Grading my top 20 stem cell predictions for 2016: how’d I do?

Below are the 2016 stem cell predictions I made last year and their status now color-coded near year’s end. Green is right, orange is mixed bag, and red is flat out wrong.

Overall, I did better than most past years with only having entirely blown it on four.

Stay tuned later this week for my 2017 predictions, which looks to be a dramatic year in the field of stem cells and regenerative medicine.

The Score Card on 2016 Predictionsstem-cell-predictions

  1. Another stem cell biotech acquisition by pharma (recall Ocata (now finally sold to Astellas) & CDI in 2015). Grade: Some acquisitions, but not huge news.
  2. 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. Grade:  Correct.
  3. Stem cell clinics and doping in sports flares up more. Grade:  not really the two together.
  4. Organoids continue to excite. Grade:  Correct.
  5. Bioheart and some other small stem cell companies struggle. Grade:  Correct.
  6. Stem cell stocks overall have a bad year. Grade:  Unfortunately, generally correct.
  7. Stem cell clinics ever more aggressively use celeb clients for PR and marketing. Why? It is powerful, effective, and essentially free advertising. Grade:  Correct.
  8. More news on human-animal chimeras. Grade:  Correct.
  9. FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products. Grade:  Sadly correct.
  10. 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 public hearing on the draft guidances. Grade:  Correct.
  11. FDA receives increasing public criticism for “slowness” on approving new stem cell therapies including from beyond the stem cell clinic industry. Grade:  Correct.
  12. One or more lawsuits against a stem cell clinic. Grade:  Correct in a big way. E.g. versus U.S. Stem Cell, Lung Institute, and Stemgenex.
  13. A new stem cell scandal pops up related to publication issues. Grade:  Correct. You just have to go visit Retraction Watch (e.g. the Spain mess), For Better Science, or PubPeer, and then also see the continuing Macchiarini debacle in particular.
  14. Some hiccups on mitochondrial transfer/3-person IVF in the UK or China. Grade:  Correct. Diseased mitochondrial carry-over and mito-nuclear cross-talk issues have popped up and deserve serious attention. Remarkably, nevertheless UK folks are going forward with it in humans anyway.
  15. The trend last year of increasingly blurred lines between legit research entities such as universities and dubious stem cell enterprises continues. This is worrisome. Grade:  Correct. For instance, see Rasko paper.
  16. 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. Grade:  Correct.
  17. ViaCyte has some big news. Grade: Not yet… 
  18. High-profile developments on veterinary use of stem cells. Grade:  Correct. 
  19. Animal cloning, particularly in China, continues to proliferate. Grade:  Correct.
  20. More rumblings on possible human reproductive cloning attempts. Grade:  Some here and there, but not much. See this piece on cloning focusing on 20th Anniversary of Dolly.

REGROW Act, Mark Kirk Lobbying & Contributions Yield Stem Cell Surprises

Center for Responsive PoliticsThe money behind a piece of legislation can provide unique insights into the back story and this is definitely true for the REGROW Act that would reduce FDA oversight of the investigational use of stem cells in patients.

Senator Mark Kirk of Illinois, who is facing probable defeat next week in his reelection bid according to polls, has been the leading backer of the REGROW Act. Kirk has been more in the news of late due to extremely controversial Trump-like comments he made about his opponent, veteran Tammy Duckworth. Some have characterized these comments as “racist” and inflammatory.

Kirk has received campaign contributions from a number of businesses involved in stem cell product development that could stand to benefit financially if there was weaker oversight by the FDA. Data on these contributions come from research on the Center for Responsive Politics website (note that only the top 100 are listed there out of thousands of contributors, while others can be searched for manually, and the list changes over time). This money came directly or more often indirectly to him, as sometimes contributions came from second parties or employees.

Certainly, companies may contribute to Kirk just because they like him overall and with no specific interest in REGROW, but it seems to be his signature piece of legislation these days.

Senator Mark KirkU.S. “Big Pharma” companies Baxter and Abbott Laboratories contributed to Kirk. A small contribution came from Astellas Pharma, a Japanese big pharma company involved in stem cell clinical research (e.g. it bought the small American stem cell biotech Ocata last year). The “drop in the bucket” donation from Astellas to Kirk is notable if nothing else symbolically because in Japan the stem cell clinical arena has recently been subject to substantially reduced regulatory oversight and proponents of REGROW often point to the Japanese stem cell regulatory system as a model for what they want to achieve in the U.S.

A $10K contribution to Kirk’s campaign came from MiMedx Group, a stem cell company with some history with the FDA. I did a post on MiMedx in 2013 here on this blog because of an FDA letter sent to the company regarding its unusual placental “stem cell magnet”. More recently, the financial website The Street also reported in May of this year that MiMedx filed suit against another stem cell company, Osiris, for “allegedly falsifying and misleading consumers with clinical data.” That’s a pretty harsh allegation, but I’m not aware if there’s any hard evidence to back it up.

