When False Information Goes Viral, COVID-19 Patient Groups Fight Back

KFF Health News, November 12, 2020

The fear and uncertainty regarding the coronavirus have made online groups targets for the spread of false information.

This article was published on Thursday, November 12, 2020 in Kaiser Health News.

By Alex Smith, KCUR

For decades, people struggling with illnesses of all kinds have sought help in online support groups. This year, such groups have been in high demand for COVID-19 patients, who often must recover in isolation.

But the fear and uncertainty regarding the coronavirus have made online groups targets for the spread of false information. And to help fellow patients, some of these groups are making it a mission to stamp out misinformation.

Shortly after Matthew Long-Middleton got sick on March 12, he joined a COVID-19 support group run by an organization called Body Politic on the messaging platform Slack.

"I had no idea where this road leads, and so I was looking for support and other theories and some places where people were going through a similar thing, including the uncertainty," said Long-Middleton, 36, an avid cyclist who lives in Kansas City, Missouri. His illness started with chest discomfort, then muscle weakness, high fever, loss of appetite and digestive problems. In addition to all the physical symptoms, the mystery weighed on him, making him feel like he and other patients "have to figure this out for ourselves."

But with the support came misinformation. Group members reported taking massive amounts of vitamins — including vitamin D, which can be harmful in excess — or trying other home remedies not backed by science.

Experts warned that such false or unverified information spread on online support groups can not only mislead patients, but also potentially undermine trust in science and medicine in general.

"Even if we're not actively seeking information, we encounter these kinds of messages on social media, and because of this repeated exposure, there's more likelihood that it's going to seep into our thinking and perhaps even change the way that we view certain issues, even if there's no real merit or credibility," said Elizabeth Glowacki, a health communication researcher at Northeastern University.

In an effort to help fellow COVID-19 sufferers, some patients, like Vanessa Cruz, spend most of their days fact-checking their online support groups.

"It's really become like a second family to me, and being able to help everybody is a positive thing that comes out of all this negativity we're experiencing right now," Cruz said.

Cruz, a 43-year-old mother of two, moderates the Facebook COVID-19 support group called "have it/had it" from her home in the Chicago suburbs. She's also a "long-hauler" who has been dealing with COVID-19 symptoms, including fatigue, fever and confusion, since March.

The worldwide group has more than 30,000 members and has recently been buzzing with reports from India about treating COVID-19 with a common tapeworm medication (it's not FDA-approved and there's little evidence it works) — as well as speculation about President Donald Trump's recent diagnosis.

Other troubling posts include people pushing hydroxychloroquine, which has not been proved effective in treating COVID-19, and sharing the viral video "America's Frontline Doctors," which promotes other unproven treatments and spreads conspiracy theories.

Cruz said supporting fellow patients can be a tricky balance of getting the facts right but also giving people who are scared the chance to be heard.

"It's like you really don't know what to question, what to ask for, how to reach for help," Cruz said. "Instead of doing that, they just write up their story, basically, and they share it with everybody."

To keep the group evidence-based, it has built up a 17-person fact-checking team, which includes two nurses and a biologist. Someone on the team reviews every post that goes up.

However, many online COVID-19 groups don't have the resources or strategy to address misinformation.

Mel Montano, a 32-year-old writing instructor who lives in New York and has also felt sick since March, said she left a large Facebook support group because she was frustrated by the conspiracy theories that filled its posts.

"All of these conflicting theories completely took away from the focal point of it," Montano said. "It was a mess."

Montano is now a moderator of the Body Politic group on Slack.

Facebook and Twitter have made changes in their approaches toward COVID-19 misinformation, including additional fact-checking, removing posts that contain falsehoods and removing users or groups that spread them.

However, critics say more changes are needed.

Fadi Quran, director of campaigns for Avaaz, a human rights group that focuses on disinformation campaigns, said Facebook needs to revise the way it prioritizes content.

"Facebook's algorithm prefers misinformation, prefers the sensational stuff that's going to get clicks and likes and make people angry," Quran said. "And so the misinformation actors, because of Facebook, will always have the upper hand."

A study by Avaaz showed that misinformation and disinformation had been viewed on Facebook four times as often as information from official health groups, like the World Health Organization.

Facebook did not respond to inquiries for this story.

COVID-19 patient Long-Middleton thinks the problem goes deeper than getting the data right. He said a lot of bad information is spread because patients so badly want to find ways to feel better.

After nearly six months of symptoms, Long-Middleton said he's returned to better health in the past month, though he continues to check in on fellow support group members who are still struggling.

He never tried risky treatments discussed in the group himself, but he understands why someone might.

"You want to find hope, but you don't want the hope to lead you down a path that hurts you," he said.

This story is part of a partnership that includes KCUR, NPR and Kaiser Health News.

Alex Smith, KCUR: @AlexSmithKCUR

Five Important Questions About Pfizer's COVID-19 Vaccine

KFF Health News, November 11, 2020

So did Pfizer's stock deserve its double-digit percentage bump? The answers to the following five questions will help us know.

This article was published on Wednesday, November 11, 2020 in Kaiser Health News.

By Arthur Allen

Pfizer’s announcement on Monday that its COVID-19 shot appears to keep nine in 10 people from getting the disease sent its stock price rocketing. Many news reports described the vaccine as if it were our deliverance from the pandemic, even though few details were released.

There was certainly something to crow about: Pfizer’s vaccine consists of genetic material called mRNA encased in tiny particles that shuttle it into our cells. From there, it stimulates the immune system to make antibodies that protect against the virus. A similar strategy is employed in other leading COVID-19 vaccine candidates. If mRNA vaccines can protect against COVID-19 and, presumably, other infectious diseases, it will be a momentous piece of news.

“This is a truly historic first,” said Dr. Michael Watson, the former president of Valera, a subsidiary of Moderna, which is currently running advanced trials of its own mRNA vaccine against COVID-19. “We now have a whole new class of vaccines in our hands.”

But historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions, not through company press releases.

So did Pfizer’s stock deserve its double-digit percentage bump? The answers to the following five questions will help us know.

1. How long will the vaccine protect patients?

Pfizer says that, as of last week, 94 people out of about 40,000 in the trial had gotten ill with COVID-19. While it didn’t say exactly how many of the sick had been vaccinated, the 90% efficacy figure suggests it was a very small number. The Pfizer announcement covers people who got two shots between July and October. But it doesn’t indicate how long protection will last or how often people might need boosters.

“It’s a reasonable bet, but still a gamble that protection for two or three months is similar to six months or a year,” said Dr. Paul Offit, a member of the Food and Drug Administration panel that is likely to review the vaccine for approval in December. Normally, vaccines aren’t licensed until they show they can protect for a year or two.

