Tag Archives: ‘offered

White House staffers working close to Trump, Pence to be offered early COVID-19 vaccine access

Senior U.S. government officials, including some White House officials who work in close proximity to President Donald Trump and Vice-President Mike Pence, will be offered coronavirus vaccines as soon as this week, while its public distribution is limited to front-line health workers and people in nursing homes and long-term care facilities.

Doses of the newly approved vaccine from Pfizer-BioNTech will be made available to those who work in close quarters with the country’s top leaders, two people familiar with the matter confirmed. They said the move was meant to prevent more COVID-19 spread in the White House, which has already suffered from several outbreaks of the virus that infected Trump and other top officials, and other critical facilities.

It was not immediately clear how many officials would be offered the vaccine initially and whether Trump or Pence would get it.

The Trump administration is undertaking the vaccination program under federal continuity of government plans, officials said.

“Senior officials across all three branches of government will receive vaccinations pursuant to continuity of government protocols established in executive policy,” said National Security Council spokesperson John Ullyot. “The American people should have confidence that they are receiving the same safe and effective vaccine as senior officials of the United States government on the advice of public health professionals and national security leadership.”

A nurse administers the Pfizer-BioNTech vaccine in London, U.K., on Tuesday. (Frank Augstein/AP)

The two people spoke on condition of anonymity because they were not authorized to discuss the matter publicly. The New York Times first reported the news.

The move to vaccinate top U.S. officials would be consistent with the rollout of rapid testing machines for the coronavirus, which were similarly controlled by the federal government with kits reserved to protect the White House complex and other critical facilities.

According to guidance from the U.S. Centers for Disease Control and Prevention, there is not yet enough information to determine whether those who have had COVID-19 should also get the vaccine. Pence has not come down with the virus, and his aides have been discussing when and how he should receive the vaccine as the administration looks to boost public confidence in the shot.

The Pfizer-BioNTech vaccine requires two doses administered three weeks apart, meaning Trump administration officials would receive the final shot just weeks before leaving office.

WATCH | Small players will play big roles in ‘cold chain’ of vaccine delivery:

On both sides of the border, small companies are taking on a big role in helping perfect the cold chain to keep the Pfizer-BioNTech COVID-19 vaccine cold enough for safe delivery. And one key component is making sure there’s enough dry ice to keep the vaccine cold enough. 2:06

The Trump administration’s vaccination plan could prove to be a boon for his successor, as aides to President-elect Joe Biden have been discussing when and how he should receive the vaccine and working to establish plans to boost virus safeguards in the West Wing to keep the 78-year-old Democrat healthy.

The White House vaccinations come as Trump and his aides have consistently flouted the COVID-19 guidelines issued by his own administration, including hosting large holiday parties with maskless attendees this December.

According to a Capitol Hill official, lawmakers have not been informed how many doses would be made available to them, adding it would be premature to speculate who might receive them. The official was not authorized to discuss it publicly and spoke on condition of anonymity.

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CBC | World News

Trump asked China to help him win in 2020, offered ‘favours to dictators,’ John Bolton says in book

In a withering behind-the-scenes portrayal, U.S. President Donald Trump’s former national security adviser John Bolton accused him of sweeping misdeeds that included explicitly seeking Chinese President Xi Jinping’s help to win re-election.

Bolton, a longtime foreign policy hawk who Trump fired in September over policy differences, also said that the U.S. president had expressed a willingness to halt criminal investigations to give “personal favours to dictators he liked,” according to a book excerpt published in the New York Times ahead of its release.

Trump hit back at Bolton, calling him “a liar” in an interview with the Wall Street Journal. The paper also published excerpts Wednesday of the book, titled The Room Where It Happened: A White House Memoir, as did the Washington Post.

Trump told Fox News in a separate interview that Bolton had broken the law by including highly classified material in the book.

Together, the excerpts portray a U.S. president mocked by his top advisers and who exposed himself to far more extensive accusations of impropriety than those that drove the Democratic-led House of Representatives to impeach Trump last year.

WATCH | Bolton’s book claims Trump is uninformed, White House is in chaos:

According to several U.S. media reports, John Bolton’s new book alleges that U.S. President Donald Trump is uninformed and all his decisions were made with the 2020 presidential election in mind. 2:00

The Republican-led Senate acquitted Trump in early February. Trump was accused of withholding U.S. military aid last year to put pressure on newly elected Ukrainian President Volodymr Zelensky to provide damaging information on Democratic political opponent Joe Biden.

“Had Democratic impeachment advocates not been so obsessed with their Ukraine blitzkrieg in 2019, had they taken the time to inquire more systematically about Trump’s behaviour across his entire foreign policy, the impeachment outcome might well have been different,” Bolton wrote, according to excerpts in the Wall Street Journal.

Critics of Bolton note he declined to testify before the House inquiry when his disclosures could have been critical.

Representative Adam Schiff, the California Democrat who led the prosecution of Republican Trump, slammed Bolton for saying at the time that “he’d sue if subpoenaed.”

“Instead, he saved it for a book,” Schiff said on Twitter. “Bolton may be an author, but he’s no patriot.”

Still, Bolton’s allegations provide new ammunition to critics ahead of the Nov. 3 presidential election, including his behind-the-scenes accounts of Trump’s conversations with China’s Xi — which, in one case, broached the topic of the U.S. vote.

“Trump then, stunningly, turned the conversation to the coming U.S. presidential election, alluding to China’s economic capability and pleading with Xi to ensure he’d win,” Bolton wrote, in the most in-depth, damaging portrayal by a Trump administration insider to date and just days after former defence secretary Jim Mattis accused the president of trying to divide America.

Lighthizer denies Bolton’s account

Biden said in a statement: “If these accounts are true, it’s not only morally repugnant, it’s a violation of Donald Trump’s sacred duty to the American people.”

U.S. Trade Representative Robert Lighthizer said in Senate testimony that Bolton’s account was “absolutely untrue.”

“I was at the meeting. Would I recollect something as crazy as that? Of course I would,” Lighthizer said. “This never happened in it for sure. Completely crazy.”

