Tag Archives: stem

Biden announces new vaccine czar, massive spending to stem COVID-19 ‘suffering’ in U.S.

U.S. president-elect Joe Biden has picked a former Food and Drug commissioner to lead vaccine science as part of his drive to put 100 million shots into the arms of Americans in his administration’s first 100 days to stem the COVID-19 pandemic.

Dr. David Kessler, who will have the title of chief science officer of COVID response, headed the Food and Drug Administration in the 1990s under presidents of both political parties. He has been acting as a top pandemic adviser to Biden and his appointment was announced Friday by the presidential transition office.

Kessler will work out of the federal Department of Health and Human Services, assuming responsibility for the scientific side of Operation Warp Speed, an effort launched under the Trump administration to rapidly develop vaccines and treatments. The drive has already helped produce two highly effective vaccines, and more are on the way.

A person advising the Biden transition team said Kessler will take on the role now being carried out by Dr. Moncef Slaoui, a prominent vaccine scientist and innovator who has been serving as chief advisor to Operation Warp Speed.

Kessler will co-ordinate vaccine review and approval, as well as the logistics of manufacturing millions of more doses. Experts say the U.S. will need to vaccinate upwards of 250 million people to approach the goal of “herd immunity,” where there is widespread resistance to virus allowing for a return to normal life.

This comes on the heels of an announcement on Thursday evening, in which Biden has unveiled a $ 1.9 trillion US coronavirus plan to end “a crisis of deep human suffering” by speeding up vaccines and pumping out financial help to those struggling with the pandemic’s prolonged economic fallout.

Called the “American Rescue Plan,” the legislative proposal would meet Biden’s goal of administering 100 million vaccines by the 100th day of his administration and advance his objective of reopening most schools by the spring. On a parallel track, it delivers another round of aid to stabilize the economy while the public health effort seeks the upper hand on the pandemic.

“We not only have an economic imperative to act now — I believe we have a moral obligation,” Biden said in a nationwide address Thursday. At the same time, he acknowledged that his plan “does not come cheaply.”

Stimulus plan prospects in Senate unclear

Biden proposed $ 1,400 checks for most Americans, which on top of $ 600 provided in the most recent COVID-19 bill would bring the total to the $ 2,000 that Biden has called for. It would also extend a temporary boost in unemployment benefits and a moratorium on evictions and foreclosures through September.

The political outlook for the legislation remained unclear. In a joint statement, House Speaker Nancy Pelosi and soon-to-be Senate leader Chuck Schumer, both Democrats, praised Biden for including liberal priorities, saying they would move quickly to pass it after Biden takes office next Wednesday.

But Democrats will have narrow margins in both chambers of Congress, and Republicans will likely push back on issues that range from increasing the minimum wage to providing more money for states, while demanding inclusion of their priorities, such as liability protection for businesses.

“Remember that a bipartisan $ 900 billion COVID-19 relief bill became law just 18 days ago,” tweeted Republican Sen. John Cornyn from Texas. But Biden says that was only a downpayment, and he promised more major legislation next month, focused on rebuilding the economy.

People wait in line in a Disneyland parking lot to receive a dose of the Moderna COVID-19 in Anaheim, Calif. The amusement park is one of a number of mass vaccination sites opening in the U.S. to speed delivery of doses. (Mario Anzuoni/Reuters)

Biden’s relief bill would be paid for with borrowed money, adding to trillions in debt the government has already incurred to confront the pandemic. Aides said Biden will make the case that the additional spending and borrowing is necessary to prevent the economy from sliding into an even deeper hole. Interest rates are also low, making debt more manageable.

Economy linked with control of COVID-19

Biden has long held that economic recovery is inextricably linked with controlling the coronavirus, and that squares with the judgment of the U.S. Chamber of Commerce, the most powerful business lobbying group and traditionally an adversary of Democrats.

“We must defeat COVID before we can restore our economy and that requires turbocharging our vaccination efforts,” the Chamber said in a statement Thursday night, which welcomed Biden’s plan but stopped short of endorsing it.

So far, more than 385,000 people have died of COVID-19 in the U.S, with daily deaths having topped 4,000. Government numbers out Thursday reported a jump in weekly unemployment claims, to 965,000, a sign that rising infections are forcing businesses to cut back and lay off workers.

Under Biden’s multi-pronged strategy, about $ 400 billion would go directly to combating the pandemic, while the rest is focused on economic relief and aid to states and municipalities.

About $ 20 billion would be allocated for a more disciplined focus on vaccination, on top of some $ 8 billion already approved by Congress. Biden has called for setting up mass vaccination centres and sending mobile units to hard-to-reach areas.

A month after the first vaccines were given in the U.S., the nation’s vaccination campaign is off to a slow start, with only about 11 million people getting the first of two shots, although more than 30 million doses have been delivered.

Biden called the vaccine rollout “a dismal failure so far” and said he would provide more details about his vaccination campaign on Friday.

The plan also provides $ 50 billion to expand testing, which is seen as key to reopening most schools by the end of the new administration’s first 100 days. About $ 130 billion would be allocated to help schools reopen without risking further contagion.

More direction for states planned in rollout

The plan would fund the hiring of an additional 100,000 public health workers, to focus on encouraging people to get vaccinated and on tracing the contacts of those infected with the coronavirus.

