Paolo Macchiarini (born 22 August 1958)
is a Swiss-born Italian
thoracic surgeon
Cardiothoracic surgery is the field of medicine involved in surgical treatment of organs inside the thoracic cavity — generally treatment of conditions of the heart (heart disease), lungs (lung disease), and other pleural or mediastinal struc ...
and former
regenerative medicine
Regenerative medicine deals with the "process of replacing, engineering or regenerating human or animal cells, tissues or organs to restore or establish normal function". This field holds the promise of engineering damaged tissues and organs by st ...
researcher who became known for
research fraud and
manipulative behavior
Manipulation in psychology is a behavior designed to exploit, control, or otherwise influence others to one’s advantage. Definitions for the term vary in which behavior is specifically included, influenced by both culture and whether referring t ...
.
He has been convicted of research-related crimes in Italy and Sweden.
Previously considered a pioneer for using both biological and synthetic scaffolds seeded with patients' own
stem cells
In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type o ...
as
trachea
The trachea, also known as the windpipe, is a Cartilage, cartilaginous tube that connects the larynx to the bronchi of the lungs, allowing the passage of air, and so is present in almost all air-breathing animals with lungs. The trachea extends ...
transplants, Macchiarini was a Visiting Professor and Director on a temporary contract at Sweden's
Karolinska Institutet
The Karolinska Institute (KI; sv, Karolinska Institutet; sometimes known as the (Royal) Caroline Institute in English) is a research-led medical university in Solna within the Stockholm urban area of Sweden. The Karolinska Institute is consiste ...
(KI) from 2010. Macchiarini has been accused of unethically performing experimental surgeries, even on relatively healthy patients, resulting in fatalities for seven of the eight patients who received one of his synthetic trachea transplants. Articles in ''
Vanity Fair'' and ''
Aftonbladet
''Aftonbladet'' (, lit. "The evening paper") is a Swedish daily newspaper published in Stockholm, Sweden. It is one of the largest daily newspapers in the Nordic countries.
History and profile
The newspaper was founded by Lars Johan H ...
'' further suggested that he had falsified some of his academic credentials on résumés.
, the secretary of the
, resigned in February 2016, owing to his involvement in recruiting Macchiarini to KI.
Shortly afterwards KI's vice chancellor, , who in 2015 had cleared Macchiarini of misconduct, also resigned.
KI terminated its clinical relationship with Macchiarini in 2013 but allowed him to continue as a researcher; in February 2016, the university announced that it would not renew his research contract, which was due to expire in November, and terminated the contract the following month.
After being dismissed from KI, Macchiarini worked at the
Kazan Federal University
Kazan (Volga region) Federal University (russian: Казанский (Приволжский) федеральный университет, tt-Cyrl, Казан (Идел буе) федераль университеты) is a public research uni ...
in Russia until that institution terminated his project in April 2017, effectively firing him.
After a one-year
medico-legal investigation, the
Swedish Prosecution Authority
The Swedish Prosecution Authority ( sv, Åklagarmyndigheten) is the principal agency in Sweden responsible for public prosecutions. It is a wholly independent organisation; not dependent on the courts or the police, and although it is organized un ...
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.
[ Also in October, Sweden's Expert Group on Scientific Misconduct found evidence of research fraud by Macchiarini and his co-authors in six papers and called for them to be retracted.][ As of 2020, Macchiarini has had eight of his research papers retracted, and two have received an expression of concern.
]
Education and career
Macchiarini obtained his medical degree
A medical degree is a professional degree admitted to those who have passed coursework in the fields of medicine and/or surgery from an accredited medical school. Obtaining a degree in medicine allows for the recipient to continue on into special ...
(equivalent to MD) at the Medical School of the University of Pisa
The University of Pisa ( it, Università di Pisa, UniPi), officially founded in 1343, is one of the oldest universities in Europe.
History
The Origins
The University of Pisa was officially founded in 1343, although various scholars place ...
