Tag Archives: stem cell research

The ethical minefield of stem-cell science

Fr. Thomas Berg: Medical advances show promise, but progress is fraught with dilemmas . . .

Fr. Thomas Berg

Fr. Thomas Berg

For better or worse, the age of regenerative medicine is upon us. The goal is the streamlined and cost-effective production of genetically matched, patient-specific tissues for use in therapies. While still rather elusive, that goal appears attainable by both licit and illicit means.

One morally reprehensible area of stem-cell research deserves special note. Human embryonic stem-cell (hESC) research relies on a procedure in which cells are obtained from six-day-old human embryos (usually donated by assisted fertility clinics), killing the embryos in the process. Those cells are then placed in a culture where they acquire the capacity for indefinite self-replication. They are called “pluripotent,” meaning they can be coaxed to develop into any tissue type.

For far too long, the hype over hESC research drew much attention away from the morally unproblematic field of adult stem-cell research which, unlike hESC research, has a formidable and growing track record for producing a steady stream of clinical trials and patient-ready therapies. There has been a shift of scientific interest and funding away from hESC research and toward morally acceptable approaches.

The hESC field ran into an unprecedented challenge when federal Judge Royce C. Lamberth ruled on Aug. 23 (in Sherley v. Sebelius) that the Obama administration’s guidelines for funding hESC research violate federal law. He placed a temporary injunction on any further federal funding. On Sept. 7, the same court denied the government’s request for a stay of the preliminary injunction pending appeal. Two days later, the Court of Appeals granted an administrative stay of the injunction pending further review. Meanwhile, the merits of the case still remain to be examined before the District Court. In the interim, federal funding of hESC research through the National Institutes of Health (NIH) continues, but prospects of future funding remain questionable.

Fervor over hESC research notably waned in the past year as public frustration over the lack of tangible progress toward long-promised therapies mounted. Most notable was a January 2010 editorial in Investor’s Business Daily, which angrily criticized the California Institute for Regenerative Medicine (CIRM), created in 2004 by popular referendum with a mandate to manage $6 billion of California tax-payer dollars to conduct embryo-destructive research. “Five years after a budget-busting $3 billion was allocated to embryonic stem-cell research,” wrote the editors, “there have been no cures, no therapies and little progress.”

The announcement in 2009 that biotech firm Geron was granted FDA approval for a first-ever clinical trial with human subjects (all spinal cord injury patients) with hESC-derived tissues sparked hardly a blip of interest in the media. But the decision drew criticism of the FDA from scientists who expressed grave concerns for the safety of the human subjects involved in the trial. Since the Geron venture is only a safety trial using a small number of human subjects, it will still take years and further trials to assess whether any actual spinal cord treatment can be derived.

Following that same shift of interest toward more promising areas of research, stem-cell researchers have focused primarily on “induced pluripotent stem cells” or iPSCs for the better part of the past three years. Unlike hESCs, which are obtained by destroying embryos, iPSCs are made directly from adult cells — such as skin cells. Scientists can “reprogram” them to a pluripotent state (much like rebooting a hard drive), rendering them functionally identical to stem cells obtained from embryos.

Much of the iPSC work done to date has regrettably relied on tissues derived from aborted fetuses or has otherwise involved lines of hESC cells. However, it’s certainly possible to accomplish iPSC research in morally licit ways. At the current state of iPSC research, however, it does not remain entirely clear when it will produce therapeutic applications.

As for the human cloning enterprise, while currently somewhat of a scientific sideshow, potential remains for it to go mainstream as a research tool of choice in the field of regenerative medicine.

Once remaining technical obstacles to the successful cloning of human embryos are overcome, it could very well emerge as the technology of choice for specific therapies. Consequently, as we begin 2011, we find ourselves only at the very tip of the iceberg of morally problematic issues that will arise as the broader project of regenerative medicine continues to unfold.

Rev. Thomas V. Berg is a priest in the Archdiocese of New York, member of the New York State Task Force on Life and the Law, member of the Ethics Committee of the Empire State Stem Cell Board, and adjunct professor of Medical Ethics at St. Joseph’s Seminary in Yonkers, N.Y.

