Malinowski, Michael J.

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Louisiana State University Law Center LSU Law Digital Commons Journal Articles Faculty Scholarship 2001 Foreword: Academic-Industry Collaborations in the Clinic Michael J. Malinowski Louisiana State University Law Center, mjmalin@lsu.edu Follow this and additional works at: https://digitalcommons.law.lsu.edu/faculty_scholarship  Part of the Law Commons Repository Citation Malinowski, Michael J., "Foreword: Academic-Industry Collaborations in the Clinic" (2001). Journal Articles. 357. https://digitalcommons.law.lsu.edu/faculty_scholarship/357 This Article is brought to you for free and open access by the Faculty Scholarship at LSU Law Digital Commons. It has been accepted for inclusion in Journal Articles by an authorized administrator of LSU Law Digital Commons. For more information, please contact kreed25@lsu.edu. FOREWORD: ACADEMIC-INDUSTRY COLLABORATIONS IN THE CLINIC The "genetics revolution" has reached the clinic.1 Consequentially, clinical research has been infused with unprecedented innovation and potential for improving human health. 2 However, the maturation of contemporary biomedical research also has advanced an entanglement of ethical and regulatory complications associated with intense academic-industry collaboration, competition, and commercialization.3 Critics and many concerned participants claim that the life science communities and policy makers have launched this genetic revolution in science, and brought research into an era of academic­industry alliances, without first establishing sufficient safeguards to ensure the protection of human subjects and the integrity of research. 4 �In response to this concern and related controversies which have captured media attention,5 the 1. For identification of the drug development pipeline, see http:/ /www.phrma.org (last visited Aug. 23, 2001) (site of the Pharmaceutical Researchers and Manufacturers of America (PhRMA), the world's leading phannaceutical trade organization); http:/ /www.bio.org (last visited Aug. 23, 2001) (site of the Biotechnology Industry Organization (BIO), the world's leading biotechnology i ndustry trade organization); http:/ /www.clinicaltrials.gov (last visited Aug. 23, 2001) (details on approximately 5,SOO mostly government-funded clinical trials); http://cancertrials. nci.n ih.gov (last visited Aug. 23, 2001) (the National Cancer lnstitute's clinical trial li.�ting); http:/ /www.actis.org (last visited Aug. 23, 2001) (the AIDS clinical trial information service (ACTIS)); http:/ /www.centeiwatch.com (last visited Aug. 23, 2001) (one of the earliest and the most comprehensive private sites); http://www.emergingrned.com (last visited Aug. 23, 2001) (privately-funded cancer trials; under expansion to cover other diseases); http://www. veritasrnedicine.com Oast visited Aug. 23, 2001) (list� trials and standard treatments for numerous diseases); http:/ /www.americasdoctor.com (last visited Aug. 23, 2001) (trials in various disease categories, excluding cancer); and http:/ /www.acurian.com Qast visited Aug. 23, 2001) (developing lists of trials in numerous disease categories). 2. S tt generai!J JlljJra note 1. 3. S tt Press Release, Department of Health and Hum an Services, Secretary Shalala Bolsters Protections for Human Research Subjects (May 23, 2000) [hereinafter DHHS Press Release], avai/ab/eathttp://www.hhs.gov/news/press/2000pres/20000523.htrnl. Seea/soElizabethA.Boyd & Lisa A. Bero, Am;.sing F1Jt11/Jy Financial &latiomhips With Indmtry: A Cast St11tfy, 284 JAMA 2209 (2000); Mildred K. Cho et al., Po/icie; on Faat/!y Conjlim of lnttml at US Uniwr.sititJ, 284 JAMA 2203 (2000); Catherine D. DeAngelis, Conflid oflntemt and the P11b/i, Tf'llJI, 284 JAMA 2237 (2000). See gentral!J David Korn, Conjli&/; of Intm;t in Bio111 di&al RJJtarrh, 284 JAMA 2234 (2000). 