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A Star Surgeon Left a Trail of Dead Patients—and His Whistleblowers Were Punished – LeapsMag (Eve Herold | October 2018)0

Posted by Admin in on February 22, 2019
 

[Editor’s Note: This is the first comprehensive account of the whistleblowers’ side of a scandal that rocked the most hallowed halls in science – the same establishment that just last week awarded the Nobel Prize in Medicine. This still-unfolding saga is a cautionary tale about corruption, hype, and power that raises profound questions about how to uphold integrity in scientific research.]

When the world-famous Karolinska Institutet (KI) in Stockholm hired Dr. Paolo Macchiarini, he was considered a star surgeon and groundbreaking stem cell researcher. Handsome, charming and charismatic, Macchiarini was known as a trailblazer in a field that holds hope for curing a vast array of diseases.

This horrifying case will be depressingly familiar for New Zealand readers, because it could easily be described as Sweden’s v own ‘unfortunate experiment’

He claimed that he was regenerating human windpipes by seeding plastic scaffolds with stem cells from the patient’s own bone marrow—a holy grail in medicine because the body will not reject its own cells. For patients who had trouble breathing due to advanced illness, a trachea made of their own cells would be a game-changer. Supposedly, the bone marrow cells repopulated the synthetic scaffolds with functioning, mucus-secreting epithelial cells, creating a new trachea that would become integrated into the patient’s respiratory system as a living, breathing part. Macchiarini said as much in a dazzling presentation to his new colleagues at Karolinska, which is home to the Nobel Assembly – the body that has awarded the Nobel Prizes in Physiology or Medicine since 1901.
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Karl-Henrik Grinnemo was a young cardiothoracic surgeon and researcher at Karolinska in 2010, when Macchiarini was hired. “He gave a fantastic presentation with lots of animation and everyone was impressed,” Grinnemo says of his first encounter with Macchiarini. Grinnemo’s own work focused on heart and aortic valve regeneration, also in the field of stem cell research. He and his colleagues were to help establish an interdisciplinary umbrella organization, under Macchiarini’s leadership, called the Advanced Center for Translational Regenerative Medicine, which would aim to deliver cures from Karolinska’s world-class laboratories to the bedsides of patients in desperate need.
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Oft-quoted paper on spread of fake news turns out to be…fake news – Retraction Watch (Adam Marcus | January 2019)0

Posted by Admin in on February 20, 2019
 

The authors of an much-ballyhooed 2017 paper about the spread of fake news on social media have retracted their article after finding that they’d botched their analysis.

Sometimes the irony of a forced retraction is too delicious to ignore. The story is also a painful reminder of why researchers need to triple check the data and analysis, then check it again. The career damage retractions, even self retractions, is too serious to risk.

The paper, “Limited individual attention and online virality of low-quality information,” presented an argument for why bogus facts seem to gain so much traction on sites such as Facebook. According to the researchers — — from Shanghai Institute of Technology, Indiana University and Yahoo — the key was in the sheer volume of bad information, which swamps the brain’s ability to discern the real from the merely plausible or even the downright ridiculous, competing with limited attention spans and time.
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As they reported:
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Our main finding is that survival of the fittest is far from a foregone conclusion where information is concerned.
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The Ethical Governance of German Physicians, 1890-1939: Are There Lessons from History? (Papers: Robert Dingwall & Vienna Rozelle | 2011)0

Posted by Admin in on December 20, 2018
 

The limitations of the traditional historiography of the ethical regulation of biomedical research are becoming increasingly well recognized. A simplistic history has been used to justify a simplistic policy, in the elaboration of regulatory instruments associated with a bureaucracy of administration and enforcement that has acquired its own material interests in self-perpetuation and jurisdictional expansion. The official history of institutionalized ethical regulation sees a clear and self-evident line of descent from the Nazi experiments of World War II to the various legal and quasi-legal instruments that now govern most scientific and, increasingly, social scientific practice. Without regulatory interventions, it is claimed, researchers will revert to barbarism.

