Prescription Data Mining and the Protection of Patients' Interests

Donohue J. M. Cevasco M. , and Rosenthal M. B. , “A Decade of Direct-to-Consumer Advertising of Prescription Drugs,” New England Journal of Medicine 357, no. 7 (2007): 673–681, at 676 (reporting annual expenditures on detailing of about $7 billion between 2002 and 2005); Coleman D. L. Kazdin A. E. Miller L. A. Morrow J. S. , and Udelsman R. , “Guidelines for Interactions between Clinical Faculty and the Pharmaceutical Industry: One Medical School's Approach,” Academic Medicine 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. Russell J. , “Lilly's Shrinking Sales Force,” Indianapolis Star, January 17, 2010, at A18.

Council on Ethical and Judicial Affairs, “Guidelines on Gifts to Physicians from Industry: An Update,” Food & Drug Law Journal 47, no. 4 (1992): 445–458 (establishing the American Medical Association's restrictions on gift-giving); Coyle S. L. , and the Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine, “Physician-Industry Relations, Part 1: Individual Physicians,” Annals of Internal Medicine 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. Randall T. , “AMA, Pharmaceutical Association Form ‘Solid Front’ on Gift-Giving Guidelines,” JAMA 265, no. 18 (1991): 2304–2305. See also Zweifler J. Hughes S. Schafer S. Garcia B. Grasser A. , and Salazar L. , “Are Sample Medicines Hurting the Uninsured?” Journal of the American Board of Family Practice 15, no. 5 (2002): 361–366 (expressing concerns with free drug samples).

See Coleman , supra note 1.

Greene J. A. , “Pharmaceutical Marketing Research and the Prescribing Physician,” Annals of Internal Medicine 146, no. 10 (2007): 742–748 (describing the history of data mining from its origins in the mid-twentieth century).

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. O'Reilly K.B. , “New Hampshire Ban on Sale of Prescribing Data Upheld,” American Medical News, December 22/29, 2008.

IMS Health, Inc. v. Ayotte, 490 F. Supp. 2d 163, 170 (D.N.H. 2007).

Klocke J. L. , Comment, “Prescription Records for Sale: Privacy and Free Speech Issues Arising from the Sale of De-Identified Medical Data,” Idaho Law Review 44, no. 2 (2008): 511–536, 515. The Prescription Project provides excellent materials on data mining, available at <www.prescriptionproject.org/newscenter/fact_sheets> (last visited December 10, 2009).

IMS Health, Inc., 490 F. Supp. 2d at 166; IMS Health Corp. v. Rowe, 532 F. Supp. 2d 153, 158 (D.Me. 2007).

IMS Health, Inc., 490 F. Supp. 2d at 165.

IMS Health, Inc., 490 F. Supp. 2d at 166.

IMS Health, Inc., 490 F. Supp. 2d at 166; Greene , supra note 4, at 744; Steinbrook R. , “For Sale: Physicians' Prescribing Data,” New England Journal of Medicine 354, no. 26 (2006): 2745–2747, 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, Musacchio Robert A. , Ph.D, Senior Vice President, Publishing and Business Services, American Medical Association (May 5, 2009).

IMS Health, Inc., 490 F. Supp. 2d at 170.

Grande D. Asch D. A. , “Commercial versus Social Goals of Tracking What Doctors Do,” New England Journal of Medicine 360, no. 8 (2009): 747–749, at 748.

N.H. Rev. Stat. Ann. § 318:47-f. Other uses of the data are also permitted, including pharmacy reimbursement, care management and utilization review. Id.

Cardarelli R. Licciardone J. C. , and 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 7, no. 13 (2006): 1–6 (finding that promotional brochures discussed alternative treatments 40 percent of the time).

Brody H. , “The Company We Keep: Why Physicians Should Refuse to See Pharmaceutical Representatives,” Annals of Family Medicine 3, no. 1 (2005): 82–86.

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 5, no. 2 (2005): 785–822, 788–791.

Id., at 788–791, 793–795; Caudill T. S. Johnson M. S. Rich E. C. , and McKinney W. P. , “Physicians, Pharmaceutical Sales Representatives, and the Cost of Prescribing,” Archives of Family Medicine 5, no. 2 (1996): 201–206, 205.

