Journalof Health & Biomedical Law, Vol. V (2009): 131-149 © 2009 Journalof Health & Biomedical Law Suffolk UniversityLaw School

Stem Cell Century: Law and Policy for a Breakthrough Technology Bob Dockendorff*

Introduction Nine-year-old Molly Nash has a hereditary genetic bone marrow disorder, and she may die without a transplant.' A successful transplant requires bone marrow from a compatible sibling, but Molly is an only child. Molly's parents cannot likely create a viable donor sibling through conventional conception, so they turn to groundbreaking reproductive technology. 2 Molly's parents can undergo in-vitro fertilization ("IVF") coupled with pre-implantation genetic diagnosis ("PGD") to create a compatible donor sibling.3 Doctors use IVF to create an embryo from a man's sperm and woman's egg, and then use PGD to choose embryos with certain genetic traits. 4 Doctors implant the selected embryos into a woman's uterus, and the newborn exhibits the desired genetic traits.5 Using this new and risky procedure, doctors impregnated Molly's mother with a compatible donor-child, Adam Nash. 6 The doctors transfused the stem cell-rich blood of Adam's umbilical cord into Molly, and her body functioned normally within a

* J.D. Candidate, Suffolk University Law School, 2009; B.A., University of Vermont, 2006. Mr. Dockendorff may be reached at doc [email protected]. I RUSSELL KOROBKIN WITH STEPHEN R. MUNZER, STEM CELL CENTURY: LAW AND POLICY FOR

232 (Yale University Press 2007) [hereinafter KOROBKIN Molly's disease, Fanconi Anemia, causes bone marrow failure and weakens the immune system, and children with Fanconi Anemia usually die before the end of childhood. See A.D. AUERBACH ET AL., Prenatalof PotenlialDonorsfor UmbilicalCord Blood Transplantationfor Fanconi Anemia, 30 TRANSFUSION 682, 682-683 (1990) (describing effects of Fanconi Anemia). 2 KOROBKIN WITH MUNZER, supra note 1, at 232-233. 3 KOROBKIN WITH MUNZER, supra note 1, at 234. 4 KOROBKIN WITH MUNZER, supra note 1, at 233. 5 KOROBKIN WITH MUNZER, supra note 1, at 233. 6 KOROBKIN WITH MUNZER, supra note 1, at 234. A BREAKTHROUGH TECHNOLOGY, WITH MUNZER].

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

month.7 In essence, reproductive technology allowed Molly's doctors to create a viable stem cell donor for her. Society requires an informed government in order to realize the full benefits of stem cell research. PGD-the practice that saved Molly Nash's life-is currently unregulated in the United States, and it is only one of many areas of stem cell technology that has outpaced the legislature. 8 PGD raises several issues and questions, including the scope of government regulation on reproductive technology, whether "donors" like Adam need to give informed consent, and whether it is acceptable to destroy an embryo to save a human life. Reproductive technology is only one area that stem cell research benefits. Many scientists and researchers believe the greatest stem cell research achievements will arise in the area of regenerative medicine.9 In the past, primary treatment involved doctors removing damaged and diseased areas of the body. Eventually, with stem cell technology, doctors could potentially implant stem cells to regenerate healthy cells in diseased areas. 10 This medical advancement moves doctors closer to successfully treating patients with diseases like cancer and Parkinson's. 1' In order to fully appreciate the opportunities stem cell research provides, society must determine solutions to the obstacles it presents. In Stem Cell Century: Law and Poliyfor a Breakthrough Technology, Russell Korobkin and Stephen R. Munzer take on this challenge. The authors identify the most important issues in advancing stem cell research, outline the legal and policy arguments surrounding the issues, and predict the resolution of these issues based on scarce

supra note 1, at 234. supra note 1, at 236. 9 See KOROBKIN WITH MUNZER, supra note 1, at 19, 20 (discussing potentially significant medical benefits of stem cell research). Korobkin identifies the most exciting potential benefit of stem cell research is the ability to cure diseases directly through the process of regenerative medicine. Id. Medical researchers consider the process of regenerative medicine the "Holy Grail" of stem cell research. Id. 7 KOROBKIN WITH MUNZER, 8 KOROBKIN WITH MUNZER,

10 KOROBKIN WITH MUNZER, supra note 1, at 19, 20. Regenerative medicine, Korobkin believes,

will revolutionize medical treatment because scientists can potentially re-grow diseased cells, in contrast to the usual treatment of removing diseased cells via radiation or surgery. Id. at 19. Whether or not this benefit is ever realized, other significant benefits of stem cell research are certain according to Korobkin, including scientists' greater understanding of cell development and the creation of new sources of material for testing pharmaceuticals. Id. The authors argue convincingly that the governmental policies towards stem cell research ultimately undermine the United States' chances of realizing the full potential of stem cell research. See id. at 48 (discussing practical consequences of governmental policy towards stem cell research). 11KOROBKIN WITH MUNZER, supra note 1, at 3.

2009

JOURNAL OF HEALTH & BIOMEDICAL LAW

applicable authority.' 2 Interesting issues include the constitutional right to clone embryos, the patent rights of stem cell researchers, and the informed consent of stem cell donors. 13 For each issue, the authors state the applicable fundamental principles of law, critique problems in application, and suggest solutions. Many times, obstacles result where existing law has fallen behind technological breakthroughs and the reality of medical science. In these instances, Korobkin's well-informed suggestions are useful. Stem cell production requires fertilizing an egg with a sperm in a Petri dish and allowing the resulting zygote to divide until it has matured into a blastocyst, consisting of 150 - 200 cells. 14 A blastocyst is made up of an outer layer of membrane and an inner cell mass ("ICM"), which contains human embryonic stem cells ("hESCs").15 Isolating the hESCs entails destroying the blastocyst and keeping the 1CM cells alive for a sufficient amount of time until they become an hESC line, which can provide viable hESCs.16 In 1998, James Thompson of the University of Wisconsin successfully placed the extracted ICM into a nutrient mix and created a stable hESC line.'" The process, which requires killing the blastocyst, presents a moral dilemma for those that believe blastocysts are morally equal to human beings. On June 9, 2000, President George W. Bush stated that his administration viewed blastocysts as morally equal to human beings. 18 As a result, the Bush administration prohibited federal funding for research on hESC lines that were not already created. 19 The public's eye focuses on the biological, philosophical, policy and religious issues surrounding the position of the Bush administration, and the authors do a good job of explaining this issue for any interested reader. The book's true value, however, lies in the rich legal analysis of more practical and economical issues that plague stem cell research, which go largely unnoticed in today's media. For example, Korobkin introduces legal analysis regarding the constitutionality

