Uncertain protection from Covid vaccines leaves cancer patients in limbo

 After 14 long months of near-isolation, Michele Nadeem-Baker was ready for her Covid-19 vaccination. Diagnosed with chronic lymphocytic leukemia in 2012, she knew her cancer made her more vulnerable to severe illness should she become infected with Covid-19. She would leave her home in Charlestown, Mass., only to walk her chocolate lab, Gabby, with her husband, dreaming of a day when she would no longer need to keep her distance from other family and friends.

She’s fully vaccinated now, but Nadeem-Baker feels left behind by the vaccine euphoria sweeping the country as it resumes something like normal life. She has only trace amounts of antibodies to show for her two doses of Moderna’s vaccine, according to test results from a study she joined, and that puts her in limbo — uncertain how much protection she has against the virus.

“With everyone else in the country, I was very excited about the vaccine and hoping I would be able to rejoin society. And unfortunately, that’s not able to happen and that was a huge disappointment,” she said. “It’s not over yet for patients like me.” 

Her cancer and the treatment she takes to control it blunt her immune system to the point that it doesn’t churn out as many antibodies as the vaccines are designed to stimulate. People who take drugs to prevent rejection of their organ transplants face a similar dismay after vaccination, as do people with certain autoimmune diseases who take medications to dampen the overactive immune response that defines their disorder.

The new Covid-19 vaccines, developed with astonishing speed and marked by stunningly high efficacy, may not work for everyone. But the jury is still out on whether antibody tests are a definitive measure of protection, for two reasons: We still don’t know the minimum level of antibodies required to fend off SARS-Cov-2 in immunocompromised people, nor do we know whether another response, known as cellular immunity, might make up the difference. It’s also too soon to determine if booster shots or monoclonal antibody infusions would help.

Just hold on, experts told STAT. Like so much in the pandemic, more is being learned every day about the virus. In the meantime, doctors strongly recommend vaccination for immunocompromised people and urge them to mask up, socially distance, and remind people around them to do the same, no matter their vaccination status.

“I think we need people to understand this doesn’t mean you have to lock yourself in a room in quarantine, but it does mean that you should exercise caution because we do not know how much antibody you need,” said Gwen Nichols, an oncologist and chief medical officer of the Leukemia and Lymphoma Society. “We don’t know all the specifics, but there are people taking what look like identical regimens and one of them has a completely normal serology and the other doesn’t, so we believe there may be something else. We know there were individual factors with Covid. It’s not going to be a simple answer.”

Studies to answer those questions are enrolling patients now. The antibody test Nadeem-Baker took is offered to patients by the Leukemia and Lymphoma Society to learn exactly what factors might influence whether vaccines work for people with blood cancer. Patients began signing up in February for an analysis that will look at variables such as their disease, their age, their therapies in the last two years, and whether they stopped treatment before vaccination. 

At this point, the Centers for Disease Control and Prevention does not recommend antibody tests to gauge vaccine response. While the tests are useful on a population level to determine the burden of Covid-19, doctors don’t know how to interpret them for this purpose — yet. 

“It’s just because we have less than one year of experience, it’s hard to know how much or how well the vaccines protect, depending on the specifics of immunocompromise in the patient. It may be that in three months we’ll be using these tests regularly,” said Meghan Baker, an infectious diseases physician and hospital epidemiologist who works with immunocompromised patients at Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston. Meanwhile, she strongly recommends vaccination. “We also know that many of our patients are very vulnerable to SARS-CoV-2 and Covid and can get very sick. And so any protection is strongly recommended.” 

All this leaves people like Greg Simon frustrated. A health policy consultant who led the Biden Cancer Initiative before it closed when the president announced his run for office, he was diagnosed with chronic lymphocytic leukemia in 2014. Simon was disappointed to learn he had no detectable antibodies to SARS-CoV-2 after his two Pfizer vaccine doses. 

“I realize that I’m part of a trend. I’m not an exception, which is too bad,” he said. “I expected that I would get some immunity, but that I would still have to be careful and maybe get a booster. So it did surprise me.” 

