As physicians and health policy experts debate the merits of Aduhelm, the first new drug for Alzheimer's disease approved in 18 years, patients want to know: "Will this medication help me — and how much?"
Doctors explaining the pros and cons of Aduhelm won't have a definitive answer. "On an individual basis, it will be absolutely impossible to predict," said Dr. Allan Levey, director of the Goizueta Alzheimer's Disease Research Center at Emory University.
Cognitive decline varies widely among people who have started experiencing memory and thinking problems or who are in the earliest stage of Alzheimer's — the patients in whom Aduhelm was tested, Levey noted.
"The nature and rate of progression varies tremendously, and we're not going to know when we treat somebody [with Aduhelm] if their progression will be fast or slow or average — we just won't be able to say," Levey explained.
Nor will it be possible to specify how much difference this drug would make for a given patient. "To try to tell an individual how much delay in progression they'll experience [if they take Aduhelm] is simply something we cannot do," said Dr. Jason Karlawish, a professor at the University of Pennsylvania Perelman School of Medicine and co-director of the Penn Memory Center.
Uncertainty about the potential benefits of Aduhelm, which received conditional approval from the Food and Drug Administration on June 7, is considerable. One phase 3 drug trial found that a high dose taken over the course of 18 months slowed cognitive decline by about four months; a second clinical trial failed to show any effect. The FDA is requiring a post-approval trial from drugmakers Biogen and Eisai Inc. to supply more data, but final results might not be available until February 2030.
With many unanswered questions about Aduhelm's approval, the House Committee on Oversight and Reform has opened an investigation. Faced with criticism over insufficient guidance, the FDA on Thursday revised the drug's label to narrow its potential use. "Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials," it now reads.
These developments make the job of educating patients and families about Aduhelm and recommending for or against it extraordinarily difficult for physicians.
Conversations are going to be "very challenging, given the complexity of the information that needs be conveyed." Karlawish said. Here are key points experts aim to explain.
Effectiveness has not been proven. Aduhelm has been shown to be very effective at removing beta-amyloid protein, a hallmark of Alzheimer's, from patients' brains. Clumps of this protein, known as amyloid plaques, are thought to be implicated in the underlying disease process. But clinical trials of other drugs that remove amyloid plaques have not demonstrated effectiveness in stopping Alzheimer's progression.
Although data from two Aduhelm clinical trials was inconsistent, the FDA granted accelerated approval to the drug noting it was "reasonably likely to result in clinical benefit." But this is speculative, not a proven result.
Potential benefits are small. Dr. G. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, was on the FDA advisory committee that reviewed Aduhelm, a group that recommended against approving the medication.
He characterized positive results from one clinical trial of Aduhelm as "a tiny clinical change." On an 18-point scale used to evaluate cognition and functioning, patients who responded to the drug experienced a 0.39 slowing in the rate of decline over 18 months. Roughly, this translates into a four-month delay in subtle symptoms.
Neuropsychological tests to evaluate cognition typically ask patients to copy a diagram, subtract 7 from 100 and spell a word backward, among other tasks. "But navigating your daily life is much more complicated, and it's not at all clear whether Aduhelm's purported benefit would be enough to impact an individual's daily living," said Dr. Samuel Gandy, a professor of neurology and psychiatry at Mount Sinai's Icahn School of Medicine in New York City.
Disease progression will continue. "Let's say someone has cognitive impairment or other functional impairments and decides to take Aduhelm. Will they return to normal? There's no evidence that this will happen," said Dr. Henry Paulson, a professor of neurology and director of the Michigan Alzheimer's Disease Center.
"The expectation has to be that disease progression will continue," agreed Levey of Emory.
Potential side effects are common. Brain bleeds and swelling occurred in 41% of patients treated with the highest dose (10 milligrams) of Aduhelm, the subgroup that showed some response in one clinical trial, according to a document released by the FDA. Brain scans identified these as mild in 30% of cases, moderate in 58% and severe in 13%. Most cases resolved, without serious incident, within three months.
The FDA recommends that patients taking Aduhelm get at least three MRI scans of the brain in the first year to check for side effects. Physicians and health systems are discussing what kind of safety protocols are needed beyond these scans.
Other tests will be necessary. Aduhelm was tested on patients with beta-amyloid deposits in their brain that had been confirmed by positron emission tomography (PET) brain imaging.
In clinical practice, only patients who have those deposits should take Aduhelm and imaging to confirm that should be required, experts agreed. But that presents a problem for many patients. Because of their age, most are covered by Medicare, which doesn't pay for PET imaging outside of research settings. Instead, most medical centers will rely on amyloid cerebrospinal fluid tests, obtained through spinal taps.
Genetic tests for a form of the apolipoprotein E gene known as APOE4, whose presence raises the risk of Alzheimer's, will also probably be in order, Gandy suggested. Patients were more likely to respond to Aduhelm if they carried an APOE4 gene; at the same time, they were more likely to experience brain bleeding and swelling, he noted. But Medicare doesn't pay for APOE4 testing or related counseling, and a positive test could significantly affect patients' families. "Once you find the APOE4 genotype, all those person's first-degree relatives are at risk," Gandy noted, "and you change the psychology of a family immediately."
Therapy will be expensive. Medicare and private insurers have not yet decided whether to impose restrictions on who can get coverage for Aduhelm, which will be administered through monthly infusions at medical centers. Considering an annual list price of $56,000 for the drug alone, KFF researchers estimate that some Medicare beneficiaries could pay as much as $11,500 out-of-pocket to cover their coinsurance obligation.
Add to that the costs for brain scans, monthly infusions, physician services, amyloid tests and APOE4 genetic testing and expenses could approach $100,000 a year, some experts suggest.
"The most pressing thing we need is an understanding of payment for this medication," said Dr. Aaron Ritter, a dementia expert with the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. "Many patients are going to be on a fixed income with limited capacity to pay large amounts." More than 1,000 patients at the clinic are good candidates for Aduhelm, he noted.
Specialists will not prescribe to all Alzheimer's patients. Although physicians can prescribe an approved drug to whomever they think it will help, dementia experts say Aduhelm should be considered only for patients similar to those in the clinical trials: individuals with mild cognitive impairment (memory and thinking concerns that don't interfere with their functioning) and with early-stage Alzheimer's (when symptoms are still mild but functioning becomes impaired).
"We are going to start small and go slow until we understand more" about the medication and how patients respond, said Dr. Maria Torroella Carney, chief of geriatrics and palliative medicine at Northwell Health, New York's largest healthcare system.
Since Aduhelm was not tested on people with moderate or severe Alzheimer's, it shouldn't be given to these patients, several experts said. "If patients in these later stages ask for the drug, we'll say we don't have any evidence that it will work in you and we can't justifiably give it to you," said Paulson of the University of Michigan.
Physicians will respect patients' wishes. Even physicians who worry that Aduhelm's potential harms might outweigh potential benefits said they will prescribe the medication with caution and careful consideration. Karlawish of the University of Pennsylvania is among them.
"Now that this medication is available, I have to adhere to a core ethic of the practice of medicine, which is respect for patient autonomy," he said. "If patients and family caregivers ask for Aduhelm after a thorough discussion, I'll be a reluctant prescriber."
We're eager to hear from readers about questions you'd like answered, problems you've been having with your care and advice you need in dealing with the healthcare system. Visit khn.org/columnists to submit your requests or tips.
Contrary to pharmaceutical industry arguments that large profits fund extensive research, the major drug companies plow more of their billions in earnings back into their own stocks, dividends and executive compensation.
This article was published on Friday, July 9, 2021 in Kaiser Health News.
