ChimonasS.PattersonL.RaveisV.RothmanD., “Managing Conflicts of Interest in Clinical Care: A National Survey of Policies at U.S. Medical Schools,”Academic Medicine86, no. 3 (2011): 293–299, at 293–295.
4.
MartinJ. B., “The Pervasive Influence of Conflicts of Interest: A Personal Perspective,”Neurology74, no. 24 (2010): 2016–2021, 2016–2021.
5.
HafemeisterT. L.BryanS. P., “Beware Those Bearing Gifts: Physicians' Fiduciary Duty to Avoid Pharmaceutical Marketing,”University of Kansas Law Review57, no. 491 (2009): 491–537, at 507.
6.
RothmanD. J.ChimonasS., “Academic Medical Centers' Conflict of Interest Policies,”JAMA304, no. 20 (2010): 2294–2295, at 2294. It appears that in some cases physicians are allowed to add additional material to the officially sanctioned slide deck. However, with the recent crackdown on off-label marketing, it seems that pharmaceutical companies are more and more requiring all speakers to use the slides they provide and to present them in the order specified by the pharmaceutical company. Companies that do allow a speaker to give feedback on the content of slides typically require any modifications to the slide-deck to be pre-approved by the pharmaceutical company.
BrennanT. A., “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers,”JAMA295, no. 4 (2006): 429–433, at 432. One individual described his experience as an industry-sponsored speaker: In 2001, he was “flown to New York for a ‘faculty-development program’ [and] pampered in a Midtown hotel for two nights'” to educate him about the product. He was subsequently paid between $500 and $750 for a one-hour “Lunch and Learn” in which he spoke at local doctors' offices about Effexor. In one year of speaking to doctors on behalf of Wyeth, he made approximately $30,000 in supplementary income. He recognized that he persuaded many physicians to prescribe Effexor, and posited that his lectures may have contributed to “faulty medical decision making” or led doctors “to make inappropriate drug choices” that may have made “their patients suffer needlessly” from Effexor's poorly published, but significant withdrawal symptoms.” As cited in HafemeisterT. L.BryanS. P., “Beware Those Bearing Gifts: Physicians' Fiduciary Duty to Avoid Pharmaceutical Marketing,”University of Kansas Law Review57, no. 491 (2009): 491–537, 496–497.
10.
Research indicates that such influence occurs in ways that individuals cannot perceive and creates subtle biases that are not humanly possible to eliminate. See, BrennanT. A., “Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers,”JAMA295, no. 4 (2006): 429–433; see, DanaJ.LowensteinG., “A Social Science Perspective on Gifts to Physicians from Industry,”JAMA290, no. 2 (2003): 252–255; see, Baylor College of Medicine, The Scientific Basis of Influence and Reciprocity: A Symposium, Association of American Medical Colleges, 2007.
11.
See ChimonasPattersonRaveisRothman, supra note 5. See RothmanChimonas, supra note 3, at 2294–95.
Pharmaceutical companies that engage speakers primarily to increase their own scripts are able to cull that information from a process known as pharmaceutical “data mining.” Data mining organizations purchase certain prescriber-identified raw data from pharmacies, combine it with physician information purchased from other organizations, even including the AMA, and sell to pharmaceutical companies. Records include such information as the prescribing habits of individual physicians and allow them to identify and target those physicians who routinely prescribe the company's product or a competitor's product. Since one of the goals of Speakers' Bureaus is to engage as speakers those physicians who write certain prescriptions, the purchase of prescriber-identified data achieves that goal. It also makes clear the proposition that Speaker's Bureaus are purely a marketing enterprise.
16.
U.S. ex. rel. Jeremy Garrity v. Novartis Pharmaceutical Corp., First Amended False Claims Act Complaint, Civ. Action No. 08 CV 2588 (August 17, 2010).
17.
31 U.S.C. § 3729 et. seq
18.
U.S. ex. rel. Jeremy Garrity v. Novartis Pharmaceutical Corp., First Amended False Claims Act Complaint ¶ 48, Civ. Action No. 08 CV 2588 (August 17, 2010).
