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Insulin pumps linked to more reports of injury and death than any other medical device, records show

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“What’s your birth date?”

“November … November … 27… November 27, 1963,” says Christine Landry, her voice fading over the phone.

The 49-year-old registered nurse from Cornwall, Ont., sounds tired and confused.

It’s the night of July 22, 2012, and Landry called a 24-hour helpline run by Medtronic, the company that manufactured her insulin infusion pump, because a button on her device was stuck and making a loud beeping sound.

On a recording of the conversation, she can be heard struggling to answer basic questions as she arranges for a replacement pump to be delivered to her home.

The next morning, her son, Philippe, then just 20 years old, found her unconscious in her bed.

“As soon as I walked up the stairs, I could hear heavy breathing,” he said. “When I went into her room, she was foaming at the mouth and I couldn’t wake her up. So I called 911 right away.”

His mother did eventually wake up, but with severe brain damage.

Christine Landry’s family now suspects she was never well suited to use an insulin pump. (Landry family)

The recorded conversation with the helpline was the last time Christine Landry’s family heard her speak. They say it’s clear from the recording that she was slipping into a diabetic coma.

She died this past September.

Like millions of people with diabetes around the world, Landry used an insulin infusion pump to try to improve her quality of life.

But a CBC News/Radio-Canada/Toronto Star investigation finds that for some people with diabetes, depending on their level of training and knowledge, the popular device might not be the safest way to regulate their blood glucose levels.

Health Canada data obtained under Access to Information reveals that in the past ten years, insulin pumps have been the subject of at least 40 recalls and may have a played a role in 103 deaths and more than 1,900 injuries — more than any other high-risk medical device in the health agency’s database.

The device acts as an artificial pancreas, slowly dripping insulin through a tube and needle under the skin, helping a person with diabetes to control their blood sugar levels. It’s marketed as an alternative to injecting insulin using disposable needles or pens several times a day.

Insulin pumps are increasingly popular among Canadians with diabetes. (Craig Chivers/CBC)

Pumps were first approved in Canada in the early 1980s and have become increasingly high-tech. They are now just a bit smaller than an iPhone and come with special features such as a “wizard” button that calculates a recommended dose based on the user’s carb and insulin intake history.

Manufacturers and provincial governments consider pumps so safe and simple to use, they are recommended and insured for children.

Many people with diabetes say insulin pumps are convenient and provide them with more control over their blood glucose levels than the traditional syringe or pen methods. The pump uses only rapid-acting insulin, which means the user can have worry-free meals and snacks at the touch of a button.

The pump’s constant drip of insulin can also help with the so-called dawn phenomenon, a potentially dangerous surge in blood sugar in the early morning.

But some doctors warn the convenient device requires considerable knowledge and skill to be used safely and effectively.

Dr. Peter Senior, an Edmonton-based endocrinologist who has done consulting work for pump makers, says the devices can be life-changing, but only for people with diabetes who have learned to manage their blood sugar levels.

“The misconception,” he said, “is that [pumps] will think for you. They will make the decisions. But the pump is just a dumb device that will do what you ask it to do. If you forget to ask it to do important things, or you ask it to do wrong things, then problems can arise.”

‘She was not even a candidate for the pump’

Initially, Philippe Landry didn’t understand how his mother could have been so severely injured using a device she was convinced made her life so much better.

She used to struggle to control her blood glucose levels, he says. She thought her Medtronic pump was the solution.

She loved her insulin pump so much she became a certified pump trainer, paid by Medtronic to help other Cornwall-area residents with diabetes to use their devices.

But her family now says it’s possible using a pump was never a good idea for her. They say she was a “brittle” diabetic, which means her blood sugar levels were unstable and sometimes reached extreme highs and lows.

“If she knew what we know now, she wouldn’t have gotten involved in that,” said Christine’s mother, Huguette. “She was … not even a candidate for the pump. I don’t know if anybody had mentioned that to her.”

The Landry family is suing Medtronic, alleging Christine Landry’s pump and infusion set malfunctioned, causing catastrophic and permanent injuries.

The company recalled the VEO Paradigm Insulin Pump model a year after Landry’s injury.

In its statement of defence, Medtronic says Landry acted negligently and was “fully aware and informed of the nature of the risks associated” with her insulin pump.

The manufacturer says Landry “failed to properly manage her alcohol and food consumption, monitor her glucose levels and instruct family members on the appropriate response to diabetic incidents.”

