Executive Summary

NIH PROPOSED CONFLICT OF INTEREST GUIDELINES WILL HARM ACTG PROGRAM, the executive committee of the National Institute of Allergy and Infectious Disease's AIDS Clinical Trials Group (ACTG) program asserts in a Dec. 5 letter to NIH Deputy Director for Extramural Research Katherine Bick. "The way the proposed guidelines are written, ACTG investigators could no longer do NIH-sponsored clinical trials and consult for pharmaceutical companies whose drugs are being tested," the committee asserted. The viability of the program depends on collaboration of individual investigators with the pharmaceutical industry and NIH, the committee maintains. The committee said the new guidelines would force industry to "choose between conducting trials within the ACTG system or maintaining their own private consultative links." In addition, investigators "would become involved in a bidding war between government and industry." "Most of the leading pharmaceutical companies would choose to conduct their own trials outside the NIH system; the rigor and integrity of the trials would suffer and many of the best compounds would be withheld from the governmental testing "It is possible," the committee warns, that NIH's ACTG "would collapse because of investigator withdrawal and lack of pharmaceutical industry participation." The committee's letter was discussed at NIH's Dec. 11-12 AIDS Program Advisory Committee meeting. National Institute of Allergy and Infectious Diseases Director Anthony Fauci concurred with the ACTG executive committee. He said the proposed guidelines represent a "potential disaster" that could destroy the institute's AIDS program. Fauci said it would be reasonable to determine on a case-by-case basis whether an individual's investment in, or consultation with, a particular company would make it inappropriate for the person to be in a decision-making position for a particular clinical trial. However, he stated, "to say that you cannot be involved with industry at all, I think, is going to have a practical consequence of losing our best investigators." NIH's proposed guidelines, announced in September, 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, results, or the reporting or interpretation of results of NIH or ADAMHA-supported research." The guidelines also prohibit investigators funded by NIH or the Alcohol, Drug Abuse and Mental Health Administration from sharing information with a company until the information is publicly available. In addition, the guidelines require disclosure of all research funding. The AIDS Program Advisory Committee also drafted recommendations on the proposed guidelines. The committee requests elimination "of any prohibitions that limit public-private sector collaboration." In addition, the committee objects to the statement in the guidelines that: "Confidentiality shall be maintained at all times unless that confidentiality would interfere with the interest of the institution or the federal government." Instead, the committee requests that the provision be revised to require institutions to "incorporate in their policies substantive and procedural guidelines for determining circumstances in which confidentiality of disclosure statements will not be maintained." The committee says the federal government should develop similar guidelines.