Confronting conflict: Addressing institutional conflicts of interest in academic medical centers

American Journal of Law and Medicine

Volumn 36, Issue 1, 2010, Pages 136-187

  Liang, Bryan A ^a,b   Mackey, Tim ^a  

^a CALIFORNIA WESTERN SCHOOL OF LAW   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONFLICT OF INTEREST; DRUG INDUSTRY; ETHICS; HUMAN; LEGAL ASPECT; MEDICAL RESEARCH; POLICY; PRACTICE GUIDELINE; PUBLIC RELATIONS; STANDARD; UNITED STATES; UNIVERSITY HOSPITAL;

ACADEMIC MEDICAL CENTERS; BIOMEDICAL RESEARCH; CONFLICT OF INTEREST; DRUG INDUSTRY; ETHICAL REVIEW; GUIDELINES AS TOPIC; HUMANS; INTERINSTITUTIONAL RELATIONS; PUBLIC POLICY; UNITED STATES;

EID: 77953642827     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885881003600103     Document Type: Article

References (322)

1. Individual conflicts of interest in the health care setting are rife, where "physicians are tempted to deviate or do deviate from their professional obligations for economic or other personal gain. " Troyen A. Brennan et al., Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers, 295 JAMA 429, 430 (2006);
2. see also Niteesha K. Choudhry et al., Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry, 287 JAMA 612, 615 (2002) (up to 59% of physician authors of clinical practice guidelines had financial relationships with drug companies).
3. Note that pharmaceutical companies have a completely different, and legitimate, focus. Pharmaceutical manufacturers engage in research and development of drugs that can benefit patients and at the same time attempt to make products that are economically viable for the purposes of profit. See Brennan, supra note 1, at 429. While there are clearly patient benefits that result from industry efforts, their ultimate fiduciary duty is to bring value to their shareholders through profit-maximizing behavior. This distinction often directly conflicts with the needs and welfare of the patient.
4. See id. This reifies the need for AMCs to manage conflicts of interest.
5. These conflicts pose significant challenges to patient care by imposing competing, nonmedical interests in clinical decision making. The root cause of the majority of conflicts of interest is the direct relationships between physicians and the pharmaceutical industry. See id.
6. With a recent survey showing that 94% of physicians reported some type of relationship with the pharmaceutical industry, it is clear that industry interactions are commonplace with physicians. Eric G. Campbell et al., A National Survey of Physician-Industry Relationships, 356 NEW ENG. J. MED. 1742, 1746 (2007);
7. see also Kamran Abbasi & Richard Smith, No More Free Lunches: Patients Will Benefit From Doctors and Drug Companies Disentangling, 326 BRIT. MED. J. 1155 (2003) (reporting similar data). The primary public policy issue that emerges from this data is whether the marketing and promotional efforts that create these conflicts of interest lead to negative outcomes in provider prescribing habits and in decisions regarding patient care. This is not a new question. as early as the late 1950s, when the late Senator Estes Kefauver expressed concerns regarding predatory pricing, excessive markups in costs and pricing due to large expenditures in marketing, and questionable effectiveness of new drugs compared to more established drugs, today's echoing of these identical issues has resulted in growing scrutiny of the practice of pharmaceutical marketing to physicians.
8. See Marc-Andre Gagnon & Joel Lexchin, The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotional Expenditures in the United States, 5 PLOS MED. 29, 29 (2008).
9. See Bryan A. Liang, Crisis on Campus: Student Access to Health Care, 43 (3) U. MICH. J. L. REFORM (forthcoming 2010);
10. U. S. GOVERNMENT ACCOUNTABILITY OFFICE, FEDERAL FAMILY EDUCATION LOAN PROGRAM: INCREASED DEPARTMENT OF EDUCATION OVERSIGHT OF LENDER AND SCHOOL ACTIVITIES NEEDED TO HELP ENSURE PROGRAM COMPLIANCE (2001), available at http://www.gao.gov/new.items/d07750.pdf;
11. Associated Press, College Loan Scandal 'Like Peeling an Onion, ', MSNBC, April 10, 2007, http://www.msnbc.msn.com/id/l8040824.
12. See Justin E. Bekelman et al., Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review, 289 JAMA 454, 463 (2003).
13. th of U. S. medical schools improved their conflict-of-interest rules in a one year period. However, in the second year of the project 17 institutions (11%) received "D" grades and 35 (13%) received "F" grades. See Press Release, Pew Prescription Project, Med. Students, Pew Prescription Project Find Improvements in Med. School Pharmaceutical Conflict-ofinterest Policies, but Many Lag (June 16, 2009) available at http://www.prescriptionproject.org/ news/pressreleases?id=0023.
14. AMSA Pharm Free Scorecard methodology includes a rating system on policy domains focusing on individual conflicts of interest. The scorecard does not assess AMC policies on equity arrangements, intellectual property transfer programs, or board participation in lieu of potential conflicts of interest. See AMSA, AMSA PharmFree Scorecard 2009: Methodology, http://www.amsascorecard.org/ methodology (last visited December 24, 2009).
15. On the individual level, hidden effects include negative results from the interactions between physicians and the pharmaceutical industry. See infra text accompanying note 40. Studies show that physicians requesting additions to drug formularies are more likely to have accepted free meals and travel, and that the rate of specific drug prescribing increases after detailing (i.e., sales visits and promotional activities conducted by pharmaceutical sales representatives directly to physicians, acceptance of samples, and attendance at industry sponsored symposia).
16. See Puneet Manchanda & Elisabeth Honka, The Effects and Role of Direct-to-Physician Marketing in the Pharmaceutical Industry: An Integrative Review, 5 YALE J. HEALTH POL'Y, LAW & ETHICS 785, 786-87 (2005). The pharmaceutical industry is heavily invested in pharmaceutical detailing, with the majority of its vast marketing expenditures going towards these activities through legions of sales representatives.
17. See Brennan, supra note 1, at 431;
18. see also Michael A. Steinman et al., Characteristics and Impact of Drug Detailing for Gabapentin, 4 PLOS MED. 743, 747 (2007) (pharmaceutical industry also utilizes sophisticated marketing techniques that allow for tracking of prescribing habits, delivery of tailored marketing messages, and customization of content when visiting with a physician to achieve maximum influence). Unfortunately, physicians have come to rely on the association of gifts with medical education. While the pharmaceutical industry may argue that these forms of promotion help educate physicians and allow them to make better and more informed decisions for their patients, studies show that attendance at educational events would decline if it were not for gifts and meals.
19. See Ashley Wazana, Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?, 283 JAMA 373, 375 (2000). Studies have also shown that physicians remain skeptical of the motives of pharmaceutical companies in these interactions, yet changes in prescribing habits and professional behavior can still be correlated with these kinds of promotion.
20. See id. at 378. However, physicians show little concern about the influence of marketing activities on their own practice of medicine in comparison to the practice of other physicians, creating a dangerous combination of ambivalence.
21. See id. A common misguided assumption is that gifts of small value do not influence physician behavior.
22. See Brennan, supra note 1, at 430. However, social science research has assessed these corporate strategies and come to the conclusion that even gifts of small value can affect physician prescribing habits.
23. See id. These beliefs may manifest themselves in inappropriate management of ICOIs for the decision maker's own institution.
24. See David J. Rothman, Academic Medical Centers and Financial Conflicts of Interest, 199 JAMA 695, 696 (2008).
25. See Leslie E. Wolf & Bernard Lo, Ethical Issues in Clinical Research: An Issue for All Internists, 109 Am. J. Med. 82, 82 (2000).
26. See Sheryl G. Stolberg, The Biotech Death of Jesse Gelsinger, N. Y. TIMES (Magazine), Nov. 28, 1999, § 6, at 137.
27. See Wolf, supra note 11, at 82.
28. See Stolberg, supra note 12, at 137.
29. See id.
30. See id.
31. See id.
32. See Tom Hollon, Researchers and Regulators Reflect on First Gene Therapy Death, 6 NATURE MED. 6, 6 (2000). (Pubitemid 30048499)
33. Id.
34. See Sheryl Stolberg, A Death Puts Gene Therapy Under Increasing Scrutiny, N. Y. Times, Nov. 4, 1999, at A24.
35. See Stolberg, supra note 12, at 137.
36. See Wolf & Lo, supra note 11, at 83.
37. See Sheryl Stolberg, F. DA. Officials Fault Penn Team in Gene Therapy Death, N. Y. Times, Dec. 9, 1999, at A22.
38. Id.
39. Id.
40. See Julian Savulescu, Editorial, Harm, Ethics Committees and the Gene Therapy Death, 27 J. MED. ETHICS 148, 148 (2001).
41. See Penn Settles Suit on Genetic Test, N. Y. TIMES, NOV. 4, 2000, at A18.
42. See Press Release, Department of Justice, U. S. Settles Case of Gene Therapy Study that Ended with Teen's Death, at 1-2 (Feb. 9, 2005), available at http://www.durrelllaw.com/UofPSettlementReleaseFinal.pdf. Note that the National Institutes of Health ("NIH") has had its own challenges in addressing ICOIs. NIH acts as the steward of billions of dollars of federal grants for funding of research in the US.
43. See National Institutes of Health Website, About NIH, http://www.nih.gOv/about/mission (last visited July 11, 2009) (reporting $30.6 billion in grant monies in FY 2009 Budget). This responsibility requires that NIH employees and its policies be held to the highest standards to ensure that relationships with industry do not unduly influence NIH decisions and that these decisions are not based on financial incentives. Further, all grantee institutions that receive NIH funding must provide evidence that they have established a written policy for identifying financial conflicts of interest and any existing or subsequent conflicts will be reported, managed, reduced or eliminated pursuant to federal regulations.
