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Paper raises new questions about the federal government’s decision to sell licensing rights to Ebola vaccine

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The U.S. drug company that has made tens of millions of dollars licensing the Canadian-developed Ebola vaccine did “next to nothing” to get that vaccine into production, the lead author of a newly published paper charges.


A young woman reacts as a health worker injects her with the Ebola vaccine, in Goma, Democratic Republic of Congo, August 5, 2019.


Baz Ratner / REUTERS

The U.S. drug company that has made tens of millions of dollars licensing the Canadian-developed Ebola vaccine did “next to nothing” to get that vaccine into production, the lead author of a newly published paper charges.

Instead, it was Canadian scientists — including a former Ottawa woman who never had a permanent job in Canada’s national microbiology laboratory — and others supported by public funding, who did the crucial work that enabled the vaccine to be used experimentally during the 2014-2015 West African Ebola outbreak, potentially saving thousands of lives.

The paper was published Thursday in the Journal of Law and the Biosciences and is based on 1,600 partly redacted documents obtained through access to information by authors Matthew Herder, director of Dalhousie University’s Health Law Institute, Janice Graham of Dalhousie’s department of pharmacology and Richard Gold of the faculty of law at McGill University.

In 2010, the Public Health Agency of Canada granted sole license of the vaccine that was created in its labs to a small Iowa-based startup called BioProtection Systems Inc. (BPS) for around $205,000 Canadian, according to the authors. The company, which had never developed a product through to regulatory approval, later sublicensed it to Merck for $50 million (U.S). Merck is now producing the vaccine, which became the world’s first licensed Ebola vaccine last month.

The paper is raising new questions about the federal government’s decision to sell licensing rights for the vaccine to the small company, BPS, which was later bought by NewLink Genetics Corporation. It also raises questions about the prevailing theory that only private industry can bring drugs and vaccines to market, saying the Ebola vaccine example suggests otherwise.

Although Merck earned recognition for its support of the clinical trials that were run partway through the West African Ebola epidemic, the record shows that “it was the public sector, not Merck, that provided all of the financing, including for clinical trials, during the West African epidemic,” write the authors.

The paper questions whether the vaccine could have been available earlier, at the beginning of the deadly outbreak, if the federal government had taken a different approach to its development.

Critics have, in the past, raised concerns that the company that bought licensing rights to the Ebola vaccine allowed it to languish during the deadly Ebola outbreak, despite requirements under the licensing agreement that it actively move it toward production. The paper supports those concerns.

The vaccine was developed at the Public Health Agency of Canada’s National Microbiology Laboratory in Winnipeg, a project that began in 1999 when the lab recruited Heinz Feldmann from the University of Marburgh in Germany to be the chief of its special pathogens program. Within three years, he and his colleagues developed an Ebola vaccine candidate, which still had to be tested on humans in a series of clinical trials before it could be licensed. The government sold sole licensing rights to the vaccine under a contract that required BioProtection Systems Inc. to make reasonable efforts to commercialize the vaccine and to deliver written reports on its progress.

The agreement spelled out that shelving the vaccine would be tantamount to “fundamental breach” of the contract, according to the paper. The agreement between the Public Health Agency of Canada and the small Iowa-based startup also included an agreement that BPS would make “reasonable efforts” to develop the vaccine and deliver written reports on the progress.

But Herder said the documents obtained by the authors show BPS did “virtually nothing.”

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“Contrary to the terms of the license, BPS failed to deliver a single written report of its commercialization progress during 2010-2014 (the four years leading up to the West African epidemic),” according to the paper. “Other documentation betrays a pattern of delay,” when it came to running pre-clinical experiments.

Among actions the company did take were meeting with the Federal Drug Administration to clarify what types of testing would be needed for a Phase 1 trial. It took a year and a half, according to the paper, for the company to arrange that meeting.

“In short, BPS did not complete any of the experimental objectives outlined in its vaccine development plan.”

The paper also highlights the work done by former Ottawa resident Julie Alimonti, an immunologist who volunteered to take over as project manager for the vaccine at a time when the project was at risk of being scrapped as scientists left the Public Health Agency of Canada.


Judie Alimonti.

Postmedia

In an interview, Herder said Alimonti, who was precariously employed by the Public Health Agency of Canada and never had a permanent contract, deserves recognition for the crucial role she played in getting the vaccine candidate ready to be used in clinical trials in West Africa.

