Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Sunday, January 31, 2021

The Presence of Cannabis Dispensaries and Reduced Opioid Deaths

"Our findings suggest that higher storefront cannabis dispensary counts are associated with reduced opioid-related mortality rates at the county level."
"While the associations documented cannot be assumed to be causal, they suggest a potential association between increased prevalence of medical and recreational cannabis dispensaries and reduced opioid-related mortality rates."
"This association holds for both medical and recreational dispensaries, and appears particularly strong for deaths associated with synthetic [non-methadone] opioids, which include the highly potent synthetic opioid fentanyl and its analogs."
"This study highlights the importance of considering the complex supply side of related drug markets and how this shapes opioid use and misuse."
Greta Hsu, University of California, Davis/Balazs Kovacs, Yale University
An exterior view of the Marijuana Paradise store in Portland Oregon
                    MedPage Today
 
A new study published in the BMJ medical journal (formerly British Medical Journal) this week points out that the presence of cannabis dispensaries has a pronounced effect on the incidence of opioid-induced deaths through overdoses. Where one legal storefront cannabis dispensary was established in an area, an estimated 17 percent fewer opioid deaths were seen to occur. With two dispensaries the decrease in deaths was even more pronounced at 21 percent, according to the study.
"The high rate of cannabis use for chronic pain and the subsequent reductions in opioid use suggest that cannabis may play a harm reduction role in the opioid overdose crisis, potentially improving the quality of life of patients and overall public health."
Canadian study, Journal Pain Medicine
Two pictures of green crosses, which delineate medical marijuana dispensaries.
Pot dispensaries impacts on public health.
The impression of the U.S. study suggests that using marijuana as an alternative to prescription opioids in pain management would result in improved health prospects. An earlier Canadian study found a "marked decline" in the volume of opioids prescribed across Canada since the legalization of cannabis in the country which found that "easier access to cannabis for pain may reduce opioid use for both public and private drug plans".

Canada legalized the use of cannabis for medicinal purposes in 2018. Since that time, licensed cannabis retail outlets have appeared just about everywhere, particularly since the expansion legalizing cannabis for recreational use -- even while cannabis is still illegal under U.S. federal law, while an increasing number of American states have themselves legalized its use and sale, most frequently for medical use, but in some areas for recreational use as well.

Opioids, a class of drugs including heroin, prescription pain relievers like oxycodone and synthetic opioids such as fentanyl -- have been responsible for overdose deaths which incidence has risen sharply in other countries as well, besides the U.S. and Canada. Fentanyl, a particularly powerful pain killer, as well as carfentanil, even more powerful, have been the cause of the majority of overdose deaths in both the U.S. and Canada.

Highly addictive opioids represent over two-thirds of all U.S. drug overdose deaths in U.S. figures for 2018. In Canada, statistics indicate 17,602 opioid-related overdose deaths between January 2015 and June 2020. The impact that cannabis dispensaries have on the use, abuse and impact of other drugs in the past was the focus of the Canadian research, with mixed results. 

In contrast, the two American researchers focused on a more local level, in comparing data in U.S. counties that happened to have dispensaries, instead of studying statewide or nationwide data and their study took into account the number of dispensaries operating in each county, to determine the count of cannabis dispensaries relating to opioid deaths.

""
Canadian Centre on Substance Use and Addictions

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Saturday, January 30, 2021

COVID Stress and Child Abuse

ABSTRACT: Children are widely recognized as a vulnerable population during disasters and emergencies. In BC there are growing concerns that children may be at higher risk of abuse and neglect as a consequence of the current COVID-19 pandemic and the public health measures to limit its spread. Increased family and financial stress, disrupted routines, and lack of access to community supports can all contribute to child maltreatment. At the same time, physical distancing has restricted contact between children and the protective adults, such as teachers, who most commonly report cases of suspected child maltreatment. Despite the pandemic, physicians continue to interact with children and families and are uniquely situated to identify cases of suspected child maltreatment. All physicians have a role to play in ensuring the safety and protection of children. Specific approaches to clinical practice in the pandemic era and resources adapted for the pandemic can help physicians assess risk of child maltreatment, support children and families, and recognize and respond to child abuse and neglect.
By: Kristopher T. Kang, MD Nita Jain, MD, FRCPC     B.C.Medical Journal 
Experts sound the alarm over child abuse during the global pandemic, NBC News
A study documenting an alarming rise in abuse-related head injuries among children in the United Kingdom adds to increasing evidence that the novel coronavirus pandemic and efforts to contain it are taking a serious toll on children.
The study found that between March 23 and April 23, 2020—the first month of self-isolation in the United Kingdom—10 children were treated for suspected abusive head trauma at the Great Ormond Street Hospital for Children in London. The injuries included brain bleeding and skull fractures. The hospital’s monthly average of such injuries was 0.67 during the previous 3 years. Two parents reported delaying care because they feared infection with the novel coronavirus. The authors expressed concern that children with less profound abuse-related injuries may be going untreated.
A World Health Organization report on global child abuse noted that schools were closed to 1.5 billion children worldwide because of the pandemic, and their parents face heightened stress and anxiety from lost income, social isolation, and potential crowding in the home. Additionally, more time online may expose children to an increased risk of online sexual exploitation or bullying.
“Violence against children has always been pervasive, and now things could be getting much worse,” Henrietta Fore, executive director of UNICEF, said in a statement about the report. “Lockdowns, school closures and movement restrictions have left far too many children stuck with their abusers, without the safe space that school would normally offer. It is urgent to scale up efforts to protect children during these times and beyond.”
Bridget M. Kuehn, MSJ   JAMA Network
"In my 16 years at CHEO [Children's Hospital of Eastern Ontario], I have never seen this many infants with serious maltreatment injuries. It is a stressful time for parents and caregivers. We all know it takes a village to raise a child. With staying at home during the pandemic, it can feel like the village is gone. Be reassured, it is not."
"I think everyone is struggling right now, everyone's stress level is higher and their coping skills are less."
"These things typically happen when people are at the end of their ropes and their coping skills fail. It happens to people with all levels of education and from all socioeconomic backgrounds."
"Parenting is hard. And it's normal for parents to feel overwhelmed sometimes. But serious injuries can happen in just a few seconds of frustration."
Dr.Michelle Ward, pediatrician, medical director, child and youth protection, CHEO
https://images.theconversation.com/files/356368/original/file-20200903-22-1yy6j1q.jpg?ixlib=rb-1.1.0&rect=554%2C546%2C4729%2C2360&q=45&auto=format&w=1356&h=668&fit=crop
Many families have had a hard time since schools and day care centers had to shut their doors. Westend61/Getty Images