Many of us point to the Nuremberg Code as the first formal attempt to govern the ethical conduct of human research.  While the atrocities committed by the Nazi scientists are no less horrific, this paper by Robert Dingwall and Vienna Rozelle paints quite a different picture of the early evolution of the governance of ethics in bio-medicine. The lessons and implications should cause us pause. Perhaps regulation is not a safeguard against ethically compromised research and we need to stop referring to the inhuman acts of the Nazis to justify our current human research ethics arrangements.

This version of the “rise of bioethics” tends to place considerable emphasis on the Nuremberg Doctors Trial, and the Nuremberg Code promulgated at its conclusion, and to use these as an “origin myth” that legitimizes its professional project. As a narrative, it says little, for example, about the lengthy gap between the conclusion of the Nuremberg trial in 1948 and the development of regulatory interventions for medical research in the victor countries during the 1960s. It tends not to acknowledge the evidence, from writers like Henry Beecher in the United States and Maurice Pappworth in the United Kingdom, that ethically questionable experiments continued in the victor countries well after World War II, a phenomenon explored further by Tal Bolton in a recent PhD. thesis and her article in this journal issue. However, it also tends to equate an absence of regulation with an absence of ethical concern, despite the evidence from Susan Lederer and Sydney Halpern about the effective operation of informal social controls in the United States before World War II. Most crucially, it neglects Jenny Hazelgroves exploration of the difficulty that the prosecutors faced in framing charges against the Nuremberg defendants because they were unable to point to any clear set of regulations or standards in any country other than Germany that could be said to have been violated.
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The publication of further analyses of the pre-World War II German experience provides an additional resource for the critical examination of the claims being made about the importance of formal regulation in the maintenance of ethical standards in biomedical research. This body of work has documented the rise of attempts at ethical research governance in Germany from the late nineteenth century through to the 1930s. In so doing, it may seem to provide us with an opportunity to explore the limits of regulation. Why did it fail to protect the victims of the Nazi medical experiments? Why did it seemingly attract so little international interest, despite Germany’s leading role in science and biomedicine over much of this period? However, as a number of influential historians of late nineteenth- and early twentieth- century Germany have observed, the study of this period has suffered from the imposition of narrative arcs, influenced by sociology or political science, that see it only as the precursor to the disaster of the Nazi regime. No actor at the time consciously sought this end for their actions: even the Nazi leadership sought power rather than defeat. Accounts that find a logic in the events from the late nineteenth century to the end of World War II may overlook the unintended consequences of actors dealing with contingent events on the basis of partial information interpreted according to what were contemporaneously considered valid knowledge or theories. It is important, then, to avoid constructing an equally simplistic counter-narrative about the general ineffectiveness of regulation.

Dingwall, R and Rozelle, V (2011) The ethical governance of German physicians, 1890–1939: Are there Lessons from History? Journal of Policy History 23(1): 29-52. http://irep.ntu.ac.uk/id/eprint/16649/1/205167_7323%20Dingwall%20Publisher.pdf

Dropped manslaughter probe of former Karolinska surgeon Macchiarini to be reviewed – The Local SE (December 2017)0

Posted by Admin in on January 14, 2018
 

The Swedish Public Prosecution Authority is to re-examine manslaughter and related charges against former Karolinska surgeon Paolo Macchiarini, following a new appeal by plaintiffs.

The Public Prosecution Authority in Gothenburg will inspect four cases even though only two plaintiffs made an appeal.

In October, public prosecutor Jennie Nordin dropped the case following the conclusion that Macchiarini’s failed plastic trachea operations did not directly cause the death of three patients operated on at the Stockholm-based Karolinska University Hospital.

Read the rest of this news story

Also see
(19/12/2017) – Dropped manslaughter probe of former Karolinska surgeon Macchiarini… – The Local SE
(29/09/2016) – Macchiarini scandal: overstepping the research ethics mark – Euroscientist
(01/09/2017) – Dr Con Man: the rise and fall of a celebrity scientist who fooled… – The Guardian

 

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