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Paper raises new questions about the federal government's decision to sell licensing rights to Ebola vaccine – Ottawa Citizen

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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.”

Related

“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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Pakistan says trial of Chinese traditional medicine for COVID-19 successful

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Pakistani health authorities on Monday announced the completion of a successful clinical trial of Chinese traditional herbal medicine for treating COVID-19, as the South Asian nation enters a fifth wave of the pandemic driven by the Omicron variant.

The Chinese medicine, Jinhua Qinggan Granules (JHQG) manufactured by Juxiechang (Beijing) pharmaceutical Co Ltd, is already being used in treatment of COVID-19 patients in China.

“Since it was tried on patients with different variants of COVID-19, we expect it to be effective on Omicron as on other variants,” Professor Iqbal Chaudhry, director of the International Center for Chemical and Biological Science (ICCBS) where trials were conducted, told reporters.

The trials were conducted on 300 patients who were treated at home, and would work on mild to moderate COVID-19 cases, Dr Raza Shah, principal investigator in the trials, told reporters, adding that the efficacy rate was around 82.67%.

The trials were approved by the Drug Regulatory Authority Pakistan.

Pakistan reported 4,340 COVID-19 cases on Monday, the highest recorded in a 24-hour period in three months. Karachi, the country’s largest city, recorded a positivity rate – the percentage of tests coming back positive – of 39.39% at the weekend, the highest so far.

“In the last seven days, COVID cases in Pakistan have increased by 170% while deaths have also increased by 62%,” the National Command Operation Centre (NCOC), which is overseeing the pandemic response, said in a tweet on Monday.

 

(Reporting by Syed Raza Hassan; Editing by Alex Richardson)

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How (and why) to 'green' your Mediterranean diet – The Globe and Mail

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An 18-month trial published Jan. 10 in the American Journal of Clinical Nutrition investigated the effect of a ‘green’ Mediterranean diet) on age-related brain atrophy.Hayden Bird/Getty Images/iStockphoto

A Mediterranean diet has been tied to better cognitive function, a lower rate of cognitive decline and a reduced risk of Alzheimer’s disease.

This eating pattern, plentiful in fruits and vegetables, whole grains, nuts and olive oil, has also been associated with lower rates of age-related brain atrophy, brain damage which can lead to cognitive impairment and dementia.

So far, though, there’s sparse data from randomized controlled trials on whether following a Mediterranean diet can preserve brain volume.

Until now.

New research from Israel has shown that eating a Mediterranean diet slowed the age-related loss of brain tissue. What’s more, a new take on the diet, a “green” Mediterranean diet, had even greater brain-health benefits.

The latest study

The 18-month DIRECT PLUS trial, published Jan. 10 in the American Journal of Clinical Nutrition, investigated the effect of a high-polyphenol Mediterranean diet (a “green” Mediterranean diet) on age-related brain atrophy.

Polyphenols are naturally occurring compounds found in a wide range of plant foods. DIRECT PLUS stands for Dietary Intervention Randomized Controlled Trial – Polyphenols Unprocessed.

The researchers assigned 284 adults with abdominal obesity, average age 51, to one of three diet groups: 1) healthy diet guidelines, 2) a Mediterranean diet or, 3) a higher-polyphenol green Mediterranean diet.

Both Mediterranean diets were calorie-restricted and included 28 g of walnuts (e.g., 14 walnut halves), nuts high in polyphenols.

To boost polyphenols, the green Mediterranean diet included four to five cups of green tea daily and a green shake containing Mankai, a branded strain of an aquatic plant called duckweed (or water lentils). Those in the green Mediterranean diet group also further reduced their intake of processed and red meat.

All participants received free gym memberships and a program of aerobic and resistance exercise.

Participants underwent brain MRI (magnetic-resonance-imaging) scans before and after the trial. Specific areas of the brain were measured as indicators of brain atrophy and predictors of future dementia risk.

Over 18 months, participants in both Mediterranean diet groups had a significantly lower decline in brain atrophy compared to the healthy diet guideline group. The greatest decline in brain tissue loss, however, was observed among those consuming the green Mediterranean diet, especially in people over age 50.