44. See DANIEL R. LEVINSON, OFFICE OF INSPECTOR GENERAL, NATIONAL INSTITUTES OF HEALTH: CONFLICTS OF INTEREST IN EXTRAMURAL RESEARCH (2008), available at http://www.oig.hhs.gov/oei/reports/oei-03-06-00460.pdf. Although the NIH requires that its grantees adhere to certain federal regulations regarding conflicts of interest, NIH itself has been challenged in the area of ensuring that its own employees and the institution are free of these influences. Primarily, questions regarding the financial ties of high-ranking NIH officials with the pharmaceutical industry have been reported in the media.
45. See Robert Steinbrook, Conflicts of Interest at the NIH - Resolving the Problem, 351 NEW ENG. J. MED. 955, 955 (2004). In December 2003, the los Angeles Times broke a story exposing serious financial conflicts of interest between senior NIH officials, including directors of the NIH, and industry, immediately bringing into question the integrity of NIH.
46. See Jennifer L. Gold, Conflict over Conflicts of Interest: An Analysis of the New NIH Rules, 34 J. LAW, MED. & ETHICS 105, 105 (2006). These reports brought to light potential conflicts involving NIH employees who were engaged in outside consulting arrangements or had other financial ties to the industry as well as instances where employees did not disclose or receive approvals for their outside consulting agreements appropriately.
47. See Steinbrook, supra, at 955. The repercussions of the NIH's limited policy on this issue further emerged in 2006 when an NIH researcher was charged with and plead guilty to a misdemeanor criminal offense stemming from a conflict of interest for earning private consulting fees from Pfizer.
48. See Alex Dominguez, NIH Scientist Pleads Guilty in Ethics Case, DESERET NEWS, Dec. 10, 2006, at A22. In these examples, ICOIs within the NIH existed when senior officials made decisions as part of their representation and employment by this important government institution. Even though policies at mitigating conflicts of interest existed, they were not adequately managed either for individual conflicts and, importantly, for the institution itself. This result is another in a long line of problems with NIH efforts to address conflicts of interest generally. Prior to 1995, NIH rules governing employees' involvement with the industry were severely restrictive.
49. See Gold, supra, at 105-06. In an effort to strengthen recruitment of top talent in researchers, the NIH's outside activity policies were loosened by removing restrictions on dollar caps and outside hours for consulting payments and ownership of stock options in 1995.
50. See id. at 106. This change in policy opened the floodgates for industry involvement with NIH employees, and as a result of this change and subsequent media reports, congressional investigations into the NIH were initiated.
51. See id. These revelations led to comprehensive reform and the tightening of conflict of interest policies and guidelines by the NIH in August of 2005 in an effort to shore up public perception and trust in the agency.
52. See Press Release, National Institutes of Health, NIH Announces Final Ethics Rules (Aug. 25, 2005), available at http://www.nih.gov/news/pr/aug2005/ od-25.htm. The changes in conflict of interest rules included restrictions on: stock holdings (including divestiture); receiving gifts or anything of monetary value from the industry; and on outside employment and consulting activities.
53. See id. Many NIH employees reacted to these changes negatively based on the belief that they were overly restrictive, would be detrimental to the NIH talent pool, and that the vast majority of NIH employees were doing nothing wrong.
54. See Gold, supra, at 106-07. Yet another report by the Government Accountability Office in 2007 reported that recusal policies for senior employees of the NIH were unclear and could exacerbate situations in which conflicts of interest could potentially be avoided.
55. See U. S. GOV'T ACCOUNTABILITY OFFICE, NIH CONFLICT OF INTEREST: RECUSAL POLICIES FOR SENIOR EMPLOYEES NEED CLARIFICATION 17-24 (2007), available at http://www.gao.gov/new.items/d07319.pdf. More problems have arisen with respect to NIH efforts. In June 2008, US Senator Chuck Grassley expressed his concerns that the NIH was not meeting its obligations of effectively monitoring financial conflict of interests of individuals.
56. See Sen. Chuck Grassley, Press Release, U. S. Senate, Committee on Finance, Grassley Calls on Congress and NIH Leaders to Identify Conflicts of Interest in Taxpayer Sponsored Medical Research (June 25, 2008), available at http://finance.senate.gov/press/Gpress/2008/prg062508CEG%20urges%20NIH.pdf. An article in the New York Times highlighted the passiveness of the NIH in verifying the accuracy of voluntary disclosures when it was discovered that physicians receiving NIH grants were receiving exorbitant sums of money from pharmaceutical companies and did not disclose those relationships as required.
57. See Gardiner Harris & Benedict Carey, Researchers Fail to Reveal Full Drug Pay, N. Y. TIMES, June 8, 2008, at A1. Unfortunately, despite challenges to managing conflict of interest issues on the institutional level, NIH has focused instead on monitoring conflicts of interest of external researchers and grantees.
58. See Steinbrook, supra, at 955. However, OIG investigation in concert with this effort did provide important findings with respect to ICOIs. In 2008, OIG issued findings that the NIH was not maintaining accurate conflict of interest reports from institutions receiving grants, that such reports did not provide relevant information on the nature of reported conflict or how they are managed, that NIH's primary method of oversight was based on assurances by grantees that they were following conflict of interest regulations, and that NIH did not appropriately follow up on reported conflicts.
59. See LEVINSON, supra, at 9-13. OIG subsequently recommended that NIH: (1) increase its oversight of grantee institutions to ensure compliance; (2) require grantee institutions to provide more details regarding the nature of conflicts of interest and how they deal with them; and (3) ensure that all reports are accurately contained in a centralized database.
60. See id. at 16-18. In a recent November 2009 report by the GAO it was further reported that the most common type of financial conflict of interest was equity ownership, that grantee institutions rarely reduce or eliminate these financial conflicts, and that vulnerabilities continue to remain in detection, reporting, and management of conflicts of interests of grantee institutions and researchers.
61. See U. S. GENERAL ACCOUNTING OFFICE., HOW GRANTEES MANAGE FINANCIAL CONFLICTS OF INTEREST IN RESEARCH FUNDED BY THE NATIONAL INSTITUTES OF HEALTH (2009), available at http://www.oig.hhs.gov/oei/reports/oei-03-07-00700.pdf. Given the continued difficulty of NIH regulating conflict of interest within and outside itself, relying upon it to ensure effective oversight of ICOIs is likely misplaced.
62. See Rothman, supra note 10, at 696.
63. See Jeffrey Fox, Gene-Therapy Death Prompts Broad Civil Lawsuit, 18 NATURE BIOTECH. 1136, 1136 (2000).
64. See id. at 1136.
65. See id.
66. This factor resulted in the FDA suspending genetic research at the institute. Rothman, supra note 10, at 696.
67. Wolf & Lo, supra note 11, at 83.
68. See Sheryl Stolberg, Teenager's Death is Shaking Up New Field of Human Gene-Therapy Experiments, N. Y. TIMES, Jan. 27, 2000, at A20.
69. See Press Release, U. S. Dept. of Justice, supra note 28, at 1-5.
70. See id.
71. See David Blumenthal, Academic-Industrial Relationships in the Life Sciences, 349 NEW ENG. J. MED. 2452, 2456 (2003).
72. A Boston Globe article describes several cases in which investigators in clinical trials for antipsychotic drugs disregarded exclusion criteria, used questionable recruitment methods and incentives for participants, and engaged in fraudulent activity for the purpose of maximizing revenue derived from conducting clinical trials. In some of these cases, participants died as a result of their participation in a study from which they should have been excluded. See Robert Whitaker, Doing Harm: Research on the Mentally Ill, BOSTON GLOBE, Nov. 17, 1998, at A1. In addition, fraud on the taxpayer has occurred even with government participation in oversight. For example, allegations of individual conflicts of interest at the University of Southern California ("USC") in a federally funded HIV/AIDS educator training program led to the issuance of an OIG audit report in 2004 which recommended that the university repay over $1 million dollars in federal funds that may have been misappropriated on the basis of fraud.
73. See OFFICE OF INSPECTOR GENERAL, AUDIT OF HEALTH RESOURCES AND SERVICES ADMINISTRATION COOPERATIVE AGREEMENT NUMBER U69-HA-00040, UNIVERSITY OF SOUTHERN CALIFORNIA, LOS ANGELES, CALIFORNIA III (2004), available at http://oig.hhs.gov/oas/reports/region9/90201004.pdf. In September 1999 the Health Resources and Services Administration ("HRSA") awarded $2.5 million dollars in federal funds to USC for the development of a HIV/AIDS peer treatment educator program to provide counseling and treatment education in certain communities.
74. Id. at i, 1. as part of this award, USC entered into a cooperative agreement that established the objectives of the program and also outlined the role the HRSA would play in assessing the program and providing technical assistance.
75. See id. at 1. In performance of the cooperative agreement, USC utilized several organizational components to administer the program, including a grants office with responsibility to ensure that the university was in compliance with applicable requirements of the award and which prepared and administered subcontracts for the program, and an IRB that ensured the safety of human subjects and reviewed research proposals.
76. Id. at 1-2. USC also utilized program positions such as a principal investigator ("PI"), director or co-PI, project manager, and other administrative positions. In addition, a portion of the work to be performed for the program, including providing office and training space, equipment, and salary support, was subcontracted to a nonprofit corporation whose founder was also the program's co-PI, a clear violation of federal conflict of interest regulations.
77. Id. at 3. In July of 2001, HRSA conducted an audit of USC in response to concerns regarding adherence to IRB conditions, misuse of federal funds, failure to deliver program objectives, and concerns relating to conflicts of interest.
78. Id. At this point, the majority of funds incurred by USC for the program had already been reimbursed by the federal government, close to half of which were paid to the aforementioned subcontractor and were unverifiable.
79. See id. at 4. After the audit, the OIG concluded, among other deficiencies, that USC failed to adequately address the conflict of interest held by the co-PI who also was the chief executive officer, president, and executive director of the subcontractor, constituting a violation of federal regulations.
80. Id. at 11. After HRSA expressed concerns about this conflict of interest, the co-PI resigned his managerial positions but continued to serve as chairman of the board of the subcontractor thus retaining his managerial authority.