See Manchanda Honka , supra note 17, at 800–804.

Chren M. M. Landefeld C. S. , “Physicians' Behavior and Their Interactions with Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary,” JAMA 271, no. 9 (1994): 684–689, at 687; Lurie N. Rich E. C. Simpson D. E. Meyer J. Schiedermayer D. L. Goodman J. L. , and McKinney W. P. , “Pharmaceutical Representatives in Academic Medical Centers: Interaction with Faculty and Housestaff,” Journal of General Internal Medicine 5, no. 3 (1990): 240–243.

Figueiras A. Caamano F. , and 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 56, nos. 9–10 (2000): 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).

Wazana A. , “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” JAMA 283, no. 3 (2000): 373–380, at 378.

Avorn J. Chen M. , and Hartley R. , “Scientific versus Commercial Sources of Influence on the Prescribing Behavior of Physicians,” American Journal of Medicine 73, no. 1 (1982): 4–8. To be sure, not all studies find that drug detailing distorts physician prescribing decisions. Donohue J. M. Berndt E. R. Rosenthal M. Epstein A. M. , and Frank R. G. , “Effects of Pharmaceutical Promotion on Adherence to the Treatment Guidelines for Depression,” Medical Care 42, no. 12 (2004): 1176–1185, 1182 (finding “no evidence … that detailing affected rates of adherence to guideline treatment of depression.”)

See Cardarelli , supra note 15, at 4; Lexchin J. , “What Information Do Physicians Receive from Pharmaceutical Representatives?” Canadian Family Physician 43, no. 5 (1997): 941–945; Sernyak M. Rosenheck R. , “Experience of VA Psychiatrists With Pharmaceutical Detailing of Antipsychotic Medications,” Psychiatric Services 58, no. 10 (2007): 1292–1296; Ziegler M. G. Lew P. , and Singer B. C. , “The Accuracy of Drug Information from Pharmaceutical Sales Representatives,” JAMA 273, no. 16 (1995): 1296–1298.

The FDA posts its warning letters to pharmaceutical companies on its website, available at <www.fda.gov/cder/ddmac/lawsregs.htm> (last visited December 16, 2009).

See Manchanda Honka , supra note 17, at 799–800; Council on Ethical and Judicial Affairs, supra note 2, at 447–449; Chren M. M. Landefeld C. S. , and Murray T. H. , “Doctors, Drug Companies, and Gifts,” JAMA 262, no. 24 (1989): 3448–3451; Dana J. Loewenstein G. , “A Social Science Perspective on Gifts to Physicians from Industry,” JAMA 290, no. 2 (2003): 252–255.

Roughead E. E. Harvey K. J. , and Gilbert A. L. , “Commercial Detailing Techniques Used by Pharmaceutical Representatives to Influence Prescribing,” Australian & New Zealand Journal of Medicine 28, no. 3 (1998): 306–310, 308.

New York Times v. Sullivan, 376 U.S. 254, 270 (1964) (observing that “the fitting remedy for evil counsels is good ones”).

Graham S. D. , “Effect of an Academic Detailing Intervention on the Utilization Rate of Cyclooxygenase-2 Inhibitors in the Elderly,” Annals of Pharmacotherapy 42, no. 6 (2008): 749–756; Soumerai S. B. Avorn J. , “Principles of Educational Outreach (‘Academic Detailing’) to Improve Clinical Decision Making,” JAMA 263, no. 4 (1990): 549–556.

Had the Supreme Court ruled in favor of federal preemption in Wyeth v. Levine, 129 S. Ct. 1187 (2009), that might have given state legislatures an additional reason to eschew direct regulation of drug detailing. In Wyeth, the Court rejected a claim that compliance with Food and Drug Administration (FDA) regulations should insulate pharmaceutical manufacturers from state tort law claims. Id., 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.

Panel on Antiretroviral Guidelines for Adults and Adolescents, Guidelines for the Use of Antiretroviral Agents in HIV-1-infected Adults and Adolescents, Washington D.C., Department of Health and Human Services, November 3, 2008, at 38, available at <http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf> (last visited December 16, 2009).

