The huge return on investing in coronavirus tests

Report: Government spending on testing and tracing pays for itself more  than 30 times over - Axios

Government spending on testing and contact tracing pays for itself more than 30 times over, according to yet another paper published in JAMA (good series!).

What they found: Harvard economists David Cutler and Lawrence Summers calculated the total cost of the coronavirus pandemic at more than $16 trillion in the U.S. alone. Of that, about $7 trillion is attributable to loss of life and long-term impairment from the disease, Axios’ Felix Salmon writes.

  • Enhanced testing and tracing would cost about $6 million per 100,000 inhabitants, they calculate. Out of that population, 14 lives would be saved, on which they place a value of $96 million, and 33 critical and severe cases would be avoided, representing savings of $80 million.
  • That adds up to $176 million in benefits from $6 million in costs — before taking into account any second-order effects from even fewer cases down the road.

The bottom line: “Currently, the U.S. prioritizes spending on acute treatment,” write Cutler and Summers, “with far less spending on public health services and infrastructure.”

  • Going forward, they write, “a minimum of 5% of any COVID economic relief intervention should be devoted to such health measures.”

The coming vaccine chaos

The coming coronavirus vaccine chaos - Axios

The first coronavirus vaccine will likely get authorized within months, but that will only be the beginning of what’s likely to be a long, chaotic vaccination process, the New York Times’ Carl Zimmer reports.

The big picture: The first vaccines probably will offer only moderate protection against the virus, meaning we can’t ditch our masks even if we get one. And we probably won’t have a good way to choose between these vaccines once several of them are on the market.

  • Some vaccines that are in earlier stages of development today may struggle to cross the finish line, even if they work better than earlier vaccines.
  • And some vaccines may be pulled off of the market because they’re unsafe.

Between the lines: Some of this is inherent to the breakneck speed of the vaccination effort, but some of it is a result of how that effort was designed.

  • Earlier this year, some government scientists had wanted to test vaccine candidates against each other, instead of testing all of them against a placebo. But these kinds of trials are risky for drug companies, because they show the value of one vaccine against another.
  • That information could be useful for patients, but is a business risk for manufacturers.
  • You have to have the total cooperation of the pharmaceutical companies to get involved in a master protocol,” top infectious disease expert Anthony Fauci told NYT. “That — I don’t know what the right word is — didn’t turn out to be feasible.”

Trying to reach herd immunity is ‘unethical’ and unprecedented, WHO head says

The head of the World Health Organization said Monday that allowing the novel coronavirus to spread in an attempt to reach herd immunity was “simply unethical.”

The remark was a sharp rebuke of the approach amid mounting new infections around the world. Recent days have seen the most rapid rise in cases since the pandemic began in March.

“Never in the history of public health has herd immunity been used as a strategy for responding to an outbreak, let alone a pandemic,” WHO Director-General Tedros Adhanom Ghebreyesus said at a Monday media briefing. “It is scientifically and ethically problematic.”

In a public health context, herd immunity typically describes a scenario in which a large enough share of the population is vaccinated against a disease to prevent it from spreading widely, thereby providing default protection to a minority of people who have not been vaccinated.

But as there is still no vaccine for the coronavirus, achieving herd immunity in the current environment would require a large number of people to contract the virus, survive covid-19, and then produce sufficient antibodies to provide long-term protection.

While the scientific community has roundly rejected herd immunity the approach, public interest in it has waxed and waned amid pressure to reopen schools and economies.

Last month, President Trump appeared to praise the idea during a town hall in Pennsylvania.

“You’ll develop herd — like a herd mentality,” he said. “It’s going to be — it’s going to be herd developed — and that’s going to happen.”

British Prime Minister Boris Johnson’s government initially expressed interest in the theory before backtracking amid public outcry over the dangers of letting the virus spread. Johnson himself was hospitalized with a severe case of covid-19, which he said could have killed him.

Tedros, noting that there had been “some discussion” about the concept recently, told reporters Monday that allowing people to be exposed to a deadly virus whose effects are still not fully known was “not an option.”