The company did not release any safety information. To date, no serious side effects have been revealed, and most tend to occur within six weeks of vaccination. But scientists will have to keep an eye out for rare effects such as immune enhancement, a severe illness brought on by a virus’s interaction with immune particles in some vaccinated persons, said Dr. Walt Orenstein, a professor of medicine at Emory University and former director of the immunization program at the Centers for Disease Control and Prevention.

2. Will it protect the most vulnerable?

Pfizer did not disclose what percentage of its trial volunteers are in the groups most likely to be hospitalized or to die of COVID-19 — including people 65 and older and those with diabetes or obesity. This is a key point because many vaccines, particularly for influenza, may fail to protect the elderly though they protect younger people. “How representative are those 94 people of the overall population, especially those most at risk?” asked Orenstein.

Both the National Academy of Medicine and the CDC have urged that older people be among the first groups to receive vaccines. It’s possible that vaccines under development by Novavax and Sanofi, which are likely to begin late-phase clinical trials later this year, may be better for the elderly, Offit noted. Those vaccines contain immune-stimulating particles like the ones contained in the Shingrix vaccine, which is highly effective in protecting older people against shingles disease.

3. Can it be rolled out effectively?

The Pfizer vaccine, unlike others in late-stage testing, must be kept supercooled, on dry ice around 100 degrees below zero, from the time it is produced until a few days before it is injected. The mRNA quickly self-destructs at higher temperatures. Pfizer has devised an elaborate system to transport the vaccine by truck and specially designed cases to vaccination sites. Public health workers are being trained to handle the vaccine as we speak, but we don’t know for sure how well it will do if containers are left out in the Arizona sun too long. Mishandling the vaccine along the way from factory to patient would render it ineffective, so people who received it could think they were protected when they were not, Offit said.

4. Could a premature announcement hurt future vaccines?

There’s presently no way to know whether the Pfizer vaccine will be the best overall or for specific age groups. But if the FDA approves it quickly, that could make it harder for manufacturers of other vaccines to carry out their studies. If people are aware that an effective vaccine exists, they may decline to enter clinical trials, partly out of concern they could get a placebo and remain unprotected. Indeed, it may be unethical to use a placebo in such trials. Many vaccines will be needed in order to meet global demand for protection against COVID-19, so it’s crucial to continue additional studies.

5. Could the Pfizer study expedite future vaccines?

Scientists are vitally interested in whether the small number who received the real vaccine but still got sick produced lower levels of antibodies than the vaccinated individuals who remained well. Blood studies of those people would help scientists learn whether there is a “correlate of protection” for COVID-19 — a level of antibodies that can predict whether someone is protected from the disease. If they had that knowledge, public health officials could determine whether other vaccines under production were effective without necessarily having to test them on tens of thousands of people.

But it’s difficult to build such road maps. Scientists have never established correlates of immunity for pertussis, for example, although vaccines have been used against those bacteria for nearly a century.

Still, this is good news, said Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health and a former FDA deputy commissioner. He said: “I hope this makes people realize that we’re not stuck in this situation forever. There’s hope coming, whether it’s this vaccine or another.”

Biden Plan to Lower Medicare Eligibility Age to 60 Faces Hostility From Hospitals

KFF Health News, November 11, 2020

Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.

This article was published on Wednesday, November 11, 2020 in Kaiser Health News.

By Phil Galewitz

Of his many plans to expand insurance coverage, President-elect Joe Biden's simplest strategy is lowering the eligibility age for Medicare from 65 to 60.

But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.

Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation's hospitals, a powerful political force, are poised to derail any effort. Hospitals fear adding millions of people to Medicare will cost them billions of dollars in revenue.

"Hospitals certainly are not going to be happy with it," said Jonathan Oberlander, professor of health policy and management at the University of North Carolina-Chapel Hill.

Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.

"It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this," said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.

Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can't find jobs with health benefits.

"It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs," Biden wrote in April.

Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)

Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden's plan.

Critics, especially Republicans on Capitol Hill, will point to the nation's $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won't be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.

Moreover, it's unclear whether expanding Medicare will fit on the Democrats' crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.

Biden's proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders' (I-Vt.) government-run "Medicare for All" health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.

To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this "public option" initiative in 2009 during the congressional debate over the ACA.

The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.

"It is hard to find a reform idea that is more popular than opening up Medicare" to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.

The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson's Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.

While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they're old enough.

Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It's unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.

Avalere says 3.2 million people in that age group buy coverage on the individual market.

While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.

About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.

Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.

Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. "Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates," he said.

"Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole," he said.

President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry's prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.

Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.

Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.

Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.

"Congress is not good at parallel processing," Hacker said, referring to handling multiple priorities at the same time. "And the window is relatively short."

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

California Stands to Lose Big if SCOTUS Cancels Obamacare

KFF Health News, November 11, 2020

The state enthusiastically embraced Obamacare, and it gets more money than any other state under the law.

This article was published on Wednesday, November 11, 2020 in Kaiser Health News.

By Angela Hart

SACRAMENTO, Calif. — Of any state, California has the most to lose if the U.S. Supreme Court overturns the Affordable Care Act.

Healthcare coverage for millions of people is at stake, as are billions in federal dollars. Yet Democratic California leaders don't have a plan to preserve the broad range of healthcare programs the state has adopted since it aggressively implemented Obamacare — including initiatives that go far beyond the federal healthcare law.

"We have made great strides and we don't want to go back," said Katie Heidorn, executive director of the nonprofit Insure the Uninsured Project. "This is real and we have to get our ducks in a row."

The Supreme Court heard arguments Tuesday in the case, now known as California v. Texas. Texas and 18 Republican attorneys general are challenging the law, with backing from President Donald Trump and his administration. They argue that Obamacare is unconstitutional because the law cannot stand without the tax penalty that accompanies the individual mandate, which is the requirement to have health coverage. The Republican-controlled Congress zeroed out the mandate's tax penalty as part of the 2017 tax bill, which the Republican attorneys general say rendered both the mandate and the rest of the law unconstitutional.

California Attorney General Xavier Becerra is leading the defense and says the law can stand without the mandate.

Legal experts predict the court is unlikely to rule until spring 2021, at the earliest. It could strike down the law entirely or keep parts of it, such as the ability for states to expand Medicaid to more adults, which has brought health insurance to roughly 12 million Americans. Or, the justices could preserve the law as is.

Even as legal experts say the addition of three Trump-nominated justices to the Supreme Court since the last time it weighed in on the law amounts to a legal wild card, Becerra is optimistic.

"We feel pretty confident that, as in the past, when the justices look to the fundamentals of the Affordable Care Act, they're going to find that it is constitutional," Becerra told California Healthline. "It would be near impossible right now to keep a state's head above water without the Affordable Care Act."

Democratic Gov. Gavin Newsom's administration agreed the situation would be "catastrophic" for California if the law, or core parts of it, are overturned.

