UNDER THE INFLUENCE: AN EXAMINATION OF THE TACTICS PHARMACEUTICAL COMPANIES USE TO MANIPULATE PHYSICIANS Shena T. Wheeler • I. INTRODUCTION .................••.....••...•.•......•.....•••......•......•.....•.•............ 90 A. The Issue .................................................................................... 90 B. Roadmap .................................................................................... 93 II. BACKGROUND: STATE AND FEDERAL LEGISLATION LIMITING PHARMACEUTICAL COMPANY ADVERTISING EXPENDITURES AND GIFTS TO PHYSICIANS FROM PHARMACEUTICAL COMPANIES ..•.••... 93 A. Massachusetts: A Total Ban ...................................................... 93 B. Minnesota: Partial Ban with Recordkeeping Requirements and Several Notable Exceptions ....................................................... 95 C. New York: A Proposal Lawmakers Can't Refuse? ................... 97 D. Vermont, West Virginia, District of Columbia, and Maine: Big Brother is Watching ................................................................... 98 E. Proposed Federal Legislation: Is it Enough? ......................... IOO Ill. BACKGROUND: AMERICAN MEDICAL AsSOCIATION STANDARDS FOR PHYSICIAN GIFTS, FOOD & DRUG ADMINISTRATION STANDARDS FOR ADVERTISING, AND INDIANA STATE MEDICAL GUIDELINES FOR Born ................................................................... 101 A. American Medical Association Standards ............................... 101 B. Food and Drug Administration Limitations: An Historical Perspective ............................................................................... 102 C. Indiana State Medical Association Compliance and Guidance 103 N: ANALYSIS: Do LIMITS AND BANS ON PHYSICIAN GIFTS AND ADVERTISING HELP OR HURT PATIENTS? ........................................ 103 A. What Effect do Gifts have on Physicians' Prescribing Habits? ..................................................................................... 104 B. Are Pharmaceutical Representatives Qualified to Educate Doctors about New Drugs? ..................................................... 106 C. Economic Concerns ................................................................. 107 D. Does Banning Free Drug Samples Hurt Patients? .................. 109 E. Ethical Concerns ...................................................................... 111 G. First Amendment Issues ........................................................... 113 H. What is the Best Solution? ....................................................... 114 V. CONCLUSION .................................................................................. 115 * J.D. Candidate, 2010, Indiana University School of Law- Indianapolis; B.S., 2005, Central Michigan University 90 INDIANA HEALTH LAW REVIEW [Vol. 7:89 L INTRODUCTION Marie Fishel has some deep regrets: while celebrating her twenty­ fifth wedding anniversary last night, she inhaled five plates of baby-back ribs at the local steakhouse's All-You-Can-Eat Ribs Monday. As a result, Marie's persistent heartburn is flaring up again. In the past, over-the­ counter medications, such as Prilosec, Pepcid AC, and Pepto Bismol, have not relieved her symptoms. Frustrated, Marie made. an appointment with her family physician. As she swings her feet from the examination table in the doctor's office, internally rehearsing a list of her symptoms and their longevity for when the doctor shows up, she looks around the examination room, hoping to distract her mind from the painful burning in her esopha­ gus. Prominently featured on the wall are posters of a human digestive tract, sponsored by Nexium. Bored with the graphic representation of her small intestine, she reaches for the remote control to the exam room's tiny television set. In between Kathie Lee Gifford and Hoda Kotb's pleasantries about the latest thigh cream, she is bombarded with commercials for pre­ scription drugs. As the wait grows increasingly painful, she reaches for this week's People magazine, with a smiling Patrick Swayze on its cover. Be­ tween gossip tidbits and human interest stories, Marie notices glossy pages with columns in tiny typeface, touting the benefits and risks of everything from birth control pills to blood pressure medication. By the time the phy­ sician enters, carrying a Cymbalta clipboard, with a menagerie of drug­ name inscribed ink pens in her lab coat pocket, Marie cannot help but won­ der who is really prescribing her medication - her physician or the pharma­ ceutical companies? · While Marie's fictional situation has been embellished for dramatic effect, concerns about pharmaceutical companies' gifts to physicians and pharmaceutical advertisements are far from fictional and are creating quite a buzz in both the medical and legal professions. As lawmakers and industry watchdogs create new regulations in hopes of increasing pharmaceutical company accountability and decreasing prescription drug costs, there is an increasing need to examine the risks and benefits of such regulations. A. Thelssue Pharmaceutical companies strive to create and maintain relationships with physicians through advertising and gift-giving, in hopes of influencing them to prescribe their drugs more frequently than their competitors.1 Ac­ cording to a survey published in the New England Journal of Medicine in 2007, 94% of physicians reported having arelationship with pharmaceutical 1. Eric G. Campbell et · al., A National Survey of Physician-Industry Relationships, 356 NEW ENG. J. MED. 1742, 1743 (2007). 2010] UNDER THE INFLUENCE 91 companies.2 Of those physicians, 83% claimed that those relationships in­ volved free meals, while 78% of those physicians received free drug sam­ ples. 3 Other types of gifts include trinkets, honors for . speaking engagements, reimbursement of travel expenses, and free admission to en­ tertainment events or medical conferences.4 Recently, several states have proposed {)f adopted total or partial bat1S on gifts made by pharmaceutical companies to physicians.5 Most of these statutes include disclosure requirements for advertising expenditures made by pharmaceutical companies.6 Although the definition varies state-by­ state, advertising expenditures typically include gifts given· over a certain dollar threshold made to physicians.7 Legislation has also been introduced in the United States ·Congress which would require pharmaceutical compa­ nies to report all ''payment[s} or transfer[s] of value" made to physicians.8 Medical schools across the country have also adopted this trend, restricting gifts made by pharmaceutical companies to their students.9 In addition, the Pharmaceutical Research and Manufacturers ofAmer­ ica (PhRMA) recently released voluntary guidelines prohibiting pharma­ ceutical . companies from offering physicians trinkets such as pens, notepads, and. calendars emblazoned with a drug name.10 Under these guidelines, small gifts lacking any educational purpose and· that-are valued under $100 are prohibited.11 . . Both physicians and patients can be affected by drug advertisements· paid for by pharmaceutical companies.12 Pharmaceutical companies spend nearly twice as much on advertising and marketing as on pharmaceutical 2. /d. at 1742. 3. /d 4. /d. at 1743. 5. VT. STAT. ANN. tit. 18, § 4632 (2008); MINN. STAT. ANN.§ 151.461 (West 2008). 6. Id. 7. Id 8. Physician Payments Sunshine Act of2007, S.2029, llOth Cong. (2007). 9. For example, the University of Pennsylvania, Stanford University, Yale Universi­ ty, and the University of Maryland medical schools all prohibit phannaceutical company gift-giving on their campuses. Johns Hopkins University School of Medicine was consider­ ing a ban as recently as March 2009. The University of Minnesota is considering a "con­ flict-of-interest policy" that would have effects similar to that of a gift ban. See generally, Julekha Dash, Johns Hopkins University Eyeing Ban on Drug lm:fustry 's Free Pens, Food, and Fun, BOSTON Bus. J., Mar. 6, 2009, available at http://bQstoo.b~oumals.comlboston/ othercities/baltimore/stories/2009103/09/story3.h1ml?b=1236571200%5El789736; Janet Moore, U Medical School Plan: Ban All Gifts to Doctors, STAR TRIB.-Oct. 21, 2008, available at http:/lwww.startribune.com/lifestylelhealth/31435329.html?c;lr=KArksLckD8EQDUoaEyqy P40:DW3ckUiD3aPc:Yyc:aUUJ. . 10. Mary Ellen Schneider, Voluntary PhRMA Guidelines will Ban Trinkets, ENTREPRENEUR, (October 2008), htlp:/lwww.entrepreneur.com/tradejoumals/article/18894 3082.h1ml. 11. Id 12. Matthew Arnold, Consumer Ads Influence Doctors: Study, MED. MARKETING & MEDIA, (June 2005), http://findarticles.oonilp/articles/mi _ qa5351/is _200506/ai _ n21373090. 92 INDIANA HEALTH LAW REVIEW [Vol. 7:89 research and development; this includes the aforementioned gifts and free samples, as well as advertisements pe8pering primetime television and four-page spreads in glossy magazines. 