This article reports the results of an investigation performed in Iceland by the Landspítali University Hospital, concerning the scandal surgeon Paolo Macchiarini and his past host, the Karolinska Institutet (KI) and their University Hospital. The Iceland resident Andemariam Teklesenbet Beyene was the first ever person, or in fact a living being, to receive a plastic trachea. He was 39 at that time and died two and a half years later, slowly suffocating on the collapsing and rotting plastic graft, with Macchiarini still claiming that the patient had originally no more than 6 months left to live and that his plastic trachea transplant had his life significantly extended. The investigation shows that this was not truth. A palliative laser debulking surgery was denied to Beyene, while Macchiarini and his KI decided in advance to use the unsuspecting patient for their plastic trachea experiment, and even skipped the necessary medical examinations to achieve their goal. No ethics approvals were sought, Macchiarini simply lied about those. Beyene went to KI to be examined,  clueless of what awaited him, and just 2 days later, instead of returning home to discuss the therapy options, he signed his own death sentence.

The Erithrean patient was working on his PhD in Iceland, where he was diagnosed with a slow growing form of tracheal cancer, which obstructed his airways. The surgeon Tomas Gudbjartsson operated Beyene in 2009, when he removed part of the tumour. After Beyene developed breathing difficulties again, Gudbjartsson referred him to Macchiarini and KI, to discuss treatment options. Yet the Icelandic surgeon was informed in advance that Macchiarini decided to transplant Beyene with a plastic trachea. He even helped Macchiarini remove the therapeutic option of laser debulking from the patient’s assessment. Afterwards, Gudbjartsson travelled to Stockholm to join the trachea transplant operation on Beyene. Even when during the operation the tumour proved to be much smaller than diagnosed by Macchiarini, the native trachea was removed and replaced with the deadly plastic contraption.

After the operation, Macchiarini and KI stopped caring for the patient Beyene, except of using him as material source for their publication in the elite journal The Lancet (Jungebluth et al, 2011). The first author of this lies- and misconduct-tainted masterpiece, which retraction was now requested by a Swedish Ethics Board investigation, is the German doctor Philipp Jungebluth, a student and acolyte of Macchiarini. Jungebluth is suing me in court, and there he used that same Lancet publication to convince the judge that his medical research saved patient lives. Jungebluth also convinced the same Berlin judge that he had nothing at all to do with Beyene or any other trachea transplant patient of Macchiarini’s. It does not matter that in this (and another manuscript) Jungebluth wrote that he “assisted the surgery and with collection of secondary data”. The latter means,  as the Iceland investigation uncovered, that he helped Macchiarini chase after Gudbjartsson to call in Beyene for bronchoscopies and other examinations, which sole purpose was to provide data which the Lancet peer reviewers have requested. Gudbjartsson complied unquestioningly, for which he now received a reprimand.

According to my source, Prof Gudbjartsson was now sent on a 4 week leave, while the Landspítali University Hospital decides about his professorship.

Update 11.11.2017. Please read the comment section, where I publish

75e4ba2914200865ea42dffbc76982aa38548560c7b0765cba0daf1548a6dd30_713x0
Gudbjartsson and Beyene. Source: Visir.

Beyene’s story, in brief

Beyene was originally not supposed to be the first ever plastic trachea recepient. As the assistant and Russian biographer of Macchiarini’s, Elena Kokurina, wrote in her 2015 book “Megagrant”, Macchiarini toyed with the idea to use plastic tracheas since 2009, because the decellurised cadaveric grafts took too long to prepare and were troubled by heavy safety regulations Macchiarini wanted to avoid. The first ever recipient for the plastic novelty was supposed to be the little US-Korean child patient Hannah Warren. Because the US FDA kept refusing permission, and because KI wanted to finally see at work the magic of their new expensive guest professor Macchiarini, Beyene was chosen as their human Guinea pig. There were no previous animal tests whatsoever, as a Karolinska investigation from 2016 determined.

The same book Megagrant also tells about Beyene, who is quoted to have had this conversation with Macchiarini:

– What did Dr Gudbjartsson tell you after you phoned me at night? [according to the book, Beyene phoned Macchiarini prior to his visit to KI and expressed his fears and reluctance to receive a plastic trachea, -LS]

– He said: “Do you want to see your children grow up? In this case even one-two years of life is luck. Beyond that: noone can know”. After that I spent a whole day on Internet, studied the information and understood that I have no other chance”.

