Academic–Industrial Relationships
http://www.100md.com
《新英格兰医药杂志》
To the Editor: With regard to the article by Stossel (Sept. 8 issue),1 the road of collaboration between academia and industry is dappled with episodes of squabbling and success. One such episode is known as the "insulin famine." In the wake of the discovery of insulin by a team of Toronto academicians in May 1921 and the clinical trials six month later, the Toronto team was unable to increase production of insulin to satisfy even its own clinical needs. Furthermore, the potency of the hormone that was produced in the laboratories in Toronto varied from batch to batch, and impurities commonly led to pain and injection-site abscesses among patients. The Toronto team, realizing the enormous potential of insulin in diabetes treatment, was nevertheless reluctant to relinquish control over insulin production. George H.A. Clowes, research director of Eli Lilly, convinced the Toronto team that the pharmaceutical industry was best able to solve the challenges of the scaling up, mass production, purification, and formulation of insulin. He argued that collaboration was necessary in order to avoid a loss of momentum in insulin production. Under pressure from patients, their families, and clinicians, the Toronto team accepted the offer, and Lilly began work in June 1922. After six months of intensive work, Lilly had the production problem solved. By February 1923, large quantities of insulin could be produced.2
Industry and academia complement each other; each brings its unique expertise to the table. Collaboration is the avenue to expediency and high quality from which we can all benefit. To Stossel, the most complex issues to surmount are ethical. It behooves academia and industry to join in a comprehensive dialogue, with clear and unambiguous guidelines established to allow successful collaboration.
Ehud Arbit, M.D.
Emisphere Biotechnologies
Tarrytown, NY 10591
earbit@emisphere.com
References
Stossel TP. Regulating academic–industrial research relationships — solving problems or stifling progress? N Engl J Med 2005;353:1060-5.
Rosenfeld L. Insulin: discovery and controversy. Clin Chem 2002;48:2270-2288.
To the Editor: Although Stossel decries recent concern regarding financial conflicts of interest in clinical research as "the triumph of emotion over fact," his description better applies to his own defense of a free-market approach to the research relationship between academia and industry. Stossel dismisses such ethical concern as worry about "mere" appearances. One may define a "conflict of interest" as a situation in which one is exposed to a temptation to neglect a professional duty and in which reasonable onlookers would find it plausible that the average person could be swayed by a temptation of that form and magnitude.1 Concern about conflicts of interest, then, is not about "mere" appearances. We are talking about whether the public at large could plausibly judge those conducting medical research to be trustworthy.
Careful ethical analysis considers both potential benefit and harm. Stossel applauds the purported benefits of close collaboration with industry on the part of medical scientists without acknowledging that most important medical innovations have derived from research sponsored by the National Institutes of Health (NIH).2 The actual and potential harm associated with academic–industrial research collaboration, well documented in recent books and articles, is summarily dismissed.3,4,5
(The opinions expressed in this letter are those of the authors and do not necessarily reflect the policy of the NIH, the Public Health Service, or the Department of Health and Human Services.)
Howard Brody, M.D., Ph.D.
Michigan State University
East Lansing, MI 48824
brody@msu.edu
Franklin G. Miller, Ph.D.
National Institutes of Health
Bethesda, MD 20892
References
Erde EL. Conflicts of interest in medicine: a philosophical and ethical morphology. In: Spece RG Jr, Shimm DS, Buchanan AE, eds. Conflicts of interest in clinical practice and research. New York: Oxford University Press, 1996:12-41.
Goozner M. The $800 million pill: the truth behind the cost of new drugs. Berkeley: University of California Press, 2004.
Kassirer JP. On the take: how America's complicity with big business can endanger your health. New York: Oxford University Press, 2005.
Avorn J. Powerful medicines: the benefits, risks, and costs of prescription drugs. New York: Alfred A. Knopf, 2004.
Krimsky S. Science in the private interest: has the lure of profits corrupted biomedical research? New York: Rowman & Littlefield, 2003.
