Category: From California Healthline.org

As public demand grows for limited supplies of covid-19 vaccines, questions remain about the vaccines’ appropriateness for older adults with various illnesses. Among them are cancer patients receiving active treatment, dementia patients near the end of their lives and people with autoimmune conditions.

Recently, a number of readers have asked me whether older relatives with these conditions should be immunized. This is a matter for medical experts, and I solicited advice from several. All strongly suggested that people with questions contact their doctors and discuss their individual medical circumstances.

Experts’ advice may be helpful since states are beginning to offer vaccines to adults over age 65, 70 or 75, including those with serious underlying medical conditions. Twenty-eight states are doing so, according to the latest survey by The New York Times.

Q: My 80-year-old mother has chronic lymphocytic leukemia. For weeks, her oncologist would not tell her “yes” or “no” about the vaccine. After much pressure, he finally responded: “It won’t work for you, your immune system is too compromised to make antibodies.” She asked if she can take the vaccine anyway, just in case it might offer a little protection, and he told her he was done discussing it with her.

First, some basics. Older adults, in general, responded extremely well to the two covid-19 vaccines that have received special authorization from the Food and Drug Administration. In large clinical trials sponsored by drugmakers Pfizer and Moderna, the vaccines achieved substantial protection against significant illness, with efficacy for older adults ranging from 87% to 94%.

But people 65 and older undergoing cancer treatment were not included in these studies. As a result, it’s not known what degree of protection they might derive.

Dr. Tobias Hohl, chief of the infectious diseases service at Memorial Sloan Kettering Cancer Center in New York City, suggested that three factors should influence patients’ decisions: Are vaccines safe, will they be effective, and what is my risk of becoming severely ill from covid-19? Regarding risk, he noted that older adults are the people most likely to become severely ill and perish from covid, accounting for about 80% of deaths to date — a compelling argument for vaccination.

Regarding safety, there is no evidence at this time that cancer patients are more likely to experience side effects from the Pfizer-BioNTech and Moderna vaccines than other people. Generally, “we are confident that these vaccines are safe for [cancer] patients,” including older patients, said Dr. Armin Shahrokni, a Memorial Sloan Kettering geriatrician and oncologist.

The exception, which applies to everyone, not just cancer patients: people who are allergic to covid-19 vaccine components or who experience severe allergic responses after getting a first shot shouldn’t get covid-19 vaccines.

Efficacy is a consideration for patients whose underlying cancer or treatment suppresses their immune systems. Notably, patients with blood and lymph node cancers may experience a blunted response to vaccines, along with patients undergoing chemotherapy or radiation therapy.

Even in this case, “we have every reason to believe that if their immune system is functioning at all, they will respond to the vaccine to some extent,” and that’s likely to be beneficial, said Dr. William Dale, chair of supportive care medicine and director of the Center for Cancer Aging Research at City of Hope, a comprehensive cancer center in Los Angeles County.

Balancing the timing of cancer treatment and immunization may be a consideration in some cases. For those with serious disease who “need therapy as quickly as possible, we should not delay [cancer] treatment because we want to preserve immune function and vaccinate them” against covid, said Hohl of Memorial Sloan Kettering.

One approach might be trying to time covid vaccination “in between cycles of chemotherapy, if possible,” said Dr. Catherine Liu, a professor in the vaccine and infectious disease division at Fred Hutchinson Cancer Research Center in Seattle.

In new guidelines published late last week, the National Comprehensive Cancer Network, an alliance of cancer centers, urged that patients undergoing active treatment be prioritized for vaccines as soon as possible. A notable exception:  Patients who’ve received stem cell transplants or bone marrow transplants should wait at least three months before getting vaccines, the group recommended.

The American Cancer Society’s chief medical and scientific officer, Dr. William Cance, said his organization is “strongly in favor of cancer patients and cancer survivors getting vaccinated, particularly older adults.” Given vaccine shortages, he also recommended that cancer patients who contract covid-19 get antibody therapies as soon as possible, if their oncologists believe they’re good candidates. These infusion therapies, from Eli Lilly and Co. and Regeneron Pharmaceuticals, rely on synthetic immune cells to help fight infections.

Q: Should my 97-year-old mom, in a nursing home with dementia, even get the covid vaccine?

The federal government and all 50 states recommend covid vaccines for long-term care residents, most of whom have Alzheimer’s disease or other types of cognitive impairment. This is an effort to stem the tide of covid-related illness and death that has swept through nursing homes and assisted living facilities — 37% of all covid deaths as of mid-January.

The Alzheimer’s Association also strongly encourages immunization against covid-19, “both for people [with dementia] living in long-term care and those living in the community, said Beth Kallmyer, vice president of care and support.

“What I think this question is trying to ask is ‘Will my loved one live long enough to see the benefit of being vaccinated?’” said Dr. Joshua Uy, medical director at a Philadelphia nursing home and geriatric fellowship director at the University of Pennsylvania’s Perelman School of Medicine.

Potential benefits include not becoming ill or dying from covid-19, having visits from family or friends, engaging with other residents and taking part in activities, Uy suggested. (This is a partial list.) Since these benefits could start accruing a few weeks after residents in a facility are fully immunized, “I would recommend the vaccine for a 97-year-old with significant dementia,” Uy said.

Minimizing suffering is a key consideration, said Dr. Michael Rafii, associate professor of clinical neurology at the University of Southern California’s Keck School of Medicine. “Even if a person has end-stage dementia, you want to do anything you can to reduce the risk of suffering. And this vaccine provides individuals with a good deal of protection from suffering severe covid,” he said.

“My advice is that everyone should get vaccinated, regardless of what stage of dementia they’re in,” Rafii said. That includes dementia patients at the end of their lives in hospice care, he noted.

If possible, a loved one should be at hand for reassurance since being approached by someone wearing a mask and carrying a needle can evoke anxiety in dementia patients. “Have the person administering the vaccine explain who they are, what they’re doing and why they’re wearing a mask in clear, simple language,” Rafii suggested.

Q: I’m 80 and I have Type 2 diabetes and an autoimmune disease. Should I get the vaccine?

There are two parts to this question. The first has to do with “comorbidities” — having more than one medical condition. Should older adults with comorbidities get covid vaccines?

Absolutely, because they’re at higher risk of becoming seriously ill from covid, said Dr. Abinash Virk, an infectious diseases specialist and co-chair of the Mayo Clinic’s covid-19 vaccine rollout.

“Pfizer’s and Moderna’s studies specifically looked at people who were older and had comorbidities, and they showed that vaccine response was similar to [that of] people who were younger,” she noted.

The second part has to do with autoimmune illnesses such as lupus or rheumatoid arthritis, which also put people at higher risk. The concern here is that a vaccine might trigger inflammatory responses that could exacerbate these conditions.

Philippa Marrack, chair of the department of immunology and genomic medicine at National Jewish Health in Denver, said there’s no scientifically rigorous data on how patients with autoimmune conditions respond to the Pfizer and Moderna vaccines.

So far, reasons for concern haven’t surfaced. “More than 100,000 people have gotten these vaccines now, including some who probably had autoimmune disease, and there’s been no systematic reporting of problems,” Marrack said. If patients with autoimmune disorders are really worried, they should talk with their physicians about delaying immunization until other covid vaccines with different formulations become available, she suggested.

Last week, the National Multiple Sclerosis Society recommended that most patients with multiple sclerosis — another serious autoimmune condition — get the Pfizer or Moderna covid vaccines.

“The vaccines are not likely to trigger an MS relapse or to worsen your chronic MS symptoms. The risk of getting COVID-19 far outweighs any risk of having an MS relapse from the vaccine,” it said in a statement.

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 health care system. Visit khn.org/columnists to submit your requests or tips.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

It was the end of April — just as the U.S. confirmed its millionth covid-19 case and 50,000 deaths — when White House adviser Dr. Anthony Fauci announced “highly significant” news about a drug called remdesivir.

That was surprising because the antiviral drug, owned by Gilead Sciences and developed with investment from the federal government, had languished for years with no apparent commercial use. It had struck out as a treatment for hepatitis C and Ebola.

But early in 2020, when the first global cases of a new pneumonia-like viral illness emerged in China, Gilead resurfaced the compound, branded as Veklury, and shared it with scientists across the globe. From the Oval Office, Fauci, director of the National Institute of Allergy and Infectious Diseases, said remdesivir would be the “standard of care” for treating coronavirus disease.

Its emergency-use approval by the Food and Drug Administration immediately drew a storm of criticism. Clinical trials suggested it was only modestly helpful to covid patients. The World Health Organization recommended against its use. Politicians railed at its $3,120 price tag.

Yet, nine months later, it appears Fauci was right: As U.S. infections climb above 24 million, doctors with no other FDA-approved treatment options are now prescribing remdesivir to half the covid patients in U.S. hospitals.

“We want to shorten their hospital stay,” said Dr. Jade Le, an infectious diseases specialist with Access Physicians in Texas, where hospitals have been at capacity for weeks. Le prescribes remdesivir on average three to five times a day, always in concert with a low-cost steroid.

This month, Gilead chief executive Daniel O’Day raised the profit estimates of the company, headquartered in Foster City, California, noting that remdesivir alone would deliver about $2.8 billion in 2020 sales, bolstered by its use in U.S. and European markets. The company is proud of the role the treatment is playing during the pandemic, he said.