The largest drug companies are far more interested in enriching themselves and investors than in developing new drugs, according to a House committee report released Thursday that argues the industry can afford to charge Medicare less for prescriptions.
The report by the House Oversight and Reform Committee says that contrary to pharmaceutical industry arguments that large profits fund extensive research and innovation, the major drug companies plow more of their billions in earnings back into their own stocks, dividends and executive compensation.
And they can do it largely because Congress has imposed few restrictions on their pricing in the United States — including in the Medicare program, which is not permitted to negotiate drug prices, House Democrats say.
"What we have found is shocking," said Oversight Committee Chair Carolyn Maloney (D-N.Y.). "Drug companies are actively and intentionally targeting the United States for price increases, often while cutting prices in the rest of the world."
According to the data crunched by the committee, the 14 largest drug manufacturers paid themselves and investors $578 billion from 2016 to 2020 through dividends and stock buybacks, while investing $56 billion less — $522 billion — on research and development.
On top of that, the report says, some of that R&D money is spent researching ways to suppress competition, such as by filing hundreds of new, minor patents on older drugs that make it harder to produce generics.
"Despite Big Pharma's lip service about innovation, many drug companies are not actually spending significant portions of their research-and-development budget to discover innovative new treatments," Maloney told reporters in a conference call. "Instead, these companies are spending their research-and-development dollars on finding ways to game the system."
"How can Pharma say with a straight face … that lower drug prices for Americans will have to come at the expense of research and development?" House Speaker Nancy Pelosi asked on the call.
The release of the report during a congressional recess seemed aimed at least partly at boosting support for the House Democrats' Lower Drug Costs Now Act, which, among other things, would allow Medicare to negotiate drug prices, let Americans with private insurance pay those same rates and limit U.S. prices to an average price other countries pay.
Pelosi said she would like to see the measure, numbered H.R. 3, included in a massive bill that Democrats are preparing under what is known as the budget reconciliation process. That process allows taxing and spending bills to be packaged together and get though the Senate on a simple majority vote exempt from a filibuster. Democrats are expected to use the process for a number of key initiatives, including possible changes in Medicare eligibility and benefits, outlined by President Joe Biden and congressional leaders and panned by Republicans.
"With the savings on the lower drug prices, we can invest in transformational improvements in American healthcare," Pelosi said. "We have an historic opportunity to do so as we craft the reconciliation bill. We'll see how we proceed there."
Some more moderate Democrats have raised concerns about H.R. 3, in part echoing industry assertions that curbing drugmakers' revenues might cut their ability to innovate. Pelosi can afford to have only a handful of Democrats defect in the House, and all 50 Democrats in the Senate are needed to pass a reconciliation measure.
Among the starker examples the report highlights, the company Novo Nordisk spent twice as much on executive pay and buying back its own stock as on R&D over the five years.
The drugmaker Amgen especially cashed in on the 2017 tax cuts pushed through a Republican Congress, spending five times as much on buybacks as on research, the report says.
According to the report, if the 14 large companies maintain roughly their current practices, they will pay themselves and investors $1.15 trillion over the next decade, which the committee notes is double the estimated cost of H.R. 3.
The report also singles out internal documents from the pharmaceutical giant AbbVie as an illustration of "research and development" being aimed at suppressing cheaper competition, in this case by seeking new minor patent enhancements on the rheumatoid arthritis drug Humira, which costs $77,000 a year.
"An internal presentation emphasized that one objective of the 'enhancement' strategy was to 'raise barriers to competitor ability to replicate,'" the report says, likely delaying lower-priced biosimilar drugs at least until 2023. It also notes that the company identified about $5.19 billion in R&D for Humira, about 7.4% of the drug's net U.S. revenue.
In another case, the report highlights an internal presentation from Celgene, which makes the $16,744-a-month cancer drug Revlimid and has since been bought by Bristol Myers Squibb.
The report says Celgene targeted the United States for its profitable price hikes and admitted in a presentation that it was because of the country's "highly favorable environment with free-market pricing."
In some other cases, the combined $3.2 billion that the 14 companies' top management earned over the five years was conditioned on U.S. price hikes.
A spokesperson for Novo Nordisk said its buybacks were entirely justified and included them in what he described as the company's overall long-term investments.
"These investments have led to the discovery of innovative treatments that have made substantial impacts on peoples' lives," said Michael Bachner, director of communications for Novo Nordisk.
"Given the complex challenges in the healthcare system, we remain committed to developing solutions in cooperation with policymakers and other stakeholders," he said. "We will continue to work towards maintaining a sustainable business that will foster innovation and provide patients with access to needed new therapies."
Frank Benenati, a spokesperson for AbbVie, took issue with the report's emphasis on Humira's R&D costs. He said the report "is misleading in that it focuses on the R&D spend for one drug, not the total R&D spend, which was approximately $50 billion since 2013."
Other companies did not immediately answer requests for comment, but a spokesperson for the industry's lobbying arm, the Pharmaceutical Research and Manufacturers of America, said the release of the report was political and aimed at backing legislation that PhRMA said would harm Medicare.
"While we can't speak to specific examples cited in the report, this partisan exercise is clearly designed to garner support for an extreme bill that will erode Medicare protections and access to treatments for seniors," said PhRMA spokesperson Brian Newell. "Every year, biopharmaceutical research companies invest tens of billions of dollars in the research and development of new cures and treatments, as well as our significant investments in time and resources creating treatments and vaccines to combat the global pandemic."
Despite the report, he said, net prices on drugs are coming down, when rebates to customers are included. He added that the greater problems are with high deductibles charged by insurers and with profits taken by middlemen such as pharmacy benefit managers.
"We are committed to working with policymakers on commonsense, bipartisan solutions that address the real challenges patients face," Newell said. "Working together we can make sure medicines are affordable and accessible for everyone."
A federal court's decision could mean that hospitals will need to revise their policies barring workers from talking to the news media and posting on social media.
This article was published on Friday, July 9, 2021 in Kaiser Health News.
Karen Jo Young wrote a letter to her local newspaper criticizing executives at the hospital where she worked as an activities coordinator, arguing that their actions led to staffing shortages and other patient safety problems.
Hours after her letter was published in September 2017, officials at Maine Coast Memorial Hospital in Ellsworth, Maine, fired her, citing a policy that no employee may give information to the news media without the direct involvement of the media office.
But a federal appellate court recently said Young's firing violated the law and ordered that she be reinstated. The court's decision could mean that hospitals and other employers will need to revise their policies barring workers from talking to the news media and posting on social media.
Those media policies have been a bitter source of conflict at hospitals over the past year, as physicians, nurses and other health care workers around the country have been fired or disciplined for publicly speaking or posting about what they saw as dangerously inadequate COVID-19 safety precautions. These fights also reflect growing tension between health care workers, including physicians, and the increasingly large, profit-oriented companies that employ them.
On May 26, the 1st U.S. Circuit Court of Appeals unanimously upheld a National Labor Relations Board decision issued last year that the hospital, now known as Northern Light Maine Coast Hospital, violated federal labor law by firing Young for engaging in protected "concerted activity." The NLRB defines it as guaranteeing the right to act with co-workers to address work-related issues, such as circulating petitions for better hours or speaking up about safety issues. It also affirmed the board's finding that the hospital's media policy barring contact between employees and the media was illegal.
"It's great news because I know all hospitals prefer we don't speak with the media," said Cokie Giles, president of the Maine State Nurses Association, a union. "We are careful about what we say and how we say it because we don't want to bring the hammer down on us."
The 1st Circuit opinion is noteworthy because it's one of only a few such employee speech rulings under the National Labor Relations Act ever issued by a federal appellate court, and the first in nearly 20 years, said Frank LoMonte, a University of Florida law professor who heads the Brechner Center for Freedom of Information.
