Letter to U.S. President on Genetic Manipulation

April 21, 2021

Dear President Biden:

I am writing to urge you to take action to address the rapidly growing need for regulation of in vitro fertilization (IVF) and genetic manipulation of organisms, especially human cells.  Increasing understanding of how to select embryos with specific traits for IVF, as well as modify the genes of cells using technologies like CRISPR, without regulation we will see ethical boundaries tested.  Without a regulatory body to address four key recommendations:

  1. Establish and regularly update a set of standard policies, and procedures for IVF and genetic modification of cells.
  2. License and inspect IVF clinics to ensure they are following this set of standards.
  3. Develop standard policies and procedures for controlling genetic manipulation of cells of humans and non-humans.
  4. Work towards development of an international agency that ensures that similar standard policies and procedures are established and implemented around the world.

This message is stimulated by a book titled Hacking Darwin by Jamie Metzl,[i] about which Sanjay Gupta writes, “If you can only read one book about the future of our species, this is it.”  Metzl serves on the expert advisory committee on developing global standards for the governance and oversight of human genome editing for the World Health Organization.  Among other experience Metzl has worked with the U.S. National Security Council, State Department, Senate Foreign Relations Committee, the United Nations, and a biotechnology company.  My training as a Doctor of Pharmacology with extensive knowledge of genetics and work on research projects that would take advantage of biotechnology, I am intimately aware of the accuracy and the threats that Metzl discusses.

I was rather intrigued to hear about the model regulatory agency of the United Kingdom called the Human Fertilization and Embryo Authority[ii] and the Code of Practice[iii] that the HFEA has developed.

Please seriously consider these recommendations, since they are just as important as climate change, as they threaten the future of humanity.

Thank you and a response to this message would be appreciated.


Thomas P. Caruso, Ph.D., MBA

CC: Senator Elizabeth Warren 
    Senator Edward J. Markey
    Representative Jake Auchincloss

[i] Metzl, Jamie. Hacking Darwin: Genetic Engineering and the Future of Humanity. 1st Edition. Sourcebooks, 2019.

[ii] “Human Fertilization and Embryology Authority.” Accessed April 20, 2021. https://www.hfea.gov.uk/.

[iii] “Code of Practice.” Human Fertilization and Embryo Authority, December 3, 2019.  https://portal.hfea.gov.uk/media/1605/2019-12-03-code-of-practice-december-2019.pdf.