Recent Developments in Health Law

Thomson J. A. “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>.

National Bioethics Advisory Commission (NBAC), “Ethical Issues in Human Stem Cell Research” (Spring 1999), available at <http://www.georgetown.edu/research/nrcbl/nbac/execsumm.pdf>, at 8.

NIH Revitalization Act of 1993, Pub. L. No. 103-43, 107 Stat. 122, codified at 42 U.S.C. § 289a-1.

International Foundation for Genetic Research v. Shalala, 1995 U.S. App. LEXIS 14790 (4th Cir.).

The ban, which had been renewed each year, appears in the 2002 appropriations bill, H.R. 3061 §510 as:

(a) None of the funds made available in this Act may be used for – (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).

(b) For purposes of this section, the term ‘human embryo or embryos’ includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

See American Association for the Advancement of Science, Center for Science, Technology and Congress, “AAAS Policy Brief: Stem Cell Research,” (updated August 2004), available at <http://www.aaas.org/spp/cstc/briefe/stemcells/index.sbtml>.

NBAC, supra note 3.

Draft NIH guidelines, 64 Fed. Reg. 67,576 (December 2, 1999); final guidelines, 65 Fed. Reg. 51,976 (August 25, 2000).

Later appealed as Doe v. Shalala, 2004 U.S. App. LEXIS 25146 (4th Cir. 2004).

Note that this organization's legal theory that the embryos are “born” seems to be at odds with their organizational name, the “National Association for the Advancement of Pre born Children.”

Bush G. W. , “Remarks by the President on Stem Cell Research,” (August 9, 2001), available at <http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html>.

Id., and Executive Order No. 13237 of November 28, 2001, 66 Fed. Reg. 59851.

66 Fed. Reg. 57,107 (November 14, 2001).

Brulliard N. , “Bipartisan Bill Advocates More Stem Cell Research” Atlanta Journal-Constitution, February 17, 2005, at 2C.

“Stem Cell Lines Compromised?” Wired News, January 23, 2005 at <http://wired.com/news/medtech/0,1286,66375,00.html>; see also Martin M. Muotri A. Gage F. , and Varki A. , “Human Embryonic Stem Cells Express an Immunogenic Nonhuman Sialic Acid,” Nature Medicine 11 (2003): 228–32.

Caplan A. L. , “Stem-Cell Research A Pawn In Election Politics; Bush's Policy Makes A Mockery Of Moral Issues Involved,” Bioethics on NBC (October 5, 2004), available at <http://www.bioethics.net/articles.php?view-Cat=2&articleId=69>.

For example, Harvard University launched a major initiative in 2004, making seventeen additional stem cell lines available for research. See, Powell J. H. , “Harvard Bigwigs Tout Stem Cell Center,” Boston Herald April 24, 2004, at 19.

For a recent survey of action in the states, see Gelles K. , “Stem Cells' Promise Pits Jobs vs. Values,” USA Today, February 16, 2005, at 1B.

See Sappenfield M. , “Woes for California's Stem-Cell Experiment,” Christian Science Monitor, December 20, 2004, available at <http://www.bioethics.net/News/?id=234>.

Weiss R. , “Bills Renew Fight on Stem Cells,” Washington Post, February 17, 2005, at A6.

H. R. 162, Stem Cell Replenishment Act of 2005.

Editorial, “Stem Cell Policy Collapses,” USA Today, January 26, 2005, at 12A.

Landry D. W. and Zucker H. A. , “Embryonic Death and the Creation of Human Embryonic Stem Cells,” Journal of Clinical Investigation 114 (2004): 1184–86, available at <http://www.jci.org/cgi/content/full/114/9/1184>.

Philipkoski K. , “Stem-Cell Method May Cheat Death,” Wired News (December 22, 2004), at <http://wired.com/news/medtech/0,1286,66113,00.html?tw=wn_story_page_prev2>; see also Strelchenko N. Verlinsky O. Kukharenko V. , and Verlinsky Y. , “Morula-Derived Human Embryonic Stem Cells,” Reproductive BioMedicine Online 9 (2004): 623–629.