81. Id. at 11-12. In sum, HRSA concluded that USC failed to properly manage the situation and in doing so, failed to comply with federal regulations.
82. Id. at 4-5. This led to continuing violations and mismanagement of federal funds that may have been spent by the subcontractor on activities not connected with the program. See id. at ii. Further, of the program costs incurred, 85% were deemed as inappropriate and thus recommended to be disallowed.
83. Id. at 13. In addition, these conflicts led to research involving human subjects without the approval of the monitoring IRB, also in violation of federal regulations.
84. Id. at 8-9.
85. Strategies include various gifts, free lunches/dinners, and other payments to physicians. See Catherine D. DeAngelis, Conflict of Interest and the Public Trust, 284 JAMA 2237, 2237 (2000). Other strategies include no-fee continuing medical education ("CME"), payment for travel, grants for research projects, payment for consulting services, and payment of honorarium. Brennan, supra note 1, at 430. Studies have shown that such interactions between physicians and the pharmaceutical industry can lead to negative results for patients including: (a) inability to identify wrong claims about medications; (b) making formulary requests for medications with no apparent significant advantage over existing medication; (c) non-rational prescribing behavior; and (d) prescribing fewer generics in favor of newer medications with no demonstrated advantage. Wazana, supra note 9, at 378. Pharmaceutical companies start their marketing efforts early, beginning their courtship of medical professionals as early as medical school and continue to meet with them in varying frequency through residency by providing industry-sponsored meals and samples.
86. See id. at 375. as physicians enter practice, marketing from pharmaceutical companies is more targeted towards the payment of honoraria, conference travel, and research funding.
87. Id. In addition, media outlets have uncovered such activities. A 2007 New York Times investigative article interviewed several former pharmaceutical sales representatives. Each agreed that the marketing practices that they employed were used for the purposes of influencing physicians' prescribing habits and manipulating physicians into favorable opinions about their products.
88. See Gardiner Harris & Janet Roberts, A State's Files Put Doctor's Ties to Drug Makerson Close View, N. Y. TIMES, Mar. 21, 2007, at A1. They also explained that financial incentives easily seduced physicians, and that there are many ways to provide for mutual financial benefit for both the physician and the pharmaceutical company.
89. See id. In another New York Times article, the perspective of a physician who was paid by the pharmaceutical industry for detailing drugs was outlined. It revealed a glamorous, highpaying, benefit-filled lifestyle in which the physician provided "education" to other physicians, in the form of lunches. The purpose of these events was to change prescribing habits and for the detailing physician to advocate questionable positive clinical conclusions about the company's products.
90. See Daniel Carlat, Dr. Drug Rep, N. Y. TIMES (Magazine), Nov. 25, 2007, at 64. He eventually ended his detailing career based on his own admissions that gifts and payments may have clouded his own clinical judgment.
91. See id. In another New York Times article the Senate's Special Committee on Aging made public a marketing document used by Forest Laboratories for its expensive antidepressant drug Lexapro which details a $34.7 million dollar marketing campaign that included dinners, lunches and questionable funding of CME in order to influence physician prescribing habits.
92. See Gardiner Harris, Document Details Plan to Promote Costly Drug, N. Y. TIMES, September 2, 2009, at B1. Other even more questionable strategies have been employed. A recent New York Times article discussed a particularly novel method by which pharmaceutical companies attempt to influence physicians. This article outlined company active recruitment of cheerleaders for pharmaceutical sales representative positions.
93. See Stephanie Saul, Gimme an Rx! Cheerleaders Pep Up Drug Sales, N. Y. TIMES, Nov. 28, 2008, at A1. Good looking and highly energetic, these individuals may represent a "variation" on traditional forms of industry marketing and promotion, but nevertheless represent a potential to lead to conflict of interest situations. The demand is so great for cheerleaders that specialized recruiting firms have been established to meet needs of prospective pharmaceutical employers.
94. See id. Often times a cheerleader's educational background is of no consequence.
95. See id. Reports of sexual harassment and allegations that pharmaceutical companies have encouraged the use of sex to promote drug sales and have their female employees exploit their personal relationships with physicians have also served to scrutinize these practices of hiring and marketing.
96. See id. Other well known examples include a Business Week investigation of the world's best selling drug, Lipitor. Questions regarding the efficacy of Lipitor in patients without heart disease, and the inherent risk in taking the drug if there is no apparent health benefit, have brought industry influence through pharmaceutical promotion to the forefront of our public debate.
97. See John Carey, Do Cholesterol Drugs Do Any Good?, 4068 BUS. WK., Jan. 28, 2008, at 52. In a recent fraud and abuse settlement, Pfizer agreed to pay a record $2.3 billion dollars and pleaded guilty to a single felony charge for its marketing of its anti-inflammatory drug Bextra.
98. See Carrie Johnson, In Settlement, A Warning to Drugmakers, WASH. POST, Sept. 3, 2009, at A1. Pfizer allegedly influenced doctors by providing expensive vacations, sending unsolicited advertising materials to physicians, and drafting of articles promoting their product without disclosing its role in funding the articles.
99. Id. Certain physician groups have also been supportive of physician-industry financial relationships, with the recently formed group, Association of Clinical Researchers and Educators, advocating benefits of industry interaction and condemning recent reforms and policy proposals to regulate these activities. Association of Clinical Researchers and Educators, Who We Are, http://www.acreonline.org/eng/pages/who-we-are (last visited July 28, 2009).
100. See Ezekiel J. Emanuel & Daniel Steiner, Institutional Conflicts of Interest, 332 NEW ENG. J. MED. 262, 262 (1995).
101. Note, however, that there have been federal prosecutions against pharmaceutical companies for inappropriate marketing and promotion to physicians. See David Studdert et al., Financial Conflicts of Interest in Physicians' Relationships with the Pharmaceutical Industry - Self-Regulation in the Shadow of Federal Prosecution, 351 NEW ENG. J. MED. 1891, 1893 (2004) (discussing TAP Pharmaceuticals case, which resulted in a settlement with government prosecutors of $290 million in criminal fines and $585 million in civil penalties and numerous private class action lawsuits; $355 million criminal fraud fine against AstraZeneca; and $350 million fine against Schering-Plough). A $499 million civil fine has also been administered against Bristol Meyers Squibb.
102. See Press Release, Office of Inspector General, OIG Reports More Than $2 Billion in Recoveries From Fighting Fraud, Waste, and Abuse for First-Half FY 2008 (June 12, 2008), available at http://www.oig.hhs.gov/ publications/docs/press/2008/semiannual-press-spring2008.pdf. Yet appropriately transparent marketing may be beneficial for patient access particularly for rare disease treatment if regulatory structures are put into place, again emphasizing the need for sound infrastructures and policies that integrate government and industry.
103. See, e.g., Bryan A. Liang & Tim Mackey, Reforming Off-Label Promotion to Promote Orphan Disease Access, 327 SCIENCE 273 (2010).
104. See Michael M. E. Johns et al., Restoring Balance to Industry-Academia Relationships in an Era of Institutional Conflicts of Interest, 289 JAMA 741, 742 (2003).
105. See AAU TASK FORCE ON RESEARCH ACCOUNTABILITY, ASS'N OF AM. UNIVS., REPORT ON INDIVIDUAL AND INSTITUTIONAL FINANCIAL CONFLICT OF INTEREST 10 (2001).
106. See id. at 11-12. Note that ICOIs can extend to any situation in which a financial relationship with the industry affects an institutional process or decision making or when the institution has a direct financial interest. This can include more common forms of individual financial conflicts of interest such as funding of CME, research and development, and scholarship or training grants that have an institutional impact.
107. See Brennan, supra note 1, at 430;
108. DeAngelis, supra note 40, at 2237
109. See Johns et al., supra note 43, at 742.
110. See Emanuel & Steiger, supra note 41, at 263.
111. See Johns et. al., supra note 43, at 741.
112. See AUU TASK FORCE ON RESEARCH ACCOUNTABILITY, ASS'N OF AM. UNIVS., supra note 44, at 11.
113. See Susan H. Ehringhaus et al., Responses of Medical Schools to Institutional Conflicts of Interest, 299 JAMA 665, 665 (2008).
114. See AUU TASK FORCE ON RESEARCH ACCOUNTABILITY, ASS'N OF AM. UNIVS., supra note 44, at 12. Note that individual conflicts of interest have been extensively assessed, and management strategies proposed and employed. These strategies include state law as in California, Minnesota, Maine, Massachusetts, West Virginia, Vermont, and the District of Columbia.
115. See. Troyen A. Brennan & Michelle M. Mello, Sunshine Laws and the Pharmaceutical Industry, 297 JAMA 1255, 1255-56 (2007);
116. Joseph S. Ross et al., Pharmaceutical Company Payments to Physicians, 279 JAMA 1216, 1216-17 (2007);
117. Press Release, Mass. Office of Health and Human Servs., Patrick Admin. Passes Tough New Rules Governing Pharm. and Med. Device Indus. (March 11, 2009), http://www.mass.gov/?pageID=eohhs2pressrelease&L=l&L0=Home&sid= Eeohhs2&b=pressrelease&f=090311-tough-new-rules&csid=Eeohhs2. New Jersey has recommended a ban on gifts and imposing disclosure requirements directly on physicians licensed in the state.
118. See N. J. OFFICE OF THE ATTORNEY GEN., REPORT ON PHYSICIAN COMPENSATION ARRANGEMENTS 2, 3, 6-8, available at http://www.nj.gov/oag/newsreleases09/ pr20091203b-ReportOnPhysicianCompensationArrangements.pdf. In addition, proposed federal legislation has sought to address individual conflicts of interest through increased transparency.
