Morning Briefing
Summaries of health policy coverage from major news organizations
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Ńîšóĺú´ŤĂ˝Ňîl Health News Original Stories
As Broad Shutdowns Return, Weary Californians Ask âIs This the Best We Can Do?â
Californiaâs ping-ponging approach to managing the pandemic â twice reopening large portions of the service sector economy only to shut them again â has residents and business owners on edge. But experts say the push and pull on businesses may be what success looks like in much of the U.S. for months to come, given COVID-19âs pervasive spread.
Lost on the Frontline: New Profiles This Week
As of Wednesday, the ongoing KHN-Guardian project is investigating 1,396 deaths of U.S. health workers in the fight against COVID-19. Today we add eight profiles, including a woman who crafted pandemic safety messages and protocols and a transporter of patients who died early in the pandemic. You can explore our interactive database, now containing 268 profiles. It investigates the question: Did they all have to die?
Anger After North Dakota Governor Asks COVID-Positive Health Staff to Stay on Job
Doctors and nurses say order puts lives in danger, amid a COVID surge and a statewide shortage of health care workers.
Government-Funded Scientists Laid the Groundwork for Billion-Dollar Vaccines
Drugmakers will walk away with massive profits, but much of the pioneering work on mRNA vaccines was done with government money.
Push Is On in US to Figure Out South Asiansâ High Heart Risks
While thereâs growing momentum to understand South Asiansâ high propensity for cardiovascular disease, researchers stress culturally tailored prevention.
Summaries Of The News:
Covid-19
The Final Results Are In: Pfizer Vaccine Is 95% Effective
A final analysis of the Phase 3 trial of Pfizer's coronavirus vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, the company said Wednesday. The company counted 170 cases of coronavirus infection among volunteers who took part in the trial. It said 162 infections were in people who got placebo, or plain saline shots, while eight cases were in participants who got the actual vaccine. That works out to an efficacy of 95%, Pfizer said. The data show Pfizer's initial claim of a better than 90% efficacy -- a claim that stunned and pleased health officials and vaccine developers last week -- holds up. (Fox and Sealy, 11/18)
If the F.D.A. authorizes the two-dose vaccine, Pfizer has said that it could have up to 50 million doses available by the end of the year, and up to 1.3 billion by the end of next year. However, only about half of its supply will go to the United States this year, or enough for about 12.5 million people â a sliver of the American population of 330 million. Americans will receive the vaccine for free, under a $1.95 billion deal the federal government reached with Pfizer for 100 million doses. (Thomas, 11/18)
If the FDA gives the vaccine the green light, Pfizer will likely make history as the first company with an FDA-authorized COVID-19 vaccine. ... Itâs not known yet what level of immunity or how long the immunity lasts after receiving the vaccines. Trial volunteers will be followed for two years to answer questions like durability of protection. (Salzman, 11/18)
The U.S. drugmaker and partner BioNTech SE said their vaccine protected people of all ages and ethnicities, with no significant safety problems so far in a trial that includes almost 44,000 participants. ... The vaccineâs efficacy in people older than 65 was more than 94%, the companies said. Most people who received the shot tolerated it well. Severe fatigue was seen in 3.7% of volunteers after the second dose in the two-shot regimen, but that was the only severe side effect that occurred in more than 2% of people, according to the analysis. (Langreth, 11/18)
Pfizer, which did not accept research funding from the federal Operation Warp Speed initiative, has agreed to supply 100 million doses to the U.S. government in exchange for $1.9 billion. The U.S. has the option to buy 400 million more. Moderna received about $1 billion in federal funds to support its vaccine development and has agreed to provide 100 million doses to the U.S. for $1.5 billion. (Garde and Herper, 11/18)
For Pfizer And Moderna, The Hard Part Isn't Over Yet
The promising news that not just one but two coronavirus vaccines were more than 90 percent effective in early results has buoyed hopes that an end to the pandemic is in sight. But even if the vaccines are authorized soon by federal regulators â the companies developing them have said they expect to apply soon â only a sliver of the American public will be able to get one by the end of the year. The two companies, Pfizer and Moderna, have estimated they will have 45 million doses, or enough to vaccinate 22.5 million Americans, by January. (Thomas, 11/17)
As the market revelry at the news continued, attention quickly turned to practical matters given the unprecedented logistical challenge posed by producing and distributing vaccines, should they receive final regulatory approval, to a global population of around 7 billion people. Vaccines need to be produced and transported in specific (and cold) conditions otherwise they can be rendered ineffective; this poses a huge challenge for global drugmakers when it comes to vaccine distribution. (Ellyatt, 11/18)
In a vast Pfizer warehouse in Kalamazoo, Mich., with hundreds of ultracold freezers standing sentry, the final leg of an unprecedented scientific, medical and industrial relay race is about to get underway. Each day, the large freezers fill with stacks of white trays â âpizza boxes,â workers call them, because theyâre about the size of a personal pan pizza â loaded with 195 identical glass vials. Each tube, about the size of a pinkie finger, contains a few precious droplets of frozen coronavirus vaccine, enough, when thawed and diluted, to give five people a first shot of protection against a pathogen that has killed more than 247,000 people in the United States. (Johnson, 11/17)
Pfizer's CEO on Tuesday sought to calm concerns about the distribution challenges of needing ultra-cold storage for his company's COVID-19 vaccine. "I feel very very confident about it," Albert Bourla said during an interview at a STAT News event. Bourla said the company has developed a special isothermic box which will not need to be shipped in refrigerated trucks or planes. (Weixel, 11/17)
Airlines are scrambling to prepare ultra-cold shipping and storage facilities to transport COVID-19 vaccines developed by Pfizer and Moderna, whose doses, which require deep freezing, are likely to be among the first to be distributed. A recent survey by an air cargo association and a drug shippers' group found only 15% of industry participants felt ready to transport goods near the minus 70 degrees Celsius (-94°F) required by the Pfizer Inc vaccine, while around 60% could meet Moderna Inc's less stringent -20°C requirement. (Frost and Wissenbach, 11/18)
Also â
Two COVID-19 vaccines might be nearing the finish line, but scientists caution itâs critical that enough people volunteer to help finish studying other candidates in the U.S. and around the world. Moderna Inc. and competitor Pfizer Inc. recently announced preliminary results showing their vaccines appear more than 90% effective, at least for short-term protection against COVID-19. (Neergaard, 11/17)
KHN: Government-Funded Scientists Laid The Groundwork For Billion-Dollar VaccinesÂ
When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr. Barney Graham, then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic. Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by Graham and his colleagues, a concept that emerged from a scientific quest to understand a disastrous 1966 vaccine trial. (Allen, 11/18)
The strong early results for two leading Covid-19 vaccines have implications that go far beyond the current pandemic: They suggest the time has come for a gene-based technology that could provide new treatments for cancer, heart disease and other infectious diseases. The unproven technology, named messenger RNA after the molecular couriers that deliver genetic instructions, has long eluded researchers. An mRNA vaccine has never been cleared by regulators. It is now the basis for Covid-19 vaccines from Moderna Inc. and Pfizer Inc. and its partner BioNTech SE. (Loftus, Hopkins and Pancevski, 11/17)
