Axios Vitals: A backstop against political influence on the FDA

1 big thing: A backstop against political influence on the FDA | Tuesday, September 01, 2020

View in browser   Presented By the Surgical Care Coalition   Vitals By Caitlin Owens ·Sep 01, 2020 Good morning. If you have not yet taken time off over the last six months, I highly recommend it. Also, how is it September already? Situational awareness: The Department of Health and Human Services is bidding out a more than $250 million contract to a communications firm, aiming to "defeat despair and inspire hope" about the pandemic, Politico reports. Today's word count is 965, or a 4-minute read.     1 big thing: A backstop against political influence on the FDA Eli Lilly CEO David Ricks. Photo: Axios on HBO   The pharmaceutical industry will police itself when it comes to coronavirus treatments and vaccines, Eli Lilly chairman and CEO and PhRMA chairman-elect David Ricks told "Axios on HBO." Why it matters: Recent controversial decisions by the Food and Drug Administration, following complaints by President Trump that the agency was moving too slowly, have ignited fears that approval of coronavirus treatments and vaccines could be influenced by politics. What they're saying: "I think most of the principals in our industry and their scientific teams would say we're not going to make something or we're not going to sell it until we've proven to our own standards it's safe and effective, subjected it to scientific scrutiny from the outside world. And then we submit it also to the regulator," Ricks said. "If we were making scientific decisions, medical decisions about health purely based on non medical or scientific things, that would be very concerning ... I think our industry has an interest in preserving that as an objective process," he added. Eli Lilly is currently running a phase 3 clinical trial of a coronavirus treatment that would essentially serve as a synthetic antibody in patients. Between the lines: This is a high-stakes, high-pressure process, and there have already been big deviations from the normal drug-making process — like leaked anecdotal information and what Politico called "science by press release." Related: Ricks also said that it'd be smart to share a vaccine with other countries rather than going America first, Axios' Justin Green writes. But 66% of Americans don't want to share a vaccine right away with the rest of the world if the U.S. gets there first, according to a recent Harris poll. Go deeper.     2. Harsh verdict for government's response Data: Axios/Ipsos survey of 1,100 U.S. adults, Aug. 28-31, 2020; Chart: Danielle Alberti/Axios Most Americans think the federal government is making the coronavirus pandemic worse, according to the latest installment of the Axios-Ipsos Coronavirus Index. Why it matters: This is a pretty searing indictment of the federal response — not only that it has not helped, but that it's part of the problem, Axios' Sam Baker writes. Between the lines: There's a stark partisan divide here. 74% of Republicans say the federal government is making things better, while 80% Democrats say the federal government is making things worse. Most independents (68%) also say the government is making things worse. Overall trust in the federal government hasn't changed much over the past few weeks, but it's far below the levels we measured in the spring. Yes, but: Despite that lack of faith in the federal government, most Americans are optimistic that this will all be in better shape relatively soon. 57% said they're somewhat or very hopeful that the U.S. will get the pandemic under control within the next six months, while 43% were not too hopeful or not hopeful at all. More educated respondents — those with at least some college — were somewhat less hopeful about a quick turnaround, as were Black and Hispanic respondents. But partisanship was, yet again, the main dividing line: 82% of Republicans and 42% of Democrats were hopeful that things would be under control in six months. Reality check: It's almost impossible to predict where the U.S. will be in February.     3. The latest in the U.S. Data: The COVID Tracking Project; Note: Does not include probable deaths from New York City; Map: Andrew Witherspoon/Axios The number of confirmed coronavirus cases in the U.S. was just short of 6 million on Monday, Johns Hopkins data shows. Senior Trump administration officials privately warned several states that spikes in coronavirus cases put them in high-risk "red zones" while publicly downplaying the threat of the virus, according to documents released by a special House committee overseeing the coronavirus response. Six states set new highs last week for coronavirus infections recorded in a single day, according to the COVID Tracking Project and state health departments. Iowa surpassed its record set the previous week.     A message from the Surgical Care Coalition New Medicare cuts could reduce access to care for older Americans     A proposed change to Medicare, with cuts of up to 9%, is jeopardizing patient care. What this means: A third of private surgical practices are already at risk of permanently closing due to COVID-19. Cuts would make a bad situation worse. To prevent closures, Congress must act now.     4. The world's highest coronavirus death rates Data: European Centre for Disease Prevention and Control via Our World in Data; Chart: Naema Ahmed/Axios Peru's coronavirus death rate is now the highest in the world, surpassing Belgium and exceeding even Brazil (seventh) and the U.S. (eighth), Axios' Dave Lawler reports. Why it matters: Peru and Belgium illustrate the divergence between the world's two hardest-hit regions since the eye of the storm shifted from Europe to Latin America in the spring. Zoom in: Belgium saw an incredibly sharp spike over a single month, from its first death on March 11 to a daily high of 321 deaths on April 9. The post-lockdown descent was nearly as sharp. It has now been three months since Belgium last recorded more than 15 deaths in one day. The trend is similar in other European countries, like Italy: a terrifying spike, a steady decline and consistently low death tolls even after the lifting of lockdowns. The flipside: Peru was hit later than Belgium, and it imposed a lockdown in March before recording a single death. Death tolls climbed much more slowly, but over nearly three months rather than one. What to watch: While death tolls remain relatively low across Europe, cases have begun to spike dramatically in Spain and France while ticking upward elsewhere, including in Belgium. Family gatherings and domestic travel have been cited as potential drivers, in addition to significantly higher testing rates. The bottom line: Latin America was unable to match Europe's success in quickly suppressing the virus — but we'll see if Europe can sustain it.     5. Hurricane recovery amid a pandemic Pandemics make everything about hurricane season harder, including recovery. Between the lines: "Hurricane Laura is the first major test of whether the Gulf Coast is prepared to handle two disasters at once," NPR writes. "Coronavirus case numbers in Southwest Louisiana were already spiking at an alarming rate. Then a Category 4 hurricane came ashore." Residents are coming home to power outages and disruptions to their water system, which complicates staying safe from the virus. Tasks like food distribution and searching for survivors are much more difficult than in normal times. The Red Cross says it has received an unprecedented number of requests for assistance, and far fewer shelters than normal appear to have been set up in the state. Go deeper: The collision of hurricane season and the coronavirus has arrived     A message from the Surgical Care Coalition Medicare cuts will force surgical practices to close     Impending Medicare cuts would make a bad situation worse. The reason: One-in-three private practice surgeons are already in danger of closing due to COVID-19, Medicare cuts of up to 9% could make this worse. Now is not the time for more health care cuts that could cause even more closures.     Axios thanks our partners for supporting our newsletters. Sponsorship has no influence on editorial content. Axios, 3100 Clarendon B‌lvd, Suite 1300, Arlington VA 22201   You received this email because you signed up for newsletters from Axios. 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