Prescription data mining and the protection of patients' interests

Journal of Law, Medicine and Ethics

Volumn 38, Issue 1, 2010, Pages 74-84

  Orentlicher, David ^a  

^a Indiana University School of Law Indianapolis   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONFIDENTIALITY; DATA MINING; DRUG INDUSTRY; ETHICS; GOVERNMENT REGULATION; HUMAN; HUMAN RELATION; LEGAL ASPECT; MARKETING; MEDICAL INFORMATION SYSTEM; PRESCRIPTION; STATISTICS; UNITED STATES;

CLINICAL PHARMACY INFORMATION SYSTEMS; CONFIDENTIALITY; DATA MINING; DRUG INDUSTRY; DRUG PRESCRIPTIONS; GOVERNMENT REGULATION; HUMANS; MARKETING; PROFESSIONAL-PATIENT RELATIONS; UNITED STATES;

EID: 77952861131     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2010.00468.x     Document Type: Article

References (96)

1. Donohue J M, Cevasco M, Rosenthal M B. A Decade of Direct-to-Consumer Advertising of Prescription Drugs. New England Journal of Medicine 2007, 357(no. 7):673-681. at 676 (reporting annual expenditures on detailing of about $7 billion between 2002 and 2005); D. L. Coleman, A. E. Kazdin, L. A. Miller, J. S. Morrow, and R. Udelsman, " Guidelines for Interactions between Clinical Faculty and the Pharmaceutical Industry: One Medical School's Approach," 81, no. 2 (2006): 154-160, 154 (reporting that pharmaceutical companies employ more than 80,000 sales representatives and that the average physician meets with a sales representative four times per month). Drug companies appear to be reducing their sales forces. J. Russell, " Lilly's Shrinking Sales Force," , January 17, 2010, at A18
2. Guidelines on Gifts to Physicians from Industry: An Update. Food & Drug Law Journal 1992, 47(no. 4):445-458. Council on Ethical and Judicial Affairs, establishing the American Medical Association's restrictions on gift-giving); S. L. Coyle, and the Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine, " Physician-Industry Relations, Part 1: Individual Physicians," 136, no. 5 (2002): 403-406; Institute of Medicine, Conflict of Interest in Medical Research, Education and Practice (Washington, D.C.: National Academies Press, 2009). The American Medical Association's gifts guidelines evolved into the guidelines of the Pharmaceutical Research and Manufacturers of America. T. Randall, " AMA, Pharmaceutical Association Form 'Solid Front' on Gift-Giving Guidelines," 265, no. 18 (1991): 2304-2305. See also J. Zweifler, S. Hughes, S. Schafer, B. Garcia, A. Grasser, and L. Salazar, " Are Sample Medicines Hurting the Uninsured?" 15, no. 5 (2002): 361-366 (expressing concerns with free drug samples)
3. See Coleman, et al., note 1
4. Greene J A. Pharmaceutical Marketing Research and the Prescribing Physician. Annals of Internal Medicine 2007, 146(no. 10):742-748. (describing the history of data mining from its origins in the mid-twentieth century)
5. O'Reilly KB. New Hampshire Ban on Sale of Prescribing Data Upheld: American Medical News. December 22/29, 2008, 22 Me.Rev.Stat. § 1711-E(2)-(2.A); N.H. Rev. Stat. Ann. § 318:47-f; 18 Vt. Stat. Ann. § 4631(d). Legislators in a number of other states have introduced bills to regulate data mining.