MiMedx made this remarkable claim at that time about why its product doesn’t need further testing:

“Mother nature did safety and efficacy testing on the tissue,” MiMedx CEO Pete Petit told ABCNews.com, likening treatment with a placenta-based product to a kidney transplant rather than the use of a drug. Since the placenta product is made from human tissue, he said testing is unnecessary because placental cells already work in the human body.”

More broadly, according to the Center for Responsive Politics, 26 groups in all are registered to lobby on REGROW, a collection of entities including some for it and some against it. REGROW is also reportedly being promoted by Ed Bosarge, whose company Bosarge Life Sciences is on that REGROW lobbying list.

Overall, there have been hundreds of thousands of dollars spent on REGROW lobbying including from big pharma. Some of the more vocal proponents for less FDA oversight of stem cells have claimed for years that the big pharma industry has interfered with stem cell treatment development and has undue or even corrupt influence on the FDA to block patients getting access to stem cells. This always seemed like a wild conspiracy theory to me and now with these data on lobbying we can all confidently say that “Big Pharma opposing stem cells” myth is officially 100% busted.

Some might argue that some big pharma being supportive of REGROW is a sign that the bill is meritorious. Notably, however, some other groups including industry associations are opposed to REGROW as well including the Alliance for Regenerative Medicine (ARM).

REGROW has also evolved over time to be less extreme and I wonder if in yet another new incarnation the bill could be more balanced in the future so that it might garner more broad support within the stem cell community. I hope so. The goal of getting stem cell and regenerative medicine therapies to patients more efficiently is a noble one that I support as long as it doesn’t sacrifice the common sense, biomedical science-based need for rigorous data on safety and efficacy in the process.

It’s important to point out for context that certain companies lobbying on REGROW and/or contributing to Kirk also give out dozens of contributions all the time to many different lobbying and election efforts. This means that REGROW might be just one of many targets for them and in some cases the dollar amounts aren’t huge, but still REGROW is clearly on their radar screens.

What is happening now and will happen in the future? It’s interesting to speculate about whether the FDA is under political pressure and subject to lobbying to weaken or back down on its four guidances related to stem cells that are still in draft form, but to my knowledge there is no publicly accessible information on this area of lobbying. If anyone has information on that, please share it with the community.

Stem Cell News Briefs: Anversa, Japan Regs, Ocata Suit, More

It’s been a busy few weeks for the stem cell field. Below are some news briefs on developments.

  • RetractionWatch reports that Piero Anversa is leaving Harvard/Brigham and Women’s Hospital after an investigation and dismissed lawsuit he filed against the institution. All still quiet on the STAP cell front at the same institutions.
  • There’s some more clarity and confusion over the Japanese regulatory sphere for IPS cells. New regs may not be issued for another 4 or more months, leaving the clinical studies there in some limbo timing-wise. JapanNews asks “Are the mutations found in the RPE study relevant?” and quotes an anonymous source that they aren’t.
  • An interesting new paper on direct reprogramming to a cardiac phenotype. What do you think of this work?
  • Shareholders in Ocata, in the process of being acquired by Astellas Pharma, are unhappy with the deal and perceived undervaluing of Ocata in the purchase. A number of reactions are in the works including a class action lawsuit. Note: I have a very small, long-term stake in the company.Timothy J. Kieffer
  • 2015 Till-McCulloch prize goes to Timothy J. Kieffer (pictured)
    and his lab for outstanding research on production of insulin-secreting cells.
  • A link between Duchenne and stem cells could be important.

What is Astellas Pharma, the purchaser of Ocata?

Fish eating fish

Photo from freestockphotos

Astellas Pharma is on track to purchase Ocata Therapeutics (formerly Advanced Cell Technology).

This has stirred a lot of strong feelings amongst investors in Ocata.

I’ve also been wondering what exactly is Astellas Pharma?

Astellas is a giant compared to Ocata with reportedly $11 billion USD in revenue and $1.3 billion in profit just in the year 2013 alone. While Ocata was worried about a few million dollars here or there, Astellas operates in the billions.

Not only that, but Astellas is just part of a much larger entity called Mitsubishi UFJ Financial Group, which has more than $2 trillion (yes, with a T) in holdings. So you almost have to imagine one of those drawings with increasingly bigger fish eating smaller and smaller fish. Mitsubishi UFJ is a blue whale to Ocata’s minnow.

There are many unanswered questions at this point.

Some have pointed out that this is a Japanese company buying an American biotech that has received NIH funding. Should there be special considerations in a case like that? I’m not aware of that issue playing a significant role in past purchases of this kind.

Will this purchase provide an influx of much needed financial support to Ocata’s pipeline and in the end help patients? Or could Ocata’s work get lost inside the whale? Time will tell.