Year: 2003
Type: article
Abstract: THESE CONFERENCES AROSE in 2000-2001 out of conversations with investigators and members of the pharmaceutical industry and out of a commitment to develop new and better agents for the treatment and prevention of osteoporosis. While effective antifracture agents became available to physicians in the 1990s, it remained clear that further improvement in treatment was desirable and possible. New clinical trials began, and more were planned. However, some investigators and their IRBs began questioning the ethics of the randomized, placebo-controlled, antifracture efficacy trial that had been the standard for gaining regulatory approval for new osteoporosis drugs. It became evident that there was no consensus on which osteoporosis trial designs might be both ethical and scientifically valid or whether other designs should be explored. To help study this question, the ASBMR began an initiative that started with a small conference at the Center for Health Policy and Ethics at Creighton University, June 24-25, 2001, and culminated in a conference held at the National Institutes of Health (Natcher Conference Center) on June 14, 2002, followed by a discussion meeting the following morning. The June 2001 meeting introduced the leadership of the ASBMR to a group of world renowned medical ethicists to discern whether an ethical problem truly existed in this area, and if so, to understand the nature of the problem. The June 2001 meeting was a preamble for a much broader meeting to be held at a later date. It brought together a small number of ethicists, investigators, and ASBMR leadership for a daylong series of presentations and discussions. The ASBMR leadership wanted to use this meeting and these discussions to decide whether another larger conference was indicated and what the outline and nature of a later conference might be. It should be understood that the paper describing the proceedings of the Omaha meeting represents the opinions of the authors and not an official ASBMR position on issue. Indeed, the ASBMR leadership present at the Omaha meeting was not sure whether the conclusions and areas of consensus (or nonconsensus) would hold up when they were presented to a larger and more varied audience. The Omaha conference proceedings and the discussions surrounding the individual presentations made clear to the ASBMR leadership that a much broader discussion was needed (as we suspected), including as many of the “stakeholders” that we could gather. Thus, an organizing committee was appointed and the Natcher conference was planned and held on June 14-15, 2002. The manuscripts emanating from that conference are presented in this supplement after the report of the Omaha meeting. (The Natcher conference was widely advertised, but not all of the publicly available seats were taken. About 150 persons attended.) The organizers regarded the Natcher conference and the session that followed the next day as providing a forum for full and open discussion of the issue. Accordingly, the meeting was organized to include presentations by investigators, ethicists, government administrators (Food and Drug Administration [FDA], OHSRP, National Institutes of Health), and others. Because it was clear beforehand that there would be no consensus on the issues, the purpose was to hold discussion and not to attempt to form (or force) a consensus where none exists. The goal was to inform and discuss, not create policy. The outcome was a series of papers provided by the presenters, and a summary statement prepared by a distinguished panel, whose members attended the conference and reacted to the presentations and discussions. The following papers reflect the opinions of the presenters of the Omaha meeting, the presenters of the Natcher meeting, and the reflections and opinions of the panel. They are not intended to be the official position of the ASBMR. The ASBMR has functioned in the capacity of facilitator of discussion of an issue that is of considerable importance to the bone community.
Author: Robert R Recker
Institution: American Society for Bone and Mineral Research
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2020591360