Simon even got a third vaccine dose — of the Johnson & Johnson one-shot vaccine — in hopes of spurring a response. And he’s looking into monoclonal antibody treatments such as those developed by Regeneron, AstraZeneca, Bristol Myers, and GlaxoSmithKline, though he knows such treatments have so far been shown to help people only once they’re infected. He’s being extra cautious to ensure he can meet his first grandson, who’s due to be born in July.

“I’m not going to be hanging out in a restaurant anytime soon because the risk-reward ratio is bad,” Simon said. 

He sees another element to the story for not just cancer patients like him, but also people with autoimmune diseases or who have had organ transplants.

“I’m a well-insured white guy, so I can go get these tests every month and it’s covered,” he said. “But not everybody is well-insured and not everybody has access to all the things that some of us have access to. We can share the knowledge we have, which is the lack of protection, even if there’s not a solution.” 

More information is coming on how transplant recipients are responding to Covid vaccination, and the picture is discouraging. Only 15% of the people in a Johns Hopkins study published this month mounted a response to both the first and the second dose of either the Moderna or Pfizer vaccine. It’s well-known that transplant recipients, who take immunosuppressive drugs for the rest of their lives to prevent rejection, don’t respond well to vaccination in general. Like cancer patients, they are also at greater risk of severe illness and death from Covid-19, so even some protection would be beneficial.

Brian Boyarsky, a research fellow and surgeon at Johns Hopkins School of Medicine and a co-author of the study, was surprised by how low the antibody response was. His group is looking into two options: modulating the immunosuppression regimen patients take and adding booster doses to see if they might confer some additional protection, as they do against hepatitis B.

There’s another potential downside for immunocompromised patients, Boyarsky said. “If the vaccines are not working, that could mean that transplant recipients are not only at a higher risk for developing the disease, but also for harboring potentially resistant strains of the virus that could render the vaccine ineffective for everybody.”

For people with autoimmune diseases, in which the body attacks its own tissues in an overactive immune response, the picture is more nuanced than with cancer, where both the disease and many of the treatments knock out the cells involved in the body’s immune response. The therapies to keep autoimmune patients healthy pose the barrier to vaccination. 

Some autoimmune patients take drugs from the same class of antimetabolites as transplant patients use. “From an antibody standpoint, clearly they are not going to make a good response,” said Ignacio Sanz, who heads rheumatology at Emory School of Medicine. He is leading a study of Covid-19 vaccine responses in people with autoimmune diseases.

Unlike cancer or transplant patients, people with some autoimmune diseases might be able to pause treatment until vaccine-induced antibodies translate into immune memory cells, he suggested.

“Unless there’s some major clinical concern that the disease is active, I’d rather wait one or two months for the next treatment, which I think is perfectly fine in most cases,” he said. “It depends on the individual case, obviously, but if I think that the patient can afford to wait a couple of months, I’d rather vaccinate and then delay that particular therapy for a couple of months.”

Like Nichols of the Leukemia and Lymphoma Society and Baker of Dana-Farber, Sanz urges cancer, transplant, and autoimmune disease patients to get vaccinated, and to remain vigilant until more is known about protection against Covid-19.

While she waits for answers, Nadeem-Baker feels like her life is still stagnant. A communications professional, she keeps active in patient advocacy groups such as Patient Power, WEGO Health, and AnCan, spreading the word about Covid vaccination.

“It’s not just leukemia patients,” she said. “This is not over for everyone and there’s still a great danger to many of us.”

https://www.statnews.com/2021/05/14/uncertain-protection-from-covid-vaccines-leaves-cancer-patients-in-limbo/

Billions remain in provider relief fund, but hospitals still waiting for relief

 The federal government amassed a staggering $178 billion in funds last year that were intended to prop up the nation's healthcare providers amid the swell of COVID-19 cases. Yet, more than a year later, billions of dollars are still sitting in the provider relief fund, triggering anxiety among those left waiting for financial relief.  

Industry experts are frustrated over the lack of information on how, and when, those remaining funds will be made available. The American Hospital Association is calling on HHS to expedite delivery of the remaining funds, according to a letter the powerful lobby sent to HHS Secretary Xavier Becerra this week.  

"We can't even get information about a next step," Mara McDermott, vice president of McDermott+Consulting, said. She has been closely tracking the issue as she advises her provider clients.   

Initially the relief money went out fast and furious, appearing one day in bank accounts of providers across the country early into the pandemic. 