The U.S. government has sued to block Bolton from publishing the book, citing risks to national security, and is seeking a court hearing on Friday.

Publisher Simon & Schuster has dismissed the accusations, and said “hundreds of thousands of copies” of the book have already been distributed.

Although Trump’s administration had been critical of China’s mass detention of the mostly Muslim Uighur minority and other Muslim groups, Trump gave Xi Jinping, right, a green light in June 2019 in Osaka, Japan, Bolton said. (Kevin Lamarque/Reuters)

Although Trump’s administration had been strongly critical of China’s mass detention of the mostly Muslim Uighur minority and other Muslim groups, Trump gave Xi a green light in June 2019 in Osaka, Japan, Bolton said.

“According to our interpreter, Trump said that Xi should go ahead with building the camps, which Trump thought was exactly the right thing to do,” Bolton wrote, saying another top White House official said Trump made similar comments during his November 2017 trip to China.

Bolton cited a number of conversations in which Trump demonstrated “fundamentally unacceptable behaviour that eroded the very legitimacy of the presidency.”

A former U.S. ambassador to the United Nations and Fox News television commentator, Bolton’s hawkish approach had worn on a president weary of foreign military entanglements, officials say.

Pompeo mocked Trump, Bolton writes

Trump would sometimes chide Bolton in meetings, introducing him to visiting foreign leaders by saying, “You all know the great John Bolton. He’ll bomb you. He’ll take out your whole country.”

In excerpts published in the Washington Post, Bolton writes that Trump said invading Venezuela would be “cool” and that it was “really part of the United States.”

The U.S. government has publicly said it does not favour using force to topple Venezuela’s socialist President Nicolas Maduro.

The book also exposed the sometimes dim view that Trump’s advisers have of him. During a 2018 meeting with North Korean leader Kim Jong-un, Bolton says he got a note from Secretary of State Mike Pompeo mocking Trump.

“He is so full of shit,” Pompeo’s note said, according to a Bolton excerpt in the Washington Post.

Although Trump is publicly critical of journalists, Bolton’s book quotes the U.S. president making some of his most alarming remarks to date. In a summer 2019 meeting in New Jersey, Trump allegedly said journalists should be jailed so they have to divulge their sources: “These people should be executed. They are scumbags,” according to another excerpt in the Post.

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CBC | World News

COVID-19 test to be offered to anyone in Sask. working outside the home starting Monday

Beginning Monday, Saskatchewan is expanding COVID-19 testing to include anyone working outside the home who desires a test, no symptoms necessary.

The broadened criteria will make Saskatchewan’s testing program the most expansive in Canada, with other provinces still requiring people in the general population to feel sick or show symptoms before they qualify for a test.

Thus far, health officials have reserved widespread testing of asymptomatic people to outbreak locations, such as long-term care homes and meat-processing plants.

Saskatchewan’s testing capacity is relatively high, at about 1,500 tests a day, but the demand has dropped significantly in recent weeks to roughly 300 a day.

On Wednesday, the government of Saskatchewan announced additional details on how expanded COVID-19 testing will work and who will be able to access a test. Residents must still call 811 HealthLine to make arrangements.

Expanded testing availability will now include: 

  • Anyone working outside the home currently or returning as part of the province’s reopening plan.
  • All patients upon admission, or in advance of a planned admission, to an acute care hospital for a stay expected to be longer than 24 hours. This includes all expectant mothers entering a health facility to give birth.
  • Immunocompromised asymptomatic individuals, including cancer patients in advance of undergoing immunosuppressive procedures such as chemotherapy. 
  • All health staff working with immunocompromised patients.
  • Increased testing for the homeless or those living in vulnerable situations.
  • Mobile (work site) testing in high-volume work settings (such as factories, industrial settings, etc.).

“I think testing is important not just for yourself and your family’s health but … for all of us. It helps all of us reopen in a safe manner,” Saskatchewan Chief Medical Health Officer Dr. Saqib Shahab said  on Tuesday.

“We have fairly low COVID activity and that’s where we want to keep it. I think is important just to maintain that testing level and that kind of reassurance that we are maintaining COVID-19 circulation in the community at a very low level,” Shahab said.

Saskatchewan Health Authority CEO Scott Livingstone said the expanded testing was set for Monday because those operating the 811 line need time to prepare for the “extensive” list of people testing will be offered to.

“Until that’s in place it would be essentially a free-for-all,” Livingstone said.

He said Saskatchewan already has “one of the broadest” testing programs in all of Canada in its list of symptoms which can qualify a person for a test.

“If you have the sniffles, you can go in for COVID testing.”

Livingstone said the testing criteria will continue to evolve and will be evaluated to see how it is working, and where infections are occurring that may have been missed.

“We don’t have an idea of how many folks will come in. We do expect to see expanded numbers.”

As of May 20, a total of 41,951 COVID-19 tests had been performed in Saskatchewan. As of May 18, Saskatchewan’s per capita testing rate was 32,410 people tested per million population, while the national rate was 35,570 people tested per million population, according to the province.

Infection control specialist applauds approach

University of Toronto associate professor Colin Furness, an infection control specialist, said Saskatchewan’s plan is “proactive.”

“That sounds quite responsible. It sounds wise, it sounds like the population is being well taken care of,” he said.

“I think Saskatchewan’s approach is good. I think they have managed the pandemic very well.”

Furness suggested Saskatchewan and other provinces should be even more aggressive and undertake “sentinel surveillance.”

“You don’t wait at the hospital for people to show up [looking] desperately ill, but you go with your testing equipment and you go to people who have known occupational risk.”

He said examples of workers at risk include grocery store employees, taxi and bus drivers, and front-line health workers.

“They are the canaries in the coal mine. They’re the ones who are going to get sick and not necessarily know it, but they’ll be among the first to get sick,” Furness said.

“If we can test all the grocery store workers in the province and we come up … negative, that would be an excellent sign.”

He said that would allow for tracking community spread in a way that may not have been noticed before.

“We did the lockdown to stop occupational exposure. We know occupational exposure is risky. We know where to find grocery store workers,” he said.

“There’s no mystery here. It’s really just a question of having the resolve to say we’re going to actually go where the risk is.”

