Annotated Bibliography; Ethics

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The Path to Cheaper and Safer Drugs: Revamping the Pharmaceutical Industry in Light of GlaxoSmithKline's Settlement

falseFalit, Benjamin. The Journal of Law, Medicine & Ethics 33.1 (Spring 2005): 174-179.

Abstract (summary)

Falit discusses the facts and the settlement agreement on the case of GlaxoSmithKline involving the concealment of information about safety and efficacy of paroxetine HCL. He further discusses the importance of FDA rating system on the basis of cost-effectiveness, efficacy, and safety in reducing pharmaceutical companies' ability to misrepresent the results of clinical trials.

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Suicide is the eighth leading cause of death in the United States and accounts for 1.5% of all annual deaths.1 For approximately the last decade, there has been a controversy as to whether selective serotonin reuptake inhibitor (SSRI) antidepressants can increase suicidality and suicidal ideation in vulnerable individuals.2

On June 2, 2004, Eliot Spitzer, the Attorney General of the State of New York, filed a complaint against GlaxoSmithKline in New York state court, alleging that the drug manufacturer concealed information about the safety and efficacy of paroxetine HCL (Paxil).3 On August 26, 2004, the parties entered into a settlement whereby GlaxoSmithKline agreed to pay $2.5 million in damages and publicly disclose information on all clinical studies in the future.4 Although this settlement marks a great victory for the public, insofar as GlaxoSmithKline's disclosure policy possesses the potential for setting a precedent that all pharmaceutical companies will follow, policy makers must ensure that firms do not prematurely terminate studies that are likely to produce negative results.

Background

The first report of a link between SSRIs and suicidality came in 1990 with a study conducted by several researchers at Harvard Medical School.5 Their report described six patients who experienced paradoxical reactions to fluoxetine (Prozac) characterized by intense, violent, and suicidal thoughts.6 Following Teicher's report, numerous additional reports and comments appeared in the literature.7 While many studies bolstered Teicher and colleagues' tentative conclusions,8 others were highly critical of their findings.9 In 1991, Dr. Bruce Stadel, Branch Chief of the Food and Drug Administration's (FDA's) Division of Epidemiology and Surveillance, announced that the FDA's spontaneous reporting system had received almost 15,000 physician reports of adverse events from fluoxetine, of which 519 were suicide attempts.10 Nevertheless, the FDA refused to withdraw its approval for the drug and declined to mandate a black box warning regarding the link between fluoxetine and suicidality.11

Since the release of fluoxetine in 1987, numerous other SSRIs have hit the market, including paroxetine HCL.12 David Healy, a researcher at the North Wales Department of Psychological Medicine in England, performed a meta-analysis on the medical literature to determine if SSRI antidepressants can trigger suicidality and/or suicidal ideation in vulnerable individuals.13 Healy's study revealed the following: (1) The vast majority (if not all) of prior studies suggesting no causal relationship between SSRI use and suicidal impulse rest on shaky methodological ground;14 (2) Numerous independent studies have observed a causal link between SSRI use and suicidality;15 (3) Evidence suggests that SSRIs reduce suicidality in some patients, and thus the net increase in SSRI-related suicidal acts observed in prior studies indicates that SSRIs have the potential to increase suicidality in some patients by a much larger degree than previously thought.16

Although hundreds of suits have been brought against SSRI manufacturers,17 only three cases have been decided by a jury verdict,18 and only one resulted in a judgment for the plaintiff.19 On June 2, 2004, Spitzer filed a complaint against GlaxoSmithKline in New York state court, alleging that the drug manufacturer concealed and misrepresented information about the safety and efficacy of paroxetine HCL (Paxil).20

