Ground-breaking work on synthetic organ transplants made Paolo Macchiarini one of the most famous doctors in the world. But some of his academic research is now seen as misleading, and most of the patients who received his revolutionary treatment have died. What went wrong?
In July 2011, the world was told about a sensational medical breakthrough that had taken place in Stockholm, Sweden. The Italian surgeon Paolo Macchiarini had performed the world’s first synthetic organ transplant, replacing a patient’s trachea, or windpipe, with a plastic tube.
The operation promised to reshape organ transplantation. No longer would patients have to wait for a donor organ, only to run the risk of biological rejection. Plastic tracheas – and possibly other organs – would be produced quickly, safely, and made-to-measure for each patient.
It was a story that befitted the reputation of Dr Macchiarini’s workplace, the prestigious Karolinska Institute, whose professors decide each year who will receive the Nobel Prize in Medicine.
But five years on, Macchiarini’s headline-making work has brought KI and its sister organisation, the Karolinska University Hospital, no glory. Of the nine patients that received the treatment, in Sweden and elsewhere, seven have died. The two still alive have had their synthetic tracheas removed and replaced with a windpipe from a donor.
Last week, an independent report sharply criticised the three synthetic trachea operations that took place at Karolinska University Hospital.
The investigation, led by Kjell Asplund, Chairman of the Swedish Council on Medical Ethics, found that the scientific foundation for the new operation was weak, and condemned the failure to carry out risk analyses before the patients received their operations, or seek the necessary ethical approval.
On Monday, a separate investigation at KI identified mistakes made when Macchiarini was recruited and when allegations of misconduct were made against him two years ago.
In the picture that emerges from these reports, we see a doctor persisting with a technique that showed few signs of working and able to take extraordinary risks with his patients, and a medical institution so attached to their star doctor that they ignore mounting evidence of his poor judgement.
Macchiarini arrived in Stockholm in 2010, already a leader in the field of regenerative medicine – the project of growing tissue or organs to be implanted in sick patients.
Not only was Macchiarini known as a brilliant surgeon, he was handsome and impressive – able to give press conferences in several languages.
At the hospital, a “bandwagon effect” emerged around his work. “Regenerative medicine” was at the cutting edge of scientific fashion, and few colleagues raised questions or objections about the basic science underlying the procedures.
The patient who received that first synthetic organ transplant, in 2011, was 36-year-old Andemariam Beyene, a graduate student from Eritrea living in Iceland. After unsuccessful treatment for a rare form of cancer, he had been referred by his Icelandic doctors to the experts at Karolinska University Hospital.
Macchiarini told Beyene that the revolutionary surgery was his only chance of survival and persuaded him to agree to the new procedure.
The synthetic “scaffold” for Beyene’s new trachea was made in a lab in London. It was seeded with stem cells taken from the patient’s bone marrow, then placed in a shoe-box sized machine called a bioreactor, where it rotated in a solution designed to encourage cell growth.