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Posted on August 30, 2019 at 12:10 AM

The first meeting of the International Commission on the
Clinical Use of Human Germline Genome Editing was held in Washington, DC on
August 13.  This is a US/UK commission
convened by the UK Royal Society, the US National Academy of Medicine, and the
US National Academy of the Sciences.  Space
for in-person attendance at these meetings appears limited, but information is
freely accessible on the internet.  For
example, the meeting materials and videos from the August 13 can be accessed here,
and one can register to be on the Commission’s mailing list at
this link.
 

It is challenging for anyone with a “day job” whose
work is not dedicated to the field of gene editing to try to keep up with
developments, so the open access to information is welcome.  The August 13 meeting included numerous basic
science discussions as well as some from biotechnology companies seeking to develop
gene editing approaches.  As discussed
often on this blog and elsewhere, so-called “somatic” gene editing—that
is, gene therapy of fully-formed individuals by editing an undesirable gene
such as one known to cause disease–appears generally to fall within the
existing regime of human research ethics and regulation and pose relatively few
unique ethical issues.   The day included industry presentations
regarding somatic gene editing, either “in vivo”—involving injecting
the gene editor into a person—or “ex vivo”—involving removing cells
from a person, editing the cells in the medical lab, then re-injecting the
gene-edited cells into the person’s body as a form of treatment.  In neither case is the editing inherited
across generations, avoiding the larger issues of manipulating human beings more
fundamentally, and, as your present correspondent has consistently argued, unacceptably.

Even for somatic gene editing, however, “getting it
right” in the form of editing the genes intended, and only those, and
developing approaches to assess and control for longer-term or unintended risks
is still a substantial set of tasks, as was described in a
presentation by an official from the FDA
.

The day also included a presentation from the separate World Health
Organization multidisciplinary advisory panel
, which held its first
meeting in March 2019
with another one having been due this week in Geneva,
Switzerland.  At the March meeting, the
WHO panel adopted three
main recommendations for developing oversight of human genome editing
:

  • Establish a structured mechanism for collecting and
    curating details about proposed and ongoing research;
  • “it would be irresponsible at this time for
    anyone to proceed with clinical applications [they mean trying to establish a
    pregnancy or birth] of human germline genome editing”
  • Establish approaches to obtain input from the
    “broadest possible range of stakeholders” and “explore
    opportunities for an open, online mechanism for seeking input.”

All that said, the Salk Institute in San Diego is working on a new
technique of editing, called SATI (short for intercellular linearized Single
homology Arm donor mediated intron-Targeting Integration [say THAT three times
fast!], which is expected to be more versatile than the current “preferred”
technique called CRISPR-Cas9.  Biologic
details between the two differ, but the ethical issues mainly apply to
applications, and are therefore the same for both.  But don’t be surprised if you hear about
“SATI” for 5-10 minutes in the news sometime.

And scientists at Cornell Medical Center in New York City are trying
to gene-edit human sperm
to alter the characteristics of children conceived
using them.  Pressing ahead with getting
ready for the WHO panel’s “clinical applications.”

Mildred
Solomon of the Hastings Center has recently added her voice
to those
pointing out that whether heritable human genome editing should ever be done is
not just a matter of weighing benefits vs risks, but involves much more momentous
possibilities that should give us pause. 
The key graphs:

“Even
as [the WHO and US/UK commissions] regroup to produce clearer guidance,
however, I sense a shift in the debate. For a very long time, the scientific
and bioethical consensus was that we must not do human germ-line
modifications—that we should not change gametes and embryos in ways that would
be permanent, affecting all future generations. In contrast, somatic
modifications, which affect only the person in whom the edits are made, have
been mainly uncontroversial.

But that border
between germ-line and somatic genome modification is blurring; the zeitgeist
feels different. There is a growing sense of inevitability that we will
eventually do human germ-line modification and that our only obligation is to
wait until it is safe. When that day comes, we may want to make permanent
heritable changes to the human species to eradicate otherwise intractable
diseases. We should, however, enter this discussion with eyes wide open,
considering each application on its own merits and anticipating a wide range of
issues that go well beyond safety. Many of these issues are explored in
Human
Flourishing in an Age of Gene Editing
, which will be
published by Oxford University Press on
August 28, 2019.”

I’m willing to forgive the plug for a book from people at Dr.
Solomon’s institution, which is where the editors of the book in question
work.  It looks worth checking out.  In the meantime, the US/UK commission has
called for “expert evidence” to assist them in the task “to develop a framework for considering
technical, scientific, medical, regulatory, and ethical requirements for human
germline genome editing, should society conclude such applications are
acceptable.”  Follow this link to have a
look at their questions.


