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Fetal tissue research: an ongoing story of professionally responsible success
Viewpoint
ajog.org
OBSTETRICS
Fetal tissue research: an ongoing story of professionally responsible success Shari E. Gelber, MD, PhD; Laurence B. McCullough, PhD; Frank A. Chervenak, MD
Introduction Procuring fetal tissue for research and treatment has recently become politically controversial in the United States.1,2 The result has been to obscure professional responsibility in this matter, which has been a disservice to the medical community and the patients who can and do benefit from resulting medical advances. In this commentary we explain why the use of fetal tissue for research and treatment should not be controversial but, instead, viewed as a professionally responsible success story. A brief history of fetal tissue research and treatment The 1954 Nobel Prize in Physiology or Medicine was awarded to John Enders, Thomas Weller, and Frederick Robbins for the discovery of the ability of poliomyelitis viruses to grow in cultures of various types of tissue. Although great progress had been made in fighting bacterial infections in the prior decades, viruses were difficult to cultivate. Preventive or therapeutic agents were therefore mostly unattainable. Although animal models are informative for many diseases, viruses are often species specific, so nonhuman studies were often not informative. As early as the 1930s, Olitsky et al3 had attempted to grow poliovirus in cultures of chick, mouse, monkey, and human embryo cells. Only the human brain tissue from embryos that were the product of induced abortion was successful as a host. This line of research was continued by Enders et al4 who found that the virus could be grown in cells from numerous embryonic tissue types in addition to neurons. Ultimately, these advances in human embryo-derived viral culture advanced the field and led to the ability to cultivate varicella, measles, and numerous other viruses. This research was instrumental in the ability to produce viruses to study and develop vaccines. Without such research, the polio vaccine and other vaccines may not have been developed or may have been delayed by decades.5 From the Department of Obstetrics and Gynecology, Weill Medical College of Cornell University, New York, NY (Drs Gelber and Chervenak) and Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX (Dr McCullough). Received Aug. 23, 2015; revised Sept. 17, 2015; accepted Sept. 22, 2015. This study was supported by departmental funds. The authors report no conflict of interest. Corresponding author: Shari E. Gelber, MD, PhD. [email protected]. edu 0002-9378/$36.00 ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2015.09.079
Although the teratogenicity of congenital rubella was known since the 1940s,6,7 progress in understanding the disease and developing vaccines only came later, when research was undertaken on embryonic and fetal tissue from patients who opted for termination because of acquisition of rubella in pregnancy. The tissue from those aborted embryos and fetuses was used both to purify virus and to understand viral host reactions.8 Research using cadaveric fetal tissue led to the development of the rubella vaccine and the subsequent elimination of congenital rubella in the Americas, thereby decreasing the need for induced abortion due to congenital rubella. More recently, fetal tissue became a cornerstone of some of the most promising therapies for Parkinson disease and other difficult-to-treat adult conditions. More than 100 patients with Parkinson disease have received cells transplanted from the midbrain of aborted embryos.9-12 Initial studies indicated that the patients most likely to benefit were young, had early-stage disease, and had large numbers of cells of fetal origin integrated. Those studies were used to help design a new trial of 150 patients in Europe. Although there is hope that pluripotent stem cells may provide an alternative in the future, “right now the fetal cell is the gold standard we need to match.”12 Cadaveric fetal tissue benefits scientific research across many fields, including physicians and scientists who may not even realize its contribution to their work. The HEK293 cell line originated from the kidney cells of an aborted embryo.13 Due to the ease of transfection, and the subsequent ease of production and purification of human proteins, they have become ubiquitous in research. A PubMed search for “HEK293” reveals >28,000 articles. Studies in the American Journal of Obstetrics and Gynecology in areas as diverse as preeclampsia, fetal drug exposure, and placental gene transfer also utilized this cell line.14-16 The cell line can be purchased from repositories. Protein production can also be outsourced to companies that maintain these cell lines and will transfect and purify the protein of interest. These cells have been used in the development and production of therapeutics.17 Induced abortion before viability is legally permissible in the United States18 Induced abortion before viability authorized by the pregnant woman’s informed consent is permissible in professional obstetric ethics.19 It is well understood that the informed consent process should convey evidence-based information about the medically reasonable alternatives for managing a previable pregnancy, the biopsychosocial benefits and risks of each alternative, and the disposition of the fetal cadaver.20 DECEMBER 2015 American Journal of Obstetrics & Gynecology
