The Doctor is a Fraud

The rise and fall of the famous scientist who deceived almost everyone

Dr Con Man: the rise and fall of a celebrity scientist who fooled almost everyone John Rasko and Carl Power, the Guardian, Friday 1 September 2017

Translated by Vyacheslav Golovanov, Geektimes

A pioneer of science, a star surgeon, a magician – under such epithets Paolo Macchiarini has been famous for several years. He looked like that, dressed in a white coat or in the clothes of a surgeon, with his broad, pretty face and ability to charm people. And he deceived almost everyone.

Macchiarini began the path to success in 2008 when he created a new trachea for Claudia Castillo, a girl from Barcelona. He chemically removed cells from the trachea of the deceased donor and seeded the bare skeleton with stem cells taken from the bone marrow of Castillo herself. She soon returned home and was able to run with her children again. According to Macchiarini and his colleagues, her artificial organ coped with its role perfectly, worked and looked like a real one. And since it was created from Castillo's own cells, there was no need for her to use dangerous immunosuppressants.

It was Macchiarini's first high-profile success. Countless news articles have declared it a medical breakthrough. It was said that he saves lives and changes all medicine. Now we know that this is not the case. However, the serious complications that Castillo suffered from were hidden for quite a long time. 

And Macchiarini's career took off. By 2011, he was working in Sweden at one of the most prestigious medical universities in the world, the Karolinska Institute, whose professors annually select the winner of the Nobel Prize in Physiology or Medicine. There he rediscovered his technique. Instead of removing cells from the trachea of donors, Macchiarini made custom-made plastic frames. Andemariam Beyen, a graduate student in geology at the University of Iceland, was the first to receive it. His recovery brought Macchiarini to the cover of the New York Times.

Macchiarini was turning the dream of regenerative medicine into reality. Here's how NBC's Meredith Vieira talked about him in her documentary called "Leap of Faith": "Imagine a world in which any damaged or diseased organ or body part can be replaced with a new, artificial one made in the laboratory especially for you." And thanks to Macchiarini, this wonderful world was already on the threshold.

However, last year the dream turned sour, revealing an ugly reality.

Macchiarini has installed "regenerative" tracheae in at least 17 patients worldwide. Most of them, including Andemariam Beyen, died. Those who are still alive – including Castillo – survived despite the artificial tracheae he installed.

* * *

In January 2016, Macchiarini was criticized by the press. First there was an article in Vanity Fair about his affair with Benita Alexander, an award-winning NBC News producer. She met Macchiarini while producing Leap of Faith, and soon broke one of the main rules of journalism: not to fall in love with the hero of your story.

By the time the program was released in mid-2014, the couple had already planned to get married. This event was supposed to be held with a lot of celebrities. Macchiarini often boasted to Alexander about his famous friends. And now they were all on the guest list: the Obamas, the Clintons, Vladimir Putin, Nicolas Sarkozy and other world leaders. Andrea Bocelli was supposed to speak at the ceremony. The service was to be conducted by Pope Francis himself, and the venue of the ceremony was to be his papal palace. So Macchiarini told his fiancee.

But as this date approached, Alexander began to see the exposure of these plans and eventually realized that her lover had lied about almost everything. The pope, the palace, world leaders, the famous tenor – he made it all up.

As well as the idea of the wedding itself: Macchiarini was still married to his 30-year-old wife.

The deception of Macchiarini was so ridiculous that Vanity Fair sought the advice of Harvard professor Ronald Schouten, an expert on psychopathy, who made a diagnosis in absentia: "Macchiarini belongs to an extreme kind of trust-abusing scammers. He is obviously smart, he has achievements, but he does not control himself. There is a void in his personality that he is trying to fill by deceiving more and more people."

A big burning question hung in the air: if Macchiarini was a pathological liar in love, what about his medical research? Did he deceive his patients, colleagues and the scientific community?

The answer came just a couple of weeks later, when Swedish television began showing the unmasking of Macchiarini and his work, in three parts. 

In the film Experimenten ("Experiments"), it was convincingly shown that Macchiarini's artificial trachea were not life-saving miracles, as we were all convinced. On the contrary, they did more harm than they saved – and this Macchiarini hid for years, or downplayed their harm in his articles, press releases and interviews.

Faced with such a public disaster, the Karolinska Institute immediately promised to investigate the allegations, and then, a few days later, suddenly announced that it would not renew the contract with Macchiarini.

