stem cell century: law and policy for a breakthrough technology · 2017. 10. 21. · in stem cell...

Journal of Health & Biomedical Law, Vol. V (2009): 131-149

© 2009 Journal of Health & Biomedical Law

Suffolk University Law School

Stem Cell Century: Law and Policy for aBreakthrough 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 aviable 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 genetictraits.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] RUSSELL KOROBKIN WITH STEPHEN R. MUNZER, STEM CELL CENTURY: LAW AND POLICY FOR

A BREAKTHROUGH TECHNOLOGY, 232 (Yale University Press 2007) [hereinafter KOROBKIN

WITH MUNZER]. Molly's disease, Fanconi Anemia, causes bone marrow failure and weakens theimmune system, and children with Fanconi Anemia usually die before the end of childhood. SeeA.D. AUERBACH ET AL., Prenatal of Potenlial Donors for Umbilical Cord Blood Transplantation for FanconiAnemia, 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.

JOURNAL OF HEALTH & BIOMEDICAL LAW

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 Poliy for 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

7 KOROBKIN WITH MUNZER, supra note 1, at 234.8 KOROBKIN WITH MUNZER, supra note 1, at 236.

9 See KOROBKIN WITH MUNZER, supra note 1, at 19, 20 (discussing potentially significant medicalbenefits of stem cell research). Korobkin identifies the most exciting potential benefit of stemcell 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 stemcell research. Id.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, incontrast 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 arecertain according to Korobkin, including scientists' greater understanding of cell developmentand the creation of new sources of material for testing pharmaceuticals. Id. The authors argueconvincingly that the governmental policies towards stem cell research ultimately undermine theUnited States' chances of realizing the full potential of stem cell research. See id. at 48 (discussingpractical consequences of governmental policy towards stem cell research).11 KOROBKIN WITH MUNZER, supra note 1, at 3.

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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 aspioneer of stem cell research).18 Address to the Nation on Stem Cell Research from Crawford, Texas, 37 Weekly Compilationof 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.

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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

based on the commerce clause, the right to privacy, and the right of procreation.20

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

20 KOROBKIN WITH MUNZER, supra note 1, at 73 (noting banning the practice of cloning creates

constitutional issues). The government prohibits funds for some stem cell research; however thedebate over cloning involves a blanket ban on the practice of cloning itself. Id. Korobkinaddresses the ban in light of the Commerce Clause, the right to receive medical treatment, andreproductive rights. See id. at 75-91 (discussing constitutionality of cloning ban in light ofcommerce clause, right to medical treatment, and right to reproduce). See infra pp. 5-6 and notes46-56 (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 forstem cell pioneers and balancing them with interests of society).22 See KOROBKIN WITH MUNZER, supra note 1, at 165 (arguing research on tissues from donorsfor 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 (analyzingdefault rules property tights of bodily tissue). The authors argue that common conception ofproperty 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).25 Id.26 Id.

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fellow at the UCLA Center for Society and Genetics. He received his Bachelor of Artsand Juris Doctor degrees at Stanford University.27

Stephen R. Munzer is also a professor of law at the UCLA School of Law and asenior fellow at the UCLA Center for Society and Genetics. 28 He teaches classes in

contracts and property and gives seminars in legal philosophy and biotechnology.29

Professor Munzer is a recipient of the David Baumgart Memorial Fellowship and theBerger 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 Political Theory of Property. Professor Munzinis a graduate of the Univeristy of Kansas (B.A.), Oxford University (B. Phil.) and Yale

University (J.D.).3 1

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

Korobkin argues this position is scientifically illogical and inherently contradictory. 33

27 Id.

28 Id

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

2009).30 See id.31 Id.32 See Address to the Nation on Stem Cell Research from Crawford, Texas, 37 WeeklyCompilation 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 areequal to human beings). Korobkin states that the argument for blastocysts being equal tohumans must rest either on the proposition that embryos are equal to humans because they sharecertain human characteristics or because they have the "potential" to be humans. Id. at 29. Inrefuting the first argument, Korobokin states that a five-day old blastocyst lacks every humancharacteristic other than DNA, and is not an individual because twinning remains possible. Id. at30 - 31. The second argument, though stronger, is equally unpersuasive because of the lack of aconcrete definition of "potential." Id. at 33. One is that there is "potential" because an embryo