(UniPi) in 1986 and a Master of Surgery
The Master of Surgery (Latin: Magister Chirurgiae) is an advanced qualification in surgery. Depending upon the degree, it may be abbreviated ChM, MCh, MChir or MS. At a typical medical school the program lasts between two and three years. The p ...
in 1991.[ He was an assistant professor at UniPi from 1990 to 1992.][ He took a course on statistics in clinical research at University of Alabama at Birmingham in 1989.][ Macchiarini 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
The University of Franche-Comté (UFC) is a pluridisciplinary public French university located in Besançon, Franche-Comté, with decentralized campuses in Belfort, Montbéliard, Vesoul and Lons-le-Saunier.
It is a founding member of the communi ...
in France.[ According to Germany's ]Hannover Medical School
The Hannover Medical SchoolAlthough the English spelling of the city name is "Hanover", this form of the name, using the German spelling of the city name, is used as the English-language name of the school, for example . (german: Medizinische Ho ...
, 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.[ Macchiarini was an investigator at the Institut d'Investigacions Biomèdiques-Instituto de Investigaciones Biomédicas in ]Barcelona
Barcelona ( , , ) is a city on the coast of northeastern Spain. It is the capital and largest city of the autonomous community of Catalonia, as well as the second most populous municipality of Spain. With a population of 1.6 million within ci ...
, Spain, from 2006 to 2009; he was affiliated with but not an employee of the University of Barcelona
The University of Barcelona ( ca, Universitat de Barcelona, UB; ; es, link=no, Universidad de Barcelona) is a public university located in the city of Barcelona, Catalonia, in Spain. With 63,000 students, it is one of the biggest universities i ...
and was apparently an employee at the Hospital Clínic de Barcelona during this time.[ He had an honorary appointment as a Visiting Professor from 2009 to 2014, at ]University College London
, mottoeng = Let all come who by merit deserve the most reward
, established =
, type = Public research university
, endowment = £143 million (2020)
, budget = ...
.[ He was a consultant and project manager at University Hospital Careggi (AOUC) starting in 2010.][
Later in 2010, Macchiarini was appointed as a visiting professor at the ]Karolinska Institute
The Karolinska Institute (KI; sv, Karolinska Institutet; sometimes known as the (Royal) Caroline Institute in English) is a research-led medical university in Solna within the Stockholm urban area of Sweden. The Karolinska Institute is consist ...
(KI) in Stockholm
Stockholm () is the Capital city, capital and List of urban areas in Sweden by population, largest city of Sweden as well as the List of urban areas in the Nordic countries, largest urban area in Scandinavia. Approximately 980,000 people liv ...
and as a part-time position as surgeon at the affiliated university hospital.[ In 2013, KI terminated its clinical relationship with Macchiarini but allowed him to continue as a researcher; in February 2016, the university announced that it would not renew Macchiarini's research contract, which was due to expire in November, and terminated the contract the following month.] KI published the incomplete results of its verification of Macchiarini's CV in February 2016.[
Macchiarini made ties in Russia after he gave a master class in 2010, at the invitation of politician ]Mikhail Batin
Mikhail Batin (Михаил Александрович Батин) (born July 3, 1972) is a Russian businessman and politician. He is Chairman of the Board of the NGO "Science For Life-Extension".
Mikhail Batin, a follower of the Russian cosmis ...
; a few months later he did a trachea
The trachea, also known as the windpipe, is a Cartilage, cartilaginous tube that connects the larynx to the bronchi of the lungs, allowing the passage of air, and so is present in almost all air-breathing animals with lungs. The trachea extends ...
transplant there which was widely covered in Russian media.[ This led to Macchiarini's 2011 appointment at ]Kuban State Medical University
Kuban State Medical University is a medical school in Russia. It is located in Krasnodar, the capital of Krasnodar Krai in South Russia. Kuban State Medical University was founded by the government of the Russian Federation
The Government o ...
