Macchiarini and the bonfire of greed

The aftermath of the Paolo Macchiarini scandal: many dead or mutilated trachea transplant patients, many stellar academic careers destroyed or damaged beyond repair, the reputation of the once world leading Karolinska Institutet (KI) in shatters and even the Nobel Prize itself is dented. The latter is because several members of the 50-head strong committee of the Nobel Prize in Physiology or Medicine were forced to resign:

• Urban Lendahl, KI professor of genetics, quit his postas Nobel Committee Secretary General already in February, due to his involvement into Macchiarini recruitment. Lendahl also used to be Macchiarini’s superior, as director of three research centres in stem cell research and regenerative medicine: DBRM, StratRegen and WIRM(the Wallenberg Institute for Regenerative Medicine).
• Hans-Gustaf Ljunggren, former KI Dean of Research resigned from this post and Nobel Committee in February 2016. Ljunggren decreedin August 2015 together with the then-Rector Anders Hamsten that Macchiarini did not commit any misconduct, and trashed the results of the Bengt Gerdin investigation.
• Katarina Le Blanc, immunology professor and Macchiarini co-author, who is apparently herself under investigation on suspicion of misconduct and data manipulation.
• Anders Hamsten and Harriet Wallberg-Henriksson were asked to resign by the new Secretary of the Nobel Assembly, Thomas Perlmann, after the KI report was published. Both ex-Rectors played a crucial role in the Macchiarini recruitment and the cover-up of his patient abuse and misconduct.

Two more members of the Committee were possibly asked to step down, but this information is not confirmed. Bo Risberg, emeritus professor of surgery at the University of Gothenburg and longstanding Macchiarini critic (see his earlier guest post for my website), proposed “a moratorium for two years to the Nobel prize” and for the award money to be donated to Macchiarini’s victims and their families.

The corrupt Ethics Council of KI was dissolved by the new Rector Karin Dahlman-Wright, other heads rolled as well. Two investigations, one by KI and one by Karolinska University Hospital revealed a culture of cover-up and disregard for basic research integrity and medical ethics. Meanwhile, the entire KI University Board was dismissed by a governmental decision.

What drove so many scientists and doctors to support Macchiarini and his outrageous visions? It seems, the driving force was, just as elsewhere in science, greed. Greed for research funding and the fame and power it brings. And Macchiarini attracted many millions of Kronen, Euros, Dollars and even Roubels, and he kept promising even more. It seems the lust for money and fame made everyone at Karolinska switch off their brains. As the result, innocent people have died.

Money for magic

“Stem-cells” is a magic word which opens many funding coffers, especially if combined with “regenerative medicine” and clinical applications directly on patients, to cure incurable diseases. Macchiarini offered all of this. Trachea is a very complicated organ, very difficult to transplant (mostly due to its blood vessel structure), and Macchiarini offered a simple solution.  He based his claims on long-discredited research about alleged pluripotency of bone marrow cells (see my analysis here) and a magic box called bioreactor. When a dead piece of trachea cartilage or even a plastic pipe is stuck in there and seeded with bone marrow cells, it will grow a living organ. There is no scientific evidence for that, but nevertheless Macchiarini and his colleagues were showered in funding money, including millions of euros from the European Union for his project Biotrachea (see my coverage here) and AmbuLung (there, Macchiarini was accused by the project coordinator Nova Lung GmbH of confidentiality breach and intellectual property theft) . In fact, the EU happily continues to fund a clinical trial on cadaver trachea transplants, regardless of the death and suffering its coordinator Martin Birchall brought together with Macchiarini upon their earlier research subjects (see my detailed report here). The bioreactor fairy tale sounds just too great.

It all started in 2008-2009 with the SEK 30 Million (ca. €3.2 Million) per year given to KI by the Swedish Research Council, specifically earmarked for stem cell research. This 5-year grant was about to become permanent upon subsequent evaluation. KI used this money to lure the Italian star scientist to perform his stem cell miracles in Stockholm. More and come money came from Swedish public funders and charities (see list here).

By 2015 however, Macchiarini was in a tight spot. The deaths of his patients became known, police began investigations for manslaughter and the investigative report by the surgery professor Bengt Gerdin found him guilty of misconduct (see details here). Even worse, the Research Council suspended in June 2015 his grant funding for the “Development of natural and cultivated bioartificial esophagus”, because there was no ethics permit for the transplants. The guest professor Macchiarini became untenable and very close to being sacked. Remarkably, the miracle surgeon managed to extricate himself from this predicament and even to get his professorship contract at KI extended by one year. How did he achieve this, you wonder? He simply bribed them with a promise of 10 Million Dollars in funding.

An offer they can’t refuse

From the KI investigative report by the Heckscher commission (see Google-translated chapter 9, provided by Liz Woeckner) we learn that Macchiarini declared at a September meeting with his KI superiors, Rector Hamsten and head of CLINTEC department, Li Felländer-Tsai:

“that he had been contacted by an American philanthropist who offered him a large research donation. […] The donation manager was informed that it concerned a possible donation of 10 million US dollars (approximately 80 million Swedish kronor). The donor wanted to support a research center in translational and regenerative medicine that was based on a research plan that Macchiarini had developed.
According to the responsible for the donations the US donation would have been at that time the Karolinska Institute’s third largest donation ever”.

On October 5^th, some weeks after he saved Macchiarini from the consequences of Gerdin’s investigative report, the greedy rector Hamsten emailed his guest professor:

“Hope life at your end has now returned to a more relaxed and enjoyable state. […] As a matter of priority on my side, I would like to return to the briefing, the initial discussion we had regarding the potential donation from the lady in the US. Also, we need to touch base again regarding the intermittent bridging employment we need to get in place for you, prior to proceeding with the tenure”.

