Just as it says: the comments of a philosopher on the high and the low; world events, phenomena encountered and, occasionally, the esoteric happenings of academia.
As you may imagine, the research ethical and misconduct scandal around Paolo Macchiarini's surgical experiments at the Karolinska Institutet (a radio summary is here, text ones are here and here) has been a big deal for anyone engaged in bio- and research ethics in Sweden the past year. But not only here, as Macchiarini has had many international links and seemingly hopped between employers and affiliations all over the place for many years, where he has inspired others to work with similar techniques as himself.
Now, some of these people and institutions apparently do all they can to wash their hands free of any Macchiarini-stains, attempting to suppress and silence any public mention of the past associations and stall potential inquiries, especially to impede them to stimulate big news media to take an interest. Possibly for short-sighted reasons of protecting reputation, but possibly also for the reason of preventing more in-depth investigations of research ethical breach, possible scientific misconduct or, as has happened in the Macchiarini case, violent crime. Actions taken usually include unwillingness to share relevant documentation with external inquirers, or refusal to answer their queries, thus undermining the basis for objective public reporting. Lately, however, some have escalated to aggressive legal actions against inquirers, in order to threat them with financial damage to have them stop reporting and even to withdraw already published material. The rationale of such actions is, of course, not to establish wrongdoing or actual libel (that would take years of legal procedure all the way up to the European court of human rights), but to strategically use the law to construct a financial threat that already at the preliminary investigation and hearing phase undermines the practical possibility of further critical inquiry, as the very economic cost of the legal process itself (regardless of its outcome) will often be impossible to bear for independent inquirers. This, of course, adds to the reason of the tainted researcher to have the tooth paste back into the tube before Big Media gets a whiff, as those would have the financial muscle not to be liable to these kinds of bullying tactics.
A recent example is the German team of Thorsten Walles and Heike Walles (formerly Mertsching) at the university hospital of Wurzbürg, who have recently taken action against critical science blogger Leonid Schneider, who runs the blog For Better Science. Citing their fundamental legal right to be able to freely use their talents ( ≈ pursuit of happiness) – in this case meaning, having successful scientific careers, being able to have better salary, accrue research funds, get new jobs, etc. – they have demanded that Schneider stops reporting about their past experimental trachea transplants, and also won an emergency court injunction that threatens Schneider with jail unless he removes a section of a Macchiarini-report, where the link to the Walles-team is made explicit, and to pay the legal fees for the process leading up to this result. The court order has been made without any hearing of Schneider's side of things, and this is apparently (possibly) OK under German civil law, as he has the right to appeal (provided he can raise the money to pay a lawyer). Schneider has, of course, accepted the injunction and removed the paragraph awaiting an appeal, as can be viewed in this updated version of the original post (linked above), with the relevant section as screenshot here (double click to enlarge):
The original section (cashed here) looked like this (the removed paragraph highlighted by me):
The action has been discussed extensively in a Twitter thread, to be found here. There, among other things, it is made clear that the Walles trachea surgery experiments – like those of Macchiarini – have been retrospectively found to be against European regulation. Moreover, it seems that the information that the Walles so desperately want to be removed from public view is essentially already available for any curious German, through the book Patient meines Lebens – Von Ärzten, die alles wagen by prized journalist Bernard Albrecht, cited by Schneider in his blog post.
I can, of course, acknowledge the vestedself-interest of the Walles to suppress publicity around their past Macchiarini-association, and the fact that they apparently have performed very similar type of irregular trachea surgery experiments as he did at the Karolinska. However, it is clear that there is an overwhelming public interest of having this information publicly available – not only in Germany, but internationally; for potential employers, funders and – not least – patients, who have every right to avoid the risk of consulting a doctor that may make them into guinea pigs in irregular experiments.
Had the Walles acted out of honest and honourabe scientific and medical professional motives, they would, of course, have seen to this themselves long ago, initiating and welcoming transparent inquiries and press reporting the very minute that the Macchiarini scandal emerged. Instead, they have done their best to blinker the public and has, ultimately, resorted to petty threats against those trying to make public the professional actions for which they are, without doubt, responsible and which there is an overwhelming public interest in having open to public view. This course of action, especially the court order to Schneider to censor his past posts, makes it highly likely that this is the path they will continue to thread. Leonid Schneider will undoubtedly do his best to fight back, but as the basis here is financial muscle, not moral or legal righteousness, it is unlikely that he will be able to (afford to) prevail, and the Walles of course know this. Here are the actions those who disapprove of this development can take to make their dishonourable actions moot:
1. Continuously report in social media about the Walles' legal bullying of Schneider (and others), taking every piece of news about the processes as a reason to recite the details of their Macchiarini-association, their experimental surgeries, etc., thus keeping this information in the public domain.
