Paolo Macchiarini

Paolo Macchiarini (born August 22, 1958)[1]:2 is a Swiss-born Italian thoracic surgeon and a former researcher on regenerative medicine, who became known for research fraud and manipulative behavior.[2][3]

Paolo Macchiarini
Born (1958-08-22) August 22, 1958
Basel, Switzerland
NationalityItaly
OccupationFormer surgeon
Known forScientific misconduct, plastic tracheas

Previously he was considered a pioneer in the field of regenerative medicine using both biological and synthetic scaffolds seeded with patients' own stem cells as trachea transplants, and he was a visiting researcher on a temporary contract at Karolinska Institutet in Sweden from 2010.[3] Macchiarini has been accused of research misconduct and unethically performing experimental surgeries, even on relatively healthy patients. Seven of the eight patients who received one of his synthetic trachea transplants have died.[4] Also, an article in Vanity Fair suggested that Macchiarini had falsified some of his academic credentials on résumés.[5] Similar accusations have been published in the Swedish newspaper Aftonbladet according to which Macchiarini's claim to have been a professor at universities in Hannover and Barcelona has turned out to be false.[6]

The secretary of the Nobel Committee for Physiology or Medicine, Urban Lendahl, resigned in February 2016, owing to his involvement in recruiting Macchiarini to Karolinska Institutet in 2010.[7] Shortly afterwards the vice chancellor, Anders Hamsten, who in 2015 had cleared Macchiarini of scientific misconduct, also resigned.[8] In 2013 Karolinska terminated its clinical relationship with Macchiarini but allowed him to continue as a researcher; in February 2016 Karolinska announced that it would not renew Macchiarini's research contract, which was due to expire in November, and the next month Karolinska terminated the contract.[9] After being dismissed from Karolinska, he worked at the Kazan (Volga region) Federal University in Russia,[10] until the university terminated his project in April 2017, effectively firing him.[11]

After a one-year medico-legal investigation, the attorney general's office announced in October 2017 that Macchiarini had been negligent in four of the five cases investigated due to the use of devices and procedures not supported by evidence, but that a crime could not be proven because the patients might have died under any other treatment given.[12][13] Also in October, Sweden's national scientific review board found scientific misconduct by Macchiarini and his co-authors in six papers about the procedures, and called for them to be retracted.[14] As of 2020, Macchiarini has had eight of his research papers retracted, and two have received an expression of concern.[15]

Education and career

Macchiarini obtained his medical degree (equivalent to MD) at the Medical School of the University of Pisa, Italy in 1986 and a Master of Surgery in 1991.[16] He was an assistant professor there from 1990 to 1992.[16] He took a course on statistics in clinical research at University of Alabama at Birmingham in 1989.[16] He obtained degree certificates—a masters in organ and tissue transplantation dated 1994 and a doctorate in the same dated 1997, from University of Franche-Comté.[16] According to Hannover Medical School he never had a salaried position there, but was head of the department of thoracic and vascular surgery at the Heidehaus Hanover hospital between 1999 and 2004.[16] He was an investigator at the Institut d’Investigacions Biomèdiques-Instituto de Investigaciones Biomédicas in Barcelona from 2006 to 2009; he was affiliated with but not an employee of University of Barcelona and was apparently an employee at the Hospital Clínic de Barcelona during this time.[16] He had an honorary appointment as a Visiting Professor from 2009 to 2014 at University College London.[16] He was a consultant and project manager at University Hospital Careggi starting in 2010.[16] He was appointed as a visiting professor at the Karolinska Institute in 2010, and as a part-time position as surgeon at the affiliated university hospital.[16] In 2013 Karolinska terminated its clinical relationship with Macchiarini but allowed him to continue as a researcher; in February 2016 Karolinska announced that it would not renew Macchiarini's research contract, which was due to expire in November, and the next month Karolinska terminated the contract.[9][17] The Karolinska Institute published the incomplete results of its verification of Macchiarini's CV in February 2016.[16]

Macchiarini made ties in Russia after he gave a master class in 2010 at the invitation of Mikhail Batin; a few months later he did a trachea transplant there which was widely covered in Russian media.[11] This led to an appointment at Kuban State Medical University funded by the university and the Russian government,[11] in 2011, along with an honorary doctorate.[16] In 2016 Macchiarini moved to Kazan Federal University and the grant money moved with him.[11] In April 2017 the university terminated Macchiarini's research project there.[11]

Notable trachea surgeries

Claudia Castillo

In June 2008, Macchiarini conducted a transplant of a donated trachea colonized with the stem cells of the recipient, Claudia Castillo; the tissue was used to replace her left bronchus, which had been damaged by tuberculosis, and her left lung had collapsed.[18] The trachea came from a cadaver, and was stripped of its cells and seeded with cells taken from Castillo's bone marrow.[18][19][20] The bone marrow cells were cultured at Bristol University, the donor trachea was stripped at University of Padua, the stripped trachea was seeded with the cultured cells at University of Milan, and the trachea was transplanted by a team led by Macchiarini at Hospital Clinic in Barcelona.[18][21]