Check E. , “Stem Cell Library Boosts the Case For Change,” Nature 429 (2004).

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 In Re Long Island Jewish Medical Center, 641 NY Supp 2d 989 (N. Y. Superior Ct. 1996).

Landry and Zucker , supra note 24, at 1185.

See note 6, supra.

See PCBE, supra note 27; Hurl-But W. B. , “Altered Nuclear Transfer As a Morally Acceptable Means for the Procurement of Human Embryonic Stem Cells,” The President's Council on Bioethics (December 2004), at <http://www.bioethics.gov/background/hurl-but.html>.

See Melton D. Daley G. , and Jennings C. , “Altered Nuclear Transfer in Stem-Cell Research – A Flawed Proposal,” N. Engl. J. Med., 351 (2004): 2791–92.

This point was made by Melton , supra note 35, and by Paul McHugh in the PCBE discussion, supra note 27, as well as by two commentators in the PCBE public comment session at the December 4, 2004 meeting, available at <http://www.bioethics.gov/transcripts/dec04/session7.html>.

PCBE transcript, supra note 27.

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.

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>.

Hoem v. State, 756 P.2d 780, 783 (Wyo. 1988).

Id. at 784.

Id. at 784.

Mountain Fuel Supply Company v. Emerson, 578 P.2d 1351, 1354 (Wyo. 1978).

Hoem, 756 P.2d at 783.

Id. at 783. Other states cited are California and Rhode Island, Boucher v. Sayeed, 459 A.2d 87, 94 (R.I. 1983), American Bank & Trust Co. v. Community Hospital of Los Gatos-Saratoga, Inc., 163 Cal. Rptr. 513, 522 (Cal. App. 1980).

Hoem, 756 P.2d at 783.

Id. at 784.

State ex rel. Wyoming Ass'n of Consulting Engineers and Land Surveyors v. Sullivan, 798 P.2d 826, 828, (Wyo. 1990). Chief Justice Urbigkit listed the covered professions in his concurring opinion in State v. Sullivan, “some or all of the practitioners of abstracting, accountancy, architecture, attorneys-at-law, pawnbrokers, barbers, boxing exhibitors, podiatrists, chiropractors, collection agencies, cosmetologists, dance hall operators, debt adjusters, dentists, embalmers, hotel keepers, junk dealers, merchants-itinerants or temporary, nursing home administrators, optometrists, pharmacists, physicians, psychologists, real estate brokers, surveyors and engineers, veterinarians, warehousemen and professional counsellors, and most recently augmented to include real estate appraisers. Id. at 830.

Id. at 828.

Id. at 829.

Id. at 830.

Freudenthal D. , “Letter to the Joint Judiciary Interim Committee and the Joint Health, Labor, and Social Services Interim Committee of June 21, 2004,” available at <http://wyoming.gov/governor/press_releases/2004/june2004/text_session_suggestions.asp>.

Office of the Governor, State of Wyoming, “Governor Proposes Constitutional Amendment,” Press Release (October 23, 2003), available at <http://wyoming.gov/governor/press_releases/2003/october2003/text_ConstitutionalAmendment.asp>.

H. J. 0011, 57th Wyoming Legislature, Special Budget Session (2004), available at <http://legisweb.state.wy.us/2004/enroll/HJ0011.pdf>.

Available through <http://legisweb.state.wy.us/2004/Interim/SPIndex.HTM>.

Id. at 1.

Available through <http://legisweb.state.wy.us/2005/billsInfo.htm>.

H. B. 0083, 58th Wyoming Legislature, General Session (2005), available at <http://legisweb.state.wy.us/2005/Introduced/hb0083.pdf>.

H.B. 0083, supra (digest), available at <http://legisweb.state.wy.us/2005/digest/hb0083.htm>.

