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Is Paxlovid, the Covid Pill, Reaching Those Who Most Need It?

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Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

As the nation largely abandons mask mandates, physical distancing, and other covid-19 prevention strategies, elected officials and health departments alike are now championing antiviral pills. But the federal government isn’t saying how many people have received these potentially lifesaving drugs or whether they’re being distributed equitably.

Pfizer’s Paxlovid pill, along with Merck’s molnupiravir, are aimed at preventing vulnerable patients with mild or moderate covid from becoming sicker or dying. More than 300 Americans still die from covid every day.

National supply counts, which the Biden administration has shared sporadically, aren’t the only data local health officials need to ensure their residents can access the treatments. Recent federal changes designed to let large pharmacy chains like CVS and Walgreens efficiently manage their supplies have had an unintended consequence: Now many public health workers are unable to see how many doses have been shipped to their communities or used. And they can’t tell whether the most vulnerable residents are filling prescriptions as often as their wealthier neighbors.

KHN has repeatedly asked Health and Human Services officials to share more detailed covid therapeutic data and to explain how it calculates utilization rates, but they have not shared even the total number of people who have gotten Paxlovid.

So far, the most detailed accounting has come from the drugmakers themselves. Pfizer CEO Albert Bourla reported on a recent earnings call that an estimated 79,000 people received Paxlovid during the week that ended April 22, up from 8,000 a week two months earlier.

Unlike covid vaccinations or cases, HHS doesn’t track the race, ethnicity, age, or neighborhood of people getting treatments. Vaccination numbers, initially published by a handful of states, allowed KHN to reveal stark racial disparities just weeks into the rollout. Federal data showed that Black, Native, and Hispanic Americans have died at higher rates than non-Hispanic white Americans.

Los Angeles County’s Department of Public Health has worked to ensure its 10 million residents, especially the most vulnerable, have access to treatment. When Paxlovid supply was limited in the winter, officials there made sure that pharmacies in hard-hit communities were well stocked, according to Dr. Seira Kurian, a regional health officer in the department. In April, the county launched its own telehealth service to assess residents for treatment free of charge, a model that avoids many of the hurdles that make treatment at for-profit pharmacy-based clinics difficult for uninsured, rural, or disabled patients to use.

But without federal data, they don’t know how many county residents have gotten the pills.

Real-time data would show whether a neighborhood is filling prescriptions as expected during a surge, or which communities public health workers should target for educational campaigns. Without access to the federal systems, Los Angeles County, which serves more residents than the health departments of 40 entire states, has to use the limited public inventory data that HHS publishes.

That dataset contains only a slice of information and in some cases shows months-old information. And because the data excludes certain types of providers, such as nursing homes and Veterans Health Administration facilities, county officials can’t tell if patients there have taken the pills.

Because so little data is available, Kurian’s team created its own survey, asking providers to report the ZIP codes of patients who have received the covid therapies. With the survey, it’s now easier to figure out which pharmacies and clinics need more supplies.

But not everyone completes it, she said: “Oftentimes, we have to still do some guesstimating.”

In Atlanta, staff at Good Samaritan Health Center would use detailed information to direct low-income patients to pharmacies with Paxlovid. Though the drug wasn’t readily available during the first omicron surge, the next one will be “a new frontier,” said Breanna Lathrop, the center’s chief operating officer.

Ideally, she said, her staff would be able to see “everything you need to know in one spot” — including which pharmacies have the pills in stock, when they’re open, and whether they offer home delivery. Student volunteers built the center a similar database for covid testing earlier in the pandemic.

Paxlovid and molnupiravir became available in the U.S. in late December. They have quickly become the go-to treatments for non-hospitalized patients, replacing nearly all the monoclonal antibody infusions, which are less effective against current covid strains.

Though the government doesn’t record Paxlovid use by race and ethnicity, researchers tracked those trends for the first-generation infusions.

Amy Feehan, co-author of a CDC-funded study and a clinical research scientist at Ochsner Health in Louisiana, found that Black and Hispanic patients with covid were significantly less likely than white and non-Hispanic patients to receive those initial outpatient treatments. Other researchers found that language difficulties, lack of transportation, and not knowing the treatments existed all contributed to the disparities. Feehan’s study, using data from 41 medical systems, found no large discrepancies for hospitalized patients, who didn’t have to seek out the drugs themselves.