To me, Gutbjartsson denied these Kokurina descriptions:

“This is not true, and has been discussed in details by different media. This was a conversation between Macchiarini and Andemariam she is referring to. I was not involved in the decision to do the tracheal transplant at all”.

As we learn below, he may have not been involved into this transplant decision, but he sure didn’t try to stop or even delay it. And he certainly wanted to be on that Lancet paper.
The plastic graft was made in London by the physicist Alexander Seifalian, who recently received the entire blame from the investigation at his past employer UCL (read here). The UCL committee even insinuated that Beyene’s death might have been caused by the lacking GMP certification of the plastic material, which they insist (against all evidence) Seifalian smuggled to KI without the knowledge of UCL and Macchiarini’s clinical partner Martin Birchall there.

After the operation on June 9th 2011, complications started. As a source in Iceland, who also forwarded me the committee’s report explains:

“Already in August there was a videotaped bronchoscopy that showed that there was no epithelialisation of the plastic trachea and there was a fistula already into the mediastinum.

When the Lancet article was accepted and the galley proofs were sent to co-authors neither Tomas (nor the bronchoscopist, Oskar Einarsson) did object to the description in the paper that there was new epithelium on the scaffold and that the patient was well. He wasn´t; he was coughing and being sent back to Stockholm where stents were placed into a collapsing plastic trachea about two days before the Lancet publication was made official on the internet.

Tomas then held a conference in Reykjavik in June 2012 with Macchiarini as the main speaker where they advertised the operation as being a success. The received world-wide acclaim. At that time Andemariam´s condition had deteriorated markedly, he had had new stents added, I think at least twice at that point. He smelled as if was rotting inside”.

The horrible suffering and death of the patient Beyene were narrated in the Swedish TV  documentary “Experimenten“, by Bosse Lindquist.  Macchiarini still claims he extended Beyene’s life. Up to 10 more patients received a plastic trachea from Macchiarini (list here), it seems only one of them was lucky enough to survive when the graft was removed.

The Iceland Committee

One year ago, on October 26th 2016, Páll Matthíasson, CEO of Landspítali University Hospital, and Jón Atli Benediktsson, Rector of the University of Iceland, appointed a committee to investigate the Beyene trachea transplant case. The focus was on the involvement of Landspítali University Hospital and the University of Iceland and their employees, of which Gudbjartsson was a key figure. As investigation committee members were appointed Páll Hreinsson, Judge of the EFTA Court in Luxembourg and former Judge of the Supreme Court, Georg Bjarnason, medical oncologist and Senior Scientist at the Sunnybrook Health Sciences Centre in Toronto, Canada, as well as María Sigurjónsdóttir, psychiatrist at Oslo University Hospital in Norway.

The full report, in Icelandic language is available here. It contains many quotes in English, as well as a long English-language summary, which I provide extra here

Selected for experiment

We first learn from the report that Gudbjartsson was informed by his Italian colleague at KI, several times and in writing, that Macchiarini was not really interested in examining the patient Beyene, but in testing his idea of a plastic trachea on this human Guinea pig:

“It is the opinion of the investigation committee that Tómas Guðbjartsson was aware that Macchiarini and his colleagues were at least considering a trachea transplant as a treatment option for Andemariam before he was admitted to Karolinska University Hospital. The aforementioned phrasing of Tómas’ application to Icelandic Health Insurance confirms this, where it is stated: “or possibly curative resection with or without tracheal-transplant.”

Written correspondence between Macchiarini and Tómas also provides evidence that Tómas should have suspected that the transplant referred to a synthetic trachea rather than a trachea from a deceased donor. Thus, Macchiarini describes this treatment option in an email to Tómas, dated 15 April 2011, as “a tissue engineered transplant using a new technique via nanomedicine approach”. It should, however, be noted that in an interview with the investigation committee on 23 January 2017, Tómas stated that he had not understood the meaning of this word. In Macchiarini’s email to Tómas, dated 20 April 2011, Macchiarini mentions the need for information regarding the size and shape of Andemariam’s trachea:
“[…] so that we could generate a tissue engineered graft. […] With this measures we could make a scaffold and eventually use it if primary reconstruction would not be feasible.”

