Sexism in Science and Tim Hunt

Tim HuntSexism in science is a very real, big problem.

The Tim Hunt situation is just one example. For a reality check on that particular train wreck and background see this piece by Connie St Louis.

The sexism prevalent in science not only has negatively affected tens of thousands of scientists, but also is quite harmful to science overall and to society.

This sexism manifests at countless levels from words to policies to actions. It can be conscious or unconscious. It can be outright sexual harassment.

In Tim Hunt’s case, I find his words to be very harmful, but what concerns me more is that I believe that his words are an accurate window into his thoughts and mentality. He may have done some positive things over the years for some women in science such as his own trainees, but his particular brand of “man versus girl” mentality reflects a persistent and toxic world view. As a Nobel Laureate and leader in science, over the decades his sexist views may well have infected countless others and harmed many.

I don’t buy the “it was just a joke” attempt to walk it back. I’m not really buying the “this is an attack on academic freedom” gambit either when it comes to the push back against the reaction to Hunt.

Sure, social media can be a hell of a maelstrom and a very unforgiving one. I regularly find myself thinking about that reality as a science blogger and academic. Who isn’t worried they might say or write the wrong thing?  It would be nuts not to be awed and conscious over the power of that maelstrom to explode. At the same time, Tim Hunt himself is responsible for his words and actions. He has a special responsibility in his position and in that regard he failed. Was the reaction to his words an overreaction on social media or appropriate all things considered?

As much as this recent high-profile case has caused understandable concern and even some anger, at the same time there is the at least mildly heartening sense that the overall level of consciousness is increasing. Still is that already translating to major concrete outcomes that are positive and measurable? I’m not sure.

For myself I would say that today as compared to past years I am far more conscious of the gender make up of the committees that I serve on, the meetings that I go to or cover on this blog, etc. and aware of the possibility of unconscious bias on my part. I continue to be committed to the importance of diversity and equality in science.

Battling sexism and other discrimination in science is a long slog of a marathon, but I believe the efforts will pay off overall.

Landmark IPSC clinical study on hold due to genomic issue

IPSC RPE sheetThe pioneering induced pluripotent stem cell (IPSC) clinical study in Japan led by top stem cell clinical researcher Dr. Masayo Takahashi has been stopped reports the WSJ in Japan. This development is confirmed by other sources and in a PDF report by RIKEN (in Japanese here).

One patient was transplanted in September 2014 with their own IPSC-derived retinal pigment epithelial cells (using an innovative RPE sheet, see image) for treatment of macular degeneration.

The study then moved on to a possible second patient, whose IPSC did not pass a genomic validation step. Reportedly, these IPSC contained a mutation, potentially in a known oncogene, which is a serious concern. Thus, the team decided to at least temporarily suspend the trial pending a possible redesign. The new plan could involve a change in how the IPSC are produced. For example, the team is reportedly considering the possible use of allogeneic IPSC as well, which could come from CiRA (Center for iPS cell Research and Application, Kyoto University).

It remains unclear at this time whether the mutation in the second patient’s IPSC was pre-existing in the patient’s skin cells or if it occurred during the reprogramming process itself. This is a critically important question to resolve. If the mutation was caused by/associated with reprograming then that would be a deeper issue.

Overall, this situation is of course a concern, but it also reflects the very rigorous and appropriate degree of caution that this team was using in validation studies. Notably, the first transplanted patient is apparently doing well.

I hope to learn more details from Dr. Takahashi and will pass that along on the blog when possible. She has also been tweeting about this development (you can follow her at @masayomasayo). Until we learn more it is advisable to take a cautious approach in interpreting this development.

At mid-year, how are my top 20 stem cell predictions for 2015 doing?

Stem Cell PredictionsEach year towards the end of December I make predictions for the coming year as I did for 2015. In the past I usually make a top 10 prediction list, but for this year I made 20 predictions. Admittedly some of them may have been more hopes than predictions.

At mid-year today on June 30th, how am I doing? See below. Note that of course for some the jury is still out.

BTW, stay tuned for more on an upcoming update on the Japan IPSC macular degeneration trial where there seems to have been a (hopefully minor) hitch.