But the brunt of the crisis hit many providers the hardest in the fall and winter, as cases and hospitalizations peaked in January, putting enormous strain on healthcare facilities months after receiving the initial tranches of federal aid. 

Yet, some providers still have yet to see relief funds for this period in which they were hardest hit. Some have faced significant losses, and it's unclear whether government funds are coming to help.

Currently, there's nowhere to apply for additional funds and efforts to obtain information have been difficult to come by, compliance experts said.  

However, the agency tasked with overseeing the fund, the Health Resources and Services Administration, said relief is on the way.   

"HRSA is working as quickly as possible to distribute these funds and will soon provide updates and guidance for providers," a spokesperson said.

What's left?

There is about $24 billion remaining in unallocated funds as of May 5, according to HRSA. Plus, there's an additional $8.5 billion that was allocated specifically for rural providers by the American Rescue Plan.  

In that bill, there are directives for HHS on how to disburse those funds.

The American Rescue Plan stipulates that HHS disburse another distribution of funds that takes into account the last two quarters of 2020 and the first quarter of 2021. 

Still, providers have been left in a wait and see mode, said Tim Fry, an associate with McGuireWoods who is an expert in healthcare compliance. Many want to know whether they can expect more funds to show up.

That's exactly what Dave Schreiner wants to know. He runs Katherine Shaw Bethea Hospital in Dixon, Illinois, which sits two hours west of Chicago.

"My greatest frustration is just the unknown. There seems to be a vacuum of information out there about how much is there, when would you expect it, how do you apply for it. It's just crickets," Schreiner said.

Schreiner, who has worked at the 80-bed hospital since the 1980s, is craving some predictability. Each day his executive team reviews the hospital's cash report and has to make operational decisions based on that information. 

He's anxious that a decision they make now to change any services or operations may be unnecessary if they find out in short order they're eligible for more help. 

Pandemic's squeeze

As the pandemic started to strangle the economy last spring, Congress signed the largest rescue package in U.S. history, $2 trillion in relief intended to fortify industries and households from the downturn in the economy spurred by the global pandemic.     

The first rescue package, known as the Coronavirus Aid, Relief, and Economic Security Act, earmarked $100 billion for providers. In sum, additional packages brought the provider relief fund to a total of $186.5 billion.   

How those funds were initially doled out sparked criticism. There was concern that hospitals with significant scale and already hefty cash reserves were capturing a large share of rescue funds. HHS later attempted to correct the imbalance as the first tranches of money were to the advantage of systems that did not have large shares of Medicaid patients, or patients with low incomes.   

Some of those large health systems with already healthy balance sheets went on to return all or some of the money they received. In one example, for-profit giant HCA returned all of the $6 billion in relief funds it received. 

But not all hospitals were as fortunate.  

Smaller, independent hospitals like Schreiner used up those funds as soon as they received them, he said. 

The most important lingering questions experts have is when can providers expect to apply for new money and how long will it take to receive the actual funds after applying. 

"Should all this money just be like sitting in a bank account in the federal government?" McDermott said. "Sitting on it seems to me to defeat the congressional purpose."

https://www.healthcaredive.com/news/billions-of-dollars-remain-sitting-in-the-provider-relief-fund-hospital-ex/599830/

One Medical loss twice views in Q1 as chain preps for Baylor Scott & White partnership

 

• One Medical's earnings per share loss was about double what analysts expected in the first quarter, sending its stock plummeting and continuing a downward trend started earlier this year after the Google-backed chain of medical clinics faced criticism for inappropriate coronavirus vaccination practices.
• The San Francisco-based company reported a loss of $39.3 million, or 29 cents a share, on revenue of $121.4 million. Analysts on consensus expected One Medical to report a loss of 14 cents a share on sales of $116.2 million.
• Despite the heavier loss, One Medical remains bullish on growth. The provider said Wednesday it plans to enter the Dallas-Fort Worth market through a partnership with Baylor Scott & White, the biggest nonprofit health system in Texas.

Like many other tech- and consumer-focused companies, One Medical, which went public in January last year, has seen accelerated growth during the pandemic. But it hasn't been entirely smooth sailing: One Medical's stock hit a peak in mid-February but has fluctuated since, falling 35% over the past three months though still up 49% since its IPO.