The state enthusiastically embraced Obamacare, and it gets more money than any other state under the law. It expanded its Medicaid program, called Medi-Cal, adding nearly 4 million enrollees as of June. It was the first to create a health insurance exchange, Covered California, which offers tax credits to help qualified Californians pay for coverage. Currently, about 1.5 million people are enrolled.

Since 2014, when the major provisions of the law took effect, California has cut its uninsured rate to historic lows — down to about 7% from 17% — and health insurance premiums for those buying coverage on the individual market are rising slower than before. The statewide average premiums for Covered California plans in 2020 and 2021 have increased less than 1%.

But if the court finds the law unconstitutional, about 5 million residents could lose health coverage, and the state stands to lose an estimated $27 billion in federal funds annually.

Of that, Medi-Cal would lose $20 billion and Covered California would lose nearly $7 billion, according to the state Department of Finance. Public health agencies, which also receive federal Obamacare funding, would also take a nearly $50 million hit.

California also offers much more than Obamacare provides, such as state subsidies to help low-income and middle-class families pay for their Covered California plans. It also covers full Medicaid benefits for unauthorized immigrants up to age 26. And as the Trump administration cut funding for outreach and enrollment, Covered California has continued to plow more money — $157 million this year — into such efforts.

Should Obamacare be struck down during a deepening financial and public health crisis, Newsom administration officials and lawmakers say California could not afford to continue its Medicaid expansion on its own. Millions of other low-income residents on Medi-Cal could face cuts to their benefits and insurance markets could be destabilized, sending insurance premiums soaring, state lawmakers warn.

And Covered California would be in peril, said Covered California Executive Director Peter Lee.

Lee told lawmakers in October that coming up with a replacement strategy would be a waste of time because the state couldn't make up for such a monumental loss in funding.

"Talking about contingency plans is like talking about adding a few lifeboats to the Titanic," he said. "We are not spending time on contingency plans, I'll be really frank about that."

Instead, Democratic lawmakers say they'd be forced to make painful healthcare cuts because, unlike the federal government, states can't operate with budget deficits. And legislative leaders say they wouldn't be able to finance the far more ambitious healthcare agenda they are eyeing under a Joe Biden-Kamala Harris administration.

"Peter Lee is right. I don't know how we'd pivot and replace resources that should be coming to us from the federal government, because we're in a budget crisis brought on by the pandemic," Senate President Pro Tem Toni Atkins told California Healthline.

"We've gone from a $26 billion budget reserve and surplus in March to a $54 billion deficit, so this would put us in an impossible situation to continue to move forward creating more access from a healthcare perspective," Atkins said.

Powerful lawmakers who lead the health committees in the state Senate and Assembly said they fear California would have to rescind programs approved just last year, including the state subsidies for low- and middle-income Californians.

To date, roughly 40,000 low- and middle-income people have benefited from those subsidies, expected to cost $240 million this year, according to Covered California.

Most likely, lawmakers said, the state would no longer be able to afford its 2019 expansion of Medi-Cal to unauthorized immigrants between ages 19 and 25, which is expected to cost roughly $100 million per year. About 75,000 unauthorized immigrants in that age group signed up for the program this year, according to the Department of Healthcare Services.

California has codified other parts of Obamacare into state law that don't require major state spending. These laws would preserve protections for some Californians should the federal law be invalidated.

For instance, state-regulated plans must cover dependents up to age 26, and this year Newsom approved laws prohibiting them from imposing annual or lifetime coverage limits. Also, state-regulated insurers are required to cover preventive care such as mammograms and vaccines.

But millions of Californians in plans regulated by the federal government would lose those protections.

"We've passed some bills that do a little patchwork, but it's a fraction of what's needed," said state Sen. Richard Pan (D-Sacramento), who chairs the Senate Health Committee. "People with preexisting conditions are going to be in big trouble."

Because the Supreme Court likely won't issue its ruling for months, Newsom administration officials and lawmakers said they have time to come up with a plan should Obamacare be deemed unconstitutional. If necessary, they could call a special legislative session and Democratic lawmakers, with a supermajority in the legislature, could enact emergency legislation.

Dr. Robert Ross is a member of the Healthy California for All Commission, which is studying the feasibility of enacting a state-based single-payer system. He said the commission, with deep health policy expertise, also could be well poised to respond.

"All the lofty aspirations to do something that transformative turn to dust if the Affordable Care Act is blown up," said Ross, president of the California Endowment, a foundation that focuses on expanding healthcare access among Californians. "We'd be having an entirely different, sobering conversation, and I'd hope our commission could put ideas in front of the governor for consideration."

Samantha Young of California Healthline contributed to this report.

This KHN story first published on California Healthline, a service of the California Healthcare Foundation.

Angela Hart: ahart@kff.org, @ahartreports

Orange County Struggles With Health Equity — And Battles State Restrictions

KFF Health News, November 10, 2020

Orange County supervisors argue that it's infeasible to quickly address the socioeconomic factors — including poverty and crowded housing — that cause some communities to have higher COVID positivity rates.

This article was published on Tuesday, November 10, 2020 in Kaiser Health News.

By Anna Almendrala

California's most popular amusement park has become the focal point of a struggle over how best to contain COVID-19 while keeping the economy afloat.

California's Democratic leaders have tied the fate of Disneyland — "the Happiest Place on Earth" — to the health of the people who live around it, who have been hit hard by the virus. But conservative Orange County officials want to ease restrictions to allow for the reopening of the lucrative tourist attraction, saying the economic health of all residents depends on it.

State rules say large theme parks can't open, even in a limited capacity, until there's less than one new case per day per 100,000 county residents. The state also requires counties to lower infection rates in their poorest communities to near the average level of the county overall. In Orange County, as in the rest of the state, Latinos have borne the brunt of COVID cases and deaths.

Under these requirements, Disneyland and Knott's Berry Farm, another big county amusement park, will likely remain shut down until next summer or later, said Dr. Clayton Chau, director of the Orange County Healthcare Agency.

Orange County supervisors argue that it's infeasible to quickly address the socioeconomic factors — including poverty and crowded housing — that cause some communities to have higher COVID positivity rates, and that the whole county shouldn't be punished because of it.

"If we have disadvantaged communities that are, because … of living conditions and other circumstances, damaged significantly by the virus, why must we thus visit the pain of the lockdown and shutdown on the children in other communities?" asked Supervisor Donald Wagner — who represents prosperous Anaheim Hills, Irvine and Orange, which have low positivity rates — at a meeting last month.

While the county has invested additional resources to fight COVID-19 in Santa Ana and Anaheim, which are majority Latino, the best way to help them is to return "some semblance of a normal life" to the entire county, to generate the revenue it needs to help the disadvantaged, Wagner said.