The 1st Circuit and NLRB rulings should force hospitals to "pull out their handbook and make sure it doesn't gag employees from speaking," he said. "If you are fired for violating a 'don't talk to the media' policy, you should be able to get your job back."
The American Hospital Association and the Federation of American Hospitals declined to comment for this article.
While the 1st Circuit's opinion is binding only in four Northeastern states plus Puerto Rico, the NLRB decision carries the force of law nationwide. The case applies to both unionized and non-unionized employees, legal experts say.
Hospitals and health care organizations often have policies requiring employees to clear any public comments about the workplace with the organization's media office. Many also have policies restricting what employees can say on Facebook and other social media.
Hospitals say requiring employees to go through their media office prevents the spread of inaccurate information that could damage the public's confidence. In Young's case, the hospital argued that her letter contained false and disparaging statements. But the 1st Circuit panel agreed with the NLRB that her letter was "not abusive" and that its only false statement was not her fault.
Health care organizations have undisputed legal authority to prohibit employees from disclosing confidential patient information or proprietary business information, legal experts say.
But the 1st Circuit panel made clear that an employer cannot bar an employee from engaging in "concerted actions" — such as outreach to the news media — "in furtherance of a group concern." That's true even if the employee acted on her own, as Young did in writing her letter. The key in her case was that she "acted in support of what had already been established as a group concern," the court said.
"I think employers with a blanket ban on talking to the media need to relook at their policies," said Eric Meyer, a partner at FisherBroyles in Philadelphia who often represents companies on employment law matters. "If you go to the media and say, 'There are unsafe working conditions impacting me and my colleagues,' that's protected concerted activity."
Chad Hansen, Young's attorney in a separate federal lawsuit alleging discrimination based on a disability against the hospital, said she has not yet been reinstated to her job. Young would not comment.
The hospital's parent company, Northern Light Health, said only that its news media policy — which was amended after Young's firing — meets the NLRB and 1st Circuit requirements and will not be further changed. The new policy created an exception allowing employees to speak to the news media related to concerted activities protected by federal law.
Speech rights under the National Labor Relations Act are particularly important for employees of private companies. Although the Constitution protects people who work for public hospitals and other government employers with its guarantee of unrestricted speech, employees at private companies do not have a First Amendment right to speak publicly about workplace issues.
"I hope this case keeps alive the right of health care workers to speak out about something that's dangerous," said Dr. Ming Lin, an emergency physician who lost his job last year at PeaceHealth St. Joseph Medical Center in Bellingham, Washington, after publicly criticizing the hospital's pandemic preparedness.
Lin, who was employed by TeamHealth, which provides emergency physician services at the hospital, lost his assignment at PeaceHealth in March 2020 soon after saying on social media and in interviews with news reporters that PeaceHealth was not taking urgent enough steps to protect staff members from COVID. He had worked at the hospital for 17 years.
In an April 2020 YouTube interview, PeaceHealth's chief operating officer, Richard DeCarlo, said Lin was removed from the hospital's ER schedule because he "continued to post misinformation, which was resulting in people being afraid and being scared to come to the hospital." DeCarlo also alleged that Lin, who was out of town for part of the time he was posting, refused to communicate with his supervisors in Bellingham about the situation. PeaceHealth declined to comment for this article.
PeaceHealth's social media policy at that time stated that the company does not prohibit employees from engaging in federally protected concerted activity and that they "are free to communicate their opinions." TeamHealth's social media policy, dated July 15, 2020, states the company reserves the right to take disciplinary action in response to behavior that adversely affects the company.
Lin, who's now working for the Indian Health Service in South Dakota, has sued PeaceHealth, TeamHealth and DeCarlo in state court in Washington claiming wrongful termination in violation of public policy, breach of contract and defamation.
Dr. Jennifer Bryan, board chair of the Mississippi State Medical Association, who publicly defended two Mississippi physicians fired for posting about the inadequacy of their hospitals' COVID safety policies, said she faced pressure from her hospital for speaking to the news media without approval.
The medical association pushed its members to talk to the media about the science of COVID, while employers insisted doctors' messages had to be approved by the media office. That reflected a conflict, she said, between medical professionals primarily concerned about public health and executives of for-profit systems who were seeking to shield their corporate image.
Bryan predicted the court ruling and NLRB decision will be helpful. "Physicians have to be able to stand up and speak out for what they believe affects the safety and well-being of patients," she said. "Otherwise, there are no checks and balances."
I set out to test that statement by comparing prices in two major California hospital systems. I am sorry to report that, at least for now, that status quo — the tangled web that long has cloaked hospital pricing — is alive and well.
I have spent hours toggling among multiple spreadsheets, each containing thousands of numbers, in an effort to compare prices for 20 common outpatient procedures, such as colonoscopies, cataract surgeries, hernia repair and removal of breast lesions.
After three months of glazed eyes and headaches from banging my head against walls of numbers, I am throwing in the towel. It was a fool's errand. My efforts ultimately yielded just one helpful piece of advice: Don't try this at home.
I was most of the way to that realization when a conversation with Shawn Gremminger helped push me over the line.
"You are a healthcare reporter, I'm a healthcare lobbyist, and the fact that we can't do this ourselves is an indictment of where things stand at this point," said Gremminger, health policy director at the Purchaser Business Group on Health, which represents large employers who pay their employees' medical bills directly and have a big stake in price transparency. "The subset of people who can do this is pretty small, and most of them work for hospitals."
I heard similar comments from other veterans of the healthcare industry, even from the former managed-care executive who inspired the story.
He had come to me with a spreadsheet full of price info that appeared to show that a Kaiser Permanente hospital in the East Bay charged significantly higher prices for numerous procedures than a nearby hospital run by archcompetitor Sutter Health.
That was a compelling assertion, since Sutter is widely viewed in California as the poster child for excessive prices. Nearly two years ago, Sutter settled a high-profile antitrust case that accused the hospital system of using its market dominance in Northern California to illegally drive up prices.
I knew from the outset it would be tricky to compare Kaiser and Sutter because, operationally, they are apples and oranges.
Sutter negotiates separate deals with numerous health plans, and its prices can vary by thousands of dollars for the same service, depending on your insurance. Kaiser's hospitals are integrated with its insurance arm, which collects premiums — so, in effect, it is playing with house money. There is just one Kaiser health plan price for each medical service.
Still, the story seemed worth looking into. Those Sutter and Kaiser prices matter, because they are used to calculate how much patients pay out of their own pockets. And helping patients know what they'll owe in advance is one of the goals of the transparency rule.
The federal rule requires hospitals to report prices for all the medical services they provide in huge spreadsheets that can be processed by computers.
It also obliges them to provide prices in a more "consumer-friendly" format for 300 so-called shoppable services, which are procedures that can be scheduled in advance. And it requires that they report the cost of any "ancillary services," such as anesthesia, typically rendered in concert with those procedures. Of the 300 "shoppables," 70 are specified by the government and the rest are chosen by each hospital.
Most of the 20 common medical procedures I attempted to compare were among those 70. But a few, from lists of top outpatient procedures provided by the Healthcare Cost Institute, were not. I decided to use the more comprehensive, less friendly spreadsheets for my comparisons, since they contained all 20 of the procedures I'd chosen.
Each carried a five-digit medical code known as a CPT, a term trademarked by the American Medical Association that stands for "current procedural terminology." The transparency rule requires hospitals to include billing codes, because they supposedly provide a basis for price comparison, or in the rule's jargony language, "an adequate cross-walk between hospitals for their items and services."