The Complaint

The State of New York filed suit under N.Y. Executive Law § 63(12), which authorizes the Attorney General to seek a judgment that "enjoins repeated or persistent fraudulent or illegal business acts or practices, including any misrepresentation, concealment or suppression of a material fact."21 In the complaint, the State of New York alleged that GlaxoSmithKline permitted public disclosure of information that supported pediatric use of paroxetine (Paxil), but concealed and distorted information that questioned the safety and efficacy of the drug in children and adolescents.22 Although the FDA had not approved paroxetine for use in children, the State of New York permits physicians to prescribe FDA-approved drugs for "off-label" uses when they feel that the potential benefits outweigh the costs.23 Spitzer contended that GlaxoSmithKline's policy of disclosing only favorable data supplied physicians with false and misleading information regarding paroxetine's off-label pediatric uses.24

Prior to the initiation of the lawsuit, GlaxoSmithKline conducted randomized, placebo-controlled, double-blind studies (referred to by the company as studies 329, 377 and 701) to assess the safety and efficacy of treating childhood and adolescent depression with paroxetine.25 The company also conducted "extension studies" of studies 329 and 701, which specifically focused on safety rather than efficacy.26 According to the State of New York, studies 377 and 701 failed to show that paroxetine was more effective than a placebo, while study 329 presented a mixed picture of paroxetine's efficacy.27 Additionally, the three original studies suggested that potentially suicidal behavior was two times more likely in the paroxetine group than in the placebo group, and the extension studies supported these findings.28

The complaint alleged that GlaxoSmithKline attempted to suppress and misrepresent the studies' findings on several levels.29 First off, the company permitted the study with ambiguous results, study 701, to be published, but did not release the results of studies 377 and 701 or the extension studies.30 Secondly, the complaint asserted that GlaxoSmithKline misrepresented the safety and efficacy outcomes to its drug representatives, tacitly encouraging the reps to distribute the information to physicians.31 The complaint cites an internal memo to all sales representatives selling Paxil, which stated: "Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression."32 The word "remarkable" appeared in capital letters and the entire sentence was printed in bold-faced type.33 Thirdly, the State of New York alleged that GlaxoSmithKline misrepresented the data in the "medical information letters" that it provided to doctors upon their unsolicited requests for information." Finally, the Attorney General contended that the company knew that its conduct misrepresented the data, since its behavior conflicted with various admissions to drugrelated administrative agencies (including the FDA).35 According to the complaint, on numerous occasions GlaxoSmithKline admitted that paroxetine should not be used to treat pediatric depression because of its lack of efficacy and potential for generating suicidal behavior.36

The Settlement

On August 26, 2004, after the defendant removed the case to federal court, GlaxoSmithKline and the State of New York entered into a settlement whereby the pharmaceutical company agreed to pay $2.5 million in damages and publicly disclose information on all clinical studies in the future.37 The settlement agreement specifically stated that GlaxoSmithKline does not admit or deny any of the acts alleged in the complaint by agreeing to the entry of the consent order and judgment.38

Under the binding settlement, GlaxoSmithKline has committed tc establish and maintain a Clinical Trial Register (CTR) that will provide public on-line access to summaries of all company-sponsored clinical studies from December 27 2000 forward, and any earlier studies likely to affect a physician's medical judgment.39 The CTR must be maintained from February 1, 2005 until February 1, 2015, and a link to the register must be conspicuously displayed on the company's website during this time.40 Additionally GlaxoSmithKline must "use reasonable efforts" to exclude provisions limiting the publication of clinical study summaries in the future, and "make reasonable efforts" to secure the right to publish summaries of trials conducted prior to the settlement.41

The settlement additionally stipulated that, for ten years following the entry of the consent order and judgment, GlaxoSmithKline must provide the Attorney General with copies of any communications (including medical information letters) sent to a New York physician concerning the use of paroxetine to treat pediatric depression.42 Finally, GlaxoSmithKline was obligated to arrange and pay for the publication of an "advertisement" to run in the print and electronic editions of major medical journals such as The Journal of the American Medical Association and The New England Journal of Medicine.43 The uniform advertisements explained the CTR and discussed the company's commitment to maintaining it.44