“She is an unsung hero who has, to date, in my view not received the credit she deserves.”

He said he is “highly skeptical” that the vaccine could have been used in clinical trials during the West African outbreak without her intervention.

Alimonti died of cancer in 2017. She was 57 years old. Before her death, she left the Public Health Agency of Canada and was working at the National Research Council on a Zika vaccine.

The research paper also raises broader questions about the prevailing theory of drug and vaccine development — that only the private sector can do it.

Herder said that needs to be rethought and public institutions like the National Microbiology Laboratory, which has faced ongoing budget cuts, need to be properly funded to allow such work to flourish. The issue is particularly important, the paper suggests, at a time of exorbitant drug costs.

Development of the Ebola vaccine is a case study of why that thinking should change, according to the paper.

Instead of celebrating the milestone of the Canadian-developed vaccine finally obtaining market approval, the paper says, “our analysis raises the question as to whether (the vaccine) could have been available earlier if public laboratories had taken a different approach to the vaccine’s development.”

The article can be found at: https://academic.oup.com/jlb/advance-article/doi/10.1093/jlb/lsz019/5706941

 

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Older patients, non-English speakers more likely to be harmed in hospital: report

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Patients who are older, don’t speak English, and don’t have a high school education are more likely to experience harm during a hospital stay in Canada, according to new research.

The Canadian Institute for Health Information measured preventableharmful events from 2023 to 2024, such as bed sores and medication errors,experienced by patients who received acute care in hospital.

The research published Thursday shows patients who don’t speak English or French are 30 per cent more likely to experience harm. Patients without a high school education are 20 per cent more likely to endure harm compared to those with higher education levels.

The report also found that patients 85 and older are five times more likely to experience harm during a hospital stay compared to those under 20.

“The goal of this report is to get folks thinking about equity as being a key dimension of the patient safety effort within a hospital,” says Dana Riley, an author of the report and a program lead on CIHI’s population health team.

When a health-care provider and a patient don’t speak the same language, that can result in the administration of a wrong test or procedure, research shows. Similarly, Riley says a lower level of education is associated with a lower level of health literacy, which can result in increased vulnerability to communication errors.

“It’s fairly costly to the patient and it’s costly to the system,” says Riley, noting the average hospital stay for a patient who experiences harm is four times more expensive than the cost of a hospital stay without a harmful event – $42,558 compared to $9,072.

“I think there are a variety of different reasons why we might start to think about patient safety, think about equity, as key interconnected dimensions of health-care quality,” says Riley.

The analysis doesn’t include data on racialized patients because Riley says pan-Canadian data was not available for their research. Data from Quebec and some mental health patients was also excluded due to differences in data collection.

Efforts to reduce patient injuries at one Ontario hospital network appears to have resulted in less harm. Patient falls at Mackenzie Health causing injury are down 40 per cent, pressure injuries have decreased 51 per cent, and central line-associated bloodstream infections, such as IV therapy, have been reduced 34 per cent.

The hospital created a “zero harm” plan in 2019 to reduce errors after a hospital survey revealed low safety scores. They integrated principles used in aviation and nuclear industries, which prioritize safety in complex high-risk environments.

“The premise is first driven by a cultural shift where people feel comfortable actually calling out these events,” says Mackenzie Health President and Chief Executive Officer Altaf Stationwala.

They introduced harm reduction training and daily meetings to discuss risks in the hospital. Mackenzie partnered with virtual interpreters that speak 240 languages and understand medical jargon. Geriatric care nurses serve the nearly 70 per cent of patients over the age of 75, and staff are encouraged to communicate as frequently as possible, and in plain language, says Stationwala.

“What we do in health care is we take control away from patients and families, and what we know is we need to empower patients and families and that ultimately results in better health care.”

This report by The Canadian Press was first published Oct. 17, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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Alberta to launch new primary care agency by next month in health overhaul

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CALGARY – Alberta’s health minister says a new agency responsible for primary health care should be up and running by next month.

Adriana LaGrange says Primary Care Alberta will work to improve Albertans’ access to primary care providers like family doctors or nurse practitioners, create new models of primary care and increase access to after-hours care through virtual means.

Her announcement comes as the provincial government continues to divide Alberta Health Services into four new agencies.

LaGrange says Alberta Health Services hasn’t been able to focus on primary health care, and has been missing system oversight.

The Alberta government’s dismantling of the health agency is expected to include two more organizations responsible for hospital care and continuing care.