Patients at Atlanta’s Good Samaritan Health Center often don’t know that if they get tested quickly they can receive treatment, Lathrop said. Some assume they don’t qualify or can’t afford it. Others wonder if the pills work or are safe. There are “just a lot of questions in people’s minds,” Lathrop said, about whether “it benefits them.”

When Dr. Jeffrey Klausner was a deputy officer at the San Francisco Department of Public Health, “our first priority was transparency and data sharing,” he said. “It’s important to build trust, and to engage with the community.” Now a professor at the University of Southern California, he said federal and state officials should share the data they have and also collect detailed information about patients receiving treatment — race, ethnicity, age, illness severity — so that they can correct for any inequities.

Public health officials and researchers who spoke with KHN said that HHS officials may not think the data is accurate or have adequate staff to analyze it. The head of HHS’ therapeutics distribution effort, Dr. Derek Eisnor, suggested as much during an April 27 meeting with state and local health officials. One local official asked the federal agency to share local numbers so they could increase outreach in communities with low usage. Eisnor responded that because HHS doesn’t require providers to say how much they use, the reporting “is kind of mediocre at best,” adding that he didn’t think it was his agency’s role to share that information.

Eisnor also said that state health departments should now be able to see local orders and usage from pharmacy chains like CVS, and that the agency hopes to soon release weekly national data online. But counties like Los Angeles — which has requested access to the federal systems with no success — still don’t have access to the data they need to focus outreach efforts or spot emerging disparities.

Spokesperson Tim Granholm said that HHS is looking into ways to share additional data with the public.

Recordings of the weekly meetings, in which HHS officials share updates about distribution plans and answer questions from public health workers, pharmacists, and clinicians, were posted online until March. HHS’ media office has since repeatedly declined to grant KHN access, saying “the recordings are not open to press.” That’s because HHS wants to encourage open conversation during the meetings, according to Granholm. He did not say what legal authority allows the department to bar media from the public meetings. KHN obtained the public records through Freedom of Information Act requests.

A senior White House official said that the Biden administration is attempting to collect accurate data on how many people receive Paxlovid and other treatments but said it doesn’t define success by how many people do so. Its focus, the official said, is on making sure the public knows treatments are available and that doctors and other providers understand which patients are eligible for them.

We still need to know where the pills are going, Feehan said. “We need that data as soon as humanly possible.”

Until then, Los Angeles County’s Kurian and her peers will keep “guesstimating” where residents need more help. “If someone can just give us a report that has that information,” she said, “of course, that makes it easier.”

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Charts Paint a Grim Picture 2 Years Into the Coronavirus Pandemic

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Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

The coronavirus pandemic is now stretching into its third year, a grim milestone that calls for another look at the human toll of covid-19, and the unsteady progress in containing it.

The charts below tell various aspects of the story, from the deadly force of the disease and its disparate impact to the signs of political polarization and the United States’ struggle to marshal an effective response.


 

Covid rocketed up the list of leading killers in the U.S. like nothing in recent memory. The closest analogue was HIV and AIDS, which ranked among the top 10 causes of death from 1990 to 1996. But even HIV/AIDS never reached higher than eighth on that list.

By contrast, covid shot up to third in 2020, its first year of existence, covering only about nine months of the pandemic. Only heart disease and cancer killed more Americans that year.

“The leading causes of death are relatively stable over long periods of time, so this is a very striking result,” said Dr. William Schaffner, a professor of preventive medicine and health policy at Vanderbilt University.



 

Covid generally hit people of color harder, a pattern experts trace back to historical disparities in income, geography, medical access, and educational attainment.

“This tells us something about our society — it’s a kind report card,” Schaffner said. Studies have shown that illness and prevention are even more strongly correlated with educational background than with income.

“There was some effort to correct the disparities,” said Arthur Caplan, a professor of bioethics at New York University’s Grossman School of Medicine. “But these were band-aids on a system that remains broken.”



 

Older people tend to be more vulnerable to disease than younger people, because of weaker immune systems and underlying health problems. That’s been especially true with covid.

