CLONING INFORMATION

Letter Requesting Massachusetts Look Into Advanced Cell Technology's Actions Related to Cloning

Christian Legal Society

November 29, 2001

VIA FACSIMILE AND
REGULAR MAIL

Dear Gentlemen:

The undersigned write to request that you investigate possible past, present, and/or future violations of Massachusetts law by researchers at Advanced Cell Technology, Inc. (ACT), located in Worcester County, Massachusetts¹, who announced on Sunday that after a year of work they had created human embryos through cloning². Questions remain about the bona fides of their success³, but ACT experimenters Jose B. Cibelli, Robert P. Lanza and Michael D. West⁴ represented that the results of their experimentation "were, to our knowledge, the first human embryos produced using the technique of nuclear transplantation, otherwise known as cloning⁵."

According to its report, ACT used two methods to create clones. In the first, "it took a total of 71 eggs from seven volunteers before we could generate our first cloned early embryo. Of the eight eggs we injected with cumulus cells [found in ovaries], two divided to form early embryos of four cells-and one progressed to at least six cells-before growth stopped⁶." In another set of experiments, "we also sought to determine whether we could induce human eggs to divide into early embryos without being fertilized by a sperm or being enucleated [removing their nucleus] and injected with a donor cell⁷." With this second approach, "After five days of growing . . . six eggs had developed into what appeared to be blastocysts, but none clearly contained the so-called inner cell mass that yields stem cells⁸."

The researchers announced their purpose for this experimentation as follows: "We intended to isolate human stem cells from the blastocysts [embryos at 4 to 5 days after conception] to serve as the starter stock for growing replacement nerve, muscle and other tissues that might one day be used to treat patients with a variety of diseases⁹." ACT has already "forged partnerships with a number of prestigious labs to use therapeutic cloning to cure diseases in animals¹⁰." "Human embryonic stem cells could, in theory, grow into any of the body's tissues and organs, and the company wants to provide them as replacement cells to patients suffering from any of a wide variety of diseases¹¹."

ACT researchers admit that "we are continuing our therapeutic cloning experiments to generate cloned or parthenogenetically produced human embryos that will yield stem cells¹²." The experimenters' continuing research protocol provides, "No embryo created by means of N[uclear] T[ransfer] technology may be maintained beyond 14 days of development¹³." Alternatively, ACT's extraction of stem cells from the early embryos would itself be "a process that destroys the embryos¹⁴."

Based on the foregoing public record and a review of Massachusetts law, we believe that the past, present, and/or future conduct of ACT experimenters involving the destruction of cloned human embryos and planned transfer of extracted stem cells of cloned human embryos could be deemed a violation of Massachusetts law.

M.G.L. Chap. 112, § 12J(a)(IV) provides: "No person shall knowingly sell, transfer, distribute or give away any fetus for a use which is in violation of the provisions of this section. For purposes of this section, the word 'fetus' shall include also an embryo or neonate." ACT scientists concede that they are conducting experiments on living human subjects with the specific intent to sell, transfer, distribute or give their constituent parts and/or products of their constituent parts away to third parties. In fact, they assert that the sole objective for their experimentation is to mass produce embryos, then extract their stem cells and other parts to sell, transfer, distribute or give the parts or products of the parts to third parties such as laboratories that would grow human tissue.

We are unaware of any written approval for this procedure provided by an Institutional Review Board or state court. If such an approval has been filed with the office of the District Attorney for the county in which the board acts exists, the undersigned hereby request one copy mailed to the above address or the right to review the same, together with any attached protocol, pursuant to M.J.L. Chap. 112 12J, (a)(VI) and M.J.L. Chap. 66 § 10. The undersigned will reimburse the reasonable expense of any copies.

M.G.L. Chap. 112, § 12J(b)(I) empowers the district attorney for the district where ACT's procedure was performed to file a complaint in the Superior Court if he or she has reasonable grounds to believe, regardless of the IRB's conclusion, that the procedure already performed, being performed, or about to be performed is prohibited under subsection (a). We hereby respectfully request that District Attorney Conte file a complaint pursuant to this section and provide us with notice of the same.

For the following reasons, we also request that Attorney General Reilly and District Attorney Conte investigate and seek judicial review to determine the lawfulness of ACT's activities under the homicide law for any experiments that they have conducted, may be conducting, or will soon conduct that have destroyed or threaten to destroy human embryonic life.

