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Canadian doctors urge caution after FDA approves controversial new opioid pill

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Canadian doctors specializing in pain management say a pill form of sufentanil — an opioid related to fentanyl but even more potent that was recently approved in the United States — could do more harm than good.

The U.S. Food and Drug Administration (FDA) has drawn fire since it gave the go-ahead to Dsuvia — a pill containing sufentanil that is placed under a patient’s tongue — as an alternative to administering the powerful narcotic intravenously during or after surgery.

Critics say having sufentanil available as a pill will open it up for abuse, worsening an already devastating opioid crisis in the U.S.

FDA commissioner Dr. Scott Gottlieb has issued a statement to try to reassure the American public that the risk is being addressed.

“There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis,” he said Friday.  

This ad in downtown Vancouver highlights the dangers of fentanyl. Sufentanil is five to 10 times more potent than fentanyl and is currently only approved for intravenous use in acute pain management in Canadian hospitals. (Jonathan Hayward/Canadian Press)

Sufentanil is five to 10 times more potent than fentanyl, but less potent than carfentanil, which was made as a veterinary opioid and never intended for human use.  

Each Dsuvia pill comes in a pre-filled, single-dose applicator and can only be dispensed within a hospital or other “medically supervised health-care setting,” Gottlieb said. Patients won’t be allowed to take the medication home or get it in pharmacies. 

A big driver in the FDA’s decision to approve the drug was the U.S. Department of Defence, Gottlieb said, which wants sufentanil in a pill format to treat wounded soldiers on battlefields where setting up an IV might not be easy.  

It was a “priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need,” he said.

The pills can also be used in hospital-based situations where it’s difficult to administer an IV, including patients whose veins are hard to access, according to a news release from California-based manufacturer AcelRx Pharmaceuticals.

A company spokesperson also told CBC News it was “seeking a partner” that could pursue approval to market sufentanil pills in Canada.

“We do not intend to commercialize Dsuvia on our own in Canada and would be open to partnering Dsuvia in Canada with another pharmaceutical company. That company would be responsible for obtaining approval from Health Canada,” the company said in an email. 

Health Canada confirmed it has not yet received an application for approval of sufentanil​ in a pill formulation, and that it is currently only approved for use in IV format in hospitals. 

The potential for abuse if sufentanil were available in pill format is concerning, says Dr. Daniel Bainbridge, a professor of anesthesiology at Western University in London, Ont. (Canadian Anesthesiologists’ Society )

If AcelRx does find a partner company to try to get that approval, Health Canada needs to very carefully weigh the risks versus the benefits, said Dr. Daniel Bainbridge, president of the Canadian Anesthesiologists’ Society and a professor of anesthesiology at Western University in London, Ont.

As the society does not yet have a position on whether a pill form of sufentanil would be useful in Canada, Bainbridge noted he was speaking independently as a anesthesiologist. 

Sufentanil is one of the “main potent drugs” used to manage intense surgical pain in hospitals, he said, and its intravenous delivery makes it difficult to take away and abuse. But a pill is a different story, he said.

“If you have a pill under your tongue, all you do is you reach in, grab the pill, pull it out. And so you have an instant ability to divert the medication,” Bainbridge said. 

Health-care practitioners are already “being asked to do a lot” to prevent the abuse of narcotics, including locking them up in hospitals and monitoring who has access to them, he said, questioning whether the limited clinical use of a sufentanil pill would be worth the potential problems it could create.

“Do we have a real need for this sort of medication in practice in Canada?” Bainbridge asked. “From reading the literature, [I] don’t see it as a big benefit.”

In contrast, the “abuse potential” is a big concern, he said, especially because sufentanil is so potent: It takes only a “few grains of powder” to have an effect.

“[It’s] yet another narcotic that people aren’t familiar with that, if it makes its way to the street, may result in even more people suffering from overdoses and dying,” he said.

Dr. Hance Clarke, medical director of the pain research unit at Toronto General Hospital, agreed that the risks versus the benefits of a sufentanil pill need to be fully assessed.  

A pill form of sufentanil could be useful to alleviate pain for wounded soldiers in battlefield conditions, but the benefit in hospital settings is questionable, says Dr. Hance Clarke. (University Health Network)

Clarke said he would support its use with injured soldiers in a battlefield situation, as the Pentagon has proposed in the U.S., because it “could help to alleviate suffering after critical wounds.”

But apart from that, he said he could only see “a handful of scenarios” in which sufentanil couldn’t otherwise be readily administered through an IV. 