In an email to Tómas, dated 21 April 2011, Macchiarini discusses “the hypothetical trachea that needs to be implanted”. Here, he emphasizes the need to hurry to get the dimensions of Andemariam’s trachea: “to get in time the scaffold and the bioreactor.” This is reiterated in an email, dated, 3 May 2011, to radiologists Pétur Hannesson and Maríanna Garðarsdóttir, of which Tómas received a copy. There, Macchiarini explains the need for the dimensions of Andemariam’s trachea in the following manner:

“we could implant a bioengineered synthetic grafts but to do so we would need to know all the measures of the native trachea (proximal, distal, etc.) so that we can generate a graft that matches the sizes of the native trachea.” “

When interviewed during the investigation, Gudbjartsson claimed to have overlooked Macchiarini’s numerous references to plastic trachea in those emails. The commission however saw that this was not the “diligent” way to treat a patient and decided:

“Under these circumstances, the investigation committee believes that a normal response would have been to request further information regarding the procedure, if the information provided in the emails had been unclear. Such an inquiry could have led to questions regarding the type of treatment under consideration at Karolinska University Hospital. Answers to these questions could then have led to a discussion about the desirability of the choice of treatment among specialists in Iceland before the patient travelled to Sweden”.

No other options? Actually…

Beyene was offered by surgeons in Boston, USA, an established therapy method of laser debulking to reduce his tumour. Gudbjartsson initially put this therapeutic possibility into his assessment, but removed it upon Macchiarini’s insistence. The patient was to be presented to the Swedish ethics committee as without any other options but a plastic trachea transplant. Gudbjartsson did as told, and the new assessment no longer mentioned laser debulking as a viable option for cancer therapy. Only that Macchiarini never actually bothered to contact any ethics authorities, his Karolinska decided to move ahead without. From the Iceland committee report:

“Macchiarini mentions in an email to Tómas, dated 11 April 2011, that “any reference to a transplant would be appropriate”. Due to this, Tómas appears to have added the following text to the referral:

‘Now (early May, 2011), the patient has increasing stridor and is in need of either laser debulking of the tumor (palliative treatment), or possibly curative resection with or without a trachea-transplant. Professor Paolo Macchiarini at the Karolinska Hospital in Stockholm has been consulted and he wants to have the patient over to Stockholm for evaluation. Preliminary date for surgery or laser treatment is May 24, 2011′.

In an email, dated 12 May 2011, Macchiarini once again requested that Tómas change his letter regarding Andemariam’s medical history, which had been attached to Tómas’ email to Macchiarini from 11 April 2011. These emails are included in Chapter 5.4.1. above. The changes involved replacing the words “Is surgery a possible treatment modality for his patient?” with the following text:

‘This patient has already exhausted every medical treatment and his only hope of survival and cure is, given that the tumor is only locally invasive and has no regional or systemic metastasis, the resection of the tumor with a safe reconstruction, either via standard airway surgery or using a transplant. I kindly ask you to help us in this difficult case”.

These changes never entered Beyene’s medical records. Neither did the original assessment by doctors from the Massachusetts General Hospital in Boston, US.  That final assessment, which was actually the basis for this patient’s initial referral to Karolinska, recommended laser debulking as the best course of action in Beyene’s case. To leave it out of the medical records was in breach of the Icelandic Health Records Act.

Entering the trap

When Beyene arrived in Stockholm, Macchiarini and Karolinska were already set and ready to transplant him with a plastic trachea. Long before they saw the patient for the first time, Karolinska doctors decided to make him the first living organism to test this technology. The patient had no clue of this, but the place and even date of his operation were already set. In fact, as the reports from Iceland and Sweden acknowledge, Beyene’s medical records suggest that he was never told about the plastic trachea treatment awaiting him at Karolinska University Hospital (though Kokurina’s book suggests something different). It apparently slipped Gudbjartsson’s mind to tell his patient about the big plan. Beyene might have only learned of it when he arrived in Stockholm and met Macchiarini. Instead of going back to Iceland to discuss his treatment options as scheduled, Beyene ended up signing the “informed” consent and subjected himself to a deadly experiment:

“As mentioned above, the formal referral of Andemariam to undergo treatment at Karolinska University Hospital, which was sent 11 May 2011 to Dr. Ulf Lockowandt, requested from Karolinska University Hospital a professional evaluation by specialists as to whether laser debulking of the cancer or surgery were possible. Despite this, Macchiarini seems to almost immediately have gone on to convince Andemariam that a synthetic trachea transplantation was the only possible course of action, which, however, had never been performed on a human anywhere in the world. Only forty-eight hours after admission, i.e. on 26 May 2011, Andemariam signed a declaration of consent to undergo the procedure. He did not return to Iceland on 27 May as planned.