Still, controversies abound. Tension mounted last summer as shortages of remdesivir taxed the global medical community and raised urgent questions about how the federal government could step in. While doctors rationed the drug, politicians and advocates said U.S. taxpayers had invested enough in remdesivir’s development to merit a lower price.

“The remdesivir story is actually a story that is all too common,” said Zain Rizvi, law and policy researcher at the consumer advocacy group Public Citizen. Rizvi — and other advocates — say the drug would not have come to market if it wasn’t for federal grants and the help of U.S. scientists.

They said the rags-to-riches story of remdesivir, a losing prospect turned blockbuster, holds lessons in how Americans end up paying more for medicine than anyone else in the world. Remdesivir used taxpayer dollars to be developed but, in a public health emergency, patients have no option but to pay whatever the pharmaceutical giant demands.

Rizvi has estimated that federal grants of “at least” $70 million supported the scientific discovery of remdesivir. He pointed to early research done, including a collaboration between Gilead and university scientists, using federal grants, to test remdesivir’s antiviral compounds against coronaviruses, such as MERS and SARS. Others figure the investment could be much higher.

Kathryn Ardizzone, legal counsel for the patent rights group Knowledge Ecology International, is among those, though she agreed the amount is at least $70 million and declined to estimate the total amount of federal dollars used for remdesivir’s discovery. There is no publicly available database of how much the government has spent to develop any drug, including remdesivir.

The NIH said in an emailed statement that it “did not develop remdesivir.” The agency confirmed it funded research on the drug’s uses as well as providing money to institutions that worked with Gilead to develop the drug.

KEI filed a Freedom of Information Act request to view the grants and clinical trials related to remdesivir. In October, the group sued the National Institutes of Health because it had failed to respond. Ardizzone said she expects the records will counter Gilead’s justification of remdesivir’s price: “When the government has played such a critical role at every step of the way, that argument falls apart.”

Gilead, in an emailed statement, said its investment in the drug predates any government involvement and “disagrees with the premise that the government has any rights to Gilead’s remdesivir intellectual property.” No federal scientists are named on remdesivir’s patents.

The company has defended the price of the drug, saying it invested more than $1 billion in 2020 to support clinical trials as well as to manufacture and distribute remdesivir. Gilead priced it at $3,120 for a five-day course of treatment in the U.S. market, and $2,340 for other developed countries. Some smaller U.S. government entities, like the Indian Health Service, pay the lower price as well. Noting the price for developed countries, Gilead spokesperson Arran Attridge said the drug is priced “significantly below the potential value” it delivers.

But U.S. Sen. Ron Wyden, a top-ranking Democrat from Oregon on the Senate Finance Committee, said he has been concerned about Gilead’s price for a five-day course of treatment since it was announced. “My previous investigative work … has shown Gilead’s willingness to put profits over patients,” Wyden said. Wyden, along with Sen. Chuck Grassley (R-Iowa), released an investigation in 2015 of Gilead’s hepatitis C drug prices and marketing.

At its core, remdesivir is a simple, “small molecule” drug. Generics manufacturers in India have copied the design and priced it at $53.34 per vial, or $320 for a course of treatment.

The U.S. government, so far, has not exerted its intellectual property rights. But there are signals that could change.

In late summer, California Attorney General Xavier Becerra led a group of more than 30 attorneys general calling for the federal government to license remdesivir to another manufacturer, such as a lower-cost provider from overseas. President Joe Biden nominated Becerra to lead the Department of Health and Human Services.

Another Biden pick, Dr. Rochelle Walensky, an infectious diseases specialist who has been tasked to lead the Centers for Disease Control and Prevention, co-authored a New York Times opinion piece suggesting that HHS could buy the drug from another company (including a generics maker overseas) and pay royalties to Gilead. This fall, U.S. Rep. Lloyd Doggett (D-Texas) held a news conference supporting the approach Walensky and others proposed.

Neither maneuver, however, was meant as a lever to lower its price for patients, said Adam Mossoff, a law professor at George Mason University. Mossoff doubted that either of the strategies would hold up in court and noted there are plenty of congressional proposals to lower drug prices and sometimes “people get ahead of themselves.” They try to use the law to advocate for what should be a policy goal, he said.

Underlying Becerra’s and Walensky’s proposals is the deeper, nagging question of whether Gilead should fully own the rights to remdesivir if the U.S. funded research and its scientists worked with Gilead to discover the drug.

Doggett put it this way: “Gilead is overcharging on a drug that was saved from the scrap heap of failed drugs only because of taxpayer-funded research.”

Sen. Debbie Stabenow (D-Mich.) and Rep. Carolyn Maloney (D-N.Y.) have asked the government’s federal watchdog agency, the Government Accountability Office, to investigate “what legal rights do federal agencies have” in relation to remdesivir. Gilead said it is cooperating with the investigation; government officials expect the review to be completed this spring.

Gilead, in an emailed statement in response to a question about the GAO review, called the government’s involvement “limited.” In response to questions about the patents, Gilead said its own investments predate any government involvement and its inventors identified the drug’s antiviral activity, optimized the formula and scaled up the manufacturing process.

Gilead confirmed it has eight listed patents on remdesivir, with the last expiring in 2038.

In the abstracts of two patents, filed in 2014 and 2015, the CDC and USAMRIID, the U.S. Army Medical Research Institute of Infectious Diseases, are mentioned as places studies were conducted. Each patent emphasizes its focus on treating the Ebola virus and other filoviruses that cause fatal hemorrhagic fevers.

Christopher Morten, deputy director of technology law and policy clinic at New York University School of Law, said those two patents should list government scientists as co-inventors. Referring to one patent (No. 9,724,360), Morten said its earliest filing was October 2014. “Which makes perfect sense, because the U.S. government collaboration started in 2013 with Ebola and the CDC,” Morten said. While not attaching specific government investment dollars to its descriptions, Gilead confirms the collaboration, as well, saying it “worked with the U.S. government to confirm remdesivir’s preclinical activity against Ebola.”

Morten, who previously represented pharmaceutical companies as a patent lawyer, said he believes the question of inventorship should be raised in court, using the legal tactic proposed by CDC chief Walenksy. Morten co-authored a white paper on remdesivir with the HIV advocacy group PrEP4All.

Notably, PrEP4All also challenged Gilead’s patents for the HIV drug Truvada. In 2019, the U.S. Departments of Justice and Health and Human Services sued Gilead over patent rights for Truvada. The case is ongoing.

Back on the pandemic’s front lines, U.S. doctors administer remdesivir even after the World Health Organization recommended against the drug in November. The WHO’s recommendation, which referenced results from an international trial called Solidarity, found remdesivir did not improve a covid patient’s chance of survival.

The Food and Drug Administration gave remdesivir full regulatory approval in October, making it the only approved U.S. treatment for the deadly disease.

Dr. Rajesh Gandhi, a member of the Infectious Diseases Society of America’s panel on covid-19 treatment guidelines, pointed to another clinical trial of more than 1,000 hospitalized patients run by the National Institutes of Health. The trial, called ACTT-1, showed hospital stays of about 10 days for those who received remdesivir compared with 15 days for those who did not, he said.

“Many of us believe remdesivir has a role,” Gandhi said, “though we wish it had a greater effect.” He noted that the trial showed one group of patients saw the biggest benefit: those who need supplemental oxygen but are not yet on a ventilator. It’s clear, he said, “we need better drugs than remdesivir.”

Remdesivir — along with a steroid — was enough for Shirley Lewis.

The 69-year-old Florida resident said she was sick for about a week when she found herself unable to breathe and went to the hospital.

“I’m telling you, I was like half-dead and half-alive … all I could do was pray,” Lewis said. Doctors put her on supplemental oxygen and began IV bags of remdesivir paired with steroids. Lewis said she felt the difference right away.

“I said, Oh, thank God,” Lewis recalled about a month after being released from the hospital. “I thought it was some kind of miracle, I really did. So don’t let them say it doesn’t work, because it did.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Americans’ reluctance to get vaccinated for covid-19 is waning, according to a poll released Wednesday.

Nearly half of adults surveyed in January said they have either already been vaccinated or want the vaccine as soon as they can, up from about a third of adults polled in December, according to the latest KFF survey. (KHN is an editorially independent program of KFF.)

About 20 million Americans have been vaccinated for covid since distribution of the first vaccines began in mid-December. The pace has also picked up in recent weeks, with more than a million Americans on average getting vaccinated every day. The survey found that when people know someone close to them who has been vaccinated, they are more likely to want the shots.

About half of those who said they want the shot as soon as possible know someone who has already gotten a dose, a much larger share than among those who said they’ll get it only if required (29%) or will refuse to get it (36%).

Nearly half (47%) of adults said they have personally received at least one vaccine dose or know someone who has. People posting their vaccination status on social networks such as Facebook and Twitter has helped spread the word.

Racial, ethnic and economic disparities continue, however. White adults (51%) are more likely than Black (38%) or Hispanic (37%) respondents to have either been vaccinated or know someone who has, and those with annual household incomes of at least $90,000 are almost twice as likely as those with incomes under $40,000 to say so (64% vs. 34%). (Hispanics can represent any race or combination of races.)

