Sumitran-Holgersson and Olausson guilty of misconduct and unethical experiments on children

Sumitran-Holgersson and Olausson  guilty of misconduct and unethical experiments on children

Game over apparently near for the indestructible Swedish regenerative medicine researcher Suchitra Sumitran-Holgersson, after investigations at her University of Gothenburg  draw to an end. It is about experimental transplants of decellurised veins “regenerated” with the patient’s own bone marrow cells into three child patients, all of whom ended up in life-long medical care, one patient received  a liver transplant after her graft failed, another child suffered severe complications (see this earlier report about an external investigation by Bengt Gerdin into that matter). The University of Gothenburg then established an investigative committee, which followed up on the Gerdin report and specific concerns voiced by a journal editor and a colleague. I publish below the two decisions which revealed that Sumitran-Holgersson and her surgeon partner Michael Olausson never performed any animal testing before recruiting their human patients, they also failed to obtain ethics permits for these operations. Instead the two lied in their publications (Olausson et al, Lancet, 2012; Olausson et al EBioMedicine, 2014) about having obtained ethics votes (something I already uncovered before). During the investigation, Olausson and Sumitran-Holgersson were caught submitting false information to the committee. They were now found guilty of misconduct and ethics breach in both these publications. Continue reading “Sumitran-Holgersson and Olausson guilty of misconduct and unethical experiments on children”

Collapse of Biotrachea, or how Macchiarini’s greed saved human lives

Collapse of Biotrachea, or how Macchiarini’s greed saved human lives

The trachea transplant experiments by Paolo Macchiarini left many of his trusting patients dead or mutilated. His €5.5 Million EU-funded research project Biotrachea started in April 2012 and was specifically designed to treat even more human beings with lethal plastic tracheas (and with the slightly less lethal cadaveric ones). The consortium was terminated in 2014 (see some background here), but not because the Biotrachea scientists or EU officials suddenly had second thoughts when the Macchiarini scandal unraveled and when his misconduct, ethics breaches as well as painful deaths and suffering of his plastic trachea recipients became known. Unlike an EU spokesperson previously insisted, there were no ethics concerns at all regarding Biotrachea. In fact, all ethics approvals were in place, human Guinea pigs were supposed to be lured en masse using a highly inappropriate patient consent form towards their likely deaths for the sake of EU-funded mega-science.

In truth, Biotrachea collapsed only because of Macchiarini’s greed for money. His financial conflict about patent revenues with the British university UCL drove the star surgeon to seek another plastic transplant manufacturer and then to destroy the entire multinational research consortium which he was presiding over, after the EU rejected his new plastic provider. Not because that one was also deemed unsafe, but as the EU negotiators mentioned, it was because that new type of plastic trachea lacked novelty. All this only became known after the original Biotrachea documents, which the EU and all consortium participants refused to grant me any insight into, were fully legally obtained by Jonas Malmstedt under Swedish transparency from Macchiarini’s ex-employer, the Karolinska Institutet (KI). Thanks to this brave and decent surgeon, I make all that secret documentation available below.

Continue reading “Collapse of Biotrachea, or how Macchiarini’s greed saved human lives”

“Notification of Suspected Research Misconduct”, by 4 Macchiarini-whistleblowers

Below I am publishing a recent letter to the Vice-Chancellor of Karolinska Institutet (KI) Karin Dahlman-Wright, authored by the four KI medical researchers, Matthias Corbascio, Oscar SimonsonKarl-Henrik Grinnemo and Thomas Fux. They have been for some time attempting to alert KI to the irregularities in patient records and published data by Paolo Macchiarini, but were instead harassed and persecuted under the former Vice-Chancellor of KI, Anders Hamsten. The four whistle-blowers previously made their evidence public in an open letter to KI directorate. In April 2016 they received a prize from Transparency International for their courage.

The KI had much of its leadership as well as of its Ethics Council removed in the wake of Macchiarini-scandal (see updates to this article). Most likely, there will be more resignations among senior scientists and managers, as the investigations progress and conclude. At the same time, the associated Karolinska University Hospital seems to have sneaked out of responsibility, no investigations are being performed there, as Bosse Lindquist, author of seminal Macchiarini documentary, has criticised. The hospital was Macchiarini’s employer and approved all his controversial trachea transplant operations on patients, some performed inside the hospital. Correction: according to Swedish media, the hospital director, Melvin Samsom, initiated an investigation which results are to be expected in August 2016. The external examiner is Kjell Asplund, professor emeritus of medicine and chairman of Smer, the Swedish council on medical ethics.

The evidence presented by the four KI whistle-blowers deals with data irregularities in Macchiarini’s paper in The Lancet (Jungebluth et al, 2011). This first recipient of a plastic “regenerated” trachea transplant was Andemariam Beyene, who died two years later (details see here). The scaffold was produced by the nanotechnology lab of the UCL professor Alexander Seifalian (details in my report here). Unfortunately, The Lancet has ceased replying and even acknowledging receiving my emails (in particular in regard to another misconduct case in regenerative medicine in Sweden, that of Sumitran-Holgersson). The Lancet previously declared to me not to be addressing  themselves any available evidence of ethics breach and data manipulation, but instead wait for the results of institutional investigations.

