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Charges of racial bias in the design of an Oregon study of COVID-19’s spread are raising questions about whether it will do anything to help Black and Latino communities, which have been among those hardest hit by the pandemic...“All it will be able to say is if white people are fine. And then we open up counties and people of color will die,” said Andres Lopez, research director for the Coalition of Communities of Color, a Portland-based alliance of organizations representing a number of different communities of color...The Key to Oregon Study, which plans to enlist 100,000 Oregonians and monitor them for a year for COVID-19 symptoms, will include what its designers are calling “a focus on enrolling people who fully represent the state, including our diversity in geography, socioeconomic status and communities of color.”...critics doubt Key to Oregon will succeed in its goal. They say the study design is fundamentally flawed, and that those flaws could have been avoided if people of color had been brought to the table when the study was being created...READ MORE

-Responding with listening sessions
-Advocates say study design suppresses Black and Latino voices
-OHSU methodology overlooks lessons of the past
-The principle of ‘nothing about us without us’
-OHSU researchers respond

The European Commission called...for global leaders to cooperate to buy bulk quantities of potential COVID-19 vaccines, to avoid “harmful competition” in the race for a shot and ensure any future vaccine is available for poor countries...With around a dozen potential vaccines now in human trials, rich countries have been rushing to buy up doses in advance from pharmaceutical companies, to make sure they will have enough supply should any prove successful...The European Commission, the EU executive arm, is worried that such competition could raise the prices of vaccines for everyone, and also leave many countries, mostly poor ones, struggling to obtain a supply...READ MORE

How accurate are the coronavirus tests used in the U.S.?...Months into the outbreak, no one really knows how well many of the screening tests work, and experts at top medical centers say it is time to do the studies to find out...The FDA said in a statement that it has already asked multiple test makers to do follow-up accuracy studies, although it didn’t say for how many of the more than 110 authorized screening tests. The agency also said it is tracking reports of problems. Accuracy has also been an issue with blood tests that look for signs of past infections...the FDA warned doctors of a potential accuracy problem with Abbott Laboratories’ rapid ID Now test, which delivers results in roughly 15 minutes...READ MORE

The Department of Health and Human Services will dole out another $25 billion in funding targeted at healthcare providers that primarily serve Medicaid and low-income patients...The agency will distribute $15 billion to providers that participate in Medicaid and CHIP programs, and another $10 billion to safety-net hospitals...The funds are intended to help hundreds of thousands Medicaid providers that did not receive funding through the general distribution that went out to providers in April and May...Safety-net hospitals, which provide a significant proportion of care to uninsured and low-income patients, will be able to receive between $5 million and $50 million. HHS said it plans to distribute the funds to hospitals this week...READ MORE

The FDA released a warning to health care providers concerning an update on potential drug reactions for remdesivir, an antiviral drug that is being evaluated as a potential treatment for the novel coronavirus disease 2019 and has also been granted emergency use authorization status for treating hospitalized patients with severe COVID-19...The FDA is also revising their fact sheet for health care providers to include the warning that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate may result in less effective antiviral activity of remdesivir. The revised fact sheet also clarifies dosing and administration recommendations, and will provide additional safety data and updates from clinical trials from the National Institutes of Health and Gilead Sciences, Inc, the company that sponsors the drug and has donated 607,000 vials of remdesivir to the United States government...READ MORE

Around 10 million people will be on the waiting list for NHS treatment by the end of the year, more than double the current figure, health bosses have warned...Projections show the combined effects of keeping up social distancing, the backlog of treatments and challenges around staffing mean the list could rise from 4.2 million currently to around 10 million by Christmas...This is the most realistic scenario, and assumes the health service making a steady return to full capacity within the next 12 months...The pessimistic scenario, according to the NHS Confederation, assumes a second wave of Covid-19 and a lack of treatments or a vaccine, pushing the waiting list to around 11 million by the end of the year...The confederation, which represents health and care leaders, published a new report warning that the health service in England "faces an uphill battle" as it continues to manage thousands of sick and recovering Covid-19 patients while also trying to restart services such as those for cancer, stroke and heart disease...READ MORE

U.S. regulators on Monday revoked emergency authorization for malaria drugs...amid growing evidence they don’t work and could cause serious side effects...The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”...The move means that shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities for use against the coronavirus. The drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing...READ MORE

The report on...a powerful treatment for the new coronavirus brought skepticism along with optimism among U.S. doctors, who said the recent withdrawal of an influential COVID-19 study left them wanting to see more data...Global pressure to find a cure or vaccine has accelerated the process of reporting coronavirus study results, feeding confusion over whether therapies have been proven effective. One influential COVID study was withdrawn this month by respected British medical journal The Lancet over data concerns...Researchers in Britain said dexamethasone, used to fight inflammation in other diseases, reduced death rates of the most severely ill COVID-19 patients by around a third, and they would work to publish full details as soon as possible...But hours later South Korea’s top health official cautioned about the use of the drug for COVID-19 patients due to potential side effects...READ MORE

Following in the footsteps of British Columbia, other Canadian provinces are working to implement their own biosimilars initiatives that would switch patients from some of the most costly reference biologics to biosimilar counterparts...A look at the numbers explains why Canadian provinces are introducing automatic biosimilar switching policies...In Ontario, one of 4 provinces that are moving forward with forced switching, a total of $800,000 was spent on publicly funded biologic medications in 2018, up nearly 3-fold from $259.4 million in 2010, and the projection is for the total to reach $1 billion in 2021...“The Biosimilars Initiative is a result of PharmaCare’s evidence-informed strategy to better optimize our public resources, get the best value for new treatments and services, and improve access to biologic medications for patients,” BC government officials said...READ MORE

With little still known about the novel coronavirus and its treatments, some shady websites are grabbing coronavirus-related URLs to push unproven products to consumers...The Food and Drug Administration has issued more than 20 warning letters since mid-May to websites selling unproven COVID-19 treatments. These online retailers are selling products like hydroxychloroquine, essential oils and alternative sanitizers that claim to treat COVID-19 or kill the virus on surfaces...The FDA took action against these websites, requiring that they remove claims that certain products will treat COVID-19 and stop selling drugs like chloroquine for unapproved uses...READ MORE