Connect with us

Health

Will price be a barrier to new cancer immunotherapy?

Editor

Published

on

[ad_1]

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 not 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.


To read the entire Second Opinion newsletter every Saturday morning, please subscribe.

[ad_2]

Source link

قالب وردپرس

Health

Health Ranger posts new microscopy photos of covid swabs, covid masks and mysterious red and blue fibers

Editor

Published

on

By

(Natural News) What follows is a series of microscopy photos of covid swabs (a synthetic swab, then a cotton swab), a covid mask and some zoomed-in photos of mysterious red and blue fibers found in the masks.

The magnification range for these photos is 50X to 200X. Most were taken with white light, but several (as indicated) were taken with UV light.

The images shown here are 600 pixels wide. We have higher resolution images available to researchers and indy media journalists; contact us for those hi-res images.

More microscopy investigations are under way, and new images will be posted as they are finalized.

First, this series shows the carbon fiber layer of a covid mask, illuminated with UV light:

Continue Reading

Health

5,800 test positive, 74 die of coronavirus at least 14 days after getting fully vaccinated

Editor

Published

on

By

(Natural News) The Centers for Disease Control and Prevention (CDC) on Thursday, April 15, confirmed some 5,800 breakthrough coronavirus (COVID-19) cases in the U.S.

A breakthrough COVID-19 case is defined as someone who has detectable levels of SARS-CoV-2 – the virus that causes COVID-19 – at least 14 days after getting fully vaccinated against the disease.

Nearly 400 breakthrough cases required treatment at hospitals and 74 died. A little over 40 percent of the infections were in people 60 years and above and 65 percent were female. About 29 percent of the vaccine breakthrough infections were reportedly asymptomatic. The figures were for cases through April 13.

CDC Director Rochelle Walensky told a congressional hearing on Thursday that the causes of the breakthrough cases are being probed. “Some of these breakthroughs are, of course, failure of an immune response in the host. And then some of them we worry might be related to a variant that is circulating. So we’re looking at both,” she said.

The CDC is monitoring reported cases “for clustering by patient demographics, geographic location, time since vaccination, vaccine type or lot number, and SARS-CoV-2 lineage.” It has created a national COVID-19 vaccine breakthrough database, where state health departments can enter, store and manage data for cases in their region.

Where available, respiratory specimens that tested positive for COVID-19 will be collected for genomic sequencing “to identify the virus lineage that caused the infection.”

Positive test less than two weeks after getting fully vaccinated is not a breakthrough case

The number of cases the CDC has identified does not include people who contracted COVID-19 less than two weeks after their final dose. The two-week marker is important, said infectious disease expert Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.

A human body should have enough time to develop antibodies to SARS-CoV-2 after that timeframe. Before then, a person won’t necessarily have the built-up immunity needed to fight off an infection. According to Dr. Adalja, cases that occur before the two-week mark are not considered breakthrough cases.

Dr. Adalja also noted that more research is needed to determine if highly infectious variants of the virus are behind the breakthrough cases. “It is crucial to study breakthrough cases to understand their severity, their contagiousness and what role variants may be playing,” Dr. Adalja said.

More than 78 million people have been fully vaccinated against COVID-19 in the U.S. as of April 15.

“To date, no unexpected patterns have been identified in case demographics or vaccine characteristics,” the CDC said in a statement. “COVID-19 vaccines are effective and are a critical tool to bring the pandemic under control.”

But the CDC conceded that “thousands of vaccine breakthrough cases will occur even though the vaccine is working as expected.”

Dr. William Schaffner, an infectious disease specialist and professor at the Vanderbilt University School of Medicine, agreed with the CDC. “These vaccines that we’re using are fabulous but they’re not perfect,” he said. “At best, they’re 95 percent effective in preventing serious illness, but minor illnesses can occur.”

According to U.S. drug regulators, Pfizer’s COVID-19 vaccine is 95 percent effective in preventing infection. Moderna’s was shown in a clinical trial to be 94.1 percent effective while Johnson & Johnson’s was 66.9 percent effective. Only Johnson & Johnson vaccine, which received its emergency use authorization from the Food and Drug Administration (FDA) on Feb. 27, was tested when variants were circulating.

The percentages are based on results from vaccine recipients two weeks after the final vaccination.

Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, stated in a briefing last week that the breakthrough cases are not a cause for concern.

“I think the important thing is to look at what the denominator of vaccinated people is. Because it is very likely that the number of breakthrough cases is not at all incompatible with the 90-plus percent vaccine efficacy,” he said. “So I don’t think that there needs to be concern about any shift or change in the efficacy of the vaccine.”

More info needed before drawing conclusions from breakthrough cases

The percentage of vaccine breakthroughs in a population depends on multiple factors, including vaccine efficacy, the amount of virus circulating and the length of time since vaccination, according to Natalie Dean, an assistant professor of biostatistics at the University of Florida.

“I love to see small numbers as much as anyone, but know that numbers like this cannot be directly interpreted as a measure of vaccine efficacy (although I have a feeling they will be). We can only interpret them against a background rate in unvaccinated people,” Dean wrote on Twitter.