Once again, one of the leading coronavirus vaccine candidates delivered promising news and the stock market jumped while most everyone celebrated. But there is a lot we do not know about this vaccine. ... Are these drugs preventing infection or are they just producing antibodies that keep the virus from harming us when we get infected? How long will these vaccines last? Will we need a booster shot? How often? (Tompkins, 11/17)
First At-Home COVID Testing Kit Approved By FDA
The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes. The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said. (11/17)
A handful of other tests have been cleared by the F.D.A. for at-home collection of samples, which are then shipped to a lab for processing. But Luciraâs test is the first to remove the need for an intermediary. (11/18)
The new test, which uses self-collected nasal swab samples, is authorized for people 14 and older with suspected Covid-19 and people under 13 when performed by a health care provider. It is also authorized for use in point-of-care settings, such as doctor's offices, hospitals, urgent care centers and emergency rooms for all ages but must be collected by a health care provider, the FDA said. (Erdman, 11/18)
The Lucira COVID-19 test grew out of research the company was doing to develop an at-home flu test, according to the companyâs website. Lucira adapted its technology to detect COVID-19 after the outbreak. The test uses technology similar to genetic laboratory-based tests that are the standard tool for COVID-19 screening. Thatâs different than most rapid tests currently used in the U.S., which look for viral proteins called antigens â not the virus itself. (Perrone, 11/18)
In other FDA EUA news â
In response to blistering criticism, the Food and Drug Administration committed to publicly disclosing reviews of scientific data and other information that are used to authorize, revise or revoke emergency use of a medicine. The announcement came the same day that the U.S. Government Accountability Office issued a report noting the agency has failed to âuniformly disclose its scientific review of safety and effectiveness dataâ for emergency use authorization as it does for medicines undergoing the normal review process. (Silverman, 11/17)
State Restrictions Tighten â Even In Some With Republican Governors
Governors in Ohio, Maryland and Illinois imposed restrictions on business hours and crowd sizes Tuesday, and their counterparts in Wisconsin and Colorado proposed economic relief packages. Los Angeles County, with a population of 10 million, ordered similar business restrictions. (Foley and Kunzelman, 11/18)
A growing number of Republican governors, including some who had written off mask mandates as unenforceable or unacceptable to freedom-loving Americans, are now requiring people to cover their faces in public â a response to escalating coronavirus outbreaks overwhelming hospitals across the country. After eight months of preaching personal responsibility in place of mandates, these governors have brought their states in line with much of the world by instituting the simple requirement backed by science but, in the United States, shot through with politics. (Stanley-Becker, 11/17)
Since Covid-19 hit US shores, Republican governors in the Upper Midwest and Northern Plains have largely taken a hands-off approach. The results of that strategy have been poor. When adjusted for population, no states have had more new Covid-19 infections, hospitalizations and deaths over the past seven days than North and South Dakota. The nearby states of Iowa, Wyoming, Nebraska and Idaho are not far behind. (Levenson, 11/17)
In news from the states â
Ohio Gov. Mike DeWine on Tuesday ordered a statewide curfew, mandating that residents be in their homes by 10 p.m., beginning Thursday. The curfew will be in place every day for at least three weeks, lasting overnight until 5 a.m. But there are exceptions, including for those who need to be at work or see to medical needs. The order will also not stop grocery shopping or drive-through and pickup food services. (Oxner, 11/17)
Maryland tightened pandemic-related restrictions Tuesday for the second time this month as coronavirus cases across the greater Washington region have set new highs each day for two weeks. Gov. Larry Hogan (R) issued an executive order that clamps down on the hours that restaurants and bars can operate and the number of people allowed in retail stores and at religious facilities. Local officials have strengthened policies several times in recent days, looking for ways to slow a virus spreading at record rates in the Washington area and across the country. (Wiggins, Tan and Zauzmer, 11/17)
Pennsylvaniaâs top health official issued a broader mask mandate Tuesday, a bid to force people to wear face coverings as coronavirus case numbers continue to soar. Imposing new rules to combat the surge without ordering shutdown-style restrictions, Health Secretary Rachel Levine ordered that people wear masks when with anyone outside their own households and directed that anyone entering from out of state must get tested for the coronavirus within 72 hours of arriving as of Friday. (McDaniel, McCarthy, Tornoe and Laughlin, 11/18)
Oregon's governor issued an executive order Tuesday implementing a new wave of restrictions on public life as part of the state's efforts to fight coronavirus. A notice from Kate Brown's (D) office indicated that all restaurants in the state would be restricted to takeout and delivery service, while gyms, museums and some other businesses would be forced to close entirely. (Bowden, 11/17)
Coronavirus cases have spiked in Pennsylvania and New Jersey over the past month, surpassing the numbers of the pandemicâs first wave in April, and yet many people have continued to meet up with friends at indoor gatherings and make plans to see family at Thanksgiving. To curb the spread, Philadelphia officials announced restrictions Monday that closed indoor dining, gyms and museums, and limited the capacity of outdoor gatherings. Gov. Phil Murphy also introduced new restrictions on gatherings in New Jersey. (Ao, 11/18)
Iowa Gov. Kim Reynolds urged residents Tuesday to follow her new partial mask mandate, while claiming âthereâs science on both sidesâ about whether masks reduce the spread of coronavirus. After months of opposition, Reynolds signed an order Monday that requires people to wear masks in indoor public places under some circumstances. (Foley, 11/18)
Less than a week after New York Gov. Andrew Cuomo instilled an executive order limiting the number of people at Thanksgiving gatherings, several upstate sheriffs say they plan to ignore it. Cuomo's order limits the number of people New York residents can have in their private homes to 10. (Johnson, 11/17)
Also â
Anthony Fauci, the countryâs top infectious disease expert, said Tuesday he should have more aggressively pushed the federal government to flood communities where the coronavirus was starting to spread with testing early in the U.S. outbreak. (Joseph, 11/17)
National Institute of Allergy and Infectious Diseases Director Anthony Fauci said Tuesday that âa uniform approachâ is necessary to tackle the coronavirus pandemic, rather than strategies that vary state by state. âWe need some fundamental public health measures that everyone should be adhering to, not a disjointed, âOne state says one thing, the other state says another thing,ââ Fauci said Tuesday in a virtual conference with Andrew Ross Sorkin of The New York Times. (Budryk, 11/17)
Elections
Transition Stonewall Imperils Vaccine And COVID Prep, Biden Advisers Warn
President-elect Joe Biden's advisers on the coronavirus pandemic urged the Trump administration on Tuesday to take the formal step that will allow them to tap into data on the pandemic and have conversations with people inside the administration who can tell them what the federal government already has in the works in their COVID-19 response. They said it is urgent that the General Services Administration formally "ascertain" the winner of the presidential election so that they can learn more about plans for vaccine distribution. They told reporters they don't have access to the government's real-time data on the pandemic and its spread. (Keither, 11/17)