“Most people who are infected with the virus that causes covid-19 develop an immune response within the first few weeks, but we don’t know how strong or lasting that immune response is, or how it differs for different people,” he said.

Though rare, there are multiple documented instances of people being infected for a second time after recovering from covid-19. An 89-year-old woman in the Netherlands died after being infected with the coronavirus for a second time, Dutch news reported Monday.

Antibody studies suggest that less than 10 percent of people in most countries have contracted covid-19, Tedros said, which is nowhere near the majority that would be needed for herd immunity.

With the “vast majority” of the world’s population susceptible, letting the virus spread “means allowing unnecessary infections, suffering and death,” he said.

Just in the last four days, Tedros said Monday, the global coronavirus count has continued to break its daily record for the number of new confirmed infections.

“Many cities and countries are also reporting an increase in hospitalizations and intensive care bed occupancy,” he added.

Tedros has urged governments to pursue comprehensive plans that include widespread testing, social distancing, and other preventive measures, such as face-mask wearing, alongside a global push to develop a vaccine. The WHO is spearheading an effort to distribute coronavirus vaccines equitably once they are available, which Trump declined to join.

America’s newest wave of Covid-19 cases, explained

https://www.vox.com/coronavirus-covid19/2020/10/11/21511641/covid-19-us-cases-update-testing-deaths-hospitalizations

A new wave of Covid-19 cases is building across the United States, a harbinger of difficult winter months ahead.

America is now averaging nearly 48,000 new confirmed cases every day, the highest numbers since mid-August, according to the Covid Tracking Project. More than 34,500 Americans are currently hospitalized with Covid-19 in the US, up from less than 30,000 a week ago. Nearly 700 new deaths are being reported on average every day, too — and while that is down from August, when there were often more than 1,000 deaths a day, deaths are going to eventually start increasing if cases and hospitalizations continue to rise. It’s a pattern we have seen before.

Public health experts have been warning for months that fall and winter could lead to a spike in Covid-19 cases. Why? Because the best way to slow down the coronavirus’s spread is to keep your distance from other people and, if you are going to be around others, to be outside as much as possible — and both become harder when the weather gets cold.

We may now be seeing those predictions start to come true. The US already has more than 7.7 million confirmed cases and 214,000 deaths. Both numbers will continue to climb.

Eight months into the pandemic, America’s failures to contain Covid-19, and states’ eagerness to reopen even if they haven’t gotten their outbreaks under control, is once again leading to a surge in cases and hospitalizations.

Covid-19 cases are rising everywhere across the country

Earlier in the year, there was limited value to discussing “waves” because some states would have a decline in cases while other states were experiencing surges. What distinguishes this autumn wave is that it seems to be happening everywhere.

Case numbers are up in the Northeast, the Midwest, and the West. The South appears to be, at best, plateauing at a level even higher than that which the Northeast endured during the worst of New York’s outbreak.

What’s so worrisome is that no one state or region can be blamed for this new wave. Just 13 states have seen their number of new Covid-19 cases drop over the last two weeks, according to Covid Exit Strategy. Cases are up in all the others.

Raw case numbers can, of course, obscure important differences in population; 100 new cases means something different for California than it does for Wyoming. Experts will use another metric — new cases per million people — to gauge how saturated a given state is with Covid-19.

The goal would be to have fewer than 40 new cases per million people. But just three states — Maine, Vermont, and New Hampshire — meet that threshold. Meanwhile, North Dakota (627 cases per million), South Dakota (596), Montana (474), and Wisconsin (434) are some of the states seeing very high levels of new infections.

As Vox’s German Lopez reported this week, just one state — Maine — meets all of the benchmarks established by experts for a state to consider its Covid-19 outbreak contained. And yet, most states have reopened many of the businesses that were closed in the spring: 40 or so states have reopened restaurants, bars, gyms, movie theaters, and nonessential retail.

“Part of the problem is America never really suppressed its Covid-19 cases to begin with,” Lopez wrote, explaining why experts were anticipating a new surge in cases. “Think of a disease epidemic like a forest fire: It’s going to be really difficult to contain the virus when there are still flames raging in parts of the forest and small embers practically everywhere. The country always risks a full blaze with each step toward reopening and with each failure to take precautions seriously.”