The Massachusetts General Court and the state courts define murder as "[t]he killing of a human being, with malice aforethought¹⁵." Similarly, "[t]he crime of manslaughter imports the taking of human life by an act not justified in law, but without malice aforethought which is necessary to constitute murder¹⁶." Moreover, "[i]n keeping with approved usage, and giving terms their ordinary meaning, the word 'person' is synonymous with the term 'human being'¹⁷."

Thus, as to any purported distinctions among the terms "person," "human life," or "human being," Massachusetts jurisprudence has settled the legal question in the Commonwealth. All of these terms are to refer to the same subject. The use of any one term is not to be construed as an attempt to make what the Supreme Judicial Court has considered "arbitrary" distinctions between persons, human lives, and human beings¹⁸. Thus, for example, "[b]y the use [in a homicide statute] of the term[] 'person' . . . . the Legislature has given no hint of a contemplated distinction between pre-born and born human beings¹⁹."

By their own admission, ACT experimenters have created and plan to continue creating living human embryos in order to destructively extract stem cells from them or, alternatively, terminate the living human embryos after fourteen days. The experimenters claim that they have not yet succeeded at harvesting stem cells, because the embryos they have already created perished before reaching the stage of development at which stem cells are available. Regardless, ACT experimenters concede that they are trying again to clone human life.

If they succeed and harvest stem cells from their creation, then they will kill a (1) living, (2) human (3) being. The experimenters cannot avoid this reality by reclassifying the human embryos as "activated cells²⁰." In Commonwealth v. Cass, the Supreme Judicial Court determined that for common law purposes, "[a]n offspring of human parents cannot reasonably be considered to be other than a human being, and therefore a person, first within, and then in normal course outside, the womb²¹." If the experimenters are correct when they describe their creation as a "human embryo," then their creation "cannot reasonably be considered to be other than a human being," and, therefore, subject to the homicide law's protection.

The General Court has already determined as a matter of public policy in the abortion context that a human child in utero is "the individual human life in existence and developing from fertilization until birth²²." In this respect, Massachusetts joins 29 other states officially recognizing by statute, state convention resolution, or appellate court ruling that "fertilization" or "conception" initiates the life of a human being²³. Indeed, at least eleven states expressly treat the destruction of human embryos outside the abortion context as homicide from the moment of conception²⁴. In the context of cloning, where technologically isolated DNA and cytoplasmic material substitute for sperm, "fertilization" or "conception" must be deemed the point at which fusion occurs, when an experimenter artificially stimulates life by creating a human being capable of becoming an adult if implanted in a woman's uterus. Logic and fairness dictate the inclusion of all human beings, including cloned ones, within the law's protective scope.

Obviously, the United States Supreme Court has removed from the state homicide code's protection certain abortions that destroy human beings in utero²⁵. However, in 1989, the United States Supreme Court upheld the right of states to determine as a matter of state policy "when life begins in a non-abortion context, a traditional state prerogative²⁶." Accordingly, Roe v. Wade and its progeny have no bearing on the lawfulness of ACT's conduct.

In a series of rulings, the Supreme Judicial Court has extended protection from conception forward to prenatal human beings existing outside of the womb. Commonwealth v. Cass found that, where "[m]edical science . . . may provide competent proof as to whether the fetus was alive at the time of the defendant's conduct²⁷," the "infliction of prenatal injuries resulting in the death of a viable fetus, before or after it is born, is homicide²⁸." The Court has yet to address a case under the homicide laws involving the killing of a non-viable human being. However, the Court has considered the question of civil liability in such cases brought under tort law. In Torigian v. Watertown News Co., Inc., the Court allowed for wrongful death recovery for uterine injuries to a nonviable child when the child subsequently is born live, but is unable to survive because of prematurity²⁹. Thus, a nonviable human being must be counted as a "person," as that term is used in the wrongful death statute³⁰. In Payton v. Abbott Labs, the Court ruled that "'[i]f the tortious conduct and the legal causation of the harm can be satisfactorily established, there may be recovery for any injury at any time after conception³¹.'" While in Thilbert v. Milka the Court denied recovery for prenatal injuries to a nonviable child delivered stillborn, its explanation of the grounds for denial inform the debate over the legal status of non-viable humans at the zgyotic or embryonic stages. According to the Court, the wrongful death statute was designed to provide a separate cause of action only to persons capable of maintaining a "separate" or "independent existence³²." Thus, "[t]here is recovery where a child is born alive, regardless of viability at the time of injury, because a 'live person was presently suffering from the injuries'³³."

