Are CRISPR Babies Healthy? Enhanced? Speculation Takes a Disturbing Turn/ Center for Genetics and Society

https://www.geneticsandsociety.org/biopolitic...ion-takes-disturbing-turn

Getting serious about the challenge of regulating germline gene therapy

Arthur Caplain, Ph.D. is the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at New York University Langone Medical Center & founding director of the Division of Medical Ethics.

The announcement of He Jiankui's germline editing of human embryos has been followed by a torrent of almost universal criticism of the claim on scientific and ethical grounds. That criticism is warranted. There is little room for anything other than vociferous condemnation of He's announcement. Presenting the results of groundbreaking work by press conference and You Tube is not science. The issue now is not whether the work supporting the claims reported from China was done in an ethical manner. It was not. What is required to move forward is a justification for doing germline editing in humans. Many think there is none, and prohibitions abound. If such work is justifiable, a serious, rigorous framework must be imposed that insures that such research is done following the highest ethical standards that both protect human subjects and insure public trust and support.

http://dx.plos.org/10.1371/journal.pbio.3000223

Alarmed by new 'CRISPR babies' plan, top science figures say they are powerless to stop it

Note the link to the National Public Radio interview with Russian molecular biologist Denis Rebrikov where he defends his plans.

https://www.statnews.com/2019/06/24/outraged-...yre-powerless-to-stop-it/

https://www.who.int/news-room/detail/22-07-20...option-in-all-populations

https://www.worldcommunitygrid.org/research/fahb/overview.do - aids drugs

" WHO recommends dolutegravir as preferred HIV treatment option in all populations
22 July 2019 News release Mexico City
中文 Español
Based on new evidence assessing benefits and risks, the WHO recommends the use of the HIV drug dolutegravir (DTG) as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential.

Initial studies had highlighted a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to women using the drug at the time of conception. This potential safety concern was reported in May 2018 from a study in Botswana that found 4 cases of neural tube defects out of 426 women who became pregnant while taking DTG. Based on these preliminary findings, many countries advised pregnant women and women of childbearing potential to take efavirenz (EFV) instead.

New data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base. The risks of neural tube defects are significantly lower than what the initial studies may have suggested.

The guidelines group also considered mathematical models of the benefits and harms associated with the two drugs; the values and preferences of people living with HIV, as well as factors related to implementation of HIV programmes in different countries, and cost.

DTG is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used. DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to EFV and nevirapine-based regimens. In 2019, 12 out of 18 countries surveyed by WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%.

All of above findings informed the decision to update the 2019 guidelines.

In 2019, 82 low- and middle-income countries reported to be transitioning to DTG-based HIV treatment regimens. The new updated recommendations aim to help more countries improve their HIV policies.

As for any medications, informed choice is important. Every treatment decision needs to be based on an informed discussion with the health provider weighing the benefits and potential risks.

WHO also stresses the importance of providing information and options to help women make an informed choice. To this end WHO has convened an advisory group of women living with HIV from diverse backgrounds to advise on policy issues related to their health, including sexual and reproductive health. WHO highlights the need to continually monitor the risk of neural tube defects associated with DTG."

For rules on creating 'CRISPR babies' from edited embryos, scientists call for a do-over

Guidelines from 2017 on CRISPRing human embryos didn't stop He Jiankui from creating "CRISPR" babies. Now a commission is redrafting the rules.

https://www.statnews.com/2019/08/12/crispr-ba...entists-call-for-do-over/