For most people at all times the very suggestion of child abuse, aggression and violence, verbal and physical, directed against children is an intolerable thought. Impossible to imagine as it is, it occurs. And not only among people who have a short temper fuse, but among those who normally are capable of managing the multi-dimensional task order involved in looking after children, who suddenly find themselves without the 'normal' backups they've become accustomed to, in this era of lockdowns when childcare, school attendance, visits with grandparents have surrendered to the imperative of COVID avoidance.
 
One hospital in Ontario, in the nation's capital of Ottawa saw fit to issue a desperate appeal to parents asking them to seek help wherever they can to ease their burden of stress. This, for the simple enough reason that doctors have seen an increasingly larger number of presentations of children with broken bones, infants with head trauma, than they have been accustomed to. Presentations of shocking reminders that not all childhood experiences are happy, nurturing ones. Health workers steel themselves against recoiling at the presence of infants in pain and physical trauma.

It is the sheer growing numbers of these presentations that terrify them, however. At the Children's Hospital of Eastern Ontario a trend appeared to be building momentum which began in the fall and continued into the winter months, of infants arriving at the hospital with symptoms of "serious maltreatment injuries", such as bleeding around the brain, and broken bones. CHEO, according to Dr.Michelle Ward, is seeing over twice as many babies with serious trauma injuries and maltreatment concerns than during a like period of the year before.

During the past five months, concurrent with some of the toughest times of the second wave of the pandemic, 20 infants under one year of age have been treated for injuries that include head trauma and broken bones; the injuries obviously the result of peaking parental stress levels. Last year at the same time eight infants were treated with similar injuries, by comparison. Ottawa Public Health paired with CHEO in joining the Children's Aid Society of Ottawa to issue an extraordinary public announcement to urge pandemic-stressed parents and caregivers that help can be found.

Physicians in other areas of the country have reported seeing similar increases in maltreatment injuries to infants. On the other hand, fewer child abuse referrals have taken place among school-aged children during the pandemic. An educated hypothesis is that this could be linked to the fact that children have been unable to attend school during lockdowns amid school closures, with remote Internet teaching in effect, so school officials and teachers who are frequently those who spot child abuse are now out of the picture.
 
Dr.Ward is intent on communicating to people that community supports are available -- with community resources and support services listed on Public Health websites and that caregivers who require support can find what they need to help them weather a storm of unprecedented proportions in home life through health care support services to gain grater coping skills and endurance during the pandemic.
 
Study: Reporting of child maltreatment during the SARS-CoV-2 pandemic in New York City from March to May 2020Image Credit: Africa Studio / Shutterstock
Study: Reporting of child maltreatment during the SARS-CoV-2 pandemic in New York City. Image Credit: Africa Studio / Shutterstock



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Friday, January 29, 2021

Socializing by Screen

"In the big picture, we're all spending too much time in front of screens. I see it in my workplace. I see kids who don't know how to pick up a phone and call someone for a job interview. I see kids who struggle with just having a conversation, with looking you in the eye. A lot of them are struggling with social skills that they would have figured out if they didn't have a screen getting in the way."
"Parents tell us, 'My kid is addicted to Fortnite. He's normally a sweet kid, but, after four hours of Fortnite, he's irritable. He can't focus. He's not calm. He's like a drug addict because when I try to get him off Fortnite, he has a tantrum."
"First and foremost, you have to connect with your kid. We call it 'connection before direction'. If you have a stressful relationship, you're going to cause even more stress by just telling them to get off their device. You have to be willing to show empathy and validation, to know how to listen rather than just give advice all the time."
Dr.Michael Cheng, child and family psychiatrist, Children's Hospital of Eastern Ontario
 
"Screen time is a constant battle. At that age, it's kind of their job to fight with us and develop their own independence. They're definitely happy to try to sneak some screen time whenever they can and to push every boundary that we set."
"As frustrating as that is, I recognize that it one day might make them really excellent lawyers. There's a lot of negotiations, so we think, 'OK, there's life skills we're building here', even if it makes me want to tear out my hair."
Dennis Murphy, father of nine- and six-year-old children
HarvardPilgrim.org
 
The 'no screens before noon' rule in the Murphy/Burns household is a difficult one to monitor much less adhere to, when put up against the determination of two young children accustomed to and comfortable with technology their parents were just being introduced to when they were no longer young, but which has at this juncture been advanced and streamlined for the use of children who've been familiar with screens all their lives for entertainment and education and communication.

That Dennis Murphy and Erin Burns are home-schooling their children, Lilith 9, and Garnet 6, during the pandemic hasn't made it any easier to discipline bright young minds to the necessity of limiting screen time. Dr.Cheng from his perspective as a psychiatrist is concerned not only with the physical effects of immobility and fixation, but the isolation aspect and the move away from real-time, real-life socialization with limited interaction between physical contact and the life-lessons derived therefrom, as opposed to an internal life harnessed to technology.

Smartphones and tablets have taken over children's lives, and are doing actual harm to their mental equilibrium. The iPhone phenomenon has celebrated its 13th anniversary and the iPad has been around almost as long; screens are ubiquitous and upfront in children's daily lives. An American study undertaken in 2019 confirmed over half of young children had their own smartphones by age 11, with 'tweens' --  age eight to twelve -- spending on average four hours and 44 minutes daily online, exclusive of school time.