Discussion and Recommendations

At first glance it appears as if the GlaxoSmithKline settlement represents an incontrovertible victory for the public, insofar as GlaxoSmithKline's disclosure policy possesses the potential for setting a precedent that all pharmaceutical companies will follow. A closer analysis, however, reveals that the universal establishment of clinical trial registers by all pharmaceutical companies carries the potential to make drugs even more dangerous. Aware that summaries of all completed trials will inevitably be released to the public, pharmaceutical companies will rationally choose to prematurely terminate projects that are likely to produce negative results.45 The premature abortion of such studies may lower the number of negative studies that become available to physicians, thereby increasing the chance that a patient will receive inefficacious treatment or suffer an adverse reaction. In order to prevent the pharmaceutical industry from falling subject to such perverse incentives, the government could require all drug companies to publicly disclose the termination of clinical trials, along with the rationale for each decision. This mandate, in conjunction with a commitment by all companies to publicly release summaries of completed trials, could go a long way in making sure that doctors are fully informed about the products they are prescribing.46

In its complaint, the State of New York alleged that GlaxoSmithKline both concealed and misrepresented the nature of clinical trials.47 Although the adoption of the aforementioned proposal could help to address the problem of concealment, it may not have any effect on firms' ability to distort the truth. In fact, if pharmaceutical companies are required to disclose negative findings, firms whose products are faced with the potential of losing market share due to adverse data will have an incentive to "twist the truth" in order to meet investors' expectations. Therefore, in order to prevent the occurrence of such misrepresentation, it may be necessary for the government to intervene a bit further.

Under the current regime, the FDA is responsible for approving the release of new drugs, but refrains from evaluating the products any further.48 In other words, once the FDA decides that a given product meets the threshold level of efficacy and safety necessary to receive approval, it avoids any further assessment of the drug. This leaves pharmaceutical companies responsible for informing physicians about the efficacy and safety of their drugs beyond that of the initial market approval. Pharmaceutical representatives are the primary vehicles by which the companies provide doctors with information about their products.49 Typically, pharmaceutical sales representatives are college graduates who spend approximately six to eight weeks in training before entering the field.50 Despite their ability to effectively promote drugs by delivering samples51 and providing physicians with perks (pens, free meals, etc.),52 evidence suggests that the majority of drug reps have limited information to offer prescribing physicians after their product has been on the market for six months to a year.53 Furthermore, notwithstanding the fact that the majority of doctors fail to recognize errors, research suggests that a significant percentage of pharmaceutical representatives provide physicians with inaccurate information.54

Pharmaceutical companies are for-profit enterprises, and drug representatives are paid to promote their products in the same way that a car salesman is paid to sell cars.55 We therefore should expect the information that they provide to physicians to be biased, a fact that is not a cause for concern since physicians can pool the data that they receive from competing companies in order to arrive at the "truth."56 There is a fine line, however, between partiality and misrepresentation. Policy makers should devise a scheme that (1) makes it difficult for sales representatives to distort the truth, (2) makes it easier for physicians to identify inaccurate information, and (3) reprimands companies (and possibly reps) who disseminate misleading information. These three goals could be served by instituting a program whereby the FDA, in addition to approving or denying drugs, rates new products on three dimensions: (1) cost-effectiveness (whether the drug makes financial sense to patients - an issue that is addressed by weighing the benefits of the treatment against its pecuniary and non-pecuniary costs), (2) efficacy, and (3) safety.57 These ratings could be included on the package insert of each drug, as well as in the Physician's Desk Reference (PDR), and could be accompanied by brief explanations of the rationales behind the ratings. Physicians could be required to report any perceived distortion to the FDA, a process that would be furthered by establishing a web-site where doctors can easily submit complaints.

