[Justin]

..... continued...

George Daley

Associate Professor, Children's Hospital Boston, Massachusetts, USA.

Put the NIH in charge of stem-cell guidance and oversight.

The Obama administration has given every indication that it will swiftly eliminate restrictions on federal funding for research on human embryonic stem cells. This could potentially allow labs to study the nearly 1,000 cell lines that have been derived since August 2001, the arbitrary cut-off date chosen by president George W. Bush's administration. Newer cell lines have important properties that make them valuable for medical research. For example, lines generated from preimplantation genetic diagnosis can be used to model human diseases such as fragile X syndrome, neurofibromatosis and various forms of bone-marrow failure.

Still, significant challenges remain in harmonizing stem-cell research and reasserting the United States's role as a leading force in this field. Under the Bush policy, a number of US states have stepped in to fund embryonic stem-cell research — California, most prominently, but also states including New Jersey, New York, Wisconsin, Connecticut, Illinois, Maryland and, most recently, Massachusetts. That has created a Balkanized set of principles for regulation and protocol, and has obfuscated financial administration in laboratories that must keep these funding streams separate. Moreover, ethical guidelines for deriving and maintaining human stem-cell lines have taken a parochial turn, with subtle but sometimes meaningful discrepancies that could complicate future collaboration across state and international boundaries.

The situation reflects the fact that the National Institutes of Health (NIH) — which should have been the main arbiter in charge of oversight of stem-cell research in the United States — has largely been sidelined during some of the most dramatic and game-changing discoveries and debates of the past eight years.

The best policy outcome would be to return the NIH to its rightful role as arbiter of stem-cell research in the United States, making funding decisions based on scientific merit rather than ideology, and ensuring uniform standards of ethical oversight, most readily by endorsing the Guidelines from the National Academy of Science and the International Society for Stem Cell Research. Because so many countries look to the leadership of the NIH to set principles for how they operate within their own borders, this would have an enormous impact on policies worldwide.

A second issue looms on the horizon. The Dickey amendment, which has been a rider on the Department of Health and Human Services appropriations bill since 1995, precludes using federal money for the creation or destruction of human embryos for research purposes. So although hundreds of cell lines could be approved for federally funded research projects, subject to NIH approval, the amendment bars funding for research such as somatic cell nuclear transfer or work on embryos discarded from in vitro fertilization procedures to derive new cell lines.

In my opinion, this legislative barrier represents a blockade to essential forms of embryo research that could aid health care for birth defects, women's infertility and some cancers. The political reality may dictate that the few labs doing this (mine included) will have to continue to rely on state or private funding in the near term for this work. But the new Obama administration would be well advised to commission a comprehensive and thoughtful analysis of the scientific, medical and ethical issues pertinent to human-embryo research, and to act on the recommendations in the best interest of society as a whole.

Beyond the stem-cell issue, there is a pressing need for increased funding for all areas of biomedical research, given the inadequate NIH budgets of the past few years. It would be a Pyrrhic victory to win expanded federal funding of embryonic stem-cell research without seeing a greater overall investment in the NIH. Even in the current financial crisis, funding for biomedical research is a smart investment that is certain to yield handsome returns.