Perspectives: FDA approves 1st GM animal (fast growing salmon) to eat

AquaAdvantage Salmon

GM Salmon?, FDA image

After a seemingly endless period of review, the FDA has approved the genetically modified (GM) AquaBounty salmon for sale and consumption.

I don’t see any particular reason to think that this GM fish as a food would pose any significant health risks to people. The fish’s hypothetical risk to the ecosystem is greatly reduced by restrictions on where it can be grown to areas away from natural waterways. Note that it cannot be grown anywhere in the US at present.

It’s also worth pointing out that the fish are sterile so even if by some weird fluke they ended up in the wild (e.g. some bozo intentionally set them “free” in a river feeding into the ocean), there would be a huge obstacle to them having negative environmental impact. Some rare GM fish that escaped both captivity and the sterility or some other unpredicted event would have to happen. Zero risk? No, but it seems very low. And for that matter, what exactly is zero risk? Certainly not unmodified foods that can cause allergies, etc.

The AquaBounty salmon, called AquaAdvantage, grow better than wild salmon due to a sustained period of growth hormone production via genetic modification. The FDA does not view the salmon as meaningfully different than wild fish in terms of safety or nutrition so no labeling will be required.

Will consumers eat it? Will we all eat enough of it to make a profit for the company and sustain the product? Time will tell.

Another key aspect to this story is that the corporate owner of AquaBounty is the genetic engineering company Intrexon (XON), which is also interested in human genetic modification.

A number of companies interested in both cloning and genetic modification are working (or have goals toward working) in both animals and humans. I’m not quite sure how to view that overlap. Concerning? Or a logical and productive synergism possible?

Haunting Doudna nightmare about Hitler wanting CRISPR

Nazi Propaganda Poster Eugenics

Nazi Propaganda Poster Eugenics. Source unknown

A recent piece on CRISPR-based genetic modification in the New Yorker called The Gene Hackers or Human 2.0 by Michael Specter is striking in a number of ways. I highly recommend it.

The article provides an in-depth look at CRISPR and its potential use for human editing. I like how the article brings so many viewpoints to bear on this important topic.

The thing that struck me the most was the recounting of a dream, really a nightmare, that left CRISPR pioneer Jennifer Doudna waking up in a cold sweat.

In the nightmare Adolph Hitler wants to learn more about CRISPR and presumably to use it for eugenics (see Nazi eugenics poster above). This dream can be seen as a reflection of the disturbing possible future reality that some may take CRISPR technology in unethical directions and there could be not a whole lot that any of us including a leading scientist like Dr. Doudna could do to stop them.

At the same time this also highlights the importance of a moratorium on clinical human genetic modification. We must make efforts at public education and at frankly doing all we can to stop misguided or even outright destructive people from running with CRISPR in the eugenics direction.

This theme is also dealt with in my upcoming book due out December 1, GMO Sapiens: The Life Changing Science of Designer Babies, which you can now pre-order.

Here is the recollection of the Dr. Doudna’s dream:

“I had a dream recently, and in my dream”—she mentioned the name of a leading scientific researcher—“had come to see me and said, ‘I have somebody very powerful with me who I want you to meet, and I want you to explain to him how this technology functions.’ So I said, Sure, who is it? It was Adolf Hitler. I was really horrified, but I went into a room and there was Hitler. He had a pig face and I could only see him from behind and he was taking notes and he said, ‘I want to understand the uses and implications of this amazing technology.’ I woke up in a cold sweat. And that dream has haunted me from that day. Because suppose somebody like Hitler had access to this—we can only imagine the kind of horrible uses he could put it to.”

Could the “next Hitler”, if there is one which I hope there isn’t, already be interested in human modification?

There are so many amazing, positive things being done and learned via CRISPR and it truly does have great potential for health, but in addition there will be huge risks including to society. That’s not from a dystopian work of fiction. It’s a possible reality that comes with this transformative technology. One at least partial solution is more public engagement and transparency. Sugarcoating what is going on or dishing out overly optimistic views of only positive possible outcomes for the public doesn’t help anything or anyone.

Dr. Doudna deserves enormous kudos not only for her science, but also for her leadership, balanced views and public engagement on wider CRISPR issues. She and her colleagues at IGI really started the ball rolling with discussions of the key, larger CRISPR issues last year. That spark has catalyzed more recent and still ongoing healthy discussions of this revolutionary technology that are incredibly valuable (see more in my interview with her here).

Poll: Would you have a genetically modified baby?


Please tell us in the comments why you voted the way you did.

Are you going to the World Stem Cell Summit? Top reasons you should

WSCSBy Heather Main

This year I will be attending the World Stem Cell Summit for the first time (see @WSCSummit on Twitter).

I was surprised when I looked at the program and recognized so few of the names of speakers; which made me question what this event was about, if not focused on stem cell research. This was a relatively naïve step from someone who has spent their entire academic career working on mouse embryonic stem cells and attending academic-focused conferences, far away from human patients and all of the issues and expertise that would be required to take my academic work and apply it to ‘society’ and humans in the clinic….

