1 Ray Dorsey, E. et al., Funding of US Biomedical Research, 2003-2008, 303 JAMA 137, 142 (2010)Google Scholar (citing Gail R. Wilensky, Developing a Center for Comparative Effectiveness Information, 25 Health Aff. w572 (2006)).

2 See Gagnon, Marc-Andre & Lexchin, Joel, The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States, 5 PLoS Med. 29, 32 n.4 (2008);CrossRefGoogle ScholarPubMed id. at 32 (discussing a PhRMA press release claiming that in the U.S. the industry spent $29.6 billion on R&D in 2004 and $27.7 billion for all promotional activities, which the authors note excluded several major categories of promotional activities, suggesting a conclusion that “pharmaceutical companies spend almost twice as much on promotion as they do on R&D”). Whatever its precise size, such an enormous investment in promotional activities would be irrational if it did not change the behavior of physicians and consumers. Some such changes in behavior are of course salutary, if they drive a doctor away from an obsolete treatment and towards one that is instead effective, safe, and economical—one that just happens to be patented by a major pharmaceutical company.

3 See, e.g., Thompson v. W. States Med. Ctr., 535 U.S. 357 (2002) (overturning certain regulations that pertained to prescription drug compounding as unconstitutional restrictions on commercial speech).

4 See, e.g., IMS Health Inc. v. Sorrell, 630 F.3d 263, 267 (2d Cir. 2010) (holding that a Vermont statute violated the First Amendment by restricting prescribing information available to manufacturers who used such information to send “detailers” to influence physicians), cert. granted, 131 S. Ct. 857 (2011).

5 Fugh-Berman, Adriane & Melnick, Douglas, Off-Label Promotion, On-Target Sales, 5 PLoS Med. 1432, 1433 (2008).CrossRefGoogle ScholarPubMed

6 Smith, Richard, Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies, 2 PLoS Med. 364 (2005)CrossRefGoogle ScholarPubMed; see Dan Wikler, A Crisis in Medical Professionalism: Time for Flexner II, in Ethics and the Business of Biomedicine 249, 251 (Denis G. Arnold ed., Cambridge Univ. Press, 2009) (compiling this and other sources cited below).

7 Moffatt, Barton & Elliott, Carl, Ghost Marketing: Pharmaceutical Companies and Ghostwritten Journal Articles, 50 Persp. Biology & Med. 18, 19 (2007)CrossRefGoogle ScholarPubMed (quoting a document that was produced in Motus v. Pfizer, 358 F.3d 659 (9th Cir. 2004)).

8 See generally Thomas O. McGarity & Wendy E. Wagner, Bending Science: How Special Interests Corrupt Public Health Research (2008) (describing ways in which scientific processes are corrupted by special interests).

9 Irwin, Richard S., The Role of Conflict of Interest in Reporting of Scientific Information, 136 Chest 253, 254 (2009)CrossRefGoogle ScholarPubMed (writing as the former editor-in-chief of the journal).

10 Richard Horton, The Dawn of McScience, 51 N.Y. Rev. Books, Mar. 11, 2004, at 9.

11 In re Zyprexa Prods. Liab. Litig., 253 F.R.D. 69, 106 (E.D.N.Y. 2008), rev’d, UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121 (2d Cir. 2010) (reversing on the question of causation).

12 Dorsey et al., supra note 1, at 139; Moses, H. III et al., Financial Anatomy of Biomedical Research, 294 JAMA, 1333, 1333 (2005CrossRefGoogle ScholarPubMed); Bekelman, Justin E. et al., Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review, 289 JAMA 454, 454 (2003)CrossRefGoogle ScholarPubMed; see also Zinner, D. E., Participation of Academic Scientists in Relationships with Industry, 28 Health Aff. 6, at 1814-25 (2009)CrossRefGoogle ScholarPubMed (explaining further the financial conflicts of interest present in biomedical research).

13 Bodenheimer, Thomas, Uneasy Alliance—Clinical Investigators and the Pharmaceutical Industry, 342 New Eng. J. Med. 1539, 1539 (2000).CrossRefGoogle ScholarPubMed

14 Rose, Susannah L. et al., Relationships Between Authorship Contributions and Authors’ Industry Financial Ties Among Oncology Clinical Trials, 28 J. Clinical Oncology 1316, 1316 (2010).CrossRefGoogle ScholarPubMed

15 See Alex Wayne, GOP Budget Cuts Likely to Hurt Research, NIH Says, Wash. Post, Nov. 9, 2010, available at http://www.washingtonpost.com/wp-dyn/content/article/2010/11/09/AR2010110906764.html.

16 Institute of Medicine, Board on Health Sciences Policy, Conflict of Interest in Medical Research, Education, and Practice 104 (2009) [hereinafter IOM Report]; see also Golder, Su & Loke, Yoon K., Is There Evidence for Biased Reporting of Published Adverse Effects Data in Pharmaceutical Industry-Funded Studies?, 66 Brit. J. Clinical Pharmacology 767, 767 (2008)CrossRefGoogle ScholarPubMed; Hirsch, Laurence, Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals, 84 Mayo Clinic Proc. 811, 812 (2009)CrossRefGoogle ScholarPubMed (discussing evidence that these discrepancies may be due to publication bias, i.e., the industry’s self-censoring of unfavorable results).

17 Friedberg, Mark et al., Evaluation of Conflict of Interest in Economic Analyses of New Drugs Used in Oncology, 282 JAMA 1453, 1455 (1999)CrossRefGoogle Scholar; see generally Sax, Joanna K., Protecting Scientific Integrity: The Commercial Speech Doctrine Applied to Industry Publications, 37 Am. J.L. & Med. 203 (2011)Google ScholarPubMed; see also Bekelman, J. E., Li, Y. & Gross, C.P., Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review, 289 JAMA 454, 454-65 (2003)CrossRefGoogle ScholarPubMed; Joel Lexchin et al., Pharmaceutical Industry Sponsorship and Research Outcome and Quality: Systematic Review, 326 Brit. Med. J. 1167 (2003) (showing that, over the course of multiple studies, research funded by drug companies was more likely to have outcomes favoring the sponsor than studies with non-drug company sponsors).

