The questions
- The process building up to success, for example awards, prizes, fancy publications, big research grants, high ranking for his home university etc.
- The parallel process where accountability mechanisms were put out of function one after another – as his success became greater, the control mechanisms became weaker, eventually leading to terrifying consequences.
- A survey of how the pair of words HOPE/HYPE have been used in other academic articles. Usually these words are used to describe a phenomenon, not as theoretical concepts
The success of dr. Paolo Machiarinni
Background
Dr. Paolo Macchiarini was born on August 22, 1958 and earned his medical degree in the School of Medicine of the University of Pisa in Italy in the year 1986, then proceeded to complete his postgraduate surgery training at the same university. He moved on later to the University of Alabama in Birmingham where he did his two-year clinical fellowship under the supervision of Dr. John Kirklin and Dr. Richard McElvin. At the Centre Chirurgical Marie-Lannelongue (CCML) in Paris, Prof. Macchiarini started his training as a specialist in general thoracic and vascular surgery and heart-lung transplantation and research under the supervision of his senior Dr. Philippe Dartevelle.
Dr. machiarinni was a consultant at the CCML until 1998, a period marked by him earning a PhD in tissue and organ transplantation at the University of Franche-Comte- with a thesis in ‘tracheal allotransplanting’. He later became the Chairman of the Department of General Thoracic and Vascular Surgery at the Heidehaus Hospital in the year 1999- the same year, he also became the professor of Surgery at the Hannover Medical Scholl in Germany. Later, Dr. Macchiarini became the Chairman of the Department of general Thoracic surgery at the Barcelona Hospital Clinic (Spain), joined the Stockholm Karolinska Institute as a Professor of Regenerative Surgery and Director of the European Airway Institute and Advanced Centre of Translational Regenerative Medicine. He was also the Director of the European Thoracic Research Centre in Florence, Italy.
Summary of his background: University of Pisa Medical School (MD, 1986); University of Pisa General Surgery Residence (1986-1991); University of Birmingham in the USA Oncology and Thoracic Surgery Fellowship (1989-1990). University of Paris-Sud Cardiothoracic Fellowship (1991-1993); university of Franche-Comte (PhD, 1993-1997); Research Director at the Paris-Sud University (1998); Head of Department of Thoracic and Vascular Surgery, Heidahaus Hospital (1999-2004); Head of Department General Thoracic Surgery in the University of
Interests
The clinical interests of Dr. Macchiarini included surgery for both pediatric and adult complex lung, mediastinal, esophageal diseases, as well as non-cardiothoracic transplantation (lung, heart, airways), intrathoracic. Primarily, his research interest revolved around the role and effectiveness of allotransplantation of airways, where he is recorded to describing the first ever technique for the laryngotracheal allotransplantation and, recently, the replacement of airways with tissue-engineered airway transplants. Dr. Macchiarini made history in the transplant sector by using laboratory cultured stem cells to help in the achievement of the first ever worldwide in-human transplantation of a windpipe (tissue-engineered organ) without the use of pharmacotherapy (immunosuppression), this occurred in Barcelona in the year 2008, on 2010 he oversaw the first laryngotracheal allotransplantation at the University California at Davis, and recently, the first tracheobronchial replacement using a completely artificial, lab-made nanocomposite in Stockholm, 2011. He has contributed to more than 150 articles in peer-reviewed journals and 40 book chapters. He has received numerous awards and is Visiting or Honorary Professor in several leading Academic Institutions worldwide. Has been recently nominated “Knight” for scientific merits by the President of Italy.
| Interests | Below is a summary list of Dr. Macchiarini’s interest areas 1. Adult and pediatric tracheal surgery 2. Extended surgeries for the Tumors in the Esophagus, Lung and Mediastinum 3. Education, Training, experimental Research of Lung and Heart-Lung Transplantation 4. Pulmonary Endarterectomy 5. Artificial (Bio-artificial) Lungs |
| Research Area | Tissue Engineering of intrathoracic organs |
| Practice Areas | General thoracic surgery |
| Organizations | The organizations he worked for include: 1. Cardiothoracic Surgery Network |
Pioneer discoveries/findings
Pioneer in synthetic trachea replacement surgeries
Awards
Publications
The first publication was “Relation of neovascularisation to metastasis of non-small-cell lung cancer” published in 1992 together with his colleagues Dr. Fontanini, MD, Dr. Squartini, MD, Dr. Angeletti, MD and Dr. Hardin, PhD. In this publication, dr. Machiarini and his colleagues assessed the intensity of angiogenesis in correlation to the metastasis of non-small-cell lung cancer by counting the number of micro vessels and grading their densities in 87 T1 NOMO patients.
The fall of Dr. Paolo Machiarini
Exposure of his work by the media
In the medical circle, the Italian Surgeon Dr. Macchiarini’s star was rising and by 2010, he was invited to the Stockholm University as a visiting professor; arriving as a leader in Regenerative Medicine. His world fame came in July 2011 for “successfully” transplanting an ingenious windpipe that was made of seeded plastic cells from the patient’s stem cells to recipient in Stockholm, Sweden. The operation was a promising revolutionary step in the medical world, and was bound to reshape organ transplants. Patients would no longer have to wait on long lists for compatible donors, on at the end to depend of immunosuppression drug to combat the lifetime rejection. His discovery of plastic trachea- and a guarantee for research into other possible organs, would ne quickly produced, safely made and tailored to meet the biological requirements of the patient. The story would be a befitting fete for the for the Surgeon’s workplace, the Karolinska Institute, as it was known to churn out professors who would sit on the Nobel Prize panel of judges.