6. IMS Health, Inc. v. Ayotte. 490 F. Supp. 2d 163, 170 (D.N.H. 2007)
7. Klocke J L. Prescription Records for Sale: Privacy and Free Speech Issues Arising from the Sale of De-Identified Medical Data. Idaho Law Review 2008, 44(no. 2):511-536. http://www.prescriptionproject.org/newscenter/fact_sheets, Comment, 515. The Prescription Project provides excellent materials on data mining,, last visited December 10, 2009
8. IMS Health, Inc., 490 F. Supp. 2d at 166; , 532 F. Supp. 2d 153, 158 (D. Me. 2007)
9. IMS Health, Inc., 490 F. Supp. 2d at 165
10. IMS Health, Inc., 490 F. Supp. 2d at 166
11. Steinbrook R. For Sale: Physicians' Prescribing Data. New England Journal of Medicine 2006, 354(no. 26):2745-2747. IMS Health, Inc., 490 F. Supp. 2d at 166; Greene, note 4, at 744, 2745. Data mining companies do not need to purchase access to the AMA's Physician Masterfile to obtain the information that they need about physicians. However, it would be more costly to use other sources since they would have to invest the time and expense to recreate the information in the Masterfile. Personal communication, Robert A, Musacchio, Ph.D, Senior Vice President, Publishing and Business Services, American Medical Association (May 5, 2009)
12. IMS Health, Inc., 490 F. Supp. 2d at 170
13. Grande D, Asch D A. Commercial versus Social Goals of Tracking What Doctors Do. New England Journal of Medicine 2009, 360(no. 8):747-749. at 748
14. N.H. Rev. Stat. Ann. § 318:47-f. Other uses of the data are also permitted, including pharmacy reimbursement, care management and utilization review.
15. Cardarelli R, Licciardone J C, Taylor L G. A Cross-sectional Evidence-Based Review of Pharmaceutical Promotional Marketing Brochures and Their Underlying Studies: Is What They Tell Us Important and True?. BMC Family Practice 2006, 7(no. 13):1-6. (finding that promotional brochures discussed alternative treatments 40 percent of the time)
16. Brody H. The Company We Keep: Why Physicians Should Refuse to See Pharmaceutical Representatives. Annals of Family Medicine 2005, 3(no. 1):82-86.
17. Manchanda P, Honka E. The Effects and Role of Direct-to-Physician Marketing in the Pharmaceutical Industry: An Integrative Review. Yale Journal of Health Policy Law & Ethics 2005, 5(no. 2):785-822. 788-791
18. Caudill T S, Johnson M S, Rich E C, McKinney W P. Physicians, Pharmaceutical Sales Representatives, and the Cost of Prescribing. Archives of Family Medicine 1996, 5(no. 2):201-206. , at 788-791, 793-795, 205
19. See Manchanda and Honka, note 17, at 800-804
20. Chren M M, Landefield C S. Physicians' Behavior and Their Interactions with Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary. JAMA 1994, 271(no. 9):684-689. at 687; N. Lurie, E. C. Rich, D. E. Simpson, J. Meyer, D. L. Schiedermayer, J. L. Goodman, and W. P. McKinney, " Pharmaceutical Representatives in Academic Medical Centers: Interaction with Faculty and Housestaff," 5, no. 3 (1990): 240-243
21. Figueiras A, Caamano F, Gestal-Otero J J. Influence of Physician's Education, Drug Information and Medical-Care Settings on the Quality of Drugs Prescribed. European Journal of Clinical Pharmacology 2000, 56(nos. 9-10):747-753. 750 (studying practices of primary care physicians and using three measure of quality - whether the physicians prescribed drugs that had been shown to be effective, that were suitable for use in primary care settings, or that were included in the formulary of the Spanish National Health Service)
22. Wazana A. Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?. JAMA 2000, 283(no. 3):373-380. at 378
