The misconduct-tainted University of Gothenburg professor of transplantation biology Suchitra Sumitran-Holgersson (see my detailed report here), has now lost a critical publication due to data manipulation, her funding by the charity Hjärt-Lungfondens (Heart-Lung-Foundation) has been frozen. This is what the General Secretary of Hjärt-Lungfondens, Kristina Sparreljung told me:
“Suchitra Sumitran-Holgersson has an ongoing support from us during 2016 and 2017 with 500,000 Swedish crowns per year. She has received 500,000 Swedish crowns so far. As soon as the cheating issue came to our attention, we have made every effort to assess the situation and act properly based on the information we have. As a first step, we decided to freeze the payments. We have also asked the institution [University of Gothenburg, -LS] to freeze its payments, but they have decided to let Suchitra Sumitran-Holgersson research further until the investigation is complete. She will not receive any more money from us until the investigation is complete”.
“The funding of equipment to the Gothenburg University for Professor Sumatran-Holgerssons research has temporarily been suspended awaiting the outcome of the investigation re. Professor Sumitran-Holgersson’s research”.
The retracted paper by Sumitran-Holgersson (Berg et al, Tissue Eng Part A. 2014) concerns her experiments with Macchiarini-style “regenerated” trachea. There, an alleged cure of a 76-year old chronic asthma patient is described, who suffered death from infection shortly after receiving the trachea transplant. The operation was performed by Sumitran-Holgersson’s close collaborator, Michael Olausson, director of the Transplant Center at the University of Gothenburg.
“The Editors of Tissue Engineering are officially retracting the published article entitled, ‘‘Replacement of a Tracheal Stenosis with a Tissue-Engineered Human Trachea Using Autologous Stem Cells: A Case Report,’’ by Berg M, et al., Tissue Eng Part A; 2014;20 (1/2):389–397; DOI: 10.1089/ten.tea.2012.0514.
The corresponding author, Suchitra Sumitran-Holgersson, of the above-named article contacted the Editors via email to ask for a figure in the article to be replaced nearly three years after publication because it was duplicated from a previously published article1 from her group. As requests of this kind are highly irregular and are often cause for concern, the editors determined that a retraction was in order.
The editorial leadership of Tissue Engineering is committed to the highest standards of scientific content and integrity, and does not tolerate any improprieties”
This is Sumitran-Holgersson’s second retraction for data manipulation, the first one for Elsheikh et al, Blood 2005 happened after an external investigation at her former place of work, the Karolinska Institutet (KI) in Stockholm. Other journals promised to investigate, when I contacted them in March 2016. There may be more retractions, or maybe nothing at all will happen, as one journal boldly announced. Though the same image was also reused in another paper of Sumitran-Holgersson’s in the Scandinavian Journal of Gastroenterology (Patil et al, 2014), its Editor-in-Chief Helge Waldum wrote this to me in his email from March 16th, 2016:
“Thank you for contacting us about double publishing of figures by Suchitra Sumitran-Holgersson. We agree with you that some parts of figures first published in Scandinavian Journal of Gastroenterology later were used in another publication. We have written to the author about this, but will not do anything more about it. After all, the pictures used twice only made up a minuscule part of the figures, and we do not find this error of such a degree to do anything more”.
Waldum likely oriented himself on the decision by the Swedish Research Council (Vetenskapsradet, VR) from 2011 to acquit Sumitran-Holgerssson of all proven accusations of research misconduct and data manipulation and to restore all her funding. The story of this investigation by the biomedicine professors from Uppsala University, Olle Kämpe and Lena Claesson-Welsh, is so bizarre that it could make an entertaining film. Kämpe and Welsh were able to prove beyond doubt that Sumitran-Holgersson has been manipulating data (their report is available exclusively from my site), because of this, her above mentioned paper in Blood had to be retracted. Yet since the main evidence concerned a manuscript which was never published, VR decreed that this was not actual research misconduct as such, since there was no intention to deceit in a scientific publication. Moreover, VR used the rather unambiguous evidence of deliberate research misconduct as pretext to dismiss the entire investigation as biased and to claim that Kämpe and Welsh overstepped their mandate by finding it. The decision by the then-VR president Mille Millnert is available exclusively here, where he declared:
“The expert group was not supposed to judge whether such a lack of adherence to good scientific practice had been done in good or ill faith, or whether scientific fraud had been committed“.
However, neither Kämpe nor Welsh were part of this expert group. They were specifically invited as external investigators, while the VR expert group had separate meetings and finalized their report on their own, as I was informed by a reliable source.
Even more puzzling, a detailed report on Sumitran-Holgersson’s misconduct, which Kämpe purportedly personally delivered to KI, disappeared into thin air. This file was allegedly hand-delivered to the KI Registrar and addressed to KI professor Martin Ingvar, but now it could not be found anywhere at KI. I however provide a (incomplete) copy exclusively here. Finally, because of their investigations, Kämpe and Welsh were threatened with a ruinous lawsuit by the company Adsorber, owned by Sumitran-Holgersson’s husband and Gothenburg professor, Jan Holgersson. VR apparently chose to stay out of this. Despite our extensive communications, the Research Council chose not to explain to me on why they allowed this blackmail to happen, through their explicit refusal to provide legal protection to their own investigators.
What next for this controversial Gothenburg professor of regenerative medicine? I will provide updates below, whenever new information or developments on the Sumitran-Holgersson case arrive.