There’s also a proposal to boost investment in genetic sequencing to help track new virus strains, including the more contagious variants identified in the United Kingdom and South Africa.

WATCH l Dr. Anthony Fauci predicted grim January for the U.S. last month:

Dr. Anthony Fauci, the top infectious disease expert in the U.S, talks to National co-host Andrew Chang about getting people to take COVID-19 vaccines, the new coronavirus variant, and why travel over the holidays could result in a ‘pretty dark January’ for the country. 7:48

Biden is asking Americans to overcome their pandemic fatigue and recommit to wearing masks, practising social distancing and avoiding indoor gatherings, particularly larger ones.

Biden believes the key to speeding that up lies not only in delivering more vaccines but also in working closely with states and local communities to get shots into the arms of more people. The Trump administration provided the vaccine to states and set guidelines for who should get priority for shots, but largely left it up to state and local officials to organize their vaccination campaigns.

It’s still unclear how the new administration will address the issue of vaccine hesitancy, the doubts and suspicions that keep many people from getting a shot. Polls show it’s particularly an issue among Black Americans.

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CBC | World News

Manitoba mulls curfew to stem tide of COVID-19 cases

Manitoba Premier Brian Pallister is vowing to ramp up COVID-19 enforcement, and says his government is “seriously considering” imposing a curfew, but an infectious disease expert questions whether it’s all coming too late.

Pallister said the province’s chief public health officer has recommended steps to curb group gatherings to limit the current surge in cases.

“These late-night situations in Winnipeg have expanded our number of COVID cases significantly,” Pallister said Monday morning. “According to Dr. [Brent] Roussin, this is an action that we should seriously consider, and I am seriously considering it now.”

Pallister made the announcement at a news conference on the first day Winnipeg and the surrounding area were placed under heightened pandemic restrictions.

The region moved into the red, or critical, stage of the provincial pandemic response plan as of Monday. Movie theatres, libraries, sports facilities, restaurants, bars and dining rooms are closed for at least two weeks, among other restrictions.

Hospital visits have been suspended amid multiple hospital outbreaks and an intensive care unit system that is nearing capacity.

The premier urged Manitobans to restrict the number of personal contacts they have by 75 per cent for the month of November.

‘COVID is beating us’

Over the past four days, Manitoba has reported 1,382 cases of COVID-19, including 241 new cases on Monday — the fourth highest number reported in a day.

There were 241 cases announced in Manitoba on Monday. (Bryce Hoye/CBC)

Manitoba Chief Provincial Public Health Officer Dr. Brent Roussin announced five more deaths. Eighty Manitobans have died of COVID-19 so far, more than half of them in October.

“If we do not reverse this trend, we will see many more deaths, we will see strains on our health-care system,” Roussin said.

Winnipeg is in the midst of a COVID-19 surge that has raised dire concerns from experts about Manitoba’s health-care capacity.

A series of incremental restrictions rolled out just over a month ago has done little to stem the spread.

“Some of us lost our way, and now COVID is beating us,” Pallister said. “Perhaps we were cursed by our early success.”

WATCH | Pallister implores Manitobans to reduce their number of contacts:

Manitoba Premier Brian Pallister thinks the province can and should do more to enforce public health orders. 1:04

Pallister doesn’t think past efforts to increase enforcement have worked sufficiently well. He suggested more people need to be fined and pointed to recent examples:

  • A house party was being promoted in the south end of Winnipeg over Halloween weekend.
  • Only three tickets were handed out last week.

“That is totally unacceptable,” he said.

“It’s clear that talking about enforcement is not the same as doing enforcement, and so we need to step up.”

A University of Manitoba virus expert questions Pallister’s emphasis on enforcement.

“You can’t ticket or fine your way out of a pandemic,” said Jason Kindrachuk, an assistant professor and the Canada Research Chair in emerging viruses at the U of M.

He’s uncertain whether Monday’s restrictions came soon enough.

“We are somewhat a little bit late to the game,” he said.

Strained hospital capacity

Pallister said he plans to release more details about enforcement plans later this week. He’s asking Manitobans to weigh in online on the idea of a curfew.

WATCH | Province seeking feedback on possible curfew:

Premier Brian Pallister is mulling a curfew to curb the rising number of COVID-19 cases in Manitoba. 1:24

Winnipeg Mayor Brian Bowman said his government learned of the possible curfew Monday and has no details from the province in terms of how it will implemented in the city.

“If the province feels this is the right thing to do, I would encourage them to just do it and not wait another day for a survey,” he said. “The virus doesn’t take a night off.”

The province has been criticized for not having a more robust response to the second wave.

There were 124 Manitobans in hospital due to COVID-19 as of Monday, 18 of whom were in intensive care. (Bryce Hoye/CBC)

Two groups of doctors have penned letters to the premier and health minister in recent days imploring them to act swiftly to bring COVID-19 numbers down or risk “grave peril” in the health-care system. 

Fifty health-care workers tested positive last week, said Lanette Siragusa, chief nursing officer of Shared Health, the organization to co-ordinates health care in the province.

She said 94 per cent of Manitoba’s ICU capacity was full as of Monday. Nearly a quarter of the 75 ICU beds in use are COVID-19 patients.