4. See, 1.g., DHHS Press Release, JlljJranote 3 (addressing the need to bolster protections for human subjects); Donna Shalala, Prottding &semrh S11Uj1as-What M11st Bt Drm, 343 NEW ENG. J. MED. 808 (2000). , S. The incident which has captured the most attention is the circumstances surrounding the death of Jesse Gelsinger, an 18-year-old gene-therapy subject in a protocol approved by the University of Pe nnsylvania. Stt Gelsinger v. Trustees of the Univ. of Pa., Case No. 000901885 (Ct. Corn. Pl., Phila. County, filed Sept. 18, 2000), athttp://www.ssluplaw.com/ l.inks/healthcare2.html -ii-United States (including the government, industry, and academia sectors), is reassessing the soundness of its regulatory regimes to protect human subjects and research integrity.6 Consequentially, fundamental reform is being contemplated in t he midst of an extraordinary amount of important, ongoing clinical research.7 On March 15, 2001, approximately 200 representatives from the biomedical industry, the medical conununity, government agencies, and multiple disciplines in academia gathered at the Widener University School of Law's Delaware campus to advance critical thinking about this pressing topic. This effort was a shared undertaking by the Widener Lzw SympoJium Journal and the Widener Health Law Institute in cooperation with the American Bar Association, Delaware Bar A ssociation, Pennsylvania Bar Association, Pennsylvania Biotechnology A ssociation, and with the financial sponsorship of Centocor, Inc. and Eckert Seamans Cherin & Mellott, LLC. The primary objective of the conference was to bridge legal academia with the life science and medical communities and to create a forum that could make a meaningful "real world" contribution through pragmatic discussion and by raising awareness. This issue of the Widener Law Sympoti11111 ]o111'11al contains a collection of written contributions originating from and complementing the livdy and informative conference proceedings. Oast visited Aug. 23, 2001); Thomas Petzinger Jr., Yes, Ttch11oloo S1t1111 to Cho11ge Almost Dai!J. B11t Some T mulr are Lllu!y Jo Remain in Force far 11 Ltmg Time, WAIL ST. J., Jan. 1, 2000, at R 12. 6. The Department of Health & Human Services (DHHS), Office of the Secretary, hosted a forum on August 15-16, 2000, entitled "Human Subject Protection and Financial Conflict of Interest." This forum also was sponsored by the National Institutes of Health (NIH), Centers for Disease Control (CDC), and Food & Drug Administration (FDA). Sn Agenda. Human Subject Protection and Financial Conflicts of Interest Conference (Aug. 15, 2000), at http:/ I ohrp.osophs.dhhs.gov I coif a genda. httn. Subsequently, NIH undertook "visits" to recipient institutions throughout the country to see first-hand how they a.re dealing with conflicts of interest. See Patrick Healy, Ht1n1ard For11111 Eye.r Ovmight of BiometliMI &.r1arrh, BoSTON GLOBE, July 21, 2000, at A 13. More signjficantly, the FDA issued guidance to assist industry in dealing with potential conflicts of interests. FOOD & DRUG ADMJN., DEPT HEALrn & HUMAN SERVS., GUIDANCE FOR INDUSTRY: FINANCfAL DISCLOSURE BY CLINICAL INVESTIGATOR S (2001), 11/ http:/Iwww.fda.gov/ oc/ guidance/ financialdis.html (last visited Sept. 4, 2001). Along these same lines, representatives from several of the nation's top medical schools (Harvard, Baylor College of Medicine, Columbia University, Johns Hopkins University, the University of Pennsylvania, the Uni versity of Washington, Washington University, Yale University, and the University of California at San Francisco and Los Angeles) have jointly drafted proposed conflict of interest guidelines that require researchers to disclose any financial interests they have in studies involving patients. Ste Carey Goldberg, Medical School! Offer Ralls 011 Doctors' Co11flid of I 11tm.1t, N.Y. TIMES, Feb. 8, 2001, at A23. Several Professional Societies, including the American Society of Human Genetics, have done the same. s tt AMER. Soc'y OF GENE THERAPY (ASG1), POLICY OF THE AMERICAN SOCIETY OF GENE THERAPY ON FINANCIAL CONFLICT OF INTEREST IN CLINICAL REsEARCH (2000), at http://www.asgt.org/policy/index.html (last visited Sept. 4, 2001). 7. See general!J supra note 1. -w-The issue begins with two overview pieces. First, in Financial Conflicts of Interest: How are we Managing?,8 Erica Rose surveys a multitude of fundamental issues introduced by financial conflicts of interest, including how conflicts of interest arise and attempts to identify and manage them. Second, in Globalization of Interests and Clinical R.esearch: An Overview of Trends and Issues,9 Timothy Caulfield surveys the trends of globalization and commercialization in clinical research relating to the issue of conflicts of interest. Caulfield sets forth several proposals, including the need to create research policy and Institutional Review Board structures to minimize conflicts and reduce the threat of forum shopping introduced by globalization.111 The next four contributions focus on the roles and obligations of institutions, individual researchers, and involved physicians. In Institutional Conflicts and R.e.rponsibilities in an Age of