Macchiarini's downfall was rapid, but there are still questions about how he was allowed to conduct experiments for so long. Some responses were received after official requests made to the Karolinska Institute and the Karolinska University Hospital. They revealed a lot of problems with how these organizations worked with Macchiarini.

Macchiarini's fame has earned him good patrons. Among them is Harriet Wahlberg, the former deputy head of the Karolinska Institute in 2010, when he hired Macchiarini. She dragged through his appointment, despite the presence of very bad reviews and questionable statements in the resume.

This became a dangerous example, and made it clear to the heads of departments of the institute and colleagues that Macchiarini needed special treatment.

He could do almost anything he wanted. During his first couple of years at the Karolinska Institute, he implanted plastic tracheas in three patients. Since this procedure was radically new, it had to be tested on animals first. But Macchiarini and his colleagues did not.

They also did not properly assess the possible risks of this procedure, did not receive permission from the government to manufacture plastic trachea, use stem cells and chemical growth stimulants. They have not received the approval of the Stockholm Ethics Commission, based at the Karolinska Institute.

And although Macchiarini was in plain sight, he managed to circumvent the usual rules and procedures. Or, more precisely, his star status helped him in this. The management of the institute expected great results from its superstar, such as would increase prestige and increase funding.

They also seized on the concept of "using out of compassion." They claimed that Macchiarini did not conduct clinical studies, but was simply very worried about his patients, who were threatened with certain death in the absence of time and other treatment options. And in such difficult circumstances, new treatment options can be used as a last resort.

But this argument did not pass with the people who conducted the investigation of this case. From their point of view, Macchiarini was conducting a real clinical study. In addition, a sense of compassion does not negate the basic principles of patient safety and informed consent. Macchiarini replies that he "does not accept" the conclusions of the disciplinary committee.

* * *

It turns out that Macchiarini's patients were not at all on the verge of death at the moment when he treated them. For example, Andemariam Beyen had recurrent tracheal cancer, but apart from coughing, nothing bothered him. But even if his days were numbered, it didn't justify what Macchiarini had put him through.

Beyen's death two and a half years after surgery due to the failure of an artificial trachea was severe. According to Pierre Delaere, professor of respiratory surgery at the Catholic University of Leuven in Belgium, Macchiarini's experiments were doomed to a sad end. As he says in Experimenten: "If I were choosing between a synthetic trachea and a firing squad, I would choose the latter, since it would be a less painful execution option."

Delaere was one of the first and most strident critics of Macchiarini's artificial trachea. He always considered reports of their successes to be "empty chatter." He did not see any real evidence that the tracheal skeletons became living, functioning organs – and in this case they were doomed to failure. The question was only about the timing – weeks, months, or several years.

Delaere's criticism appeared in major medical journals, including the Lancet, but was not taken seriously by the leadership of the Karolinska Institute. She was also not impressed by the ethical council of the institute when Delaere filed a formal complaint.

Macchiarini was actively supported even after his patients began to die. In particular, this was because the restoration of the trachea was a niche area. Few people at the Karolinska Institute, especially among the decision-makers, knew enough about this to evaluate Delaere's statements. In addition, in such areas with high competition, people tend to be loyal to their superiors and are reluctant to criticize them. The official report on this effect was entitled "the effect of the winning party".

Given the exploits of Macchiarini, encouraged by the management and breathlessly covered in the media, it was very easy to join the camp of his fans.

And it is very difficult to jump off this platform. In early 2014, four doctors from the Karolinska Institute broke their silence and filed a complaint against Macchiarini. From their point of view, he very ugly distorted the results of his work and the state of health of his patients. An independent researcher agreed with them. But the vice-president of the institute, Anders Hamsten, was not satisfied with this. He officially dismissed the charges of negligence from Macchiarini, leaving only a remark that he sometimes allowed himself to act "without due care."

Four doctors were punished for trying to rat on the surgeon. When Macchiarini accused one of them, Karl-Henrik Grinnemo, of stealing his own grant-related work, Hamsten found the latter guilty. Grinnemo recalls that it almost destroyed his career: "I didn't get any new grants. No one wanted to cooperate with me. Our research was qualitative, but no one was interested in it. I thought I was going to lose my job, my employees, everything."

This went on for three years, until eventually Grinnemo was cleared of all charges.

