With great caution, scientists seek Covid treatments in old drugs

‘After two small studies, a cheap drug shows promise. But scientists still feel burned by hydroxychloroquine.

‘Repurposing is a long shot, yet compared to creating drugs and vaccines, the approach has clear advantages during a fast-moving pandemic. “If it works and it’s on the shelf, you don’t have any development time,” said Lisa Danzig, a specialist in infectious diseases who consults with companies, investors, government and philanthropies. One of the best treatments in the Covid arsenal — the common steroid dexamethasone — is a repurposed drug. But it is recommended only for hospitalized patients who are seriously ill.

‘Danzig was “very excited” last April by news that a team led by University of California-San Francisco researchers had identified 69 possible drugs that, when used early on, might counteract infections with SARS-CoV-2, the virus that causes Covid. “I’m thinking, if we can rapidly test some of these in clinical trials, we can have answers by October.”

‘Yet these studies struggled to get off the ground...’

Read here (Undark, Mar 30, 2021)

From the pandemic, a roadmap for lowering the costs of medicine

‘To speed Covid-19 treatments, federal officials adopted a new, nimbler regulatory posture. The change was long overdue...

‘In recent decades, for example, the FDA — scarred by episodes like the Vioxx debacle and buoyed by scientists’ increased understanding of the body — has pressed drug makers to demonstrate increasingly rigorous understanding of the mechanisms by which their medicines work. Yet, one might argue that these guidelines reflect either hubris or naivete: The vast majority of safe and effective drugs were approved despite uncertainty about their mechanisms of action. Even today, scientists do not completely understand how acetaminophen works, yet the world is a far healthier place for having this drug...

‘In some high-profile cases during the pandemic, the FDA leaned less on mechanistic proof of effectiveness and more on empirical indicators, such as patient survival rates. For instance, when objective data revealed that the steroid dexamethasone helped severely ill patients survive what might otherwise have been deadly coronavirus infections, the FDA was quick to support the drug’s use, despite scientists having only a speculative understanding of how the steroid works against the disease. To be sure, the FDA must continue to prioritize its mandate to protect patients and clinical trial volunteers. But the pandemic has shown that safety and speed need not be an either-or proposition.’

Read here (Undark, Mar 25, 2021)

Lab leak: A scientific debate mired in politics — and unresolved

‘More than a year into the SARS-CoV-2 pandemic, some scientists say the possibility of a lab leak never got a fair look...

‘As it stands now, pandemic preparedness faces two simultaneous fronts. On the one hand, the world has experienced numerous pandemic and epidemic outbreaks in the last 20 years, including SARS, chikungunya, H1N1, Middle East Respiratory virus, several Ebola outbreaks, three outbreaks of norovirus, Zika, and now SARS-CoV-2. Speaking of coronaviruses, says Ralph Baric, an epidemiologist at the University of North Carolina, Chapel Hill, “it’s hard to imagine there aren’t variants” in bats with mortality rates approaching MERS’ 30 percent that also have “a transmissibility that is much more efficient. And that is terrifying.” Baric is emphatic that genetic research with viruses is essential to staying ahead of the threat.

‘Yet according to Richard Ebright, a molecular biologist at Rutgers University, lab-release dangers are growing as well. The risk increases in proportion with the number of labs handling bioweapons and potential pandemic pathogens (more than 1,500 globally in 2010), he says, many of them, like the Wuhan lab, located in urban areas close to international airports. “The most dramatic expansion has occurred in China during the last four years — driven as an arms-race-style reaction to biodefense expansion in the U.S., Europe, and Japan,” Ebright wrote in an email to Undark. “China opened two new BSL-4 facilities, in Wuhan and in Harbin, in the last four years,” he added, “and has announced plans to establish a network of hundreds of new BSL-3 and BSL-4 labs.”

Read here (Undark, Mar 17, 2021)