Much to my chagrin, I soon discovered they don't provide an adequate crosswalk even within one hospital.
My first inkling of the insuperable complexity came when I noticed that Sutter's Alta Bates Summit Medical Center in Oakland listed the same outpatient procedure with the same CPT code three times, thousands of rows apart, with entirely different prices. CPT 64483 is the designated code for injection of anesthetics or steroids into a spinal nerve root with the use of imaging, which relieves pain in the lower back, legs and feet caused by sciatica or herniated discs. The spreadsheet showed a maximum negotiated price of $1,912 in row 12,718, $3,650.85 in row 19,014 and $5,475.80 in row 19,559 (let your eyes glaze over for just a few seconds, so you know what it feels like). The reason for the triple listing is tied to Medicare billing guidelines, Sutter later told me. I'll spare you the details.
My head really began to hurt when I decided to double-check some of the prices I had pulled from the big spreadsheets against the same items on the shorter shoppables sheets. Kaiser's prices were generally consistent across the two, but for Alta Bates, there were large discrepancies.
The highest negotiated price for removing a breast lesion, for example, was $6,156 on the big sheet and $23,069 on the shorter one. The difference seems largely attributable to the estimated cost of additional services, some rather nonspecific, that Sutter lists on the smaller sheet as accompaniments to the procedure: anesthesia, EKG/ECG, imaging, laboratory, perioperative, pharmacy and supplies.
But why not include them in both spreadsheets? And what do the two dramatically divergent prices actually encompass?
"How many bills they really represent and what they mean is difficult to interpret," said Dr. Merrit Quarum, CEO of Portland, Oregon-based WellRithms, which helps employers negotiate fair prices with hospitals. "It depends on the timing, it depends on the context, which you don't know."
In some cases, Sutter said, its shoppables spreadsheets show charges not only for ancillary services typically rendered on the day of the procedure, but also for related procedures that may precede or follow it by days or weeks.
The listings for Kaiser's ancillary services do not always match Sutter's, which further clouds the comparison. The problematic fact of the matter is that hospitals performing the same procedures bundle their bills differently, use different medications, estimate varying amounts of time in the operating room, and utilize more or less advanced technology. And physician charges are not even included in the posted prices, at least in California.
All of which makes it almost impossible for mere mortals to anticipate the total cost of their medical procedures, let alone compare prices among hospitals. Even if they could, it might be of limited value, since independent imaging centers and surgery centers, which are increasingly common — and generally less expensive — aren't required to report their prices.
The bottom line, I'm afraid, is that despite my efforts I don't have anything particularly insightful to reveal about how Kaiser's prices compare with Sutter's. The prices I examined were as transparent to me as hieroglyphics, and I'm pretty sure that hospital executives — who unsuccessfully sued to stop implementation of the price transparency rule — are not losing any sleep over that fact.
GRAND JUNCTION, Colo. — Dr. Rachel LaCount grasped a metal hoop at a playground and spun in circles with her 7-year-old son, turning the distant mesas of the Colorado National Monument into a red-tinged blur.
LaCount has lived in this western Colorado city of 64,000 nearly her whole life. As a hospital pathologist, she knows better than most that her hometown has become one of the nation's top breeding grounds for the delta variant of COVID-19.
"The delta variant's super scary," LaCount said.
That highly transmissible variant, first detected in India, is now the dominant COVID strain in the United States. Colorado is among the states with the highest proportion of the delta variant, according to the Centers for Disease Control and Prevention.
Mesa County has the most delta variant cases of any county in Colorado, state health officials report, making the area a hot spot within a hot spot. A CDC team and the state's epidemiologist traveled to Grand Junction to investigate how and why cases of the variant were moving so quickly in Mesa County.
At her hospital, LaCount has put in orders for more rapid COVID tests as the caseload has grown. She's seen the intensive care unit start filling up with COVID patients, so that hospital officials are placing two in a room against normal practices.
Despite these alarming signs, many in Mesa County have let down their guard. The rate of eligible residents fully vaccinated has stalled at about 42%. LaCount has noticed that few people wear masks anymore at the grocery store. Thousands of people recently flocked to Mack, 20 miles from Grand Junction, to attend the Country Jam music festival, which could accelerate the variant's spread to the concertgoers' hometowns.
"We're making national news for our COVID variant and the CDC is here investigating, but we have a huge festival where people aren't masking," said LaCount. "Are we going to get herd immunity over here just because everyone's going to get it? I mean, that's probably going to happen at some point, but at what cost?"
LaCount's worries aren't necessarily for herself or her spouse — they are both vaccinated — but for their son, who can't be vaccinated because he is under 12. She is uneasy about sending him to school in the fall for fear of exposure to the variant. She is reluctant to take him to birthday parties this summer knowing there's a good likelihood he'll be teased for wearing a mask.
A few yards away from LaCount and her son on the playground, a man fished in a still pond with his 10-month-old daughter in a backpack. Garrett Whiting, who works in construction, said he believes COVID is still being "blown out of proportion," especially by the news media.
"They got everybody scared really, really fast," said Whiting, slowly reeling in a sparkly blue lure from the water. "There's no reason to stop living your life just because you're scared of something."
Whiting tested positive for COVID about three months earlier. He said he doesn't plan to get vaccinated, nor does his wife. As for the baby on his back, he said he's not sure whether they'll have her vaccinated when regulators approve the shot for young children.
The delta variant is one of six "variants of concern" circulating in the U.S., according to the CDC, because the delta strain spreads more easily, might be more resistant to treatment and might be better at infecting vaccinated people than other variants.
The delta variant has raised alarms around the world. Parts of Australia have locked down again after the variant leapfrogged its way from an American aircrew to a birthday party where it infected all unvaccinated guests, health officials said, and after it also jumped between shoppers in a "scarily fleeting" moment in which two people walked past each other in a mall. Israel reissued an indoor mask requirement after a spate of new cases linked to schoolchildren. A leading health official there said about a third of the 125 people who were infected were vaccinated, and most of the new infections were delta variant.
A rise in delta variant cases delayed the United Kingdom's planned reopening in June. But public health officials have concluded after studying about 14,000 cases of the delta variant in that country that full vaccination with the Pfizer-BioNTech vaccine is 96% effective against hospitalization. Studies around the world have made similar findings. There is also evidence the Moderna and Johnson & Johnson vaccines are effective against the variant.
Los Angeles County recently recommended that residents resume wearing masks indoors regardless of vaccination status, over concern about the delta variant. The World Health Organization is also urging vaccinated people to wear masks, though the CDC hasn't changed its guidelines allowing vaccinated people to gather indoors without masks.
The variant arrived in Mesa County this spring, when it accounted for just 1% of all cases nationwide, said Jeff Kuhr, executive director of Mesa County Public Health.
"We were winding down just like everyone else. We were down to less than five cases a day. I think we had about two people hospitalized at one point," Kuhr said. "We felt as if we were out of the woods."
He even signed off on Country Jam, which bills itself as the state's "biggest country music party."
But in early May, the delta variant appeared in a burst, with five cases among adults working for the school district.
"It started to hit the children, those that were not of the age to be vaccinated," Kuhr said. "That was telling me that, you know, wearing masks in school was not providing the protection with this new variant that it had previously."
The county then started to see breakthrough cases in fully vaccinated elderly residents in long-term care facilities. The hospitals began to fill once more. Nine vaccinated people died, seven of them since the delta variant's arrival, though it's still unclear whether the variant is to blame. All were at least 75 years old, and seven lived in long-term care facilities. Now, Kuhr estimates, "above 90%" of cases in the county are delta variant.
