Want $250 as well as at least a sliver of science-related glory?
Within my new book GMO Sapiens on CRISPR and human genetic modification, I’ve hidden a scientific Easter egg.
There’s more Easter egg info over here including the rules.
If you are the first one to find and properly explain this egg to me after buying the book, you win $250. I had originally limited it to the print edition, but e-version purchase is fine too.
So far no one has gotten the hidden egg right.
To give people a better chance, today in this post I’m giving a hint.
The clue is: crack the Easter egg code.
Professor Rudolf Jaenisch of MIT and his former postdoc/now assistant professor at The Jacob Hanna have gotten into a very public, stem cell skirmish over conflicting papers. Hanna raised concerns over a Jaenisch lab paper and things have escalated from there.
This mess is playing out before our eyes on PubMed (there was a comment from Hanna on the Jaenisch lab paper, but now removed), PubPeer (scroll down near the bottom of the comments on that page for several items), on the website of the journal Cell Stem Cell where Hanna also left a comment, and on Twitter, where Hanna posted an edgy series of tweets (see latest below).
Note that the now deleted PubMed comment was nearly the same as the one from Hanna still on PubPeer. Hanna also posted a comment on a Jaenisch PNAS paper from this year and that comment has now been removed as well from PubMed.
It’s not every day that you see biologists duking it out in the wide open like this. Well, maybe a stem cell skirmish happens every month or two, but not every day. This one has quickly gotten pretty ugly.
That much-anticipated public FDA stem cell meeting that was postponed from April will now take place in September and will have a much larger array of diverse speakers.
Many more voices at an FDA stem cell meeting are collectively a good thing, but delay is not.
The large and growing U.S. stem cell clinic industry makes it ever more important for the FDA to move forward quickly with clearer and more definitive guidelines on clinical use of stem cells. At the same time those investigators doing rigorous Phase I, II, etc. FDA-approved clinical trials on stem cells also need clarity. The current ambiguity that has been persisting for years is harmful.
Key questions need concrete resolution from the FDA. Are fat stem cells a drug? Besides some very specific cosmetic applications can fat stem cells ever be used in a homologous fashion? What about the use of bone marrow for conditions that intuitively seem clearly non-homologous such as brain, lung, and other conditions? What about devices? Marketing? The list goes on.
Looking through the participants it is striking how many different stakeholders are slated to talk, ranging from stem cell clinics to patients to associations to university representatives…and even to California’s own stem cell agency, CIRM. I’m very curious to hear what everybody has to say. Unfortunately due to prior conflicts, I cannot attend, but I’m hoping it will be webcast.
There are going to be a bunch of different opinions articulated at this meeting. Sometimes starkly opposing ones will be put forth one right after the other. Maybe this meeting will be a turning point for the FDA to provide a detailed regulatory roadmap for all of us and then consistently enforce what they say. Or maybe not.
If a year from now we find ourselves in basically the same gray zone situation as we are in today with stem cell oversight from the FDA and lack of consistency, then I’m guessing that there will be a near consensus amongst stake holders (despite their diverse opinions on the FDA when it comes to stem cells) that the agency failed in a big way because lack of clarity is harmful across the board.
You can listen to my co-author Leigh Turner’s interview on Science Friday here about our Cell Stem Cell paper on the stem cell clinic industry in the U.S. Start listening around the 8:30 mark.
It’s great that this paper has so strongly raised awareness about the booming stem cell clinic industry in America as well as the urgent need for much more open and active discussion of the serious issues that this reality raises on a number of levels.
You can follow Leigh on Twitter here.
Also, you can read about Leigh’s excellent presentation about stem cell clinics that he gave at ISSCR Vancouver here.
Each December I make stem cell predictions for the coming year and I did that for 2016 where I made 20 predictions. At around mid year I do a checkup on how my predictions are doing halfway and that is the purpose of this post.
Below are my predictions that I made in 2015 for stem cells in 2016 and my general sense in green of where they stand. Overall, I’m doing reasonably well, but I kind of wish I wasn’t because so many of these are not positive developments. However, in general I remain very optimistic for the field and expect major positive advances in coming years on a number of fronts using both adult and pluripotent stem cells.
The predictions and status so far.
- Another stem cell biotech acquisition by pharma (recall Ocata (now finally sold to Astellas) & CDI in 2015). Checkup: Not yet.
- Charging patients for clinical trial participation, particularly in Japan due to the new policy and here in the US related to predatory clinics remains a hot topic. Checkup: Correct.
- Stem cell clinics and doping in sports flares up more. Checkup: Clinics yes, doping not yet.
- Organoids continue to excite. Checkup: Correct. What a great technology.
- Bioheart and some other small stem cell companies struggle. Checkup: Correct so far. The PPSs of small stem cell biotechs have generally not been pushed up this year by investors, but rather the reverse. Note that Bioheart is now called US Stem Cell, Inc. We can all hope that there is a turnaround for small stem cell biotechs in the market in the 2nd half of the year.
- Stem cell stocks overall have a bad year. Checkup: Correct so far also sadly. Note, by way of disclosure I do not currently have any direct stem cell stock investments.
- Stem cell clinics ever more aggressively use celeb clients for PR and marketing Why? It is powerful, effective, and essentially free advertising. Checkup: Correct.
- More news on human-animal chimeras. Checkup: Correct. Another hot topic.
- FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products. Checkup: Correct.
- Pressure from industry and some academics on FDA to not regulate adipose products as drugs and/or to not enforce some other draft guidances including at the upcoming public hearing on the draft guidances. Checkup: Correct. REGROW and other efforts have been unprecedented. Note that the FDA public meeting will now be held in September rather than in April.
- FDA receives increasing public criticism for “slowness” on approving new stem cell therapies including from beyond the stem cell clinic industry. Checkup: Correct in a big way.
- One or more lawsuits against a stem cell clinic. Checkup: Correct and several more seem to be brewing. Note that it appears that the part of the suit involving US Stem Cells, Inc. has been settled, while a separate part of the case against other defendants continues.
- A new stem cell scandal pops up related to publication issues. Checkup: Correct. You just have to go visit Retraction Watch (e.g. the Spain mess) or PubPeer, and then also see the continuing Macchiarini saga.
- Some hiccups on mitochondrial transfer/3-person IVF in the UK or China. Checkup: Correct. Diseased mitochondrial carry-over and mito-nuclear cross-talk issues have popped up and deserve serious attention.
- The trend last year of increasingly blurred lines between legit research entities such as universities and dubious stem cell enterprises continues. This is worrisome. Checkup: Correct.
- Stem cell-derived human germ cells stay in the headlines. This has exciting potential for providing new windows into human development and tackling infertility, but also raises thorny issues such as human genetic modification. Checkup: Correct.
- ViaCyte has some big news. Checkup: Not yet. What a great company.
- High-profile developments on veterinary use of stem cells. Checkup: Correct. For instance see this piece in Scientific American. Cool stuff!
- Animal cloning, particularly in China, continues to proliferate. Checkup: Correct.
- More rumblings on possible human reproductive cloning attempts. Checkup: Not much concretely yet. See this piece on cloning focusing on 20th Anniversary of Dolly.
Stay tuned as near the end of 2016 I will do a final assessment of how I did on my stem cell predictions and then make stem cell predictions for 2017. What are your stem cell predictions?