But public health experts say that the key to a strong economy is a healthy population and that the county, Southern California's most densely populated, isn't ready for the park to reopen.

"I'm the biggest Disney fan in the whole wide world, and for mental health, I'd love to open up," said Bernadette Boden-Albala, director of the public health program at the University of California-Irvine. "But we're going into flu season, and we have not got a hold of this virus."

"How can you be a strong county when your low-income neighborhoods are devastated by this pandemic, and are super vulnerable to being victims of another pandemic or another wave?" said Dr. America Bracho, CEO of Latino Health Access, a nonprofit group that has been tapped by the county to lead a health equity initiative targeting Latinos.

In part, the battle over what the state calls its "health equity metric" reflects the changing politics of Orange County, which encompasses poor, Latino and heavily immigrant communities such as Anaheim — home to Disneyland — as well as tony Newport Beach. Four of the five members of the board of supervisors are Republican. The county as a whole, however, is trending Democratic. It voted for a Democratic president for the first time in 80 years in 2016, and initial results gave Vice President Joe Biden 54% of this year's vote. The most Democratic areas of the county tend to be those hit hardest by COVID-19.

The Walt Disney Co. is the biggest employer in the county, responsible for 3.6% of all jobs, according to an analysis in 2019 by the Woods Center for Economic Analysis and Forecasting at California State University-Fullerton. Disney had about 30,000 of its own employees, and almost 27,000 other jobs in Southern California relied on the resort, according to the report. On Nov. 1, an estimated 10,000 Disneyland resort workers received layoff notices.

There's a consensus among local politicians, management, unions and many workers that Disneyland should reopen as soon as possible.

Union reps say Disneyland workers have health concerns but want to return to work, noting that the federal CARES Act's weekly $600 unemployment benefit expired in July.

Disney says it knows how to reopen its parks safely. Since Walt Disney World began gradually reopening in Florida in July, no COVID outbreaks have been linked to it, said Orange County, Florida, health department spokesperson Kent Donahue.

Disneyland proposes reopening with a host of safety measures, including mandatory face covers for staff and guests, more hand-washing stations, physical barriers, temperature screenings and reduced capacity.

Chau, the Orange County public health leader, wants the state to allow the theme park to open once the county hits the orange tier, the second-best status among the state's four-tiered, color-coded system that tracks counties by case and infection positivity rates. The orange tier allows for an official case rate of up to 3.9 cases per 100,000 people. The county is currently in the red tier, the second-worst, with a rate of six per 100,000 overall and a test positivity rate of 3.6%. In its poorest neighborhoods, the positivity rate is 5.7%, while it is as low as 0.9% in a Laguna Woods ZIP code.

Under the tiered system, which followed a surge in cases and deaths throughout the state in June and July, the state requires counties to achieve lower case and test positivity rates and then maintain them for at least two weeks before progressing to the less restrictive tier, which allows businesses greater flexibility to reopen.

Other counties, including Riverside and 12 northern rural counties, also are challenging the stringent tiered system, which has helped tamp down infections but has fatigued residents and stoked fears of widespread business closures.

While Orange County supervisors have claimed the system is unscientific, the state health department points to studies it says underscore the importance of a gradual relaxing of COVID lockdowns. States like New York and Massachusetts also have tiered reopening schedules.

"We're in the middle of an unprecedented pandemic that we haven't seen since 1918," said Dr. George Rutherford, a University of California-San Francisco professor who has advised the state on its approach. "You've got to give the state a little latitude to try to figure out how to best go about this."

Viral hot spots ripple far beyond their initial boundaries, he said, so a failure to commit to health equity for the poor imperils everyone.

"All of a sudden you're going to be dealing with a mini-Wisconsin in downtown Santa Ana, and it's going to seed the rest of the county, and the rest of Southern California, and the rest of the state."

Throughout the pandemic, a vocal minority of Orange County residents have protested angrily against mask mandates and business closures. Death threats have been so intense they prompted the county's top public health official to resign in June.

Yet county health officials have worked hard to help hard-hit areas, said Bracho, of Latino Health Access.

She successfully advocated for the county's COVID rates to be broken out by ZIP code in May, and her group was contracted to work with the Latino populations most affected by the virus through testing, education, contact tracing and other services.

Positivity rates in Santa Ana and Anaheim, which were approaching 30% in early July, have declined to less than 10% since late August. It's dramatic progress but not enough to meet the county's health equity metric.

The case numbers are slowly rising again in Orange County and throughout Southern California, in what public health experts fear could be the start of a third wave of infections.

Chau, who thinks Disneyland can reopen safely, has shown a commitment to health equity, which included the creation of a new director position for population health and equity efforts, Bracho said.

Yet the lack of solidarity among those representing the old and new Orange County has been disheartening, said Dr. José Mayorga, executive director of UCI Family Health Center, which treats primarily low-income Latinos in Santa Ana and Anaheim.

At work, Mayorga delivers COVID diagnoses to patients, who cry at the news and fear they've already exposed loved ones to the virus. When he visits mostly white towns like Newport Beach or San Clemente, where he lives and his daughter is in school, many of those he encounters are maskless.

It breaks his heart, Mayorga said. "People act like there's nothing happening."

Anna Almendrala: aalmendrala@kff.org, @annaalmendrala

Search for a Snakebite Drug Might Lead to a COVID Treatment, Too

KFF Health News, November 9, 2020

Snakebites kill nearly 140,000 people a year, overwhelmingly in impoverished rural areas of Asia and Africa without adequate medical infrastructure and knowledge to administer anti-venom.

This article was published on Monday, November 9, 2020 in Kaiser Health News.

By Jim Robbins

Dr. Matthew Lewin, founder of the Center for Exploration and Travel Health at the California Academy of Sciences, was researching snakebite treatments in rural locations in preparation for an expedition to the Philippines in 2011.

The story of a renowned herpetologist from the academy, Joseph Slowinski, who was bitten by a highly venomous krait in Myanmar and couldn't get to a hospital in time to save his life a decade earlier, weighed on the emergency room doctor.

"I concluded that I needed something small and compact and that doesn't care what kind of snake," Lewin said.

It didn't exist. That set Lewin in pursuit of a modern snakebite drug, a journey that finds his Corte Madera, California, company, Ophirex, nearing a promising oral treatment that fits in a pocket; is stable, easy to use and affordable; and treats the venom from many species. "That's the holy grail of snakebite treatment," he said.

His work has gotten a boost with multimillion-dollar grants from a British charity and the U.S. Army. If it works — and it has been shown to work extremely well in mice and pigs — it could save tens of thousands of lives a year.