18 See infra note 59 and accompanying text.

19 See Dorsey et al., supra note 1, at 141 (describing the industry’s “preference for [research] investments of lower risk”).

20 See Bodenheimer, supra note 13 (describing an interview).

21 Noordin, Shahryar et al., Relationship Between Declared Funding Support and Level of Evidence, 92 J. Bone & Joint Surgery Am. 1647, 1647 (2010)CrossRefGoogle ScholarPubMed. But see Lexchin et al., supra note 17, at 1167 (finding that within the category of randomized controlled trials, that industry sponsored studies were no worse methodologically).

22 For this distinction in another context, see, Caperton v. A.T. Massey Coal Co., 129 S. Ct. 2252, 2266 (2009), observing “[o]ne must also take into account the judicial reforms the States have implemented to eliminate even the appearance of partiality.”

23 Christopher T. Robertson, Blind Expertise, 85 N.Y.U. L. Rev. 174, 178 n.11 (2010) (quoting Langbein, John H., The German Advantage in Civil Procedure, 52 U. Chi. L. Rev. 823, 836 (1985)CrossRefGoogle Scholar).

24 Angell, Marcia, Industry-Sponsored Clinical Research: A Broken System, 300 JAMA 1069, 1070-71 (2008).CrossRefGoogle ScholarPubMed Angell goes on to say: “It is self-evidently absurd to look to investor-owned companies for unbiased evaluations of their own products. Yet many academic investigators and their institutions pretend otherwise, and it is convenient and profitable for them to do so.” Id.

25 Section 801 of the Food and Drug Administration Act of 2007 does require researchers to register interventional clinical trials and, for marketed products, to disclose the results of such trials within twelve months after study completion, on www.clinicaltrials.gov. See Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (to be codified in scattered sections of 21 U.S.C.). Following several state laws, as of 2013, federal law will also require the industry to disclose its financial relationships with physicians, though there are questions about the completeness and accuracy of such disclosures. See Charles Ornstein & Tracy Weber, Drug Companies’ Reports Aren’t Always Accurate, Star-Trib., Dec 12, 2010, available at http://www.startribune.com/business/111704609.html (discussing an analysis of Minnesota’s required disclosures).

26 See, e.g., UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121 (2d Cir. 2010) (holding that even if plaintiff could prove misrepresentations, it would be unable to prove a causal effect on the prices paid for drugs).

27 See Kesselheim, Aaron, Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech, 37 Am. J.L. & Med. 225, 241 tbl.1 (2011)Google ScholarPubMed (reviewing DOJ enforcement actions).

28 130 S. Ct. 1784 (2010).

29 Bombardier, Claire et al., Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis, 343 New Eng. J. Med. 1520, 1526 (2000).CrossRefGoogle ScholarPubMed

30 Gregory D. Curfman et al., Editorial, Expression of Concern: Bombardier et al., Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis, 353 New Eng. J. Med. 2813, 2813-14 (2005).Google Scholar

31 See Merck, 130 S. Ct. 1784.

32 There are also a variety of less prominent interventions. JAMA, for example, requires independent statistical analysis of industry-sponsored studies. See Hirsch, supra note 16, at 813 (discussing this policy and the backlash against it).

33 See Arturo Casadevall & Ferric C. Fang, Editorial, 77 Infection & Immunity 1273 (2009) (editor-in-chief of the journal, weighing the argument that peer review is censorship).

34 See DeAngelis, Catherine D., Editorial, The Influence of Money on Medical Science, 8 JAMA 996, at 996-98 (2006)CrossRefGoogle Scholar (arguing that certain studies were valid because they survived peer review, even though there were improprieties in the process of disclosing financial relationships with industry).

35 Peer reviewers are often not provided with the authors’ financial disclosures. See DeAngelis, Catherine D. et al., Editorial, Reporting Financial Conflicts of Interest and Relationships Between Investigators and Research Sponsors, 286 JAMA 89, 90 (2001)CrossRefGoogle ScholarPubMed. This policy is apparently intended to preserve the anonymity of the authors, so that the reviewers do not succumb to personal biases, pro or con. Some journals are moving towards a single-blind review, in part to allow reviewers to assess conflicts of interests.

36 Smith, Richard, Peer Review: A Flawed Process at the Heart of Science and Journals, 99 J. Royal Soc’y Med. 178, 179 (2006).Google ScholarPubMed

37 See sources cited supra Part I.B.1.

38 The Supreme Court tells a similar story in the context of mandatory disclosures for political campaign finance. Citizens United v. FEC, 130 S. Ct. 876, 916 (2010) (asserting that a disclosure mandate “enables the electorate to make informed decisions and give proper weight to different speakers and messages”). But see Hitoshi Mayer, Lloyd, Disclosures About Disclosure, 44 Ind. L. Rev. 255 (2010)Google Scholar (drawing on psychological literature to criticize this assumption as being too simplistic).

39 Such “off-label” prescribing is quite common and is perfectly legal; physicians can prescribe a drug for any indication as long as the drug has been approved for one indication. See generally Kesselheim, supra note 27.

40 Even with FDA approval of an on-label prescription, physicians still must make epistemic assessments when there are multiple competing treatment options, or where there are significant risks of side-effects, or generally if there is a risk that the FDA’s assessment may be unreliable.

41 See generally Tennenbaum, Joshua B. et al., Theory-Based Bayesian Models of Inductive Learning and Reasoning, 10 Trends Cognitive Sci. 309 (2006)CrossRefGoogle Scholar (describing Bayesian reasoning).

42 We are simply assuming, for the sake of argument, that a 0.5 estimate of the likelihood of efficacy is the threshold for a doctor prescribing the drug off-label. In reality, the threshold could be higher or lower, given the risks, costs, and benefits of the drug compared to alternative courses of treatment.

43 See Christopher T. Robertson, Biased Advice, Emory L.J. (forthcoming 2011) (an experimental study showing that disclosures of conflicting interests only helped laypersons when laypersons also had access to unconflicted advice).