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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 embryos-

those 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

protecting blastocysts are appeased, and society is deprived of the benefits of research.35

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 CellResearch 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 becomehuman is still very low, with the likelihood of a bout 20 - 40%, and the complete lack of ability tobecome 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 toprofit from them. Id.35 KOROBKIN WITH MUNZER, supra note 1, at 35 - 36. The policy sweeps too narrowly for theneeds 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 tosociety's chances to benefit from stem cell research. Id. at 37.36 See Stem Cell Research Enhancement Act of 2005, H.R. 810, 109th Congress § 2 (2005)(allowing stem cell research on discarded embryos created for IVF). The bill, after passing in theHouse and Senate, was vetoed by Bush and Congress failed to gather enough support to overridethe veto. KOROBKIN WITH MUNZER, supra note 1, at 43.37 KOROB3KIN WITH MUNZER, supra note 1, at 45 (referencing Stem Cell Research EnhancementAct of 2005, H.R. 810, 109th Cong. § 2 (2005). IVF clinics maximize the potential of success bycreating as many embryos as possible, and the result are thousands of extra embryos that willultimately be destroyed. Id. at 46.38 See KOROBKIN WITH MUNZER, supra note 1, at 45 (arguing Congress' distinction equalsarbitrary 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 DickeyAmendment, Pub. L. No. 104-99, § 128 (1995). Congress has renewed the Dickey Amendmentevery year since it was created in 1995. See KOROBKIN WITH MUNZER, supra note 1, at 27(explaining the Dickey Amendment).

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the top. '39 Korobkin's position is simple: society needs more stem cell research and

government attempts to appease the moral constituency are detrimental to society. 40

Korobkin best exemplifies the federal government's misunderstood andunreasonable aversion to stem cell research by describing the government's response toa 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, leavingthe other seven intact.42 The governmental response was extremely negative.43

Members of Congress attacked the method as morally wrong, and stated that seven-

celled embryos were less healthy and an extracted cell had human potential. 44 Inarguing 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

research of President Bush and his allies." 45

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, Korobkinstates that Congress' attempt to allow for research on discarded embryos wh-ilc blatantly ignoringthe 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 FederalGovernment's policy on stem cell research).41 KOROBKIN WITH MUNZER, supra note 1, at 57 (describing ground-breaking method discoveredby scientist Robert Lanza).42 KOROBKIN WITH MUNZER, supra note 1, at 57.43 See KOROBKIN WITH MUNZER, supra note 1, at 59 (describing unexpected overwhelmingopposition to Lanza's method from the Federal Government). Emily Lawrimore, a White Housespokeswoman, stated: "[a]ny use of human embryos for research purposes raises serious ethicalconcerns. This technique does not resolve all those concerns." Nicholas Wade et al., In NewMethodfor Stem Cells, Viable Embryos, N.Y. TIMES, Aug. 24, 2006, at Al.44 See KOROBKIN WITH MUNZER, supra note 1, at 60 (pointing out Senatorial Response to Lanza'sdiscovery). Senator Sam Brownback equated the method to creating twins and then killing oneof them. Id.45 KOROBKIN WITH MUNZER, supra note 1, at 60.46 See KOROBKIN WITH MUNZER, supra note 1, at 74-79 (discussing cloning in light of theCommerce Clause); id. at 79-85 (arguing constitutional right to receive medical treatment mayprotect some cloning practices against government interference); id. at 85-91 (arguing cloning

