Interest in Conflicts (2010)

It seems that nearly every day my hometown newspaper, The New York Times, describes a new scandal relating to conflicts of interest among academics and academic physicians. From signing off on ghostwritten articles, giving talks for pharma to slanting or even fabricating the results of their research, academic physicians are accused of violating the public trust. Moreover, the NIH, Congress, and the press have criticized universities because their procedures do not seem to safeguard against conflicts of interest by their faculty. The outrage described in the November 19th, 2009 edition of The New York Times was that 90% of universities depend on the investigators involved to report conflicts relevant to their research (http://www.nytimes.com/2009/11/19/health/policy/19nih.html?_r=1&scp=2&sq=conflict%20of%20interest&st=cse). Clearly, the credibility of research and the continuation of support for this research, particularly patient-oriented research, is at stake when the research is compromised by potential bias for a specific sponsor. Universities lack subpoena power and have no access to personal financial information so it is unclear how universities are supposed to police potential conflicts that investigators themselves do not report. A recent query on a listserv for individuals with an interest and responsibility in regulating conflicts (compliance officers, chairs, or members of faculty committees, etc.) raised the possibility of requiring faculty to submit copies of their tax returns to the university, a suggestion that was met with a notable lack of enthusiasm. Some states require pharmaceutical companies to report payments to physicians in that state and the Federal government forced manufacturers of orthopedic devices to disclose payments to physicians as part of a consent agreement. None of these databases are easily searchable for universities with large clinical faculties. Moreover, many physicians are paid by a third party, or a medical education company, to speak or to write monographs in support of specific drugs and these companies may not disclose payments made to physicians. Aside from a few spectacularly egregious cases, investigators have not produced much evidence that underreporting of conflicts is widespread and has tainted research. The Inspector General of the NIH has recently reported that universities do not require nor do they report detailed information about investigators to the NIH and note that the biggest underreporting problem is related to equity holdings, possession of which could affect research results. Although not stated, it is likely that much of the equity has no precise value because shares in startup companies are not freely traded and often have no value due to the failure of the companies to generate any revenue. Nonetheless, many universities are moving toward more frequent disclosures and, as described above, the pharmaceutical industry may publicly report on physicians whom they have paid. Institutional conflicts present a problem of particular relevance to the NCRR's Clinical and Translational Science Award (CTSA) awardees. A major goal of the CTSAs is to rapidly translate progress at the bench to benefits for patients and the community. At the recent meeting of the Executive Committee of the CTSAs in Rockville this fall it became clear that conflict of interest considerations might be problematic. A number of projects were presented that could serve as demonstration projects for collaboration among CTSAs. All of the projects presented were interesting and relevant; any single collaborative project would have stood on its own as a competitive multi-center project. Nonetheless, it was very clear that most of the projects could not be performed as initially proposed because all of the projects clearly involved inventions, or intellectual property, that could potentially generate royalties or, in one case, equity for either the investigators proposing and executing the studies or their home institutions. No prior consideration to the potential for institutional conflict of interest was made and most of the meeting attendees seemed to be unaware of the potential conflicts of interest. Although the policies on institutional conflicts of interest are not as well established as those for individuals, my institution currently does not permit research at NYU School of Medicine on drugs or devices in which NYU has intellectual property except under very special circumstances. Other institutions have adopted more liberal policies on institutional conflict. Interestingly, many of the people who would like to become engaged in specific research projects are totally unaware of the potential for an institutional conflict of interest, as they have no idea that the institution has any rights to the technology to be tested. At NYU and most other institutions, the potential conflicts of interest of collaborating investigators, even those at another institution, must be disclosed. Indeed, the potential institutional and investigator conflicts at collaborating institutions would likely be the subject of management plans imposed by every other institution involved in the project. Moreover, it is likely that these institutional disclosures would trigger significant restrictions on the performance of the research or at least a significant delay in starting the research as safeguards are put into place. Clearly, restrictions on institutional conflicts of interest will have a broader effect on translating bench advances to the clinic and, thereby, interfere with one of the key objectives of the CTSA program. The investigators and institutions involved, in concert with the NIH, should develop a broadly applicable and acceptable policy for institutional disclosure and conflicts of interest so that recipients of institutional awards that promote collaboration are not subject to future penalties for violating rules that are neither fully articulated nor accepted. This work was supported by grants from the National Institutes of Health (AR54897 and AR56672), OSI Pharmaceuticals, the NYU-HHC Clinical and Translational Science Institute (UL1RR029893), and by the Kaplan Cancer Center of New York University School of Medicine. Intellectual Property: Dr. Cronstein holds or has filed applications for patents on the use of adenosine A2A receptor agonists to promote wound healing and use of A2A receptor antagonists to inhibit fibrosis; use of adenosine A1 receptor antagonists to treat osteoporosis and other diseases of bone; the use of adenosine A1 and A2B Receptor antagonists to treat fatty liver; and the use of adenosine A2A receptor agonists to prevent prosthesis loosening. Consultant (within the past two years): King Pharmaceutical (licensee of patents on wound healing and fibrosis above). CanFite Biopharmaceuticals, Savient Pharmaceuticals, Bristol-Myers Squibb, Roche Pharmaceuticals, Cellzome, Tap (Takeda) Pharmaceuticals, Prometheus Laboratories, Regeneron (Westat, DSMB), Sepracor, Amgen, Endocyte, Protalex, Allos, Inc., Combinatorx, Kyowa Hakka. Honoraria: Tap (Takeda) Pharmaceuticals. Stock: CanFite Biopharmaceuticals received for membership in Scientific Advisory Board.