The leaders of President-elect Joe Bidenâs coronavirus advisory board said Tuesday the Trump administrationâs continued refusal to allow the transition to move forward is hurting their preparedness planning on multiple fronts, from addressing mask shortages to recommending targeted closures in hot spots and laying the groundwork to distribute prospective vaccines. The transition team is unable to consult with federal health officials or access real-time data on available hospital beds, the status of the National Strategic Stockpile and therapeutics, among other things. For now, they said that's forcing them to rely on piecemeal data from state and local officials and public sources like the Covid Tracking Project. (Miranda Ollstein, 11/17)
Medical experts advising President-elect Joe Biden on the COVID-19 pandemic fear that the federal governmentâs delay in recognizing Bidenâs election victory could be compromising the U.S. response to the virus, the experts said on Tuesday. Dr. Vivek Murthy, co-chair of Bidenâs COVID-19 task force, said the experts had not been able to speak to current administration officials dealing with the virus, even as the United States is hit by a surge in coronavirus cases and hospitalizations. (Lewis, 11/17)
The incoming Biden administration has been blocked from coordinating with the federal governmentâs civil servants who are planning a massive vaccination campaign, forcing the president-electâs team to meet with local health leaders and pharmaceutical companies to piece together information in an attempt to get around President Trumpâs obstruction. The delay caused by Trumpâs continued false insistence he won the election is putting lives at risk, President-elect Joe Biden declared this week. (Goodwin, 11/17)
President Donald Trumpâs refusal to cooperate with his successor is forcing President-elect Joe Biden to seek unusual workarounds to prepare for the exploding public health threat and evolving national security challenges he will inherit in just nine weeks. Blocked from the official intelligence briefing traditionally afforded to incoming presidents, Biden gathered virtually on Tuesday with a collection of intelligence, defense and diplomatic experts. None of the experts is currently affiliated with the U.S. government, raising questions about whether Biden is being provided the most up-to-date information about dangers facing the nation. (Peoples, Riechmann and Miller, 11/18)
Also â
The countryâs top associations representing hospitals, doctors and nurses are calling on the Trump administration to share information on its coronavirus response with President-elect Joe Biden's team âso that there is no lapse in our ability to care for patients. âThe American Hospital Association, American Medical Association, and American Nurses Association wrote in a letter to President Trump on Tuesday that cooperation on the coronavirus response with Biden transition officials is crucial. (Sullivan, 11/17)
The U.S. medical establishment on Tuesday urged President Donald Trump to share critical COVID-19 data with President-elect Joe Bidenâs team to avoid needless, deadly lags in tackling a raging pandemic that is threatening to overwhelm hospitals nationwide. The extraordinary rebuke, weighing in on the White House post-election transition fray, came in an open letter from three leading healthcare organizations as state and local governments scrambled to fight the virus in the absence of a coordinated national strategy. (Borter and Gorman, 11/17)
President-elect Joe Biden will meet with healthcare workers on the front lines of the raging coronavirus health crisis in a virtual event on Wednesday, while President Donald Trump faces further legal hurdles to overturn his election loss. Biden has pledged to make the pandemic, which has killed more than 247,000 people in the United States and cost millions their jobs, a top priority when he takes office on Jan. 20. (Hunnicutt and Whitesides, 11/18)
Team Biden Connects Early With Leading Public Health Groups
Nearly all of the nationâs leading public health organizations have already heard directly from President-elect Bidenâs transition team since the election was called in his favor less than two weeks ago. The Association of State and Territorial Health Officials has met with the Biden team three times, the National Association of County and City Health Officials met with the Biden team once and the Association of Immunization Managers had informal conversations with the team, the groups all confirmed to STAT. The Big Cities Health Coalition, which represents cities like Boston and New York, is scheduled to meet with them later this week. (Florko, 11/18)
President-elect Joe Biden on Tuesday named top aides who will work in his White House, rewarding loyal supporters and longtime advisers as he builds his administration-in-waiting while keeping a spotlight on the Trump administrationâs refusal to assist his transition into office. The moves reflected Bidenâs two-pronged strategy for navigating the difficulties surrounding his ascent to the presidency: While he is stepping up attempts to show how President Trumpâs unwillingness to cooperate with his team could harm Americans, Biden is also signaling that the roadblocks are not stopping his endeavor to assemble a government prepared to address the crises gripping the nation. (Sullivan, 11/17)
[Joe] Biden is not breaking ranks with congressional Democrats on coronavirus relief negotiations. He could publicly endorse holding a vote on the scaled-back package that Senate Republicans want, but instead he expressed support on Monday for the bill that House Democrats advanced several months ago which has been a non-starter with the GOP. Even as Biden called on both sides to work together and to pass legislation immediately, his message was intentionally delivered in a way that would not be interpreted as undercutting the Democratic negotiating position on Capitol Hill. (Hohmann, 11/17)
Also â
An incoming Biden administration could quickly implement new infection control standards that would require stronger protections for healthcare workers. House Democrats have pushed to require the Occupational Safety and Health Administration to create an emergency temporary standard on infection control during the COVID-19 pandemic, as no such standard directly covering exposure to airborne or aerosol diseases in the workplace exists. Republicans have blocked the provision in all coronavirus-related stimulus legislation that has passed so far, but Democrats may get the standard anyway under a Biden administration. (Cohrs, 11/17)
A recently retired military officer who worked as a coronavirus crisis planner says the rollout of a future vaccine will be âone of the most daunting challenges any president has ever faced.â âThe virus is everywhere, and spreading deeply into every corner of the country. This is where the Biden administration will face its biggest challenge, especially as it pertains to rolling out a potential vaccine,â Kris Alexander, a former COVID-19 crisis planner for the militaryâs Northern Command (Northcom), wrote in a Monday op-ed for the Daily Beast. (Mitchell, 11/17)
Administration News
Trump Absents His Administration At COVID Emergency Tipping Point
New Covid-19 diagnoses and hospitalizations are continuing to rise sharply across the US, with deaths following behind, in the worst outbreak of the entire pandemic. Experts say the federal government, led by the lame duck president Donald Trump, has âchecked outâ, weeks away from what would be early vaccine approvals. On Tuesday, a coronavirus taskforce update from the office of Mike Pence made no mention of transition efforts involving the president-elect, Joe Biden, as Trump has refused to concede defeat. Last weekend, leading public health expert Dr Anthony Fauci said Trump had not attended a taskforce meeting in five months. (Glenza, 11/17)
The White House says the President is regularly briefed on the virus, but there is a lot to do. The federal government has paid for millions of doses of vaccines and faces a massive logistical challenge to work with state and local health departments to distribute them over the next several months. But it will be months or longer before enough of the population is covered by a vaccine for community immunity to kick in. In the meantime, the virus is ripping through the country again, putting a strain on protective equipment and hospitals. (Bennett, 11/17)
In other news from the Trump administration â
Wreaths Across America will not be canceled this year in spite of the coronavirus pandemic, President Donald Trump announced Tuesday. The announcement comes after Arlington National Cemetery said it would be closed to volunteers hoping to lay wreaths to honor fallen soldiers as a precaution against the spiking pandemic. That move was quickly criticized by Republicans, and Secretary of the Army Ryan McCarthy said Tuesday he directed the cemetery to reverse the decision. Shortly after, Trump said he had insisted the tradition carry on this year. (Choi, 11/17)
