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NIH Receives Nearly 50,000 Comments

Newsweek, June 5, 2009

In the one-month period that transpired between April and May of this year, the National Institutes of Health received no less than 49,015 comments in response to the first draft of its new stem cell guidelines. The comments were submitted not only from people throughout the U.S. but also from people around the world who represent a broad spectrum of interests from the scientific and religious communities as well as from the public at large. NIH solicited and invited such comments, apparently thinking that matters which require a certain level of scientific expertise to understand can be decided democratically among the general public on the basis of majority vote. NIH did not disclose exactly how many of these nearly 50,000 comments were actually read, however.

As reported in Newsweek, "There has been something of a collective mood swing among stem cell scientists this year. Researchers were ebullient when President Obama lifted Bush-era restrictions on federal funding for embryonic stem cell research in March. But many were hugely disappointed when the NIH's draft guidelines came out a month later." As has already been reported in related news articles on this website, one of the most hotly debated points in the new guidelines involves legalities of informed consent. As summarized in Newsweek, "Many of the (stem cell) lines developed from human embryos over the last decade would not meet these stringent new standards, and research using those cells would therefore be ineligible for government money." Among other organizations, the International Society for Stem Cell Research (ISSCR) stated in a letter to NIH that, "It is critical that a mechanism be developed to ensure that the past ten years of scientific progress with these lines not be lost to federally-funded research." (Please see the related news article on this website, entitled, "Embryonic Stem Cell Advocates Protest NIH Guidelines", dated May 25, 2009).

Another point of debate involves the procedure known as somatic cell nuclear transfer (SCNT), which can be used both for reproductive cloning as well as for so-called therapeutic cloning, neither of which are allowed under the new NIH guidelines although there are many scientists who wish to be able to use SCNT strictly for research purposes, despite the inherent risks.

Among the many religious groups who oppose embryonic stem cell research altogether and who advocate adult stem cell therapies instead, the United States Conference of Catholic Bishops also submitted a letter to NIH in which they stated their side of the argument. Unaffiliated with any religious group, however, are the many legitimate scientists and physicians who are already achieving great success with adult stem cells and who are eager to cite the many advantages of adult stem cells over embryonic stem cells, not for ethical or political reasons but purely for very concrete, scientific and medical reasons.

There remains one fundamental problem, however, which is rarely mentioned and which is therefore conspicuous by its absence in most debates over national stem cell policy in the United States. That problem has to do with the fact that the U.S. Food and Drug Administration (FDA) has insisted that the endogenous, autologous, naturally occurring adult stem cells, which are found in every human being's body, should be classified as "drugs" and therefore must be regulated by the FDA and cannot be administered in any therapeutic manner, not even to the same person from whom the cells are derived, without first being subject to the same lengthy, lethargic, outdated approval process as a pharmaceutically manufactured drug, which is a process that typically takes a decade or longer and cost millions of dollars. This is the main reason why adult stem cell therapy is not available in the U.S. except to people who are accepted into a limited number of government-approved clinical trials, and this is precisely what is forcing legitimate adult stem cell physicians to relocate overseas, outside of the U.S., where even the most reputable and scientifically sound clinics must compete against the most disreputable and unscientific, and where it is not always easy for the patient-consumer to tell the two apart. A group of physicians, patients and other concerned citizens have formed a grass-roots advocacy movement in the U.S. in response to this grossly flawed stance by the FDA, and more info is available at www.safestemcells.org as well as at www.stemcelldocs.org. If it weren't for the fact that each person's own tissue and cells, which are found in each person's own body, have been erroneously categorized as "drugs" by the FDA, subject to regulation and laws created by the FDA, then the numerous adult stem cell clinical therapies that have already been in use for years outside of the U.S. would also be available within the U.S., thereby rendering the debate over the hypothetical future clinical potential of embryonic stem cells irrelevant. (Please see the related news article on this website, entitled, "Two U.S. Adult Stem Cell Companies Form Collaboration in Asia", dated May 11, 2009).

Meanwhile, however, the debate rages on, with no realistic end in sight. Regardless of the details of the national stem cell policy which NIH is expected to unveil in its final form next month, however, there seems to be one point on which all parties can agree, which Newsweek summarized perfectly by stating, "Fireworks are expected one way or the other. Stay tuned."



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