About 3 in 10 adults said they want to wait until the vaccine “has been available for a while to see how it is working for others” before getting it themselves. About 7% of adults said they will get the vaccine only “if required to do so for work, school or other activities,” and just 13% said they will “definitely not get” the vaccine, not a significant change.

The poll also found about 1 in 3 health care workers planned to wait to see how the vaccine is working or would get it only if required to.

The percentage of people who said they want the vaccine immediately is up among the racial and ethnic groups surveyed, although white (53%) adults remained more likely to say so than Black (35%) and Hispanic (42%) adults. Black (43%) and Hispanic (37%) adults were more likely than white adults (26%) to say they want to “wait and see” before getting vaccinated, according to the poll.

Democrats and independents also showed increased enthusiasm, though Republicans’ views were little changed since December.

Republicans remained the least enthusiastic political group, with 32% saying they have already been vaccinated or want the vaccine as soon as they can, 33% saying they want to wait and see how it works for others, and 25% saying they will definitely not get the vaccine.

The KFF survey of 1,563 adults was conducted Jan. 11-18 and had a margin of error of +/-3 percentage points.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

In case you need your blood to boil, read this story about a woman’s surprise medical bill for lab tests she never requested and was never informed would happen. #health #healthcare #fixhealthcarehttps://t.co/SiK8TmpFhP

— John McQuiston (@JohnMcQuiston) December 23, 2020

— John McQuiston, Tampa, Florida

Reading Between the Lines on STD Testing

In your Bill of the Month feature “Retiree Living the RV Dream Fights $12,387 Nightmare Lab Fee” (Dec. 23), the implication that monogamous older people need not worry about sexually transmitted diseases caught me off guard.

I know this extreme example of an older lady being bullied to pay thousands of dollars for care she didn’t ask for was the heart of the piece (and I completely agree with the coverage you gave to this important issue — how dare they overcharge this lady and go after so many for unnecessary tests). But I found adding the sex appeal-STD example and including the jab she made about young people with multiple boyfriends was unnecessary and hides a clear problem: All people, including monogamous people, aren’t taking STD precautions or testing as seriously as they should. I know in this case it was particularly problematic that she didn’t ask for these tests, but the repeated focus on her not needing them because she’s been monogamous and she’s older was a little problematic.

In particular, I found this quote stigmatizing of non-monogamous people and increasing stigma around testing in general as well as specifically among older adults: “They ran all these tests that one would run on a very young person who had a lot of boyfriends, not a 60-year-old grandmother that’s been married for 26 years.”

When surveyed, non-monogamous people report the same rates of STDs as non-monogamous people, despite having had a greater number of lifetime partners — likely because of the conversations and actions taken around safer sex practices (such as condom use and STD testing).

Additionally, the elderly are at higher risk when contracting STDs and, although their rates are comparatively smaller, their rates are actually growing.

As stigma is high and knowledge about risks and the science of STDs is especially low among older adults, and even young people find it’s hard to talk to their doctors about STDs — I’d encourage you to write more on the topic of STD screenings among all ages and relationship orientations. You could very well save lives.

— Lily Colby, Sacramento, California

Why is the U.S. healthcare industry unlike every other industry? It’s a black box. Bills are works of fiction, not math. The argument of market vs. gov-run misses the point – its both and neither. When will Americans stop tolerating it? https://t.co/2V4yW2vdIt

— Jonathan Reisman MD (@jonreismanMD) December 23, 2020

— Dr. Jonathan Reisman, Philadelphia

Speak up! Don’t be afraid to ask what tests your doctor is running and whether or not they’re truly necessary. At the end of the day, you’re the one receiving the bill. #patientadvocacy https://t.co/zLx9dPPH3p

— Kayla Carlough (@CarloughKayla) December 29, 2020

— Kayla Carlough, Austin, Texas

Terrific column by ⁦@CaraRAnthony⁩ about the complications evoked by her new haircut. (Which looks great.) For anybody who thinks white privilege is a myth—when was the last time your family worried your haircut might endanger your life? https://t.co/26Eimy4rWX

— Lenny Kleinfeld (@LennyKleinfeld) November 9, 2020

— Lenny Kleinfeld, Los Angeles

Getting to the Roots of Racism

I write to express my extreme enjoyment of Cara Anthony’s article “Black Hair Matters: How Going Natural Made Me Visible” (Nov. 13). It started out about a recent hairstyle change and then evolved into a wonderfully warm, strong and enriching cultural expression. Thank you for your professional affiliation with her as a reporter. I was touched and enhanced by her writing. It also pointed the way to your organization and the needed services you provide. Happy New Year and much success to you.

— Rodney L. Jones, St. Louis

Try to get your head around the fact that a haircut can make you unsafe. Op-Ed: What a buzz cut during the pandemic taught me about racism and sexism https://t.co/dz36vqDIG8

— Debra Newby Watkins (@DebWoi) November 9, 2020

— Debra Newby Watkins, Austin, Texas

As we remember the nurses and health care workers who died on the front lines of this #pandemic, make no mistake: this didn’t have to happen. #ProtectNurseshttps://t.co/HrIfbqIsCY

— Bonnie Castillo (@NNUBonnie) January 9, 2021

— Bonnie Castillo, Oakland, California

Covid Is Bound to Haunt Health Care Workers

It bothers me that hospital officials say many of these nurses got covid-19 from outside the hospital (“More Than 2,900 Health Care Workers Died This Year — And the Government Barely Kept Track,” Dec. 23). My daughter is a nurse in Ohio. She moved out on her own so she wouldn’t give the coronavirus to her family and is now living like a ghost. It was the same when the Whirlpool Corp. said my wife got a repetitive stress disorder from life at home and not on the line making washers. Yeah, right. And coal miners get black lung from starting a fire in the fireplace.

I believe that even when covid-19 is over, for a lot of nurses and others, it will never end. They have seen too many people die alone. It will be just like the soldiers from the war, always tossing in bed, whimpering into the darkness of the night, yet never wishing they had failed the National Council Licensure Examination test that got them their jobs with dads, like me, so proud. Yeah, then will come layoffs from hospitals taxed from covid-19 causing them to lose money. The stock in antidepressants will skyrocket. When my daughter began as a nurse, I drove her to work. The nurses coming into work were happy and bubbly. Now they are draggy and long-faced, as if they just got off a flight from Vietnam to a home where no one cares. But we, the public of America, care.

— Steven Littlejohn, Bellevue, Ohio

It doesn’t bother you that 330k Americans are dead? That many “survivors” are fighting long term health problems? That healthcare workers are dying at rates not seen in 100 years?https://t.co/Q9celYaXsqhttps://t.co/XqfReP9nzK

— Derek Aupperlee (@DAupperlee) December 30, 2020

— Derek Aupperlee, Grand Rapids, Michigan

Last time I mentioned this it was 1,700. Now it’s 2,900. Most recently, a physician here in Indianapolis. 2,900 being missed at Christmas. While some continue to dismiss their deaths as only a small percentage, like they didn’t matter. They mattered. https://t.co/2h80xQJ4Bp

— Summer Steenburg (@scubagirl007) December 24, 2020

— Summer Steenburg, Indianapolis

Dialysis’ Other Stakeholders

Your story is a bit unbalanced (“Dialysis Industry Spends Millions, Emerges as Power Player in California Politics,” Dec. 9). Yes, it’s true that DaVita and Fresenius have profits to protect, but the Service Employees International Union is guilty of its own self-aggrandizement at its sites. And, it’s not just the for-profit dialysis companies that opposed the SEIU initiatives. Not-for-profit dialysis companies, e.g., Satellite Health Care and Dialysis Clinic Inc., did as well, and their opposition was backed by academic and professional societies representing physicians and registered nurses, with little or no support for the initiatives coming from non-aligned parties or (and I believe this is critical) from patients themselves, who had reasons to worry that the economic and structural burdens imposed by success of any of them would inevitably result in closure of many clinics — particularly in rural areas where some of the mandates would have been impossible to implement.

— James Robertson, Hamilton, Montana

Yes! Also tangentially related was this dialysis spending on marketing from last week. You’d think with enough market power they wouldn’t be as worried about policy makers https://t.co/xxeT9F9Agf

— Dr. Lacey Loomer (@lacey_loomer) December 21, 2020

— Dr. Lacey Loomer, Duluth, Minnesota

Fighting the ‘Same Old Thinking’ on Alzheimer’s

We were saddened to see KHN’s article “Alzheimer’s Inc: Colleagues Question Scientist’s Pricey Recipe Against Memory Loss” (Dec. 17), which unfairly characterizes the motivations of Dr. Dale Bredesen and Apollo Health. Each member of our workforce has been impacted by the scourge of Alzheimer’s, and suggesting that we are trying to benefit financially from conveying false hope is hurtful to us and harmful to those seeking treatment options.

We have many success stories already, and we look forward to sharing clinical trial results in the coming months, but we respect those who argue it is too soon to offer the protocol. After all, while we have had strong results and over 200 published studies laying the foundation for our work, we have not yet published definitive results.