An FDA rating system could make it more difficult for pharmaceutical representatives (and pharmaceutical companies in general) to distort the truth, and easier for physicians to identify misrepresentations, since representatives who sell products with sub par ratings would be forced to explain their products' poor performance. The establishment of such a rating system may also help to control the high costs of pharmaceuticals. The pharmaceutical industry currently spends approximately $54 billion on marketing, which is almost double what it spends on research and development.58 Industry experts believe that a mutual scale-back in the number of sales representatives would benefit the entire industry.59 It appears that no company is willing to make the change, however, because doing so would hurt market share if the firm's competitors failed to adopt a similar policy.60 The establishment of an FDA rating system would likely catalyze an efficiency-generating scale-back of pharmaceutical representatives that resulted in lower drug prices (assuming that drug companies do not pocket the savings). Drugs whose FDA ratings dwarfed the competition's would essentially sell themselves, and thus the marginal return on the employment of additional sales reps would decline.61 Moreover, it is reasonable to believe that the quantification of a drug's value would lower physicians' susceptibility to the fringe benefits doled out by pharmaceutical representatives. Each drug's threepronged score would serve as a constant reminder to doctors that they must carefully weigh the pros and cons of competitors' products before writing a prescription.

The FDA rating system may also serve to decrease the conflict of interest inherent in post-approval surveillance. Under the current allor-nothing approval process, the FDA does not explicitly distinguish between drugs that barely reach the efficacy and safety thresholds, and those that clear the hurdles by a mile. Therefore, to the American public, all FDA-approved drugs are essentially equal. This distorted public schema interjects bias into the FDA's post-launch monitoring efforts by exacerbating the backlash associated with withdrawing a drug from the market whose efficacy and safety were marginally sufficient upon approval. In other words, the FDA is hesitant to remove a drug's approval status because the public is prone to overestimating the magnitude of the administration's change in judgment. The FDA rating process may make the FDA more willing to withdraw dangerous or inefficacious products from the market, since the public will be fully cognizant of the fact that the drugs were barely approvable in the first place.

The establishment of an FDA rating system will likely involve significant upfront costs (including the retraining of pharmaceutical sales representatives who lose their jobs), as well as the downstream costs associated with paying experts to make these important judgments. Funding for the project could come from the pharmaceutical companies in the form of higher fees (for the use of the FDA approval process). The ability to downscale sales forces will likely more than offset the increased user fees, and thus the American public could still reap the benefits of lower drug prices (assuming again that the firms pass the savings on to the consumer).62

Conclusion/Summary

The State of New York's ability to secure a settlement from GlaxoSmithKline in which they agreed to publish summaries of completed trials is a step in the right direction. It is likely that other pharmaceutical companies will follow suit and establish Clinical Trial Registers for their own drugs. In order to make such a transition positive, however, the government could consider further remedies, including mandating that pharmaceutical companies publicly disclose all premature terminations of clinical trials. If such a policy is not adopted, firms may have an incentive to withdraw funding for projects that are likely to produce negative results. In order to reduce pharmaceutical companies' ability to misrepresent the results of clinical trials, the FDA could begin rating drugs on the basis of their costeffectiveness, efficacy and safety. Such a policy would have the effect of both improving patient outcomes and reducing the cost of pharmaceuticals.

Sidebar

The pharmaceutical industry currently spends approximately $54 billion on marketing, which is almost double what it spends on research and development.

References

1. A. E. Falsetti, "Fluoxetine-Induced Suicidal Ideation: An Examination of the Medical Literature, Case Law, and the Legal Liability of Drug Manufacturers," Food and Drug Law Journal 57 (2002) 273-292, at 273.

2. D. Healy, "Lines of Evidence on the Risks of Suicide with Selective Serotonin Reuptake Inhibitors," Psychotherapy and Psychosomatics 72 (2003) 71-79, at 71.

3. The People of the State of New York v. GlaxoSmithKline, Verified Complaint at 1.

4. The People of the State of New York v. GlaxoSmithKline, Verified Consent Order & Judgment at 5-6.

5. A. E. Falsetti, supra note 1 at 275 (citing M. H. Teicher et al., "Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment," American Journal of Psychiatry 147 (1990) at 207-10).

6. Id. at 275 (citing M. H. Teicher et al., "Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment," American Journal of Psychiatry 147 (1990) 207-10, at 207.).

