“If I had the choice between a transplant of a synthetic trachea and the firing squad I’d choose the last option because this is the least painful form of execution,” says Professor Pierre Delaere.
At times, the language in Fatal Experiments: the Downfall of a Supersurgeon is far from clinical. The documentary, which sparked controversy in Sweden earlier this year and which airs on the BBC this week, slices open the somewhat murky story of Paolo Macchiarini – a brilliant surgeon accused of falsifying scientific results and being investigated over potential charges akin to manslaughter, after attempts to implant plastic windpipes failed and patients died.
In the documentary, we watch archive footage of Macchiarini operate on a young Russian woman with a non-fatal condition; we see him pose for photos alongside apparently “saved” patients; we watch him take phone calls on the beach, holding his shoes; we hear from the families of patients who have died; we hear from the doctors who complained about his methods; we read the disputed extracts from his research papers and, finally, we watch him turn on the documentary-maker Bo Lindquist, as he dismisses the accusations put to him.
“I regarded Macchiarini as a friend through the 00s. From time to time he’d confide that he felt very lonely and that I was his only friend in the world,” explains Martin Birchall, professor of laryngology at UCL, who worked with Macchiarini on tracheal replacements [using trachea taken from donors then embedded with patient’s own stem cells] and who features in the film. “But his efforts had got increasingly crazy by 2010, so I stopped working with him.”
This meant, explains Guri Sandhu, an ENT surgeon who also features and who worked with Macchiarini when he held an honorary position at UCL, that Macchiarini no longer had access to donated biological trachea. So he moved on to using synthetic tracheas embedded with a patient’s stem cells instead. “The holy grail has been to custom design a piece of ‘windpipe’, plug it in the patient’s airway and all their breathing problems are solved,” says Sandhu. “But Mr Macchiarini’s are basically a bit of plastic, however clever that plastic may be … and they didn’t work.”
The problem, says Sandhu, is that unlike major vessels in the chest, which are sterile, the windpipe is exposed to the air we breathe and all the micro-organisms within it. This means implants quickly become infected, as any bacteria that you breathe in will simply colonise the foreign material.
“If you look at the history of synthetic scaffolds in tissue engineering, they have been researched and experimented with for more than 20 years – this was not completely uncharted territory,” Macchiarini tells me on email when I contacted him after watching the documentary. Which, needless to say, he argues “grossly misrepresents” him.
“The first patient was referred to me as I was moving my research base to Sweden … insurance would not cover him in Italy, so I tried to arrange a donor trachea in Sweden. It was not possible in the timeframe.” Here is where things get complicated.
According to Macchiarini, “there had been experiments in many different animals, and some clinical work in humans too – but I had never done it myself, and nor had anyone else in Sweden where the patient could be treated,” and yet he went ahead with the surgery anyway, on compassionate grounds. “We all wrote a protocol, which was approved by the hospital’s ethics board, the patient gave his informed consent … and the transplant took place. For that patient, the choice was stark: it was palliative care only, or an opportunity to try something experimental.” A year later, the patient died.
It is Macchiarini’s lack of animal modelling – testing the procedure on, say, rats, pigs or monkeys before humans – that seems to mark him out from the other surgeons I, and the documentary producer Lindquist, spoke to. “Macchiarini was using technology that wasn’t proven ... this type of research should take place in steps,” says Sandhu.
“Macchiarini’s pattern was to carry out these high-profile surgeries then not be available for follow-up. He would disappear and ignore phone calls. He blamed the doctors who picked up his cases for the poor outcomes.” And there were often poor outcomes: patients with synthetic windpipes either died, or had to have the plastic trachea replaced with biological ones, from donors. The two patients who lived the longest – Andemariam Beyene and Julia Tuulik – survived two and a half years and three years respectively, after being implanted with one of Macchiarini’s plastic tracheas.
Though the series is about surgery, not psychology, it is hard not to speculate about why Macchiarini behaves as he does – moving from institution to institution, taking huge risks, responding aggressively to criticism, even, possibly, falsifying results in scientific papers. Not to mention the now-infamous Vanity Fair article that accuses Macchiarini of being an adulterer and fantasist – the sort of man who can claim that the Pope will officiate and Andrea Bocelli will sing at his wedding, when he is already married and has made contact with neither man.
“He was very much like other brilliant scientists I’d met previously who pursue big international projects with high stakes,” says Lindquist. “It’s clear that in his mind he’s justified. I don’t think he’s a bad person or an evil person. He believed he’s helping mankind and that he’ll succeed given enough time and enough patients.”
Of course, there is always risk when working at the forefront of science and surgery. “I have a nurse in London who scrubbed for Christiaan Barnard [who performed the world’s first successful human-to-human heart transplant] and when I described Paolo Macchiarini to him he said Barnard was exactly the same,” says Birchall. “That’s not to say there weren’t a lot of problems about the way Macchiarini did things, because there were ... But maybe Christiaan Barnard wasn’t much better, and yet he’s lauded for introducing cardiac transplantation, which later proved to be so good.”
For his part, Macchiarini argues that the documentary is at best selective and at worst misrepresentative. He argues that the Swedish doctors who first raised complaints against him at the prestigious Karolinska Institute in Stockholm (the story that caught Lindquist’s attention) did so because they were found guilty of plagiarising his team’s work. He claims the footage that seems to show the poor health of Macchiarini’s patients and questionable decisions made by the surgeon was used “without permission” to “tell a story that simply wasn’t what happened”.
He argues that the documentary team interviewed patients who “owe their lives directly, or indirectly, to the work of my research team” and yet weren’t featured at all. He says that as a result of the programme he has been subjected to personal threats and abuse. To which Lindquist responds that “the independent inquiries of the Swedish Karolinska University Hospital, Karolinska Institute and Ethical Board support the findings of the documentary, blaming Macchiarini and themselves for the alleged research fraud and disastrous patient outcomes”.
“I don’t want him to go to prison,” says Birchall, perhaps surprisingly. “I’d like him to accept how badly he’s gone wrong and rejoin the fold. But I simply can’t see it happening … there are so many layers of regulation in the UK, to protect patients, that it’s simply not possible [for these things to happen here]. That actually makes it very difficult to do the things that I do, but I understand why. We are probably living in the safest country in the world when it comes to experimental mavericks.”
And yet, in his email to me, Macchiarini assures that “both the UCL team and mine know that we did the best we could for those patients in the circumstances. As research continues, we will continue to refine the materials and the methods for tissue engineering incorporating synthetic materials.” Macchiarini now, he tells me, has the support of “a new institution” and “a team of excellent researchers”. It’s not, it appears, all over yet for Mr Macchiarini.
Fatal Experiments: the Downfall of a Supersurgeon starts on BBC4 on Tuesday at 10pm.
Illustration via Flickr/J E Theriot
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