However, it is wrong to assert that we are immoral profiteers. We have chosen to translate research success into consumer availability earlier than some would like because the standard of care offers patients with a fatal, progressive disease, no hope of success. In effect, our critics only want people to have access to options that have proven to fail. Medicine has a long history of “compassionate use” when no other treatment options are available. We offer access to a promising, no-risk alternative that has passed every step of the research journey so far.

The same old thinking and treatment will not solve the Alzheimer’s epidemic. However, we are confident in our revolutionary approach and in consumers’ ability to choose their treatment and prevention options for themselves.

— Laura Lazzarini, Burlingame, California

Computer science teacher Suzy Lebo saw covid-19 dangers frequently in her Indiana high school: classes with about 30 students sitting less than 18 inches apart. Students crowding teachers in hallways. Students and staff members taking off their masks around others.

“I’m concerned,” said Lebo, who teaches at Avon High School in the Indianapolis suburbs. “We’re not controlling the virus in our county. We’re not controlling it in our state. And we’re not controlling it in our schools.”

President Joe Biden’s covid response proposes $130 billion to improve school safety, offers federal guidance for making schools safer and improves workplace protections to safeguard teachers and other workers from covid.

This comes after many school districts and states holding in-person classes have ignored recommendations from public health officials or written their own questionable safety rules — creating a tinderbox where covid can sicken and kill.

A KHN analysis of federal and state Occupational Safety and Health Administration data found more than 780 covid-related complaints covering more than 2,000 public and private K-12 schools. But those pleas for help likely represent only a small portion of the problems, because a federal loophole prevents public school employees from lodging them in 24 states without their own OSHA agencies or federally approved programs for local and state employees. Still, the complaints filed provide a window into the safety lapses: Employees reported sick children coming to school, maskless students and teachers less than 6 feet apart, and administrators minimizing the dangers of the virus and punishing teachers who spoke out.

KHN also found that practices contradicting safety experts’ advice are codified into the patchwork of covid rules put out by states and districts. For instance, about half of states don’t require masks for all students — including 11 that have exempted schoolchildren of various ages from mandatory masks, with New Hampshire excluding all K-12 students. Districts can craft stricter rules than their states but often don’t.

“The response to the virus has been politicized,” said Dr. Chandy John, an expert in pediatric infectious diseases at the Indiana University School of Medicine. “There’s a willingness to ignore data and facts and go with whatever you’re hearing from the internet or from political leaders who don’t have any scientific knowledge.”

But even with Biden’s rollout of new school safety steps, struggles over balancing the need for education with covid safety are sure to continue, since it will be months before the nationwide vaccine rollout reaches all school staff members, and the shots haven’t yet been approved for kids.

Meanwhile, the scope of covid in schools remains unknown. Biden’s order calls for tracking it on the federal level, which wasn’t happening. States haven’t collected uniform data either. The Covid Monitor, a project launched by volunteers and public health researchers, has counted more than 505,000 cases in K-12 schools — more than a quarter of them among staffers. Although kids are less likely than adults to become seriously ill, recent research suggests they can spread the virus even if asymptomatic. The American Federation of Teachers estimates covid-19 has killed at least 325 school employees, though it’s unclear whether they caught it at school.

Among them was Susanne Michael, 47, a fourth grade teacher at Harrisburg Elementary School in northeastern Arkansas. As a cancer survivor with diabetes, she rarely went anywhere outside her home this past fall, according to her husband, Keith. She told him she worried about catching the coronavirus while teaching, but she “went and did it because she loved it.”

She tried her best to keep more than 20 students 6 feet apart, he said, but told him it was nearly impossible.

Though she always wore a mask, he doesn’t know if every student did. According to the district’s website, masks are required in grades 4-12 “when social distancing is not feasible,” and “physical distancing will be practiced to the extent practical.” District leaders did not respond to requests for comment.

Michael wound up hospitalized on a ventilator. Doctors let her husband visit in protective gear because he, too, had the virus. He held her hand as she slipped away Oct. 1.

The loss hits him hardest at night. “For 27 years, I always had somebody there next to me,” he said. “It’s difficult and weighs on your mind and heart a lot when you’re laying there in an empty bed and your best friend’s gone.”

She left five children, ages 3 to 22, including a former student and her two siblings adopted in July.

A Litany of Lapses

Doctors said covid risks can be drastically reduced by following straightforward safety practices.

“First and foremost, mask mandate, mask mandate, mask mandate,” said Dr. Jason Newland, a pediatrics and infectious diseases professor at Washington University in St. Louis.

But school employees across the nation complain such measures don’t exist or aren’t enforced.

“School officials openly scoff at covid-19 and believe it is a hoax. This attitude trickles down to staff, so hardly anyone has been wearing their mask or wearing it correctly,” an unidentified employee of Hart Public Schools, in rural western Michigan, wrote in an OSHA complaint in September. The complaint also described large crowds of students sitting too close in cafeterias. The employee alleges being terminated for whistleblowing.

Hart Superintendent Mark Platt said in an email that he won’t comment on personnel matters, but “takes seriously its health and safety protocols for students and staff.” The district’s covid preparedness and response plan requires staffers and older students to wear masks in classrooms, common areas and buses, while K-5 students must wear them everywhere except in their own classrooms with their own class.

At the public Avon Community School Corp. in Indiana, Lebo said, problems festered since the beginning of the fall semester in July, when an OSHA complaint was lodged. In addition to crowding in the halls and difficulty keeping students 6 feet apart in classrooms, Lebo said, the school’s many extracurricular activities — including football, wrestling and show choir — brought their own risks.

Avon schools spokesperson Kevin Carr wouldn’t comment except to say students and staff members have tried their best to abide by the district’s health and safety protocols.

Over the semester ending in December, Avon schools reported 346 covid cases among nearly 9,800 in-person students and staffers, a rate of 3.5% compared with 2.1% for 1,412 remote learners. The covid rate reached 5.5% at the high school, which went remote briefly in the fall after the number of people quarantining skyrocketed.

Like the vast majority of school OSHA complaints, the one about Avon was closed without an inspection. Across all industries, research shows, just a small percentage of pandemic-related complaints have led to inspections or fines.

A Biden executive order on worker safety calls for OSHA to bolster enforcement and work with states and local governments to ensure workers, including those in the public sector, are protected from covid.

Without strong laws, “workers are facing big challenges: Do I speak up? Do I show up to work?” said Rebecca Reindel, director of occupational safety and health for the AFL-CIO. “They’re making a decision between needing a paycheck and risking bringing the virus home.”

Varied, Questionable Guidance

That decision gets even harder when potentially unsafe practices are written into official recommendations.

Missouri and Iowa, for example, advise that students exposed to covid don’t need to be quarantined as long as infected and exposed children are both wearing masks correctly — which goes against Centers for Disease Control and Prevention advice to quarantine anyone who has had close contact with a person who has the virus.

Some districts in South Carolina, Tennessee, Florida and Nebraska — with green lights from the Trump administration and their states — classified teachers as “critical infrastructure workers,” allowing them to keep working after exposure if they don’t develop symptoms.

A superintendent in Billings, Montana, told administrators in October to “disrupt the 15-minute timeline” required to be deemed a close contact “through movement, distancing or masking.” Following media reports, he issued a statement saying he hadn’t intended to “game the system” and no one should move students to avoid quarantines.

In many communities, mask rules are lax.

In Missouri, where there’s no statewide mask rule, Ozark School District requires them only “when social distancing is not an option,” according to its website, which describes spacing desks and using barriers to give people a “break” from masks.

Lakeland Joint School District in Idaho recommends masks when physical distancing isn’t possible. Dacia Chaffee, parent of an eighth grader and a high school freshman in the district, said “it’s almost like normal,” with few students wearing masks. Her kids don’t either, she said; they don’t want to stand out.

Public health experts said making schools safer will require clear, consistent data and guidance — and political will. They said governments also need to give public schools enough resources to keep more than 50 million students and 3.2 million teachers safe. A recent CDC report estimated that the cost of covid mitigation measures for the 2020-21 school year ranges from $55 per student for items such as masks, plexiglass barriers and face shields to $442 per student with added custodians and transportation, such as buses and drivers, to allow for better physical distancing.

And crucially, experts said, covid policies for schools must be rooted in science, not politics.

“Behaviors and attitudes flow from the top down,” said Dr. Mark Schleiss, a pediatrics professor at the University of Minnesota Medical School. “We have to hold people accountable. This is a life-and-death situation.”

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

This story is part of a partnership that includes NPR and KHN. It can be republished for free.

As states await the promise of a renewed federal pandemic response and expand the number of Americans who qualify for a shot, some governors are trying to scale up their covid vaccine operations — and smooth out the kinks — with the help of the private sector.

In Washington state, Starbucks, Microsoft and Costco are lending logistical expertise and manpower to public health agencies that are trying to dispatch their doses of vaccines more efficiently.

Over the weekend, thousands of people filed through the Charlotte Motor Speedway in North Carolina — now serving as a mass vaccine site — run by Honeywell and other local businesses that have partnered with the state.

And on Monday, Google pledged $150 million to “promote vaccine education and equitable distribution” and to make it easier for people to find “when and where to get the vaccine.”

