By

Dr. Anthony G. Payne

One of the arguments advanced against utilizing embryonic stem cells in research and ultimately therapy for various diseases and maladies is a moral or ethical one: Many people view viable human life as beginning with the union of sperm and egg. By this definition, a scientist who employs an embryo - even at the earliest stages of development (blastocyst) - is essentially engaged in harvesting and exploiting viable human life (The stem cells are extracted and the blastocyst or such is oftentimes dispensed with).

 There is compelling scientific as well as ethical arguments to the contrary. But for people whose faith tradition or religious perspective views the fusion of sperm and egg as marking the advent of a human life, these do not satisfy them nor disabuse them of the belief that even a zygote (egg + sperm) is viable human life.

 Beliefs predicated on faith that are not testable lie outside the purview of science. For example, the religious concept that every human has a soul or spirit imputed by the Almighty at conception or thereafter is not something that can be tested and verified or refuted using the tools of science. There is no laboratory assay that will disclose or measure something that is held to have no material substance as we know it and which is not physically manifest in cells or tissues or such.

 For religionists who hold that ensoulment (i.e., spirit is imputed) occurs at conception, and (who) refuse to consider even slightly modifying this perspective in light of contrary biological evidence or ethical reasoning, there exists an impasse that cannot be readily breeched (If at all). And when enough people embrace such a spin on what constitutes viable human life, their collective influence on the direction federally funded research takes in a democracy will be very manifest (Some would argue disproportionately so). This is clearly the case here in the United States.

 Many scientists regard the convictions of those who hold that viable human life begins at conception or during the very early stages of development as both presumptuous and naive. Many religionists and theologians agree. Among those who happen to hold fast to a belief that a fertilized egg is entitled to full status as a viable human, the use of blastocytes or very early stage embryos constitutes a species of murder. Some even go so far as to decry those who take exception to their faith-based beliefs as being immoral or amoral.

 Does the truth lie somewhere between the strictly secular and the sacred? Most of us probably harbor a feeling that somewhere in all this - lurking in the facts of biology and the world of polemics and logic, ethics and religion - there is an answer that will win the day. If this is the case, it is quite obviously going to take time for such a truth to fully emerge.

 Many have asked me, “What is your spin on what constitutes viable human life?” Being as I have a foot in both worlds - which is to say religious belief and science - it seems logical to suppose that I would be able to offer up a “faith and science-friendly” definition of when viable human life begins. Well, yes, I do have something to offer up for consideration. And here it is - informed by biology, of course.

 The heart begins beating at three weeks of gestation and the first neural reflex is manifest at eight weeks (and consists of hand withdrawal in response to stimulation of the fetal lip region). During weeks 9-13 the first brain waves appear and are discernible using special medical instrumentation.

 Given that death is defined (in part) as a cessation of both heart and brain wave activity, one could argue conversely that to be alive in any meaningful sense beyond mere biological existence (Potential life begins when both heart and brain are operational - (Week 9 onwards).

 Interestingly, according to Orthodox Jewish teachings the fetus generally becomes a viable human life after day 40 of gestation [As Jewish history, ethics and religious principles influenced the development of both Christianity and Islam, its teachings should be carefully weighed by adherents of both faith traditions]. In the ancient Jewish context, the fetus is deemed to be little more than water until “quickening” occurs, about 40 days after insemination. “What Do Orthodox Jews Think About Abortion and Why? By Judith Shulevitz - Orthodox Jews on Abortion If we take week 9 as our bench mark -- the heart and brain being recognizably functional - then the fetus would be deemed viable from about day 63 onward.

 Applying this definition of when human life becomes viable, it follows that embryos from conception to week 9 or so are “pre-viable” or “proto-viable.”