2. Link to existing cashed versions of the original reports. However, it is likely that the Walles will take action to have these scrubbed, so therefore it is also desirable to:
3. Reposting the original, uncensured blog posts on public Google+ and other pages, blogs, etc. I have done so here (uncensured Macchiarini post), and here (detailed post on the Walles history of human experimentation).
This is a crosspost of the original, uncensored version of a post
relating facts and developments related to past surgical human experiments by the German researchers Thorsten Walles and Heike Walles, linked to scandal surgeon Paolo Macchiarini, from the For Better Science blog. The crosspost has been prompted by legal threats having forced Leonid Schneider to remove relevant details regarding the German researcher team from another post, making it likely that such claims will be extended also to the article here crossposted. More details and background on how I view this development can be found here.
A similar crosspost has been made of the For Better Science post on Macchiarini that the Walles have already managed to bully Schneider into censoring, and is available here.
*** BEGINNING OF CROSSPOST (All of this is citation, of the original version of this post by Leonid Schneider):
This is the story of three tracheal transplants, performed by the husband and wife team Thorsten Walles and Heike Mertsching (now Walles), former collaborators of Paolo Macchiarini. My investigation quickly led to the Walles couple setting their lawyer on me, demanding almost €3000 immediately and up to €100,000 later. All because of a single short paragraph from this Macchiarini story,
which mentioned their earlier activities. None of their current or
former employers nor their lawyer chose to share any specific
information about the 3 tracheal transplants, and the fate of these 3
patients.
Macchiarini and the Walleses started their tracheal transplant activities at the Medical University Hannover (MHH), under the regenerative medicine enthusiast Axel Haverich.
Together, the team implanted in 2003 a tracheal patch into a cancer
patient using a piece of pig intestine, and moved their separate ways
soon afterwards. Macchiarini went in 2004 to Barcelona, where he had
his famous trachea transplant breakthrough in 2008 (see my report here). The Walles couple went in the same year to Stuttgart in southern Germany. The thorax surgeon Thorsten to the Robert Bosch Hospital, Clinic Schillerhöhe,
the regenerative medicine-specialising biologist Heike (back then
carrying the name of her previous husband, Mertsching) became professor
at the Fraunhofer Institute for Interfacial Engineering and Biotechnology
(Fraunhofer IGB). There, the husband and wife team transplanted between
2007 and 2009 two more patients with tracheal replacements made from
pig intestine. The clinical success and the actual performance of these
transplants is unclear, it is also not helpful that authors chose to
omit certain key aspects when the two cases were eventually published.
The bill I received from Walles’ lawyer , with threat of up to €100,000 more to come
Heike Walles developed at her Fraunhofer Institute a technology to
grow any kind of tissues and even organs in her high-tech safety
bioreactors: skin, liver, intestine, bone
and of course the trachea, all according to this scientist and her
husband, with its own bioreactor-grown vasculature. This is how the
technology works, according to Thorsten Walles as posted on ResearchGate:
“We developed a bioartificial tissue (TraVaSc-TERM ®) for
the surgical reconstruction of extensive tracheo-bronchial defects
including circumferent airway replacement. The tissue is generated from a
xenogene biological scaffold [pig intestine, -LS] that is
decellularized, preserving the structure of the vascular network. For
transplant generation, these vascular structures are reseeded with
autologous endothelial precursor cells of the recipient. Two more
autologous cell types are needed to generate a functional airway
substitute. Our approach results in a vascularized autologous transplant
tissue that can be connected to the recipient’s blood supply at time of
implantation to guarantee transplant survival. Tissue generation takes
about five weeks. The TraVaSc-TERM ® was applied successfully in three
patients between 2006 and 2009 [actually, it seems one patient was
counted as two, -LS]. As a result of the ATMP-legislation in Europe the
TraVaSc-TERM ®-generation process had to be transferred from an F&E
environment into GMP. This task was finished in 2015 and we wait for
regulatory approval”.