12 KOROBKIN WITH MUNZER,

supra note 1, at 5 (setting forth three interrelated goals to run

through the book). 13 See KOROBKIN WITH MUNZER, supra note 1, at 5 (outlining chapters of the book). 14 KOROBKIN WITH MUNZER, supra note 1, at 8. See also President's Council on Bioethics, MONITORING STEM CELL RESEARCH 7 (2004) (describing process of stem cell creation). '5 President's Council on Bioethics, MONITORING STEM CELL RESEARCH 167 (2004). 16 KOROBKIN WITH MUNZER, supra note 1, at 8. 17 See Frederic Golden, Stem Winder, TIME, Aug. 20, 2001, at 26 (profiling James Thompson as pioneer of stem cell research). 18 Address to the Nation on Stem Cell Research from Crawford, Texas, 37 Weekly Compilation of Presidential Documents 1149 (Aug. 9 2001), available at http://findarticles.com/p/articles/ mim2889/is_32_37/ai_78546558 (last visited Mar. 23, 2009). 19 Id.

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

of the federal government's attempt to ban the practice of cloning, which is an alternative way to create hESCs. There are creative arguments in support of cloning 20 based on the commerce clause, the right to privacy, and the right of procreation. Additionally, the authors address economic issues among researchers; such as the right to patent stem cell research methods and discoveries. This discussion concerns the intellectual property dispute between stem cell pioneers and subsequent researchers hoping to improve on initial discoveries without licensing restrictions. 21 Subsequently, the authors provide insight on the informed consent of stem cell donors while stressing the importance of honoring the autonomy of donors. 22 Finally, the authors shed light on the monetary compensation of tissue donors and the property rights of bodily tissue as influenced by the landmark California Supreme Court case Moore v. Regents of the University of California.23 While the book addresses a spectrum of issues on stem cell research that is informative for any interested party, the analysis given to specific legal obstacles in certain areas is rich enough to benefit even readers well-versed on the topic of stem cell research. Russell Korobkin is a professor of law at the University of California at Los Angeles ("UCLA") School of Law where he teaches contracts, negotiation, and health care law. 24 He has authored over forty law journal articles in areas such as behavioral law and economics, negotiation and alternative dispute resolution, contract law, health care law, and stem cell research. 25 Professor Korobkin also authored a negotiation textbook entitled Negotiation Theory and Strategy and is a frequent Op-Ed contributor to The Los Angeles Times. 26 In addition to teaching at UCLA, Professor Korobkin is a senior supra note 1, at 73 (noting banning the practice of cloning creates constitutional issues). The government prohibits funds for some stem cell research; however the debate over cloning involves a blanket ban on the practice of cloning itself. Id. Korobkin addresses the ban in light of the Commerce Clause, the right to receive medical treatment, and reproductive rights. See id. at 75-91 (discussing constitutionality of cloning ban in light of commerce clause, right to medical treatment, and right to reproduce). See infra pp. 5-6 and notes 46-56 (explaining Korobkin's arguments for a constitutional tight to clone). 21 See KOROBKIN WITH MUNZER, supra note 1, at 93-127 (discussing breadth of patent rights for stem cell pioneers and balancing them with interests of society). 22 See KOROBKIN WITH MUNZER, supra note 1, at 165 (arguing research on tissues from donors for non-stem cell research purposes should require informed consent). 23 793 P.2d 479 (Cal. 1990). See also KOROBKIN WITH MUNZER, supra note 1, at 211 (analyzing default rules property tights of bodily tissue). The authors argue that common conception of property rights based on the Moore decision is overbroad. Id. 24 See UCLA Law School, http://www.law.ucla.edu/home/index.asp?page=571 (last visited Mar. 16, 2009). 20 KOROBKIN WITH MUNZER,

25 26

Id. Id.

JOURNAL OF HEALTH & BIOMEDICAL LAW

2009

fellow at the UCLA Center for Society and Genetics. He received his Bachelor of Arts 27 and Juris Doctor degrees at Stanford University. Stephen R. Munzer is also a professor of law at the UCLA School of Law and a senior fellow at the UCLA Center for Society and Genetics. 28 He teaches classes in 29 contracts and property and gives seminars in legal philosophy and biotechnology.

Professor Munzer is a recipient of the David Baumgart Memorial Fellowship and the Berger Prize in the Philosophy of Law from the American Philosophical Association and was a Rhodes Scholar at Oxford University. 30 He authored A Theory of Properoy and

served as editor of New Essays in the Legal and PoliticalTheory of Property. Professor Munzin is a graduate of the Univeristy of Kansas (B.A.), Oxford University (B. Phil.) and Yale University (J.D.).

31

Stem Cell Research and the Federal Government Chapter two provides a comprehensive overview the federal government's position on the moral implications of stem cell research. Korobkin argues that, in trying to please their moral constituencies, Congress and the Bush administration adopted illogical positions that hinder the necessary amount of stem cell research.

The Bush

administration stated that blastocysts have the same moral value as human beings and thus we should not destroy them for medical research. Bush banned federal funding for hESC lines created after June 9, 2000-the date Bush declared his position to society. 32 33 Korobkin argues this position is scientifically illogical and inherently contradictory.

28

Id. Id

29

UCLA Law School, http://www.law.ucla.edu/home/index.asp?page=627 (last visited Mar. 16,

27

2009). 30

See id.

31 Id.

See Address to the Nation on Stem Cell Research from Crawford, Texas, 37 Weekly Compilation of Presidential Documents 1149 (Aug. 9 2001), available at http:// findarticles.com/p/articles/mi_m2889/is-32-37/ai78546558 (last visited Mar. 23, 2009) (prohibition on federal funding for stem cell research announced). 33 See KOROBKIN WITH MUNZER, supra note 1, at 11 (criticizing argument that blastocysts are equal to human beings). Korobkin states that the argument for blastocysts being equal to humans must rest either on the proposition that embryos are equal to humans because they share certain human characteristics or because they have the "potential" to be humans. Id. at 29. In refuting the first argument, Korobokin states that a five-day old blastocyst lacks every human characteristic other than DNA, and is not an individual because twinning remains possible. Id. at 30 - 31. The second argument, though stronger, is equally unpersuasive because of the lack of a concrete definition of "potential." Id. at 33. One is that there is "potential" because an embryo 32

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

Bush's position is contradictory because he makes an arbitrary distinction and wants to benefit from a supposed moral wrong. In allowing researchers to kill some embryosthose that existed before June 9, 2000-Bush recognized the value of stem cell research and wanted to benefit from it. 34 Yet, Bush undermined research efforts because he believes killing blastocysts is morally wrong. Thus, neither the researchers nor those 35 protecting blastocysts are appeased, and society is deprived of the benefits of research. In 2005, Congress also made an arbitrary distinction to pander to a constituency yet simultaneously recognized the benefits of stem cell research. 36 The failed Stem Cell Research Enhancement Act would have allowed research on embryos that were left over from IVF clinics.

