Friday, April 20, 2018

Patients actually died

Thanks to Judith Curry: Why the Karolinska Institute in Sweden, home of the Nobel Prize for Medicine, furthered and then covered up research misconduct that caused the deaths of patients. Agencies that had a clear financial incentive, in this case to further the misconduct, were better organized, and had better access to the media, then the well-informed critics who could have helped bring the misconduct to an end.

Wikipedia:

Paolo Macchiarini
Born August 22, 1958 (age 59) in Basel, Switzerland
Nationality Italy
Occupation Former surgeon
Known for Scientific misconduct; synthetic trachea
Paolo Macchiarini (born August 22, 1958)[1]:2 is a Swiss-born thoracic surgeon and a former researcher on regenerative medicine, who became known for research fraud.[2][3]

Previously he was considered a pioneer in the field of regenerative medicine using both biological and synthetic scaffolds seeded with patients' own stem cells as trachea transplants, and he was a visiting researcher on a temporary contract at Karolinska Institutet in Sweden from 2010.[3] Macchiarini has been accused of research misconduct and unethically performing experimental surgeries, even on relatively healthy patients. Seven of the eight patients who received one of his synthetic trachea transplants have died.[4] Also, an article in Vanity Fair suggested that Macchiarini had falsified some of his academic credentials on résumés.[5] Similar accusations have been published in the Swedish newspaper Aftonbladet according to which Macchiarini's claim to have been a professor at universities in Hannover and Barcelona has turned out to be false.[6]

The secretary of the Nobel Committee for Physiology or Medicine, Urban Lendahl (sv), resigned in February 2016, owing to his involvement in recruiting Macchiarini to Karolinska Institutet in 2010.[7] Shortly afterwards the vice chancellor, Anders Hamsten (sv), who in 2015 had cleared Macchiarini of scientific misconduct also resigned.[8] In 2013 Karolinska terminated its clinical relationship with Macchiarini but allowed him to continue as a researcher; in February 2016 Karolinska announced that it would not renew Macchiarini's research contract, which was due to expire in November, and the next month Karolinska terminated the contract.[9] After being dismissed from Karolinska, he worked at the Kazan (Volga region) Federal University in Russia,[10] until the university terminated his project in April 2017, effectively firing him.[11] Since June 2016, Macchiarini was under legal investigation by the public prosecutor's office on a suspicion for manslaughter and grievous bodily harm based on the material leading to death of the three patients operated on in Sweden released from the scientific inquiry.[clarification needed]

After a one-year medico-legal investigation, the attorney general's office announced in October 2017 that Macchiarini had been negligent in the four of the five cases investigated due to the use of devices and procedures not supported by evidence, but that a crime could not be proven because the patients might have died under any other treatment given.[12][13] Also in October, Sweden's national scientific review board found scientific misconduct by Macchiarini and his co-authors in six papers about the procedures, and called for them to be retracted.[14]

Hmmm... medical devices. I've borrowed a book from the library called "The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One man's Battle to Survive It." The author, Jeanne Lenzer, seems quite reputable. I haven't made it beyond the Prologue: Lenzer was a Physician Associate (PA), often the only prescribing person at a rural medical facility. During one period she wouldn't hesitate to respond to a patient's premature ventricular contractions (PVCs) with a drug called lidocaine. It was known that the contractions might or might not be a step on the way to a serious heart attack, but if there was no big downside to lidocaine use, why not use it? Later studies indicated that use of this drug actually increased the risk of heart attack. Lenzer: "Could it be true that we were killing patients when we were eyewitnesses to so many cures? And if so, if we were really killing patients, why didn't we see the carnage we'd caused?" I guess it takes a lot of discipline to keep testing your own working hypotheses--not just waiting for some new paper to come along.

Macchiarini and Lendahl: both boomers.

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