, funded by the university and the Russian government,[ along with an ]honorary doctorate
An honorary degree is an academic degree for which a university (or other degree-awarding institution) has waived all of the usual requirements. It is also known by the Latin phrases ''honoris causa'' ("for the sake of the honour") or ''ad hon ...
.[ In 2016, he moved to ]Kazan Federal University
Kazan (Volga region) Federal University (russian: Казанский (Приволжский) федеральный университет, tt-Cyrl, Казан (Идел буе) федераль университеты) is a public research uni ...
and the grant money moved with him.[ In April 2017, the university terminated Macchiarini's research project there.][
]
Notable trachea surgeries
Claudia Castillo
In June 2008, Macchiarini conducted a transplant of a donated trachea colonized with the stem cell
In multicellular organisms, stem cells are undifferentiated or partially differentiated cells that can differentiate into various types of cells and proliferate indefinitely to produce more of the same stem cell. They are the earliest type o ...
s of the recipient, Claudia Castillo; the tissue was used to replace her left bronchus
A bronchus is a passage or airway in the lower respiratory tract that conducts air into the lungs. The first or primary bronchi pronounced (BRAN-KAI) to branch from the trachea at the carina are the right main bronchus and the left main bronchus. ...
, which had been damaged by tuberculosis
Tuberculosis (TB) is an infectious disease usually caused by '' Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in ...
, and her left lung had collapsed. The trachea came from a cadaver, and was stripped of its cells and seeded with cells taken from Castillo's bone marrow.[ The bone marrow cells were cultured at the ]University of Bristol
, mottoeng = earningpromotes one's innate power (from Horace, ''Ode 4.4'')
, established = 1595 – Merchant Venturers School1876 – University College, Bristol1909 – received royal charter
, type ...
, the donor trachea was stripped at University of Padua
The University of Padua ( it, Università degli Studi di Padova, UNIPD) is an Italian university located in the city of Padua, region of Veneto, northern Italy. The University of Padua was founded in 1222 by a group of students and teachers from B ...
, the stripped trachea was seeded with the cultured cells at University of Milan
The University of Milan ( it, Università degli Studi di Milano; la, Universitas Studiorum Mediolanensis), known colloquially as UniMi or Statale, is a public research university in Milan, Italy. It is one of the largest universities in Europe ...
, and the trachea was transplanted by a team led by Macchiarini at Hospital Clinic in Barcelona.[
]
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
Great Ormond Street Hospital (informally GOSH or Great Ormond Street, formerly the Hospital for Sick Children) is a children's hospital located in the Bloomsbury area of the London Borough of Camden, and a part of Great Ormond Street Hospital ...
in London. The boy was born with a 1 mm diameter trachea, and efforts to widen it had caused life-threatening complications.[ 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. In 2010, Macchiarini performed 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.
Woman in Russia
In 2010, Macchiarini implanted a seeded donated trachea in a woman in Russia, while working with surgeon Vladimir Parshin.[
]
Andemariam Teklesenbet Beyene
Andemariam Teklesenbet Beyene was a man from Eritrea who was earning a master's degree in Iceland when he was diagnosed with cancer; the cancer was treated with chemotherapy
Chemotherapy (often abbreviated to chemo and sometimes CTX or CTx) is a type of cancer treatment that uses one or more anti-cancer drugs (chemotherapeutic agents or alkylating agents) as part of a standardized chemotherapy regimen. Chemotherap ...
and surgery in 2009, but in 2011 his trachea was obstructed again. Beyene's doctors recommended palliative care, but also reached out to Macchiarini, who was at KI by that time. 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 it had been done before.[ The operation occurred in June 2011 and was widely covered in the media, including a front page story in '']The New York Times
''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid ...