After her 3 allegedly successful tracheal transplants, Heike Walles became a member of the German Ethics Council
(Ethikrat) In June 2010 and served the nation by safeguarding patient
protection and medical ethics in Germany until September 2012. Mightily
impressed by her research achievements, the federal state of Bavaria dumped in 2014 €10 Million
over Heike Walles and invited her to head the new translational centre
for “Regenerative Therapies for Oncology and Musculoskeletal Diseases”
in Würzburg. The new director remained affiliated with her Fraunhofer
institute, but additionally became in August 2009 professor at the
University Clinic Würzburg. Her husband Thorsten received a
professorship at the same place in January 2012. There, the couple began
to collaborate with the technology giant Siemens and are apparently
almost ready to churn out tissues and organs to save hundreds of
patients, based on their previous success stories. As Walles’ co-worker Jan Hansmann from Fraunhofer declared in Siemens-magazine article from September 2016:
“Hansmann describes one of the major successes of tissue
engineering in Würzburg: “Working with the University Hospital and the
Robert Bosch Hospital, we recently produced a complete section of a
human windpipe in the bioreactor and successfully implanted it into a
very seriously ill patient as part of a ‘compassionate use’ program.” In
fact, no other research group in the world has to date produced such a
complex biological implant”.
Silent night
The case of that and other two tracheal transplants was very tangled.
At points, my perception was that the publicly owned German research
institutions deliberately wanted me to follow false leads I picked up on
internet, in order to discredit my reporting. Indeed, the fact that the
Walleses used their official University Clinic Würzburg affiliations in
the lawyer’s letter suggests an involvement of their employer, who received (but never really answered) my questions 2 weeks before my previous article appeared. That would be indeed an interesting new way for a German university to react to a blogger’s inquiry.
The current Walles employers, University of Würzburg and the Fraunhofer Institute for Interfacial Engineering and Biotechnology
(Fraunhofer IGB) chose not to share any useful information with me.
Würzburg categorically denied their University Clinic’s involvement in
the operation described by Hansmann above, Siemens magazine refused to
explain and Hansmann never replied to my email. Thorsten Walles’ former
boss, head of thorax surgery at Schillerhöhe Clinic in Stuttgart, Godehard Friedel,
who co-developed the technology, forwarded my email to his PR
spokesperson, who refused to share any information citing protection of
patient privacy. Thus, no thanks at all go to them. In the end however, I
think I could reconstruct the three trachea transplants made by the
Walles couple quite truthfully.
It got that bad that the press relations offices of the Fraunhofer
IGB, whose job it is to promote the institute’s research and
publications, repeatedly refused to name me the papers where Walles’
three trachea transplant patients had been described. I found those
anyway, and I also found out that some very important aspects have been
omitted from the publications. Small issues like the suspected failure
of the transplants, or these patients being long dead at the time when
the papers were published.
The same Fraunhofer PR officer Claudia Vorbeck who denied me any
information whatsoever, also by insisting that the federally-sponsored
public research institution is exempt from Freedom of Information
inquiries, authored in 2009 a press release
hailing one of these Walles trachea transplants (see 3rd patient
below). All I was made understand was that the Fraunhofer Institute
takes enormous pride in the research of their professor Heike Walles:
“Prof. Walles develops and uses methods of tissue
engineering to produce the most diverse, complex human tissues that are
used for risk assessment in chemical and pharmaceutical research as well
as in regenerative medicine. Prof. Walles and her team use biological
carrier materials for the production of these human tissues. In the
course of her research at the Fraunhofer IGB, Prof. Walles has developed
a biological matrix consisting of a decellularized pig intestine as a
scaffolding structure for a potential trachea implant”.
Vorbeck then added:
“The research work of Prof. Walles for the development
and production of trachea grafts on a biological matrix was carried out
at the Fraunhofer Institute IGB according to the requirements of the
German medicinal product (https://www.gesetze-im-internet.de/amg_1976/).
The authorities responsible in this context were always involved in
accordance with legal requirements. These authorities also have all the
necessary documents on good scientific practice, such as ethics or
animal welfare applications”.
The University of Würzburg refuse to comment on anything which
happened before Walleses became their professors. At least I managed to
get this out, after some yanking:
“The professors Walles declare that the cooperation with
Mr. P. Macchiarini ended already in early 2005. The last common
publications stems from the year 2006“.
The first patient, or Macchiarini-led kick-off in Hannover
I reported previously about this Macchiarini operation in my article
about his patients. As the local newspaper, Hannoversche Allgemeine
Zeitung (HAZ) reported on September 6th 2003,
Macchiarini and the Walles couple transplanted the cancer patient Ernst
Fromhage with a tracheal patch of decellurised pig intestine seeded
with patient’s own muscle cells. The intervention was published as MacChiarini (sic!) et al 2004 and the method as Walles et al, 2004.
