On June 5th, the Trump administration announced extreme restrictions on lifesaving medical research. Under the administration’s new policy, researchers at the National Institutes of Health (NIH) have been forced to halt any research that utilizes human fetal tissue acquired from elective abortions. Additionally, funding for this type of research has become far more difficult for scientists outside of the NIH to obtain. While this was a win for some, it was a dark day for science and medicine, and thus for humankind.
Since the 1930s, human fetal tissue has been a key component of many studies aiming to create vaccines against, or treatments for serious and life-threatening human diseases. Fetal tissue has been involved in research for the understanding of, and/or formulation of treatments for: Alzheimer’s, Parkinson’s, DiGeorge syndrome, diabetes, heart disease, eye disorders, birth defects, infectious diseases, cancers, HIV/AIDS, premature birth, rheumatoid arthritis, cystic fibrosis, hemophilia, and more. Fetal tissue has also been used to understand human development, test the quality of lab-grown kidneys, and generate vaccines used to protect against polio, measles, chickenpox, hepatitis A, and rabies.
In order to really understand the significance of fetal tissue research, it may help to get into some of the details of its impact. Let’s start with some examples of its contribution to infectious disease prevention. Chickenpox and polio are two examples of highly contagious and once common infectious diseases. While chickenpox manifests itself as itchy, blister-like rashes that cover the body, polio infects human brains and spinal cords which results in paralysis. During the early 1990s, chickenpox caused about 4 million cases, 10,600 hospitalizations and 100-150 deaths each year. As for polio, the disease paralyzed more than 350,000 people in the world each year by 1988. Since vaccination against these diseases began, incredible improvements have been made. For chickenpox, there has been a 90% decrease in annual deaths, an 84% decrease in hospitalizations, and 92% fewer cases. For polio, incidents have dropped by more than 99% and, in 2017, it was estimated that greater than 16 million people had been saved from paralysis. Fetal tissue was key for the development of the polio vaccine and is still used today to produce the chickenpox vaccine.
More recent research applications of fetal tissue include using it to generate mice with humanized immune systems. These mouse models allow researchers to study an immune system that is far more representative of the one found in humans, but in an ethical, controlled, and substantive way. At the University of California, San Francisco (UCSF), these mice were created to study HIV and test potential cures. HIV is responsible for one of the world’s most grave health complications: AIDS. As of 2017, there were approximately 36.9 million people worldwide suffering from AIDS, with 1.8 million of these individuals falling under the age of 15. In 2017 alone, the lives of 940,000 people were claimed by AIDS-related illnesses. Fetal tissue is integral to the research being done by UCSF, but these scientists lost their funding in June because of the Trump administration’s new restrictions.
Fetal tissue has also proven valuable in the study of human birth defects. Carolyn Coyne, at the University of Pittsburgh School of Medicine, studies the placenta—a fetal tissue organ produced during pregnancy. One of its roles is to protect the human fetus from viral infection. Some viruses have the ability to cause severe birth defects or death in the developing fetus. For example, congenital Zika syndrome is found in fetuses and babies that were infected by the Zika virus during pregnancy. This syndrome manifests as microcephaly, which is characterized by decreased brain tissue, brain damage, damage to the back of the eye, and restriction of body movement. By studying healthy human placentas, researchers have gained a much greater understanding of how the placenta protects the human fetus against viral infections and why some viruses are able to bypass the placental barrier. Coyne’s lab identified placental cell types that potently restrict viral infections. Additionally, they recently uncovered the pathways that the Zika virus may use to cross the placenta, allowing it to reach and attack fetal brain cells. With decreased access to fetal tissue, critical research on birth defects will forcibly be slowed or discontinued and very young lives will regrettably suffer the consequences.