Ages 12- to 18-year-olds have seen their recreational screen time leap into seven hours, 22 minutes' daily use. Since the emergence of the pandemic, screen time for young people has soared. Guidelines from the Canadian Paediatric Society pre-pandemic, recommended kindergarten children spend an hour daily, tops, in front of a screen -- with no screen time whatever the preferred option. Ontario's curriculum for online leaning requires kindergarten kids to be online for 180 minutes daily which Dr.Cheng considers "unprecedented" in time volume.
 
Siblings practice yoga for children with a classroom programme broadcast national television
UNICEF/UNI314054/Klincarov
Twins Maksim and Jan (5) practice yoga for children in their home following along with TV-classroom programme broadcast on national television.
 
According to Dr.Cheng, excessive screen time detracts children from basic needs required for mental wellness which includes face-to-face interactions, adequate sleep, physical movement, and quality time spent immersed in natural surroundings, along with a sense of belonging, purpose and hope. Yet fast-paced video games like Fortnite or Call of Duty, quick and addictive sources of dopamine satisfies the rush brains crave which can lead to hyper-arousal, interfering with a normal lifestyle; taking the place of a normal lifestyle.

Dr.Cheng dreams of possible solutions to this modern-day, COVID-complicated dilemma, imagining the utility of going cold-turkey, for a complete detoxification. Reasonably, the good doctor recommends "gentle nudges" to pry and persuade children from their smartphones by setting screen curfews and enforcing bedtime rules. Limiting who and what a child sees online is a parental responsibility. He eschews social media like Facebook and Instagram for children, pursuing "likes". At the same time he recognizes screens represent a mode of connecting with others at a time of isolation.
"Obviously you don't want your kids spending all their time looking at a screen, but the world they're growing up in is a virtual one. It's going to be a fight they'll have their entire lives, that battle of algorithms that's trying to make them keep clicking versus trying to maintain their own well-being."
"My eyeballs are getting cooked by the screen as much as anybody else's. It's a new way of life to learn how to navigate and there's not a lot of guidance for parents. It's one giant social experiment with everybody anyway."
Dennis Murphy
Child practices the alphabet on a tablet at home
UNICEF/UNI316266/Bajornas
Margot, 4, practices the alphabet on a tablet at home rather than being at daycare with her friends, with the city largely shut down as a prevention measure against the further spread of coronavirus

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Thursday, January 28, 2021

Delineating Death

"However, transient resumption of cardiac activity did occur, which suggests that the physiologic processes of somatic [bodily] death after removal of life-sustaining measures occasionally include  periods of cessation and resumption of cardiac electrical and pulsatile arterial activity."
"With the heart being an organ that is strong and robust, the idea that it pauses before finally stopping is actually quite reasonable, physiologically, and probably not unreasonable for us to expect it does so."
DePPaRT Study, New England Journal of Medicine
Dr. Sonny Dhanani   Photo: Jean Levac/Postmedia
"People don't die right away."
"One of the fundamental principles of organ donation is that you must be dead to donate. We wanted to provide scientific evidence ... that one is dead before donation."
"I think  if doctors and nurses are aware that this [cardiac activity restarts] can happen, that they'll expect it, they'll counsel families."
Dr.Sonny Dhanani, critical care physician, chief, critical care, Children's Hospital of Eastern Ontario, Ottawa

 

"It's not unusual to see a flatline on the electrical tracing of the heart, followed by electrical beats, or a minute or so where there was no heartbeat, and then a heartbeat, again."
"But this is why this research was important. It helped confirm that this event can occur, but it also provides reassurance [under the current five-minute rule that] the duration of time is satisfactory."
"That somebody, when they have their organs recovered, is truly dead."
Dr.Christopher Doig, head, critical care medicine, University of Calgary
When life support is withdrawn, the process commences with the heart contracting with vigor as it is gradually starved of blood and oxygen while muscle cells begin to die off, and blood pressure drops; all of which contribute to the heart going into cardiac arrest. No longer does the brain receive blood and oxygen, nor do other organs. All the while monitors inform doctors in attendance; the catheter in the radial artery to measure blood pressure, and five sticky pads with electrocardiogram leads on chest and abdomen as second-by-second monitors record signals of a pulse, blood pressure or electrical heart activity. These monitors measure death.

 Dr.Dhanani and co-authors of the study they have named DePPaRT -- Death Prediction and Physiology after Removal of Therapy study -- as morbidly serendipitously contrived a naming as can be imagined -- monitored heart rate, blood pressure and oxygen saturation levels in over 600 people who had undergone the withdrawal of life support. From the very time that breathing tubes and heart-supporting medications were withdrawn to a full thirty minutes following death-declaration, they were fixated on their goal; to define when death occurs.

In 14 percent of instances the researchers discovered the heart stopped and then spontaneously restarted in brief bursts of cardiac activity to evince a heart beat, a pulse. This phenomenon occurred between 6.4 seconds and four minutes and 20 seconds, intervals identifying the variance in presentations following 'pulselessness' in various dying patients. From among the entire group of some 600 subjects, none among them regained consciousness or survived beyond this end-of-life event, though the rare occasion when some do is well known.

Among all those studied no circulation restarted, and when the heart did finally stop, it was forever. None among them experienced their heart spontaneously begin beating again and continue to beat as has occurred rarely in those who have been pronounced dead once CPR ceased. What the study succeeded in doing was to validate the "no touch" rule currently in use in Canada; the obligatory five-minute wait once the heart stops, prior to definitively declaring death leading to the harvesting of the heart for an organ donation. Elsewhere, such protocols of wait-times vary from two to ten minutes.

There are over four thousand people awaiting a heart transplant to save their futures, in Canada. Dr.Dhanani's concern revolved around an lack of accepted uniformly of organ donations linked to fears of  "stories, unrelated to organ donation, about people coming back to life following a determination of death." And that determination can be decided as brain death when medical and legal death is accepted while the heart still beats, or circulatory death; the irreversible loss of heart function. Some 30 percent of organs derive from circulatory death donors, the remainder from brain death.