Dando S. Tohen M. , “Olanzapine – Relapse Prevention Following Mania,” Journal of Psychopharmacology 20, no. 2 Suppl. (2006): 31–38, at 31.

Orentlicher D. , “Genetic Privacy in the Patient-Physician Relationship,” in Rothstein M. , ed., Genetic Secrets: Protecting Privacy and Confidentiality in the Genetic Era (New Haven: Yale University Press, 1997): 77–91, at 77–78.

Hall M. A. Bobinski M. A. , and Orentlicher D. , Health Care Law and Ethics, 7th ed. (New York: Aspen Publishers, 2007): at 175–185.

See Klocke , supra note 7, at 518–521; IMS Health, Inc., 490 F. Supp. 2d at 171.

See Greene , supra note 4, at 747; Steinbrook , supra 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 , supra note 7, at 520–521; Zoutman D. E. Ford B. D. , and Bassili A. R. , “The Confidentiality of Patient and Physician Information in Pharmacy Prescription Records,” Canadian Medical Association Journal 170, no. 5 (2004): 815–816. 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.

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).

IMS Health Corp., 532 F. Supp. 2d at 163.

The author relied on The Medical Letter during his years as a practicing physician. The Medical Letter describes itself as follows: The Medical Letter on Drugs and Therapeutics 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, The Medical Letter publishes an article on a new non-drug treatment or a new diagnostic aid. Avaliable at <www.medicalletter.org/html/who.htm#about_newsletters> (last visited December 16, 2009).

See Brody , supra note 16.

See Greene , supra note 4, at 742.

Musacchio R. A. Hunkler R. J. , “More Than a Game of Keep Away,” Pharmaceutical Executive, May 1, 2006, available at <http://pharmaexec.findpharma.com/pharmaexec/article/articledetail.jsp?id=323311>(last visited February 16, 2010); Steinbrook , supra 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.)

IMS Health, Inc., 490 F. Supp. 2d at 166.

Orentlicher D. , “The Influence of a Professional Organization on Physician Behavior,” Albany Law Review 57, no. 3 (1994): 583–605.

Personal communication with Mark Frankel, American Medical Association (April 26, 2009) (reporting the 22,000 figure for enrollment); Greene , supra note 4, at 746 (estimating at 650,000 the number of physicians who actively prescribe drugs).

Personal communication, supra note 11.

See, supra, text accompanyig note 37.

See, supra, text accompanyig notes 23–24.

N.H. Rev. Stat. Ann. § 318:47-f.

Id.

See Klocke , supra note 7, at 524.

N.H. Rev. Stat. Ann. § 318:47-f.

18 Vt. Stat. Ann. § 4631(d).

22 Me.Rev.Stat. § 1711-E(2)-(2.A).

22 Me.Rev.Stat. § 1711-E(1-B).

IMS Health, Inc., 490 F. Supp. 2d at 171–173; 18 Vt. Stat. Ann. § 4631(a).

IMS Health, Inc., 490 F. Supp. 2d at 183; IMS Health Corp., 532 F. Supp. 2d at 182–183.

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., Rowan v. Post Office Department, 397 U.S. 728 (1970) (permitting individuals to direct the postal service not to deliver pornographic mail from a particular person or organization).

IMS Health v. Sorrell, 631 F. Supp. 2d. 434 (D. Vt. 2009).

For useful treatment of this issue by legal scholars, see, Richards N. M. , “Reconciling Data Privacy and the First Amendment,” U.C.L.A. Law Review 52, no. 4 (2005): 1149–1222; Schauer F. , “The Boundaries of the First Amendment: A Preliminary Exploration of Constitutional Science,” Harvard Law Review 117, no. 6 (2004): 1765–1809; Volokh E. , “Freedom of Speech and Information Privacy: The Troubling Implications of a Right to Stop People from Speaking About You,” Stanford Law Review 52, no. 5 (2000): 1049–1124.

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.

IMS Health, Inc., 490 F. Supp. 2d at 175.