Academic-Industry Alliances, 11 I focus on the impact of biotechnology and the genetics revolution on clinical research and the resulting issue of institutional conflicts of interest. I conclude that the issue of conflicts of interest transcends, and requires reforms to, the regulatory regimes for both technology transfer and human subject protections.12 I introduce several proposals for reform, the foremost being to write uniform, workable, and enforceable federal conflicts of interest standards directly into federal technology transfer policy.13 Pilar Ossorio and Janet Aeetwood address the roles and responsibilities of clinical researchers. Ossorio's contribution, entitled Pills, Bills and Shills: Physician­R.esearcher's Conflicts of Interest, is a primer on research, emphasizing the multi­faceted nature and, consequentially, the varied roles of, and influences upon, physician-researchers.14 Ossorio offers suggestions to minimize and manage conflicts of interest, including the involvement of third parties in the consent process 15 and institutional policies for professional advancement which prioritize research quality over quantity. 16 Ossorio emphasizes the importance of disclosure and institutional oversight.17 8. Erica Rose, Fina11aa/Conjlkts ojltrltmt: How an"" Managing?, 8 WIDENER L. SYMP. J. 1 (2001). 9. Timothy Caulfield, G�baliz.atio11 of Itrltmls and Cliniwl Rnearch: An Overview ofT rends and Imm, 8 WIDENER L. SYMP. J. 31 (2001). 10. Stt id 11. Michael J. Malinowski, Institlllional Conflitis and RupotrnbilititS in an Agt of Acadmric-lndNstry Alliatrtts, 8 WIDENER L. SYMP. J. 47 (2001). 12. Su id 13. Stt id at 69-70. 14. Pilar N. Ossorio, Pills, Bills and Shi/J.r: Pl!Jsidan-&starchtr's Conflicts of Intmsl, 8 WIDENER L. SYMP. J. 75 (2001). 15. Sttid at96-97. 16. Id. at 97. 17. Id at 100. -1V-In Conflicts of Interest in Clinical &search: Advocating/or Patient-Subjects, Janet Fleetwood focuses on the doctor-patient relationship and the obligations to patient-subjects. Fleetwood attributes the ongoing nature of the conflicts of interest problem to three major factors: complications to the consent process attributable to the doctor-patient relationship, lack of sufficient subject-patient knowledge, and inadequate ongoing oversight by IRBs.18 She concludes that conflict of interest policies have done little to inform or protect patients.19 The series of symposium articles concludes with a comprehensive treatment by Patricia Kuszler, entitled Curing Conflicts of Interest in Clinical &search: Impossible Dreams and Harsh Realities. 20 Kuszler surveys a broad range of conflicts issues, financial and non-financial, in basic research and the delivery of care as well as in clinical research. Kuszler concludes tha� "conflicts of interest, both financial and non-financial are now deeply embedded in the fabric of biomedical research"21 and, consequentially, "the traditional boundaries and values differential between the market and the ivory tower of academia are blurred, if not completely obliterated."22 In addition to these pieces originating from the conference proceedings, this issue includes a book review by William Charles Lucas of Cynthia Robbins­Roth's book, FROM ALCHEMY TO !PO: THE BUSINESS OF BIOTECHNOWGY. 2' In reviewing FROM ALCHEMY TO IPO, 24 a best-selling "industry insider's" account of the biotechnology sector, Lucas draws heavily from his own experience as the Vice President and Associate General Counsel of Pharmacia and former Vice President and General Counsel of Zeneca Pharmaceuticals. Lucas concludes that "the book ... provide[s] the potential investor with a helpful compendiwn of due diligence concerns and enough background to begin to understand this very complex industry."25 Michael J. Malinowski Faculty Chair 18. Janet Fleetwood, Conflict1 of Inteml in Clinical &mmh: Advocating far Politnt-S11ijec/1, 8 WIDENER L. SYMP. J. 105, 105-06 (2001 ). 19. Seeitl at 106. 20. Patricia C. Kuszler, CmingConjlicuoflntemtin Clinical&mmh: Impouible Drran11 and Harsh Reolitie1, 8 WIDENER L. SYMP. J. 115 (2001). 21. Id at 152. 22. Id 23. William Charles Lucas, From Alchemy to IPO: The B11sint11 ofBiot1&hnology, 8 WIDENER L. SYMP. J. 153 (2001) (book review). 24. CYNTHIA ROBBINS-ROTH, FROM ALCHEMY TO IPO (2000). 25. See Lucas, sttpra note 23, at 155. -v-

Foreword: Academic-Industry Collaborations in the Clinic

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Foreword: Academic-Industry Collaborations in the Clinic

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