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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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Post-vaccine surge? Michigan’s spring coronavirus case spike close to previous year’s autumn high

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(Natural News) The spike in new Wuhan coronavirus infections recorded in Michigan over the spring is similar to a spike seen during the 2020 fall season. According to a Wall Street Journal analysis, the state’s daily coronavirus case count averaged more than 7,000 for almost two weeks – before taking a slight dip to 6,891 on April 20. This echoed similar figures back in November and December 2020, which saw sharp rises in infections for those two months before plunging.

Back in autumn of last year, Michigan averaged more than 7,000 cases per day for a span of 10 days. New infections dropped slightly, then briefly spiked as the December holidays approached. It then fell to the low 1,000s for the succeeding two months – until ascending again in March.

According to University of Michigan internal medicine professor Dr. Vikas Parekh, the sudden increase in new infections could be attributed to several factors. Among the factors he cited was re-openings, which increased people’s interactions and mobility. Parekh said the loosened restrictions contributed to the spread of the highly contagious U.K. B117 variant.

“As the B117 variant spreads nationally, we will likely see other stats [with] their own surges – although I hope none are as bad as Michigan,” the professor remarked. He continued: “The milestone just tells us we are not yet in the clear, especially as we still have large portions of our population who are not vaccinated yet.”

Parekh also expressed optimism over the lower daily caseloads the Great Lakes State reported. He said he believes both cases and hospitalizations have plateaued and will likely decline soon. The professor commented: “[COVID-19] positivity has been declining now for one week, which is usually a leading indicator of case decline.”

Meanwhile, the state cited younger populations and youth sports, such as basketball, wrestling and hockey, to increase new COVID-19 infections. Because of this, Gov. Gretchen Whitmer called to suspend youth sports and indoor dining in the state. She also exhorted high schools to conduct remote class sessions for two weeks to curb the spread of the pathogen.

Michigan still experienced the spike in cases despite having one of the highest vaccination rates in the country

During the opening stages of the U.S.’s immunization drive against COVID-19, Michigan boasted of having one of the highest vaccination rates nationwide. A report by Bridge Michigan even noted the initial “frenzy for vaccines” that “far exceeded the state’s limited supply.” But things have appeared to turn around for Michigan, as it now struggles to reach the 70 percent vaccination rate needed for herd immunity.

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Scottish mom’s legs turn into a pair of “giant blisters” after first dose of AstraZeneca’s coronavirus vaccine

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(Natural News) Sarah Beuckmann of Glasgow, Scotland, felt a tingling sensation in her legs and noticed a rash flaring up around her ankles a week after getting her first dose of AstraZeneca’s coronavirus (COVID-19) vaccine on March 18.

She also had flu-like symptoms right after the vaccination.

Beuckmann called her doctor to arrange an appointment the morning she noticed the rash, but by the afternoon her skin was already breaking out into blood-filled blisters. Blisters also appeared on her legs, hands, face, arms and bottom.

“I ended up asking my husband to take me to A&E,” said Beuckmann, referring to “accident and emergency,” the equivalent of an emergency room (ER). “When I got there, my heart rate was sitting at 160bpm, which they were very concerned about. I got put on an ECG machine.”

Doctors determine AstraZeneca’s COVID-19 vaccine triggers the rash

Medics carried out tests for HIV, herpes and other skin conditions to work out what triggered the rash, but all results came back negative. Doctors finally determined that the vaccine caused her rare reaction after carrying out two biopsies.

“Once they found that it was a reaction to the vaccine, they put me on steroids and that really seems to be helping my progress,” said Beuckmann. She had been advised by her doctor not to get the second dose of AstraZeneca’s COVID-19 vaccine because of her reaction.

Beuckmann spent 16 days at Queen Elizabeth University Hospital. She was discharged to recover at home. The 34-year-old mother of one is currently wheelchair-bound due to the bandages on her legs and blisters on the soles of her feet. She may need physiotherapy to help strengthen her leg muscles.

“They are starting to heal and they’re looking a lot better than they were but as the blisters started to get worse, they all sort of merged together,” she said. “I didn’t know what was going on.”

With the blisters merging, her legs have looked like a pair of “giant blisters.” Beuckmann admitted that at one point she feared her legs might have to be amputated.

Dermatologist agrees COVID-19 vaccine causes the blisters

Dr. Emma Wedgeworth, a consultant dermatologist and spokeswoman at the British Skin Foundation, agreed that Beuckmann had likely suffered a reaction to the vaccine.

“Vaccines are designed to activate the immune system. Occasionally people will have quite dramatic activation of their immune systems which, as happened in this case, can manifest in their skin” Wedgeworth told MailOnline. “This poor lady had a very severe reaction, which thankfully is extremely rare.”

It is not clear why Beuckmann, who works in retail, was invited for a vaccine. Scotland’s vaccine rollout was focused on people over the age of 50 when she got vaccinated, although vaccines are available to those who are considered at risk from the virus, or live with someone considered vulnerable.

At least 20 million Briton have had AstraZeneca’s COVID-19 vaccine, which drug regulators say causes a rash in one percent of cases. They say rashes caused by the jab tend to go away within a week.

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Trojan labs? Chinese biotech company offers to build COVID testing labs in six states

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In 2012, BGI acquired Complete Genomics, a DNA sequencing company and equipment maker. The funds for the $117.6 million purchase were raised from Chinese venture capitals. The company has expanded its footprint globally. According to its website, BGI conducts business in more than 100 countries and areas and has 11 offices and labs in the U.S.

People are concerned about China’s access to American DNA data

Some said that with Complete Genomics providing an American base, BGI would have access to more DNA samples from Americans, helping it compile a huge database of genetic information. Some also worried about the protection of the genetic information’s privacy.

According to a 2019 report from the U.S.–China Economic and Security Review Commission (USCC), BGI “has formed numerous partnerships with U.S. healthcare providers and research organizations to provide large-scale genetic sequencing to support medical research efforts,”

There are three main reasons why many people in the biotech community and government have expressed concerns about China’s access to American DNA data.

In the “60 Minutes” interview, Evanina discussed the very likely scenario in which Chinese companies would be able to micro-target American individuals and offer customized preventative solutions based on their DNA.

Evanina asked: “Do we want to have another nation systematically eliminate our healthcare services? Are we okay with that as a nation?”

The second concern is that China may use DNA to track and attack American individuals. As the USCC report states: “China could target vulnerabilities in specific individuals brought to light by genomic data or health records. Individuals targeted in such attacks would likely be strategically identified persons, such as diplomats, politicians, high-ranking federal officials or military leadership.”

The third concern is that China may devise bioweapons to target non-Asians. Steven Mosher, president of the Population Research Institute, discussed it in his article “What Will China Do With Your DNA?” published by The Epoch Times in March 2019.

He wrote: “We know that the Asian genome is genetically distinct from the Caucasian and African in many ways. … Would it be possible to bioengineer a very virulent version of, say, smallpox, that was easily transmitted, fatal to other races, but to which the Chinese enjoyed a natural immunity? … Given our present ability to manipulate genomes, if such a bio-weapon can be imagined, it can probably – given enough time and resources – be realized.”

An article from Technocracy said: “China’s aggressive collection of American DNA should be doubly alarming because it can only spell one ultimate outcome: biowarfare. That is, genetically engineering viruses or other diseases that will be selectively harmful to U.S. populations.”

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