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“A Decision They’ll Regret” – Australia Regulator Bans Ivermectin Use As COVID-19 Treatment

"A Decision They’ll Regret" – Australia Regulator Bans Ivermectin Use As COVID-19 Treatment

Authored by Mimi Nguyen Ly via The Epoch Times,

Australia’s medicine and therapeutics regulator, the Therapeutic Goods Administration (TGA), has…

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"A Decision They'll Regret" - Australia Regulator Bans Ivermectin Use As COVID-19 Treatment

Authored by Mimi Nguyen Ly via The Epoch Times,

Australia’s medicine and therapeutics regulator, the Therapeutic Goods Administration (TGA), has introduced new restrictions on the prescribing of ivermectin for COVID-19 and other off-label use.

The TGA, an agency under Australia’s Department of Health, announced that the changes were introduced “because of concerns with the prescribing of oral ivermectin for the claimed prevention or treatment of COVID-19.”

The new restrictions mean that general practitioners may only prescribe the drug for TGA-approved conditions and not for other non-approved purposes—also referred to as “off-label” use. No penalties were specified in the TGA announcement in the event of a GP skirting the rules.

The Epoch Times has reached out to the TGA for further information.

Only certain specialists can continue to prescribe oral ivermectin for off-label use. They include infectious disease physicians, dermatologists, gastroenterologists, and hepatologists, the TGA announced.

Stromectol ivermectin 3mg is the only oral ivermectin product that is TGA-approved. The indications approved are river blindness, threadworm of the intestines, and scabies.

Ivermectin is not TGA-approved for use to treat COVID-19 in Australia. The TGA said that its use for COVID-19 in the general public is “currently strongly discouraged” by three entities—the National COVID Clinical Evidence Taskforce (pdf), the World Health Organization, and the U.S. Food and Drug Administration.

TGA Lays Out Concerns

The TGA in its announcement asserted that 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.”

The agency added that people who think they are protected from COVID-19 by taking ivermectin “may choose not to get tested or to seek medical care if they experience symptoms,” and claimed that doing so “has the potential to spread the risk of COVID-19 infection throughout the community.”

The TGA said that a second concern involves “unreliable social media posts and other sources” that have reportedly advocated for the use of ivermectin in “significantly higher” doses compared to what is approved and found safe for the treatment of scabies or parasites.

“These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as dizziness, seizures, and coma.”

The regulator also said that there has been a three- to four-fold increase in the dispensing of ivermectin prescriptions in recent months, which has resulted in “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,” its statement reads.

“Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities.”

Immediate Backlash by MPs

Two Australian politicians immediately issued announcements late Sept. 10 criticizing the TGA restrictions.

Federal MP George Christensen, a Liberal Party member from the state of Queensland, posted on Telegram a photo of his medications, writing, “My ivermectin treatment pack. Prescribed by a GP. Now the TGA has banned GPs from prescribing the drug off-label. It’s a decision they will regret.”

Christensen also shared a lengthy list of studies, writing, “here’s some REAL INFO on IVERMECTIN.”

Federal MP Craig Kelly, a former Liberal Party member and now leader of the United Australia Party, in a statement posted on Telegram called the TGA move “OUTRAGEOUS” and accused the agency of having “interfered with the sanctity of the Doctor patient relationship in Australia, by ignoring the evidence of over 50 published studies and also ignoring expert medical advice from doctors that have treated thousands of patients successfully with Ivermectin—by prohibiting doctors from prescribing this medicine to sick Australians.”

“The UNITED AUSTRALIA PARTY tonight calls for [an] urgent Royal Commission in this TGA over this decision,” he wrote, saying that the decision “could be investigated for possible corruption.”

“It’s a sad day for the nation, as the expert medical evidence from overseas indicates that this outrageous decision by the TGA will result in the death of Australians,” Kelly added.

A health worker shows a box containing a bottle of Ivermectin in Cali, Colombia, on July 21, 2020. (Luis Robayo/AFP via Getty Images)

On Ivermectin

Ivermectin is a generic medicine that can be produced cheaply in many places around the world and has been widely used in humans against some parasitic worms, and to combat scabies, lice, as well as rosacea. It is also used as an anti-parisite drug in livestock, including horses and cows.

William Campbell and Satoshi Omura in 2015 won the Nobel Prize in Physiology or Medicine for the discovery and applications of ivermectin. The World Health Organization features ivermectin on its List of Essential Medicines. It is also an FDA-approved antiparasitic agent.