A precise choreography of response-and-action takes place in sequence with organ donation where doctors wait the minimal time for certainty that circulation loss is permanent before declaring death, bearing in mind that time is of the essence and not a moment longer must lapse before that declaration to ensure that the organ does not deteriorate from blood flow stoppage.

Sixteen adult ICUs in Canada, three in the Czech Republic and one in the Netherlands represented sites of study involving 631 patients whom a catastrophic illness or accident had stricken and where grieving families had agreed to their loved ones' vital signs being recorded for study purposes after removal from life support. In the study, death following cardiac arrest was declared from one minute following withdrawal of life support to as long as 11 days, five hours and 54 minutes with the median time being 60 minutes.

Unassisted resumption of heart activity was detected in 13 people by doctors and staff in the ICU. The researchers studying the data provided by the monitors identified a stop, and then a restart in 67 of 480 people using complete waveform data. A total of 30 people showed a return of cardiac activity in zero to three percent after life support withdrawal, with the longest duration of no pulse before heart activity resumed at one minute and 42 seconds. Another surprise for the researchers was the realization that electrical activity of the heart can continue for minutes once blood pressure ends.

Picture of the Heart and Great Vessels in Heart Transplant
Picture of the Heart and Great Vessels in Heart Transplant   MedicineNet

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Wednesday, January 27, 2021

Hope for Spinal Cord-Injured Patients

A hand picking up a tiny bead
Marcus Donner/Center for Neurotechnology
"As a rehabilitation physician, my experience was that there was always a limit to how much people would recover."
"But now it looks like that's changing. It's so rewarding to see these results."
Dr.Fatma Inanici, lead author, research, University of Washington 

"Both people [in the study] who had no hand movement at the beginning of the study started moving their hands again during stimulation, and were able to produce a measurable force between their fingers and thumb."
We're seeing a common theme across universities -- stimulating the spinal cord electrically is making people better."
Chet Moritz, associate professor of electrical and computer engineering, rehabilitation medicine and physiology and biophysics, University of Washington
A timeline blocking out the treatment plan for each month of the study
 
Participants in a new study out of the University of Washington have seen significant improvements in their mobility with a five-month exposure to physical therapy and spinal cord electrical stimulation. The complete mobility impairment that results from spinal cord injury devastates lives; victims are unable to engage in simple taken-for-granted tasks like eating or drinking on their own; they become completely dependent physically on vital daily assistance to aid in ordinary life-tasks.

Spinal Cord Injury B.C. estimates there are 85,556 people in Canada whose physical decline has resulted from spinal cord injury, with no cure for the condition. Typically, patients take part in exercise therapy in hopes of improving motor function, while previous research has indicated that implanting a stimulator to deliver electric current to a damaged spinal cord could offer help to paralyzed patients in their goal to recover mobility.
 
Two researchers watch as a participant squeezes a device to test his grip strength
Chet Moritz (left) and Fatma Inanici (center) observe as a participant (right) measures grip strength (by squeezing the device in his hand). The participant has sensors on his arms (black cases) to measure his arm muscle activity during the task. Note: This photo was taken in 2019.  Marcus Donner/Center for Neurotechnology
 
Researchers at University of Washington have gone one step further in a bid to accelerate the drive toward success in restoration of a measure of mobility for those with spinal cord injuries. A non-surgical therapy with the use of patches to stick to the skin like a Band-Aid delivers electrical pulses to the injured area. Their study, operational for five months, recruited six people with spinal cord injuries among whom some were able to move fingers and thumbs, and others possessed no mobility at all.

Researchers monitored baseline limb movement in the first four weeks of the study, moving on to include intensive physical therapy for the second month, training three times weekly for two hours. In the third month physical therapy was combined with Transcutaneous Electrical Spinal Cord Stimulation. The last two months of the study saw participants grouped in the severity of injuries where those with less severe injuries received an additional month of training followed by a month of training in combination with stimulation.
 
The participants with more severe injuries saw their training combined with stimulation followed by training alone, and while some participants regained some level of hand function during training alone, all six participants realized improvements when stimulation was combined with training. Participants moreover, maintained improvements, able to resume hobbies some three to six months following treatment. 

What turned out to be equally if not more encouraging was that some participants saw improvements in other health areas including achieving normal heart rate, improved body temperature regulation and in bladder function.

A researcher attaches small round patches to the back of a participant's neck
Fatma Inanici applies small patches that will deliver electrical currents to the injured area on a participant’s neck.    Marcus Donner/Center for Neurotechnology

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Tuesday, January 26, 2021

China's Contractual Obligations

Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
This randomised, double-blind, placebo-controlled, phase 2 trial of the Ad5-vectored COVID-19 vaccine was done in a single centre in Wuhan, China. Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate and were randomly assigned to receive the vaccine at a dose of 1 × 1011 viral particles per mL or 5 × 1010 viral particles per mL, or placebo. Investigators allocated participants at a ratio of 2:1:1 to receive a single injection intramuscularly in the arm. The randomisation list (block size 4) was generated by an independent statistician. Participants, investigators, and staff undertaking laboratory analyses were masked to group allocation. The primary endpoints for immunogenicity were the geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses. This study is registered with ClinicalTrials.gov, NCT04341389.
CanSino Biologics, China   The Lancet
Courtesy of CanSino Biologics

China-based CanSino Biologics is the brainchild of Yu Xuefeng, who studied in Canada and earned his doctorate at McGill University. He later was in the employ of Sanofi Pharmaceutical based in Toronto and eventually returned to China where he launched his vaccine business. His links to Canada gained him an insider status. The National Research Council agreed to allow the use of a Canadian-created cell line to aid in the development of a vaccine first for Ebola and following that, SARS-CoV-2. 

For reasons known only to Canada's prime minister an agreement was signed with CanSino for collaboration in the development of a COVID vaccine, at a time when relations with Beijing were beyond  strained and bad faith was redolent and in full view when the Chinese Communist Party launched its hostage diplomacy initiative by arresting and charging two Canadians in China with security breaches endangering China, and then initiating a trade war. 
 