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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

regulation.5

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 personalmedicinal use was valid under the commerce clause. 545 U.S. 1, 26 (2005). The majority basedtheir decision on the government's right to control activities that have a substantial effect oninterstate commerce, and argued that there was a substantial market for marijuana supported bythe very practices undertook by the defendant in Raich. Id. at 17 - 24. This line of reasoningcomes from the depression era case, Wickard v. Filburn, 317 U.S. 111, 129 (1942), where theSupreme Court held that the Commerce Clause supported a statute governing the amount ofwheat an individual could grow in their back yard because of the aggregate amount of wheat thatends 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 thatcloned embryos may not be considered "commodities" because there is no legal or illegal marketfor them, unlike marijuana or wheat. Id. Alternatively, Korobkin states that a court mightnarrow its finding to prohibit only cloning for commercial purposes as opposed to cloning forresearch. 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 reasonseven if true motivation is to correct moral wrong). Korobkin states that, under Heart ofAtlanta, acourt could use interstate commerce reasons to ban cloning, while really banning the practice formoral 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 regulatorypower ought to place judgments about the ethics of cloning in the states' bailwick, along with theregulation 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).

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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

protect the practice as a fundamental right.57 The third argument for the

constitutionality of cloning concerns an individual's fundamental right of reproduction.58

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, 530U.S. 913, 938 (2000) (holding partial birth abortion ban unconstitutional for lack of exception topreserve mother's health); Planned Parenthood v. Casey, 505 U.S. 833, 878 (1992) (holding statelaws cannot create "undue burden" for women exercising abortion rights).55 See Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 445 F.3d470, 479-483 (D.C. Cir. 2006) (holding terminally ill patients have fundamental right to accesspotential life saving drugs not approved by FDA). But see Abigail Alliance for Better Access toDevelopmental 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 unapproveddrags for terminally ill patients).56 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, butrecognizes that access to therapeutic cloning may not yet be considered life saving medicine, as itis still in its early stages.57 See KOROBKIN WITH MUNZER, supra note 1, at 84-85 (citing lack of history for right to narrowpractice 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 havefundamental right of procreation); Skinner v. Oklahoma, 316 U.S. 535, 541 (1942) (holdingprocreation 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 ofreproductive 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 childrenfrom 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

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Economic Incentives for Researchers and Taxpayers

Chapter four, co-authored by Stephen R. Munzer, begins with an informativeexplanation 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 fromusing 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 itcreates 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 andMunzer 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

other methods license-free. 63

In setting forth the legal grounds for a stem cell patent, Korobkin and Munzerentertain the possibility that individuals may be unable to patent stem cell methods

under the "product of nature" doctrine.64 This doctrine prohibits patenting a naturalphenomenon 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 wouldbecome 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'sbroad patent on the research community). WARF allows breaks to academic institutions butcharges 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 97-98. 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 bedetrimental to research due to lack of compensation).63 See KOROBKIN WITH MUNZER, supra note 1, at 103-104 (arguing for happy medium of patentclaims for benefit of society and researchers alike). Korobkin and Munzer argue that WARFshould 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 developtheir own for free. Id. This allows for the best financial return for WARF and level of researchfor society. Id.64 See 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 "Hewho discovers hitherto unknown phenomenon of nature has no claim to a monopoly of it.').

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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

interpreted this safe harbor, and it may protect certain methods of stem cell research.68

Korobkin discusses another economical issue in chapter five-how taxpayers

should benefit from government-funded stem cell research. Under California's

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

65 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

information about manufacturing drugs). This safe harbor was created to allow drug

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

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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 encouragedto 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 reversedAmerica's "slide into industrial irrelevance").73 See KOROBKIN WITH MUNZER, supra note 1, at 133 (discussing recent criticism that Bayh-DoleAct inhibits beneficial communication among researchers). Korobkin argues that thetransactions costs that go along with obtaining protected information can ultimately bedetrimental to research, and therefore California should not have simply assumed that mirroringthe 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 linebased on how expensive a product will cost to patent, which affects how much people are willingto 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 withlittle or no further investment needed for development. Id. at 136. "Applied Products,"however, are substantially more expensive to develop, requiring large amounts of money andtime before they produce a financial return." Id. According to Korobkin, the risk and money ofdeveloping an "applied" product is on a private corporation, and thus they should be rewardedwith 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 researchersto place their own interest over the public's interest). Korobkin suggests a number of revenue-sharing alternative agreements such as providing in-kind revenue sharing as opposed to solelycash compensation. Id. at 150.77 KOROBKIN WITH MUNZER, supra note 1, at 150. Korobkin states that CIRM, in allowinggrantees 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.

