Haruko Obokata (小保方 晴子) website posts dubious STAP cell validation data

Haruko Obokata is most well-known for her role as first author of the now retracted two STAP cell Nature papers. These manuscripts claimed to have made pluripotent and even totipotent stem cells simply by stressing cells out with acid treatment or in other ways. Nobody else could get this method to work to create the so-called STAP cells.

It was an all around scientific disaster and I don’t know anyone who believes that STAP cells are real, but Obokata and another one of her mentors, Dr. Charles Vacanti have still at times indicated their belief in STAP.

STAP cell Obokata 2016

Screenshot from STAP Hope website

Obokata appears to have launched a new website at the end of March of this year and there was a sense that this site along with her memoir-like book would together tell her side of the story plus might continue to push the notion that STAP is real. Update: it is formally possible that Obokata is not running this website so I have made a few change to this post.

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Huge clinical trial patient fees allowed by FDA at times, details often secret

stem cell monopolyI am often critical of for-profit stem cell clinics on this blog for numerous reasons. For instance, one thing that concerns me greatly about these clinics is that they charge patients to get experimental “treatments” that have not been proven to be safe or effective.

But as some patients have pointed out to me over the years, certain FDA-approved stem cell clinical trials also charge patients to receive unproven stem cell therapies.

Should someone (even if that someone is an academic clinical researcher) be able to charge a patient a large access fee to be in a clinical trial in which that patient will be subject to an experimental therapy that could ultimately be proven unsafe and ineffective?

I have serious doubts about this.stem cell monopoly quote

You might be surprised to learn that the FDA in some instances allows patients to be charged to be in trials including stem cell trials and others. Those running the trials can request permission from the FDA to charge patients. The agency then has to evaluate the request. The FDA has a draft guidance on this, but frankly it’s difficult to learn that much from that document in terms of details in how this plays out.

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TGIF Science: funding, CRISPR v. NgAgo, secrets, Zika, & more

Some stuff on my mind for our TGIF Science this week.

Research Funding Ups: NIH. Is it my imagination or is NIH funding slightly improving? This is the overall vibe I’m hearing from the trenches.

TGIF science dart board

Modified Wikipedia image

Research Funding Ups and Downs: CIRM.  CIRM funded some basic research to the tune of a total of $4 million, which is great. On a personal level, just wish my “great idea” had fared better in review there. Kind of a downer, but after a while you get a really thick skin.

I’m still trying to decide what I think of CIRM 2.0’s grant review, especially their “positive” pre-review where there is no scoring or comments. You either make it or are triaged with no explanation or score given to applications. No sour grapes here from me on this particular DISC1 CIRM grant review, but even though my proposal made the cut to get fully reviewed, the actual review was too short, just a handful of vague sentences in total. That’s not helpful.

Secret genome meeting? I’m still scratching my head over that “secret” meeting on a synthetic human genome over at Harvard. They closed the door on the public, the press, etc. The reason given was that a journal had embargoed the heck out of ideas that would be presented at the meeting or something like that. 

CRISPR obsolete soon? George Church was quoted that CRISPR will be obsolete soon because of synthesizing entire genomes from scratch instead (see secret meeting entry above). Then of course there’s the upstart NgAgo that could be simpler and with broader applicability than CRISPR. What do you think of CRISPR versus NgAgo?

My sense is that talk of CRISPR obsolescence is premature kind of like Mark Twain’s quote that reports of his death were exaggerated.

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UK should freeze mitochondrial replacement as Egli paper ID’s serious problem

An important new Cell Stem Cell paper from Dieter Egli’s lab points to an inherent, serious problem with so-called 3-person IVF or mitochondrial replacement technology that warrants putting an immediate hold on all efforts to use it in humans. I have pasted the graphical abstract from the paper below.

Egli genetic drift paper

Graphical Abstract, Cell Stem Cell

For years a few of us scientists and policy groups have argued strongly that this experimental technology is far too risky to try in humans for reproductive efforts in the near future. There were simply not enough data to support the reasonable expectation that the technique would be safe and effective to use to create new children. I felt so strongly I wrote an open letter to the UK Parliament suggesting that they not proceed and this led to a bit of a kerfuffle.

The UK leadership approved the clinical use of 3-person IVF, which was a bold, but highly risky decision.  I believe the UK is now going to have to step back and authorities there should now freeze all clinical efforts at 3-person IVF/mitochondrial transfer for the time being because of seriousness of this new paper’s findings.

What concerns me specifically?

One of the big potential issues about 3-person IVF raised by those of us who earlier argued for more time and more data before pulling that regulatory approval trigger to proceed with use in humans is that the nuclear transfer from the mom-to-be’s egg into the donor’s enucleated egg would bring some diseased mitochondria with it and those faulty mitochondria could amplify. The new paper from Egli’s lab proves that this kind of thing can happen. It suggests that in some cases this troublesome phenomenon is likely to occur after 3-person IVF and in my view this is likely to lead to health consequences for the future offspring.

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Poll: what’s your view of mandatory increase to postdoc pay

Labor law changes will mandate a pay increase to around $47,000 to start for the nation’s postdoctoral fellows because of overtime rules that in most cases will lead to a bump in postdoc pay. It’s about time, right? However, despite good intentions, some concerns have been raised about this new change in terms of potential unintended negative consequences.

For instance, some worry that it could lead to fewer postdocs being employed. The change also comes at a time when many labs are scrambling financially to even continue to exist due to difficulties in getting grants.

Another issue is that the change must take place within a few months rather than over the course of a few years.

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