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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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Five Below makes checkout changes shoppers may not like

The value retailer is discouraging theft at the checkout counter.

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Huge retail chains like Walmart  (WMT) , Target  (TGT) , CVS  (CVS) and others have faced a high amount of retail theft, or what they call inventory shrink, since 2020 and have been implementing measures to eliminate those costly losses.

Among the most common measures used by Walmart, Target and some others has been locking up popular items behind glass cases to prevent shoplifting. Customers shopping at these stores have encountered a lot of their favorite products, such as cosmetics, shampoo, over-the-counter drugs and even laundry detergent locked up in those cases.

Related: Target limits self-checkout, makes a change customers will love

Shoppers need to either push a button near the product to alert a worker to unlock the case or, in some situations, run around the store looking for a worker with the proper key to open the case. It's a very inconvenient problem for shoppers, and not all stores are consistent with their lockup policies.

For example, one Walmart store might lock up some of their instant coffee products, while another cross-town Walmart location, or even a Target competitor, doesn't lock up any coffee.

Retail stores have also implemented new self-checkout rules to discourage inventory shrink, but again, stores are inconsistent with their rules. Walmart stores have a 20 items or less rule for their self-checkout lanes to try to steer shoppers with more items to checkout clerks that might help reduce the occurrence of theft. But neither customers, nor workers seem to be observing that rule. Target on March 17 implemented a new 10 items or fewer rule in its self-checkout lanes, but we'll see if anyone enforces it.

These self-checkout requirements are also supposed to speed up the checkout process, but that only works if all the self-check registers are working and an adequate amount of checkout clerks are working registers as well.

The next step for retailers in addressing inventory shrink at self-checkout would be to eliminate self-check altogether.

Shopping in a Five Below store.

Pat Greenhouse/The Boston Globe via Getty Images

Five Below cuts back on self-checkout lanes 

After finishing the fourth quarter of 2023 with a "higher-than-planned shrink," or higher level of theft than expected in its stores, value retailer Five Below  (FIVE)  has implemented associate-assisted checkout in all of its stores for 2024, CEO Joel Anderson said on the company's earnings call on March 20.

"In addition, in our high-shrink stores, the primary option for checkout is more of the traditional, over-the-counter associate checkout," Anderson said. "We expect to have 75% of our transactions chain-wide assisted by an associate with a goal of 100% in our highest shrink, highest-risk stores to be fully transacted by an associate."

The retailer also checks receipts and adds guards

"Additionally, in those stores, we’re implementing further mitigation efforts, including receipt checking, additional store payroll and guards. We intend to measure progress as soon as Q2 when we perform a limited number of store counts," Anderson said.

Five Below tested several inventory shrink mitigation initiatives late in the third quarter and into the fourth quarter of 2023, which included product-related tests, front-end initiatives and guard programs, Anderson said in the earnings call. He said the most significant change the Philadelphia-based company made across most of the chain was to limit the number of self-checkout registers that were open, while positioning an associate upfront to further assist customers.

Anderson said he is confident the company's measures will help it over time, but the company has not included any financial impact for shrink reduction in its 2024 guidance. The company, however will aggressively pursue returning to pre-pandemic levels of shrink or offsetting the impact over the next few years, he said.

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Another major retailer cracks down on self-checkout at its stores

The value retailer is discouraging theft at its self-checkout counters by introducing more associate-assisted checkout transactions in its stores.

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on

Huge retail chains like Walmart  (WMT) , Target  (TGT) , CVS  (CVS) and others have faced a high amount of retail theft, or what they call inventory shrink, since 2020 and have been implementing measures to eliminate those costly losses.

Among the most common measures used by Walmart, Target and some others has been locking up popular items behind glass cases to prevent shoplifting. Customers shopping at these stores have encountered a lot of their favorite products, such as cosmetics, shampoo, over-the-counter drugs and even laundry detergent locked up in those cases.

Related: Target limits self-checkout, makes a change customers will love

Shoppers need to either push a button near the product to alert a worker to unlock the case or, in some situations, run around the store looking for a worker with the proper key to open the case. It's a very inconvenient problem for shoppers, and not all stores are consistent with their lockup policies.

For example, one Walmart store might lock up some of their instant coffee products, while another cross-town Walmart location, or even a Target competitor, doesn't lock up any coffee.

Retail stores have also implemented new self-checkout rules to discourage inventory shrink, but again, stores are inconsistent with their rules. Walmart stores have a 20 items or less rule for their self-checkout lanes to try to steer shoppers with more items to checkout clerks that might help reduce the occurrence of theft. But neither customers, nor workers seem to be observing that rule. Target on March 17 implemented a new 10 items or fewer rule in its self-checkout lanes, but we'll see if anyone enforces it.

These self-checkout requirements are also supposed to speed up the checkout process, but that only works if all the self-check registers are working and an adequate amount of checkout clerks are working registers as well.