Widespread testing needed to ‘quash’ COVID-19

An epidemiologist at the University of Ottawa said it is “good news” that Saskatchewan is expanding its testing criteria as it reopens its economy.

“That has to be done. Ultimately, we should have testing on demand for everyone and even those who don’t want it,” said Raywat Deonandan, an epidemiologist and associate professor at the University of Ottawa. 

“That is how we’re going to get out of this, is to identify the cases in real-time and quash them.”

Deonandan said a lack of access to rapid test results is among the many barriers to mass testing. Currently, patients who go into a hospital have to wait to find out if they are positive.

“We would like to have our results back in minutes, not days.” 

A nurse in personal protective equipment walks with a patient into a Saskatchewan Health Authority assessment centre. (Bryan Eneas/CBC)

Provinces should be seeking out the virus, and not waiting, he said.

“We’re not actively hunting the disease yet. We should be.”

Another issue with the current tests, he said, is false negatives.

“Some have high false positive rates. High false negative rates are more distressing because people think they haven’t got it and they’re walking around behaving as if they don’t have it.”

British Columbia’s provincial health officer, Dr. Bonnie Henry, warned in April of the danger of false negatives in mass testing.

“The testing, unfortunately, doesn’t tell us the whole story. People can be negative one minute and positive within an hour,” she said.

“The false negative rate can be as high as 30 per cent early on in infection.”

Testing criteria varies across Canada

Saskatchewan would be the first province to offer a test to workers regardless of symptoms. However, people will still require a referral.

In other western provinces, referrals are not required.

Alberta recently offered testing to asymptomatic people in the Calgary zone. About 3,400 people with no symptoms got tested, and more than a hundred were found to have the virus. 

Both B.C. and Alberta have proactively tested in outbreak situations, such as meat plants and prisons.

Ontario just recently expanded testing for people with mild or moderate symptoms. It had previously required multiple symptoms, travel or contact with a positive person.

Both Quebec and Ontario have proactively tested in long-term care homes.

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CBC | Health News

Father says people with disabilities should be offered support to have children, not dissuaded from doing it

Framed family photographs, plaques, medals and homemade artwork compete for space on the walls of the Haddad family home. Shane Haddad is particularly proud of the wall that leads to his children’s bedrooms: three smiling portraits in full high school cap and gown. 

“We had a dream that our kids would be graduating, successful and important people in society and they’ve become just that.”

It’s a testament to a life of hard work and a constant battle to defy the expectations of others. 

Growing up in Regina in the 1960s and 1970s as a people with intellectual disabilities, Shane and his wife, Brenda, both had to fight for basic human rights. 

“People were calling us ‘retards’ growing up; ‘not being able to amount to much.'”  

So many people are challenging in saying, ‘Well, you are different, why should you have children?’ They should be telling people, ‘Yeah, you should have children but how can we support you?’– Shane Haddad

At the time, the local school board said it didn’t have the proper resources to teach Shane. He was forced to leave his family and spend four years at a school run by nuns in Edmonton. Ultimately, he learned to read and earned his Grade 9. 

Sports have always played a really important role in Shane’s life, and he can credit the Special Olympics for introducing him to Brenda.

She was attracted to his honesty and said “he let me be myself.”

Brenda and Shane Haddad got married on May 20, 1989, despite the misgivings of her parents. (Nichole Huck/CBC )

The couple decided to get married, despite the misgivings of her parents. 

“A lot of people said, you can’t do this. You can’t be normal like everybody else. They were thinking things, but they didn’t always say things. You could see it in their eyes and face,” said Brenda. 

Her parents worried that Shane wouldn’t be able to adequately support their daughter. 

“We basically told Brenda’s mom and dad that we were getting married on May 20, 1989, and show up or don’t bother, but that’s the date,” said Shane.

They newlyweds were excited when they became pregnant in the first year of marriage. They had the first of three children, all of whom have special needs, according to Shane. He said their doctor was encouraging and arranged for a parent aid to come to their home and help out a couple of times a week to teach some parenting skills. 

It’s a support Shane said would be helpful for any new parent. 

The Haddads always knew they’d be great parents; what they needed to fight was society’s expectations of what was possible for people with intellectual disabilities. 

Brenda and Shane have been married for 30 years. Here, they stand in front of a wall showcasing all of the family’s wedding photos. (Nichole Huck/CBC)

According to Inclusion Saskatchewan, an organization dedicated to the inclusion of people with intellectual disabilities, people with special needs having children is still quite rare. Shane said this will continue to be the case until there is a fundamental shift in how our society functions. 

“I think because so many people are challenging in saying, ‘Well, you are different, why should you have children?’ They should be telling people, ‘Yeah, you should have children but how can we support you?'”

Brenda said one of the biggest lessons she’s learned in parenting is that it’s OK to not know everything and it’s OK to ask for help if you don’t understand.

“You don’t try and solve it on your own.” 

All three Haddad children competed in the Special Olympics. Tyler (left) and Matthew (right) competed with their father for Team Canada. Tyler won the male athlete of the year award in 2018. Matthew lives in Regina and works construction. (Submitted by Tyler Haddad )

Shane had hoped to become a high school janitor, but that required a Grade 12. Doors were repeatedly shut in his face. 

“No one would hire me and give me a legitimate chance to make a living,” he said. 

Out of necessity, he started his own yard care business. 

Shane and Brenda also fought to make sure their children had the access to resources in their local school that they had been denied growing up. 

“We wanted him to be in the neighbourhood school, inclusion where he could be with his friends and he doesn’t have to uproot every three years and go to a different school and maybe not have very many friends because of it,” said Shane.

The children were taught from a young age to “see the ability, not the disability.” The family motto “never give up” adorns bedroom walls on handwritten posters, and it’s lived out by every member of the family. 

Over the years Shane has won countless awards for his involvement with the Special Olympics and in his role as an advocate for people with intellectual disabilities. (Nichole Huck CBC )

In Grade 8, their oldest son, Tyler, desperately wanted to go to Cochrane High School, but he was told he’d need to raise his reading level by six grades. He got a tutor, and did. 

Their youngest child, Whitney, struggled to get her driver’s licence. 

