Hospitals in southwestern Missouri are overflowing. As of July 19, Centers for Disease Control and Prevention data show Missouri is worst in the nation for covid case rates over the past week, and in the bottom 15 states for vaccinations against the potentially deadly virus.

This article was published on Wednesday, July 21, 2021 in Kaiser Health News.

By Lauren Weber

ST. LOUIS — The day after Missouri Gov. Mike Parson finished his bicentennial bus tour to drum up tourism to the state in mid-July, Chicago issued a travel advisory warning about visiting Missouri.

Earlier this summer, as covid-19 case counts began to tick up when the highly transmissible delta variant took hold in the state, the Republican-majority legislature successfully enacted laws limiting public health powers and absolving businesses from covid legal exposure.

The state health officer post has sat vacant since Dr. Randall Williams resigned suddenly in late April — leaving Missouri without a permanent leader as the covid numbers grew. And Brian Steele, a mayor in the Springfield area, which is at the epicenter of swelling cases, faces a recall vote for his masking mandate that ended in April.

Hospitals in southwestern Missouri are overflowing. As of July 19, Centers for Disease Control and Prevention data show Missouri is worst in the nation for covid case rates over the past week, and in the bottom 15 states for vaccinations against the potentially deadly virus. Though cases are not even half of what they were during the winter spike, they continue to rise rapidly, sending a warning to other states with low vaccination rates about the havoc the coronavirus’s delta variant can bring.

Divisions abound in Missouri, where vaccines are widely available but only 40% of the state has been vaccinated. Public health mitigation measures to reel in the rising case counts would be wildly unpopular in a state that never had a statewide mask mandate. And the more the virus circulates, the higher the chance it could mutate further into something more transmissible or deadly, even for those already vaccinated.

Escalating political backlash to public health efforts has the state staring down the barrel of potential incoming disaster, said Kelley Vollmar, executive director of the Jefferson County Health Department.

“Missouri is the Show Me State,” Vollmar said, as the state has made headlines for its surging cases among its many unvaccinated residents. “I just wish we could do it for the right reasons.”

Kelli Jones, a spokesperson for the governor, said the national media spotlight on Missouri is misdirected. Flare-ups where vaccination rates are low are to be expected, she said, adding that hospitals in those areas may be strained, but that’s partly because a backlog of elective procedures are being performed during this iteration of the pandemic.

“When the national media catches on stuff, they don’t have all the full facts of all the details,” she said.

Jones and Lisa Cox, spokesperson for the Missouri Department of Health and Senior Services, both pointed to a $5 million multimedia campaign aimed at encouraging vaccinations. They have been heartened to see an increase in vaccine orders from vaccinators — this past week, it was more than triple the usual demand, Cox said.

Vaccines, however, take time to take effect.

Meanwhile, hot spot Springfield has requested state funding for an alternative covid care site to treat patients, saying health systems are at capacity. The Springfield-Greene County Health Department Facebook page shows the stark contrast between the vaccinated and those resisting the call, as it’s littered with warring comments, some containing vaccine misinformation.

Will Marrs, a lobbyist for the Missouri Association of Local Public Health Agencies, was born and raised in the heavily afflicted Springfield area. He’s been trying to persuade high school friends to get vaccinated but said it’s difficult to penetrate misinformation echo chambers.

Marrs blames national politics seeping into the Statehouse and the political lifeblood of Missouri, arguing state legislators are following national Republican Party trends instead of shouting from the rooftops about the importance of vaccinations. Earlier this month at the Conservative Political Action Conference in Dallas, attendees cheered over the country not hitting vaccination rates.

And the state’s Senate delegation shows the trend: Sen. Josh Hawley, a Republican eyeing higher national office, has appeared on Fox News likening a vaccine misinformation initiative from President Joe Biden to a “surveillance state” that is “out of Beijing.” His counterpart, Republican Sen. Roy Blunt, who has frequently stressed the importance of getting vaccinated, is not seeking reelection.

“We’re in a crisis not only here in Missouri but around the country and the world, and we are acting like it’s just business as usual,” Democratic state Sen. Jill Schupp said of the Republican leadership in the state. “They have chosen to take the side that says, ‘I’m going to turn a blind eye to this, to this pandemic and to this variant, and I’m going to pretend like it doesn’t exist.’”

Parson has urged Missourians to get their vaccinations to prevent covid. But he also took a public shot at the federal government, tweeting: “I have directed our health department to let the federal government know that sending government employees or agents door-to-door to compel vaccination would NOT be an effective OR a welcome strategy in Missouri!”

Local public health workers, not federal agents, have been going door to door in Springfield and elsewhere in the state to encourage vaccinations.

Jones said some of the critiques that Parson isn’t doing enough to promote vaccinations come from an ideological divide: The governor does not believe the government has the power to mandate such things, much as he doesn’t believe in mandating masks, she said.