Doctors and health care professionals have considered ivermectin as a repurposed medicine in tackling COVID-19, especially when used in early treatment. Many have praised ivermectin for having successfully helped thousands of their patients survive the initial waves of COVID-19.

As of Sept. 9, there are at least 63 studies, of which 45 are peer-reviewed, on the treatment of COVID-19 with ivermectin.

Two groups, the Front Line COVID-19 Critical Care Alliance and the British Ivermectin Recommendation Development Group, have been campaigning for the off-label use of the drug to combat the disease amid the pandemic.

Monash University, based in the Australian state of Victoria, announced in April 2020 that a study it led showed that “a single dose of the drug, Ivermectin, could stop the SARS-CoV-2 virus growing in cell culture.”

But it cautioned that ivermectin “cannot be used in humans for COVID-19 until further testing and clinical trials have been completed to confirm the effectiveness of the drug at levels safe for human dosing.”

“The potential use of Ivermectin to combat COVID-19 remains unproven, and depends on funding to progress the work into the next stages,” the university said at the time.

Tyler Durden Sat, 09/11/2021 - 17:30

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Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid ‘Green Pass’ Takes Effect

Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid ‘Green Pass’ Takes Effect

Following Israel across the Mediterranean being the first country in the world to implement an internal Covid passport allowing only vaccinated citize

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Huge Dock Worker Protests In Italy, Fears Of Disruption, As Covid 'Green Pass' Takes Effect

Following Israel across the Mediterranean being the first country in the world to implement an internal Covid passport allowing only vaccinated citizens to engage in all public activity, Italy on Friday implemented its own 'Green Pass' in the strictest and first such move for Europe

The fully mandatory for every Italian citizen health pass "allows" entry into work spaces or activities like going to restaurants and bars, based on one of the following three conditions that must be met: 

  • proof of at least one dose of Covid-19 vaccine

  • or proof of recent recovery from an infection

  • or a negative test within the past 48 hours

Via AFP

It's already being recognized in multiple media reports as among "the world's strictest anti-COVID measures" for workers. First approved by Italian Prime Minister Mario Draghi's cabinet a month ago, it has now become mandatory on Oct.15.

Protests have been quick to pop up across various parts of the country, particularly as workers who don't comply can be fined 1,500 euros ($1,760); and alternately workers can be forced to take unpaid leave for refusing the jab. CNN notes that it triggered "protests at key ports and fears of disruption" on Friday, detailing further:

The largest demonstrations were at the major northeastern port of Trieste, where labor groups had threatened to block operations and around 6,000 protesters, some chanting and carrying flares, gathered outside the gates.

    Around 40% of Trieste's port workers are not vaccinated, said Stefano Puzzer, a local trade union official, a far higher proportion than in the general Italian population.

    Workers at the large port of Trieste have effectively blocked access to the key transport hub...

    As The Hill notes, anyone wishing to travel to Italy anytime soon will have to obtain the green pass: "The pass is already required in Italy for both tourists and nationals to enter museums, theatres, gyms and indoor restaurants, as well as to board trains, buses and domestic flights."

    The prime minister had earlier promoted the pass as a way to ensure no more lockdowns in already hard hit Italy, which has had an estimated 130,000 Covid-related deaths since the start of the pandemic.

    Meanwhile, the requirement of what's essentially a domestic Covid passport is practically catching on in other parts of Europe as well, with it already being required to enter certain hospitality settings in German and Greece, for example. Some towns in Germany have reportedly begun requiring vaccination proof just to enter stores. So likely the Italy model will soon be enacted in Western Europe as well.

    Tyler Durden Sat, 10/16/2021 - 07:35

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    Tracking Global Hunger & Food Insecurity

    Tracking Global Hunger & Food Insecurity

    Hunger is still one the biggest – and most solvable – problems in the world.

    Every day, as Visual Capitalist’s Bruno Venditti notes, more than 700 million people (8.8% of the world’s population)..

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    Tracking Global Hunger & Food Insecurity

    Hunger is still one the biggest - and most solvable - problems in the world.

    Every day, as Visual Capitalist's Bruno Venditti notes, more than 700 million people (8.8% of the world’s population) go to bed on an empty stomach, according to the UN World Food Programme (WFP).

    The WFP’s HungerMap LIVE displayed here tracks core indicators of acute hunger like household food consumption, livelihoods, child nutritional status, mortality, and access to clean water in order to rank countries.

    After sitting closer to 600 million from 2014 to 2019, the number of people in the world affected by hunger increased during the COVID-19 pandemic.

    In 2020, 155 million people (2% of the world’s population) experienced acute hunger, requiring urgent assistance.

