O Brave New World of regenerative medicine…oops, never mind


When I first heard about this idea for repairing damaged tracheas, I thought it was brilliant. Strip the cells from the cartilaginous framework of a cadaver’s trachea — or build your own immunologically inert framework from other materials — and then populate it with stem cells from the patient themself, so you end up with a new, living trachea with immunocompatible cells that you can transplant into the patient. No rejection issues! No scrabbling for compatible donors!

It’s still a brilliant idea, but the execution is wanting. Paolo Machiarini, a famous surgeon and proponent of this treatment, has been exposed as a fraud. And worse still, the entire medical establishment that welcomed and absorbed him as one of their own has been exposed as, shall we say, insufficiently critical of their colleagues.

Oh, he’s a real doctor, so he’s not that kind of fraud. But he is prone to narcissistically inflating his importance. For instance, in his personal life, he was engaged and announced his wedding plans.

By the time the program aired, in mid-2014, the couple were planning their marriage. It would be a star-studded event. Macchiarini had often boasted to Alexander of his famous friends. Now they were on the wedding guest list: the Obamas, the Clintons, Vladimir Putin, Nicolas Sarkozy and other world leaders. Andrea Bocelli was to sing at the ceremony. None other than Pope Francis would officiate, and his papal palace in Castel Gandolfo would serve as the venue. That’s what Macchiarini told his fiancee.

Only none of that was true. He lied to his fiancee — even with her, he had to puff himself up. Also, it turned out that he was already married to someone else, and had been for 30 years.

That’s horrible enough. But then it also turned out that he’d been lying about his results.

…Macchiarini’s artificial windpipes were not the life-saving wonders we’d all been led to believe. On the contrary, they seemed to do more harm than good – something that Macchiarini had for years concealed or downplayed in his scientific articles, press releases and interviews.

That’s an understatement. His patients died agonizingly.

Beyene’s death two and a half years after the operation, caused by the failure of his artificial airway, was a grueling ordeal. According to Pierre Delaere, a professor of respiratory surgery at KU Leuven, Belgium, Macchiarini’s experiments were bound to end badly. As he said in Experimenten: “If I had the option of a synthetic trachea or a firing squad, I’d choose the last option because it would be the least painful form of execution.”

Then there were the ethical lapses. There are rules about experimentation, especially human experimentation, and he and his institution just ignored them.

He could do pretty much as he pleased. In the first couple of years at Karolinska, he put plastic airways into three patients. Since this was radically new, Macchiarini and his colleagues should have tested it on animals first. They didn’t.

Likewise, they didn’t undertake a proper risk assessment of the procedure, nor did Macchiarini’s team seek government permits for the plastic windpipes, stem cells, and chemical “growth factors” they used. They didn’t even seek the approval of Stockholm’s ethical review board, which is based at Karolinska.

Though Macchiarini was in the public eye, he was able to sidestep the usual rules and regulations. Or rather, his celebrity status helped him do so. Karolinska’s leadership expected big things from their superstar, things that would bring prestige and funding to the institute.

This story is truly ripe for an in-depth analysis by philosophers and sociologists of science (oh, I forgot, science is always objective and non-ideological and independent of social influences, so maybe none of this happened).

Support for Macchiarini remained strong, even as his patients began to die. In part, this is because the field of windpipe repair is a niche area. Few people at Karolinska, especially among those in power, knew enough about it to appreciate Delaere’s claims. Also, in such a highly competitive environment, people are keen to show allegiance to their superiors and wary of criticising them. The official report into the matter dubbed this the “bandwagon effect”.

With Macchiarini’s exploits endorsed by management and breathlessly reported in the media, it was all too easy to jump on that bandwagon.

Yeah, and when whistleblowers tried to flag Macchiarini’s shortcuts and dishonest evaluations, they were the ones punished, not the superstar of regenerative medicine.

It’s an excellent article that finds critical problems at all levels — read the whole thing. The science isn’t there yet; it turns out that the stem cells were not repopulating and rebuilding functional windpipes. The press loved a charismatic surgeon, though. The institutions he worked in loved the money and good press he brought in. The patients flocked to him because he offered hope. His colleagues wanted a ride on that bandwagon. And it was all built on lies and wishful thinking.

Comments

  1. David Marjanović says

    The link works fine for me. The article is dated 1 September 2017.

    I struggle to understand how anyone could have believed any part of the wedding plans!

    Karolinska’s leadership expected big things from their superstar, things that would bring prestige and funding to the institute.

    …wherein the rub lies.

    Fund the institute, and it won’t care about outside funding or prestige. When science administrators get scared about their livelihoods is when they start fucking things up.