Too many Covid-19 tests are coming back positive right now

Another closely watched indicator for renewed Covid-19 spread is the percentage of coronavirus tests that come back positive. The number of tests being conducted doesn’t actually tell you all that much; if a high percentage of them are positive, that suggests that many others aren’t being caught at all and the virus could continue to spread unchecked.

So while the US is now averaging nearly 1 million tests every day, that is not quite the triumph it might sound like (or President Donald Trump would like to believe it is). The country’s positive test rate is 5 percent, right at the threshold experts say would reflect adequate testing. Ideally, it would be even lower, 2 percent or less.

But even with that passable national positivity rate, most states are still not conducting nearly enough testing. Here are the 10 states with the highest positive test rates, according to Covid Exit Strategy:

  1. Idaho (25 percent)
  2. South Dakota (20.6 percent)
  3. Wisconsin (19.5 percent)
  4. Iowa (17.1 percent)
  5. Kansas (16.1 percent)
  6. Wyoming (15.5 percent)
  7. Utah (14.7 percent)
  8. Nevada (14.4 percent)
  9. Indiana (13.6 percent)
  10. Alabama (13.3 percent)

It’s really only a handful of better-performing states — namely, New York, with more than 115,000 tests conducted per day and a 1.2 percent positivity rate — that’s keeping the US’s overall positive test rate from looking a lot worse.

America has never had a cohesive Covid-19 testing strategy. Since February, there have been regular supply shortages delaying test results. States have been fighting each other for precious testing resources. Contact tracing has not been a priority for the federal government, and most states have still not hired nearly enough people to perform that work.

Wealthy countries like Germany and South Korea have used effective test-trace-isolate programs to keep their Covid-19 outbreaks in check. The US, meanwhile, is still struggling to perform enough tests or scale up its contact tracing capabilities. Just 11 states, plus the District of Columbia, could realistically expect to perform adequate contact tracing, according to Covid Exit Strategy, considering their positivity rate.

Without improvement in both of those areas, it will continue to be difficult for the US to contain the coronavirus before a vaccine becomes available.

More Americans are being hospitalized with Covid-19 too

Both case numbers and the positive test rate can be a little deceptive, depending on how many tests are being performed. They suggest what’s happening on the ground — in this case, Covid-19 is spreading — but they do have their limitations. There is some truth to the president’s claim that more tests will mean more cases, though that is not a reason to stop testing.

Hospitalizations, on the other hand, are more concrete. If more people are developing symptoms severe enough to warrant being hospitalized, that is a strong indicator that the real number of people being infected with Covid-19 is growing, regardless of whether they are getting tested.

And after a dip in September, the number of Americans currently in the hospital with Covid-19 is higher than it’s been in a month. That trend has been seen across the country.

The worry becomes that if hospitals take in too many patients, they’ll have to turn other people away, or that overwhelmed staff and facilities could lead to some patients receiving substandard care. According to Covid Exit Strategy, 20 states currently have reduced ICU capacity that puts them in a danger zone; 21 states have an elevated occupancy rate in their regular hospital beds.

Wisconsin, where the number of hospitalized Covid-19 patients has risen over the last month from about 300 to 876 today, recently established a new field hospital on its state park fairgrounds over fears that the state’s hospitals wouldn’t have enough beds given the recent surge in cases.

Fortunately, hospitals have gotten much better at treating Covid-19. They have proven treatments, like remdesivir and dexamethasone, that reduce the length of hospital stays and reduce mortality in patients with severe symptoms. They have learned techniques like putting patients on their stomach to improve breathing. Hospitals that have endured multiple spikes of Covid-19 cases report patients in the later waves are spending less time in the hospital and dying less frequently.

Nevertheless, more people developing severe symptoms, as we are starting to see, will inevitably lead to more deaths. Over the summer, people wondered why deaths were falling while cases and hospitalizations rose — until deaths did start to increase. There is a long lag between cases rising and deaths rising, because it can take a month or more between when a person first contracts Covid-19 and, if they die, when their death is reported.

