Montreal Gazette

Pioneering doctor plagued by scandal

- JOSEPH BREAN

Hannah Genevieve Warren, a Korean-Canadian girl who died just before her third birthday in 2013, was born without a trachea.

Just a few years ago, her case would have been hopeless, but thanks to an experiment­al surgery by a Swiss-born Italian pioneer in synthetic human organs, she survived three months after a new one was implanted in her throat.

In the end, it was her lungs that failed, not the new windpipe, which grew around a plastic scaffold from stem cells harvested from Hannah’s bone marrow, to minimize the risk of rejection.

It was a breakthrou­gh surgery, the first of its kind on a child and an early test of Paolo Macchiarin­i’s controvers­ial stem- cell bio- engineerin­g technique, developed at Sweden’s elite medical university, the Karolinska Institute.

Now the swashbuckl­ing surgeon’s reputation is collapsing in a scandal of research fraud, retracted papers, exaggerate­d credential­s and dodgy surgical ethics. Not only have almost all people who received his surgery died, even one who was previously healthy, he has engaged in elaborate deceptions to boost his own public image, even a sham marriage proposal to an NBC producer who profiled him in an Emmy- nominated report.

Last weekend, the scandal claimed two high-profile resignatio­ns: Anders Hamsten, vice-chancellor of Karolinksa, who last summer cleared Mac chi ari ni of misconduct, and Urban Lendahl, a geneticist and secretary general of the Nobel Assembly, which is affiliated with the school and chooses the Nobel Prize in physiology or medicine.

Mac chiari ni himself has been given until November to wrap up his research, close his lab and leave the university, which said it has “lost confidence” in him. But despite the scandal, he still has the gratitude of the Warren family.

“Our opinion of Paolo has not changed,” said Darryl Warren, Hannah’s father, who is originally from Paradise, N. L ., and met her mother, Young-Mi, in South Korea, where Hannah spent most of her life in hospital.

Warren now works for the Children’s Wish Foundation of Canada in Charlottet­own, and though he did not wish to comment on the current scandal, he said Macchiarin­i “was the only chance for Hannah, and we were blessed to have him with us and her at the time.”

In a memorial after her death, her parents said Hannah was “a pioneer in stemcell technology and her impact will reach all corners of our beautiful Earth.”

But that legacy is now in serious doubt. Just like other major research scandals — such as the debacle at Riken in Japan over stem cells that can be triggered to grow into any type of human cell, later shown to be fraudulent— Macchiarin­i’s threatens to undermine the promise of an entire scientific frontier, the synthetic organ transplant.

This scandal has simmered for months, with whistle blow er reports of scientific misconduct in how he reported surgical results in academic papers. In an op- ed piece to announce his resignatio­n on the weekend, Hams ten said he “completely misjudged” Macchiarin­i when he cleared him last summer, and he now believe she committed “research fraud.”

The affair blew up in earnest last month, when Swedish public broadcaste­r SVT aired a documentar­y claiming Macchiarin­i did not fully inform patients of risks, nor properly obtain consent, and broadly misreprese­nted failure as success.

In 2008, working in Barcelona, he implanted a donor trachea seeded with the recipient’s stem cells, marking a breakthrou­gh in transplant science. Italy lured him home for a few years, before he moved to Sweden, where he did away with the donated organ in favour of a manmade plastic scaffold.

He started operating on severely ill patients in Stockholm in 2011. Two died, and the third has not left hospital. One woman, Yesim Cetir, 25, from Turkey, needed nearly 100 surgeries to support the tissue that was supposed to grow around her new synthetic trachea.

Macchiarin­i later used a Russian affiliatio­n to do similar work in Krasnodar, Russia, in 2012, where three patients died, including Julia Tuulik, 33, whose trachea was damaged years earlier in a car accident and who was in good health before surgery.

Hannah Warren’s surgery followed in 2013 in Peoria, Ill ., with an American surgical team, after are view concluded her situation was so dire and her options so limited the operation was justified.

In all , Macchiarin­i has done this trachea transplant eight times, and six patients have died.

In an email to the news outlet Science, he called the SVT documentar­y a “gross mis representa­tion off act ,” but has otherwise stayed silent in recent weeks.

The final nail appears to have been an article in Vanity Fair last month, which claimed to reveal dramatic exaggerati­ons and outright falsificat­ions of his credential­s. It also documented in lu rid detail Macchiarin­i’s romantic pursuit of Benita Alexander, an NBC producer who worked on a profile of him. On trips to Venice and his mother’ s home in Lucca, he told her elaborate

HER IMPACT WILL REACH ALL CORNERS OF OUR BEAUTIFUL EARTH.

lies about having operated on U.S. President Ba rack Obama and Emperor Akihito of Japan, and claimed to be the “personal doctor” to Pope Francis, who was going to officiate their wedding at his summer retreat, Castel Gandolfo.

The couple even printed invitation­s, enclosed in lambskin, addressed to, among others, Bill and Hillary Clinton, Vladimir Putin, Nicolas Sarkozy, Kofi Annan, Elton John and Kenny Rogers.

Though the stories were all fabricatio­ns, and he was eventually caught out by Alexander, they fit the image of the surgeon, fluent in six languages, and compared by one Vanity Fair source to the Dos Equis beer pitchman, The Most Interestin­g Man In The World.

 ?? JIM CARLSON / OSF SAINT FRANCIS MEDICAL CENTER / THE ASSOCIATED PRESS ?? Hannah Warren was two- years- old when she received a new windpipe in a landmark operation in 2013. The future promise of that surgery is now in doubt, as Paolo Macchiarin­i, the doctor who developed the controvers­ial technique, is caught in a scandal of research fraud and shoddy ethics.
JIM CARLSON / OSF SAINT FRANCIS MEDICAL CENTER / THE ASSOCIATED PRESS Hannah Warren was two- years- old when she received a new windpipe in a landmark operation in 2013. The future promise of that surgery is now in doubt, as Paolo Macchiarin­i, the doctor who developed the controvers­ial technique, is caught in a scandal of research fraud and shoddy ethics.
 ??  ?? Dr. Paolo Macchiarin­i
Dr. Paolo Macchiarin­i

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