37

In making a distinction between "'discarded" embryos from IVF

clinics and "created" embryos for the purpose of being destroyed, Korobkin believes Congress was contradictory in its statements. 38 Scientists create most embryos in IVF clinics fully knowing they will be destroyed, and thus denying stem cell researchers from doing the same was like "holding your finger in a dike while tsunami waves crash over

has a high chance of becoming a human being (likelihood), and the other is that there is "potential" because an embryo might be able to grow into a human without external assistance (self-actualizability). Id. On either definition, according to Korobkin, the "potential" to become human is still very low, with the likelihood of a bout 20 - 40%, and the complete lack of ability to become a person on its own without outside help. Id. at 34. 34 KOROBKIN WITH MUNZER, supra note 1, at 34 - 35. Korobkin describes the position as one of "causal complicity": The Bush Administration does not want to cause bad acts but wants to profit from them. Id. 35 KOROBKIN WITH MUNZER, supra note 1, at 35 - 36. The policy sweeps too narrowly for the needs of researchers but too broadly for groups that want to protect the rights of blastocysts. Id. Ultimately, the interests of both groups are compromised, creating a substantial detriment to society's chances to benefit from stem cell research. Id. at 37. 36 See Stem Cell Research Enhancement Act of 2005, H.R. 810, 109t h Congress § 2 (2005) (allowing stem cell research on discarded embryos created for IVF). The bill, after passing in the House and Senate, was vetoed by Bush and Congress failed to gather enough support to override the veto. KOROBKIN WITH MUNZER, supra note 1, at 43. 37 KOROB3KIN WITH MUNZER, supra note 1, at 45 (referencing Stem Cell Research Enhancement

Act of 2005, H.R. 810, 109th Cong. § 2 (2005). IVF clinics maximize the potential of success by creating as many embryos as possible, and the result are thousands of extra embryos that will ultimately be destroyed. Id. at 46. 38 See KOROBKIN WITH MUNZER, supra note 1, at 45 (arguing Congress' distinction equals

arbitrary political pandering). All legislation must be made in light of the Dickey Amendment, which prohibits federal funding to any research that creates or destroys embryos. See The Dickey Amendment, Pub. L. No. 104-99, § 128 (1995). Congress has renewed the Dickey Amendment every year since it was created in 1995. See KOROBKIN WITH MUNZER, supra note 1, at 27 (explaining the Dickey Amendment).

2009

JOURNAL OF HEALTH & BIOMEDICAL LAW

the top. '39 Korobkin's position is simple: society needs more stem cell research and 40 government attempts to appease the moral constituency are detrimental to society. Korobkin best exemplifies the federal government's misunderstood and unreasonable aversion to stem cell research by describing the government's response to a breakthrough method of creating hESC lines that did not require the destruction of embryos.41 The method--which many researchers hoped would be met with governmental enthusiasm-required taking one of the eight cells of an embryo, leaving the other seven intact.42 The governmental response was extremely negative. 43 Members of Congress attacked the method as morally wrong, and stated that sevencelled embryos were less healthy and an extracted cell had human potential. 44 In arguing that the opposition misses the point, Korobkin persuasively states "it is difficult to imagine how any scientific advance could ever soften the opposition to hESC 45 research of President Bush and his allies."

A Constitutional Right to Clone In chapter three, the authors take an interesting turn and discuss whether the government has the right to ban cloning under the Constitution. This exhaustive analysis cites the Commerce Clause, the right to pursue medical treatment, and reproductive rights. 46 Under the Commerce Clause, Korobkin predicts that the

39 KOROBKIN WITH MUNZER, supra

note 1, at 45. While the bill was unsuccessful, Korobkin states that Congress' attempt to allow for research on discarded embryos wh-ilc blatantly ignoring the superfluous amounts of embryos created in IVF clinics is pure hypocrisy. Id. 40

See KOROBKIN WITH MUNZER, supra note 1, at 48 - 49 (discussing negative effects of Federal

Government's policy on stem cell research). 41KOROBKIN WITH MUNZER, supra note 1,at 57 (describing ground-breaking method discovered

by scientist Robert Lanza). KOROBKIN WITH MUNZER, supra note 1,at 57. 43 See KOROBKIN WITH MUNZER, supra note 1, at 59 (describing unexpected overwhelming 42

opposition to Lanza's method from the Federal Government). Emily Lawrimore, a White House spokeswoman, stated: "[a]ny use of human embryos for research purposes raises serious ethical concerns. This technique does not resolve all those concerns." Nicholas Wade et al., In New Methodfor Stem Cells, Viable Embryos, N.Y. TIMES, Aug. 24, 2006, at Al. 44See KOROBKIN WITH MUNZER, supra note 1, at 60 (pointing out Senatorial Response to Lanza's

discovery). Senator Sam Brownback equated the method to creating twins and then killing one of them. Id. 45 46

KOROBKIN WITH MUNZER, supra note 1,at 60. See KOROBKIN WITH MUNZER, supra note 1, at 74-79 (discussing cloning in light of the

Commerce Clause); id. at 79-85 (arguing constitutional right to receive medical treatment may protect some cloning practices against government interference); id. at 85-91 (arguing cloning

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

Supreme Court would uphold a cloning ban under the "substantial effects" test and aggregation principal set forth in the 2005 decision Gonzalez v. Raich.47 In attempting to equate cloned embryos to other commodities, Korobkin wrestles with an abundance of variables that may allow a court to overrule a cloning ban. 48 Such variables include technological issues, lack of a market for cloned embryos, and lack of commercial goals among research scientists. 49 Ultimately, Korobkin says the Supreme Court could ban the activity for moral reasons under the guise of the Commerce Clause.50 The author, however, believes that cloning is the type of activity that should be left to state 5

regulation.

Next, Korobkin considers whether the government needs a compelling interest to ban cloning if cloning is necessary to save someone's life.5 2 Roe v. Wade53 and other authorities severely restrict the government's right to prohibit abortion when doing so

may be protected by constitutional right of reproduction). 47 KOROBKIN WITH MUNZER, supra note 1, at 77 (analyzing Commerce Clause in light of Raich).

