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Scrutinizing Industry-Funded Science: the Crusade Against Conflicts of Interest

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Scrutinizing Industry-Funded Science: the Crusade Against Conflicts of Interest Scrutinizing Industry-Funded Science: The Crusade Against Conflicts of Interest By Ronald Bailey March 2008 AMERICAN COUNCIL ON SCIENCE AND HEALTH 1995 Broadway, 2nd Floor, New York, NY 10023-5860 Tel. (212) 362-7044 • Toll Free (866) 905-2694 • Fax (212) 362-4919 URLs: http://www.acsh.org • http://www.HealthFactsFears.com E-mail: [email protected] The American Council on Science and Health gratefully acknowledges the comments and contributions of the following individuals, who reviewed this publication. Robert L. Brent, M.D., Ph.D. Thomas R. DeGregori, Ph.D. A.I. duPont Hospital for Children Department of Economics Thomas Jefferson University University of Houston George E. Ehrlich, M.D., MACR, FACP, Ruth Kava, Ph.D., R.D. FRCP Director of Nutrition University of Pennsylvania School of American Council on Science and Health Medicine New York University School of Medicine Gilbert L. Ross, M.D. Executive and Medical Director Shayne C. Gad, Ph.D., DABT, ATS American Council on Science and Health Gad Consulting Services Past Pres., American College of Thomas P. Stossel, M.D. Toxicology Brigham & Women’s Hospital Harvard Medical School Arthur Caplan, Ph.D. Center for Bioethics University of Pennsylvania ACSH accepts unrestricted grants on the condition that it is solely responsible for the conduct of its research and the dissemination of its work to the public. The organization does not perform proprietary research, nor does it accept support from individual corporations for specific research projects. All contributions to ACSH—a publicly funded organization under Section 501(c)(3) of the Internal Revenue Code—are tax deductible. Individual copies of this report are available at a cost of $5.00. Reduced prices for 10 or more copies are available upon request. Copyright © 2008 by American Council on Science and Health, Inc. This book may not be reproduced in whole or in part, by mimeograph or any other means, without permission. TABLE OF CONTENTS Executive Summary -------------------------------------------------------------------------------- 4 Introduction ------------------------------------------------------------------------------------------ 5 Scenes from the Conflicts of Interest Campaign ----------------------------------------------- 8 Brief History of Funding of Scientific Research --------------------------------------------- 10 The Conflict of Interest Campaign Begins ---------------------------------------------------- 12 Conflict of Interest Defined --------------------------------------------------------------------- 13 Industry Bias --------------------------------------------------------------------------------------- 18 1998 Calcium Channel Blocker COI Study --------------------------------------------------- 18 The 2003 JAMA Study --------------------------------------------------------------------------- 19 Skewing the Scientific Literature --------------------------------------------------------------- 21 Disclosure ------------------------------------------------------------------------------------------ 21 Industrial Disinformation—The Tobacco Institute ------------------------------------------- 23 The Problem of Epidemiology ------------------------------------------------------------------ 23 Federal Scientific Advice ------------------------------------------------------------------------ 26 The Food and Drug Administration ------------------------------------------------------------ 27 The National Academies ------------------------------------------------------------------------- 32 The Environmental Protection Agency -------------------------------------------------------- 33 Effect of Regulatory Agency Support on Research Results -------------------------------- 37 The National Institutes of Health --------------------------------------------------------------- 38 Not Much Evidence that Industry/Academic Cooperation Has Undermined Biomedical Research -------------------------------------------------------------------------------------------- 40 Public Trust ---------------------------------------------------------------------------------------- 40 Patient Safety -------------------------------------------------------------------------------------- 41 Cost of Medical Care ----------------------------------------------------------------------------- 42 How Ethical Are Researchers Who Have No Commercial Ties? -------------------------- 44 Peer Review and Disclosure --------------------------------------------------------------------- 45 Register All Trials --------------------------------------------------------------------------------- 47 Conclusion ----------------------------------------------------------------------------------------- 49 Appendix: The Canonical Conflict of Interest Cases ---------------------------------------- 51 About the Author/Disclosure -------------------------------------------------------------------- 56 References ----------------------------------------------------------------------------------------- 58 Executive Summary For approximately a century, industry has been a powerful motivating force in the cre- ation of new technology and the underwriting of scientific research. Yet the last two decades have seen the development of a sweeping conflicts of interest movement aimed squarely at curtailing academic/industry biomedical research collaborations and restrict- ing membership on government scientific advisory boards to researchers associated with industry. Conflicts of interest activists assert that ties between researchers and industry are harm- ing patients and consumers, undermining public trust in research, food safety and envi- ronmental regulation and boosting the costs of medicine and other products. As evi- dence, they repeatedly point to the same handful of research “scandals” and have pro- duced a number of studies correlating industry sponsorship with favorable results in clin- ical research. In addition, the anti-industry activist groups are trying to exclude academic researchers who have any ties whatsoever to industry from government scientific adviso- ry boards. However, even the activists’ own flawed studies can’t demonstrate that indus- try “influence” is distorting the decisions made by those boards. The campaign to purge any experts with industry ties—no matter how slender—from advisory panels is chilling scientific debate and depriving regulators and the public of valuable insights. These conflicts of interest activists focus almost entirely on the alleged baleful effects of financial conflicts of interest while ignoring how other conflicts can bias scientific research and advice to government agencies. People are influenced by all sorts of inter- ests besides money. Why should having once consulted with Pfizer or DuPont disqualify a scientist from serving on a government advisory board or writing a review article in a scientific journal, while being a lifelong member of Greenpeace does not? And if owning $10,000 in Dow stock represents a potential conflict of interest, surely $10,000 in fund- ing from the Union of Concerned Scientists does too. Contrary to the claims of conflicts of interest activists, the overwhelming majority of patients and research subjects are not being harmed, public trust in scientists and scien- tific research remains extremely high, and new drugs not only save lives but money. CenterWatch, which tracks 59,000 clinical trials in the United States, found that indus- try-sponsored drug trials are in fact safer than those at academic institutions funded by government. Polls regularly show that physicians and scientists are two of the most trust- ed professions. In fact, a recent poll found that three-quarters of cancer patients would have no qualms about enrolling in a study of a treatment sponsored by a company in which a researcher owns stock or from which he/she receives royalties. And finally, econometric research shows that newer drugs, rather than increasing overall medical costs (and thus arguably being foisted in a fraudulent fashion on a cash-strapped public), reduce other medical expenses by a factor of five.1 4 The current obsession with conflicts of interest is not harmless. The activists have pro- voked the development of unnecessary and complex academic regulations and restric- tions that are interfering with the speedy translation of scientific discoveries into effec- tive treatments and new products and technologies. Instead of improving public health or making our environment safer and cleaner, the activities of conflict of interest activists are harming them. Researchers are abandoning universities and some are even leaving the country for locales in which academic-industry collaboration is encouraged rather than denigrated and penalized. Government agencies are being denied access to sound scientific advice, which distorts regulatory priorities, risks lives and raises costs. When abuses have been uncovered, private entities including journals, universities and scientific professional societies have adequately addressed them. Such private solutions include the advent of permanent online peer-review of scientific studies and the require- ment by scientific journals that all clinical trials be registered. These private efforts are undercutting the campaign by activists to have Congress enact onerous conflicts of inter- est regulations. The plain fact of the matter is that there is very little evidence that alleged conflicts of interests are significantly distorting scientific research, harming consumers and
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