119. See, e.g., Affordable Health Care for America Act of 2009 ("Physician Payment Sunshine Provision"), H. R. 3962 111th Cong. § 1451 (2009), available at http://frwebgate.access.gpo.gov/cgibin/getdoc. cgi?dbname=lll-cong-bill&samp;docid=f:h3962pcs.txt.pdf;
120. Patient Protection and Affordable Care Act, H. R. 3590 111th Cong. (2009), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname= lll-cong-bill&samp;docid=f:h3590eas.txt.pdf;
121. Physician Payments Sunshine Act of 2009, S. 301, 111th Cong. (2009), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=lll-cong- bill&samp;docid=f:s301is.txt.pdf;
122. Drug and Medical Device Company Gift Disclosure Act, H. R. 3023, 110th Cong. (2007), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi? dbname=110-cong-bill&samp;docid=f:h3023ih.txt.pdf;
123. Physician Payments Sunshine Act of 2007, S. 2029, 110th Cong. (2007), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110-cong- bill&samp;docid=f:s2029is.txt.pdf. Guidelines for individual conflicts of interest have emanated as well from stakeholder groups, e.g., the American Medical Association
124. see AM. MED. ASS'N, CODE OF MEDICAL ETHICS, OPINION E-8.061 - GIFTS TO PHYSICIANS FROM THE INDUSTRY (1992), available at http://www.ama-assn.org/ama/ pub/physician-resources/medical-ethics/code-medical-ethics/opinion806l.shtml (last visited July 10, 2009), the Pharmaceutical Research and Manufacturers of American ("PhRMA")
125. see PHRMA, CODE ON INTERACTIONS WITH HEALTHCARE PROFESSIONALS (2008), available at http://www.phrma.org/files/attachments/ PhRMA%20Marketing%20Code%202008.pdf (last visited July 10, 2009), as well as individual drug and device companies in anticipation of Congressional action. In the latter case, Medtronic will report consulting fees, royalties or honoraria to physicians of $5, 000 or more.
126. Sarah Rubenstein, Medtronic to Report Pay to Doctors Who Get $5, 000 Annually, WALL ST. J. HEALTH BLOG, http://blogs.wsj.com/health/2009/02/24/ medtronic-to-report-pay-to-doctors-who-get-5000-annually (Feb. 24, 2009, 16:32 EST). Pfizer and Eli Lilly have announced that they will report payments that total more than $500 annually.
127. Jacob Goldstein, How Pfizer's Doctor-Payment Disclosure Compares to Grassley Plan, WALL ST. J. HEALTH BLOG, http://blogs.wsj.com/health/2009/02/10/ how-pfizers-doctor-payrnent-disclosure-comparesto-grassley-plan/(Feb. 10, 2009, 09:20 EST);
128. Jacob Goldstein, Eli Lilly to Disclose Payments to Doctors, WALL ST. J. HEALTH BLOG, http://blogs.wsj.com/health/2008/09/24/eli-lilly-todisclose- payments-to-doctors/(Sept. 24, 2008, 09:06 EST). Merck has stated that it will report payments made to doctors for speaking arrangements.
129. Jacob Goldstein, Merck to Report (Some) Payments to Doctors, Medical Education Groups, WALL ST. J. HEALTH BLOG, http://blogs.wsj.com/health/2008/09/ 25/merck-to-report-some-payments-to-doctorsmedical-education-groups/(Sept. 25, 2008, 17:23 EST). Glaxo Smith Kline has announced that it will publicly report payments to physicians and cap payments at $150, 000 per year.
130. Jacob Goldstein, Another Drug Maker to Report Payments to Doctors, WALL ST. J. HEALTH BLOG, http://blogs.wsj.com/health/2008/l0/23/another-drug-maker- to-report-payments-todoctors/(Oct. 23, 2008, 09:07 EST). And Johnson & Johnson announced that it would support the proposed Physician Payments Sunshine Act and begin disclosing payments made to physicians by its pharmaceutical, medical device, and diagnostic companies. Press Release, Reuters, Johnson & Johnson Announces Support for Kohl-Grassley Physician Payment Sunshine Act of 2009 (May 7, 2009), http://www.reuters.com/article/pressRelease/idUS203817+07- May-2009+PRN20090507. In addition, the Office of Inspector General of the Department of Health and Human Services has entered the discussion for individual conflicts of interest. OIG has taken a much more comprehensive approach in its guidance statements on conflict of interest. Its approach is detailing to both physicians and manufacturers the types of industry practices that will most likely give rise to federal prosecution under fraud and abuse laws and encourages structuring of physician-industry relationships within certain statutory "safe harbors", i.e. business arrangements which will not be subject to enforcement.
131. See Studdert et al., supra note 42, at 1898-99. In instances that are not covered by safe harbors, the government uses four factors in determining whether a payment to a physician constitutes a kickback, including, (a) the likelihood of the arrangement interfering with clinical decisions or objective professional judgment; (b) the likelihood of increasing prescribing of product; (c) the potential to lead to increased expenditures for federal health care programs; and (d) whether the arrangement compromises patient safety or quality of care.
132. See id. at 1899. The OIG also provides guidance in relation to conflicts of interest in medical education by advising that physicians and researchers face potential liability when manufacturers have influence over the content of education programs and when education is used as a method of remuneration for physicians.
133. See id. The guidance further provides that research support from manufacturers should not be directed or funded by sales and marketing departments and that gifts and entertainment to physicians are potentially in violation of anti-kickback regulations.
134. See id. Comments by Tony Maida, deputy chief of the OIG's administrative and civil remedies branch, have reinforced the agency's position that pursuing anti-kickback violations against both physicians and the industry and further scrutinizing physician financial relationships will be a priority of federal enforcement.
135. See Bureau of Nat'l Affairs, HHS Official Says Physician Relationships with Device Makers are Enforcement Priority, 12 Health Care Fraud Rep. 927 (Nov. 19, 2008). Note, however, that none of these efforts extend to institutional conflicts of interest.
136. Ehringhaus et al., supra note 50, at 668. This national survey of all 125 accredited U. S. allopathic medical schools in 2006 revealed that policies regarding institutional forms of conflicts of interests are not being adequately addressed by AMCs.
137. See id. This study provides strong evidence that even though the AAMC has provided specific recommendation to deal with ICOIs, many institutions have failed to do so.
138. See id.
139. AMCs have adopted individual conflict of interest policies for between 60% and 81% of individuals at these institutions.
140. Id.
141. See ASS'N OF AM. MED. COLLS., PROTECTING SUBJECTS, PRESERVING TRUST, PROMOTING PROGRESS II: PRINCIPLES AND RECOMMENDATIONS FOR OVERSIGHT OF AN INSTITUTION'S FINANCIAL INTERESTS IN HUMAN SUBJECT RESEARCH (2002), http://www.aamc.org/research/coi/2002coireport.pdf.
142. See Ehringhaus et al., supra note 50, at 668.
143. 5S University and Small Business Patent Procedures Act, 35 U. S. C § 200 (2000);
144. C. F. R. § 401 (2000).
145. See U. S. GENERAL ACCOUNTING OFFICE, BIOMEDICAL RESEARCH: HHS DIRECTION NEEDED TO ADDRESS FINANCIAL CONFLICTS OF INTEREST 6 (2001), available at http://www.gao.gov/new.items/d0289.pdf.
146. See U. S. GENERAL ACCOUNTING OFFICE, TECHNOLOGY TRANSFER, AGENCIES' RIGHTS TO FEDERALLY SPONSORED BIOMEDICAL INVENTIONS 1 (2003), available at http://www.gao.gov/new.items/d03536.pdf.
147. See U. S. GENERAL ACCOUNTING OFFICE, supra note 57, at 6.
148. See Bekelman et al., supra note 6, at 454.
149. See Rothman, supra note 10, at 696.
150. See Wendy H. Schacht, THE BAYH-DOLE ACT: SELECTED ISSUES IN PATENT POLICY AND THE COMMERCIALIZATION OF TECHNOLOGY, CRS REPORT FOR CONGRESS 8 (2006), available at http://ncseonline.org/NLE/CRSreports/07Jan/RL32076.pdf.
151. See U. S. GENERAL ACCOUNTING OFFICE, supra note 57, at 1.
152. th Century: The World Before and After Bayh-Dole, 35 RES. POLY 772, 786 (2006).
153. See id. at 786-87.
154. Studies have questioned the actual benefits of the Bayh-Dole Act on technology licensing, indicating that there is little empirical evidence to show that the Act was the primary moving force that led to increased patent activities and licensing in universities over the past almost 30 years. See David C. Mowery et al., The Growth of Patenting and Licensing by U. S. Universities: An Assessment of the Effects of the Bayh-Dole Act of 1980, 30 RES. POL'Y 99, 100-01 (2001). These studies also indicate that even without the passage of the Act, universities would have nonetheless continued their corporate relationships and expansion of licensing and patenting activities due to other factors, such as the growth in biomedical research and technology.
155. See id. Other factors such as U. S. Supreme Court rulings allowing patenting of novel organisms, increased government funding, and the increase of research companies in information technology that utilize university research are also cited as reasons for the upswing in university patenting and licensing.
156. See id. at 101-03. Given this possibility, the Bayh-Dole Act may be counterproductive to the overall progress of technology transfer and bringing such technology to market as the exclusivity of patents acts to restrict the use of scientific research. Indeed, without the passage of the Act, the public good may have been better served through the dissemination of such discoveries in the public domain.
157. See id. at 103.
158. See Clifton Leaf, The Law of Unintended Consequences, 152 FORTUNE MAG., September 19, 2005, at 250-68.
159. See Josephine Johnston, Conflict of Interest in Biomedical Research, THE HASTINGS CENTER 32 (2008), available at http://www.thehastingscenter.org/ uploadedFiles/Publications/Briefing-Book/conflict%20of%20interest%20chapter.pdf.
160. See supra Part II (discussing the Jesse Gelsinger case).
161. See Leaf, supra note 67, at 250-68.
162. See id. Emory later sold its rights to Emtriva for a lump sum of $525 million, at that time the largest university-related IP transaction.