Elective surgeries have been suspended.

‘Manitobans have lost confidence’: NDP leader

Opposition NDP Leader Wab Kinew said Pallister failed to act quickly enough on reinforcements, or to ensure hospital capacity was there, heading into a fall season experts predicted would bring a second wave of COVID-19.

“I think Manitobans have lost confidence in this premier’s ability to manage the pandemic,” Kinew said.

“Every measure that he said that he’s thinking about doing today are things that should’ve happened weeks ago, and worse, he ignored the No. 1 priorities out there.”

The province moved forward with an economic agenda this summer following weeks of few or no cases.

During question period at the Manitoba Legislature, Kinew said the province should have invested in ramping up testing and contact tracing capacity then.

Pallister said that “would’ve been idiocy,” as the province had “no COVID cases.”

A record nine per cent test positivity rate was announced in Manitoba on Monday. The rate for Winnipeg was 9.8 per cent. (Bryce Hoye/CBC)

He touted the province’s attempts to improve contact tracing and testing over the past several weeks, following weeks-long backlogs.

He said three large sites have been added in the past week, which have increased daily testing capacity by 40 per cent.

An appointment-based COVID-19 test-booking system has registered 10,000 appointments since it was unveiled on Oct. 20. Wait times in that system are less than one minute, the premier said.

Manitobans will have a total of 30 sites in the coming weeks, and that will increase testing capacity to 4,250 per day.

Monday’s news conference marked the first time the premier has spoken publicly since the enhanced restrictions for the province were announced last week. Asked why he did not attend the announcement on Friday, Pallister suggested 

Pallister did not speak at a Friday news conference announcing the new measures, and instead issued a news release after the public health update.

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CBC | Health News

Halt drug possession charges during pandemic to stem spike in overdose deaths, advocates say

More than 50 human rights, drug and legal policy groups are pushing the federal government to halt criminal charges for simple drug possession as part of its response to COVID-19, arguing the pandemic has led to more dangerous drug use practices and a spike in overdose deaths.

In a letter to Health Minister Patty Hajdu, Public Safety Minister Bill Blair and Justice Minister David Lametti, the organizations say COVID-19 has forced supervised consumption sites and safe needle programs to either close down or reduce their hours.

Additional street-level policing to enforce pandemic public health measures has also increased fears of arrest, causing many drug users to forego safety precautions or consume alone.

“Heightened law enforcement surveillance in the context of the pandemic further hampers their access to vital health services and ability to use drugs safely, while also increasing their risk of arrest and detention,” the letter reads.

“Not surprisingly, some cities are already seeing reports of increasing overdose deaths since the onset of the COVID-19 pandemic.”

The organizations report the situation is also increasing the risk of HIV and hepatitis C infections among intravenous drug users at a time when Canada is already battling another public health emergency — the opioid crisis.

Between January 2016 and September 2019, there were about 14,700 opioid-related deaths across the country.

Cities reporting spike in overdoses

Many cities, including Toronto, are reporting a rise in suspected overdoses and deaths over March and April of this year, after a widespread shutdown of businesses and support services was imposed in response to the pandemic. 

The groups that signed the letter — which include Amnesty International, the Canadian Nurses Association, the Canadian Public Health Association and the Criminal Lawyers’ Association — say the Controlled Drugs and Substances Act gives the federal health minister the authority to issue an exemption for criminal charges “on the basis that it is necessary for a medical or scientific purpose or is otherwise in the public interest.” 

In  2015, the government granted exemptions for supervised consumption services using that same section of the act. 

The groups say the federal cabinet also could issue a directive.

Harm reduction advocates have been pushing federal officials to decriminalize simple drug possession for years, arguing that such a move would offer major public health advantages while posing few risks to public safety.

“We’ve wanted (the government) to decriminalize simple drug possession more broadly, but we think now there’s even more urgency given the increase in deaths,” said Sandra Ka Hon Chu, director of research and advocacy at the Canadian HIV/AIDS Legal Network.

“The fact that people who use drugs are more often in public spaces means they’re more vulnerable to police surveillance, potential harassment or detention. And the last place we want them to be at this point is detention.”

Limiting the spread in jails, prisons

Ka Hon Chu said it would make little sense to put drug users in jail when provincial and federal prisons are taking steps to depopulate to limit the spread of COVID-19 behind bars.

The confined environment in detention – coupled with the fact that many incarcerated people have chronic health conditions – has led many to warn that the virus could spread quickly behind bars and lead to severe symptoms.

People who use drugs, especially those who are homeless or have precarious housing arrangements, are more likely to have the kind of chronic health issues that make them prone to developing severe symptoms if they’re infected with the virus, the groups say.

An expert in the United Nations Office of the Commissioner for Human Rights issued a statement last month outlining the additional risks that people who use drugs face during the pandemic. It said the COVID-19 crisis requires countries to take “extraordinary measures” to protect their health.

“To prevent unnecessary intake of prisoners and unsafe drug consumption practices, moratoria should be considered on enforcement of laws criminalizing drug use and possession,” the April 16 statement reads.

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A stem cell ‘cautionary tale’ as Health Canada cracks down on private clinics

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

For the medical team at the Health Sciences Centre in St. John’s, N.L., it was a shocking discovery — a patient had cells from his nose growing in his spine. It was the result of a stem cell treatment gone terribly wrong. 