 Now is this to say that embryos prior to week 9 are “fair game”? Say, that we can create embryos strictly for the purposes of harvesting their stem cells? These embryos aren’t viable, so why not? Well this brings us full circle to religious and ethical concerns. Rather than belabor that in this op-ed piece, I would direct readers to an excellent treatment of this subject in this posted article: Jewish Virtual Library - Abortion

 OK, so we don’t create embryos to harvest, how about using intentionally aborted fetuses as a source of embryonic stem cells? As one fellow actually said to me, “Hey, Doc, they are going to die anyway, so why not get some good out of them for sick and ailing people”. To my mind, this comes uncomfortably close to the arguments advanced by physicians and scientists who performed hideous experiments on human subjects in Nazi concentration camps. This very line of reasoning was, in fact, used as a defense by some of the physicians being tried for war crimes in the 1946 “Doctor’s Trail” in Germany). Granted, there is a world of difference between an abortion by consent and the intentional dispatch of life at the hands of doctors (such as the late Nazi “Angel of Death” Dr. Josef Mengele and his ilk) who abandoned universally acknowledged medical ethics in the service of the state; But even so, harvesting aborted fetuses from any source does strike many folks in America as constituting a form of callous utilitarianism. And even if the intentional abortion of a fetus before week 9 were universally embraced as morally and ethically acceptable - in no way offensive to humankind or the Almighty - there remains something hauntingly “predatory” about utilizing material from intentionally terminated “pre-viable” human material.

 Moving on, what about extracting stem cells from fetuses that are spontaneously aborted? This is probably a more acceptable alternative to that of taking stem cells from intentionally aborted fetuses to many folks, provided one can show that the stem cells coming from such a fetus are not defective (Genetic abnormalities cause many spontaneous abortions.) This is not yet easy to do, which would lend most of us to take a “better safe than sorry tactic” -- use these cells only when they can be declared free of genetic defect with great confidence.

 Clearly, resolving the question of exactly when viable human life begins will not make doing embryonic stem cell research here in America as easy and straightforward as some imagine it would be. And even if we could resolve or set aside every conceivable moral or ethical difficulty connected with using embryos tomorrow morning, it will be quite some time before the safety issues and technical challenges surrounding embryonic stem cells are adequately addressed and resolved or surmounted. Until then, embryonic stem cells must remain confined to laboratory and clinical research. No doubt FDA approval for specific clinical applications is a decade or more down the road. A few scientists are now mentioning timeframes of a quarter century or more.

 So while we as a society continue to grapple with the moral and ethical concerns, and scientists try to work out matter of safety and efficacy, many folks who might be helped by stem cell therapy must wait. Unfortunately, for many suffering Americans their window of opportunity to stabilize and even reverse or cure their health challenges will pass them by. This has resulted in scores of ailing people leaving US shores and undergoing experimental treatments with stem cell-rich embryonic or fetal material or stem cells in clinics abroad (In countries where stem cell therapy is legal, such as Costa Rica, Mexico, and such). See For Those Considering Doing Stem Cell Therapy Abroad

 I can and do fully sympathize with people who have intractable conditions or incurable illnesses or such who elect to take their changes on getting some manner of improvement from embryonic stem cell therapy in foreign lands. My concern lies in the realm of safety issues. Will today’s palliative, curative or even restorative embryonic stem cell treatment result in something more insidious cropping up a few years down the line? Is relief from the anguishing symptoms of advanced progressive MS or some other neurological disease over the short-term really worth it if one (say) winds up with an embryonic stem cell therapy-spawned tumor in a vital organ in a year or two or so? At what level is the risk acceptable? Is a 1 in 20 chance of developing complications or worse in time an acceptable risk level? Is a 1 in 10 risk acceptable? How about 1 in 5?