''. By end of the year the implant was failing, and while Beyene was able to complete his Ph.D
A Doctor of Philosophy (PhD, Ph.D., or DPhil; Latin: or ') is the most common Academic degree, degree at the highest academic level awarded following a course of study. PhDs are awarded for programs across the whole breadth of academic fields ...
in 2012, he died in January 2013 despite undergoing many treatments at KI.[ The ]autopsy
An autopsy (post-mortem examination, obduction, necropsy, or autopsia cadaverum) is a surgical procedure that consists of a thorough examination of a corpse by dissection to determine the cause, mode, and manner of death or to evaluate any di ...
showed that Beyene had a chronic lung infection, a clot in his lung, and the synthetic trachea had come loose.[
]
Christopher Lyles
Christopher Lyles lived in the United States; he had tracheal cancer
Lung cancer, also known as lung carcinoma (since about 98–99% of all lung cancers are carcinomas), is a malignant lung tumor characterized by uncontrolled cell growth in tissue (biology), tissues of the lung. Lung carcinomas derive from tran ...
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. Macchiarini obliged, creating a fully synthetic trachea seeded with stem cells from Lyles and implanting it at KI in November 2011.[ Lyles died suddenly in 2012 after he had returned home; no autopsy was performed.][
]
Yulia Tuulik
In June 2012, Macchiarini implanted a fully synthetic seeded trachea in Yulia Tuulik at Kuban State Medical University; Tuulik had a tracheostomy
Tracheotomy (, ), or tracheostomy, is a surgical airway management procedure which consists of making an incision (cut) on the anterior aspect (front) of the neck and opening a direct airway through an incision in the Vertebrate trachea, trache ...
resulting from a car accident, but her life was not in danger. The graft
Graft or grafting may refer to:
*Graft (politics), a form of political corruption
* Graft, Netherlands, a village in the municipality of Graft-De Rijp
Science and technology
*Graft (surgery), a surgical procedure
*Grafting, the joining of plant t ...
included a cricoid cartilage
The cricoid cartilage , or simply cricoid (from the Greek ''krikoeides'' meaning "ring-shaped") or cricoid ring, is the only complete ring of cartilage around the trachea. It forms the back part of the voice box and functions as an attachment si ...
, part of the voice box, which Macchiarini had not tried before.[ The trachea later collapsed, and was replaced; she died in 2014.][ An audit by the Russian government later found that Macchiarini had operated without a Russian medical license.][
]
Alexander Zozulya
Also in June 2012, Macchiarini implanted a second synthetic seeded trachea on Alexander Zozulya, who also had a tracheostomy resulting from a car accident and whose life was not in danger.[ The effects from the first implant in 2012 prompted a second surgery in November 2013. Zozulya died in February 2014 under unclear circumstances.][
]
Yesim Cetir
Turkish national Yesim Cetir underwent a routine surgery in 2011 to treat excessive sweating
Hyperhidrosis is a condition characterized by abnormally increased sweating, in excess of that required for regulation of body temperature. Although primarily a benign physical burden, hyperhidrosis can deteriorate quality of life from a psychologi ...
in her hands, but due to an error her trachea was severely injured and her left lung was damaged.[ She came to Macchiarini at the KI for treatment, and in 2012 he first removed her left lung and replaced her trachea with a pipe, then replaced the pipe with a fully synthetic seeded trachea.][ The next year the implant collapsed and Macchiarini replaced it with a second one.][ Cetir had many complications from this procedure, remained in constant need of having her airway cleared, and suffered ]kidney failure
Kidney failure, also known as end-stage kidney disease, is a medical condition in which the kidneys can no longer adequately filter waste products from the blood, functioning at less than 15% of normal levels. Kidney failure is classified as eit ...
.[ In 2016 she underwent multiple organ transplants in the U.S., and her trachea was replaced with one from a cadaver.][ Cetir died in March 2017.
]
Hannah Warren
In April 2013, Macchiarini implanted a fully synthetic seeded trachea in two-year-old Hannah Warren, who had been born without one. The operation was performed at OSF Saint Francis Medical Center
OSF Saint Francis Medical Center, located in Peoria, Illinois, United States, is a teaching hospital for the University of Illinois College of Medicine at Peoria and part of the OSF Healthcare System. The center, which is the largest hospital in th ...
in Peoria, Illinois
Peoria ( ) is the county seat of Peoria County, Illinois, United States, and the largest city on the Illinois River. As of the United States Census, 2020, 2020 census, the city had a population of 113,150. It is the principal city of the Peoria ...