VOL. V NO. 1


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

erring on the side of informed consent.81

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

Cafornia,83 the California Supreme Court held that researchers must disclose their

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 acceptedprinciples 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 publicstudies, mandates that researchers to disclose any and all material information to subjects about astudy prior to receiving informed consent. Id. at 155. Korobkin explains common rule andinformed 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 researchthat falls outside the reach of the common rule, which is called non-therapeutic research. Id. at158. This research, as opposed to therapeutic research, is not conducted with the goal ofbenefiting 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 norexperimenting 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).

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entirely on professional judgment.8 4 Recent authority states, however, that non-

therapeutic research settings, like stem cell research, do not require disclosure of

financial interests. 85 The Greenbeqg court justified this position when ruling on a non-

therapeutic 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

84 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 researchwithout direct contact with the subject because the facts in Moore contained a therapeutic ordirect relationship between subject and researcher. KOROBKIN WITH MUNZER, supra note 1, at161-162.85 See Greenbe, 264 F. Supp. 2d at 1070-1071 (holding no requirement for non-therapeuticresearchers to disclose financial interests).86 KOROBKIN WITH MUNZER, supra note 1, at 162. Korobkin believes that the Greenber case isdirectly on point because it involved a researcher without a therapeutic relationship with thedonors. Id. In Greenberg, however, the court distinguished non-therapeutic donors as distinctfrom 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, 264F. Supp. 2d. at 1070-1071.87 See KOROBKIN WITH MUNZER, supra note 1, at 162 -163 (arguing against reasoning in Greenberg).Korobkin states that disclosure of financial interest would not chill medical research unlesssubjects had a moral opposition to donating tissues to researchers that seek profits, and while it isunlikely, 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 todecide 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 intereststo non-therapeutic voluntary cell donors); see id. at 168-169 (arguing informed consent should berequired 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 researchon dually donated embryos).

VOL. V NO. 1


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 low-

income sectors of the economy, and we risk ignoring the needs of the less fortunate. 93

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) (prohibitingcash 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-OD-02-007.html (prohibiting inducements, monetary or otherwise, for embryo donations). A numberof states that support stem cell research have made no-compensation rules for donation oftissues 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 orimprisonment buying any organ or "subpart" for transplant); UNIFORM ANATOMICAL GIFT ACT5 6(a) (1987) (prohibiting selling body parts for transplants or therapy, omitting research).91 See KOROBKIN WITH MUNZER, supra note 1, at 180-181 (distinguishing NOTA and UAGA aspotentially inapplicable to stem cell tissue donations for research). Korobkin argues that neitheract 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, haveexplicitly banned tissue sales. Id. The free purchase and sale of gametes for IVF purposes inmany states, according to Korobkin, See id. at 183-190 (arguing monetary compensation for tissuewould not create involuntary and coerced donations); Id. at 190-195 (stating anti-commodifcationarguments unfairly equates tissues to human beings); see id. at 195-203 (arguing compensation willnot 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 no-compensation rule).94 See KOROBKIN WITH MUNZER, supra note 1, at 184 (making free will argument forcompensation for donors). Korobkin views the choice of money for tissue as another positivechoice that will be afforded to individuals, and prohibiting this choice is detrimental. Id. at 184-185. Simply because a choice is made pursuant to monetary inducement does not make thechoice ill-informed. Id. at 185.