819
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ajog.org
Obstetrics
Discussion of procurement of tissues or organs from the fetal cadaver, which may or may not be intact, is not part of the informed consent process for induced abortion. Indeed, concern that the benefit of research may encourage women to choose induced abortion led to the 1988 fetal tissue transplantation panel to recommend that tissue donation not be addressed until after the decision to terminate.1 In fact, the oversight of fetal tissue research is carried out in the same way as other human subjects research. The Department of Health and Human Services has clear rules: 45CFR 46.204 (i): “Individuals who use fetal tissue in their research will have no part in any decisions as to the timing, method, and procedures used to terminate the pregnancy, and (j) “individuals engaged in the research will have no part in determining the viability of a neonate.”21 Attestation that the researchers will adhere to these guidelines is part of the prospective review process for obtaining permission to do such research. In fact, the practice of procuring fetal tissue for research with consent is consistent with professional responsibility18 as the patient has a right to assert her value-based preference. Deidentified tissue from surgical procedures is used routinely in research without consent. By obtaining consent for use of fetal tissue in research we are adding additional protections. This is a level of respect for women that is not required in other spheres of medicine. Once a patient has independently made her informed decision to authorize induced abortion, it is reasonable to present her with the opportunity to consider authorizing procurement of tissues and organs from the fetal cadaver for purposes of research and treatment. Those who agree may do so from diverse motivations. Some women may find value in the knowledge that donating organs and tissues may benefit other patients from research and treatment using such tissues. This is an expression of a common motivation for participation in research of all kinds: altruism. This is analogous to the value that parents find in donating organs and tissues after a child has been determined to be dead. There is no evidence that the potential for societal benefit causes patients to choose termination of pregnancy or that research on fetal tissue causes abortion. Any claims to the contrary are pure speculation. Moreover, neither the woman nor her physician derives financial benefit from authorizing procurement of fetal tissues, thus removing incentives to act on financial selfinterest that could bias the decision-making process.
The justice-based obligation to tolerate what one judges to be morally impermissible Even though induced abortion is permissible both in law and professional obstetric ethics,20 some regard induced abortion to be ethically impermissible, usually on theological grounds. Those who do not share this moral conviction are nonetheless obligated to respect the fact that those with such moral convictions are sincere. Individuals who regard induced abortion to be morally impermissible but live in a society in which it is legally available sometimes regard themselves as 820 American Journal of Obstetrics & Gynecology DECEMBER 2015
having to tolerate what is ethically intolerable or even evil. This belief should also be respected. These beliefs, however, are not the whole of ethical reflection on how to live with mutual respect in a morally pluralistic society. As has been argued in the case of human embryonic stem cell research, the ethical issue that needs to be addressed is not the morality of abortion but whether this ethical burden of tolerating what one sincerely believes to be morally impermissible should be regarded as unacceptable to those who have to bear this burden.22 This ethical issue should be addressed using the justicebased concept of exploitation. Fairness in society requires the prevention of exploitation, ie, circumstances in which one group is unduly burdened, another group benefits, and the burdened group does not have the opportunity to experience these benefits. Justice requires that burdens be distributed so that those who are burdened have the opportunity for offsetting benefit. As no one is compelled to have an induced abortion or to authorize procurement of cadaveric fetal tissue, individuals who have theological objections to induced abortion can decline to take part. While some may object to living in a society that requires them to tolerate cadaveric fetal tissue being used in research, this burden is offset by the benefit to society in the form of improved clinical care for millions of patients and the advancement of biomedical research with the potential for such benefit. In fact, those who object to what they judge to be the evil of induced abortion, and their children, benefit from fetal tissue research. Because they experience significant offsetting clinical benefit, they should not be considered exploited. That is, one can be morally burdened by procurement and use of cadaveric fetal tissue and not be exploited. The objection that some are unacceptably morally burdened in this way is therefore not determinative because, in the absence of exploitation, there is a justice-based obligation to tolerate what one considers to be morally impermissible.