  • FDA ‘breakthrough’ on stem cells. FDA grants an investigational stem cell biological drug therapy the breakthrough status designation. Status: so far no luck, but still hoping.
  • Adult & pluripotent stem cell advances both impress. More encouraging publications and news on the clinical and translational fronts for both pluripotent and adult stem cell drug development including MSCs. Status: Definitely correct.
  • Doc training in stem cells. More new academic-related training programs for doctors to be true stem cell and regenerative medicine specialists. Status: so far no luck, but still hoping.
  • Big pharma’s big interest in stem cells grows further. Big pharma’s interest in stem cells & regenerative medicine continues to grow including at least one major development that might be takeover of a stem cell biotech or something else. That are some small stem cell biotechs that seem ripe as takeover targets. Status: Mixed bag. Both some positive and some negative signs on this.
  • RTT spread. At least one more state (and probably more) pass Right To Try (RTT) laws setting up a collision course between state and federal laws on investigational drugs including stem cell products. Status: Definitely correct. Tons of states moving on RTT.
  • Pro sports gets a bit more serious about dubious stem cell “treatments”. A pro sport players association or league acknowledges growing and difficult stem cell issues for players. Status: Mixed bag. 
  • More high-profile stem cell paper problems. At least one and probably more major stem cell paper problems pop up and could include retractions. Status: Yes, unfortunately (just see Retraction Watch on stem cells)
  • The UK Parliament OKs 3-parent baby tech. The parliament approves 3-parent/mitochondrial transfer technology, but more steps are required before it is practiced in humans. Status: Correct
  • Stem cell clinic chains Cell Surgical Network and continue to grow for at least the first half of 2015 and probably beyond. They operationally challenge recent FDA draft guidances on adipose and minimal manipulation. Status: Correct
  • STAP-related news on the American front. We learn something on the US side of the story of the retracted STAP cell Nature papers. Status: Not yet, but stay tuned.
  • Muddier stem cell waters. More mixing of “legit” stem cell companies and researchers with the non-compliant side of the tracks. Status: Unfortunately correct
  • More stem cell paper debates and developments on PubPeer. A volatile situation continues with notable twists and turns. Status: Yep.
  • IPSC RPE safety. The IPSC-based RPE trial for wet AMD in Japan continues in 2015 without a reported safety hitch. Status: Probably Wrong (again stay tuned, but don’t freak out).
  • A stem cell biotech finds itself in a hairy situation. What a tangle. Status: stay tuned.
  • At least one patient is harmed or files suit for a dubious stem cell clinic treatment. This is a sad prediction, but unfortunately I think it is likely. Status: publicly not yet.
  • VSEL hell. There will be even more bad news for these Sasquatch of stem cells after the Weissman lab paper that seemed to refute these “very small embryonic-like” stem cells in 2013. What does this mean for NeoStem ($NBS) now known as Caladrius? Status: Nothing public yet, but I still expect it to be a bad year for VSELs. For Caladrius, I’m thinking the impact is minimal since their focus seems elsewhere under new leadership.
  • Celltex is going for an IND. This is an interesting development. Status: not publicly.
  • GOP on stem cells. Republications make some noise on stem cells or personhood. Status: not yet, but they are on CRISPR as my old soccer coach would say when I was a kid “like a duck on a june bug”.
  • FDA back in the game of taking action on dubious stem cell clinics. After a long quiet period in 2014, the FDA takes some action on dubious stem cell clinics. Status: depressingly, not yet.
  • Stem cell-based organs. The red-hot trend of bioengineering organs and tissues in part using stem cells as a material continues to develop. Status: Yes, organs and organoids are one of the hottest trends of 2015.

Monday morning musings: stem cell stocks, ISSCR, grants, CRISPR, New Book, & more

Wake up, it's Monday

What’s on your mind on this Monday morning? Are you caffeinated enough yet? Depending on where you live it may even be time for dinner, bed, or already early Tuesday.

Here’s some musings…

To get safe and effective stem cell treatments to patients in a responsible, compliant manner you need commercial efforts and that in almost all cases means biotechs.

Doing this blog for 5+ years has made it really sink in just how crucial the commercial side is to all of our shared goals. This means that things like stocks, patents, etc. are really important for us all to think about including academics, patients, students, and more. Of course stocks are very important more directly to investors too.

I’m not a big investor overall and my only stock in the stem cell biotech world now is Ocata ($OCAT) in which I have a very small holding (consider this a disclosure). I like the company’s scientific leadership and its technology. Throw in some promising clinical trials for an area of huge need like macular degeneration and it’s hard not to get excited about Ocata. However, even as Ocata rang the bell at NASDAQ last week, the OCAT stock price has been getting its bell rung this year and in particular more recently it has dropped off a (small) cliff. I don’t claim to understand the subtleties of stock investing super well, but one gets a sense that the company is at a sensitive moment in its history right now. The above issues as well as some rumors and intangibles give a feeling of change in the air.