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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 andtradeoffs). "Coal mining is unpleasant, often dangerous, and correlated with a reduction inlifespan. These facts rarely lead to suggestions that society should leave the task of coal miningto 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 structuresto account for certain costs, in-kind compensation similar to IVF or blood donations. Id. at 204-205. Finally, Korobkin points out that no-compensation rules for transplants are to preventbidding 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 derivedimproper conclusion from Moore). Korobkin states that the common rule and informed consentgrant 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 compeldefendant to donate life saving bone marrow to plaintiff); National Organ Transplant Act of1984, 42 U.S.C. §§ 273, 274 (2005) (granting right to donate renewable or non-necessary organswhile 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 adefault 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 Korobkinargued that the majority's failure to address the issue implied a default rule to the contrary. Id. at216. See also Moore, 793 P.2d. at 501 (Broussard, J., dissenting) (recognizing property rights inplaintiffs emanated spleen). See Hecht v. Superior Court, 20 Cal. Rptr. 2d. 275, 281-284 (Cal. Ct.

VOL. V NO. 1


In Greenberg, the court had the opportunity to clarify this issue, but only produced moreconfusion. 10 2 Thus, with scant legal authority, Korobkin opts for a weak no-compensation default rule, which would allow courts to liberally interpret the intentionsof a donor in favor of compensation.'0 3 Korobkin's thorough and thoughtful analysis ofcurrent law implies confusion on the part of courts and scholars alike, which pushes thereader towards his sensible and informed solution.

In the final chapter, we learn about Molly Nash and the practice of PGD ingeneral.104 Korobkin notes that new reproductive technologies like PGD have outpacedlegal regulation in the United States, but that such practices are regulated abroad.105 Inthe 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 thatsaved Molly Nash's life, but other children have not been so lucky.'0 7 The HFEA makesa 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 newhuman being, the practice would be morally wrong and illegal. Korobkin argues thisstrict Kantian analysis-that one person should not be used solely to benefit another-

App. 1993) (holding decedent sperm donor had ownership interest in donated sperm held insperm bank).102 See Greenberg, 264 F. Supp. 2d. at 1066-1067 (defaulting to no-compensation despitecontractual language to contrary). Korobkin points out in inherent inconsistency in this decisionin that the court recognized the defendant's unjust enrichment and expressly recognizing thatdefendant accepted a benefit without compensating. KOROBKIN WITH MUNZER, supra note 1, at218.103 See KOROBKIN WITH MUNZER, supra note 1, at 219 (setting forth benefits of weak defaultrule). Korobkin believes that language indicating a benefit to the donor should be liberallyinterpreted or read into the contract to inhibit against subtle offers or representations byresearchers 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 236.107 See R v. Human Fertilisation and Embryological Auth., [2005] UKHL 28 (House of Lords2005) (affirming right of couple to use PGD to create donor child). But see KOROBKIN WITHMUNZER, supra note 1, at 236-237 (2007) (explaining case of Charlie Whitaker). In the case ofCharlie Whitaker, the HFEA denied a family's application to use PGD to save a three year oldchild 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 distinctionbetween using an embryo solely for the benefit of a living child or for the simultaneous benefit ofthe embryo. Id. In cases like that of Molly Nash, PGD is justified because the practice creates ahigher probability that the child will be born without disease. Id.

2009


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 pro-

stem cell research position. Furthermore, he uses the unique factors of stem cell

research to narrow the breadth of potential legal obstacles. When Korobkin

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

109 KOROBKIN 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 theKantian analysis; the first is that even acceptable PGD entails killing embryos with diseases, andthus 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.

VOL. V NO. 1


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 thisbreakthrough technology. On March 9, 2009, President Barack Obama signed anexecutive order that granted federal funding for stem cell research.1 12 This is a step inthe right direction for stem cell research and supporters, however, as Stem Cell Centuyexplains, it is not a solution to the myriad of obstacles society faces in realizing the

benefits of stem cell research.

112 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/ST200903090-1104.html (describing Executive Order to grant federal funding to stem cell research). The ordergave the National Institutes of Health 120 days to resolve moral concerns and set guidelines toassess candidates for funding. Id.

2009