Lewin and Ophirex are not alone in their quest. Snakebites kill nearly 140,000 people a year, overwhelmingly in impoverished rural areas of Asia and Africa without adequate medical infrastructure and knowledge to administer anti-venom. Though just a few people die each year in the U.S. from snakebites, the problem has risen to the top of the list of global health concerns in recent years. Funding has soared, and other research groups have also done promising work on new treatments. Herpetologists say deforestation and climate change are increasing human-snake encounters by forcing snakes to move to new habitats.

Lewin's research is centered on a drug called varespladib. The enzyme inhibitor has proven itself in in-vitro lab studies and has effectively saved mice and pigs dosed with venom.

Along the way, Lewin and his team have come across another potential use for the drug. Varespladib has a positive effect on acute respiratory distress syndrome, associated with COVID-19. Next year, Ophirex will conduct human trials for the possible treatment of the condition funded with $9.9 million from the Army.

The link to a snakebite? The inflammation of the lungs caused by the coronavirus produces the sPLA2 enzyme. A more deadly version of the same enzyme is produced by snake venom.

The other companies that have come up with promising approaches to snakebite aren't as far along as Ophirex. At the University of California-Irvine, chemist Ken Shea and his team created a nanogel — a kind of polymer used in medical applications — that blocks key proteins in the venom that cause cell destruction. At the Technical University of Denmark, Andreas Laustsen is looking at engineering bacteria to manufacture anti-venom in fermentation tanks.

The days of incising a snakebite and sucking out the poison are long over, but the current treatment for venomous snakebites remains archaic.

Since the early 1900s, anti-venom has been made by injecting horses or other animals with venom milked from snakes and diluted. The animals' immune systems generate antibodies over several months, and blood plasma is taken from the animals and antibodies extracted from it.

It's extremely expensive. Hospitals in the U.S. can charge as much as $15,000 a vial — and a single snakebite might require anywhere from four to 50 vials. Moreover, anti-venom exists for little more than half the world's species of venomous snakes.

A major problem is the roughly two hours it takes on average for a snakebite victim to reach a hospital and begin treatment. The chemical weapon that is venom starts immediately to destroy cells as it digests its next meal, making fast treatment essential to saving lives and preventing tissue loss.

"The two-hour window between fang and needle is where the most damage occurs," said Leslie Boyer, director of the University of Arizona's Venom Immunochemistry, Pharmacology and Emergency Response — VIPER — Institute. "We have a saying, 'Time is tissue.'"

That's why the search for a new snakebite drug has focused on an inexpensive treatment that can be taken into the field. Lewin's drug wouldn't replace anti-venom. Instead, he thinks of it as the first line of defense until the victim can reach a hospital for anti-venom treatment.

Lewin said he expects the drug to be inexpensive, so people in regions where snakebites are common can afford it.

Venom is extremely complicated chemically, and Lewin began his search by sussing out which of its myriad components to block. He zeroed in on the sPLA2 enzyme.

Surveying the literature about drugs that had been clinically tested for other conditions, he came across varespladib. It had been developed jointly by Eli Lilly and Shionogi, a Japanese pharmaceutical company, as a possible treatment for sepsis. They had never taken it to market.

If it worked, Lewin could license the right to produce the drug, which had already been thoroughly studied and was shown to be safe.

He placed venom in an array of test tubes. Varespladib and other drugs were added to the venom. He then added a reagent. If the venom was still active, the solution would turn yellow; if it was neutralized, it would remain clear.

The vials with varespladib "came up completely blank," he said. "It was so stunning I said, 'I must have made a mistake.'"

Dr. Matthew Lewin holds up a vial containing varespladib, a drug being tested for snakebite treatment. Varespladib may also help treat a respiratory condition caused by COVID-19. (Daniel Z. Lewin)

With a small grant, he sent the drug to the Yale Center for Molecular Discovery and found that varespladib effectively neutralized the venom of snakes found on six continents. The results were published in the journal Toxins and sent ripples through the small community of snakebite researchers.

Lewin then conducted tests on mice and pigs. Both were successful.

Human clinical trials are next, but they have been delayed by the pandemic. They are scheduled to get underway next spring.

Along the way, Lewin was fortunate enough to make some good connections that led to funding. In 2012, he attended a party at the Mill Valley, California, home of Jerry Harrison, the former guitarist and keyboardist for Talking Heads. Harrison had long been interested in business and startups — he said he was the most careful reader of the '80s band's contracts — and at the party he asked "if anyone had any ideas lying fallow," Harrison said.

"And Matt pipes up and says, 'I have this idea how to prevent people from dying from snakebites,'" Harrison said.

The musician said he was a bit taken aback by such an unusual and dire problem, but "I thought if it can save lives we have to do it," he said. He became an investor and co-founder of Ophirex with Lewin.

Lewin met Lt. Col. Rebecca Carter, a biochemist who was assigned to lead the Medical Modernization Division of Air Force Special Operations Command, in 2016 when she attended a Venom Week conference in Greenville, North Carolina. He was presenting the results of his mouse studies. She told him about her first mission: to find a universal anti-venom for medics on special operations teams in Africa. She persuaded the Special Operations Command Biomedical Research Advisory Group, which specializes in getting critical projects to production, to grant Ophirex $148,000 in 2017. She later retired from the Air Force and now works for Ophirex as vice president.

More multimillion-dollar grants followed, including the Army's COVID grant. Clinical trials are scheduled to begin this winter.

Despite the progress and the sudden cash flow, Lewin tamps down talk of a universal snakebite cure. "There's enough evidence to say the drug deserves to have its day in clinical trials," he said.

What to Know as ACA Heads to Supreme Court — Again

KFF Health News, November 9, 2020

The case, California v. Texas, is the result of a change to the health law made by Congress in 2017.

This article was published on Monday, November 9, 2020 in Kaiser Health News.

By Julie Rovner

The Supreme Court on Tuesday will hear oral arguments in a case that, for the third time in eight years, could result in the justices striking down the Affordable Care Act.

The case, California v. Texas, is the result of a change to the health law made by Congress in 2017. As part of a major tax bill, Congress reduced to zero the penalty for not having health insurance. But it was that penalty — a tax — that the high court ruled made the law constitutional in a 2012 decision, argues a group of Republican state attorneys general. Without the tax, they say in their suit, the rest of the law must fall, too.

After originally contending that the entire law should not be struck down when the suit was filed in 2018, the Trump administration changed course in 2019 and joined the GOP officials who brought the case.

Here are some key questions and answers about the case:

What Are the Possibilities for How the Court Could Rule?

There is a long list of ways this could play out.

The justices could declare the entire law unconstitutional — which is what a federal district judge in Texas ruled in December 2018. But legal experts say that's not the most likely outcome of this case.

First, the court may avoid deciding the case on its merits entirely, by ruling that the plaintiffs do not have "standing" to sue. The central issue in the case is whether the requirement in the law to have insurance — which remains even though Congress eliminated the penalty or tax — is constitutional. But states are not subject to the so-called individual mandate, so some analysts suggest the Republican officials have no standing. In addition, questions have been raised about the individual plaintiffs in the case, two consultants from Texas who argue that they felt compelled to buy insurance even without a possible penalty.