The author replies: Elias A. Zerhouni, director of the NIH, recently wrote in the Journal, "It is the responsibility of those of us involved in today's biomedical research enterprise to translate the remarkable scientific innovations we are witnessing into health gains for the nation."1 This statement underscores that the public wants results — not research for its own sake. And no matter who does the research, only industry delivers the results to the public. Entrepreneurial academic and government researchers, working with industry, have accelerated and should continue to accelerate the process.
Dr. Arbit's account of the development of insulin-replacement therapy is one example of such collaboration. But Dr. Arbit alludes to the importance of ethics, and if interactions between academia and industry have created serious ethical problems (as Drs. Brody and Miller note), we may need more ethical oversight. If, however, they have not created such problems, do we need ethics entrepreneurs to invent such problems, entrepreneurial commentators to hype them, and entrepreneurial politicians to deplore them — and then goad administrators to make rules vainly intended to prevent them? Facts can be elusive, but my article examined the empirical evidence of actual damages that can be ascribed to financial conflicts of interests in academic–industrial relationships and the balance of benefit and harm from such interactions. My conclusion was that the damages are largely speculative and that the balance is far to the good. My evidence included anecdotes always raised by critics, including those "well documented" in the books cited by Drs. Brody and Miller but never analyzed in the context of far more adverse incidents unrelated to academics' commercial interactions. "Potential harm," or what reasonable onlookers find plausible on the basis of appearances, is opinion, not fact. Emotion and ideology have enabled ethics activists, unjustifiably, to hijack the dictionary definition of conflict of interest (a conflict) and convert it into an outcome (unacceptable bias).
Nor is it factual to say that "most important medical innovations have derived from research sponsored by the ." The public sector has produced many discoveries that have resulted in products, but the NIH itself has acknowledged that the vast majority of the chemical compounds that became medicines originated in industry.2,3 More important, this dismissive view of industry's role in delivering results, continuously if imperfectly, demeans the stupendous risk and difficulty attached to that delivery.
Finally, we should ask whether the NIH director's call for more translational research is well served by his ban on corporate consulting by NIH scientists.4
Thomas P. Stossel, M.D.
Brigham and Women's Hospital
Boston, MA 02115
References
Zerhouni EA. Translational and clinical science -- time for a new vision. N Engl J Med 2005;353:1621-1623.
National Institutes of Health. NIH response to the Conference Report request for a plan to ensure taxpayers' interests are protected. July 2001:1-18. (Accessed November 22, 2005, at http://www.nih.gov/news/070101wyden.htm.)
Gortler D. The spread, and end, of life-saving drugs. Yale Daily News. October 23, 2002. (Accessed November 22, 2005, at http://www.yaledailynews.com/article.asp?AID=20297.)
National Institutes of Health. Conflict of interest information and resources. (Accessed November 22, 2005, at http://www.nih.gov/about/ethics_COI.htm.)
Industry and academia complement each other; each brings its unique expertise to the table. Collaboration is the avenue to expediency and high quality from which we can all benefit. To Stossel, the most complex issues to surmount are ethical. It behooves academia and industry to join in a comprehensive dialogue, with clear and unambiguous guidelines established to allow successful collaboration.
Ehud Arbit, M.D.
Emisphere Biotechnologies
Tarrytown, NY 10591
earbit@emisphere.com
References
Stossel TP. Regulating academic–industrial research relationships — solving problems or stifling progress? N Engl J Med 2005;353:1060-5.
Rosenfeld L. Insulin: discovery and controversy. Clin Chem 2002;48:2270-2288.
To the Editor: Although Stossel decries recent concern regarding financial conflicts of interest in clinical research as "the triumph of emotion over fact," his description better applies to his own defense of a free-market approach to the research relationship between academia and industry. Stossel dismisses such ethical concern as worry about "mere" appearances. One may define a "conflict of interest" as a situation in which one is exposed to a temptation to neglect a professional duty and in which reasonable onlookers would find it plausible that the average person could be swayed by a temptation of that form and magnitude.1 Concern about conflicts of interest, then, is not about "mere" appearances. We are talking about whether the public at large could plausibly judge those conducting medical research to be trustworthy.