That’s why these new Covid-19 trends in the US are so worrisome. Cases are rising, as are hospitalizations. It could be only a matter of time before deaths start to spike as well.

Nevada man’s COVID-19 reinfection, the first in the US, is ‘yellow caution light’ about risk of coronavirus

https://www.yahoo.com/news/nevada-mans-covid-19-reinfection-223155707.html

COVID-19 reinfection: Nevada man is first confirmed American case

An otherwise healthy 25-year-old Nevada man is the first American confirmed to have caught COVID-19 twice, with the second infection worse than the first.

He has recovered, but his case raises questions about how long people are protected after being infected with the coronavirus that causes the disease, and potentially how protective a vaccine might be.

“It’s a yellow caution light,” said Dr. William Schaffner, an infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee, who was not involved in the research.

Respiratory infections like COVID-19 don’t provide lifelong immunity like a measles infection. So, Dr. Paul Offit, an infectious disease expert at Children’s Hospital of Philadelphia, said he’s not at all surprised people could get infected twice with the coronavirus, SARS-CoV-2. 

It’s too soon to know whether the man from Washoe County, Nevada, who had no known health problems other than his double infection, was highly unusual or if many people could easily get infected more than once with SARS-CoV-2, Schaffner said.

“There’s hardly an infectious disease doctor in the country who hasn’t encountered a patient who thinks they’ve had a second infection,” he said. “Whether that’s true or not, we don’t know. There are lots of respiratory infections out there.”

How rare is he?

There have been at least 22 documented cases of reinfection worldwide since the start of the pandemic, but it’s unclear how many cases there have actually been, and how common it may be among people who don’t even know they’re infected.

“It could be a one in a million event, we don’t know,” said Akiko Iwasaki, an immunologist at Yale University and an investigator with the Howard Hughes Medical Institute, who wrote a commentary with the study.

With millions of people infected, it’s hard to know if case studies like the new one represent very rare events or the tip of an iceberg, she said. “It’s possible that the vast majority of people are completely protected from reinfection, but we’re not measuring them, because they’re not coming to the hospital.” 

Also, many people don’t know they are infected the first time, so it’s hard to say whether they’re getting re-infected.

In one of the recent cases, a Hong Kong man only knew he was reinfected because it was caught during a routine screening when he returned from outside the country, months after he had cleared an infection and tested negative. 

One reason there may not be more documented cases of reinfection: It’s tough to prove, said Mark Pandori, a pathologist at the University of Nevada, Reno School of Medicine, and senior author on the new study

His team coordinated early in the pandemic with members of the Washoe County Health District to look for repeat infections. They had the benefit of sequencing equipment on campus, as well as microbiologists, he said. And they got lucky finding someone who had been tested both times he was infected and cleared in between. 

Why his infection was worse the second time remains unclear, said Pandori, director of the Nevada State Public Health Laboratory. “I can’t tell you if it tells us anything in particular about the biology of this virus.”

The man caught a slightly different version of the virus the second time, according a genetic analysis of the man’s infections. It’s possible the second version was more dangerous, though there is no evidence of that, or that it was just different enough that his body didn’t recognize it, the paper said.

Implications for vaccination

Iwasaki said the study raises questions about how long immunity lasts after a natural infection. Protection with a vaccine is likely to be quite different, she said.

“Vaccines can be designed to induce much higher levels of antibody and much longer lasting immunity,” she said. Just because the natural infection doesn’t give you protection doesn’t mean the vaccines cannot. It’s a separate issue.”

Offit, also a vaccine expert at the Perelman School of Medicine at the University of Pennsylvania, said he expects protection from vaccines will likely last at least a year or two.

The protection provided by infection or vaccination isn’t 100% perfect until the day it disappears completely, he said. Instead, protection fades gradually, so someone exposed to a huge dose of the virus might get re-infected within months, while others could be protected for years, Offit said.