The green Mediterranean diet components – green tea, Mankai and walnuts – were each associated with reduced brain atrophy, as was eating less red and processed meat.

Participants in both Mediterranean diet groups also had improvements in insulin sensitivity, which was also tied to less brain volume loss.

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Limitations, strengths

The study didn’t show a significant effect of either Mediterranean diet on cognition, perhaps because the study wasn’t long enough and/or it involved relatively young and healthy people.

All diet groups participated in physical exercise, which may have contributed to the slowdown of brain atrophy.

The strengths of this study include participants high adherence to their diets and that, to date, it’s the longest and largest brain MRI study investigating the effect diet on brain atrophy.

How polyphenols protect the brain

The beneficial effect of the Mediterranean diet on brain aging is thought to be due, at least in part, to its abundance of polyphenols, phytochemicals which have antioxidant and anti-inflammatory properties.

Polyphenols can cross the blood-brain barrier and have been shown to reduce nerve cell inflammation and stimulate an increase in brain cells.

Eating a Mediterranean diet rich in fish, vegetables and olive oil is also thought to protect the brain from a buildup of proteins that form plaques and destroy brain cells.

‘Greening’ your Mediterranean diet

Following a Mediterranean eating pattern means including vegetables, fruit, whole grains, pulses, nuts and olive oil in your daily diet.

Limit red meat to three meals a week. The green Mediterranean diet limits meat even further, getting more protein from beans, lentils and nuts. Flavour meals with polyphenol-rich herbs and spices.

Build on these staples by adding more polyphenol-rich foods to your daily diet, including 28 g of walnuts. Drink three or four cups of green tea each day (white and oolong tea also have polyphenols).

Drinking a Mankai green shake may be more challenging, though, at least for Canadians. In the U.S., frozen cubes of Mankai duckweed are sold online through Amazon and WW (Weight Watchers). Mankai duckweed powder is also available online.

Add other polyphenol-rich foods to your diet, too, such as berries, apples, kale, broccoli, spinach, cocoa, tofu, edamame, flaxseed and pecans.

Leslie Beck, a Toronto-based private practice dietitian, is director of food and nutrition at Medcan. Follow her on Twitter @LeslieBeckRD

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Moderna CEO says data for Omicron-specific shot likely available in March

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Moderna Inc’s vaccine candidate against the Omicron coronavirus variant will enter clinical development in the next few weeks and the company expects to be able to share data with regulators around March, CEO Stephane Bancel said on Monday.

“The vaccine is being finished … it should be in the clinic in coming weeks. We are hoping in the March timeframe to be able to have data to share with regulators to figure out next steps,” Bancel said at the World Economic Forum’s virtual Davos Agenda conference.

Moderna is also developing a single vaccine that combines a booster dose against COVID-19 with its experimental flu shot. (https://reut.rs/3FAeyya)

Bancel said the best case scenario was the combined COVID/flu vaccine would be available by the fall of 2023, at least in some countries.

“Our goal is to be able to have a single annual booster so that we don’t have compliance issues where people don’t want to get two to three shots a winter.”

Many countries are already offering a third dose of a COVID-19 vaccine to their citizens, especially to older individuals and those who are immunocompromised, while Israel has started offering its citizens a fourth dose.

Earlier in January, Moderna’s CEO said people may need a fourth shot in the fall of 2022 as the efficacy of boosters against COVID-19 was likely to decline over the next few months.

However, booster programs have met with skepticism from some disease experts over whether, and how widely, additional doses should become available, including the European Union’s drug regulator, which has expressed doubts about the need for a fourth booster dose.

Speaking at the same event, top U.S. infectious disease expert Anthony Fauci said there was no evidence that repeat booster doses would overwhelm the immune system.

“Giving boosters at different times, there is really no evidence that’s going to hinder (immune response).”

Fauci said the goal should be to have a booster that induces a response against multiple potential variants.

 

(Reporting by Mrinalika Roy in Bengaluru; Editing by Mark Potter)

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