“It comes down to some personal responsibility; the governor said that from the very beginning,” she said. “And people are just gonna have to decide to, you know, hopefully, to get vaccinated.”

Amid the uptick in cases, the White House announced it was sending a “surge response team” to help Missouri.

That “team” currently consists of one epidemiologist on the ground in southwestern Missouri and a vaccination specialist offering virtual support, numbers based on what the state said it needed. Cox said the state is requesting more resources.

But two people — one remote — are hardly enough to combat decades of underfunding and a year and a half of political vitriol, said Brian Castrucci, CEO of the de Beaumont Foundation, which advocates for public health.

“We are being forced to apply band-aids where we don’t have the resources for stitches,” he said.

Back in eastern Missouri, Vollmar’s county is inching back up the covid case chart. She suspects everyone went to tourist (and delta) hot spots in southwestern Missouri over the Fourth of July.

While she’s thrilled to have the game-changing vaccine, only roughly 30% of Jefferson County is vaccinated. Unlike last year during a similar rise in cases, she feels she doesn’t have the political buy-in from her area for mitigation measures like masking. Candidates for her local school board ran and won on the idea of eliminating mask mandates in schools.

The state health department’s advisories to hot spots say “social distancing, masking, and other precautions remain important” but do not mandate them.

Vollmar also warned about a lack of funding for contact tracers and other public health measures needed for the wave she worries is coming. Funding has been slow to reach local health departments, much as it was last year when some county commissioners around the state withheld funding for local departments, angry about lockdowns and other restrictions. Platte County in the Kansas City area paid roughly the same in pandemic relief funding to a local cruise ship company as it did to its health department, which served nearly 90,000 people.

“We all hoped that once the elections were over, that this would die down,” Vollmar said. “If you don’t have the support of your leaders, you don’t have the support of the community.”

Without a state health officer coordinating the response or getting the ear of the governor, Vollmar said, local officials like her have been interacting more with federal officials. The governor’s office said a new director will be announced Wednesday. Cox said the acting director, Robert Knodell — formerly Parson’s deputy chief of staff, who does not have a public health background — had been “very involved” in the response.

A 2020 KHN and AP investigation found Missouri’s public health spending was one of the bottom 10 in the nation at $50 per Missourian per year before the pandemic. Missouri public health staffing had fallen 8% from 2010 to 2019 with the loss of 106 full-time employees.

Williams’ departure was one of at least 10 Missouri public health leadership departures this year, according to another piece of the KHN and AP investigation. Nationally, that report found at least 248 state and local public health leaders had departed since the beginning of the pandemic — leaving nearly 1 in 6 Americans without a local public health leader for some length of time.

But Schupp asked, considering the recent legislation and political climate in Missouri, will any qualified state health officer want to come? “We’re not allowing anyone to do a good job,” she said.

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. 

This article was published on Wednesday, July 21, 2021 in Kaiser Health News.

By Elisabeth Rosenthal

The drugmaker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of covid-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now — and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them last week.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective”?

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior covid shot. The booster is likely to be safe — hundreds of millions have taken the earlier shots — and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe and effective in one sense but simply not needed — at least for now?

Reliance on the simple “safe and effective” standard — which certainly sounds reasonable — is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in covid revenue this year.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and Type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness — the health value of a product relative to its price — a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker — like an antibody level — a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the price being offered. But there’s no such automatic process in the U.S.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out-of-pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Dr. Anthony Fauci has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.

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Healthcare will account for a large proportion of the cost.

This article was published on Tuesday, July 20, 2021 in Kaiser Health News.

By Michael McAuliff

Exactly what American healthcare will look like if Democrats can pass their $3.5 trillion spending plan is unclear, but the senator negotiating its health-related provisions hopes what emerges will be dramatic: the first complete healthcare system for older Americans and significantly reduced costs for everyone else.

"We are setting very, very ambitious goals," Sen. Ron Wyden (D-Ore.) told KHN. "And that's appropriate because the fact is a lot of challenges have gotten short shrift — and I'm not just talking about the last four years, I'm talking about 10 years."

But the budget plan is highly controversial within the Democratic caucus and on a tight time frame. Senate Majority Leader Chuck Schumer set a Wednesday deadline for Democrats to agree on the broad outlines. Wyden insists that lawmakers from different wings of his party can come together to support a framework to move forward.

"He told us to be ready on Wednesday, and we will be," said Wyden, who chairs the powerful Finance Committee and is also a member of the Budget Committee.

While health policy questions have generally taken a back seat in the recent debate over possible infrastructure and climate provisions in the package, healthcare will account for a large proportion of the cost.

Provisions would include steps to reduce prescription drug costs, to extend the generous federal subsidies for people buying insurance on the Affordable Care Act's marketplaces, to provide coverage for low-income residents in states that did not expand their Medicaid programs and to massively increase healthcare options for older Americans.