In Raich, the Supreme Court held that a statute prohibiting the growth of marijuana for personal medicinal use was valid under the commerce clause. 545 U.S. 1, 26 (2005). The majority based their decision on the government's right to control activities that have a substantial effect on interstate commerce, and argued that there was a substantial market for marijuana supported by the very practices undertook by the defendant in Raich. Id. at 17 - 24. This line of reasoning comes from the depression era case, Wickard v. Filburn, 317 U.S. 111, 129 (1942), where the Supreme Court held that the Commerce Clause supported a statute governing the amount of wheat an individual could grow in their back yard because of the aggregate amount of wheat that ends up in interstate commerce. Raich, 317 U.S. at 26. 48

See KOROBKIN WITH MUNZER, supra note 1, at 77 (recognizing Supreme Court's likely

determination that stem cell research is "economic activity"). Korobkin poses the idea that cloned embryos may not be considered "commodities" because there is no legal or illegal market for them, unlike marijuana or wheat. Id. Alternatively, Korobkin states that a court might narrow its finding to prohibit only cloning for commercial purposes as opposed to cloning for research. Id. 49 KOROBKIN WITH MUNZER, supra note 1, at 77. 50

KOROBKIN WITH MUNZER, supra note 1, at 79. See also Heart of Atlanta Motel, Inc. v. United

States, 379 U.S. 241 (1964) (allowing Congress to ban racial discrimination for commerce reasons even if true motivation is to correct moral wrong). Korobkin states that, under Heart ofAtlanta, a court could use interstate commerce reasons to ban cloning, while really banning the practice for moral reasons. KOROBKIN WITH MUNZER, supra note 1, at 79. 51 See KOROBKIN WITH MUNZER, supra note 1, at 79 (arguing issues of cloning best addressed by

state regulation). Korobkin states "a principled division between federal and state regulatory power ought to place judgments about the ethics of cloning in the states' bailwick, along with the regulation of schools, at issue in Lope.7 and the regulation of violence, at issue in Morrison." Id. 52

KOROBKIN WITH MUNZER, supra note 1, at 80 (recognizing a pregnant woman's constitutional

right to end pregnancy when her life is in jeopardy). 53

410 U.S. 113 (1973).

2009

JOURNAL OF HEALTH & BIOMEDICAL LAW

risks a woman's life.54 Furthermore, terminally ill patients have a fundamental right to prevent the Food and Drug Administration ("FDA") from blocking their access to potentially life saving drugs.55 Therefore, when a medically controversial treatment is necessary to save a patient's life, the government may need a compelling interest to intervene.5 6 The problem with this position is the tenuous connection between a researcher's experiment and a patient's right to obtain the fruits of the research. As Korobkin recognizes, there are too many variables in the space between for a court to The third argument for the protect the practice as a fundamental right.57 58 constitutionality of cloning concerns an individual's fundamental right of reproduction. Citing landmark "zones of privacy" cases, Korobkin believes there is a slim chance the court could extend an individual's reproductive rights to include at least a liberty interest in reproductive cloning.59

54

See KOROBKIN WITH MUNZER, supra note 1, at 80 (recognizing a pregnant woman's

constitutional right to end pregnancy when her fife is in jeopardy) See also Stenberg v. Carhart, 530 U.S. 913, 938 (2000) (holding partial birth abortion ban unconstitutional for lack of exception to preserve mother's health); Planned Parenthood v. Casey, 505 U.S. 833, 878 (1992) (holding state laws cannot create "undue burden" for women exercising abortion rights). 55 See Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 445 F.3d 470, 479-483 (D.C. Cir. 2006) (holding terminally ill patients have fundamental right to access potential life saving drugs not approved by FDA). But see Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 495 F.3d 695, 714 (D.C. Cir. 2007), cert. denied, 128 S. Ct. 1069 (2008) (upholding original district court denial of constitutional right to unapproved drags for terminally ill patients). See KOROBKIN WITH MUNZER, supra note 1, at 84. Korobkin derives the proposition that the government may not interfere with life-saving opportunity absent a compelling interest, but recognizes that access to therapeutic cloning may not yet be considered life saving medicine, as it is still in its early stages. 57 See KOROBKIN WITH MUNZER, supra note 1, at 84-85 (citing lack of history for right to narrow practice of therapeutic cloning). 58 KOROBKIN WITH MUNZER, supra note 1, at 85. 59 KOROBKIN WITH MUNZER, supra note 1, at 85-91. See Lawrence v. Texas, 539 U.S. 558, 578 (2003) (recognizing fundamental right of privacy in realm of sexual behavior); Eisenstadt v. Baird, 405 U.S. 438, 453 (1972) (recognizing fundamental right to be free of government intrusion in procreation); Griswold v. Connecticut, 381 U.S. 479, 498 (1965) (holding married couples have fundamental right of procreation); Skinner v. Oklahoma, 316 U.S. 535, 541 (1942) (holding procreation is "basic civil right of man"). These cases, according to Korobkin, make it not inconceivable that the Supreme Court may recognize a constitutional right to make use of reproductive cloning for the purposes of procreation. KOROBKIN WITH MUNZER, supra note 1, at 87. The two scholarly arguments against this would be one that aims to protect the health of the clones, and another to protect the rest of the society from the negative effects of cloning. Id. The first argument, that the government has a compelling interest in protecting potential children from substantial risk of being born with birth defects, is flawed because it assumes that a potential parent would resort to other means of reproduction is cloning were banned, which is 56

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

Economic Incentives for Researchers and Taxpayers Chapter four, co-authored by Stephen R. Munzer, begins with an informative explanation of patent law that is valuable to anyone seeking a broad strokes understanding of the procedure and significance of patenting technological discoveries. The Wisconsin Alumni Research Foundation ("WARF"), the first research group to create a viable hESC from a blastocyst, claims the legal right to prevent anyone from using hESC technology created by any method.60 The breadth of this patent, as the authors explain, is destructive to the advancement of stem cell research because it creates financial burdens that may inhibit research. 61 Conversely, without patents, the authors emphasize, there would be little monetary incentive to make discoveries. This could decrease research, resulting in a smaller benefit to society. 62 Korobkin and Munzer propose a happy medium where WARF patents only the chemical compounds necessary to create hESCs by WARF's method, but other researchers could use their 63 other methods license-free. In setting forth the legal grounds for a stem cell patent, Korobkin and Munzer entertain the possibility that individuals may be unable to patent stem cell methods under the "product of nature" doctrine. 64 This doctrine prohibits patenting a natural phenomenon of nature, such as a research patent on the natural phenomenon of

