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.

Stem cell checkup: how are my 2016 predictions doing half way?

Stem Cell PredictionsEach 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.

  1. Another stem cell biotech acquisition by pharma (recall Ocata (now finally sold to Astellas) & CDI in 2015). Checkup: Not yet.
  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. Checkup: Correct.
  3. Stem cell clinics and doping in sports flares up more. Checkup: Clinics yes, doping not yet.
  4. Organoids continue to excite. Checkup: Correct. What a great technology.
  5. 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.
  6. 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.
  7. Stem cell clinics ever more aggressively use celeb clients for PR and marketing Why? It is powerful, effective, and essentially free advertising. Checkup: Correct.
  8. More news on human-animal chimeras. Checkup: Correct. Another hot topic.
  9. FDA continues its slow-go approach to action on stem cell clinics/unapproved stem cell products. Checkup: 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 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.
  11. 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. 
  12. 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.
  13. 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.
  14. 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.
  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. Checkup: Correct.
  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. Checkup: Correct.
  17. ViaCyte has some big newsCheckup: Not yet. What a great company.
  18. High-profile developments on veterinary use of stem cells. Checkup: Correct. For instance see this piece in Scientific American. Cool stuff!
  19. Animal cloning, particularly in China, continues to proliferate. Checkup: Correct.
  20. 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?

Vanity Fair Dissects Stem Cell Surgeon Macchiarini in Exposé

benita-alexander-paolo-macchiarini-a-leap-of-faith-man-of-her-dreams

Benita Alexander Photo of Paolo Macchiarini and herself in Venice

 

Forget retracting a paper, could Paolo Macchiarini try to get a retraction of Vanity Fair piece on his wild personal life an CV?

Macchiarini is one of the more well-known stem cell and regenerative medicine researchers, and not always related to good news. You can see read posts I’ve done on him on this blog including this most recent one related to dismissal of alleged misconduct charges. That development had been some relatively good news for the man sometimes known as the “super surgeon”. He is most recognized for his work on bioengineered trachea made in part from stem cells.

Now Macchiarini is the subject of a scathing exposé in Vanity Fair that reads like something out of the Kardarshian universe.

The Vanity Fair piece alleges amongst other things that Macchiarini proposed to NBC News Producer Benita Alexander, while they were working on an NBC news piece on stem cells called “A Leap of Faith”, even while he was very much married. Reportedly, a wedding with Alexander was fully planned.

Vanity Fair also reports that the stem cell surgeon made claims of knowing many celebrities who would come to the wedding (more below) and that the Pope would officiate their wedding. Allegedly in addition he made the surprising assertion that:

“he was part of a “highly classified group of doctors from around the world who cater to the world’s V.I.P.’s.”

This sounds like the super heroes of medicine.

The wedding reportedly was to have some extraordinary VIP guests too at least according to the names on the invitations:

“the invitations were addressed to, among others, the Obamas, the Clintons, the Putins, the Sarkozys, Andrea Bocelli, Kofi Annan, Russell Crowe, Elton John, John Legend, Kenny Rogers, Meredith Vieira, and His Holiness Pope Francis.”

But it all fell apart according to Vanity Fair.

So what happened?

Benita eventually found out that things were not as they seemed. Macchiarini was already married. The Pope would not have been officiating at their wedding and more.

Vanity Fair went so far as to consult Dr. Ronald Schouten, a Harvard Professor of Law and Psychiatry Service about Macchiarini and Schouten described him as, “the extreme form of a con man.”

Vanity Fair also claims that numerous listings on Macchiarini’s CV are invalid.

What’s next for Macchiarini? It’s hard to say.

Hopefully as for Ms. Alexander, she can go on with her life.

TGIF links to tip-top weekend science reading

Some stuff to read, think about, and do.

Paolo Macchiarini cleared of misconduct, but some charges remain

There has been a great deal of excitement during the past several years over the regenerative medicine work of often-called “super surgeon” Dr. Paolo Macchiarini.

For an update on Macchiarini from a recent scathing Vanity Fair piece, see here.

Paolo Macchiarini

STAFFAN LARSSON/KAROLINSKA INSTITUTE

Hei has done pioneering work. For instance, he created and transplanted bioengineered windpipes that were produced in part via stem cells. However, Macchiarini also faced allegations of multiple serious instances of misconduct from others at Karolinska Institute, where he was a visiting professor. These allegations included charges of deleting or falsifying patient data, and involve seven different publications.

The engineered windpipes were transplanted into three seriously ill patients, two of whom have died while the third has remained hospitalized ever since surgery. We cannot know for sure, but it is quite possible that without treatment all of the patients would have died.

The Karolinska Institute has investigated at least some of the charges and now reportedly has exonerated him. This is a particularly striking outcome because just a few months ago in May a separate, independent investigator (surgeon Dr. Bengt Gerdin) had concluded that the misconduct had in fact occurred. Macchiarini and others reportedly provided additional information to the institution that may have played an important role in the Karolinska decision.

The NYT reports that Macchiarini is not entirely out of the woods yet though as he faces other accusations:

“Dr. Hamsten said that other accusations against the surgeon, regarding whether he had obtained the necessary permits and ethical clearances for the work, were not included in the decision, and that a prosecutor was conducting a preliminary inquiry on those issues.”

In addition to these unresolved issues, the Karolinska wasn’t exactly thrilled with how some of the work had been by done by Macchiarini:

“But the report said that Dr. Macchiarini’s work “does not meet the university’s high quality standards in every respect,” and that it “could therefore be appropriate” for him to submit corrections to some of the published scientific papers that described his work.”

The NYT was able to reach him by email in Russia, where he is now working, for comment on the resolution of the misconduct charges:

“To have been falsely accused of such serious misconduct is every researcher’s nightmare,” he said. “I am very keen that this case prompts a discussion of how such events can be avoided in the future.”

The original investigator, Dr. Gerdin, apparently was not made privy to the new documents of the Karolinska investigation and hence couldn’t comment on the new decision, but he didn’t seem pleased with today’s outcome according to a piece in Science:

“Gerdin says he has not yet read the material submitted in response to his report. But he says the process was flawed, in that it allowed Macchiarini to pull “aces from his sleeve” after the external investigation was complete. That seriously undermined the impartiality of the investigation, he says. “It’s a meaningless process” to commission an independent external reviewer if the final decision is based on documents available only to Karolinska officials, he says.”

In past years, Macchiarini had faced charges in Italy as well, where he reportedly had been arrested (also see news piece in Italian) and related to this some of his work was retracted. I was not able to determine the outcome of the charges in Italy so far, but some have speculated that that was a case of an overzealous Italian prosecutor going after a famous surgeon.

It remains unclear what comes next for the super surgeon, but at least overall Macchiarini appears to have been cleared of the most serious allegations stemming from the Karolinska situation.