Medicare could wind up with new programs to provide people with dental, vision and hearing care for the first time. The plan could realize President Joe Biden's proposal to spend $400 billion so seniors would get home-based and community healthcare to live at home longer instead of moving to nursing homes.

Drug spending would be lowered partly by allowing Medicare to negotiate prices with pharmaceutical companies, thus saving the federal government and consumers money.

In raw dollars, the healthcare components of the plan Democrats announced last week could easily exceed the initial $940 billion cost estimates of the Affordable Care Act.

"I think it's huge," said Paul Ginsburg, a professor of health policy at the University of Southern California and senior fellow at the Brookings Institution.

"Many of these components of the plan on their own would be considered major policy accomplishments, maybe the highlight of a congressional session," Ginsburg said. "This just multiplies it all, puts a number of these programs together, many of which on their own would be major, major accomplishments."

Yet there remain major question marks, as well. For instance, some of the proposals tread into territory that has never been tried before, and policy experts aren't sure how they will work. Ginsburg pointed to the dental, hearing and vision proposals for Medicare, noting there has been relatively little careful analysis related to including those benefits in Medicare.

"Nobody's talked about that. We don't know how to do it," Ginsburg said. "It's very different from medical insurance issues."

The plan is moving through what's known as the budget reconciliation process. First Congress approves budget instructions for bills that affect spending, revenue or debt. Under congressional rules, those bills can then advance on an expedited basis and pass in the Senate with a simple majority, with no threat of a filibuster.

Still, there is no room for error. With just 50 Democrats, Schumer will need every one of them — and Vice President Kamala Harris' tie-breaking vote — if Republicans remain united against the package. In the House, Democrats also have a tiny majority and could likely lose only a handful of members as they try to pass the budget framework.

Wyden and others are trying to help lawmakers reach consensus on a plan. Moderate Democrats have raised concerns about how these initiatives would be paid for, and not all are keen on the drug price measures, including allowing Medicare to negotiate. Progressives, on the other hand, have called for higher spending to cover even more robust initiatives.

Wyden said he is shuttling between the Senate and the House and moderates and progressives, and he intends to stay glued to the Capitol to meet Schumer's deadline.

He cautioned, though, that people should not expect to see every detail in whichever package is released this week. It will be an outline that tells committees to get to work on specifics. More details will come later.

"They will not be bills that people think of as legislation — Section 406-B and paragraph three and the like. This is a general framework. We're kind of flushing this out," Wyden said.

And even though he calls the overall effort ambitious, Wyden prefers to work out the details quietly, and make sure they are acceptable to his colleagues and the Senate parliamentarian, who determines if provisions of the bill qualify for the reconciliation process. "We're putting in the time to do this right," Wyden said, pointing to previous bills he has gotten passed. "That's kind of my style — underpromise and lower the decibel level and focus on getting it done."

That leaves ample wiggle room in terms of what would emerge, probably in the fall if Democrats can pass the budget reconciliation this summer. Lawmakers' tinkering and negotiations over how much each item will cost, how long to fund it and how comprehensive a specific program will be could leave certain elements looking skimpy.

Wyden said Democrats may need to settle for very basic versions of these new programs. But the key, he added, is to get the programs started, and show people what is possible.

"The way we're talking about it — and this is going to be the subject of many, many discussions — is we want to get the architecture of these changes, bold changes," Wyden said.

Exactly how grand each change turns out to be in the short run may not be the most important thing, Wyden suggested.

"There's going to be a discussion — this number of years, that number of years and the like," he said. "But what's really important, and we've talked about it — the Budget Committee's talked about it — if we get the architecture right, we can start serving people and build on it."

Wyden often talks about how he got into politics after spending nearly seven years running the Gray Panthers advocacy organization in Oregon and teaching gerontology. What he's believed for a long time is that Medicare simply is not enough to meet people's needs.

"I would say Medicare is a half a loaf," Wyden said.

He wouldn't quite promise a full baguette when the reconciliation process is done.

"This is going to make a significantly bigger set of healthcare options for seniors. I'm not going to start dividing loaves," Wyden said.

Michael McAuliff: @mmcauliff ‏

Masks are back for anyone who works in the building, and unvaccinated employees must be tested in the basement twice a week.

This article was published on Monday, July 19, 2021 in Kaiser Health News.

By Rachel Bluth

SACRAMENTO, Calif. — The best part about returning to the pandemic-besieged state Capitol is that the elected officials are so unused to seeing us reporters after more than a year that some are occasionally extra chatty. The bad part is that the masks make it harder to eavesdrop on the rest of them.

