal herpes..."

I am troubled by any attempt to persuade physicians to use a drug treatment for any reason other than the patient's condition and the drug's effectiveness in treating it.

Senator Kohl, at least as far as the Medscape program is concerned, appears to be missing its point. The program (as far as I read it) stresses the detection of subclinical HSV during pregnancy to reduce the risk of congenital HSV (which, at the risk of repeating myself, isn't relevant to the aging). Senator Kohl is also probably out of his league here and out of line when it comes to questioning the diagnostic and therapeutic recommendations of physicians (particularly academic physicians)—even if recommended treatment is off-label (which is any physician's prerogative, even duty). I certainly wouldn't want to get into a debate with Dr. Brown on this particular issue.

Therefore, it was with great interest that the Committee took note of the ACCME's credentialing standards and practices for CME courses.

In an effort to better understand the ACCME's credentialing standards and practices for CME courses, please provide us with the following documentation and information.

1.) a copy and written description of the accreditation process for CME courses;

2.) any criteria the ACCME uses, as part of the accreditation process, regarding the scientific validity of course content;

3.) any mechanisms that ACCME has in place to ensure that no undue influence by any industry is being exerted through CME courses; and

4.) any further plans the ACCME may have in place to develop such mechanisms.

Senator Kohl appears to be making a common error here, confusing accreditation with certification. Organizations are accredited by the ACCME to deliver certified CME. An accredited organization (eg, Medscape) certifies the CME programs it produces (and can do so, because it is accredited). Therefore, the ACCME does not oversee the production of individual CME programs and would not have direct oversight of an individual program's scientific validity (nor would the ACCME have the wide expertise that is necessary to oversee the scientific validity of the myriad CME programs). The duty is left largely to the faculty who participate in the content development and delivery of CME programs, as well as the employees of the accredited organization (which are often CME experts and/or health care professionals). The mechanisms that the ACCME has in place to mitigate undue industry influence are contained in the ACCME Standards for Commercial Support. The Committee can find "further plans...to develop such mechanisms" in the ACCME's recent Policy Announcements, a document I absolutely adore. 

MECCs = medical education communications companies.

* For example, see Harris G. Pfizer to pay $430 million over promoting drug to doctors. NYT. May 14, 2004.

I've deigned to think differently from Daniel Carlat. 

A fervent critic of all industry-supported CME and the host of The Carlat Psychiatry Blog, Dr. Carlat initially expressed cautious optimism last Thursday about the ACCME's newly proposed guidelines ("ACCME Gets Serious With 'New Paradigm'") to monitor industry-supported CME. However, he showed serious disdain for the very same guidelines 48 hours later ("Using ACCME's New Rules for Bias and Profit"), evidently in response to my criticism on Friday of the ACCME's overblown and confusing verbiage in its document and the organization's apparent failure to entertain the consequences of its proposed actions.

What's somewhat perplexing, other than Dr. Carlat's turnaround opinion, is his not-so-subtle castigation—and even analysis—of me. (So what do I owe you, doctor?) Of course, the absolute gorgeousness of having a blog (other than the fact that I can use words like "gorgeousness" without fear of editing) is that I can respond to Dr. Carlat's post right here on my own little cyber-acre. So here I go.

Dr. Carlat began:

In bmartin's pro-industry-CME blog Pathophilia, there is an interesting post about the newly proposed ACCME rules intended to stamp out commercial bias while still allowing commercial support.

I wouldn't characterize my blog as "pro-industry-CME"; however, I'm not against industry-supported CME, particularly given the current guidelines for its production. Nor am I in favor of stifling the flow of information, whatever its source. It's important to remember that industry-supported CME isn't consumed in a vacuum, but that it exists in the context of commercially supported CME from various industry competitors, as well as a wealth of educational information from nonindustry sources. And doctors are a pretty independent bunch. They can and do decide, individually, what to believe and how to apply information in practice on the basis of a piece of information's provenance and a whole host of other factors, like data reproducibility and clinical experience. Moreover, to my knowledge, there are absolutely no controlled studies demonstrating that participation in industry-supported CME leads to suboptimal medical care or poor patient outcomes. 

Bmartin parses out the wording of ACCME's proposal in order to try to divine the organization's actual intentions, and finds much to ridicule. 