Macchiarini is corresponding author on both publications and thus the
principal investigator chiefly responsible for the development of that
technology. However, Thorsten Walles claimed the credit in a 2009
interview for himself and his wife:
„In 2003, I specialized in thoracic surgery for my
surgical training. Here, I first met patients with tracheal injuries
that could not be treated anymore. I was able to convince my then-boss
Paolo Macchiarini of the concept of treating such injuries with
bioartificial tissues. Together we modified the procedures for the
production of human bioartificial tissues for trachea transplants,
originally developed by Prof. Mertsching and myself. Already in 2004 we
were able to successfully treat the first patient”.
Not everyone was impressed. The famous late thorax surgery specialist Hermes Grillo took an issue with this method (Grillo, 2005):
“One must also question placement of a free graft of any
tissue over an area that is still contaminated, even if not grossly
infected, by the bacteria that necessarily are present in such a
situation, despite all cleanup treatment before repair. More to the
point, however, is the fact that defects of this sort have long been
closed by vascularized pedicled autogenous tissues (omentum,
pericardium, intercostal muscle, and other muscle flaps). Addition of an
engineered tissue graft seems superfluous”.
Yet according to Walles, the 2003 operation on the patient Fromhage in Hannover was a success for regenerative medicine:
“The implant healed easily into the airway and there were
no problems. The patient lived for 16 months a self-determined life.
Unfortunately, his cancer caught up with him and he died”.
Now it makes sense why back in spring 2016 the Hannover hospital
refused to share with me any information about the fate of that patient,
claiming that his medical records were not available.
The second patient and his half-story
Of the second patient, a 63-year old man, we do not know the name,
and we do not know exactly what kind of transplant he received. This is
what the 2013 book by the German journalist Bernhard Albrecht, “Patient of My Life” in its chapter “Breathing” (see Google-Books version), tells us about Walles’ tracheal transplants:
“Twice they operated patients whose windpipes were
corroded by cancer. Both did not live long after the operation. The
first patient [Fromhage, operated together with Macchiarini in 2003,
-LS] died on his main disease, but the second one began to question all
their efforts. The artificial trachea rotted namely inside his body. The
fault lied with the absence of own blood supply in the artificial
tissue”.
As Walles lawyer made clear, the artificial material was not plastic,
where “the blood supply does not function”, but based on a biological
scaffold. But the lawyer did not specify how the capillary blood supply
inside dead decellurised scaffold is supposed to succeed. Macchiarini
and his partners in Spain, Italy and UK transplanted many patients with
such, using decellurised donor tracheas. It seems all these transplants
either rotted and collapsed or were overgrown with scar tissue, unless
you trust those authors’ own claims of vascularisation and full
regeneration. It would be nice to know more about Walles’ pig intestine
transplant and how it fared inside that 63-year old man’s throat, but
alas, this is none of public’s business apparently. There was however
this very informative interview from 2009 with Thorsten Walles with the German magazine The Stem Cell (Die Stammzelle):
“Dr. Walles: The technology was ready for operation from
2007 onwards. In the same year a patient with a combined injury from the
trachea and esophagus was arrived to us from another clinic. The
63-year-old has been unable to eat, drink or speak for three years. He
therefore had a tracheostomy and took his food through a stomach probe,
which was introduced through his nose. In the 3 years, a total of 14
surgeries were performed by the various clinics on the patient in order
to close the defect. Unfortunately, all unsuccessful. A surgeon who
treated this patient had heard of our new procedure and referred the
patient to us.
The stem cell: And you implanted a piece of the air tube?
Dr. Walles: Not immediatedly. Due to the large defect, it was
necessary to use an implant with its own vascular supply. We had never
done this before in a human being and we were honestly afraid to use
these new implants in the chest and risk that they would fail and cause
serious complications.
The stem cell: So what did they do then?
Dr. Walles: We grew a bioartificial tissue as we needed it for the
repair of the airway defect and implanted it into the left upper arm of
the patient.
The stem cell: Why exactly there?
Dr. Walles: The blood vessels in the upper arm are easy to reach and
do not require any major surgery. We have connected the graft to the
upper arm vessels with two microsurgical vascular anastomoses. After one
week we removed the transplant again and it was examined by the
researchers in the Fraunhofer IGB.