23. Avorn J, Chen M, Hartley R. Scientific versus Commercial Sources of Influence on the Prescribing Behavior of Physicians. American Journal of Medicine 1982, 73(no. 1):4-8. To be sure, not all studies find that drug detailing distorts physician prescribing decisions. J. M. Donohue, E. R. Berndt, M. Rosenthal, A. M. Epstein, and R. G. Frank, " Effects of Pharmaceutical Promotion on Adherence to the Treatment Guidelines for Depression," 42, no. 12 (2004): 1176-1185, 1182 (finding " no evidence ... that detailing affected rates of adherence to guideline treatment of depression." )
24. Lexchin J. What Information Do Physicians Receive from Pharmaceutical Representatives?. Canadian Family Physician 1997, 43(no. 5):941-945. See Cardarelli et al., note 15, at 4, M. Sernyak and R. Rosenheck, " Experience of VA Psychiatrists With Pharmaceutical Detailing of Antipsychotic Medications," 58, no. 10 (2007): 1292-1296; M. G. Ziegler, P. Lew, and B. C. Singer, " The Accuracy of Drug Information from Pharmaceutical Sales Representatives," 273, no. 16 (1995): 1296-1298
25. http://www.fda.gov/cder/ddmac/lawsregs.htm, The FDA posts its warning letters to pharmaceutical companies on its website,, last visited December 16, 2009
26. See Manchanda and Honka, note 17, at 799-800; Council on Ethical and Judicial Affairs, note 2, at 447-449; M. M. Chren, C. S. Landefield, and T. H. Murray, " Doctors, Drug Companies, and Gifts," 262, no. 24 (1989): 3448-3451; J. Dana and G. Loewenstein, " A Social Science Perspective on Gifts to Physicians from Industry," 290, no. 2 (2003): 252-255
27. Roughead E E, Harvey K J, Gilbert A L. Commercial Detailing Techniques Used by Pharmaceutical Representatives to Influence Prescribing. Australian & New Zealand Journal of Medicine 1998, 28(no. 3):306-310. 308
28. 1964, , 376 U.S. 254, 270, observing that " the fitting remedy for evil counsels is good ones"
29. Graham S D. Effect of an Academic Detailing Intervention on the Utilization Rate of Cyclooxygenase-2 Inhibitors in the Elderly. Annals of Pharmacotherapy 2008, 42(no. 6):749-756. S. B. Soumerai and J. Avorn, " Principles of Educational Outreach ('Academic Detailing') to Improve Clinical Decision Making," 263, no. 4 (1990): 549-556
30. Had the Supreme Court ruled in favor of federal preemption in Wyeth v. Levine. 2009, 129 S. Ct. 1187, that might have given state legislatures an additional reason to eschew direct regulation of drug detailing. In , the Court rejected a claim that compliance with Food and Drug Administration (FDA) regulations should insulate pharmaceutical manufacturers from state tort law claims. , at 1190. If the Court had sided with the drug companies, state legislatures might worry that the Court would view regulation of drug detailing as falling within the sole purview of the FDA
31. Guidelines for the Use of Antiretroviral Agents in HIV-1-infected Adults and Adolescents November 3, 2008, 38. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf, Panel on Antiretroviral Guidelines for Adults and Adolescents, Washington D.C., Department of Health and Human Services, at, , last visited December 16, 2009
32. Dando S, Tohen M. Olanzapine - Relapse Prevention Following Mania. Journal of Psychopharmacology 2006, 20(no. 2 Suppl.):31-38. at 31
33. Orentlicher D. Genetic Privacy in the Patient-Physician Relationship. Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era 1997, 77-91. Rothstein M. in, New Haven, Yale University Press, at 77-78
34. Hall M A, Bobinski M A, Orentlicher D. Health Care Law and Ethics 2007, 175-185. 7th ed., New York, Aspen Publishers, at
35. See Klocke, note 7, at 518-521; IMS Health, Inc., 490 F. Supp. 2d at 171
36. Zoutman D E, Ford B D, Bassili A R. The Confidentiality of Patient and Physician Information in Pharmacy Prescription Records. Canadian Medical Association Journal 2004, 170(no. 5):815-816. See Greene, note 4, at 747; Steinbrook, note 11, at 2746. To be sure, patient confidentiality can be compromised. It is often possible to deduce a patient's identity from de-identified prescription records, particularly in small towns. Klocke, note 7, at 520-521, But the risk to patient privacy is created by the existence of the prescription records, whether are not they are mined for physician prescribing information