One Medical shares have fallen more than 14% since it released its first quarter results aftermarket Wednesday.

Rebecca Pifer/Healthcare Dive, NYSE data

 

That decline is not unique to One Medical, however — numerous digital health companies have seen their stock contract in the past few months amid investor concerns about the sustainability of digitally delivered or augmented care post-COVID-19.

But the chain's stock has suffered following accusations of coronavirus vaccine favoritism and lax distribution oversight late February. Reports found the chain allowed family and friends of company leadership, along with younger, healthier people, to receive the shot at a time when supplies were scarce and most states guided providers to prioritize elderly and high-risk individuals.

Numerous state departments of health cut ties with One Medical following the allegations, which also sparked a congressional investigation. CEO Amir Dan Rubin has strongly refuted the claims, calling them "gross mischaracterizations" in early March.

One Medical offers concierge healthcare direct-to-consumer and also has about 8,000 employer clients, including large corporations like Google, which is a major investor in the business and made up about a 10% of One Medical's revenue at the time of its IPO.

In the first quarter, One Medical's revenue exceeded analyst expectations and was up 54% year over year.

Membership revenue was $20.2 million, growing 33% year over year, and net patient service revenue was $44.5 million, up 30% year over year. Its topline also included a $1.8 million income grant from the provider fund set up by the Coronavirus Aid, Relief, and Economic Security Act.

However, its loss was significantly greater than Wall Street expected, growing 16% compared to the same time last year.

Management didn't address the wide loss miss on the call, instead highlighting One Medical's membership and market growth. The chain notched record net new membership addition in the first quarter: Membership jumped 31% year over year to 598,000 members.

The new partnership with system Baylor Scott & White represents One Medical's 19th planned market entry and third in Texas. The chain launched in Austin at the end of last year and has plans to expand to Houston. Other previously announced market entries include Raleigh-Durham, North Carolina; Columbus, Ohio; Milwaukee; and Miami.

One Medical is on track to expand its network from just nine in-person markets at the time of its IPO to 22 markets representing almost 40% of the commercially insured population in the U.S., Rubin said on a Wednesday call with investors.

The medical network also recently inked a partnership with employee benefits solutions company ParetoHealth, which has about 1,400 small and mid-size employer clients in the U.S. As part of the deal, One Medical will expand its network in the Midwest and Southeast to reach ParetoHealth clients in Alabama and Kansas City, Rubin said.

Jefferies analyst Stephanie Wissink called the partnership with the payer "highly intriguing," as it opens the door for down-market expansion. Management said One Medical is open to partnerships with larger payers, but in the near-term remains focused on expanding its footprint among employers and health systems.

The company maintained its full-year guidance following the results, forecasting sales of $465 million to $485 million in 2021, with between $111 million and $118 million in the second quarter.

The guidance "suggests a deceleration in both revenue and membership growth," SVB Leerink analyst Stephanie Davis said in a note on the results. Davis noted the "severe" slowdown could be due to management conservatism, but "anything short of perfection is not enough for a high multiple name in this market."

A potential headwind for the medical network is a drop in COVID-19 testing, though the ongoing need for coronavirus vaccines and potential booster shots later in the year, along with routine flu vaccines, could bolster finances throughout 2021.

On the call, CFO Bjorn Thaler said the company saw a "meaningful drop" in diagnostic testing starting in April, earlier than One Medical predicted.

"We had initially expected COVID-19 testing volumes to decline meaningfully in the second half of 2021," Thaler said. "At this point, we do not expect testing volumes to return to prior levels."

https://www.healthcaredive.com/news/one-medical-losses-double-than-expected-in-q1-as-chain-preps-for-baylor-sco/600160/

Covid-19 Drugmakers Take On Your Favorite TV Shows to Tackle Vaccine Hesitancy

 Late-night host Jimmy Kimmel wore a white lab coat and head mirror strapped to his forehead on his talk show last month and talked about Covid-19 vaccines that use messenger RNA. "This technology could be a real game-changer," he says.

The skit was sponsored by vaccine maker Moderna Inc., one of a number of direct-to-consumer advertisements paid for by pharmaceutical companies aimed at hesitancy and lack of awareness toward vaccines and drugs for Covid-19.

