Stories
Slash Boxes
Comments

SoylentNews is people

FDA Warns Doctor Against Marketing Three-Person IVF Technique

posted by Fnord666 on Wednesday August 09 2017, @11:56AM   Printer-friendly
from the three's-a-crowd dept.

takyon writes:

Back in September, it was reported that spindle nuclear transfer was used to successfully transfer mitochondrial DNA into an egg in order to prevent a child from inheriting a mitochondrial disorder. The procedure was carried out in Mexico due to U.S. laws against it. Now, the FDA has warned the doctor behind this milestone to stop using the achievement in marketing materials for his fertility clinic:

The US Food and Drug Administration has told a New York fertility doctor to stop marketing a controversial three-parent fertility treatment, which makes it possible for babies to be made from two women and a man.

The health watchdog published a letter to Dr. John Zhang, founder of the New Hope Fertility Center in New York City, whose "spindle nuclear transfer" technique was used to conceive a boy born in Mexico in April 2016.

Zhang detailed the procedure in the journal Fertility and Sterility [open, DOI: 10.1016/j.fertnstert.2016.08.004] [DX] last year and is now marketing the technique, but the letter reminds Zhang the FDA has not authorized his use of the procedure in humans.

Original Submission

 
This discussion has been archived. No new comments can be posted.
FDA Warns Doctor Against Marketing Three-Person IVF Technique | Log In/Create an Account | Top | 2 comments | Search Discussion
Display Options Threshold/Breakthrough Mark All as Read Mark All as Unread
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
(1)

  • (Score: 1, Informative) by Anonymous Coward on Wednesday August 09 2017, @12:35PM (1 child)

    by Anonymous Coward on Wednesday August 09 2017, @12:35PM (#551069)

    This appears to be about some kind of Obama era political thing rather than safety concerns:

    Since December 2015, the United States Food and Drug Administration (FDA) has been prohibited by Congress in provisions in annual federal Appropriations Acts from using funds to accept IND submissions for clinical investigations that involve “a human embryo . . . intentionally created or modified to include a heritable genetic modification.” See, e.g., The Consolidated Appropriations Act, 2017, Pub. L. No. 115-31; H.R. 244, 115th Cong. § 736 (2017) (enacted). Consistent with this prohibition, FDA declined your pre-IND meeting request, because your proposed human subject research would involve the intentional creation of a genetically modified embryo.

    https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM570225.pdf [fda.gov]

    Looks like some of the babies mitochondria still do have the mutation, but it is a much smaller percent than her earlier children:

    She had 4 pregnancy losses and 2 deceased children at age 8 months and 6 years from Leigh syndrome as confirmed by >95% mutation load.
    [...]
      Transfer of the euploid embryo resulted in an uneventful pregnancy with delivery of a healthy boy at 37 weeks of gestation. The average level of transmitted mother’s mtDNA in several neonatal tissues including buccal epithelium, hair follicles, circumcised foreskin, urine precipitate, placenta, amnion, umbilical blood, and umbilical cord was less than 1.60 ± 0.92%. The baby is currently 3 months old and doing well.

    http://www.fertstert.org/article/S0015-0282%2816%2962670-5/fulltext [fertstert.org]

    If the other child lived to 6 yrs old though it may be wise to see what happens here. If the baby was at least 3 months old last September it is over a year old now. Any update on that?

    • (Score: 3, Interesting) by EvilSS on Wednesday August 09 2017, @05:12PM

      by EvilSS (1456) Subscriber Badge on Wednesday August 09 2017, @05:12PM (#551195)
      Yep, he can't advertise the procedure without clinical trials, but he can't get approval for clinical trails due to rules. It's a catch 22. The law that created these rules needs to be repealed, or at least heavily modified to allow for cases like this. This isn't creating some sort of mutant, and it's not cosmetic, it's purely to prevent a life threatening disease from being passed on. Hell in this case the core genetics of the child are not being changed, just the mitochondrial DNA and that's not being artificially edited, it's being replaced with natural occurring donor mDNA.
(1)