I parsed the ACCME's wording to express my opinion that the ACCME is in love with its own bombastic voice at the expense of meaning. 

You can detect a heavy dose of financial anxiety in this post. It's an attempt to read the tea leaves in ACCME's new policy in the hopes that it will not actually mean any significant changes in the current system. But bmartin ends on a decidedly pessimistic note, predicting that the regulations will lead to less industry funding, and ultimately, to the disappearance of ACCME itself.

Well, maybe Dr. Carlat detects financial anxiety. I thought I was just pissed off at the writing style and lack of forethought of yet another bureaucratic organization.

While I wish I could agree with bmartin, unfortunately I see this as very good news for industry support. Anybody who owns a CME company and has undergone accreditation and reaccreditation (as I have) knows that there is really nothing new in this "new" guidance. Any company will be able to demonstrate compliance with each of these and yet still produce promotional and biased CME. Let's take each of these elements point by point and apply it to a recent promotional CME article produced by Medscape (see here for more details, and see Barnard Carroll's excellent investigative journalism on Medscape here and here).

I'm not sure if Dr. Carlat's implying that I don't know what I'm talking about; however, for what it's worth, I have experienced an ACCME reaccreditation process (which, BTW, generated a lot of printed paper). But more to the point, the ACCME's newly proposed guidelines are different from the existing guidelines (other than the general guideline that content should be free of commercial bias). For instance, there is currently no mandate that educational needs must be identified by an organization that does not receive commercial support—which eliminates most (if not all) MECCs, professional organizations, and university-based CME offices. My main beef with the ACCME's newly proposed guidelines is that they're too vague in how they should or can be executed.

1. Needs assessment will have to be identified by a neutral organization. Not a problem! You want to keep the flow of money coming from Janssen to help it promote Invega? Many non-industry funded organizations will report that practitioners have a need to learn more about the appropriate use of antipsychotics. Bingo—you've just done your needs assessment.

Of course, those in the CME business know that a 1-sentence rationale from any organization is not a sufficient assessment of educational need. Needs assessments are typically multipage documents that include information from literature searches, clinician interviews, outcomes from prior CME programs, physician surveys, and other sources. 

2. Practice gaps will have to be identified by neutral organizations. Same non-issue as number one. Any reasonable organization will identify adequate treatment of schizophrenia as a "practice gap." For example, the AHRQ produced this document which can be cited to support the need for education about how to use atypical antipsychotics. Medscape will argue that focusing an article on treating a schizophrenic patient with liver disease (which just happens to be the specialty of Invega, its sponsor's medication) fills an identified "practice gap," and ACCME won't argue with them.

This point indicates that there are government sources to guide the treatment of conditions like schizophrenia, and that these sources can be used in an assessment of educational need. However, an educational activity that focuses on antipsychotic use and liver dysfunction could not rest (at least, in my experience) on the one generality—namely, that there is a need for education on the use of atypical antipsychotics. But my question to the ACCME would be Must the authors of these government-dispensed treatment recommendations have no ties to industry?

3. The curriculum must be specified by a bona fide organization. This is a hard one...let me see...okay, how about psychiatry's specialty board, the American Board of Psychiatry and Neurology, Inc., which publishes these "core competencies" in psychiatry. Go to the "Somatic treatment" section and you'll find the following recommended curriculum for psychiatrists:

Again, my question to the ACCME would be Is a specialty board, or more specifically, are the drafters of a board's core competencies sufficiently commercial-free? 

4. It must be verified as "free of commercial bias."

This is a redundancy, since this is already a centerpiece of ACCME Standards for Commercial Support. The organization will never have the resources to monitor the thousands of industry-supported CME activities hatched yearly.

Maybe they will; maybe they won't. In my scenario, I guess it's possible that there could be a point of equilibrium, where the dwindling number of CME providers can be sufficiently managed by a beefed-up ACCME—until the organization collapses from lack of fees.

So don't fret, bmartin—in fact, I would argue that this is a cause for great joy. ACCME is handing you the perfect mechanism for a commercial CME whitewash. Use some of that industry money to celebrate.

Okay, it's my turn for analysis...um, bilious sarcasm?

