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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Friday afternoon’s funny – Reclaiming medical devices0

Posted by Admin in on August 14, 2020

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

This chuckle touches on an important point for medical device clinical trials: There needs to be monitoring and support arrangements funded and in place for a period well beyond the duration of the trial.

Publication by association: the Covid-19 pandemic reveals relationships between authors and editors (Papers: Clara Locher, et al | July 2020)0

Posted by Admin in on August 9, 2020

During the COVID-19 pandemic, the rush to scientific and political judgments on the merits of hydroxychloroquine was fuelled by dubious papers which may have been published because the authors were not independent from the practices of the journals in which they appeared. This 5example leads us to consider a new type of illegitimate publishing entity, “self-promotion journals” which could be deployed to serve the instrumentalisation of productivity-based metrics, with a ripple effect on decisions about promotion, tenure, and grant funding.

Medicine and Health Sciences, Bioethics and Medical Ethics

Bibliometrics, Conflicts of interest, Editor Hydroxychloroquine, Research intergrity

Locher, C., Moher, D., Cristea, I., & Florian, N. (2020). Publication by association: the Covid-19 pandemic reveals relationships between authors and editors. Metaarxiv.
Publication (CC):

(US) Where Should COVID-19 Vaccines Be Tested? It’s a Moving Target – WIRED (Maryn Mckenna | July 2020)0

Posted by Admin in on August 6, 2020

Developers need to test in hotspots, but those keep changing. And they must avoid ethical problems, like testing in low-income areas but only selling in rich ones.

MORE THAN 140 possibilities for making a vaccine against Covid-19 are being studied around the world. The vast majority of them are still just concepts in a lab, but more than a dozen have been injected into humans, mostly in small-scale trials to make sure each formula is safe to receive. Three are headed toward large human trials this summer, and a surprise announcement on Monday revealed that China is allowing military use of one vaccine being developed there.

That pace, faster than any vaccine has ever been produced, is intended to satisfy the US federal government’s goal of delivering a safe and potent vaccine by January. But as developers race toward broad testing, they are about to crash into a complication: the patchwork nature of the pandemic across the United States.

In order to know whether a vaccine works as intended, you have to pick your test site with care: There has to be enough virus circulating there to create a reasonable chance that vaccinated trial participants will be exposed to it. But even though the United States’ case count keeps heading upward, with 2.68 million cases as of Tuesday, the pandemic isn’t uniformly distributed across the country.

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(US) Study of Pepcid as virus remedy stalls after $21M – Northwest Arkansas Democrat Gazette (Richard Lardner and Jason Dearen | July 2020)0

Posted by Admin in on August 4, 2020

Conflict, misconduct alleged in fast-tracked federal effort

A nearly $21 million government-funded study to see if a popular, over-the-counter heartburn medication could be a covid-19 remedy has fizzled amid allegations of conflicts of interest and scientific misconduct, according to interviews, a whistleblower complaint and internal government records obtained by The Associated Press.

At a time when the world is desperate for a cure, misinformation swirls and economies struggle, the behaviour described by this story is diabolical.

In mid-April, the Trump administration funded a study of famotidine, the main ingredient in Pepcid, despite a lack of published data or studies to suggest heavy doses would be effective against the novel coronavirus.

Now, the Pepcid project faces an uncertain future. Northwell Health, the New York health care provider hired to conduct the testing at its hospitals, put the trial on hold due to a shortage of hospitalized covid-19 patients in that state. Northwell is partnered with Alchem Laboratories, the Florida-based pharmaceutical company that received the contract.

Read the rest of this discussion piece