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., U.S West, Inc. v. FCC, 182 F.3d 1224 (10th Cir. 1999); Nat'l Cable & Telecomms. Ass'n v. FCC, 555 F.3d 996 (D.C. Cir. 2009).

IMS Health, Inc. v. Ayotte, 550 F.3d at 52–53.

See Jackson T. H. Jeffries J. C. , Jr. “Commercial Speech: Economic Due Process and the First Amendment,” Virginia Law Review 65, no. 1 (1979): 1–41. 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. Chemerinsky E. , Constitutional Law: Principles and Policies, 3rd ed. (New York: Aspen Publishers, 2006): At 625–629.

IMS Health, Inc., 550 F.3d at 52–53.

IMS Health, Inc., 490 F. Supp. 2d at 177. Under Central Hudson, speech does not qualify for first amendment protection under the commercial speech doctrine if it is false or misleading. Central Hudson Gas v. Public Service Commission of New York, 447 U.S. 557, 566 (1980).

IMS Health, Inc., 490 F. Supp. 2d at 180–183; IMS Health, Corp., 532 F. Supp. 2d at 168–180.

IMS Health, Inc., 550 F.3d at 54–60.

IMS Health, Inc., 550 F.3d at 55–59.

IMS Health, Inc., 631 F. Supp2d. at 451–453.

IMS Health, Inc., 631 F. Supp2d. at 453–455.

Compare Florida Bar v. Went for It, 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 Lorillard Tobacco Co. v. Reilly, 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 Post R. , “Prescribing Records and the First Amendment—New Hampshire's Data-Mining Statute,” New England Journal of Medicine 360, no. 8 (2009): 745–747, 746.

IMS Health, Inc., 490 F. Supp. 2d at 180–181; IMS Health Corp., 532 F. Supp. 2d at 172–176.

IMS Health, Inc., 550 F.3d at 55–59; IMS Health, Inc., 631 F. Supp2d. at 453–454.

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.

IMS Health, Inc., 550 F.3d at 59–60.

IMS Health, Inc., 631 F. Supp2d. at 454–455.

Chemerinsky , supra 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).

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 supra note 65.

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. United States v. Caronia, 576 F. Supp. 2d 385 (E.D. N.Y. 2008); United States v. Caputo, 517 F.3d 935, 939–940 (7th Cir. 2008). See also Rogers J. Essay , “Freedom Of Speech & The FDA's Regulation Of Off-Label Drug Uses,” George Washington Law Review 76, no. 5 (2008): 1429–1443; Hall R. F. Sobotka E. S. , “Inconsistent Government Policies: Why FDA Off-Label Regulation Cannot Survive First Amendment Review Under Greater New Orleans,” Food & Drug Law Journal 62, no. 1 (2007): 1–48.

U.S West, Inc. v. FCC, 182 F.3d 1224 (10th Cir. 1999).

Nat'l Cable & Telecomms. Ass'n v. FCC, 555 F.3d 996 (D.C. Cir. 2009).

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. Id. 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. Stone G. R. Seidman L. M. Sunstein C. R. Tushnet M. V. , and Karlan P. S. , The First Amendment 3rd ed. (New York: Aspen Publishers, 2008), at 495–517.: 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.

Shiffrin S. , “The First Amendment and Economic Regulation: Away from a General Theory of the First Amendment,” Northwestern University Law Review 78, no. 5 (1983): 1212–1283, 1256–1265.

535 U.S. 357 (2002).

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.” Id., 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.

Id., at 365 (citing 21 U.S. C. § 353a(c)).

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.

IMS Health, Inc., 550 F.3d at 53.

IMS Health, Inc., 490 F. Supp. 2d at 182.

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,” American Journal of Health-System Pharmacy 65, no. 24 (2008): 2312–2314; Guadagnino C. , “Pa. Launches Academic Drug Detailing,” Physician's News Digest, December 2005, available at <www.physiciansnews.com/spotlight/1205.html> (last visited February 11, 2010).

IMS Health, Inc., 550 F.3d at 60.

See Donohue , supra, note 1.

Rust v. Sullivan, 500 U.S. 173 (1991).

National Endowment for the Arts v. Finley, 524 U.S. 569 (1998).