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COVID-19 research scandal: Unwanted diversion during pandemic – Egypt Independent

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June 6, 2020
10:04 am


The first research scandal of the coronavirus pandemic has created unnecessary distraction around the politically divisive drug hydroxychloroquine, scientists say, as questions swirl around the tiny health care company at the center of the affair.

On Thursday, most of the authors of major studies that appeared in The Lancet and the New England Journal of Medicine (NEJM) retracted their work and issued apologies, saying they could no longer vouch for their data after the firm that supplied it — Chicago-based Surgisphere — refused to be audited.

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At any other time the matter might have led to hang-wringing within academia, but it has taken on a new dimension as the world grapples with a virus that has claimed some 400,000 lives.

Of particular interest was the paper in The Lancet that claimed to have analyzed the records of 96,032 patients admitted to 671 hospitals across six continents, finding that hydroxychloroquine showed no benefit and even increased the risk of death.

Its withdrawal is seen as a boost to backers of the decades-old anti-malarial drug, who include US President Donald Trump and his Brazilian counterpart Jair Bolsonaro.

“It’s very politicized — there is a group, probably not particularly small, who have learned to mistrust science and scientists, and this just feeds into that narrative,” Gabe Kelen, a professor of emergency medicine at Johns Hopkins University, told AFP.

This is despite the fact that even without The Lancet paper, evidence has been building against hydroxychloroquine’s use against COVID-19.

On Friday, results from a fourth randomized controlled trial — carefully designed human experiments considered the most robust form of clinical investigation — showed it had no impact against the virus.

– Mystery company –

The Lancet, which first published in 1823, is one of the world’s most trusted medical journals.

As a result, the hydroxychloroquine paper had an outsized impact: the World Health Organization, Britain and France all suspended ongoing clinical trials.

But things soon began unravelling after researchers noticed numerous red flags, from the huge number of patients involved to the unusual level of detail about the doses they had received.

Both The Lancet and the equally prestigious NEJM, which had published a paper on whether blood thinners elevated the risk of COVID-19 that relied on the same company, issued expressions of concern — before the authors themselves pulled both papers.

Surgisphere, founded in 2007 by vascular surgeon Sapan Desai, had refused to share data with third-party reviewers, saying it would violate privacy agreements with hospitals.

However, when science news site The Scientist began reaching out to hospitals throughout the US to ask whether they had participated, it found none.

Surgisphere’s internet profile has also raised numerous questions. Only a handful of employees could be found on LinkedIn, and most have now deactivated their accounts.

According to the Guardian newspaper, its employees included an adult model and until last week the contact page on its website redirected to a WordPress template for a cryptocurrency website, leaving it unclear how hospitals could have reached out to them.

Meanwhile Desai, who according to court records has three outstanding medical malpractice suits against him, has written extensively in the past on research misconduct.

“The most serious cause of fraud in medical publishing is manufactured data that authors use to support high impact conclusions,” he said in a 2013 paper.

– Systemic issues –

For Ivan Oransky, who founded Retraction Watch in 2010, the affair is far from surprising, serving instead to highlight systemic issues in science publishing and the way science is reported to the public.

“No one took a hard look at the data,” said Oransky. “But we’ve known about these issues for literally decades.”

Policymakers should get away from the idea of using the results of a single study to inform their decisions, he added, as was the case for the WHO — and the media has a responsibility to place papers in context instead of hyping them up.

The problem also stems from the fact that even leading journals rely too heavily on an honor system, but “you never know when a catastrophe is going to happen, if you’re not willing to put into place some reasonable safeguards,” added Oransky.

As to the future, the current episode is unlikely to serve as a wake-up call, he said. If one journal increases its diligence, more blockbuster papers will start appearing in its competitors.

Image: AFP/File / GEORGE FREY A pharmacy tech holds a tablet of hydroxychloroquine


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Whooping cough cases up slightly in N.L., as officials warn about risks to infants – CBC.ca

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Newfoundland and Labrador’s top doctor is warning people to stay up to date on whooping cough vaccinations after a small increase in cases this year.

The province usually sees three to four cases of the disease annually. Up to 10 cases have been reported already since January, however, prompting the province’s chief medical officer to raise the issue publicly.

The increase “generally means there’s a little bit more circulating in the community than what’s presenting for care and testing,” Dr. Janice Fitzgerald said Tuesday.

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While officials aren’t overly concerned about a future spike in cases, Fitzgerald said, higher infection rates place infants in particular at risk.