In light of this jurisprudence, important principles should apply to the determination of the legal status in Massachusetts of cloned human embryos existing ex utero. First, the concept of "person" must be broadly construed, embracing all "human beings" or "human lives." Second, living human beings capable of an "independent existence," regardless of their ability to survive to term or maturity, are subjects of rights in Massachusetts. Thus, any purported ethical distinction between so-called "therapeutic cloning," whereby the cloned human embryo is prevented intentionally from reaching maturity, and "reproductive cloning," whereby the embryo is implanted and brought to term, has no relevance in the legal context. Finally, Massachusetts precedent governing the tortious treatment of embryonic human life that dies after existing outside the womb logically dictates the application of the homicide law to conduct deliberately causing the death of a human embryo created ex utero in an experimental setting³⁴.

On behalf of the interested organizations listed below, I thank you for your attention to our requests and we look forward to your response.

Respectfully submitted,

CHRISTIAN LEGAL SOCIETY

Nathan A. Adams, IV, Ph.D., M.A., Esq.
Chief Litigation Counsel

Cosignatories:

Catholic Alliance, Raymond L. Flynn, President, U.S. Ambassador to the Vatican, Former Mayor of Boston, phone: 617-269-0909.

Christian Medical Association, David Stevens, M.D., President, P.O. Box 7500, Bristol, TN 37621; phone: 423-844-1000.

Family Research Council, Connie Mackey, Vice President of Government Affairs, 801 G Street, N.W., Washington, D.C. 20001, phone: 202-393-2100.

Harvard Law School Society for Law, Life, & Religion, Roger Severino, President, HLS Holmes Mail Center,
Cambridge, MA 02138; phone: 617-493-9329, email: rseverin@law.harvard.edu.

Massachusetts Citizens for Life, Anne Scarpato, President, Marie Sturgis, Executive Director, Schrafft Center, 529 Main Street, Charlestown, MA 02129, phone: 617-242-4199.

Massachusetts Family Institute, Ron Crews, Executive Director, 381 Elliot Street, Newton Upper Falls, MA 02464,
phone: 617-928-0800.

Pro-Life Legal Defense Fund, Inc., Philip D. Moran, President, 1150 Walnut Street, Newton, MA 02461, 265 Essex Street,
Suite 202, Salem MA 01970, phone: 978-745-6085.

The Center for Bioethics and Culture, Jennifer C. Lahl, Executive Director, P.O. Box 20760, Oakland, CA 94620,
phone: 510-496-2740 x5874.

The Wilberforce Forum, Nigel M. de S. Cameron, Ph. D., P.O. Box 1550, Merrifield, VA 22116-1550; phone: 847-267-8809.

