¹ See Shalala, Donna, Protecting Research Subjects - What Must be Done, 343 New Eng. J. Med. 808, 809-10 (2000)CrossRefGoogle Scholar.

² Drgs or Diagnosis Related Groups are the basis for Medicare Part A payments under the prospective inpatient payment system. For more information on Drgs, see Steps in Determining a PPS Payment, available at http://www.hcfa.gov/medicare/ippsover.htm (last visited Apr. 13, 2001).

³ See The Bayh-Dole Act, Pub. L. No. 96-517, 94 Stat. 3019 (codified as amended at 35 U.S.C. §§ 200-212 (1980)).

⁴ See id.

⁵ See Press, Eyel & Washburn, Jennifer, The Kept University, Atlantic Monthly, Mar. 2000Google Scholar, at 39, 41 (noting that in response to the rising competition from Japan, the 1980 Bayh-Dole Act for the first time allowed universities to patent results of federal funded research).

⁶ See Neuer, A., Academic Technology Offices Evolve into Marketing Units, Scientist, Apr 17, 1995Google Scholar, at 1, 1.

⁷ See Hans Weisendanger, A history of Otl, available at http://www.Stanford.edu/about/resources/history.html (last visited Sept. 1, 2000).

⁸ See K. M. Ludmerer, Time to Heal: American Medical Education From The Turn of The Century to The Era of Managed Care 340 (1999).

⁹ See Press & Washburn, supra note 5, at 41, 46 (discussing how patents for universities have increased from 250 a year to 4,800 a year as well as the increase in business spin off from “faculty innovations”).

¹⁰ See Weisendanger, supra note 7 (observing how the Bayh-Dole Act has significantly impacted university licensing at Stanford; for example the number of invention disclosures has since doubled).

¹¹ See Ludmerer, supra note 8, at 340.

¹² See Press & Washburn, supra note 5, at 41, 47-48.

¹³ See Press & Washburn, supra note 5, at 47 (discussing how the biotechnology industry essentially developed in university research labs); Weisendanger, supra note 7.

¹⁴ See Lee Silver, Who Owns the Human Genome?, N.Y. Times, Mar. 16, 2000, at A23 (describing the debate over the ownership of the human genome as more of a struggle for profit and control than a fight over ethics).

¹⁵ See, E.G., S. Klaidman, Saving The Heart: The Battle to Conquer Coronary Disease (2000).

¹⁶ See id.

¹⁷ See Neuer, supra note 6, at 1; Weisendanger, supra note 7.

¹⁸ See Neuer, supra note 6, at 1; Weisendanger, supra note 7.

¹⁹ See Neuer, supra note 6, at 1; Weisendanger, supra note 7.

²⁰ See Neuer, supra note 6, at 1; Weisendanger, supra note 7.

²¹ See Neuer, supra note 6, at 1; Weisendanger, supra note 7. See also Martin, Joseph B. & Kasper, Dennis L., In Whose Best Interest? Breaching the Academic-Industrial Wall, 343 New Eng. J. Med. 1646, 1649(2000)CrossRefGoogle Scholar.

²² See Thompson, Dennis F., Understanding Financial Conflicts of Interest, 329 New Eng. J. Med. 573, 573(1993)CrossRefGoogle Scholar.

²³ See Kassirer, Jerome P. & Angell, Marcia, Financial Conflicts of Interest in Biomedical Research, 329 New Eng. J. Med. 570, 571 (1993)CrossRefGoogle Scholar (considering the evolution of the Journal's conflict of interest policies).

²⁴ See infra Part VI.

²⁵ See Kurt Eichenwald & Gina Kolata, When Physicians Double as Entrepreneurs, N.Y. Times, Nov. 30, 1999, at Al (interviewing doctors that expressed this belief).

²⁶ See infra Part V.

²⁷ See, e.g., Hirsch, Martin S. et al., Antiretroviral Drug Resistance Testing in Adult HlV-1 Infection: Recommendations of an International Aids Society-USA Panel, 283 Jama 2417, 2417 (2000)CrossRefGoogle Scholar (listing the authors and their commercial associations under the heading “Financial Disclosures”); Carpenter, Charles C.J. et al., Antiretroviral Therapy for HIV Infection, 276 Jama 146, 152 (1996)CrossRefGoogle Scholar (placing the “Financial Disclosure” section at the end of the article); National Task Force on the Prevention & Treatment of Obesity, Long-Term Pharmacotherapy in the Management of Obesity, 276 Jama 1907, 1914 (1996) (describing members' financial interests in companies related to the pharmaceutical or weight loss industries).

²⁸ See Angell, Marcia, Is Academic Medicine for Sale?, 342 New Eng. J. Med. 1516, 1516 (2000)CrossRefGoogle Scholar (discussing “the extent to which academic medicine has become intertwined with the pharmaceutical and biotechnology industries” and, in particular, the increasing level of financial conflicts of interest).

