Tag: 9/11/20

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Controversy Reigns over Remdesivir FDA Approval

On By ModernMedia

According to an article by Science, the approval of remdesivir by the US Food and Drug Administration (FDA) has shown irregularities in the approval process.

Remdesivir is particularly well-remembered for being approved by the FDA for emergency use, and again for the results of the Solidarity trial, which was organised by the WHO across the world. The Solidarity trial had shown no benefit for mortality benefit for remdesivir – or any other measures. There were high hopes for remdesivir initially: early on, an NIH trial found that it shortened the disease – but a similar Chinese study found no evidence of that. A later study sponsored by remdesivir’s manufacturer, Gilead, found that it reduced recovery time for a 5 day course – but not for a 10 day course. Gilead was aware of the Soldiarity results early on, and then when they became public because they were conducted across multiple countries with different standards of care.

Meanwhile, the FDA went ahead with its approval process. The Solidarity researchers described the results to the FDA on Oct. 10, and in a preprint paper five days later, but the FDA still gave approval, apparently ignoring the Solidarity results in favour of those of the NIH and other studies. Furthermore, the FDA had not convened a key advisory group – yet it had for all of the COVID vaccine approvals.

Meanwhile, the European Commission signed a procurement for 500 000 doses of remdesivir worth $1.2billion. A European Commission spokesperson confirmed that it only received word of the failure of remdesivir in the Solidarity trial the following day.

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“Long COVID” Linked to Pre-existing Conditions

On By ModernMedia

Studies on re-admission of diseases other than COVID, such as influenza, concluded that they were caused by complex interactions within the immune system.

Patients are currently considered cleared of COVID after two sequential negative tests.

Researchers from the bio-information firm “nference” performed a retrospective analysis of 266 patients treated for COVID.
This analysis compared patients admitted or re-admitted after viral clearance with patients hospitalised before viral clearance but did not require hospitalisation after viral clearance.
The researchers at nference used neural network models to draw out factors such as comorbidities in their dataset. The results showed that the hospitalised post-viral clearance group showed acute kidney injury (n=15 (16.1%)), anaemia (n=20 (21.5%)), and cardiac arrhythmia (n=21 (22.6%)) in the year preceding the onset of COVID.

The authors of the study by nference hope the information will guide further research into risk factors for COVID.

Source: News-Medical.Net

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Ask Patients about Any Cannabis Use Frankly

On By ModernMedia

With legalisation and increasingly widespread use of cannabis, healthcare providers should be as open-minded about cannabis use in their patients as possible

Marian Wilson, registered nurse and associate professor at the Washington State University College of Nursing, argues in a recent paper that enquiring about it like they would alcohol or tobacco is necessary to obtain adequate patient histories and build trust.

Many studies have indicated that patients are using it to treat pain in much the same way they do opioids. Since they are using it in this way, they need to be asked about it for pain management. Since patients are reluctant to disclose this information with clinicians, there is currently a lack of information on prevalence and usage habits.

“We want this paper to guide providers in how they can start opening up this conversation and normalising it,” Wilson said. “Central to patient-centred conversations is understanding the top priorities of patients. Researchers have suggested that clinicians should ask ‘What matters to you?’ as well as ‘What is the matter?'”

Source: News-Medical.Net

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Biden to Hit the Ground Running with COVID Response

On By ModernMedia

Mounting an effective response to COVID was one of presidential hopeful Joe Biden’s campaign promises, and now that he has won the US elections, he is seeking to implement this response as soon as possible.

This comes at a critical time, as the US has been struggling with record new cases, breaking 100 000 per day in the last few days, with sombre predictions of another 100 000 deaths by January, stoked by the advent of winter and people socialising for the festive season. Biden has begun assembling a science-focussed team to prepare to take on managing the COVID pandemic as soon as he takes office.

Numerous challenges will face Biden’s team when he assumes office. One of them is the extreme distrust that has emerged as a result of the politicisation of the virus. 

Angela Rasmussen, a virus researcher at Columbia University in New York, said: “The past year of misinformation, confusion and gaslighting from the White House has really left people without any trust that our government is capable of handling this. It’s going to be critical to begin communicating that, yes, this administration will be led by the science.” 

 Some believe that, unfortunately, that it is a case off too little, too late, and that attitudes cannot be so easily changed. Kris Mathews, the administrator of Decatur Health, a small hospital in rural Kansas, said, “I think the damage is done. People have made up their minds about how they react to it.”  

Biden has also promised to have the US rejoin the World Health Organization on the first day of his presidency. Dr. Soumya Swaminathan, the WHO’s chief scientist, said: “Everyone recognises that for a pandemic, you cannot have a country-by-country approach. You need a global approach.” She expressed optimism that the US under Biden would join the global Covax scheme led by the WHO to distribute the vaccine to the needy.

Source: Medical Xpress

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Hydroxychloroquine Confirmed Ineffective in the Prevention of COVID

On By ModernMedia

An article published in The Lancet examines the evidence for the drug hydroxychloroquine’s controversial application as a treatment for COVID, which was initially very encouraging based on the drug in vitro inhibition of the SARS-CoV-2 virus. However, the evidence now definitively shows that hydroxychloroquine is ineffective for COVID.

This would have been very useful if hydroxychloroquine, regularly used to treat rheumatic diseases, could have been used as an easily available treatment.

However, numerous studies since the beginning of the COVID pandemic have reiterated the same findings: that hydroxychloroquine does not reduce mortality risk for people hospitalised with COVID, nor does it shorten recovery times. Nevertheless, interest persisted in the possible preventative effects of hydroxychloroquine against COVID.    

Using electronic health records for 30 569 patients, a study comparing hydroxychloroquine use by rheumatoid arthritis or systemic lupus erythematosus sufferers to non-users with the same maladies reported no significant difference in standardised cumulative COVID mortality associated with hydroxychloroquine use (0.23% among hydroxychloroquine users and 0.22% among non-users) with an adjusted hazard ratio of 1.03 (95% CI 0·80–1·33).

These results reflect those of two studies where hydroxychloroquine was administered as prophylaxis to frontline and health care workers, which also showed no effect.