This backup from businesses comes as states continue to navigate uncertainty around when they’ll receive doses. A patchwork of vaccination eligibility rules and ways to sign up for a shot have left many Americans confused, frustrated and even frightened, as those at high risk of serious complications from the covid virus continue to wait with little news on when they’ll be inoculated.

Washington Gov. Jay Inslee calls private enterprise the “arsenal” of the coronavirus vaccination campaign, comparing the partnership to the production of battleships during World War II, but even Inslee, a Democrat, did not oversell the immediate impact.

“This is not going to be an expectation of an Amazon delivery system,” Inslee said while announcing his state’s plan last week. “There will be times when people will not have dosages available in their community because there isn’t enough being delivered.”

Washington and more than half of all states have opened up vaccines to anyone 65 and older — greatly spiking demand — yet a major hang-up continues to be making use of all the delivered vaccines.

Of the approximately 41 million vaccines delivered to states, more than 19 million have not yet been given, according to data from the Centers for Disease Control and Prevention.

“It’s a dance that requires a lot of complex choreography,” said Alison Buttenheim, an associate professor of nursing and health policy at the University of Pennsylvania.

“We aren’t always so innovative and nimble in public health and this is the moment where we need that — we need innovation and we need states trying different things.”

The Washington state partnership is using Starbucks to streamline the vaccine clinics, Microsoft to provide tech support and space on its campus, and Costco to manage logistics around delivering the shots.

Every state should be looking to its businesses to fill gaps in the vaccination operations, whether around online scheduling, public messaging or the nitty-gritty details of coordinating delivery and clinics, Buttenheim said.

“There’s no one corporate entity that’s going to solve this, but most have something to offer,” she said.

Many public health departments have struggled with making the vaccine process “customer friendly” because they don’t typically provide this kind of direct service, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials (ASTHO), which represents state health directors.

“It has been challenging to scale those kinds of things up,” he said. “Then you add in that public health departments have been dealing with covid for a year, with limited resources and people are tired.”

In North Carolina, Atrium Health, a nonprofit health care system, is part of the business partnership with Honeywell that aims to give 1 million shots by July.

“It allows us as the health care system to focus on what we do best — getting the shots in the arms and making sure people are tolerating it and the aftercare,” said Dr. Scott Rissmiller, Atrium’s executive vice president.

“Our hospitals are full, and it’s the same people that are working in our hospitals that we are needing to redeploy for the vaccines.”

Looking Ahead 

The Biden administration has pledged more transparency around the availability of doses and enlisted the Federal Emergency Management Agency to set up mass vaccination sites, as many as 100 in the next month.

While the pace of vaccination has picked up, public health experts warn the U.S. must move faster as at least one more contagious variant of the virus shows up in a growing number of states and threatens to drive another devastating surge.

A federal partnership with large pharmacies has faced criticism for not moving more quickly. Some states have gone through the majority of their doses, while others have used fewer than half of what’s been delivered.

Public health can get a boost from the private sector, but there are limits to what can be outsourced, said epidemiologist Jennifer Nuzzo of Johns Hopkins University.

“This isn’t just handing somebody a package; this is a clinical encounter,” said Nuzzo.

Data entry involves sensitive personal information, and the actual vaccinators need to be trained and credentialed.

Nuzzo, who has studied the U.S. capacity for mass vaccination, estimates the U.S. will need anywhere from 100,000 to 184,000 people to staff vaccine clinics, of which 17,000 would have to be vaccinators, to meet the Biden administration’s goal of 100 million shots in 100 days.

“I think it would be extraordinarily difficult to just find those vaccinators,” she said.

The private sector may be able to contribute, but Nuzzo cautioned that any partnerships cannot appear to favor the employees of the company.

Last week, Amazon offered to assist the Biden administration on the vaccine rollout and has signaled it hopes to vaccinate its own front-line workers as soon as possible.

The shaky supply has limited the ability of some states to pursue mass vaccine sites, and many providers are still hesitant to schedule vaccines too far in advance. A hospital in Arlington, Virginia, canceled 10,000 appointments after the state changed how it allocates its supply of vaccines.

In Arizona, which has two mass vaccine sites so far, appointments are already booked through February.

Since the early days of the vaccine rollout — when the Trump administration promised 20 million doses before 2021 — the public has received confusing messages about when they’ll be able to get a shot.

States still face the challenge of how to set realistic expectations. Many are ramping up their capacity for giving vaccines, even before the supply has caught up.

“The worry I have is that if we create expectations for how quickly people can get vaccinated and then don’t deliver, people will become perhaps jaded or disappointed or, worse, mistrustful of vaccination efforts,” she said.

More than half of unvaccinated Americans say they need more information about when or where they’ll get vaccinated, according to a national survey from the Kaiser Family Foundation. (KHN is an editorially independent program of KFF.)

At his grocery store in Everett, Wash., Wil Peterson, a cashier, hears this confusion around the vaccine process from his co-workers.

“There’s a lot of information that’s been floating around, so I’m just trying to keep up with the latest developments,” said Peterson, who’s in his 50s and expects his turn to get a shot will come sometime in February.

Peterson worries about catching the virus every day he goes to work and still deals with customers who refuse to wear masks, so he’s eager to get vaccinated.

But he also knows it may not go smoothly, after hearing from a friend who tried to sign up for his shot.

“But the site crashed, so I’m kind of bracing for maybe that happening when I try to do it, but I’m hoping that won’t be the case,” he said.

This story is part of a partnership that includes NPR and KHN, an editorially independent program of the Kaiser Family Foundation.

Americans are dying of covid-19 by the thousands, but efforts to ramp up production of potentially lifesaving vaccines are hitting a brick wall.

Vaccine makers Moderna and Pfizer-BioNTech are running their factories full tilt and are under enormous pressure to expand production or collaborate with other drug companies to set up additional assembly lines. That pressure is only growing as new viral variants of the virus threaten to launch the country into a deadlier phase of the pandemic.

President Joe Biden has said he plans to invoke the Cold War-era authority of the Defense Production Act to provide more vaccines to millions of Americans. Consumer advocates — who had called for Donald Trump to use the Defense Production Act more aggressively as president — are now asking Biden to do the same.

But even forcing companies to gear up production won’t provide much-needed doses anytime soon. Expanding production lines takes time. Establishing lines in repurposed facilities can take months.

“The big problem is that even if you can get the raw material and get the infrastructure set up, how do you get a company that is already producing at maximum capacity to go beyond that maximum capacity?” said Lawrence Gostin, a professor of global health law at Georgetown University.

Ordering the companies to work 24/7 “would be a naïve solution,” said Dr. Nicole Lurie, a senior adviser to the CEO of the Coalition for Epidemic Preparedness Innovations, an international group that finances vaccines for emerging diseases. “They’re probably already doing that to the extent they have the raw materials.”

Lurie added, “If you completely wear people out, mistakes happen. You have to balance speed with quality and safety.”

The technological challenges involved are daunting, and the companies haven’t been forthcoming about what’s needed to overcome any supply shortfalls.

“We don’t know what the holdup is. Is it capacity? Raw materials? People? Glass vials? We just don’t know what the bottleneck is,” said Erin Fox, senior director of drug information and support services at the University of Utah Health Hospitals.

Forcing other companies to start making the vaccines might not work either, Gostin said.

“I’m not sure if Biden could require a private company to transfer its technology to another company,” Gostin said. “That is highly questionable legally. … President Biden’s room for maneuvering isn’t as great as people think.”

Drug companies define “trade secrets” broadly, Fox said. “In general, drug companies don’t have to tell me who is making their product, where it’s made, the location of the factory. … That’s considered proprietary.”

Part of the challenge relates to how these vaccines are made. The first two authorized products use lipid nanoparticles to deliver a snippet of the coronavirus’s genetic material — called messenger RNA, or mRNA — into cells. The viral genes teach our cells how to make proteins that stimulate an immune response to the novel coronavirus.

Messenger RNA is fragile and breaks down easily, so it needs to be handled with care, with specific temperatures and humidity levels.

The vaccines “are not widgets,” said Lurie, who served as assistant secretary for preparedness and response at the Department of Health and Human Services during the Obama administration.

Every step, experts say, to get vaccines to market has its complexities: obtaining raw materials; building facilities to precise specifications; buying single-use products, such as tubing and plastic bags to line stainless steel bioreactors; and hiring employees with the requisite training and expertise. Companies also must pass safety and quality inspections and arrange for transportation.

The Defense Production Act, for instance, would allow the government to commandeer a plant that already has a fermenter — there are plenty in the biotech industry — to expand production. But that’s just the first stage in making an mRNA vaccine and, even then, it would take about a year to get going, said Dr. George Siber, a vaccine expert who is on the advisory board of CureVac, a German mRNA vaccine company.

Companies would first have to do a breathtakingly thorough cleaning to prevent cross-contamination, Siber said. Next, they would need to set up, calibrate and test equipment, and train scientists and engineers to run it. Finally, Siber said, unlike a drug, whose components can be tested for purity, there’s no way to be sure a vaccine produced in a new facility is what it claims to be without testing it on animals and people.

“Making vaccines is not like making cars, and quality control is paramount,” said Dr. Stanley Plotkin, a vaccine industry consultant credited with inventing the rubella vaccine. “We are expecting other vaccines in a matter of weeks, so it might be faster to bring them into use.”