²⁹ See Angell, Marcia et al., Disclosures of Authors' Conflict of Interest: A Follow-Up, 342 New Eng. J. Med. 586, 586 (2000)CrossRefGoogle Scholar (discussing failure of the journal to uphold its conflict of interest policy).

³⁰ See id.

³¹ See Keller, Martin B. et al., A Comparison of Nefazodone, the Cognitive Behavioral-Analysis System of Psychotherapy, and their Combination for the Treatment of Chronic Depression, 342 New Eng. J. Med. 1462, 1469 (2000)CrossRefGoogle Scholar.

³² See Angell, Marcia & Kassirer, Jerome P., Editorials and Conflicts of Interest, 335 New Eng. J. Med. 1055, 1055 (1996)CrossRefGoogle Scholar (reporting that the doctors, solicited by the New England Journal of Medicine to supply an opinion on pharmacotherapy for obesity, were paid consultants for companies and stood to gain from the sale of one of the anti-obesity agents studied); Matthew Kauffman & Andrew Julien, Scientists Aided Industry in Pushing Diet Drug, Medical Research: Can We Trust It?, Hartford Courant, Apr. 10, 2000, at Al (discussing the controversy surrounding scientists' affiliation with industry).

³³ See Barinaga, Marcia, Confusion on the Cutting Edge, 257 Science 616, 616 (1992)CrossRefGoogle Scholar (revealing the lack of consensus about how to handle financial conflicts and considering why disclosure may be beneficial for scientific integrity and potential investors); Wendy Hower, Few Science Journals Reveal Investment Ties, Boston Bus. J., Oct. 5, 1992, at 1, 26-27 (discussing potential conflicts of interest when scientists have a dual role in academia and industry).

³⁴ See Grady, Dennis, F.D.A. Reviews Accusations About Diabetes Drug, N.Y. Times, Mar. 16, 2000Google Scholar, at A16 (discussing information given to the FDA regarding Rezulin, a diabetes drug).

³⁵ See Eichenwald & Kolata, supra note 25, at Al (citing that a prominent cardiologist did not disclose his conflicting interests in the success of a medical device).

³⁶ See Kauffman & Julien, supra note 32, at A10 (citing that the Chairman of Anesthesia and Medicine at the University of Southern California School of Dentistry touted a dental device while neglecting to mention the potential financial awards that would accrue to him should the device succeed).

³⁷ See Dembner, Alice & Kowalczyk, Liz, Doctor Stirs Questions on Genetics' Frontier, Boston Globe, May 21, 2000Google Scholar, at Al (citing that a doctor at St. Elizabeth's Hospital had conflicting interests); see also Andrea Knox & Huntly Collins, Rival to Buy Local Biotech Pioneer Genovo, Phil. Inquirer, Aug. 10, 2000, at Al, A13.

³⁸ See Knox & Collins, supra note 37, at Al (reporting on Targeted Genetics Corp.'s acquisition of Genovo, Inc., in which the University of Pennsylvania and Biogen, Inc. of Cambridge, MA held stock).

³⁹ See id.

⁴⁰ See Kauffman & Julien, supra note 32, at Al (discussing the effect of corporate money on academic research, in particular resulting in researchers “finding” results to meet the agendas of their corporate sponsors).

⁴¹ See Dennis Cauchon, FDA Advisers Tied to Industry, USA Today, Sept. 25, 2000, at Al (offering statistics to support the claim that more than half of the experts hired to advise the FDA have financial relationships with the potentially affected pharmaceutical companies).

⁴² See Noble, Holcomb B., Hailed as a Surgeon General, Koop Criticized on Web Ethics, N.Y. Times, Sept. 5, 1999Google Scholar, at Al (discussing claims that the objectivity of the health information on Koop's web site may be tainted by his financial ties to the businesses on the site).

⁴³ See id.

⁴⁴ Kauffman & Julien, supra note 32, at A10.

⁴⁵ Id.

⁴⁶ Eichenwald & Kolata, supra note 25, at C16 (analyzing physicians' financial conflicts of interest).

⁴⁷ Kauffman & Julien, supra note 32, at A10.

⁴⁸ Id. at Al (quoting Richard Atkinson of the University of Wisconsin, a nationally known obesity expert).

⁴⁹ See Stelfox, Henry Thomas et al., Conflict of Interest in the Debate Over Calcium-Channel Antagonists, 338 New Eng. J. Med. 101, 104 (1998)CrossRefGoogle Scholar (concluding that authors who publish work in support of a drug are more likely to have financial associations with the drug's manufacturer than authors who publish critical work).