163. See Dave Chokshi, Improving Access to Medicines in Poor Countries: The Role of Universities, 3, PLOS MED. 723, 724 (2006). However, questions have been raised regarding accessibility of Emtriva for poorer countries and the need to establish favorable licensing provisions for humanitarian access in future IP transactions by universities.
164. Id.
165. See Leaf, supra note 67, at 250-68.
166. See id.
167. See id.
168. See id.
169. See id. New Molecular Entities ("NMEs") are active ingredients that the FDA considers to have never been marketed in the United States in any form.
170. See U. S. Food and Drug Administration, Drugs@FDA Glossary of Terms, http://www.fda.gOv/Drugs/InformationOnDrugs/ucm079436.htm#NewMolecularEntity (last visited July 11, 2009). During the period from 2000-2003 the average number of priority NMEs was half as much as the previous 4 years.
171. See Leaf, supra note 67, at 250-68. This indicates the possibility that increasing patenting and commercialization of pharmaceuticals may be attributed to reformulations, old compounds with new indications for use, or "me too" drugs, and that discovery of innovative drugs may be limited.
172. See id.
173. "March-in rights" are statutory rights exercised by the government to compel licensing of university government-funded patents if the university or its licensee has not taken, or is not expected to take effective steps in achieving practical application of the patent, or if licensing is necessary to alleviate public health or safety needs or requirements for public use as specified by federal regulations. 35 U. S. C. § 203 (2006). However, historically the NIH has declined to utilize the march-in rights statutorily afforded to the agency. Examples such as the CellPro petition in which CellPro, Inc. requested that the NIH investigate Baxter Healthcare Corporation's alleged failure to successfully commercialize government-funded stem cell isolation technology, resulted in a denial of that petition by the NIH.
174. See Amy Schofield, The Demise of Bayh-Dole Protections Against Pharmaceutical Industry's Abuses of Government-Funded Inventions, 32 J. L. MED. & ETHICS 777, 778 (2004). Similarly, the NORVIR petition in which it was alleged that Abbott Laboratories' 400% price increase of its HIV/AIDS drug NORVIR in 2003 constituted a failure to reasonable satisfy the needs and safety of public health, resulted in a denial by the NIH as well.
175. See id. at 778-79.
176. See Richard Nelson, Observations on the Post-Bayh-Dole Rise of Patenting at American Universities, 26 J. TECH. TRANSFER 13, 17 (2001).
177. See JENNIFER HENDERSON & JOHN SMITH, CENTER FOR INTEGRATION OF MEDICINE AND INNOVATIVE TECHNOLOGY, ACADEMIA, INDUSTRY, AND THE BAYH-DOLE ACT: AN IMPLIED DUTY TO COMMERCIALIZE 6 (2002), available at http://www.cimit.com/ news/regulatory/coi-part3.pdf.
178. See Hamilton Moses III & Joseph Martin, Academic Relationships With Industry: A New Model for Biomedical Research, 258 JAMA 933, 933 (2001).
179. Senator Chuck Grassley has continually voiced his concerns over the lack of oversight in conflict of interest monitoring which has resulted from the Bayh-Dole Act. He has targeted individual physicians, universities and government funded researchers in an attempt to address concerns regarding biased decisions in research. See Jocelyn Kaiser, Ethics: Private Money, Public Disclosure, 325 SCIENCE 28, 29-30 (2009).
180. This is particularly true in research. Conflicts of interest that occur in research settings can lead to adverse effects on collection, analysis and interpretation of results, hiring decisions, procurement activities, study design, information dissemination, and participation of human subjects. See AUU TASK FORCE ON RESEARCH ACCOUNTABILITY, ASS'N OF AM. UNIVS., supra note 44, at 2. Physicians and researchers participating in a study often receive direct financial benefit, such as patient recruitment incentives, which complicates their relationship with the industry, commercializes the practice of medical research, and can lead to compromised research data.
181. See Trudo Lemmens & Paul Miller, Regulating the Market in Human Research Participants, 3 PLOSMED. 1237, 1237 (2006). Even scientific journals have participated in incentivizing physicians for the purpose of profit, with a recent report revealing that publishing company Elsevier offered gift cards to academics in exchange for favorable reviews of publications.
182. See Helen Mooney, Elsevier Says Offering $25 Gift Cards for Positive Reviews of Psychology Textbook was a Mistake, 339 BRIT. MED. J. 125, 131 (2009). Further, more institutionalized forms of financial conflicts of interest include equity ownership in companies that sponsor research and commercialize such discoveries, research support and funding through grants and contracts, consultancy arrangements, and other forms of researchrelated remuneration and gifts from the industry, which are particularly problematic and difficult to manage.
183. See Michael M. E. Johns et al., Restoring Balance to Industry-Academia Relationships in an Era of Institutional Financial Conflicts of Interest, 280 JAMA 741, 741-42 (2003). In these cases, researchers as well as other staff and faculty, may be heavily invested in the outcome and success of research they are conducting, and thus act upon these influences that may compromise study participant safety. Further, success in the academic enterprise focuses upon research publications, and hence corporate strategies have exploited this as well. Recent studies and news reports have shed light on a troubling practice that is commonly known and practiced in the scientific community known as "ghost writing" or "ghost authorship", where pharmaceutical companies or their agents write academic articles for publication and pay researchers to place their names on the pieces.
184. See, e.g., Barton Moffatt & Carl Elliot, Ghost Writing: Pharmaceutical Companies and Ghostwritten Journal Articles, 50 PERSPECTIVES IN BIOLOGY & MED. 18, 19-20 (2007). Variation include co-writing an article or collaborating with a ghost writer by reviewing, revising, or, in some cases, simply signing their name to a manuscript.
185. See id. at 20-22. For the pharmaceutical company, these hired experts lend credibility and legitimacy to the paper; yet these relationships clearly create questions regarding the accuracy of findings and issues regarding accountability and responsibility of its content.
186. See Stephanie Ngai et al., Haunted Manuscripts: Ghost Authorship in the Medical Literature, 12 ACCOUNTABILITY RES. 103, 104-05 (2005). These papers, which health professionals rely upon heavily, may be the product of marketing campaigns coordinated by pharmaceutical companies or their agents rather than the result of scientifically sound research. They may unduly influence and mislead physicians about the benefits and risks involved with specific pharmaceuticals and endanger the public's health.
187. See, e.g., Moffatt & Elliot, supra, at 19-20 (discussing pharmaceutical publication strategy linked to product marketing). Unfortunately, the literature is now rife with examples of this practice.
188. See, e.g., id. at 22-23 (study conducted on articles published on Pfizer's antidepressant Zoloft during a 3 year period showed that 57% of articles potentially involved ghost writing, including articles in prestigious journals such as Annals of Internal Medicine and the Journal of the American Medical Association);
189. see also Joseph S. Ross et al., Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents from Rofecoxib Litigation, 299 JAMA 1800, 1802-03 (2008) (Vioxx papers ghost written). Recently, a federal judge ordered the unsealing of documents regarding ghostwriting practices by Wyeth for its drugs Prempro and Premarin, which are the subject of litigation alleging that these hormonereplacement drugs caused breast cancer in more than 10, 000 women.
190. See Jeff Feeley & Sonny Rhodes, Wyeth Ordered to Unseal Prempro Ghostwriting Files (Update 2), BLOOMBERG, July 24, 2009, http://www.bloomberg. com/apps/news?pid=newsarchive&sid=a0QT8. Bt2Ud4. This follows both a federal study which found that the drug increased the risk of breast cancer and requests made by US Senator Chuck Grassley for Wyeth to disclose documentation of payments, articles and activities associated with possible ghost writing with a medical communication and education company and physicians.
191. See Duff Wilson, Investigation Links Wyeth to Articles on its Drugs, N. Y. TIMES, Dec. 13, 2008, at B1. Senator Grassley has recently expanded this request by asking eight leading medical journals to describe their policies and practices regarding ghostwriting, disclosure policies, and enforcement mechanisms.
192. See Sen. Chuck Grassley, Press Release, US Senate, Committee on Finance, Grassley Asks Top Medical Journals About Ghostwriting (July 2, 2009), available at http://finance.senate.gov/press/Gpress/2OO9/prg0702O9.pdf. Grassley, in a recent letter, has also requested that the top ten medical schools explain what steps they are taking with professors whose names are included in ghostwritten articles in medical journals.
193. See Duff Wilson, Medical Schools Quizzed on Ghostwriting, N. Y. TIMES, November 18, 2009, at B2. Unfortunately, it appears that journals themselves condemn conflict of interest non-disclosure yet engage in the practice themselves if it furthers their own agenda.
194. See, e.g., Bryan A. Liang, Commentary: Accuracy of Conflict-of-interest Disclosures by Physicians, SURVEY OF ANESTHESIOLOGY (2010), forthcoming (describing New England Journal of Medicine nondisclosure of generic industry author bias despite "requiring" full conflict of interest disclosure stated in the journal only a week before).
195. Potential revenue includes, for example, increased dividend payments of equity ownership or revenue derived from royalty/licensing fees. Licensing revenues derived from technology transfer, such as university originated patents and licensing revenues, are significant revenue and profit streams for universities with a recent survey reporting $1.5 billion dollars in research-related income.
196. Maureen Farrell, Universities That Turn Research into Revenue, FORBES. COM, Sept. 12, 2008, http://www.forbes.com/2008/09/l2/googlegeneral-electric- ent-tech-cx-mf-0912universitypatent.html. Another study has shown that equity positions in start-up companies by universities can lead to increased revenues over traditional licensing arrangements further emphasizing the need for oversight of ICOIs.
197. See Michael J. Bray & James N. Lee, University Revenues from Technology Transfer: Licensing Fees vs. Equity Positions, 15 J. BUS. VENTURING. 385, 391 (2000).