44 See sources cited supra notes 16-21.

45 Chaudhry, Samena et al., Does Declaration of Competing Interests Affect Readers’ Perceptions? A Randomised Trial, 325 Brit. Med. J. 1391, 1392 (2002)CrossRefGoogle ScholarPubMed; see also Schroter, Sara et al., Does the Type of Competing Interest Statement Affect Readers’ Perceptions of the Credibility of Research? Randomised Trial, 328 Brit. Med. J. 742 (2004)CrossRefGoogle ScholarPubMed (finding similar results with multiple papers and testing both stock ownership and research grants disclosures).

46 See Thompson, Dennis F., Understanding Conflicts of Interest, 329 New Eng. J. Med. 573, 575 (1993)CrossRefGoogle ScholarPubMed (arguing that “[a] deficiency of disclosure is that those who receive the information may not know how to interpret it and may not in any case have reasonable alternative courses of action in the circumstances”); see also Kerber, Kevin A. & Mark Fendrick, A., The Evidence Base for the Evaluation and Management of Dizziness, 16 J. Evaluation Clinical Pract. 186, 189 (2010)Google ScholarPubMed (concluding that “[p]hysicians rely on the medical literature to inform decisions, but our study suggests that the evidence base for dizziness evaluation and management is weak”); see generally Eddy, David M., Variations in Physician Practice: The Role of Uncertainty, 3 Health Aff. 74 (1984)CrossRefGoogle Scholar (arguing that the practice of medicine is permeated by profound uncertainty about the comparative effectiveness of treatment options).

47 Silverman, Gabriel K. et al., Failure to Discount for Conflict of Interest When Evaluating Medical Literature: A Randomised Trial of Physicians, 36 J. Med. Ethics 265, 265-70 (2010).CrossRefGoogle ScholarPubMed

48 See also Licurse, Adam et al., The Impact of Disclosing Financial Ties in Research and Clinical Care: A Systematic Review, 170 Archives Internal Med. 675, 681 (2010)CrossRefGoogle ScholarPubMed (providing a literature review and concluding that “these disclosures appear to have a limited effect on behavioral outcomes”); Bonnie E. Glaser & Lisa A. Bero, Attitudes of Academic and Clinical Researchers Toward Financial Ties in Research: A Systematic Review, 11 Sci. & Engineering Ethics 553 (2005) (also reviewing this literature).

49 See generally Blum, Jared A. et al., Requirements and Definitions in Conflict of Interest Policies of Medical Journals, 302 JAMA 2230 (2009).CrossRefGoogle ScholarPubMed

50 Drazen, Jeffrey M. et al., Uniform Format for Disclosure of Competing Interests in ICMJE Journals, 361 New Eng. J. Med. 1896, 1896 (2009).CrossRefGoogle ScholarPubMed

51 Kevin P. Weinfurt et al., Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents, PloS ONE, May 7, 2008, available at http://www.plosone.org/article/info:doi/10.1371/journal.pone.0002128.

52 See IOM Report, supra note 16, at 77.

53 Pitkin, Roy M. et al., Accuracy of Data in Abstracts of Published Research Articles, 281 JAMA 1110, 1110-11 (1999)CrossRefGoogle ScholarPubMed (finding that 18-68% of abstracts (varying by journal) include findings “that are inconsistent with or absent from the article’s body . . . even in large-circulation general medical journals”). There is a debate about what information should be included in biomedical abstracts, and how they can be made more accurate. See generally Ad Hoc Working Group for Critical Appraisal of the Medical Literature, A Proposal for More Informative Abstracts of Clinical Articles, 106 Annals Internal Med. 598, 598-604 (1987).CrossRefGoogle Scholar

54 See Weiss, Scott T. & Samet, Jonathan M., An Assessment of Physician Knowledge of Epidemiology and Biostatistics, 55 J. Med. Educ. 692, 697 (1980)Google ScholarPubMed (“[P]hysicians may not be prepared adequately to evaluate medical literature”); Kuklin, Bailey, Probability Misestimates in Medical Care, 59 Ark. L. Rev. 527, 537 (2006)Google Scholar (discussing physicians’ difficulties with statistical reasoning).

55 Sally Hopewell, Better Reporting of Randomized Trials in Biomedical Journal and Conference Abstracts, 34 J. Info. Sci. 173 (2008) (suggesting that physicians form their first impressions of articles based on the abstracts); Tversky, Amos & Kahneman, Daniel, Judgment Under Uncertainty: Heuristics and Biases, 185 Science 1124, 1128 (1974)CrossRefGoogle ScholarPubMed (describing research on the anchoring effect).

56 For other research suggesting disclosure policies, see Rodwin, Mark A., Physicians’ Conflicts of Interest: the Limitations of Disclosure, 321 New Eng. J. Med. 1405, 1405-08 (1989)CrossRefGoogle ScholarPubMed; Brody, Baruch A. et al., Expanding Disclosure of Conflicts of Interest: The Views of Stakeholders, 25 IRB: Ethics & Hum. Res. 1, 1-8 (2003)CrossRefGoogle ScholarPubMed; Foster, Roger S., Conflicts of Interest: Recognition, Disclosure, and Management, 196 J. Am. Coll. Surgeons 505, 505-15 (2003)CrossRefGoogle Scholar; Michael S. Jellinek, IRBs and Pharmaceutical Company Funding of Research, 4 IRB: Ethics & Hum. Res. 9 (1982); Roizen, Ron, Why I Oppose Drug Company Payment of Physician/Investigators on a Per Patient/Subject Basis, 10 IRB: Ethics & Hum. Res. 9, 9-10 (1988)CrossRefGoogle ScholarPubMed; Spiro, Howard M., Mammon and Medicine: The Rewards of Clinical Trials, 255 JAMA 1174, 1174 (1986)CrossRefGoogle ScholarPubMed; Forster, Heidi P. et al., The 2000 Revision of the Declaration of Helsinki: A Step Forward or More Confusion?, 358 Lancet 1449, 1449-53 (2001)CrossRefGoogle ScholarPubMed; and Rothman, Kenneth J., Conflict of Interest: The New McCarthyism in Science, 269 JAMA 2782, 2782-84 (1993).CrossRefGoogle Scholar

57 Cain, Daylian M., Loewenstein, George & Moore, Don A., The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Interest, 34 J. Legal Stud. 1, 18 (2005)CrossRefGoogle Scholar; see also Ming Li & Kristóf Madarász, When Mandatory Disclosure Hurts: Expert Advice and Conflicting Interests, 139 J. Econ. Theory 47, 48–50, 60, 62–63 (2008).