    The Fight to Feed the World

    The problem of global hunger isn’t new, and attempts to solve it have making headlines for decades.

    On July 13, 1985, at Wembley Stadium in London, Prince Charles and Princess Diana officially opened Live Aid, a worldwide rock concert organized to raise money for the relief of famine-stricken Africans.

    The event was followed by similar concerts at other arenas around the world, globally linked by satellite to more than a billion viewers in 110 nations, raising more than $125 million ($309 million in today’s dollars) in famine relief for Africa.

    But 35+ years later, the continent still struggles. According to the UN, from 12 countries with the highest prevalence of insufficient food consumption in the world, nine are in Africa.

     

    Approximately 30 million people in Africa face the effects of severe food insecurity, including malnutrition, starvation, and poverty.

     

    Wasted Leftovers

    Although many of the reasons for the food crisis around the globe involve conflicts or environmental challenges, one of the big contributors is food waste.

    According to the United Nations, one-third of food produced for human consumption is lost or wasted globally. This amounts to about 1.3 billion tons of wasted food per year, worth approximately $1 trillion.

    All the food produced but never eaten would be sufficient to feed two billion people. That’s more than twice the number of undernourished people across the globe. Consumers in rich countries waste almost as much food as the entire net food production of sub-Saharan Africa each year.

    Solving Global Hunger

    While many people may not be “hungry” in the sense that they are suffering physical discomfort, they may still be food insecure, lacking regular access to enough safe and nutritious food for normal growth and development.

    Estimates of how much money it would take to end world hunger range from $7 billion to $265 billion per year.

    But to tackle the problem, investments must be utilized in the right places. Specialists say that governments and organizations need to provide food and humanitarian relief to the most at-risk regions, increase agricultural productivity, and invest in more efficient supply chains.

    Tyler Durden Fri, 10/15/2021 - 23:30

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    Retail And Food Sales: If It’s Not Inflation, And It’s Not, Then What Is It?

    OK, so we went through the ways and reasons consumer price increases are not inflation, cannot be inflation, are nowhere near actual inflation, and what all that really means. The rate they’ve gone up hasn’t been due to an overactive Federal Reserve,…

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    OK, so we went through the ways and reasons consumer price increases are not inflation, cannot be inflation, are nowhere near actual inflation, and what all that really means. The rate they’ve gone up hasn’t been due to an overactive Federal Reserve, so it has to be something else. This is why, though the bulge has been painful, it’s already beginning to normalize. Without a persistent monetary component (in reality, not what’s in the media) the economy will adjust eventually.

    It already has. Several times, and that’s part of the problem.



    If not money, and it’s not, then what is behind the camel humps? No surprise, Uncle Sam’s ill-timed drops along with reasonable rigidities in the supply chain.

    An Economist might call this an accordion effect. One recently did:

    The closures and reopenings of different industries, coupled with the surges and lags in consumer purchasing during the pandemic, have caused an “accordion effect,” says Shelby Swain Myers, an economist for American Farm Bureau Federation, with lots of industries playing catch-up even as they see higher consumer demand.

    Not just surges and lags, but structural changes that have been forced onto the supply chain from them. With the Census Bureau reporting US retail sales today, no better time than now and no better place than food sales to illustrate the non-economics responsible for the current “inflation” problem.

    When governments panicked in early 2020, they shut down without thinking any farther than “two weeks to slow the spread.” This is, after all, any government’s modus operandi; unintended consequences is what they do.

    The food supply chain had for decades been increasingly adapted to meeting the needs of two very different methods of distributing food products; X amount of capacity was dedicated to the at-home grocery model, while Y had been set up for the growing penchant for eating out (among the increasingly fewer able to afford it). Essentially, two separate supply chains which don’t easily mix; if at all.

    Not only that, food distributors can’t simply switch from one to the other. And even if they could, the costs of doing so, and the anticipated payback when undertaking this, were and are massive considerations. McKinsey calculated these trade-offs in the middle of last year, sobering hurdles for an already stretched situation back then:

    Moreover, many food-service producers have already invested in equipment and facilities to produce and package food in large multi-serving formats for complex prepared-, processed-, frozen-, canned-, and packaged-food value chains. It would be highly inefficient to reconfigure those investments to single service sizes.

    And if anyone had reconfigured or would because they felt this economic shift might be more permanent:

    For food-service producers, the dilemma is around the two- to five-year payback period of new packaging lines. Reinvesting and rebalancing a food-service network for retail is not a straightforward decision. Companies making new investments would be facing a 40 percent or more decline in revenue. And any number of issues could extend the payback period or make investments unrecoverable. Forecasts are uncertain, for example, about the duration of pandemic-related demand shifts, the recovery of the food-service economy, and the timeline of returning to full employment.