198. The potential adverse results of these forms of individual financial conflicts of interest in research can also extend to include the manipulation of study design to produce favorable results, inappropriate encouragement for human subject participation, changes of inclusion/exclusion criteria to affect participation, see Emanuel & Steiner, supra note 41, at 264, failure to disclose conflicts of interest
199. see AAU TASKFORCE ON RESEARCH ACCOUNTABILITY, ASS'N OF AM. UNIVS., supra note 44, at i, and inadequate or incomplete informed consent
200. see ASS'N OF AM. MED. COLLEGES, PROTECTING PATIENTS, PRESERVING INTEGRITY, ADVANCING HEALTH: ACCELERATING THE IMPLEMENTATION OF COI POLICIES IN HUMAN SUBJECTS RESEARCH 15 (2008), available at. https://services.aamc.org/ publications/showfile.cfm?file=versionl07-pdf.
201. Eric G. Campbell et al., Institutional Academic-Industry Relationships, 298 JAMA 1799, 1783 (2007).
202. See Bekelman et al., supra note 6, at 463.
203. See Leaf, supra note 63, at 250.
204. See Janet Rae-Dupree, When Academia Puts Profit Ahead of Wonder, N. Y. TIMES, Sept. 7, 2008, at BU4.
205. See Ezekiel J. Emanuel et al., Oversight of Human Participants Research: Identifying Problems to Evaluate Reform Proposals, 141 ANNALS INTERNAL MED. 282, 283 (2004).
206. See Food and Drug Admin., Running Clinical Trials: Frequently Asked Questions (Aug. 21, 2009), http://www.fda.gov/ScienceResearch/SpecialTopics/ RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucmll5632.htm.
207. See Emanuel et al., supra note 89, at 283.
208. See supra text accompanying note 82 (discussing industry practices of selective publishing, manipulation of data and ghost writing in clinical trials);
209. Emanuel et al., supra note 89, at 283 (discussing funding of IRBs by institution conducting research IRB reviews);
210. Michael A. Morse et al., Monitoring and Ensuring Safety During Clinical Research, 285 JAMA 1201, 1202-03 (2001) (discussing challenges faced by IRBs in evaluating adverse event reports).
211. DANIEL R. LEVINSON, OFFICE OF INSPECTOR GENERAL, THE FOOD AND DRUG ADMINISTRATION'S OVERSIGHT OF CLINICAL TRIALS 8 (2007), available at http://www.oig.hhs.gov/oei/reports/oei-01-06-00l60.pdf.
212. See Bekelman et al., supra note 6, at 464. A recent informal survey of medical schools found that up to sixteen percent of some medical schools' annual budgets originate from the pharmaceutical industry. Joe Neel, Medical Schools and Drug Firm Dollars (Natl Pub. Radio broadcast June 9, 2005), http://www.npr.org/templates/story/story.php?storyId=46963l6.
213. S. Van McCrary et al., A National Survey of Policies on Disclosure of Conflicts of Interest in Biomedical Research, 343 NEW ENG. J. MED. 1621, 1621 (2000).
214. See id.
215. See id.
216. See id. at 1624-25.
217. Evidence of the failure to self-police conflicts of interests in the public sector of U. S. government agencies provide some interesting parallels to this discussion. Recent controversies regarding financial ties to the industry between government agency officials such as the NIH, see Steinbrook, supra note 28, at 955-57, and the FDA
218. see Robert Steinbrook, Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees, 353 NEW ENG. J. MED. 116, 118 (2005), have resulted in congressional inquiry, demands for agency reform, and criminal convictions
219. see Janice Hopkins Tanne, Former FDA Commissioner Pleads Guilty to Two Charges, 333 BRIT. MED. J. 874, 874 (2006). Even more recently, conflict of interest allegations of top level FDA employees, including current FDA Commissioner Margaret Hamburg, have emerged.
220. See Ellen Brown, The Mercury Mischief: as Obama Warns of Hazards, The FDA Approves Mercury Dental Fillings, THE HUFFINGTON POST, Aug. 28, 2009, http://www.huffIngtonpost.com/ellen-brown/the-mercury-mischief-aso-b-271520.html
221. and Alicia Mundy, Drug Chief at the FDA Is Accused of Conflict, WALL ST. J., August 12, 2009, at B1.
222. See Kanu Okike et al., Accuracy of Conflict-of-interest Disclosures Reported by Physicians, 361 NEW ENG. J. MED. 1466, 1471 (2009).
223. On May 8, 2009 the NIH issued an Advanced Notice of Proposed Rulemaking in the federal register to solicit public comment on whether changes to the agency's conflict of interest policies regarding federally funded research should be adopted. See DHHS, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors; Request for Comments, 74 Fed. Reg. 21610 (proposed May 8, 2009), available at http://edocket.access.gpo.gov/2009/pdf/E9- 10666.pdf.
224. The NIH proposal includes discussion regarding requiring institutions who are recipient of federal funds for research to implement additional controls to identify and manage financial conflicts of interests such as an independent committee to review conflicts of interests, development and disclosure of a conflict management plan when a conflict arises, additional limitations for participation by investigators who have a potential conflict of interest, and imposing maximum thresholds for financial contributions from certain organizations. See id. at 21612.
225. See id.
226. See Press Release, Senator Chuck Grassley of Iowa, Grassley, Kohl Work to Bring Transparency to Biomedical Research Funding (July 9, 2009), available at http://grassley.senate.gov/news/Article.cfm?customel-dataPageID-1502=21709.
227. The amendment would have required the NIH to actively enforce conflict of interest policies and respond in a timely manner to any violations by grant fund recipients. 155 CONG. REC. S1709 (daily ed. Feb. 5, 2009), available at http://frwebgate.access.gpo.gov/cgibin/getpage.cgi?dbname=2009-record&page= Sl709&position=all. It would have also required additional disclosures by recipients regarding the degree and amount of financial conflicts of interest as well as a report detailing how conflicts of interest would be managed by the recipient.
228. Id.
229. See DHHS, supra note 101, at 21612.
230. See Steinbrook, supra note 28, at 955 (noting the failure of NIH to address internal and external ICOIs).
231. See INSTITUTE OF MEDICINE, CONFLICT OF INTEREST IN MEDICAL RESEARCH, EDUCATION, AND PRACTICE 1 (2009). The IOM also suggested methods by which individual conflicts of interest be addressed. These included: establishment of federal regulations requiring disclosure of physician payments by the industry; removal of individual conflicts of interest from research; prohibition of gifts, meals and entertainment as well as forms of physician remuneration by the industry; restrict access to AMCs by pharmaceutical representatives; and establishment of system of accredited CME providers free of industry influence.
232. See id. at 18-22.
233. See id. at 217.
234. See id. at 18-22.
235. See Robert Steinbrook, Controlling Conflict of Interest - Proposals from the Institute of Medicine, 360 NEW ENG. J. MED. 2160, 2160 (2009).
236. See id. at 2162.
237. See supra Part IV.
238. There is little question that the practice of pharmaceutical industry marketing, estimated to be valued between some $27.7 billion and $57.5 billion in 2004, is a key strategy to attempt to secure physician prescriptions. Gagnon, supra note 4, at 30. The pharmaceutical industry spent some $9.2 billion dollars in 1996 for marketing and promotion that tripled to $27-7 billion in 2004, according to IMS Health and Competitive Media Reporting, a firm specializing in pharmaceutical marketing intelligence. See Gagnon, supra note 4, at 30;
239. see also THE NAT'L INST, FOR HEALTH CARE MGMT. RESEARCH AND EDUC. FOUND., PRESCRIPTION DRUGS AND MASS MEDIA ADVERTISING 11 (2001), available at http://www.nihcm.org/-nihcmor/pdf/DTCbrief2001.pdf. The pharmaceutical industry has also enjoyed increased profits during this time, indicative of the fact that such marketing and promotion may have a positive effect on sales of product.
240. See id.
241. Vermont's law on pharmaceutical marketing has expanded to include disclosures of payments made to institutions such as medical schools. See Robert Steinbrook, A Higher Bar - Vermont's New Law on Marketing Prescribed Products, 361 NEW ENG. J. MED. 8, 8 (2009).
242. Proposed federal legislation in the Senate only requires the disclosure of payments made to receiving physicians and teaching hospitals of certain information regarding forms of transfer or payment and ownership or investment interests held by physicians. Patient Protection and Affordable Care Act, H. R.3590, 111th Cong. § 1128G (1st Sess. 2009). Disclosure requirements do not include payments made to other institutions or their nonphysician representatives. It should be noted that the Physician Payment Sunshine provisions contained in the House of Representative's version of the Affordable Health Care for America Act of 2009 includes many forms of institutions, including medical schools, as "covered recipients" subject to reporting requirements.
243. Id. at § 1128G (e) (6). This would enhance federal disclosure legislation to include reporting of payments made to institutions. However, it is questionable whether these disclosure requirements will make it into the final reconciled bill. Additionally certain sections specifically limit the effectiveness of the proposed bill by excluding reporting of discounts and rebates, delaying certain reporting requirements related to product development and clinical investigation, and classifying same data as confidential and thus not accessible to the public.
244. See Affordable Health Care for America Act, H. R. 3962, 111th Cong. § 1451 (1st Sess. 2009).
245. See supra text accompanying notes 99-102 (describing complexity and limited mechanisms to detect ICOIs).
246. The Medicare Payment Advisory Commission, or MedPAC, is an independent congressional agency that advises the U. S. Congress on issues affecting the Medicare program. MedPAC, About MedPAC, http://www.medpac.gov/about.cfm (last visited July 24, 2009).
247. See Steinbrook, supra note 111, at 2162.
248. Julie Steenhuysen, US Senator Seeks Med Schools' Disclosure Policies, REUTERS, June 24, 2009, http://www.reuters.com/article/idUSN2419553620090624. In addition, Senator Grassley has recently sent letters to the American Medical Association and thirty-two other disease and medical advocacy groups. He requested the groups provide details regarding funding that they and their directors received from both the pharmaceutical and medical device industry given the strong influence of these groups over public policy.
