Talk about timely. When we decided, several months ago, to hold a Standards Working Group (SWG) meeting to talk about the impact of CRISPR, a tool that is transforming the field of human gene editing, we had no idea that our meeting would fall smack in the midst of a flurry of news stories about the potential, but also the controversy, surrounding this approach.
Within a few days of our meeting lawmakers in the UK had approved the use of CRISPR for gene editing in human embryos for fertility research —a controversial first step toward what some see as a future of designer babies. And a U.S. Food and Drug Advisory report said conducting mitochondrial therapy research on human embryos is “ethically permissible”, under very limited conditions.
So it was clear from the outset that the SWG meeting was going to be touching on some fascinating and fast moving science that was loaded with ethical, social and moral questions.
Reviewing the rules
The goal of the meeting was to see if, in the light of advances with tools like CRISPR, we at CIRM needed to make any changes to our rules and regulations regarding the funding of this kind of work. We already have some strong guidelines in place to help us determine if we should fund work that involves editing human embryos, but are they strong enough?
There were some terrific speakers – including Nobel Prize winner Dr. David Baltimore; Alta Charo, a professor of Law and Bioethics at the University of Wisconsin-Madison ; and Charis Thompson, chair of the Center for the Science, Technology, and Medicine in Society at the University of California, Berkeley – who gave some thought-provoking presentations. And there was also a truly engaged audience who offered some equally thought provoking questions.
CIRM Board member Jeff Sheehy highlighted how complex and broad ranging the issues are when he posed this question:
“Do we need to think about the rights of the embryo donor? If they have a severe inheritable disease and the embryo they donated for research has been edited, with CRISPR or other tools, to remove that potential do they have a right to know about that or even access to that technology for their own use?”
Alta Charo said this is not just a question for scientists, but something that could potentially affect everyone and so there is a real need to engage as many groups as possible in discussing it:
“How and to what extent do you involve patient advocates, members of the disability rights community and social justice community – racial or economic or geographic. This is why we need these broader conversations, so we include all perspectives as we attempt to draw up guidelines and rules and regulations.”
It quickly became clear that the discussion was going to be even more robust than we imagined, and the issues raised were too many and too complex for us to hope to reach any conclusions or produce any recommendations in one day.
As Bernie Lo, President of the Greenwall Foundation in New York, who chaired the meeting said:
“We are not going to resolve these issues today, in fact what we have done is uncover a lot more issues and complexity.”
Time to ask tough questions
In the end it was decided that the most productive use of the day was not to limit the discussion at the workshop but to get those present to highlight the issues and questions that were most important and leave it to the SWG to then work through those and develop a series of recommendations that would eventually be presented to the CIRM Board.
The questions to be answered included but were not limited to:
1) Do we need to reconsider the language used in getting informed consent from donors in light of the ability of CRISPR and other technologies to do things that we previously couldn’t easily do?
2) Can we use CRISPR on previously donated materials/samples where general consent was given without knowing that these technologies could be available or can we only use it on biomaterials to be collected going forward?
3) Clarify whether the language we use about genetic modification should also include mitochondrial DNA as well as nuclear DNA.
4) What is the possibility that somatic or adult cell gene editing may lead to inadvertent germ line editing (altering the genomes of eggs and sperm will pass on these genetic modifications to the next generation).
5) How do we engage with patient advocates and other community groups such as the social justice and equity movements to get their input on these topics? Do we need to do more outreach and education among the public or specific groups and try to get more input from them (after all we are a taxpayer created and funded organization so we clearly have some responsibility to the wider California community and not just to researchers and patients)?
6) As CIRM already funds human embryo research should we now consider funding the use of CRISPR and other technologies that can modify the human embryo provided those embryos are not going to be implanted in a human uterus, as is the case with the recently approved research in the UK.
Stay tuned, more to come!
This was a really detailed dive into a subject that is clearly getting a lot of scientific attention around the world, and is no longer an abstract idea but is rapidly becoming a scientific reality. The next step is for a subgroup of the SWG to put together the key issues at stake here and place them in a framework for another discussion with the full SWG at some future date.
Once the SWG has reached consensus their recommendations will then go to the CIRM Board for its consideration.
We will be sure to update you on this as things progress.
2 thoughts on “Timing is everything: could CRISPR gene editing push CIRM to change its rules on funding stem cell research?”
Freedom and the FDA: The Matt Bellina Story
Matt was diagnosed with ALS at 30 years old which forced him to retire from the air force at a very early age. The video talks about the FDA’s outdated approval system for deadly diseases like ALS that have no treatments or cures.
It’s the same thing, year over year, about funding but when are you all going to push HARD for those needing access to treatments, now?
I’d like to add this story because I find it very disturbing:
Ex-FDA Head Accused of Conspiring to Suppress Information About Harmful Effects of Johnson & Johnson (JNJ) Antibiotic February 9, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON — Margaret Hamburg, the former commissioner of the U.S. Food and Drug Administration, conspired to conceal harmful side effects of Johnson & Johnson (JNJ)’s antibiotic drug Levaquin, according to a lawsuit filed by six patients, Qmed reported this morning.
The lawsuit alleges that Hamburg suppressed information about the drug’s side effects so her husband, Peter Brown, co-chief executive officer of Renaissance Technologies, a hedge fund, could profit from Johnson & Johnson stock. Attorney Larry Klayman, who filed the lawsuit on behalf of the plaintiffs, speculated Brown earned approximately $500 million in Johnson & Johnson stock due to his wife’s suppression of information, according to a statement on his website. In addition to Hamburg, her husband and Johnson & Johnson are listed as defendants.
“This is a major scandal, one that seriously affects the health of not just plaintiffs, but thousands of others. Defendants are alleged to have callously reaped large financial gains and profits at the expense of my clients. The entire sad episode is an example of how some in private industry are alleged to conspire and act with Washington D.C.
Wonder how many effective drugs are kept off market to maintain monopoly pricing ? re:How Corporations Killed Medicine http://www.counterpunch.org/2016/02/09/how-corporations-killed-medicine/