⁵⁰ See Davidson, Richard A., Source of Funding and Outcome of Clinical Trials, 1 J. Gen. Internal Med. 155, 156 (1986)CrossRefGoogle Scholar; Rochon, Paula A. et al., A Study of Manufacturer Supported Trials of Non-Steroidal Anti-Inflammatory Drugs in the Treatment of Arthritis, 154 Arch. Internal Med. 157, 162 (1994)CrossRefGoogle Scholar (finding that manufacturer-associated trials for drugs are likely to be reported as more efficacious and less toxic than reports for comparison drugs).

⁵¹ See Cho, Mildred K. & Bero, Lisa A., The Quality of Drug Studies Published in Symposium Proceedings, 124 Annals Internal Med. 485, 489 (1996)CrossRefGoogle Scholar (“[Ajrticles with drug company support are more likely than articles without drug company support to have outcomes favoring the drug of interest.”).

⁵² See Friedberg, Mark et al., Evaluation of Conflict of Interest in Economic Analyses of New Drugs Used in Oncology, 282 Jama 1453, 1455 (1999)CrossRefGoogle Scholar (finding “that pharmaceutical company sponsorship of economic analyses is associated with reduced likelihood of reporting unfavorable results”).

⁵³ See Chen, Mary-Margaret & Landesfeld, C. Seth, Physicians' Behavior and Their Interactions With Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary, 271 Jama 684, 688 (1994)Google Scholar (finding a strong correlation between physician's contact with drug companies and physician requests to add drugs to the hospital formulary).

⁵⁴ See Bodenheimer, Thomas, Uneasy Alliance: Clinical Investigators and the Pharmaceutical Industry, 342 New Eng. J. Med. 1539, 1543 (2000)CrossRefGoogle Scholar (discussing the impact of financial incentives on drug studies and publications). See generally Bero, Lisa A. & Rennie, Drummond, Influences on the Quality of Published Drug Studies, 12 Int'L J. Tech. Assess. Health Care 209 (1996)CrossRefGoogle Scholar (studying the effects of different financial incentives on drug trials).

⁵⁵ See Bodenheimer, supra note 54, at 1539 (arguing that industry funded research is easily manipulated according to the industry's needs); see also Blumenthal, David et al., Participation of Life-Science Faculty in Research Relationships with Industry, 335 New Eng. J. Med. 1734, 1734 (1996)CrossRefGoogle Scholar (reporting on a study concluding that university clinical faculty with industry-supported research are more likely to withhold results from colleagues and less likely to be academically productive); Buderi, Robert, Universities Buy Into the Patent Chase, Scientist, Dec 12, 1988Google Scholar, at 1, 5 (arguing that commercialization will lead to ethical dilemmas).

⁵⁶ See Klaidman, supra note 15.

⁵⁷ See Blumenthal, David et al., Relationships Between Academic Institutions and Industry - An Industry Survey, 334 New Eng. J. Med. 368, 371 (1996)CrossRefGoogle Scholar (reporting that academic institutions are often required to protect confidential information during the time it is necessary to file a patent application); see also Press & Washburn, supra note 5, at 41-42 (discussing companies' desire for confidentiality and delay in publication of their research results).

⁵⁸ See Press & Washburn, supra note 5, at 42 (discussing “the possibility that behind closed doors some corporate sponsors are manipulating manuscripts before publication to serve their public interests”).

⁵⁹ See Klaidman, supra note 15.

⁶⁰ See Press & Washburn, supra note 5, at 51-52 (discussing examples where some programs such as humanities were cut while sciences flourished).

⁶¹ See Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, 64 Fed. Reg. 72,090, 72,093 (Dec. 23, 1999). See also Eugene Russo, Regulating Researchers' 'Picks and Shovels': Scientists Continue to Review NIH Research Tool Guidelines, Scientist, May 1, 2000, at 8, 8 (noting that some are fearful that guidelines could become too restrictive on research); Gina Shaw, Does the Gene Patenting Stampede Threaten Science?, AAMC Reporter, Feb. 2000, at 8, 8 (describing the effect of licensing and patenting on research).

⁶² See Angell, supra note 28, at 1517 (describing financial ties between pharmaceutical companies and researchers); Kassirer, Jerome P., Financial Indigestion, 284 Jama 2156, 2157 (2000)Google Scholar (discussing how pharmaceutical company-sponsored events create a sense of entitlement in students and young physicians).

⁶³ See Angell, supra note 28, at 1516 (describing free gifts and favors given to medical students and house officers by pharmaceutical companies); Kassirer, supra note 62, at 2156 (discussing how even a free lunch can effect a doctor's prescribing habits); see also Rothman, David J., Medical Professionalism—Focusing on the Real Issues, 342 New Eng. J. Med. 1284, 1285 (2000)CrossRefGoogle Scholar (stating that gifts from pharmaceutical companies influence prescribing practices); Waud, Douglas R., Pharmaceutical Promotions—A Free Lunch, 327 New Eng. J. Med. 351, 352 (1992)CrossRefGoogle Scholar (stating that even a minor gift can turn a doctor into a drug advertiser).