Canada been burned in the past when dealing with China when Chinese technologists were hired to work for Canada's then-telecommunications giant Nortel Networks attaining positions of trust enabling them to lift trade secrets for their own, and Chinese hackers infiltrated and gained access to Nortel's top executive accounts spiriting away additional Nortel data which eventually helped lead to the company's demise but gaining China's telecommunications industry through Huawei where former Nortel employees worked, the edge they looked for, linked with China's military.

Once again the trusting Canadian government of Prime Minister Justin Trudeau who was personally transfixed with the notion that Canada would benefit hugely by association with China, in lucrative trade deals and investment, laid itself open to expropriation of Canadian technical and scientific expertise, signing a contract with CanSino to test their vaccine at Dalhousie University in conjunction with the National Research Council, which could produce samples of the vaccine. A vaccine which never arrived in Canada, as per the agreement.
Inside the CanSino Phase 3 COVID-19 vaccine trial at Pakistan’s Shifa Hospital
A general view of Shifa International Hospital in Islamabad, Pakistan where a Phase 3 trial of CanSino's COVID-19 vaccine is undergoing trials. (Reuters)
 
A vaccine that Beijing refused to allow entry to Canada, while shipping it off elsewhere for testing. "In June, the vaccine (based on the Canadian cell line) was approved for use by Chinese military forces. As for the rights to the cell-line, a comment to Global News from Innovation, Science and Industry Minister Navdeep Bains was 'The NRC (National Research Council) retains the intellectual property related to the cell line, while CanSino in turn owns all intellectual property rights for the vaccines it develops.' Canada cannot claim any revenue if the vaccine proves successful", wrote Radio Canada International journalist Mark Montgomery.

"What exactly motivated Canada to enter into such an unstable partnership in the first place given the dire state of Canada-China relations and the scandalous history of China's vaccine industry?" questioned science writer Iris Kulbatski in the health-care journal Healthy Debate. She quoted Margaret McCuaig-Johnston, former assistant deputy minister in charge of Canada's vaccine collaboration with Beijing, that China's history of creating customs 'obstacles' in any trade disagreements, as leverage was well known.

"McCuaig-Johnston further said that 'China's success in vaccines is standing on the back of Canadian researchers and scientists. Over the years we helped China develop its capacity. But China is no longer a reliable partner." There is, in fact, nothing new about China's penchant for infiltration, sabotage and subterfuge along with the stealth mining of technological and scientific data originating elsewhere, than the ill-gotten gains used by China to further its own interests. 
 
This is merely one more instance in a long history of unprincipled looting of other nations' research and development. With China taking the short-cut route to using others' intellectual property, parading it as their own, and reaping the financial benefits thereof. The question remains: why would this Canadian government see fit, all this being well known, to engage in a contractual agreement with a country that cannot be trusted, with a pharmaceutical company that has direct links to the People's Republic of China's Military?

https://static.reuters.com/resources/r/?m=02&d=20201221&t=2&i=1545302862&r=LYNXMPEGBK0Y0&w=1600
Vials of a COVID-19 vaccine candidate, a recombinant adenovirus vaccine named Ad5-nCoV, co-developed by Chinese biopharmaceutical firm CanSino Biologics Inc and a team led by Chinese military infectious disease expert, are pictured in Wuhan, Hubei province, China. China Daily via REUTERS

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Monday, January 25, 2021

Safe Freedom to Drive for the Elderly

"A society in which the elderly can drive safely is crucial for their active social participation and healthier, fuller lives."
"Our ultimate goal is, of course, to have zero casualties from traffic accidents."
Toyota Motor Corp., Japan

"It would be impossible to eradicate all fatal accidents without utilizing artificial intelligence."
"It's [EyeSight technology] a technologically tough area [to place stereo cameras in mass produced vehicles]."
"Equipping the technology in cars that people ordinarily use is a huge task."
Eiji Shibata, Subaru Motors, Japan

"Anyone can cause an accident."
"I don't want to see divisions like the young and the elderly hating each other."
"We need to think about the people who are suffering: the elderly in rural areas."
Takuya Matsunaga, Tokyo
An woman boards a taxi in Tokyo, Japan, on Tuesday, July 9, 2019. Japan’s wages dropped for a fifth month, according to Japan's Ministry of Health, Labour and Welfare, adding to concerns over the resilience of consumer spending as a sales tax increase approaches in October. Photographer: Kiyoshi Ota/Bloomberg
Bloomberg 
 
In April of 2019 Takuya Matsunaga's wife and his toddler died, and several other people were injured when a Toyota Prius driven by a senior retired public servant plowed through a crossing. The former senior bureaucrat, 89, was on his way to a French restaurant with his wife in Ikebukuro district when the accident occurred. The driver appeared in court recently pleading not guilty. The accident aroused so much public backlash that a debate on the national stage arose with respect to the growing ranks of elderly drivers on Japan's highways.

The latest rear-view cameras give 180 degree back views.
Close to 30 percent of the Japanese population is age 65 and above. Increasingly, accidents involving older people driving vehicles has placed pressure on regulators to have advanced safety driving features in vehicles standardized and all new vehicles sold domestically will be required to have automatic braking systems beginning 2021. Carmakers such as Toyota Motor Corp. and Nissan Motor Co. are emphasizing smart technology for their products to be more user-friendly for older people.

Following the accident for which Japanese prosecutors indicted Kozo Iizuka on a charge of negligence resulting in death and injury, elderly Japanese began in droves to stop driving and according to the National Police Agency, 350,428 people 75 and over returned their driver's licences in that year, the highest on record. "Young people tell us seniors to return our driver's licences, but they aren't around", 90-year-old Hideaki Fukushima complained.

He and his wife live in Takamori, a small town in the central mountainous areas a two-hour drive from Nagoya where their children live. Central Japan Railway Co. trains are scheduled once-hourly. "There's nothing you can do without a car", observed Mr. Fukushima. And so with these elderly people and the mass of others like them in mind, Toyota upgraded its Safety Sense features last year, technology designed to prevent or mitigate frontal collisions; which also keep drivers in their lane.