An email by Macchiarini to Magnús Páll Albertsson at Icelandic Health Insurance, dated 29 May 2011, states that the “transplant Protocol” for the synthetic trachea transplantation was ready at the time and the electronic document 28 MB in size. It is quite interesting that an email from Macchiarini to Tómas, dated 12 May 2011, i.e. 12 days prior to Andemariam’s admission, states that the place where the “transplant” were to take place had been established as being in Huddinge. This email is included in Chapter 5.4.1. At that point, both the type of treatment and place for the surgery had been chosen.

Bengt Gerdin’s report states that six days before Andemariam was admitted to
Karolinska University Hospital, a referral was issued for a PET/CT scan. The referral explained that the purpose of the scan was to determine whether a synthetic trachea could be implanted. Emails, which Jan-Erik Juto sent Tómas five and six days prior to Andemariam’s admission also seem to confirm this understanding. These emails are included in Chapter 5.2.1. In the later email, Jan-Erik Juto states that the major surgery (swe: den stora operationen) would be 7 June, i.e. two weeks later. The two weeks were needed to prepare the stem cells (swe: förberedelser av stamceller). In this context, it is important to bear in mind that stem cells were only needed if the intent was to implant a stem-cell-seeded synthetic trachea into Andemariam. Stem cells had not been discussed in connection with other treatment options for Andemariam”.

With such a modified referral for patient Beyene from Landspítali University Hospital to Karolinska University Hospital, Richard Kuylenstierna, Medical Director of the Division of Ear, Nose and Throat Diseases at Karolinska University Hospital (who also played a key role in recruiting Macchiarini), decided that they now had “a proper referral” at hand and that one of the “obstacles” has been eliminated, as he put it in his email to Macchiarini from May 24th 2011. What was lacking, was the minor issue of patient’s own consent to become the Guinea pig for Karolinska. Which Beyene signed on May 26th 2011.

Skip the diagnosis

It is peculiar that the medical reality of the patient was utterly irrelevant to his Karolinska doctors. They had no inclination to run any cancer biopsies in order to determine the type and growth rate of the cancer and to establish the intervention in the best interests of the patient. No oncologist was invited to contribute on these surgeons’ decision on cancer cure. Fact was, Beyene’s tumour was certainly not as big or immediately life-threatening as Macchiarini still claims. A histological examination of the patient’s trachea, after it had been removed during the surgery at Karolinska University Hospital, revealed the same type of very slow-growing cancer, which had been diagnosed and partially removed when Beyene underwent surgery in Iceland on October 29th 2009, namely grade 2 mucoepidermoid carcinoma. It did not at all look like it became more malignant in the meanwhile. From the report:

“If Andemariam’s condition had been evaluated at Karolinska University Hospital such that it was considered an urgent matter, then it is the assessment of the investigation committee that there was a strong argument for following the recommendation of the best specialists in Boston in the Unites States of America by doing a palliative “laser debulking” procedure, thus gaining more time to assess the patient’s condition. “Laser debulking” might have been sufficient to improve Andemariam’s breathing for many months. The procedure could potentially have been repeated several times, since the tumour was extremely slow-growing. Following “laser debulking”, it would also have been possible to assess other treatment options, once more was known about the extent and histological type of the tumour.
Andemariam underwent the synthetic trachea transplantation, since he had been told that this procedure could cure him and was the only curative treatment option available.
Unfortunately, many cancer treatments are palliative. Nonetheless, patients can live a long life with these types of treatments, particularly when the tumour is slow-growing and non-metastatic, as in Andemariam’s case. Doctors need to be able to advise their patients about realistic treatment options in each case. When it comes to difficult or unusual cases, it is important to seek advice from doctors in all specialities which could be applicable. It is striking that in this particular case, oncologists in Iceland and at Karolinska University Hospital did not have any input regarding the conclusion that a synthetic trachea transplantation should be carried out. No other surgeons or pulmonologists in Iceland were consulted regarding this decision. The decision was made by Macchiarini, who convinced Andemariam of the desirability of this procedure forty-eight hours after Andemariam ‘s admission to Karolinska University Hospital”.