MartinJ. B., “The Pervasive Influence of Conflicts of Interest: A Personal Perspective,”Neurology74, no. 24 (2010): 2016–2021, at 2019.
27.
DubovskyS. L., “Can Academic Departments Maintain Industry Relationships While Promoting Physician Professionalism?”Academic Medicine85, no. 1 (2010): 68–73, at 68.
28.
TabasJ. A., “Clinician Attitudes about Commercial Support of Continuing Medical Education,”Archives of Internal Medicine171, no. 9 (2011): 840–846, at 842.
29.
See WazanaA., “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?”JAMA283, no. 3 (2000): 373–380; See, IsersonK. V.CerfolioR. J.SadeR. M., “Politely Refuse the Pen and the Note Pad: Gifts from Industry to Physicians Harm Patients,”Annals of Thoracic Surgery84, no. 4 (2007): 1077–1084; SpiegelA., “How to Win Doctors and Influence Prescriptions,”NPR, October 21, 2010, available at <http://www.npr.org/templates/story/story.php?storyid=130730104> (last visited April 18, 2012).
LaddE., “Pharmaceutical Industry Sponsorship and the NP Prescriber: Policy and Practice Implications,”Journal of Nurse Practitioners7, no. 2 (2011): 102–108, at 103.
36.
FischerM. A.AvornJ., “Economic Consequences of Underuse of Generic Drugs: Evidence from Medicaid and Implications for Prescription Drug Benefit Plans,”Health Services Research38, no. 4 (2003): 1051–1064, at 1055.
37.
DresserR., “Pharmaceutical Company Gifts: From Voluntary Standards to Legal Demands,”Hastings Center Report36, no. 3 (May-June 2006): 8–9, at 8.
38.
See FDA regulations under the Food, Drug and Cosmetic Act at 21 U.S.C §331(d); 21 C.F.R. §202.1(e)(4)(i)(a).
39.
See 21 C.F.R. § 201.128 (2010).
40.
See 21 CFR 312.3(b)(2010).
41.
Scientists, physicians, and others are free to consider and discuss of-label uses of approved drugs for purposes unrelated to the promotion or marketing of company products. See 21 C.F.R. § 201.128. See also WeberT.OrnsteinC., “Drug Companies Retain Tight Control of Physicians' Presentations,”Propublica, December 19, 2010, available at <http://www.propublica.org/article/drug-companies-retain-tight-control-of-physicians-presentations/single> (last visited April 18, 2012).
42.
The FDA views as speaker as having control over a presentation when the speaker is “independent” of pharmaceutical influence over the content of an educational presentation. The FDA states that influence can be both direct (a pharmaceutical company being involved in the selection of speakers or treatment of topics), or indirect (“through the nature of the relationship between the company and the provider [e.g., if the provider has reason to believe that future financial support from the company depends upon producing programs that promote the company's products]).” To assess independence, the FDA looks at the following: (1) control of content and selection of presenters and moderators; (2) whether meaningful disclosures are made; (3) the focus of the program; (4) relationship between provider and supporting company; (5) provider involvement in sales or marketing; (6) provider's demonstrated failure to meet standards; (7) multiple presentations; (8) audience selection; (9) opportunities for discussion; (10) dissemination; (11) ancillary promotional activities; and (12) complaints. “Guidance for Industry: Industry-Supported Scientific and Educational Activities,” 62 Fed. Reg. 232, 64093 (Wednesday, December 3, 1997); see Kassirer, supra note 20.
43.
See 2011 litigation filed in Massachusetts by Attorney General Martha Coakley against Ortho-McNeil-Janssen alleging illegal off-label marketing of its product, Risperdal.
44.
See Kassirer, supra note 20.
45.
See WeberOrnstein, supra note 41.
46.
The FDA requires there to be a “fair balance” between risk and benefit information presented in pharmaceutical advertisements. The fair balance standard means that “the presentation of true information relating to side effects and contraindications is comparable in depth and detail with the claims for effectiveness or safety.” 21 C.F.R § 202.1(e)(5)(ii) (2011).