3 There is evidence that patient­ directed advertisements impact physicians as wel1.14 One study found that doctors are discussing advertisements with their patients more than ever before.15 That same study found that physicians mention these ads to their patients just as often as their patients ask their doctors about the ads. 16 When pharmaceutical advertising began, it was directed solely at prescrib­ ing physicians; advertisements were directed to consumer-patients for the first time in 1981.17 Since then, there has been an influx of consumer­ patient-directed pharmaceutical advertisements on television, on the radio, and in magazines. This is important because although the target audience for these ads consists of consumer-patients, physicians will inevitably be exposed to them as well, which will likely influence their prescribing ha­ bits. In Indiana, a state which serves as home to many pharmaceutical companies, 18 there has been some progress in this area of the law. After being the first pharmaceutical company in the nation to endorse the Physi­ cian Payments Sunshine Act (PPSA), 19 Eli Lilly and Company ~lans to launch an online registry of its payments to physicians in 2009. 0 Lilly would create a database accessible to the public via the Internet, which, by 2011, would include all payments made to physicians, and payments made for speaking engagements, bringing it into anticipatory compliance with the PPSA, should it be passed by Congress?1 Despite Lilly's voluntary antic­ ipatory compliance with the PPSA, it is not currently held to any state re­ quirements: The Indiana state legislature, unlike some other states, has yet 13. York University, Big Pharma Spends More On Advertising Than Research And Development, Study Finds, SCI. DAILY (Jan. 7, 2008), http://www.sciencedaily.com/releases/ 2008/01/080 l 05140107 .htm. 14. Arnold, supra note 12. 15. Id 16. Id 17. Francis B. Palumbo, and C. Daniel Mullins, The Development of Direct-to­ Consumer Prescription Drug Advertising Regulation, 57 Fooo & DRUG L.J. 423, 424 (2002). 18. Indiana's pharmaceutical companies include, but are not limited to, Bayer, Bristol Mayer Squibb, Eli Lilly & Co., Covance, Pfizer, and Schwarz Pharma. Pharmaceutical Companies in Indiana, http://www.purdue.edu/dp/ptec/companies.pdf. 19. The Physician Payments Sunshine Act, so named because of its intention to shed light on payments from pharmaceutical companies to physicians, is proposed Federal legisla­ tion. If passed, it would require pharmaceutical companies to issue quarterly reports for most categories of physician gifts. It does not, however, purport to ban physician gifts alto­ gether. Physician Payments Sunshine Act of2007, S.2029, llOtb Cong. (2007). 20. Erik Greb, Lilly to Establish Registry of Its Payments to Physicians, THE ELECTRONIC NEWSL. OF PHARMACEUTICAL TECH. (Oct. 2, 2008), http:// pbarm­ tech.findpharma.com/pharmtecb/Manufacturing!Lilly-to-Establish-Registry-of-its-Payments-to­ Phy/ ArticleStandardl Article/detail/55570 I ?contextCategoryid=40939&ref-=25. 21. Id. 2010] UNDER THE INFLUENCE 93 to introduce legislation banning or partially banning gifts to physicians. B. Roadmap This Note discusses external factors influencing physicians' prescrib­ ing habits, including gifts from pharmaceutical companies and drug adver­ tisements, and the current and pending state and federal regulations designed to curb such practices. In order to foster an understanding of the current legislation, Section II provides a historical background of several state statutes and federal legislation regulating physician gifts, including motivation and criticisms of each. Section III offers historical background of drug advertising regulations nationwide, with a special focus on such regulations in Indiana. Section IV discusses whether current and pending bans on physician gifts help or hurt consumer-patients and contains an analysis of gifts from pharmaceutical companies and drug advertising in light of the current economic crisis and the state of America's health care system. Finally, Section V concludes the discussion with the suggestion that achieving a balance between accurate dissemination of information about new drugs and therapies and limits on undue influence from pharma­ ceutical companies may be the best way to resolve the issue. II. BACKGROUND: STATE AND FEDERAL LEGISLATION LIMITING PHARMACEUTICAL COMPANY ADVERTISING EXPENDITURES AND GIFTS TO PHYSICIANS FROM PHARMACEUTICAL COMPANIES In order to facilitate a better understanding of the necessity of state and federal legislation regulating physician gifts, a discussion of the current and pending state and federal legislation is imperative. The state statutes can be placed into three broad categories: 1) total bans on physician gifts; 2) partial bans on physician gifts; and 3) required recordkeeping of all ad­ vertising costs, including physician gifts, with disclosure to the state gov­ ernment. A. Massachusetts: A Total Ban Massachusetts is the only state thus far to prohibit all gifts made by pharmaceutical companies to physicians.22 The ban, introduced by Senate President Therese Murray in March 2008, is the first of its kind in the Unit­ ed States.Z3 It allows for fines of up to $5,000 for a single infraction?4 22. MAss. GEN. LAWS ANN. ch. lllN, § 2 (West 2008). 23. Megan Woolhouse, Ban on Gifts to Doctors Sought, BoSTON GLOBE, Mar. 4, 2008, available at http://www.boston.com/newslhealth/articles/2008/03/04/ban _on _gifts_ to _doctors_ sought! 24. ld. 94 INDIANA HEALTH LAW REVIEW [Vol. 7:89 Touted as an "Act to promote cost containment, transparency and effi­ ciency in the delivery of quality health care;.25 the Massachusetts statute was passed in August 2008 and became effective on January 1, 2009.26 It requires the Massachusetts Department of Health to ''adopt a standard mar­ keting code of conduct for all pharmaceutical or medical device manufac­ turing companies that employ a person to sell or market prescription drugs or medical devices in the commonwealth.'.27 In turn, the new code created by the Department of Health must, by law, prohibit meals bought for physi­ cians by pharmaceutical companies for entertainment, absent informational presentations, outside the physician's office, or for the physician's spouse.28 In addition, it must prohibits gifts of tickets for sporting events or leisure activities; reimbursement for travel expenses; compensation for a physi­ cian's participation in a continuing medical education (CME) presentation; meals at conferences; cash payments, unless for services; and grants or scholarships related to the prescription drug_29 However, the new code al­ lows for an exchange of academic or scientific information; purchase of ad space in academic journals; drug samples; payment for participation in clin­ ical trials; and reimbursement for expenses relating to technical training on use of a medical device.30 These specific prohibitions and requirements demonstrate the state's balancing act: outlaw unnecessary and frivolous gifts. and payments to physicians while fostering the need to disseminate information related to new drugs and therapies. The Massachusetts statute allows a pharmaceutical company to educate physicians on its new drug innovations, but draws the line at social means and compensation for atten­ dance at various CME events. Critics of the ban cite concerns about disrupting the free flow of drug information between drug companies, physicians, and patients. They assert that pharmaceutical company representatives are experts regarding the drugs they sell. 31 Although there are concerns that physician gifts raise pre­ scription· drug costs, at least one critic of the Massachusetts statute, Julie Corcoran, deputy vice president of PhRMA, says there is no evidence to support such a·contention.32 Other critics of the Massachusetts statute have expressed concern that the ban will suppress drug innovation and investment in the state.33 Eli Lil- 25. Massachusetts S.B. No. 2863 (Mass. 2008). 26. MAss. GEN. LAWS ANN. ch. lllN, § 2 (2008). 27. !d. 28. Id 29. Id 30. ld 31. Woolhouse, supra note 23. 32. Id 33. Mark Hollmer, Eli Lilly CEO says Gifts Ban could Drive Drug Research from Massachusetts, BOSTON Bus. J.,Sept. 19, 2008, available at http://www.bizjoumals.com/ boston!stories/2008/09/15/daily78.html (last visited Jul. 8, 2009). 2010] UNDER THE INFLUENCE 95 ly president and CEO John Lechleiter noted the ban has "the potential not only to stifle clinical research in Massachusetts, but also to complicate a key part of market access: the ability to share information.',34 Lechleiter fears the law will "subject doctors, hospitals and academic institutions to complex financial disclosure requirements about payments for clinical re­ search.',35 These rising administrative costs may even parlay into increased prescription drug costs. Thomas Sullivan, president of a medical communi­ cations company, argued that the ban would have ''devastating effects on the research institutions that make Boston the largest healthcare economy in the country. "36 Sullivan estimates that the ban "could disqualify as many as 20% of our faculty, as the ban covers all honorarium and travel ... we would have no way to pay speakers from Massachusetts to travel to events, and no way to pay them for their time. "37 However, the ban has not been in effect long enough to determine the legitimacy of these concerns. B. Minnesota: Partial Ban with Recordkeeping Requirements and Several Notable Exceptions Minnesota legislators passed a partial ban on physician gifts in 2008.38 In Minnesota, pharmaceutical companies are prohibited from giving any gifts to any physician with a "combined retail value" exceeding $50, subject to a few exceptions?9 The exceptions include: drug samples; compensation to sponsor medical conferences, as long as the compensation is not paid to the physician and the conference is for educational purposes only; consult­ ing fees for research projects; publications; employee salaries; and "reason­ able honoraria and payment of the reasonable expenses of a practitioner who serves on the faculty at a professional or educational conference or meeting.'