Tumour proved much smaller

Gudbjartsson joined Macchiarini in operating Beyene, because he was also the surgeon who operated this patient in 2009 in Iceland. The Landspítali University Hospital paid Gudbjartsson his salary and covered his travel expenses for the plastic trachea transplantation at Karolinska.  The investigative report addresses the exact role Gudbjartsson had in the operation. Unlike he originally claimed in the media back in 2011-2012, the Icelandic surgeon was not actively involved in the regenerative stem cell magic with bone marrow and nasal epithelial cells, his tasks were the following:

“In a conversation with the investigation committee on 18 November 2016, it was
stated that Tómas assisted Jan Liska, one of the leading Scandinavian cardiac surgeons, in opening Andemariam. Macchiarini was then responsible for implanting the synthetic trachea. The committee based its assessment in this case on this explanation by Tómas. In his letter of protest, dated 30 October 2017, however, Tómas Guðbjartsson makes an entirely different statement. There, Tómas states that he “was highly involved in the surgery”. He was involved in opening Andemariam, which was very complicated due to adhesions between the sternum and heart following the 2009 surgery as well as radiation therapy. Then Jan Liska and Tómas, who were the chief surgeons, worked on removing the tumour together with Macchiarini, who, however, was often otherwise occupied, such as with preparing the synthetic trachea away from the operating table. Tómas stated, moreover, that he also sewed on the left bronchus of the synthetic trachea and sutured the patient’s surgical incision together with Karl H. Grinnemo [later, one of the four KI whistleblowers, -LS]”.

During the operation it turned out that the tumour was not as big as a golf ball, like Macchiarini claimed. It was merely 25x11x9 millimetres in size, yet Gudbjartsson proceeded with removing Beyene’s trachea, together with Macchiarini and the Swedish colleagues.

Karolinska lost interest in patient aftercare

After the operation, Beyene returned to Iceland, and Macchiarini and Karolinska stopped caring what happened to him afterwards, aside of the money for the operation and of course their Lancet paper. The Landspítali University Hospital and Karolinska made a cost sharing agreement on June 6th 2011, with which the latter soon proved as unwilling to comply. Also: “the doctors in charge at Karolinska University Hospital continued to be rather reluctant to receive Andemariam for treatment“.  They didn’t even bother to tell their Icelandic colleagues what exactly they did to Beyene and how he should be cared for afterwards, no “clinical trial protocol” was issued by the Swedish doctors in this regard.

“It is striking that in all instances when Andemariam returned for aftercare to
Landspítali University Hospital after having undergone procedures at Karolinska University Hospital, he was never provided with a formal summary letter from his doctors at Karolinska University Hospital, describing Andemariam’s condition and the treatment he received as well as other information Icelandic doctors required to make correct decisions with regard to his aftercare”.

Since 2009, Gudbjartsson and Beyene became friends, and it seems the doctor abused this friendship somewhat. The investigation committee decided that the patient was dragged in front of the media by his Icelandic doctors in order to advertise for the Lancet article while being in no position to have refused it:

“Tómas, as a staff member of Landspítali University Hospital as well as the patient’s doctor, should have realised that Andemariam was in no position to refuse his
requests to speak with the media, whether Andemariam was in favour of such requests or not. At that point, Andemariam was dependent both on Landspítali University Hospital with regard to his aftercare and on the University of Iceland with regard to his studies. He was, therefore, in an extremely difficult position to refuse requests to speak with the media or release information to the media”.

Need to publish in Lancet!

Gudbjartsson was urged by Macchiarini and Jungebluth to deliver postoperative bronchoscopy and other patient analyses to satisfy the peer reviewers at The Lancet, and prior to that, at NEJM, where Macchiarini originally hoped to publish Beyene’s “success” story. From the report:

“The investigation committee assesses that there is no evidence to suggest that Tómas Guðbjartsson’s friendship with Andemariam had a negative effect on the quality of Andemariam’s aftercare. However, the investigation committee also assesses that it cannot be ruled out that Andemariam was in a weak position and had little chance of denying Tómas’ wish to undergo the scientific tests, which were carried out at Landspítali University Hospital in connection with the drafting of a scientific article, which was published in Lancet 2011”.

While pretending to have treated Beyene as compassionate use case under hospital exemption for medical emergencies, Macchiarini was set to make this plastic trachea transplant work for his own academic fame and his scientific success story. His first author Jungebluth played a big part in this. As the committee report put it:

“Andemariam underwent blood sampling, CT scans, flexible bronchoscopies (during which tissue samples were taken), and spirometries at Landspítali University Hospital to obtain medical information, explicitly for the purpose of using this information for the writing of the scientific article, which was published electronically in Lancet on 24 November 2011”.