7. Id. at 276 (citing, inter alia, T. D. Brewerton, "Fluoxetine-Induced Suicidality, Serotonin, and Seasonally," Biological Psychiatry 30 (1991) at 190-96; G. Chouinard, "Fluoxetine and Preoccupation with Suicide," American Journal of Psychiatiy 148 (1991) at 1258-59; K. Dasgupta, "Additional Cases of Suicidal Ideation Associated with Fluoxetine," American Journal of Psychiatry 147 (1990) at 1570; J. Downs et al., "Preoccupation with Suicide in Patients Treated with Fluoxetine," American Journal of Psychiatry 148 (1991) at 1090-91.

8. Id. at 276. See, specifically, A. J. Rothschild and C. A. Locke, "Reexposure to Fluoxetine After Serious Suicide Attempts by Three Patients: The Role of Akathisia," Journal of Clinical Psychiatry 52 (1991), 491-93.

9. Id. at 277 (citing, inter alia, R. B. Berkley, "Discussion of Fluoxetine and Suicidal Tendencies," American Journal of Psychiatry 147 (1990), 1572).

10. Id. at 279 (citing S. R. Ahmad, "USA: Fluoxetine 'Not Linked to Suicide,'" Lancet 338 (1991), at 875).

11. Id. at 279 (citing S. R. Ahmad, "USA: Fluoxetine 'Not Linked to Suicide,'" Lancet 338 (1991), at 876).

12. Id. at 274.

13. D. Healy, supra note 2.

14. Id. at 74.

15. Id. at 74 and 77.

16. Id. at 74.

17. A. Thompson, "Paxil Maker Held Liable in Murder/Suicide," Lawyers Weekly USA, July 9, 2001, at <http:// www.baumhedlundlaw.com/media/ ssri/Paxil_murder.htm> (last visited January 25, 2005).

18. Id.

19. Id.

20. The People of the State of New York v. GlaxoSmithKline, Verified Complaint at 1.

21. Id. at 3.

22. Id. at 2.

23. Id. at 4.

24. Id. at 4-5.

25. Id. at 5.

26. Id. at 5.

27. Id. at 6. Prior to study 329, GlaxoSmithKline identified seven measures of efficacy which it purported to test. Two of these were identified as "primary" endpoints, while the other five were considered "secondary" endpoints. According to the State of New York's interpretation of study 329, paroxetine was superior to the placebo with regard to three of the five secondary endpoints but neither of the primary endpoints.

28. Id. at 6-7.

29. Id. at 8.

30. Id. at 8.

31. Id. at 9.

32. Id. at 9. The memorandum also stated that the information was for pharmaceutical consultants' information only and should not be distributed to physicians. The Attorney General, however, asserted that this was clearly the company's purpose for they would have no other reason to release such a memo.

33. Id. at 9.

34. Id. at 10.

35. Id. at 11-14.

36. Id. at 11-14.

37. The People of the State of New York v. GlaxoSmithKline, Verified Notice of Removal; The People of the State of New York v. GlaxoSmithKline, Verified Consent Order & Judgment at 5-6.

38. Id. at 1

39. Id. at 5.

40. Id. at 7.

41. Id. at 6.

42. Id. at 8.

43. In the Matter of GlaxoSmithKline, Verified Assurance of Discontinuance Pursuant to Executive Law Section 63, Subdivision 15 at 5.