“And every time she came back and she was crying because she was so disappointed in herself, and I kept telling her, believe in yourself and sooner or later you’ll do it,” said Shane. 

On the fifth attempt, Whitney came home with a big smile on her face. 

Society had already lit a match under us with, you can’t do this, you can’t do that. I can do this. I can do that, look at me now.– Shane Haddad

The family hasn’t just advocated for their own members.  Shane has been involved in groups representing people with intellectual disabilities. He served as president of People First of Canada. The family has continued to be heavily involved in the Special Olympics, competing in games all over the world. 

In high school, Tyler served as a peer support worker.

“They knew they could talk to me because I wouldn’t judge them,” he said.

Whitney Haddad, 22, displays photos of her niece on her bedroom walls. Whitney works at McDonald’s and helps her family take care of her niece. (Nichole Huck/CBC)

And when a 21-year old Tyler came home with the news that his girlfriend was pregnant, the family supported the young couple. When it ended after a year, Tyler moved back in with his parents and they welcomed his daughter, Rylie, into the household. 

The eight-year-old proudly shows off her own awards in the bedroom that used to belong to her father, smiling largely as she points to one for courage she received from her school. 

The handwritten message “Never give up. You can do this!” greet her every time she enters her room. 

It’s a way of approaching life that Rylie was born into.

“For us it was easy, because society had already lit a match under us with, you can’t do this, you can’t do that. I can do this. I can do that, look at me now,” said Shane. 

Beautiful Mess is a series that aims to glean wisdom from parents. Read other pieces here.

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‘Stem cell’ therapies offered at private clinics need to be approved as drugs, Health Canada says

This is an excerpt from Second Opinion, a weekly roundup of eclectic and under-the-radar health and medical science news emailed to subscribers every Saturday morning. If you haven’t subscribed yet, you can do that by clicking here.

Canada’s direct-to-consumer cell therapy industry is thriving.

Across the country, private clinics continue to sell expensive procedures advertised as a form of “regenerative medicine.”

The clinics use what they claim are stem cells that are siphoned from a patient’s bone marrow or fat tissue and injected or given intravenously to treat a range of conditions including joint pain, multiple sclerosis and nerve disorders.

There is a lack of clinical trial evidence to determine whether the procedures are safe and effective. And there has been a long-running debate about whether they’re legal.

This week Health Canada issued a public policy position on that point.

“All cell therapies are considered drugs under the Food and Drugs Act. This means that they must be authorized by Health Canada to ensure that they are safe and effective before they can be offered to Canadians,” Health Canada said in a news release.

That policy statement confirms that cell therapies are not legal in Canada unless they’ve been formally approved as drugs, after going through a rigorous review. And so far Health Canada has not approved any of the direct-to-consumer treatments.

Health Canada also warned Canadians about potential safety risks.

“Unauthorized treatments have not been proven to be safe or effective and may cause life-threatening or life-altering risks, such as serious infections.”

What happens next?

If these procedures are not approved, and might not be safe, are they still happening? The answer is yes.

Almost a dozen clinics across Canada confirmed to CBC News that they are still doing the procedures, with prices quoted as high as $ 15,000. Ten other clinics that advertised the procedures on their website could not be reached for comment.

Health Canada has been in touch with some of the clinics to inquire about their practice, but so far the agency has not taken any action to stop clinics from doing the autologous procedures. (“Autologous” means the patient’s own cells or tissue are being used.)

That’s puzzling to University of Minnesota researcher Leigh Turner, who provided his research notes to Health Canada months ago showing that there were 43 clinics in Canada doing the procedures. Turner’s findings were published last September.

“It’s like Health Canada is saying, ‘We know these business aren’t complying with Canadian law, and even in our latest document we’re confirming that. Nonetheless, we’re going to stand here on the sidelines with our hands in our pockets and not doing anything about it.’ And that, to me, is the problem,” Turner said.

“I don’t understand why it’s not more of a priority for Health Canada.”

University of Minnesota researcher Leigh Turner says it’s time for Health Canada to take meaningful action. (University of Nebraska)

Health Canada spokesperson André Gagnon told CBC News in an email that the agency is “currently working to bring clinics into compliance with the applicable regulatory framework.” 

“This will include requesting clinics to stop selling and advertising cell therapy products that do not meet the applicable requirements.”

Health Canada did not indicate when it would take that action.

Turner said it’s long overdue.

“We’re talking about a nationwide phenomenon right now that has received national news coverage,” he said. “There’s a tremendous amount of empirical information. Health Canada has interacted with people willing to provide more information. Years have ticked by. That’s enough time for Health Canada to take meaningful action.”

One Alberta clinic announced on its website that it has officially stopped doing the procedures because they fall into a regulatory grey area.

“It was a decision we made and it was our decision alone,” said Joe Burnham, regulatory manager at the Capri Clinic in Lacombe, Alta. The clinic performed about 1,500 procedures before deciding to stop in March. But patients are still calling.

“That’s 80 per cent of our calls to this day. When are you guys up and running?”

Burnham said his clinic is investigating how to comply with Health Canada’s regulations, but it’s not yet clear how that can be done.

“Doctors that are doing procedures aren’t drug companies. And the minute you call a procedure a drug, even if you have a regulatory right to, it turns doctors into drug manufacturers. That’s the confusion,” Burnham said.

Health Canada acknowledged that challenge, telling CBC News: “There is uncertainty surrounding the practical means of meeting federal product safety regulatory requirements for the sale of cell therapies that aren’t mass produced, especially once initial clinical trials are completed.

“Health Canada is working to identify and overcome challenges specific to meeting regulatory requirements for the manufacturing and sale of autologous cell therapy products, including those prepared at the bedside.”

They’re not stem cells

Despite the claims from clinics that they are extracting stem cells, the clinics don’t examine the fluid to determine what sorts of cells and other cellular products it contains.

And scientists point out that it is unlikely to contain true stem cells, which are cells that can transform into any tissue in the body. The extract from bone marrow and fat tissue contains another type of cells that were originally called “mesenchymal stem cells.” But scientists now say that name is inaccurate and confusing. 