“It was really surprising,” said Dr. Nanette Hache, a radiologist and assistant professor at Memorial University. “We offered him radiation in the hopes that it would slow down growth.”

The 38-year-old patient sought medical treatment because he was losing function in his arms. 

The doctors assumed he was experiencing complications from a spinal cord injury almost two decades earlier that resulted in partial paralysis.

This should be a cautionary tale for the manipulation of stem cells– Dr. Nanette Hache, Memorial University 

Instead, they discovered a spinal tumour. A biopsy revealed that nasal cells had somehow ended up in his spinal column and they were growing.

That’s when the doctors learned their patient had travelled to Portugal 11 years ago and paid $ 50,000 for an experimental stem cell treatment. 

“He was desperate. He would have done anything basically to walk again,” said Hache. “These guys were providing him with hope and obviously he was willing to spend the money if there was any chance at all he could walk.”

The Portuguese doctors were doing the controversial procedure based on a theory that glial cells harvested from a patient’s nose could be transplanted into the spinal cord where they might help regenerate neurons and promote healing in spinal injuries. 

When Hache and her colleagues searched the medical literature, they discovered reports of several other patients who also developed spinal cord tumours after receiving the same treatment.

“This should be a cautionary tale for manipulation of stem cells in the body because realistically we don’t know what the long-term adverse effects are,” said Hache. “If you transplant stem cells from one organ type into another these type of risks would be a reasonable thing to expect.”

This magnetic resonance image shows a spinal tumour caused by olfactory mucosal cells transplanted from the patient’s nasal cavity in a controversial stem cell procedure performed in Portugal more than a decade ago. (CMAJ)

Hache did not reveal her patient’s name, but said he agreed to have his story published to warn others about the risks of stem cell therapies.

“He’s doing okay. He’s obviously very disappointed with the outcome and everything that occurred,” said Hache. “He wanted people to be aware of this complication because he really didn’t want this to happen to anyone else

Although the Portuguese researchers patented their procedure and published their early results, there has been no long term follow-up for the estimated 140 people around the world who received the treatment, Hache said. Through her research she learned that Portugal group is no longer doing the operations. The lead researcher died in 2012.

‘Not enough evidence’ for effectiveness: Health Canada

The “cautionary tale” was published this week in the midst of a mounting stem cell controversy in Canada now that Health Canada has started cracking down on private clinics offering so-called “stem cell” therapies. 

The agency has sent letters to 36 clinics across the country requesting them to stop doing the procedures until they have received regulatory approval.

None of the Canadian clinics are known to be harvesting nasal cells and performing the type of surgical implants that the Newfoundland patient received in Portugal. Most use cellular fluid extracted from a patient’s bone marrow or fat tissue. That fluid is put into a centrifuge and then some of it is either injected back into the patient’s body, infused intravenously or inhaled through a respirator. 

The clinics do not examine the fluid to determine what kinds of cells it contains, but they assume that there are at least some mesenchymal stromal cells (MSC) sometimes called “adult stem cells” although some experts dispute the validity of that term. 

In May, Health Canada announced that it considers the cell therapies to be a form of drug treatment, which means they must undergo a rigorous review and be formally approved before they can be legally offered to the public.

It’s Health Canada’s first action aimed at reigning in Canada’s thriving cell therapy industry, which has flourished for several years despite warnings from researchers that the safety and effectiveness of the treatments has not been proven. 

My position is I’m a surgeon and I’m doing surgery.– Dr. Scott Barr, Ontario Stem Cell Treatment Centre

Legitimate clinical trials are underway testing the use of cells extracted from adipose or bone marrow tissue for a variety of conditions. But those studies are tightly controlled and patients volunteer to be tested free of charge. Clinics selling direct-to-consumer cell therapies are operating outside of the clinical trial system and Health Canada has ruled that neither the safety nor the efficacy of the procedures has been proven. 

“Generally, products using stem cells to cure or treat disease remain at the investigational stage of development. This means that Health Canada has not yet seen enough evidence that they are safe and effective,” a Health Canada spokesperson told CBC News in an email.

Sudbury clinic continues to do cell procedures

Dr. Scott Barr, a plastic surgeon at the Ontario Stem Cell Treatment Centre in Sudbury received what he described as Health Canada’s “cease and desist” letter on May 23. But he said he is not stopping the treatments. 

“My position is that I’m a surgeon and I’m doing surgery,” said Barr. “They’re saying we’re manufacturing a drug and we’re not. We’re basically allowing patients to use their own cells.”

“I sent a note to Health Canada inviting them to my office to review what we’re doing.”

In fact, Barr said he performed one of the cell procedures on Thursday, treating a patient with Parkinson’s disease by extracting material from the patient’s fat tissue and infusing it intravenously into the patient’s blood. 

Barr said he also administers the tissue extract using respirators and direct injections to treat a range of conditions.

“We do all sorts of stem cell procedures. We do joint injections —hip joints, knee joints, shoulder joints — for arthritic changes. We do other patients with neurologic conditions some people with respiratory conditions so there’s lots of conditions that we’re doing.”

The patients pay thousands of dollars for the treatments.

“It could be anywhere from $ 6,500 and sometimes a little bit more,” said Barr. 