58 This dynamic is similar to that documented by behavioral researchers in which imposition of a fine for a given behavior actually caused the frequency of that behavior to increase. See Uri Gneezy & Aldo Rustichini, A Fine is a Price, 29 J. Legal Stud. 1 (2000).

59 See generally Moffatt & Elliott, supra note 7.

60 Sismondo, Sergio, Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry?, 4 PLoS Med. 1429, 1429 (2007)CrossRefGoogle ScholarPubMed (quoting Alex Berenson, Evidence in Vioxx Suits Shows Intervention by Merck Officials, N.Y. Times Apr. 24, 2005, available at http://www.nytimes.com/2005/04/24/business/24drug.html).

61 David H. Freeman, Lies, Damned Lies, and Medical Science, Atlantic Monthly, Nov. 2010, at 80, available at http://www.theatlantic.com/magazine/archive/2010/11/lies-damned-lies-and-medical-science/8269/ (quoting John Ioannidis).

62 Schafer, Arthur, Biomedical Conflicts Of Interest: A Defence of the Sequestration Thesis – Learning From the Cases of Nancy Olivieri and David Healey, 30 J. Med. Ethics 8, 23 (2004).CrossRefGoogle Scholar

63 Id. In a provocative article, Ioannidis offers a mathematical model that demonstrates that because of these rampant commercial and other biases, and the many opportunities to express them, “most claimed research findings are false.” Ioannidis, John P. A., Why Most Published Research Findings Are False, 2 PLoS Med. 0696, 0696 (2005)CrossRefGoogle ScholarPubMed; see also Sackett, David L., Bias in Analytic Research, 32 J. Chronic Diseases 51, 51-63 (1979)CrossRefGoogle ScholarPubMed (describing some of these sources of bias); Bero, Lisa A. & Rennie, Drummond, Influences on the Quality of Published Drug Studies, 12 Int’l J. Tech. Assess. Health Care 209, 209-37 (1996)CrossRefGoogle ScholarPubMed (also describing some sources of bias).

64 See Robertson, supra note 23, at 185-88 (reviewing some of this literature); Michael Risinger, D. et al., The Daubert/Kumho Implications of Observer Effects in Forensic Science: Hidden Problems of Expectation and Suggestion, 90 Cal. L. Rev. 1, 18 (2002)Google Scholar (reviewing the behavioral research literature).

65 Many commentators opine that an outright ban on industry funding and a replacement with tax dollars is the only viable solution. See, e.g., Schafer, supra note 62, at 23 (“If the community values public science in the public interest then it will have to be paid for by public tax dollars.”). But see William M. Sage, Some Principles Require Principals: Why Banning “Conflicts of Interest” Won’t Solve Incentive Problems in Biomedical Research, 85 Tex. L. Rev. 1413, 1448–49 (2007) (arguing for more direct regulation of privately funded biomedical research).

66 Bodenheimer, supra note 13, at 1543.

67 Rosenthal, Robert, How Often Are Our Numbers Wrong?, 33 Am. Psychologist 1005, 1007 (1978)CrossRefGoogle Scholar; see generally D. Michael Risinger, The NAS/NRC Report on Forensic Science: A Glass Nine-Tenths Full (This Is About the Other Tenth), 50 Jurimetrics J. 21 (forthcoming 2011), available at http://ssrn.com/abstract=1437276 (discussing similar problems and potential solutions in the forensic science field).

68 See TMJ Implants, Inc. v. Aetna, Inc., 498 F.3d 1175, 1195 (10th Cir. 2007) (recognizing that the double-blind study is the gold standard in medicine); Grade Working Group, Grading Quality of Evidence and Strength of Recommendations, 328 Brit. Med. J. 1, 2 (2004)Google Scholar (explaining that reviewers assessing the quality of a study “may state that failure to blind patients and physicians reduced the quality of evidence for an intervention’s impact on pain severity and that they considered this a serious limitation”).

69 See Byar, David P. et al., Design Considerations for AIDS Trials, 323 New Eng. J. Med. 1343, 1345 (1990)CrossRefGoogle ScholarPubMed (“Blinding is especially desirable when subjective end points, such as pain, functional status, or quality of life, are studied, because such evaluations are open to substantial bias.”).

70 In some contexts, it is simply not feasible to require single or double blinding. For example, in the testing of surgical techniques or medical devices, both the surgeon and the patient may need to know what is being done. See Noah, Lars, Medicine’s Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community, 44 Ariz. L. Rev. 373, 391 (2002)Google Scholar (describing these limits).

71 Alternatively, following on the “double blind” model, this method could be called a “triple blind.” Alas, the term has already been deployed for other purposes. Triple Blind, Dorland’s Medical Dictionary for Health Consumers (2007), available at http://medical-dictionary.thefreedictionary.com/triple+blind (defining “triple blind” as “pertaining to clinical trial other experiment in which neither the subject nor the person administering the treatment nor the person evaluating the response to treatment knows which subjects are receiving a particular treatment or lack of treatment”).

72 Dennis Thompson has suggested that blinding could be employed in the medical context to solve conflict of interest problems. See Thompson, supra note 46, at 575 (“Because of the limitations of disclosure, more stringent methods of enforcement deserve consideration, especially in cases of more severe kinds of conflict of interest. Other methods (roughly in order of increasing stringency) include mediation (devices such as blind trusts that insulate the physician from the secondary interest) . . . .”). Sheldon Krimsky has called for the establishment of a new National Institute for Drug Testing (NIDT), which would receive industry funds but then itself organize the clinical trial. Sheldon Krimsky, Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? 229 (2003). Arthur Schafer has suggested that, “One practical possibility might be to require of any drug company which desires to bring a new drug to market that it provide to an independent institute all the funding necessary for the design and performance of a clinical trial of its drug. The institute would then allocate to qualified university and hospital researchers the task of conducting the necessary clinical trials.” Schafer, supra note 62, at 23. See also Marcia Angell, The Truth About the Pharmaceutical Industry: How They Deceive Us and What to Do About It 245 (2004) (calling for an independent drug evaluation agency within the NIH).