Conclusion The procurement of cadaveric fetal tissue for research and treatment is legally permitted and regulated and is supported by professional responsibility in obstetrics and gynecology. Those who object on the grounds that induced abortion is ethically impermissible for theological reasons deserve recognition of and respect for the seriousness of their moral convictions. However, these individuals are not exploited by the procurement and clinical and research use of cadaveric fetal issue. Such procurement is therefore supported by the ethical principle of justice. The success story of cadaveric fetal tissue research and treatment should continue unhindered, to fulfill professional responsibility to current and future patients. REFERENCES 1. Charo RA. Fetal tissue fallout. N Engl J Med 2015;373:890-1. 2. Topulos GP, Greene MF, Drazen JM. Planned Parenthood at risk. N Engl J Med 2015;373:963.
ajog.org 3. Olitsky PK, Sabin AB, Cox HR. An acquired resistance of growing animals to certain neurotropic viruses in the absence of humoral antibodies or previous exposure to infection. J Exp Med 1936;64: 723-37. 4. Enders JF, Weller TH, Robbins FC. Cultivation of the Lansing strain of poliomyelitis virus in cultures of various human embryonic tissues. Science 1949;109:85-7. 5. Nobel Foundation. Presentation speech: Nobel Prize in Physiology or Medicine 1954. Nobel Lectures, Physiology or Medicine 1942-1962. Amsterdam (United Kingdom): Elsevier Publishing Company; 1954: 443-7. 6. McAllister GN. Rubella during pregnancy of the mother with its sequelae of congenital defects in the child. M J Australia 1945;1:313. 7. Berman W. Report of a survey of children born in 1941 with reference to congenital normalities arising from maternal rubella. Am J Obstet Gynecol 1949;58:198-9. 8. Alford CA Jr, Neva FA, Weller TH, Kanich LS, Giraldi LM. Virologic and serologic studies on human products of conception after maternal rubella. N Engl J Med 1964;271:1275-81. 9. Freed CR, Zhou W, Breeze RE. Dopamine cell transplantation for Parkinson’s disease: the importance of controlled clinical trials. Neurotherapeutics 2011;8:549-61. 10. Lindvall O, Brundin P, Widner H, et al. Grafts of fetal dopamine neurons survive and improve motor function in Parkinson’s disease. Science 1990;247:574-7. 11. Freed CR, Breeze RE, Rosenberg NL, et al. Survival of implanted fetal dopamine cells and neurologic improvement 12 to 46 months after transplantation for Parkinson’s disease. N Engl J Med 1992;327: 1549-55. 12. Abbott A. Fetal-cell revival for Parkinson’s. Nature 2014;510:195-6.
Obstetrics
Viewpoint
13. Graham FL, Smiley J, Russell WC, Nairn R. Characteristics of a human cell line transformed by DNA from human adenovirus type 5. J Gen Virol 1977;36:59-74. 14. Zhang Y, Diao Z, Su L, et al. MicroRNA-155 contributes to preeclampsia by down-regulating CYR61. Am J Obstet Gynecol 2010;202: 466.e1-7. 15. Smith JA, Gaikwad A, Mosley S, et al. Utilization of an ex vivo human placental perfusion model to predict potential fetal exposure to carboplatin during pregnancy. Am J Obstet Gynecol 2014;210:275. e1-9. 16. Katz AB, Keswani SG, Habli M, et al. Placental gene transfer: transgene screening in mice for trophic effects on the placenta. Am J Obstet Gynecol 2009;201:499.e1-8. 17. Swiech K, Picanço-Castro V, Covas DT. Human cells: new platform for recombinant therapeutic protein production. Protein Expr Purif 2012;84:147-53. 18. McCullough LB, Chervenak FA. Ethics in obstetrics and gynecology. New York (NY): Oxford University Press; 1994. 19. Chervenak FA, McCullough LB, Brent RL. The professional responsibility model of obstetric ethics: avoiding the perils of clashing rights. Am J Obstet Gynecol 2011;205:515.e1-5. 20. Chervenak FA, McCullough LB. An ethically justified practical approach to offering, recommending, performing, and referring for induced abortion and feticide. Am J Obstet Gynecol 2009;201:560.e1-6. 21. OHRP, OFHRP, HHS, USDOHAHS. Code of Federal Regulations. Title 45 Public Welfare Department of Health and Human Services. Part 46 protection of human subjects. 2009 Aug 22:10. 22. Chervenak FA, McCullough LB. How physicians and scientists can respond responsibly and effectively to religiously based opposition to human embryonic stem cell research. Fertil Steril 2008;90:2056-9.