Ciaran Finn-Lynch

In March 2010 Macchiarini attended a transplant performed by Great Ormond Street surgeons, similar to the one done for Castillo, on a ten year old Irish boy, Ciaran Finn-Lynch, at Great Ormond Street Hospital in London.[22] The boy was born with a 1 mm diameter trachea, and efforts to widen it had caused life-threatening complications.[22] Unlike the Castillo procedure, in this case the stripped trachea was seeded with the boy's stem cells just hours before it was implanted.

Keziah Shorten

Keziah Shorten had trachea cancer and in 2010 Macchiarini did a transplant similar to the earlier two; the transplant failed the next year, and a synthetic trachea was implanted for palliative care at University College Hospital London in 2011 after which she was able to be discharged and return home for Christmas with her family before succumbing to her underlying disease.[23]

Woman in Russia

In 2010 Macchiarini implanted a seeded donated trachea in a woman in Russia, working with the Russian surgeon Vladimir Parshin.[11][24][25]

Andemariam Teklesenbet Beyene

Andemariam Teklesenbet Beyene was a man from Eritrea who was earning a doctorate in Iceland when he was diagnosed with cancer; the cancer was treated with radiation and surgery in 2009, but in 2011 his trachea was obstructed again. His doctors recommended palliative care, but also reached out to Macchiarini, who was at Karolinska by that time.[26]:8 In this case, Macchiarini collaborated with scientists at University College London to manufacture a fully synthetic trachea, with an engineered scaffold seeded with Beyene's marrow cells, instead of using a donated and stripped trachea, as had been done before.[23] The operation occurred in June 2011 and was widely covered in the media, including a front page story in the New York Times.[27] By end of the year the implant was failing, and while Beyene was able to complete his PhD in 2012, over the course of that year he had many treatments at Karolinska and he died in January 2013.[26]:8 The autopsy showed that he had a chronic lung infection, a clot in his lung, and the trachea had come loose.[26]:8

Christopher Lyles

Christopher Lyles lived in the US; he had tracheal cancer which was treated with radiation and surgery. He heard about Beyene's treatment and through his doctor asked Macchiarini to do the same for him, and Macchiarini obliged, creating a fully synthetic trachea seeded with stem cells from Lyles and implanting it at Karolinska in November 2011.[26]:9 Lyles died suddenly in 2012 after he had returned home; no autopsy was performed.[26]:9[28]

Yulia Tuulik

In June 2012, Macchiarini implanted a fully synthetic seeded trachea in Yulia Tuulik at Kuban State Medical University; Tuulik had a tracheostomy resulting from a car accident but her life was not in danger.[11][29] The graft included a cricoid cartilage, part of the voice box, which Macchiarini had not tried before.[29] The trachea later collapsed, and was replaced; she died in 2014.[11]

An audit by the Russian government later found that Macchiarini had operated without a Russian medical license.[11]

Alexander Zozulya

Also in June 2012, Macchiarini implanted a fully synthetic seeded trachea at Kuban State University, on Alexander Zozulya, who also had a tracheostomy resulting from a car accident and whose life was not in danger.[11][23][29] The effects from the first implant in 2012 prompted a second surgery in November 2013. The patient died in February 2014 under unclear circumstances.[23]

Yesim Cetir

Yesim Cetir, a Turkish woman, underwent a routine surgery in 2011 to treat excessive sweating in her hands, but due to an error her trachea was severely injured and her left lung was damaged.[23][26]:9 She came to Macchiarini at the Karolinska Institute for treatment, and in 2012 Macchiarini first removed her left lung and replaced her trachea with a pipe, then replaced the pipe with a fully synthetic seeded trachea.[26]:9 The next year the implant collapsed and Macchiarini replaced it with a second one.[26]:9 She had many complications from this procedure, and remained hospitalized and in constant need of having her airway cleared, and suffered kidney failure as well.[26]:9 In 2016 she underwent multiple organ transplants in the U.S., and her trachea was replaced with one from a cadaver.[26]:9

Cetir died in March 2017.[30]

Hannah Warren

In April 2013 Macchiarini implanted a fully synthetic, seeded trachea in Hannah Warren, a two-year-old, who had been born without one.[31] The operation was performed in the U.S., at OSF Saint Francis Medical Center in Peoria, Illinois.[31] The operation also involved her esophagus, which didn't heal properly and required a second operation in June; she died July 6, 2013 from complications of the second surgery.[32]

Sadiq Kanaan

In August 2013 Sadiq Kanaan received a fully synthetic seeded tracheal implant from Macchiarini at Kuban State University.[10][23] He died later the same year.[10]

