Science/Environment Covid-19 Treatments

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Aug 21, 2016
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Because it's a given.

And your version of the TGA statement doesn't match the TGA statement:



Firstly, - Individuals who believe that they are protected from infection by taking ivermectin may choose not to get tested or to seek medical care if they experience symptoms.

(Note: It's a good chance it's happening already.)

Secondly, the doses of ivermectin that are being advocated for use in unreliable social media posts and other sources for COVID-19 are significantly higher than those approved and found safe for scabies or parasite treatment. These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as dizziness, seizures and coma.

(Note: No "might" at all)

Finally, there has been a 3-4-fold increased dispensing of ivermectin prescriptions in recent months leading to national and local shortages for those who need the medicine for scabies and parasite infections.

(Note: No "might" - shortages are happening.)
This is the full TGA statement for 'New restrictions on prescribing ivermectin for COVID-19'.

Today, the TGA, acting on the advice of the Advisory Committee for Medicines Scheduling, has placed new restrictions on the prescribing of oral ivermectin. General practitioners are now only able to prescribe ivermectin for TGA-approved conditions (indications) - scabies and certain parasitic infections. Certain specialists including infectious disease physicians, dermatologists, gastroenterologists and hepatologists (liver disease specialists) will be permitted to prescribe ivermectin for other unapproved indications if they believe it is appropriate for a particular patient.​
These changes have been introduced because of concerns with the prescribing of oral ivermectin for the claimed prevention or treatment of COVID-19. Ivermectin is not approved for use in COVID-19 in Australia or in other developed countries, and its use by the general public for COVID-19 is currently strongly discouraged by the National COVID Clinical Evidence Taskforce, the World Health Organisation and the US Food and Drug Administration.​
Firstly, there are a number of significant public health risks associated with taking ivermectin in an attempt to prevent COVID-19 infection rather than getting vaccinated. Individuals who believe that they are protected from infection by taking ivermectin may choose not to get tested or to seek medical care if they experience symptoms. Doing so has the potential to spread the risk of COVID-19 infection throughout the community.​
Secondly, the doses of ivermectin that are being advocated for use in unreliable social media posts and other sources for COVID-19 are significantly higher than those approved and found safe for scabies or parasite treatment. These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as dizziness, seizures and coma.​
Finally, there has been a 3-4-fold increased dispensing of ivermectin prescriptions in recent months, leading to national and local shortages for those who need the medicine for scabies and parasite infections. It is believed that this is due to recent prescribing and dispensing for unapproved uses, such as COVID-19. Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities.​
There is only one TGA approved oral ivermectin product, Stromectol ivermectin 3mg tablet blister pack which is indicated for the treatment of river blindness (onchocerciasis), threadworm of the intestines (intestinal strongyloidiasis) and scabies.​
All medical practitioners can continue to prescribe oral ivermectin for the approved indications. However, prescribing of oral ivermectin for indications that are not approved is now limited to certain specialists.​
 

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On 9 August 2021 the Therapeutic Goods Administration (TGA) granted provisional determination to Merck Sharp & Dohme (Australia) Pty Ltd (MSD) in relation to Molnupiravir.​
This oral antiviral monotherapy will be considered for treatment of COVID-19 in adults.​
Molnupiravir is considered to have broad-spectrum activity against a range of RNA viruses including SARS-CoV-2, which causes COVID-19. Molnupiravir works by inhibiting replication of SARS-CoV-2.​
The granting of a provisional determination means that the TGA has made a decision that MSD is now eligible to apply for provisional registration for Molnupiravir in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that MSD will submit an application for provisional registration shortly.​

Based on FDA's purchase commitment in the US, the treatment would cost about $AUD 950 per patient.
 

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On 9 August 2021 the Therapeutic Goods Administration (TGA) granted provisional determination to Merck Sharp & Dohme (Australia) Pty Ltd (MSD) in relation to Molnupiravir.​
This oral antiviral monotherapy will be considered for treatment of COVID-19 in adults.​
Molnupiravir is considered to have broad-spectrum activity against a range of RNA viruses including SARS-CoV-2, which causes COVID-19. Molnupiravir works by inhibiting replication of SARS-CoV-2.​
The granting of a provisional determination means that the TGA has made a decision that MSD is now eligible to apply for provisional registration for Molnupiravir in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that MSD will submit an application for provisional registration shortly.​

Based on FDA's purchase commitment in the US, the treatment would cost about $AUD 950 per patient.
Cheap if it saves your life.
 

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Brownlow Medallist
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Cheap if it saves your life.
* If it works.
* And passes safety tests.

But at that price it's not practical to give to everyone who gets infected in wealthy countries. The UK currently has about 1.3 million active cases = $1,235,000,000 on possibly a monthly basis. And it's too expensive to be used even on just sick people in poorer countries.

In contrast, a repurposed drug like Fluvoxamine has a long record of safety and is so cheap it could be given to anyone who tests positive but their close contacts too.
 

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Early treatment with inhaled budesonide shortens recovery time by a median of three days in patients with COVID-19 who are at higher risk of more severe illness and are treated in the community. A common corticosteroid, budesonide is the first widely available, inexpensive drug found to shorten recovery times in COVID-19 patients aged over 50 who are treated at home and in other community settings. The findings are based on an interim analysis, which included 751 people in the budesonide group and 1028 in the usual care group who were SARS-CoV-2 positive.
 