Dr. Scott Barr, a plastic surgeon at the Ontario Stem Cell Treatment Centre, said he will continue to do the cellular treatments despite Health Canada’s order. (Marcus Schwabe/CBC)

A Health Canada spokesperson told CBC News in an email that it intends to verify that the clinics have complied with federal requirements, adding that Health Canada “will take action to address any non-compliance and engage the appropriate provincial or territorial regulatory body as needed, including Professional Colleges within Canada.”

The College of Physicians and Surgeons of Ontario (CPSO) has the power to take disciplinary action against doctors who do not follow Health Canada directives, although a spokesperson said the CPSO could not comment on a specific case.

At the Toronto PRP and Stem Cell Clinic, Dr. Adrian Le is complying with Health Canada’s request to stop the treatments. 

“We sent an email back confirming we would comply with the order,” said Le who has been performing the cell procedures using fat tissue to treat osteoarthritis in the knee and hip. Le estimates he has done almost 100 treatments charging around $ 4,000 for the full therapy. 

He said he has mixed feelings about Health Canada’s actions. 

“On the one hand I understood where they were coming from,” said Le. “There were some clinics both in the United States and in Canada that were doing things outside the bounds of what the research or evidence would suggest stem cells are appropriate for. And I think regulation was needed.”

This an excerpt from one of the letters Health Canada sent to 36 private clinics across the country ordering them to stop advertising and selling cellular therapies. (CBC News)

Back in St. John’s, Dr. Nanette Hache said she has reservations about the safety of the cellular procedures, based on her patient’s experience.

“People are desperate and they will try anything and they will spend any amount of money if they think it can make them better,” said Hache. “With regards to these clinics we don’t know what the long term outcome will be for these patients either.”

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Unproven stem cell therapies often peddled by doctors without training

At U.S. clinics advertising unproven stem cell treatments, roughly two-thirds of the clinicians may be physicians, but a new study suggests these doctors are often trained in specialties unrelated to the services they provide.

“About half of the companies we examined offer unproven stem cell treatments for conditions [for] which they do not have a physician with the appropriate residency and fellowship training,” said senior study author Zubin Master, of the Biomedical Ethics Research Program at the Mayo Clinic in Rochester, Minn. 

“As regenerative medicine advances and potential therapies become available, it is important for patients to be treated by clinicians who are appropriately qualified to provide such care,” Master said by email.

More than 700 U.S. clinics advertise unproven stem cell treatments, Master and colleagues note in JAMA.

All too often, these treatments involve approaches that aren’t approved in the U.S. and aren’t backed by solid evidence of effectiveness from well-designed clinical trials.

Insurance typically doesn’t cover these unproven therapies, and patients may spend thousands of dollars out-of-pocket on stem cell therapies that don’t deliver promised benefits and may even leave patients worse off than before.

When clinics advertising unproven stem cell therapies promise that U.S.-trained physicians are providing these treatments, patients may be lulled into a false sense of security even when these doctors aren’t trained to provide the advertised services.

For the current study, researchers examined the training background of 608 clinicians at 166 companies advertising unproven stem cell therapies in California, Florida, and Texas.

‘Rolling the stem cell dice’ with patients

Overall, 401 clinicians, or 66 per cent, were physicians.

Out of 157 companies with a physician on staff, only about half had at least one doctor with training in the specialty needed for the type of services offered to patients.

Among orthopedic-focused practices, 77 per cent had one or more physicians with the appropriate training in this specialty.

Reports of serious harms, including septicemia, blindness, paralysis and death, have been increasing in recent years.– Douglas Sipp

For other types of unproven stem cell therapies, only 19 per cent of companies advertising services appeared to have physicians on staff with the appropriate training.

Many clinics were also staffed by other types of clinicians like nurses, physician assistants, podiatrists, physical therapists, dentists, and scientists.

The study focused on unproven treatments that might be ineffective and dangerous regardless of physicians’ training. It wasn’t a controlled experiment designed to prove whether or how clinician training might directly impact patient outcomes.

Health Canada says it needs to authorize cell therapies to ensure they are safe and effective before they are offered to Canadians. The regulator has also warned Canadians about potential safety risks. 

“Reports of serious harms, including septicemia, blindness, paralysis and death, have been increasing in recent years,” said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasn’t involved in the study.

“But even when such treatments are performed without incident, the main risk is that the patient will receive no more than an expensive, medically useless placebo,” Sipp said by email.

Dangerous territory

Unproven stem cell injections aren’t in the best interest of patients and stem cells really are not at present advisable for any medical conditions besides those already established related to blood cancers and immune disorders, said Paul Knoepfler, a professor of cell biology and human anatomy at the University of California Davis School of Medicine in Sacramento.

“Even so, the potential profits and/or illusions about the purported magic of ‘stem cells’ is clearly luring some doctors into dangerous territory outside their expertise,” Knoepfler said by email.

“Injecting unproven stem cells into patients who have health conditions outside the doctors’ area of expertise (e.g. say a dermatologist treating a brain condition) is riskier for the patient, but a surprising number of physicians are willing to do it anyway,” Knoepfler added. “They’re rolling the stem cell dice with their patients because these doctors either have unrealistic notions about the “alternative medicine” power of stem cells or the extra profit is attractive.”

