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A similar problem arises in the system's allowance of those who can afford it to be listed as an organ recipient in multiple organ transplant centers, thereby increasing their odds of receiving an organ that might otherwise go to someone listed at just one center. Currently more than 6,000 people are listed at more than one center. See Allen, S., “When Love Isn't Enough, Without Connections, Vermont Woman Died Waiting for Lung transplant,” The Boston Globe, September 7, 2004, at H-1.Google Scholar

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One of the first proposals for such a system is Kaufelt, J., Letter, Wall St. J, May 15, 1986, at 29. A more complete argument is Jarvis, R., “Join the Club: A Modest Proposal to Increase Availability of Donor Organs,” Journal of Medical Ethics 21 (1995): 199–204, at 202.Google Scholar

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This is one reason why even those systems that rely upon opt-out provisions still fail to produce sufficient organs. See Office of Inspector General, supra note 10 for an account of the wide variations between harvesting rates at medical centers.Google Scholar

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See Nagle, M. E., “State ‘Fraud’ Suits Over Clinical Trial Results Tread on Free Speech Rights,” Mealey's Litigation Report: Antidepressant Drugs, September 24, 2004; Abramson, J., 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 Psaty, B. M. and Rennie, D., “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//2004-06-30.1035.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).Google Scholar

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.+(last+visited+January+26,+2005);+“PhRMA+Clinical+Trial+Registry+Proposal”+at++(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.>Google Scholar

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See Waltz, J. A., 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.Google Scholar

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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.Google Scholar

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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.Google Scholar

Angell, M., 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/publications/policy//2004-11-10.1095.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.Google Scholar

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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.Google Scholar

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