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Executive Summary

PMA is objecting to the establishment of conflict-of-interest guidelines related to corporate equity held by investigators involved in early stage or "non-evaluative" research funded by either the National Institutes of Health or the Alcohol, Drug Abuse and Mental Health Administration. In Dec. 14 comments on proposed NIH conflict-of-interest guidelines, PMA stated: "It makes no sense for NIH/ADAMHA to police potential conflicts of interest arising out of equity positions held by investigators and others involved in non-evaluative research." As examples of non-evaluative research, the association cites "the basic chemical characterization of a new compound or the biological characterization of a potential therapeutic in in vitro systems." The guidelines state that "no investigator, key employee, consultant, or other persons with primary research, management, advisory, supervisory, or purchase authorization responsibilities, or their spouses, dependent children, or other dependents, shall be allowed to have personal equity holdings or options in any company that would be affected by the outcome of the research or that produces a product or equipment being evaluated in the research project." In general, PMA argued that the "consequences of adopting these guidelines would be devastating to companies with strong ties to the academic research community. Unless they are dramatically modified, the guidelines would severely harm the public health, the stature of biomedical science in the U.S., and the global competitiveness of the U.S. biomedical industry." The association recommended that the guidelines be "carefully re-drafted and provided to the public for additional comment before publication in final form." PMA also advised that since the guidelines deal solely with financial issues relating to outside private companies, the final guidelines should be identified as "representing specifically financial conflicts of interest." * The proposed guidelines were issued in September and have elicited opposition from several groups. On Dec. 5, for example, a National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group (ACTG) committee strongly objected to the proposal, maintaining that the guidelines could hurt the ACTG program ("The Pink Sheet" Dec. 18, T&G-8). However, Public Citizen, in Dec. 14 comments, urged that the guidelines be mandatory rather than voluntary. NIH has not announced a timetable for issuing the final guidelines. Public Citizen pointed out that if the guidelines are not mandatory, "there is a risk that only those institutions and researchers who would otherwise avoid conflicts of interest will comply with NIH's guidelines, and that NIH's own researchers, who are bound by mandatory standards, may be tempted to leave the government in order to perform similar research under NIH grants and contracts, without being subject to binding conflict-of-interest restrictions." PMA recommended relaxing the proposed standard for clinical investigators involved in "evaluative research" or "controlled clinical studies that are undertaken to evaluate materials for the diagnosis, treatment, or prevention of disease." "Because of the possible social costs entailed in rigid prohibitions on possible conflicts," PMA said, "the final guidelines should make it clear to institutions that a conflicted person may be allowed to participate in a trial when the circumstances indicate that there is little likelihood that bias on the part of that person could affect the conduct or reporting of the trial. Waivers could be granted in such cases." The guidelines state that NIH or ADAMHA may waive the no-equity-holdings requirement if the institution "determines such holdings are so insignificant they do not have the potential of influencing research results or the direction of the research." In response, PMA said: "It would be much better if the NIH defined the term 'insignificant,' the NIH and ADAMHA should consult with a wide range of groups including organizations that represent academic and research institutions, clinical investigators, and industry." PMA urged that the guidelines be revised to permit "appropriate sponsor participation" in NIH studies. The guidelines state that institutional conflict-of-interest reviews "need to be particularly careful to ensure that private companies are not in a position to influence the research plan." The association suggested that a system, such as the FDA advisory committee program, be set up to allow for sponsor participation in discussions on research results, although not in final decisions. PMA "strongly urged" that NIH alter the guidelines "to make it clear that honoraria and fees for service are an acceptable component of the interaction between industry and recipients of NIH/ADAMHA funding." The guidelines prohibit investigators from receiving "honoraria, fees for service, or a management position from a private source if that individual is involved in an NIH- or ADAMHA-supported project that is evaluating or testing a product of the source." PMA maintained: "If read literally, this provision would effectively prohibit any interaction" between a company and an investigator in the situation described. "This would seem to include support for speaking, consultancies, and serving as an investigator or advisor in research programs of the company not performed on a strictly volunteer basis." Other PMA comments relate to private disclosure of information on NIH-supported investigations. For example, the association objects to the requirement that information must not be shared "with any company with which a conflict exists unless or until the information or research products are made publicly available." The Association of Biotechnology Companies echoed PMA's concerns in separate Dec. 14 comments. ABC argued that "prohibiting private disclosure of information and/or research projects to a company with which a 'conflict' exists unless or until public disclosure is made will...seriously harm the biotechnology industry." ABC noted that research projects often depend on both private funding and NIH or ADAMHA funding. The association said that "member companies report that many ongoing biotechnology projects could be rendered commercially unviable if know-how could not be obtained from academia on a confidential and exclusive basis." NIH and ADAMHA "need to revise their guidelines to better calibrate the supposed risk and the imposed restriction," ABC maintained. "Conflict of interest issues are best handled at the institution level. The present institutional framework that is established to approve clinical study designs, monitor research, and consider ethical issues should also be utilized to make individual determinations with regard to conflict of interest issues." "This approach overlooks the deterrent effect that public disclosure can have on conflicts of interest, and it runs counter to the principle embodied in the Freedom of Information Act that sunshine is the greatest disinfectant."

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