This week, Partners Healthcare (Hospitals that serve Harvard University) adopted a strict conflict of interest policy for its hospitals that includes a full section on undergraduate and graduate continuing medical education (CME). In this document, they outline two ways for the hospitals to accept funds for education, through education approved by an educational review board, and “President’s Fund.”
The report acknowledges that support for education has historically been provided through industry, including CME and non-CME activities, fellowships, and funding for staff (preceptorships, observerships, vendor specific training for non-partners staff).
The goal of the committee was to insulate completely the influence of funding from the content of the education.
They state upfront in the area of education, they are reacting to the increased scrutiny from Senator Grassley’s investigation of academic medical centers (code for “Biederman at Mass General”), and last year’s published reports including the two Macy Foundation-funded reports: Association of American Medical Colleges’ (AAMC) Taskforce and the Macy Foundation Report on CME.
The Partners’ policies go further than the Accreditation Council for Continuing Medical Education’s (ACCME) standards for commercial support:
· Limiting access of industry representatives at educational events;
· Promoting the practice of discussing more than one company’s product at an educational course; and
· Charging participants reasonable tuition to attend an industry-sponsored course.
The commission concluded that industry funding of educational programs was still acceptable.
Partners’ institutions may not accept industry funding for educational programs except through the Educational Review Board or President’s Fund mechanisms described below.
Educational Review Board (ERB)
The ERB is responsible for approving, monitoring, and reviewing industry-supported educational programs.
· The ERB shall have a status and authority similar to that of the Institutional Review Board for human subjects research;
· The ERB shall have a stature as close to that of the IRB as possible, given the different circumstances of the underlying source of creation of the different Boards;
· De minimis values (minimum payments) should be reviewed periodically to ensure the levels remain appropriate;
· The ERB shall include prominent individuals who are unaffiliated with Partners. Partners should consider having the ERB assume the responsibilities of a CME-accredited provider;
· To approve industry support of a specific educational program, the ERB shall require compliance with at least the following conditions, as well as any others determined by the ERB:
· Funding for a specific program must come from more than one company, with no single company being responsible for a specific topic area. The policy should define specific, extraordinary circumstances whereby the ERB shall have the authority to make exceptions to this rule, for instance, for a one-time gift that creates an endowment, the interest of which will fund ongoing programs;
· Any gift of equipment for a specific educational program may be acceptable, but must be reviewed and approved by the ERB;
· Any program that involves conferences or lectures, or other forms of presentations, must meet ACCME or comparable standards (as determined by the ERB), whether for CME credit or not; and
· The ERB will review the relevant financial relationships of all individuals providing content, including speakers from other institutions.
The ERB will conduct a more specific content review of presentations or programs that are deemed to present particular concerns about conflicts of interest based upon:
· the monetary value of any faculty connections to industry sponsors of the program, with a de minimis threshold of $20,000 of income per year or $30,000 in equity interest in publicly-traded companies; the amount and/or source of industry funding for the presentation/program;
· the accrediting body; and
· any other factors determined by the ERB. In such instances, all materials for the presentation/program must be submitted to the ERB (or a subcommittee of the ERB) for prior review, to ensure the educational integrity and balance of the proposed program.
“President’s Fund for Medical Education” (Slush Fund)
· Established at each hospital to support institutionally-determined priorities in medical education;
· Industry partners will be encouraged to contribute to this fund; however, specific programs will not be identified with specific companies, and a company’s contribution to the President’s Fund must not be targeted or directed by the company to any specific educational program; and
· Educational programs funded by the President’s Fund need to be reviewed and approved by the ERB.
In recognition of the importance of industry funding for particular educational programs, the hospitals should work with departments, units, or divisions that will be substantially affected by the new policies to assist them, through the President’s Fund or other sources, during a transition period of up to five years, in maintaining programs that are currently supported by industry at a level of at least $50,000 per year.
To obtain this assistance, the department will need to demonstrate that, as a result of this new Partners’ policy, the program can no longer access industry funding that is available to other academic medical centers (AMCs); that the loss of such funding jeopardizes the continuation of the program; that the institution’s educational mission would be detrimentally affected if the program were not to continue; and that the Partners Education Committee (PEC) and the ERB concur that continuation of the program is appropriate.
Existing contracts should be carried out until their termination, but should not be renewed, and no new contracts should be entered into, unless they are consistent with this recommendation.
These policies are detrimental to the academic mission of the Partners Institutions in several ways:
Financial:
It is unclear where the institutions will find the funds to make-up for the lost support revenues for existing programs. They outline that the departments will have to provide a statement of need and that they have exhausted all efforts to get funding. The problem is that there is not some unknown source of funds sitting out there waiting to fund programs just because you are a Partners’ Hospital. Non-accredited courses (preceptorships, observerships, vendor training) will simply move to other more friendly institutions who can then bring in a Partners’ doctor if they need to do so.
Educational Review Board
The concept of only those from outside the institution being on the board will add additional cost and burden on the system, which will make them unattractive to supporters.
This is a backwards look at educational grants, typically they are submitted to the company and the company decides if it will support it or not. In this case, the company (not certain if you will find any) will be asked to submit a grant and then the educational review board will decide if they should or should not approve the grant – good luck.
President’s Fund
Where are the legal departments of these institutions when deciding on such policies as a “President’s Fund?” There are serious laws on the books against kickbacks – giving unrestricted funds to your customers. With funding a grant, either for CME or other types of education, companies can show that they are funding a specific project. To just fund education comes across as bribery by the institutions (so those who espouse how great this is (Stanford and now Partners)), need to be aware that the adage “just give me the money,” does not work any more regardless of how valuable your brand is.
Free Market
Partners has overestimated the value of their hospitals’ brands, though institutions like Massachusetts General and the Brigham and Women’s are prestigious places to work, the funds can easily be transferred to a less restrictive, more cooperative environment.
More Restrictive than ACCME
The statement that they go beyond the ACCME Standards for commercial support, sounds lofty on the surface, but by adopting these more restrictive policies it exposes the fact that they are not currently compliant to the existing standards. Why should we be led to believe that they will do a better job at complying with even more restrictive policies? This is something the ACCME and Senator Grassley should investigate.
Censorship and Appeasement
By adding restrictions on grants for education with the express purpose of completely insulating an institution from the influence of funding from the content, amounts to censorship of ideas.
For Partners to think that somehow, if we appease the Pharmascolds that life will be better is living in non-reality. In the years to come, these institutions will be asked to give up even more ties with industry and eventually be forced to dump their research relationships.
In the end, these policies amount to censorship and appeasement.
Partners’ physicians need to stand-up for themselves and say enough already, there is no honor in censorship and no gain from appeasement.