.4° However, public availability to such information is limited. Public accessibility is provided, but practically speaking, it is very difficult to ob­ tain any of the disclosure reports.41 The disclosure fonns are unavailable electronically or online .. 42 The only way for an individual to obtain the fonns is to "travel to the state office in Minnesota in order to photocopy 34. !d. 35. Id 36. Ben Comer, State Senate Approves Ban on Gifts to Physicians, MED. MARKETING & MEDIA (Apr. 21, 2008), available at http://www.mmm-online.com/State-Senate-approves­ ban-on-gifts-to-physicians/articlell 09220/. 37. !d. 38. MINN. STAT. ANN. § 151.461 (2008). 39. !d. 40. !d. 41. Robert Kirby, Karl H. Buch. & Phoebe A. Wilkinson, N.Y. Seeks to Join States Regulating Pay to Physicians, 0urSIDE CoUNS., 240 N.Y.L.J. 4, 4 (2008). 42. !d. 96 INDIANA HEALTH LAW REVIEW [Vol. 7:89 each form at a fee of$0.25 per copy.',43 This restricts public availability to those unable to travel to the state office; public access is therefore some­ what illusory. Dr. Carl Heltne, chief medical officer for SMDC Health System of Duluth, Minnesota, a nonprofit health care system of over twenty clinics and hospitals, supports the ban because he feels it stifles misconceptions about the medical industry: "No matter how you look at it, we [are] all in­ fluenced by these marketing activities ... [b ]ut patients come to us and they trust us to make decisions solely on their behalf. To uphold that trust, we can[not] have even a perception that companies influence us.'M Minneso­ ta 's ban on pharmaceutical companies' gifts of free food for physicians was the first of its kind.45 Interestingly, after the ban went into effect, pharma­ ceutical companies began inviting nurses and secretaries to informational dinners, despite the fact that nurses and secretaries lack prescription au­ thority.46 However, the real targets of the pharmaceutical company's mar­ keting blitz are the speakers at the dinners, physicians who require training about the company's drug prior to eaeh speaking engagement.~7 The doc­ tors are often paid handsomely for these presentations, some fetching up to $100,000 per year.48 However, most claim to be immune from the influ­ ence of compensation they earn from the presentations.49 After watchdog groups first raised awareness about the Minnesota law in 2007, pharmaceutical companies began spending less on Minnesota doc­ tors. 5° From 2007 to 2008, pharmaceutical company payments to doctors dropped by over $3.5 million.51 This drop could be attributed to the in­ creasing transparency of pharmaceutical company ~ayments to physicians, but it could also be a result of a suffering economy. 2 While the reason for the decline is unclear, others suggest that increasing concern over the con­ flict of interest between pharmaceutical companies and doctors is a plausi­ ble explanation. 53 43. /d. (citing Joseph S. Ross et al., Pharmaceutical Company Payments to Physi­ cians: Early Experiences with Disclosure Laws in Vermont and Minnesota, 297 JAMA 1216, 1218 (2007)). 44. Gardiner Harris, Minnesota Limits on Gifts to Doctors May Catch On, N. Y. TIMES, Oct. 12, 2007, available at http://www.nytimes.com/2007/10/12/us/l2gift.html. 45. /d. 46. /d. 47. Id 48. Id 49. Id. 50. Jeremy Olson, Pharmaceutical Companies Spending Less on Minnesota Doctors, THE PIONEER PRESS, Jul. 6, 2009, available at ht1p:l/www.twincities.com/ci_l2573822 ?nclick_ check= l. 51. Id. 52. /d. 53. Id. 2010] UNDER TiiE INFLUENCE 97 C. New York: A Proposal Lawmakers Can't Refuse? In 2008, a statute that would partially limit gifts to physicians was in­ troduced in the New York Assembly. The New York Assembly Bill cited compelling evidence that the vast majority of physi­ cians accept some type of gift or payment from phar­ maceutical and medical device manufacturers, and often such gifts and payments, even when of little value, influence physicians to prescribe treatments that are more expensive and no more effective or safe, and are sometimes less effective and more dangerous, than other available treatments. 54 The New York Assembly also found that "[l]egislation is necessary to pro­ hibit presenters at continuing professional education programs from provid­ ing false or misleading information to prescribers and to require all potential conflicts of interest be disclosed to attendees of such programs. ,,ss The proposed legislation would prohibit all gifts aggregating to more than $50 annually to physicians and medical students, with exceptions: drug samples; payment for clinical trials; manufacturer's discounts for drugs or medical devices; and "anything of economic value given by a person with a financial relationship with a manufacturer who is related by blood, marriage or adoption within three degrees of consanguinity to the recipient prescrib­ er."56 The proposed New York legislation differs from the Minnesota sta­ tute because it applies to both physician gifts and to gifts made to medical students.57 The permissible exceptions also differ: For example, the Min­ nesota statute provides exceptions for publications and employee salaries, while the proposed New York statute does not. 58 These small differences in state-by-state legislation may provide a better framework for possible fed­ eral legislation banning physician gifts, since they permit lawmakers, phar­ maceutical companies, and physicians to see what works and what does not. A federal model would likely take these findings into consideration. The proposed New York lefslation also requires yearly disclosure of any benefits given or received.5 The disclosure is mandatory when the physician or medical student "offered, gave, or received a benefit," the pharmaceutical company gave the physician a discount, or there was "a fi- 54. /d. 55. /d. 56. S. 6015, 64th Gen. Assem., 23lst Sess. (N.Y. 2009). 57. /d. 58. Compare MINN. STAT. ANN.§ 151.461 (2008) with S. 6015, #Gen. Assem., 23lst Sess. (N.Y. 2009). 59. S. 6015, 64th Gen. Assem., 231st Sess. (N.Y. 2009). 98 INDIANA HEALTH LAW REVIEW [Vol. 7:89 nancial relationship" between the pharmaceutical company and the physi­ cian or medical student.60 If one of these factors is met, a disclosure must be made in one of three categories: Disclosure of a Benefit; Disclosure of a Discount, or Disclosure of a Financial Relationship.61 Violation ofthe par­ tial gift ban or failure to comply with the disclosure requirements could re­ sult in a fine of $5,000-$50,000 for pharmaceutical companies, or $5,000- $10,000 for physicians.62 D. Vermont, West Virginia, District of Columbia, and Maine: Big Brother is Watching The least restrictive state statutes require disclosure of physician gifts. In 2008, Vermont legislators passed an initiative . requiring disclosure of marketing expenditures, including physician gifts.63 The Vermont statute requires pharmaceutical companies to record gifts made to physicians if the value of the particular gift exceeds $25, subject to a civil penalty of up to $10,000 for failure to disclose.64 Along with gifts under $25, drug samples, scholarships to medical students, and drug rebates are also exempt. 65 After reports are made to the attorney general, the disclosures are then reported to state lawmakers and the governor.66 Another important exemption from such reports is any statement which would disclose a pharmaceutical com­ pany's trade secrets.67 As a result, "61 percent of payments to physicians that had been disclosed under the Vermont law were designated 'trade se­ crets' by the reporting manufacturer, and were therefore kept confidential from the public."68 West Virginia also requires disclosure of marketing expenditures as­ sociated with prescription drugs, excluding drug samples, reimbursement for costs associated with clinical trials, and scholarships for medical stu­ dents. 69 As the least restrictive state statute for pharmaceutical companies, West Virginia's statute does not apply to medical device manufacturers.70 The disclosure information is not available to the public: "Any 'national aggregate expense [information]' disclosed to state officials is considered 60. ld. "Financial relationship" is defined by the proposed statute as "an ownership interest, investment interest, or compensation arrangement." 