www.astralcodexten.com/p/profile-the-far-out-initiative
3 corrections found
It's illegal to CRISPR humans, and you'd have to do it at the embryo stage anyway.
This is incorrect: human CRISPR treatments were already legal in regulated clinical use, and they do not have to be done at the embryo stage.
Full reasoning
By May 2024, the FDA was already regulating human somatic genome-editing products, which would make no sense if CRISPR in humans were simply illegal. In January 2024, the FDA said it had approved Casgevy and explained that the treatment is made by taking a patient's blood stem cells, editing them with CRISPR/Cas9, and transplanting them back into the patient. That is human CRISPR use in living patients, not embryo editing.
The FDA also issued formal guidance for sponsors developing human gene therapy products incorporating genome editing of human somatic cells, including what must be submitted in an IND for clinical trials. Again, that is regulated human use, not a blanket prohibition.
So both parts of the sentence are wrong:
- "It's illegal to CRISPR humans" — false for somatic editing in regulated clinical contexts.
- "you'd have to do it at the embryo stage anyway" — false because approved and investigational somatic CRISPR therapies edit cells after birth, including ex vivo editing of a patient's own cells.
3 sources
- FDA Roundup: January 16, 2024 | FDA
Today, the FDA approved Casgevy... To produce Casgevy, patients' hematopoietic (blood) stem cells are modified by genome editing utilizing novel CRISPR/Cas9 technology. The modified blood stem cells are transplanted back into the patient...
- Human Gene Therapy Products Incorporating Human Genome Editing | FDA
FDA... provid[es] recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells... including information that should be provided in an Investigational New Drug (IND) application...
- Somatic Cell Genome Editing (SCGE) | NIH Common Fund
The NIH Common Fund's Somatic Cell Genome Editing (SCGE) program aims to reduce the burden of diseases caused by genetic changes... In its second phase (FY23-27), SCGE will accelerate the translation of genome editing therapies into the clinic.
An Italian family with a mutation in ZFHX2 are immune to pain
The ZFHX2 family was not pain-immune; the published literature describes reduced or non-global pain sensitivity, with some pain still present.
Full reasoning
The cited Italian family with a ZFHX2 mutation was reported in the medical literature as having congenital hypoalgesia / pain insensitivity, not total immunity to pain.
The original study says affected family members had a "low ability to sense pain" and notes they "occasionally suffered from headaches and visceral pains." GeneReviews likewise describes ZFHX2-associated disease as "non-global pain insensitivity" and specifically notes that pain during childbirth was perceived.
So the article overstates the phenotype. The family did not completely lack pain; rather, they had markedly reduced pain sensitivity with some painful experiences preserved.
2 sources
- A novel human pain insensitivity disorder caused by a point mutation in ZFHX2 - PMC
The family consists of... subjects [who] presented a low ability to sense pain, to experience temperature and to sweat... but occasionally suffered from headaches and visceral pains.
- Congenital Insensitivity to Pain Overview - GeneReviews® - NCBI Bookshelf
ZFHX2... Non-global pain insensitivity... lower back pain, headaches, & pain during childbirth perceived.
out of 90 patients
These were not patients. The BIA 10-2474 phase I study was conducted in healthy volunteers.
Full reasoning
The people dosed with BIA 10-2474 in the 2016 first-in-human study were healthy volunteers, not patients receiving treatment.
The published clinical paper is explicitly titled "...Study in Healthy Volunteers" and says the trial involved healthy male and female participants in a phase I safety study. This distinction matters, because a phase I trial in healthy volunteers is different from a therapeutic trial in patients with disease.
So describing the affected participants as "90 patients" is factually inaccurate.
2 sources
- Safety, Tolerability, and Pharmacokinetics of FAAH Inhibitor BIA 10-2474: A Double-Blind, Randomized, Placebo-Controlled Study in Healthy Volunteers - PMC
This study evaluated... BIA 10-2474... after first administration to healthy male and female participants. Participants (n = 116) were recruited into this phase I... study.
- Safety, Tolerability, and Pharmacokinetics of FAAH Inhibitor BIA 10-2474: A Double-Blind, Randomized, Placebo-Controlled Study in Healthy Volunteers - PMC
During the 50-mg MAD part... five of six participants reported unexpected CNS serious adverse events... One male participant showed serious and sudden deterioration of clinical status with fatal outcome.