Discussed thus far are just a few examples of how fetal tissues have contributed to medicine. While this type of research has shown both success and promise in science and medicine, it naturally raises a number of ethical considerations. Opponents of fetal tissue research are primarily concerned about fetal welfare and respect for human life. From the moment a woman discovers she is pregnant to the time at which a researcher receives tissue from her aborted fetus, there are several entities that could potentially participate in ethical wrongdoing if appropriate regulations are not in place.
The typical process is as follows: the woman decides she would like to get an abortion and gives informed consent for this procedure. The woman gives informed consent for the fetal tissue to be used in research (if she chooses to). The abortion procedure takes place, and the tissue is transferred to a biotech company. The company processes, prepares and freezes the tissue in liquid nitrogen until a researcher orders the tissue for a study. Throughout this process, it is imperative that unethical conduct is prevented and, for this reason, federal law places restrictions on each step of the process.
First and foremost, it is against the law for any fetal tissue to be acquired, received or accepted by anyone if the pregnancy was initiated with the intent that the fetus would be aborted and its tissues used in research. Second, it is illegal for any entity to offer inducements, whether monetary or otherwise, in order to incite the termination of a pregnancy. By law, a woman who decides to go through with an abortion must come to this decision without being bribed or manipulated by clinicians, technicians, biotech companies, researchers, or others. In fact, valuable consideration offered by any entity and at any step of the process—from the decision to go through with an abortion to the retrieval of tissue by a research lab—is illegal. Put simply, it is illegal for anyone to profit in any way from fetal tissue.
Besides the typical process of fetal tissue research described above, it is also possible for tissue obtained from abortions to be donated for the purpose of transplantation into another human for therapeutic intentions. If this is to be the fate for a particular fetal tissue, it is against the law for the female donor to have any knowledge of the identity of the recipient and she cannot place any restrictions on which individual receives the tissue. The woman needs to sign a statement addressing her knowledge that the fetal tissue is being donated for therapeutic transplantation research and that she is unaware of and had no role in who the recipient was. Additionally, the attending physician must sign a similar statement, ensure that the tissue was obtained in accordance with the donor’s signed statement, and confirm that he or she obtained the woman’s consent for abortion prior to requesting or procuring consent for the use of the fetal tissue in research. Furthermore, it is illegal for the clinician to alter the time, method or procedure used for the abortion in order to collect the tissue in time for a particular study.
A final key regulation is that the researcher who will be using the fetal tissue in a study is not allowed to decide when or how the pregnancy is to be terminated and must certify this in writing. Thus, regulations are in place to oversee those involved at any and all steps of the fetal tissue research process, which could assuage the concerns for fetal welfare that some feel when it comes to this form of research.
Not only does federal law enforce restrictions like those described, it also mandates that individuals involved throughout steps of the fetal tissue research process are monitored by administrative bodies called the Institutional Review Boards (IRBs). The IRBs ensure that people are acting in compliance with federal requirements, approve or disapprove all research activities, require research modifications when necessary, and more. If ethical or legal misconduct occurs, the situation will be investigated by the government and those who are guilty will incur punishment like fines or imprisonment.
Given the great variety of benefits provided to medicine and humankind by fetal tissue research, and the comprehensive federal regulations already in place, the Trump administration’s new restrictions only seem detrimental. This new policy will slow critical lifesaving research and will leave science, medicine, and society burdened by its consequences. Meanwhile, it seems that this policy is not really a “win” for anyone—not for scientists, pro-life or pro-choice advocates, healthcare, fetuses, and certainly not for those suffering from potentially preventable or treatable diseases or their loved ones. A better policy would have been one that solely required an increase in research dedicated to discovering fetal tissue-alternatives, without the restrictions placed on current fetal tissue research. This would be a worthwhile endeavor as with time and progress, fetal tissue use could potentially decrease in several areas of research. However, not only are we not ready to cut that research so significantly at this point in time, but for some areas of fetal tissue research, alternatives will not exist. While the Trump administration announced its support of investigating potential alternatives, this motion combined with the new restrictions do not balance out in favor of humankind.
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