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A cadre of former FDA commissioners under Republican and Democratic presidents say that President Donald Trump has undermined the credibility of the FDA.Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andy von Eschenbach pinned a joint op-ed in the Washington Post on Tuesday.Among the group who signed the letter, Gottlieb was Trump’s longest service FDA commissioner, heading the agency for nearly two years until April 5, 2019.The former commissioners said Trump has inserted himself into the vaccine approval process.“But a safe and effective vaccine will not be enough; people will also have to choose to take it,” the former commissioners wrote. “This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”Last week, Trump said it’s possible he would overrule the FDA if the agency uses stricter guidelines to give an emergency use authorization for a coronavirus vaccine candidate.The group of former commissioners blasted Trump for his comments.“The implications of the recent shift are potentially dire,” they wrote. “When the FDA warns about a risk from contaminated food, will people heed it? When a new drug for cancer or heart disease is approved, will clinicians and families trust it to work? And most urgent for today: When the FDA approves a COVID-19 vaccine, will Americans accept it?”Trump has been at odds with many government public health experts on the timing of when a vaccine would be available to the public.There are several vaccines in Phase 3 testing. Even though a vaccine could be approved by year’s end, trials will be expected to continue for over a year to monitor for possible side effects.According to the FDA, a typical Phase 3 trial would take one to three years. 2000
A California man pleaded guilty to identity fraud in a second case unsealed Friday by special counsel Robert Mueller in his investigation into Russian interference in the US presidential election.The guilty plea results in the first criminal conviction related to Mueller's investigation into the Russian-backed ring of social media users aiming to interfere with the 2016 presidential election, prosecutors told a federal judge this month, according to unsealed court filing.Richard Pinedo's guilty plea was unsealed by the federal court in DC on Friday, minutes after the Justice Department announced charges against 13 Russian nationals. 654
A British woman was saved by the Croatian Coast Guard after spending what she said was close to 10 hours treading water overnight in the Adriatic Sea after falling off a cruise ship.Kay Longstaff spoke to Croatian news outlet HRT shortly after arriving back on land."I fell off the back of the Norwegian Star," said the woman, who lives in Spain, according to her Twitter account. "I was in the water for 10 hours, so these wonderful guys rescued me. I'm very lucky to be alive."Longstaff, 46, was then led by medical personnel to an ambulance. 552
A large crack, stretching several kilometres, made a sudden appearance recently in south-western Kenya.The tear, which continues to grow, caused part of the Nairobi-Narok highway to collapse and was accompanied by seismic activity in the area.The Earth is an ever-changing planet, even though in some respects change might be almost unnoticeable to us. Plate tectonics is a good example of this. But every now and again something dramatic happens and leads to renewed questions about the African continent splitting in two.The Earth's lithosphere (formed by the crust and the upper part of the mantle) is broken up into a number of tectonic plates.These plates are not static, but move relative to each other at varying speeds, "gliding" over a viscous asthenosphere.Exactly what mechanism or mechanisms are behind their movement is still debated, but are likely to include convection currents within the asthenosphere and the forces generated at the boundaries between plates.These forces do not simply move the plates around, they can also cause plates to rupture, forming a rift and potentially leading to the creation of new plate boundaries. The East African Rift system is an example of where this is currently happening.The East African Rift Valley stretches over 3,000km from the Gulf of Aden in the north towards Zimbabwe in the south, splitting the African plate into two unequal parts: the Somali and Nubian plates.Activity along the eastern branch of the rift valley, running along Ethiopia, Kenya and Tanzania, became evident when the large crack suddenly appeared in south-western Kenya. 1624
A historic and disproportionate number of women have left the workforce since the start of the pandemic, and new studies are showing many more are still considering downshifting their career.“I had just found another position that I was going to start part-time in addition to the one I had, and I was hoping to build my career with that,” said Ashley Stewart in Virginia.Stewart is a mother of three young children, who at the beginning of the year was hoping to transition to full-time work as an occupational therapist. However, when the pandemic hit, she had to reevaluate what was best for her family.“I switched to doing just a couple of virtual sessions on my computer during the week,” said Stewart. "It ended up that it was just too much to handle here, with the kids screaming in the background or climbing on me while I am trying, so I ended up stopping altogether.”It was a bittersweet decision. She was sad to halt a blossoming career, but grateful her family could afford to make that decision. She felt it was safer for her children and worth the sacrifice on her end. Stewart’s decision has become a common one for women across the country. The latest data from the Department of Labor shows that between August and September, 865,000 women dropped out of the labor force, compared to 216,000 men. That is essentially women dropping out of the workforce four time faster than men.“The number of women who have left is startling,” said C. Nicole Mason. “Because at the beginning of the year, we were celebrating the fact that women were 50% of the workforce, so we have lost significant gains since then.”Mason is the president and CEO of the Institute for Women’s Policy Research.“We can draw the direct line between the lack of childcare and daycare closures to women exiting,” said Mason.Experts, like Mason, are concerned a decade or more of women’s equality and progress in the workforce could be erased, if women continue to drop out of the labor force at this rate.“Employers have a role to play by making sure workplace policies are flexible, providing access to childcare,” said Mason. “The federal government has a role to play by instituting a national care infrastructure that will do more to keep women in the workforce by making sure they have childcare and other supports."Many companies have begun to offer more flexibility during the pandemic, but the data indicates more may need to be done. In terms of government responding to this disproportionate loss of women in the workforce, the childcare industry has been calling on Congress for funding for weeks. The industry’s plea is not only to save providers but to support women needing their service to go back to work. Congress has not been able to make true progress toward a new stimulus package, for months now.In addition to the disproportionate number of women who have already left the workforce, a new study shows another one in four women are considering leaving or downshifting their careers because of COVID-19. 3014