unlikely. Id. at 88-89. The second argument fails because it is unlikely that cloning would become so widespread as to pose a biological risk to society. Id. at 90. 60 KOROBKIN WITH MUNZER, supra note 1, at 93. 61 See KOROBKIN WITH MUNZER, supra note 1, at 96-97 (discussing negative effects of WARF's broad patent on the research community). WARF allows breaks to academic institutions but charges heavy fees for any inventions developed with the help of WARF's technology. Id. at 97. WARF also sought compensation from the California Institute for Regenerative Medicine (CIRM), which is funded by the state of California and earns royalties for tax payers. Id. at 9798. See id. at 99 (discussing negative effects of broad patents). 62 See KOROBKN WITH MUNZER, supra note 1, at 100 (noting lack of patents would ultimately be detrimental to research due to lack of compensation). 63 See KOROBKIN WITH MUNZER, supra note 1, at 103-104 (arguing for happy medium of patent claims for benefit of society and researchers alike). Korobkin and Munzer argue that WARF should have a patent only for the nutrient mix they used to create the first sustainable hESC lines. Id. That way, anyone could use WARF's nutrient mix for a fee, but could also try to develop their own for free. Id. This allows for the best financial return for WARF and level of research for society. Id. 64See KOROBKIN WITH MUNZER, supra note 1,at 107 (discussing "product of nature" doctrine). See also Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948) (holding "He who discovers hitherto unknown phenomenon of nature has no claim to a monopoly of it.').

2009

JOURNAL OF HEALTH & BIOMEDICAL LAW

osmosis. 65 The authors cite authority that may protect WARF from the product of nature doctrine, but also note that the Supreme Court is still largely undecided on many product of nature issues. 66 In the last part of the chapter, the authors mention a statutory safe harbor for the use of patented information when researchers attempt to compile information for an eventual submission to the FDA.67 Courts have liberally 68 interpreted this safe harbor, and it may protect certain methods of stem cell research. Korobkin discusses another economical issue in chapter five-how taxpayers Under California's should benefit from government-funded stem cell research. Proposition 71, the state legislature created the California Institute of Regenerative Medicine ("CIRM"). 69 The CIRM can patent inventions realized through state-funded stem cell research, and taxpayers receive a share of the profit. 70 Proposition 71 mimics the Bayh-Dole Act, a federal law enacted in 1980, which grants patent ownership to researchers for government-funded inventions.7' While the Bayh-Dole act is generally KOROBKIN WITH MUNZER, supra note 1, at 107. 66 See Diamond v. Chakrabarty, 447 U.S. 303 (1980) (holding one could hold a patent over modified bacteria). The authors point out that the critical inquiry is not whether the matter is living or not, but whether it has been modified by man. KOROBKIN WITH MUNZER, supra note 1, at 108. The answer to whether stem cells isolated from blastocysts are natural or man made, according to the authors, depends on the characterization of WARF's supposed patent and whether researchers developed a certain "method." Id. at 109. However, hESCs are natural and thus WARF should not be able to preclude scientists from researching with hESCs that were developed by some method other than one patented by WAR. Id. Some argue that WARE has the right to a functionally new type of matter because their method sufficiently manipulates the end product. Id. at 110. 67 See The Drug Price Competition and Patent Term Restoration Act, 35 U.S.C. 5 271(e)(1) (1984) (creating safe harbor when using patented invention reasonably related to producing This safe harbor was created to allow drug information about manufacturing drugs). manufacturers to start creating copycat generic drugs before the originals went off patent. KOROBKIN WITH MUNZER, supra note 1, at 122. 68 KOROBKIN WITH MUNZER, supra note 1, at 123. Korobkin finds a recent Supreme Court decision that loosely interprets this safe harbor as encouraging support for researchers trying to get around broad patents related to hESCs. Id. See also Merck KGaA v. Integra Lifesciences I, Ltd. 545 U.S. 193, 200 (2005) (holding safe harbor covers research "reasonably related" to development and submission of data the FDA would require to approve a new drug). 69 See California Stem Cell Research and Cures Initialive § 2-3; available at http://vote2004.ss.ca.gov/ voterguide/propositions/prop7ltext.pdf (last visited Mar. 16, 2009) (giving taxpayers share of financial returns on state funded stem cell research). 70 See id. Korobkin notes that the grantee may retain the first $500,000 to share with individual inventors and to cover costs, but other than that, they must return twenty five percent to the state's general fund. KOROBKIN WITH MUNZER, supra note 1, at 127. 71 See The Bayh-Dole Act, 35 U.S.C. 55 200 - 211 (2000) (creating rules for ownership of federally funded inventions, granting many property rights with inventors). Under the Bayh-Dole 65

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

considered successful, it is open to criticism as applied to stem cell research.7 2 Many scientists, researchers, and physicians argue that monetary incentives will prohibit the free flow of information among researchers, which could ultimately inhibit research progress.7 3

Similarly to the argument in chapter four regarding patents among

researchers, Korobkin argues for an intermediary position depending on the type of invention.7 4

The distinction between inventions that are commercially marketable to

consumers ("applied") versus inventions that are valuable to researchers only ("research tools") illustrates a problem in giving researchers unfettered patent rights.75 According to Korobkin, this distinction should be at the forefront because unfettered patent rights are best for applied inventions, but stem cell research is not yet marketable to consumers.7 6 Thus, Korobkin believes the financial return analysis should focus on the research-side inventions, and the investment should be worthwhile to scientists and taxpayers alike.

Korobkin's creative wrestling with the issue exemplifies how the practicalities of financial return may undercut stem cell benefits to society. 77

Act, universities were given the right to patent federally funded inventions and were encouraged to commercialize the inventions. KOROBKIN WITH MUNZER, supra note 1, at 129. 72 See KOROBKIN WITH MUNZER, supra note 1, at 132 (discussing praise for Bayh-Dole Act). See also Innovafion's Golden Goose, Economist, Dec. 14, 2002 at 3, 3 (claiming Bayh-Dole Act reversed America's "slide into industrial irrelevance"). 73 See KOROBKIN WITH MUNZER, supra note 1, at 133 (discussing recent criticism that Bayh-Dole Act inhibits beneficial communication among researchers). Korobkin argues that the transactions costs that go along with obtaining protected information can ultimately be detrimental to research, and therefore California should not have simply assumed that mirroring the Bayh-Dole Act was the best approach. Id. 74 See id.at 134-135 (arguing lopsided approach gives too much leverage to private inventors, public must be considered as well). 75 KOROBKIN WITH MUNZER, supra note 1, at 135. Korobkin argues that we should draw the line based on how expensive a product will cost to patent, which affects how much people are willing to invest in the development of the product so that it is ultimately commercially viable. Id. "Research tool" products, such as the specific hESC lines that WARF patents, are useful with little or no further investment needed for development. Id. at 136. "Applied Products," however, are substantially more expensive to develop, requiring large amounts of money and time before they produce a financial return." Id.According to Korobkin, the risk and money of developing an "applied" product is on a private corporation, and thus they should be rewarded with a patent. Id. Thus, society is benefited from allowing less patent rights for "research tool" inventions and more patent rights for "applied" inventions. Id. at 137. 76 See KOROBKIN WITH MUNZER, supra note 1, at 140 (criticizing CIRM for allowing researchers to place their own interest over the public's interest). Korobkin suggests a number of revenuesharing alternative agreements such as providing in-kind revenue sharing as opposed to solely cash compensation. Id.at 150. 77KOROBKIN WITH MUNZER, supra note 1, at 150. Korobkin states that CIRM, in allowing grantees the choice to patent their inventions or not, has made a big mistake. Id. In some cases, a grantee's monetary incentive to patent a research tool invention will deprive the public. Id.