Pumps not for everyone, doctors say

Dr. Senior estimates that as many as 10 per cent of Type 1 diabetics are using an insulin pump, which could amount to 30,000 Canadians. In the U.S., it’s now 40 per cent.

He worries the devices are being “pushed too heavily at patients who’ve not been adequately trained in managing their diabetes.”

Dr. Simon Heller runs a five-day course for people with Type 1 diabetes in the U.K. As part of a study, the professor of clinical diabetes at the University of Sheffield gave a group of 317 insulin pump and needle users the same training and compared their glycemic levels and quality of life over time.

“One of the reasons we did this trial,” he said, “is that we are concerned that people might use the pump expecting the pump to fix them.”

His two-year study, published in the British Medical Journal, found that after both groups completed intensive training on insulin management, participants using pumps reported only a slightly better quality of life than those using needles.

He found that increasing a person’s understanding of how to manage their condition is just as important as technology.

Health Canada ‘ill-equipped’ to investigate

Ontario’s Mary Krueger says Health Canada has a knowledge gap of its own when it comes to insulin pumps.

Krueger says her son, Steven, was an energetic and adventurous young man, living life to the fullest despite his Type 1 diabetes, with plans of becoming a licensed pilot and certified diver.

Mary Krueger’s 27-year-old son, Steven, may have died as a result of a malfunction with his insulin pump, according to a coroner’s report. (Craig Chivers/CBC)

He’d purchased his Paradigm MMT-511 insulin pump in 2002, shortly after it was approved by Health Canada.

He loved the freedom the pump afforded him. He told his mother it was working great.

But, on June 18, 2006, the 27-year-old was found dead in his bed at his home on B.C.’s Thetis Island.

Steven Krueger’s family says Health Canada wasn’t properly equipped to investigate the cause of his death. (Submitted by Mary Krueger)

A coroner’s inquiry ruled his death was accidental. The report said a “malfunctioning insulin pump” might have contributed to an insulin overdose. Looking for answers, the Kruegers shipped Steven’s pump to Health Canada’s medical device laboratory for analysis.

“We felt that Medtronic needed to be held accountable for what had happened,” Mary Krueger said. “We wanted them to acknowledge that something had gone wrong with the pump.”

The family soon realized the government’s expertise was limited, she says.

We should have had the answers right away when he died. We had to do a lot of the investigation ourselves.– Mary Krueger

Health Canada found a malfunction with the pump: it was stuck in “prime” mode, a setting used to test the insulin drip. Instead of injecting a few test drops, Steven’s pump didn’t stop, the report says. It “ejects all the insulin in the cartridge,” which could cause an overdose.

But inspectors couldn’t open the pump casing to confirm the cause of the problem. Mary Krueger was told to return the product to its manufacturer, Medtronic MiniMed, for further investigation.

Steven’s pump model was the subject of multiple recalls in Canada and the U.S. since his death, including an alert in 2014 that mentioned “users who have unintentionally programmed the pump to deliver the maximum bolus amount.”

Looking back now, Krueger thinks Health Canada was ill-equipped to investigate.

“We should have had the answers right away when he died. We had to do a lot of the investigation ourselves.”

Cutting costs

The problem isn’t unique to Canada. In the U.K., a 2013 coroner’s inquiry into the sudden death of another insulin pump user expressed concern about a “lack of analysis of medical devices post-mortem,” especially since insulin pumps had become so popular.

However, in 2010, Health Canada actually closed its Bureau of Medical Devices labs to cut costs.

Briefing notes sent to Health Minister Leona Aglukkaq at the time, and obtained by CBC News, show the department was under pressure to approve licences for a growing number of medical devices. To pay for that work, cuts had to be made to “lab research in low-impact or non-critical areas.”

In a statement to CBC, Health Canada said lab testing is now done by device manufacturers themselves or outsourced to third parties.

“This is more cost-effective and allows the department to access state-of-the-art facilities across all areas, rather than maintain lab capacity related only to specific scientific domains.”

Health Canada also said because of “recent post-market concerns” with all infusion pumps, including insulin pumps, it now requires manufacturers to submit evidence of more rigorous testing on their devices before they can be approved for sale.

In a written statement to the International Consortium of Investigative Journalists, Medtronic said “numerous clinical studies” have shown its insulin pumps “improve blood glucose control in patients with diabetes.”

The company also points out that adverse event reports sent to Health Canada do not establish whether a medical device actually caused an injury or death.

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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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