47.
The FDA requires that promotional materials, among other things, should: (1) be accurate and not misleading, (2) make claims about a product only when properly substantiated, (3) reflect a fair balance between risks and benefits, and (4) not promote uses for which that product has not been approved. Prescription Drug Advertising 21 C.F.R. § 202.1 (2011). 62 Fed. Reg. 232, 64093 (December 3, 1997).
Dudley MillerJ., “Conflict of Interest Spurs New Rules, Not Consensus,”Journal of the National Cancer Institute98, no. 23 (2006): 1678–1679.
55.
See, StosselT.KirbyL., “Has the Hunt for Conflicts of Interest Gone Too Far?”BMJ336, no. 7642 (March 1, 2008): 476–477.
56.
On June 8, 2011, Pfizer announced that it would invest $100 million in a research center called The Center for Therapeutic Innovation. The Center for Therapeutic Innovation will be based in the Longwood Medical Area in Boston and will collaborate with several area hospitals as well as Boston University, Tufts University School of Medicine, and Harvard University.
57.
StellL. K., “Drug Reps Off Campus! Promoting Professional Purity by Suppressing Commercial Speech,”Journal of Law, Medicine & Ethics37, no. 3 (Fall 2009): 431–443, at 435.
58.
DanaJ.LowensteinG., “A Social Science Perspective on Gifts to Physicians from Industry,”JAMA290 (2003): 253–255; Association of American Medical Colleges, Baylor College of Medicine, The Scientific Basis of Influence and Reciprocity: A Symposium,Association of American Medical Colleges, Washington, D.C., 2007.
59.
RosboroughR. S., “Comment: A ‘Great’ Day for Academic Freedom: The Threat Posed to Academic Freedom by the Supreme Court's Decision in Garcetti v. Ceballos,”Albany Law Review72, no. 565 (2009): 565–596, at 573–574.
60.
Id.
61.
Id.
62.
Id.
63.
Jeffries v. Harleston, 52 F.3d 9, 12–13 (1995) (anti-semitic speech with potential to disrupt university operations); Water v. Churchill, 511 U.S. 661, 675 (1994) (U.S. Supreme Court earlier held that an employee's extramural speech was not protected if it interferes with the employer's activities).
64.
See Rosborough, supra note 59.
65.
126 S.Ct. 1951, 1960 (2006).
66.
Justice Kennedy, writing for the majority, noted that his opinion leaves open the question of “whether the analysis we conduct today would apply in the same manner to a case involving speech related to scholarship or teaching.” 126 S.Ct at 1962.
67.
694 F. Supp.2d 817 (S.D. Ohio 2010).
68.
Id., at 844.
69.
474 U.S. 214 (1985).
70.
Id., at 225.
71.
561 F.3d 179 (3rd Cir. 2009).
72.
Id., at 186. Note that this was a public university setting.
73.
See Anderson v. Ohio State University, 26 Fed. Appx 412, 414 (6th Cir 2001) in which the Sixth Circuit Court of Appeals held that in a public university university officials are entitled to qualified immunity for a decision revoking tenure as a violation of due process. See also O'NeillR. M., “Judicial Deference to Academic Decisions: An Outmoded Concept?”Journal of College & University Law36 (2010): 729–747.
74.
Gressley v. Deutsch, 890 F.Supp 1474, 1490–91 (D.Wyo. 1994). (University trustees granted quasi-judicial immunity for faculty disciplinary decision that resulted in termination for cause.)
75.
The data and narratives on reciprocity suggest that payment by industry alone, whether as part of a marketing activity or not, is sufficient for physicians to feel an obligation to reciprocate and therefore be influenced by their relationship with the pharmaceutical industry. See, see DanaLowenstein, supra note 10, at 253–255 and Kassirer, supra note 20. The FDA further reinforces that industry influence can be indirectly present if “the provider has reason to believe that future financial support from the company depends upon producing programs that promote the company's products.” Guidance for Industry: Industry-Supported Scientific and Educational Activities, 62 Fed. Reg. 232, 64095 (December 3, 1997).