High resolution cameras on the windscreen, and bumper-mounted radar can detect oncoming cars or pedestrians in daylight hours -- even bicycles -- with audible and visual alerts. Should drivers fail to respond, automatic braking may come into play. Intersection functionality is part of the new software, assisting with the detection of oncoming obstacles when cars turn from a stationary position.

One of Honda's Kei cars on a Tokyo street.
One of Honda's Kei cars on a Tokyo street
Correction of unintentional lane departures, automatic toggling between high and low beam at night depending on surrounding traffic, and the detection of slower-moving vehicles on a highway ahead, along with automatic maintenance of a pre-set distance, comprise other Toyota Safety Sense features. Stop and speed signs are detected by road-sign assistance technology as the vehicle passes, displaying a dashboard alert should drivers have missed the signs themselves. 

Subaru Corp. has stated its intention to help eliminae all fatal accidents by 2030 and it too is making use of stereo cameras with two or more lenses and a separate image sensor for each. This presents as a feature to capture three-dimensional images; EyeSight technology that looks ahead and alerts drivers to potential danger. According to Subaru, its EyeSight-equipped vehicles see 61 percent fewer rear-end crashes -- and pedestrian-related injuries are diminished by 35 percent.

Prototype Subaru Levorg vehicles equipped with the company's EyeSight driving support system are driven during a test in 2017. | BLOOMBERG
Prototype Subaru Levorg vehicles equipped with the company's EyeSight driving support system are driven during a test in 2017. | BLOOMBERG

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Sunday, January 24, 2021

Vaccine Hesitancy versus Vaccine Envy in the Medical Community

"I've never had people request a photo when they've gotten a vaccine before. I think it points to how terrible the pandemic has been and what a historic moment it is ... I'll be very excited and enthusiastic for when my turn comes up."
"One of the personal support workers I was vaccinating said her mom who lives in the Philippines was  told by her local public-health official that she wouldn't be getting it [inoculated] until 2023."
Monika Winnicki, dermatologist, Toronto, vaccine volunteer administer
 
"When we are on the front lines and seeing, on social media, vaccinations being given to child psychiatrists doing Zoom meetings or doctors on maternity leave ... it gives us the message that we've been forgotten."
Alan Drummond, emergency physician, Perth, Ontario
 
"I feel like the urban centres are getting covered. I feel like rural Canada is being missed."
"Every time I see a friend posting, I'm happy for them but feel incredibly anxious."
"We were told [a vaccine] is three months away. There is no vaccine rollout where I'm working -- no one has received a vaccine."
"I'm just disappointed. My hospital covers several different communities and there are outbreaks and we definitely see COVID-positive patients ... Rural lives matter too." 
Sarah Giles, rural family and emergency physician, Kenora, Ontario
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Photo: Michelle Morais
"As selfies continued to show up, the emotions turned a little bit complex. I caught myself in a more envious state, and then feeling guilt around feeling envy."
"It's never about individuals; it's more about feeling [the rollout] should be going faster than it is."
"I think it's a normal feeling. But I think it's important to acknowledge the feelings of envy and guilt."
Audrey Marcotte, emergency medicine resident, Montreal

"We haven't really seen a ton of cases ... My life hasn't really changed a whole lot in the past year ... I've had Thanksgiving and Christmas dinners with my family. Birthday parties have been celebrated."
"I haven't posted anything for fears of how it would make my deserving colleagues who haven't gotten theirs yet feel. Seeing their anxiety on social media has made me realize that posting a picture ... might not help their morale."
Aleisha Murnaghan, emergency doctor, Charlottetown, P.E.I.

"When Ontario Public Health put out its guidelines for vaccinations, they excluded pregnant and lactating women."
"About eight to 11 percent of pregnant women who acquire COVID19 will end up sick enough to be admitted to hospital, and two to four percent end up in ICU with severe complications, including being on a ventilator for weeks to months and [with] long-term effects from COVID."
"The risk for non-pregnant women is one to two percent by comparison, so we're looking at a two to four times higher rate of severe disease in the unvaccinated."
"Pregnant doctors are posting to show people that they feel it's safe enough to get it themselves."
Constance Nasello, chair, Ontario Society of Obstetrics and Gynaecology
In a sense, the medical community, comprised of individuals from all backgrounds and beliefs and walks of life in their private lifestyles is no different than the general public in their concerns, their likes and dislikes ,their distrust of systems. People from outside the medical community likely think that those within it have some kind of insider knowledge and confidence the general public lacks. A general public among whom a substantial contingent of people view the prospect of being vaccinated askance, not willing to trust medical science when it says the vaccines are safe and effective. 

People in the medical community have their own groups of medical professionals unwilling to chance taking a vaccine they feel has been inadequately tested and researched, much less the time it has taken to develop the vaccine; they view it with distrust. So much for being a medical insider; those job descriptions don't automatically come with an app to instill confidence and trust. And so, from within the medical community itself a campaign was initiated to persuade their unwilling collegial peers that all is well -- look, I've taken the vaccine and I'm fine!

Image
Photo: Michelle Morais
As part of their convincing campaign, medical personnel have been taking selfies of having their vaccination and posting them on social media sites for the benefit of their colleagues in medical practise. And those selfies have garnered some surprising results. One emergency doctor in Vancouver who happens also to be an outstanding athlete was amazed to see her vaccine selfie acquire more likes than a Facebook post showing her finishing an Ironman competition. "I think it speaks to how everyone is looking forward to the light at the end of the tunnel".

There are, however, critics of the vaccine-selfie campaign, those who feel the new social media campaign has been the cause of anxiety, envy and frustration at a time that many physicians still await their turn in a slow-motion rollout across the provinces. Dr.Drummond the emergency physician in Perth as an example, feels the postings to be "tiresome" and "demoralizing". 