Another new agency, Recovery Alberta, recently took over the mental health and addictions portfolio of Alberta Health Services.

This report by The Canadian Press was first published Oct. 15, 2024.

The Canadian Press. All rights reserved.

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Experts urge streamlined, more compassionate miscarriage care in Canada

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Rana Van Tuyl was about 12 weeks pregnant when she got devastating news at her ultrasound appointment in December 2020.

Her fetus’s heartbeat had stopped.

“We were both shattered,” says Van Tuyl, who lives in Nanaimo, B.C., with her partner. Her doctor said she could surgically or medically pass the pregnancy and she chose the medical option, a combination of two drugs taken at home.

“That was the last I heard from our maternity physician, with no further followup,” she says.

But complications followed. She bled for a month and required a surgical procedure to remove pregnancy tissue her body had retained.

Looking back, Van Tuyl says she wishes she had followup care and mental health support as the couple grieved.

Her story is not an anomaly. Miscarriages affect one in five pregnancies in Canada, yet there is often a disconnect between the medical view of early pregnancy loss as something that is easily managed and the reality of the patients’ own traumatizing experiences, according to a paper published Tuesday in the Canadian Medical Association Journal.

An accompanying editorial says it’s time to invest in early pregnancy assessment clinics that can provide proper care during and after a miscarriage, which can have devastating effects.

The editorial and a review of medical literature on early pregnancy loss say patients seeking help in emergency departments often receive “suboptimal” care. Non-critical miscarriage cases drop to the bottom of the triage list, resulting in longer wait times that make patients feel like they are “wasting” health-care providers’ time. Many of those patients are discharged without a followup plan, the editorial says.

But not all miscarriages need to be treated in the emergency room, says Dr. Modupe Tunde-Byass, one of the authors of the literature review and an obstetrician/gynecologist at Toronto’s North York General Hospital.

She says patients should be referred to early pregnancy assessment clinics, which provide compassionate care that accounts for the psychological impact of pregnancy loss – including grief, guilt, anxiety and post-traumatic stress.

But while North York General Hospital and a patchwork of other health-care providers in the country have clinics dedicated to miscarriage care, Tunde-Byass says that’s not widely adopted – and it should be.

She’s been thinking about this gap in the Canadian health-care system for a long time, ever since her medical training almost four decades ago in the United Kingdom, where she says early pregnancy assessment centres are common.

“One of the things that we did at North York was to have a clinic to provide care for our patients, and also to try to bridge that gap,” says Tunde-Byass.

Provincial agency Health Quality Ontario acknowledged in 2019 the need for these services in a list of ways to better manage early pregnancy complications and loss.

“Five years on, little if any progress has been made toward achieving this goal,” Dr. Catherine Varner, an emergency physician, wrote in the CMAJ editorial. “Early pregnancy assessment services remain a pipe dream for many, especially in rural Canada.”

The quality standard released in Ontario did, however, prompt a registered nurse to apply for funding to open an early pregnancy assessment clinic at St. Joseph’s Healthcare Hamilton in 2021.

Jessica Desjardins says that after taking patient referrals from the hospital’s emergency room, the team quickly realized that they would need a bigger space and more people to provide care. The clinic now operates five days a week.

“We’ve been often hearing from our patients that early pregnancy loss and experiencing early pregnancy complications is a really confusing, overwhelming, isolating time for them, and (it) often felt really difficult to know where to go for care and where to get comprehensive, well-rounded care,” she says.

At the Hamilton clinic, Desjardins says patients are brought into a quiet area to talk and make decisions with providers – “not only (from) a physical perspective, but also keeping in mind the psychosocial piece that comes along with loss and the grief that’s a piece of that.”

Ashley Hilliard says attending an early pregnancy assessment clinic at The Ottawa Hospital was the “best case scenario” after the worst case scenario.

In 2020, she was about eight weeks pregnant when her fetus died and she hemorrhaged after taking medication to pass the pregnancy at home.

Shortly after Hilliard was rushed to the emergency room, she was assigned an OB-GYN at an early pregnancy assessment clinic who directed and monitored her care, calling her with blood test results and sending her for ultrasounds when bleeding and cramping persisted.

“That was super helpful to have somebody to go through just that, somebody who does this all the time,” says Hilliard.

“It was really validating.”

This report by The Canadian Press was first published Oct. 15, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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