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Canadian advocates call for all medical implants to be registered

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In the wake of the Implant Files investigation, a growing number of countries have said they will better track medical implants and warn patients faster by creating or expanding medical device registries.

The international series revealed that tens of thousands of medical devices distributed worldwide — like pacemakers and artificial hips — were approved for sale with little scientific evidence, and that several countries had failed to warn patients once they were recalled.

In the U.K., the Royal College of Surgeons called for “urgent and drastic changes” to protect patient safety, including a registry so doctors can know if new products are causing harm.

The German government announced that all implantable devices would have to be formally registered in a system independent from the industry, which will notify patients and collect data on the lifespan of products.

Italy said it would make it mandatory for all regional health bodies to register devices. 

Meanwhile, the United States and the European Union have been working to assign unique barcodes to devices, as a first step to eventually tracking them through the supply chain.

That’s in addition to Sweden, Finland, Norway, Denmark, Hungary and Australia, which have similar versions of mandatory registries for specific products or all devices.

Registries find problematic devices faster, said Dr. Stephen Graves. The Australian orthopedic surgeon told the International Consortium of Investigative Journalists that the nationwide mandatory joint replacement registry he created in the late 1990s has identified more than 150 poorly performing joint replacement products,  including some sold in Canada.

Canada has a similar system — the Canadian Replacement Joint Registry — but registration is not mandatory in all provinces and data is collected from hospitals sometimes months and up to a year after the surgery.

30 years of failed proposals

In Canada, after three decades of failed proposals, Ottawa seems to be warming up to the idea.

“Is the registry a good idea? Yes,” said Health Minister Ginette Petitpas Taylor.

“But what type of information should be collected for that registry? That’s the conversation I’m having right now with our officials. I want to make sure that information is useful to Canadians.”

Documents obtained by CBC News show Ottawa has wavered on the issue for decades, despite 16 petitions, recommendations, motions and private member’s bills calling for change.

In a letter exchange dating back to 1988, the federal department Health and Welfare Canada, Health Canada’s predecessor, said it was looking into creating a national breast implants registry, but it warned “costs could be considerable.”

In 1992, a committee of national health-care leaders charged with reviewing medical device regulations also recommended the creation of “registries to identify problems with high-risk devices.”

In 1992, a committee of national health-care leaders recommended the creation of ‘registries to identify problems with high-risk devices.’ Four years earlier, the federal government said it was looking into creating a national breast implants registry, but warned ‘costs could be considerable.’ (Craig Chivers/CBC)

Retired politician Mac Harb unsuccessfully introduced legislation, the Medical Devices Registry Act, six times — once as a Liberal MP and five times as a senator. He resigned in August 2013 during the Senate expenses scandal.

In an interview with CBC News about his efforts, he said, “It’s a national security issue. It’s health and safety. It’s a must-do. It’s not if. It’s when.”

During Senate hearings in early 2013, the proposed legislation was endorsed by the Canadian Nurses Association, as well as various physicians and researchers, while the industry trade group MEDEC testified that registry would be no better than the existing system.

The Canadian Cardiovascular Society has been lobbying for a registry for more than a decade.

After facing major recalls of cardiac devices, CCS created its own reporting system: they keep in touch with manufacturers and have an expert committee review advisories, issue guidelines for surgeons and survey hospitals across Canada about failure rates. 

Carolyn Pullen, chief executive officer of the Canadian Cardiovascular Society, says the lack of communication about medical devices is ‘a big gap in our health system.’ (Marc Robichaud/CBC)

“It’s clear that this transparency, accountability and really important communication mechanism is a big gap in our health system”, said Carolyn Pullen, chief executive officer of the society.

Encouraged by Petitpas Taylor’s comments to CBC News, the cardiovascular society said it had contacted a senior official at Health Canada to offer input and expertise. But there was little interest — a reaction the society called “alarming.”

Like ‘a giant Walmart with no cash registers’

Nova Scotia surgeon Dr Alex Mitchell said  there’s “no reliable medical device identification in Canada at present.”

Mitchell said when a device is recalled it can take months to review hospital records, usually paper-based, to find and contact affected patients. That delay puts them at greater risk.

He said one of the challenges with a device registry is the lack of a standardized barcodes for individual devices that can be scanned and entered into the system.