In a commentary in Nature, with the title “Clear up this stem cell mess,” Turner and some colleagues explained how the science has evolved since the cells in question were first described and named 25 years ago.

“They don’t behave like stem cells,” Michael Rudnicki, stem cell scientist at the Ottawa Hospital Research Institute, told CBC News last September when we first wrote about the name controversy. “None of the criteria we use to define stem cells are present in this population.”

“There are clinical trials exploring their ability to modulate the immune system, but it’s not a regenerative phenomenon,” said Rudnicki, adding that most researchers in the scientific community have abandoned the term “mesenchymal stem cells” and instead call them “mesenchymal stromal cells.”  

By continuing to use the term “stem cell” for the fluid that is taken from a patient’s bone marrow and fat, there is concern that patients will be misled into believing the therapies are able to regenerate bone and tissue, which has not been proven.

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CBC | Health News

Facing crackdown in Canada, drugmakers offered billions in price cuts

Canadian pharmaceutical industry lobby groups, trying to head off a planned crackdown on prescription drug prices, offered to give up $ 8.6 billion ($ 6.6 billion US) in revenue over 10 years, freeze prices or reduce the cost of treating rare diseases, according to interviews and documents seen by Reuters.

Those industry offers did not impress federal officials last year, as Canada prepared to expand the powers of a little-known federal watchdog called the Patented Medicine Prices Review Board (PMPRB) to reduce the cost of prescription drugs.

The government proposals would change the countries Canada compares its prices to, dropping the United States where they are highest, and set a formula to assess cost-effectiveness of medicines.

Announced in 2017, the new rules were scheduled to come into effect last month but have been delayed as the government reviews feedback, which has some wondering if they will ever be implemented.

The delay is a setback for supporters of the changes. But documents detailing counter offers from lobby groups Innovative Medicines Canada and BIOTECanada show an industry struggling to win over federal officials.

Unlike other countries with universal health care, Canada's government-funded health-care system does not cover prescription drugs. Most Canadians rely on an expensive patchwork of public and private insurance plans for that. Among industrialized nations, only the United States and Switzerland spend more on prescriptions per capita.

I think it's a little early for people to panic and lament the demise of this policy initiative.– Douglas Clark

Declan Hamill, a vice-president at Innovative Medicines Canada, said the proposed regulations go too far and could hurt patient access to new drugs in Canada. But his group recognizes that the Canadian government wants to make drugs more affordable, he said.

"We'd like to help the government out with that, and we've been trying to have discussions with them," Hamill said.

Lower prices in Canada could eventually hit drugmakers in the most lucrative U.S. market, as Washington evaluates a proposal to base drug prices paid under the government's Medicare program on the cost of medicines in other developed nations, including Canada.

Global drugmakers, including Johnson & Johnson, Merck & Co, Amgen Inc and others, have argued against the Canadian proposal. They referred questions back to Innovative Medicines Canada.

'Would not achieve the goal'

With major drugmakers united in their condemnation of proposed regulations to rein in prices, Health Canada hired former Bank of Canada governor David Dodge and health economist Ake Blomqvist to assess the government proposal. Their review, completed in August 2018, broadly endorsed the government's plan, documents seen by Reuters showed.

Prime Minister Justin Trudeau's senior ministers will eventually decide how to proceed. PMPRB Executive Director Douglas Clark told Reuters the new regime could be running by early 2020.

I fear the consequences when you do something without really working with industry.– Andrew Casey

"People have a tendency to presume that the sky is falling," Clark said. "I think it's a little early for people to panic and lament the demise of this policy initiative."

Health Canada said the industry's offers do not address drug price problems created by outdated rules.

"The non-regulatory counter-proposals that Innovative Medicines Canada and BIOTECanada jointly submitted to the government would not achieve the goal of ensuring appropriate consumer protection in these circumstances," the ministry said in an emailed statement.

One offer was to "secure a price reduction target of C$ 8.6 billion" in net present value terms, according to a letter from officials seen by Reuters.

Hamill said the $ 8.6 billion Cdn figure was borrowed from a government estimate of how much the PMPRB reforms would reduce revenue and would have been spread over 10 years. He did not say exactly how it would have worked. Total patented medicine sales were $ 16.8 billion Cdn ($ 12.8 billion US) in 2017, according to the PMPRB.

Canada's government-funded health-care system does not cover prescription drugs. (CBC)

Health Canada also rejected an offer to freeze prescription drug prices, saying it would not meet its objective of lowering prices. Health Canada said the industry had also committed to improving access for patients with rare diseases, but that proposal would not help those who have drug plans.

Meanwhile, ahead of a fall election, Trudeau's government is preparing to announce a limited expansion of Canada's universal health-care system to cover part of the cost of prescription medicines, as drug plans grapple with the extremely high cost of newer specialty drugs.

'We don't want to shut that door'

The PMPRB caps prices of drugs still under patent protection. If new regulations are adopted, it would change the list of countries whose drug pricing it uses to decide whether costs are excessive, dropping the United States and adding countries with lower prices.

The regulator would also consider for the first time a type of value-based pricing, measuring how cost-effective drugs are in terms of quality-adjusted life years, and force drug companies to privately disclose some confidential discounts.

It is not entirely clear how the PMPRB would use its new powers. In documents posted online, the agency said it could apply new rules to drugs already on the market. But Health Canada said the regime would not apply to those.

Andrew Casey, president of BIOTECanada, would like "a more rigorous sit-down" with the government. "I fear the consequences when you do something without really working with industry," he said. "We don't want to shut that door." 

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'There is no validity': Unproven blood tests for food sensitivity widely offered in Canada

Feeling fat, itchy or bloated? Got tummy trouble? Want to help your hair or fix your skin? Could what you're eating be ailing you? That's certainly the sales pitch from companies behind food sensitivity tests.

They're often advertised as a quick solution to a range of health issues, including by two of Canada's biggest labs — despite the fact the science behind these questionable tests has been discredited by medical groups around the world.

And consumers, including Laura Chapnick, are buying in.

