- EMA urged to release full clinical trial data upon authorizing Covid-19 treatments (statnews.com)
Amid worldwide clamor for Covid-19 medicines and vaccines, the European Medicines Agency is being urged by several international clinical evidence experts...to publish all trial data on the same day any product is authorized for use against the novel coronavirus...In a letter to the European regulator, four country directors from the independent watchdog Cochrane and leaders from Germany’s Institute for Quality and Efficiency in Health Care argued that it is critical to promptly release clinical study reports to support further research and proper medical care. The reports are go-to documents that contain myriad details about the methods and results of a clinical trial...READ MORE
- U.S. sends Brazil 2 million doses of hydroxychloroquine, drug touted by Trump (reuters.com)
The United States has supplied Brazil with 2 million doses of hydroxychloroquine for use against the coronavirus, the two governments said...despite medical warnings about risks associated with the anti-malaria drug...The White House released a joint announcement on the drug, whose use has been touted both by U.S. President Donald Trump and Brazilian President Jair Bolsonaro, just days after the World Health Organization suspended testing it in COVID-19 patients because of safety concerns...HCQ will be used as a prophylactic to help defend Brazil’s nurses, doctors and healthcare professionals against the virus. It will also be used as a therapeutic to treat Brazilians who become infected...READ MORE
- As Nevada ramps up antibody testing, CDC issues accuracy warning (reviewjournal.com)
The federal Centers for Disease Control and Prevention warned this week that some coronavirus antibody tests are inaccurate and cautioned that even the better tests should not be used to determine who can safely return to work or school...“Suffice to say, CDC is adequately worried about all the junk (antibody) tests that FDA let out on the market,” Mark Pandori, the director of Nevada State Public Health Laboratory, said...The CDC’s guidance comes at a time when public health agencies in Nevada are ramping up to offer the antibody tests to the public...READ MORE
- Taxpayers paid to develop remdesivir but will have no say when Gilead sets price (chron.com)
One drug that has shown promise for treating COVID-19 is remdesivir, an experimental antiviral product...The drug that buoyed expectations for a coronavirus treatment and drew international attention for Gilead Sciences, remdesivir, started as a reject, an also-ran in the search for antiviral drugs. Its path to relevance did not begin until Robert Jordan cleared it…To make progress, Gilead needed help from U.S. taxpayers. Lots of help. Three federal health agencies were deeply involved in remdesivir's development every step of the way, providing tens of millions of dollars of government research support. Now that big government role has set up a political showdown over pricing and access...federal agencies have not asserted patent rights to Gilead's drug, potentially a blockbuster therapy worth billions of dollars. That means Gilead will have few constraints other than political pressure when it sets a price in coming weeks..."Without direct public investment and tax subsidies, this drug would apparently have remained in the scrap heap of unsuccessful drugs...READ MORE
- Delays getting records means crucial virus questions go unanswered (reviewjournal.com)
Nevada Gov. Steve Sisolak has touted open government as a crucial aspect to the state’s response to the COVID-19 outbreak. “You deserve transparency,” he proclaimed during an April 8 news conference, a statement reflecting the Nevada Public Records Act’s promise of open access to most government documents...But records vital to evaluating how Sisolak’s administration and state agencies have navigated the unprecedented emergency have proved difficult to obtain...Even a simple request for daily reports on hospital capacity made in early April, which would have spanned only a few pages at the time, was met with a response from a senior policy analyst in Sisolak’s office to wait “eight to 10 weeks” to receive the record...Among the requested documents that state agencies have delayed in producing or denied access to are the following:
■ Emergency management plans related to disease outbreaks or widespread health emergencies. Officials took more than 40 days to deny the request.
■ Documents tracking testing of prison inmates and staff for COVID-19. Denied by officials after 13 days.
■ Written communications among top prison officials about COVID-19 testing. Officials said they would respond “in the next 45 days.”
■ Records related to Nevada’s government stockpile of personal protective gear for medical workers. Officials said it will take “eight to ten weeks or longer” to compile the documents....READ MORE
- UNR medical students face their fears to help test community for COVID-19 (thenevadaindependent.com)
Evans (Lauran Evans, a recent graduate of the University Nevada, Reno’s School of Medicine) was the first medical student at the university to volunteer as a swabber at the district site at the Reno-Livestock Events Center...She started helping out in March after the university canceled in-person classes...About 70 medical students are now volunteering as testers, babysitters and phone bankers through the Washoe County Health District, Reno’s Emergency Medical Services Authority and other providers...READ MORE
- Trump cutting U.S. ties with World Health Organization over virus (reuters.com)
The United States will end its relationship with the World Health Organization over the body’s handling of the coronavirus pandemic, U.S. President Donald Trump said on Friday, accusing the U.N. agency of becoming a puppet of China...The move to quit the Geneva-based body, which the United States formally joined in 1948, comes amid growing tensions between Washington and Beijing over the coronavirus outbreak...Speaking in the White House Rose Garden, Trump said Chinese officials “ignored their reporting obligations” to the WHO about the virus - that has killed hundreds of thousands of people globally - and pressured the agency to “mislead the world.”...READ MORE
- As casinos prepare to reopen, the Culinary Union remains uneasy about worker safety (thenevadaindependent.com)
Gov. Steve Sisolak announced casinos could reopen June 4. Then the Nevada Gaming Control Board updated its health and safety policy, which outlines requirements aimed at preventing the spread of COVID-19. Gaming companies quickly followed suit and unveiled which of their properties would be reopening along with some of the steps they’re taking to protect both workers and guests...But the process hasn’t appeased the powerful Culinary Workers Union Local 226, which represents roughly 60,000 employees who work in casinos-resort properties as guest room attendants, cooks, porters, baristas, bartenders and cashiers, among other roles...READ MORE
- Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine (statnews.com)
Heavy hearts soared Monday with news that Moderna’s Covid-19 vaccine candidate — the frontrunner in the American market — seemed to be generating an immune response in Phase 1 trial subjects…But was there good reason for so much enthusiasm?...based on the information made available...there’s really no way to know how impressive — or not — the vaccine may be...While Moderna blitzed the media, it revealed very little information — and most of what it did disclose were words, not data...Even the figures the company did release don’t mean much on their own, because critical information — effectively the key to interpreting them — was withheld...Experts suggest we ought to take the early readout with a big grain of salt...READ MORE
- Doctors sue to block FDA abortion pill rule during pandemic (apnews.com)
Requiring patients to visit a hospital, clinic or medical office to get an abortion pill is needlessly risking their health during the COVID-19 pandemic, a group of physicians allege in a lawsuit that seeks to suspend the federal rule...The federal lawsuit, which the American Civil Liberties Union filed...in Maryland, questions why patients can’t fill a prescription for mifepristone by mail. The U.S. Food and Drug Administration approved mifepristone to be used in combination with a second drug, misoprostol, to end an early pregnancy or manage a miscarriage...“Of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic, or medical office, yet may self-administer, unsupervised, at a location of their choosing,” the lawsuit says...READ MORE