61. Id. 62. ld. 63. VT. STAT. ANN. tit. 18, § 4632 (2008). 64. Id. 65. !d. 66. !d. 67. Kirby, supra note 41. 68. !d. (citing Joseph S. Ross et al., Pharmaceutical Company Payments to Physi­ cians: Early Experiences with Disclosure Laws in Vermont and Minnesota, 297 JAMA 1216, 1218 (2007}). 69. W.VA. CoDE§ 5A-3C-13 (2008). 70. Kirby, supra note 41. 2010] UNDER THE INFLUENCE 99 confidential and is not subject to release under West Virginia's Freedom of Information Act."71 In addition, the West Virginia statute does not incen­ tivize pharmaceutical companies to comply with the law because there are no penalties levied for failure to do so. 72 Critics of the West Virginia statute, including some pharmaceutical companies, allege that. it may violate the First Amendment of the United States Constitution; since the "communication [is] made for the sole pur­ pose of selling products or services," the speech should be protected under the commercial speech doctrine?3 It may also be seen as a violation of Free Speech because the information, released in aggregate, may reflect poorly upon a pharmaceutical company and "discourage the public" from purchas­ ing its products. 74 The District of Columbia's statute simply requires a reporting of all advertising costs made by pharmaceutical companies?5 Legislation in Maine,.however, is considerably more complicated. The Maine statute re­ quires "manufacturers or labelers" of prescription drugs to report their ad­ vertising expenses annually.76 Advertising expenses include direct expenditures for television, radio, and print ads, gifts to physicians over $25 in value, and travel expenses. It also includes drug samples, if those sam­ ples will not be given to patients for free.77 Exclusions include expenses of $25 or less; "reasonable compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy or treat­ ment," and educational scholarships.78 The statute's stated purpose is to "enabl[ e] [Maine]·· to determine the scope of prescription drug marketing costs and their effect on the cost, utilization and delivery of health care ser­ vices and further[ ] · the role of this State as guardian of the public inter- est."79. . A similar Maine statute was challenged in IMS Health Corp. v. Rowe. 80 Prescription Drug Iilformation Intermediaries (PDlls) intercept valuable information regarding pharmaceutical companies, physicians, and patients, including prescribing pattern information. They later sell such information back to pharmaceutical companies, who in turn use it to ad­ vance their market research practices.81 The court weighed several advan- 71. !d. 72. !d. 73. Brienne Taylor Greiner, A Tough Pill to Swallow: Does the First Amendment Prohibit WV from Regulating Pharmaceutical Companies ' Advertising Expenses to Lower the Cost of Prescription Drugs? 109 W.VA. L. REv. 107, 119-20 (2006). 74. !d. 75. D.C. CODE § 48-833.01 (2008). 76. ME. REv. STAT. ANN. tit 22,. § 2698-A (2008). 77. Jd. 78. Jd 79. !d. 80. IMS Health Corp. v. Rowe, 532 F.Supp.2d 153, 154 (D. Me. 2007). 81. !d. at 158. 100 INDIANA HEALTH LAW REVIEW [Vol. 7:89 tages and disadvantages of such PDIIs, including cost, efficiency, and vacy. The court also noted the widespread use of questionable sales me­ thods and pharmaceutical industry misconduct. 82 IMS challenged the con­ constitutionality of 22 M.R.S.A. §§ 1711-E, which "restrict[ ed] the use of prescriber identifying information" in an effort to "decrease drug detailing that targets the prescriber, thus increasing decisions to prescribe lower priced drugs and decisions made on the basis of medical and scientific knowledge and driving down the cost ofhealth care."83 The state also ar­ gued that 22 M.R.S.A. § 1711-E would enhance the effectiveness of other laws, including MRSA § 2698-A; the court held that this was a legitimate governmental interest. 84 Despite the legitimacy of this interest, the court held "that the provisions of the Maine Law that seek to restrict the use and disclosure of commercial information violate the free speech guarantee of the First Amendment. "85 E. Proposed Federal Legislation: Is it Enough? The United States Congress has addressed the issue of pharmaceutical company gifts to physicians with the Physician Payment Sunshine Act of 2007 (PPSA), so named because it is intended to shed light on the relation­ ship between the pharmaceutical industry and physicians. 86 The PPSA was introduced in the Senate in September 2007; a similar bill was introduced in the House in March 2008.87 The sponsors of the PPSA intended that it would yield "'transparency' to such payments and ... 'foster accountability by empowering consumers and other watchdogs."'88 The PPSA primarily addresses means of disclosure, rather than outright limits or bans on physi­ cian gifts.89 PPSA requires quarterly reports by "manufacturers of covered drugs, devices, or medical supplies under Medicare, Medicaid, or SCHIP [State Children's Health Insurance Program]."90 The reports required by the PPSA must include physician's name, ad­ dress, and facility with which the physician is associated, as well as the amount, date, and description of the payment.91 The description can fall into one of eight categories, including: compensation; food, entertainment, or gifts; trips or 82. !d. at 160-66. 83. !d. at 160 (quoting ME. REv. STAT. AN~I. tit. 22 § 17ll-E)(2008)). 84. IMS Health Corp., 532 F.Supp. 2d at 175. 85. !d. at 182. 86. Kirby, supra note 41. 87. !d. 88. /d. 89. Physician Payments Sunshine Act of2007, S.2029, I lOth Cong. (2007). 90. !d. 91. !d. 2010] UNDERTHElNFLUENCE travel; a product or other item provided for less than market value; participation in a medical conference, continuing medical education, or other educational or informational program or seminar, provision of mate­ rials related to such a conference or educational or in­ formational program or seminar, or remuneration for promoting or participating in such a conference or educational or informational program or seminar; product rebates or discounts; consulting fees or hono­ raria; or an1 other economic benefit, as defined by the Secretary. 9 101 If the federal legislation is passed, it will preempt existing pharmaceutical industry disclosure laws in many states, which will eliminate inconsistency in this area of the law.93•94 III. BACKGROUND: AMERICAN MEDICAL ASSOCIATION STANDARDS FOR PHYSICIAN GIFTS, FOOD & DRUG ADMINISTRATION STANDARDS FOR ADVERTISING, AND INDIANA STATE MEDICAL GUIDELINES FOR BOTH A. American Medical Association Standards In the early 1990s, the American Medical Association (AMA) devel­ oped its own standards to address the issue of physician gifts.95 The AMA Opinion states that gifts should only be accepted when they benefit a patient and are not too lavish.96 Certain gifts may be appropriate if they serve an informational purpose, including meals or textbooks.97 In addition, "[i]ndividual gifts of minimal value are permissible as lon~ as the gifts are related to the physician's work (e.g., pens and notepads)." 8 According to the AMA Opinion, subsidies from the industry should not be accepted di­ rectly or indirectly to pay for the costs of travel, lodging, or other personal expenses of physicians attending conferences or meetings, nor should sub- 92. Id. 93. Kirby, supra note 41. 94. In early 2009, the PPSA was reintroduced in the Senate, with some amendments. Maribel Rios, Physician Payments Sunshine Act Reintroduced for 2009 (Jan. 29, 2009), available at http://pharmtech.findpharma.com/pharmtech!News/Physician-Payments­ Sunshine-Act-Reintroduced-for 2/ ArticleStandard/ Article/detailf577973?contextCategoryld =35097. 95. American Medical Association, Opinion 8. 061- Gifts to Physicians from the Indus­ try, adopted December 1990, http://www.ama-assn.org/ama!pub/category/400l.html (last visited Jul. 9, 2009). 96. !d. 97. Id. 98. /d. 102 INDIANA HEALTH LAW REVIEW [Vol. 7:89 sidies be accepted to compensate for the physicians' time.99 Finally, [n]o gifts should be accepted if there are strings at­ tached.100 For example, physicians should not accept gifts if they are given in relation to the physician's prescribing practices. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the se­ lection of content, faculty, educational methods, and materials should belong to the organizers of the con- ferences or lectures.101 · B. Food and Drug Administration Limitations: An Historical Perspective The Food & Drug Administration (FDA) has also imposed advertising limitations on pharmaceutical companies. First regulated by the FDA, then the Federal Trade Commission, now FDA again, spending on direct-to­ consumer (DTC} advertising rose from just $12 million in 1989 to over $2.3 billion in 2001. 