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Leading clinical trials lawyer calls for research misconduct investigations following report

A leading clinical trials lawyer has called for one of the country’s leading universities to consider wide-reaching research misconduct investigations following the publication of an independent inquiry into the links between the university and a disgraced Italian doctor.

5 October 2017

Gene Matthews, from law firm Leigh Day, commented following a special inquiry into regenerative medicine research at University College London, which was led by Stephen Wigmore, professor of transplantation surgery at the University of Edinburgh.
The inquiry was set up in January 2017 to provide an independent investigation of the involvement of UCL and its personnel in regenerative medicine research with a particular focus on tracheal and large airway tissue engineering and UCL's relationship with Professor Paolo Macchiarini and the Karolinska Institute.
Macchiarini was a visiting researcher at Sweden’s Karolinska Institute when he was accused of research misconduct and unethically performing experimental surgeries, even on relatively healthy patients.
Six of the eight patients who received one of his synthetic trachea transplants have died.
According to an article by the Observer newspaper experimental implants that should only have been used in laboratory or animal tests were sent overseas and used on patients.
According to the newspaper the report found that an artificial windpipe, an arterial graft and a synthetic tear duct manufactured by scientists at UCL were used in operations despite not being approved for use in humans.
The report said that a 26-year-old in Tehran was implanted with a graft to bypass the femoral artery. According to an expert in vascular surgery who gave evidence to the inquiry, this amounted to clinical negligence.
“In [the expert’s] opinion it was almost inevitable that that would result in the patient would lose their limb or their life,” the report states.
According to the Observer, documents suggested that plastic discs had been sent to India where they were implanted under the skin of a patient in need of an ear reconstruction to test that the material was bio-compatible.
“It’s very serious and it’s quite frightening to think that someone could be manufacturing this kind of device without knowing the regulations that govern it,” Professor Wigmore states.
The plastic scaffold used on the first recipient of a synthetic trachea in June 2011 was constructed by former UCL Professor, Alexander Seifalian, who has since been dismissed from UCL on an unrelated matter.
According to the report Seifalian’s laboratory was not licensed to make clinical grade devices, the report states:
“On direct questioning Seifalian confirmed that he did not seek approval or advice regarding the legality or otherwise of manufacturing a clinical grade product or transferring this to Macchiarini for the purpose of transplantation in a human.”
Permission was not sought from the health regulator, the MHRA, to use an unlicensed device.
Whilst there is no suggestion that the death of a patient in 2014 was linked to failings by UCL scientists, the report states that due to the oversight UCL is now seeking advice about whether the university could be held legally liable.
The report strongly criticises Seifalian, who is facing two ongoing research misconduct inquiries according to the Observer. The former professor claims that he has been unfairly singled out.
“Many people were involved in the regenerative medicine work with me but I have been dismissed and [they are] using me as a scapegoat for the work carried out,” Seifalian told the Observer.
Gene Matthews, a specialist clinical trials lawyer at Leigh Day, said:
“I am pleased that this report has now been made public and that it has recommended that the cases it looked at should be immediately reported to the MHRA for further investigation.
“We would also like for UCL to come out strongly, in light of this evidence, and announce whether it intends to conduct any additional research misconduct investigations into its staff/ partnerships to ensure its reputation as a world leading centre for regenerative medicine is maintained.
“The safety of patients and volunteers is paramount.  The boundaries between academic research, manufacturing and clinical treatment cannot be allowed to become blurred.  Where there are allegations of malpractice those allegations must be thoroughly investigated, with the brightest spotlight shone upon them, and appropriate action taken.”
Prof David Price, UCL vice-provost for research, said: “As a world-leading university, UCL takes the integrity of its research very seriously ... The recommendations of the inquiry will help us to continue building on our culture of research excellence and innovation, to address global health challenges in a responsible and ethical manner.”

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