¹The corporation's website (www.advancedcell.com) lists its mailing address as One Innovation Drive, Biotech Three, Worcester, MA 01605.
²Jose B. Cibelli et al., Rapid Communication: Somatic Cell Nuclear Transfer in Humans: Pronuclear and Early Embryonic Development, 2 e-biomed: J. REGENERATIVE MED (NOV. 26, 2001), available online at www.liebertpub.com/ebi [hereinafter E-biomed Report]; Jose B. Cibelli et al., The First Human Cloned Embryo, SCIENTIFIC AMERICAN (Nov. 24, 2001), available on-line at www.sciam.com/explorations/2001/112401ezzell [hereinafter Scientific American Report].
³See, e.g., Gina Kolata and Andrew Pollack, A Breakthrough on Cloning? Perhaps, or Perhaps Not Yet, N.Y. TIMES A:1, A:12 (Nov. 27, 2001).
⁴The E-biomed Report included additional authors Ann A. Kiessling, Kerrianne Cunniff, and Charlotte Richards.
⁵Scientific American Report, supra note 2.
⁶Id.
⁷Id.
⁸Id.
⁹Id. See also E-biomed Report, supra note 2, at 30 ("[T]he goal is to derive primordial stem cells in vitro, such as embryonic stem cells from the inner cell masses of blastocysts as a source of cells for regenerative therapy.").
¹⁰Joannnie Fischer, Scientists Have Finally Cloned a Human Embryo, U.S. NEWS & WORLD REPORT (Dec. 3, 2001).
¹¹Gina Kolata and Andrew Pollack, A Breakthrough on Cloning? Perhaps, or Perhaps Not Yet, N.Y. TIMES A:1, A:12 (Nov. 27, 2001). See also ACT Press Release (Nov. 25, 2001), available on-line at www.advancedcell.com/pr_11-25-2001.html ( "[I]f the human cells behave as animal cells have in previous studies, we may have found a means of rebuilding the lifespan of cells at the same time. This would allow us to supply young cells of any kind, identical to the patient, that could be used to address the tidal wave of age-related disease that will accompany the aging of the population.")
¹²Scientific American Report, supra note 2.
¹³E-biomed Report, supra note 2, at 27. See also Antonio Regaldo, Experiments in Controversy-Ethicists, Bodyguards Monitor Scientists' Effort to Create Copy of Human Embryo, WALL ST. J. at B1 (July 13, 2001), available on-line at wsj.com ("Dr. West says no embryo will be allowed to develop for more than two weeks.").
¹⁴Antonio Regaldo, Experiments in Controversy-Ethicists, Bodyguards Monitor Scientists' Effort to Create Copy of Human Embryo, WALL ST. J.at B1 (July 13, 2001).
¹⁵M.G.L. Chap. 277, § 39 (emphasis added) (determining the construction of words used in indictments); Commonwealth v. Campbell, 375 Mass. 308, 312 (1978) (incorporating identical definition); Commonwealth v. McCauley, 355 Mass. 554, 559 (1969) (same); Commonwealth v. Gricus, 317 Mass. 403, 411 (1944) (observing that when a felony "causes the death of a human being, the killing is with malice aforethought and is murder"). See also Porter v. Sorell, 280 Mass. 457, 461 (1932) construing the Massachusetts wrongful death statutes as civil measures intended "to punish those who through [noncriminal] negligence cause the death of a human being"). ¹⁶Commonwealth v. Demboski, 283 Mass. 315, 322 (1933) (emphasis added). See also Commonwealth v. Simpson, 434 Mass. 570, 590 (2001) (defining involuntary manslaughter as "an unlawful homicide (1) where wanton and reckless conduct causes death, or (2) where an unintentional killing 'result[s] from a battery not amounting to a felony which the defendant knew or should have known endangered human life'") (citation omitted); Commonwealth v. Jackson, 432 Mass. 82, 89 (2000) (referring to felonious conduct "inherently dangerous to human life").
¹⁷Commonwealth v. Cass, 392 Mass. 799, 801 (1984) (construing M.G.L. Chap. 90, § 24G(a)).
¹⁸Cass, 392 Mass. at 801. See also Commonwealth v. Lawrence, 404 Mass. 378, 398 (1988) (Abrams, J., concurring) ("[The defendant] argues that Massachusetts law does not recognize a fetus as a human being for purposes of construing the common law crime of murder. This argument is clearly incorrect in light of Cass, which address not only the vehicular homicide statute but also the common law.").
¹⁹Cass, 392 Mass. at 801.
²⁰Scientific American Report, supra note 2.
²¹Cass, 392 Mass. at 801.
²²M.G.L. Chap. 112, § 12K (providing definitions applicable to abortion statute).
²³The individual state statutes, resolutions and court opinions are listed in Daniel Avila, The Present Standing of the Human Embryo in U.S. Law, 1 NAT'L CATHOLIC BIOETHICS Q. 203, 213 n.55 (2001).
²⁴See Clarke Forsythe, Human Cloning and the Constitution, 32 VALPARAISO U. L. REV. 469, 499 n.136 (1998).
²⁵Roe v. Wade, 410 U.S. 113 (1973); Moe v. Secretary of Admin. & Finance, 382 Mass. 629, 647 (1981).
²⁶Webster v. Reproductive Health Services, 492 U.S. 490, 505 (1989).
²⁷392 Mass. at 806.
²⁸Id. at 807.
²⁹352 Mass. 446 (1967).
³⁰Id. at 449 (construing M.G.L. Chap. 229, § 2).
³¹386 Mass. 540, 563 (1982) (quoting Restatement (Second) of Torts § 869 comment d (1979)).
³²419 Mass. 693, 695-96 (1995).
³³419 Mass. at 695.
³⁴See, e.g., Commonwealth v. Edelin, 371 Mass. 497, 511-12 (1976) (overturning conviction of doctor for death of a child during failed abortion and delivery because there was "no indication that [the defendant] had a living being in his hands" at the time of the alleged homicidal conduct, and "[m]anslaughter assumes the victim was a live and independent person").