One of President Trump's top advisers on the coronavirus pandemic raised concerns on Monday about excluding older family members from Thanksgiving celebrations, citing the risks of isolation. Scott Atlas, who has promoted controversial ideas about the virus such as herd immunity, said on Fox News that it's important to protect "vulnerable, high-risk, senior family members." But he suggested it may be worth including them in holiday gatherings. (Samuels, 11/17)
After a weekend with dozens of arrests and scattered clashes between supporters and opponents of President Donald Trump, both sides took to social media to accuse the other of instigating violence. Meanwhile, a long-standing D.C. bar stands in danger of losing its liquor license after becoming a haven for Trump supporters who refused to follow local COVID-19 restrictions. All told, 21 people were arrested, including one juvenile, for charges that included disorderly conduct, inciting violence and assault. (Khalil, 11/16)
The Health and Human Services department has scrapped a planned ad campaign featuring celebrities discussing Covid-19, a senior HHS official told a congressional oversight panel in a letter shared with POLITICO. The abandoned $15 million contract with Atlas Research, part of a larger $300 million taxpayer-funded campaign aimed at "defeating despair" over the pandemic, was conceived by a close political ally of President Donald Trump this summer. It was met with outrage from Democratic lawmakers, who charged it was an attempt to boost lagging public opinion of Trump's coronavirus response ahead of the election. (Diamond, 11/17)
CDC Walks Back Guidance On Risks Of COVID To Kids And Schools
The Centers for Disease Control and Prevention (CDC) has quietly removed controversial guidance from its website that pushed for schools to reopen in the fall and downplayed the transmission risks of COVID-19 to children and others. ... The CDCâs website now states that âthe body of evidence is growing that children of all ages are susceptible to SARS-CoV-2 infection and contrary to early reports might play a role in transmission.â The website also acknowledges that âteachers and students are in close contact for much of the day, and schools can become a place where respiratory diseases like COVID-19 can quickly spread.â (Hellmann, 11/17)
If youâre going to a holiday gathering and want to limit your chance of contracting the novel coronavirus, you might have to give up caroling, loud music and alcohol, according to the U.S. Centers for Disease Control and Prevention. In a holiday-focused health and safety guideline published by the agency on Wednesday, the CDC offered detailed considerations people should take if they are hosting or attending a gathering or plan to stay or host guests overnight. These guidelines suggest people modify their holiday activities to minimize the spread of COVID-19. (Moore, 11/17)
Also â
New reporting from the Centers for Disease Control and Prevention (CDC) shows that Black, Latino, Hispanic and Native American people are being hospitalized with COVID-19 at nearly four times the rate of non-Hispanic white persons. The agency said that between March 1 and Nov. 7, it received reports of over 70,000 laboratory-confirmed COVID-19-associated hospitalizations, of which 67,259 include race and ethnicity data. (Folley, 11/17)
The head of the National Institutes of Health (NIH) is urging the public to abide by safety guidelines and socially distance, saying that while recent results for COVID-19 vaccine candidates are "encouraging," people must take extra precautions for at least "a few more months." (Choi, 11/17)
Medicare
Trump Moves Ahead With 'Most Favored Nation' Medicare Drug Plan
President Donald Trump has resurrected a long-delayed plan to slash drug prices, with advisers pitching him on an added benefit: It would hit an industry that Trump believes slow-walked coronavirus vaccine development until after the election. The about-face came after Oval Office meetings last week where Trump railed against vaccine maker Pfizer for not revealing that its vaccine was more than 90 percent effective until after Election Day, according to three people familiar with the discussion. (Owermohle and Diamond, 11/17)
The Trump administration is preparing to move forward with a major proposal to lower drug prices and rulemaking could come as soon as this week, according to people familiar with the effort. The move, fiercely opposed by the pharmaceutical industry, would implement President Trumpâs âmost favored nationâ proposal and lower certain Medicare drug prices to match prices in other wealthy countries. (Sullivan, 11/16)
The Trump administrationâs revived rule to end rebates that drugmakers give to middlemen in Medicare is awaiting approval from the Office of Management and Budget and a final rule could be imminent, according to a person familiar with the matter. The administration has said the rule would drive down the prices consumers pay for prescription drugs. An earlier version of the rule, a signature part of President Trumpâs plan to lower drug prices, was withdrawn in 2019 because some White House advisers raised concerns that it could increase Medicare premiums. Mr. Trump in July signed an executive order that revived the rule and added a requirement that it not raise premiums or increase federal spending. (Armour, 11/13)
The Trump administration's executive order placing restrictions on rulemaking requiring middlemen to pass drug rebates directly to patients may not be legally binding. HHS on Friday submitted a final rule to the White House budget office that would prohibit pharmacy benefit managers from retaining rebates paid by drugmakers. The president in July signed an executive order stating that the HHS secretary must publicly certify that any such policy will not increase insurance premiums, federal spending or Medicare beneficiaries' out-of-pocket costs. However, regulatory experts say the agency could likely work around the order. (Cohrs, 11/16)
The CEO of a biotech and pharmaceutical trade group warned Tuesday that the industry could sue to try to stop a proposal from the Trump administration to lower drug prices. The Trump administration could move forward as soon as this week on a proposal to lower certain Medicare drug prices by tying them to lower prices paid in other wealthy countries, an idea fiercely opposed by drug companies, which are now mobilizing both to try to stop the rule and plan for a fight if it does go forward. (Sullivan, 11/17)
Also â
A lot of attention and a bevy of proposals have focused on the rising cost of drugs, among all Americans, including older adults covered by Medicare. But are these costs really rising as fast as people think? Or is the concern over drug spending due to something I call the prescription escalator? (Mandel, 11/13)
This summer, the University of Maine System said it would be switching to a new plan in 2021 as part of a plan expected to save $2.5 million annually and affecting 2,875 retirees and dependents. After some research, Wanderer found that the plans most beneficial to her are much more costly. (Schroeder, 11/10)
CMS: Improper Medicare Payments Drop $15B Since 2016
The number of improper payments made under Medicare fee-for-service declined by $15Â billion since 2016, according to new figures from the Trump administration. The Centers for Medicare & Medicaid Services said that the data released late Monday is the result of a coordinated effort to identify the root cause of Medicare improper payments, which can include over or underpayments to providers in addition to fraud. The agency also updated data on Medicaid and the Childrenâs Health Insurance Program. (King, 11/17)
Medicare fee-for-service (FFS) improper payments have declined by $15 billion since 2016, according to a report released by the Centers for Medicare & Medicaid Services (CMS) Monday. The Medicare FFS estimated improper payment rate fell to 6.27% in fiscal year (FY) 2020, down from 7.25% in FY 2019. Skilled nursing facility claims experienced a $1 billion reduction in improper payments last year as the result of a policy change and other regulatory efforts taken by CMS. (O'Brien, 11/17)
Also â