DECEMBER 2015 American Journal of Obstetrics & Gynecology
821
Viewpoint
Obstetrics Supplemental Materials
ajog.org
ABSTRACT
Fetal tissue research: an ongoing story of professionally responsible success Therapies derived from fetal tissue research are some of the greatest success stories in medicine. Research using fetal tissue has allowed for development of vaccines for numerous diseases including polio, rubella, and measles. These vaccines have saved countless lives, improved quality of life, and decreased the need for induced abortion secondary to congenital infection. Research using cell lines derived from fetal tissue has assisted in better understanding disease pathogenesis and has served to produce human proteins as research reagents and therapies. Ongoing research points to the potential for fetal tissue to be used to cure debilitating diseases such as Parkinson disease. These scientific and medical advances are dependent on the use of fetal tissue from aborted fetuses. While the practice of induced abortion despite societal benefit may be theologically objectionable to some, these practices are professionally responsible. Federal regulations exist to
819.e1 American Journal of Obstetrics & Gynecology DECEMBER 2015
discourage patients from being influenced by the societal benefit of fetal research in arriving at the decision to terminate as well as to prevent researchers from influencing a patient’s decision. After a patient has chosen termination of pregnancy, it is consistent with professional responsibility to allow her to choose the disposition of the cadaveric fetal tissue. While some may view induced abortion and societal benefit from this practice as an ethical burden, the principle of justice makes it ethically obligatory to bear this ethical burden. The success story of cadaveric fetal tissue research and treatment should continue unhindered, to fulfill professional responsibility to current and future patients. Key words: fetal tissue, induced abortion, justice, professional responsibility, respect for autonomy, respect for women
ajog.org
OBSTETRICS
Fetal tissue research: an ongoing story of professionally responsible success Shari E. Gelber, MD, PhD; Laurence B. McCullough, PhD; Frank A. Chervenak, MD
Introduction Procuring fetal tissue for research and treatment has recently become politically controversial in the United States.1,2 The result has been to obscure professional responsibility in this matter, which has been a disservice to the medical community and the patients who can and do benefit from resulting medical advances. In this commentary we explain why the use of fetal tissue for research and treatment should not be controversial but, instead, viewed as a professionally responsible success story. A brief history of fetal tissue research and treatment The 1954 Nobel Prize in Physiology or Medicine was awarded to John Enders, Thomas Weller, and Frederick Robbins for the discovery of the ability of poliomyelitis viruses to grow in cultures of various types of tissue. Although great progress had been made in fighting bacterial infections in the prior decades, viruses were difficult to cultivate. Preventive or therapeutic agents were therefore mostly unattainable. Although animal models are informative for many diseases, viruses are often species specific, so nonhuman studies were often not informative. As early as the 1930s, Olitsky et al3 had attempted to grow poliovirus in cultures of chick, mouse, monkey, and human embryo cells. Only the human brain tissue from embryos that were the product of induced abortion was successful as a host. This line of research was continued by Enders et al4 who found that the virus could be grown in cells from numerous embryonic tissue types in addition to neurons. Ultimately, these advances in human embryo-derived viral culture advanced the field and led to the ability to cultivate varicella, measles, and numerous other viruses. This research was instrumental in the ability to produce viruses to study and develop vaccines. Without such research, the polio vaccine and other vaccines may not have been developed or may have been delayed by decades.5 From the Department of Obstetrics and Gynecology, Weill Medical College of Cornell University, New York, NY (Drs Gelber and Chervenak) and Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX (Dr McCullough). Received Aug. 23, 2015; revised Sept. 17, 2015; accepted Sept. 22, 2015. This study was supported by departmental funds. The authors report no conflict of interest. Corresponding author: Shari E. Gelber, MD, PhD. [email protected]. edu 0002-9378/$36.00 ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2015.09.079
