FasterCures Comments on the National Institutes of Health’s Draft Guidelines for Human Stem Cell Research

Human embryonic stem cell research holds great promise for millions of Americans suffering from many diseases and disorders. Thanks to substantial private and State investment in this area of research over the past decade, significant strides have been made. Expanded investment by the Federal Government will rapidly accelerate progress, however, the final guidelines issued by NIH to govern federally funded research must build on this progress so that cures and new therapies can get to patients as quickly as possible. The final guidelines should not create new bureaucratic hurdles that will slow the pace of progress.

We are pleased that these draft guidelines, specifically in section IIB, would appear to permit federal funding of research using stem cell lines previously not eligible for federal funding and for new lines created in the future from embryos donated by patients no longer needing them for infertility treatments. However, as drafted, Section IIB does not ensure that some currently existing stem cell lines will meet the new criteria and thus research using them would be ineligible for federal funding. It is important that the final guidelines allow federal funds for research using all stem cell lines created by following ethical practices at the time they were derived – essentially “grandfathering in” many existing stem cell lines. If cell lines were derived in accordance with the existing guidelines at the time – those of either the National Academy of Sciences or the International Society for Stem Cell Research, which were quite stringent – and their derivation was approved by either an Embryonic Stem Cell Oversight Committee or an Institutional Review Board, then research on those lines should be eligible for federal funding. Otherwise, we will have negated six years’ worth of progress in stem cell research.

We also note with concern that the draft guidelines do not permit federal funding of research using stem cell lines derived from sources other than excess IVF embryos, specifically through somatic cell nuclear transfer (SCNT), also known as “therapeutic cloning.” We understand that no human stem cell lines have yet been successfully derived and maintained through SCNT, and therefore it may not yet be considered necessary to grapple with this issue. But it must be recognized that the scientific community widely believes that the potential use of genetically customized or characterized stem cells will be of the greatest value in research to more effectively treat and even cures diseases such as Parkinson’s, Alzheimer’s, and multiple sclerosis. In addition, it will be critical to use SCNT in treating patients with their stem cell lines to minimize immune rejection. It is therefore essential that NIH not hamstring its ability to continue to monitor developments in this field and to update these guidelines as the research progresses.

In addition, we strongly recommend that the final guidelines include the continuation of an NIH-funded registry that will list lines that are eligible for research using NIH funds. Without a registry, each institution will be required to review each stem cell line’s derivation process and informed consent compliance, regardless of how widely that line is used elsewhere for NIH-funded research. This will create a significant burden on institutions and researchers and slow the pace of their work.

FasterCures is dedicated to saving lives by saving time. Our mission is to identify ways to accelerate the discovery and development of new therapies for the treatment of deadly and debilitating diseases both in the United States and around the globe. The organization was founded in 2003 under the auspices of the Milken Institute to aggressively catalyze systemic change in cure research and to make the complex machinery that drives breakthroughs in medicine work for all of us faster and more efficiently. FasterCures is independent and non-partisan. We do not accept funding from companies that develop pharmaceuticals, biotechnology drugs, or therapeutic medical devices. Our primary mission is to improve the lives of patients by improving the research environment, research resources, and research organizations.