Vaccine maker Pfizer Inc. has made ads featuring people spending time with loved ones that conclude by asking " Why will you get vaccinated?" Regeneron Pharmaceuticals Inc., maker of a monoclonal antibody drug treatment, recently began running ads on television, radio and social media. Eli Lilly & Co., maker of a rival antibody therapy, has ads on social media and search engines targeted at people in areas with high infection rates.

Moderna's consumer outreach is primarily focused on digital advertising, says the company, including the sponsorship of online video discussions on a news website focused on historically Black colleges and universities.

The advertising isn't typical for pharmaceutical companies. Unlike most drug promotions, the ads aren't aimed at gaining a leg up on competitors or boosting sales in the next quarter, the companies said. The goal is to persuade Americans to use potentially lifesaving products that are already bought and paid for by the U.S. government and provided free to consumers.

The campaigns more closely resemble those for launches of new drugs for diseases with few or subpar treatment options, such as the unbranded disease-awareness campaigns that hepatitis C drugmakers sponsored in the 2010s urging people to get tested for the liver disease. Except that with Covid-19, the window for reaching consumers is smaller, says Kristen Eisterhold, Eli Lilly & Co.'s marketing director for Covid-19 antibody treatments, because of the urgency to control the pandemic.

"Oftentimes in healthcare, it takes months, years, and sometimes even decades to create awareness," says Ms. Eisterhold. "Our challenge really was how do you as quickly as possible establish broad awareness with healthcare providers and consumers that these treatment options exist."

The ads don't mention products by name, in part because of marketing restrictions imposed by the emergency-use authorizations granted by the Food and Drug Administration. Instead, the ads refer to broader categorizations such as "monoclonal antibodies" or "mRNA vaccines."

Vaccine makers are trying to reach the roughly one-third of Americans who are reluctant to get vaccinated, according to the most recent opinion polling from the Kaiser Family Foundation. Some 15% of people polled by Kaiser in April said they want to "wait and see" before being vaccinated, and 19% said they would definitely not get vaccinated or would do so only if required.

Regeneron and Lilly say they are trying to raise awareness that their drugs are available to recently diagnosed people at risk of developing severe cases. In clinical trials, the drugs helped reduce hospitalizations or death by 70% compared with placebos. Since being authorized last November, however, the drugs have been underused, partly because many patients and doctors don't know about them, according to the companies.

Through early May, just 49% of the nearly one million antibody doses made by Regeneron and Lilly have been used by patients, according to a Department of Health and Human Services spokeswoman. From last year through the first quarter of 2021, Lilly has recorded $1.5 billion in U.S. sales from the drugs; Regeneron's U.S. antibody revenue was $448 million over the same period.

Regeneron ran its first TV ad in late April just before the Academy Awards broadcast on ABC. The 30-second spot features actors repeating the phrase "monoclonal antibodies" in an attempt to familiarize the public with a term that doesn't roll off the tongue, and a narrator who says the drugs may help certain people stay out of the hospital.

"It is a mouthful," says Maya Bermingham, Regeneron vice president for public policy and government affairs. "And for the average person, what they want to know is: 'Is there a treatment? When do I get it?' "

Another Regeneron TV commercial urges patients diagnosed with Covid-19 to call their doctors immediately to ask about monoclonal antibodies if they are at high risk of severe disease.

Regeneron's campaign is scheduled to run through the end of the second quarter and is targeting 19 markets including Atlanta, Baltimore and Detroit, and expected to reach roughly 40% of the U.S. population, a spokeswoman says.

Priya Nori, an infectious disease specialist in Bronx, N.Y., says she saw the Regeneron ad while watching the Oscars. She thought the ads would be helpful in raising awareness but were poorly timed because infection rates have fallen so much in recent months.

"I was texting with my colleagues saying, 'This is really cool, I just wish this commercial was not in April when things were ramping down and lot of people had gotten their first vaccine doses,'" says Dr. Nori, who oversees Covid-19 antibody drug infusions for Montefiore Health System. "That commercial should've come out in January, that would have helped us the most."

Regeneron has spent about $545,000 on national TV ads related to Covid-19 and its commercial have been seen 142.5 million times, according to iSpot.tv Inc., a TV ad-measurement firm. The company declined to comment.

Moderna declined to comment on its advertising budget, but said in its first-quarter financial statement that its spending on marketing and other expenses increased by $10 million compared with the year-earlier quarter.

