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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) Ethics questions swirl around historic Parkinson’s experiment – STAT (Sharon Begley | May 2020)0

Posted by Admin in on May 30, 2020
 

A secretive experiment revealed this week, in which neurosurgeons transplanted brain cells into a patient with Parkinson’s disease, made medical history. It was the first time such “reprogrammed” cells, produced from stem cells that had been created in the lab from the man’s own skin cells, had been used to try to treat the degenerative brain disease. But it was also a bioethics iceberg, with some issues in plain sight and many more lurking.

This story raises an interesting bioethics question.  Should the wealthy be able to fund research, with a  view to receiving the treatment it develops?

In 2013, the soon-to-be patient, George Lopez, gave $2 million to underwrite research on cells in lab dishes and rats that was required to show that the surgery might be safe and possibly even effective. Lopez, a former physician and the wealthy founder of a medical equipment company, also paid for the legal work required to get Food and Drug Administration approval for the two surgeries. Cells were implanted on the left side of Lopez’s brain in September 2017 and the right side in March 2018.
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“When individuals paying to fund research leading to a therapy are also the first to receive it, there are concerns,” said Brian Fiske, vice president for research at the Michael J. Fox Foundation, which funds research on Parkinson’s.
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Read the rest of this discussion piece

Waste in covid-19 research (Editorial – Paul P Glasziou, et al | May 2020)0

Posted by Admin in on May 26, 2020
 

A deluge of poor quality research is sabotaging an effective evidence based response

The medical research world is responding to the covid-19 pandemic at breathtaking speed. There has been a maelstrom of global research, with mixed consequences. Positives include the greater provision of open access to covid-19 studies, some increased collaboration, expedited governance and ethics approvals of new clinical studies, and wider use of preprints. But many problems have become evident. Before the pandemic, it was estimated that up to 85% of research was wasted because of poor questions, poor study design, inefficiency of regulation and conduct, and non or poor reporting of results.1 Many of these problems are amplified in covid-19 research, with time pressures and inadequate research infrastructure contributing.

A fabulous editorial piece by Paul P Glasziou, et al about all the …noise/junk… being rushed to publication about COVID-19.  An important read.   We have included links to 21 related reads.  Who is hurt by this questionable behaviour?  Us as we wait tensely for a cure.

Trials
An extraordinary number of covid-19 trials have been registered since the pandemic started. The National Library of Medicine registry ClinicalTrials.gov lists 1087 covid-19 studies, and though some will provide useful information, many are too small and poorly designed to be helpful, merely adding to the covid-19 noise. Of the 145 registered trials of hydroxychloroquine, for example, 32 have a planned sample size of ≤100, 10 have no control group, and 12 are comparative but non-randomised. Outcome measures vary widely, and only 50 seem to be multicentre. Strikingly, only one provides a protocol, and even limited registry details reveal unjustified outcome switching.2
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The imbalance in trial topics is worrying, in particular the paucity of trials on non-drug interventions. Despite non-drug interventions being the mainstay of current mitigation,3 we could find just two trials of masks on ClinicalTrials.gov and none examining social distancing, quarantine effect or adherence, hand hygiene, or other non-drug interventions. Covid-19 research funding mirrors this woeful imbalance. A search of Covid-19 Research Project Tracker, a live database of funded covid-19 projects, found almost no primary research of the effects of non-drug interventions on transmissibility, compared with hundreds of drug intervention projects worth at least $74m (£60m; €67m).

Glasziou, P. P., Sanders, S. & Hoffmann, T. (2020) Waste in covid-19 research. BMJ 2020; 369 :m1847
Publisher: https://www.bmj.com/content/369/bmj.m1847

(US) JetBlue’s Founder Helped Fund A Stanford Study That Said The Coronavirus Wasn’t That Deadly – Buzzfeed News (Stephanie M. Lee | May 2020)0

Posted by Admin in on May 22, 2020
 

A Stanford whistleblower complaint alleges that the controversial John Ioannidis study failed to disclose important financial ties and ignored scientists’ concerns that their antibody test was inaccurate.

A highly influential coronavirus antibody study was funded in part by David Neeleman, the JetBlue Airways founder and a vocal proponent of the idea that the pandemic isn’t deadly enough to justify continued lockdowns.

That’s according to a complaint from an anonymous whistleblower, filed with Stanford University last week and obtained by BuzzFeed News, about the study conducted by the famous scientist John Ioannidis and others. The complaint cites dozens of emails, including exchanges with the airline executive while the study was being conducted.

The study — released as a non-peer-reviewed paper, or preprint, on April 17 — made headlines around the world with a dramatic finding: Based on antibodies in thousands of Silicon Valley residents’ blood samples, the number of coronavirus infections was up to 85 times higher than believed. This true infection count was so high that it would drive down the virus’s local fatality rate to 0.12%–0.2% — far closer to the known death rate for the flu.

Read the rest of this discussion piece

Friday afternoon’s funny – Somethings should not be trialled at the same time, in the same place0

Posted by Admin in on May 22, 2020
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

When planning a trial it’s important to sit back and think about how the details will work in the planned setting.  If research ethics review is focussed on facilitating excellent ethical research hopefully it can also potentially spot a situation that’s going to go in an unexpected direction.  A trial might comply with the rules, but is still a bad idea.

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