The court could also rule that by eliminating the penalty but not the rest of the mandate (which Congress could not do in that 2017 tax bill for procedural reasons), lawmakers "didn't mean to coerce anyone to do anything, and so there's no constitutional problem," University of Michigan law professor Nicholas Bagley said in a recent webinar for the NIHCM Foundation, the Commonwealth Fund and the University of Southern California's Center for Health Journalism.

Or, said Bagley, the court could rule that, without the tax, the requirement to have health insurance is unconstitutional, but the rest of the law is not. In that case, the justices might strike the mandate only, which would have basically no impact.

It gets more complicated if the court decides that, as the plaintiffs argue, the individual mandate language without the penalty is unconstitutional and so closely tied to other parts of the law that some of them must fall as well.

Even there the court has choices. One option would be, as the Trump administration originally argued, to strike down the mandate and just the pieces of the law most closely related to it — which happen to be the insurance protections for people with preexisting conditions, an extremely popular provision of the law. The two parts are connected because the original purpose of the mandate was to make sure enough healthy people sign up for insurance to offset the added costs to insurers of sicker people.

Another option, of course, would be for the court to follow the lead of the Texas judge and strike down the entire law.

While that's not the most likely outcome, said Bagley, if it happens it could be "a hot mess" for the nation's entire healthcare system. As just one example, he said, "every hospital is getting paid pursuant to changes made by the ACA. How do you even go about making payments if the thing that you are looking to guide what those payments ought to be is itself invalid?"

What Impact Will New Justice Amy Coney Barrett Have?

Perhaps a lot. Before the death of Justice Ruth Bader Ginsburg, most court observers thought the case was highly unlikely to result in the entire law being struck down. That's because Chief Justice John Roberts voted to uphold the law in 2012, and again when it was challenged in a less sweeping way in 2015.

But with Barrett replacing Ginsburg, even if Roberts joined the court's remaining three liberals they could still be outvoted by the other five conservatives. Barrett was coy about her views on the Affordable Care Act during her confirmation hearings in October. But she has written that she thinks Roberts was wrong to uphold the law in 2012.

Could a New President and Congress Make the Case Go Away?

Many have suggested that, if Joe Biden assumes the presidency, his Justice Department could simply drop the case. But the administration did not bring the case; the GOP state officials did. And while normally the Justice Department's job is to defend existing laws in court, in this case the ACA is being defended by a group of Democratic state attorneys general. A new administration could change that position, but that's not the same as dropping the case.

Congress, on the other hand, could easily make the case moot. It could add back even a nominal financial penalty for not having insurance. It could eliminate the mandate altogether, although that would require 60 votes in the Senate under current rules. Congress could also pass a "severability" provision, saying that, if any portion of the law is struck down, the rest should remain.

"The problem is not technical," said Bagley. "It's political."

What Is the Timeline for a Decision? Could the Court Delay Implementation of Its Ruling?

The court usually hears oral arguments in a case months before it issues a decision. Unless the decision is unanimous or turns out to be very simple, Bagley said, he would expect to see an opinion "sometime in the spring."

As to whether the court could find some or all of the law unconstitutional but delay when its decision takes effect, Bagley said that happened from time to time as recently as the 1970s. "That practice has been more or less abandoned," he said, but in the case of a law so large, "you could imagine the Supreme Court using its discretion to say the decision wouldn't take effect immediately."

If the court does invalidate the entire ACA, Congress could act to fix things, but it's unclear if it will be able to, especially if Republicans still control the Senate. If the justices strike the law, Bagley said, "I honestly think the likeliest outcome is that Congress runs around like a chicken with its head cut off, doesn't come to a deal, and we're back to where we were before 2010," when the ACA passed.

Julie Rovner: jrovner@kff.org, @jrovner

As Faith in Vaccines Falters, Biden Is Under Pressure to Name New FDA Chief Stat

KFF Health News, November 8, 2020

Even if Biden moves at breakneck speed to replace outgoing Commissioner Stephen Hahn, it could be weeks after Biden is in the White House before his pick could get to work.

This article was published on Sunday, November 8, 2020 in Kaiser Health News.

By Rachana Pradhan

President-elect Joe Biden made COVID-19 a linchpin of his campaign, criticizing President Donald Trump’s leadership on everything from masks and packed campaign rallies to vaccines.

That was the easy part. Biden now has the urgent job of filling top health care positions in his administration to help restore public trust in science-driven institutions Trump repeatedly undermined, and oversee the rollout of several coronavirus vaccines to a skeptical public who fear they were rushed for political expediency.

At the top of that list is a new commissioner of the Food and Drug Administration, an agency where Biden faces immense pressure to move faster than any other modern president as the pandemic rages and COVID deaths are expected to surge through the winter. That agency and its beleaguered personnel will be relied on to give the green light to vaccines and therapeutics to fight the COVID pandemic.

Biden is expected to swiftly announce his choices to lead the FDA and the Centers for Disease Control and Prevention, given their importance in informing the federal government’s COVID strategy, according to interviews with Biden advisers, former agency officials and Democrats with knowledge of the transition team’s inner workings. But how soon they’ll be able to begin work after Biden’s Jan. 20 inauguration is unclear.

The CDC director does not need Senate confirmation, avoiding a hurdle that could slow that process. That is not the case for the FDA commissioner, who now appears increasingly likely to face a Republican-controlled Senate that may not be as keen as Democrats to swiftly clear Biden’s nominees. As a result, even if Biden moves at breakneck speed to replace outgoing Commissioner Stephen Hahn, it could be weeks after Biden is in the White House before his pick could get to work.

In the meantime, the FDA will face critical decisions about vaccines needed to help put the nation on its path out of the pandemic. Biden will have to rely on a temporary head of the FDA to steer the 17,000-employee agency during one of the most challenging times in its history.

“It’s not ideal timing, for sure,” a former FDA official said. “It’s a huge job.”

The transition of power will occur at one of the most high-profile times for the FDA, as it vets multiple coronavirus vaccine candidates that could reach the public before the inauguration. The Trump administration could oversee emergency authorizations of initial vaccines from two front-runners, Pfizer and Moderna, that would be prioritized for health care workers and other groups at higher risk of severe COVID complications. But other companies’ vaccines that could be available for many more Americans — such as teachers, adults at lower risk of severe health consequences if they get sick, and children — are all but certain to fall under Biden’s FDA for review because the data on safety and efficacy isn’t expected until next year.