Frazer J. , “Medical Reviews Get OK,” Wyoming Tribune-Eagle, January 28, 2005, available at <http://www.wyomingnews.com/news/more.asp?StoryID=104414&arch=true>.

Hoem, 756 P.2d at 781.

See Frazier , supra note 23.

H. B. 0083, supra note 20.

Wyo. Const art I, § 8, available at <http://legisweb.state.wy.us/statutes/titles/title97.htm>.

Hoem, 756 P.2d at 786.

Hoem, 756 P.2d at 785.

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).

Falit B. , “The Path to Cheaper and Safer Drugs: Revamping the Pharmaceutical Industry in light of GlaxoSmithKline's Settlement,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 182–184.

Rennie D. , “Trial Registration: A Great Idea Switches from Ignored to Irresistible,” JAMA 292 (2004): 1359–62, at 1360.

Id. at 1361.

“Global Position on Disclosure of Information about Clinical Trials,” at <http://www.efpia.org/3_press/20050106.htm> (last visited February 6, 2005).

“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 February 6, 2005). In 2002, PhRMA published its “Principles on the Conduct of Clinical Trials and Communication of Clinical Trials Results,” in which member companies committed to disclosing “meaningful” results (positive or negative) of “hypothesis testing” clinical trials. PhRMA did not, however, launch a register for trial results until September, 2004, and did not commit to disclose information about unfinished trials. See “Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results,” at <http://www.phrma.org/publications/policy/2002-06-24.430.pdf> (last visited February 19, 2005); “PhRMA Clinical Trial Registry Proposal,” at <http://www.phrma.org/publications/policy/06.01.2005.1111.cfm> (last visited February 6, 2005).

See, e.g., Easterbrook P. Berlin J. Gopalan R. , and Matthews D. , “Publication Bias in Clinical Research,” Lancet 337 (1991): 867–72; Dickersin K. Min Y. , and Meinert C. , “Factors Influencing Publication of Research Results,” JAMA 267 (1992): 374–78; Callaham M. L. Wears R. L. Weber E. J. Barton C. , and Young G. , “Positive-outcome Bias and other Limitations in the Outcome of Research Abstracts Submitted to a Scientific Meeting,” JAMA 280 (1998): 254–57; “AMA Recommends that DHHS Establish a Registry for all U.S. Clinical Trials,” at <http://www.ama-assn.org/ama/pub/category/13934.html> (last visited February 6, 2005).

Dickersin K. and Rennie D. , “Registering Clinical Trials,” JAMA 290 (2003): 516–23, at 517.

Id. at 516.

Id. at 517 (citing Pich J. Carne X. Arnaiz J. A. Gomez B. Trilla A. , and Rodes J. , “Role of a Research Ethics Committee in Follow-up and Publication of Results,” Lancet 361 (2003): 1015–16. See also Falit B. , supra note 2, at note 45; Lievre M. Menard J. Bruckert E. , “Premature Discontinuation of Clinical Trials for Reasons not Related to Efficacy, Safety, or Feasibility,” British Medical Journal 322 (2001): 603–05.

See Olson C. M. Rennie D. Cook D. , “Publication Bias in Editorial Decision Making,” JAMA 287 (2002): 2825–28; Dickersin K. , “How Important is Publication Bias? A Synthesis of Available Data,” AIDS Education and Prevention 9 (1997): 15–21; Dickersin K. Olson C. M. Rennie D. , “Association between Time Interval to Publication and Statistical Significance,” JAMA 287 (2002): 2829–31.

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.

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.

Id. at 518.

Id. at 520–521.

“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.

Rennie , supra note 4, at 1360.

Id. at 1360.

“AMA recommends that DHHS establish a registry for all U.S. Clinical Trials,” supra note 8.

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).

DeAngelis C. D. Drazen J. M. , and Frizelle F. A. , “Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors,” JAMA 292 (2004): 1363–64. The ICMJE represents the Journal of the American Medical Association, the New England Journal of Medicine, the New Zealand Medical Journal, the Norwegian Medical Journal, the Canadian Medical Association Journal, The Lancet, MEDLINE, Annals of Internal Medicine, the Croatian Medical Journal, the Dutch Journal of Medicine, the Journal of the Danish Medical Association, and the Medical Journal of Australia.