However, even that will require patience. Johnson & Johnson, expected to announce clinical trial results this month, has said that it won’t be able to deliver as many shots as planned because of manufacturing delays. The company did not confirm a manufacturing delay and declined to respond to questions.

AstraZeneca’s vaccine, also funded in part by U.S. taxpayers, is in use already in the United Kingdom and India, but the Food and Drug Administration has raised questions about its late-stage trial, so it may not be available here until the spring.

Novavax, another U.S.-funded vaccine maker, has been plagued by delays and only recently began recruiting volunteers for its big trial. Merck, the most recent company to get federal support for covid vaccines, announced Monday it was scrapping its two candidates after they failed to produce adequate immune response in early tests.

“None of the vaccine makers are manufacturing at the volume they ultimately want to be at,” Lurie said. “They all have manufacturing delays.”

Pfizer, which has committed 200 million doses to the U.S. government by the end of July, said last week it expected “no interruptions” in shipments from its primary U.S. covid manufacturing plant in Kalamazoo, Michigan. Pfizer spokesperson Sharon Castillo said the company has expanded manufacturing facilities and added more suppliers and contract manufacturers. Those efforts, and the company’s announcement that its five-dose vials actually contain an extra dose, mean “we can potentially deliver approximately 2 billion doses worldwide by the end of 2021.”

The U.S. government also has an option to acquire another 400 million doses of the Pfizer-BioNTech vaccine, though the company declined to provide details on that option when asked.

But countries around the world are competing for the same supplies and raw materials, Gostin said.

Biden could use the Defense Production Act “to force Pfizer to prioritize U.S. contracts, but that would be politically risky,” given that other countries could retaliate by hoarding supplies. Although Pfizer is an American company, it has partnered with BioNTech, of Germany, to make covid its vaccine. “That would lead to a global mess.”

Trying to corner the world market on vaccine ingredients or supplies would look bad, experts say, given that the United States just this week joined Covax, an international venture to source and distribute vaccines, in an effort to ensure poor countries aren’t left behind.

Paradoxically, the rush to get vaccines to market may have resulted in a less efficient manufacturing process.

Vaccine companies typically spend months making their factories run as efficiently as possible, as well as finding an ideal dose and the most effective interval between doses, Lurie said. Given the urgency of the pandemic, however, they delayed parts of this process and launched straight into mass production.

Pfizer angered European countries last week when it paused vaccine production at a Belgian plant to upgrade its capacity. Pfizer said the weeklong closure would decrease vaccine deliveries to Europe for three to four weeks before boosting supplies in February. The move doesn’t affect U.S. vaccine supplies.

“The U.S can’t necessarily readily access stuff that’s being held for vaccines in other countries,” Lurie said.

And forcing other companies to make covid vaccines could jeopardize production of other important shots, such as measles, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Routine childhood immunization rates have fallen during the pandemic, raising the risk of epidemics.

Using the act to prioritize covid vaccine manufacturing has already disrupted supplies of at least one drug, Fox noted. In December, Horizon Therapeutics warned doctors and patients to expect a shortage of a drug called Tepezza, used to treat thyroid-related eye disease, because its manufacturer was ordered to prioritize covid shots.

Lawmakers and consumer advocates such as Public Citizen called on the government to use the Defense Production Act more aggressively. In a letter sent earlier this month, Sen. Elizabeth Warren (D-Mass.) and Rep. Katie Porter (D-Calif.) said Moderna should share its technique for stabilizing its vaccine at normal refrigerator temperatures, without “ultracold” freezers.

Moderna officials have said the intrinsic differences in the two companies’ mRNA material make that technology hard to share. Besides, they say, Pfizer has declined to share data with Moderna. Pfizer has declined to comment on the issue.

Since Moderna’s effort is federally funded, the government presumably has march-in rights and could take over production, said Mike Watson, former president of Moderna subsidiary Valera, in an email. “The reality is that however far you push production capacity, you sooner or later reach a bottleneck.”

Experts say it’s not as simple as demanding that glassmaker Corning step up and make glass vials, for example. Of course, the vials will need to meet rigorous requirements. But there’s also this: The U.S. is facing a shortage of mined sand, the main component needed to make glass vials.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

SACRAMENTO — As intensive care units filled and coronavirus cases surged over the holidays, Carmela Coyle invoked a World War II-era quote attributed to British Prime Minister Winston Churchill to rally her own troops: “If you’re going through hell, keep going.”

Coyle is head of the California Hospital Association, and her “troops” are the highly paid hospital executives she represents. Throughout the pandemic, as in the December memo in which she quoted Churchill, she has employed battlefield rhetoric to galvanize their massive political and financial clout.

That’s because Coyle believes hospitals are quite simply “in battle conditions” — a sentiment she has impressed upon the state’s top health care officials.

While Coyle, 60, is unknown to many Californians, she is a power player in the state Capitol, one whose profile and influence have grown in the past year. She has used her position as president and CEO of the association to lobby for the multibillion-dollar hospital industry, including asking officials to temporarily relax guidelines intended to safeguard patients and workers.

Along the way, she has been granted personal access to Gov. Gavin Newsom and other top officials, helping shape the state’s response to covid-19.

“Having spent many, many hours embedded with the Governor’s team in the state’s Office of Emergency Services, everyone is working 18-plus hours a day,” she wrote to hospital executives in March, “and the dedication to supporting what hospitals need to do their jobs is impressive.”

Though she hasn’t won every battle, Coyle has scored some big wins for the industry.

She successfully petitioned the Newsom administration to relax nurse-to-patient ratios and allow health care workers exposed to the coronavirus to continue to work — critical but contentious rule changes intended to keep hospitals staffed that were approved over union objections.

When hospitals started to fill with covid patients last summer, Newsom agreed with Coyle that hospitals could care for them while also performing moneymaking elective surgeries, which hospitals had voluntarily canceled in the spring.

Newsom invited her to a July press briefing to explain that logic to the public. At the briefing, he described Coyle as an “outstanding partner” and a leader with a “seriousness of purpose.”

“I just can’t thank her enough, more publicly than I have in the past, but I need to repeat it yet again,” Newsom said. “We’re all being put to the test, particularly our hospital system at this moment.”

That Coyle, a relative newcomer to Sacramento politics, is such an influential advocate in the Capitol comes partly with the job. She represents more than 400 hospitals that provide not just critical care, but also jobs to Californians in every corner of the state.

In the first three quarters of 2019, California’s hospitals earned about $101.7 billion in net patient revenue, according to financial data filed with the Office of Statewide Health Planning and Development. During the same time last year, they earned about $97.6 billion — representing a 4% decline — despite the loss of elective surgeries and a drop in emergency room visits early in pandemic.

The California Hospital Association is a health care heavyweight in Sacramento, along with the doctors’ lobby, the dialysis industry and others. It spent nearly $5.3 million on lobbying from Jan. 1, 2019, to Sept. 30, 2020, and $4.3 million to support state and local political campaigns, according to filings with the California secretary of state’s office.

In 2019, the association paid Coyle $1.4 million, it said.

“The hospitals are such a big player that you have to be working with them,” especially during a public health outbreak, said David Panush, a Sacramento health care policy consultant who worked in state government for 35 years.

Coyle also has the ear of Mark Ghaly, secretary of the state Health and Human Services Agency. Ghaly and Coyle have corresponded often since March — sometimes multiple times a day — by phone and email about the state’s response to the pandemic, according to emails obtained by California Healthline.

For instance, in March, Coyle shared a letter with Ghaly that she had sent to hospital executives, in which she warned them — and by extension, him — that “we are in battle conditions, and it’s all hands on deck to turn the tide.”

In other letters and emails, Coyle pressed Ghaly to allow health care workers exposed to the virus to continue working as long as they didn’t show symptoms. Newsom later issued the rule in an executive order.

“Nurses are the heartbeat of the hospital,” said Stephanie Roberson, government relations director of the California Nurses Association — whose leaders, unlike Coyle, have not been invited into the governor’s state operations center since it was activated in March. “Instead, we have someone who basically represents the opposite of nursing interests standing alongside the governor discussing the importance of public health.”

In a recent statement, Ghaly said the pandemic has required the state to work not only with hospitals but also with doctors, nurses, public health departments, nursing homes, laboratories and emergency services agencies to save lives.

“I am grateful to Carmela and our hospital partners for their tremendous work, particularly during this current surge when hospitals are overwhelmed with patients and intensive care units are filled,” Ghaly said.

It took the administration six months to direct hospitals to test health care workers for covid at least once a week after requiring nursing homes to do so — a testament, critics say, to the hospital industry’s political and economic impact.

“The association exists to increase profits for hospitals, increase the bottom line,” said Sal Rosselli, president of the National Union of Healthcare Workers. The union lobbied for the mandatory testing rule, which took effect in December. “That’s why they oppose every patient care advocacy issue, every worker issue.”

Coyle countered that hospitals have no choice but to make trade-offs while they provide crisis care. She emphasized that the hospitals’ requests for exemptions are temporary.

“If we don’t flex some of these requirements, it means that people will not get the care they need and, worse, people may die,” she said at a news conference earlier this month.

Coyle, a Minnesota native, is known for her intelligence and the expertise she has honed working on health care policy for more than 30 years.