02 The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) contains one provision for pharmaceutical advertisements, which "requires simply that the advertisement include the drug's generic name and formula, and a brief summary describing the effectiveness of the drug and its risks."103 This "brief summary" must include drug side effects and warnings.104 "Second, the "fair balance doctrine" provides that the entire advertisement must present a balanced account of all clinically relevant in­ formation; the risks must be presented grominently and legibly so that the benefits are not unfairly emphasized."1 5 Balancing information must be prominently mentioned in the ad so that patient-consumers can properly weigh the pros and cons of taking the drug.106 The advertising cannot be false or misleading and should be consistent with the drug's label.107 In addition, the FDA has created three "categories of prescription drug advertisements ... : 1) reminder advertisements, 2) help-seeking or disease­ oriented advertisements, and 3) product-claim or indication advertise­ ments."108 Reminder advertisements show the drug name but do not pro­ vide information about the drug itself, such as pens, Post-Its, desk 99. /d 100. Id 101. Id. 102. Palumbo, supra note 17, at 423-24. 103. Id at 428. 104. Id 105. Id. 106. Jd 107. /d 108. Palumbo, supra note 17, at 428. 2010] UNDERTHE!NFLUENCE 103 calendars, or coffee mugs imprinted with a drug's name!09 Help-seeking or "see your doctor" advertisements are the opposite: they "typically de.; scribe the symptoms of a disease or condition, and encourage consumers to consult their ph6sician to discuss treatment options, but do not mention the drug's name."ll Since neither reminder advertisements nor help-seeking advertisements show consumers the effectiveness of a particular drug, the brief summary and fair balance requirements are inapplicable.111 Product-claim advertisements are a combination of the previous two types of advertisements, meaning they present the drug's name as a drug for certain medical symptoms.112 Because of this, product claim advertise­ ments "must satisfy the brief summary requirements and maintain fair bal­ ance."113 In 1999, the FDA decided that television advertisements must contain a "disclos[ure of] the product's major risks," which is presumably why the phrase, "if you experience an erection lasting more than four hours," has become part of the American lexicon.114 An ad must now include a toll­ free phone number that consumers may call to receive more information; offer of further information in another medium ("see our ad in Soap Opera Digest"); a web address that has drug label information; and that consumer­ patients may consult their physicians for more information.115 C. Indiana State Medical Association Compliance and Guidance In Indiana, although gifts from the industry are not addressed by Indi­ ana law, the Indiana State Medical Association defers to the AMA ethical standards in this area.116 IV: ANALYSIS: Do LIMITS AND BANS ON PHYSICIAN GIFTS AND ADVERTISING HELP OR HURT PATIENTS? The arguments on both sides of this compelling issue are comparably persuasive. On one hand, those opposing physician gift limits and bans consider industry guidelines sufficient to curb any inappropriate conduct by both pharmaceutical companies and physicians. In addition, some physi­ cians are offended by the implication perpetuated by gift limits and bans that they are not prescribing drugs according to their patients' needs and 109. Id 110. /d. Ill. Id. at 428-29. 112. /d. 113. /d. 114. Palumbo, supra note 17, at 431. 115. Id. 116. Indiana State Medical Association, Legal Resources: Compliance and Guidance Documents, available at http://www.ismanet.org/legal/compliance _ docs.htm. 104 INDIANA HEALTH LAW REVIEW [Vol. 7:89 abhor the thought of further regulations that some fear could inhibit the free flow of information about new drugs. In contrast, proponents of limits and bans on physician gifts cite ethi­ cal concerns and higher prescription drug costs as their primary criticisms of such gifts. This anti-pharm hysteria is widespread: Websites such as pharmedout.org and nofreelunch.org condemn the use of pharmaceutical company freebies to influence physicians' prescribing habits. A recent sur­ vey of patient-consumers revealed that many were opposed to pharmaceuti­ cal company gifts to physicians. 117 Over 80% of respondents said that pharmaceutical companies should be prohibited from gifting physicians with free dinners and travel. 118 In addition, over half of those surveyed thought that drug sam~les from pharmaceutical companies to physicians should be prohibited.11 Perhaps even more telling is that nearly 70% of respondents would support legislation requiring gift disclosure. 120 The major concerns about the practice of pharmaceutical companies' gifts to physicians were enumerated by Dr. Ogan Gurel: Unsustainable high cost (hence the massive layoffs that Pfizer announced in 2007)[;] [ c ]oncerns that marketing costs add to the cost of drugs passed on to patients[;] [e]thical concerns about inappropriate pressures being made on physicians with respect to gifts and other benefits being distributed by drug rep­ resentatives[;] [t]he banning of pharmaceutical drug representatives from some medical campuses includ­ ing Stanford, Henry Ford and Rush University medi­ cal centers.121 Further exploration of each issue is necessary to foster an understand­ ing of the pros and cons of physician gift bans by state and federal legisla­ tures. A. What Effect do Gifts have on Physicians' Prescribing Habits? In a study conducted in 2000 and published in the Journal of the American Medical Association, Ashley Wazana found that freebies and 117. The Prescription Project Survey, (June 2008), http://www.prescriptionproject.org/ assets!pdfs/Prescripton%20Project%20Survey _ 0618.pdf (last visited Jul. 9, 2009). 118. Jd. 119. Id. 120. Id. 121. Ogan Gurel, MD, Counterdetailing: A Cure for a Pharmaceutical Addiction? (Mar. 17, 2008), http://www.midwestbusiness.com/news!viewnews.asp?newsletteriD= 19002 (last visited Jul. 9, 2009). 2010] UNDER THE INFLUENCE 105 honorariums had a significant impact on physicians' prescribing habits.122 W azana found that when pharmaceutical companies paid for a physician to attend a conference2 the physician prescribed that company's drugs 4.5-10 times more often.1 3 Physicians who answered that they "occasionally'' accepted free meals from pharmaceutical companies "were 2.3 times more likely than other doctors to request that the sponsor's drug be added to a hospital formulary. "124 When physicians "often" accepted free meals from pharmaceutical companies, they "were 14 times more likely to do so."125 Despite the fact that many physicians admitted to some form of interaction with drug representatives, when asked if those representatives ''fairly por­ tray their product," 80% said no, while 75% said that the representatives ''use unethical practices."126 It is unnecessary to paint physicians as villains who are easily swayed by free pizza or readily seduced by cunning drug representatives. Even the most well-intentioned doctor could fall pre~ to his or her subconscience after being subjected to freebies and drug ads.1 7 Despite what some physicians say, studies and social science show that pharmaceutical companies' gifts to physicians have a profound impact on physicians' prescribing habits.128 Dr. David Blumenthal suggests that "humans are vulnerable to a powerful, unconscious 'self-serving bias'; that is, they have trouble seeing themselves as biased when the bias serves their needs or advances their own perceived interests."129 This means that even the smallest gifts from pharmaceutical companies may influence physi­ cians' prescribing habits, since they may feel an obligation to reciprocate, either consciously or subconsciously.130 Blumenthal is skeptical that states' disclosure laws and gift limits will affect the relationship between pharma­ ceutical companies and physicians in the long run because such relation­ ships are important to both parties: pharmaceutical companies need to sell their product, while physicians need to stay educated on cutting-edge drugs and therapies.131 He predicts recurring cycles of scandal and reform for the future. 132 122. Ashley Wazana, Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?, 283 JAMA 373 (2000) 123. Id at 378. 124. Alex Roslin, Big Pharma's Pill Pushers- Why Americans Are Addicted to Expen­ sive Prescription Drugs (Sep. 4, 2008), http://www.straight.com/print/160083# (last visited Jul. 21, 2009). 125. Id 126. Wazana, supra note 122, at 377. 127. David Blumenthal, MD, Doctors and Drug Companies, 351 NEW ENG. J. MED. 1885, 1887 (2004), available at http://contentnejm.org/cgi/reprint/351118/1885.pdf. 128. See, eg., Wazana, supra note 122, at 377; Blumenthal, supra note 129, at 1887. 129. Blumenthal, supra note 129, at 1887 (citing Jason Dana & George Loewenstein, A Social &ience Perspective on Gifts to Physicians from Industry, 290 JAMA 252, 252-5 (2003)). 130. Blumenthal, supra note 129, at 1887. 131. /d. at 1889. 