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Why this Toronto man is trying to boost diversity on Canada’s stem cell registry

In 2014, Tom Wong learned he had Myelodysplastic syndrome (MDS), a rare form of blood cancer.

The disease prevented his stem cells from maturing — meaning they couldn’t carry oxygen, fight infections or help his body heal from bruises.

He found himself on the Canadian Blood Services Stem Cell Registry waiting for a match.

“They kept telling me that my best chance of a match was going to come from a male within my own ethnicity,” he said.

But Wong found out a match from his Chinese background would be hard to come by.

Out of the 450,000 Canadians registered with Canadian Blood Services as potential stem-cell donors, 68 per cent are white and about six to seven per cent are Asian. Even fewer are Chinese.

“When I heard these stats I decided to try and do something about it,” he said. “So I go out to communities to talk and go out to universities and corporate events just to get a more ethnically diverse mix into the database.”

Canadian Blood Services says right now its registry is almost 70 per cent Caucasian. (CBC)

Five years after his journey began, the numbers haven’t moved much.

The amount of diverse registrants have risen three per cent from 28 to 31 per cent overall, but the numbers for many ethnicities are still low.

For example, black and Indigenous donors each make up less than one percent of the registry.

Finding a match

According to Jonas Mattsson, director of the Hans Messner stem cell program at the Princess Margaret Cancer Centre, a successful match occurs when patients have similar human leukocyte antigen (HLA) systems, responsible for regulating the immune system.

“It’s like a personal signature that we have on our own cells. Those signatures actually play a very important role in the immune system,” he said.

(Submitted by Canadian Blood Services)

“It should be the same signature between the patient and the donor.”

In some cases, a match can be found in a sibling, as half of your HLA system comes from your mother and half from your father.

If that’s not successful, the next place to look for a match is in a patient’s ethnic group.

Through his advocacy, Wong found one of the reason why many Chinese people haven’t signed up is because they don’t want anything to be taken out of their body unnecessarily.

“I’m finding that there’s more people … that are more receptive now,” he said. “I’m happy to hear that.”

Sharr Cairns with Canadian Blood Services says one of the reasons why some people don’t donate is because they’re frightened of the process, but she says donating stem cells is similar to donating blood. (CBC)

Sharr Cairns, the Ontario territory manager for the Canadian Blood Services Stem Cell Registry, said she can’t pinpoint why certain groups don’t register, but she does believe many people are misinformed about how stem-cell donation actually works.

“I think what happens is a lot of people are frightened of the program,” she said.

“It’s very similar to a blood donation, so we hook you up to a machine that does all the work.”

Cairns said although they have work to do to encourage more diverse adult stem cell donations, they are seeing more diversity through their cord-blood bank.

The program runs at Brampton Civic Hospital, and Cairns said that registry is up to 60 per cent diversity.

Cairns said at any given time, about 1,000 Canadians are looking for a stem cell match.

To improve the registry’s diversity, she said people like Wong are the ones making a huge difference.

‘He has been a great advocate’

“Unfortunately, with a lot of our programs at Canadian Blood Services, people tend to not really take notice until they see someone from their own circle of family or friends who is in need,” she said.

“He has been a great advocate for us.”

Wong continues to do speaking events in many communities, from Asian to Jamaican to South Asian.

A few weeks ago, he said students at a Bramalea Secondary School gave him hope.

He planned a swabbing event and 88 graduates turned out. That’s crucial, he said, because men between 17 and 35 are ideal donors as their stem cells provide a better post transplant survival rate.

“I’ve never had more than 25 people at one event and these 88 kids were heroes,” he said.

Wong found his match in Germany

As for Wong’s case, he didn’t end up finding his donor in Canada.

But through an international network of more than 33 million potential donors worldwide, he did find a one.

“I found out that my donor was actually a woman from Germany,” he said. “I was more than surprised, but man, I was feeling pretty blessed.”

While on a business trip to Germany last year, Tom met his donor, Doreen. (Submitted by Tom Wong)

Now healthy, Wong is continuing to fight to ensure others can find their match.

“I’m not going to stop. This is dear to me and whatever weakness this created, it kind of made me stronger.”

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Trump threatens tariffs on Mexico if it does not stem flow of migrants into the U.S.

In a surprise announcement that could compromise a major trade deal, U.S. President Donald Trump announced Thursday that he is slapping a five per cent tariff on all Mexican imports to pressure the country to do more to crack down on the surge of Central American migrants trying to cross the border.

He said the percentage will gradually increase “until the Illegal Immigration problem is remedied.”

The announcement comes as the administration has been pushing for passage of the Canada-United States-Mexico Agreement that would update the North American Free Trade Agreement.

Trump broke the news by tweet after telling reporters earlier Thursday that he was planning “a major statement” that would be his “biggest” so far on the border.

Trump has accused the Mexican government of failing to do enough to crack down on the surge of Central American migrants who have been flowing to the U.S in search of asylum from countries including El Salvador, Honduras and Guatemala.

But the sudden tariff threat comes at a peculiar time, given how hard the administration has been pushing for passage of the United States-Mexico-Canada Agreement that would update the North American Free Trade Agreement. It also comes less than two weeks after Trump lifted import taxes on Mexican and Canadian steel and aluminum, a move that seemed to clear an obstacle to passage of his North American trade deal.