The stem cell: Why?
Dr. Walles: We wanted to make sure that the artificially produced
vessels work in the implant and that the transplant does not die. We
have therefore clinically checked whether our implant has the function
we expect at all. We also wanted to ascertain whether there were any
side effects, such as, for example, inflammatory reactions occurring
after rejection. We had prepared a second implant for the reconstruction
of the airway and esophageal end defect, which would be ready for use 1
week after explantation of the arm implant. So we had 1 week to prove
how well our technology works in humans. For this the researchers at the
Fraunhofer IGB had to do night shifts. The studies showed that the
transplant was fully functional even after one week. The results have
now been published in the scientific journal Transplantation”.
The paper appeared as Mertsching et al 2009,
but it never mentions that the one-week in-arm experiment was followed
up by the actual trachea transplant into the throat. Surely that bit
would have been most interesting for the worldwide community of thorax
surgeons and stem cell researchers? According to Heike Walles
presentation to the German Ethics Council, the transplant was “fully
functional over a short period of time”.
When the Mertsching et al 2009 paper was published and when Thorsten Walles gave that interview to “The Stem Cell”,
the patient had been dead for almost 2 years already. This was
indirectly suggested by Heike Walles’ Ethics Council presentation,
confirmed by the 2013 dissertation of her PhD student Iris Dally (page 126), as well as by a press release of the state of Baden-Württemberg from October 2008 which quoted Thorsten Walles:
“Walles does not want to rush: “We want to approach the
clinical application of this method slowly.” Despite all the initial
successes, transplantations are still an experimental and risky
intervention. There will always be setbacks. The last patient implanted
with a piece of bioartificial tissue died a few weeks after surgery as a
result of unexpected complications”.
Whatever their reasons to be modest, the ground-breaking tracheal
replacement operation and the ensuing unexpected demise of the patient
were omitted in the Mertsching et al 2009
article. What lead to his death? In his available interviews, Thorsten
Walles never mentioned anything about cancer (but the Albrecht book did,
see above), only a physical injury to the trachea and oesophagus, and
everyone involved refused to divulge any information. It is not clear
therefore why the patient died so soon after a piece of pig intestine
was inserted into his chest as his new breathing tube.
The 3rd patient and another puzzle around the transplant
The interview in The Stem Cell is from August 2009, yet Walles does not mention his 3rd
patient, the Indian Pavninder Singh, whom he and his wife transplanted
just half a year before with a “regenerated” piece of pig intestine. Not
a single word. Instead, Walles speaks of new European regulations and
changes in German medicinal product regulations, which stopped his big
plans:
“In July 2009, we received funding from the German
Federal Ministry of Education and Research (BMBF) (FKZ 0315575) to fund a
clinical trial for the treatment of patients with tracheal and
esophageal defects with our bioartificial transplants. First, we must
provide the regulatory authorities with the information they need in
order to get a manufacturer’s license at the end. Our aim is to obtain a
European approval for our bioartificial tissue implants within the
framework of the study”.
The trial obviously never happened, lacking approval from
authorities. The Walles methodology suffered a major setback when the
new German medicinal produce legislation (Arzneimittelgesetz) became
officially binding on July 17th 2009,
less than three months after Walleses performed the third (and
apparently last) trachea transplant. According to Albrecht book, the
investigations by the authorities into suspected breach of regulations
were therefore aborted.
Singh originally came to Germany illegally, but integrated quickly,
married a German wife and learned German language. On December 9th
2008, the young man in his twenties attempted suicide by swallowing
oven cleaner fluid. Singh survived, but his oesophagus and trachea were
damaged irreparably. He had to be saved by tracheostomy, a permanent
hole in his throat. Because of his burned epiglottis, the patient had to
keep an erect posture at all times to avoid stomach acid flowing into
his airways and lungs. In April 27th 2009, Singh received a
tracheal transplant from the Walles couple, fashioned from pig
intestine. This is how the University of Würzburg described the breakthrough achievements of their new professors:
“Thorsten Walles and his colleagues carried out the
successful transplantation of the replacement trachea at the
Schillerhöhe Lung Clinic in Gerlingen near Stuttgart in April 2009. The
artificial organ was accepted by the body without rejection and
adequately supplied with blood. Unfortunately, after this encouraging
world premiere, the further development and dissemination of the
procedure has been stalled due to European changes in the drug
legislation”.