In such cases an official patient consent was necessary, also a permission from the National Bioethics Committee should have been obtained. This did not happen, because Gudbjartsson didn’t think about it.  He even had patient files sent to Macchiarini’s private home in Barcelona, Spain, in breach of all privacy and ethics regulations. For that, the Icelandic Committee issued a reprimand. It also instructed the Landspítali University Hospital to pay Beyene’s widow financial support, so she can hire a lawyer and sue for compensation. Unsurprisingly, she informed the committee that Karolinska avoided contacting her about any possible liability for what their doctors did.

Samples for peer reviewers

This was how Macchiarini and Jungebluth urged Gudbjartsson to make his patient comply with their peer reviewer requests. On August 3rd, 2011, Macchiarini wrote in an email to his Icelandic partner:

“I had a conformation about the high interest that the NEJM has in considering our paper. To increase the changes to get it accepted, we would need the blood and biopsies samples listed in the attached file. Especially the blood samples would be of extreme importance since they will be compared to the perioperative blood samples. We should need to have them by the end of next week. Is this please possible? Just let me know please?”

In a document attached to this email, Gudbjartsson was expected to send “Heparin-blood samples (as much as you can)” and “Biopsies from the native bronchi and graft” to Jungebluth at KI. “Non-heparinized blood” however was to be sent to Tom Lüdde, gastroenterologist at the University Clinic Aachen in Germany.  On October 14th, Jungebluth wrote to Gudbjartsson and other coauthors:

„Dear all, we submitted the manuscript on Tuesday to the Lancet. Let´s see what happens this time. The coming week (21.10.2011) the next patient will come to Stockholm to receive his CT-scan [Chris Lyles?, -LS]. Beside we would like to make a bone marrow aspiration, isolate the mononuclear cells and tested them on the new synthetic material that our new collaborator has developed. We should like to ask you to help to standardize and improve the entire concept. I will meet Everen [Evren Alici, -LS] this weekend to work on the transplantation protocol. We would highly appreciate if you could think about in the next days how things could be optimized in terms of taking samples (amount of cells, at which day? etc.) or time schedule for your specific field of interest. Please let me know if you have any suggestions for the protocol. Have a nice weekend.“

There was also a need to deal creatively with the fungus infection growing on Beyene’s plastic graft, which certainly did not look too good in a success story of the Lancet manuscript.  On October 21st 2011 Jungebluth wrote to Gudbjartsson:

„Hej Tomas. Do not worry. We won’t submitted it before you saw it. The current version is on the drop box. I sent you the login. Will put in the biopsy samples showing the fungi contamination and we will relativate the comments on the totally healthy epithelium.“

To satisfy the reviewers, Beyene also underwent a special spirometry test, to measure the amount of air inhaled and exhaled. On October 23rd 2011, Jungebluth asked Gudbjartsson:

“Hej Tomas. Do you think you will get a new lung function test tomorrow? Because otherwise the post-op test is [worse] than the pre-op? Please find attached the current version. I would like to send Paolo my last version within the next few hours so he can work on it also.”

Afterwards, still in October, Jungebluth was chasing after Gudbjartsson for the patient consent which the journal Lancet requested as prerequisite for publication:

„Do you have any news for me regarding the patient´s consent form? The Lancet asked today again for it (I guess this is a good sign, when they ask within such a short time for this specific paper)?“

The Icelandic surgeon replied that he will get Beyene to sign it:

„He had some problems to load it down. So I sent him the form again. But he knows about it and will respond tonight or tomorrow. He will do it for me.“

A Lancet paper full of lies

The investigation committee also concluded that the description of Beyene’s state in the Jungebluth et al Lancet 2011 paper that he “has an almost normal airway” or that he was asymptomatic four to five months after surgery “does not correspond with the information and test results Tómas Guðbjartsson and Óskar Einarsson had about Andemariam’s state of health when the article was submitted to Lancet“. Macchiarini did however prefer his version of reality to that of Gudbjartsson’s, who according to the report:

“did not succeed in ensuring that the information in the scientific article was in accordance with the test results of the bronchoscopies, clinical condition, and adverse reactions Andemariam experienced following the surgery and of which Tómas and Óskar were aware. Tómas had, however, sent Macchiarini and his assistant Philipp Jungebluth all relevant results of the tests carried out on Andemariam at Landspítali University Hospital and had specifically raised the issue of adverse effects and other health problems Andemariam experienced after the procedure. At that point, Tómas and Óskar had only one acceptable and ethical choice, which was to decline further participation in writing the article and withdraw their names from the list of co-authors. This they did not do”.