37. IMS Health, Inc. v. Ayotte. 550 F.3d 42, 55 (1st Cir. 2008). See also IMS Health, Inc., 490 F. Supp. 2d at 178-180 (rejecting the argument based on prescriber privacy)
38. IMS Health Corp., 532 F. Supp. 2d at 163
39. http://www.medicalletter.org/html/who.htm#about_newsletters, The author relied on during his years as a practicing physician. describes itself as follows: is an independent, peer-reviewed, nonprofit publication that offers unbiased critical evaluations of drugs, with special emphasis on new drugs, to physicians and other members of the health professions. It evaluates virtually all new drugs and reviews older drugs when important new information becomes available on their usefulness or adverse effects. Published every other week in a four-page newsletter format, it carries no advertising and is supported entirely by subscription fees. A typical issue appraises two or three new drugs in terms of their effectiveness, toxicity, cost and possible alternatives. Occasionally, publishes an article on a new non-drug treatment or a new diagnostic aid. Avaliable at, last visited December 16, 2009
40. See Brody, note 16
41. See Greene, note 4, at 742
42. Musacchio R A, Hunkler R J. More Than a Game of Keep Away: Pharmaceutical Executive. May 1, 2006, http://pharmaexec.findpharma.com/pharmaexec/article/articledetail.jsp?id=323311, last visited February 16, 2010); Steinbrook, note 11, at 2745-2746. (Initially, the program was called the Prescribing Data Restriction Program, but the name was changed to Physician Data Restriction Program since the AMA maintains physician data rather than prescribing data
43. IMS Health, Inc., 490 F. Supp. 2d at 166
44. Orentlicher D. The Influence of a Professional Organization on Physician Behavior. Albany Law Review 1994, 57(no. 3):583-605.
45. Personal communication with Mark Frankel, American Medical Association (April 26, 2009) (reporting the 22,000 figure for enrollment); Greene, note 4, at 746 (estimating at 650,000 the number of physicians who actively prescribe drugs)
46. Personal communication, note 11
47. See, , text accompanyig note 37
48. See, , text accompanyig notes 23-24
49. N.H. Rev. Stat. Ann. § 318:47-f
50. See Klocke, note 7, at 524
51. N.H. Rev. Stat. Ann. § 318:47-f
52. 18 Vt. Stat. Ann. § 4631(d)
53. 22 Me.Rev.Stat. § 1711-E(2)-(2.A)
54. 22 Me.Rev.Stat. § 1711-E(1-B)
55. IMS Health, Inc., 490 F. Supp. 2d at 171-173; 18 Vt. Stat. Ann. § 4631(a)
56. IMS Health, Inc., 490 F. Supp. 2d at 183; IMS Health Corp., 532 F. Supp. 2d at 182-183
57. IMS Health, Inc., 550 F.3d at 64. The court of appeals reviewed only the New Hampshire district court decision, but because the First Circuit encompasses Maine as well as New Hampshire, its holding that data mining constitutes commercial conduct should clear the Maine data mining provision for implementation. As this article is being written, the First Circuit has been breifed on Maine's appeal of the district court, but oral arguments has not been schedualed. Personal communication with Nancy Macirowski, Assistant Attorney General, State of Maine, January 22, 2010. Although legitimate disagreement may exist regarding the constitutionality of the New Hampshire statute, it is difficult to make sense of the district court's decision in Maine. That statute does not prohibit drug companies from selling the information that they create from data mining. Rather it simply permits physicians to maintain the confidentiality of their own prescription practices, and the Supreme Court has permitted the public to opt out when it does not want to be involved in the speech of others. See, e.g., , 397 U.S. 728 (1970) (permitting individuals to direct the postal service not to deliver pornographic mail from a particular person or organization)