, United States.[ The operation also involved her ]esophagus
The esophagus (American English) or oesophagus (British English; both ), non-technically known also as the food pipe or gullet, is an organ in vertebrates through which food passes, aided by peristaltic contractions, from the pharynx to the ...
, which didn't heal properly and required a second operation in June; she died 6 July 2013, from complications of the second surgery.
Sadiq Kanaan
In August 2013 Sadiq Kanaan received a fully synthetic seeded tracheal implant from Macchiarini at Kuban State Medical University.[ He died later the same year.][
]
Dmitri Onogda
In June 2014, Macchiarini implanted a fully synthetic seeded trachea in Dmitri Onogda at the Kuban State Medical University.[ The implant failed and was replaced, and as of 2017 Onogda was still alive.][
]
Allegations
University Hospital Careggi patient extortion
In 2012, Macchiarini was arrested in Italy and charged with asking patients at AOUC for money to expedite their procedures; the charges were dismissed in May 2015 and the prosecutor's appeal was dismissed in September 2015.
Research misconduct
In 2014, Macchiarini was accused by four former colleagues and co-authors of having falsified claims in his research with KI. The following April, KI's ethics committee
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.
Specific regions
An ethics committee in the E ...
issued a response to one set of allegations with regard to research ethics and peer review at ''The Lancet
''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823.
The journal publishes original research articles, ...
'', and found them to be groundless.
KI 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 the university in May 2015. Gerdin found that Macchiarini had committed research misconduct
Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in the publication of professional scientific research. A '' Lancet'' review on ''Handling of Scientific Misconduct in Scandinavian countrie ...
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.[
In August 2015, after considering the findings and a rebuttal provided by Macchiarini, KI vice-chancellor Anders Hamsten found that he had acted "without due care" but had not committed misconduct. ''The Lancet'', which published Macchiarini's work, also published an article defending him.
On 13 January 2016, Gerdin criticized the vice-chancellor's dismissal of the allegations in an interview with ]Sveriges Television
Sveriges Television AB ("Sweden's Television Stock Company"), shortened to SVT (), is the Sweden, Swedish national public broadcasting, public television broadcaster, funded by a public service tax on personal income set by the Riksdag (national ...
(SVT). Later that day, the SVT investigative program ''Dokument inifrån'' began broadcasting a three-part series, titled "Experimenten", in which Macchiarini's work was investigated.[ The documentary shows Macchiarini continuing operations with his new transplant method even after it showed little or no promise, exaggerating the health of his patients in articles as they died. 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.][
On 28 January, KI issued a statement saying that the documentary made claims of which it was unaware, and that it would consider re-opening the investigations. These concerns were echoed by KI's chairman, Lars Leijonborg, and the chairman of the ]Swedish Medical Association
The Swedish Medical Association (SMA) is the union and professional organization for medical doctors and medical students in Sweden. In the main, it deploys activities on behalf the Swedish doctors' employment conditions, ethics, working environm ...
, Heidi Stensmyren, calling for an independent investigation that would also look at how the issue was dealt with by the university and hospital management.
In February 2016, KI published a review of Macchiarini's CV that identified discrepancies. The university 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.[
In October 2016, the ]BBC #REDIRECT BBC #REDIRECT BBC
Here i going to introduce about the best teacher of my life b BALAJI sir. He is the precious gift that I got befor 2yrs . How has helped and thought all the concept and made my success in the 10th board exam. ...
...
'' documentary, ''Fatal Experiments: The Downfall of a Supersurgeon'', directed by
and based on the earlier Swedish programmes about Macchiarini.
After the special aired, KI 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
, 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.
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: