Scientists sometimes disagree about research including not just what data might mean, but also what kinds of rules there should be about research like stem cell-based embryo models (SCBEM). It makes sense that the most cutting-edge research tends to spark the strongest disagreements. For instance, there’s no consensus on how much clinical trial data should be required before agencies like the FDA approved a new drug.
When it comes to SCBEM, there have been disagreements about which team’s models are the best (whatever that means). There is also uncertainty about how long these models and even real human embryos should be grown in the lab for research. What’s permissible and logical?
A new article proposes a two-tier framework that I see as very smart. Even so, some researchers are likely to see it as too limiting. I expect they will object most strongly to the proposed upper limit of 8 weeks on growth of the models in the lab.
Proposed SCBEM framework
Here it is: A two-tier framework for responsible research on human embryo models in Cell with senior author Robin Lovell-Badge. The two proposed tiers make sense:
“Tier 1 sets a developmental limit at two criteria: neural tube closure or the appearance of both a defined number of somites and limb buds, corresponding to ∼Day 28 post-fertilization analogue (PFA). Tier 2 allows research requiring a higher level of oversight up to Day 56 PFA.”
In my reading of this framework, no more research would be permissible after 56 days or 8 weeks. What does SCBEM researcher Jacob Hanna (not an author on this paper, while Magda Z-G is) think of the proposed limit? His biotech Renewal Bio is proposing to use the lab-grown models as a source of cells and probably tissues for clinical use in humans. An 8-week limit is going to make some potential clinical applications difficult. Maybe even impossible? On the other hand, can SCBEM even be grown beyond the equivalent of 8 weeks?
As with some many things, while an 8-week equivalent upper limit might make sense, it comes with big risks. I’ll discuss those soon in another piece.
Iffy peptide article
Tired of wellness peptides? They aren’t going away. Here’s a new pice from NY Magazine that’s both interesting and problematic: Peptides are the new wellness cure-all. I talked with the author Ezra but I don’t recall him mentioning that he had injected himself with peptides.
That reminds me of pieces in the biologics sphere where reporters end up getting stem cell injections or their face microneedled with blood.
We’re not talking here about a reporter going out and trying a new donut or computer that they is the focus of a story they are doing. Getting the unproven medical procedures that are writing about seems to cross a line.
Reporters doing these things encourages their readers to follow suit too.
RFK Jr. and stem cells
I’m sure many of you remember that RFK Jr. seems to love peptides, but he’s also up on unproven stem cells.
Here’s a new piece on that angle: RFK Jr. Wants to End the “War” on Unproven Treatments Like Stem Cell Therapy, Mother Jones.
It feels like Kennedy could be announcing some new, weaker FDA oversight approach to certain stem cells soon. And, as we’ve talked before, something like that is probably coming for peptides as well.
More recommended reads
- Alex Pretti remembered by health care workers at a Minneapolis vigil as a ‘stand-up guy’. The VA ICU nurse shot by federal agents had left a lab job to be ‘closer to the frontlines’, STAT News. This could have been almost anyone. I didn’t realize he had worked in a lab earlier.
- Developmental convergence and divergence in human stem cell models of autism, Nature. About six months ago there was a study suggesting there are specific genetically-defined subgroups of ASD. Other data has supported that idea as well. The new paper suggests both divergent and convergent mechanisms, concluding, “These data illustrate how risk associated with genetically defined forms of ASD can propagate by means of transcriptional regulation to affect convergently dysregulated pathways, providing new insight into the convergent impact of ASD genetic risk on human neurodevelopment.” Only a fraction of autism cases are known to have a major genetic component. Do the cases not so clearly linked to genetic variants (for example maybe more environmental) still converge on specific transcriptional mechanisms?
Dear Paul:
The authors of the Cell “SCBEM” article continue to extrude public ruses to mislead the public about the research they desire to pursue with nascent living human beings. Before you join them in disingenuous objections that these beings are not human beings, let me state emphatically that if they were not human beings, then you and the authors would be not be proposing limitations on how long they can be used as human research subjects before killing them.
We do not become human beings because of our neural activity. We are human beings because of our human genome’s presence in the cytoplasm of a human oocyte. Period. Every word after that is superfluous to our intrinsic biological humanity.
Among the authors are scientists who led the tacit establishment of the landmark 14-day rule for limiting the days of development of embryonic human beings in research experiments. They ridiculed their fellow scientists who warned that accepting the 14-day rule put humanity on a slippery slope to producing more and more mature nascent human beings for death by experimentation, including genomic engineering followed by implantation for gestation and birth.
So, here they are now, proposing 56 days as another “regulation.” Surely by now, everyone must recognize that they have their fingers crossed behind their backs again.
James