While waiting for other blood tests and an ultrasound in a Dynacare clinic, Chapnick saw an ad stating that 45 per cent of people suffer from food intolerances. Desperate for answers to her ongoing stomach problems, Chapnick later asked to take the $ 325 food intolerance test.

She said she "genuinely believed that doing … the blood test was going to give me absolute factual answers that I needed."

Laura Chapnick decided to ask for an IgG blood test for food sensitivities after seeing an ad in a Dynacare clinic. She was there for other blood tests and an ultrasound. (CBC)

Within weeks, she received a report outlining 26 foods she should reduce or eliminate altogether. Many were foods she had been eating regularly, including corn, potatoes, peanuts, wheat, milk and eggs.  

"These tests scared the crap out of me," she said. "These food tests scared me into believing that whatever I put in my mouth was toxic."

Grocery shopping and eating quickly became a challenge. "I felt like a prisoner in my own head almost," Chapnick said, "and became very obsessive, trying to figure out what can I eat."

  • Also on Marketplace this week: Investigating the rise of 'tech abuse' and the truth about popular (and pricey) 'teatoxes.' Watch at 8 p.m. Friday on CBC TV or online.

Chapnick is not alone. The value of the global food allergy and sensitivity industry is expected to hit a whopping $ 24.8 billion US by 2020. And with food sensitivity tests specifically ranging in cost from more than $ 100 to nearly $ 400, companies are cashing in on the craze.

Two of Canada's biggest labs, Dynacare and LifeLabs, promote and offer something known as IgG food tests at their labs, marketed as a way to test for food sensitivities.

But medical experts, including the Canadian Society of Allergy and Clinical Immunology (CSACI), call IgG tests for food sensitivities "unvalidated," and more than two dozen organizations warn about the misuse of such tests.

The reports being generated by the IgG test taken by Chapnick and countless others are being grossly misinterpreted, critics say.

Food sensitivities are different from food allergies. An allergy is an immediate, immune response, and foods like nuts and seafood are often known to cause allergic responses that can be life-threatening.

Sensitivities or intolerances, on the other hand, are not related to the immune system and often take hours, if not days, to take effect — and are therefore very difficult to diagnose.

Exposure not intolerance

Dr. Douglas Mack, a pediatric allergy, asthma and immunology specialist, argues the results of an IgG test are an indication that you had exposure to the foods — not an intolerance of them.

IgG tests measure levels of an antibody known as Immunoglobulin G — or IgG, for short.

"It should be used to track whether a patient actually is developing tolerance, not intolerance," he said.

Dr. Douglas Mack is a pediatric allergy, asthma and immunology specialist. (Dave MacIntosh/CBC)

Interpreting the test otherwise is not only incorrect, but potentially hazardous to your health, Mack argues. By unnecessarily eliminating foods, he says he sees "kids that are coming in with nutritional deficiencies, with failure to grow very well."

Removing foods from your diet could also lead to development of a food allergy, especially in children, says Mack. One young patient of his developed a milk allergy after eliminating it from his diet when a food sensitivity test suggested he had a milk intolerance.

"If these tests result in the harm of a child, we really gotta think twice about whether or not these labs should be offering these," he said.

Putting the test to the test

To test the accuracy of these food sensitivity tests, Marketplace ran several different kinds on host Charlsie Agro, including drawing blood for the IgG tests offered by Dynacare and Rocky Mountain Analytical, which is owned by LifeLabs.

Both tests require a requisition from a naturopathic doctor or licensed physician. LifeLabs' test is typically offered through naturopaths or other health outlets, however, while Dynacare's food intolerance test is advertised and promoted directly to the consumer in its clinics.

The results from the Rocky Mountain Analytical test reported intolerances to 52 foods, while Dynacare reported 30 intolerances.

The tests offered by both Dyancare and Rocky Mountain Analytical require a requisition from a naturopathic doctor or licensed physician. (Tyana Grundig/CBC)

Before taking the tests, Agro had tracked what she was eating. Yet both tests reported intolerances to foods she regularly consumed, with absolutely no adverse reactions.

For example, Agro had a smoothie, which included flax seeds, for breakfast daily. Yet both tests suggested Agro is intolerant to flax. She also ate vegetable soup — containing barley, kidney beans and corn — without problem. Both IgG tests again claimed Agro is intolerant to these foods.

Both sets of lab results also showed Agro is "intolerant" of egg whites, all milks, wheat and gluten — all foods she eats regularly without issue.

What the results say

IgG is really a memory antibody, says Dr. David Stukus, an associate professor of pediatrics with the allergy and immunology department at the Ohio-based Nationwide Children's Hospital.

"Measuring specific IgG levels merely detects that the person has eaten it at some point in the past," he said. "It is a normal physiological response to eating."

Stukus also said it wasn't surprising that foods Agro hadn't consumed in the weeks leading up to her blood tests showed up in her results.

One set of Charlsie Agro's test results showed flax was a problem food for her. Yet she puts flax seed into her morning smoothie daily and has never felt negative effects. (John Lesavage/CBC)

Some foods "have cross-reactivity," he said, meaning the proteins in one food are similar to the proteins in another.

"So it is possible that [the test] is picking up the memory antibody of other similar foods that have been eaten in the past," Stukus said.  

He points to peanuts as a common example: If you've eaten peanut butter, your results might suggest you are intolerant to other legumes, like soy or other beans.

Serious side effects

More than 25 leading health organizations from around the world have warned about the misinterpretation of IgG tests, including a Health Canada scientist who wrote "these tests are not reliable and should not be recommended as a single diagnosis tool."

Position papers from international medical communities have called the IgG blood test for food sensitivities "irrelevant," "unvalidated" and "inappropriate," warning that the test provides "false diagnoses" and that "the test should not be performed" for such a purpose.

There can also be adverse effects to drastically limiting your diet, including malnutrition and disordered eating patterns, says Stukus.

Chapnick said her eating patterns changed significantly after she got her IgG test back, which was done by Dynacare. So she turned to registered dietitian Elke Sengmueller to develop a diet she was comfortable with based on those results.

But Sengmueller says the radical changes the test was calling for would put Chapnick's already compromised health in jeopardy.