Lilly and Pfizer declined to say how much they have spent on Covid-19 advertising. One of Pfizer's commercials showing a baby announcement as a reason to be vaccinated, iSpot said, was seen 8.3 million times and had $78,000 in national TV ad spend.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Covid-19-Drugmakers-Take-On-Your-Favorite-TV-Shows-to-Tackle-Vaccine-Hesitancy-33273103/

Unmasking Covid Realities - CDC Still Needs To Find The Data

 Mark Twain famously said: Get your facts first, and then you can distort them as much as you please. As if to stand these words on their head, the US Covid-19 response has been an exercise in selective data collection. This is not only hubristic but also unscientific. The consequences, if the process continues, will result in further pain and suffering. Making matters worse, the Centers for Disease Control, CDC in its new mask guidance has introduced confirmational bias into the equation. Confirmational bias happens when we search for, favor, and recall information that supports our desired outcome while, simultaneously, dissuading us from collecting any facts that might prove counter to that desired end. In this case, the desired end is a rapid return to normalcy.

The desire for a return to normalcy (however defined) is understandable, but in this case, it cannot be achieved at any cost because that cost will be devastating. Many politicians, and even some scientists, are ignoring Twain’s advice. They are less interested in acquiring all the facts and prefer to embrace those select views which comport to proclamations of successful crisis management.

The news in this case, is not all bad – nor is it all good. There is ample evidence that we are seeing some progress in dealing with the Covid-19 pandemic; witness the declining infection and death rates in the U.S. - presumably in response to vaccinations, better social and personal responsibility, and the seemingly indefatigable care provided by health care workers.  However, one need only realize that the U.S. still has moving 7-day averages of over 38,534 new cases and 780 deaths to realize that this is far from over. Or, if you prefer, look at India with 2.9% of its population fully vaccinated and Seychelles with 61.9%. The former has 23 million cases and 250,000 deaths while the latter has a higher number of infections per capita than India!

India’s catastrophe may be blamed in part on poor planning and false claims of Covid-19 control, but Seychelles seemed to be doing everything right yet is entering very dire straits. What is missing? We lack comprehensive data.

A few days ago The Senate Health, Education, Labor, and Pensions Committee held a hearing on efforts to combat the COVID-19 pandemic and made it pellucidly clear that we are implementing policies, expending resources, and confusing the public because of incomplete, or totally absent, data. All four witnesses (Anthony Fauci, Rochelle Walensky, David Kessler, and Peter Marks) repeatedly stated that they lacked the data to be more specific in answering direct questions. The answers they did provide, were based on reports that were weeks or months old rather than on more current information. One telling exchange was that between Senator Susan Collins and Dr. Rochelle Walensky over The New York Times article ‘A Misleading C.D.C. Number’ which presented the exaggerated risk of outdoor transmission of Covid-19. Dr. Walensky cited an earlier report for the C.D.C. recommendation as there was no current data available to justify a revision.

Within two days of her testimony, Dr. Walensky reversed herself and announced that masks were no longer needed for outdoor, and even many indoor, gatherings of vaccinated individuals. This action suggests that the response was based on political and public pressure rather than cold, unbiased, and sterile data. Is this relaxation of mask-wearing warranted? We will know within weeks. We may not like the outcome.

Another example of the importance of data collection and analysis comes in the form of a recent report from the Institute for Health Metrics and Evaluation (IHME) that suggests 6.9 million people worldwide have died from the disease, more than twice as many people as has been officially reported. The IHME analysis mined data and considered six drivers:

1.   the total Covid-19 death rate, that is, all deaths attributed to Covid-19 infection;

2.    the increase in mortality due to needed health care being delayed or deferred during the pandemic;

3.   the increase in mortality due to increases in mental health disorders including depression, increased alcohol use, and increased opioid use;

4.   the reduction in mortality due to decreases in injuries because of general reductions in mobility associated with social distancing mandates;

5.   the reductions in mortality due to reduced transmission of other viruses, most notably influenza, respiratory syncytial virus, and measles; and

6.   the reductions in mortality due to some chronic conditions, such as cardiovascular disease and chronic respiratory disease, that occur when frail individuals who would have died from these conditions died earlier from Covid-19 instead.