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Tocilizumab (Actemra®) is registered for use in Australia for the treatment of arthritis, giant cell arteritis and cytokine release syndrome but not for the treatment of COVID-19.

The National COVID-19 Clinical Evidence Taskforce gave a conditional recommendation for it be used for patients hospitalised with COVID-19 who require supplemental oxygen - because it "probably reduces the risk of death". They are basing that on this trial published in the Lancet. The results don't seem too convincing. 31% of the patients allocated Tocilizumab died within 28 days and 35% allocated to usual care died.

It's relatively cheap but there are supply problems.
 

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Brownlow Medallist
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Pfizermectin is a step closer.

Pfizer said it is launching a mid-to-late-stage clinical trial to test whether the antiviral drug, PF-07321332, can prevent Covid-19 infection in some 2,660 healthy adults living in the same house as someone with a confirmed symptomatic infection.

While there are numerous effective and safe vaccines to prevent Covid-19, there are few drugs to treat those who have already contracted or been exposed to the virus. Those we do have—such as corticosteroids—tend to target the body’s response to infection, not the virus, and those that do actually target the virus—such as monoclonal antibodies like Regeneron—are expensive, in short supply and must be administered intravenously in hospital settings. An oral therapy could help eliminate many of the barriers to treatment and help keep people out of hospital.
 

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What are the clinical guidelines for the use of Sotrovimab? Will it be given to all symptomatic cases, or is it reserved for only the high risk cases?
Australian Medical Association rural chair Marco Guiseppin said those challenges related to the intensity of the treatment, which could require a hospital bed and staff to monitor the patient.

"This medication is expensive and is going to be in limited supply because the global demand is quite high," he said.

The US Federal Drug Authority authorised its emergency use in May. The headline cost is $US2100 a dose.
 

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Aspirin lowers risk of COVID: New findings support preliminary Israeli trial

The treatment reduced the risk of reaching mechanical ventilation by 44%. ICU admissions were lower by 43%, and an overall in-hospital mortality saw a 47% decrease.

 

SaintsSeptember

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Because it's a given.

And your version of the TGA statement doesn't match the TGA statement:



Firstly, - Individuals who believe that they are protected from infection by taking ivermectin may choose not to get tested or to seek medical care if they experience symptoms.

(Note: It's a good chance it's happening already.)

Secondly, the doses of ivermectin that are being advocated for use in unreliable social media posts and other sources for COVID-19 are significantly higher than those approved and found safe for scabies or parasite treatment. These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as dizziness, seizures and coma.

(Note: No "might" at all)

Finally, there has been a 3-4-fold increased dispensing of ivermectin prescriptions in recent months leading to national and local shortages for those who need the medicine for scabies and parasite infections.

(Note: No "might" - shortages are happening.)
I just hope the shortages aren't affecting the supply to Africa.
It would be pretty shitty if some kids went blind because someone had used their annual treatment instead of the good snakeoil.
 

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SaintsSeptember

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Aspirin lowers risk of COVID: New findings support preliminary Israeli trial

The treatment reduced the risk of reaching mechanical ventilation by 44%. ICU admissions were lower by 43%, and an overall in-hospital mortality saw a 47% decrease.

That's interesting.
When i first heard that the disease could cause thrombosis I wondered about Asprin, but early research indicated that it did nothing and i seem to recall some saying it may be harmful in conjunction with the disease.

Luckily there are enough people who take daily Aspirin ( and catching Covid ) to allow the investigation you described.
 

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Brownlow Medallist
Aug 21, 2016
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That's interesting.
When i first heard that the disease could cause thrombosis I wondered about Asprin, but early research indicated that it did nothing and i seem to recall some saying it may be harmful in conjunction with the disease.

Luckily there are enough people who take daily Aspirin ( and catching Covid ) to allow the investigation you described.
I think there's enough evidence that taking low dose aspirin lowers your risk of stroke or a heart attack.

Then the study shows that if you take low dose aspirin you are 29% less likely to become infected with Sars-Cov-2 virus.

But if you do get infected, those taking low dose aspirin had reduced risk of several parameters by almost half: reaching mechanical ventilation by 44%, ICU admissions by 43%, and overall in-hospital mortality by 47%.
 

SaintsSeptember

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I think there's enough evidence that taking low dose aspirin lowers your risk of stroke or a heart attack.

Then the study shows that if you take low dose aspirin you are 29% less likely to become infected with Sars-Cov-2 virus.

But if you do get infected, those taking low dose aspirin had reduced risk of several parameters by almost half: reaching mechanical ventilation by 44%, ICU admissions by 43%, and overall in-hospital mortality by 47%.
Yeah its interesting, i wonder if they know what the mechanism is.
Aspirin can help stroke because it affects the platelets in the blood , thinning the blood and preventing some of the natural clotting. People prone to blood clots from heart cavitation benefit from that. Covid19 also interacts with the blood platelets.

However if someone is prone to haemorrhage its to be avoided.
 

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