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.

Id. at 1363.

“Medical Journals Act to Limit Drug Firms' Influence,” <CNN.com/Health>, at<http://archives.cnn.com/2001/HEALTH/09/09/journals.drugfirms/> (last visited, February 9, 2005) (“These firms crave publication in a prestigious journal because physicians rely on these to decide whether to prescribe a particular drug”).

“Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” supra note 7; “PhRMA Clinical Trial Registry Proposal,” supra note 7.

“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).

“Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” supra note 7.

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.

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.”

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.

Id. at 1363; “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” supra note 7.

See id. at 1364 (“Research sponsors may argue that public registration of clinical trials will result in…[the destruction of] their competitive edge by allowing competitors full access to their research plans.”); Rennie , supra note 4 (“Should the results of trials be regarded as ‘highly proprietary,’ a view espoused by the manufacturers who pay for the trials?”)

Id. at 1364.

“ICH Topic E 9 – Statistical Principles for Clinical Trials: Note for Guidance on Statistical Principles for Clinical Trials,” supra note 28, at 5–6.

“Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” supra note 7; DeAngelis , supra note 23, at 1364.

“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).

Dickersin , supra note 9, at 520–521; Rennie , supra note 4, at 1360.

“Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” supra note 7.

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.

See, e.g., DeAngelis , supra note 23; Rennie , supra note 4.

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.

“Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” supra note 7.

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]).

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 subjects' participation.

DeAngelis , supra note 23, at 1364.

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.

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.

See Dickersin , supra note 9, at 522; Rennie , supra note 4, at 1360.

352 F.3d 1222 (9th Cir. 2003), cert. granted 124 S.Ct. 2909 (2004).

Cal. Health & Safety Code §11362.5 (2004).

Controlled Substances Act, 21 U.S.C.S. 812(b) (2000).

352 F.3d 1222 (9th Cir. 2003), cert. granted 124 S.Ct. 2909 (2004). See also Muldrew B. L. , “Drug Enforcement: Controlled Substances Act Inapplicable to Medicinal Marijuana,” Journal of Law, Medicine & Ethics 32, no. 2 (2004): 371–72.

U.S. Const, Art. I, §8, cl. 3.

United States v. Real Property Located at 5300 Lights Creek Lane, No. 03-17231, (9th Cir. 2004).

Ashcroft v. Raich, 124 S.Ct. 2909 (2004).

Epstein R.A. , “Rethink ‘Wickard’,” National Law Journal 68 (2005): 27; see also Greenhouse L. , “States' Rights Defense Falters in Medical Marijuana Case,” New York Times, November 30, 2004, at A1; Totenburg N. , “Supreme Court Hears Case on Medical Use of Marijuana,” All Things Considered, National Public Radio, November 29, 2004 (“By the time [plaintiffs' lawyer] Barnett sat down, it wasn't clear that he had any votes on his side at all”).

U.S. Constitution, Art I, sec. 8, cl 3, 18. (“The Congress shall have the Power to…regulate Commerce with foreign nations, and among the several States, and with the Indian Tribes…And [t]o make all Laws which shall be necessary and proper for carrying into Execution the foregoing Powers…”)

Wickard v. Filburn, 317 U.S. 111 (1942).

514 U.S. 549 (1995).

529 U.S. 598 (2000).

Morrison, 529 U.S. at 615 (Congress found that gender-motivated crimes affect interstate commerce by “deterring potential victims from traveling interstate, from engaging in employment in interstate business, by diminishing national productivity, increasing medical and other costs, and decreasing supply of and demand for interstate products”).

Id. at 608–09.

Id. at 610.

See Choper J. H. , “Taming Congress's Power Under the Commerce Clause: What Does the Near Future Portend?” Arkansas Law Review, 55 (2003): 731–93, at 737.