It’s also possible the Nevada man has an undiagnosed problem with his immune system. “He probably should be seen by an immunologist,” Offit said. 

The length of time an infection will be protective remains one of the key open questions about the virus.

Infected twice, two months apart

The Nevada man, considered an essential worker, started feeling ill in late March, with a sore throat, cough, headache, nausea and diarrhea. His workplace had been hit with an outbreak early in the pandemic, before safety measures like masks could be put in place, said Heather Kerwin, senior epidemiologist at the Washoe County Health District and a co-author on the paper. 

He went for testing on April 18 and his infection with the coronavirus was confirmed.

On April 27, he reported his symptoms had all resolved and he felt fine, but at the time, employees were required to test negative for COVID-19 twice before they would be allowed back to work, Kerwin said. So he remained isolated at home.

A month later, he began feeling poorly again. At the same time, there was an outbreak where one of his parent’s, also an essential worker, was employed, Kerwin said.

On May 31, he went to an urgent care center, reporting fever, headache, dizziness, cough, nausea and diarrhea. On June 5, he went to see a doctor who found his oxygen levels dangerously low and had him hospitalized. Again, the man tested positive for the virus, even though he still had antibodies to the virus in his bloodstream, Kerwin said.

Genetic differences between the viruses responsible for each of his infections suggested he was infected two separate times. The virus doesn’t mutate quickly enough within a single person to explain the differences between the two infections, the researchers found. 

A parent living with the man also caught COVID-19 and was diagnosed on June 5.

Mark Pandori, pathologist
Mark Pandori, pathologist

The paper reports it’s possible the man was reinfected because he was exposed to a higher dose of the virus the second time, perhaps from the family member.

His cough lingered and he suffered from shortness of breath and mental fog, and was on oxygen for six weeks after the second infection, Kerwin said. He has now fully recovered.

Reinfections imply so-called herd immunity cannot be obtained just through natural infection. If natural infection protects for only a few months, then it will be impossible for enough people to be protected simultaneously to reach herd immunity.

The moral of the case study, said co-author Pandori, is even people who already have been sick with COVID-19 need to protect themselves by wearing a mask, avoiding large gatherings, washing hands frequently and maintaining social distance.

“You’re not invulnerable to this,” Pandori said. “In fact, you could get it worse the second time.”

A high-profile reminder of the importance of therapeutics

https://mailchi.mp/45f15de483b9/the-weekly-gist-october-9-2020?e=d1e747d2d8

Stemline Therapeutics Inc (NASDAQ:STML): What's The Other Side Of The  Story? - Market Exclusive

Along with the many political and public health questions raised by President Trump’s recent and very public bout with COVID-19 is the issue of when the public might have access to the same monoclonal antibody therapy that he received from doctors last week.

Having seen the President tout the benefits of Regeneron’s experimental antibody cocktail, COVID patients have reportedly been asking physicians about participating in clinical trials of the therapy, which is only available on a “compassionate use” basis outside of ongoing studies.

On Wednesday, Regeneron announced it had submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for the treatment, claiming that early data from ongoing trials showed promise in moderating coronavirus symptoms.

Eli Lilly, which is developing a similar antibody therapy, also announced plans to apply for an EUA, saying its drug has shown the ability to reduce hospitalizations among those infected with the virus.

The US government has already paid Regeneron $450M to access up to 300,000 doses of the therapy, and on Friday a spokesman for the Department of Health and Human Services (HHS) said the government would acquire up to a million doses from Regeneron and Eli Lilly by the end of the year, which it will allocate to hospitals in a similar approach to the way it has distributed Gilead Science’s antiviral drug remdesivir, which the President was also given last week.
 
News on the availability of potentially effective therapies to mitigate the impact of COVID-19 is welcome, particularly as the timeline for COVID vaccines appears to be lengthening.

In guidance released this week, the FDA said it would require pharmaceutical companies to submit two months’ worth of data on vaccine safety and efficacy after patients received their final dose, as part of the EUA application process. The data requirement effectively means that, despite repeated promises from the White House, none of the vaccine candidates being developed will be available before the November 3rd Presidential election.