Dmitri Onogda

In June 2014, Macchiarini implanted a fully synthetic seeded trachea in Dmitri Onogda at the Kuban State University.[10][23] The implant failed and was replaced, and as of 2017 Onogda was still alive.[10][23]

Allegations

University Hospital Careggi patient extortion

In 2012, Macchiarini was arrested in Italy and charged with asking patients at the University Hospital Careggi for money to expedite their procedures;[33] the charges were dismissed in May 2015[34] and the prosecutor's appeal was dismissed in September 2015.[35]

Research misconduct

In 2014 Macchiarini was accused by four former colleagues and co-authors of having falsified claims in his research.[36]

In April 2015, the ethics committee of the institute issued a response to one set of allegations with regard to research ethics and peer review at the Lancet, and found them to be groundless.[37]

The Karolinska Institute had also appointed an external expert, Bengt Gerdin, to review the charges, comparing the results reported to the medical record of the hospital; the report was released by Karolinska in May 2015.[38][39][40] Gerdin found that Macchiarini had committed research misconduct in seven papers, by not getting ethical approval for the some of his operations, and misrepresenting the result of some of those operations, as well as work he had done in animals.[38][39][41]

In August 2015, after considering the findings and a rebuttal provided by Macchiarini, vice-chancellor of Karolinska Institute Anders Hamsten found that Macchiarini had acted "without due care" but had not committed misconduct.[42][43] The journal The Lancet, which published Macchiarini's work, also published an article defending Macchiarini.[44]

On January 13, 2016—the same day that the first part of a three-part documentary about Macchiarini would air on Swedish television—Gerdin criticized the vice-chancellor's dismissal of the allegations in an interview on Swedish television.[45]

Later that day, Sveriges Television investigative TV show Dokument inifrån started airing a three-part series, titled "Experimenten", in which Macchiarini's work was investigated.[46][47] The documentary shows Macchiarini continuing operations with the new method even after it showed little or no promise, exaggerating the health of his patients in articles as they died one by one. While Macchiarini admitted that the synthetic trachea did not work in the current state, he did not agree that trying it on several additional patients without further testing had been inappropriate. Allegations were also made that patients' medical conditions both before and after the operations, as reported in academic papers, did not match reality. Macchiarini also stated that the synthetic trachea had been tested on animals before using it on humans, something that could not be verified.[9][17][23]

On January 28, Karolinska issued a statement saying that the documentary made claims of which it was unaware, and that it would consider re-opening the investigations.[48][49] These concerns were echoed by the chairman of the Karolinska Institute, Lars Leijonborg, and the chairman of the Swedish Medical Association, Heidi Stensmyren, calling for an independent investigation that would also look at how the issue was dealt with by the university and hospital management.[50]

In February 2016, the Karolinska Institute published a review of Macchiarini's CV that identified discrepancies.[16]

in February 2016 Karolinska announced that it would not renew Macchiarini's research contract, which was due to expire in November, and the next month Karolinska terminated the contract.[9]

In October 2016, the BBC broadcast a three-part Storyville documentary, Fatal Experiments: The Downfall of a Supersurgeon, directed by Bosse Lindquist and based on the earlier Swedish programmes about Macchiarini.[51]

After the special aired, the Karolinska Institute requested Sweden's national scientific review board to review six of Macchiarini's publications about the procedures. The board published its findings in October 2017, and concluded that all six were the result of scientific misconduct, in particular by failing to report the complications and deaths that occurred after the interventions; one of the articles also claimed that the procedure had been approved by an ethics committee, when this had not happened. The board called for all six of the papers to be retracted. It also said that all of the co-authors had committed scientific misconduct as well.[14]

Retractions

The following papers authored by Macchiarini have been retracted:

  • November 2012, retracted by the journal for copying a table from another paper without citing it:[33]
    • Gonfiotti, Alessandro; Jaus, Massimo Osvaldo; Barale, Daniel; Baiguera, Silvia; Polizzi, Leonardo; Jungebluth, Philipp; Paoletti, Matteo; Pistolesi, Massimo; Macchiarini, Paolo (2012). "RETRACTED: Development and Validation of a New Outcome Score in Subglottic Stenosis". The Annals of Thoracic Surgery. 94 (4): 1065–1072. doi:10.1016/j.athoracsur.2012.05.107. PMID 22858276.
  • March 2017, retracted by authors[52] after Karolinska requested retraction in December 2016;[53][54] after Nature had issued an editorial notice of concern in October 2016:[55]
  • Macchiarini's 2011 Lancet paper described the treatment of Beyene. In February 2016 the Royal Swedish Academy of Sciences called for the Lancet to correct the paper, as Beyene had died,[56][57] in March 2016 four authors asked to be removed as authors, and in April 2016 the Lancet issued a notice of concern;[58] this paper too has since been retracted.
    • Jungebluth, Philipp; Alici, Evren; Baiguera, Silvia; Blomberg, Pontus; Bozóky, Béla; Crowley, Claire; Einarsson, Oskar; Gudbjartsson, Tomas; Le Guyader, Sylvie; Henriksson, Gert; Hermanson, Ola; Juto, Jan Erik; Leidner, Bertil; Lilja, Tobias; Liska, Jan; Luedde, Tom; Lundin, Vanessa; Moll, Guido; Roderburg, Christoph; Strömblad, Staffan; Sutlu, Tolga; Watz, Emma; Seifalian, Alexander; Macchiarini, Paolo (2011). "RETRACTED: Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: A proof-of-concept study". The Lancet. 378 (9808): 1997–2004. doi:10.1016/S0140-6736(11)61715-7. PMID 22119609.