Justice served in stem cell case

The blind desire of scientific researchers for embryonic stem cells is distressing . . .

Dr. Edward Furton

Dr. Edward Furton

On Aug. 23, Federal District Judge Royce C. Lamberth blocked President Obama’s 2009 executive order expanding federal funding of embryonic stem cell research.

The decision was a breath of fresh air in an otherwise poisonous environment for abandoned human embryos. The administration appealed, and in September the U.S. Court of Appeals put that injunction on hold while Lamberth reviews the lawsuit itself.

The blind desire of scientific researchers for embryonic stem cells has been one of the more distressing and regrettable developments of our time. Much of the news media seems to applaud this effort, and has used its influence to portray the debate as a struggle between enlightened science and benighted religious believers. How sad!

There is no need for us to kill our fellow human beings in order to make progress in the sciences. Most people know that there are two basic types of stem cells: adult (or perhaps better put, post-natal) and embryonic. Most have also heard that adult cells are generating all the progress in the effort to cure disease. Adult stem cells have been in practical application for decades and have a proven record of success.

Embryonic stem cells do not. The first human trial using embryonic stem cells was just recently approved, though Lamberth’s decision has thrown a legal wrench into the effort, along with the whole cause of embryonic stem cell research. Millions of dollars allocated by the National Institutes of Health for this type of work is up in the air because a judge faced and boldly acknowledged one simple fact: that embryos must first be killed to get their cells.

Lamberth ruled that the use of taxpayer dollars to fund embryonic stem cell research violates the Dickey-Wicker Amendment, a law passed by Congress each year since 1996 that prohibits federal funding for “research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death.” This law reflects the majority view of Americans, who don’t want their tax monies used to support embryo destruction.

The Obama administration had argued that federal funding would not be distributed for the actual killing of the embryo, but only for the research on the cells taken afterwards. This reasoning didn’t fool Lamberth. “Had Congress intended to limit the Dickey-Wicker to only those discrete acts that result in the destruction of an embryo,” he said, “Congress could have written the statute that way. Congress, however, has not written the statute that way, and this Court is bound to apply the law as it is written.”

If you want to make an omelet, you have to break some eggs. Only these are not eggs, but human beings. They result from the union of human sperm and eggs. This isn’t a benighted “religious” view, but standard science. We begin with the scientific fact that human embryos are human beings, and therefore should not be killed.

Of particular interest to Catholics is that the judge’s ruling followed the judgment of the Congregation for the Doctrine of the Faith in its recent Instruction, Dignitas Personae. In paragraph 35, the Congregation discussed the “criterion of independence” often used to defend the use of embryonic stem cell lines.

Some Catholic researchers said that if as they personally didn’t want these embryos destroyed, and weren’t responsible for their death, it would be licit to use the resulting lines. But as the Vatican pointed out, there can be no “radical separation of the act from its subsequent uses and applications.” One’s personal expression of opposition to embryo destruction suffers an immediate contradiction as soon as one willingly makes use of the resulting remains.

The Obama administration had made a similar argument. So long as federal money was not spent on the destruction of the embryo, taxpayers could fund embryonic stem cell research independently — and so without violation of the letter of law.

Remarkably, we have no need for embryonic stem cells today. We have known since 2006 that it’s possible to reprogram adult cells, giving us embryonic-like stem cells that don’t require the destruction of embryos.

These “induced pluripotent stem cells” have essentially the same properties as the embryonic, and so not only the same potential, but also the same problems. These cells tend to grow wildly and often produce dangerous tumors and clumps of tissue. Embryonic stem cells, which induced pluripotent stem cells mimic, are the earliest cells of the human body. They have an inherent drive to produce a variety different cell types. Not surprisingly, when that drive is not regulated by the embryo, they grow unchecked.

But what matters most for us as Catholics is not that adult stem cells are far more successful, or that induced pluripotent stem cells are a viable alternative to the embryonic, but that human life be respected from the moment of conception. Judge Lamberth has recognized that our law demands that respect.

Edward J. Furton, Ph.D., is the director of publications for the National Catholic Bioethics Center.