 Is there an alternative to embryonic? There are, after all, two other kinds of stem cell available: Adult and umbilical cord.* Adult stems cells been employed to successfully treat many diseases and conditions. However, there appear to be many limitations associated with using adult stem cells. For one thing, they are often present in only minute quantities and are often difficult to isolate and purify. But stem cell-rich umbilical cord blood provides a ready source of stem cells that can be readily isolated and expanded. Human umbilical cord stem cells (hUCSC) also boast an impressive clinical pedigree: Stem cell-rich cord blood has been successfully employed to combat many intractable and even terminal illnesses for more than 20 years now. And by-and-large, very few folks so treated went on to develop a secondary illness or such due to the umbilical cord blood treatment. This track record suggests that the safety margin is substantial. This said, some scientists argue that cord blood stem cells are eliminated by the recipient's immune system and by virtue of this it is wiser to look to stem cells taken from a patient's own tissues or blood (Autologous à  from self). 

This brings us to autologous bone marrow and the stem cells it contains. Bone marrow has been harvested and used by doctors for quite some time to treat various diseases including various forms of cancer and some autoimmune diseases. The established approach often involves chemoablation (chemo eradication) of the patient's own bone marrow followed by an infusion of healthy stem cells extracted from the marrow sample. The infused stem cells then migrate to the bones where they create new marrow. Of course, with autologous stem cell therapy there is zero risk of rejection.

More recently, stem and progenitor (precursor) cells are extracted from a patient’s bone marrow, expanded in the lab, transformed (differentiated) into whatever cell type (say a heart cell) that is needed to confer clinical benefit, then infused into the patient by IV drip,  catheter,  direct implantation into an organ or specific tissue,  or such.  As this approach involves manipulating the marrow, the FDA requires doctors doing this here in the USA to obtain an IND (Investigational New Drug permit), usually as part of a formal clinical study.

There are countries outside the US which allow greater latitude in terms of what doctors doing stem cell medicine can do with stem cells derived from bone marrow as well as other sources. Mexico is one.   As a result, many suffering people are having stem cell therapy abroad.

 Clearly many suffering people need a shot at improvement or clinical benefit that only stem cell therapy is likely provide. Ethical, safety and technical challenges are immense when it comes to embryonic stem cells and thus takes them out of the picture -- for now. Adult stem cells do not carry the ethical baggage true of embryonic, but appear to have limits in terms of the kinds of cells they can be transformed into (For instance, some umbilical cord stem cells can be transformed into neuron-like cells in the lab – but not full-fledged neurons). This said, some recent advances in technology and lab methodology is pushing the envelope in terms of what can be done with adult stem cells, i.e., some adult stem cells can be programmed to zero in on specific tissues, etc. 

 Until and if such time as “We the people” reach a consensus on the question of when viable human life begins and reach an accord on assorted other ethical issues connected with the use of embryonic material, this plus the unanswered safety and technical challenges will no doubt keep embryonic stem cell therapy a distant hope for quite some time to come (At least here in the states). Thankfully, we have an apparently safe, less controversial alternative in adult stem cells harvested from allogenic (non-self) sources such as umbilical cord blood, and autologous (self) ones such as fat tissue and bone marrow. 

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 *There are also induced pluripotent stem cells – iPS--- stem cells with embryonic-like characteristics created from liver, skin or other somatic cells in the laboratory. As the first such iPS was created only recently (2007) and typically involves inserting or manipulating specific genes, it is unlikely that these will be used in humans in the US or the EU for many years to come. This said -- experimental use of iPS in adults with terminal and intractable diseases & conditions for which modern medicine has little to offer is reportedly being pursued in Mexico, China and a few other countries. At least one private foreign stem cell operation has licensed US patent pending technology and lab methods for transforming somatic cells into iPS cells using recombinant proteins alone (No viruses). This approach appears to produce very safe pluripotent stem cells. Animal safety studies are in-progress.    

 Readers interested in learning more about the safety issues that surround the use of embryonic stem cells should visit STEM CELL RESEARCH.ORG , specifically STEM CELL RESEARCH.ORG - QUOTES.

 Stem cell basics from the National Institutes of Health: NIH STEM CELL BASICS

 Dr. Anthony G. Payne can be readily reached by e-mail at DrAGPayne@yahoo.com

 

 

© 2009 by Dr. Anthony G Payne. All rights reserved.

 

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