The head of the government’s vaccine program said separately this week that he expects data on vaccines being developed by Pfizer and Moderna to be available by December. As many have predictedit will take months beyond that for a safe and effective vaccine to be distributed and administered to a majority of Americans.

Challenges will abound: ensuring sufficient manufacturing capacity, managing a complex supply chain, setting up specialized distribution and vaccination centers, and tracking those vaccinated (especially if two shots will be required). A massive public education campaign will also be needed to overcome vaccine hesitancy and ensure widespread immunization. And all of that will take time, and money. 

President Trump’s recent and unfortunate illness underscores the importance of paying equal attention to the development of therapies and treatments—which are essentially a holding maneuver to get us through the coming winter and spring, and eventually to the promise of immunity that lies beyond.

Medical ethics in pandemic times

https://www.axios.com/medical-ethics-clinical-trials-pandemic-eb77f819-76f1-45b0-af8a-cf181bc1607b.html

The Importance of Medical Ethics | Medical Ethics – theMSAG

The COVID-19 pandemic is rife with scientific and medical uncertainty, including debates about the ethics of using experimental treatments.

The big picture: As the global pandemic continues, the tension between providing the best available care for patients and performing trials to determine whether that care is effective risks complicating the medical response.

The big question: Is it unethical to withhold a possible treatment from someone who instead receives a placebo, or to continue to administer that treatment without having collected data on whether it works?

Driving the news: President Trump received an experimental monoclonal antibody cocktail via expanded access or “compassionate use,” which allows someone to access a treatment outside of a clinical trial before it is approved, provided their doctor, the drug company and the FDA agree.

  • Experts say his subsequent claims of the treatment being a cure risks reducing enrollment in clinical trials, flooding companies with requests for access to a limited number of doses and creating false hope for patients.
  • And the president’s treatment raised questions about fairness — would other COVID-19 patients have similar access?
  • “It’s important that we not say the president got access to a beneficial experimental intervention because we don’t know if it is beneficial or if there are adverse events associated with it, says Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University. 

He and other ethicists say the president’s treatment highlights a broader question about the ethical obligation doctors have to the science needed to determine if those treatments are effective.

Between the lines: Offering patients experimental COVID-19 drugs via emergency use authorizations, expanded access programs and compassionate use can slow needed clinical trials.

  • Researchers have struggled to enroll people in clinical trials in which they may receive a placebo if patients can access a drug directly.
  • One example: “There’s been some hiccups with the expanded access use for convalescent plasma, because it was something that precluded people from enrolling in a randomized control trial, so it took longer, and we still don’t quite know how well convalescent plasma works,” says Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security.

More than 100,000 COVID-19 patients at almost 2,800 U.S. hospitals received convalescent plasma from people who survived the virus and developed antibodies to it.

  • “It’s easy for people to say you enrolled 100,000 people, there should have been a trial. But a small number of those 2,800 hospitals would have been capable of doing those trials,” says the Mayo Clinic’s Michael Joyner, who leads the program.
  • There are now smaller trials taking place to answer questions about the effectiveness of plasma in treating the disease in different stages.
  • But if this happens again, Joyner says programs at academic medical centers should be peeled off earlier to form clinical trials run in parallel.

The gold standard for determining whether a treatment works is through randomized controlled trials in which people are randomly assigned to receive a treatment or to be in a control group.

  • In the uncertainty and urgency of a pandemic, some physicians argue randomizing people to receive a placebo goes against physicians’ ethics and that it is better to do something to help patients than do nothing.
  • “That’s a false dichotomy because the question is, what should we do?” says London.

From a doctor’s perspectiveit’s important to weigh the collective value of theearly drug data and the individual needs of the patient, Adalja says.

  • “I do think you have to be extra careful when you’re thinking about drugs that you don’t have strong randomized control trial data for, or the data is incomplete or inconclusive,” he adds.
  • “What people have to ask themselves is what constitutes evidence or proof and where do you want to make the bets in a pandemic?” says Joyner.
  • “There is a moral, legal and public health obligation to do those trials before people use those products,” says Alison Bateman-House, a professor of medical ethics at NYU’s Grossman School of Medicine who co-chairs an international working group on pre-approval access to treatments.
  • She says she understands the emotional pull on doctors to help patients whose health is quickly deteriorating, “but it is not evidence-based medicine.”

