The Reality of Research
BY Daniel Kuebler
Jan. 1-14, 2012 Issue | Posted 12/21/11 at 5:50 PM
Ever since the first human embryonic stem-cell lines were established in 1998, the Catholic Church has maintained that this type of research was ethically unacceptable. The fact that such research requires the creation and subsequent destruction of human life makes it a non-starter for the Church, which has continually upheld and defended the sanctity and value of human life in all its forms. Unfortunately, the Church’s opposition to this research has exposed it to harsh criticism from those who would paint the Church as an institution bent on holding back the tide of scientific progress.
Yet, if one were to stack up all the clinical studies demonstrating either the safety or possible therapeutic benefits of embryonic stem-cell (ESC) therapies and compare this to the track record of adult stem-cell therapies, there would be no contest. ESC therapies have yet to make it out of the garage, while clinical applications of morally acceptable adult stem cells are reported in the scientific literature regularly.
Despite the evidence to the contrary, ESC research supporters confidently claim that ESC therapies will be the wave of the future. It may take longer to get these therapies to the clinic, they argue, but once they arrive, miraculous cures will abound. As optimistic as these supporters are, recent developments in ESC research illustrate the folly of these beliefs. In addition, they lay waste to the claim that the Church is holding back true scientific progress.
The first development of note comes from research done at the New York Stem Cell Foundation Laboratory. In what was widely heralded as a landmark breakthrough in the ESC field, researchers were able, for the first time, to derive embryonic stem cells from cloned human embryos. Up until this point, human embryonic cells had been derived mainly from in vitro fertilized embryos. Cells derived from in vitro fertilized embryos are genetically unique and, therefore, inserting such cells into a patient would involve the risk of tissue rejection. Deriving ESCs via cloning would theoretically overcome this drawback and allow the production of ESCs that are a genetic match to the patient.
The procedure used to produce cloned embryos, known as somatic cell nuclear transfer, involves taking the nucleus from an adult cell — in this case, a skin cell — and inserting it into an unfertilized egg. The egg is then tricked to think that it has been fertilized, and it begins to develop in a dish through the first few days of normal human development.
At around five days, the embryo reaches the stage called a blastocyst. Once it reaches this stage, it is killed in order to harvest and grow the embryonic stem cells that it contains. The key point with this type of procedure is that the developing embryo is genetically identical to the person who donated the skin-cell nucleus — it is a clone of that individual. As a result, the stem cells derived from this embryo are a genetic match to the donor and can be used therapeutically in that person without the risk of his or her immune system rejecting them.
Until these researchers published their results, no one had been able to do this with human cells. Despite years of effort, no one could get cloned embryos to develop to the stage at which ESCs could be harvested. This recent “breakthrough” led one researcher to comment that “the findings validate this controversial method and may one day allow therapeutic stem cells to be created from a patient’s own genetic material.”
That, at least, is what the embryonic stem-cell research supporters would have you believe. The truth of the matter is that this study neither validated the method, nor did it get researchers any closer to the therapeutic use of such cells. It turns out that in order to get the cloned embryos to develop long enough to actually harvest stem cells from them, the researchers had to leave the genetic material of the egg in the clone. As a result, the cloned cells had three copies of genetic material, one from the egg and two from the donor nucleus, as opposed to the two copies that are normally present in our cells.
There is no possible therapeutic use for cells that have three copies of genetic material. Such triploid cells would be even more unstable, harder to control and even more likely to develop tumors than normal diploid ESCs. All that the researchers demonstrated was that they could produce genetically aberrant ESCs via this process, hardly a scientific breakthrough.
The only real breakthrough of this study, if you could call it that, is the manner in which the researchers obtained the eggs they needed to perform their experiments. In the past, researchers had to get women to donate eggs for free (something that rarely, if ever, happens) or they had to resort to using excess eggs that were leftover after in vitro treatments. ESC researchers have long lamented the fact that these leftover eggs were of poor quality. They argued that, to advance the field, they needed better quality eggs — and the only way to do that was to pay women for them.
In 2010, that is exactly what the New York board overseeing that state’s stem-cell research fund decided to do. In fact, it approved payments of up to $10,000 to women who donated eggs for ESC research. And the researchers who published this “breakthrough” study took advantage of this new protocol to get fresher, better eggs.
Amongst the scientific community, there seems to be little concern that the procedure used to harvest the eggs is inherently risky to the women involved. Over 10% of women who undergo this procedure experience what is known as ovarian hyperstimulation syndrome (OHSS). In mild cases, OHSS involves abdominal pain and nausea, but in severe cases, it can lead to infertility and even death.
Yet the New York board ignored the inherent danger of enticing women with large sums of cash to undergo such a risky elective procedure. Even in the aftermath of this research, ESC supporters have downplayed this possibility. One commentator claimed that there was no undue enticement in this study because all the women who donated eggs where fully employed. Really? Is it too difficult to imagine an employed person who might be swayed to do something risky for $10,000?
The truth is that such commonsense concerns about the undue enticement of women donors must be swept under the rug because obtaining fresh eggs for scientifically dubious research is much more important than the health of a few women. What?
Given all the efforts to keep this research going, one might think the field was poised to take off. For all the hype, one would be excused for believing that ESC researchers stand poised at the brink of major, exciting therapeutic breakthroughs. Instead, the opposite is occurring: ESC research seems to be stuck in neutral, and the reason has everything to do with the scientific and economic realities of ESC research and little to do with political or ethical pressure.
Over the past few years, companies interested in pursuing ESC research have seen venture capital funding for this research disappear because of the lack of any promising therapeutic uses. Geron Corp., a biotech leader in this field, is a case in point. Geron, the first company to get FDA approval for a clinical trial using ESCs, recently announced that it would move out of the ESC field entirely. This move was prompted by the fact that its ESC clinical trial for spinal-cord injuries, which was delayed repeatedly because of safety issues, found that no therapeutic benefits were associated with the treatment. Financially, it made no sense to pursue these costly studies, given the probability that there would be no payoff in terms of marketable therapies.
The most ironic aspect of this whole situation is that — for years — ESC supporters have criticized the Church’s stance on ESC research as anti-science or just one more example of the Church being out of touch with reality. Yet it has been the Catholic Church that, from the start, has promoted adult stem-cell therapies, the only stem-cell therapies that have displayed any type of therapeutic benefit. In fact, these scientifically tested therapies have already reached the clinic and have benefitted a multitude of patients.
The Church has been so supportive of this ethical research and its scientific promise that it has even begun to support it financially, as the Register has reported in these pages. In 2010, the Vatican donated roughly $3 million to support researchers who were looking at the therapeutic benefits of adult intestinal stem cells. In 2011, the Vatican donated $1 million to develop a partnership with an adult stem-cell company called NeoStem. Just this past November, it organized a conference on adult stem cells that brought together leading scientists and ethicists to promote and facilitate research in this area.
The Church, from the start, has thrown its complete support behind the ethically sound, scientifically viable and therapeutically successful adult stem-cell field. Its critics continue to bull-headedly throw their support behind ESC research that is so ethically problematic and scientifically suspect that it is being abandoned in droves by biotech companies and investors alike. Who is it, then, exactly, that is out of touch with reality?
Daniel Kuebler, Ph.D., is a biology professor at Franciscan University in Steubenville, Ohio.
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