"Because she had drastically cut down her foods already, because of her symptoms and her pain and not getting any answers, she was afraid to eat," she said. "If she were to continue this … for an extended period of time, given her medical history I could see it … possibly leading to death."

Registered dietitian Elke Sengmueller said the radical changes outlined in Chapnick's IgG food test results made her client 'afraid to eat.' (CBC)

Mack says he is especially troubled by the IgG claims being made by LifeLabs and Dynacare through its marketing, as these are two of Canada's largest blood labs, conducting millions of tests annually for everything from cancer screening to workplace drug testing.

"These are labs that we send patients to to get their bloodwork done for their iron, or to see if they have cancer, or to see whatever," he said. "But in the same place, these labs are now offering a test for which there is no validity."

Sengmueller echoes that concern.

"I'm surprised that an organization as reputable as Dynacare would be offering this to their clients, especially while they're waiting to get their blood work done — they're kind of a captive audience. It's disappointing."

Answering for IgG

When Marketplace asked the Ontario Ministry of Health about the manner in which IgG tests are being marketed in the province, a spokesperson said that labs are "operating as private businesses … and are allowed to provide a variety of tests that they are licensed to perform."

Health Canada told Marketplace it has issued medical device licences for some IgG tests, but that none are "intended to be a single tool to be used for diagnosis of food intolerance."

In its response, Dynacare said that "debate exists" about the use of the tests for food sensitivities, but  "peer-reviewed articles support the use of the food IgG test as an additional source of information."

And the company said it "relies on the expertise of the ordering health professional to determine the appropriateness of a particular test for a particular patient."

LifeLabs, the parent company of Rocky Mountain Analytical, also said that "numerous studies in peer-reviewed journals have shown the health benefits of removing IgG-reactive foods," and that "a test does not need to be diagnostic to be clinically relevant and useful."

Dynacare and LifeLabs provided those peer-reviewed studies to Marketplace, which were then analyzed by clinical epidemiologist and biostatician Jason Busse, DC, PhD. He found that "all of the studies were very problematic," and said he was "amazed that many of them were published."

If you're worried about how the food you're eating might be affecting you, health professionals say the best place to start is by keeping a detailed food and symptom diary, tracking what you're eating and how it makes you feel. It's important to visit a registered dietitian or family physician before starting any kind of elimination diet, they say.

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Usain Bolt offered deal by Australian A-League soccer club, says agent

Olympic sprint champion Usain Bolt managed to upstage the first weekend of Australia's A-League season without kicking a ball after his agent said he had been offered a professional contract by the Central Coast Mariners.

The 32-year-old Jamaican has been on trial with the Gosford-based club since August as he attempts to make an audacious switch to a second professional sport after one of the most decorated careers in track and field.

The Mariners on Monday were sticking to their line from last week that his "indefinite" trial continues as do negotiations between the club and Bolt.

Club manager Mike Mulvey said after the club's season-opening 1-1 draw with Brisbane Roar on Sunday that he knew nothing about any contract, even if he admitted such matters would be well above his "pay grade."

The former Manchester United trainee has said in the past that he thinks it might be until next year that Bolt was fit enough to make a proper call on, and questioned on Sunday whether he could displace any of the club's front three.

Questions will always be asked about whether signing Bolt was more about public relations than footballing prowess and, despite two goals in one pre-season friendly, it is fair to say that his performances for the Mariners have not been overly impressive.

Several former players and coaches, including former Australia boss Ange Postecoglou, have expressed doubts about whether the sprint champion could make the switch.

'Marquee' money not available, says federation

The public relations value of having Bolt as a squad player might prove tempting to a smaller club, however, as Maltese outfit Valletta FC proved last week when they made the Jamaican an offer of a two-year contract that he turned down.

Football Federation Australia (FFA) have made it clear that the "marquee" money that has in the past helped Australian clubs lure the likes of Alessandro Del Piero to the A-League will not be available to sign Bolt.

That means any contract from the Mariners, whose average home crowd last season was just over 7,000, is unlikely to be highly lucrative.

"I understand from the Central Coast Mariners that they have tabled an offer to Usain Bolt's management, which he's currently considering," A-League chief Greg O'Rourke told local radio.

"That offer is much, much less than what they were originally requesting and that's really reflecting that if Usain wants to join that club and become a professional footballer then he needs to follow a journey followed by many other triallists…"

According to Forbes, Bolt was earning upwards of $ 20 million US a year mostly from endorsements before his retirement from athletics in 2017 and he has made it clear that his football dream is about a lot more than money.

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Children out of cancer treatment options offered hope by new Terry Fox program

Seeing children suffering with cancer when he was being treated himself broke Terry Fox’s heart and inspired his Marathon of Hope.

Now, those efforts have fuelled a unique initiative to give kids and young adults across the country a chance to live when there are few, if any, treatment options left.

Eight-year-old Marlow Ploughman of Shannonville, Ont., has relapsed four times and is on a new drug thanks to genetic testing involving a project that brings together collaborators from over 30 pediatric cancer research and funding organizations.

The girl was diagnosed at age 2½ with late-stage rhabdomyosarcoma, or cancer of the soft tissue, such as muscle, after a vine-like tumour was found in her calf, said her mother, Tanya Boehm.

After three rounds of radiation, chemotherapy protocols and at least four clinical trials, there were no therapies left to try as the cancer spread to the girl’s neck and lungs.

‘Families like ours have hope’

A program called Terry Fox PROFYLE, short for Precision Oncology for Young People, seemed to be the only hope for Marlow, Boehm said.

PROFYLE provides precision treatment by sequencing tumour samples on a molecular level and analyzing the vast amount of information at any of three labs in Vancouver, Toronto and Montreal for patients up to age 29, regardless of where in Canada they live.

Until now, such testing was not always available for young cancer patients in rural or remote areas, let alone the collaboration of scientists and researchers from across the country to guide treatment.

“It presents options and time,” Boehm said. “We were told with Marlow when the cancer came back the first time that she was going to die. … I think it’s fantastic that finally, families like ours have hope.”

Marlow’s oncologist and project leader, Dr. David Malkin of the Hospital for Sick Children in Toronto, said the focus of the five-year project is the approximately 20 per cent of pediatric cancer patients whose disease is considered hard to treat.