“Similarly, ‘most breakthroughs have been in elderly adults’ should not be read as the vaccine is less effective in elderly adults. The majority of vaccinations (and the longest amount of follow-up time) have been in elderly adults. Again, we need more info to interpret.”

Continue Reading

Health

More people died from fentanyl overdose than coronavirus in San Francisco last year

Editor

Published

on

By

(Natural News) More people died from fentanyl overdose than coronavirus (COVID-19) in San Francisco last year, a microcosm of a larger nationwide problem coinciding with the pandemic.

Data from San Francisco’s Office of the Chief Medical Examiner shows that 708 people were killed by fentanyl in 2020, an astonishing 118 times more since the introduction of the drug in the city just five years earlier.

That figure nearly tripled the 254 COVID-19 deaths recorded in the city for the whole of last year. More than 8 in 10 deaths were male, and just under half were white. People aged 55 to 64 made up nearly a quarter of the fatalities. Nearly 40 percent of the deaths occurred in open-air drug markets such as the Tenderloin and South of Market.

The number of overdose deaths in the city could have been far worse as more than 3,000 addicts suffering from an overdose were administered with naloxone, the lifesaving medication that reverses overdoses.

San Francisco’s death rate from fentanyl overdose continues to rise this year as 135 died by overdose in January and February, putting the city on pace for more than 800 deaths by the end of the year.

The city has become a significant part of a larger trend. The Centers for Disease Control and Prevention (CDC) released data on Wednesday, April 14, showing that more than 87,000 Americans died from drug overdose over the 12-month period that ended in September last year – the highest since the opioid epidemic began in the 1990s.

Lockdowns lead to more cases of drug overdose

The surge represents an increasingly urgent public health crisis that may be correlated to the government’s monotonous battle plan against the COVID-19 pandemic.

On March 19 last year, California became the first state in the U.S. to implement a stay-at-home order. It subsequently endured the longest lockdown of any state in the country.

The pandemic and accompanying lockdowns are believed to be partly responsible for the soaring number of drug deaths for obvious reasons. Lockdowns have badly disrupted the social services in the city, including drug addiction treatment. Drug experts say the isolation of the past 12 months is causing vulnerable residents to turn to opioids.

“We see the death and devastation getting worse right in front of us,” said Matt Haney, San Francisco Board of Supervisors member. “It’s an unprecedented spiraling, directly connected to the introduction of fentanyl in our city.”

Fentanyl first appeared on the streets of San Francisco in 2015. There were just six deaths from the synthetic opioid that year, 12 deaths in 2016 and 37 deaths in 2017. The figure skyrocketed when the drugs became widely available in the city in 2018.

Kristen Marshall, manager of the national drug harm reduction DOPE Project, noted the grim irony that while social isolation could save lives from COVID-19, it had undoubtedly contributed to the number of overdose deaths.

“Isolation is also the thing that puts people at the absolute highest risk of overdose death,” she said.

Pandemic exacerbates rise in deaths from drug overdose

The number of deaths from drug overdose started rising in the months leading up to the coronavirus pandemic, making it hard to gauge how closely the two phenomena are linked. But the pandemic unquestionably exacerbated the trend. The biggest jump in overdose deaths took place in April and May when fear and stress were rampant, job losses were multiplying and the strictest lockdown measures were in effect.

Many treatment programs closed during that time while drop-in centers, which provide support, clean syringes and naloxone, cut back services.

The data released by the CDC shows a 29 percent rise in overdose deaths from October 2019 through September 2020 compared with the previous 12-month period. Illicitly manufactured fentanyl and other synthetic opioids were the primary drivers, although many fatal overdoses have also involved stimulant drugs like methamphetamine.

Unlike in the early years of the opioid epidemic, when deaths were largely among white Americans in rural and suburban areas, the current crisis is affecting Black Americans disproportionately.

“The highest increase in mortality from opioids, predominantly driven by fentanyl, is now among Black Americans,” Dr. Nora Volkow, the director of the National Institute on Drug Abuse, said at a national addiction conference last week.

“And when you look at mortality from methamphetamine, it’s chilling to realize that the risk of dying from methamphetamine overdose is 12-fold higher among American Indians and Alaskan Natives than other groups.”

Dr. Volkow added that more deaths than ever involved drug combinations, typically of fentanyl or heroin with stimulants.

“Dealers are lacing these non-opioid drugs with cheaper, yet potent, opioids to make a larger profit,” she said. “Someone who’s addicted to a stimulant drug like cocaine or methamphetamine is not tolerant to opioids, which means they are going to be at high risk of overdose if they get a stimulant drug that’s laced with an opioid like fentanyl.”

The Drug Enforcement Administration (DEA) supported Dr. Volkow’s claim, saying that transnational criminal organizations cause a spike in overdoses by mixing fentanyl into illicit narcotics.

According to the DEA, Mexican cartels often purchase the drug components in China and use human mules to smuggle the narcotics to lucrative drug markets north of the border.

Continue Reading

Chat

Trending