The original Compare tools CMS first launched over 15 years ago will be removed from the Medicare website on December 1, replaced by a new version. CMS released in September a redesigned website that consolidates its eight online tools intended for Medicare beneficiaries and their caregivers to compare healthcare providers and settings. The renovated site was an effort by CMS to create a more streamlined user experience. The original Compare tools forced a user to use different interfaces on the Medicare website depending on the care setting in which they were interested. (Castellucci, 11/17)
When you need to get benefits like SNAP or Medicaid â time is usually of the essence. So is ease. But oftentimes, those processes can be full of complications. According to a new survey by Cleveland-based think tank The Center for Community Solutions, users say Ohioâs online benefits self-service portal isnât meeting their needs. âWhen a website doesnât work, then your only option is to call â then you get these really long wait times,â said consultant Rachel Cahill. (Bash, 11/16)
In nursing home news â
Only 12.5% of the country's one million nursing home staff has completed government COVID-19 training, according to CMS. So far, 125,506 people at 7,313 nursing homes have taken the training, which was announced Aug. 25, CMS said Tuesday. There are 1,092 nursing homes at which 50% or more of staff have completed the training. The agency made the names of those nursing homes publicly available. (Christ, 11/17)
Weekly COVID-19 cases in nursing homes have eclipsed earlier pandemic peaks as cases across the U.S. climb, according to a new report by the American Health Care Association and National Center for Assisted Living, which represents nursing homes and assisted living communities. Weekly new cases in the U.S. rose 140% to 572,613,527 in the U.S. the week of Nov. 1 and continue climbing by more than 100,000 cases per day, according to Johns Hopkins University and CMS data. In nursing homes, there has been a 73% increase from mid-September when cases in nursing homes first started to rise again after falling since late July. (Christ, 11/17)
Capitol Watch
Iowa Sen. Chuck Grassley, Third In Line Of Presidential Succession, Has COVID
Iowa Sen. Chuck Grassley, the longest-serving Republican senator and third in the line of presidential succession, said Tuesday that he has tested positive for the coronavirus. Grassley, 87, had announced earlier Tuesday that he was quarantining after being exposed to the virus and was waiting for test results. On Tuesday evening, he tweeted that he had tested positive. (Jalonick, 11/18)
The senator was at the Capitol on Monday and spoke on the Senate floor, taking off his mask to do so. Grassleyâs illness follows news late last week that fellow octogenarian Rep. Don Young (R-Alaska,) the dean of the House as the longest-consecutive-serving member, was diagnosed with the coronavirus. (Itkowitz and DeBonis, 11/17)
In other news from Capitol Hill â
Colorado Rep. Ed Perlmutter (D) announced Tuesday that heâs tested positive for COVID-19, becoming the latest House lawmaker to be diagnosed with the virus. Perlmutter said in a statement that he is currently asymptomatic and will isolate in his Washington apartment as he works remotely. (Axelrod, 11/17)
Sen. Rob Portman is participating in a Covid-19 vaccine trial to try to boost public confidence in a shot when it becomes available, the Ohio Republican said in an interview. Portman, who has broken with many of his fellow Republicans on issues like mask wearing, joined a large, late-stage trial of Johnson & Johnsonâs vaccine candidate almost two weeks ago. He said polls showing skepticism about an eventual Covid-19 shot convinced him that public figures need to demonstrate confidence in a vaccine. (Luthi, 11/17)
And on stimulus negotiations â
In a letter to McConnell on Tuesday, Schumer, D-N.Y., and Pelosi, D-Calif., asked the Kentucky Republican to âjoin us at the negotiating table this week so that we can work towards a bipartisan, bicameral COVID-19 relief agreement to crush the virus and save American lives.â As they called for money for schools, small businesses, state and local governments and unemployment insurance, the Democrats wrote that the âpandemic and economic recession will not end without our help.â (Pramuk, 11/17)
As coronavirus cases spike around the country, hospitalizations reach new records and President Donald Trump continues to refuse to concede the election, lawmakers on Capitol Hill are less and less confident that any stimulus deal can be reached in the lame duck with focus turning instead to a government spending negotiation that must be finished by December 11. (Fox and Zaslav, 11/17)
Obstacles to housing affordability have been exacerbated by the coronavirus and will require government assistance to help Americans weather the pandemic, lawmakers and experts said Tuesday. âWeâve had a moratorium on eviction, but lots of people fall through those cracks,â said Sen. Sherrod Brown (Ohio), the top Democrat on the Senate Banking, Housing and Urban Affairs Committee. (Bautista, 11/17)
Preparedness
Need A COVID Test? Brace For Long Lines And Shortages Again
With the pandemic out of control in the United States, the nation's precarious coronavirus testing system is starting to strain again. Long lines are again forming in some places as the surge of infections drives a surge in demand for testing. Testing companies, lab directors and testing policy experts warn that waiting times for results could soon start to lengthen. In fact, one of the largest commercial testing companies Tuesday reported turnaround times had already started creeping up. (Stein, 11/17)
In other testing news â
A new type of test can detect a personâs immune response to the coronavirus better than a widely used antibody test, according to research released on Tuesday. The test, if authorized by the Food and Drug Administration, would be the first commercial product to detect the response of a T cell â a type of immune cell â to the virus. Antibodies have dominated the conversation on immunity since the start of the pandemic, but scientists believe that T cells may be just as important in preventing reinfection. (Mandavilli, 11/17)
El Pasoans living near an East Side Walmart can get an at-home COVID-19 testing kit delivered by drone. The service started Tuesday. In partnership with Quest Diagnostics and DroneUp, Walmart on Tuesday announced the drone delivery system offered from the store at 1850 N. Zaragoza Road. The delivery will be to single-family homes within a 1.5 mile radius of the store and will depend on weather conditions. (Cortes Gonzalez, 11/17)
About 800 Nurses Go On Strike Near Philadelphia
Nearly 800 nurses were on a picket line Tuesday in Pennsylvania. The nurses work at St. Mary Medical Center in Langhorne, near Philadelphia, and they say they are walking off the job to fight for their patients. At issue is the hospitalâs contract with the nurseâs union. The nurses want a new contract with higher wages and safeguards for patient safety. The nurses say they are caring for more patients during the coronavirus pandemic than they should, and that is putting patients at risk. (11/17)
Harris County health authority Dr. Umair Shah will step down to take a job as Washington stateâs health secretary, his office announced Tuesday. As the executive director of Harris County Public Health, Shah has led the countyâs response to the COVID-19 pandemic. His last day will be Dec. 18. His departure comes as the pandemic worsens in Harris County. The Houston area reported 1,273 COVID-19 hospitalizations on Monday, higher than any point since Labor Day. (Despart, 11/17)
When a man in his 40s with Covid-19 and low oxygen saturation arrived at the Boston hospital where Brittany Bankhead-Kendall treated patients in April, he was quickly put on a ventilator, a standard first response at many American hospitals at the time. She relied on WhatsApp messages and video calls from doctors overseas, who were also using trial and error to treat a spreading virus few knew much about. Incoming patients at her hospital were randomly assigned to antiviral and other drug trials to see what might stem the disease. âWe were really flying blind,â she said. (Krouse, 11/18)
In other health industry news â
Manulife Financial Corp. has added gender-affirmation coverage that pays for some surgeries and other treatments for its transgender employees in the U.S. and Canada, putting the insurer in a select group of companies that offer such benefits. The coverage includes surgeries such as Adamâs apple reductions, cheek or breast augmentation and treatments like voice training, the Toronto-based insurer and wealth manager said Tuesday. (Orland, 11/17)
