HUMAN FERTILISATION & EMBRYOLOGY AUTHORITY IN

On March 15th, 2019, U.S. Congress issued "Personhood Concern" to American Society for Reproductive Medicine (ASRM) related to preimplantation genetic testing for aneuploidy (PGT-A or PGS, S for Screening). Two years later, in April, 2021, Human Fertilisation & Embryology Authority (HFEA) in UK issued a law and showed red light on PGT-A (see the following snapshot). The reason is: "There is no evidence from RCTs (Randomised Control Trials) to show that it is effective at improving the chances of having a baby for most fertility patients". HFEA further emphasized that "Patients should not be charged extra to take part in research, including clinical trials."

Just three weeks ago (March, 2021), HFEA still online SEO emphasized "Preimplantation Genetic Diagnosis is safe". Now this "safe" claim was disappeared or might be put in a online corner. Instead, red light for PGT-A is on. What can make HFEA to have a 180 degree turnaround so quick? Only one possible reason might be explained: embryo biopsy used in preimplantation genetic testing (PGT) is severely not safe. In embryo biopsy, laser will scatter through the whole human embryo, which may produce high incidence of embryo biopsy syndrome (EB Syndrome)- new artificial hereditary diseases. EB syndrome is not a genetic disease but a cytoplasmic hereditary diseases - cytohetic diseases). If a lot of call-in happened to oppose the claim of safety of PGT, HFEA might turnaround as above description. Obviously, safety issue is more severe issue for patients and HFEA to consider than the issue to have a baby. No family or country prefers babies with embryo biopsy syndrome. Who may afford to raise those people with EB syndrome all life? Tax payer? It may be. IVF clinics? It may be too. That may be the key reason why the red light is put on for PGT-A by HFEA. HFEA is protecting national interest, patients' interest and IVF clinic interest.

Although HFEA tried to use the softest way to ban PGT-A, it already set up enough legal bases for lawyers and jury to justify patients' lawsuit about their children's embryo biopsy syndrome. The families may require payment of the children's syndrome for life support due to PGT-A, which severe artificial cytohetic diseases (EB syndrome) had not been explained by the clinics or physicians. These legal bases may be:

1. HFEA has defined PGT-A to be an "add-on treatment". It meant that PGT-A is not an indispensable treatment, but is with a business (or other) aim. It also meant that infertility is not a medical indication for embryo biopsy (PGT-A).

2. HFEA claimed: "There is no evidence from RCTs (Randomised Control Trials) to show that it is effective at improving the chances of having a baby for most fertility patients". It meant that PGT-A is not scientific.

3. HFEA showed Red light (Stop light) to PGT-A. It meant that PGT-A is highly unsafe for future children, thus stop it right away. Hold yourself accountable for serving PGT-A.

4. HFEA stated: Patients should not be charged extra to take part in research, including clinical trials. It meant that PGT-A is not suitable for routine clinical practice. If for research, patients should not be charged extra according to the law.

5. HFEA has set up an international red light for PGT-A, because UK and US governments are closely correlated in this matter.

6. In case of lawsuit, a plaintiff and his (or her) lawyer will show proof of child's embryo biopsy syndrome and Hereditics, Cytohetics and Epicytohetics to confirm the defendant's clinical malpractice. The defendant's will show Genetics to confirm that the clinic is not guilty with signed consent form, which consent form shows ignorance in Hereditics, Cytohetics and Epicytohetics. Under this circumstance, the plaintiff always has the upper hand.

After US Congress issued "Personhood Concern" to PGT-A in march, 2019, 30-year experienced "pioneers" of PGT-A Dr. Munné and Dr. Handyside, etc. published a paper in Sept., 2019 confessed: when PGS was compared “versus morphology as selection criteria” for embryo transfer, PGS “did not improve overall pregnancy outcomes in all women, as analyzed per embryo transfer or per ITT” [Munné, et al., 2019]. It showed that both of them felt the PGT-A neither scientific nor safe for them to keep on and they jumped out of the "PGT-A boat" quickly. To further prevent accountability of PGT-A, Dr. Munné published reprinted 1995 paper in Oct. 2019 Fert. & Steril. to confirm the fact again, that embryo morphology is closely related to aneuploidy condition. It meant that PGT-A is not necessary to go on to detect aneuploidy, embryo morphology may detect aneuploid cells easier. When a person knew his mistake and corrected, it is good. It is an good example for the recent working-hard clinics in PGT-A to follow and quit PGT-A in front of HFEA's red light, thus prevent the future lawsuit nightmare of EB syndrome.

It seems that the lawsuit cases in reproductive medicine have been increasing very fast after "mosaicism tornado (i.e. why genetically diagnosed 'mosacism' embryo producing normal babies) in 2016 ASRM meeting". It looks like a severe "lawsuit tornado" never happened before is on its way. The omen was: In February, 2021, Journal Fertil & Steril (Volume 115, Issue 2), published 6 papers related to legal consideration. (Please see the following snapshots). No any scientific journal published so many papers about legal problems in one issue in the journal history. The first wave of the lawsuit might be related to PGT-A misdiagnoses (i.e. mosaic or aneuploid embryos producing euploid babies). Second wave of the lawsuit may be related to the safety of embryo biopsy (i.e. EB syndrome). Especially, blastocyst and laser biopsy will lead to more neuropathy problems and other problems, because the blastocysts have differentiated rather than the original totipotent embryos. It will be obvious that the lawsuit results will be closely related to the time on which HFEA issued red light on the PGT-A. The time of red light on should be the time to stop PGT-A.

Reference:

Munné, S., Kaplan, B., Frattarelli, J. L., et al. Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertil Steril. 2019, 112: 1071-1079 e7.