44. Id. at Appendix C.

45. See M. E. Nagle, "State 'Fraud' Suits Over Clinical Trial Results Tread on Free Speech Rights," Mealey's Litigation Report: Antidepressant Drugs, September 24, 2004; J. Abramson, Overdosed America (New York: HarperCollins, 2004): at 104-105 (Discussing the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) study, a five-year study sponsored by Pharmacia that was stopped two years early because the results up to that point demonstrated that Pharmacia's more expensive blood pressure medication Covera was slightly less effective at preventing the complications of high blood pressure than less expensive drugs; see B. M. Psaty and D. Rennie, "Stopping Medical Research to Save Money: A Broken Pact with Researchers and Patients," JAMA 289, no. 16 (2003) 2128-2131). Critics might argue that in virtually all trials, the investigators, sponsors and patients are all blinded to the treatment each participant receives, and thus it is impossible for pharmaceutical companies to know in advance whether or not a study is likely to produce negative results. In such double-blind studies, Data and Safety Monitoring Boards (DSMBs) are responsible for monitoring interim results in order to protect patients' welfare. Although employees of the trial's sponsor are not permitted to serve as members of DSMBs, they are allowed to assist the DSMB in its evaluation of clinical data. Moreover, voting members of DSMBs are permitted to have limited financial ties to the sponsor, and non-voting members are allowed even greater financial connections to the company funding the trial. See Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, at <http://www.phrma. org/publications/publications//2004-060-30.1035.pdf>. With such poor boundaries between DSMBs and sponsors, it seems likely that decisions to prematurely terminate clinical trials are often based at least in part on a study's potential for generating adverse data. Requiring pharmaceutical companies to submit data from all unfinished (as well as completed) trials in order to achieve FDA approval would not adequately deter the premature termination of projects that are likely to produce negative results. Under the current regime, FDA approval is granted on an all-or-nothing basis and thus public disclosure of a study with negative results could hurt market share, even though the results are not sufficiently damning to foreclose FDA approval. Under a system in which the FDA rates drugs in addition to approving them (see infra), however, such a mandate may sufficiently deter the premature termination of studies conducted prior to the product's launch. In order to prevent the inappropriate abortion of post-launch studies, the government would have to either (a) require all companies to publicly disclose the termination of trials, along with the rationale for each decision (see infra), or (b) regularly adjust the "ratings" of previously launched products according to all available data (both completed and unfinished trials).

46. The pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), has recently committed to disclosing information pertaining to all "non-exploratory," industry-sponsored clinical trials. See "Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases," at <http://www.efpia.org/ 4_pos/sci_regu/Clinicaltrials2005. pdf> (last visited January 26, 2005); "PhRMA Clinical Trial Registry Proposal" at <http://www.phrma.org/ publications/policy/06.01.2005.1111. cfm> (last visited January 26, 2005). Although this policy has the potential to reduce pharmaceutical companies' incentive to prematurely terminate studies that are likely to produce negative data, the extent to which this occurs will depend on several factors such as (a) the number and types of studies that companies classify as "exploratory" and are thus exempted from the disclosure requirements, (2) whether the industry's commitment to disclosing "trial phase" and "trial status" includes an obligation to disclose trial terminations, (3) if pharmaceutical companies have indeed committed to announcing trial terminations, the (a) language used to convey this point, (b) the amount of time that is allowed to lapse between a trial termination and disclosure of this fact, (c) whether companies will be able to circumvent their obligations by slowing the progress of a trial to a virtual standstill instead of aborting the project entirely.

47. The People of the State of New York v. GlaxoSmithKline, Verified Complaint at 2.

48. See M. Meadows, "The PDA's Drug Review Process: Ensuring Drugs are Safe and Effective," FDA Consumer, July 2002, at <http://www.fda.gov/ fdac/features/2002/402_drug.html> (last visited January 25, 2005).

49. J. A. Waltz, "CMS Report Analyzes Factors Affecting the Marketing of Prescription Drugs," Medscape from WebMD, April 22, 2003, at <http: //www.medscape.com/viewarticle/ 452211_1> (last visited January 25, 2005).

50. R. E. Herzlinger, W. Lagor, C. Perry, S. St. Germain, "I've Got Rhythm: Selling Cardiac Rhythm Management Devices" Harvard Business School case Number 9-304-012, August 20, 2004, at 6.

51. See J. A. Waltz, supra note 50. Although such a discussion is beyond the scope of this paper, it is highly questionable whether the distribution of samples effectuates laudable societal goals. Anecdotal evidence suggests that a high percentage of samples go to individuals who have adequate insurance coverage or can afford the medicine by themselves. Thus, the dissemination of samples does not address any distributional concerns (and may even exacerbate problems of wealth disparity), insofar as all drug users pay for the cost of samples in the form of higher insurance premiums or higher drug costs.

