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