The White House sees the deal, which was agreed to by the three nations’ leaders in November, as the cornerstone of Trump’s 2020 legislative agenda. But it needs approval from lawmakers in all three countries for it to be ratified.

The White House said Trump would use the International Emergency Economic Powers Act to implement the tariff.

“If the illegal migration crisis is alleviated through effective actions taken by Mexico, to be determined in our sole discretion and judgment, the Tariffs will be removed,” the White House said in a statement.

A May 29 photo released by U.S. Customs and Border Protection showing some of 1,036 migrants who crossed the U.S.-Mexico border in El Paso, Texas, the largest group the Border Patrol says it has encountered. (U.S. Customs and Border Protection/Associated Press)

But if Trump is not satisfied, the five per cent figure will increase to 10 per cent on July 1, to 15 per cent on Aug. 1, to 20 per cent on Sept. 1 and to 25 per cent on Oct. 1.

“Tariffs will permanently remain at the 25 per cent level unless and until Mexico substantially stops the illegal inflow of aliens coming through its territory,” the statement read.

Jesus Seade, the trade negotiator for Mexican President Andres Manuel Lopez Obrader, said Thursday in a news conference that if the tariffs come to pass, “we should respond in a forceful way.” But he said right now that it is important to find out whether these tariffs are “really on the table.”

He says if Trump is serious, the move is bad for “two countries that are trying to arrive at a marvellous free trade treaty, the best in history, according to President Trump.”

Tariffs ‘not linked’ to trade deal: White House

On a briefing call with reporters Thursday evening, acting White House chief of staff Mick Mulvaney said there were several things Mexico could do to prevent the tariffs from kicking in.

He said the White House had specifically refrained from setting specific benchmarks but would be looking at progress “on a day-to-day and a week-to-week basis.”

He also insisted that tariffs were “completely” “separate and apart from the USMCA” because one pertained to trade and the other immigration.

“The two are absolutely not linked,” he claimed.

U.S. Vice-President Mike Pence was in Ottawa Thursday to press for passage of the new trade deal between Canada, the U.S. and Mexico. (Adrian Wyld/Canadian Press)

During a visit to Canada on Thursday, Vice-President Mike Pence vowed the new trade deal would be passed this year.

“Our administration is working earnestly with leaders in the Congress of the United States to approve the USMCA this summer,” he said. Asked by reporters about the new tariff consideration, Pence said Mexico and the U.S. Congress need to do more and that Trump is determined to use his authority to call on them to do so.

Trump had said Thursday morning that he was planning “a major statement on the border” later Thursday or Friday that would be his “biggest statement, so far, on the border.”

“This is a big-league statement. But we are going to do something very dramatic on the border, because people are coming into our country — the Democrats will not give us laws,” he said as he headed to a commencement speech for 2019 United States Air Force Academy graduates.

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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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Safer opioids needed to stem overdose epidemic, Canada's top doctor says

Canada's chief public health officer says the need to increase access to a "safer supply" of opioids is being reviewed with provinces and territories — a move encouraged by a number of public health experts.

The comments from Dr. Theresa Tam, Canada's chief public health officer, come as the Public Health Agency of Canada releases data that says in the first half of 2018, opioid drugs were a factor in more than 2,000 deaths. That's a higher death rate than the previous year.

Tam says a toxic drug supply is causing a key part of this epidemic.

Fentanyl, a drug more powerful than heroin, is often mixed into opioids sold on the street, meaning users can't know the potency of the drugs they take.

Tam said the country must "double down" on its efforts to address the opioid crisis, stressing the need for escalated treatment.

The health agency found more than 9,000 lives were lost in Canada between January 2016 and June 2018, suggesting the country has not been able to turn the tide on the crisis.

Data released by the Canadian Institute for Health Information on Wednesday showed a 27 per cent increase in hospitalizations due to opioid-related poisonings over the past five years. In 2017, hospitalization rates were 2.5 times higher in smaller communities with a population of between 50,000 and 100,000, compared to  Canada's largest cities. 

The Canadian reports come as the U.S. government officials reported a bigger share of overdose deaths in that country are being caused by methamphetamine.

The number of fatal overdoses involving meth more than tripled between 2011 and 2016, the U.S. Centers for Disease Control and Prevention reported Wednesday. The percentage of overdose deaths involving meth grew from less than 5 per cent to nearly 11 per cent. 

Meth is not the main killer among illicit drugs in the U.S. Fentanyl was involved in the highest percentage of fatal overdoses in 2016, followed by heroin and cocaine. Meth was fourth. 
But it was only eighth as recently as 2012.
It's not clear why meth overdoses are growing, but some people who had been abusing opioid pain pills or shooting heroin have turned to meth, a stimulant, to offset the downer effects of those drugs, said Theodore Cicero, a Washington University researcher who has studied the rise of meth use among people who use opioid drugs.
The CDC report looked at death certificates on 64,000 U.S. overdose deaths in 2016 and compared them with the five previous years. Many of the people who died had used multiple drugs —​ fentanyl was often in the mix.

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More Canadian clinics are offering unproven stem cell therapies, study finds

Dozens of unlicensed clinics offering stem cell treatments for a wide variety of medical conditions have sprung up in Canada, marketing their services through direct-to-consumer online advertising, a study has found.