Gudbjartsson and Einarsson wrote to Lancet on 24 February 2017, asking to be removed from the list of authors, but the journal meanwhile ended this practice of co-authors jumping ship, probably to avoid being left with just the first and last authors Jungebluth and Macchiarini.

The big party in Reykjavik

In 2012, the University of Iceland decided to celebrate the first anniversary of the successful plastic trachea transplant with a Symposium, featuring Macchiarini, Jungebluth as well as KI eminence (Macchiarini was hesitant and insisted that KI president is to be there as well). The then-rector Kristín Ingólfsdóttir sent an invitation to Macchiarini on March 30th 2012. There is this bit of exchange between Macchiarini and Gudbjartsson with reference to Jungebluth and the dead patient (obviously Chris Lyles) quoted in the report:

Gudbjartsson: „You would perhaps talk about tracheal surgery and the challenges there, and together with Philipp tell how stem cells can be used in surgery like this. Then there will be some sort [of] lectures from Iceland on stem cell research. The rector has also invited the rector of [KI] to make a short speech.“
Macchiarini: „It is a bad idea to involve Philipp. I would prefer to leave him out, especially after the death of the last patient. I would kindly ask you therefore not to invite him. I will speak with Philipp as well.“
[…]

Gudbjartsson: „No prob. I hope you are good friends! But we will invite him to
come over, but not for lecturing. Is that OK?“
Macchiarini: „We are more than friends and this is the reason why I am
protecting him.“

iceland

Problem was, Beyene was not doing too well, not that many were bothered by that. From the report we learn he was coughing up blood already during the first part of May 2012, for which he was admitted to Karolinska University Hospital on May 21st 2012. There, granulation tissue was removed from the suture area at the left and right main bronchi, a stent was placed. Beyene was discharged 3 days later. Gudbjartsson knew that Beyene was not feeling any better after the treatment, but decided to go ahead with the conference on June 9th 2012, which his patient had to attend.

wodmvcp2-_4_992x620_f8fba3jl
Beyene, middle being paraded at the 2012 conference in Reykjavik. Left to right: Macchiarini, Gudbjartsson, Beyene, Jungebluth, David Green (CEO of Harvard Apparatus). Source: SVT

On October 12th, 2013, Gudnjartsson wrote to his Karolinska colleagues Lotte Orre, Ulf Lockowandt and Jan-Erik Juto, with Philipp Lars Lundell and Magnus Nilsson in cc, to request a treatment for the failing patient. The conclusion about Beyene in the letter was:

“he is hopeless and depressive. He is very disappointed about how long this is taking. He feels exploited and wants to talk to the media, something I Do not think is of any help for either Karolinska or my institution. We have to move faster. Otherwise, I’m afraid this will have a sad ending. I want him transferred to KS before it is too late. “

Beyene died on January 30th 2014, his horrible suffering finally ended. Noone in Sweden cared, aside of the whistleblowers who soon felt the wrath of their KI. Until some Swedish journalists did care.


For background information on the Beyene case, please refer to these articles on my site:

Macchiarini’s trachea transplant patients: the full list
Swedish Central Ethics Review Board finds Macchiarini guilty of misconduct, requests retraction of 6 papers
Swedish police investigation acquitted Macchiarini on advice of misconduct-tainted trachea transplanters
Alexander Seifalian, UCL’s Persian Scapegoat
Macchiarini investigations outcome: Karolinska University Hospital
Expert review: Macchiarini papers on plastic trachea transplants are misconduct
The vexatious life-saving question of cadaveric tracheas
Yuletide greetings from Jungebluth’s lawyer
“Notification of Suspected Research Misconduct”, by 4 Macchiarini-whistleblowers
Macchiarini and the tracheal regeneration scandal, by Pierre Delaere
Macchiarini and Karolinska: the biomedical ethics meltdown

Donate!

If you are interested to support my work, you can leave here a small tip of $5. Or several of small tips, just increase the amount as you like. Your generous patronage of my journalism, however small it appears to you, will greatly help me with my legal costs.

€5,00

7 thoughts on “How trachea transplanters tricked Andemariam Beyene to sacrifice himself for a Lancet paper

  1. There are only two places these guys should placed: jail or hell.
    I expect the committee to change its opinion regarding investigation of criminal activity.