The entire document is available here, below is the abbreviated version.

Continue reading ““Notification of Suspected Research Misconduct”, by 4 Macchiarini-whistleblowers”

Macchiarini’s patients, the real situation

Macchiarini’s patients, the real situation

Paolo Macchiarini, former star surgeon at Swedish Karolinska Insitutet (KI), came back to Sweden to give his version of the events, about the failed tracheal transplants he performed, and some other things. He had two core messages: he extended the lives of the dying patients by transplanting them with untested plastic tracheas, and he did all this certainly not behind everyone’s back, but with full knowledge, approval and supervision of his colleagues at KI.

Macchiarini’s interviews can be read at the medical newspaper Läkartidningen, the tabloid Expressen and the most interesting one was with the TV channel SVT (which previously aired the documentary Experimenten, which kick-started the scandal).

Update 23.05.2016 Macchiarini’s SVT interview from May 4th was transcribed by the KI whistleblowers (who also highlighted those in their views most untruthful passages in red). With the permission of the SVT interviewer Nike Nylander I am making the transcript available here.

The interviews focussed around the plastic “stem cell”-regenerated tracheas Macchiarini implanted into 8 patients. The first recipient, Andemariam Teklesenbet Beyene, was operated in 2011 and died two years later, after the implant came loose. On SVT, Macchiarini now claimed Beyene’s life expectancy was less than 6 months, and the operation was approved by a “multidisciplinary team” at KI and the Karolinska University Hospital. The material was tested as safe, insisted Macchiarini. Not as trachea in the unsterile airway environment, but in other setups, such as blood vessel surgery, he declared. This synthetic trachea scaffold was manufactured by the lab of UCL nanotechnology professor Alexander Seifalian, later on by the US company Harvard Apparatus under a shared patent with Macchiarini (as I reported here). Continue reading “Macchiarini’s patients, the real situation”

The stem cell faith healers, or magic inside your bone marrow

The stem cell faith healers, or magic inside your bone marrow

Bone marrow stem cells are magic, they can do everything. If you don’t believe it, you are simply a loser scientist and will never get funded.

Prior to his bombastic fall from grace, the celebrity surgeon and professor of regenerative medicine Paolo Macchiarini was considered a genius stem cell wizard and a miracle healer. He not only fully trusted bone marrow cells to generate any kind of tissue inside his patients, nay, he also published his results in highest profile journals like The Lancet (which, by standard academic definition, is proof enough that his theory and methods were valid). Macchiarini did not chase money, neither funding nor salary, it was chasing him. Even after media revealed mass patient deaths and gross inconsistency between Macchiarini’s published reports and the actual medical files of his patients, the Elsevier-run Lancet is reluctant to retract his papers.

Simply put, the faith in the force of the bone marrow stem cells is stronger than their science. These cells are often referred to as mesenchymal stem cells; basically they are those undifferentiated cells from the bone marrow which do not carry the established markers of hematopoietic (blood-generating) stem cells.  What these “mesenchymal stem cells” are actually a mixture of, and which types of cells or tissues they are really able to differentiate into, is still a subject of an ongoing research. Unless you are a stem cell believer, that is, then you don’t bother with such details. Continue reading “The stem cell faith healers, or magic inside your bone marrow”

Does The Lancet care about patients?

Does The Lancet care about patients?

The Lancet, an elite medical journal published by Elsevier, is responsible for a number of controversial publications, on which its Editor-in-Chief Richard Horton and his editorial office have not always acted to everyone’s satisfaction.

The Lancet and the magic of stem cells

The probably biggest Lancet scandal now is that of the trachea transplant surgeon Paolo Macchiarini, the recently sacked professor at the Swedish Karolinska Institutet (KI). His most prominent critic, Belgian thoracic surgeon Pierre Delaere has publicly called on my site for a retraction of all four of Macchiarini’s paper in The Lancet (Macchiarini et al. 2008Jungebluth et al. 2011Badylak et al 2012,  Gonfiotti et al. 2014); also the Swedish Academy of Sciences asked the journal to act on Macchiarini’s papers. Elsewhere, Italian media provided evidence that the Gonfiotti et al. 2014 case report paper “The first tissue-engineered airway transplantation: 5-year follow-up results” misrepresented the true medical condition of Macchiarini’s first stem –cell regenerated trachea recipient. Corriere Fiorentino reported in February 2016: Continue reading “Does The Lancet care about patients?”

Macchiarini and the tracheal regeneration scandal, by Pierre Delaere

This is an open letter to the academic community by Pierre Delaere, professor for respiratory surgery at KU Leuven, Belgium, and one of the earliest and fiercest critics of Paolo Macchiarini. Delaere recently published a paper explaining that “the engineered trachea is an example of blatant scientific deception” (Delaere and Van Raemdonck, J Thorac Dis. 2016). For the background of Macchiarini’s misconduct and patient deaths after his trachea transplants, as well as Delaere’s attempts to prevent those, please refer to my articles here, here and here. An earlier open letter by Bo Risberg, emeritus professor of surgery at the University of Gothenburg, is also available exclusively on my site Continue reading “Macchiarini and the tracheal regeneration scandal, by Pierre Delaere”