132. Id 106 INDIANA HEAL Til LAW REviEW [Vol. 7:89 B. Are Pharmaceutical Representatives Qualified to Educate Doctors about New Drogs? Shahram Ahari, former drug representative for Eli Lilly, made a splash when he disclosed the dark side of pharmaceutical companies to sponsors ,of the PPSA and ABC News.133 Ahari alleged that drug repre­ sentatives were hired on the basis of looks and charisma, and in his expe­ rience, the vast majority lacked any sort of science background.134 Ahari alleged that drug representatives are encouraged to use questionable sales tactics, "including how to exceed spending limits for important clients, be­ ing generous with free samples to leverage sales, using friendships and per­ sonal gifts to foster a 'quid pro quo' relationship, and how to exploit sexual tension. "135 There is also widespread concern in the medical community that bans and limits on physicians' interactions with drug representatives hurt patients because they limit the drug comp;my's ability to convey information about new drugs and the latest innovations in medical research. Logic dictates that a prescribing physician cannot recommend a therapy or drug if he or she does not know it exists. Scott Lassman, PhRMA counsel, expressed such a concern: "[T]he new policies [are] a 'disservice to patients and phy­ sicians' because they keep doctors from interacting with sales representa­ tives. 'The company sales representatives, in our point of view, have a lot of useful information on drug products and how to use them, and how not to use them. "'136 This view is undoubtedly shared by many in the medical community. While some drug representatives, such as Ahari, claim that they are instructed to participate in questionable sales tactics, a spokesman for Eli Lilly countered Ahari's claims: 'We think his examples are exaggerated. We have policies in place that allow us to engage in interac­ tions with health care professionals at an appropriate level and they are intended to provide infonnation about our products so that they will be able to make appropriate medical decisions for their patients.' 137 . 133. Marcus Baram. Ex-Drug Sales Rep Tells All, ABC News, (2009) http://abcnews.go.com/US/story?id=4438095&page=l (last visited Jul. 9, 2009). 134. Id 135. /d. 136. Andrew Pollack, Stanford to Ban Drug M.alrers' Gifts to Doctors, Even Pens, N.Y. DMEs, Sep. 12, 2006, available at http:/lwww.nytimes.com/2006/09/12/business/ 12drug.html? _r= l &ref=business&oref--slogin. 137. Baram.supranote 135. 2010] UNDER THE INFLUENCE 107 Meanwhile, Stanford University Medical Center prohibited even the smallest gifts to its physicians by pharmaceutical companies in an effort to reduce the influence that pharmaceutical companies have on its physician's prescribing habits.138 . . .. · In response to the New York Times article, some physicians claimed that·the Stanford limits were much too strict; in fact, some claimed that the AMA guidelines were too stringent as well.139 These physicians claim that the interaction between drug representatives and physicians is vital to. in­ forming their prescribing habits; others expressed outrage at the insinuation that a trinket, such as a pen or a measuring tape with a drug's name on it, would have a great effect on their prescribing habits.140 • · . A key concern is the accuracy of the information provided by pharma"' ceutical representatives. One study, conducted by researchers at the .Uni-· versity of California at San Diego School of Medicine, found that 12 of 106 statements made by ~harmaceutical representatives, and later tested for ac­ curacy, were false.1 This means that 11% of the statements contradicted information available to the representatives.142 Most frightening is. the fact that the physicians to· whom the information was given were not·aware of the inaccuracy of the statements.143 Unsurprisingly, marketing material used by pharmaceutical companies often has a bias toward ·the company distributing it.144 In addition to providing skewed information, marketing material sometimes does not comport with FDA regulations "against. pro­ moting unapproved uses of drugs."145 The fact that some pharmaceutical representatives fail to accurately inform physicians about their product, coupled with questionable marketing materials suggests that pharmaceutical companies are not the best resource from which physicians should receive information about new drugs and therapies. C. Economic Concerns If these advertisements and gifts bring physicians to a level of aware­ ness about new innovations in drug therapy without adverse influence on their prescribing habits, what is the harm? Look no further than your pock- 138. Pollack, supra note 138. 139. Reader Feedback: Is Limiting Industry Gifts a Smarl Policy?, FIERCE HEALmcARE, Sep. 15, 2006, available at http:/lwww.fiercehealthcare.com/storylreader-feedback-is-limiting­ industty-gifts-a-smart-policy212006-09-15. 140. Jd. 141. M.G. Ziegler, et al, The Accuracy of Drug Information from Pharmaceutical Rep- resentatives, 273 JAMA 1296, 1296-7 (1995). . . 142. Id. 143. Id. at 1297. 144. Daniel Stryer ·& Lisa Bero, Characteristics of Materials Distributed by Drug Companies, 11 J. GEN. INTERN. MED. 575, 579 ( 1996), available at http://www.springerlink. com/content/f625624628q5m333/fulltext.pdf. 145. Id. . 108 INDIANA HEALTH LAW REVIEW [Vol. 7:89 etbook. Most state legislatures have cited the growing costs of prescription drugs as a primary concern when enacting legislation banning gifts to phy­ sicians.146 While Massachusetts' approach is very specific and may come with some administrative costs, other states' disclosure laws may not get to the root of the problem. There is little evidence that requiring pharmaceuti­ cal companies to be accountable for their advertising expenditures reduces spending on physician gifts and other marketing avenues. Marketing can have a drastic effect on how a drug is perceived. '"The explosion in drug costs is directly proportional to marketing,"' says Alan Cassels7 a pharmaceutical 1p.3rketing researcher from the University of Vic­ toria.14 Cassel further stated, "'[p]harmacists have told me they can tell when a certain company's dru§ rep has been in town because of a spike in that company's prescriptions.'" 48 AstraZeneca, makers of Prilosec and Nexium, has exhibited "bio­ chemical chutzpah" in its marketing of the drugs. 149 The patent on Prilosec, the world's best-selling drug, ran out in 2001, prompting AstraZeneca to use a mirror image of the drug's isomers to create Nexium; the only differ­ ence between the two drugs is that ''Nexium is 3 percent better at relieving symptoms."150 [NT A: The previous citation was nearly a direct quote from the source; to simplify, I made is a direct quote]. Despite the lack of"signif­ icant clinical advance," Nexium was approved by the FDA that same year. 151 Immediately after approval was granted, AstraZeneca launched an aggressive marketing campaign aimed at "getting doctors and patients to switch from Prilosec to ... Nexium."152 As a result of this marketing blitz, Prilosec is still available over-the-counter, and costs consumers about $30.153 Its nearly identical counterpart, Nexium, costs about $200.154 This demonstrates the remarkable effect that marketing techniques have on pre­ scribers and patients. Economic concerns of rising marketing and advertising expenditures of pharmaceutical companies cannot be overlooked. According to Jason Dana and George Loewenstein, "[g]ifts from the pharmaceutical industry contribute to the rapidly increasing cost of medical care, and more specifi­ cally, to the increase in expenditures on prescription drugs."155 This is sup- 146. See eg., Massachusetts Senate Bill No. 2863 (2008). 147. Roslin, supra note 124. 148. /d. 149. Robert Bazell, The Costly Side Effects of Nexium 'sAd Blitz, NBC News (August 14, 2007), available at http:/ /www.msnbc.msn.com/id/202495911. 150. /d. 151. /d 152. Id 153. /d. 154. Id. 155. Jason Dana & George Loewenstein, A Social &ience Perspective on Gifts to Phy­ sicians from Industry, 290 JAMA 252,252 (2003). 2010] UNDER THE INFLUENCE 109 ported by the doubling of prescription drug spending by patient consumers from 1995 to 2000, with an increase of 17%, attributable to physicians' pre­ scribing more expensive drugs, in 2001.156 Pharmaceutical representatives tout the innovation of new drugs to physicians, which is supposed to offset or justifY the increased cost of these new drugs. However, [f]rom 1989 to 2000, the US Food and Drug Adminis­ tration judged 76% of all approved new drugs to be no more than moderate innovations over existing treatments, with many being a modification to an old­ er product with the same ingredient. In 2000, the av­ erage price of these standard-rated new drugs was nearly twice the average price of existing drugs pre­ scribed for the same indications. 