A doctor in New York had been reprimanded by the US FDA for marketing an unapproved experimental ‘three-parent baby’ procedure. Dr John Zhang, CEO of the New Hope Fertility Centre, was told to stop the promotion as it is currently not approved in the US.

He first made headlines in 2016 after helping a couple from Jordan to conceive a baby using the controversial procedure.

Dr Zhang also heads a fertility-related company, Darwin Life Inc., where he continued the marketing claims on the company’s website. Naming the technique as HER IVF (Human Egg Rejuvenation In Vitro Fertilization), the claims lauded the “first live birth” using the “three-parent baby” technology. It was also claimed to be the “first proven treatment” for specific genetic diseases and successful treatment of “age-related” infertility.

Health regulatory hurdles in the three-parent baby technique


In the three-parent baby technique, DNA from three people – the mother, the father and an egg donor – are used.

In the Jordanian couple case, the mother carries DNA that could give her offspring a severe neurological disorder called Leigh Syndrome. This would normally kill a child early in life. The family already had suffered four miscarriages and the death of two children.

The experimental technique involves removing some of the mother’s DNA and excludes the disease-causing DNA. The healthy DNA is inserted into a donor’s egg which contains a very small amount of DNA, and then fertilised.

This procedure was reported to have taken place at the New York Clinic. The embryo was then taken to Mexico and implanted there. In September 2016, a healthy baby boy was born.

This is not the first time that babies were born from three ‘parents’. In the late 1990s, 17 babies were born with DNA from three people in an experimental infertility treatment. The breakthrough made at St Barnabas Institute in New Jersey, however, was short-lived.

The FDA intervened and ordered a stop in carrying out such procedures due to safety and ethical concerns. Nevertheless, by then, it is believed that about 30 to 50 children had been born with DNA from three people.

From helping couples with infertility problems to helping carriers of fatal genetic diseases


The latest case in 2017 marked a shift in what the technique serves to aim. From serving as an infertility treatment, the technique is helping mothers who have defective mitochondrial DNA from passing down their mutations.

The effects of the controversial surrogacy process is yet unknown, posing hidden issues which may emerge later in life.

The UK’s Human Fertilisation and Embryology Authority, however, had passed laws in late 2016 to allow clinics to seek licenses for the three-parent procedure.

The issue is expected to be hotly debated. Fertility experts had called on to push ahead with the procedure, but to tread with caution. Critics however, highlighted that ignoring the cautious approach of regulators is irresponsible behaviour.

Dr Zhang and his team will be presenting their findings at the American Society for Reproductive Medicine meeting in October 2017. MIMS

Read more:
CRISPR study findings hint that the future of ‘designer babies’ may still be far off
American scientists use CRISPR to modify human embryos
More than 96% of add-on treatments for IVF lack proper evidence of efficacy

Sources:
https://www.statnews.com/2017/08/05/doctor-told-stop-marketing-3-parent-baby-technique/
https://www.theverge.com/2017/8/5/16100680/three-parent-baby-fertility-doctor-fda-letter-violations
https://www.statnews.com/2016/10/26/children-3-way-dna/
http://us.blastingnews.com/lifestyle/2017/08/why-three-parent-baby-fertility-procedure-should-not-be-commercialized-001910253.html
http://www.bbc.com/news/health-37485263
https://www.theguardian.com/science/2016/dec/15/three-parent-embryos-regulator-gives-green-light-to-uk-clinics