Although the teratogenicity of congenital rubella was known since the 1940s,6,7 progress in understanding the disease and developing vaccines only came later, when research was undertaken on embryonic and fetal tissue from patients who opted for termination because of acquisition of rubella in pregnancy. The tissue from those aborted embryos and fetuses was used both to purify virus and to understand viral host reactions.8 Research using cadaveric fetal tissue led to the development of the rubella vaccine and the subsequent elimination of congenital rubella in the Americas, thereby decreasing the need for induced abortion due to congenital rubella. More recently, fetal tissue became a cornerstone of some of the most promising therapies for Parkinson disease and other difficult-to-treat adult conditions. More than 100 patients with Parkinson disease have received cells transplanted from the midbrain of aborted embryos.9-12 Initial studies indicated that the patients most likely to benefit were young, had early-stage disease, and had large numbers of cells of fetal origin integrated. Those studies were used to help design a new trial of 150 patients in Europe. Although there is hope that pluripotent stem cells may provide an alternative in the future, “right now the fetal cell is the gold standard we need to match.”12 Cadaveric fetal tissue benefits scientific research across many fields, including physicians and scientists who may not even realize its contribution to their work. The HEK293 cell line originated from the kidney cells of an aborted embryo.13 Due to the ease of transfection, and the subsequent ease of production and purification of human proteins, they have become ubiquitous in research. A PubMed search for “HEK293” reveals >28,000 articles. Studies in the American Journal of Obstetrics and Gynecology in areas as diverse as preeclampsia, fetal drug exposure, and placental gene transfer also utilized this cell line.14-16 The cell line can be purchased from repositories. Protein production can also be outsourced to companies that maintain these cell lines and will transfect and purify the protein of interest. These cells have been used in the development and production of therapeutics.17 Induced abortion before viability is legally permissible in the United States18 Induced abortion before viability authorized by the pregnant woman’s informed consent is permissible in professional obstetric ethics.19 It is well understood that the informed consent process should convey evidence-based information about the medically reasonable alternatives for managing a previable pregnancy, the biopsychosocial benefits and risks of each alternative, and the disposition of the fetal cadaver.20 DECEMBER 2015 American Journal of Obstetrics & Gynecology
819
Viewpoint
ajog.org
Obstetrics
Discussion of procurement of tissues or organs from the fetal cadaver, which may or may not be intact, is not part of the informed consent process for induced abortion. Indeed, concern that the benefit of research may encourage women to choose induced abortion led to the 1988 fetal tissue transplantation panel to recommend that tissue donation not be addressed until after the decision to terminate.1 In fact, the oversight of fetal tissue research is carried out in the same way as other human subjects research. The Department of Health and Human Services has clear rules: 45CFR 46.204 (i): “Individuals who use fetal tissue in their research will have no part in any decisions as to the timing, method, and procedures used to terminate the pregnancy, and (j) “individuals engaged in the research will have no part in determining the viability of a neonate.”21 Attestation that the researchers will adhere to these guidelines is part of the prospective review process for obtaining permission to do such research. In fact, the practice of procuring fetal tissue for research with consent is consistent with professional responsibility18 as the patient has a right to assert her value-based preference. Deidentified tissue from surgical procedures is used routinely in research without consent. By obtaining consent for use of fetal tissue in research we are adding additional protections. This is a level of respect for women that is not required in other spheres of medicine. Once a patient has independently made her informed decision to authorize induced abortion, it is reasonable to present her with the opportunity to consider authorizing procurement of tissues and organs from the fetal cadaver for purposes of research and treatment. Those who agree may do so from diverse motivations. Some women may find value in the knowledge that donating organs and tissues may benefit other patients from research and treatment using such tissues. This is an expression of a common motivation for participation in research of all kinds: altruism. This is analogous to the value that parents find in donating organs and tissues after a child has been determined to be dead. There is no evidence that the potential for societal benefit causes patients to choose termination of pregnancy or that research on fetal tissue causes abortion. Any claims to the contrary are pure speculation. Moreover, neither the woman nor her physician derives financial benefit from authorizing procurement of fetal tissues, thus removing incentives to act on financial selfinterest that could bias the decision-making process.
