At this point, one would think the story would be over.

From Science Fictions by Stuart Ritchie.  Page 47.

But here’s a story of how even scientific effects as pure as these can be perverted and corrupted. A story of how patients who thought they were receiving a cutting-edge, transformative medical treatment ended up victims of one of the worst scientific frauds we’ve seen this century. To make things worse, it wasn’t a scam run by some alternative-medicine mountebank recruiting desperate patients online. It was a fraud perpetrated in the halls of the world’s most distinguished medical schools and in the pages of one of the world’s most respected scientific journals. It’ll show us that even the most outrageous fraudsters can sometimes be hiding in plain sight.

When the trachea (the windpipe) is badly damaged by disease or injury, surgeons can no longer reattach the broken ends of the tube, and providing a new trachea is the only way of saving the patient.2 As with any large organ transplant, transplanting a trachea is extremely difficult: not only is it hard to find potential donors (who obviously have to be dead), but if the donor is genetically different to the recipient, the trachea is usually rejected by the recipient’s immune system. So instead of using transplants, surgeons have for decades tried implanting their patients with artificial tracheas, made from an amazing variety of materials: plastic, stainless steel, collagen, even glass. Yet the attempts almost always failed: the synthetic windpipes moved around, became obstructed and attracted infection. By the beginning of the twenty-first century, it was the medical consensus that artificial tracheas just weren’t a viable option.

Enter Paolo Macchiarini, an Italian surgeon who in 2008 had published a blockbuster paper in the top medical journal the Lancet on his successful transplant of a trachea.4 Macchiarini’s new notion was to ‘seed’ the donor trachea with a sample of the recipient’s stem cells – cells that can divide endlessly, repairing and replacing other cells in the body – before it was implanted. After some time in a specially designed incubator, the stem cells had ‘colonised’ the donor trachea and so seemed to prevent its rejection during the later transplant. This was a big step. But the holy grail was still the creation of completely artificial tracheas, ones that wouldn’t require donors at all. Could Macchiarini’s idea – making foreign objects more acceptable to the body by having an outer layer of compatible cells grown around them – finally reach that goal?

Just a few years later, the answer appeared to be ‘yes’. Since his 2008 paper Macchiarini’s reputation as a surgical genius had blossomed, and in 2010 he’d been recruited – at the recommendation of fourteen professors who already worked there – by Sweden’s Karolinska Institute, where he became a visiting professor, and its associated Karolinska Hospital, where he was made a lead surgeon. The Karolinska Institute isn’t just the number-one university in a country with a lot of great universities; it’s the home of the Nobel Prize in Physiology or Medicine. It made perfect sense that Macchiarini, a surgeon who was revolutionising regenerative medicine with his ingenious stem cell techniques, would be employed by such an august institution.

In July 2011, the Institute excitedly announced that the next step had been taken: Macchiarini had just successfully transplanted, ‘for the first time in history’, a completely synthetic carbon-silicon trachea, seeded with stem cells, into a cancer patient at the Karolinska Hospital.  In November that year, the scientific paper reporting the details of the operation was published, by which time Macchiarini had performed a similar operation on another Karolinska patient.  The paper, again published in the Lancet, described the ‘solid evidence’ of the transplantation’s success. During 2012, Macchiarini conducted artificial trachea operations on another three patients, one at the Institute and two at his secondary base of operations in Krasnodar, Russia. Two more operations in Russia would happen across the next two years, and Macchiarini spread the good news by publishing even more scientific papers.7

One of these papers, a 2014 report in the journal Biomaterials, bursting with pretty electron-microscope photos of the ‘electrospun tracheal scaffold’, admitted rather tersely that the first patient had experienced some difficulties, before continuing on briskly to describe the wonders of the new technology. The authors had omitted a devastating detail: the patient in question had died – seven weeks before the paper was even accepted for publication.  The patient from the second operation had died even earlier, just three months after his procedure.  The third Karolinska patient would die in 2017 after several failed follow-up surgeries.  The Russian patients fared little better. The first of them, a ballet dancer from St Petersburg named Julia Tuulik, described her tragic state to a journalist:

Everything is very, very bad with me. I have spent over six months in the hospital in Krasnodar. I have undergone over thirty surgeries under general anaesthesia. Three weeks after the first operation a purulent fistula [a hole leaking pus] opened, and my neck has since rotted. I weigh 47kg. I can barely walk. I have trouble breathing, and now I have no voice. And it smells so strongly … that people back away. 

Tuulik died in 2014, two years after her operation.  Most heart-breakingly, she hadn’t even been in a life-threatening situation before the operation.  One other Russian patient died in what was described as a ‘bicycle accident’, another died in uncertain circumstances the year after the operation, and another survived but only after the synthetic trachea had been removed.  Macchiarini also operated on a Canadian-South Korean toddler at a hospital in Peoria, Illinois in the US in 2013, amid substantial media attention. She died just a few months later.

It had all been a fraud.  Instead of recognizing and dealing with that, the various institutions reacted in damage control trying to disguise what had happened.  Everything that theoretically should not happen in the pursuit of science happened as people defended their social order and status.  

A group of doctors at the Karolinska Hospital who had looked after Macchiarini’s patients post-operation couldn’t reconcile the patients’ terrible condition with the glowing outcomes reported in the scientific papers. They got together and complained to the heads of the Karolinska Institute. Instead of surprise and concern, they were met with stonewalling and attempts to have them silenced. The Institute even reported the doctors to the police, alleging that by looking through the patients’ medical records they had violated their privacy (these charges were rapidly dismissed).16 Eventually, however, the Institute high-ups bowed to the pressure, bringing in an independent researcher – a professor from nearby Uppsala University – to investigate the claims.

His report, which appeared in May 2015 and ran to 20,000 words, couldn’t have been clearer: Macchiarini was ‘guilty of scientific misconduct’ on multiple counts.  Across seven papers, Macchiarini had: falsely claimed that patients’ conditions had improved, when the necessary examinations hadn’t even taken place; misstated the follow-up periods to make it seem like the patients had been healthier for longer; failed to report that the patients had experienced severe complications and sometimes had to undergo further operations; failed to get the correct ethical permission to run what was essentially medical experimentation on human subjects; and falsified data in a lab study where he’d replaced the tracheas of rats.

At this point, one would think the story would be over.

But it wasn't.  The rest of the sordid story is in the book.