To expand its "operational elements," the Accreditation Council for Continuing Medical Education plans to increase its current fees and to introduce new fees for accredited providers of CME. The ACCME—the US organization that confers accreditation on universities, medical societies, and MECCs to provide CME—stated its intent to increase its revenue in an abstrusely worded annual Policy Announcements. Presently the ACCME's initial and reaccreditation fees are $6500, and its annual accreditation fee is $2000; according to its website, the ACCME provides accreditation for 740 organizations.

The ACCME did not specify its newly proposed fees in the announcements, but additional revenue is intended to support substantial staff increases and "an enhanced monitoring and surveillance system." And while information in this section of the policy document, "An Expansion to Operational Elements," remains vague, it is certainly the clearest in meaning among all sections of the document. Other informational parts of the announcements and proposed policies "for comment" are written in an overbearing, and often senseless, wordiness. Perhaps the ACCME knows what it means; the rest of us can only guess.

Let's begin with the introductory "Accredited CME is[sic] Education That Matters to Patient Care."*

The ACCME continues to emphasize that CME must be a strategic asset to all stakeholders who seek to improve health care in the US. Since 2006, the ACCME has maintained a focus on supporting a well-organized transition to a criterion-based system for the accreditation of CME providers that matches the gaps in physician competence, performance, and patient outcomes (ie, professional practice gaps) with practice-based learning and change.

In the first sentence, I pretty much stumble after "that" and then experience a full-body wince at the use of "stakeholders." In the phrase, "CME must be a strategic asset," "strategic asset" apparently means some important, positive thing; but it's really axiomatic that a cited asset would be important, so the adjective, in my mind, is unnecessary. And then I'd argue that "asset" should be supplanted with an adjective like "important." Then there's the phrase, "all stakeholders who seek to improve health care in the US." That's pretty much everybody, isn't it? So the first sentence can be distilled to something like, "The ACCME continues to emphasize that CME is important to everybody"—which is not a particularly useful or insightful introductory sentence. So just delete the whole thing. 

Then there's the second sentence: "Since 2006, the ACCME has maintained a focus on supporting..." For starters, how about, "Since 2006, the ACCME has focused..." or even "has supported..."? What has the ACCME "maintained a focus on supporting"? A "well-organized transition to a criterion-based system for the accreditation of CME providers." There are at least a few problems with this phrase. The ACCME supports a transition (and not a poorly organized transition, mind you) to a criterion-based system (BTW, it is really just 1 criterion?), but the ACCME doesn't indicate what the transition is from. A non-criterion-based system? Something like astrology? But even an astrological sign is a criterion, albeit a capricious one. So the distinction of a "criterion-based system" is nonsensical without further definition. 

To that point, the remainder of the ACCME's second sentence indicates that the "criterion-based system... matches the gaps in physician competence, performance, and patients outcomes...with practice-based learning and change." The ACCME now defines its "criterion-based system" for accreditation as something that matches gaps—or really, addresses deficiencies—in "physician competence, performance" (which are really the same) and "patients[sic] outcomes." And then the method by which these deficiencies are addressed is "practice-based learning and change." But all medically related learning is potentially applicable to practice, depending on whose practice you're talking about.

So the ACCME's definition of its "criterion-based system" for accreditation (which, when it comes down to it, is not really a system) is the CME provider's act of demonstrating (and I'm helping out the ACCME here) that there is information which has the potential to improve medical practice. Therefore..."Since 2006, the ACCME has supported the accreditation of [or simply "accredits"] CME providers who attempt to provide knowledge that elevates medical practice," or something to that effect. This statement, in its distillation, is also kind of self-evident and, therefore, unnecessary. 

I could go on and on, but the exercise is life sucking. Anyway you get my drift, even if you read only part of the Policy Announcements.

The most controversial aspect of the ACCME's Policy Announcements is in a "For Comment" section, which proposes that the commercial support of CME should only be allowed to continue after several considerable changes. These changes are likely to make the production of timely CME difficult and probably more trouble than it's worth for many providers. (The ultimate and ironic consequence [described below] of the ACCME's proposed conditions should be evident to anyone who has played chess.)

1. When educational needs are identified and verified by organizations that do not receive commercial support and are free of financial relationships with industry.

The ACCME cites government agencies as a example; although, it does not stipulate which government agencies engage in or would engage in the identification of CME needs, or how current CME providers would access or use this information to obtain grant support from industry. Also, what defines freedom from financial relationships?