Posted on

The first meeting of the International Commission on the
Clinical Use of Human Germline Genome Editing was held in Washington, DC on
August 13.  This is a US/UK commission
convened by the UK Royal Society, the US National Academy of Medicine, and the
US National Academy of the Sciences.  Space
for in-person attendance at these meetings appears limited, but information is
freely accessible on the internet.  For
example, the meeting materials and videos from the August 13 can be accessed here,
and one can register to be on the Commission’s mailing list at
this link.
 

It is challenging for anyone with a “day job” whose
work is not dedicated to the field of gene editing to try to keep up with
developments, so the open access to information is welcome.  The August 13 meeting included numerous basic
science discussions as well as some from biotechnology companies seeking to develop
gene editing approaches.  As discussed
often on this blog and elsewhere, so-called “somatic” gene editing—that
is, gene therapy of fully-formed individuals by editing an undesirable gene
such as one known to cause disease–appears generally to fall within the
existing regime of human research ethics and regulation and pose relatively few
unique ethical issues.   The day included industry presentations
regarding somatic gene editing, either “in vivo”—involving injecting
the gene editor into a person—or “ex vivo”—involving removing cells
from a person, editing the cells in the medical lab, then re-injecting the
gene-edited cells into the person’s body as a form of treatment.  In neither case is the editing inherited
across generations, avoiding the larger issues of manipulating human beings more
fundamentally, and, as your present correspondent has consistently argued, unacceptably.

Even for somatic gene editing, however, “getting it
right” in the form of editing the genes intended, and only those, and
developing approaches to assess and control for longer-term or unintended risks
is still a substantial set of tasks, as was described in a
presentation by an official from the FDA
.

The day also included a presentation from the separate World Health
Organization multidisciplinary advisory panel
, which held its first
meeting in March 2019
with another one having been due this week in Geneva,
Switzerland.  At the March meeting, the
WHO panel adopted three
main recommendations for developing oversight of human genome editing
:

  • Establish a structured mechanism for collecting and
    curating details about proposed and ongoing research;
  • “it would be irresponsible at this time for
    anyone to proceed with clinical applications [they mean trying to establish a
    pregnancy or birth] of human germline genome editing”
  • Establish approaches to obtain input from the
    “broadest possible range of stakeholders” and “explore
    opportunities for an open, online mechanism for seeking input.”

All that said, the Salk Institute in San Diego is working on a new
technique of editing, called SATI (short for intercellular linearized Single
homology Arm donor mediated intron-Targeting Integration [say THAT three times
fast!], which is expected to be more versatile than the current “preferred”
technique called CRISPR-Cas9.  Biologic
details between the two differ, but the ethical issues mainly apply to
applications, and are therefore the same for both.  But don’t be surprised if you hear about
“SATI” for 5-10 minutes in the news sometime.

And scientists at Cornell Medical Center in New York City are trying
to gene-edit human sperm
to alter the characteristics of children conceived
using them.  Pressing ahead with getting
ready for the WHO panel’s “clinical applications.”

Mildred
Solomon of the Hastings Center has recently added her voice
to those
pointing out that whether heritable human genome editing should ever be done is
not just a matter of weighing benefits vs risks, but involves much more momentous
possibilities that should give us pause. 
The key graphs:

“Even
as [the WHO and US/UK commissions] regroup to produce clearer guidance,
however, I sense a shift in the debate. For a very long time, the scientific
and bioethical consensus was that we must not do human germ-line
modifications—that we should not change gametes and embryos in ways that would
be permanent, affecting all future generations. In contrast, somatic
modifications, which affect only the person in whom the edits are made, have
been mainly uncontroversial.

But that border
between germ-line and somatic genome modification is blurring; the zeitgeist
feels different. There is a growing sense of inevitability that we will
eventually do human germ-line modification and that our only obligation is to
wait until it is safe. When that day comes, we may want to make permanent
heritable changes to the human species to eradicate otherwise intractable
diseases. We should, however, enter this discussion with eyes wide open,
considering each application on its own merits and anticipating a wide range of
issues that go well beyond safety. Many of these issues are explored in
Human
Flourishing in an Age of Gene Editing
, which will be
published by Oxford University Press on
August 28, 2019.”

I’m willing to forgive the plug for a book from people at Dr.
Solomon’s institution, which is where the editors of the book in question
work.  It looks worth checking out.  In the meantime, the US/UK commission has
called for “expert evidence” to assist them in the task “to develop a framework for considering
technical, scientific, medical, regulatory, and ethical requirements for human
germline genome editing, should society conclude such applications are
acceptable.”  Follow this link to have a
look at their questions.

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