52. See J. Dana and G. Loewenstein, "A Social Science Perspective on Gifts to Physicians from Industry," JAMA 290, no. 2 (2003) 252-255 (Concluding that, notwithstanding physicians' belief to the contrary, doctors are heavily influenced by the fringe benefits provided by pharmaceutical companies); A. Wazana, "Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?" JAMA 283, no. 3 (2000) 373-380; P. Jhon, "Drug Company Dependent?," Medscape from WebMD, 2003, at <http://www. medscape.com/viewarticle/414513> (last visited January 25, 2005).

53. R. E. Herzlinger, note 51 supra, at 5 (stating: "Physicians felt they had enough information within the first six months to year of launch...Some physicians felt they could learn more about new drugs themselves than from their sales reps. Frequently, drug reps did little more than drop off samples to the nurses or the supply cabinets.")

54. P. Jhon, supra note 53.

55. Pharmaceutical sales representatives are clearly subject to much higher regulation (both internally and by the FDA) than car salesmen. The point, however, is merely that both parties are expected to carefully select language (and potentially data) that portrays their products in the most favorable light.

56. See T. A. M. Kramer, "A Plea for Biased Information," Medscape from WebMD, February 10, 2004, at <http://www. medscape.com/viewarticle/468112_1> (last visited January 25, 2005).

57. Ratings could be made on a 1 to 100 scale or any other scale that allows for sufficient differentiation. The FDA currently assesses the efficacy and safety of drugs in an attempt to determine if they reach the threshold required for approval. This suggests that the FDA would be the best equipped (compared to other governmental bodies) to engage in the additional evaluation necessary to provide products with relative rankings. Of course, in order to accurately assess cost-effectiveness, personnel with different backgrounds (e.g. economists) would have to be hired. Although a detailed discussion of this point is beyond the scope of this paper, the FDA could establish a standardized process through which it regularly reevaluates pharmaceuticals after their launch. The FDA could be required to reassess all drugs every few years on the basis of post-launch clinical trials, and pharmaceutical companies could be permitted to petition the government for reevaluation when sufficient data becomes available.

58. M. Angell, The Truth about the Drug Companies (New York: Random House, 2004): at 40 and 122. The exact amounts of money that pharmaceutical companies spend on marketing and R&D are hotly debated. The pharmaceutical industry, speaking through the Pharmaceutical Research and Manufacturers of America (PhRMA), contends that R&D expenditures "far exceed" spending on marketing and promotion (see Pharmaceutical Marketing and Promotion, at <http: //www.phrma.org/puhlications/ policy//20040 -ll0 -10.1095.pdf>) (last visited January 25, 2005). Resolution of this issue is far beyond the scope of this paper, but it is important to realize, that regardless of which figures are used, pharmaceutical companies' marketing expenditures are large enough that a relatively modest reduction in the percent of revenue spent on promotional activities could have a substantial impact on drug prices.

59. R. E. Herzlinger, note 51 supra, at 5.

60. Id. at 5.

61. Of course, idiosyncrasies amongst the patient population may make it preferable for some patients to forego higher rated pharmaceuticals for lower rated drugs that are better suited to the patients' needs. Pharmaceutical representatives can provide physicians with valuable information by alerting them to such instances. When certain classes of people (as a whole) respond more favorably to a drug than others, the FDA may wish to provide a separate set of ratings for each group. Such disparate ratings may be warranted for SSRIs, since an antidepressant's effect on suicidality appears to depend on the personality of the user (see supra note 2). Therefore, it may be appropriate for the FDA to issue different safety ratings that correlate with users of different personalities. The funding necessary to create the FDA rating system from scratch and retrain pharmaceutical sales representatives will likely raise costs for pharmaceutical companies in the beginning. However, once the rating system is in place and reps have been retrained, it is likely that firms will experience significant savings.

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