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Will price be a barrier to new cancer immunotherapy?

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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.


A revolutionary new cancer treatment is now available in Canada, but provinces are being advised not to cover it until the price comes down — a price that is being kept secret from Canadians.

Health Canada approved Kymriah (tisagenlecleucel) in September. It’s a form of CAR-T immunotherapy, in which a patient’s blood cells are removed, reprogrammed to attack cancer and then re-injected back into their body.

For the first time ever, some Canadians with specific forms of hard-to-treat leukemia and lymphoma can be treated with this therapy. If their doctors decide they’re candidates, they won’t have to wait to be accepted into a clinical trial.

But that approval created a Rubik’s Cube of decision-making problems: How to pay for a treatment so expensive that something else in the health care budget will have to be dropped, a treatment so new that there is no long-term survival data, a treatment so complex that some regions don’t have the facilities to offer it?

It is an expensive intervention so the opportunity cost of money spent for this is money not spent on something else.– Dr. Harindra Wijeysundera, CADTH

At the same time, how can the health-care system deny access to what could be a last chance for desperately sick children and adults?

These are patients who “typically are given a prognosis of months, often after a long treatment journey, sometimes in the order of years,” said the report of the ethics committee of the Canadian Agency for Drugs and Technologies in Health (CADTH). “In a medically fragile state, they face ongoing deterioration in their health.”

CADTH is an organization that assesses the costs and benefits of new treatments and advises provincial governments about whether to fund them.

After grappling with the tangle of ethical and financial questions, this week CADTH released its decision recommending provincial governments provide Kymriah for children with a rare form of leukemia (refractory/relapsed B-cell acute lymphoblastic leukemia) and adults with a form of non-Hodgkin lymphoma (refractory/relapsed diffuse large B-cell lymphoma).

But there were two major caveats.

First, there must be an interprovincial agreement so that all Canadians who qualify can travel to other provinces to get the treatment, if necessary, along with eligibility criteria and a standardized system to collect patient data.

Second, Novartis must drop the price — and, in the case of adults, by more than half.

“It is an expensive intervention, so the opportunity cost of money spent for this is money not spent on something else,” said  Dr. Harindra Wijeysundera of CADTH.

Cost of CAR-T therapy kept secret 

Right now, Canadians don’t know how much Kymriah will cost because the price was blacked out in the report released to the public.

“Whenever we do these types of evaluations, when we ask for submission data from the manufacturer, it includes data that is not available in the public realm,” said Wijeysundera.

Daphne Weatherby, a spokesperson for Novartis Canada, said in an email to CBC News that the company “does not typically publically disclose list prices of therapies for use in hospital.”

An IV bag of the Novartis drug Kymriah. (Novartis via AP)

The provinces are in the midst of negotiations with Novartis. There is no public disclosure of the price under discussion.

But the CADTH committee — using the undisclosed price Novartis provided, and adding in the cost of supportive care — estimated that it would cost the health care system about $25 million over three years for the estimated 48 children who would be eligible for Kymriah. And it would cost up to $387 million to provide the therapy for an estimated 600 to 900 adults.

“We are exploring innovative ways we can support health system stakeholders, including innovative pricing models, early access mechanisms, risk-sharing with payers, and patient and caregiver support,” said Weatherby. “Novartis is committed to bringing Kymriah to patients in Canada in a sustainable manner.”

So far, no Canadians have been treated with the commercial therapy, although 14 Canadians were treated during clinical trials.

The results for some patients have been promising, with a 76 per cent probability of overall survival at 12 months for children. For adults, the data so far shows a probability of survival at 12 months of 49 per cent.

Ottawa drops funding for made-in-Canada CAR-T 

The first commercially available CAR-T therapy is a bittersweet moment for a team of Canadians that have been working on a made-in-Canada version.

“I’m really excited about it because I think it’s a shame that it hasn’t been available to us yet in any form,” said John Bell, an immunotherapy researcher at the Ottawa Hospital Research Institute.

John Bell is researching a made-in-Canada CAR-T therapy at the Ottawa Hospital Research Institute. Last month, the federal government abruptly cut funding to the program. (Ottawa Hospital)

“Canada is slow in terms of clinical implementation. We need to have an infrastructure to manufacture and produce these things.”

Bell was trying to set up a cross-Canada CAR-T infrastructure through the federally funded BioCanRx network.

“Our goal is to try to find a model that would fit better in Canada’s health-care system.”

Our plans have now turned to dust.– John Bell, scientific director, BioCanRx 

But Bell’s team was stunned last month when the federal government abruptly cut the funding to the Centres of Excellence programs, which includes the BioCanRx network.

Ottawa is phasing out the 30-year-old funding program and replacing it with a new system to fund “fast-breaking and high-risk research.” 

“Our plans have now turned to dust,” said Bell. “We had thought we were going to have 10 more years to get this going.”

The Canadian team is still planning human trials of their therapy sometime in 2019.


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dermatologist agrees COVID-19 vaccine causes the blisters

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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