2009

JOURNAL OF HEALTH & BIOMEDICAL LAW

Autonomy and Financial Rights of Donors Chapter six addresses the autonomy and informed consent of donors with respect to health risks and the disclosure of researchers' financial interests. Under "the common rule," researchers must apprise donors of all risks and obtain informed consent before taking samples from donors. 78 In stem cell research, however, a majority of research is privately funded and thus researchers are not under the legal obligations of the common rule. 79 Korobkin asks whether private research is under a separate tort obligation to obtain the informed consent of human tissue donors-a duty not imposed on most recipients of goods or services.80 There is little authority to support such an obligation, but the author believes in honoring the autonomy of donors, and therefore 81 erring on the side of informed consent. A separate issue is whether the researcher must disclose his or her financial interest prior to obtaining informed consent.82 In Moore v. Regents of the Universiy of 3 the California Supreme Court held that researchers must disclose their Cafornia,8 financial interests to donors because patients expect professional decisions to be based

78

See 45 C.F.R.

§5 46.103(b), 46.109, 46.119 (2005) (setting forth the "common rule"). This

developed mainly in response to the Tuskegee Syphilis Study, which violated many accepted principles of medical and scientific ethics. KOROBKIN WITH MUNZER, supra note 1, at 154

(describing organics of the "common rule"). The common rule, exclusively required in public studies, mandates that researchers to disclose any and all material information to subjects about a study prior to receiving informed consent. Id. at 155. Korobkin explains common rule and informed consent, which is imposed by tort law, as connected but ultimately distinct bodies of law designed to protect the autonomy rights of patients. Id. at 156. 79 See KOROBKIN WITH MUNZER, supra note 1, at 157 (noting the common rule only applies to federally funded studies). 80 KOROBKIN WITH MUNZER, supra note 1, at 157. The key issue will turn on the area of research

that falls outside the reach of the common rule, which is called non-therapeutic research. Id. at 158. This research, as opposed to therapeutic research, is not conducted with the goal of benefiting the subject, but merely for scientific experimentation. Id. 81 See Greenberg v. Miami Children's Hospital Research Inst., Inc., 264 F. Supp. 2d. 1064, 1066

(S.D. Fla. 2003) (holding informed consent required where researchers neither treating nor experimenting on subject, merely researching on tissue). The court decided this issue on oral argument, and thus Korobkin fails to recognize it as substantial authority on the subject. KOROBKIN WITH MUNZER, supra note 1, at 159. While the case reaches the right conclusion, according to Korobkin, the reasoning should focus on an unfair disparity of information between researcher and subject that would require informed consent to preserve decisional autonomy. Id. at 160. 82 KOROBKIN WITH MUNZER, supra note 1, at 160. 83 793 P.2d 479 (Cal. 1990).

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

entirely on professional judgment.8 4 Recent authority states, however, that nontherapeutic research settings, like stem cell research, do not require disclosure of financial interests. 85 The Greenbeqg court justified this position when ruling on a nontherapeutic donor's voluntary choice to supply tissue and the negative effects that disclosure would have on research. 86 Korbokin fiercely disagrees with this position and cites materiality as the sole factor for disclosure and states that the commercial interest of researchers is material. 87 The author supports the autonomy of donors over access to embryos that may otherwise go unused and argues for researcher's use of tissue only with express informed consent. 88 This chapter seems to go against the progressive theme of the book because Korobkin wishes to assume autonomy does not exist if it is not express. This position may ultimately inhibit research based on a requirement that, in many situations, could be arbitrary and unnecessary. The requirement could create the type of bureaucracy and procedural requirements that would exclude large amounts of viable donated embryos when the donor can no longer be reached for express consent. On a related topic in chapter seven, Korobkin asks whether it is proper for

See 793 P.2d at 485 (requiring disclosure of financial interests). Korobkin states the Moore decision is not squarely on point with whether researchers conducting non-therapeutic research without direct contact with the subject because the facts in Moore contained a therapeutic or direct relationship between subject and researcher. KOROBKIN WITH MUNZER, supra note 1, at 161-162. 85 See Greenbe, 264 F. Supp. 2d at 1070-1071 (holding no requirement for non-therapeutic researchers to disclose financial interests). 86 KOROBKIN WITH MUNZER, supra note 1, at 162. Korobkin believes that the Greenber case is directly on point because it involved a researcher without a therapeutic relationship with the donors. Id. In Greenberg, however, the court distinguished non-therapeutic donors as distinct from subjects because they voluntarily donated, stating that disclosure of financial interests would "chill" research, and holding that disclosure of financial interests was not required. Greenberg, 264 F. Supp. 2d. at 1070-1071. 87 See KOROBKIN WITH MUNZER, supra note 1, at 162 -163 (arguing against reasoning in Greenberg). 84

Korobkin states that disclosure of financial interest would not chill medical research unless subjects had a moral opposition to donating tissues to researchers that seek profits, and while it is unlikely, if it were true it would undermine the concept of informed consent. Id. For the second

justification, Korobkin believes that non-therapeutic donors must have more information to decide if the researcher's interests are truly for the benefit of society. Id. 88 See KOROBKIN WITH MUNZER, supra note 1, at 165 (arguing for disclosure of financial interests to non-therapeutic voluntary cell donors); see id. at 168-169 (arguing informed consent should be required prior to using unidentified samples provided for non-stem cell use); see id. at 170 (arguing blanket consent prior to donating tissues not truly informed and thus could not suffice); see id. at 172-173 (arguing that informed consent from both spouses is required prior to research on dually donated embryos).