Dr.Giles in Kenora has had experience working with Doctors Without Borders in Sierra Leone, Pakistan, South Sudan and Myanmar and her concern is the effect the vaccine postings of photographs may have on people living in lower-income countries: "My friends in those countries are not posting vaccines selfies", she said of countries where vaccines are not in circulation and most certain not to be for years to come in an unequal world of access and non-access. 

Many other doctors are convinced the selfies have a useful purpose; to educate and motivate those who remain vaccine-hesitant within health care to be convinced inoculations are the best course of action for themselves personally, their families and their communities at large. "There's a lot of mistrust and conspiracy theories around 'Big Pharma'", explained Jennifer Chu, a St.Michael's Hospital emergency physician in Toronto. "A lot of people also don't understand how drugs are made and think that the vaccine can't be safe because it was rolled out so quickly."

In Canada, the South Asian population is notorious from within the medical community for its suspicion of vaccinations. Kashif Pirzda, a Toronto emergency doctor who works with Canada's South Asian COVID Task Force, posted a selfie with captions in Hindi and Urdu meant to turn the situation of false information around. "Usually the same claims will come up, such as that the vaccine will change your DNA, or that it hasn't been properly tested, or that it contains pork products, which would make it forbidden for Hindus or Muslims", he said.
 
As well, a situation of vaccine hesitancy has emerged among health-care workers at long-term care facilities where some centres in Ontario see vaccination rates of a mere 20 percent. Since many of those workers are of South Asian heritage working with vulnerable elderly and infirm residents, it's critical for them to accept inoculations. 
"I think we have an obligation as medical experts to spread sound medical knowledge and facts to our non-medical friends and family."
"I think the time to address and remove vaccine hesitancy is now ... as physicians, we are highly mindful of staying in our own lane when it comes to various societal issues."
"This is our lane."
Kavitha Passaperuma, oncologist, Richmond Hill, Ontario

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Saturday, January 23, 2021

Patience, People, Patience

"This review is being done through a rolling submission, where data is submitted by the manufacturer and reviewed by Health Canada as it becomes available." 
"Additional data to support the quality, safety and efficacy of the vaccine are needed before a decision can be made."
Eric Morrisette, spokesperson, Health Canada

"There is a large AstraZeneca study that's ongoing in the United States, and we still are expecting to get some information from that study that's almost 40,000 participants."
"We're working very closely with our international partners, but there's still some questions to be sorted through before we make a final decision."
Dr.Supriya Sherma, chief medical adviser, Health Canada

"Health Canada is doing the right thing by clearly taking their time to evaluate the vaccine. They've got it right. There should be no external pressure and no political interference."
"That study [by AstraZeneca] was actually conducted in a very sloppy manner, and reported in a very sloppy manner."
"These vaccines will only work if people take it and if people don't have trust in the product, they're not going to take the vaccine."
"Even if we don't get access to AstraZeneca, and even if we hypothetically don't get access to Johnson & Johnson, we'll have enough vaccine between Moderna and Pfizer to vaccinate all of Canada."
Dr.Isaac Bogoch, infectious disease physician, member Ontario Vaccine Task Force
Area chart showing global cases. Updated 22 Jan 
 
Have patience, all will be well. Eventually, orders that the Canadian federal government placed with various promising sources to enable the provinces to vaccinate all Canadians willing to receive the inoculations, will come to pass. Of course, there's that little irritating matter of people dying in the meanwhile,awaiting that relief, but that's evidently another story altogether. On the positive side, the vaccines developed, tested and approved contested the theory that under normal circumstances such a process takes years to come to fruition.

On the negative side, the very speed with which brilliant scientists were able to knit together new biotechnologies to produce effective and safe vaccines is troubling to many who find it difficult to credit that pharmaceutical companies were able to pull off a feat of this magnitude safely and effectively. So apart from the anxiety perturbing the public, and the mental strain involved in what seems to be an interminable wait for rescue from the nightmare of the novel coronavirus, we come back to its victims, countless lives lost, countless others whose lives will be forever changed.

Oh, wait, not 'countless' at all. For in very fact, up to the moment the world is poorer by 2,130,293 million deaths, with 99,321,020 million global infections. As for Canada, it is not among the countries whose infection and death toll have been stupendously incalculable. It's just that -- let's see -- every case is another burden on the health care system, and each death is a tragedy. Canada's statistics stand at 742,531 infections and 18,994 deaths to the present time. Relatively minor in comparison to the numbers reflecting cases and deaths in the United States just across the border with its 25,566,789 million infections and 427,636 deaths.

Canada is largely dependent for the time being on two U.S.-based pharmaceutical companies, Pfizer, linked with its German partner and Moderna, both of which represent the only two vaccine producers whose product has been approved by Health Canada. Yet at this stage in the inoculation process both products are in short supply, with Pfizer advising a complication in one of its facilities impairing production and now AstraZeneca too, recently approved for use in Britain and India has stated that its production has run into difficulties.

Health Canada has no firm timeline for a decision to be made for either AstraZeneca or Johnson & Johnson, both of whose vaccine products are being evaluated. The latter has provided Health Canada with safety data up to the present but has nothing yet to report on efficacy despite a large clinical trial underway and results expected to be released within weeks. Its one-dose vaccine, if proven to be both safe and effective will simplify the storage, distribution and vaccination process considerably.

As for AstraZeneca, its product developed with Oxford University has more relaxed storage requirements than Pfizer-BioNTech's vaccine and its production can be accommodated in more facilities around the world; India in fact produces a huge output of the AstraZeneca vaccine under a different name, and is using it internally, as well as making it available elsewhere to benefit its neighbours. AstraZeneca estimates it has the potential to produce three billion dozes of its vaccine.

The fly in its ointment as a vaccine success is the questionable results that came out of a clinical trial late in 2020, with a dosing error where a number of participants received two full doses while others were given a half-dose combined with a full dose. The vaccine was shown to be 70 percent effective in preventing people from developing COVID, but a second trial was started due to the error, to gather additional data.
 
