Response: First Birth Following Spindle Cell Transfer

Reproductive BioMedicine Online

James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in Reproductive BioMedicine Online, titled “Response: First Birth Following Spindle Cell Transfer.”

Following is an excerpt:

In a letter in this issue of RBMOnline, Norbert Gleicher and colleagues (2017) criticize a paper describing the birth of the first mitochondrial replacement therapy (MRT) baby (Zhang et al., 2017) and debate the views expressed in the accompanying editorial (Alikani et al., 2017). Here, we offer a point of discussion related to the argument of legality posed by Dr Gleicher and colleagues. Regarding the now-published details of the location of (i) IVF, egg donation and MRT procedures in New York City, (ii) blastocyst vitrification and biopsy in New York City, (iii) cryopreserved embryo transport from the USA to Mexico and (iv) embryo transfer to the patient in Dr Zhang's New Hope Clinic in Mexico, the argument is made by Gleicher and colleagues that this ‘clearly established intent to breach FDA guidelines’. We would like to elaborate, as the authors of the letter appear misinformed about the USA Food and Drug Administration (FDA) guidelines in this area of research.