2. If the CME addresses a professional practice gap of a particular group of learners that is corroborated by bona fide performance measurements (eg, National Quality Form[sic]) of the learners' own practice.

Another ill-considered hoop. Other than citing the National Quality Forum, a nonprofit "performance-improvement" organization, it's not clear what would qualify as valid corroboration. At its website, the NQF notes that it endorses a number of "clinician-level performance measures" and is currently asking for measures related to cancer, infectious disease, and surgical care. But how this information may be obtained or used by CME providers is not described by the ACCME or the NQF. 

3. When the CME content is from a continuing education curriculum specified by a bona fide organization, or entity (eg, AMA, AHRQ, ABMS, FSMB).

Again, how CME providers may obtain and use another organization's curriculum for content is not clear (and perhaps not yet known).

4. When the CME is verified as free of commercial bias.

And who or what determines commercial bias?

Now the big irony of the ACCME's proposed crackdown on commercially supported CME is that it conceivably leads to the organization's undoing through the following process. 

• Industry will provide less commercial support for CME (as has been the case during the last year or so).
• There will be considerably fewer organizations producing certified CME and, therefore, fewer organizations will need accreditation to provide CME.
• Fewer accredited CME providers will reduce the ACCME's fee revenue.

High five, ACCME.

CME = continuing medical education; MECCs = medical education communications companies.

*BTW ACCME, always capitalize verbs, no matter how short, in titles.

In an expected move, representatives of the primary voting blocks of the AMA House of Delegates—primary care doctors, state medical societies, and specialty medical societies—strongly objected to an AMA proposal to eliminate commercially supported CME, according to today's Medical Marketing & Media. The AMA's Council on Ethical and Judicial Affairs (CEJA) had recommended the phasing out of nearly all commercial support for CME, an issue which was debated at a committee hearing on Sunday, during the annual meeting of the AMA House of Delegates in Chicago.

John Kamp, executive director of the Coalition for Healthcare Communication, reported that the proposal "went down in flames," according to the paper. The CHC, along with the North American Association of Medical Education and Communication Companies (NAAMECC), objected to the CEJA proposal on the basis of 3 general arguments:

[T]he report ignores the dramatic difference between certified CME and other non-certified 'education' and thus overlooks the significant advances in the management and resolution of conflicts of interest mandated in the last several years by government, industry and the [ACCME].

[T]he report's conclusions are not based on current and scientifically relevant and rigorous evidence in the context of certified CME and do not respect dramatic progress in the past decade.

[T]he report lacks a plausible, detailed plan to ensure that the proposed elimination of $1 billion in certified CME funding would improve the quality of certified CME and patient care.

Given the objections voiced at the AMA meeting, the CEJA proposal is "referred back to the council, effectively tabling it for the year," wrote the paper.

Moving through this morning's pharma blogosphere is an AP story describing the responses of some drug or medical-device companies to Senator Chuck Grassley's request that they disclose their CME funding to outside groups. The current industry model is that of Eli Lilly, which provides a highly itemized (and therefore, very difficult-to-synthesize) online grants registry report for each financial quarter of 2007.

Among the companies' soup-to-nuts replies to Grassley:

• Medtronic will post payments for professional meetings and patient groups on May 1 (no mention of funds to medical communications companies);
• AstraZeneca will do the same on August 1;
• Merck is "currently in the process of developing an action plan";
• Amgen and Abbott have formed "working groups"; and
• nose-thumbing Schering-Plough reports that it has no plans "at the moment" to publish the requested information.

Today's WSJ Health Blog notes that Grassley's also sponsoring the Physician Payments Sunshine* Act of 2007, which will require quarterly reports from drug or medical-device companies to the DHHS regarding payments made to individual physicians or their employers.

CME = continuing medical education.

*As in, blow sunshine up my...?

From Pharmalot by way of The Carlat Psychiatry Blog: Both highlight a relatively recent editorial in Medical Meetings that was written by Donna Beales, librarian and CME coordinator at Lowell General Hospital in Lowell, MA. In the editorial, Beales maligns the current state of industry-funded CME and outlines a provocative "5 Steps to Building Real Firewalls" to separate CME from commercial interests.

My own very blunt view of Beales's editorial is that it comes from a place of ignorance, and I specify some of my objections to her proposals in the comments section of the relevant Pharmalot post.