Tag: Mayo Clinic

Legal challenges threaten Biden’s COVID-19 vaccine rule

Volume 398, Issue 10314
20 November 2021

 

WORLD REPORT  Almost a year after the first COVID-19 vaccine was approved for emergency use in the USA, roughly a third of adults have still not received it. After urging Americans to get vaccinated, US President Joe Biden has taken a tougher approach: under his administration’s new workplace safety standard, people must get vaccinated or undergo weekly tests for the virus if they work for companies with at least 100 employees. “The rule will protect more than 84 million workers from the spread of the coronavirus on the job”, said Jim Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health. …A day after OSHA’s announcement on Nov 4, 2021, multiple lawsuits to block the rule started rolling in to federal courts across the country.[Continued here.]  

 …

US FDA defends approval of Alzheimer’s disease drug

Volume 398, Issue 10294
3 July 2021

 

WORLD REPORT An avalanche of criticism has forced the US Food and Drug Administration to defend its decision to grant accelerated approval for aducanumab, the first new Alzheimer’s disease treatment in two decades. “It will be a very long time before we ever figure out whether or not this drug really works”, said Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School who resigned in protest from an FDA advisory panel that recommended against approval.[Continued here.]

 …

Federal Regulators split on antimalarials for COVID-19

Volume 395    Number 10231     
11 April 2020                          
WORLD REPORT   US and French authorities have authorised the use of chloroquine and hydroxychloroquine, but the EU regulator and WHO say the science doesn’t support the decision. Susan Jaffe reports. 
With no “adequate, approved and available” alternative, the US Food and Drug Administration (FDA) is allowing the use of the antimalarial drugs hydroxychloroquine and chloroquine to treat coronavirus disease 2019 (COVID-19).

The FDA’s emergency use authorisation (EUA) issued last week gives physicians the option to prescribe the drugs, which President Donald Trump has recommended. However, both drugs are unproven and untested for COVID-19, and have rare but potentially deadly side-effects.  The decision bypassed the usual drug approval process including doubleblind, placebo-controlled clinical trials, stoking a worldwide debate about whether the drugs are appropriate for treating the disease.

“I think it was resorted to more out of a sense of desperation”, said Joseph Masci, an infectious disease specialist and director of global health at Elmhurst Hospital in Queens, a borough of New York City, which is at the centre of the epidemic in the USA. “It is just an indication of how sudden and massive this outbreak has been.” [Continued here.]  

…

Congressional showdown threatens NIH funding boost

lancet cover 2Volume 386, Issue 9996,  29 August 2015

WORLD REPORT    Bills providing extra funding for the National Institutes of Health while cutting other programmes could a face presidential veto.  Susan Jaffe, The Lancet’s Washington correspondent,  reports.

After years of mostly stagnant funding for the US National Institutes of Health (NIH), two powerful congressional committees that control government spending have approved separate budget bills containing record increases for the agency.
But last month, President Barack Obama’s Office of Management and Budget director Shaun Donovan wrote to the chairman of the Senate Committee on Appropriations warning that he expects the president to veto its bill. Among other reasons, Donovan said it “drastically” cuts money for public health programmes including Medicare for the elderly and Medicaid, serving low-income Americans. And it would deny funds for operating the health insurance exchanges essential to the president’s signature health reform law, the Affordable Care Act. [Continued in full text or PDF ]
…