Now however, the PR person of the University of Würzburg, Esther
Knemeyer Pereira replied to my inquiry that all three tracheal
transplant operations by Walles took place before 2009, and had nothing
to do with the university or its clinic. At the same time, the Würzburg
professors Walles operated until 2014 a personal website “Bioartificial organs”,
where patients were invited to contact Thorsten Walles at Clinic
Schillerhöhe about “bioartificial implants for reconstructive thoracic
surgery” (screenshots of the website here).
This might explain why my inquiry if further tracheal transplants are
intended in Würzburg went unanswered. Meanwhile, a legal action against
me was being prepared.
What Walles or their academic employers never ever mentioned: Singh’s
trachea transplant most likely did not work. Shortly after the
operation, Walles re-opened the tracheostomy, the hole in the throat
remained until Singh’s suicide death in December 2011. This information
is only available in the Albrecht book (“the hole in his throat was his
misery”), because the author met the patient personally in November
2011, shortly before Singh’s accomplished suicide:
“Why does he need the hole [tracheostomy, -LS] still? Dr.
Walles initially closed it, told Singh. But then he had always been
chocking, food and saliva entered the windpipe. The oven cleaner had
also corroded the epiglottis in his throat. Due to heavy scarring, it
did not close properly when swallowing.”
We do not know for sure if the transplant integrated as announced,
but given the tracheostomy, it was unlikely to be of any use even if it
did. Heike Walles declared to the Ethics Council in 2010 that the patient Singh “has no problems whatsoever”. Also her lawyer now sternly told me:
“The patient described in the book by Mr Albrecht lived self-determined life over a long period of time after the operation”.
No mention of tracheostomy, again, but the lawyer did declare that
all information in the Albrecht book was correct. Thorsten Walles
himself spoke in a 2014 interview (which was recently removed from the BioRegio-Stern website, backup copy here):
“We have used a method for the treatment which we have
been researching on since 2000 and where we already had initial
successes in the application. Since the patient wanted the treatment and
we also had the impression that he can make it, we grew a trachea from
the cells of his body and implanted it successfully. Unfortunately,
however, this has not improved his private situation and a few years
later he then took his own life”.
Asked about Singh’s suicide despite the miracle cure which allegedly restored his health, Walles elaborated:
“In the first moment, this pulled the ground from under
our feet. We asked ourselves why we carried out this elaborate treatment
in the first place. This experience prevented us so far from publishing
our scientific results of the applied technology, because we were
questioning the rationale of the treatment in this case”.
The next year however, a paper was published which described a
patient case perfectly fitting that of Singh. With one exception: the
patient in Steinke et al, Tissue Engineering Part A, 2015,
is seemingly alive and well. Where Singh killed himself 2.5 years after
the operation, his published doppelgänger was examined just after the
same period and was found that he “could eat and drink normally and was
also able to play soccer”. No tracheostomy was mentioned, instead:
“The early postoperative course was uneventful and the
transplanted airway tissue was integrated into the host. 2.5 years after
transplantation, a bronchoscopy confirmed the scar-free reconstruction
of the former airway defect. Histological work-up documented respiratory
airway mucosa lining the bronchial reconstruction, making it
indistinguishable from native airway mucosa. After transplantation, our
bioartificial airway tissue provided perfect airway healing.”
Was it indeed a biopsy as the authors report, or possibly an autopsy
of a suicide victim? I tried to find out from the paper’s authors if the
patient was indeed Singh. Walles’ PhD student Dally (who herself
declared Singh as dead in her dissertation), threw down the phone on me,
the corresponding author Maria Steinke,
Chair of Tissue Engineering and Regenerative Medicine in Würzburg, did
the same after telling me she is not entitled to comment. The Fraunhofer
PR person Vorbeck declared to me that the responsibility for the
content and correctness of the two discussed Walles publications
featuring Fraunhofer affiliation lied predominantly with the clinicians
who treated these patients. But not with Fraunhofer or their own
scientist Heike Walles, who according to Vorbeck never performed any
“human experimenting”.
In that Steinke et al, 2015
publication, the authors state that they did not replace a segment of
trachea, but introduced a large pig-intestine-made patch of “membranous
part of the trachea”. This is strange, all other sources (like this Spiegel magazine article from 2011, or even Fraunhofer own press release)
clearly suggest a replacement of the tracheal tube, not a patch. What
did the second patient receive then, the one who died so soon after the
operation? The corresponding Mertsching et al 2009
paper clearly showed a tubular piece of pig intestine. Yet all
information is kept secret by the Fraunhofer Institute, the Clinic
Schillerhöhe and the University of Würzburg. Also the Walles lawyer does
not speak of that unlucky 63-year old man at all.