2009

JOURNAL OF HEALTH & BIOMEDICAL LAW

researchers to give monetary or in kind compensation for the donation of blastocysts or embryos. Currently, many stem cell research guidelines and state laws are strictly against compensation for tissue donation for stem cell research. 89 Legally, the statutes on point are the National Organ Transplant Act ("NOTA") and the Uniform Anatomical Gift Act ("UAGA"), which are facially against compensation. 90

Korobkin notes the

ambiguity of the statutes regarding donation and attacks the policy of no-compensation rules. 91 His position is that we should allow compensation for donors as long as there is sufficient informed consent.92

A popular anti-compensation argument states that

compensation will increase involuntary and coerced donations mainly among low93 income sectors of the economy, and we risk ignoring the needs of the less fortunate. Korobkin responds that-assuming there is informed consent--donors would be apprised of any negative benefits that would create the necessary hedge against the likely few attempts at coercion on the part of researchers. 94 Furthermore, while money may

89

See Committee on Guidelines for Human Embryonic Stem Cell Research, National Research

Counsel,

GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH 85 (2005) (prohibiting cash or in-kind compensation for embryos beyond clinical research necessities); NATIONAL INSTITUTE FOR HEALTH GUIDELINES FOR RESEARCH USING HUMAN PLURIPOTENT STEM CELLS AND NOTIFICATION OF REQUEST FOR EMERGENCY CLEARANCE, 65 FED. REG. 51,976,

51,979 (Aug. 25, 2000); available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD02-007.html (prohibiting inducements, monetary or otherwise, for embryo donations). A number of states that support stem cell research have made no-compensation rules for donation of tissues for stem cell research. See generaly MASS. GEN. LAWS. ch. 111 5 8 (2005); N.J. STAT. ANN. 5 26:2Z-1 (2004); CONN. GEN. STAT. ANN. 05-149 § 1(c)3 (2005). 90 See National Organ Transplant Act, 42 U.S.C. S 274e(c)(1) (1984) (punishes with fine or imprisonment buying any organ or "subpart" for transplant); UNIFORM ANATOMICAL GIFT ACT 5 6(a) (1987) (prohibiting selling body parts for transplants or therapy, omitting research). 91See KOROBKIN WITH MUNZER, supra note 1, at 180-181 (distinguishing NOTA and UAGA as potentially inapplicable to stem cell tissue donations for research). Korobkin argues that neither act applies to gametes and notes that federal law prohibits only the sale of HIV infected gametes, which may imply the right to sell healthy gametes. Id. at 181. Many states, however, have explicitly banned tissue sales. Id. The free purchase and sale of gametes for IVF purposes in many states, according to Korobkin, See id. at 183-190 (arguing monetary compensation for tissue would not create involuntary and coerced donations); Id. at 190-195 (stating anti-commodifcation arguments unfairly equates tissues to human beings); see id. at 195-203 (arguing compensation will not inhibit altruistic donations or increase cost of research). 92 KOROBKIN WITH MUNZER, supra note 1, at 183. 93 See KOROBKIN WITH MUNZER, supra note 1, at 183 (explaining paternalistic justification for nocompensation rule). 94 See KOROBKIN WITH MUNZER, supra note 1, at 184 (making free will argument for compensation for donors). Korobkin views the choice of money for tissue as another positive choice that will be afforded to individuals, and prohibiting this choice is detrimental. Id. at 184185. Simply because a choice is made pursuant to monetary inducement does not make the choice ill-informed. Id. at 185.

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

induce more low-income donors, our capitalistic society allows for many situations where the poor must undertake dangerous and unpleasant professions that the wealthy might object to. 95 The chapter ultimately concludes that compensation could suit the needs of researchers and donors alike, while staying consistent with no-compensation justifications for transplants set forth in NOTA and the UAGA. 96 In chapter eight, Korobkin examines potential default rules for tissue donation in light of Moore and other authority. In Moore, the court denied a claim for conversion based on the defendant's financial benefit from undisclosed research on the plaintiff's spleen. 97 Korobkin argues that academics have widely misinterpreted this decision to mean that individuals do not have property rights in disembodied human tissues. 98 In support of a contrary position, Korobkin cites longstanding legal authorities that recognize a donor's property rights in extracted organs. 99 Korobkin argues that Moore established a default rule that tissue donation is done altruistically, and not for financial return. 100 This interpretation has garnered support in decisions subsequent to Moore.'0' 95 See KOROBKIN WITH MUNZER, supra note 1, at 187 (arguing for economic choice and tradeoffs). "Coal mining is unpleasant, often dangerous, and correlated with a reduction in lifespan. These facts rarely lead to suggestions that society should leave the task of coal mining to altruists willing to work for free." Id. at 188. 96 See KOROBKIN WITH MUNZER, supra note 1, at 204 (discussing potential alternatives to compensation or non-compensation). Korobkin suggest things such as specific cash structures to account for certain costs, in-kind compensation similar to IVF or blood donations. Id. at 204205. Finally, Korobkin points out that no-compensation rules for transplants are to prevent bidding wars for organs that would give low-income individuals little or no access to organs. Id. at 206. These justifications are not present in the context of stem cell research. Id. at 207. 97 See Moore, 793 P.2d. at 488 (denying claim defendants converted plaintiff's spleen). 98 See KOROBKIN WITH MUNZER, supra note 1, at 211 (stating academic journals and press derived improper conclusion from Moore). Korobkin states that the common rule and informed consent grant a right to exclude others from using our tissue, and that other property rights are derived from NOTA and UAGA. Id. at 212-213. 99 See, e.g., McFall v. Shimp, 10 Pa. D. & C.3rd 90, 92 (1978) (holding court could not compel defendant to donate life saving bone marrow to plaintiff); National Organ Transplant Act of 1984, 42 U.S.C. §§ 273, 274 (2005) (granting right to donate renewable or non-necessary organs while we are alive); UNIFORM ANATOMICAL GIFT ACT 5 2 (1987) (granting right to bequeath organs). 100 KOROBKIN WITH MUNZER, supra note 1, at 216.

The dissent in Moore favored a default

compensation rule and Korobkin states that the majority's failure to address this issue implies a default rule to the contrary. Id. 101 See KOROBKIN WITH MUNZER, supra note 1, at 215-216 (noting no explicit agreement reached

either way in Moore). The dissent in Moore favored a default compensation rule and Korobkin argued that the majority's failure to address the issue implied a default rule to the contrary. Id. at 216. See also Moore, 793 P.2d. at 501 (Broussard, J., dissenting) (recognizing property rights in plaintiffs emanated spleen). See Hecht v. Superior Court, 20 Cal. Rptr. 2d. 275, 281-284 (Cal. Ct.