“Bringing this to Canada, and for use in the hospital system, should very much be questioned,” Clarke said in a email. “From a societal/harm reduction perspective, the potential for abuse is significant.”

Dsuvia is expected to be available in the U.S. in early 2019. The wholesale price per dose will likely be $50 to $60 US, AcelRx Pharmaceuticals said. 

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Bill Gates: Third Shot May Be Needed to Combat Coronavirus Variants

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With more than 40 million Americans having received at least the first dose of the Pfizer or Moderna vaccine, a third dose may be needed to prevent the spread of new variants of the disease, Bill Gates told CBS News Tuesday.

Gates’ comments come amid growing concern that the current vaccines are not effective against the more contagious Brazilian and South African variants.

Pfizer and Moderna have stated that their vaccines are 95% and 99% effective, respectively, against the initial strain of COVID. However, some scientists have questioned those statements. Additionally, the World Health Organization and vaccine companies have conceded that the vaccines do not prevent people from being infected with COVID or from transmitting it, but are only effective at reducing symptoms.

Gates told CBS Evening News:

“The discussion now is do we just need to get a super high coverage of the current vaccine, or do we need a third dose that’s just the same, or do we need a modified vaccine?”

U.S. vaccine companies are looking at making modifications, which Gates refers to as “tuning.”

People who have had two shots may need to get a third shot and people who have not yet been vaccinated would need the modified vaccine, explained Gates. When asked whether the coronavirus vaccine would be similar to the flu vaccine, which requires yearly boosters, Gates couldn’t rule that out. Until the virus is eradicated from all humans, Gates said, additional shots may be needed in the future.

AstraZeneca in particular has a challenge with the variant,” Gates explained. “And the other two, Johnson & Johnson and Novavax, are slightly less effective, but still effective enough that we absolutely should get them out as fast as we can while we study this idea of tuning the vaccine.”

The Bill & Melinda Gates Foundation is funding the studies being conducted in Brazil and South Africa, CBS News said. The foundation has also invested in the AstraZeneca, Johnson & Johnson and the Novavax vaccines, which are being tested against new variants. Once the AstraZeneca vaccine is approved, the Global Alliance for Vaccine Initiative or GAVI, founded by Gates, will distribute it globally.

“Gates continues to move the goalposts,” said Robert F. Kennedy, Jr., chairman and chief legal counsel of Children’s Health Defense. “Meanwhile the strategies he and others have promoted are obliterating the global economy, demolishing the middle class, making the rich richer and censoring vaccine safety advocates, like me.”

Kennedy said that the exclusive focus on vaccines has prevented the kind of progress required to actually address and recover from the pandemic:

“From the pandemic’s outset, clear-headed people familiar with the challenges inherent in the vaccine model have understood that the path out of crisis would require multiple steps. Those steps would need to include the development and/or identification of therapeutic drugs, the sharing of information among doctors to hone improved treatment models that reduce infection mortality rates below those for flu, and the kind of broad-spectrum long-term herd immunity that protects against mutant strains and that only derives from natural infection.”

Instead, Gates and vaccine makers are proposing a lifetime of boosters, supporting insufficient testing to determine safety and failing to address the inadequate monitoring of vaccine injuries, Kennedy said.

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.

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Young nurse suffers from hemorrhage and brain swelling after second dose of Pfizer’s COVID-19 vaccine

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(Natural News) A 28-year-old healthcare worker from the Swedish American Hospital, in Beloit, Wisconsin was recently admitted to the ICU just five days after receiving a second dose of Pfizer’s experimental mRNA vaccine. The previously healthy young woman was pronounced brain dead after cerebral angiography confirmed a severe hemorrhage stroke in her brain stem.

Her family members confirmed that she was “breaking out in rashes” after the vaccine. She also suffered from sudden migraine headaches, and got “sick” after taking the second dose of the vaccine. At the very end, she lost the ability to speak and went unconscious. The migraines, nausea, and loss of speech were all symptoms of a brain bleed and brain swelling, something her family did not understand at the time, and something nobody would expect after vaccination.

While on life support, neurologists used angiography to image the damage inside the brain. They found a subarachnoid hemorrhage, whereas a bulging blood vessel burst in the brain, bleeding out in the space between the brain and the tissue covering the brain. The ensuing swelling cut off oxygen to the brain and caused brain death. On February 10, 2021, Sarah reportedly had “no brain activity.” Some of the woman’s organs are now being procured, so they can be donated to other people around the world.