As head of the Maryland Hospital Association for nine years before she took the California job in 2017, Coyle built a reputation as a consensus builder even as she looked out for her constituency. For instance, she cultivated relationships with Maryland’s congressional delegation and lobbied it for federal funding in 2014 to help the state’s hospitals prepare for and treat Ebola patients, most of whom were American health care workers who had contracted the virus in Africa.

“She really understood the old maxim that there’s no such thing as permanent friends or permanent enemies. There are only permanent interests,” said Stan Dorn, a senior fellow at the advocacy group Families USA, who previously served on a Maryland commission on health care costs with Coyle. “She understood that it’s good to have good relationships with everybody because you never know, day after tomorrow, who is going to be important to your cause.”

Along with her credentials comes a strong streak of determination. After Coyle graduated from Minnesota’s Carleton College with degrees in economics and Spanish literature, she worked at a Washington, D.C., flower shop until the Congressional Budget Office offered her a two-year internship. She had called to check on her application every Friday for three months.

Coyle “was raised to know” such perseverance as she grew up in a working-class family, the daughter of a Colombian immigrant father.

“Kids teased me and called me names when I was a kid, my father being dark-skinned and having a heavy accent,” Coyle said. “I was dark-skinned as well, and they just thought we were so strange.”

Laughed at for the way her father spoke, Coyle today unabashedly harnesses the power of language to sway government officials and public opinion — and to marshal her own hospital forces to lobby “with one voice.”

#SB977 would give California’s AG unprecedented decision-making authority over your health care. Tell #CAleg to support access to quality health care. #NoOnSB977 pic.twitter.com/6ch0svvqeu

— California Hospital Association (@CalHospitals) August 31, 2020

In the waning days of last year’s legislative session, Coyle warned hospital executives of the battles before them in the Capitol: bills that would come with hefty costs to hospitals should they pass.

In the end, the industry succeeded in blocking a bill that would have made it harder for hospitals to consolidate. But they didn’t get legislative approval to delay seismic retrofits at hospitals, as they had wanted. Lawmakers also passed a bill opposed by hospitals that requires them to maintain a 45-day stockpile of personal protective equipment, which Coyle had argued was unreasonable given that it has been in short supply.

“They’re not all-powerful, but certainly they’re influential,” said state Sen. Richard Pan (D-Sacramento), who chairs the Senate Health Committee. “And during covid, they’re taking care of patients. They’re the ones saving the lives of people who are intubated.”

When Coyle readied her troops for the legislative fights, she acknowledged they weren’t going to win every battle. She borrowed another World War II quote, this time from Gen. Douglas MacArthur, to explain to hospital executives that they may need to compromise.

“In war, you win or lose, live or die,” she wrote. “And the difference is just an eyelash.”

California Healthline correspondent Angela Hart and KHN data editor Elizabeth Lucas contributed to this report.

Methodology

To compile total contributions from the California Hospital Association, California Healthline analyzed filings from two committees, both controlled by the association: the California Hospitals Committee on Issues and the California Hospital Association PAC.

To assess California hospitals’ net patient revenue, California Healthline analyzed quarterly financial data reported to the Office of Statewide Health Planning and Development. We summed the “total net patient revenue” for all hospitals that filed reports in each of the first three quarters of 2019 and 2020, and excluded any that reported only sporadically (representing less than 1% of revenue).

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Anti-vaccine groups are exploiting the suffering and death of people who happen to fall ill after receiving a covid shot, threatening to undermine the largest vaccination campaign in U.S. history.

In some cases, anti-vaccine activists are fabricating stories of deaths that never occurred.

“This is exactly what anti-vaccine groups do,” said Dr. Peter Hotez, an infectious diseases specialist and author of “Preventing the Next Pandemic: Vaccine Diplomacy in a Time of Anti-Science.”

Anti-vaccine groups have falsely claimed for decades that childhood vaccines cause autism, weaving fantastic conspiracy theories involving government, Big Business and the media.

Now, the same groups are blaming patients’ coincidental medical problems on covid shots, even when it’s clear that age or underlying health conditions are to blame, Hotez said. “They will sensationalize anything that happens after someone gets a vaccine and attribute it to the vaccine,” Hotez said.

As more seniors receive their first covid shots, many will inevitably suffer from unrelated heart attacks, strokes and other serious medical problems — not because of the vaccine but, rather, their age and declining health, said epidemiologist Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy.

For example, in a group of 10 million people — about the number of Americans who have been vaccinated so far — nearly 800 people ages 55 to 64 typically die of heart attacks or coronary disease in one week, Osterholm said. Public health officials “are not ready” for the onslaught of news and social media stories to come, he cautioned.

“The media will write a story that John Doe got his vaccine at 8 a.m. and at 4 p.m. he had a heart attack,” Osterholm said on his weekly podcast. “They will make assumptions that it’s cause and effect.”

Public health officials need to do a better job communicating the risks — real and imagined — from vaccines, said Osterholm, who has been advising President Joe Biden on the pandemic since his election.

“You get one chance to make a first impression,” Osterholm said. “Even if we come back later and say, “No, [the deaths] had nothing to do with vaccination, it was coronary artery disease,’ the damage has already been done.”

Anti-vaccine groups such as the National Vaccine Information Center and Children’s Health Defense, founded by Robert F. Kennedy Jr., are already inflaming fears about a handful of deaths — mostly in Europe — that have followed the worldwide rollout of immunizations.

In a blog post, Kennedy scoffed at autopsy results that concluded a Portuguese woman’s death was unrelated to a vaccine. He cast doubt on statements by medical authorities in Denmark who said the deaths of two people there after vaccination were due to old age and chronic lung disease. In an interview, Kennedy said the post-vaccination deaths of some very frail and terminally ill nursing home patients in Norway are a danger sign. Norwegian officials have said the elderly patients died of their underlying illnesses, not from the vaccine.

“Coincidence is turning out to be quite lethal to COVID vaccine recipients,” Kennedy wrote. Kennedy described the deaths as suspicious, accusing medical officials of following an “all-too-familiar vaccine propaganda playbook” and “strategic chicanery.”

Here in the U.S., vaccine opponents have pounced on the tragedy of Dr. Gregory Michael, a 56-year-old Florida obstetrician-gynecologist, to sow doubts about vaccine safety and government oversight. Michael died Jan. 5 after suffering a catastrophic drop in platelets — elements in the blood that control bleeding — suggesting he may have developed immune thrombocytopenia..

According to a Facebook post by his wife, Heidi Neckelmann, doctors tried a variety of treatments to save her husband, but none worked.

A spokesperson for the Centers for Disease Control and Prevention said the agency is investigating Michael’s death, as it does for all suspected vaccine-related health problems. California authorities have recommended pausing vaccinations with a particular batch of covid vaccines made by Moderna because of a high rate of allergic reactions.

“We’re going to see these events happen, and we have to follow up on every one of these cases,” Osterholm said. “I don’t want people to think that we’re sweeping them under the rug.”

Many Americans were already nervous about covid vaccines, with 27% saying they “probably or definitely” would not get a shot, even if the shots were free and deemed safe by scientists, according to a December survey by KFF. (KHN is an editorially independent program of KFF.)

These people may be particularly susceptible to vaccine misinformation, said Rory Smith, an investigator at First Draft News, a nonprofit that reports on misinformation online.

A Rare Condition

Seven experts in blood disorders interviewed by KHN said there’s not enough information available to blame Michael’s decline on a vaccine and that the demonstrated benefits of covid vaccinations vastly outweigh any potential risk of bleeding. Even if investigators conclude that Michael’s vaccine caused his death, it would still be an incredibly rare event, given that more than 12 million doses have been administered.

“It shouldn’t give anyone pause about whether the vaccine is safe or not,” said Dr. James Zehnder, a hematologist and director of clinical pathology at Stanford Medicine.

Michael’s bleeding disorder could have been developing silently for some time, said Dr. Adam Cuker, director of the Penn Blood Disorders Center at the Hospital of the University of Pennsylvania. It could be a coincidence that Michael started showing symptoms shortly after vaccination, he said. About 30 Americans are diagnosed with immune thrombocytopenia every day.

The timing of Michael’s illness suggests it had another cause, doctors said. According to his wife’s Facebook post, his bleeding problems began three days after his first covid shot. It takes the body 10 to 14 days after vaccination to generate antibodies, which would be needed to cause immune thrombocytopenia, said Dr. Cindy Neunert, a pediatric hematologist at the Columbia University Irving Medical Center in New York City.

In most cases, the cause of thrombocytopenia is never known, said Dr. Deepak Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston.

Immune thrombocytopenia is linked, rarely, to certain vaccines, with about 26 cases for every 1 million doses of measles-mumps-rubella vaccine.

But it can also be caused by viruses themselves, including measles and the novel coronavirus, said Dr. Sven Olson, an assistant professor of hematology-medical oncology at Oregon Health & Science University’s school of medicine.

Many patients with immune thrombocytopenia are now wondering if they should be vaccinated against covid, Cuker said. Cuker said he urges nervous patients to be vaccinated, noting that any problems could be managed by closely monitoring their platelet levels and adjusting medication if needed.

Even in patients with underlying bleeding conditions, “it’s still safer to get vaccinated than to get covid,” Zehnder said.