There are several concurrent tracks at the WSCS;

  • Discovery – latest scientific discoveries in stem cells and regenerative medicine research, with consideration given to clinical product thinking at early discovery stages…bench to industry to bedside is the slogan.
  • Regmed capital conference – advancing investment and commercialization to accelerate cures. Connects regenerative medicine companies to investors, bringing start-up angel capital and new money into the field.
  • Technology innovation showcase – technologies, products and services focus on defining quality systems to meet manufacturing, regulatory, clinical trial needs, specialized expertise, training and sharing data
  • Translation and clinical trials – showcases significant clinical trials from around the world discussing overcoming regulatory obstacles and the role of patients
  • Regenerative services and applications – the emerging role of regenerative medicine in clinical practice aimed at preparing clinicians and hospital administrators transitioning regenerative medicine into day-to-day medical practice and giving families the tools to make informed decisions about future treatments
  • Hot topics and future trends – focusing on bold and innovative solutions, showcasing guru-visionaries and inspiring advocacy leaders as well as the critical unmet need for cell standardization, integrity of scientific progress and how insurance products will revolutionize the cell therapy and storage industries.
  • Ethics, law and societyuniversal consents for research and clinical trials, technology transfer, intellectual property, comparative law; regulatory law; compliance with FTC, FDA, EMA, best practices for IRB’s and ESCRO committees, moratorium on modifying the human germline, right-to-try legislation and more

What struck me in this program is that there is little focus on ‘basic’ research and instead a heavy focus on translational and applied research, representing the vast diversity of stakeholders critical to this. I have been to ISSCR a few times and never seen a session directed to hospital administrators or talks on insurance products. There are so many worlds in this program that as an academic I have never been exposed to and guaranteed I will never master them all. However, I feel that to validate my ‘significance’ slide, I need to learn a little about these fields or at least make contact with experts in these fields.

While we in the pluripotent world are just getting excited about preliminary results from PSC macular degeneration clinical trials, this program shows just how many ‘real world’ technologies and applications there already are, a wealth of knowledge to the researcher who wants to better plan the direction of their technologies to clinical and commercial applications. As someone said to me recently, there are only so many things you can do with cells, you grow them, dissociate them, concentrate them, and deliver them. Whether you do this with adult stem cells or pluripotent stem cells a lot of the practical and regulatory issues are going to overlap so there is a lot to learn from current applications.

What I love about the Genetics Policy Institute and the WSCS is how nicely their goals and focus complement ISSCR. ISSCR guarantees that basic and applied stem cell research will always get the attention and support it deserves. The board of ISSCR is full of PhD and MD titles that ensure this organization will always uphold the values and importance of the scientific method and development of innovative and efficacious treatments. This is not a small job and requires a wealth of scientific knowledge and experience. The GPI represents the ‘real world’ where human interaction determines the success of a technology, regardless of how brilliant it is. To form the right networks for engaging scientists, business, public, patient, policy, finance, insurance, law etc., towards “a positive policy, regulatory and societal framework to allow research to flourish under high ethical and medical standards” is the premiere goal of GPI.

To finish, I hope that every stem cell researcher puts the World Stem Cell Summit high in your priorities to attend and to send your lab members. The vast majority of PhDs/post docs will need to leave academia at some stage and the earlier we are exposed to the plethora of career options required to get our beloved stem cells to the public the better!

Parkinson’s IPS cell trial in Japan switching to allogeneic

Jun TakahashiIn a major shift earlier this year, the induced pluripotent stem (IPS) cell trial in Japan for treatment of macular degeneration (MD) switched gears from using the patients’ own cells (called “autologous”) to using banked cells from other people, termed “allogeneic”.

Dr. Masayo Takahashi, the leader of this MD trial indicated the main reason was due to regulatory changes related to stem cells in Japan. This decision has delayed the clinical study, but there is hope it will restart soon. It appears for some as yet unknown reason the Japanese government has decided to only allow the use of allogeneic, matched IPS cells from cryobanks.

Now a second clinical study in the works in Japan also using IPS cells but as the basis for treatment of Parkinson’s Disease (PD) appears to be following suit. The PD trial, run by Dr. Jun Takahashi (pictured above; spouse of Masayo Takahashi, making them the world’s stem cell power couple), reportedly will also switch to focus on allogeneic cells.

The advantages of allogeneic cells include the fact that they can be validated and batch prepared in advance. In theory in this allogeneic system there might be no waiting period for patients while their own cells are turned into IPS cells. However, finding matches from a bank of IPS cells may prove somewhat difficult for allogeneic use for some patients. Even with major HLA type matching, minor mismatches could lead to some level of rejection. This could necessitate the use of immunosuppression. By contrast, autologous use of IPS cell-based products would likely require no immunosuppression after transplantation.

Together these changes in IPS cell clinical plans suggest a significant, broader shift in the field potentially toward allogeneic use of IPS cells. It’s not clear if other groups with IPS cell-based therapies in the translational pipeline, including in other countries, will follow suit or stick with the originally hoped for autologous focus.