As the coronavirus pandemic collides with flu season, barriers to accessing medical information could undermine not only individual patient care but public health. Our ability to successfully prevent, isolate, and control outbreaks of infectious disease will depend on how we leverage data and technology to track its spread and treat individual patients. (Broussard, 11/18)
Pharmaceuticals
PhRMA Unveils Guidelines To Improve Racial Diversity In Clinical Trials
The pharmaceutical industryâs largest lobbying organization released guidelines on Tuesday to enhance racial and ethnic diversity among participants in clinical trials run by its member drug makers. The principles address a problem that has long hampered the development of new medicines and vaccines, including the studies of potential Covid-19 shots. (St. Fleur, 11/17)
In other pharmaceutical and biotech news â
A bankruptcy judge approved an $8.34 billion settlement between Purdue Pharma LP and the Justice Department that requires the drugmaker to plead guilty to three felonies over its marketing and distribution of OxyContin and is structured to support state and local government programs addressing the opioid crisis. Approval of the agreement Tuesday by Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, N.Y., marks a milestone in Purdueâs chapter 11 case and advances the drugmakerâs goal to turn itself into a corporate trust run for the benefit of the public. (Randles, 11/17)
Amazon customers in the U.S. can get prescriptions delivered to their home and receive up to an 80% discount when paying without insurance, the e-commerce giant announced Tuesday in its latest push into the healthcare industry. Amazon Prime members across 45 states will have access to unlimited, free two-day deliveries and can compare prices across 50,000 pharmacies. They can also save up to 80% on generic drugs and 40% off branded products when paying without insurance, which is administered by Evernorth subsidiary Inside Rx. (Kacik, 11/17)
Walmart, Walgreens Boots Alliance, CVS Health and Rite Aid report that demand for flu shots at their U.S. pharmacies is up sharply â in some cases double from last year â as people try to protect themselves from influenza in the midst of a worsening covid-19 pandemic. The pharmacies have told Reuters they are giving millions more flu shots than they have in past years, filling a gap from covid-19 for wary consumers who are avoiding the doctorâs office. The gains represent millions of dollars in potential profit. (Humer, 11/17)
Medtronic this week continued its expansion into the artificial-intelligence surgery space, a push it's mainly pursued through acquisitions. The newly acquired company, Medicrea, uses AI to ease pre-operative planning and tailor implants for spine surgeries. It marks Medtronic's seventh acquisition this year. (Kim Cohen, 11/17)
As the United States braces for a bleak winter, hospital systems across the country are ramping up their efforts to develop AI systems to predict how likely their Covid-19 patients are to fall severely ill or even die. Yet most of the efforts are being developed in siloes and trained on limited datasets, raising crucial questions about their reliability. (Brodwin, 11/18)
Science And Innovations
Deep Sleep Can Help Ward Off Alzheimer's Disease, Studies Show
During deep sleep, the brain appears to wash away waste products that increase the risk for Alzheimer's disease. A host of new research studies suggest that this stage of sleep â when dreams are rare and the brain follows a slow, steady beat â can help reduce levels of beta-amyloid and tau, two hallmarks of the disease. (Hamilton, 11/17)
In other science and research news â
Brainstorm Cell Therapeutics reported disappointing results Tuesday from a late-stage clinical trial involving its experimental stem cell therapy for patients with amyotrophic lateral sclerosis, or Lou Gehrigâs disease... Despite the negative study results, âinformal discussionsâ between the company and the Food and Drug Administration are being held to determine if certain types of ALS patients with less severe disease might benefit enough from the treatment to support approval. (Feuerstein, 11/17)
For years, the prevailing âwisdomâ about people diagnosed with chronic fatigue syndrome was they were just terribly out of shape and harbored irrational fears they had an organic illness. The favored treatments were graded exercise therapy, designed to counter the deconditioning with a program of progressively increasing activity, a form of cognitive behavior therapy specifically designed to address the unfounded illness beliefs, or a combination of the two. (Tuller and Lubet, 11/17)
In a tiny cup in a cramped, concrete block office, a billion-dollar idea sits, small enough to fit about 2,000 of itself across the head of a penny. Iowa State University researchers Jonathan Mochel and Karin Allenspach-Jorn have examined these cups through a microscope for four years, watching stem cells grow into dog small intestines. Their goal? Create a faster way for pharmaceutical companies to determine whether a new drug will work. (Jett, 11/17)
Some mouthwashes can kill the novel coronavirus within 30 seconds after being exposed to it in a lab, according to a study that scientists at Cardiff University in Wales say could signal âpromising signsâ for mouthwashes being used to help curb the spread of the pandemic. A report released Friday from the university showed that mouthwashes containing at least 0.07 percent cetylpyridinium chloride showed an ability to eradicate the virus. The study has yet to undergo peer review. (Castronuovo, 11/17)
KHN: Push Is On In US To Figure Out South Asiansâ High Heart RisksÂ
For years, Sharad Acharyaâs frequent hikes in the mountains outside Denver would leave him short of breath. But a real wake-up call came three years ago when he suddenly struggled to breathe while walking through an airport. An electrocardiogram revealed that Acharya, a Nepali American from Broomfield, Colorado, had an irregular heartbeat on top of the high blood pressure he already knew about. He had to immediately undergo triple bypass surgery and get seven stents. (Ramachandran, 11/18)
Public Health
End To England's Quarantine?: British Airways Announces Testing Plan
British Airways said Tuesday that it will start testing passengers flying from the U.S. to Londonâs Heathrow Airport for COVID-19 in an effort to persuade the British government it should scrap rules requiring most international travelers to quarantine for 14 days. The airline says the pilot program will offer voluntary testing starting Nov. 25 in partnership with American Airlines for passengers flying to Heathrow from New York, Los Angeles and Dallas. (Kirka, 11/17)
In the early days of the coronavirus pandemic, even as nations shut their borders and airlines struggled with record-low passenger levels, there was a lot of optimism about âtravel bubblesâ â a controlled return of quarantine-free air travel between designated cities or countries. Since then, with few countriesâ outbreaks truly under control, there has been far more chatter about potential travel bubbles than there have been actual bubbles implemented. But this weekend, Asiaâs first bubble, between Hong Kong and Singapore, will finally make its debut.The two citiesâ âAir Travel Bubble,â set to start Sunday, will test whether regions can safely partner in a return to quarantine-free travel in the pandemic era. (McMahon, 11/17)
Norwegian-owned cruise ship operator SeaDream Yacht Club, which returned to Barbados just five days ago, has canceled sailing for the rest of the year after several positive coronavirus tests among passengers and staff on one of its cruises. (Hassan, 11/17)
In sports news â
The Canadian government is reviewing a proposal from the NBA and the Raptors to play in Toronto amid the pandemic. A spokesman for Health Minister Patty Hajdu said Tuesday officials have been in contact with the Raptors and will continue to engage with them âin the coming weeks.â Raptors general manager Bobby Webster told Sportsnet television the team needs to know âin the coming days. This is not a next week type thing.â (Gillies, 11/18)