“Many other infections affect the very young and the very old disproportionately, but covid-19 stands out in being so age-dependent,” said Dr. Monica Gandhi, a professor of medicine at the University of California-San Francisco. “Children were remarkably spared from severe disease in the U.S., as they were worldwide.”

Deaths among older Americans, however, were especially widespread in the early days of the pandemic due to the close contact of seniors living in nursing homes.

“Some will argue that [the] old are frail anyway, but I find that morally repugnant,” Caplan said. The deaths of so many older people “makes me extremely sad.”



 

The good news, experts say, is that older Americans were the most likely to get vaccinated, with a 91% full vaccination rate for those between ages 65 and 74. This almost certainly prevented many deaths among older people as the pandemic ground on, Schaffner said.



 

Although the pandemic has had its peaks and valleys, due to largely seasonal factors and the emergence of new variants, it has continued to produce deaths at a fairly steady rate since its beginning two years ago.

The pandemic is “impressive in how it just keeps going,” Schaffner said.

The slow grind is “why we’re exhausted,” Caplan said. “It’s like we can’t make a significant dent, no matter what we do.”



 

There have been five distinct peaks: the initial one in April 2020, a summer spike in August 2020, a winter spike in January 2021, the initial outbreak of the delta variant in September 2021, and the omicron surge in January 2022.

The on-off nature of the pandemic “has led to a lot of the confusion and grumpiness,” Schaffner said. Caplan compared it to the exhaustion of the American public when hearing body counts during the Vietnam War.

Once a natural disaster like a hurricane or a tornado has passed, Schaffner added, it’s gone and people can rebuild. With covid, it’s just been a matter of time before the next wave arrives. The coronavirus also affected the whole world, unlike a localized disaster.

Such factors “stretched the capacity of the public health system and our governance,” Schaffner said.



 

Not surprisingly, the number of deaths in each state was heavily dependent on the size of the state’s population. California and Texas each lost more than 80,000 people to covid, while Vermont lost 546.



 

But once you adjust for population, distinct differences emerge in how various states fared during the pandemic.

The seven states with the worst death rates include densely populated New Jersey, an affluent, educated Northeast state, and Arizona, a fairly diverse Southwestern state. The other five are Southern states that rank among the 11 states with the lowest levels of educational attainment and median income: Mississippi, Alabama, Louisiana, Tennessee, and West Virginia.

Among the states with the lowest death rates, Hawaii and Alaska (and, to an extent, Vermont and Maine) are isolated and may have had an easier time keeping the virus out.

“For all the grumbling you hear about federal mandates and enforcement, you can’t help but look at this list and see that the pandemic has been handled state by state,” Caplan said.



 

The world’s performance in battling covid is analogous to the United States’: Some places did it well, and others did not.

And in the international context, the United States’ record was not so hot.

When comparing death rates around the world, it’s clear how much worse the U.S. has fared than other wealthy industrialized nations.

The countries that have a higher death rate than the U.S. are largely medium-size and middle-income. The industrialized Western nations that are the United States’ closest peers all managed to do better, including the United Kingdom, France, Germany, Italy, and Canada.

Meanwhile, other affluent countries did far better than the U.S. did, including Japan, South Korea, and Taiwan (which have more experience with airborne diseases and greater public tolerance for masking), and two island nations: Australia and New Zealand.

In general, Schaffner said, countries that performed better than the U.S. tended to have “sustained, single-source, science-based communication. They communicated well with their populations and explained and justified why they were doing what they were doing.”



 

It’s impossible to look at the United States’ response to covid without factoring in the extent to which it became politicized. Almost from the beginning, basic communications about the severity of the disease and how to combat its spread broke down along partisan lines. The way Americans responded also followed a partisan pattern.

Most states that voted for Joe Biden for president in 2020 had above-average vaccination rates. Most states that voted for Donald Trump in 2020 had below-average rates.

Among the outliers in that pattern were Arizona, Nevada, Michigan, and Georgia, which supported Biden but had below-average vaccination rates. All four had very tight races in 2020; and Trump won three of them in 2016. The outliers on the other side were Florida and Utah, which supported Trump but had higher-than-average vaccination rates.

Efforts to promote vaccination as advancing the common good “got beaten back by arguments about autonomy and individual freedom,” Caplan said.



