Nov. 6, 2012 – The Association of Clinical Researchers and Educators (ACRE) recently published a statement to assist physicians as they navigate how to become involved appropriately in research, education or other collaborations with industry. This statement calls for careful consideration of collaborations, but also notes that these collaborations “have added considerably to patient care and have been conducted with integrity and commitment.”
ACRE wrote the guidelines “because we were getting concerned about the number of conflicting statements and comments being made about involvement by physicians in collaborations with industry,” said Michael Weber, M.D., Chair of the ACRE Writing Committee. “We wanted to give clinicians some basic ideas that they could use in making up their own minds about how to work on projects with companies.”
“All sectors should applaud these common–sense ideas because they enable doctors, educators and scientists to effectively collaborate with industry,” according to John Kamp, Executive Director, Coalition for Healthcare Communication.
ACRE states in its code of conduct guidelines that “the active and continuing collaboration of clinicians and industry is vital to patient care. … Many of the major therapeutic advances across the spectrum of medical practice during recent years have been linked to these collaborations.” The ACRE document includes recommendations for eight types of physician interaction with industry:
- Clinical and scientific research
- Consulting and advisory activities
- Continuing medical education (CME)
- Product-specific education
- Expert witness activities
- Professional medical societies.
The ACRE Code of Conduct Guidelines span 25 pages (the document can be viewed in its entirety by clicking on the document name) and differ from the more stringent rules and bans established by the federal Sunshine Act, medical school deans and other organizations because they are based “on the premise that collaborations with industry [can] create medical progress that adds to the well-being of patients,” Dr. Weber told the Coalition.
Several of ACRE’s key recommendations, which are designed to ensure that physicians do not enter into industry relationships blindly and point out ethical issues that physicians must address, are listed here:
- Physicians should be clear regarding the reasons underlying their research commitments and roles (Research);
- Physicians should be clear about the distribution of funding to be provided by the outside source (Research);
- When asked by industry to serve as public spokespeople, it is generally appropriate for faculty experts to explain scientific and clinical data arising from collaborative work in which they took part (Consulting);
- Faculty members are strongly encouraged to participate in the planning of CME events, and in particular to ensure that they have control over the content of their presentations and are comfortable with their educational and scientific value (CME);
- In deciding whether to join product-specific education programs, physicians should ask whether participation by faculty members provide teaching that ultimately contributes to patient care and should assert their independence and avoid the appearance of selling the product (Product-specific Education);
- Physicians should ensure – before a study begins – that the decision to publish study findings will be made by them (Publishing);
- Overall, it is appropriate to take the position that physicians should not accept money from industry for authorship (Publishing);
- Physicians should ensure that travel support is used for legitimate reasons and that acceptance of travel support is not linked in any way to prescribing performance or other perceived endorsement of a sponsor’s product (Travel); and
- There is a strong obligation for the leaders of medical societies to create internal operational procedures to ensure that their much-needed corporate support does not create inappropriate endorsements of industry products or give the appearance of doing so (Medical Societies).
ACRE also states in the document’s final notes that does not wish to continue the “disturbing trend” of using the terms “conflict of
interest” or “competing interests” when describing relationships between physicians and industry because they are “pejorative.” “Conflict of interest implies that a physician is being rewarded for an action that may not be in the best interests of science or medical progress,” Dr. Weber explained. ACRE prefers the term “acknowledgements of support” when making disclosures, according to the document.
A more balanced approach to monitoring physician-industry relationships appears to be warranted. A Policy and Medicine article discussing ACRE’s recommendations notes that “the absence of bias in CMA programs has been documented in three large studies and several surveys” (to view this article, go to: http://www.policymed.com/2012/11/association-of-clinical-researchers-and-educators-releases-statement-on-relationships-between-physicians-and-industry.html). Dr. Weber remarked that “there is no real evidence of [problems] with CME. The unfortunate fact is that critics assume that the involvement of industry, by definition, is a bad thing.”
Authors of the ACRE guidelines disagree with this characterization. “We believe, if done right, everyone – patients, physicians and industry – benefit from the process,” Dr. Weber stated. “It is important, however, to follow the rules carefully, and we stress this in our guidelines.”
The ACRE guidelines are certainly a step in the right direction, according to the Coalition’s Kamp. “Creating reasonable standards for dealing with the relationship issues that does not call for relationship bans – or extensive paperwork having the effect of a ban – supports both the necessary transparency these relationships require and the value they bring to patients,” Kamp said.