249. Gardiner Harris, Senator Grassley Seeks Financial Details From Medical Groups, N. Y. TIMES (Online), Dec. 7, 2009, http://www.nytimes.com/2009/l2/07/ health/policy/07grassley.html.
250. See supra text accompanying notes 7, 8 (discussing results of AMSA PharmFree Scorecard). UC Davis Health System is an example of one such school which received an "A" grade (the highest grade possible) on the AMSA scorecard with a policy enacted in July 2007 that includes a ban on gifts and samples, limitations on industry funding of on-campus and off-campus education, controls on consulting compensation, limited disclosure, mandatory training and other controls designed to limit potential financial conflicts of interest. UC Davis Health System, Medical School Receives "A" Grade for Conflict-of-interest Policies, http://www.ucdmc.ucdavis.edu/welcome/features/ 200807l6-no-conflict/(last visited July 11, 2009).
251. A survey of the top US institutions receiving funding from the NIH in 1998 were analyzed for their policies of conflicts of interest including an examination of their processes for disclosure, review and management. This study showed a high variation in policies in regards to requiring disclosure of financial relationships and sanctions for violations of rules. See Mildred Cho et al., Policies on Faculty Conflicts of Interest at U. S. Universities, 284 JAMA 2203, 2207-08 (2000);
252. see also Van McCrary et al., supra note 95, at 1622-23 (discussing substantial differences in conflict of interest policies at AMCs including the percentage having conflict of interest policies, variation on the definition and management of conflicts, percentage of policies which exceed current federal guidelines, and policies on disclosure of conflicts of interest).
253. The results of the AMSA Pharm Free Scorecare reported in June 2008 revealed that only 21 of 150 medical schools had strong policies (scored A or B)
254. Id.
255. Note that relying upon voluntary industry efforts will likely be ineffective if individual conflicts of interest experience is any guide. For example, concerns regarding the voluntary nature of the revised PhRMA code have been expressed by the Prescription Project, a project aimed at promoting evidence-based medicine and research, which has concluded that enforcement through self-policing of PhRMA members is not effective. Press Release, The Pew Charitable Trusts, Prescription Project Statement on PhRMA's Revised Code on Marketing (July 10, 2008) available at http://www.pewtrusts.org/news-room- detail.aspx?id=41964. Since the enactment of the 2002 code, promotional spending has increased not decreased, state disclosure data shows that promotional activities have not adhered to the 2002 code, and PhRMA members have not been investigated or sanctioned for violations.
256. Id. In addition, the revisions to certain sections of the Code still allow the industry to provide meals to healthcare professionals provided they are accompanied by educational presentations and pay physicians "fair market value" for consultancy relationships, further limiting the effectiveness of such restrictions. Natasha Singer, No Lipitor Mug? Drug Makers Cut Out Goodies for Doctors, N. Y. TIMES, Dec. 31, 2008, at Al. Code of Conduct revisions enacted by the pharmaceutical industry provide for questionable self-regulation and compliance with federal regulations on individual conflicts of interest and fraud and abuse violations, which further emphasizes the need for independent, mandatory intervention for ICOIs.
257. See Ehringhaus et al., supra note 50, at 665.
258. See Van McCrary et al., supra note 95, at 1623-24 (discussing survey results of federal agency policies on conflicts of interest in extramural research).
259. Joseph B. Martin & Dennis L. Kasper, In Whose Best Interest? Breaching the Academic-Industrial Wall, 343 NEW ENG. J. MED. 1646, 1651 (2000).
260. See Duff Wilson, Patching a Wound, N. Y. TIMES, Mar. 3, 2009, at B1. In addition, in January 2009 Harvard Medical School re-convened a conflict of interest review committee which at the time did not include notable critics of AMC-industry relationships such as Jerry Avorn, a proponent of "academic detailing' and also a past member of the Prescription Project's advisory group.
261. See Harvard Medical School, HMS Review Committee, January 2009, available at http://hms.harvard.edU/public/coi/review/index.html#members (last visited Dec. 24, 2009);
262. Press Release, The Pew Charitable Trusts, New Campaign Champions Changes in Medical Prescribing to End Conflicts of Interest (Feb. 12, 2007), available at http://www.pewtrusts.org/news-room-detail.aspx?id=30377
263. As the rate of clinical research trials continues to increase while the availability of federal funding in research continues to lessen, issues regarding these conflicts as well as dependency and pressure from commercial sponsors for faster and more favorable results creates concerns regarding the erosion of patient safety and public trust in the integrity of scientific research. See Lemmens, supra note 82, at 1238. as seen by the Gelsinger case, financial incentives and conflicts of interest can place personal financial gain over objective judgment. This can lead to tragic results in which patients are harmed or even die as a result of the unethical actions of investigators under such influences.
264. Id. (discussing alteration of patient medical records to influence enrollment eligibility as well as the act of convincing potentially high risk patients to participate in research).
265. The USC example, supra note 39, illustrates a failure at both an educational and government institutional level of effectively dealing with ICOIs. In this case, the university and federal government had shared responsibilities of oversight, and had many of the traditional tools and organizational components necessary for the monitoring and policing of conflicts of interest. Yet in this case, even though an ICOI situation was identified, both the university and government failed to take the steps necessary to mitigate an ICOI situation and prevent the subcontractor from continuing to misuse federal funds. From the AMC standpoint, though USC had conflict of interest policies in place, and institutional units that could manage these conflicts, they were not sufficient in ensuring that federal funds were used responsibly, or that once an ICOI was detected, it was dealt with in a manner consistent with the requirements of federal regulations. This case is a clear example of the ineffectiveness of self-policing and limited oversight of AMC policies on both individual conflicts of interest and ICOIs and how government involvement does not guarantee effective management of these conflicts.
266. The regulation of financial incentives and managing these forms of individual conflicts of interest in scientific research is yet to be adequately addressed. Much of this regulation falls to IRBs, which simply lack the required federal regulation oversight and needed independence from investigators and sponsors required to protect patient safety. Lemmens, supra note 82, at 1239; see also supra text accompanying notes 89, 90 (discussing IRB issues and ICOI).
267. Other policy reasons also exist that support reform in this area. Concerns regarding the need for exemptions to use technology for noncommercial research, providing access to technology for upstream inventions and research tools, preventing fragmented ownership of inventions, and allowing access of technology for humanitarian purposes all are important policy goals that may be blocked without attention to ICOIs. See Sara Boettiger & Alan B. Bennett, Bayh-Dole: If We Knew Then What We Know Now, 24 NATURE BIOTECH. 320, 321 (2006). Without these reforms, other universities and non-profit organizations cannot take advantage of technological innovations that may be completely or partially funded by the taxpayer. This lack of access prevents the overall progress of noncommercial research by restricting use of research tools while at the same time creating financial interdependent relationships that blur the lines between public and private interests.
268. Id. at 321-22.
269. See U. S. GENERAL ACCOUNTING OFFICE, supra note 57, at 5.
270. See Rothman, supra note 10, at 696.
271. See Emanuel & Steiner, supra note 41, at 265.
272. See Ehringhaus et al., supra note 50, at 665.
273. See supra text accompanying notes 52, 53 (discussing how few AMCs are concerned with or recognize ICOIs).
274. Compliance Officers at AMCs may report to a variety of top level management including Directors, Deans, Vice provosts, Vice chancellors, Chief Financial Officers, and other research-related offices or departments. See Geoffrey Grant et al., Creating Effective Research Compliance Programs in Academic Institutions, 74 ACAD. MED. 951, 958 (1999). This structure has the potential to influence decision making. Hence, there are arguments in favor of both a centralized approach and independent approach of establishing a compliance program.
275. See id. at 957. However, ownership of the compliance program by senior-level management, appointment of a "high level" individual to oversee the program, appointment of a compliance officer, committee and liaisons, reporting responsibility to the board of an AMC, and independent authority of a compliance officer are essential in the success of any compliance structure that is implemented.
276. See id. at 957-63.
277. Several AMCs, such as the University of Pittsburgh, have already taken steps to ensure that pharmaceutical samples are not distributed directly to physicians, establishing methods to assess and approve use of samples, and implementing centralized systems for disbursement of samples to eliminate industry-physician interaction. See, e.g., AMSA, AMSA PharmFree Scorecard 2009, University of Pittsburgh Medical Center (June 16, 2009), http://www. amsascorecard.org/institutions/37-Efforts to promote access via public-private partnerships for pharmaceutical samples at AMCs could also be modeled after patient assistance programs enacted by state legislation establishing "central fill" pharmacies such as West Virginia's Pharmaceutical Discount Program.
278. See NAT'L CONF. OF STATE LEGISLATURES, STATE PHARM. ASSISTANCE PROGRAMS (June 30, 2009), available at http://www.ncsl.org/IssuesResearch/Health/ StatePharmaceuticalAssistanceProgramsNCSL2OO/tabid/14334/Default.aspx.
279. A mandatory system of auditing for conflict of interest policies by the Centers for Medicare & Medicaid Services ("CMS") could be incorporated into federal regulations for conditions for coverage & conditions of participation for the administration of hospitals. See 42 C. F. R. § 482 (B) (2009). In addition, the requirements of the National Institutes of Health, Office of Extramural Research, terms and conditions for grants award could be expanded to include the proposed conflict of interest auditing system as part of requirement for all participants to maintain a written and enforced policy on conflict of interest.
280. See 42 C. F. R. § 50. 604 (2009).
281. These audits could also be accomplished by the implementation of third party accreditation or independent review boards that would also manage mandatory event reporting and disclosure by AMCs, such as the American Association for the Accreditation of Human Protection Programs ("AAHRPP"). AAHRP already provides accreditation for research institutions, and its mission in this area would provide important experience and applicability for ICOI assessment. See AAHRPP, About AAHRPP: Indications of Quality in Human Research Protection, http://www.aahrpp.org/www.aspx?PageID3284 (last visited June 29, 2009). Another potential auditor could be the AAMC, whose activities and work focuses on AMCs. These organizations would provide independent accreditation of institutions and also could provide guidance on how AMCs should implement such policies. Accreditation would require policies managing institutional forms of conflicts of interest and would be contingent upon successful implementation of such policies as prescribed by the government. State governments could also adopt conflict of interest regulations equal in scope or more restrictive than federal regulations in an attempt to address regional differences of industry interactions and influence.