The Macchiarini scandal has affected many of his powerful friends. The vice president, Anders Hamsten, has resigned. So is the Dean of Research. As well as the chief secretary of the Nobel Committee. The university council was dissolved. And even Harriet Wahlberg, who by that time had been promoted and became president of all Swedish universities, lost her job.

Unfortunately, the scandal turned out to be large and went beyond the Karolinska Institute, which was visited by only three patients who received "regenerating" tracheas from Macchiarini.

Other patients were treated in hospitals in Barcelona, Florence, London, Moscow, Krasnodar, Chicago and Peoria. None of them has been subjected to the same thorough public analysis. No one was forced to conduct a full independent investigation. But it should have been.

And if the mistakes of the Karolinska Institute were repeated in other places, then in particular it happened because medical research institutes have the same environment in which the same dangers lurk. One of them is the hype about stem cells.

Stem cell research is a popular topic in science, and, according to statistics, one of the most scandalous. Articles on this topic are recalled 2.4 times more often than the average article on biomedicine, and more than half of the reviews are due to fraud.

Does the popularity of stem cell research – big grants, prestige and media coverage – encourage fraud? Our familiarity with the field of medical research suggests that perhaps it is. There is not enough data for a rigorous proof, but we have some key indicators.

For example, there is a growing list of stars of the scientific world who have committed serious deceptions in the field of stem cell research. In South Korea, there is Hwang Woo-seok, who in 2004 made a false statement about the creation of human embryonic stem cells by cloning. A few years ago, a researcher from Japan, Haruko Obokata, committed a similar fraud, announcing that she had managed to develop a new, simple method for converting ordinary body cells into stem cells.

Hwang, Obokata and Macchiarini were attracted by the hype associated with the fashionable topic of stem cell research, which gave the greatest hopes for making scientific breakthroughs. In Macchiarini's case, the hope was that patients could be treated with stem cells taken from their own bone marrow.

For many years, this possibility has been the subject of increased interest and a huge amount of research. But, for most of these treatment attempts, there is no rigorous evidence of their effectiveness. A big exception is blood stem cell transplantation, which has been saving the lives of patients with leukemia and other types of blood cancer for many decades.

This is enough to make regulators from the US Food and Drug Administration (FDA) concerned about this issue. They recently published an article in the New England Journal of Medicine, where they acknowledged that stem cell research has largely failed to keep its therapeutic promises.

A dangerously large gap is growing between what we expect from stem cells and what they can actually give us. Each new scientific discovery is supplied with a stream of stories about how it will soon revolutionize medicine. But this day is constantly postponed.

One of the undesirable results of such a situation is the appearance of pseudoscientific methods of treatment. Stem cell clinics grow like mushrooms and offer to cure any disease you come up with. Instead of clinical data, they boast positive reviews. There are quite a lot of patients in a desperate situation who believe in the healing power of stem cells (because they were constantly told about it), and are unable to wait for treatment from conventional medicine. They and their loved ones become victims of false hopes.

Scientists also suffer from the same false hopes. They believed Macchiarini to some extent, because he was saying what they wanted to hear. This can be judged by the speed with which his "breakthrough" was accepted by science. Just four months after Macchiarini operated on Claudia Castillo, his results–preliminary, but extremely positive– were published in the online version of the Lancet magazine. And after that, they were replicated by the news.

The media also has something to answer for. They constantly feel sympathy for unproven methods of treatment. Studies show that the media often describe stem cell tourism in a positive way, hinting at the effectiveness of treatment and low risk. The same thing happened with Macchiarini and his tracheal replacements. A good example is the NBC documentary "Leap of Faith". It is very interesting to revise it – as a lesson on how not to talk about medical science.

It is significant that Macchiarini's career unfolded at the Karolinska Institute. Where they give out the Nobel Prize in physiology or medicine. The Institute strives to create scientific stars. Every year he turns science into show business, choosing from the crowd of medical researchers those who deserve to enter the world of stars. The idea is that scientific progress is driven by the efforts of a small number of ideas.

And this is a problematic idea with unpleasant side effects. A genius is by definition a revolutionary who takes risks and violates laws. Is that why Macchiarini received special treatment at the Karolinska Institute? He remained unpunished for so long because he was considered an exception to the rule and a candidate for Nobel laureates. In any case, after all, some of his most influential friends themselves participated in the selection of candidates for the award, until they fell into disgrace together with him.

If there is a moral to this story, it is that we need to be wary of medical messiahs promising salvation to all of us.

Portal "Eternal youth" http://vechnayamolodost.ru  02.10.2017