2009

JOURNAL OF HEALTH & BIOMEDICAL LAW

In Greenberg, the court had the opportunity to clarify this issue, but only produced more confusion. 10 2 Thus, with scant legal authority, Korobkin opts for a weak nocompensation default rule, which would allow courts to liberally interpret the intentions of a donor in favor of compensation.'0 3 Korobkin's thorough and thoughtful analysis of current law implies confusion on the part of courts and scholars alike, which pushes the reader towards his sensible and informed solution. In the final chapter, we learn about Molly Nash and the practice of PGD in general.10 4 Korobkin notes that new reproductive technologies like PGD have outpaced legal regulation in the United States, but that such practices are regulated abroad.105 In the United Kingdom ("UK"), the Human Fertilisation and Embryological Authority ("HFEA") regulates practices such as PGD and other methods of creating stem cell donors. 10 6 Under the UK's rules, the HFEA would have approved the procedure that saved Molly Nash's life, but other children have not been so lucky.'0 7 The HFEA makes a distinction between killing embryos to benefit a living child and a future being (Molly Nash and Adam Nash) and killing an embryo to benefit only a living human being 0 8 Thus, if scientists were only using embryos to save Molly's life and not to create a new human being, the practice would be morally wrong and illegal. Korobkin argues this strict Kantian analysis-that one person should not be used solely to benefit anotherApp. 1993) (holding decedent sperm donor had ownership interest in donated sperm held in sperm bank). 102 See Greenberg, 264 F. Supp. 2d. at 1066-1067 (defaulting to no-compensation despite contractual language to contrary). Korobkin points out in inherent inconsistency in this decision in that the court recognized the defendant's unjust enrichment and expressly recognizing that defendant accepted a benefit without compensating. KOROBKIN WITH MUNZER,supra note 1, at 218. 103 See KOROBKIN WITH MUNZER, supra note 1, at 219 (setting forth benefits of weak default rule). Korobkin believes that language indicating a benefit to the donor should be liberally interpreted or read into the contract to inhibit against subtle offers or representations by researchers that may induce donations. Id. 104 See KOROBKIN WITH MUNZER,supra note 1, at 232-234 (telling the story of Molly Nash). 105 KOROBKIN WITH MUNZER, supra note 1, at 236. 106 KOROBKIN WITH MUNZER,

supra note 1, at 236.

See R v. Human Fertilisation and Embryological Auth., [2005] UKHL 28 (House of Lords 2005) (affirming right of couple to use PGD to create donor child). But see KOROBKIN WITH MUNZER, supra note 1, at 236-237 (2007) (explaining case of Charlie Whitaker). In the case of Charlie Whitaker, the HFEA denied a family's application to use PGD to save a three year old child because the practice would only benefit the living child, and not the embryo. Id. at 237. 108 See KOROBKIN WITH MUNZER, supra note 1, at 237. Korobkin recognizes a strict distinction between using an embryo solely for the benefit of a living child or for the simultaneous benefit of the embryo. Id. In cases like that of Molly Nash, PGD is justified because the practice creates a 107

higher probability that the child will be born without disease. Id.

JOURNAL OF HEALTH & BIOMEDICAL LAW

VOL. V NO. 1

is inapplicable to curing diseases in children. 10 9 According to Korobkin, a utilitarian cost-benefits analysis about the happiness of the child and family as a whole is more appropriate.10 The chapter then moves to the FDA's long and arduous pre-approval

procedure, which Korobkin finds to be outdated as applied to stem cell research."' Conclusion Korobkin's method of identifying and resolving potential problem areas for stem cell research is clever and frequently convincing. First, he identifies how our current system may prohibit society from realizing the benefits of stem cell research. Next, he proposes a solution of compromise between parties that also furthers his prostem cell research position. Furthermore, he uses the unique factors of stem cell When Korobkin research to narrow the breadth of potential legal obstacles. respectfully-and frequently unsuccessfully-attempts to extract legal principles, the reader forms his or her own conclusions that parallel Korobkin's proposals. This is difficult because it is hard to accept the application of authority to a factual situation that lawmakers never contemplated. As the book portrays, lawmakers that created authority

109KOROBKIN WITH MUNZER, supra note 1,at 237. Philosopher Immanuel Kant argued that immoral choices are those that justify ends with inappropriate means. See IMMANUEL KANT, GROUNDWORK OF THE METAPHYSICS OF MORALS, 98 (H. J. Paton trans., Harper & Row 1964) (1785). Kant stated that a human life is an end in itself, and thus using a human life as a means to an end is always immoral. Id. The HFEA seems to take this approach with PGD, in that developing an embryo for PGD is only permissible if doing so helps the embryo develop into a healthy human being. See KOROBKIN WITH MUNZER, supra note 1, at 237 (arguing against Kantian analysis for regulation of PGD). Specifically, Korobkin makes two points about the Kantian analysis; the first is that even acceptable PGD entails killing embryos with diseases, and thus the distinction is contradictory. Id. at 237-238. The second is that the good health of the living child and the family unit should be considered as well, not just whether the embryo is used as a means or an end. Id. 110 KOROBKIN WITH MUNZER, supra note 1, at 237.

111 See KOROBKIN WITH MUNZER, supra note 1, at 242-245 (explaining current FDA pre-market approval process). The current process entails several steps to show the safety and efficacy of a product of biological products, and takes seven and a half years on average. Id.at 244. Furthermore, the process is very expensive and thus creates two bad consequences: patients are deprived of timely treatment and manufacturers must cover their risk with higher prices. Id. A third problem is that manufacturers have an incentive to create widely marketable products, which usually means drugs and treatments must be continually prescribed. Id. All of these consequences are at odds with the goals of stem cell research; there are unknown risks, many patients cannot wait for approval, and it will not be widely marketable like traditional drugs and treatments. Id.For these reasons, Korobkin argues we need a different system of approval to account for the unpredictable risks of stem cell research, but simultaneously allow for timely treatment when necessary. Id. at 246.

2009

JOURNAL OF HEALTH & BIOMEDICAL LAW

which is now applicable to stem cell research did not contemplate stem cell research, and thus there is need for change. Stem Cell Century attempts to answer questions that are arguably unanswerable, however, the ultimate message is clear: Society will benefit from more stem cell research. On each step of the way, Korobkin explains how the status quo may hinder stem cell research and argues against such a result. In suggesting solutions, Korobkin recognizes a void in stem cell-informed legal authority, and respects the capriciousness of this breakthrough technology. On March 9, 2009, President Barack Obama signed an executive order that granted federal funding for stem cell research.1 12 This is a step in the right direction for stem cell research and supporters, however, as Stem Cell Centuy explains, it is not a solution to the myriad of obstacles society faces in realizing the benefits of stem cell research.

See Rob Stein, Obama Aims to Shield Sdence From Politics, WASH. POST, Mar. 9, 2009, at A2, available at http://www.washingtonpost.com/wpdyn/content/story/2009/03/09/ST2009030901104.html (describing Executive Order to grant federal funding to stem cell research). The order gave the National Institutes of Health 120 days to resolve moral concerns and set guidelines to assess candidates for funding. Id. 112