Of course Ocata is not alone. The stem cell  sector is super volatile and the stock prices of other stem cell companies routinely take beatings. For instance, StemCells, Inc. has had a pretty awful time of it lately on the stock front and things seem pretty dicey right now for them. I hope it can turn around. By the way, this post is clearly not financial advice.

More broadly in this area I suppose we can just hope for the best in terms of trial results and financials holding up during tough periods of time. This has been a tougher year than I had imagined on this front for the field. Stay tuned for more posts on stem cell stocks soon. Still it was good to see many stem cell biotechs at ISSCR making presentations of largely encouraging data.

Speaking of ISSCR, I wasn’t there myself, but the sense I got from some attendees is that it was fairly upbeat. Again, seeing more biotechs presenting talks than in the past is very encouraging. I believe that the more diverse that ISSCR can become the better. Stay tuned also for one or two more posts on ISSCR Stockholm including possibly more from Heather Main (see her posts here). It’s looking like Heather may become a more regular contributor to this blog, which I think would be awesome.

Grants are on everyone’s minds even more now than in historical times in science (i.e. meaning a few decades ago). In my 2+ decades in science in various positions I’ve never seen it quite this bad. These days it seems like I’m always working on at least one grant and sometimes several simultaneously. It eats up a lot of time, focus, and energy, but that seems to just be the new reality.

I consider myself lucky to have gotten one foundation grant funded recently. Even so we’ve all got constant worries on grants. I also recently participated again in another NIH study section, which is always a lot of hard work, but a huge learning experience.

CRISPR science has moved at warp speed, but there is also rapidly growing focus in the life sciences on policy issues related to CRISPR-Cas9 technology, particularly in 2015. The next 6-12 months are likely to prove crucial in determining the path forward including possible action by Congress, the NAS, and more.

In addition to participating in the dialogue, I am also currently finishing a new book on human genetic modification that will probably come out late this year or in early 2016. I hope that it educates and sparks more dialogue without getting me in too much hot water. Stay tuned for some previews/teasers on this book in the next month or two.

There’s been a lot of talk lately about the “postdoc crisis” of there being too few academic positions for postdocs, postdoc training periods being too long, etc. This problem has been growing over the years, sometimes the same possible solutions get trotted out, and people wring their hands, but nothing substantive changes. I don’t have some kind of miracle solution, but it is something we should all be thinking about. What might be some creative solutions?

US Congress Wants FDA to Consult Religious Experts and Ban Human Embryo Genetic Modification

Crystal_Structure_of_Cas9_in_Complex_with_Guide_RNA_and_Target_DNAThe US Congress recently held its first hearing on human germline genetic modification.

The meeting included CRISPR-Cas9 pioneer Jennifer Doudna (see video here) on the panel. See image of Cas9 structure from Wikipedia. CRISPR-Cas9 is a powerful, strikingly efficient tool for genetic engineering of cells and whole organisms.

Now Republican congressional leaders have included a provision in the current spending bill that would block editing of viable human embryos and could interfere with important research.

Concern over a possible reactive move by Congress on human embryo editing has been building so this was not exactly a shock, but is still a concern. The National Academy of Sciences and its Institute of Medicine (IOM) have taken on the task of holding a meeting more broadly on the issue of heritable human genetic modification and issuing a report.

According to multiple sources including a great new piece in Nature News by Sara Reardonthe US House would also require the US FDA to consult religious “experts” as it weighs three-person IVF, a form of human genetic modification intended to prevent genetic mitochondrial diseases. Three-person IVF has been approved in the UK, but not in the US due at least in part to unresolved safety concerns. I have been one of the main scientists openly questioning whether three-person IVF is ready for prime time because of limited relevant pre-clinical data.

From Reardon’s article:

“The House legislation calls for another layer of review. It would direct the FDA to establish “an independent panel of experts, including those from faith-based institutions with expertise on bioethics and faith-based medical associations” to review the IOM report once released.”

I am concerned over the possibility of heritable human genetic modification including the future possibility of efforts at human enhancement. However, requiring that religious figures in a sense instruct the FDA or the biomedical community is the wrong way to go.

I’m also not a fan of the idea of legislation restricting the use of genetic modification technology. So I’m with Hank Greely of Stanford who said, “This step seems dumb…”.

To me the best approach instead would be a moratorium imposed promptly by the scientific community specifically on clinical use of human germline modification technology, while allowing in vitro research to occur on a limited basis with careful bioethics training, transparency, and institutional oversight (see my ABCD plan). Could someone violate such a moratorium? Of course that is possible, but a moratorium would at least reduce that risk and importantly serve to place any rogue efforts into an appropriate context both for the scientific community itself and the public.