Children under the age of one aren’t yet old enough for the whooping cough vaccine and don’t have immunity to the disease, Fitzgerald said. Infections in small children can be more severe and lead to pneumonia, neurological issues and hospitalization. 

Fitzgerald said parents, grandparents and caregivers should check to ensure their vaccinations are up to date.

Whooping cough, also known as pertussis, causes a persistent nagging cough that’s sometimes severe enough to cause vomiting. Vaccines for the disease are offered in early childhood, during high school and in adulthood. Booster shots should be given 10 years after the high school dose, Fitzgerald said.

“Immunity can wane over time,” she said. “Pertussis does circulate on a regular basis in our community.”

The small increase in cases isn’t yet ringing alarm bells for undervaccination within the general population, she added, noting the province still has a vaccination rate over 90 per cent. 

Download our free CBC News app to sign up for push alerts for CBC Newfoundland and Labrador. Click here to visit our landing page.

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Supervised consumption sites urgently needed, says study – Sudbury.com

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A study in the Canadian Medical Association Journal (CMAJ) said the opioid drug crisis has reached such a critical level that a public safety response is urgently required and that includes the need for expanded supervised consumption sites.

The report was published by the medical journal Monday and was authored by Shaleesa Ledlie, David N. Juurlink, Mina Tadrous, Muhammad Mamdani, J. Michael Paterson and Tara Gomes; physicians and scientists associated with the University of Toronto, Sunnybrook Research Institute and the Li Ka Shing Knowledge Institute at St. Michael’s Hospital.

“The drug toxicity crisis continues to accelerate across Canada, with rapid increases in opioid-related harms following the onset of the COVID-19 pandemic,” the authors wrote. “We sought to describe trends in the burden of opioid-related deaths across Canada throughout the pandemic, comparing these trends by province or territory, age and sex.”

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The study determined that across Canada, the burden of premature opioid-related deaths doubled between 2019 and 2021, representing more than one-quarter of deaths among younger adults. The disproportionate loss of life in this demographic group highlights the critical need for targeted prevention efforts, said the study.

The researchers found that the death rate increased significantly as fentanyl was introduced to the mix of street drugs that individuals were using, in some cases, unknowingly.  

The authors said this demonstrates the need for consumption sites, not only as overwatch as people with addictions consume their drugs, but also to make an effort to identify the substances and inform those people beforehand. 

“The increased detection of fentanyl in opioid-related deaths in Canada highlights the need for expansion of harm-reduction programs, including improved access to drug-checking services, supervised consumption sites, and treatment for substance use disorders,” the authors wrote. 

The study said a more intense public safety response is needed. 

“Given the rapidly evolving nature of the drug toxicity crisis, a public safety response is urgently required and may include continued funding of safer opioid supply programs that were expanded beginning in March 2020, improved flexibility in take-home doses of opioid agonist treatment, and enhanced training for health care workers, harm reduction workers, and people who use drugs on appropriate responses to opioid toxicities involving polysubstance use.

In conclusion, the authors wrote that during the height of the COVID pandemic in 2020 and 2021, the burden of premature death from accidental opioid toxicities in Canada dramatically increased, especially in Alberta, Saskatchewan, and Manitoba. 

“In 2021, more than 70 per cent of opioid-related deaths occurred among males and about 30 per cent occurred among people aged 30–39 years, representing one in every four deaths in this age group. The disproportionate rates of opioid-related deaths observed in these demographic groups highlight the critical need for the expansion of targeted harm reduction–based policies and programs across Canada,” said the study.

The full text of the report can be found online here.

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Business Plan Approved for Cancer Centre at NRGH – My Cowichan Valley Now

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A business plan for a new BC Cancer Centre at Nanaimo Regional General Hospital has been approved by the province. 

 

Health Minister Adrian Dix  says the state-of-the-art cancer facility will benefit patients in Nanaimo and the surrounding region through the latest medical technology.
 

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The facility will have 12 exam rooms, four consultation rooms and space for medical physicists and radiation therapists, medical imaging and radiation treatment of cancer patients. 

 

The procurement process is underway, and construction is expected to begin in 2025 and be complete in 2028. 

 

Upgrades to NRGH have also been approved, such as a new single-storey addition to the ambulatory care building and expanded pharmacy. 

 

Dix says Nanaimo’s population is growing rapidly and aging, and stronger health services in the region, so people get the health care they need closer to home. 

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