The county is seeing the same trend as the state: The vast majority of people testing positive for COVID, and people being hospitalized with it, are unvaccinated. "It's a superspreader strain if there ever was one," Eric Topol with the Scripps Research Institution told Scientific American. But he said people fully vaccinated with Pfizer or Moderna shots "should not worry at all." There is less information about the protection offered by Johnson & Johnson's vaccine.
Mesa County health officials considered canceling the music festival, but "it was really too late," Kuhr said. After the announcement that the festival was on, about 23,000 people bought tickets.
Officials weighed banning alcohol or trying to get attendees a Johnson & Johnson single-dose vaccine in the weeks leading up to the festival. In the end, they settled on messaging: signs warning people online and at the venue that the area was a COVID hot spot.
According to CDC guidance, outdoor events were low risk. A sporting event at the end of May in Grand Junction that filled a baseball stadium had resulted in only one known case, which made Kuhr optimistic.
"We put messaging on Country Jam's website, and then in their social media pages, saying, you know, 'Mesa County's a hot spot. Be prepared,'" Kuhr said.
A stormy Friday dampened concert attendance at Country Jam. But on the last day of the festival, the sun was out and throngs of cowboy boot-clad concertgoers stepped around prairie dog burrows and kicked up gray-yellow dust on the path to the venue entrance.
Many reveled in being able to attend a summertime event like an outdoor festival, taking it as another sign that the pandemic was waning.
"COVID is over in Colorado," said Ryan Barkley, a college student from Durango who was playing beer pong in an inflatable pool at his campsite outside the gates.
That day, 39 people in the county were hospitalized with COVID, and a CDC investigative team had arrived just four days earlier.
Inside the gates, an open field was filled with stages, concession stands, and vendors selling cowboy hats, coffee mugs and hunting clothes — and crowds of people. Chelsea Sondgeroth and her 5-year-old daughter took in the scene.
"It's just nice to see people's faces again," said Sondgeroth, who lives in Grand Junction and previously had COVID. She described it as one of the mildest illnesses she's ever had, though her senses of taste and smell have not returned to normal. Watermelon tastes rotten to her, beer tasted like Windex for a while, and her daughter said Sondgeroth can't smell certain flowers anymore.
Sondgeroth said she's holding off on getting vaccinated until more research comes out.
Waiting in line at the daiquiri stand, Alicia Nix was one of the few people in sight wearing a mask. "I've gotten people that say, you know, 'That stuff is over. Get over yourself and take that off,'" said Nix, who is vaccinated. "It isn't over."
Amid the music, beer and dancing, a bus turned into a mobile vaccine clinic was empty. A nurse on duty played Jenga with an Army National Guard soldier. Just six people of the thousands attending were vaccinated on the bus.
"You can lead a horse to water, but you can't make them drink," Nix said from behind her blue surgical mask.
While a majority of inmates in most states are fully vaccinated, prison staffers are not, according to data on 36 states and the federal Bureau of Prisons.
This article was published on Thursday, July 8, 2021 in Kaiser Health News.
When the number of COVID-19 cases among inmates in Pennsylvania state prisons last fall topped 1,000 and staff cases hovered in the hundreds, the union representing 11,000 corrections officers began lobbying to get prison staffers to the front of the line for vaccinations.
John Eckenrode, president of the Pennsylvania State Corrections Officers Association, pressed state officials for months to give prison workers the same status as hospital staff members, first responders and teachers.
"This is a health and public safety crisis," Eckenrode said in a January statement. "It's time to prioritize vaccinating staff, so they can do their jobs and also not worry about bringing the virus home to their loved ones."
Yet, after the lifesaving shots became widely available, Pennsylvania prison guards have not rushed out to get them — even though the corrections department has had more than 4,700 staff members test positive over the course of the pandemic and eight die.
By mid-June, 22% of Department of Corrections employees were inoculated, according to voluntary reports collected by the department. At one prison, just 7% of staffers had received shots.
Meanwhile, more than 75% of the 39,000 men and women incarcerated in Pennsylvania's 24 state prisons have had the shots, according to the department.
That disparity is evident across the country. While a majority of inmates in most states are fully vaccinated, prison staffers are not, according to data on 36 states and the federal Bureau of Prisons compiled by the Prison Policy Initiative using information from several prison advocacy and journalism groups.
That report — released in April, when the vaccine was becoming more easily accessible — found 48% of prison staff members nationwide had received at least one dose, although in some states rates were in the teens or lower.
Eckenrode declined to comment to KHN. But he recently told WHYY, the NPR member station in Philadelphia, that he believes many more officers are vaccinated and not reporting their status to prison officials.
He acknowledged reluctance among his members. "I think that no matter what kind of demographic you look at, there's vaccine hesitancy," he said. The vaccines were "approved under experimental conditions, and I believe that it should be an individual choice."
One officer with the New York Department of Corrections and Community Supervision, which reported last month that it had vaccinated 43% of inmates, compared with 30% of staffers, said he waited until late June because he and his wife had survived a bout of COVID and felt they had natural protection from the virus.
Some colleagues have been spooked by internet videos from anti-vaccination groups showing doctors talking about vaccine-related deaths or stoking concerns that the Food and Drug Administration's emergency use authorization for the vaccines — rather than formal approval — means they are less dependable, said the officer, who asked to remain anonymous because corrections staffers are not authorized to speak to reporters. He added that a sense of "I don't want people to think I'm weak" machismo and right-wing politics play into the decision-making.
"There are a lot of conspiracy theorists," the New York guard said.
COVID has taken a high toll inside prisons. Two news organizations, the Marshall Project and The Associated Press, have found nearly 400,000 COVID cases in U.S. prisons and more than 2,700 inmate deaths. Among staff members, more than 114,000 cases and more than 200 deaths have been reported nationwide.
Staff vaccination statistics often do not give the full picture, since states generally don't require corrections staffers to report their status.
In California, which has the nation's second-largest prison system, a reform group is suing over low staff vaccination rates, arguing that unprotected prison workers put vulnerable inmates at risk.
State tallies show that in late June 52% of prison staffers had been fully vaccinated versus 71% of inmates. In its court filing, the Prison Law Office said that, despite efforts by California officials encouraging vaccinations, "infected and unvaccinated staff members continue to pose a significant threat to incarcerated communities."
Health experts say prison staff members also endanger surrounding communities.
Unvaccinated officers are a common cause of infection, because they go back and forth between the prison and the community, said Dr. Anne Spaulding, an associate professor in epidemiology at Emory University and former medical director at the Rhode Island Department of Corrections.
Spaulding also pointed to the "downstream effects" of unvaccinated staffers — especially corrections officers (known as COs), who are in daily close contact with inmates — on the inmates' mental health.
"If it passes from CO to CO, what does that mean with staff shortages? More lockdowns, less programming," she said. "It's going to affect the mental health of those incarcerated, who already have restricted lives."
Kirstin Cornnell, social services director with the Pennsylvania Prison Society, which advocates for reforms, said lockdowns resulting from sick staff members could lead to suspension of family visitation, disrupting connections critical to inmates' mental health.
"We have really serious concerns about how low the rate of staff vaccination is," said Cornnell. "This increases tension in an already stressful situation."
Pennsylvania Corrections Secretary John Wetzel and officials in other states say that, while they are not considering making the shots mandatory, they are pressing employees to get vaccinated.
"We continue to educate our staff and encourage them to get vaccinated for their own protection, but also for those around them," said Wetzel. "Everyone knows that prisons are breeding grounds for infectious diseases like COVID-19, largely because inmates live so close together."
While union officials in several states did not respond to queries, prison officials said their employees have the same concerns as the general public: religious or other objections, false conspiracy theories about the vaccines, worries about a new shot that was developed quickly.
