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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Is it right to cut corners in the search for a coronavirus cure? – The Guardian (Julian Savulescu | March 2020)0

Posted by Admin in on March 26, 2020
 

Vaccine and drug trials are slow, to account for safety. But in a pandemic time isn’t just money – it’s lives

The race is on to find a treatment for coronavirus. This race is split between two approaches: the trialling of pre-existing drugs used for similar diseases, and the hunt for a vaccine. In both instances, important ethical decisions must be made. Is it OK to reassign a treatment that comes with side-effects? And with thousands dying from coronavirus every day, is it acceptable to cut corners in the search for a vaccine?

We are really living through something that six months ago would have been a decidedly hypothetical bioethics vignette.   In the midst of a pandemic, how do you weigh lost and impacted lives when thinking about Phases I, II and III trials for a vaccine or cure?  We plan to write something about this for the subscribers’ area.  We have included links to 14 related items.
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You may also like to watch this special TED discussion: https://www.ted.com/talks/bill…

Last Friday, the World Health Organization announced the launch of Solidarity, a worldwide trial of the four most promising candidate treatments for Covid-19: remdesivir, an antiretroviral treatment for Ebola; chloroquine and hydroxychloroquine, both antimalarials; ritonavir, an HIV treatment; and interferon, a treatment for hepatitis C. Both Kaiser Permanente Washington Research Institute in Seattle and China’s Academy of Military Medical Sciences last week announced the start of human trials for new possible vaccines. Around 30 other research groups worldwide are working on vaccines.
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But the WHO estimates that a vaccine won’t be ready until June 2021. There are requirements that have to be observed. The gold standard for this kind of research is the clinical trial – administering the vaccine to a large number of people in controlled conditions and measuring its effect. Usually scientists wait 14 months to monitor effectiveness and possible side-effects – which is why we may have to wait until next summer. Coronavirus vaccine trials face the following dilemma: we need treatment quickly but we also need to know it will work. The worst outcome for the medical industry would be a vaccine that either did not work or, worse, was harmful or had side-effects. Globally, faith in vaccines is already at an all-time low.
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Friday afternoon’s funny – PI Action figure0

Posted by Admin in on March 20, 2020
 

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

Sometimes the different roles and special skills we demand of investigators do seem apt for an action figure from the 1980s.

Clinical trials: how to make informed consent more ethical – The Conversation (Jeremy Howick | February 2020)0

Posted by Admin in on February 19, 2020
 

It has been illegal to treat humans like guinea pigs since the Nuremberg trials, in which Nazi doctors were punished for doing unspeakable things to prisoners. These days, we have to explain the experiment to the people taking part in trials for new treatments and get their permission (their “informed consent”).

A fascinating discussion and useful suggestions.

Specifically, we have to tell them about the risks of taking part. So in a trial of a new drug, we have to tell patients about all the possible side-effects. In ethical geek-speak, we have to preserve patients’ autonomy by giving them enough information to make an autonomous decision. Which is fine, up to a point.
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It is also an ethical requirement to avoid unnecessarily harming patients. A recent study published in the BMJ Journal for Medical Ethics shows that the relatively recent discovery of so-called nocebo effects – a result of the patient’s expectation that the treatment will harm them – means that harm is being done by the way we inform patients about the trial in which they are taking part.
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‘Evidence-Based Medicine’ and the Expulsion of Peter Gøtzsche – Medscape (Daniel Kolitz | December 2019)0

Posted by Admin in on February 13, 2020
 

FOR EIGHT MONTHS in 1975, Peter Gøtzsche recalls driving around Denmark misleading doctors about a new, more expensive type of penicillin. He was 25 years old, with master’s degrees in biology and chemistry. As a pharmaceutical representative for the Sweden-based Astra Group, he was tasked with promoting Globacillin, which was said to be more effective than regular penicillin. At the time, Gøtzsche says he did not know that the claims he was making on behalf of his employer were not backed by high-quality evidence.

Gøtzsche stayed in the pharmaceutical industry for another eight years, writing brochures, strategizing ad campaigns, and, eventually, presiding over clinical trials. It was here that disillusionment set in. Gøtzsche — in his telling, still a principled naïf — would watch with dismay as his superiors twisted or suppressed any unflattering trial results. Increasingly distraught, Gøtzsche began pursuing a medical degree, leaving the industry for good in 1983.

His medical thesis, titled “Bias in Double-Blind Trials,” examined the claims of 244 reports of clinical trials for non-steroidal anti-inflammatory drugs, a group that includes ibuprofen and aspirin. Gøtzsche’s writing strongly critiqued the marketing practices of his former employer, Astra-Syntex, pointing out that no good evidence existed for their claim that the higher the dose, the better the effect.

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