The next step for retailers in addressing inventory shrink at self-checkout would be to eliminate self-check altogether.

Shopping in a Five Below store.

Pat Greenhouse/The Boston Globe via Getty Images

Five Below cuts back on self-checkout lanes 

After finishing the fourth quarter of 2023 with a "higher-than-planned shrink," or higher level of theft than expected in its stores, value retailer Five Below  (FIVE)  has implemented associate-assisted checkout in all of its stores for 2024, CEO Joel Anderson said on the company's earnings call on March 20.

"In addition, in our high-shrink stores, the primary option for checkout is more of the traditional, over-the-counter associate checkout," Anderson said. "We expect to have 75% of our transactions chain-wide assisted by an associate with a goal of 100% in our highest shrink, highest-risk stores to be fully transacted by an associate."

The retailer also checks receipts and adds guards

"Additionally, in those stores, we’re implementing further mitigation efforts, including receipt checking, additional store payroll and guards. We intend to measure progress as soon as Q2 when we perform a limited number of store counts," Anderson said.

Five Below tested several inventory shrink mitigation initiatives late in the third quarter and into the fourth quarter of 2023, which included product-related tests, front-end initiatives and guard programs, Anderson said in the earnings call. He said the most significant change the Philadelphia-based company made across most of the chain was to limit the number of self-checkout registers that were open, while positioning an associate upfront to further assist customers.

Anderson said he is confident the company's measures will help it over time, but the company has not included any financial impact for shrink reduction in its 2024 guidance. The company, however will aggressively pursue returning to pre-pandemic levels of shrink or offsetting the impact over the next few years, he said.

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CCP-Linked Virologist Fired After Transferring Ebola From Winnipeg To Wuhan Resurfaces In China – And Is Collaborating With Military Scientists

CCP-Linked Virologist Fired After Transferring Ebola From Winnipeg To Wuhan Resurfaces In China – And Is Collaborating With Military Scientists

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CCP-Linked Virologist Fired After Transferring Ebola From Winnipeg To Wuhan Resurfaces In China - And Is Collaborating With Military Scientists

A virologist who had a "clandestine relationship" with Chinese agents and was subsequently fired by the Trudeau government has popped back up in China - where she's conducting research with Chinese military scientists and other virology researchers, including at the Wuhan Institute of Virology, where she's allegedly studying antibodies for coronavirus, as well as the deadly Ebola and Niaph viruses, the Globe and Mail reports.

Xiangguo Qiu and her husband Keding Cheng were fired from the National Microbiology Laboratory in Winnipeg, Canada and stripped of their security clearances in July of 2019.

Declassified documents tabled in the House of Commons on Feb. 28 show the couple had provided confidential scientific information to China and posed a credible security threat to the country, according to the Canadian Security Intelligence Service.

The Globe found that Dr. Qiu’s name appears on four Chinese patent filings since 2020, two with the Wuhan Institute of Virology whose work on bat coronaviruses has placed it at the centre of concerns that it played a role in the spread of COVID-19 – and two with the University of Science and Technology of China, or USTC. The patents relate to antibodies against Nipah virus and work related to nanobodies, including against coronaviruses. -Globe and Mail

Canadian authorities began questioning the pair's loyalty, as well as the potential for coercion or exploitation by a foreign entity, according to more than 600 pages of documents reported by The Counter Signal.

Highlights (via CTVNews.ca):

  • Qiu and Cheng were escorted out of Winnipeg's National Microbiology Laboratory in July 2019 and subsequently fired in January 2021.
  • The pair transferred deadly Ebola and Henipah viruses to China's Wuhan Institute of Virology in March 2019.
  • The Canadian Security Intelligence Service assessed that Qiu repeatedly lied about the extent of her work with institutions of the Chinese government and refused to admit involvement in various Chinese programs, even when evidence was presented to her.
  • [D]espite being given every opportunity in her interviews to describe her association with Chinese entities, "Ms. Qiu continued to make blanket denials, feign ignorance or tell outright lies."
  • A November 2020 Public Health Agency of Canada report on Qiu says investigators "weighed the adverse information and are in agreement with the CSIS assessment."
  • A Public Health Agency report on Cheng's activities says he allowed restricted visitors to work in laboratories unescorted and on at least two occasions did not prevent the unauthorized removal of laboratory materials.
  • Cheng was not forthcoming about his activities and collaborations with people from government agencies "of another country, namely members of the People's Republic of China."

Following their firings, Qiu returned to China despite it being under a pandemic travel lockdown until January, 2023.

"It’s very likely that she received quite preferential treatment in China on the basis that she’s proven herself. She’s done a very good job for the government of China," said Brendan Walker-Munro, senior research fellow at Australia’s University of Queensland Law School. "She’s promoted their interests abroad. She’s returned information that is credibly useful to China and to its ongoing research."