Careful ethical analysis considers both potential benefit and harm. Stossel applauds the purported benefits of close collaboration with industry on the part of medical scientists without acknowledging that most important medical innovations have derived from research sponsored by the National Institutes of Health (NIH).2 The actual and potential harm associated with academic–industrial research collaboration, well documented in recent books and articles, is summarily dismissed.3,4,5
(The opinions expressed in this letter are those of the authors and do not necessarily reflect the policy of the NIH, the Public Health Service, or the Department of Health and Human Services.)
Howard Brody, M.D., Ph.D.
Michigan State University
East Lansing, MI 48824
brody@msu.edu
Franklin G. Miller, Ph.D.
National Institutes of Health
Bethesda, MD 20892
References
Erde EL. Conflicts of interest in medicine: a philosophical and ethical morphology. In: Spece RG Jr, Shimm DS, Buchanan AE, eds. Conflicts of interest in clinical practice and research. New York: Oxford University Press, 1996:12-41.
Goozner M. The $800 million pill: the truth behind the cost of new drugs. Berkeley: University of California Press, 2004.
Kassirer JP. On the take: how America's complicity with big business can endanger your health. New York: Oxford University Press, 2005.
Avorn J. Powerful medicines: the benefits, risks, and costs of prescription drugs. New York: Alfred A. Knopf, 2004.
Krimsky S. Science in the private interest: has the lure of profits corrupted biomedical research? New York: Rowman & Littlefield, 2003.
The author replies: Elias A. Zerhouni, director of the NIH, recently wrote in the Journal, "It is the responsibility of those of us involved in today's biomedical research enterprise to translate the remarkable scientific innovations we are witnessing into health gains for the nation."1 This statement underscores that the public wants results — not research for its own sake. And no matter who does the research, only industry delivers the results to the public. Entrepreneurial academic and government researchers, working with industry, have accelerated and should continue to accelerate the process.
Dr. Arbit's account of the development of insulin-replacement therapy is one example of such collaboration. But Dr. Arbit alludes to the importance of ethics, and if interactions between academia and industry have created serious ethical problems (as Drs. Brody and Miller note), we may need more ethical oversight. If, however, they have not created such problems, do we need ethics entrepreneurs to invent such problems, entrepreneurial commentators to hype them, and entrepreneurial politicians to deplore them — and then goad administrators to make rules vainly intended to prevent them? Facts can be elusive, but my article examined the empirical evidence of actual damages that can be ascribed to financial conflicts of interests in academic–industrial relationships and the balance of benefit and harm from such interactions. My conclusion was that the damages are largely speculative and that the balance is far to the good. My evidence included anecdotes always raised by critics, including those "well documented" in the books cited by Drs. Brody and Miller but never analyzed in the context of far more adverse incidents unrelated to academics' commercial interactions. "Potential harm," or what reasonable onlookers find plausible on the basis of appearances, is opinion, not fact. Emotion and ideology have enabled ethics activists, unjustifiably, to hijack the dictionary definition of conflict of interest (a conflict) and convert it into an outcome (unacceptable bias).
Nor is it factual to say that "most important medical innovations have derived from research sponsored by the ." The public sector has produced many discoveries that have resulted in products, but the NIH itself has acknowledged that the vast majority of the chemical compounds that became medicines originated in industry.2,3 More important, this dismissive view of industry's role in delivering results, continuously if imperfectly, demeans the stupendous risk and difficulty attached to that delivery.
Finally, we should ask whether the NIH director's call for more translational research is well served by his ban on corporate consulting by NIH scientists.4
Thomas P. Stossel, M.D.
Brigham and Women's Hospital
Boston, MA 02115
References
Zerhouni EA. Translational and clinical science -- time for a new vision. N Engl J Med 2005;353:1621-1623.
National Institutes of Health. NIH response to the Conference Report request for a plan to ensure taxpayers' interests are protected. July 2001:1-18. (Accessed November 22, 2005, at http://www.nih.gov/news/070101wyden.htm.)
Gortler D. The spread, and end, of life-saving drugs. Yale Daily News. October 23, 2002. (Accessed November 22, 2005, at http://www.yaledailynews.com/article.asp?AID=20297.)
National Institutes of Health. Conflict of interest information and resources. (Accessed November 22, 2005, at http://www.nih.gov/about/ethics_COI.htm.)