Transcript of Oral Argument, Ashcroft v. Raich, 352 F.3d 1222 (9th Cir. 2003), cert, granted 124 S.Ct. 2909 (2004) (No. 03-1454), at 4–5 [hereinafter “Transcript of Oral Argument”].

21 U.S.C. §801 (5) (2004) (“Controlled substances manufactured and distributed intrastate cannot be differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate”).

Transcript of Oral Argument, supra note 17, at 25.

Id., at 26.

Id., at 26–32.

Id., at.26.

317 US. at 127–128.

Transcript of Oral Argument, supra note 17, at 50–51.

Id. at 50.

McCabe T. L. , “Review of Selected 2003 California Legislation,” McGeorge Law Review 35 (2004): 545–59, at 546, 557.

See e.g., Editorial, “Stop Blocking Marijuana Research,” The Oregonian, January 7, 2005, at E08.

Boyd A. J. , “Medical Marijuana and Personal Autonomy,” John Marshall Law Review 37 (2004): 1253–87, at 1284–85.

US. v. Oakland Cannabis Buyers' Cooperative, 532 U.S. 483 (2001).

Id., at 493.

Id., at 494. (“[T]he very point of our holding is that there is no medical necessity exception to the prohibitions at issue, even when the patient is “seriously ill” and lacks alternative avenues for relief”).

Id., at 500–501 ( Stevens J. , concurring).

Savage D. G. , “Flip Sides: California Marijuana Law Tests High Court Conservatives' Commitment to Federalism,” American Bar Association Journal 90 (2004): 14.

Young E. A. , “Let Homegrowers Be,” National Law Journal 62 (2004): 23.

See, e.g., “Remarks by President Bush and Senator Kerry in the Third 2004 Presidential Debate,” Office of the Press Secretary, The White House, at <http://www.whitehouse.gov/news/releases/2004/10/20041014-1.html> (last visited February 3, 2005).

See “RxDrugs: 11 Companies Launch Discount Program for Uninsured,” American Health Line, January 12, 2005 (citing CQ Healthbeat, January 11, 2005).

See, e.g., “State of the Union Address,” Office of the Press Secretary, The White House, at <http://www.whitehouse.gov/news/releases/2005/02/20050202-11.html> (last visited February 3, 2005) (“Justice is distorted, and our economy is held back, by irresponsible class actions and frivolous asbestos claims – and I urge Congress to pass legal reforms this year.”)

See, e.g., “John Kerry's Plan To Make Health Care Affordable To Every American,” at <http://www.johnkerry.com/issues/health_care/health_care.html> (last visited February 5, 2005).

See, e.g., “RxDrugs: 11 Companies Launch Discount Program for Uninsured,” supra note 2, where Sen. Byron Dorgan (D-N.D.) reports his plans to introduce legislation permitting drug reimportation from Canada “almost immediately” after the Senate returns from recess.

“The Together Rx Access Card at a Glance,” at <http://www.togetherrxaccess.com/en/pressroom/TRx_Access_At-A-Glance.pdf> (last visited February 5, 2005).

Pear R. , “Companies Set Program to Cut Prices of 275 Prescription Drugs,” New York Times, January 12, 2005, at A12.

“Drug Firms' Together Rx Card Covers Most Uninsured,” Drug Industry Daily 4, no. 8 (2005): 13–14 (quoting Elio Evangelista, pharmaceutical analyst with Cutting Edge Information).

“Ten major pharmaceutical companies want to make it cheaper for the uninsured to buy drugs. Are they doing it out of the goodness of their corporate hearts? Probably not. Are they doing it to head off action by Washington to restrain drug prices? Absolutely. Does their motivation matter? No. It doesn't.” Opinion, “More Discount Drugs; Pharmaceutical Cards Worth Using,” Newsday, January 22, 2005, at A16.

Historical Health Insurance Tables, U.S. Census Bureau, at <http://www.census.gov/hhes/hlthins/historic/hihistt1.html> (last visited February 5, 2005).