    So, for some the accordion of shuttered restaurants squeezed food distributors far more toward the grocery and take-home way of doing their food businesses. And it may have seemed like a great bet, or less disastrous, as “two weeks to slow the spread” morphed to other always-shifting government mandates which appeared to make these non-economics of the pandemic a permanent impress.

    More grocery, less dining. Forever after.

    In one famous example, Heinz Ketchup responded to what some called the Great Ketchup/Catsup? Shortage by rearranging eight, yes, eight production lines to spit out their tomato paste in individual servings rather than bottles. CEO Miguel Patricio told Time Magazine back in June (2021) there hadn’t actually been any shortage of product, just the wrong packaging for it:

    It’s not that we don’t have ketchup. We have ketchup, but in different packages. The strain on demand started when people stopped going to restaurants and they were ordering takeout and home delivery. There would be a lot of packets in the takeout orders. So we have bottles; we don’t have enough pouches. There were pouches being sold on eBay.

    But then…vaccines. Suddenly, after over a year of the above, by April 2021 the doors were flung back open, stir-crazy Americans flew back to their local pubs and establishments (see: below) and within months, according to retail sales, it was almost back to normal again. Meaning pre-COVID.



    The accordion had expanded back out but how much of the food services supply chain had been converted to serve the eat-at-home way which many companies had understandably been led to believe was going to be a lasting transformation?

    Do they undertake even more costly and wasted investments to go back? Maybe they resist, just shipping what they have even if not fully suited in the way it had been before all this began.

    Does Heinz spend the money to reconfigure those same eight production lines so as to revert to producing their ketchup in bottles? Almost certainly, but equally certain they’re going to take their sweet time doing it; milking every last ounce of efficiency – limiting their losses, really – they can out of what may prove to have been a bad decision (again, you can’t really fault Mr. Patricio for being unable to predict pandemic politics).

    Rancher Greg Newhall of Windy N Ranch in Washington likewise told NPR that he has the animals, beef, pork, lamb, chicken, goat, but distributors are caught in the accordion (Newhall didn’t use that term):

    NEWHALL: People don’t understand how unstable and insecure the supply chain is. That isn’t to say that people are going to starve, but they may be eating alternate meats or peanut butter rather than ground beef.

    GARCIA-NAVARRO: Newhall says he hasn’t had any issues raising his animals. It’s the processing and shipping that’s the bottleneck, as the industry’s biggest players pay top dollar to secure their own supply chains.

    The usual credentialed Economist NPR asked for comment first tried to blame LABOR SHORTAGE!!! issues, including those the mainstream had associated with the pandemic (closed schools forcing parents to stay home, or workers somehow deathly afraid of working in close proximity with others) before then admitting:

    CHRIS BARRETT: And there’s also the readjustment of the manufacturing process. As restaurants are quickly opening back up, the food manufacturers and processors have to retool to begin to supply again the bulk-packaged products that are being used by institutional food service providers.

    With US retail sales continuing at an elevated rate, the pressures on the goods sector are going to remain intense.


    Because, however, this is not inflation – there’s no monetary reasons behind the price gouge – the economy given enough time will adjust. And it has adjusted in some ways, very painful ways.

    Painful in the sense beyond just hyped-up food prices and what we pay for gasoline lately, the services sector has instead born the brunt of this ongoing adjustment. Consumers have bought up goods (in retail sales) at the expense of what they aren’t buying in services (not in retail sales); better pricing for sparsely available goods stuck in supply chains, seeming never-ending recession for service providers.

    According to the BEA’s last figures, overall services spending remains substantially lower than when the recession began last year. And it shows in services prices which had been temporarily boosted by Uncle Sam’s helicopter only to quickly, far more speedily and noticeably fall back in line with the prior, pre-existing disinflationary trend following a much smaller second camel hump.



    Once the supply and other non-economic issues get sorted out, we would expect the same thing in goods, too. It is already shaping up this way, though bottlenecks and inefficiencies are sure to remain impediments and drags well into next year.

    Those include other factors beyond food or domestic logistical nightmares. Port problems, foreign sourcing, etc. The accordion has played the entire global economy, and in one sense it has created the illusion of recovery and inflation out of a situation which in reality is nothing like either.

    That’s the literal downside of transitory. We can see what the price bulge(s) had really been, and therefore what it never was.

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