FDA’s credibility in vetting the safety and benefits of COVID products has been in question for months, fueled by Hahn’s inaccurate statements about certain treatments for sick patients. Further, infighting between officials there and political appointees at the White House and the Department of Health and Human Services persisted even in the weeks leading up to the election, with HHS Secretary Alex Azar openly plotting Hahn’s removal because of disagreements over vaccine standards, Politico reported in October.

In September, eight senior FDA officials who have served in multiple administrations took the extraordinary step of publishing an op-ed in USA Today stating they would work with agency leadership “to maintain FDA’s steadfast commitment to ensuring our decisions will continue to be guided by the best science.”

“Protecting the FDA’s independence is essential if we are to do the best possible job of protecting public health and saving lives,” the officials wrote.

“Trust has eroded so significantly in these institutions that have undermined public confidence, especially on vaccines,” a Biden adviser said of the FDA and CDC. “Change in leadership is critical.”

Getting new people into the federal government — where Biden is charged with filling roughly 4,000 jobs held by political appointees — is a mammoth slog on its own, let alone while moving to take over the U.S. pandemic response. Former President Barack Obama set the record for presidential appointments in the first 100 days, securing Senate confirmation for 69 appointees. The FDA commissioner wasn’t among them — Dr. Margaret Hamburg was not nominated until March 2009 and became commissioner that May. A similar timeline held for Trump’s first FDA commissioner, Dr. Scott Gottlieb, who began in May 2017.

“It is a difficult period because you’re going to have a lot of folks who need to get into place,” said Max Stier, CEO of the Partnership for Public Service, which advises presidential candidates and their teams installing new administrations. “The track record has not been good on getting people in quickly.”

At the outset of the Biden administration, it’s expected there will be a fair number of “acting” agency heads rather than Senate-confirmed appointees, Stier said. Biden has said he’ll trust the government’s scientists on COVID vaccines. Former FDA officials said in interviews that if there’s an acting official in charge when a specific vaccine is under review, it should not make a difference because the agency’s longtime scientists conduct the necessary scientific evaluations.

Where it could make a difference is in messaging and accountability, not just to the new president but to the public: The traditionally lower profile and temporary nature of an acting FDA commissioner is at odds with the highly visible role the commissioner is expected to play during a public health emergency, particularly in convincing people that vaccines are safe.

“An agency needs a face, and it’s hard for an ‘acting’ to be the face of the agency,” a former senior agency official said. “The work could be done, but the communication is always better if there’s an FDA commissioner who’s willing to take responsibility.”

The messaging role has taken on extraordinary importance since public confidence in a coronavirus vaccine has eroded significantly. A September Pew Research Center poll found that only 51% of U.S. adults would definitely or probably get a vaccine to prevent COVID-19 if it were available, a drop of 21 percentage points since May.

“Things can only be better,” said Michael Carome, director of the health research group at Public Citizen, a left-leaning group that advocates for consumer interests. “I think an acting commissioner under a Biden administration will be far more trusted than the current FDA commissioner, who has been kowtowed by the White House.”

FDA staffing policy outlines who should be the agency’s acting head in the event there isn’t a permanent commissioner. The most recent version, from 2016, says the position is delegated to the deputy commissioner for foods and veterinary medicine, a title that has since been recast as deputy commissioner for food policy and response. The job is currently held by Frank Yiannas, a longtime food safety expert who joined the agency in 2018 after the retirement of Stephen Ostroff, a veteran FDA scientist who served as acting commissioner twice. The FDA did not respond to questions about whether it had a new staffing policy.

Some administrations, however, have ignored that policy. The Trump administration, for example, briefly installed senior HHS official Brett Giroir, a political appointee, as acting FDA commissioner, a move criticized by Democrats in Congress.

But critical decisions await the new appointee.

The earliest officials would know whether COVID vaccines from Johnson & Johnson and AstraZeneca work is January or February, said Moncef Slaoui, the top scientific adviser for Operation Warp Speed, which is funding multiple coronavirus vaccines and treatments. Other efficacy trials won’t be completed until spring, he said in October.

Safety will take even longer to assess — Johnson & Johnson’s and AstraZeneca’s late-stage clinical trials were already paused earlier this year for safety reasons —and companies will seek emergency authorization or FDA approval only once both metrics are known.

After four years of politicization of the science agency, a Biden adviser said, most important was having a “trusted, credible voice to restore trust in a vaccine.”

Biden Wins, but His Health Agenda Dims With GOP Likely to Hold Senate

KFF Health News, November 8, 2020

Party control of the Senate may not be determined until January — thanks to what preliminary returns suggest will be runoffs for both Senate seats in Georgia.

This article was published on Saturday, November 7, 2020 in Kaiser Health News.

By Julie Rovner

Former Vice President Joe Biden secured the 270 electoral votes needed to capture the White House on Saturday, major news organizations projected,  after election officials in a handful of swing states spent days in round-the-clock counting of millions of mail-in ballots and early votes.

The Democrat’s victory came after the latest tallies showed him taking an insurmountable lead in Pennsylvania, a state both Biden and President Donald Trump had long identified as vital to their election efforts.  Trump has signaled he will fight the election results in several states, filing a number of lawsuits and seeking recounts.

“America, I’m honored that you have chosen me to lead our great country,” Biden tweeted shortly after the news organizations called the race. “The work ahead of us will be hard, but I promise you this: I will be a President for all Americans — whether you voted for me or not.”

The Democratic celebration was tempered because it appeared the party would have a hard time taking back the Senate majority it lost in 2014. If that bears out, it will likely keep Biden and Democratic lawmakers from enacting many of the plans they campaigned on, including major changes in health care.

Party control of the Senate may not be determined until January — thanks to what preliminary returns suggest will be runoffs for both Senate seats in Georgia. No candidate for either seat reached the required 50% threshold.

Without a Democratic majority in the Senate, Biden will likely face strong Republican opposition to many of his top health agenda items — including lowering the eligibility age for Medicare to 60, expanding financial assistance for health insurance under the Affordable Care Act, and creating a “public option” government health plan.

However, his administration would be a bulwark to defend the ACA against Republican attacks, although the Supreme Court case challenging the health law — which will be heard next week — presents a major wild card for its future.

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Health care was a key element of Biden’s campaign, especially improving the federal response to the coronavirus pandemic. He championed the use of face masks and blasted the Trump administration for shifting to states much of the responsibility for fighting the virus and helping hospitals. He was regularly mocked by the president for wearing a mask, working and campaigning from home, and not having an in-person Democratic convention.

Even before the latest vote tallies were released late Saturday morning, Biden had begun moving toward setting up his administration. On Thursday his transition team unveiled a website, BuildBackBetter.com, although it was only one page. And the former vice president held a meeting Thursday with health and economic advisers on the coronavirus.