"They want to see how it plays out with others who are vaccinated," said John Bull, a spokesperson for the Department of Public Safety in North Carolina — where 6,607 department employees, or roughly half the staff at 55 facilities, have been vaccinated through prison clinics. "They didn't want to be guinea pigs."
Incentives, such as gift cards, cash lotteries and paid time off, have boosted staff rates in some states, officials said. But Chris Gautz, a spokesperson for the Michigan corrections department, said his state will not provide incentives, despite having only about 15% of staffers vaccinated. He said his agency decided disease prevention was a better motivator.
"The benefit of not dying is not dying," he said. "A $5 gift card to Frosty Boy is not going to put someone over the edge."
The Prison Law Office and other groups are advocating for mandatory prison staff vaccinations, but the potential face-off with powerful prison worker unions has thwarted that idea in some states.
California Gov. Gavin Newsom said at a May news conference that he had no plans to make vaccinations mandatory and would instead urge the corrections officers union to persuade its members to get the shots.
Health experts point to other public institutions, such as schools and colleges, that require vaccination.
"States have the ability to mandate vaccination when it puts someone at risk," said Joseph Amon, an epidemiologist and director of the Office of Global Health at Drexel University in Philadelphia. "This is a case that makes sense. There could be limited exemption, but there should be an expectation that all staff be vaccinated."
When a parent takes an infant to the Children's Health Center in San Francisco for a routine checkup, a pediatrician will check the baby's vitals and ask how the child is doing at home.
Then Janelle Bercun, a licensed clinical social worker, who is also in the room, will look at Mom or Dad and pipe up: What is this like for you? Your frustrations? Joys? Challenges? And she stays to work with the parent long after the pediatrician has left.
The facility's team-based treatment is a pilot project, funded by philanthropies. Yet the approach, which California may soon incorporate on a large scale, could hold the key to fostering a healthy home environment where children thrive, child development experts say. Incorporating therapy for the parents, they say, can lower a child's risk of future mental disorders stemming from family trauma and adversity.
Pediatricians' offices generally don't offer formal counseling or guidance to a child's guardian because they can't bill insurance for these services. That could soon change for the roughly 5.4 million children on Medi-Cal, California's Medicaid program for low-income residents, and their parents.
The 2021-22 state budget, which Gov. Gavin Newsom is expected to sign by Monday, dedicates $800 million, half of it in federal funds, to this new behavioral health benefit over four years. Experts say it would make California the first state to pay for "dyadic care," treating parents and children simultaneously.
"A baby is not showing up by themselves to the pediatrician's office. The caregiver is coming in with their own strengths and stressors," said Dr. Kathryn Margolis, a pediatric psychologist who launched the initiative at the Children's Health Center at Zuckerberg San Francisco General Hospital.
"Without a healthy caregiver, we can't have a healthy baby," Margolis added. "It is the most obvious thing in the world. It is unbelievable it has taken this long to pay for this service."
The new program is among a suite of behavioral health initiatives included in the nearly $263 billion state budget negotiated between Democratic lawmakers and Newsom, who has made mental health services a signature issue.
The state will spend the next year drafting guidelines for the services that could be covered and working with insurance providers on new billing codes for the new benefit. Beginning July 1, 2022, caregivers who enter a clinic or pediatrician's office with a child up to age 21 for routine well visits will be matched with a social worker or behavioral health specialist. They may be screened for depression, treated for tobacco and alcohol use, or offered family therapy, said Jim Kooler, assistant deputy director of behavioral health at the California Department of Healthcare Services. New mothers will get postpartum care; parents could also get help obtaining food vouchers, housing or other help.
"It's a pretty amazing array of services that will be available," Kooler said. "It's things we wouldn't necessarily think about right away, but the health of the young person is impacted."
States including New York and Colorado fund programs that offer holistic care to parents and children together. But California will be the first to offer the service as part of Medicaid pediatric care, said Jennifer Tracey, senior director of growth and sustainability for Zero to Three. The nonprofit organization runs HealthySteps, a program that supports babies and toddlers with integrated care in 24 states, Washington, D.C., and Puerto Rico. Getting the benefit funded in the nation's most populous state was a "groundbreaking" win for children's advocacy groups, Tracey said.
"We haven't seen any other state make this kind of investment," she said. "I hope we'll see other states following California."
Newsom and lawmakers this year had a $76 billion budget surplus and $27 billion in federal aid to fund an array of new programs, but they won't come cheap. New outlays include up to $1.3 billion a year to expand healthcare to undocumented immigrants age 50 and older; $12 billion for homeless programs over the next two years; $4.4 billion in behavioral mental health for people up to age 25 over five years; and $300 million to bolster the state's public health system beginning next July.
Critics say the spending commits Californians to programs that could be hard to fund in the future. And while offering a new Medi-Cal benefit might be worthwhile, California lawmakers would be better off fixing flaws in the government insurance program, said Susan Shelley, vice president of communications for the Howard Jarvis Taxpayers Association.
For example, the state pays physicians who participate in Medi-Cal among the lowest rates in the nation, she said. And a January 2020 report by the California State Auditor found that just under 48% of children enrolled in Medi-Cal went to the doctor for a preventive visit in 2016-17.
"It's unwise to commit taxpayers to this," Shelley said. "All these little kids are going to grow up and have one huge tax bill."
Offering caregivers preventive behavioral treatment has proven to save money by avoiding bigger health problems down the road, according to legislative budget documents. An analysis by HealthySteps of its sites in New York, Colorado, Arizona and Kentucky showed average annual savings to Medicaid of 204% for patients enrolled in their program. The group reports that children were eight times more likely to receive developmental screenings and twice as likely to go to well visits when their parents participated in the HealthySteps program.
"It's a realization that it's not just about providing services today, but it's about thinking about the services that will help defer costs down the road by doing the right things today," Kooler said.
Making a visit to the pediatrician's office more welcoming to parents, and getting mothers screened for depression and other behavioral issues, could improve California's dismal rate of child developmental screenings, said Sarah Crow, managing director of First 5 Center for Children's Policy.
"California, if it really wants to prioritize children's health, then we really need to pull out all the stops and start thinking of new, culturally relevant ways to serve our families," Crow said.
At the clinic in San Francisco, Bercun, the social worker, visits with caregivers for as long as they need, usually about half an hour but sometimes up to an hour. She counsels a mom about a job loss, shows a dad how to soothe his crying infant and guides another mom to lovingly say no to a toddler on the verge of a tantrum. She has helped caregivers develop safety plans if there is violence in the home and has connected them to community resources.
And then there's the pandemic: She talks families through the isolation so many have felt.
"It's working through these moments and feeling less alone and building confidence," Bercun said. "It's about holding space to explore feelings. My hope is that one day all families could benefit."
July Fourth was not the celebration President Joe Biden had hoped for, as far as protecting more Americans with a coronavirus vaccine. The nation fell just short of the White House's goal to give at least a first dose to 70% of adults by Independence Day. By that day, 67% of adult Americans had gotten either the first shot of the Moderna or Pfizer-BioNTech vaccine, or the one-shot Johnson & Johnson vaccine. If children ages 12-17, who are now eligible for the Pfizer product, are included, the national percentage of those who have gotten at least one shot is 64%.
Drilling down from national rates, the picture varies widely at the regional level, and from state to state. For example, Massachusetts and most states in the Northeast reached or exceeded 70% (for adults, age 18 and older) in June. Tennessee and most Southern states have vaccination rates between 50% and 60%, and administration rates are slowing down.
Local variations in demand for the vaccines and in-state strategies for marketing and distributing the shots help explain the range.