Also the head of the Ear-Nose-Throat clinic Lars Olaf Cardell was greatly interested in this donation. He met in October 2015 with Felländer-Tsai and the Dean of Research Ljunggren, where Cardell

“took up the funding deficiency at Macchiarini’s research group resulting from the Research Council’s funding withdrawal. […] When it came to Macchiarini’s employment contract renewal, the American donation offered a solution”.

The discussions on this potential cash shower continued into January 2016, lawyers as well as university director were involved. A general donation agreement was drafted to be presented by KI to the prospective donor.

A grain of truth

It does sound a bit unrealistic, knowing Macchiarini’s tendency to tell untruth. Did he once again fib everyone? Even Hamsten insisted to the Heckscher investigative committee that “he had never regarded the donation proposal to be realistic”. I actually didn’t believe in it myself, until I learned that… Macchiarini was not entirely lying. The mysterious US benefactor did exist, only the donation was never ever considered to go to KI, but straight into the miracle surgeon’s own pocket.

Macchiarini entered a business relationship with a surgeon colleague with whom he transplanted in April 2013 a plastic trachea into the 2-year old US-American patient, Hanna Warren (she died not even 3 months after). This surgeon was Mark Holterman, a deeply religious yet rather medical ethics-agnostic professor at the University of Illinois, College of Medicine at Peoria. Holterman and Macchiarini both seem to hold the peculiar view that any agreement between doctor and his patient is sacred and no governmental institution should ever interfere with their petty ethics concerns or regulations. Basically, if a doctor and patient should agree that a chronic migraine can be cured by an experimental brain removal procedure, no authority should ever quibble against a signed patient’s consent. In fact, Holterman himself operated another 2-year old child, with a non-life threatening leak in the oesophagus, which left his patient with “irreversible brain injury and cerebral palsy”, as Chicago Tribune reported. The responsible Rush University Medical Center, where Holterman performed this operation, was in February 2016 made to pay $30Mio malpractice settlement to the victim’s family.

In April 2015, Holterman recruited Macchiarini as consultant for his company Alliance for the Advancement of Cellular Therapies (AACT), with the modest salary of $10,000 per month (allegedly Macchiarini was first promised $300,000 per year). This is what AACT was about, as Holterman announced in December 2015 in a round email to a long list of doctors:

“We at AACT feel very strongly that the FDA is overstepping their regulatory mandate and interfering with the “practice of medicine”, by interjecting themselves into the physician-patient covenant, interfering with the patient’s right for treatment, and, in the case of autologous cells, placing restrictions on a person’s own healing capacity”.

On July 27^th 2015, Macchiarini and Holterman flew to California from Chicago to meet two female investors, who offered them millions in funding. However, unlike Macchiarini told to his KI superiors, the money was never intended to go to Sweden. It was designated for his and Holterman’s AACT business in the US. It is not clear if the donation ever happened, but the naïve and greedy Karolinska certainly never was part of this.

Go west!

Of course, the greediest character by far in the whole scandal is Macchiarini himself. Already from his work in Italy he was known to police for coercing desperate patients’ families into paying him huge sums for private operations. He never felt he was earning enough though. In fact, the professor of regenerative medicine was unhappy with what KI was paying him. There are rumours that he earned much more in Russia, thanks to the governmental “Megagrant” which brought Macchiarini to Krasnodar. In any case, Macchiarini wanted to go where the really big money is: to America.

In this regard, Macchiarini was negotiating in 2013 with two universities: the University of Illinois Urbana-Champaign and their Carle Illinois College of Medicine on one hand and on the other hand the University of Texas, represented by the MD Anderson Cancer Center and primarily by the Texas Heart Institute, where Macchiarini’s collaborator Doris Taylor was according to my evidence pulling all strings to get him a professorship. Taylor is a cardiologist who is also convinced that any organ can be resurrected by decellurisation and the magic of bone marrow cells. Her speciality is the heart, but she also co-authored the notorious oesophagus regeneration paper with Macchiarini (Sjöqvist et al 2014), which was on September 9^th 2016 determined as fraudulent by the Swedish Ethics Board. Since job-wise it looked very promising at both places, Macchiarini’s plan was apparently to grab both offers: a purely academic job in Texas and a clinically oriented one with focus on human experimenting in Illinois.

The miracle surgeon was officially interviewed in February 2014, first by the University of Illinois at Urbana-Champaign, Department of Bioengineering, and then by the Texas Heart Institute and MD Anderson. The University of Illinois  first offered a $650,000 annual salary for a full time faculty position in a Memo of Understanding (exclusively available here), which their Carle Health Care Incorporated and Macchiarini signed on December 23^rd 2013. It was a very nice Christmas present for a doctor who has been actually very naughty before, what with Hanna Warren and several others of his plastic trachea transplant recipients already being dead. The offer then fell to some measly $200,000 per year, and by March 2014 the two US-universities somehow changed their minds completely. Both negotiations about professorship recruitments ended abruptly.

In June 2014, Holterman tried to help his business partner with a recommendation letter which he sent to his own College of Medicine at Peoria (exclusively available here), expressing “enthusiastic and unreserved support of Professor Paolo Macchiarini’s consideration for the Breakthrough Grant funding mechanism”. Obviously, it didn’t help. But Karolinska still stood behind their lethal professor, hoping in vain for the 10 Million from his mysterious Californian donors. Until the media attention broke the toxic spell.