73 Some scholars have suggested that academic medical centers could act as an intermediary of sorts for unrestricted grants. See Brennan, Troyen A. et al., Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical Centers, 295 JAMA 429, 432 (2006)CrossRefGoogle ScholarPubMed (“To promote scientific progress, [Academic Medical Centers] should be able to accept grants for general support of research (no specific deliverable products) from pharmaceutical and device companies, provided that the grants are not designated for use by specific individuals. As long as the institution stands between the individual investigator and the company making the grant, the likelihood of undue influence is minimized but certainly not eliminated”); see also Bodenheimer, supra note 13, at 1543 (“Some investigators interviewed for this article felt that drug trials should be funded by industry but that design, implementation, data analysis, and publication should be controlled entirely by academic medical centers and investigators.”).

74 In practice, some professional judgment will be required to assess whether the funder’s stipulations are reasonable, or whether they are instead attempts to bias the design of the study. For example, if a study is designed to explore safety, then severely underfunding the study could cause the resulting study to be underpowered, which would then increase the odds of falsely affirming the null hypothesis that there are no side effects.

75 Alternatively, an investigator may conceive of a hypothesis and experiment to test some product and then seek funding from the intermediary. If the intermediary finds the proposal promising, it could then request support from the company. The company could then agree to disburse the funds to the intermediary, without knowing the identity of the researcher or the particular research design.

76 Nat’l Inst. of Health, Research Project Grants & Other Mechanisms: Competing Applications, Awards, Success Rates, and Total Funding Made with Direct Authority and Superfund Funds, by NIH Institutes/Center, Grant Mechanisms, and Activity Codes, NIH Res. Portfolio Online Reporting Tools (Dec. 17, 2010), http://report.nih.gov/FileLink.aspx?rid=601.

77 Nat’l Inst. of Health, Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC), NIH Res. Portfolio Online Reporting Tools, http://report.nih.gov/rcdc/categories/ (table data as of Mar. 15, 2011).

78 See Nat’l Inst. of Health, supra note 76 (reporting 14,600 grants distributed out of 65,000 grant applications in 2010).

79 HHS Evaluation and Disposition of Applications, 42 C.F.R. § 52.5(b) (2010).

80 Grassetti v. Weinberger, 408 F. Supp. 142, 151 (N.D. Cal. 1976).

81 The FDA, however, has greater risks of regulatory capture, see infra note 92, and may be inadequately staffed to take on these responsibilities. See U.S. Gov’t Accountability Office, Food and Drug Administration: FDA Faces Challenges Meeting its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs 16 (2009), available at http://www.gao.gov/new.items/d09581.pdf.

82 See, e.g., Early Consultation, 21 C.F.R. § 312.82 (2010) (encouraging drug makers to work with regulators “to review and reach agreement on the design” of studies before they are carried out).

83 In 2009, a review of the literature that the FDA used to approve cardiovascular devices found that although almost all the studies were industry-funded, they were extremely weak methodologically, and only nine percent of them were double-blinded. Sanket S. Dhruva et al., Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices, 302 JAMA 2679, 2682 tbl.1 (2009).

84 See discussion supra Part I.B.3.

85 See Dean Keith Simonton, Scientific Genius: A Psychology of Science 5, 42 (1990) (discussing Thomas Kuhn’s recognition of an “essential tension” between the “traditionalist” and the “iconoclast” roles of a scientist and F. C. Bartlett’s differentiation between “original and routine information processing”).

86 Indeed, the industry already outsources much of these routine testing functions to contract research organizations, the key is simply to break the yoke of influence over them. See Schafer, supra note 62, at 23 (under the status quo, “[c]ontract research organisations with a reputation for producing favourable results for drug companies’ products are likely to flourish, while those with more scrupulous standards are likely to go out of business”); see generally Phillip Mirowski & Robert Van Horn, The Contract Research Organization and the Commercialization of Scientific Research, 35 Soc. Stud. Sci. 503 (2005) (describing this trend).

87 I thank Larry Lessig for this insight.

88 See David Willman, Stealth Merger: Drug Companies and Government Medical Research, L.A. Times, Dec. 7, 2003, http://articles.latimes.com/2003/dec/07/nation/na-nih7; David Willman, Ex-NIH Director Now Favors Limiting Drug Company Ties, L.A. Times, Mar. 13, 2004, http://articles.latimes.com/2004/mar/13/nation/na-nih13.

89 Furberg, Curt D. et al., The FDA and Drug Safety: A Proposal for Sweeping Changes, 166 Archives Internal Med. 1938, 1940 (2006)CrossRefGoogle ScholarPubMed (“Another problem may relate to the source of FDA funding. Critics of the FDA have claimed that the agency has gotten too close to the industry it is supposed to regulate, in part because of its dependence on user fees. Indeed, each of the past 3 iterations of the Prescription Drug User Fee Act has required that the FDA produce or perform something of value to the pharmaceutical industry in exchange for which the industry would agree to pay the fees. Until the last iteration, the FDA was prohibited from using any funds from user fees to support postmarketing studies of safety.”).

90 See Emerson, Gwendolyn B. & Heckman, James D., Testing for the Presence of Positive-Outcome Bias in Peer Review, 170 Archives Internal Med. 1934, 1936 (2010)CrossRefGoogle ScholarPubMed (showing positive-outcome bias in a randomized trial with peer reviewers for two journals).

91 See generally Emons, Winand, Credence Goods and Fraudulent Experts, 28 RAND J. Econ. 107, 107 (1997)CrossRefGoogle Scholar (providing a skeptical analysis of a similar market for advice); Hadfield, Gillian et al., Information-Based Principles for Rethinking Consumer Protection Policy, 21 J. Consumer Pol’y 131, 144 (1998)Google Scholar (“The complex nature of information also requires careful analysis of the potential for market mechanisms to provide the information consumers might want and need. Information is a notoriously difficult commodity over which to contract. Potential buyers of information have difficulty determining, in their uninformed state, the value of the information and thus the price they are willing to pay for it.”).

92 See Robertson, supra note 43 (discussing this dynamic, and showing empirical evidence that laypersons fail to perform such discounting).