Doctors warn FDA about COVID vaccines causing autoimmune attacks in the heart and brain

Experimental COVID-19 vaccines may cause inflammation along the cardiovascular system, leading to heart attack and/or stroke. This serious issue was brought forth to the Food and Drug Administration (FDA) by Dr. J. Patrick Whelan, M.D., Ph.D. and further confirmed by cardiothoracic surgeon, Dr. Hooman Noorchashm, M.D., Ph.D. The two doctors warned that a recently-infected patient who is subject to COVID-19 vaccination is likely to suffer from autoimmune attacks along the ACE-2 receptors present in the heart, and in the microvasculature of the brain, liver and kidney. If viral antigens are present in the tissues of recipients at the time of vaccination, the vaccine-augmented immune response will turn the immune system against those tissues, causing inflammation that can lead to blood clot formation.

This severe adverse event is likely cause of death for the elderly who are vaccinated despite recently being infected. There is no adequate screening process to ensure that this autoimmune attack doesn’t occur. The elderly are not the only people vulnerable to vaccine injury and death. Pfizer’s experimental COVID-19 vaccine could be the main cause behind the sudden death of Sarah Sickles, a 28-year-old nurse from Wisconsin. The Vaccine Adverse Events Reporting System has captured five permanent disabilities in Wisconsin, 58 ER visits, and eleven deaths in just one month. This is the first case in Wisconsin of someone under 44 years of age suffering from severe COVID-19 vaccine side effects and death. There are now more than 1,170 deaths recorded in the U.S. related to the experimental mRNA vaccines, a reality that the FDA and CDC continue to ignore.

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Powering hypersonic weapons: US armed forces eyeing dangerous 5G tech

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(Natural News) Much of the conversation surrounding the benefits of 5G is geared toward the consumer side of the technology. People will be able to download videos at lightning speed and will be more connected than ever, proponents claim, although there are serious questions regarding its safety. However, some of the most important 5G applications are not civil at all – the technology will be used extensively in the military domain.

Some of its military uses are outlined in the Defense Applications of 5G Network Technology report, which was published by the Defense Science Board. This federal committee gives scientific advice to the Pentagon. Their report states: “The emergence of 5G technology, now commercially available, offers the Department of Defense the opportunity to take advantage, at minimal cost, of the benefits of this system for its own operational requirements.”

The 5G commercial network that is being built by private companies right now can be used by the American military for a much lower cost than if the network had been set up exclusively for military purposes.

Military experts expect the 5G system to play a pivotal role in using hypersonic weapons. For example, it can be used for new missiles that bear nuclear warheads and travel at speeds superior to Mach 5. These hypersonic weapons, which travel at five times the speed of sound and move a mile per second, will be flying at high altitudes on unpredictable flight paths, making them as hard to guide as they will be to intercept.

Huge quantities of data need to be gathered and transmitted in a very short period in order to maneuver these warheads on variable trajectories and allow them to change direction in milliseconds to avoid interceptor missiles.

5G for defense

This type of technology is also needed to activate defenses should we be attacked by a weapon of this type; 5G automatic systems could theoretically handle decisions that humans won’t have enough time to make on their own. Military bases and even cities will have less than a minute to react to incoming hypersonic missiles, and 5G will make it easier to process real time data on trajectories for decision-making.

There are also important uses of this technology in combat. 5G’s ability to simultaneously link millions of transceivers will undoubtedly facilitate communication among military personnel and allow them to transmit photos, maps and other vital information about operations in progress at dizzying speeds to improve situational awareness.

The military can also take advantage of the high-frequency and short-wavelength millimeter wave spectrum used by 5G. Its short range means that it is well suited for smart military bases and command posts because the signal will not propagate too far, making it less likely that enemies will be able to detect it.

When it comes to special forces and secret services, the benefits of 5G are numerous. Its speed and connectivity will allow espionage systems to reach unprecedented levels of efficiency. It will also make drones more dangerous by allowing them to identify and target people using facial recognition and other methods.

Like all technology, 5G will also make us highly vulnerable. The network itself could become an attractive target for cyber-attacks and other acts of war being carried out with cutting-edge weaponry. In fact, the 5G network is already viewed as critical infrastructure and is being carefully protected before it is even fully built.

While the focus on 5G’s dangers to human health and the environment is absolutely warranted, it is also important not to lose sight of the military implications of 5G. After all, it is not just the United States that is developing this technology for military purposes; our enemies, like China and other countries, are also making great strides in this realm.

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