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Canada has found the key to lowering drug prices, but it won’t be used anytime soon





There’s a battle being fought in the backrooms of Ottawa, and the outcome could determine how much Canadians will pay for new drugs.

The federal government has developed a series of regulations that would lower Canada’s patented drug prices, which are among the highest in the world. Canada is second only to the United States in per capita drug costs.

But the new rules were like a gauntlet thrown down in the path of the pharmaceutical industry, which has been lobbying federal government officials ever since.

“Drug companies understand very well what’s at stake, and they’re massively mobilizing to make sure nothing happens,” said Marc-André Gagnon, a pharmaceutical policy researcher at Carleton University.

Drug companies understand very well what’s at stake, and they’re massively mobilizing to make sure nothing happens.– Marc-André Gagnon, a pharmaceutical policy researcher at Carleton University

The dispute is over a policy document called Protecting Canadians from Excessive Drug Prices — a series of amendments to the Patent Medicine Regulations that former health minister Jane Philpott announced on May 16, 2017.

“Canadians are paying too much for prescription drugs,” Philpott said at the time. “These measures will go a long way towards helping Canadians afford the medicines they need to live healthy, productive lives.”

Marc-André Gagnon, a pharmaceutical policy researcher at Carleton University, says drug companies know what’s at stake and are ‘massively mobilizing to make sure nothing happens.’ (Marc-André Gagnon/Evidence Network)

Industry resistance intense

Bringing Canada’s drug prices down sounded like a reasonable idea. And the plan would work according to the industry’s own calculations.

Janssen Canada president Chris Halyk estimated “an average reduction in prices of approximately 20%,” in a submission letter sent to the federal health minister in February.

But if drug prices go down, so do industry revenues, falling by up to $26 billion over 10 years, according to one industry report.

That’s one reason why the industry’s resistance has been so intense. And it’s wielding a big stick, threatening that companies could hold back the launch of new drugs in Canada if the amendments are approved.

In Janssen Canada’s letter, Halyk wrote “the level of price reductions that are being proposed could result in it being not financially viable to launch some medicines in Canada.”

The pharmaceutical industry is also warning that it might reduce research and development in Canada, putting jobs at stake.

“[The regulations] will have negative economic implications, leading to reduced research and development (R&D) investments, less innovation in Canada and fewer jobs in our life sciences sector,” wrote AstraZeneca Canada president Jamie Freedman in a letter to Health Canada.

(A recent analysis found that the pharmaceutical industry has not been keeping up with previous R&D commitments.)

Discussions with industry reps ‘a frustrating process’

Because of the industry uproar, the staff at the Patented Medicine Prices Review Board (PMPRB) decided to start detailed consultations with stakeholders last June, inviting several industry representatives to sit on the steering committee to assist in developing an implementation roadmap.

It’s a bit like pulling teeth to engage the industry on these changes where their position is they’re opposed to the underlying policy.– Douglas Clark, executive director of Patented Medicine Prices Review Board

But so far those discussions are not going well — a fact revealed by the frustrated bureaucrat who’s leading the group.

In a newsletter last month, PMPRB executive director Douglas Clark reported that “progress on the issues under discussion has been slower than anticipated owing to the complexity of the subject matter and conflicting views of participants on the merits of the underlying policy.”

In other words, the industry representatives are reluctant to talk about ways to implement the very rules that they are fighting against.

“It’s been a frustrating process,” said Clark, who is trying to get industry input on the nuts and bolts of putting the new rules into effect.

“It’s a bit like pulling teeth to engage the industry on these changes where their position is they’re opposed to the underlying policy.”

Patient groups siding with industry, opposing changes

Innovative Medicines Canada represents more than 45 pharmaceutical companies. It has two seats at the steering committee table, but can’t comment on the discussions.

“The PMPRB’s terms of reference for the committee impose strict confidentiality on its members and deliberations,” said Innovative Medicines Canada spokesperson Sarah Dion-Marquis in an email.

There are several other industry representatives at the table, along with representatives from provincial agencies and the private insurance industry. There are also two patient organizations — the Canadian Organization for Rare Disorders (CORD) and Myeloma Canada.

After several meetings Clark said the steering committee has split into two factions.

“You’ve got public and private payers on one side and industry and patient groups on the other, and views can be quite polarized,” he said. Patient groups are aligned with industry on most of the issues, he said.

“There’s not a lot of daylight between their two positions,” said Clark.

Both patient groups have made submissions to Health Canada calling for the entire process to be halted.

Health Canada officials are also in the room, taking notes on the industry objections. And industry lobbyists are also speaking directly to federal officials on Parliament Hill.

Since last March, Innovative Medicines Canada and several other pharmaceutical companies have registered more than 50 communications with officials in the Prime Minister’s Office (PMO) and the health minister’s office.

“Our government engages regularly with health sector stakeholders, including the pharmaceutical industry, to discuss issues of [importance] to Canadians, including the price of prescriptions, national pharmacare, innovation, and drug shortages,” said PMO​ press secretary Matt Pascuzzo in an email.

In June, Innovative Medicines Canada president Pamela Fralick met face-to-face with Health Minister Ginette Petitpas Taylor. BIOTECanada, a biotechnology trade association, was also there.

“The PMPRB was raised at this meeting, along with several other topics,” said Dion-Marquis.

Firms would have to reveal confidential price deals

What are the proposed new rules that have sparked so much controversy?

Right now when deciding how much a new drug should cost in Canada, the PMPRB compares the Canadian price to the average of seven countries, including the U.S., which has the highest drug prices in the world.

The amendments would change those comparator countries by dropping the U.S. and adding other countries with lower drug prices, including Australia.

The new regulations would also force companies to reveal to the PMPRB the true price they’re charging, after confidential price negotiations with provinces.

And there would be a new formula to assess the value of new drugs, using a pharmacoeconomic measurement called “quality-adjusted life year” (QALY).

The industry has issues with each of those changes, insisting that there will be severe consequences to both drug access and to industry jobs.

As our industry, and many other stakeholders, have stated publicly on many occasions, we are deeply concerned the proposed PMPRB regulatory changes will delay and potentially limit patients’ access to new, life-saving medicines and vaccines, and will further put at risk thousands of jobs in Canada’s vital life science sector.– Innovative Medicines Canada spokesperson Sarah Dion-Marquis

“As our industry, and many other stakeholders, have stated publicly on many occasions, we are deeply concerned the proposed PMPRB regulatory changes will delay and potentially limit patients’ access to new, life-saving medicines and vaccines, and will further put at risk thousands of jobs in Canada’s vital life science sector,” said Dion-Marquis in an email.

So who’s winning the backroom drug price war?

The new rules were supposed to come into effect on Jan. 1 — just over five weeks from today.

But the federal government has quietly abandoned that plan. And so far it has not announced a new implementation date.

When asked about the progress of the proposed regulations Health Canada spokesperson Geoffroy Legault-Thivierge said in an email, ” Health Canada is taking the time required to carefully consider the comments received during consultations.”


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





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





(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





(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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