157 Therefore, even though the overall effectiveness of most prescription drugs has not changed, the price of these drugs has increased far past the rate of inflation, resulting in no more bang for your buck. Back in Massachusetts, medical conventions are being cancelled due to the new gift ban, causing some to wonder if the law is hurting the econ­ omy. The cancellation of a convention results in lost convention revenues for the city, as well as lost accommodation costs and entertainment ex- d. 158 pen 1tures. Administrative costs induced by recordkeeping mandates may out­ weigh any perceived benefit of disclosure. The added costs and effort asso­ ciated with such a recordkeeping requirement has spawned the introduction of companies seeking to capitalize on the gap in the market for physician gift registries. One company offers gift registry databases for physicians and pharmaceutical companies to maintain their compliance with record­ keeping requirements. This, of course, is not a complimentary service. D. Does Banning Free Drug Samples Hurt Patients? The availability of drug samples from pharmaceutical companies is al­ so a concern. A 2000 study examined the effect of drug samples on physi­ cians' prescribing habits. 159 Survey participants, all physicians at University of Washington-based clinics, were presented with three different 156. Id at252-3. 157. !d. at253. 158. John Gever, Medical Group Pulls Meeting from Boston over State Ethics Law, MEDPAGE TODAY (January 22, 2009), http://www.medpagetoday.com/PublicHealthPolicy/ HealthPolicy/12567 (last visited Jul. 9, 2009). 159. Lisa D. Chew, et al., A Physician Survey on the Effect of Drug Sample Availability on Physicians' Behavior, 15 J. GEN. INTERN. MED. 478,478 (2000). 110 INDIANA HEALTH LAW REVIEW [Vol. 7:89 prescribing scenarios.160 The first hypothetical patient ·was an insured woman with a simple urinary tract infection; the second was an uninsured man with hypertension.161 The third ''patient" was an uninsured woman with ·~ew onset depression."162 The survey physicians were then asked what their preferred therapy was for each hypothetical patient.163 In the first scenario, only 1% of the doctors stated that their preferred therapy was ciprofloxacin; however, when drug samples were available, 17% of those doctors dispensed ciprofloxacin, regardless of the fact that 92% of them preferred another drug.164 The doctors justified their decision by reasoning that they wanted to immediately commence the patient's treatment and save the patient a trip to the pharmacy.165 In the second scenario, 91% of doctors selected a drug Sample instead of their preferred therapy, citing prevention of extra financial burden on the uninsured patient.166 In a follow-up scenario, where the same patient re­ turned with the same symptoms but was insured, 69% of doctors said they would write a prescription for the drug sample·instead of switching the pa­ tient's medication, while 88% said they would write a prescription for their ... 1 ~ d th 167 tnttia pre1erre erapy. Finally, for the third ''patient," an uninsured woman suffering from depression, 69% of doctors preferred a selective serotonin reuptake inhibi­ tor.168 Of the 82% of respondents who said they would dispense a drug sample, 49% would dispense a drug sample inconsistent with their preferred therapy.169 As in the second scenario, most doctors cited the need to ease the financial burden on the uninsured patient as justification. for their beha­ vior. 170, , , Researchers stated that their ''most disturbing fmding [was] that the presence of drug samples may influence physicians to diwense or prescribe drugs that differ[ ed] from their preferred drug choice."1 This ultimately means that compliance with industry guidelines for dis~ensing certain ther­ apies for certain illnesses or symptoms is compromised. 72 While it would seem that drug samples help less fortunate patients, by offering doctors a free alternative· to prescription medicine, a study by re­ searchers at Harvard Medical School and Cambridge Health Alliance indi- 160. ld. at 479-80. 161. ld. at479. 162. ld. 163. ld. 164. ld. at480. 165. Chew, supra note 162, at 480. 166. ld. at481. 167. ld. 168. ld. 169. ld. 170. ld. 171. Chew, supra note 162, at 482. 172. ld. 2010] UNDER THE INFLUENCE 111 cated that most free drug samples go to aftluent patients.173 This is because poor patients do not often visit the doctor's office due to the expense of keeping an appointment.174 The study found that only 28% of patients re­ ceiving drug samples were below the poverty level.175 According to Sarah Cutrona, MD, lead author of the study, '"[d]octors like to give free samples, and patients like to get them, and no one wants to think of them as a power­ ful marketing tool of the drug industry ... But that's what samples are. And what they really are not is a safety net for the needy."'176 This is con­ trary to the opinion of Ken Johnson, vice-president ofPhRMA, who claims that drug samples help patients and "often lead to improved quality of life for millions of Americans, regardless of their income."177 Yet another doc­ tor asserts that the drug samples do not go to needy patients, but usually go home with physicians and their employees instead.178 It appears that drug samples do help some patients, but not those who need them most. E. Ethical Concerns Florida physician James P. Orlowski refuses to let pharmaceutical companies influence the way he prescribes medication to patients; he has a self-imposed ban on drug representatives entering his Tampa Bay office, rejecting all industry gifts, even pens.179 Although Orlowski would prefer that Congress and the state legislatures refrain from getting involved, he believes that the high visibility of the legislation may open up his col­ leagues' eyes to this rampant problem.180 Indeed, physicians can be inundated with gifts; one anonymous mem­ ber of the National Physician's Alliance turned down 12 free breakfasts, 18 lunches, 16 branded pens, a branded eyeglasses cleaner, two branded pen lanyards, branded pill holders, Post-it Notes, noteJM!.ds, a pocket Physicians Desk Reference, correction paper strips, a coffee mug, a poster, a hig- 173. Barbara Basler, Free Drug Samples Help the Well-Off More Than the Poor, THE PRESCRIPTION PROJECT, Jan. 4, 2008, available at http://www.prescriptionproject.org/assets/ pdfs/Basler _ AARP _samples _Jan-2008.pdf. 174. Id. 175. Id. 176. Id. 177. Id. 178. Howard Brody, MD, The Company We Keep: Why Physicians Should Refuse to See Pharmaceutical Representatives, 3 ANN. FAM. MED. 82, 84 (2005), available at http://www.annfammed.org/cgilreprint/3/1/82. 179. Kris Hundley, Doctor Combats Pull of Drug Reps, ST. PETERsBURG TIMEs, Dec.27, 2007, available at http://www.sptimes.com/2007/12/27/Business/Doctor_combats _pull_ o.shtml. 180. ld. 112 INDIANA HEALTH LAW REVIEW blighter, a diagnostic manual, a giant clip-refrigerator magnet, a ruler, a water-oil globe, a History ofViagra book and a Viagra soap dispenser - in only a month- lSI and-a-half. [Vol. 7:89 This inundation of gifts has prompted some physicians to call for the profession-wide refusal of pharmaceutical company gifts.182 Dr. Howard Brody183 frames the ethical argument in the following way: 1. As a matter of professional integrity, I claim that I ought to behave in accord with certain principles. 2. Empirical evidence shows that I am highly likely to behave in ways contrary to my professional principles when I keep company with [pharmaceutical repre­ sentatives]. 3. My professional responsibilities do not require me to keep company with [pharmaceutical representatives]. 4. If, therefore, I choose to continue to keep company with [pharmaceutical representa­ tives], I cannot claim that I truly wish to adhere to h £'. • 1 . . 1 184 t ose pro.tessiOna pnnc1p es. Brody goes on to explain that empirical evidence demonstrates not on­ ly that physicians are influenced by pharmaceutical representatives, but that they do not realize they are being influenced.185 He also says that spending time with pharmaceutical representatives is often a waste of time, and that most physicians do not allow themselves time to later check the representa­ tive's statements for accuracy and bias.186 The only way for the physician­ pharmaceutical representative relationship to be an effective educational tool would be "[for physicians to] spend time with reps in a manner that preserves professional integrity[, which] would require both refusing to ac­ cept their gifts and srending a great deal of valuable time double-checking their information."18 Brody thinks that physicians could spend their time . 1 188 morew1se y. The primary ethical concern regarding pharmaceutical company gifts to physicians is whether the gift clouds the physician's judgment in pre- 181. !d. 182. Brody, supra note 181, at 82. 183. !d. Brody is a professor and director for the Institute for the Medical Humanities, University of Texas Medical Branch at Galveston. He is also the author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry (Rowman & Littlefield 2007). 184. Brody, supra note 181, at 83. 185. !d. at 82. 186. !d. 187. Id. at 84. 188. !d. at 85. 