“Health-care facilities are like giant Walmart stores with no cash registers and no transactions. We open up the front doors and people come in and things leave. Then at the end of the day we run around with clipboards and try to figure it out.”

Tech entrepreneur Louis Roy says a registry could be built in five to 10 years, but it depends on collaboration among manufacturers, distributors, hospitals, doctors and patients. (Optel Group)

Tech entrepreneur Louis Roy said the technology to track medical products already exists.

His Quebec City company tracks everything from gold to coffee and dental implants.

“When you get all this data, it’s a clinical trial in real time, deployed to an entire country. … It’s worth so much for [companies] to be able to design the right product.”

He said a registry could be built in five to 10 years, but it depends on one factor: collaboration.

“We are talking about manufacturers, distributors, hospitals, doctors and patients, which are usually all disconnected. … That’s the main challenge.”

‘You have to make sure people actually do the hard work of analyzing the data,’ says Matthew Herder, director of Dalhousie University’s Health Law Institute. (Rachael Kelly/Dalhousie University)

Then there’s the question of who will analyze that registry, said Matthew Herder, director of the Health Law Institute at Dalhousie University.

“You have to make sure people actually do the hard work of analyzing the data … and ensure that whatever you learn will inform clinical decisions and patient choices about a given device.”

‘It took me everything I had to survive’

Scott McFie, 61, of Richmond. B.C., said a registry could have changed his life.

In March 2007, he was driving on the Coquihalla Highway in British Columbia with his four-year-old daughter when he was blinded by sudden and intense chest pain.

“I went black. I couldn’t see,” said McFie. “I thought a rock had come through the windshield.”

He found out later that the Sprint Fidelis electrical wires that connected a cardiac implant device to his heart were broken, shocking him 51 times in two hours.

“It took me everything I had to survive,” said McFie, who has joined a class action against Medtronic, the maker of the wires.

The lawsuit alleges that doctors started reporting problems as far back as 2005, but the device wasn’t recalled in Canada or the U.S. until October 2007.

Health Canada sent an urgent notice asking surgeons to stop using Medtronic’s Sprint Fidelis electrical lead with implantable cardioverter-defibrillators (CDI), warning the wires could break and deliver “multiple inappropriate shocks.” The recall said the defective lead “might have contributed” to five deaths in the U.S.

At the time, nearly 6,000 leads were in use in Canada.

In its statement of defence, Medtronic denies any negligence and says that, at the time of implant, all patients assumed the risk that their lead may fail.

“It’s another bureaucratic failure,” said McFie. “Where is the government in demanding regulatory notifications by the manufacturers and the physicians themselves?”

His lead was replaced, but he said his family suffered long-term trauma from his experience.

Learn more about your medical device by searching our database of Health Canada records. If you’re using the CBC News app, you can access the page here

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Researchers warn about the severe psychological distress caused by eating junk food

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(Natural News) Does junk food make you sad? While the current state of the American food industry is more than enough to make anyone feel depressed, new research from Loma Linda University demonstrates a link between junk-laden diets and psychological distress. Based on their findings, it appears that what you eat can and does affect your mental health — and that the prepackaged garbage peddled as “food” can have a seriously deleterious effect on your emotional well-being.

Even after adjusting for other external factors, the scientists found this relationship held steady: The more junk food a person ate, the more distress they reported feeling. When you consider the physiological effects junk food has on the body, it is no wonder that people report feeling like they are more distressed: They are in distress, they just don’t know it’s because of what the “food” they’re eating is doing to them on the inside.

Estimates suggest that the average American gets 60 percent of their daily calories from processed or junk food. Junk food consumption is a widespread problem here in the United States. Now, there are questions about whether or not junk food is a driving force in the plague of insanity (and stupidity) striking the U.S.

Scientists link junk food to poor mental health

Published in the journal International Journal of Food Sciences and Nutrition in early 2019, a study from Loma Linda University scientists finds a link between poor diet and poor mental health. Even after adjusting for external factors such as gender, age, education and income level, the association between junk food intake and mental illness remained.

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Study leader Jim E. Banta, Ph.D., MPH, an associate professor at the school, says that their conclusions support the findings of previous research. To conduct their study, Banta and his team looked at data from the California Health Interview Survey (CHIS). The scientists used 240,000 phone surveys conducted by CHIS between 2005 and 2015, and included data on socio-demographics, health status and health behaviors.