 

The rejection of vaccines by many Americans helped bring down U.S. vaccination rates compared with other countries as well.

The U.S. full-vaccination rate of just under 66% was higher than the world average of about 54%, but not especially impressive considering the United States’ wealth and the fact it was producing many of the key vaccines in the first place. Essentially every other high-income country has vaccinated a higher share of its residents than the U.S. has.

The fact that the United States has both a lower rate of full vaccination and a higher death rate than other high-income countries “makes me wonder how we might have done as a country if our pandemic response had not been so politicized and polarized,” said Brooke Nichols, an infectious-disease mathematical modeler at Boston University.

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First ‘Before-and-After’ COVID Brain Imaging Study Shows Changes

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Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Even mild cases of COVID-19 are associated with brain changes including decreased gray matter, an overall reduction in brain volume, and cognitive decline, a new imaging study shows.

In the first study to use magnetic resonance brain imaging, before and after COVID-19, investigators found “greater reduction in grey matter thickness and tissue-contrast in the orbitofrontal cortex and parahippocampal gyrus, greater changes in markers of tissue damage in regions functionally connected to the primary olfactory cortex and greater reduction in global brain size.” However, the researchers urge caution when interpreting the findings.

Gwenaëlle Douaud, PhD, Wellcome Center for Integrative Neuroimaging, Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom, and colleagues describe these brain changes as “modest.”

“Whether these abnormal changes are the hallmark of the spread of the pathogenic effects in the brain, or of the virus itself, and whether these may prefigure a future vulnerability of the limbic system in particular, including memory, for these participants, remains to be investigated,” the researchers write.

The findings were published online today in the journal Nature.

Gray Matter Loss

The investigators analyzed data from the UK Biobank, a large-scale biomedical database with genetic and health information for about 500,000 individuals living in the UK.

They identified 785 adults aged 51-81 years who had undergone two brain MRIs about 3 years apart. Of these, 401 tested positive for SARS-CoV-2 before the second scan.

Participants also completed cognitive tests at time of both scans.

Biobank centers use identical MRI scans and scanning methods, including six types of MRI scans to image distinct regions of the brain and brain function.

Results showed that although some loss of gray matter over time is normal, individuals who were infected with SARS-CoV-2 showed a 0.2% to 2% brain tissue loss in the parahippocampal gyrus, the orbitofrontal cortex, and the insula — all of which are largely involved in the sense of smell.

Participants who had contracted COVID also showed a greater reduction in overall brain volume and a decrease in cognitive function.

Most of those with COVID had only mild or moderate symptoms. However, the findings held even after the researchers excluded patients who had been hospitalized.

More Research Needed

“These findings might help explain why some people experience brain symptoms long after the acute infection,” Max Taquet, PhD, National Institute for Health Research Oxford Health BRC senior research fellow, University of Oxford, said in a press release.

Taquet, who was not a part of the study, noted the causes of these brain changes remain to be determined. Questions remain as to “whether they can be prevented or even reverted, as well as whether similar changes are observed in hospitalized patients,” children, younger adults, and minority groups.

“It is possible that these brain changes are not caused by COVID-19 but represent the natural progression of a disease that itself increased the risk of COVID-19,” Taquet said.

Other experts expressed concern over the findings and emphasized the need for more research.

“I am very concerned by the alarming use of language in the report with terms such as ‘neurodegenerative,’ ” Alan Carson, MD, professor of neuropsychiatry at the Center for Clinical Brain Sciences at the University of Edinburgh, Scotland, said in a press release.

“The size and magnitude of brain changes found is very modest and such changes can be caused by a simple change in mental experience,” Carson said.

“What this study almost certainly shows is the impact, in terms of neural changes, of being disconnected from one’s sense of smell,” he added.

The study was funded by the Wellcome Trust Collaborative. Full financial conflict information for the study authors is included in the original article. Taquet has collaborated previously with some of the investigators.

Nature. Published online March 8, 2022. Abstract

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Is Vitamin D3 Superior to D2?

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Vitamin D3 (cholecalciferol) is superior to vitamin D2 (ergocalciferol) when it comes to health effects and should be the favoured form for fortified foods and supplements say researchers from the Universities of Surrey and Brighton.

In their study, published in Frontiers in Immunology , the researchers set out to  investigate the effect of vitamin D2 and vitamin D3 supplementation on the activity of human genes.