New Mexico Stateâs menâs basketball team will temporarily move to Phoenix due to coronavirus restrictions in its home state. The Aggies are expecting to be in Arizona for five weeks, but could extend their stay depending on developments with the pandemic, deputy athletic director Braun Cartwright said Tuesday. They are hoping to play their first game next week. (11/18)
Dr. Tom Frieden, the former director of the Centers for Disease Control and Prevention, was unequivocal when asked if holding a basketball tournament in South Dakota at the moment was a sensible idea. âThatâs a no-brainer,â he said. âThe answer to that is a slam dunk: no.â (Cohen and Radnofsky, 11/17)
From The States
Louisiana Prison Didn't Isolate Inmates Who Had COVID, Report Finds
In a report released Tuesday, the Justice Departmentâs Office of the Inspector General found that a Louisiana prison did not not isolate inmates infected with coronavirus for about one week. The watchdog conducted remote inspections of two Louisiana federal prisons â FCC Oakdale and FCC Pollock â between May 7 and June 16. FCC Oakdale experienced a serious outbreak early in the pandemic, while Pollockâs was not as serious. (Williams, 11/17)
In news from Indiana, Maine and Arkansas â
Indiana Republican Gov. Eric Holcomb and first lady Janet Holcomb are quarantining after several members of his security detail tested positive for COVID-19, his office announced Tuesday. State Health Commissioner Dr. Kris Box advised Holcomb and the first lady to quarantine beginning Tuesday. They are considered close contacts to the security detail and will be tested for COVID-19 later this week, his office said. (11/17)
Tens of thousands of Mainers are set to lose unemployment benefits by the end of the year as coronavirus cases spike to record highs, adding to the financial strain of families already struggling due to long-term unemployment during the pandemic. It sets up a perfect storm as winter approaches. Every county in Maine set a record for active cases of the virus in the past week, dashing hopes of further reopening as a seasonal economy makes finding work difficult. Federal unemployment programs that have buoyed the state economy and families are set to run out for many all at once. The prospects of another relief bill during a lame duck session of Congress remain uncertain after months of gridlock. (Piper, 11/18)
The Maine Center for Disease Control and Prevention on Monday announced an outbreak of COVID-19 at another church â the Tabernacle of the Congregation in Sweden â the most recent in a handful of investigations involving houses of worship. Churches at the center of outbreaks tend to shy away from the public scrutiny they face in these instances. Some are defiant, but at least one Maine church has decided to take a very open approach to the outbreak in its midst. (Wight, 11/17)
Covid-19 hospitalizations and ventilator use in the state set daily records Tuesday as total hospitalizations rose by 34 to 895, and those requiring ventilators rose by 14 to 137, according to Health Department data. Another 1,554 new cases were added Tuesday, bringing the cumulative total to 135,902. Deaths from the virus rose by 20 to 2,245. (Roberts, 11/17)
In news from New Mexico, North Dakota and California â
New Mexico reported the death of its youngest COVID-19 victim so far â a preteen boy â as it set a number of troubling records Tuesday, including new daily highs in cases, hospitalizations and deaths. The youngsterâs identity and age werenât disclosed because of health privacy rules. But state officials described him as a male 12 or younger from Bernalillo County. (McKay and Boyd, 11/17)
North Dakotaâs coronavirus mortality rate is the highest of any U.S. state or country, according to an analysis of data from last week conducted by the Federation of American Scientists. The analysis, first reported by HuffPost, shows that North Dakota has a rate of 18.2 deaths per 1 million people. South Dakota, meanwhile, has 17.4 deaths per million, the third-worst rate in the world. The states have a total population of under 2 million. (Budryk, 11/17)
KHN: Anger After North Dakota Governor Asks COVID-Positive Health Staff To Stay On JobÂ
Nurse Leslie McKamey has gotten used to the 16-hour shifts, to skipping lunch, to the nightly ritual of throwing all her clothes in the laundry and showering as soon as she walks through the door to avoid potentially infecting her children. Sheâs even grown accustomed to triaging COVID patients, who often arrive at the emergency room so short of breath they struggle to describe their symptoms. But despite the trauma and exhaustion of the past eight months, she was shocked when North Dakota Gov. Doug Burgum said last week that health care workers who test positive for the coronavirus but do not display symptoms could still report to work. (Renwick, 11/18)
KHN: As Broad Shutdowns Return, Weary Californians Ask âIs This The Best We Can Do?âÂ
For Tom Davis, being told by the state this week that he must close his Pacific Edge Climbing Gym for the third time in six months is beyond frustrating. The first time the rock-climbing gym and fitness center shut down, co-owners Davis and Diane Russell took out a government loan to pay employees. The second time, they were forced to lay everyone off â themselves included. Now, as they face another surge of COVID cases across California, he fears he may lose the business for good. Californiaâs ping-ponging approach to managing the virus â twice reopening large portions of the service-sector economy only to shut them again â doesnât seem just or reasonable, Davis said. As of Tuesday evening, he was planning to defy the order, keeping the gym open but with additional restrictions on capacity. (Barry-Jester and Gold, 11/18)
Global Watch
China's Vaccine Appears Safe, But It Produces Lower Levels Of Antibodies
Sinovac Biotech, one of China's coronavirus vaccine front-runners, published mixed findings from its two first clinical trials Tuesday, raising the stakes in Indonesia, which has already declared plans to roll out Sinovac's vaccine. While the vaccine appeared to be safe in these early clinical trials, the company reported that it generated lower levels of protective antibodies in the bloodstream compared with those arising in recovered coronavirus patients. In comparison, Moderna and Pfizer had reported antibody levels on par with or higher than those produced in recovered coronavirus patients. (Dou, 11/18)
Russian President Vladimir Putin told BRICS leaders Tuesday that coronavirus vaccines developed in Russia âwork effectively and safelyâ and urged the group of emerging economy nations to âjoin forcesâ for the mass production of the shots. Putinâs remarks come after early results of large studies of several experimental COVID-19 vaccines, including a Russian one, were announced. The BRICS grouping is made up of Brazil, Russia, India, China and South Africa. (Litvinova, 11/17)
Even Sweden appears to be abandoning the Swedish model. On Monday, the countryâs authorities banned gatherings of more than eight people as they grappled with the second coronavirus wave surging through much of Europe. The new restrictions followed other protocols coming into effect this week, including protective measures around nursing homes and bans on alcohol sales at restaurants and bars after 10 p.m. (Tharoor, 11/18)
It was only recently that Italyâs coronavirus response was being held up as an example by newspapers around the world. Now it looks like the country is shuffling towards a slow-motion disaster. In Naples, Italyâs third-biggest city and the heart of the mezzogiorno, the countryâs south, ambulances carrying COVID-19 patients queued up outside overflowing hospitals. Images of an elderly man who died in a hospital bathroom and was reportedly left on the floor for over half an hour also prompted outrage. (Martuscelli, 11/14)
One Belgian doctor described nursing homes in his country as a scene of âcarnageâ in the first wave of the coronavirus pandemic, with fatalities inside the institutions pushing Belgium to a worst-in-the-world death toll. Afterward, policymakers vowed to fortify the care homes to protect against a potential new surge. Yet deep into a second wave, the virus is racing through nursing homes once more, and advocates say some of the same broad mistakes are cementing Belgiumâs status as a country where reported coronavirus deaths per capita are off the charts. (Birnbaum, 11/17)
