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Recent Developments in Health Law

Published online by Cambridge University Press:  01 January 2021

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JLME Column
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Journal of Law, Medicine & Ethics , Volume 33 , Issue 2 , Summer 2005 , pp. 384 - 403
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Copyright © American Society of Law, Medicine and Ethics 2005

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References

References

Thomson, J. A. et al. “Embryonic Stem Cell lines Derived from Human Blastocysts,” Science 282 (1998): 1145–47. For a useful survey of the science of stem cell research as of 2001, see Stem Cells: Scientific Progress and Future Research Directions. Department of Health and Human Services (June 2001), available at <http://stemcells.nih.gov/info/scireport>.CrossRefGoogle Scholar
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They also argue that stem cell harvesting may also be permissible just before death, while the embryo is in extremis – the final stages of dying. “Section 6: Seeking Morally Unproblematic Sources of Human Embryonic Stem Cells,” Transcript, President's Council on Bioethics (PCBE) (December 4, 2004), available at <http://www.bioethics.gov/transcripts/dec04/session6.html>. See also Landry, and Zucker, , supra note 24.. See also Landry, and Zucker, , supra note 24.' href=https://scholar.google.com/scholar?q=They+also+argue+that+stem+cell+harvesting+may+also+be+permissible+just+before+death,+while+the+embryo+is+in+extremis+–+the+final+stages+of+dying.+“Section+6:+Seeking+Morally+Unproblematic+Sources+of+Human+Embryonic+Stem+Cells,”+Transcript,+President's+Council+on+Bioethics+(PCBE)+(December+4,+2004),+available+at+.+See+also+Landry,+and+Zucker,+,+supra+note+24.>Google Scholar
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At the PCBE meeting, Council Member Michael Gazzaniga put the point this way: “normally, we generate a word to describe a biologic phenomenon and here we seem to be tinkering with biologic phenomenon to have it fit the meaning of a word, and that's not what you do….you are building something here and we're going to have to call it something. And it's not an embryo, it's something else if you want to have it play out this way.” PCBE transcript, supra note 27.Google Scholar
An August 2004 poll found that only 34% of those who reported high levels of religious commitment support stem cell research, while 66% of those with low levels of religious commitment support the research. “GOP the Religion-Friendly Party, But Stem Cell Issue May Help Democrats,” Pew Forum on Religion and Public Life, at <http://pewforum.org/docs/index.php?DocID=51> (last visited March 8, 2005). See also “Ethical Issues in Stem Cell Research; Volume III, Religious Perspectives,” National Bioethics Advisory Commission (2000), available at <http://www.georgetown.edu/research/nrcbl/nbac/stemcell3.pdf>.+(last+visited+March+8,+2005).+See+also+“Ethical+Issues+in+Stem+Cell+Research;+Volume+III,+Religious+Perspectives,”+National+Bioethics+Advisory+Commission+(2000),+available+at+.>Google Scholar

