The cat is out of the bag. Powerful factions of the U.S. economy have discovered that the practice of medicine and the commercial interests of pharmaceutical and medical device companies — and opportunistic individual physicians — don't mix.
If there was any doubt whatsoever about the extent of this problem, the recent investigation of the Senate Finance Committee into the dealings of the CME industry — itself a commercial endeavor — forever banished that doubt.
The Accreditation Council for CME's policy updates to the Standards for Commercial Support, issued in August 2007, leave a series of gaping holes large enough to drive a snake oil cart through. It's time for a major change. Here are five ways the CME industry can once and for all free itself from the vagaries of sleeping with commercial interests.
- Centralize the Vetting of Speakers and Content.
The Accreditation Council for CME's requirements regarding content validation and disclosure offinancial relationships with commercial interests are a good start, but the actual execution of these mandates leaves plenty to be desired.
Since the speaker disclosure document is not a legal and binding, and because the wording on most of these speaker agreements around commercial interests is vague and open to interpretation, right away a problem exists.
In a perfect world, all lecturers would be honest and open about their financial dealings. In the real world, this is often not the case. Ties may be unreported or underrepresented, and who is the wiser? Unless your CME program is run by the IRS, it is patently impossible for you to determine if the speaker's disclosure of financial relationships is accurate without asking for a copy of the individual's tax returns. This is hardly realistic. Not many people willingly open their personal finances to public scrutiny.
Companies themselves are often divided into branches and subsidiaries, the convolutions of which can be difficult, or even impossible, to trace. It takes considerable expertise to research company information and even more expertise to derive meaningful conclusions from what is found. The bottom line is CME providers are medical professionals, not experts in corporate finance and legal language. Exploration of speaker commercial involvement is the stuff accountants and lawyers, not CME staffers, are made of.
There are other problems with content validation. Content vetting requires CME personnel to be experts in every area of medicine. Larger CME programs, such as teaching hospitals and universities, may have at their disposal faculty from every discipline who can be tapped to scrutinize program content. However, small CME programs will be hard-pressed to find such resources. In community hospitals and medical practices, specialists are busy practicing their areas of medicine. Few are able to spare time to pore over an hour's worth of content for an upcoming CME activity.
The reality in small CME programs is that the director of medical education often serves in the role of content mediator. Imagine a pediatrician suddenly claiming expertise in podiatry or brain surgery, or an internist purporting to be an expert in pandemic flu. Yet that is what is occurring when the director of medical education alone is called upon to analyze program content.
It makes absolutely no sense for each and every accredited CME program in the United States to individually vet speakers and program content, when one centralized agency could accomplish this for all, with a savings of thousands of personnel hours for individual programs nationwide.
Vetting is best handled by a singular, unbiased agency with the time, materials, and personnel to deeply explore speaker commercial ties and to assess content for potential bias. A government agency is a likely choice for this process.
- Make physicians with commercial interests ineligible to present CME programs.
Increasingly, it's becoming a standard across all industries to disclose commercial interests. On most boards, if an individual has any conflicts, it's expected that he or she will be recused from voting on any issues that might involve personal gain.
Choosing to be a physician is a noble calling. Choosing to be a drug company representative may have lucrative financial returns for a doctor who is burned out with medical practice. Both are free enterprises. It's time to choose between one or the other — teaching, or hawking. They are not one and the same. In fact, education and enterprise are mutually exclusive. It's time for doctors to get back to the business of doctoring, and for those with aspirations toward the world of commerce to depart the profession for greener pastures.
If we're worried that we won't attract anyone to teach due to the lack of financial gain, then it's time to look at the whole structure of CME. No other educational program in the U.S. is free of charge to participants. Perhaps it's time to entertain the possibility that participants themselves should defray some of the increasing costs that will inevitably result from a real split between industry and medical education. Attorneys and accountants often pay for their own continuing education course work. If lawyers can afford to do it and bean counters can afford to do it, surely doctors can manage too.
- Prohibit MECCs from any participation in CME.
Medical education and communication companies have no place in education. They may be legally separate from their parent companies on paper, but it's a sure bet that the parent company's drug company clients hold sway and pull the strings on what happens at the teaching level.
It's time to change the laws around how such companies are allowed to exist. Case in point, from the Senate Finance Committee report: “The Committee staff's review suggests that much of the industry funding for CME occurs in the following manner: A for-profit medical education and communications company submits a grant proposal seeking funding to run an-accredited educational program. The drug company agrees to fund a program on a general topic (e.g., treatment of a specific condition — and the condition is one for which at least one of the sponsoring drug company's products is used), but the specifics of the content are determined by the medical education and communications company. The documents provided by the pharmaceutical companies do not reveal an explicit agreement that the CME program will favorably discuss a company product or an off-label use of a company product. However, it is possible that both parties reasonably expect that to be the result.” (Emphasis is mine).
It goes without saying that this should never be allowed to occur.
- Create a structure to report improper behavior on the part of any presenter. The ACCME puts the onus squarely on the shoulders of individual CME programs to vet speakers and content prior to any actual lecture, and most CME programs endeavor to do so to the best of their abilities. Yet currently, no structure is in place to track and report any problems with CME program lecturers or content.
Given the nature of faculty disclosure and content validation processes, as described above, it should come as no surprise that inevitably, speakers with hidden agendas will slip through the cracks and end up in front of rooms full of unsuspecting physicians. When this occurs, a process for reporting is critical.
Without a reporting system, invariably, biased lecturers will hop from one CME program to the next, spreading their message to hundreds, if not thousands of physicians without fear of reprisal. No one and nothing can prevent repeat occurrences.
Again, a centralized agency for overseeing speakers would be of help in addressing potential concerns. At present, no one is held accountable for lapses, save for the individual CME programs themselves. This is short-sighted and punitive, and it creates a disincentive for getting to the bottom of any incidents involving speakers.
- Lobby to make “plain language” disclosure to patients a legal requirement.
The real proof is in the pudding. Put the power in the hands of those who need it most — patients! Make it a legal requirement for physicians to fully disclose in simple, uncomplicated language any and all ways they are involved in commercial dealings, such as when they hand out samples or prescribe, or when they opt for specific procedures that involve devices from which they might benefit.
Donna L. Beales, MLIS, is librarian/CME coordinator at Lowell General Hospital, Lowell, Mass. She is also the editor of Journal of Hospital Librarianships, and president of the Northeast Massachusetts Regional Library System.
The opinions discussed in this article are the opinions of the author and do not necessarily reflect those of her employer.
Second Opinions Wanted
- To respond to these ideas, or share your strategies for ensuring CME's independence from commercial influence, contact Editor Tamar Hosansky at email@example.com.