93 See discussion supra Part I.B (discussing peer review and disclosures as ineffective solutions).

94 See Sieber, Debbie et al., Extent and Nature of Advertising in Leading Hematology-Oncology Journals, 32 Am. J. Clinical Oncology 92, 92-93 (2009)CrossRefGoogle ScholarPubMed (citing sources that the industry spent $850 million on journal advertising in 2005).

95 See Orentlicher, David & Hehir, Michael K., Advertising Policies of Medical Journals: Conflicts of Interest for Journal Editors and Professional Societies, 27 J.L. Med. & Ethics 113, 114 (1999)Google ScholarPubMed (discussing the conflicts of interest inherent in the practice of accepting industry money, and discussing journal editors’ feelings and expressions of gratitude).

96 See Journals that Have Requested Inclusion on the List of Publications that Follow the ICMJE’s Uniform Requirements for Manuscripts Submitted to Biomedical Journals, Int’l Comm. of Med. Journal Editors, http://www.icmje.org/journals.html (last visited Apr. 4, 2011) (listing journals); Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication, Int’l Comm. of Med. Journal Editors (Apr. 2011) http://www.icmje.org/urm_full.pdf (providing the policy).

97 See, e.g., Natasha Singer, Stanford Medical School to Expand Ethics Rules, N.Y. Times, Mar. 21, 2010, at B3, available at http://www.nytimes.com/2010/03/22/health/policy/22docs.html (describing a new prohibition on adjunct faculty “giving paid speeches drafted by the makers of drugs or medical devices”); School of Medicine Policy Overview, Stanford School of Medicine, http://med.stanford.edu/coi/overview.html (last visited Apr. 14, 2011). But see John Dorschner, Investigators Question Drug-Makers Payments to University of Miami Doctors, Miami Herald, Dec. 20, 2010, http://www.miamiherald.com/2010/12/20/1982509/investigators-question-drug-makers.html#ixzz18lCuiADQ (“Stanford was the lead example [of non-compliance with its own policy], with two doctors earning more than $100,000 in the past year for making speeches paid for by drug companies, even though Stanford forbids its faculty from taking such fees.”).

98 Singer, supra note 97.

99 See supra text accompanying note 7 (quoting Pfizer documents).

100 Jef Akst, Contract Research on the Rise, The Scientist (Aug. 5, 2009), available at http://www.the-scientist.com/blog/display/55878/ (describing the history of this industry and its recent changes); see also sources cited supra note 86.

101 Schematically, this mandate would be most similar to the requirement that investigators register at ClinicalTrials.gov certain clinical trials within twenty-one days of the first subject being enrolled, and then report summary results within one year of the completion date. See Nat’l Inst. of Health, NIH Grants Policy Statement, NIH Office of Extramural Research, § 4.1.3 exhibit 4, http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch4.htm#public_policy_requirements_other_mandates (last visited Apr. 4, 2011).

102 See Basic HHS Policy for Protection of Human Research Subjects: To What Does this Policy Apply?, 45 C.F.R. § 46.101 (2008) (known as “the Common Rule”); Intangible Property, 45 C.F.R. § 74.36 (2008) (giving the government the right to publish data and requiring recipient to publish data after Freedom of Information Act requests).

103 See Nat’l Inst. of Health, supra note 101, § 4.1.

104 500 U.S. 173, 191 (1991).

105 Id. at 196.

106 In this situation, journals would likely become specialized, some accepting industry-funded papers without the money blind and others accepting NIH-funded, foundation-funded, and money-blinded papers (if any). This outcome may be better than the status quo, if it helps consumers of science more appropriately weigh their reliance on the studies they read, using the journal’s name as a proxy for scientific objectivity. Nonetheless, the following analysis presumes that regulators want to go further to cause a more complete shift to money-blinding.

107 An alternative policy would be to require all investigators at the funded institution to publish exclusively in money-blinded journals, regardless of the source of their funding. This would be a more direct regulation of speech, and is set aside for now.

108 See, e.g., Health Resources and Services Admin., The Health Center Program: Summary of Key Health Center Program Requirements, http://bphc.hrsa.gov/about/requirements.htm (last visited Apr. 7, 2011) (“Health centers are non-profit private or public entities . . .”); The Office of Minority Health, Non-Profit Organizations, http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=2&lvlID=2 (last visited Apr. 7, 2011) (“Only public or nonprofit private institutions of higher learning may apply for training grants . . . .”).

109 See 40 C.F.R. § 50.605 (2010).

110 See Rumsfeld v. Forum for Academic & Inst. Rights, Inc. (FAIR), 547 U.S. 47, 58 (2006) (“Either allow military recruiters the same access to students afforded any other recruiter or forgo certain federal funds.”).

111 See 10 U.S.C.A. § 983(b) (West 2011). The Solomon Amendment was repealed in early 2011.

112 Rumsfeld v. Forum for Academic and Institutional Rights, Inc. (FAIR), 547 U.S. at 60.

113 Grove City College v. Bell, 465 U.S. 555, 575 (1984). In Grove City, the Supreme Court rejected a private college’s claim that conditioning federal funds on its compliance with Title IX of the Education Amendments of 1972 violated the First Amendment, without even reaching the First Amendment claims, because the school was free to decline federal money.

114 In the context of political campaign finance, the Supreme Court has long scrutinized the regulation of money contributions because, in the mass media age, money is a necessary precondition to speech reaching its audience. See generally Citizens United v. FEC, 130 S. Ct. 876 (2010) (holding that corporations have free speech rights); Buckley v. Valeo, 424 U.S. 1, 19 (1976) (“A restriction on the amount of money a person or group can spend on political communication during a campaign necessarily reduces the quantity of expression by restricting the number of issues discussed, the depth of their exploration, and the size of the audience reached. This is because virtually every means of communicating ideas in today’s mass society requires the expenditure of money.”). Arguably, the proposed policy also regulates the grant recipient’s right of free association by proscribing the terms in which the recipient can associate with industry. In Boy Scouts of America v. Dale, 530 U. S. 640 (2000), the Supreme Court held that the Boy Scouts’ freedom of expressive association was violated by a state law that required the organization to accept a homosexual scoutmaster. The pattern in Boy Scouts was thus the opposite of the present proposal, which prohibits certain associations. Regardless of that distinction, the Boy Scouts holding is likely inapposite to the proposed policy for the same reason that the Court distinguished the case in Rumsfeld v. FAIR: the military recruiters were not members of the universities. Id. at 648.