More via the Globe and Mail;

Documents reviewed by The Globe show that Dr. Qiu is most closely aligned with the University of Science and Technology of China (USTC) in Hefei. In March, 2023, a document posted by a Chinese pharmaceutical company listed Dr. Qiu as second amongst “major completion personnel” on a project awarded by the Chinese Preventive Medicine Association for study related to an anti-Ebola virus therapeutic antibody. Most of the other completion personnel were associated with the Chinese People’s Liberation Army.

USTC was founded by the Chinese Academy of Sciences and initially established to build up Chinese scientific expertise useful to the military, which at the time was pursuing technology to build satellites, intercontinental ballistic missiles and atomic bombs. The university has continued to maintain close military ties.

The document says Dr. Qiu works for USTC. Jin Tengchuan, the principal investigator at the Laboratory of Structural Immunology at USTC, lists her as a co-inventor on a patent. Mr. Jin did not respond to requests for comment.

A person who answered the phone at USTC told The Globe, “I don’t have any information about this teacher.”

In 2012, USTC signed a strategic co-operation agreement with the Army Engineering University of the People’s Liberation Army, designed to strengthen research on cutting-edge technology useful for communications, weaponry and other national-defence priorities.

Dr. Qiu is also listed as a 2019 doctoral supervisor for students studying virology at Hebei Medical University.

Well, that makes me wonder what circumstances she was under when she emigrated to Canada. Why did she come?” asked Earl Brown, a professor emeritus of biochemistry, microbiology and immunology at the University of Ottawa’s faculty of medicine who has worked extensively in China in the past. “People leave for more freedom from China, or to make more money. But China keeps tabs on most people so I am not sure if she came over to infiltrate or whether she came and the infiltration happened later through contact with China.”

It may be impossible to answer that question. Three former colleagues at the National Microbiolgy Lab have indicated that Dr. Qiu and her husband were diligent and pleasant to deal with, but largely kept to themselves outside of work. They say Dr. Qiu was a brilliant scientist with a strong work ethic, although her English was weak. The Globe is not identifying the three who did not want to be named.

Dr. Qiu is a medical doctor from Tianjin, China, who came to Canada for graduate studies in 1996. She started at the University of Manitoba, but began working at the national lab as a research scientist in 2006, working her way up to become head of the vaccine development and antiviral therapies section in the National Microbiology Laboratory’s special pathogens program.

She was also part of the team that helped develop ZMapp, a treatment for the deadly Ebola virus, which killed more than 11,000 people in West Africa between 2014 and 2016.

“My sense is this was part of a larger strategy by China to get access to our innovation system,” said Filippa Lentzos, an associate professor of science and international security at King’s College London. “It was a way for them to to find out what was going on in Canada’s premier lab.”

Initially trained as a medical doctor, Dr. Qiu graduated in 1985 from Hebei University in the coastal city of Tianjin, which lies southeast of Beijing. Dr. Qiu went on to obtain her master of science degree in immunology at Tianjin Medical University in 1990.

Her career at Canada’s top infectious disease lab in Winnipeg began in 2003, only four years after Ottawa opened this biosafety level 4 facility at the Canadian Science Centre for Human and Animal Health.

Over time, she built up a reputation for academic collaboration, particularly with China. It was welcomed by management who felt her work was helping build a name internationally for the National Microbiology Lab.

By the time Canadian officials intervened in 2018 and began investigating, documents show, Dr. Qiu was running 44 separate projects at the Winnipeg lab, an uncommonly large workload.

Her work with former colleague and microbiologist Gary Kobinger vaulted Dr. Qiu into the international spotlight. The pair developed a treatment for Ebola, one that in its first human application led to the full recovery of 27 patients with the infection during a 2014 outbreak in Liberia.

Mr. Kobinger’s career continued to soar and he is now director of the Galveston National Laboratory, a renowned biosafety level 4 facility in Texas. In 2022, he told The Globe that it was “heartbreaking” to see what had happened to his colleague. He declined to speak for this article.

“She had lost a lot of weight with all the stress. She was so convinced that this was all a misunderstanding … and she would go back to her job,” he said in 2022. “ Her career has been destroyed with all this. She was one of the top female Canadian scientists of virology and Canada has lost that.”

Over a period of 13 months, though, the Chinese-Canadian microbiologist and her biologist husband’s lives were turned upside down.

She went from being feted at Ottawa’s Rideau Hall with a Governor-General’s Award in May, 2018, to being locked out of the Winnipeg lab in July, 2019 – the high-security facility where she had made her name as a scientist in Canada. By January, 2021, she and Mr. Cheng were fired.

Last month, after being pressed into explaining what happened, the Canadian government finally disclosed the reasons for this extraordinary dismissal: CSIS found the pair had lied about and hid their co-operation with China from Ottawa.

A big question remains following their departure: Why would Dr. Qiu risk her career, including the stature associated with developing an Ebola treatment, for China?

Read the rest here...

Tyler Durden Thu, 03/21/2024 - 18:40

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