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Update: See the bottom of this post for the National Institutes of Health’s response to our letter. 

An Open Letter to Dr. Francis S. Collins, Director of the National Institutes of Health

D. Joy Riley, M.D., M.A.
Executive Director

Francis S. Collins, M.D., Ph.D.
Director
National Institutes of Health
9000 Rockville Pike
Bethesda, Maryland 20892
[email protected]

17 December 2018

Dear Dr. Collins:

The Tennessee Center for Bioethics & Culture lauds the position of the National Institutes of Health (NIH) as evidenced by your concluding statement of 28 November 2018: “NIH does not support the use of gene-editing technologies in human embryos.” As embryonic humans represent the most vulnerable amongst our species, the NIH is correct to protect them. Moreover, to protect future generations from the machinations of clinical progenitors now is equally—if not more—important.

The experiments announced recently by Dr. He Jiankui in Hong Kong at the Second International Summit on Human Genome Editing are absolutely concerning, and rightly condemned. At the same time, another announcement made at the same meeting needs close attention. Werner Neuhausser, of the Harvard Stem Cell Institute, announced the beginning of gene-editing of sperm, using CRISPR. The expressed hope is to reduce the risk of Alzheimer’s disease in later life. There is no embryo involved as of yet, but given the facts that Dr. Neuhausser’s expertise is in vitro fertilization (IVF), and sperm are not treated for Alzheimer’s disease, the goal appears rather lucid.

At the same Hong Kong meeting, Harvard Medical School Dean George Q. Daley spoke of working toward societal consensus regarding gene-editing, and recommended binding regulation only if there were “widespread flouting of . . . common principles” in gene-editing work. Daley thinks “we aspire to universal principles,” but recognizes that he himself is a utilitarian, stating, “in everyday life, especially as a physician, I use sort of utilitarian principles all the time” (see video here, at 44:20ff). Daley asserted that Dr. He had simply taken “a wrong turn on the right path,” according to Antonio Regalado’s reporting.

The NIH rightly condemns the gene-editing of embryos by Dr. He, but does the institution have any words regarding the positions and work of Drs. Daley and Neuhausser? The work at Harvard will also constitute germline editing. Future generations will have different genomes if the work Harvard plans comes to fruition. Will only the utilitarians amongst us have a say? Genetic modification of human beings should be a topic of wide cultural conversation. This is too important a topic to allow to percolate only in ivory towers—or in offshore conferences.

Thank you for your time, and serious consideration of this matter. I look forward to your response.

Response from the National Institutes of Health

Fri, Jan 25, 2:48 PM

Dear Dr Riley:

Thank you for your e-mail to Dr. Francis Collins, Director of the National Institutes of Health (NIH), regarding gene editing and human germline modification. Dr. Collins asked me to respond on his behalf. First and foremost, I can assure you that NIH is actively engaged in the issues you raise, and we appreciate you taking the time to express your views on gene editing.

As you may know, NIH is the largest funder of biomedical research in the world and has supported research involving genetic engineering since the advent of recombinant DNA technology in the 1970s. NIH supports both basic laboratory research and clinical trials, including human gene therapy trials, to study potential treatments for genetic or infectious diseases and cancer. More recently, gene editing technologies, such as CRISPR/Cas9, have become powerful tools that can be used to study genes and potentially treat diseases. NIH supports research on improving gene editing technologies and their use in basic research into gene functions, development of disease models, and clinical research. Many promising clinical applications of human gene editing are directed at altering genetic sequences only in somatic cells so that changes are not inherited in subsequent generations. Such research includes editing genes to correct sickle cell disease in blood cells, improve the ability of immune cells to target cancer, or create HIV-1 resistance in human immune cells. In 2018, NIH launched the Somatic Cell Genome Editing Program to improve the efficacy and specificity of genome editing approaches. The research tools developed through this program will be made widely available to the research community to reduce the time and cost required to develop new therapies.

Some gene editing applications, such as human germline modifications, raise significant safety or ethical concerns. Per the NIH Grants Policy Statement, NIH does not support gene editing of human embryos; the NIH Director issued statements on this topic in 2018 and in 2015. Furthermore, while NIH policy does not specifically prohibit basic research on human gametes, NIH does not support the creation of human embryos for research purposes; this is prohibited in the “Dickey-Wicker” amendment, which is included in the annual appropriations bill for the Department of Health and Human Services.

NIH has expressed its deep concern regarding Dr. He’s report of the birth of two children with CRISPR/Cas9-mediated germline modification of the CCR5 gene, as indicated in the 2018 Director’s statement referenced above. NIH has and will continue to actively participate in international dialogue in an effort to develop global consensus on appropriate limits and governance of such research.

Thank you for contacting NIH.

Sincerely,

Carrie D. Wolinetz, Ph.D.
Acting Chief of Staff and
Associate Director for Science Policy
Office of the Director
National Institutes of Health (NIH)

Reaction to the Response

While the Tennessee CBC is grateful for the response by the NIH, we need to point out that the NIH, as part of our government, is silent about the genome editing of germ cells. These same germ cells—in this case, sperm—could be used to produce generations of genome-altered embryos, fetuses, and birthed individuals. In other words, people who are scientists now may alter the genomes of many people yet to be born, and not only in the near-future. There is no consent for this, and there cannot be. Neither is there an obvious outcry, and more’s the pity. Is it because there is no general knowledge of the implications of such research? Is there no facility for expressing concern? We can help.

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