76.
See Ladd, supra note 35, at 104.
77.
See Tabas, supra note 30, at 843.
78.
Id., at 840; Andrew KofkeW., “Disclosure of Industry Relationships by Anesthesiologists: Is the Conflict of Interest Resolved?”Current Opinions in Anesthesiology23, no. 2 (2010): 177–183, at 177–183. See Tabas, supra note 30, at 840.
79.
Id. Similarly, in a 2001 U.S. study, 84 percent of internal medicine residents believed that the prescribing of others was influenced by interactions with pharmaceutical sales representatives, but only 39 percent believed such interactions affected their own behavior. See SteinmanM. A.ShlipakM. G.McPheeS. J., “Of Principles and Pens: Attitudes and Practices of Medicine Housestaff towards Pharmaceutical Industry Promotions,”American Journal of Medicine110, no. 7 (2001): 551–557.
80.
The decisions listed are identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content of the CME, selection of educational methods, and evaluation of the activity. Accreditation Council for Continuing Education, ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities, 2007.
81.
Id. Specifically, a CME provider cannot be required to “accept advice or services concerning teachers, authors, or participants or other education matters, including content, from a commercial interest as conditions of contributing funds or services.” Id.
82.
Stanford and UMass Memorial Health Care have both taken this step. SteinbrookR., “Future Directions in Industry Funding of Continuing Medical Education,”Archives of Internal Medicine171, no. 3 (2011): 257–258, at 258.
83.
Some AMCs, such as Memorial Sloan-Kettering Cancer Center, have stopped accepting support for CME from pharmaceutical and medical device companies; others, such as the University of Michigan, are planning to do so soon. See Steinbrook, supra note 91, at 257.
84.
American Medical Association, AMA Vote: Report 1 of the Council on Ethical and Judicial Affairs (A-11), Financial Relationships with Industry in Continuing Medical Education (Reference Committee on Amendments to Constitution and Bylaws), June 20, 2011.
MillerT. E., “Outside Counsel: Health Reform Mandates Transparency in Industry-Provider Relationship,”New York Law Journal245, no. 25 (February 7, 2011), available at <http://www.newyorklawjournal.com/PubArticleNY.jsp?id=1202480429393> (last visited April 29, 2012).
87.
Pharmaceutical and Device Manufacturer Conduct, Mass. Gen. Laws. ch.111N §§1–7 (2008).
88.
See Steinbrook, “A Higher Bar- Vermont's New Law on Marketing Prescribed Products,”New England Journal of Medicine361, no. 1 (2009): 8–9, at 8; BoumilM.BermanH., “Towards a Greater Level of Transparency: The New Massachusetts Pharmaceutical Industry Conflict of Interests Law,”Harvard Health Policy Review10, no. 1 (2009): 31–35, at 33–35.
89.
Id., at 34.
90.
Id.
91.
The law further allows: Consulting arrangements, the purchase of advertising space in academic journals, payment for participation in clinical trials, and reimbursement for expenses related to technical training in the use of a medical device.
92.
Patient Protection and Affordable Care Act, Pub.L.No. 111–148, 124 Stat. 119, amended by the Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111–152, § 6002.
93.
The law requires drug, biologics, medical supply, and medical device manufacturers who are covered under Medicare, Medicaid, or the Children's Health Insurance Program to publicly report to the Department of Health and Human Services (HHS) gifts and payments made to physicians and teaching hospitals. Pew Prescription Project, Fact Sheet: Physician Payment Sunshine Provisions in Health Care Reform, March 23, 2010, available at <http://www.prescriptionproject.org/tools/sunshine_docs/files/Sunshine-fact-sheet-6.07.10.pdf> (last visited April 19, 2012). These companies must report the physician or teaching hospital's name, address, national provider identifier (for physicians), and the value, date, form (cash or stock), and nature (gift, royalty, consulting fee) of the payment, including, if applicable, the specific drug and device to which the payment was related.
94.