Canadian-born researcher Leigh Turner, an associate professor at the University of Minnesota's Centre for Bioethics, identified 30 businesses marketing stem cell therapies at 43 clinics across Canada.

The clinics aren't approved by Health Canada, nor are their services covered by provincial health insurance plans, meaning patients typically pay thousands of dollars out of pocket for what he calls "unproven" stem cell therapies.

"I think it's hard for individual patients to navigate what's out there," Turner said in an interview from Minneapolis-St. Paul.

"And the sicker you are and the more desperate you are and the more hopeful that there's something out there, the easier it is to be taken advantage of by businesses that are savvy marketers," he said.

Watch our Stem Cell 101 explanation 0:27

His study, published Wednesday in the journal Regenerative Medicine, involved an extensive online search for direct-to-consumer websites offering stem cell therapies to Canadians.

His search turned up 24 clinics in Ontario, eight in British Columbia, six in Alberta, three in Quebec, and one each in Nova Scotia and Saskatchewan. There were 17 clinics in the Greater Toronto Area alone.

"They just sort of set up shop and put out a shingle on the internet and start making marketing claims and begin to advertise stem cell treatments," said Turner, noting that there are now hundreds of such clinics in the U.S. as well as in countries around the world.

More research still needed, experts say

Stem cells give rise to many different cell types in the body and offer the potential for treating a wide array of diseases. However, regenerative medicine experts say much rigorous research is still needed to determine how these cells can be used safely and effectively as therapies.

Even though it's too late for his own transplant, Bille Nguyen is urging people to register as donors. 2:06

Most of the Canadian clinics identified by Turner offer stem cell treatments for orthopedic and musculoskeletal conditions such as arthritis, pain relief and sports-related injuries. One B.C.-based company advertises stem cell treatments for a broad range of disorders, among them ALS, Parkinson's disease, stroke, multiple sclerosis, muscular dystrophy and erectile dysfunction.

But there is no scientific evidence that injecting or transfusing stem cells — often purportedly derived from a person's own fat tissue — has any benefit in easing the symptoms of such diseases, let alone providing a cure, he said.

And in some cases, such interventions can do harm, Turner said, citing the 2015 case of a Florida clinic using a stem-cell preparation to try to improve the sight of three women with macular degeneration, who ended up being blinded.

Stem cells from bone marrow have long been a proven therapy for rebuilding the blood system in people with leukemia, for instance. In that case, bone marrow is taken from a tissue-matched donor in what's known as an allogenic transplant.

An autologous transplant involves sourcing stem cells from an individual's own blood or other tissues and "purifying" them in some manner before injecting or infusing them back into the person.

Turner said of the 30 Canadian companies he identified, 22 market autologous stem cells derived from a person's own fat tissue; 15 from stem cells obtained from bone marrow; and two promote autologous stem cells reportedly sourced from peripheral blood.

One company markets amniotic-derived stem cell products and stem cells said to be obtained from umbilical cords.

Author challenges Health Canada

Turner said his paper is in part meant to challenge Health Canada to clarify and enforce regulations governing the clinical use of stem cells and to crack down on clinics making claims about effectiveness that are not based on scientific evidence.

"There are some meaningful things Health Canada can do not just to better regulate this marketplace, but to provide a clear and more comprehensive regulatory framework," he said.

A spokesperson for Health Canada said the federal department has been in contact with 21 clinics offering stem cell therapies that had previously been identified through media reports and complaints.

Two clinics were ordered to stop the importation and sale of unauthorized stem cell products; both clinics complied, André Gagnon told CBC News in an email. Gagnon added that Health Canada is following up on other clinics and action will be taken should any non-compliance with regulatory requirements be identified.

"Health Canada continues to assess the information gathered from the clinics to determine whether the specific activities being conducted are compliant with federal regulatory requirements," Gagnon said.

Under the Food and Drug Act, all stem cells therapies are considered drugs and must meet specific requirements before they can be marketed in Canada. Only one advanced stem cell product, Prochymal for the treatment of graft-versus-host disease, has been approved for sale in Canada.

In light of the new information provided by the study, Health Canada will be contacting Turner to request further details for follow-up, Gagnon said.

'A lot of it is placebo'

Mick Bhatia, director of the Cancer and Stem Cell Biology Research Institute at McMaster University, said he is surprised and disheartened to see so many stem cell clinics popping up on Canadian soil.

"Scientifically, are these stem cells? I'm very doubtful," Bhatia said from Hamilton.

"In some cases, they aren't using stem cells. They're using cells that were going to die anyway in the [petri] dish," he said. "They inject them in and they provide a very local, and within days, an anti-inflammatory reaction … so there's the sense that you're doing some benefit — and a lot of it is placebo [effect]."

Bhatia said such companies are taking advantage of people's hopes, when in fact there is no scientific backing for claims that stem cells can alter the course of such diseases as ALS, an always fatal neurological condition for which the cause is unknown and there is no cure.

"I can't send up a bigger set of cautions for any individual that wants to approach these companies," he said, adding that he has seen patients return to Canada from clinics in other countries and end up in hospital "for months or longer" due to complications from so-called stem cell treatments.

With files from CBC News

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