Other misconduct

A story published by Vanity Fair on January 5, 2016 discussed Macchiarini's affair with a journalist, who had written enthusiastic articles about him. The story also called into question statements he had made on his CV.[46][5] The article paints him as a serial fabulist, and as "the extreme form of a con man," remarking that "the fact that he could keep all the details straight and compartmentalize these different lives and lies is really amazing."[5] The article details a courtship and alleged subsequent marriage arrangements from the perspective of a NBC News producer, Benita Alexander. Alexander had been tasked by NBC News to produce a documentary-type programme for Dateline in 2013 called "A Leap of Faith" to portray Macchiarini and she ultimately began an affair with her subject, only to find out later in 2015 that he had been married for thirty years, including the entire period of the courtship. The details recounted in the article include Alexander relating Macchiarini's alleged lies about being a surgeon to the stars and current and former heads of state, and a planned wedding to Alexander to be the social event of the year (with Pope Francis officiating, Andrea Bocelli singing, Enoteca Pinchiorri catering, and numerous celebrities attending), among other reported falsified details about his C.V. and personal life.[5]

Macchiarini is reported to have claimed that Pope Francis had given his personal blessing for the wedding between the couple, both said to be divorcees, and would host the ceremony. The Pope's spokesman said that the Pope had no "personal doctor" named Macchiarini, knew nobody of that name, and would not have officiated.[59]

Fallout for Karolinska Institute

The secretary of the Nobel Committee for Physiology or Medicine, Urban Lendahl, resigned in February 2016, owing to his involvement in recruiting Macchiarini to Karolinska Institutet in 2010.[7][60] Shortly afterwards the vice chancellor, Anders Hamsten, who in 2015 had cleared Macchiarini of scientific misconduct, also resigned.[8][61]

In August 2016, a committee led by Kjell Asplund that had been called into being in February to investigate the three operations that Macchiarini had performed at the Karolinska University Hospital issued its report, identifying several ethical shortcomings by the hospital and Macchiarini; it also noted the pressure put on the hospital by the institute with regard to Macchiarini's hospital appointment and translational research.[26][62]

Another report was issued in early September that examined the behavior of the institute; it was authored by a committee led by Sten Heckscher. The report found that the institute had conducted almost no diligence in hiring Macchiarini nor in overseeing his work, nor in considering his performance in reviewing his contracts; the committee found that interference from people higher up in management had interfered in the processes.[62][63][64]

On September 5, 2016, the Swedish government moved to dismiss the entire board of the Institute.[65] Shortly afterwards Harriet Wallberg and Anders Hamsten were removed from the judging panel that is responsible for annually choosing the Nobel Prize for Medicine, selection of which is additionally overseen by Karolinska Institutet.[66]

In June 2016 Swedish police opened an investigation into whether Macchiarini might have committed involuntary manslaughter.[10][23] In October 2017, the public prosecutor office announced that all criminal charges against Macchiarini have been dropped, although the medical treatment in four of five cases operated in Sweden was classified as 'negligent' the criminal responsibility cannot be proven.[67] After a one-year medico-legal investigation, the attorney general's office announced in October 2017 that Macchiarini had been negligent in four of the five cases investigated due to the use of devices and procedures not supported by evidence, but that a crime could not be proven because the patients might have died under any other treatment given.[12][13]

In 2019, an Italian court sentenced Macchiarini to sixteen months in prison for abuse of office and forging documents.[68]

On 29 September, 2020, Mikael Bjork, director of Public Prosecution in Sweden indicted an unnamed surgeon on charges of aggravated assault. Swedish news agency TT said the indicted surgeon was Dr. Paolo Macchiarini. Bjork said he reopened the investigation in December of 2018 and obtained new written evidence and interviewed individuals in five different countries. Bjork said victims received "serious physical injuries and great suffering" as a result of the operations performed on them and that he "made the assessment that the three operations are therefore to be considered as aggravated assault."[68]

See also

References
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