The justice-based obligation to tolerate what one judges to be morally impermissible Even though induced abortion is permissible both in law and professional obstetric ethics,20 some regard induced abortion to be ethically impermissible, usually on theological grounds. Those who do not share this moral conviction are nonetheless obligated to respect the fact that those with such moral convictions are sincere. Individuals who regard induced abortion to be morally impermissible but live in a society in which it is legally available sometimes regard themselves as 820 American Journal of Obstetrics & Gynecology DECEMBER 2015
having to tolerate what is ethically intolerable or even evil. This belief should also be respected. These beliefs, however, are not the whole of ethical reflection on how to live with mutual respect in a morally pluralistic society. As has been argued in the case of human embryonic stem cell research, the ethical issue that needs to be addressed is not the morality of abortion but whether this ethical burden of tolerating what one sincerely believes to be morally impermissible should be regarded as unacceptable to those who have to bear this burden.22 This ethical issue should be addressed using the justicebased concept of exploitation. Fairness in society requires the prevention of exploitation, ie, circumstances in which one group is unduly burdened, another group benefits, and the burdened group does not have the opportunity to experience these benefits. Justice requires that burdens be distributed so that those who are burdened have the opportunity for offsetting benefit. As no one is compelled to have an induced abortion or to authorize procurement of cadaveric fetal tissue, individuals who have theological objections to induced abortion can decline to take part. While some may object to living in a society that requires them to tolerate cadaveric fetal tissue being used in research, this burden is offset by the benefit to society in the form of improved clinical care for millions of patients and the advancement of biomedical research with the potential for such benefit. In fact, those who object to what they judge to be the evil of induced abortion, and their children, benefit from fetal tissue research. Because they experience significant offsetting clinical benefit, they should not be considered exploited. That is, one can be morally burdened by procurement and use of cadaveric fetal tissue and not be exploited. The objection that some are unacceptably morally burdened in this way is therefore not determinative because, in the absence of exploitation, there is a justice-based obligation to tolerate what one considers to be morally impermissible.
Conclusion The procurement of cadaveric fetal tissue for research and treatment is legally permitted and regulated and is supported by professional responsibility in obstetrics and gynecology. Those who object on the grounds that induced abortion is ethically impermissible for theological reasons deserve recognition of and respect for the seriousness of their moral convictions. However, these individuals are not exploited by the procurement and clinical and research use of cadaveric fetal issue. Such procurement is therefore supported by the ethical principle of justice. The success story of cadaveric fetal tissue research and treatment should continue unhindered, to fulfill professional responsibility to current and future patients. REFERENCES 1. Charo RA. Fetal tissue fallout. N Engl J Med 2015;373:890-1. 2. Topulos GP, Greene MF, Drazen JM. Planned Parenthood at risk. N Engl J Med 2015;373:963.
ajog.org 3. Olitsky PK, Sabin AB, Cox HR. An acquired resistance of growing animals to certain neurotropic viruses in the absence of humoral antibodies or previous exposure to infection. J Exp Med 1936;64: 723-37. 4. Enders JF, Weller TH, Robbins FC. Cultivation of the Lansing strain of poliomyelitis virus in cultures of various human embryonic tissues. Science 1949;109:85-7. 5. Nobel Foundation. Presentation speech: Nobel Prize in Physiology or Medicine 1954. Nobel Lectures, Physiology or Medicine 1942-1962. Amsterdam (United Kingdom): Elsevier Publishing Company; 1954: 443-7. 6. McAllister GN. Rubella during pregnancy of the mother with its sequelae of congenital defects in the child. M J Australia 1945;1:313. 7. Berman W. Report of a survey of children born in 1941 with reference to congenital normalities arising from maternal rubella. Am J Obstet Gynecol 1949;58:198-9. 8. Alford CA Jr, Neva FA, Weller TH, Kanich LS, Giraldi LM. Virologic and serologic studies on human products of conception after maternal rubella. N Engl J Med 1964;271:1275-81. 9. Freed CR, Zhou W, Breeze RE. Dopamine cell transplantation for Parkinson’s disease: the importance of controlled clinical trials. Neurotherapeutics 2011;8:549-61. 10. Lindvall O, Brundin P, Widner H, et al. Grafts of fetal dopamine neurons survive and improve motor function in Parkinson’s disease. Science 1990;247:574-7. 11. Freed CR, Breeze RE, Rosenberg NL, et al. Survival of implanted fetal dopamine cells and neurologic improvement 12 to 46 months after transplantation for Parkinson’s disease. N Engl J Med 1992;327: 1549-55. 12. Abbott A. Fetal-cell revival for Parkinson’s. Nature 2014;510:195-6.