“This and other studies like it could have big implications for treatments in behavorial medicine,” Banta said of the findings.

“Perhaps the time has come for us to take a closer look at the role of diet in mental health, because it could be that healthy diet choices contribute to mental health. More research is needed before we can answer definitively, but the evidence seems to be pointing in that direction,” he added.

The fact that scientists in the 21st century are only now just beginning to even consider the possibility of a relationship between nutrition and mental health is truly disturbing. Natural health practitioners have long been aware of the importance of good nutrition for total well-being, including mental state.

Is poor nutrition turning America insane?

Vitamin D deficiency is a well-known cause of depression. B vitamins, iron, selenium and magnesium also support good mental health and deficiencies in these nutrients can also cause depression and anxiety. There is a growing body of research which strongly supports poor nutrition as a causative factor not only in depression, but in other mental illnesses — including schizophrenia, bipolar disorder, OCD and more.

For example, Dr. Banta notes that some research has linked high sugar consumption to bipolar disorder, while fried foods and processed grains are linked to depression. There is no ignoring the link between diet and disease — whether it is of the body or of the mind makes no difference.

Nearly 60 percent of the American population’s diet comes from disease-causing food, and it is hard not to wonder if obesity, heart disease and death aren’t the only problems being caused by junk food diets.

Are the increasingly insane leftists just running around in a nutrient-deprived, sugar-spiked frenzy? Whether you’re talking about the inanity of “social justice” score-keeping or the rapid acceptance of censorship to silence conservatives, it’s clear that the far left is missing a few bolts upstairs. A diet of GMOs, pesticides and toxic food additives will do that to you, though.

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Eat healthier to improve your physical and mental well-being

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(Natural News) The physical health and mental well-being of a person depend a lot on nutrition and the food that he eats. Diet also influences the risk of developing chronic diseases. While the relationship between physical health and diet is well-understood, little is known about how diet and its quality influence the development of mental disorders. In a recent study, researchers from the University of Regensburg in Germany investigated the behavioral effects of a Western diet on pattern separation – the process of keeping items distinct in memory. They discovered that a diet consisting of increased amounts of sugar and saturated fatty acids, reduced levels of polyunsaturated fatty acids, and an increased ratio of omega-6/omega-3 fatty acids (Western diet) harms memory. The results of their study were published in the journal Food Science and Human Wellness.

The Western diet impairs pattern separation

In this study, researchers investigated the utility of spatial separation – a behavioral process associated with the hippocampus – in the assessment of dietary interventions and the behavioral effects of the transgenerational administration of a Western diet on pattern separation. Pattern separation is the process of keeping items distinct in memory and is mediated by the hippocampus. Previous studies have suggested that there is a relationship between hippocampal function and diet quality in both humans and animals.

To examine the association between them, the researchers used rats, feeding over seven generations a diet containing increased amounts of sugar and saturated fatty acids, reduced levels of polyunsaturated fatty acids, and an increased ratio of omega-6/omega-3 fatty acids. This diet composition is characteristic of a diet known as the Western diet. The researchers administered it transgenerationally because previous studies have shown that interventional diets need to be implemented over several generations to induce behavioral effects.

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They compared the spatial pattern separation (or local discrimination) performance of these animals with that of rats fed a standard diet. For the test, they presented the rats two locations and allowed them to learn across trials to respond to the correct location. During spatial discrimination training, they designated a location as the correct one and rewarded the rats if they touched the correct location. They reversed the correct and incorrect locations every time the rats successfully got the correct ones nine times out of 10 trials.

The researchers found a separation-dependent difference between the standard and Western diet groups in the number of discriminations performed in the pattern separation task. The rats fed with a Western diet performed fewer discriminations. Rats with lesions in the dorsal hippocampus showed impaired pattern separation when the locations were close together but not when they were far apart. The researchers associated this impairment with hippocampal dysfunctioning. Their results align with previous studies which demonstrated that consumption of a Western diet impaired cognitive functions, damaged brain regions, and contributed to the occurrence of neurodegenerative diseases. Their results confirmed that pattern separation could be negatively affected by transgenerational administration of a Western diet.

The researchers concluded that spatial pattern separation can help detect the effects of dietary interventions and that the Western diet can impair pattern separation.