    Like

  2. The Swedish Higher Education Authority (UKÄ) now concluded their own investigation of the Macchiarini case, which ended with harsh criticism of Karolinska Institutet (KI).

    I provide the full report in Swedish here, following is the Google-translated summary. Please contact me to help fix the translation

    Decision:
    The surgeon Paolo Macchiarini was employed by the Karolinska Institute (KI) in 2010 as a guest professor of regenerative surgery. The employment was associated with a position as a surgeon at Karolinska University Hospital. Then Paolo Macchiarini performed a number of transplantations with artificial tracheas. In retrospect, there were have serious criticisms of the transplantations.
    Paolo Macchiarini’s activities at Karolinska Institute and Karolinska University Hospital has been subject to scrutiny in various ways, including an investigation by the Public Prosecutor for the operations carried out in Sweden, which ended in October 2017. KI’s responsibility for the operations has been investigated in a review as presented in a special report.
    The purpose of the Swedish Higher Education Authority (UKÄ) review has been to investigate a number of matters falling under the supervisory responsibility of the Office. UKÄ’s review has largely drawn from the report on Karolinska institutet and a comprehensive notification was received to the task. In addition, UKÄ has asked a number of questions to the board of directors of the KI where it was considered that there have been outstanding issues that need clarification.
    UKÄ’s review has addressed how the Karolinska Institute handled accounts of side activities, suspicions of unrighteousness in research and Paolo Macchiarini’s employment.
    UKÄ’s assessments in the decision leave the office to summarily pronounce serious criticism of KI. Overall, the investigation in the matter gives the impression that Karolinska institutet wanted at all costs to protect Paolo Macchiarini’s reputation as a researcher and keep him as employee. The reasons for this assessment include that KI:
     – Failed to fully investigate his side activities,
    – Do not raise any suspicions against him regarding the iniquity of research,
    – The investigations of the research misconduct regarding him were actually performed and initiated in an incomplete manner, and
     – extended his employment in violation of the university’s employment plan.
    The resulting shortcomings are such that UKÄ can not cope with this criticism.
    The issue will take a year to complete the Kl’s work in the year 2018, together with the action plan.
    In particular, selected areas review control documents and cases at KI, the latter by taking special measures.

    Like

  3. I publish here a letter Gudbjartsson and Einarsson wrote to then-KI rector Anders Hamsten on June 24th 2015. This letter served Hamsten as template to acquit Macchiarini of all suspicions of misconduct, which also remains until this day the official view of the journal The Lancet.
    In the letter, Gudbjartsson and Einarsson rejected the Bengt Gerdin report, defended the trachea transplant performed on Beyene, presented it as the only treatment option while insisting the tumour was immediately life-threatening and not operable. They never once mentioned the laser debulking option. They concluded:

    “Finally it should not be forgotten that our patient lived for 30 months following the implant. The last year was difficult but during the first postoperative year he had reasonably good quality of life and was only temporarily admitted for controls at the KS.During this time he could finish his studies, start working as a geophysician in Reykjavik and take care of his wife and two children here in Reykjavik”

    Like

  4. In a radio interview from November 28th 2011, Gudbjartsson presented false information about his patient Beyene, though he knew exactly what the truth was. The transcript of the interview, in English, is here.
    E.g. Gubjartsson did not mention the offer of laser debulking from Boston, and said this instead:

    ” I first asked for consultation in the USA [at the Massachusetts General hospital] and they didn´t think much could be done, the neoplasm was to widespread and they did not feel confident receiving the patient or helping us with the case”.

    He also repeated this lie of Macchiarini’s:

    “And then, fortunately, he and his coworkers had done a lot of basic scientific work with stem cells with the premise of transplanting a plastic trachea. Of course there have been experiments on animals etc “

    While Beyene was treated in Stockholm just a week before the interview for fugal infection of his plastic graft, Gudbjartsson claimed:

    “Yes, he feels well today. This is of course, I wouldn´t say that he runs a marathon or similar but he has been able to return to his studies at the university for the last three months, he is about the complete his master thesis. There have of course been all kinds of small problems. But overall his recovery has been unbelievably successful”.

    When asked if he was preeminent author of the Lancet paper, Gudbjartsson declared:

    “Yes, it is this case . Of course it is Paolo Macchiarini who is the main brain behind the method but there are many surgeons and scientists involved in the group. and I played an active role in writing the paper together with Paolo” .

    Like

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s