Update 11.05.2016. Sumitran-Holgersson featured prominently in the 2015 magazine and a now deleted 2016 interview of the Swedish Njurfonden (Kidney Fund), with the suggestion that she was funded by this charity. I introduced myself and my relevant articles to the president of Njurfonden, Håkan Hedman, who then declared to me:
“On behalf of Njurfonden (National Kidney Foundation) I confirm that that Njurfonden has not given Professor Holgersson any funding during the passed 10 years. However, she is until March a famous and a well known scientist and her research is exiting. This is the reason why we presented her on our web among many other scientists in order to show all interesting renal research going on in Sweden. Professor Holgersson is still under investigation and not judged“.
However, a related charity, “Stiftelsen Professor Lars-Erik Gelins Minnesfond” funds kidney research and its president is the same Hedman. The Gelin Foundation supported Sumitran-Holgersson regularly until 2012, in 2014 and 2015 her collaborator Olausson was financed for “reconditioning of kidneys from heart-dead donors”. I asked Hedman to comment on the status of this funding to the Gothenburg duo, and was brusquely told:
“I do not know who you are and your purposes. We have been informed about the investigation. Until now I will not answer any further questions about this matter“.
Update 13.05.2016, updated again 20.05.2016. Sumitran-Holgersson and Olausson still enjoy generous funding from other public sources, at least until the investigations are concluded.
The 2.1 Mio SEK from the Swedish Research Council (VR), for the purpose of pancreas regeneration are being duly paid out, as VR Chefjurist Anna Hörnlund notified me:
“Research Council grants are ongoing and we are following this case“
The LUA-ALF grant funding from Swedish government, which is distributed locally through universities. Lars Grip, research director of Sahlgrenska Hospital, who is also responsible for the LUA-ALF funding management there, stated to me in an email:
“There is currently an investigation ongoing regarding suspected misconduct at the University of Gothenburg. The LUA-ALF grants are handled in close collaboration between the university and the Sahlgrenska University hospital. The disposition of the actual grants are not yet decided on but will be handled in connection to this investigation”.
I asked Grip whether this means LUA-ALF funding to Sumitran-Holgersson was suspended, yet he did not reply anymore. One week later however, he notified me, together with Christina Jern, vice dean for ALF at Sahlgrenska:
“The funding for 2016 is paid out at the beginning of the year. The funding for 2017 will depend on the outcome of the investigation that is ongoing at the university“
Incidentally, the now retracted paper about the lethal trachea transplant declared to had its research funded by LUA-ALF. However, Grip explained to SVT that this operation “was health care. It was not a research project in the usual sense“. Yet the Swedish Medical Products Agency, which usually grants such hospital exceptions for already approved drugs, is not so sure. Also, the information Sumitran-Holgersson and Olausson originally provided in that retracted paper, that “the Swedish Medical Products Agency was informed and approved this surgery according to ‘‘hospital exception’’ was apparently untrue. Ann Marie Janson Lang, MPA expert in neuropharmacology and advanced therapy medicinal products, informed me:
“The Medical Products Agency has not given any approval (see legal requirement in Medicinal Product Act 2015:315), i.e. no hospital exemption has been authorized for tissue engineered human trachea using autologous stem cells replacing tracheal stenosis“.
Update 18.05.2016. It seems Olausson and Sumitran-Holgersson were repeatedly giving untrue statements about ethics approval on their human experimental transplants, both for trachea as well as regenerated veins. These approvals were never granted, unlike the two scientists assured in their publications.
This well-promoted Olausson et al 2014 paper in Cell Press/Lancet-supported Elsevier journal EBioMedicine reported regenerated vein transplants into two children, 2 and 4 years old., and contained a statement:
“As in the previous published case (Poole-Warren et al., 1996, – an obviously unrelated Australian study made in sheep, -LS) in the present two cases, a pediatric team performed the evaluation in a multidisciplinary fashion, which also includes abiding to the UNICEF Convention on the Rights of the Child. […] The parents also provided informed consent, which was given to the pediatric team in the absence of the operating surgeon to avoid pressure. Moreover, permissions from the two regulatory bodies in Sweden—The National Medical Board and The Medical Products Agency were granted.”
The MPA expert Janson Lang inform me however that, once again:
“No hospital exemption for the tissue-engineered veins using autologous peripheral whole blood has been granted by the Medical Products Agency. The classification of the product as an advanced therapy medicinal product and the requirement for GMP was communicated in the beginning of 2012, after receiving a question on this matter from the corresponding author of the paper you refer to”.
Duc H Le, Lancet-associated EiC of EBioMedicine, wrote to me:
“we will carry out our own independent investigation into this issue, starting with the authors’ institutes and the authors themselves. Depending on the outcomes of the investigation we will consider appropriate editorial actions“.
What about other Olausson/Sumitran-Holgersson papers on vein transplants into juvenile patients? This impactful Olausson et al 2012 Lancet publication was the first to report stem-cell bioengineered vein transplant into a 10-year-old patient and issued this ethics statement
“We obtained consent from all the relevant ethical organisations, including the parents, local ethical commission, and two regulatory bodies in Sweden (National Medical Board and Medical Products Agency; appendix -see relevant information in comment below, -LS). Consent for use of donated organs follows the rules of organ donation for organ transplantation at the University Hospital”.
To this, Janson Lang declared on behalf of MPA:
“I’m afraid the answer is the same – i.e. no hospital exemption or manufacturing authorization/GMP certificate for bioengineered vein transplantation with autologous stem cells has been given by the Medical Products Agency”.
Absence and especially deliberate misinformation about the ethical approval in clinical research papers usually leads to their immediate retraction. It is possible that this was the true reason for the retraction of Berg et al, Tissue Eng Part A. 2014 paper on the lethal trachea transplant. We will now have to see how journals respond to this new information.