282. NIH or CMS exclusion would be severely detrimental to both research and medical institutions which would become ineligible for federal reimbursement and/or NIH grants and funding and significantly restrict their ability to operate. Changes to include conflict of interest violations as a basis for exclusion could be made by the OIG through an amendment of the Social Security Act, see 42 U. S. C. § 1320a-7 (2007), and such excluded entities/individuals could be added to the online exclusion list database
283. see OIG, List of Excluded Individuals/Entities Search, http://exclusions.oig.hhs.gov/(last visited July 11, 2009). Exclusion from federal programs may also make institutions ineligible for NIH grants.
284. See 45 C. F. R. § 76 (2009).
285. For example, ICOI in the student loan programs, where universities were profiting off specific vendors to which they pushed their students to use resulted in state prosecutions and settlements as well as federal law that created a system of compliance with federally-based ICOI policies. See Liang, supra note 5, at 19. Using a similar approach, ensuring appropriate ICOI with respect to health insurance has been proposed through amendment of the Higher Education Act.
286. See id. at 42-44.
287. ICMJE represents the editors of some of the most prestigious academic journals in the world, see ICMJE, Journals that have Requested Inclusion on the List of Publications that follow the ICMJE's Uniform Requirements For Manuscripts Submitted to Biomedical Journals (2009), http://www.icmje.org/ journals.html (last visited July 9, 2009), and hence would have tremendous sway if excluded AMCs would not be able to publish in these forums.
288. On May 8, 2009, the NIH published proposed amendments to its regulations in relation to financial conflicts of interest and requested comments from interested parties. See DHHS, supra note 101, at 21610. These amendments include expanded requirements to ensure institutional compliance including requirements for submission or ability for NIH to audit records.
289. Id. at 21612. Included in the request for comment is the question of whether extramural investigators should be required to complete routine financial conflict of interest training.
290. Id.
291. CME is a multi-billion dollar industry estimated at $2.38 billion dollars in 2006. See Robert Steinbrook, Financial Support of Continuing Medical Education, 299 JAMA 1060, 1060 (2008). This medical education is heavily subsidized and sponsored by the pharmaceutical industry and thus has become synonymous with pharmaceutical marketing and promotion, which allows AMCs and other institutions to pass off educational responsibilities (and cost) to industry.
292. See id. The reliance upon and significant involvement of commercial support in medical education gives rise to several concerns regarding individual financial conflicts of interest and the integrity of the content of educational programs. Through its sponsorship, the pharmaceutical industry may be involved and have control over several facets of CME events, including assistance in organizing and advertising events, preparation of educational material (presentations and curriculum), subsidization of fees and expenses for attendance by medical professionals, providing attendees with gifts and incentives to participate, and coordination of speakers and payment of their honoraria.
293. See Arnold Relman, Separating Continuing Medical Education From Pharmaceutical Marketing, 285 JAMA 2009, 2009-10 (2001). Indeed, the risks of this approach to funding provider CME are apparent. The industry can create a customizable experience for physicians aimed at influencing their prescribing habits through the use of targeted marketing, potentially biased or misleading information, and the giving of gifts and entertainment all under the label of "education. "
294. Id. This has spurred the development of an industry to work in influencing continuing education. For-profit, Medical Education and Communication Companies ("MECCs") work directly with pharmaceutical manufacturers to provide organization of meetings, develop educational materials, provide public relations services, and organize and prepare marketing campaigns.
295. See Steinbrook, supra, at 1060-61. These MECCs, which rely heavily on commercial support, may act as proxies for the industry in developing and arranging CME events that solely exist to promote specific pharmaceutical products.
296. See Relman, supra, at 2009-10. However, as support for CME generally originates from the marketing budgets of pharmaceutical manufacturers, the industry's support and funding of medical education simply represents another form of pharmaceutical detailing.
297. See id. at 2009. In fact, a recent report by the Senate Finance Committee has confirmed these concerns by concluding that some CME providers may still allow industry sponsors to exert improper influence on the content of educational activities despite the guise of independence.
298. See U. S. SENATE COMM. ON FIN., COMM. STAFF REPORT TO THE CHAIRMAN AND RANKING MEMBER, use OF EDUCATIONAL GRANTS BY PHARMACEUTICAL MANUFACTURERS (2007), available at http://www.acme-assn.org/home/prb042507a.pdf. Recent Senate hearings on conflicts of interest in medical education have re-emphasized these concerns in light of growing industry funding, and have led to calls for increased transparency and better control mechanisms.
299. See Press Release, U. S. Senate Special Committee on Aging, Kohl Hearing Considers Effects of Billions in Drug, Device Funding on Medical Education in America (July 29, 2009), available at http://aging.senate.gov/hearing-detail. cfm?id=3l6395&. Testimony included in this hearing discussed accreditation standards and oversight of CME, off-label promotion in CME, and federal enforcement of industry-sponsored CME practices.
300. See Commercial Sponsorship of Continuing Medical Education: Hearing Before Senate Special Comm. on Aging, 111th Cong. (2009) (statement of Lewis Morris, Chief Counsel of the OIG DHHS), available at http://oig.hhs.gov/ testimony/docs/2009/07292009-oig-testimony.pdf. Reform considerations included establishing appropriate safeguards to prevent undue industry influence in commercial sponsorship of CME including, separating grant making functions from sales and marketing, establishing criteria or creation of independent CME grant organizations for grants to CME providers, and eliminating control over speakers or content of CME, as well as shifting the cost of CME to physicians similar to other professions.
301. Id. at 6-7. Analogous to these proposals is a recent special communication in the JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, which called for professional medical associations to adopt policies that significantly minimize or eliminate industry involvement including working. towards a complete ban on industry funding with the exception of journal advertising and exhibit hall fees, instituting interim policies in order to achieve a complete ban such as establishing central pools for CME funds, seeking alternative funding, and implementing prohibitions on certain industry marketing and sponsorship activities.
302. See David J. Rothman et al., Professional Medical Associations and Their Relationships With Industry: A Proposal for Controlling Conflict of Interest, 301 JAMA 1367, 1367-72 (2009).
303. See, e.g., supra text accompanying notes 9 and 82 (discussing off-label promotion and detailing).
304. See Stephen Graham et al., Effect of an Academic Detailing Intervention on the Utilization Rate of Cyclooxygenase-2 Inhibitors in the Elderly, 42 ANN. PHARMACOTHERAPY 749, 749 (2008).
305. See Wayne Kondro, Academic Drug Detailing: An Evidence-Based Alternative, 176 CAN. MED. ASSN. J. 429, 429 (2007).
306. See Graham et al., supra note 148, at 749.
307. See Michael Allen et al., Family Physicians' Perception of Academic Detailing: A Quantitative and Qualitative Study, 7 (36) BMC MED. EDUC. 1, 2 (2007).
308. See Kondro, supra note 149, at 429-30.
309. See id.
310. See The University of Vermont College of Medicine, Vermont Academic Detailing Program, http://www.med.uvm.edu/ahec/TBH-BL.asp?SiteAreaID=290 (last visited July 11, 2009).
311. See Independent Drug Information Service (iDiS), About Academic Detailing: PACE Program of Pennsylvania Dept. of Aging, http://www.rxfacts.org/ detailing.php (last visited July 11, 2009).
312. See South Carolina College of Pharmacy, What is SCORxE?, http://www.sccp.sc.edu/SCORxE/index.aspx (last visited July 11, 2009).
313. See Fred Gebhart, Academic Detailing Gathers Momentum, 152 (6) DRUG TOPICS 1, 1 (2008).
314. Press Release, U. S. Senate Special Committee on Aging, Kohl Hearing Seeks Alternative to Drug Industry's Controversial Practice of Educating Doctors About New Drugs (Mar. 12, 2008), available at http://aging.senate.gov/record. cfm?id=294740.
315. See THE PRESCRIPTION PROJECT, ACADEMIC DETAILING: EVIDENCE-BASED PRESCRIBING INFORMATION 3 (2009), http://www.prescriptionproject.org/tools/fact- sheets/files/0007-pdf. States such as Maine and Vermont assess fees on manufacturers to fund academic detailing programs.
316. See PRESCRIPTION POLICY CHOICES, PRESCRIBER EDUCATION PROGRAMS (2009), http://www.policychoices.org/documents/StatePrescriberEducationPrograms0909.pdf. D. C.'s SafeRx Act which requires licensure and fees for pharmaceutical detailing includes provisions for establishing and funding academic detailing programs.
317. See SafeRx Amendment Act, D. C. Law 17-131
318. D. C. Reg. 1659 (2008). Note that the Massachusetts Academic Detailing Program had a $250, 000 reduction in the FY2009 budget.
319. See Mass.gov, Fy 2009 Budget Summary, 45100716 Academic Detailing Program, June 22, 2009, available at http://www.mass.gov/bb/gaa/fy2009/app-09/ act-09/h451007l6.htm.
320. See PHRMA, PROFILE 2008 PHARMACEUTICAL INDUSTRY 2 (2008), available at http://www.phrma.org/files/2008%20Profile.pdf.
321. See Andrew Pollack, Despite Billions for Discoveries, Pipeline of Drugs Is Far From Full, N. Y. TIMES, Apr. 19, 2002, at C1;
322. see also Bryan A. Liang, Regulating Follow-On Biologies, 44 HARV. J. LEGIS. 363, 384-92 (2007) (arguing that the extensive regulatory approval system exacerbates the problem of decreasing new drug discovery).