Mills R. J. and Bhandari S. , “Health Insurance Coverage in the United States: 2002,” U.S. Census Bureau, P60–223 (September 2003), at 1, available at <http://www.census.gov/prod/2003pubs/p60-223.pdf> (last visited February 5, 2005).

Bullard R. D. , “Addressing Urban Transportation Equity in the United States,” Fordham Urban Law Journal, 31 (2004): 1183–1209, at 1204.

“Statement of Support by the California Black Health Network, Third Party Organizations in Support of the Together Rx Access Card,” at 4, at <http://www.togetherrxaccess.com/en/pressroom/TRx_Access_Third-Party_Support.pdf> (last visited February 3, 2005).

See Historical Health Insurance Tables, supra note 10.

See Mills and Bhandari , supra note 11, at 4.

Cooper S. , “New Together Rx Access Card Offers Americans with No Prescription Drug Coverage Savings at the Pharmacy Counter,” at 1, at <http://www.togetherrxaccess.com/en/pressroom/TRx_Access_PR_llJan05.pdf> (last visited February 5, 2005).

Id., at 1–2.

See Pear , supra note 7.

See Cooper , supra note 16, at 2.

See Grier C. , “Drug Companies to Offer Medicare-Like Drug-Discount Cards,” Bestwire, January 17, 2005.

Japsen B. , “Abbott, 9 Rivals Offer Drug Discount Card; Prices Would Be Cut for Uninsured,” Chicago Tribune, January 12, 2005, at C1.

The Together Rx Card at a Glance, at 1, at <http://www.togetherrxaccess.com/en/pressroom/TRx_Access_Senior_Savings_Program_At-A-Glance.pdf> (last visited February 5, 2005).

See Pear , supra note 7.

See Cooper , supra note 16.

Rowland C. , “Industry Launches US Drug-Discount Initiative,” Boston Globe, January 12, 2005, at F1.

See Cooper , supra note 16, at 2–3. For complete income eligibility information, you can refer to the table provided at <http://www.togetherrxaccess.com/en/eligibility_table.html> (last visited February 5, 2005).

Hananel S. , “Drugmakers Launch Discounts for Uninsured; Card Program Aims to Increase Access,” Washington Post, January 12, 2005, at E03.

“Statement by Thompson Tommy G. Secretary of Health and Human Services in Support of the Together Rx Access Card Announcement,” HHS Press Office, US Department of Health & Human Services, at <http://www.hhs.gov/news/press/2005pres/20050111.html> (last visited February 3, 2005).

See Japsen , supra note 23.

See “Statement by Tommy G. Thompson,” supra note 30.

“Drug Industry Offers Discount Prescription Drug Cards for Uninsured Americans,” (NBC television broadcast, Jananuary 12, 2005).

See Rowland , supra note 27.

See Rowland , supra note 27.

See “Third Party Organizations in Support of the Together Rx Access Card,” supra note 13.

Public Officials in Support of the Together Rx Access Card, at <http://www.togetherrxaccess.com/en/pressroom/TRx_Access_Public_Official_Support.pdf> (last visited February 3, 2005).

See Rowland , supra note 27.

Andrews H. , “Tommy Gives his Blessing to Drug Firm Discount Card,” Capital Times, January 12, 2005, at 8A.

See “Third Party Organizations in Support of the Together Rx Access Card,” supra note 13, at 1.

“Medical Bills Make Up Half of Bankruptcies; Study Finds Most Bankruptcy Filers had Health Insurance,” available at <http://msnbc.msn.com/id/6895896/> (last visited March 11, 2005).

See “RxDrugs: 11 Companies Launch Discount Program for Uninsured,” supra note 2 (citing CQ Healthbeat, January 11, 2005) (emphasis added).

For a description of health insurance incentives being pursued by the current Administration, see “Statement by Tommy G. Thompson,” supra note 30.

See “Drug Industry Offers Discount Prescription Drug Cards for Uninsured Americans,” supra note 33.