His troubles began in 2014 after several media outlets and his colleagues at the KI filed complaints of Macchiarini downplaying major risks associated with the procedures. His work, and wrong headlines in the Swedish media brought the Surgeon, KI and it its sister organisation, the Karolinska University Hospital no glory. Karolinska suspended Dr. Macchiarini’s work after six of his patients died after the procedures, two of the surviving got the synthetic trachea removed and replaced with a donor’s, and the ensuring allegations of causing well individuals to become critically ill. Although he is one of the most famous doctors in the world, his academic research and work is now considered misleading, and most of the patients who received his revolutionary treatment are deceased. The nine synthetic transplant patients and their fate is as tabulated below:
| Name of the Patient | Location | Date of Operation | Outcome |
| Andemariam Beyene | Stockholm | June 2011 | Died on January 2014 |
| Keziah Shorten | London | September 2011 | Died on January 2012 |
| Chrisptopher Lyles | Stockholm | November 2011 | Died on march 2012 |
| Julia Tuulik | Krasnodar | June 2012, august 2013 | Died on September 2014 |
| Alexander Zozulya | Krasnodar | June 2012, November 2013 | Died on February 2014 |
| Yasim Cetir | Stockholm | August 2012, July 2013 | Survives but remains critically ill |
| Sadiq Kanaan | Krasnodar | August 2013 | Date of death unknown |
| Hannah Warren | Peoria, US | August 2013 | Died on July 2013 |
| Dmitri Onogda | Krasnodar | June 2014 | The synthetic trachea was removed; the patient still survives. |
Allegations
Published independent reports have all sharply criticised the synthetic trachea operations that were conducted at the Karolinska University Hospital. Investigations led by the Chairman of the Swedish Council on Medical Ethics- Kjell Asplund found out that the new operation failure to carry oy risk analyses before trial on patients, lacked the necessary ethical approval and was condemned it for being weak. Further investigation pointed out the mistake that KI had committed during the recruitment of Dr. Macchiarini when allegations were levied against him in 2014. These investigations paint a doctor who persisted with a technique that had little prospects of working, had the ability to gamble with his patient’s life by taking extraordinary risks, and a medical institution that was so attached to the star doctor that they were blinded to see him for what he was- made poor judgement and ignored the mounting evidence.
Hope for the patient Beyene, and the hype in the publication
A bandwagon effect around his work as “Regenerative Medicine” is the new cutting edge of the scientific fashion ensured that colleagues never raised fingers nor objection on the basic science that was underlying the procedures. The 36-year old Andemariam Beyene was the first patient to receive the synthetic trachea in 2011- a graduate student from both Iceland and Eritrea. His Icelandic doctors failed to treat his rare form of tracheal cancer, and thus referred him to the experts at the University Hospital of Karolinska. Professor Macchiarini reassured the patient that the revolutionary procedure was the only thing that stood between him and imminent death, and consequently persuaded him to agree to the new revolutionary surgical procedure.
Beyene’s new synthetic scaffold trachea was made in London; seeded with stem cells taken from the bone marrow of the patient, placed in a bioreactor designed to stimulate rapid cell growth. Ideally, the cells were to divide and reward Beyene with a functional trachea. Silver cells from the patient’s nose were deposited into the scaffold by the Surgeon in hope that they would differentiate into the epithelial lining of the trachea. In short, the doctors were hoping to grow a trachea in the patient. In a month, reporters from around the world flocked the hospital to interview the patient who was quoted as being scared of the operation, as he would live or die. The Doctor and his colleagues by the end of the year wrote in the Lancet that the patient had a near normal airway, with growing tissue free of infection- sending miraculous news through the medical world of the new impossible fete.
Two more synthetic tracheas were on the way to be implanted by the time. In an operation on a British patient with a serious tracheal condition not overseen by Dr. Macchiarini at the London University College. The second operation saw the Surgeon himself fit a 30-year old American man with the miraculous sounding trachea. The patients on survived for a few months as the tracheas did not function well. The doctors cited lack of integration into the surrounding tissue of the new materials and loose healing tissues that were obstructing normal breathing and other reasons. Macchiarini’s work was stopped by the Karolinska University in November 2013, but continue to carry out his clinical trial in Russia.
Scientific misconduct, fall from grace and consequent arrest
Investigations into his misconduct came up with three questions: were the risks associated with the operations properly assessed? Were the patients made aware of the risks, and if, did they understand the risks? Were the subject patients ill enough for the dramatic intervention?
The Italian legal authorities in 2012 accused Prof. Macchiarini of “under the desk” demanding money from patients, and was consequently placed under house arrest. The same year, he had a scientific paper retracted because of alleged scientific misconduct, which was later followed by an investigation on falsified scientific results in a publication in The Lancet- cited in Nature. Recently, he has been accused of having performed transplant surgeries without the require informed patient consent that is a requirement of the Helsinki Declaration for clinical trials. Publication of November and December 2014 have appraised several of the allegations. Several inconsistences have been revealed by a thorough investigation of Dr. Macchiarini’s medical records of the patients who received the synthetic tracheas and relevant publications, which has compelled the KI to launch an internal investigation of such. Supporting evidence provided by four doctors who analysed the six patients of each of Macchiarini’s papers reveal inaccuracies and inconsistencies including: omission and serial fabrication of biopsy and bronchiosciopic findings; unapproved informed consent that was signed up to seventeen days after the transplant; omission and fabrication of clinical status of the patients; and inability of inquiries to identify a single application of synthetic trachea transplantation filed at the Regional Ethical Review Board.