Terry Fox Exhibition 20130704

Terry Fox, shown in August 1980 during his Marathon of Hope, was 18 when he was diagnosed with osteogenic sarcoma (bone cancer), and his right leg was amputated just above the knee in 1977. The scientific director of the Terry Fox Research Institute says Fox would have been a candidate for DNA sequencing treatment if it had been an option back then. (Canadian Press)

“Every pediatric centre across the country is part of PROFYLE and several of the adult centres will also be able to enrol their patients into the study. Even in the pilot phase, we have had patients from all provinces now enrolled,” Malkin said.

About 40 people are participating in the study and about half of them have had their tumours sequenced because of the partnership that has so far provided $ 16.4 million, including $ 5 million from the Terry Fox Research Institute.

“One of the reasons that PROFYLE is so important is that the cancers that occur in young people are inherently different than they are in adults,” said Malkin.

“We need to be collecting much, much more information on the sequences of childhood and young adult tumours and personalize it and make it more precise so we can work with industry and pharma and develop ways that we can get these drugs for kids.”

About 1,900 youth under age 18 are diagnosed with cancer every year in Canada, and about a third of them would be eligible for PROFYLE, he said, adding that only two other programs in the world come close to what PROFYLE offers.

“What is unique about PROFYLE is that it’s truly national.”

Terry Fox would have qualified

Patrick Sullivan, whose three-year-old son Finn died of rhabdomyosarcoma in 2008, has raised over $ 2 million for the BC Cancer Foundation and is on the executive committee of PROFYLE, for which he has committed another $ 250,000.

He said Finn, who was “introverted with a heavy streak of silly,” would have qualified for PROFYLE, but the cost of molecular sequencing and analysis was far too high in 2008.

“It not only offers hope for families, which would have been enough for me, it offers a way to integrate this type of approach for kids, adolescents and young adults and for all Canadians,” he said.

Dr. Victor Ling, scientific director of the Terry Fox Research Institute in Vancouver, said Fox, who was diagnosed at age 18 and died four years later, would have qualified for PROFYLE.

“We did not know how to do DNA sequencing in those days, we did not have the drugs that we have now.”

Darryl Fox, Terry’s brother and a senior adviser at the Terry Fox Research Institute, said Terry was passionate about meeting young cancer patients, especially during the Marathon of Hope.

“We’re bringing not only children’s hospitals and fundraisers together, but in 1980 he united a country. He brought Canadians together for a common cause and we continue to do that and this program is an example of that.”

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$20,000 Rebates on Nissan Leaf and BMW i3 EVs Offered in California

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Buy a Nissan Leaf or BMW i3 electric vehicle in southern California, and you can get rebates of up to $ 20,000 on EVs that sell for $ 30,000 to $ 52,000. It’s a deal through the end of September, for customers of San Diego Gas & Electric.

SDG&E is kicking in a $ 10,000 rebate that is in addition to $ 10,000 in federal and state rebates available to most buyers. Buying an EV allows a single-occupant vehicle to use high-occupancy vehicle (HOV) lanes. One caveat: Buyers should know that Nissan this fall and BMW next year will introduce models that double their range from about 100 to 200 miles.

2017 Nissan Leaf gets 107 miles per charge (EPA rating.)

Why the Deal Now? Is There Anything Wrong with Them?

From time to time, automakers and dealers offer seemingly too-low pricing or lease deals. A year ago, some SoCal dealers leased Nissan Leafs for $ 49 to $ 99 a month. This time, a local utility company is kicking in money on purchases. Utilities are under pressure (public and regulatory) to be more efficient, reduce pollution, adopt newer energy sources (solar, wind, and natural gas over coal), and promote alternative-energy devices such as time-shifting dishwashers and EVs. These are hundred-mile cars that will be replaced in 2018. The new models will roughly double the range, with the target being at or close to the 238-mile range of the Chevrolet Bolt EV.

“No SDG&E ratepayer funds were used to pay for this program,” San Diego Gas says, meaning the automakers underwrote the program. If BMW sells all 40 i3’s said to be in stock, it will cost $ 400,000.

How the Program Works

Here’s the deal: You have to be a resident of San Diego County, California, and a customer of SDG&E or living at the address of a customer. You go to any San Diego Nissan dealer or one participating BMW dealer (BMW of San Diego). The SDG&E rebate is for $ 10,000 relative to the car’s list price. It’s not clear if you can dicker on the purchase price as well. You’ll still owe sales tax and the $ 250-$ 500 in computer/processing fees dealers often tack on.

In addition, California offers up to $ 2,500 in rebates, and there’s an available $ 7,500 federal tax credit. Buyers also get access to HOV lanes and two years of free public charging.

That makes a total of $ 20,000 in possible rebates and credits. That’s more than half the cost of a Nissan Leaf, which starts at $ 29,875 for a Leaf SL (including freight) to $ 39,620 for the Leaf SL with premium pearl white paint, the premium package, and freight.

The BMW i3 sells for $ 45,445 with freight, to $ 51,595 with all options included. There’s also a range-extender (REX) version with a small gasoline engine that’s covered by the rebate, according to SDG&E’s flyer for the i3.

Teaser image for the 2018 Nissan Leaf, expected to be unveiled next month. The real Leaf won’t be this swoopy.

200-Mile Nissan, BMW EVs Coming Next Year

Our analysis: The plan is a good deal for drivers who do mostly local driving and commuting of less than 40 miles each way, or whose companies have charging stations. With the rebates and credits, you could score a new $ 25,000 Leaf for just $ 5,000 plus taxes and fees.

If you’re looking at the Leaf as your only car, though, factor in the cost of rentals for longer weekend and vacatation trips. BMW says i3 buyers will get courtesy cars for long trips. The current Leaf is rated at 107 miles of range, the i3 at 114 miles.

The new versions of the Leaf and i3 will ship most likely in the first half of 2018. The batteries will be more advanced. Nissan will use the 2018 Leaf to debut ProPilot, a autonomous module for highway self-driving with some limits (no automated lane changes). So: Reasons to buy, reasons to wait for the next new thing.

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