The miraculous method of growing new human organs inside the body of patients is still valid. You can read how to do it in The Lancet. Everything went fine, according to the authors. Critics, on the other hand, say that the article is full of misleading statements and is a potential recipe for disaster.
Eight patients have been subject to transplants from teams led by surgeon Paolo Macchiarini. Seven of them are dead. A number of them suffered from life-threatening conditions even before the operations, but the severity of their problems has been questioned by investigators and media in some cases. And in one case particularly we know that the patient, Julia Tuulik, could look forward to living many more years with her tracheostomy. That is if she hadn´t accepted an artificial biogenerated plastic trachea, a device from HART, Harvard Apparatus Regenerative Technology from Macchiarini and his team.
Macchiarini is now being investigated by his employer, Karolinska Institutet (KI) in Stockholm, mainly for his activities in Russia, especially the treatment of Julia Tuulik. This is based on information presented in the SVT documentary aired in Sweden in January. And it looks like he is going to lose his job over the activities in Krasnodar, activities the KI leadership claim they didn’t know anything about until they were exposed on tv.
It is still an open question whether KI will have a new look at the allegations of scientific misconduct against PM. The allegations concern seven articles connected to the work with the artificial tracheas. One of them is the “proof of concept”-study from 2011.
The KI leadership cleared PM from the allegations in
December August. The study was not marred by misleading statements and the results will stand, according to the final verdict.
For anyone who has read the conclusions of prof emeritus Bengt Gerdins thorough investigation of the case, and also seen the video documentation on the status of the patient on tv, this decision seems more or less absurd.
Professor Gerdin can show, with documents like the hospital journals and video footage to support him, that a number of the key claims of the study are overstated, misleading or simply false.
Just one of several examples: The study says “The biopsy sample 2 months after transplantation showed large granulation areas with initial signs of epithelialisation and more organised vessel formations, and no bacterial or fungi contamination.”
(all Gerdin quotes from his unpublished letter to Vice Chancellor Hamsten written after PM was cleared. TL)
This means roughly that the regeneration had started. The new tissue was forming, with blood vessels, in a healthy environment.
But the records from pathologist Béla Bozóky – one of the many co-authors of this study – describes the same material as, biopsies from transplanted trachea with necrotic connective tissue with fungi and bacteria…
…meaning that the tissue is dying and showing infections of both bacteria and fungi.
Just one more example:
In a later paper PM claims that”After 12 months, an almost normal airway and improved lung function were assessed.” (we are still talking about the same patient, the ”proof of concept”-case.)
The medical record is clear on the state of the transplanted man at this point in time. Gerdin:
“there was practically a total occlusion of the right primary bronchus which had been widened with a stent, and also a fistula. I developed this further in my first investigation and I am adamant in my opinion, which is the same now as it was then. There are facts in the medical record that says that the patient was in a bad state. The study says something different! I am sorry, but I really can’t understand how this can be explained away and how Macchiarini’s reply can be said to be ”satisfactory”.”
An “almost normal airway” is in real life almost totally clogged on the right side. There was also a hole (fistula) in the trachea. The trachea was artificially widened to let the man breathe. Things were really bad.
But since KI has exonerated Macchiarini, the articles are still good. And as long as KI doesn’t reopen the investigation, they will remain in the scientific record. Which means that HART, of Holliston, Massachusetts still can market their plastic devices with statements like
“Our first generation tracheal implant has been used successfully in five adult human implant procedures.”
One of these ”successful procedures” is the prolonged suffering of Julia Tuulik.
As an aside, the share price of HART soared in August when KI announced that Macchiarini was cleared; up 34 per cent.
How does The Lancet handle the situation? Well, we will see what happens if the investigation of misconduct is reopened. Until now they seem to have followed the simple principle of letting the process have its course and just follow the official decision, which is that no misconduct has been done and that the article is good.
But what surprises is the triumphant (it is hard to characterise it differently) greeting of Macchiarini’s clearance in a Lancet editorial of Sept 5 2015. They really don’t sound very neutral. See for instance their frank opinion that ”the university needs to review its procedures for investigating allegations of misconduct” because this process (Gerdin’s investigation) was ”flawed”?
How did they know it was flawed? I wonder. It is a strange statement when you consider that KI Vice Chancellor praised it. Does The Lancet have access to privileged information in the case?
I just want to remind the reader that the whole idea of creating new human organs through the stem-cell seeding of a plastic scaffold and then inserting it into the patient, is a method that was untried before these “successful processes”. It was unheard of, almost science fiction. There has been hope and dreams and visions about regenerative medicine like this, but we were far from there yet.
In spite of that, the Macchiarini transplantations were accepted at face value, with cheers and glory, only on the evidence from what the team wrote in the formal scientific studies. And those studies are still valid. Ready for replication. At least for a while longer.
info on Hart share price added 16.20 1/2, thanks Johan Frisk