 Welcome to Wednesday's Overnight Healthcare. It was a day of mixed news for President Trump's favorite drug hydroxychloroquine. COVID-19 cases are on the rise, but more businesses are opening in Florida. And a watchdog group wants the SEC to investigate stock sales made by top executives at Moderna. We'll start with hydroxychloroquine: Hydroxychloroquine ineffective in preventing COVID-19: study There’s new evidence that hydroxychloroquine, a drug touted by President Trump, is not effective as protection against the coronavirus. This was the first randomized, placebo-controlled study to look at whether the anti-malaria drug was an effective prophylactic. The study, published in the New England Journal of Medicine on Wednesday, looked at 821 people in the U.S. and Canada who had been exposed to the coronavirus and found that hydroxychloroquine was no more effective than a placebo at preventing them from becoming sick. “Our objective was to answer the question of whether hydroxychloroquine worked to prevent disease or did not work,” said David Boulware, who launched the trial at the University of Minnesota in March. “While we are disappointed that this did not prevent COVID-19, we are pleased that we were able to provide a conclusive answer. Our objective was to find an answer.” Another problem: Forty percent of patients developed non-serious side effects, including nausea, upset stomach or diarrhea, but no serious side effects or cardiac complications were detected. Context: President Trump said last month that he took the drug for several days as a precaution, even though there had been no clinical evidence of its safety. Federal regulators have cautioned against taking hydroxychloroquine outside of a hospital or a clinical trial. Read more here. More on hydroxychloroquine: WHO to resume hydroxychloroquine clinical study The muddled evidence on hydroxychloroquine was in full view on Wednesday. Before the University of Minnesota study was released, the World Health Organization (WHO) said it would resume a clinical trial to examine whether hydroxychloroquine is an effective treatment for COVID-19. Enrollment in the hydroxychloroquine arm of the WHO's Solidarity Trial was temporarily paused last week after an article in The Lancet medical journal warned about the safety of the drug. The authors of the journal article tied hydroxychloroquine to higher mortality rates in hospitalized patients with COVID-19, as well as an increased risk of a dangerously abnormal heart rate. As a result, WHO decided to pause enrollment in the trial and allow the trial’s data safety monitoring board to analyze the results and determine if there were any safety concerns. Between the lines: The Lancet study was billed as the largest examination of the effects of the drug, but it was based on analyzing a database of patient records, not a gold-standard trial. And experts have since raised questions about the accuracy of that data. There's a lot of hype around hydroxychloroquine, and President Trump has turned it into a political messaging tool. But there's been no clinical data to show safety and effectiveness, which is why the eventual outcome of the WHO trial, as well as one being conducted in the U.S. by the National Institutes of Health, could be important. Read more here.
Some reassurance: WHO says no evidence coronavirus is mutating Senior officials at the World Health Organization (WHO) said Wednesday there is no evidence that the coronavirus circulating around the globe has mutated in ways that would make it more virulent or more easily transmissible. Maria Van Kerkhove, who leads the WHO team tasked with synthesizing the science behind the virus, told reporters that virologists around the world had sequenced more than 40,000 full genomes of SARS-CoV-2. Those sequences show small and normal mutations, though nothing that suggests the virus is becoming more or less dangerous. "The virus itself is stable, is relatively stable," Van Kerkhove said. "They aren't mutating in a way that makes the virus more transmissible or more severe." Why that might be: Mike Ryan, who leads the WHO's emergency program, said mutations that make a virus more deadly are unlikely because of the virus's own biological self interest. Read more here. Watchdog group wants SEC to investigate Moderna executives An anti-corruption watchdog group wants the Securities and Exchanges Commission (SEC) to investigate top executives at the biotech company Moderna for allegedly manipulating the stock market and possible insider trading. Moderna is one of a handful of companies that the U.S. is working with to develop a coronavirus vaccine, and last month it announced promising, but limited, results from initial trials. The group Accountable.US thinks the trades are suspicious. "If the executives knew about the results of Moderna’s test trials and public announcements relating to the trials, and set trades exploiting their foreknowledge ... they profited by violating the federal securities laws," wrote Accountable.US. President Kyle Herrig. "This misconduct was particularly egregious because it involved not only financial fraud and manipulation of the financial markets, but also because it exploited widespread fears surrounding the ongoing COVID-19 pandemic." A warning sign: Florida sees largest daily number of new COVID-19 cases since mid-April On Wednesday, Florida saw its largest number of new cases of the coronavirus since mid-April as the state works to reopen its economy. The Florida Department of Health announced the state has a total of 58,764 confirmed cases of the disease, a jump of 1,317 from the day before. Wednesday’s total is Florida’s largest since April 17, when it had 1,413 cases. Some 2,566 people have died from the virus in Florida. More than half of the state’s cases are concentrated in Miami-Dade, Broward, Palm Beach and Monroe counties in South Florida. Read more here. Bipartisan lawmakers press Trump administration to get COVID-19 aid to Medicaid providers Bipartisan members of Congress on Tuesday urged the Trump administration to distribute emergency COVID-19 funding to Medicaid providers as soon as possible, noting their “serious concerns” with the delay. While Congress appropriated funding more than two months ago to help health care providers weather the COVID-19 crisis, little of that assistance has gone to those who serve low-income patients, children and people with disabilities. The delay “could result in long-term financial hardship for providers who service some of our most vulnerable populations,” according to a letter from Senate Finance Committee Chairman Chuck Grassley (R-Iowa), the committee’s top Democrat Sen. Ron Wyden (Ore.), House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-N.J.), and Rep. Greg Walden (Ore.), that panel’s top Republican. “Many of these providers are safety net providers that operate on thin profit margins, if at all. The COVID-19 pandemic has strained their already scarce resources, threatening their ability to keep their doors open in the midst of a declared public health emergency," they wrote. Why it matters: The Trump administration has distributed about $70 billion in funding to help health providers through COVID-19, but most of that money has gone to providers in the Medicare program, the federal health insurance program for the elderly. The Department of Health and Human Services says it is working on a formula to distribute aid to Medicaid providers, but lawmakers are getting impatient. Read more here. | 
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