2010] UNDER THE INFLUENCE 113 scribing medicine. Nurse practitioners with prescribing privileges are not immune to this phenomenon either.189 The problem is that "gifts entice health professionals into relationships that subtly call for reciprocity, and have been shown to influence prescribing behaviors."190 Some also fear that doctors overprescribe medications, rather than offering cheaper alterna- . . . d 191 F 1 d "b h t1ves to prescnpt10n rugs. or examp e, octors may prescn e ormone replacement therapy for menopausal women, when simply shedding a layer of clothing and ~etting a good night's sleep might help alleviate their symp­ toms, sans drug:92 Ethical concerns are also illuminated when considering advertisements in medical journals.193 Medical journals have multiple obligations that may conflict.194 Such obligations include ''the independence of journal re­ ports[both] to their professional subscribers and by extension to the public. These obligations could conflict because unbiased reporting is expected."195 When journals publish advertisements, they are making a choice to promote a particular drug due to their financial obli~ations, when independent judg- d. h . ul h . T96 ment may not 1ctate t at partie ar c mce. G. First Amendment Issues Yet another issue that concerns opponents of .physician gift bans is whether it impedes on the exercise of free speech.19 In 1976, the United States Supreme Court struck down a Virginia statute that prohibited Virgin­ ia pharmacies from advertising their drug prices. The court reasoned that the advertisements had value as commercial speech.198 Advertisements from pharmaceutical companies are generally regarded as commercial speech, rather than personal speech, which is regarded as a higher form of speech, and thus more protected.199 In order to pass Constitutional muster, a restriction on commercial speech must have a substantial governmental interest that is directly advanced by the restriction.200 In addition, the re- 189. Charlene L. Stokamer, Pharmaceutical Gift Giving: Analysis of an Ethical Di- lemma, 33 JONA 48, 48 (2003). 190. /d. 191. /d. 192. Id. at 50. 193. /d. 194. /d. 195. Stokamer, supra note 192, at 50. 196. See eg., id 197. Aaron S. Kesselheim, MD, JD & Jerry Avom, MD, Pharmaceutical Promotion to Physicians and First Amendment Rights, 358 NEW ENGL. J. MED. 1727 (2008), available at http://content.nejm.org/cgi/content/fu.IV358/16/1727. 198. /d. at 1728. (referring to and citing Virginia State Board of Pharmacy v. Virginia Citizens Council, Inc., 425 U.S. 748 (1976)). 199. Kesselheim, supra note 201, at 1728. 200. /d. 114 INDIANA HEALTH LAW REVIEW [Vol. 7:89 striction must be no more broad than necessary to accomplish its goals.201 Can state statutes limiting or banning physician gifts survive this in­ termediate level of scrutiny? Some argue that limitations on marketing ha­ bits of pharmaceutical comganies "can improve prescribing decisions and protect the public's health.' 02 It appears, however, that new state legisla­ tion preventing pharmaceutical companies from using prescribing habit in­ formation will pass constitutional muster, at least according to the First Circuit.203 The statute there, however, limited pharmaceutical companies' access to information mined for the purpose of tailoring marketing efforts to specific physicians?04 It remains to be seen whether restrictions on phar­ maceutical company gifts to physicians will be supported by the courts. H. What is the Best Solution? Limits and bans on such gifts are just one way to combat the effect of pharmaceutical industry influence on physicians. While an outright ban, such as the one implemented in Massachusetts, seems harsh, there is little evidence that lesser limitations, such as those implemented in West Virgin­ ia, have had any great effect on this problem. Indiana's biggest pharmaceutical company, Eli Lilly, has already tak­ en proactive steps to anticipatorily comply with the PPSA. The PPSA, however, only requires reporting and disclosure of gifts; it does not limit such gifts to physicians. An outright ban, such as the Massachusetts ban, would likely be more effective at curbing the influence that uninformed (though perfectly coiffed) drug representatives· have on physicians who should know better. The PPSA and the Massachusetts ban are on opposite ends of the spectrum, with Minnesota's limits in between. While a happy medium seems favorable, it is evident that drastic measures will need to be taken in order to reverse the troubling trend that is unfolding in the health care in­ dustry because of pharmaceutical companies' gifts to physicians. There appears to be a fine line between educating physicians about new pharma­ ceutical therapies and influencing them to write a prescription that they normally would not, if not for external factors. As far as institutional policies which restrict contact between pharma­ ceutical representatives and physicians go, one study has suggested that physicians who had been trained on the policy after it had taken effect were much more skeptical of statements made by pharmaceutical representa- 201. Id 202. Id. at 1731. 203. Kevin B. O'Reilly, New Hampshire Ban on Sale of Prescribing Data, AMER. MED.NEWS, Dec. 22, 2008, available at http://www.ama-assn.org/amednews/2008/12/ 22/prsc 1222.htm. 204. Id 2010] UNDER niE INFLUENCE 115 tives?05 A restrictive policy, however, did not affect whether a physician would meet with the pharmaceutical representative.206 This study seems to indicate that restrictive policies in medical institutions do affect the way physicians think about their interactions with drug companies;207 a state­ imposed policy regarding gifts and disclosure may have a similar effect. The FDA advertising limits, however, are unnecessarily stringent. Since television viewers are so inundated with parades of atrocious side effects so frequently, risks of warnings and side effects can often fall on deaf ears. Some side effects may be minimal, but because of their promi­ nent placement in drug commercials, it also could cause some viewers to be too terrified to try a drug that could help them more than hurt them. The FDA advertising limits create an advertising environment for prescription drug advertisers which forces pharmaceutical companies to produce the same bland commercials with the same frightening side effects. This likely does not aid in promoting a product as efficiently as could be done if the FDA's requirements were not so limiting. If pharmaceutical companies could realistically portray their products, rather than show people walking hand-in-hand across a field of flowers whilst discussing their genital herpes, it may create more of a desire in consumer-patients to become educated about the product. The advertisement restrictions are unfair in the sense that they prohibit the pharmaceutical companies from flaunting the positive aspects of their products and instead force them to recite a laundry list of horrendous side effects. V. CONCLUSION Studies have shown that gifts from pharmaceutical companies, phar­ maceutical. advertisements, and information tendered from pharmaceutical representatives may have an effect on physicians' prescribing habits. Eco­ nomic and ethical concerns are at the heart of the issue of pharmaceutical company influence. States have attempted to curb this influence through legislation designed to limit or ban gifts to physicians and mandate disclo­ sures for certain types of gifts. For most state legislation, it is too early to tell whether such legislation will have any effect on physicians' prescribing habits and limiting pharmaceutical company influence. There has been very little litigation relating to the state statutes. The PPSA, if passed, will provide consistency in disclosure and recordk:eeping, while allowing states to maintain stricter standards if they wish. Some physicians are concerned that they will be unable to obtain information about new drugs and thera- 205. George D. Comerci, Long-Term Effects of Restricting Residents' Contact with Drug Representatives, 7 AAP GRAND ROUNDS 32 (2002), available at http://aapgrandrounds. aappublications.orglcgi/reprint/7 /3/32. 206. /d. 207. Id. 116 INDIANA HEALTH LAW REVIEW [Vol. 7:89 pies once state and federal legislation goes into effect. There is evidence, however, that information disseminated by pharmaceutical companies can be biased and even inaccurate. The key to global peace on this issue appears to be a balancing of the free-flowing dissemination of information between pharmaceutical compa­ nies and physicians regarding new drug information and therapies with the influence of gift-giving on physicians' prescribing habits. Disclosure plays a key role in achieving this balance, as is evident in the implementation of recordkeeping and disclosure statutes in states across the nation. The best way to prevent pharmaceutical company influence on physi­ cians remains to be seen. Once the state plans have been in effect for aw­ hile, it will be easier to see what is most effective at curbing this undue influence. For now, it is important for doctors to realize that, no matter how esteemed and educated, they are not immune to pharmaceutical company influence. Awareness of the problem will lead to a better solution. Only then will fictional Marie, and the rest of the American public, be able to rest easy, confident that their doctors are making well-informed, independent decisions solely for the health of their patients.