58. 631 F. Supp. 2d. 434 (D. Vt. 2009)
59. Richards N M. Reconciling Data Privacy and the First Amendment. U.C.L.A. Law Review 2005, 52(no. 4):1149-1222. For useful treatment of this issue by legal scholars, see, F. Schauer, " The Boundaries of the First Amendment: A Preliminary Exploration of Constitutional Science," 117, no. 6 (2004): 1765-1809; E. Volokh, " Freedom of Speech and Information Privacy: The Troubling Implications of a Right to Stop People from Speaking About You," 52, no. 5 (2000): 1049-1124
60. IMS Health, Inc., 490 F. Supp. 2d at 175; IMS Health Corp., 532 F. Supp. 2d at 167 (adopting the reasoning of the New Hampshire district court); IMS Health, Inc., 631 F. Supp. 2d. at 445-44
61. IMS Health, Inc., 490 F. Supp. 2d at 175
62. IMS Health, Inc., 490 F. Supp. 2d at 175-183. IMS Health, Corp., 532 F. Supp. 2d at 169-183. There have been decisions by courts of appeal that characterize transmission of data as commercial speech. See, e.g., , 182 F.3d 1224 (10th Cir. 1999); , 555 F.3d 996 (D.C. Cir. 2009)
63. 550 F.3d at 52-53
64. Jackson T H, Jeffries J C. Commercial Speech: Economic Due Process and the First Amendment. Virginia Law Review 1979, 65(no. 1):1-41. See, Economic substantive due process has been rejected by the Supreme Court since 1937 as a basis for finding laws unconstitutional, although it has been used to limit the amount of punitive damage awards. E. Chemerinsky, , 3rd ed. (New York: Aspen Publishers, 2006): at 625-629
65. IMS Health, Inc., 550 F.3d at 52-53
66. IMS Health, Inc., 490 F. Supp. 2d at 177. Under , speech does not qualify for first amendment protection under the commercial speech doctrine if it is false or misleading. , 447 U.S. 557, 566 (1980
67. IMS Health, Inc., 490 F. Supp. 2d at 180-183; IMS Health, Corp., 532 F. Supp. 2d at 168-180
68. IMS Health, Inc., 550 F.3d at 54-60
69. IMS Health, Inc., 550 F.3d at 55-59
70. IMS Health, Inc., 631 F. Supp2d. at 451-453
71. IMS Health, Inc., 631 F. Supp2d. at 453-455
72. 515 U.S. 618, 628 (1995) (upholding a restriction on attorney solicitation of clients and observing that restrictions on commercial speech could be justified " by reference to studies and anecdotes pertaining to different locales altogether" ) with , 533 U.S. 525, 563 (2001) (striking down restrictions on tobacco advertising in part because the effect of the regulations would " vary based on whether a locale is rural, suburban, or urban" ). See also R. Post, " Prescribing Records and the First Amendment-New Hampshire's Data-Mining Statute," 360, no. 8 (2009): 745-747, 746
73. IMS Health, Inc., 490 F. Supp. 2d at 180-181; IMS Health Corp., 532 F. Supp. 2d at 172-176
74. IMS Health, Inc., 550 F.3d at 55-59; IMS Health, Inc., 631 F. Supp2d. at 453-454
75. IMS Health, Inc., 490 F. Supp. 2d at 181-183 (also suggesting that New Hampshire's Medicaid program could contain health care costs by requiring prior authorization before physicians could prescribe an expensive drug in lieu of a cost-effective alternative); IMS Health Corp., 532 F. Supp. 2d at 176-178
76. IMS Health, Inc., 550 F.3d at 59-60
77. IMS Health, Inc., 631 F. Supp2d. at 454-455
78. Chemerinsky, note 65, at 1091-1109 (discussing cases involving advertising or solicitation of clients by accountants and attorneys, advertising for gambling, alcohol or tobacco and solicitation of students for commercial transactions on a college campus)