“There is no ethical obligation to give anyone an unproven substance.”

Alison Bateman-House, NYU Grossman School of Medicine

In a forthcoming paper, London argues that when medical professionals don’t have the knowledge they need to treat patients, it is their responsibility “to band together and run studies to get evidence to discharge [their] very ancient medical obligation.”

  • Medical ethics should be updated to include a responsibility to learn in the face of uncertainty, says London, who was part of a committee that called for research to be incorporated into the response to the Ebola outbreak in West Africa in 2014.
  • The U.K.’s large randomized RECOVERY trial is based in part on the Ebola experience, says London. “Because of it, we know dexamethasone is effective and hydroxychloroquine is not.”

What to watch: How the FDA’s handling of treatments during the pandemic influences other drugs and diseases once the pandemic ends.

The bottom line: “Medicine doesn’t have a good handle on uncertainty, and that is a problem,” says London.

The first presidential debate: 7 healthcare takeaways

https://www.beckershospitalreview.com/hospital-management-administration/the-first-presidential-debate-7-healthcare-takeaways.html?origin=CFOE&utm_source=CFOE&utm_medium=email&oly_enc_id=2893H2397267F7G

5 key takeaways from Joe Biden and Donald Trump's 1st presidential debate -  ABC News

President Donald Trump and former Vice President and Democratic presidential nominee Joe Biden sparred over the future of the ACA, the COVID-19 pandemic and health insurance during a 90-minute debate in Cleveland Sept. 29.

Seven takeaways for healthcare leaders:

The ACA

1. Moderator and Fox News host Chris Wallace opened the debate with the topic of President Trump’s nomination of Judge Amy Coney Barrett of the U.S. Court of Appeals for the 7th Circuit to the U.S. Supreme Court. In the first few minutes of the debate, the discussion turned to the future of the ACA should Ms. Coney Barrett join the Supreme Court. A week after the November presidential election, the Supreme Court is set to hear a lawsuit, supported by the Trump administration, that seeks to overturn the ACA. 

2. If the Supreme Court overturns the ACA, Mr. Biden said 22 million Americans would lose insurance and 100 million would lose protections for preexisting conditions. HHS said in 2017 as many as 133 million Americans have preexisting conditions, and a KFF analysis estimates 54 million Americans have conditions serious enough to lead to coverage denials if the ACA is overturned.

3. Mr. Wallace questioned the president about his promise to repeal and replace the ACA, adding that President Trump hadn’t released a comprehensive plan to replace the health law despite pledges to do so. The president disagreed with that, saying he had gotten rid of the individual mandate. Mr. Wallace said eliminating the mandate was not a comprehensive plan. Mr. Wallace called President Trump’s recent executive orders on preexisting conditions and surprise billing “largely symbolic.” President Trump disagreed, but did not tell how the executive orders would be implemented.

Drug prices 

4. The president said drug prices would be coming down “80 or 90 percent.” The president highlighted insulin, which he said he’s getting so inexpensively, “it’s like water.” Insulin continues to retail for about $300 per vial, according to STAT, but cheaper insulin prices could be coming for some seniors. CMS recently said it is expanding the number of Medicare Advantage plans that provide insulin for a $35 or less monthly copay.

Public option

5. In an exchange with Mr. Biden, President Trump accused the Democratic Party of wanting “socialist medicine,” and claimed Mr. Biden wants to end private insurance. Mr. Biden denied those claims and said his health plan, which includes expanded ACA subsidies and a public option, would allow employees to keep their private health insurance. He has not supported Medicare-for-All proposals.