This detailed analysis gives a more accurate assessment of the problems presented by the pandemic, yet despite the obvious need for better data collection and analysis, the C.D.C. announced that it would be cutting back on data collection. This cannot go on. Only with clear, unfiltered, and unbiased data can we hope to mount an effective and efficient response to the problem. This is no time for distortion. We must start with the facts.

There is, however, a path to good news. Absent better, more widely available, and effective therapeutics, we do have a currently available, and underused, tool at our disposal that you have most likely never heard of. It is not in itself a therapeutic, but it is essential for effective and efficient pandemic planning and targeted therapeutic development.

The National COVID Collaborative (N3C) is an electronic health record repository of over 5.6 M+ patients including 1,550,337+ Covid positive patients.  This staggering amount of information is held in 6.2 B+ rows of data and provides enough substrate to currently support 173 projects. The projects range from evaluation of anti-thrombotic therapies to the effects of alcohol consumption on Covid-19 outcomes and a host of other studies.

If we need validation of this approach, the business world has recognized and invested in the collection of data for more than a generation. And some hedge funds have made hundreds of billions in the process. The Man Who Solved the Market tells the story of Jim Simons who started Renaissance Technologies and led it to become arguably one of the most, if not the most, successful hedge fund. He achieved this by replacing the emotion, intuition, and insight model with a quantitative, data-driven approach. His team mined mountains of data looking for hidden patterns of market governance. This approach is now recognized as a critical tool for not just investing, but also for innovation, research, and development. I go even further and suggest that this model, if applied to N3C, holds the promise of real solutions to the Covid-19 dilemma. Quantitative analysis offers a path. N3C provides the tools. With this information, we may understand what is going on in the Seychelles, India and of course here in The US. Then, and only then, will we be able to both understand and learn how to deal with Covid-19. If there’s any doubt of this, think of Mark Twain again, because he also said “a forgotten fact is news when it comes around again.”

Steve Brozak is President of WBB Securities, LLC, an investment bank and research firm that specializes in the biotechnology, specialty pharmaceutical and medical device sectors.

https://www.forbes.com/sites/stephenbrozak/2021/05/14/unmasking-the-covid-realitiesthe-cdc-still-needs-to-find-the-data/

US Nurses Union Condemns CDC Mask Ruling

 The largest U.S. union of registered nurses has condemned the Centers for Disease Control’s recent announcement that fully vaccinated people do not need to wear masks in most settings.

“This newest CDC guidance is not based on science, does not protect public health, and threatens the lives of patients, nurses, and other frontline workers across the country,” National Nurses United Executive Director Bonnie Castillo said in a statement. “Now is not the time to relax protective measures, and we are outraged that the CDC has done just that while we are still in the midst of the deadliest pandemic in a century.” 

NNU President Jean Ross said, “if the CDC had fully recognized the science on how this deadly virus is transmitted, this new guidance would never have been issued.” 

The union called on the Occupational Safety and Health Administration to issue emergency temporary standard (ETS) on infectious diseases “without delay.” 

“If OSHA does not issue a Covid ETS immediately, we will undoubtedly see more unnecessary, preventable infections and deaths, as well as long Covid cases among nurses and other frontline workers,” said NNU President Zenei Triunfo-Cortez.

https://www.voanews.com/covid-19-pandemic/us-nurses-union-condemns-cdc-mask-ruling

Mask rules trust Americans' honesty on vaccine status, but they'll lie.

 The Centers for Disease Control and Prevention's announcement Thursday that fully vaccinated people largely no longer need to wear a mask has left many Americans wondering: If there are no enforcement measures, won't people just lie about their vaccination status?

Public health officials admitted that the honor system will play a large role in the new rules.

"I mean, you're going to be depending on people being honest enough to say whether they were vaccinated or not and responsible enough to be wearing ... a mask," Anthony Fauci, the nation's top epidemiologist, told CNN Thursday.

There's long been talk of a "vaccine passport" model of enforcement in the USA, where vaccination status grants or limits a person's ability to travel or enter certain spaces. Such a program is mostly a theory, and multiple businesses announced that they won't ask customers to prove their vaccine status if they shop unmasked.

Although businesses and politicians say they trust Americans to be honest, experts on human behavior aren't so sure.