The law provides an exception that allows pharmaceutical companies to ensure intellectual property rights by not having to disclose research support for four years or until a newly developed product is approved, whichever is first. HughesV., “Sunshine on Conflicts,”Nature Biotechnology28, no. 7 (2010): 641–643, at 642.
95.
See Pew Prescription Project, supra note 92.The information on the website HHS will create is scheduled to be publicly available by September 30, 2013 and must be readily searchable by physician so that patients have the opportunity to learn about their physician's potential conflicts of interest.
96.
Exempted from these requirements are prescription drug and device samples, payments less than $10 (if the person does not receive an aggregate annual amount from that company of over $100), educational materials provided for the benefit of patients, rebates and discounts, loans of a covered device for a period of less than 90 days, items provided under warranty, dividend or investment interest in a publicly-traded security or mutual fund, and payments made to a physician who is a patient or an employee of the reporting company. See Pew Prescription Project, supra note 93.
97.
Each failure of one of the covered companies to report a payment made results in a fine of up to $10,000, not to exceed $150,000 annually. Each knowing failure to report results in a fine of up to $100,000, not to exceed $1,000,000 annually. Id.
98.
As this article goes to press, the final implementing regulations are not yet posted. The legislation requires that the regulations be posted 90 days prior to the effective date of the law (January 1, 2012), but it did not occur. See Proposed Rules at Fed. Reg.Vol. 76No. 159 (August 17, 2011), available at <http://www.gpo.gov/fdsys/pkg/FR-2011-08-17/pdf/2011–20776.pdf> (last visited April 19, 2012).
Id. The policies also address other means of limiting conflicts of interest such as establishing central repositories for product samples and industry funds for CME, scholarships, fellowships and travel, requiring that members of purchasing committees be free of conflicts of interest, and requiring full transparency for industry honoraria and consulting contracts.
This type of approach has been adopted by the Stanford University School of Medicine, Harvard Medical School, and the University of Colorado Denver School of Medicine.
112.
Stanford prohibits speaking which amounts to a “contractual relationships to give talks in which the topic(s) and/or content are provided by the company.” Stanford School of Medicine, Policy and Guidelines for Interactions between the Stanford University School of Medicine, the Stanford Hospital and Clinics, and Lucile Packard Children's Hospital with the Pharmaceutical, Biotech, Medical Device, and Hospital and Research Equipment and Supplies Industries (“Industry”), Revised July 22, 2010, available at <http://med.stanford.edu/coi/siip/policy.html#v> (last visited April 23, 2012).
113.
The University of Colorado at Denver defines Speakers' Bureaus as “[c]ompensation by any pharmaceutical company, medical device manufacturer or manufacturer of other health-or nutrition-related products, or their subsidiaries, for speaking engagements whether on a one-time or recurring basis.” University of Colorado Denver School of Medicine, Faculty Senate Resolution on Conflicts of Interest and Speakers Bureaus, May 2011, available at <http://www.ucdenver.edu/academics/colleges/medicalschool/facultyAffairs/RulesPolicies/Pages/RulesPolicies.aspx> (last visited April 23, 2012).
114.
This approach has been taken by the Tufts University School of Medicine, Boston University School of Medicine, and the University of Pittsburgh Schools of Health Sciences.
115.
See WeberOrnstein, supra note 41.
116.
See, e.g., Duke University School of Medicine, COI and Industry Relations, available at <http://medschool.duke.edu/modules/som_interests/index.php?id=7#Speaking%20Relationships> (no longer available online.) Duke's policy allows participation in industry Speakers' Bureaus if “(1) the activity promotes evidence-based clinical care and/or advances research; (2) financial support is appropriately disclosed; (3)…financial compensation [is pursuant to] a speaker's contract; (4) compensation…[is] reasonable (i.e. fair market value); (5) [the] lecture material represents a balanced assessment of current clinical and/or scientific treatments; [and] 6) the speaker discloses that the [content] represents his or her [own] views and not [just that of the industry sponsor].”
117.
The University of Pennsylvania and Duke have adopted this approach.
118.