Vatican calls for moral science

Dignitatas Personae addresses the complex moral issue of stem-cell research . . .

Dr. John Haas

May Catholics use a life-saving product derived from human embryonic stem-cell research? The answer may well be different depending on whether one is a researcher or a patient. The Vatican’s most recent document on bioethics, Dignitas Personae, addresses the question.

“The use of embryonic stem cells or differentiated cells derived from them — even when these are provided by other researchers through the destruction of embryos or when such cells are commercially available — presents serious problems from the standpoint of cooperation in evil and scandal” (DP #32).

Of course, there are no life-saving products that derive from embryonic stem cells. Despite years of hype, the most promising developments in this field have been made using adult stem cells, including the newly discovered induced pluripotent stem cells, which have most of the same properties as the embryonic but do not involve the destruction of embryos. An induced pluripotent stem cell is developed from a fully developed human body cell. Through various complex manipulations, it is reprogrammed and reverts to an earlier stage of development.

Dignitas Personae says the “criterion of independence” is roundly critiqued. Those who claim that the use of embryonic stem cells and their derivatives is permissible so long as someone else destroys the embryo face a contradiction. They cannot pretend to be free of moral responsibility when others commit injustices from which their own research benefits.

During the Clinton administration there was an attempt to get around the ban on federal funding of destructive embryonic stem-cell research (ESCR). The administration proposed making arrangements with scientists in the private sector who would kill the embryos, making the cells obtained through this act available to researchers using federal funds. They appealed to a “criterion of independence.” That might have met the letter of federal laws, but it does not pass the demands of the moral law since it would make those doing research with the federal funds morally complicit in the destruction of human embryos.

Some contend that this is too high a standard, especially for Catholic researchers of good conscience. But the Vatican replies that “the duty to avoid cooperation in evil and scandal relates to their ordinary professional activities.” Dignitas Personae therefore concludes that “there is a duty to refuse to use such ‘biological material’ even if there is no close connection between the researcher and the actions of those who” kill the embryo (#35).

Dr. Edward Furton

Dr. Edward Furton

The problem is only heightened when public law permits and even encourages the destruction of embryonic human life. The written law of the state must follow the unwritten law that God has inscribed into human nature if it is to be a true law that binds us in conscience.

Researchers, it seems clear, are bound not to work with embryonic stem cells, regardless of the good that might result, and despite the distance between the original act of destruction and present use. But does the same restriction apply to those who might benefit from any future lifesaving discoveries that may derive from embryonic stem cell lines?

Here the Vatican does not give a definitive answer, though one is perhaps suggested. The Vatican has stated that parents may make use of certain vaccines that have a distant origin in tissues derived from elective abortions to immunize their children when no other alternative is currently available. This is permissible (when done under protest) in view of the great goods of life and human health. This same reasoning may apply more broadly to those in the health care profession who need to be protected against the transmission of disease while engaged in their important work. Indeed, there are grounds for supposing that when the goods of health and life are at risk, the use of these products on a temporary basis (until such time as alternatives are available) is generally permissible for anyone in need of them.

This line of reasoning may apply to therapeutic products that result from ESCR, though there are some important differences between the two cases. For example, the vaccine case differs from that of research with human embryonic stem cells since there are principally only two cell lines used for vaccine production, and the fetuses were killed for reasons entirely unrelated to the production of vaccines. On the other hand, there is the ongoing destruction of human embryos for purposes of research involving human ESCR.

Would a similar conclusion follow concerning any life-saving treatment that may eventually derive from embryonic stem cells? Though the general outlines of an answer are suggested, there is no definitive response.

One thing is clear, however. Being pro-life in a biotech age can present us with gut-wrenching and mind-twisting moral dilemmas. We should pray for the day when all society, including research scientists, will respect each individual human being from his or her very inception. This is what Dignitas Personae urges us to work and pray for. Only moral science can be good science and produce the kinds of personal and social goods we all desire.

John M. Haas, Ph.D., is president of the National Catholic Bioethics Center and founding president of the International Institute for Culture. He is a member of the Pontifical Academy for Life. Edward J. Furton, Ph.D., is a staff ethicist and the director of publications for the National Catholic Bioethics Center.