⁶⁴ See Kassirer, supra note 62, at 2157 (discussing how students develop a sense of entitlement toward pharmaceutical companies through company-sponsored events, such as dinners); Rothman, supra note 63, at 1286 (stating that the relationship between drug companies and physicians is inconsistent with professionalism).

⁶⁵ See Rothman, Kenneth J., Conflict of Interest: The New McCarthyism in Science, 269 Jama 2782, 2783 (1993)CrossRefGoogle Scholar; Eichenwald & Kolata, supra note 25, at Al.

⁶⁶ See Rothman, supra note 65, at 2783.

⁶⁷ See id. at 2783-84.

⁶⁸ See, e.g., Angell, supra note 28, at 1518.

⁶⁹ See id.

⁷⁰ See id.

⁷¹ See id.

⁷² See Thompson, supra note 22, at 575; see also Rodwin, Mark A., Physicians' Conflicts of Interest: The limitations of Disclosure, 321 New Eng. J. Med. 1405, 1405-06 (1989)CrossRefGoogle Scholar (examining disclosure policies in several disciplines, including medical informed consent).

⁷³ See Thompson, supra note 22, at 574.

⁷⁴ See id. at 575.

⁷⁵ See Trudy Lieberman, You Can't Report What You Don't Pursue, Columbia Journalism Review, available at http://www.cjr.Org/year/00/2/lieberman.asp (last visited Apr. 20, 2001) (discussing editors' motivations for exercising self-censorship, including financial conflicts of interest).

⁷⁶ See id.

⁷⁷ See id.

⁷⁸ Editorial, The Wellspring of Lobby Reform, N.Y. Times, May 7, 1993, at A30.

⁷⁹ See Abner Mikva, The Wooing of Our Judges, N.Y. Times, Aug 28, 2000, at A17.

⁸⁰ See Jerome P. Kassirer, Pseudoaccountability, 134 Annals Internal Med. 587-90 (2001).

⁸¹ See Press & Washburn, supra note 5, at 45 (discussing steps taken by the federal government to help avoid conflicts of interest).

⁸² See id.

⁸³ See generally Jeffrey Brainard, The Ties that Blind?, Chron. Higher Educ, Sept. 8, 2000, at A31 (noting that Johns Hopkins and Harvard University have especially strict policies); Cho, Mildred K. et al., Policies on Faculty Conflicts of Interests at US Universities, 284 Jama 2203 (2000)CrossRefGoogle Scholar (noting that there are wide varieties in conflict of interest rules between institutions); Lo, Bernard et al., Conflict-of-interest Policies for Investigators in Clinical Trials, 343 New Eng. J. Med. 1616 (2000)CrossRefGoogle Scholar (studying the policies of the ten medical schools which receive the greatest funding from the NIH); Van McCrary, S. et al., A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research, 343 New Eng. J. Med. 1621 (2000)CrossRefGoogle Scholar (studying the various regulations that research institutions and journals impose upon their contributing authors).

⁸⁴ See J. J. Cohen, Trust Us to Make a Difference, Presidential Address to the Association of American Medical Colleges (Nov. 2000), available at http://www.aamc.org/newsroom/speeches/00amspee.htm (last visited Mar. 30, 2001) (discussing financial conflicts of interest).

⁸⁵ See Kassirer, supra note 80, at 587-90.

⁸⁶ See Vida Foubister, Gene Therapy Group Adopts Stringent Rules on Financial Ties, American Medical News (May 8, 2000), available at http://www.ama-assn.org/scipubs/amenws/pick_00/prbs0508.htm (last visited Mar. 30, 2001) (discussing how the American Society of Gene Therapy has a policy where scientists cannot have direct contact with a patient in a trial in which they have an investment).

⁸⁷ See Rothman, supra note 63, at 1285 (proposing that the medical profession should encourage disclosing conflicts of interest and managed-care companies' abuses while protecting those within the profession who do disclose).

⁸⁸ See Kassirer, supra note 62, at 2156 (noting that during his visits “to academic hospitals, [the author] encountered many departures that not only allow the companies to bring food in, but actually encourage them to do so”).

⁸⁹ See id. (describing how a house officer “saw nothing wrong with accepting gifts, … especially expensive textbooks that he could not afford”).

⁹⁰ See Angell, supra note 28, at 1518 (arguing that teaching hospitals should not tolerate on-site promotions by drug company representatives); Rothman, supra note 63, at 1286 (asserting that “[m]edical schools should adopt formal rules that prohibit all gifts from drug companies to students, whether books, stethoscopes, or meals”); Waud, supra note 63, at 353 (suggesting that “we simply not be on the take, whatever the amount or context”).

⁹¹ See Ludmerer, supra note 8, at 340.