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New NIH Stem Cell Guidelines are Slowing Research

WisBusiness.com, July 14, 2009

According to Dr. Steve Duncan, professor of human and molecular genetics at the Medical College of Wisconsin, the failure of the new NIH Guidelines to "grandfather" in the already existing hESC lines has had a "tremendously detrimental effect on our research."

As Dr. Duncan explains, "The problem is they haven't added the presidential lines as a group of lines that we can now use. So we can't do any human embryonic stem cell (hESC) research with new federal funds at this point. We're hoping within the next two months that it will be relaxed, but that's a long time in research and it's reallly upsetting, the way it's been handled."

Once again, as previously reported a number of times on this website, at the heart of the debate are the "voluntary and informed consent" rules which are contained within the new NIH Guidelines. Many, if not all, of the hESC lines that already exist were created before such rules of consent were authored, and therefore do not meet "the core ethical principles and procedures" that are defined in the new NIH Guidelines. Even though NIH says that such hESCs are subject to review by an advisory committee and might therefore be "grandfathered" in, there is still widespread doubt among the ESC scientific community that many of those lines will be approved for the federal funding of research.

In fact, contrary to popular opinion, there is one major obstacle in the U.S. which is preventing stem cell therapies from being available in clinics at this very moment, and that obstacle has nothing to do with NIH nor with embryonic stem cells nor with any restrictions that the Bush administration supposedly imposed nor with any restrictions that the Obama administration supposedly lifted. Instead, that one, single, primary obstacle is the fact that the U.S. FDA (Food and Drug Administration) has decreed that autologus (in which the donor and recipient are the same person) adult stem cells are a "drug", and therefore must be regulated as such, and therefore cannot be used for therapeutic purposes in the U.S. without having first been subjected to the lengthy, lethargic, outdated, multi-year, multi-million dollar federal governmental approval process, in the same manner as which pharmaceutically manufactured drugs are regulated. Such a stance is without any scientific basis whatsoever, and a number of individuals and organizations are attempting to initiate a much-needed and long-overdue reform of the FDA on this issue. Until the FDA is completely overhauled, however, it seems as though U.S. academicians will continue to focus all of their time and attention on arguing over the federal funding of embryonic stem cell research while apparently remaining oblivious to the fact that doctors and patients are not willing to sit around and wait another decade for something to happen, but instead are traveling overseas where adult stem cell therapies are already available in clinics in just about every country in the world except the United States. (Please see the related news articles on this website, entitled, "Arizona Man Travels to Central America for Adult Stem Cell Therapy", dated July 16, 2009; "Bangor Family Heads to Central America for Adult Stem Cell Therapy", dated July 8, 2009; "Texas Woman Travels to Central America for Adult Stem Cell Treatment", dated June 25, 2009, and "Two U.S. Adult Stem Cell Companies Form Collaboration in Asia", dated May 11, 2009).

Despite all the exaggerated hype over embryonic stem cells, usually at the complete exclusion of adult stem cells, Dr. Duncan nevertheless predicts that future stem cell research will shift more toward adult rather than embryonic stem cells, and not just for the numerous sound scientific and medical reasons but also for ethical reasons as well. Despite his own interest in hESC research at the moment, he also pointed out that, "I think we have to take into account the ethical situation."



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