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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Learning lessons from the Paolo Macchiarini case – Horizons (Matthias Egger | December 2018)0

Posted by Admin in on February 23, 2019
 

Independent bodies – not universities – should investigate suspicions of scientific misconduct, says Matthias Egger.

I was sitting next to Agneta Bladh, the chair of the Swedish Research Council, when the conversation over dinner turned to the case of Paolo Macchiarini. You may have heard of the Swiss-born, Italian ‘star surgeon’, who after several investigations was found guilty of scientific misconduct in June 2018 and dismissed from the Karolinska Institutet near Stockholm.

Food for thought for those of us who reside in countries (e.g. Australia and New Zealand) where universities/research institutions conduct their own research misconduct investigations (with the perceived conflicts of interest that raises)

Briefly, Macchiarini had become famous in regenerative medicine for using synthetic scaffolds seeded with patients’ stem cells in trachea transplants. The Lancet, which published several of his papers, praised him as someone who crosses frontiers to innovate, ominously citing the poet T. S. Eliot: “only those who risk going too far can possibly find out how far one can go”.
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The story makes sobering reading. All three patients who received a transplant in Sweden died. Macchiarini was cleared of research misconduct in 2015, with The Lancet defending him in an editorial. Events came to a head a year later after the nationwide screening of a series (‘The Experiments’) by filmmaker Bosse Lindquist, which provoked a massive response and a crisis of confidence at the Karolinska Institutet. A slew of resignations followed: the Vice-Chancellor, the dean of research and the chair of the university board, and investigations were re-opened. In June 2018, the University found Macchiarini and six others guilty of scientific misconduct, and The Lancet retracted two of his papers.
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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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Cloning monkeys for research puts humans on a slippery ethical slope – The Conversation (David Hunter | February 2019)0

Posted by Admin in on February 17, 2019
 

Scientists have many tools at their disposal to study, manipulate and copy genes.

We don’t ordinarily include animal ethics items in the newsroom/Resource Library (this is the third such item out of 1300+ entries), primarily because we feel ill-equipped to comments on such matters, and we are not ordinarily proponents of slippery slope arguments, but David Hunter’s comments here are well made and worthy of consideration.

Now it appears researchers at the Institute of Neuroscience in Shanghai, China, have combined techniques to produce a world first: gene edited, cloned macaque monkeys (Macaca fascicularis).
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Qiang Sun, a senior researcher in the project and Director of ION’s Nonhuman Primate Research Facility explains:
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We believe that this approach of cloning gene-edited monkeys could be used to generate a variety of monkey models for gene-based diseases, including many brain diseases, as well as immune and metabolic disorders and cancer.
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Whose hearts, livers and lungs are transplanted in China? Origins must be clear in human organ research – The Conversation (Wendy Rogers and Matthew Robertson | February 2019)0

Posted by Admin in on February 14, 2019
 

Scientist He Jiankui’s claimed use of the genetic tool CRISPR to edit the genomes of twin girls led to international condemnation. His actions have focused a spotlight on research ethics – and what the consequences should be when scientists “go rogue”.

The Chinese Academy of Science initially looked into He’s conduct, and a subsequent internal government investigation has allegedly identified multiple violations of state laws. He has now been fired by his university.


Read more: Tension as scientist at centre of CRISPR outrage speaks at genome editing summit


But beyond just this example, what does happen when scientists fail to comply with globally-accepted guidelines for ethical medical research? We examined this issue focusing on published research involving recipients of organ transplants performed in the People’s Republic of China.\

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