“If you give a vaccine to a large enough number of people, there are going to be rare adverse events but there are also going to be coincidental events unrelated to the vaccine,” Cuker said. “If an anti-vaccine group uses a single case, where no link has been proven, to discourage people from vaccination, that’s terrible.”

Barbara Loe Fisher, president of the National Vaccine Information Center, said her site provides balanced information from reputable news sources, including CNN, CBS and the Miami Herald, as well as Pfizer and the CDC.

In an interview with KHN, Kennedy said he questions why government officials have been so quick to dismiss connections between vaccinations and deaths. “How in the world do they know if it’s a vaccine injury or not?” he asked.

“We don’t discourage anybody from getting vaccinated,” Kennedy said. “All we’re doing is conveying the data, which is what the government should be doing. … We print the truth, which is what the medical agencies ought to do.”

Alternative Facts?

Opponents of vaccination have belittled concerns about the novel coronavirus for months, opposing masks and fighting stay-at-home orders and contact tracing, said Richard Carpiano, a professor of public policy and sociology at the University of California-Riverside.

“They have come out against every public health measure to control the pandemic,” Carpiano said. “They have said public health is public enemy No. 1.”

Recently, anti-vaccine activists have been so eager to discredit immunizations that they have blamed covid for the deaths of people who are very much alive.

Social media users selectively edited a video of a Tennessee nurse, Tiffany Dover to make it appear as if she dropped dead after being vaccinated, when in fact she simply fainted, said Dorit Reiss, a professor at the UC Hastings College of Law in San Francisco. Although Dover quickly recovered, social media users posted a fake death certificate and obituary. Anti-vaccine activists also harassed Dover and her family online, said Reiss, who chronicled Dover’s ordeal in a blog post.

Anti-vaccine activists are adept at manipulating video, Smith said.

“They are notorious for using videos and images purportedly showing the adverse effects of vaccines, such as autism in children and seizures in other vaccine recipients,” Smith said. “The more emotive and graphic the videos and images — irrespective of whether it’s actually linked at all to vaccines or not — the better.”

In December, multiple Facebook posts falsely claimed that an Alabama nurse died after receiving one of the state’s first covid vaccines. One Twitter user went so far as to identify the nurse as Jennifer McClung, who worked at Helen Keller Hospital in Sheffield, Alabama. In fact, McClung died of covid. Social media posts spread so widely that Alabama health department officials contacted every hospital in the state to confirm that no vaccinated staff member had died.

Anti-vaccine groups often build fables around “a tiny, tiny grain of truth,” Smith said. “This is why misinformation, specifically vaccine misinformation, can be so convincing. … But this information is almost always taken completely out of context, creating claims that are either misleading or outright false.”

The Ron Paul Institute for Peace and Prosperity twisted a news story about the deaths of 24 people at an upstate New York nursing home, incorrectly blaming their deaths on covid vaccinations. The original article noted, however, that a covid outbreak at the nursing home began in late December, before residents received any vaccines. Covid vaccines, which require two doses for full protection, did not arrive in time to save the residents’ lives.

Kennedy repeated the misinformation — again incorrectly blaming the residents’ deaths on vaccines — in his blog, although he linked to a local news station that reported the information correctly.

Distorting facts to discourage vaccination, Cuker said, is “very irresponsible and damaging to public health.”

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

This story also ran on Los Angeles Times. It can be republished for free.

California Gov. Gavin Newsom, under growing pressure to jump-start a faltering covid-19 vaccine rollout, jetted to Los Angeles on Jan. 15 to unveil a massive new vaccination site at Dodger Stadium that is expected eventually to inoculate 12,000 people a day.

The city-run venue had been the biggest covid testing site in the U.S., administering over 1 million tests in its nearly eight months of operation — and over 10,000 a day during the recent surge. Its redeployment to the cause of vaccination, Newsom declared, provides “an extraordinary world-class site for a world-class logistics operation.”

That effort came with a trade-off: When the city of Los Angeles ended covid tests at Dodger Stadium and closed another testing site to help staff the new vaccination center, it removed, at least temporarily, about one-third of all government-run testing in Los Angeles County — the nation’s largest county, with a population of 10 million, and one of the biggest covid hot spots.

Sites operated by the city, county or state account for just over one-third of all covid tests in L.A. County, said Dr. Clemens Hong, who heads the county’s testing operations.

Diminished testing capacity could lead to longer waits for appointments, which means infected people could potentially expose others for a longer time before learning they have the virus.

But L.A. Mayor Eric Garcetti said that has not happened so far. In what he called an instance of “perfect timing,” infection rates in L.A. County have declined since Dodger Stadium switched to vaccinations, and demand for tests has dropped by half to two-thirds, the mayor said Thursday. “We are meeting the need — actually exceeding the need.”

Still, he acknowledged that converting the stadium had been a risk – one the city took because “the vaccines will prevent and heal and finally resolve this.”

Many health experts agree that prioritizing vaccination over testing is the right move.

“The best way out of our current crisis is masks, few contacts per day and vaccines, so it makes sense to create lots more access points for vaccinations even if it means a bit less testing,” said Dr. Bob Kocher, a senior fellow at the University of Southern California’s Schaeffer Center for Health Policy & Economics and a former member of the state’s COVID-19 Testing Task Force.

But with covid caseloads still high despite their recent decline from peak levels, and mutant strains of the virus threatening to fuel new outbreaks, some senior public health officials say testing remains an equally vital part of the effort to contain — and ultimately suppress — the pandemic.

And it could become even more important in the coming months, as the inoculation campaign gains steam, since the tests could prove a valuable tool for assessing how well the vaccines are working.

“It’s hard to say right now, given how many people are sick with covid, that vaccine is more important,” said Hong. “It’s hard to balance those two against each other, because we really just need a lot of both.”

Balancing vaccinations with testing and other covid-related tasks is a significant challenge for public health officials across California and the nation, because those functions draw on many of the same resources — especially the staff needed for administration and record-keeping.

At vaccination sites, keeping good records is essential for planning from day to day how many doses to pull out of the freezer. “It’s got to be done right, or else you screw up when the second dose is,” said Dr. George Rutherford, an epidemiologist at the University of California-San Francisco.

Sara Bosse, public health director of Madera County, noted that counties across the state have asked Newsom for $400 million in the current budget year to help defray the costs of setting up vaccination sites, including facility costs, security, data entry staffers and clinicians to give the shots and watch for adverse side effects. They are also seeking $280 million for covid testing and $440 million for contact tracing and non-group housing to protect covid-vulnerable residents.

“I think that many counties are prioritizing vaccination, and based on the resources they have, they may pull from various parts of the covid response such as contact tracing or testing,” Bosse said. The funding, she said, would help county health officials avoid “those difficult decisions where we have to pull from one part of the covid response to prop up the next.”

There could also be federal help on the way: President Joe Biden has announced plans to establish 100 federally supported vaccination centers and allocate $50 billion to expand testing.

In Madera County, a poor rural area of 160,000 people that stretches from the Central Valley into the Sierra Nevada, the state has largely taken over covid testing, allowing the county to focus its resources on vaccinations, Bosse said.

The big challenge on that front, she said, is having enough trained health personnel to run the vaccination sites. The county recently heard from 85 trained clinicians willing to volunteer for the vaccine effort, “which is going to be a game changer for us,” Bosse said.

In Los Angeles, the city has the means to add testing capacity elsewhere and beef up mobile testing, Garcetti said. It had been considering a testing site at Pierce College in the San Fernando Valley, “which it looks like we won’t need to open,” the mayor said.

The city, county and state are also discussing the possibility of a partnership to expand testing at Exposition Park in South L.A.

In San Diego County, health officials expect to face a challenge due to the competition for staffing between vaccination and testing, and they are hiring to meet the need, said Sarah Sweeney, a spokesperson for the county’s Health and Human Services Agency. The county hasn’t yet converted testing venues to vaccination sites but expects to do so after vaccine supplies increase, she said.

San Bernardino County health officials are committed to maintaining testing at current volumes even as they ramp up vaccinations, said Corwin Porter, the director of public health. But he conceded that doing both at the same time “is a struggle” because “we don’t have enough vaccine and we don’t have enough staff.”

The county is holding hiring events every week and working with multiple partners to find additional resources, “because we are trying not to pull anything out of testing or contact tracing,” Porter said.

Beyond the resource question, another big challenge confronts health officials: “There is an issue of divided attention,” said L.A. County’s Hong. “Now we have two big things to deal with — three if you include contact tracing. I think we will have to be thoughtful about our strategy.”

Once a broad swath of the population has been vaccinated, which could take many months, testing volume will likely drop off sharply, said UCSF’s Rutherford.

“I don’t see hundreds of thousands of tests a day anymore once we get well up on vaccinations,” he said. “You’ll be testing thousands of people to find tens of cases.”

In the meantime, L.A. County will likely add questions to its testing appointment website asking people about their vaccination status, Hong said. “That way we can track what’s happening in people who are vaccinated.”

Ongoing covid outbreaks may require increased testing, particularly in poorer communities of color, which have been hit hardest by the pandemic — and where hesitancy to be vaccinated is likely to be more widespread, said Hong. “So the bottom line is that testing is not going away.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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