79. Government regulation of business activity does not enjoy constitutional protection. Under the Supreme Court's fourteenth amendment jurisprudence, economic substantive due process places little constraint on the state. See note 65
80. Off-label uses refer to uses of the drug that have not been approved by the FDA even though they might be justified by clinical studies. After a drug has been approved for a particular use (or uses) by the FDA, new indications for the drug may be discovered, but the drug company may not seek approval for the new indications. While this area of law is unsettled, the predominant judicial view appears to be that the FDA must have some authority to regulate the promotion of off-label uses of approved drugs, even if the first amendment sets limits on the FDA's authority to do so. , 576 F. Supp. 2d 385 (E.D. N.Y. 2008); , 517 F.3d 935, 939-940 (7th Cir. 2008). See also J. Rogers, Essay, " Freedom Off Speech & The FDA's Regulation Of Off-Label Drug Uses," 76, no. 5 (2008): 1429-1443; R. F. Hall and E. S. Sobotka, " Inconsistent Government Policies: Why FDA Off-Label Regulation Cannot Survive First Amendment Review Under Greater New Orleans," 62, no. 1 (2007): 1-48
81. 182 F.3d 1224 (10th Cir. 1999)
82. 555 F.3d 996 (D.C. Cir. 2009)
83. Stone G R, Seidman L M, Sunstein C R, Tushnet M V, Karlan P S. The First Amendment 2008, 495-517. One of the First Circuit judges in fact dissented from the court's opinion because he viewed the regulation of data mining as effectively a regulation of drug detailing. Accordingly, he concluded that the provision involved the regulation of commercial speech. IMS Health, Inc., 550 F.3d at 79-84 (Lipez, J., concurring in part and dissenting in part). Nevertheless, he concurred in the decision on the ground that the New Hampshire law also constituted permissible regulation of commercial speech. at 84-100. To be sure, the Supreme Court has permitted indirect regulation of speech even when direct regulation would not be permissible in other contexts. For example, while the press enjoys a strong first amendment right to publish news, the state has considerable leeway to erect barriers to the press' ability to gather news, 3rd ed., New York, Aspen Publishers, at, Similarly, the Court might conclude that the right to speak to potential customers does not include a right to gather information that will enhance the speech. But this is a doctrinal argument, not an argument from theory
84. Shiffrin S. The First Amendment and Economic Regulation: Away from a General Theory of the First Amendment. Northwestern University Law Review 1983, 78(no. 5):1212-1283. 1256-1265
85. 535 U.S. 357 (2002)
86. As the Supreme Court wrote, " drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product. It is a traditional component of the practice of pharmacy." , at 360. In 1997, Congress exempted drug compounding from the Food and Drug Administration's drug approval process but only if several requirements were met, including the restriction on advertising
87. at 365 (citing 21 U.S. C. § 353a(c))
88. Of course, sales representatives can find out some of the information from other sources that they ordinarily obtain from data mining. If they want to know whether a physician prescribes a competing drug, they can ask the physician
89. IMS Health, Inc., 550 F.3d at 53
90. IMS Health, Inc., 490 F. Supp. 2d at 182
91. http://www.physiciansnews.com/spotlight/1205.html, See 22 Me. Rev. Stat. § 2685; 18 Vt. Stat. Ann. § 4622; W. Va. Code § 5-16C-9(a)(5); G. Lavine, " Pharmacists Provide Academic Detailing to South Carolina Health Care Providers," 65, no. 24 (2008): 2312-2314; C. Guadagnino, " Pa. Launches Academic Drug Detailing," , December 2005, available at, last visited February 11, 2010
92. IMS Health, Inc., 550 F.3d at 60
93. See Donohue et al., , note 1
94. 500 U.S. 173 (1991
95. 524 U.S. 569 (1998