115 See generally Sullivan, Kathleen, Unconstitutional Conditions, 102 Harv. L. Rev. 1413, 1421 (1989).CrossRefGoogle Scholar

116 United States v. Am. Library Ass’n, Inc., 539 U.S. 194, 210 (2003) (quoting Bd. of Cnty. Comm’rs, Wabaunsee Cnty. v. Umbehr, 518 U.S. 668, 674 (1996) (internal quotation marks omitted); see also Perry v. Sindermann, 408 U.S. 593, 597 (1972) (“[I]f the government could deny a benefit to a person because of his constitutionally protected speech or associations, his exercise of those freedoms would in effect be penalized and inhibited. This would allow the government to ‘produce a result which [it] could not command directly.’ Such interference with constitutional rights is impermissible.”).

117 468 U.S. 364, 381 (1984).

118 518 U.S. 668, 678 (1996). The Court wrote that the plaintiff “is correct that if the Board had exercised sovereign power against him as a citizen in response to his political speech, it would be required to demonstrate that its action was narrowly tailored to serve a compelling governmental interest. But in this case, as in government employment cases, the Board exercised contractual power, and its interests as a public service provider, including its interest in being free from intensive judicial supervision of its daily management functions, are potentially implicated. Deference is therefore due to the government’s reasonable assessments of its interests as contractor.” Id.

119 Id. at 685 (part III). This analysis presumes that the speech at issue is a matter of public concern. Although the First Amendment protects government employees and contractors’ rights to speak freely “on matters of public concern[,] . . . speech on merely private employment matters is unprotected.” Id. at 675 (citing Connick v. Myers, 461 U.S. 138, 146 (1983)). It is not precisely clear where speech about the effectiveness of a drug would fall on this spectrum.

120 See Rumsfeld v. Forum for Academic & Inst. Rights, Inc. (FAIR), 547 U.S. 47, 59 (2006).

121 These policies do not arise from a single statutory source. See generally 21 U.S.C.S. § 355 (LexisNexis 2006) (prohibiting the sale of unapproved drugs, and limiting their labels and accompanying material to “prescribing, recommending, or suggesting” uses which are supported by an adequate scientific basis); Kordel v. United States, 335 U.S. 345, 348-50 (1948) (adopting an expansive definition of “accompanying material” to many forms of industry communications about their products); 21 C.F.R. § 202.1(a)(1) (expanding this definition further to encompass virtually all efforts to promote the product); Gregory Conko, Truth or Consequences: The Perils and Protection of Off-Label Drug and Medical Device Promotion, 21 Health Matrix (forthcoming 2011) (Competitive Enterprise Institute, Working Paper No. 2010-9, 2010), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1677609 (describing and criticizing this regulatory evolution).

122 Conko, supra note 121, at 14 (citing FDA, Final Guidance on Industry-Supported Scientific and Educational Activities, Notice, 62 Fed. Reg. 64,074 (Dec. 3, 1997)); see also 21 C.F.R. § 202.1(a)(1) (2010) (regulating industry sponsored CME programs). The FDA’s rationale for this broad regulatory power rests on the statutory requirement that labels must describe the product’s intended use, and that industry efforts to promote another use suggest that the product is mislabeled in the first place. See 62 Fed. Reg. at 64,075 (“The ‘intended use’ of a drug or device refers to the objective intent of the persons legally responsible for the labeling of the product. This intent is determined by such persons’ expressions or by the circumstances surrounding the distribution of the article including, for example, labeling claims, advertising matter, or oral or written statements by such persons or their representatives.”) (citing 21 C.F.R. § 201.128 (2010); 21 C.F.R. § 801.4 (2006); Alberty Food Prods. Co. v. United States, 185 F.2d 321 (9th Cir. 1950) (drug product was misbranded because its labeling failed to state the intended use of the drug as suggested by the company in newspaper advertisements)).

123 But see Klasmeier, Coleen & Redish, Martin H., Off-Label Prescription Advertising, the FDA, and the First Amendment: A Study in the Values of Commercial Speech Protection, 37 Am. J.L. & Med. 315, 343 (2011)Google ScholarPubMed (arguing that the FDA’s analysis is flawed because companies always know that their products will be used off-label, and thus such off-label promotion proves nothing). Klasmeier and Redish seem to assume that knowledge is necessarily equivalent to intent, but the distinction is routinely made throughout the law. See Holder v. Humanitarian Law Project, 130 S. Ct. 2705, 2718 (2010) (distinguishing between knowledge and intent in another context: “Congress plainly spoke to the necessary mental state for a violation of § 2339B, and it chose knowledge about the organization’s connection to terrorism, not specific intent to further the organization’s terrorist activities”); United States v. Delgado, 631 F.3d 685, 695 (5th Cir. 2011) (“It is axiomatic that more is required than mere knowledge of the purpose of a conspiracy.”).

124 FDA, Final Guidance on Industry-Supported Scientific and Educational Activities; Notice, 62 Fed. Reg. at 64,074 (Dec. 3, 1997).

125 See supra Part II.A.

126 FDA, Final Guidance on Industry-Supported Scientific and Educational Activities; Notice, 62 Fed. Reg. at 64,083 (referring to CME providers).

127 Robert Steinbrook, Financial Support of Continuing Medical Education, 299 JAMA 1060, 1062 (discussing a solution of “eliminating direct or indirect commercial support of programs but allowing contributions to a central repository of funds, which, in turn, would disburse funds to approved programs”).

128 62 Fed. Reg. at 64,084.

129 The FDA relies on this explanation from the Supreme Court:

The First Amendment’s concern for commercial speech is based on the informational function of advertising. Consequently, there can be no constitutional objection to the suppression of commercial messages that do not accurately inform the public about lawful activity. The government may ban forms of communication more likely to deceive the public than to inform it, or commercial speech related to illegal activity. If the communication is neither misleading nor related to unlawful activity, the government’s power is more circumscribed. The State must assert a substantial interest to be achieved by restrictions on commercial speech. Moreover, the regulatory technique must be in proportion to that interest. The limitation on expression must be designed carefully to achieve the State’s goal. Compliance with this requirement may be measured by two criteria. First, the restriction must directly advance the state interest involved; the regulation may not be sustained if it provides only ineffective or remote support for the government’s purpose. Second, if the governmental interest could be served as well by a more limited restriction on commercial speech, the excessive restrictions cannot survive.

Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 563-64 (1980) (citations omitted).

130 See Fugh-Berman & Melnick, supra note 5; see also United States v. Caronia, 576 F. Supp. 2d 385, 395 (E.D.N.Y. 2008) (discussing whether “promotional activities amounted to scientific and academic speech, which resides at the core of the First Amendment”); Sax supra note 17, (discussing this point, and also concluding that industry-supported science is commercial speech). For a more foundational discussion, see Cortez, Nathan, Can Speech by FDA-Regulated Firms Ever Be Noncommercial? 37 Am. J.L. & Med. 388 (2011)Google ScholarPubMed (arguing that the answer to his titular question “is yes, but only if the stars align”). Arguably, industry-funded science could be regulated through blinding even if it was not deemed commercial speech.

131 Truffer, Christopher J. et al., Health Spending Projections Through 2019: The Recession’s Impact Continues, 29 Health Aff. 522, 522 (2010)CrossRefGoogle ScholarPubMed (reporting that the health share of the gross domestic product was estimated at 17.3% in 2009).

132 See discussion supra notes 16-21 and 38-48.

133 For a similar argument in a related context, see Klasmeier & Redish, supra note 123, at 345 (“But it surely does not follow that all claims made on behalf of off-label uses are inherently false or misleading.”).

134 Whitaker v. Thompson, 248 F. Supp. 2d 1, 9 (D.D.C. 2002) (“Under the Central Hudson analysis, it is ‘clear that if the Government could achieve its interest in a manner that does not restrict speech, or that restricts less speech, the Government must do so.’”) (citing Thompson v. W. States Med. Ctr., 535 U.S. 357, 371 (2002)).

135 See, e.g., 18 U.S.C. § 201(b) (1962) (setting forth conduct constituting bribery and related fines); 18 U.S.C. § 666(a)(2) (2004) (also describing conduct constituting bribery); 41 U.S.C. § 52(2) (2009) (defining “kickback”).

136 See generally Kathleen Clark, Financial Conflicts of Interest In and Out of Government, at 6 (2011), available at http://ssrn.com/abstract=1785520 (“If a government employee advises the government on how to handle a matter that could affect her own investments, she could end up in prison. A criminal statute prohibits government employees from participating in matters that can have a direct and predictable effect on their own financial interests.”).

137 See United States v. Marchetti, 466 F.2d 1309, 1314 (4th Cir. 1972) (“Threats and bribes are not protected simply because they are written or spoken; extortion is a crime although it is verbal”); United States v. Meachum, No. 08-3082 Slip Copy, 2009 WL 1255520, at *8 (W.D. Va. May 7, 2009) (same); Roberts v. State, 278 S.W.3d 778, 790 (Tex. App. 2008) (same); Bulletin Displays, LLC v. Regency Outdoor Advertising, Inc., 448 F. Supp. 2d 1172, 1184 (C.D. Cal. 2006) (“[C]ampaign contributions made ‘with a corrupt intent to influence . . . the person to whom it is given, in his action, vote, or opinion, in any public or official capacity’ are not protected because they are not a ‘valid’ exercise of one’s constitutional rights of free speech or petition”) (quoting Paul for Council v. Ricki Hanyecz, 85 Cal. App. 4th 1356, 1366-67 (2001)); United States v. Tutein, 82 F. Supp. 2d 442, 447 (D. Virgin Is. 2000) (“[A] private party has no First Amendment right to petition the Government by means of . . . payment of bribes”) (quoting In re Airport Car Rental Antitrust Litig., 474 F. Supp. 1072, 1087 (N.D. Cal. 1979)); Dawkins v. State, 208 So.2d 119, 124 (Fla. Dist. Ct. App. 1968) (“One cannot threaten, intimidate, bribe, or otherwise imminently seek to affect the outcome of grand or petit jury deliberations and then seek refuge in the First Amendment. . .”); see also United States v. Hutson, 843 F.2d 1232, 1235 (9th Cir. 1988) (“extortionate speech . . . is undoubtedly within the government’s power to prohibit”); United States v. Quinn, 514 F.2d 1250, 1268 (5th Cir. 1975), cert. denied, 424 U.S. 955 (1976) (“It may categorically be stated that extortionate speech has no more constitutional protection than that uttered by a robber while ordering his victim to hand over the money, which is no protection at all”); People v. Hickman, 988 P.2d 628, 636-38 (Colo. 1999) (rejecting a First Amendment attack on a statute making it a crime to threaten a witness, so long as “threat” is limited to “expressions of intent to commit harm or injury to another’s person, property, or rights through commission of an unlawful act”); State v. Lance, 721 P.2d 1258, 1264-65, 1267 (Mont. 1986) (rejecting a First Amendment attack on a statute making it a crime to threaten to kidnap or unlawfully restrain any person).

138 For an explanation of the doctrine, see Kent Greenawalt, Speech, Crime, and the Uses of Language 249 (1989) (arguing that “[m]y basic position is that such utterances are genuinely situation-altering. They do not inform the listener about the environment he or she inhabits; they change that environment by generating options which did not previously exist and which would never have existed had it not been for the offer or threat. Because they do something rather than say something, they fall outside a principle of free speech.”). More accurately, an offer of a bribe both does something (create an incentive) and says something (notify of the incentive).

139 See Clark, supra note 136, at 6 (sketching out the “the principles and policy considerations that should guide the development of financial conflict standards for outsiders who do the government’s work”).

140 See 18 U.S.C § 1346 (2008) (proscribing honest services fraud); Skilling v. United States, 130 S. Ct. 2896 (2010) (construing the statute to cover only bribes and kickbacks, and arguing that the vague statute borrows content from the federal bribery statutes—which otherwise apply only to federal officials—or state officials who receive federal grant funds). I am not arguing here that the honest services statute actually criminalizes industry payments to independent biomedical researchers, though that argument would be provocative, given the seemingly limitless scope of the honest services fraud statute, even after Skilling.