Dutch Prime Minister Mark Rutte eased his countryâs coronavirus measures Tuesday amid falling infection rates, allowing public venues including cinemas, museums and libraries to reopen â with limitations on how many people can visit â after a two-week closure. The venues, which also include zoos and swimming pools, will be allowed to reopen at midnight Wednesday, Rutte said. (11/17)
Prescription Drug Watch
Perspectives: What President-Elect Biden Can Do About Drug Prices; Trumponomics Won't Go Away
As Democrats celebrate the election of President-elect Joe Biden and Vice President-elect Kamala D. Harris, we need to have an important conversation about building a 50-state party that can win up and down the ticket. But with a hobbled economy, an international health crisis, a vanishing middle class and widespread racial inequities, we also need to answer another important question â how to deliver on our campaign promises and improve the lives of the American people. (Sen. Elizabeth Warren, D-Mass., 11/11)
The U.S. pays substantially higher prices than the rest of the developed world for prescription drugs. This is primarily due to limited competition among drug companies and a patent system susceptible to gaming. Moreover, our regulatory apparatus has focused largely on drug safety while deemphasizing cost-effectiveness for new and existing drugs. The Trump administrationâs recent proposal to fix the problem were limited. Congress should follow the German example, which reins in prices by 30 percentage points as compared with the U.S. and focuses on rewarding effective drugs. Pharmaceutical companies will vigorously fight to maintain their profits, but given the universal public disdain for high drug prices, a committed bipartisan coalition may bring some relief. (Simon F. Haeder, 11/17)
Some Republican politicians are interpreting the election results as evidence that the future of the GOP is as the party of workers, not businesses elites. The GOP should put workers closer to the center of their policy agenda. But doing so would not be a continuation of Trumpâs policies. His actual accomplishments for the working class are scant. He didnât deliver on promises to reduce drug prices and strengthen healthcare. His promised manufacturing revival never materialized â his trade wars actually cost manufacturing jobs. (Michael R. Strain, 11/12)
Also â
If you were hoping that this was going to be the year of government action to lower prescription drug prices, Iâm here to say that is not going to happen â event hough the House of Representatives passed far-reaching legislation almost a year ago that would allow Medicare to begin negotiating drug prices for beneficiaries. (Trudy Lieberman, 11/16)
Editorials And Opinions
Viewpoints: Lessons On Vaccines, Possible End Dates To Social Distancing; Pros, Cons Of Amazon's Entry Into Pharmacy Orders
Now comes the news, for the second time in a week, that an experimental vaccine has proved surprisingly effective against Covid-19. Modernaâs vaccine, like Pfizerâs, has shown early protection higher than 90%. Also heard are caveats: Doses wonât be available for months. But the news may be better than we think. These announcements materially change incentives now, especially for the young who are the key spreaders. (Holman W. Jenkins, Jr., 11/17)
After years of rumors and small steps into the pharmacy business, Amazon.com Inc. finally announced a firm expansion of its prescription drug ambitions Tuesday, about two years after it signaled its intent with the purchase of mail-order drug startup PillPack. Customers will now be able to use the new Amazon Pharmacy to order medicines online, and Prime members who donât use insurance will get discounts. The move, while expected at some point, still hit pharmacy giants CVS Health Corp. and Walgreens Boots Alliance Inc. hard: Both stocks slumped in early trading Tuesday. Investors are right to be concerned. (Max Nisen, 11/17)
Regulatory authorities are gearing up for a deluge in people reporting side effects when the new Covid-19 vaccines go into use. Even as vaccines like the one from Pfizer Inc. and BioNTech SE reach safety milestones and look set for regulatory approval, managing the reporting and follow-up of what are known as adverse drug reactions will be critical to keeping to the high levels of public participation needed for a vaccination program to be successful. The U.S. Centers for Disease Control and Prevention plans to send daily texts to those who are vaccinated for the first week and then weekly texts for six weeks, while the Food and Drug Administration will also be monitoring side effects in real time. (Therese Raphael, 11/18)
The drugmakers Moderna and Pfizer buoyed hopes for an end to the coronavirus pandemic when they announced this month that their vaccines were 94.5 percent (Moderna) and 90 percent (Pfizer) effective at preventing Covid-19, based on preliminary results from ongoing clinical trials. Neither vaccine produced any serious safety concerns. Pfizerâs and Modernaâs data were analyzed by independent experts, though their findings were published in news releases, not peer-reviewed scientific journals, so the results are not yet considered conclusive. But if the numbers hold steady through the end of the trials, these vaccines would be among some of the most effective ever created. (Spencer Bokat-Lindell, 11/17)
With good vaccines apparently on the way, itâs now possible to imagine a new post-pandemic world order. One question is whether China has overtaken the U.S., and on that there is good news: In terms of ideas and relative influence, America may have opened up its lead.Start with the vaccines themselves. China has done surprisingly well, and some of its vaccines are likely to prove sufficiently effective and safe. But the U.S., working with the German BioNTech company, has produced an entirely new kind of vaccine platform, namely mRNA vaccines. They can be quickly manufactured and hold the promise of combating many future viruses. The China vaccines are mostly based on older methods, with the Chinese doing their utmost to scale up production quickly. (Tyler Cowan, 11/16)
Exit polls show that when President Trump accused Democrats of exaggerating the gravity of the COVID -19 pandemic his supporters believed him. Trump supporters showed as they voted that they donât see COVID-19 as a very urgent problem. It leaves the Biden administration with a massive public re-education challenge in red America and among Trump supporters in every state. (Drew Altman, 11/17)
The headlines about the novel coronavirus this week are both alarming and encouraging. First, the bad news: Hospitalizations in the United States have doubled since Labor Day, exceeding the numbers recorded at any time since the pandemic began. Far from "rounding the corner," the nation faces a perilous winter as temperatures start to plunge and flu season takes hold. (David Oshinsky, 11/17)
Hereâs a silver lining in the Covid-19 pandemic: Teens are talking more with their parents and showing signs of improved mental health, according to a survey from the Institute for Family Studies (where I am a contributing editor). The study, released in October, found that 56% of 1,523 U.S. high school students surveyed between May and July reported talking to their parents more during quarantine than before. Fifty-four percent said their families have dinner together more often, 46% reported spending more time with siblings, and 68% said their families had become closer during the pandemic. (Erica Komisar, 11/17)
Friends and I have been talking recently about how to make Thanksgiving celebrations safe. âYou already know what Iâm going to say,â I told one, whose enormous brood of Catholic siblings are now raising enormous Catholic broods of their own. âItâs not safe?â âItâs not safe,â I agreed. I hate playing the role of The Grinch Who Stole Thanksgiving. Like you, Iâm longing to see friends and family, and enjoy my favorite holiday. Those things make life worth living. (Megan McArdle, 11/17)
This morning, my children went to school â school, in an old brick building, where they lined up to go in the scuffed front doors. I went to work out at the gym, the real gym, where I huffed and puffed in a sweaty group class. And a few days ago, my partner and I hosted a dinner party, gathering eight friends around the dining room table for a boisterous night that went too late. Remember those? Where Iâm living, we gather without fear. Life is unfolding much as it did a year ago. This magical, virus-free world is just one long dayâs drive away from the Empire State Building â in a parallel dimension called Nova Scotia. (Stephanie Nole, 11/18)