In Massachusetts, for example, residents overwhelmed phone lines and appointment websites as soon as vaccines became available. The state began opening mass vaccination sites in January to meet demand. At Gillette Stadium in Foxborough, the home field of the New England Patriots, Jumbotron screens flashed updates and speakers blasted instructions to people arriving for a shot. When demand peaked in March, as many as 8,000 residents a day snaked through lines to a waiting syringe. Registered nurse Francesca Trombino delivered jab after jab at Fenway Park and then at the Hynes Convention Center in Boston for five months.
"I still hold a lot of interactions very dear to my heart," she said, reflecting on those months in late June. "I had so many people cry, just out of pure shock, just being able to feel free."
Heading into the long Fourth of July weekend, more than 82% of Massachusetts adults had received at least one shot. That number doesn't surprise many public health experts because residents generally have embraced vaccination recommendations in the past, and Massachusetts regularly registers some of the highest rates for pediatric and influenza inoculations in the country. In Tennessee, where only 52% of adults are at least partially vaccinated against COVID, nurses sit waiting. In some of the state's rural counties, only 30% of residents have been vaccinated.
"Our first couple weeks we had people booked, then after that we had people start no-showing," said Kirstie Allen, who coordinates COVID vaccinations at the federally subsidized clinic in Linden, Tennessee. "We had a waiting list, the people on the waiting list didn't want to come. It's gradually just gotten worse."
Allen is down to offering the vaccine just one day a week, and she aims to sign up at least 10 patients to avoid wasting doses in the multi-use Moderna vial.
Allen has witnessed plenty of vague skepticism in her town of 1,200 people. And she can sympathize. Despite administering the shots, the mother and licensed practical nurse has not yet been vaccinated and said she's waiting for more research results to be released, and to see how everyone does over time.
"I'm one of those people who are unsure at the moment about getting it," she said, adding she wouldn't get her kids vaccinated yet either.
This wait-and-see attitude is especially common among white, rural conservatives in the South, according to many surveys in recent months. After an initial surge of interest, demand for vaccinations waned, and states like Tennessee held mass vaccination events only in the most densely populated cities.
Having Reached the 70% Goal, Massachusetts Adopts Targeted Strategy
In Massachusetts, with fewer than 20% of adults still unvaccinated, the state is closing its high-volume vaccine clinics and focusing on specific demographic groups and communities with low vaccination rates.
"As these [big] sites come to their mission complete, we need to keep pushing harder into the neighborhoods," said Rodrigo Martinez, "into those locations that really need it."
Martinez is with CIC Health, a company that moved from managing mass vaccination sites to running small outdoor clinics at supermarkets where shoppers who got a shot received a $25 gift card. That hyperlocal approach is part of a growing effort in Massachusetts to bring vaccines to residents, especially those in low-income and minority communities where the virus spread quickly and vaccination rates remain low.
Massachusetts has targeted 20 such cities including Brockton, south of Boston. It's a diverse city of essential workers, a group that has been hit hard during the pandemic. First-dose vaccination rates are especially low for Latinos, at 39%, and Blacks, 41% (for all ages, not just adults).
The hyperlocal approach was on display in Brockton on a Sunday in late June, when the city, with assistance from the state, hosted a mobile vaccine clinic at a popular park. A big, yellow touring bus, retrofitted to hold vaccination stations, idled near tents offering free food, music, legal advice for immigrants and health insurance enrollment assistance.
This particular neighborhood in Brockton features residents who speak Portuguese, Spanish, English and Haitian Creole.
"Bienvenue! Welcome!" shouted Isabel Lopez, a state-funded vaccine ambassador, as she moved from one cluster of families to another, urging them to go grab a free hamburger, hot dog — and a vaccine.
"We are here, bringing the communities together, to make this a fun day and also a creative way to get people vaccinated," Lopez said.
Near the soccer field, Lopez scored a big win. She persuaded five hesitant members of one household to go to the bus and at least talk with a nurse there. A half-hour later, all five had received their first shots. Lenin Gomez said afterward that he had had doubts about the vaccine but was persuaded when the nurse stressed the need to protect the children living in Gomez's home.
"If I'm not fully protected, who will take care of the little ones?" Gomez said. "That's what opened my mind to getting vaccinated."
When Gomez gets his second dose in a few weeks, he can enter himself in a statewide lottery that will give away five $1 million prizes for anyone who's vaccinated. Massachusetts Gov. Charlie Baker said he hopes these jackpots will entice hesitant residents to roll up their sleeves.
Hefty Financial Incentives Are Less Common in the South
In the states that need most to boost vaccination rates, there's little interest in creative financial incentives. Tennessee has no plans. In Alabama, the NAACP funded a recent drawing for $1,000 prizes aimed at millennials and Gen Zers.
Overall, the daily vaccination rate across the South has slowed, worrying health officials who are watching the explosive growth and spread of the delta variant in several parts of the U.S. But some Southern residents continue to come around to the idea. In Lobelville, Tennessee, 57-year-old Laurel Grant was initially hesitant to get the shot because of possible side effects.
"But everybody I know has done real good, just maybe a little fever or a little tiredness," she said.
So Grant got her own shot in June, at a local pharmacy. It helped that the Pilot Flying J truck stop where she works offered a $75 bonus to employees who got fully vaccinated.
"There's a few down there at work who are like, 'I'm not going to get it,'" Grant said, "I'm like, 'Yes, you are. You gotta go, like it or not.'"
Converts like Grant are being seen as the best kind of evangelist for this next phase of vaccinating latecomers. Tennessee's health department has started taping video testimonials to release online. But the marketing efforts are beginning to annoy some Republican state lawmakers convinced the state is trying too hard. They're especially concerned about kids.
A recent hearing in the Tennessee state legislature included threats of disbanding Tennessee's health department. State Rep. Iris Rudder, along with other GOP lawmakers, brandished printouts of social media ads produced by state health officials. They featured smiling kids with adhesive bandages on their shoulders.
"It's not your business to target children. It's your business to inform the parent that their child is eligible for the vaccination," she told health department officials at the hearing in June. "So I would encourage you, before our next meeting, to get things like this off your website."
This criticism was mostly directed at the state's health commissioner, Dr. Lisa Piercey, who responded at the hearing by saying the state is not "whispering to kids" or trying to get them vaccinated behind the backs of their parents. She said she's not going to back off when it comes to vaccination outreach.
Piercey also said she doesn't think the risk level in Tennessee is as dire as the low vaccination rates suggest. Tennessee had a huge surge of COVID cases during the winter. That means at least 850,000 people — based on positive test results — are walking around with some level of natural immunity. Piercey said those residents are partially compensating for low vaccination rates.
"Yes, I want everybody who wants a vaccine to get it," she said. "But what I really want at the end of the day is for this pandemic to go away. I want to minimize cases and eliminate hospitalizations and deaths, and we're pretty close to getting there."
The outlook is less rosy in neighboring Arkansas. The state escaped the worst of the winter outbreaks. Now it is trying to stop flare-ups of illness caused by the more contagious delta variant. Gov. Asa Hutchinson told CBS's "Face the Nation" that if nothing else will inspire Southerners to get vaccinated, "reality will."
Data released Thursday night by Johnson & Johnson showed that the vaccine remains highly protective against the delta variant and immunity may be long-lasting.
This article was published on Friday, July 2, 2021 in Kaiser Health News.
In the past two weeks, many medical experts started to question whether the Johnson & Johnson vaccine, which is administered in a single dose, would be as effective as the two-dose Pfizer-BioNTech or Moderna vaccine in protecting against the new, highly transmissible delta variant that is poised to become the dominant strain in the U.S.