Much like the rest of the state — which is navigating ever-changing COVID rules, such as whether vaccinated people should wear masks or how far apart schoolkids should be (3 vs. 6 feet) — the building is subject to a tangle of shifting requirements. All of us — the lawmakers, their staff, the press and the tourists — are making mistakes.

When I reemerged at the Capitol to cover recent budget negotiations, I immediately committed a cardinal sin of pandemic life: I shook the hand of an Assembly member. It's one of those mistakes you immediately realize you've made, like calling your teacher "Mom."

Thankfully, she brushed it off but returned after our conversation to wordlessly offer me a squirt from a giant bottle of hand sanitizer. Probably best practices for anyone talking to the press.

Resurfacing from our pandemic isolation can get confusing. Most California workplaces no longer require vaccinated workers to be masked, in accordance with the June 17 guidance from the state's Occupational Safety & Health Standards Board. The Capitol, where 85% of members and staffers are fully vaccinated — compared with about 61% of eligible Californians — also dropped its mask mandate for vaccinated employees.

That is, until an outbreak erupted in early July, when nine Assembly staffers — eight from the same office — tested positive. Four of them say they were fully vaccinated.

That's a lot of bad luck, considering so-called breakthrough cases are said to be rare. According to the California Department of Public Health, there have been 10,430 COVID cases out of 20.4 million fully vaccinated people as of July 7, a rate of 0.051% of vaccinated people getting sick.

Some post-vaccination infections are to be expected, said Dr. Kirsten Bibbins-Domingo, who chairs the department of epidemiology and biostatistics at the University of California-San Francisco. And once a positive test pops up, you're bound to find more. In this situation, testing likely uncovered asymptomatic cases that would otherwise have gone unnoticed, she said.

In a letter to staff on July 9, Assembly Speaker Anthony Rendon and Senate leader Toni Atkins implored everyone to get vaccinated. But, so far, inoculation isn't required, even though there should "absolutely be a vaccine mandate" for the Capitol, Bibbins-Domingo said.

Meanwhile, masks are back for anyone who works in the building, and unvaccinated employees must be tested in the basement twice a week.

Visitors face all the security measures you'd expect for anyone entering a government building (metal detectors and TSA-esque bag screenings). They are advised to wear masks with at least two layers of protection and must submit to a temperature check by security guards, who, through thin slits in plexiglass barriers, aim thermometer guns at visitors' foreheads.

As I entered the building one recent morning, a gaggle of tourists loitered outside, staring at their phones trying to figure out what to do — like people hoping to get into an exclusive new club. They had all forgotten their masks and didn't know whether they could get in, but security guards were more than happy to hand out garden-variety surgical masks.

Even "Bacteria Bear," the 800-pound bronze legacy of the Schwarzenegger administration, is masked. However, it's not fully business-as-usual for the bronze statue, which guards the entrance to the governor's offices. He's roped off with strict warnings not to touch. (In hindsight, maybe officials should never have invited hundreds of germy tourists to rub their hands all over him.)

Some semblance of normalcy is creeping back into the building. Small groups of tourists roam the halls to look at exhibits, state police guard the exits and give directions to lost reporters (me), and a handful of staffers shuffle between committee rooms and offices.

Though it's much quieter than usual, and most lawmakers aren't allowing drop-in visits by constituents, the actual work of legislating doesn't look much different.

Lawmakers left town Thursday for a month for summer break, and in the past few days have rushed to pass a few dozen budget bills and wrap up committee hearings. As they deliberated, close talking, back-patting and corner huddling were common. But this time they were masked.

California's state Capitol was not built for a pandemic. Members' desks are arranged with little separation between them, and though the ceilings are high (and ornately decorated), airflow is minimal.

"This building isn't well ventilated," said Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee. "It's like an airplane in here; you can't even open the windows."

The novelty of working around people again is producing strange experiences. I'm used to pestering lawmakers and their staffers for interviews, but in the back of the Assembly's mint-green chamber, where reporters have always been quarantined regardless of the pandemic, a member came up to me to introduce herself. It's been so long since she's seen a reporter back here, she said, she just had to come over and say hello.

The state Senate chamber, which favors red and pink, feels a little more COVID-cautious than the lower house down the hall. Although state officials have repeatedly said there will be no "vaccine passports" required in California, they're alive and well for reporters trying to get near senators.

Along with our credentials, journalists need passes, printed on purple paper with the Senate seal, to get onto the chamber floor. The Capitol nurse distributes the passes only after reporters provide proof of vaccination or a recent negative COVID test.

In the Senate's smaller and more intimate chamber, there's plexiglass around the dais up front, a few members' desks and a microphone near the back.

And in the rear of the chamber, a lone "press only" desk is surrounded in clear plastic on three sides. I'm beginning to suspect they think we may be more virulent than the general public.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Healthcare Foundation.

Rachel Bluth: rbluth@kff.org, @RachelHBluth