The University of Pennsylvania policy states that “professionals should not participate in Industry marketing activities” but, of course, this falls short of an absolute prohibition. The University of Pennsylvania also allows faculty to “accept reimbursement (of travel, meals, and other expense) for presenting research findings at a meeting, presenting on clinical topics…provided that the expenses are reasonable in relation to the services provided (fair market value).” Though the Chief Medical Officer of University of Pennsylvania recently stated that he believed UPENN's policy's prohibition on marketing includes delivering drug-company lectures, the “fair market value” caveat along with the “should” seems to imply that at least some industry marketing “presentations” are fair game. See Hospital of the University of Pennsylvania/Clinical Practices of the University of Pennsylvania: Clinical Practice Guidelines. Guidelines for Interactions between Health care Professionals and Industry, effective September 26, 2006, available at <somapps.med.upenn.edu/fapd/documents/ext00159.pdf> (last visited April 29, 2012).
119.
This approach has been taken by Weill Medical College of Cornell University and Tulane University.
120.
The Cleveland Clinic requires disclosure of industry relationships on a public website but does not restrict industry speaking.
121.
To the extent that public disclosure is required, it has the potential to result in heightened public scrutiny of industry-physician relationships by policymakers, the media, and consumer advocacy groups. It also creates pressure on states and AMCs to create policy. GrandeD., “Limiting the Influence of Pharmaceutical Industry Gifts on Physicians: Self-Regulation or Government Intervention,”Journal of General Internal Medicine25, no. 1 (2010): 79–83, at 80.
122.
BoumilM. M.BermanH., “Transparency in Research and Its Effect on the Perception of Research Integrity,”JONA's Healthcare Law, Ethics, and Regulation12, no. 3 (2010): 64–68, at 66.
123.
LoB.KelchR. P.GradyD., “Illuminating Physicians' Financial Relationships with Industry,”Archives of Internal Medicine171, no. 6 (2011): 587–589, at 588.
124.
SteinbrookR., “Controlling Conflict of Interest – Proposals from the Institute of Medicine,”New England Journal of Medicine360, no. 21 (2009): 2160–2163, at 2162.
125.
AngellM., “Warning Doctor/Drug Company Interactions,”Health Affairs30, no. 2 (2011): 363–364, at 364.
126.
GrandeD., “Limiting the Influence of Pharmaceutical Industry Gifts on Physicians: Self-Regulation or Government Intervention,”Journal of General Internal Medicine25, no. 1 (2010): 79–83, at 80.
127.
CainD. M.LowensteinG.MooreD. A., “The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest,”Journal of Legal Studies34, no. 1 (2005): 1–25, at 1–25.
128.
As is apparent from the three Harvard physicians recently sanctioned for failing to disclose millions of dollars in income that they received from pharmaceutical companies, disclosure without a means of double-checking the accuracy of what is disclosed is likely to result in an inaccurate reporting of physicians true relationship with industry. If and when health care reform goes into effect, it could ease the difficulty of validating accurate disclosure of relationships, but until that time there are only a few medical schools that have the ability to validate the accuracy of their data.
129.
See WeberOrnstein, supra note 49.
130.
Williams-JonesB., “Beyond a Pejorative Understanding on Conflict of Interest,”American Journal of Bioethics11, no. 1 (2011): 1–2, at 1–2.
See Williams-Jones, supra note 130. In 2008 Senator Charles Grassley undertook an effort to examine the influence of drug companies at medical schools. He sent letters to medical schools asking them provide the Senate with their policies. He also targeted specific individuals for detailed inquiry. See, ZiegerA., “Grassley Wants to See Med Schools' Conflict of Interest Policies,”Fierce Healthcare, June 25, 2009, available at <http://www.fercehealthcare.com/story/grassley-wants-see-med-schools-conflict-interest-policies/2009-06-25> (last visited April 23, 2012).
144.
SoumeraiS. B.AvornJ., “Principles of Educational Outreach (‘Academic Detailing’) to Improve Clinical Decision Making,”JAMA263, no. 4 (1990): 549–556, at 549–556.