The study involved 97 participants selected for transcriptome analysis and was built on a previous study, in which participants had been randomised to receive either 15 μg (600 IU) vitamin D2 or 15 μg vitamin D3 daily supplementation within fortified foods, or to a placebo group for a period of 12 weeks during UK wintertime (October to March). Analysis took place at baseline and at 12 weeks after the start of treatment, with serum measurements of total 25(OH)D, 25(OH)D2, and 25(OH)D3 determined from fasting blood samples at baseline, week 6, and week 12. Of the 97 participants, aged 20-64 years and living in Surrey, 67 were white European and 30 were South Asian.

Research Showed How Vitamin D3 Boosted the Immune System

Two types of vitamin D do not have the same effect, the authors explained. The research enabled them to identify how vitamin D3 had a modifying effect on the immune system that could fortify the body against bacterial and viral diseases, including COVID-19.

Gene expression associated with type I and type II interferon activity, critical to the body’s innate response to bacterial and viral infections, differed following supplementation with vitamin D2 and vitamin D3, they said. Only vitamin D3 had a stimulatory effect. Following vitamin D3 supplementation, the majority of changes in gene expression reflected a down-regulation in the activity of genes “potentially shifting the immune system to a more tolerogenic status”.

Prof Colin Smith, lead-author of the study from the University of Surrey, who began this work while at the University of Brighton, said: “We have shown that vitamin D3 appears to stimulate the type I interferon signalling system in the body – a key part of the immune system that provides a first line of defence against bacteria and viruses. Thus, a healthy vitamin D3 status may help prevent viruses and bacteria from gaining a foothold in the body.”

COVID Has Contributed to Vitamin D Deficiency

Foods like some breakfast cereals, yoghurts, and bread, are fortified with vitamin D, but few naturally contain the vitamin. Many people have insufficient levels of vitamin D3 because they live in locations where sunlight is limited in the winter, such as the UK. The COVID-19 pandemic response has also limited people’s natural exposure to the sun due to people spending more time in their homes. The British Nutrition Foundation has highlighted that the National Diet and Nutrition Survey reported in October 2021 that about 1 in 6 adults in the UK had low vitamin D blood levels. Furthermore, 49% of British adults were unaware of the Government’s recommendation to consider taking vitamin D supplements during the autumn and winter months.

“Our study suggests that it is important that people take a vitamin D3 supplement, or suitably fortified foods, especially in the winter months,” said Prof Smith.

The researchers acknowledged that their ability to detect differences in the effects of vitamin D2 and vitamin D3 may have been negatively impacted by the relatively low statistical power; by the inclusion of two different ethnic groups among the 97 participants, and by the limited number of participants. They pointed out that, therefore, “the biological interpretation of our findings should be considered as preliminary, requiring independent verification.”

Prof Susan Lanham-New, co-author of the study and head of the department of nutritional sciences at the University of Surrey, said: “While we found that vitamin D2 and vitamin D3 do not have the same effect on gene activity within humans, the lack of impact we found when looking at vitamin D2 means that a larger study is urgently required to clarify the differences in the effects.

“However, these results show that vitamin D3 should be the favoured form for fortified foods and supplements,” she concluded.

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New COVID Variant Causing Officials to Lose Their Minds Once Again

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It is never going to end. There is a reason why we get a new flu shot every year. There is a reason why some people with the flu shot still get the flu. Viruses mutate! They mutate all the freaking time.

I guess COVID is special because officials freak out when a new COVID mutation comes out. They vomit all the hyperbole they can to keep the sheep scared and in line.

Need proof? When the vaccines came out normalcy started to come back and politicians like Fauci went to the wayside.

All of a sudden, the dangerous Delta variant came around, forcing the politicians back to the forefront.

But now the Delta variant is no longer a concern. People are letting down their guard! They’re starting to go back to normal and not paying attention to politicians.

Fauci and politicians are on the verge of losing their celebrity status! So of course a new deadly variant has been discovered.

B.1.1.529

The World Health Organization (WHO) attended a special meeting on Friday because of the B.1.1.529 COVID variant that showed up in southern Africa. They’ll need a new name if they want to keep up the panic because that’s a mouthful. It will likely receive a Greek letter.