In a speech to supporters in Delaware Saturday night, the president-elect pledged again to make the pandemic his top concern, saying that until COVID-19 is under control, the country “cannot repair the economy, restore our vitality or relish life’s most precious moments, hugging our grandchildren, our children, our birthdays, weddings, graduations, all the moments that matter most to us.”

He announced that on Monday he would name “a group of leading scientists and experts as transition advisors” to help develop a blueprint “built on bedrock science” to combat the virus.

The electoral outcome is not the one Democrats were hoping for — or, to some extent, expecting, based on preelection polling. Andy Slavitt, who ran the Centers for Medicare & Medicaid Services during the Obama administration, noted that frustration in a tweet Wednesday. “A large disappointment is that many hoped for a significant repudiation of Trump & his indifference to human life, human suffering, his corruption, and goal of getting rid of the ACA. No matter the final total it will be hard to make that claim,” Slavitt said.

Still up in the air is how willing a Republican-led Senate will be to provide further relief to individuals, businesses and states hit hard by the pandemic, and whether they will participate in previously bipartisan efforts to curtail “surprise” out-of-network medical bills and get a handle on prescription drug prices.

VA Joins Pentagon in Recruiting Volunteers for COVID Vaccine Trials

KFF Health News, November 6, 2020

The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers.

This article was published on Friday, November 6, 2020 in Kaiser Health News.

By Patricia Kime

The Department of Veterans Affairs is recruiting 8,000 volunteers for the Phase 3 clinical trials of at least four COVID-19 vaccine candidates at 20 federal medical facilities across the U.S., according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine.

The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers at five of its medical facilities, which are separate from the VA system.

DOD is also is in talks with developers of other vaccine candidates, although officials won’t say which ones.

Both federal departments have long experience in medical research and diverse populations — a crucial component of effective clinical trials, said J. Stephen Morrison, senior vice president and director of global health policy at the Center for Strategic and International Studies, a bipartisan think tank in Washington, D.C.

Since active troops are essential to national security, and veterans are extremely vulnerable to COVID-19, both departments have a vested interest in supporting the development of safe, effective vaccines, Morrison said.

“On the DOD active servicemen and -women side, it’s a question of making sure they’re ready, they are protected,” Morrison said. “With VA, their population, all elderly and infirm with underlying conditions, they could really be suffering if we don’t get a vaccine.”

According to a VA website, of its 20 medical centers involved, 17 would be part of the Johnson & Johnson vaccine trial, while the three others are recruiting — or have completed recruitment — for advanced-stage trials for Moderna, AstraZeneca and Pfizer vaccines.

Dr. Matthew Hepburn, head of vaccine development at Operation Warp Speed, said the VA effort lets veterans contribute to the overall well-being of the country.

“This is another way they can continue to serve in this way, fighting the pandemic as a volunteer,” Hepburn said during a discussion of vaccine and therapeutics development hosted by the Heritage Foundation on Oct. 27.

It’s not unusual for the military to participate in multicenter trials for treatments of ailments as diverse as cancer and trauma. Historically, many vaccines have been tested first by the military.

In the general population, clinicians often have difficulty recruiting African Americans and other minorities for medical research, and “the military provides a rich opportunity to find volunteers for those groups,” said retired Rear Adm. Thomas Cullison, a doctor and former deputy surgeon general for the Navy.

Military health facilities are held to the same standards as private research facilities, he said.

No service members will be required to participate in the COVID vaccine trials. All volunteers will be paid by the developer.

Support for routine vaccinations runs high in the military, but some have expressed concerns about new vaccines and mandatory inoculations, especially for anthrax. In a 2002 federal study, 85% of those who received that vaccine reported an adverse reaction, with just under half noticing minor redness at the injection site. But nearly a quarter of the side effects reported were more systemic, including fevers, chills, fatigue and joint pain.

That survey of a small group of National Guard and Reserve members found that, while 73% said they believe immunizations are effective, two-thirds said they did not support the mandatory anthrax program and 6 in 10 said they were not satisfied with the information they were given on the vaccines.

To quell concerns over the military’s role in supporting COVID vaccine development, the Pentagon has reiterated that troops or their dependents interested in participating in the research must provide voluntary written consent, and they will be allowed to take part only if they will be in the same location for the length of the research, expected to last at least two years.

In addition, active-duty members such as new recruits and boot camp participants will not be allowed to volunteer because they are “considered vulnerable from an ethical and regulatory standpoint,” an official said.

At the VA, officials are seeking to recruit healthy veterans from 18 to 65 years old who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities, participants will be paid by the developer, VA spokesperson Christina Noel said.

Also, VA nurses and caseworkers also are being asked to identify their sickest, highest-risk patients to determine who should be at the top of the list once a vaccine is approved, according to a VA nurse and other health officials who asked not to be identified because they were not authorized to speak with the press.

The U.S. military has a long history of contributing to research on vaccines, including a key role in developing inoculations against yellow fever and adenovirus, and the Walter Reed Army Institute of Research is developing its own vaccine against the coronavirus.

Some segments of the population remain skeptical of federal medical experiments. A survey by AP-NORC in May found that Black people are particularly reluctant to get the coronavirus vaccine. Many have concerns about federal research in part because of associations with the infamous Tuskegee Institute syphilis experiments, in which U.S. Public Health Service officials intentionally withheld a cure from Black men infected with the disease.

But Morrison, of the Center for Strategic and International Studies, said the Defense Department and VA are a “natural fit” for the COVID vaccine trials.

“DOD has lots of expertise. They know how to vaccinate; they know how to reach communities. They have a whole science infrastructure and research-and-development infrastructure. And when you are thinking what the mission of VA is, [VA] sees this is part of their mission,” Morrison said.

The Defense Department announced its agreement with AstraZeneca in September, shortly before the drugmaker’s vaccine trial was put on hold to study a serious medical condition that one participant reported. That research was approved by the Food and Drug Administration to begin again Oct. 23. The military plans to restart its efforts to recruit 3,000 volunteers.

The Pentagon has also signed an agreement with another vaccine developer, the head of the Defense Health Agency, Army Lt. Gen. Ronald Place, told reporters Oct. 8. He wouldn’t provide the company’s name.

Democratic Sens. Elizabeth Warren of Massachusetts and Mazie Hirono of Hawaii have called, unsuccessfully, for the Senate Armed Services Committee to investigate what they say is a lack of Pentagon transparency on its role in vaccine development and distribution.

The Defense Department has awarded more than $6 billion in Operation Warp Speed contracts through an intermediary, Advanced Technology International, and the two senators want more information about those contracts.

“There may well be a valuable role for DoD officials in [Operation Warp Speed] — particularly given the department’s logistical capacity,” they wrote to the committee chair and ranking member. “But it is important that Congress conduct appropriate oversight of, and understand, DoD’s activities in this area.”

Neither department has disclosed the financial arrangements they have made with developers to support the vaccine research.

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