How to make your diet healthier

A healthy diet can provide many benefits, the most important of which is the prevention of chronic diseases. Here are some things that you can do to make your diet healthier:

  • Eat slowly
  • Choose whole grains
  • Add probiotics to your diet
  • Increase your protein intake
  • Drink plenty of water
  • Avoid frying food and eating fast food
  • Take vitamin and mineral supplements
  • Try new and healthy recipes
  • Eat vegetables first before every meal
  • Eat fruits instead of drinking them
  • Exercise regularly
  • Stop drinking sweetened beverages
  • Get adequate sleep

Eating healthier and becoming aware of your nutritional needs will not only improve your physical health, but these will also benefit your mental and emotional well-being.

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Apples: Eat them to keep the doctor away – and boost stem cell therapy

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(Natural News) There is some truth behind the saying, “an apple a day keeps the doctor away.” Apples are superfoods, and they are good sources of antioxidants that protect cells from oxidative damage and boost the immune system. They also contain dietary fiber, which is good for digestion and the maintenance of gut microbiota. But there is more to apples than just being healthy, antioxidant fruits. In a recent study published in the journal Nutrition Research, researchers from Sungkyunkwan University in South Korea showed the beneficial effect of apple extracts on the proliferation of adult stem cells. They also identified the possible molecular mechanisms underlying apple’s pro-proliferative effects.

Apple ethanol extracts can enhance the proliferation of stem cells useful for tissue regeneration

Tissue regeneration using adult stem cells (ASCs) has significant potential in the treatment of many degenerative diseases. It also provides a promising means of repairing chronic tissue or organ failure due to injuries, congenital defects, and aging. Stem cells are essential in regenerative medicine because they can be used directly in cell replacement therapies. However, studies on their application in clinical settings suggest that age negatively affects the proliferation status and differentiation potential of ASCs. This presents a possible limitation in their therapeutic use.

In the hopes of addressing this limitation, researchers turned their attention to the pro-proliferative activity of apples. Apples are rich sources of valuable phytochemicals that are known to be beneficial to human health. They possess anti-inflammatory, antioxidant, and even anticancer activities. These antioxidants can help maintain human cells and protect them from harmful oxidation products. In addition, apples contain metabolites that could ensure longevity and increase the number of human cells in culture. (Related: Apples could hold key for increasing lifespan.)

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Because of this, researchers hypothesized that apple extracts might exert beneficial effects on ASCs. They obtained apple extracts using ethanol as the extraction solvent and tested these on human adipose tissue-derived mesenchymal stem cells (ADSCs) and human cord blood-derived mesenchymal stem cells (CB-MSCs). They also used 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide and Click-iT 5-ethynyl-2?-deoxyuridine flow cytometry assays to evaluate the pro-proliferative effects of the extracts.

The researchers found that treatment with apple extracts promoted the proliferation of ADSCs and CB-MSCs. Apple extracts also induced the stepwise phosphorylation of p44/42 MAPK (ERK), mammalian target of rapamycin (mTOR), p70 S6 kinase (p70S6K), S6 ribosomal protein (S6RP), eukaryotic initiation factor (eIF) 4B, and eIF4E in ADSCs. p44/42 MAPK (ERK) is a signaling pathway involved in the regulation of cell proliferation and differentiation. Inhibition of this pathway results in cell apoptosis. mTOR is a key signaling node that coordinates cell cycle progression and cell growth. p70S6K is a cytokine that regulates cell growth by inducing protein synthesis. eIFs, on the other hand, are proteins or protein complexes involved in translation and protein biosynthesis.

The researchers also reported that apple extracts significantly induced the production of vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6) in both ADSCs and CB-MSCs. VEGF is a potent angiogenic factor, which means it promotes the formation of blood vessels. VEGF also plays a role in other physiological functions, such as hematopoiesis, wound healing, and development. IL-6 is a promoter of proliferation. The researchers further confirmed that the apple extract-induced proliferation of ADSCs under serum-free conditions is mediated by ERK-dependent cytokine production because when they pre-treated cells with PD98059, a specific ERK inhibitor, it inhibited the phosphorylation of the mTOR/p70S6K/S6RP/eIF4B/eIF4E pathway.

Based on these findings, the researchers concluded that extracts from apples are potent pro-proliferative agents, and the beneficial effect of apple extract on the proliferation of ASCs may overcome the limitation in their therapeutic use in tissue regeneration.

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