According to Steven Kerfoot, associate professor of immunology at Western University, the problem with AstraZeneca's trial was its incomplete state: "And so the expectation from Canada's understanding is that they want to see a complete trial with efficacy and safety data built in. These [manufacturing issues and trial errors] are all things that happen with all drugs. And none of it, you can think of as unexpected".
 
"We like to think of all medicine as being medicine for us individually, but vaccines are really best thought of as medicines for the population as a whole", he explained. While Pfizer and Moderna's candidates were over 90 percent effective in preventing people from becoming ill from the virus, should the new vaccines prove even 70 percent effective, they will provide a high level of protection within any population, he stressed.
Map shows doses administered per 100 people. Updated 22 Jan. 


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Friday, January 22, 2021

Unscrupulous China ... Naive Canada

Prime Minister Justin Trudeau needs to tell Canadians why his government signed a deal with China-based CanSino Biologics in the first place.
"Trudeau inherited a naive affection for China's dictatorship that devolved into craven passivity in the face of blackmail."
"What else can explain his willingness to work with Tianjin-based CanSino Biologics on a COVID vaccine, given our highly contentious relationship with China and while the two Michaels [arrested on specious charges of espionage days after Huawei's CFO Meng Wanzhou was taken into custody by the RCMP on an American extradition warrant] languish in jail? The deal collapsed when Chinese authorities blocked exports of vaccine to Canada."
"The government pursued a controversial, and now delayed, $170-million initiative with a National Research Council lab that was supposed to be ready last November. Industry players were rightly skeptical and believed a better approach would have been to fund private-sector companies like bio-manufacturer PnuVax Inc or clinical-stage biopharmaceutical Medicgo, both located in Quebec."
Joe Oliver, former Conservative Minister of Finance, Canada
"The result is that the vast majority of Canadians will have to wait many months to get protection from the rampaging coronavirus. And it's all because Canada has a prime minister who's lacking in good judgement, a health minister without health expertise, a procurement minister who was a law professor and a recently departed foreign affairs minister who borrowed $1million from a Chinese bank and then thought better of it when the information became public."
"Getting vaccines for all Canadians was a moral obligation. To rely on an unscrupulous, sworn enemy like China to provide vital supplies is just asking for trouble."
"Canadians deserve answers as to why this has happened, and so do the country's premiers, who run our health-care system."
Diane Francis, columnist, Financial Post
A researcher works in a lab at Chinese vaccine maker CanSino Biologics in Tianjin, China in November 2018. A collaboration between CanSino and the National Research Council of Canada to run the first Canadian clinical trials for a possible COVID-19 vaccine has been abandoned. (Reuters)

Canada, a first-world, technologically advanced country until the SARS-CoV-2 virus causing     COVID-19 became an international menace to life and the wealth of nations, is in the grip of an devastating beast of a virus that has clamped down on a population awaiting the rescue of inoculation against its predatory presence. Each day that lapses without the ability to vaccinate as many people as possible is a day the virus advances, infecting and killing greater numbers of Canadians. The desperate need to create a safe health environment for the country has never been greater.
 
Yet the poor judgement of the federal government has made it clear that while other countries in the same position as Canada -- with equal access to necessary resources, made more practically resolute and intelligent decisions to arm themselves with vaccines as soon as they passed their final trials and were given regulatory approval for public use -- are now inoculating the most vulnerable segments of their populations against the virus sweeping the globe.
 
At present, while other countries forge ahead with their vaccination programs, in Canada a tad over one percent of the country has received one dose of a vaccine requiring two separate doses for ultimate safety. Canada's former finance minister under a previous government and a pharmaceutical industry expert have laid out a case for placing the responsibility where it belongs -- the decision-making of the current Prime Minister of Canada, Justin Trudeau. While Mr. Oliver is front and centre, the industry expert, highly placed, speaks on condition of anonymity in defence of his position.
 
It is his contention that it is no mere urban legend making the rounds in his industry and echoing in political circles, that a Chinese businessman who has the prime minister's confidence persuaded the suggestible Trudeau that Canada would do well to buy its vaccines from China. Convinced, Trudeau proceeded to order  the vaccine, signing a contract with CanSino which had a previous Canadian connection, rather than turning to American pharmaceutical companies. The agreement with CanSino was of a partnership between it and the National Research Council for testing of the final vaccine.
 
When the time arrived for the vaccine to be delivered to Canada to allow for the testing to commence through the National Research Council, Chinese authorities extended an ultimatum; the freedom of Meng Wanzhou in exchange for the vaccines. Which translated to the end of the contract signed in naive good faith in the expectation that a contract is a contract. The non-receipt of the vaccine left Canada without defences, and it quickly turned to reliable sources in the west.
 
The fly in that remediative ointment was that the line-up to acquire vaccines was growing longer day by day and Canada's place was at the very end of it. This, in any event, is the pharmaceutical industries' reading of events surrounding the manner in which the Trudeau government handled the urgency of acquiring vaccines. Former Foreign Affairs Minister Francois-Philippe Champagne who was tasked with moving the Canada-China-relations file forward along with Prime Minister Trudeau are both proteges of former Prime Minister Jean Chretien, a notorious China appeaser. 
 
 CanSino Biologics in China. (Reuters)
Canada was a loser with this contract, but China was not:The failed collaboration was based in part on the National Research Council agreeing to provide CanSino with a license to use Canada’s proprietary biological product HEK293, a line of cells that CanSino had previously used with the Chinese military to develop a vaccine for the Ebola virus. CanSino is linked to the People's Liberation Army of China; a clear warning that anything could go wrong. CanSino's CEO, Chinese scientist Dr. Xuefeng Yu, was educated at McGill University in Quebec and had worked for Sanofi Pasteur, before returning to China.  
"A vaccine is the most powerful weapon to end the novel coronavirus."
"If China is the first to develop this weapon with its own intellectual property rights, it will demonstrate not only the progress of Chinese science and technology, but also our image as a major power."
CanSino’s military partner, Major General Chen Wei 

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