America’s top experts in multiple myeloma published a manifesto on value of their working relationship with industry in the Mayo Clinic Proceedings as a response to an editorial. Over 60 oncologists expressed their support of continued collaboration with industry.
These cancer specialists expressed their concern over the “increasing scrutiny and regulation of the relationship they, as clinical educators and investigators, have with their partners in industry and the continuing medical education (CME) providers with whom they work.” As a result, they recognized that one important factor has been missing from the discussion about these relationships:
“A concerted response from those who have worked with the pharmaceutical industry and providers of CME to present the opinion that these interactions are in fact of real value.”
Accordingly, their letter represents such a response because it recognizes that “evolving institutional and national trends now in the public domain may seriously curtail the interactions between clinical educators and investigators, industry, and CME providers.” If such interactions are prohibited or hurt, it “will diminish clinical investigation and education alike, with a consequent negative effect on patient care.”
Even more detrimental to patient care, the group noted, is that “many institutions are considering the adoption of a “zero involvement” policy, which would substantially limit physician involvement in CME activities and new drug development.” They noted that “although some rare abuses have occurred and that the risks in this interaction are real,” the medical community should avoid “overzealous, ill-judged, and restrictive regulations that will curtail the current constructive interaction.”
Specifically, the clinicians emphasized that their partnership with industry has “resulted in unprecedented advances in myeloma, with a subsequent dramatic improvement in patient outcome, and to impede this progress in the treatment of multiple myeloma would be a disservice to their patients and their families.” The group then went on to assert that:
1. Synergistic interactions between physicians and the pharmaceutical industry have contributed to the development of safe and effective therapeutics that have improved individual patient outcome and thus have contributed to the greater good of society.
2. The overwhelming majority of interactions between academia and industry have been positive, productive, ethical, mutually respectful, and driven by the shared desire to bring better treatments to patients with multiple myeloma.
3. Conflict of interest concerns in these relationships have been exaggerated and diminish the integrity of physicians and coworkers engaged in clinical research in the public eye.
4. The evidence points to the overwhelmingly positive aspects of clinician-industry interaction and that a “confluence of mutual interest” exists.
5. That industry-academia interactions, conducting shared research under commonly agreed upon guidelines characterized by full disclosure and clear transparency, are in the best interests of all, and in particular our patients.
6. Enforced disengagement of such partnerships will help no one and hurt many.
7. The support provided by industry for professional meetings and publications designated to promote and foster research as well as education is a major factor in contributing to the clinical development and subsequent deployment of effective therapies in a timely manner.
8. The support provided by industry to commercial CME providers, with independent review of content for fairness and balance, has resulted in the development and implementation of a variety of educational events directed toward physicians, patients, and allied health care personnel, which has improved their understanding of the disease, the benefits and risks of different treatment strategies, and the existence of additional resources to help in patient care. Through these educational events, the quality of care delivered to patients with myeloma has improved. By accelerating deployment of new therapies, lives have been prolonged and toxicities of treatment decreased.
9. This learning activity is of high value to the recipients of such education, especially to patients. As such, remuneration to experts of content and presentation for their time (often spent away from family) is reasonable, necessary, and professionally acceptable.
10. Consulting and participation in advisory boards by highly informed specialists with first-hand experience of novel therapeutics, both clinically and preclinically, are important activities of high value to industrial partners during the development of safe and effective new drugs. Optimal sharing of this knowledge occurs with investigators who care for patients and are engaged in clinical research, thus representing a bona fide exchange of information; remuneration for this work is reasonable, necessary, and professionally acceptable.
Such support for industry relationships reaffirms the notion that “within the proper boundaries of full disclosure and compensation at fair market value for the effort involved, these interactions should not be limited, but rather encouraged with appropriate guidance and within agreed upon guidelines.” Moreover, the relationships with industry and physicians should be strengthened to further improve outcomes for patients,” because hindering the progress of such collaboration will only be to the detriment of all, in particular patients.
It is also important to remember that “we should not simply assume that because someone is paid either more or less or by one person or another person, that the quality of his or her work or his or her integrity is either better or worse.” This is especially true considering “collaborations with industry by experienced clinicians, educators, and researchers are indeed beneficial and advance the state of health care.”
Accordingly, rather than “close the door to evidence, debate, and proper decorum,” by excluding the involvement of industry and “mocking the core of science,” the medical community and public must “appreciate the enormous amount of high-quality research funded by industry to develop drugs and demonstrate their value.”