Michael McCullough, a psychology professor at the University of California, San Diego, said the new guidance will enable unvaccinated people to flout rules with "impunity."

"Many will lie. Many are lying, have been lying," he said. "In some ways, this is a really perfect recipe for lots of people to be dishonest about whether they got vaccinated. They can say, well, everyone who really is worried about it has gone out and done it, and my personal risk is low."

People lie all the time

Most people lie about once a day, and about 25% of people lie about "consequential things," according to Michael Cunningham, a psychologist at the University of Louisville who has done 35 years of research on lying, cheating and stealing.

Researchers have long studied lying through a variety of approaches – self-reported surveys, fact checking school and job applications, recruiting participants for recorded interviews and analyzing diary entries.

Many daily lies relate to the "expectation maintenance theory of lying," Cunningham said – trying to maintain cordial social relations by telling people what they want to hear.

"Most of the time, we don’t lie for malicious reasons," said Kang Lee, a professor at the University of Toronto who studies honesty and deception. "I don’t like to get you into trouble. We lie sometimes for pro-social reasons. I want to spare your feelings."

Mask rules invite deception

The greater the incentive and the lower the risk, the more likely people are to lie, researchers said.

That's a major problem in the context of differing rules for vaccinated and unvaccinated people, Lee said. It's "very, very likely people are going to lie ... because there’s no verification system and no punishment."

"This is not going to work. When people show up at the grocery store, if you ask them, have you gotten the vaccination, they’ll be more likely to say yes," Lee said.

If the first few days are any indication, many businesses don't even plan on asking customers their status, giving customers even less of a moral dilemma.

"There is this universal or global phenomenon that people have a strong desire to see themselves as honest," said Alain Cohn, a behavioral economist at the University of Michigan who has studied whether people are likely to return lost wallets. "The big problem is how to activate and make sure people cannot rationalize a bad behavior. ... They can always find a good reason why it’s OK to lie or tell a half-truth."

That's the problem with the COVID-19 vaccination honor code, Cohn said.

"I’m just worried that these people will find some self-serving justifications for not getting vaccinated without feeling bad about it," he said.

Surveys indicate more than a quarter of all Americans say they don't want a COVID-19 vaccine. Imagine if about a quarter of that subgroup lies about their status to go maskless, Cunningham said.

"People will absolutely be deceptive," Cunningham said. "Its going to be a relatively small fraction of the population, but it’s going to be a meaningful fraction of the population."

About 36% of the U.S. population is fully vaccinated, according to the CDC. People who are unvaccinated are at a high risk of contracting and spreading COVID-19, especially when spending time inside without a mask.

Do honor systems ever work?

In low-stakes situations, honor systems can work well, researchers said. Unmanned farm stands, for example, where patrons take crops and leave behind payment, have proved successful across the country.

"It does capitalize on the fact that the majority of people are honest and even altruistic," said Arthur Caplan, a bioethics professor at NYU School of Medicine. "And some people will be flattered that you trust them enough and will overcompensate, and that will make up for those that have been dishonest. But you don’t use the honor system for selling houses."

In higher-stakes settings, such as test-taking, some institutions have seen a slew of honor code violations, particularly amid the pandemic, when millions of students take tests from home.

Last month, West Point officials expelled eight cadets and required more than 50 others to repeat a year of instruction after the most extensive cheating scandal in more than 40 years at the Army's renowned academy, which had a reputation for moral rectitude. Last week, Dartmouth College accused 17 medical students of cheating on remote tests.

Lee said he published a study that found that for exams in pre-pandemic times that were not proctored and were based on honor codes, cheating rates were as high as 80%.

"If you entrust someone to trust their morality in something that has such high stakes as an exam, they are more likely to ignore their moral code and get ahead," Lee said.

Caplan said he's nervous people will feel justified in lying because the vaccine issue has become so politicized in the USA.

"It isn't just an honor system. Many people don’t want the vaccine on ideological grounds," Caplan said. "It's not the same as saying we’re going to rely on you to pay at checkout."

Lee agreed.

"My intuition is, given the situation, a lot of people feel they are justified not to take vaccinations," he said. "Therefore, they are going to feel more justified to lie to you as well."

https://news.yahoo.com/mask-rules-trust-americans-honest-225808912.html