Clinical trial cancelled?
A scheduled clinical trial with 5 patients, funded
since July 2009 by the German Federal Ministry for Education and
Research, and to be carried out at Clinic Schillerhöhe (see 2013 Dally dissertation, page 139) was apparently not approved and never performed (Heike Walles spoke of 15 patients in her Ethics Council presentation in 2010). A tragedy, certainly for the Fraunhofer Institute and their clinic partners, maybe less so for the patients.
After the hype, these alleged successes became almost forgotten. In
2010, Thorsten Walles received a Von-Langenbeck-Award of the German
Surgery Society (DGCH). The press release
mentions only the first patient from Hannover, the merits are shared
with Heike Walles. Paolo Macchiarini, the corresponding author of that
publication, is someone whom the Walleses seem to be most reluctant to
be associated with, as also the lawyer’s letter made clear.
This is a crosspost of the original, uncensured version of a post relating facts and developments related to the research ethical and scientific misconduct scandal surrounding Paolo Macchiarini from the For Better Science blog. The crosspost has been prompted by legal threats having forced Leonid Schneider to remove relevant details regarding the German researcher team Thorsten Walles and Heike Walles from the post. More details and background on how I view this development can be found here.
A similar crosspost of a For Better Science post on the specific Macchiarini-linked history of the Walles themselves can be found here.
*** BEGINNING OF CROSSPOST (All of this is citation, of the original version of this post by Leonid Schneider, fetched from this cash version):
Professor Macchiarini, because Medical University of Hannover wants it so
If these days you should bump into the miracle surgeon Paolo Macchiarini,
do not just greet him with some offhand “Ciao Paolo”. But also “Hello,
Doctor Macchiarini” would not be respectful enough. As a saying goes
among German clinicians: you must take your time, namely by addressing
the great man in full as “Professor Doctor Macchiarini”. As we
know, after investigations
into the deaths and mutilation of a large number of his patients, the
former star of regenerative medicine was sacked from his professorship
at the Swedish Karolinska Institutet (KI), so that title is now
definitely gone. Macchiarini’s other professorships which he used to
convincingly carry in his CV, namely those from the University of Paris in France and University of Florence in Italy, proved to be fictional (see also KI report here). However, his adjunct professorship from the Medical University of Hannover (Medizinische Hochschule Hannover, MHH)
in Germany is very much real. Here for a change it is not Macchiarini
who is cheating, but the German university which allows him to carry
that academic title against the state’s law on adjunct professorship,
which binds it to ongoing teaching duties. Fortunately, the federal
state of Lower Saxony (which owns this Hannover university) doesn’t seem
to mind either. In fact, their officer for data protection told me it
was none of my business asking whether Professor Macchiarini had been
giving any lectures at MHH in the last years.
Macchiarini was awarded the title of adjunct (ausserplanmässiger) professor by the MHH in 2001 (some background here). Using this faculty association, he was also able to bring his loyal acolyte Philipp Jungebluth to a prize-winning
medical doctorate at MHH in 2010. Whatever the legal frame has been
back in 2001, the higher education law (Hochschulgesetz) of the federal
state of Lower Saxony stipulates in its current version from 2007, §35a, “Adjunct Professors”:
“1. Junior professors who meet the requirements of § 30
para. 4 sentence 2 and who are not employed as professors after the end
of their employment are entitled to have the title “adjunct professor”,
as long as they engage in student teaching. 2. Other persons who fulfill
the prerequisites for professors may be awarded the title of “Adjunct
Professor” for the duration of their engagement in student teaching if
they prove a previous successful teaching activity of several years. 3.
The details are regulated by the guidelines on habilitation”.
In a nutshell, this means MHH can only grant the adjunct
professorship to Macchiarini for as long as he is teaching their
students. Well, is he? The Italian surgeon departed from MHH in 2004 for Barcelona, and left behind a research project, freshly funded by the German Research Society DFG, with the title “Development of a bioartificial trachea”, part of the larger DFG-funding scheme “Lung Transplantation”, organized by his MHH clinic head, heart surgeon and founder of a large centre for “Biotechnology and Artificial Organs”(LEBAO), Axel Haverich. Apparently, the creation of artificial tracheas was carried on in Macchiarini’s absence by his LEBAO collaborators Heike Mertsching (now Walles) and her future husband Thorsten Walles. MHH’s head of press communications Stefan Zorn told
me Haverich’s team aborted that research already in 2006. Apparently
they did not mind receiving its DFG funding for 3 more years afterwards.