Obstetrics
Viewpoint
13. Graham FL, Smiley J, Russell WC, Nairn R. Characteristics of a human cell line transformed by DNA from human adenovirus type 5. J Gen Virol 1977;36:59-74. 14. Zhang Y, Diao Z, Su L, et al. MicroRNA-155 contributes to preeclampsia by down-regulating CYR61. Am J Obstet Gynecol 2010;202: 466.e1-7. 15. Smith JA, Gaikwad A, Mosley S, et al. Utilization of an ex vivo human placental perfusion model to predict potential fetal exposure to carboplatin during pregnancy. Am J Obstet Gynecol 2014;210:275. e1-9. 16. Katz AB, Keswani SG, Habli M, et al. Placental gene transfer: transgene screening in mice for trophic effects on the placenta. Am J Obstet Gynecol 2009;201:499.e1-8. 17. Swiech K, Picanço-Castro V, Covas DT. Human cells: new platform for recombinant therapeutic protein production. Protein Expr Purif 2012;84:147-53. 18. McCullough LB, Chervenak FA. Ethics in obstetrics and gynecology. New York (NY): Oxford University Press; 1994. 19. Chervenak FA, McCullough LB, Brent RL. The professional responsibility model of obstetric ethics: avoiding the perils of clashing rights. Am J Obstet Gynecol 2011;205:515.e1-5. 20. Chervenak FA, McCullough LB. An ethically justified practical approach to offering, recommending, performing, and referring for induced abortion and feticide. Am J Obstet Gynecol 2009;201:560.e1-6. 21. OHRP, OFHRP, HHS, USDOHAHS. Code of Federal Regulations. Title 45 Public Welfare Department of Health and Human Services. Part 46 protection of human subjects. 2009 Aug 22:10. 22. Chervenak FA, McCullough LB. How physicians and scientists can respond responsibly and effectively to religiously based opposition to human embryonic stem cell research. Fertil Steril 2008;90:2056-9.
DECEMBER 2015 American Journal of Obstetrics & Gynecology
821
Viewpoint
Obstetrics Supplemental Materials
ajog.org
ABSTRACT
Fetal tissue research: an ongoing story of professionally responsible success Therapies derived from fetal tissue research are some of the greatest success stories in medicine. Research using fetal tissue has allowed for development of vaccines for numerous diseases including polio, rubella, and measles. These vaccines have saved countless lives, improved quality of life, and decreased the need for induced abortion secondary to congenital infection. Research using cell lines derived from fetal tissue has assisted in better understanding disease pathogenesis and has served to produce human proteins as research reagents and therapies. Ongoing research points to the potential for fetal tissue to be used to cure debilitating diseases such as Parkinson disease. These scientific and medical advances are dependent on the use of fetal tissue from aborted fetuses. While the practice of induced abortion despite societal benefit may be theologically objectionable to some, these practices are professionally responsible. Federal regulations exist to
819.e1 American Journal of Obstetrics & Gynecology DECEMBER 2015
discourage patients from being influenced by the societal benefit of fetal research in arriving at the decision to terminate as well as to prevent researchers from influencing a patient’s decision. After a patient has chosen termination of pregnancy, it is consistent with professional responsibility to allow her to choose the disposition of the cadaveric fetal tissue. While some may view induced abortion and societal benefit from this practice as an ethical burden, the principle of justice makes it ethically obligatory to bear this ethical burden. The success story of cadaveric fetal tissue research and treatment should continue unhindered, to fulfill professional responsibility to current and future patients. Key words: fetal tissue, induced abortion, justice, professional responsibility, respect for autonomy, respect for women