COVID-19

6. On the topic of the pandemic, Mr. Wallace asked President Trump about differing timelines for a vaccine that have been presented by him versus federal scientists like CDC Director Robert Redfield, MD. The president said he has spoken with Pfizer, Moderna and Johnson & Johnson, who’ve said “they can go faster” on a vaccine, but “it’s a very political thing.” He added that the military is already set up to distribute vaccines. Mr. Biden questioned Americans’ trust in the process. A Sept. 29 poll from the Axios/Ipsos Coronavirus Index found 8 in 10 Americans wouldn’t likely get a first generation COVID-19 vaccine if the president said it was safe.

7. President Trump and Mr. Biden took different stances on masks. Mr. Biden cited Dr. Redfield’s renewed call to wear masks, and said masking up and social distancing would save 100,000 lives between now and January. President Trump responded by saying, “They’ve said the opposite.” He alluded to early in the pandemic when public health experts, including Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, were slow to recommend widespread mask-wearing before scientists better understood how the virus spreads. The CDC currently recommends that every American wear a mask.

 

 

 

U.S. Still in First Wave of COVID-19, Fauci Says

https://www.webmd.com/lung/news/20200925/us-still-in-first-wave-of-covid-19-fauci-says

US still in first Covid-19 wave and should be prepared for 'challenge' of  fall and winter, Fauci says

Anthony Fauci, MD, says talk about a second wave of the coronavirus is premature because the United States is still dealing with the first one.

The idea of a second wave is based on the 1918 flu pandemic, when many cases were seen in the spring, he says. The spring cases “literally disappeared” and were followed by a spike in flu cases in the fall, he told CNN’s Sanjay Gupta, MD, on Thursday in an online conversation organized by Emory University.

“Rather than say, ‘A second wave,’ why don’t we say, ‘Are we prepared for the challenge of the fall and the winter?’” said Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force.

Flu shots are an important measure to help the U.S. get through the winter, he said.

He and other health care professionals have observed that the Southern Hemisphere has had a very light flu season, probably because measures to curb the coronavirus, such as social distancing and mask-wearing, have limited the spread of the flu.

“If we listen to the public health measures, not only would we diminish the effect of COVID-19, we might get away with a very, very light flu season if we combine that with getting the flu vaccine,” Fauci said.

In a separate interview, he said the arrival of the coronavirus vaccine will not stop the need for tried-and-true measures such as mask-wearing, hand-washing, and social distancing.

In a Facebook Live conversation with New Jersey Gov. Phil Murphy, Fauci said the coronavirus vaccine will not be 100% effective and won’t be taken by the entire population. That means the virus could still spread.

“So when a vaccine comes, we look at it as an important tool to supplement the public health measures that we do,” he said. “It will allow us to more quickly and with less stringency get back to some degree of normal. But it is not going to eliminate the need to be prudent and careful with our public health measures.”

Fauci said that vaccinating 75% to 80% of the population “would be a really good accomplishment.” He expects 700 million doses to be produced by the end of this year or early 2021.

 

 

 

 

Medicare won’t cover coronavirus vaccines approved under emergency use authorization

https://www.beckershospitalreview.com/pharmacy/medicare-won-t-cover-coronavirus-vaccines-approved-under-emergency-use-authorization.html?utm_medium=email

Medicare Wouldn't Cover Costs of Administering Coronavirus Vaccine Approved  Under Emergency-Use Authorization - WSJ

Medicare won’t cover the cost of a COVID-19 vaccine if it is approved under an emergency use authorization, according to The Wall Street Journal. 

The White House recently concluded that Medicare’s exclusion of emergency-use drug costs could mean 44 million Americans, or 15 percent of the U.S. population, may have to pay out-of-pocket for a vaccine if it is approved under an emergency use authorization, the Journal reported.

HHS is now exploring coverage options, and a spokesperson told the Journal any vaccine doses bought by the government will be provided free.

The administration of President Donald Trump has pushed for a COVID-19 vaccine to be approved and distributed before the presidential election, which would likely only come with an emergency use authorization, since FDA approvals take more time.

In March, lawmakers passed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which ensures no out-of-pocket costs for COVID-19 vaccines for people on Medicare.

HHS also said in August that government health insurance programs, including Medicare and Medicaid, would cover the costs of administering a COVID-19 vaccine.