The Walles couple eventually moved to the University of Würzburg and tested their Macchiarini-co-developed method (Macchiarini et al 2004, Walles et al, 2004) on two more human patients (as reported in a book
by a journalist Bernhard Albrecht). One died shortly after receiving a
pig-intestine-based trachea transplant, another one (an Indian
immigrant) received a piece of decellurised pig intestine, which
apparently quickly failed as evidenced by re-opened tracheostoma. That
patient eventually committed suicide.
Update 10.12.2016. My investigations led to a legal action of the Walles couple against myself. Details in the main story here.
So much for Macchiarini’s research at MHH after his departure. But
what about his student teaching and medical activities? I was informed
that Macchiarini hasn’t been visiting Germany since 2013, but this may
have changed in the meanwhile, since he recently claimed to have
operated patients in Germany in an interview with one of his Russian sycophants.
I placed these questions to Zorn, the PR responsible at MHH:
which courses have been offered by Prof Macchiarini at MHH since 2013?
should Prof Macchiarini not comply with his mandatory teaching obligations at the MHH, how does the MHH intend to react?
is Prof Macchiarini still clinically active at the MHH, and if not, since when?
Unfortunately, Zorn completely stopped communicating with me long
ago. Most probably because I published two critical articles about the
MHH’s patriarch and patron saint Haverich, who promised to grow a living heart in his lab before his upcoming retirement and whose private company developed growing heart valve transplants which Haverich’s own papers somehow failed to convincingly prove as actually growing.
Since all my previous emails to Zorn went unanswered, I forwarded my
original inquiry as a complaint to the responsible authority, namely Office for Data Protection of the state Lower Saxony. Then Zorn suddenly wrote back, presenting as evidence a confirmation of receipt email
which he actually originally addressed not to me, but to himself. In
any case, Zorn chose not to reply to my questions. Instead, the state’s
officially independent and utterly unbiased officer for data protection,
Christoph Lahmann, wrote to me. Lahmann declared that my inquiry on
Macchiarini’s teaching activities should not be answered by MHH since it
concerns the professor’s personal sphere:
“On the admissibility of the transfer of personal data
from authorities to third parties outside the public sphere, I refer to
the Lower Saxony Data Protection Act (NDSG), §13. Here, the conditions
under which a transmission is permissible from the point of view of data
protection are determined. As a so-called authority standard, §13 NDSG
allows data transmission under the stated conditions, but does not
oblige the public authority to transmit this data. The authority may,
for example, reject the data transmission with regard to the
administrative burden, even if the legal requirements of the NSDG are
fulfilled. […]
In your application, you refer to the freedom of information act
(FOIA) of Lower Saxony. A FOIA is indeed a standard for public sector
information, provided the requested information is actually available to
the public authority and there are no grounds for refusal (eg
protection of personal data, protection of company and business secrets,
employee data protection, copyrights, etc.). 12 federal states and the
Federal Government [of Germany, -LS] have issued freedom of information
acts. There is no such freedom of information act in Lower Saxony.
I hope to have helped you with these explanations”.
That was indeed helpful, certainly for MHH. Lahmann basically rushed
to warn Zorn that he doesn’t have to tell me and my readers anything,
while instructing me and everyone else that one professor’s university
curriculum is nobody’s business. Basically, even if Prof. Macchiarini
should be currently teaching students on trachea regeneration
(personally, I think any such lecture at MHH should be televised
worldwide) or even be operating patients at the Hannover university
clinic, we are not entitled to find out. Most likely however, neither is
happening. The MHH is probably simply quietly breaking the state law,
but thanks to the kind Dr Lahmann from the state’s authority, we are now
denied the evidence.
In fact, Lahmann has excellent colleagues elsewhere in Germany who
took upon themselves the heroic task of protecting their local
universities from nosy inquires (see my reporting here).
These brave data protection officers basically declared to me that
every single thing happening on the university campus falls under
“research and teaching”, and as such exempt from FOIA. That’s because in
Germany, we trust doctors and scientists so much that we sometimes put
them above the law. Anyone wants to place a bet on how the University of
Würzburg will answer my FOIA inquiry about the trachea transplants done
by the Walles couple?
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