One scientist described the numerous mutations of this variant as “horrific” and another told the BBC “it was the worst they’d seen”:

It is also incredibly heavily mutated. Prof Tulio de Oliveira, the director of the Centre for Epidemic Response and Innovation in South Africa, said there was an “unusual constellation of mutations” and that it was “very different” to other variants that have circulated.

“This variant did surprise us, it has a big jump on evolution [and] many more mutations that we expected,” he said.

In a media briefing Prof de Oliveira said there were 50 mutations overall and more than 30 on the spike protein, which is the target of most vaccines and the key the virus uses to unlock the doorway into our body’s cells.

Zooming in even further to the receptor binding domain (that’s the part of the virus that makes first contact with our body’s cells), it has 10 mutations compared to just two for the Delta variant that swept the world.

This level of mutation has most likely come from a single patient who was unable to beat the virus.

A lot of mutation doesn’t automatically mean: bad. It is important to know what those mutations are actually doing.

Of course, they worry the vaccine will not work against this variant. Um, duh. Again, why do you think we need a flu shot every single year?

EHRMEHGERD we’re all going to die.

The BBC also had a video explaining why we keep seeing new variants of COVID. We’re not stupid. Everyone knows viruses, like everything else in the world, evolve to survive.

Must Stop ALL TRAVEL

Anyway, the UK, EU, and Israel have already halted air travel to southern Africa.

Because, you know, the lockdowns and travel bans have worked so well in the past.

German Health Minister Jens Spahn said, “The last thing we need is to bring in a new variant that will cause even more problems.”

Israeli Prime Minister Naftali Bennett said, “We are currently on the verge of a state of emergency.” British Health Secretary Sajid Javid declared it’s a “huge international concern!”

The Japanese government will force Japanese nationals to isolate and quarantine for 10 days and have constant testing when they come home from Botswana, Eswatini, Namibia, Lesotho, South Africa, and Zimbabwe.



In other words, this is never going to end. We all knew once everyone caved, hung onto every word from people like Fauci, and didn’t back down they would find every excuse to keep their power and relevance.

It’s a shame because when we face a virus like the ones in Outbreak and Contagion, you know, a virus that is a literal death sentence for anyone who catches it, no one will care or pay attention.

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CDC is Indeed Back to Demanding Americans Wear Masks, and Americans Are Tired of It

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For some weeks now, Centers for Disease Control (CDC) Director Rochelle Walensky has been doubling down on demanding Americans continue wearing masks, adults and children alike, vaccinated or not. It doesn’t look like Americans can expect that to change. On Friday, Walensky tweeted an “Ask An Expert” video of “Why Do I Still Need to Wear a Mask?” 

“The evidence is clear,” Dr. Walensky insists. “Masks can help prevent the spread of COVID-19 by reducing your chance of infection by more than 80 percent.” It doesn’t just apply to the Wuhan coronavirus though, but the flu and even the common cold. “In combination with other steps, like getting your vaccination, hand-washing, and keeping physical distance, wearing your mask is an important step you can take to keep us all healthy.” 

Twitter did not take too kindly to that demand, as evidenced by the way in which Dr. Walensky’s video message was massively ratioed.

Many replies and retweets amounted to calling “bullsh*t.” Others pointed to how absurd it was that the common cold was included as a reason for mask-wearing.

Some users pointed out that it’s no longer sounding like such a crazy conspiracy theory to say that the powers that be want us to mask up forever.

Others said it amounted to misinformation, leading to a lack of credibility for the CDC. 

Many questioned where the 80 percent claim was coming from. One study that cites the 80 percent figure from was reported on right around the start of the pandemic, and before vaccines were available. Chris Westfall, in his article for Forbes from May 12, 2020 cites “research and scientific models from UC Berkley’s International Computer Science Institute and Hong Kong University of Science and Technology.”

And, when it comes to vaccines, while testifying before the Senate Committee on Health, Education, Labor & Pensions, Walensky couldn’t even tell Sen. Bill Cassidy (R-LA), who is also a medical doctor, how many CDC employees have been vaccinated. 

Of course, Dr. Walensky and President Joe Biden told Americans in May that mask mandates could be relaxed for those who had been vaccinated. 



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