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See, e.g., Abramson, J., Overdosed America (New York: HarperCollins, 2004); Kassier, J. P., On the Take (New York: Oxford University Press, 2005); Angell, M., The Truth about the Drug Companies (New York: Random House, 2004); Avorn, J., Powerful Medicines (New York: Alfred A. Knopf, 2004).Google Scholar
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Physicians may prescribe a new, expensive medication because the published literature indicates that it is safer and/or more effective than less costly alternatives, even though the results of unpublished studies suggest that alternative treatments are superior.Google Scholar
Dickersin, , supra note 9, at 518. Clinical Trial Results Registries (which only disclose the results of completed trials) may be insufficient to address the existing publication bias since companies that are not required to report the results of unfinished studies may prematurely terminate trials that are likely to produce negative data. See also Falit, B., supra note 2.Google Scholar
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“PhRMA Clinical Trial Registry Proposal,” supra note 7. “Hypothesis-testing clinical trials” (also termed “confirmatory clinical trials”) are those that “serve to examine pre-stated questions using statistically valid plans for data analysis and provide firm evidence of safety and/or efficacy to support product claims,” while “exploratory trials” merely serve to set direction (i.e. generate hypotheses) for possible future studies.Google Scholar
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Eli Lilly committed to releasing the results of all studies (phases I-IV) in addition to disclosing the initiation of phase III and phase IV trials. See “Lilly to Disclose Results of all Clinical Trials for Marketed Products via a Publicly Available Registry,” at <http://www.prnewswire.com/cgi-bin/micro_stories.pl?ACCT=916306&TICK=LLY&STORY=/www/story/08-03-2004/0002223862&EDATE=Aug+3,+2004> (last visited, February 21, 2005).+(last+visited,+February+21,+2005).>Google Scholar
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Id. at 1363. ICMJE defines a clinical trial as “any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.” Phase I trials are exempt from the requirement.Google Scholar
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“Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” supra note 7. For a complete explanation of the difference between confirmatory and exploratory trials, see “ICH Topic E 9 – Statistical Principles for Clinical Trials: Note for Guidance on Statistical Principles for Clinical Trials,” The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit, at <http://www.emea.eu.zint/pdfs/human/ich/036396en.pdf> (last visited February 7, 2005).+(last+visited+February+7,+2005).>Google Scholar
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Id. PhRMA member companies will utilize the U.S. government's website, <www.clinicaltrials.gov>, to register new and ongoing hypothesis-testing studies. See “PhRMA Clinical Trial Registry Proposal,” supra note 7., to register new and ongoing hypothesis-testing studies. See “PhRMA Clinical Trial Registry Proposal,” supra note 7.' href=https://scholar.google.com/scholar?q=Id.+PhRMA+member+companies+will+utilize+the+U.S.+government's+website,+,+to+register+new+and+ongoing+hypothesis-testing+studies.+See+“PhRMA+Clinical+Trial+Registry+Proposal,”+supra+note+7.>Google Scholar
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Id. The pharmaceutical associations state that member companies will not post results within one year if such action would “compromise publication in a peer-reviewed medical journal.”Google Scholar
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DeAngelis, , supra note 23. Pharmaceutical companies will often know ex ante that they will not want the results of a study published. Many trials are structured in such a way that the results will have little or no impact on physicians’ prescribing habits but have the potential to speed up competitors’ conduction of trials by illuminating the most promising research avenues (exploratory trials are paradigmatic examples). Companies will likely choose to comply with the ICMJE's requirements only when there is a substantial possibility that they will attempt to publish their findings. Since many reputable journals have not signed on to the ICMJE's requirements, the penalty associated with “guessing wrong” (assuming that publication will not be desired when in fact the results of the trial indicate that it is in the company's financial interest to publish the data) is far from onerous.Google Scholar
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“Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” supra note 7. The Joint Position states that member companies should “establish a process of verification…and are encouraged to make public how they will adhere to these standards,” but no where suggests that independent third party auditors should be secured by the individual member companies (a universal enforcement regime established by the trade associations might violate antitrust laws).Google Scholar
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The preamble to the Joint Position states that the pharmaceutical industry “is committed to increasing the transparency of clinical trials,” but such language is not included in the actual body of the proposal.Google Scholar
See, e.g., DeAngelis, , supra note 23; Rennie, , supra note 4.Google Scholar
See “ICH Topic E 9 – Statistical Principles for Clinical Trials: Note for Guidance on Statistical Principles for Clinical Trials,” supra note 28, at 6 (“Any individual trial may have both confirmatory and exploratory aspects”). Clearly, the decision regarding which trials are exploratory and which are confirmatory is not a mechanical one.Google Scholar
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See Angell, , supra note 1, at 58 (“…the few innovative drugs that do come to market nearly always stem from publicly supported research.” [emphasis in original]).Google Scholar
See Dickersin, , supra note 9, at 517 (“Patients who agree to participate in clinical research do so with the understanding that they are contributing to medical knowledge. If the knowledge gained in a trial is never communicated to others, then their contribution is unrealized and the covenant between researcher and patient, indeed between ethical review boards and patients, is broken”); Rennie, , supra note 4, at 1359 (“Should the results of trials be regarded a ‘highly proprietary,’ a view espoused by the manufacturers who pay for the trials? Or are trial results essential information for patients and their physicians – information gleaned from studying patients who might have been less willing to participate had they known the results would be traded as trade secrets and often never made public?”) Undoubtedly, many (if not most) volunteers receive substantial personal benefit from enrolling in clinical trials through monetary remuneration and the chance of ameliorating the effects of their own infirmities. It would be foolish to assume, however, that such personal gain belies the claim that a desire to contribute to the body of scientific knowledge is a significant reason for subjectsߣ participation.Google Scholar
DeAngelis, , supra note 23, at 1364.Google Scholar
If Congress mandates the registration of all clinical trials that examine “cause-and-effect relationships between a medical intervention and a health outcome,” pharmaceutical companies may begin to conduct more research abroad, where registration requirements are less restrictive or nonexistent. Therefore, it may be necessary to condition FDA approval of new drugs on compliance with the proposed legislation, regardless of where the company's trials were conducted.Google Scholar
Legislation could provide for (a) peer reviews in which a certain percentage of each auditor's evaluations are reviewed by peer auditors, and (b) criminal sanctions for independent auditors who willfully violate their duty to the public.Google Scholar
See Dickersin, , supra note 9, at 522; Rennie, , supra note 4, at 1360.Google Scholar

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