The reason for their doubts were studies showing that the J&J vaccine was less effective at preventing disease than the other two vaccines and also less protective against variants. In recent days, several scientists and even members of the public who originally got J&J decided to get a “booster dose” of an mRNA vaccine, Pfizer-BioNTech or Moderna, to bolster their immune systems.
But data released Thursday night by Johnson & Johnson showed that the vaccine remains highly protective against the delta variant and immunity may be long-lasting.
“Those who got J&J should be less worried than they may have been before about delta,” said Dr. David Diemert, a professor of medicine at George Washington University who was not involved in J&J’s research. “It is reassuring.”
The Food and Drug Administration granted the J&J vaccine emergency use authorization in February on the heels of the Pfizer-BioNTech and Moderna vaccines. After a 10-day pause in April, triggered when the vaccine was found to be associated with rare but severe blood clots, distribution resumed. About 12 million Americans have received it so far.
Experts say the delta variant, first identified in India, is 40% to60% more transmissible than other variants, meaning that unvaccinated people can more easily catch covid-19 and that those who have been vaccinated face a higher risk of breakthrough infections. The delta variant has also been associated with greater disease severity than other variants. In the U.S., it now accounts for about 25% of covid cases.
The Johnson & Johnson data released Thursday offered the first window into how well the J&J shot holds up against the delta variant.
“We believe that our vaccine offers durable protection against COVID-19 and elicits neutralizing activity against the Delta variant,” Dr. Paul Stoffels, chief scientific officer at Johnson & Johnson, said in a press release.
The data comes from two small-sample preprint studies, which have not yet been peer reviewed and were both conducted in laboratories.
One of the new studies showed that the J&J vaccine continued to produce a high number of antibodies in the presence of the delta variant. And the number was actually higher than what recent data had shown for antibody levels against the beta variant (first identified in South Africa).
The second study showed that the J&J vaccine’s immune response lasted at least eight months and that some types of immune cells increased over time. This immune response was found to provide protection even against the delta variant and other variants of concern.
This builds onto research from J&J’s clinical trial before its vaccine received authorization from the FDA. In that study, the vaccine was found to be 72% effective at preventing severe and moderate disease in the U.S. Part of the trial was also conducted in South Africa and Brazil, where variants were circulating as the vaccine was being tested. Those results were slightly lower than in the U.S. trials — 57% in South Africa and 66% in Latin American nations — but, overall, those percentages confirm a high degree of protection.
Still, those percentages were lower than what Pfizer-BioNTech and Moderna had reported in their trials — 95% and 94% effectiveness, respectively, at preventing symptomatic disease. Recent data suggests the twovaccines also protect against the delta variant.
That means that, while there is now some evidence that J&J is protective against the delta variant, its overall efficacy is still lower than that of Pfizer-BioNTech or Moderna, said John Moore, a professor of microbiology and immunology at the Weill Cornell Medical College in New York.
“I don’t think anything has changed about that,” said Moore. He had previously told KHN he thought J&J should be a two-dose vaccine, since it provides less protection than Pfizer and Moderna.
He also pointed out that, if you look closely at one of the new J&J studies, a single person did elect to get an mRNA dose after receiving J&J, which strongly boosted that person’s antibody response.
“That is just a one-off result,” said Moore. “But it is consistent with emerging data.”
Indeed, datafrom studies in the United Kingdom shows that following a single dose of the Oxford-AstraZeneca shot with a Pfizer-BioNTech shot offered an immunity boost. (The Oxford-AstraZeneca vaccine, authorized for use in the U.K. but not the U.S., operates through a similar mechanism as J&J, although two doses are required.)
Experts, though, also maintain that all the covid vaccines authorized for emergency use in the U.S. are very effective, especially compared with other types of vaccines. Flu vaccines have been found to have an average of 33% to 61% effectiveness, depending on the strain they protect against.
Still, Moore said those who got J&J should not pursue booster shots on their own but instead wait for guidance from the Centers for Disease Control and Prevention and FDA.
“If and when FDA and CDC approve a change in policy, then it looks to me entirely appropriate to consider using the mRNAs as a boost for J&J,” said Moore.
In a statement, the FDA said that J&J remains a single-dose shot and that no data is available yet on its interchangeability with other covid vaccines. The CDC said the agency is continuing “to monitor and evaluate COVID-19 vaccine effectiveness.”
Diemert said the data from J&J’s studies supports his view that at this time a booster shot isn’t necessary for those who got J&J.
“Now that we have data that is encouraging that the vaccine might be protective against delta and that the duration of protection is a thing, those two together are encouraging that a booster might not be needed,” said Diemert.
Dr. Robert Wachter, chair of the Department of Medicine at the University of California-San Francisco, said he doesn’t think an mRNA booster is necessary either — but he would still caution those who got J&J to be a bit more careful than those who received Pfizer-BioNTech or Moderna.
“The main difference would be definitely masking indoors (unless certain that everybody was vaccinated), whereas for mRNA vax recipient, I see that as more elective,” Wachter wrote in an email.
As for those who got J&J and have already gotten an mRNA booster shot? For some, the new findings come as a relief.
“These results are great news. I don’t find them surprising, but they are some of the data that was missing when I decided to take an mRNA booster,” said Jason Gallagher, a clinical pharmacy specialist in infectious diseases at Temple University Hospital in Philadelphia.
He got a dose of the Pfizer-BioNTech vaccine after receiving the J&J vaccine because he was concerned about a U.K. study that indicated one dose of the Oxford-AstraZeneca or Pfizer-BioNTech vaccine was much less effective against the delta variant than two doses.
Gallagher said he might not have gotten a booster if the J&J results had been available a month ago, but he doesn’t regret his decision.
“This is an immunologic study suggesting that the vaccine will work against the delta variant, not a clinical study describing whether it did. I’m looking forward to learning more about that,” said Gallagher.
For those who are still considering getting an mRNA booster, it’s important to know that vaccine sites may ask whether you have already been vaccinated against covid. These sites have been instructed to administer vaccines according to CDC and FDA guidelines and have not been authorized to give additional shots to those who have already received a complete vaccine regimen.
Experts also emphasized that the best way to protect against the highly transmissible delta variant is to achieve a high vaccination rate across the U.S. When more people are vaccinated, the amount of circulating virus is reduced, which means everyone is better protected, including those who got the J&J shot.
Almost 67% of U.S. adults have received at least one vaccine dose, but only 47% of the total population is fully vaccinated. Rates of vaccination also vary widely by state. In other words, location has a lot to do with risk. Several Southeastern and Midwestern states, for instance, have less than 55% of their population vaccinated, meaning the delta variant could more easily sweep through those areas.
“All of the evidence on our currently authorized vaccines in the U.S. suggests they remain highly effective against preventing severe disease even against the variants,” said Dr. William Moss, executive director of the International Vaccine Access Center at Johns Hopkins University in Baltimore.
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Veteran health journalist Marshall Allen has been exposing healthcare grifters for years. Now, he's written a book about how to fight them. Host Dan Weissmann spoke with Allen about some of the best tips from "Never Pay the First Bill: And Other Ways to Fight the Healthcare System and Win."
Allen used the skills he learned while doing healthcare deep dives for ProPublica to write the book, which he describes as a field guide to navigating the health system.
"This is not stuff you're going to hear at your company's employee enrollment meeting," Allen said.
Among the tips were some "magic words" you can use if you ever end up in the emergency room. They are worth memorizing or writing down.
In the ER, you'll be asked to sign a form that says you will pay for whatever your insurance does not cover. If you can, X out that section and write in this:
I consent to appropriate treatment and (including applicable insurance payments) to be responsible for reasonable charges up to two times the Medicare rate.