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Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

The morning after the world learned that a closely watched clinical trial of a coronavirus vaccine had been halted last week over safety concerns, the company’s chief executive disclosed that a person given the vaccine had experienced serious neurological symptoms.

But the remarks weren’t public. Instead, the chief executive, Pascal Soriot of AstraZeneca, spoke at a closed meeting organized by J.P. Morgan, the investment bank.

AstraZeneca said on Saturday that an outside panel had cleared its trial in Britain to begin again, but the company still has not given any details about the patient’s medical condition, nor has it released a transcript of Mr. Soriot’s remarks to investors, which were reported by the news outlet STAT and later confirmed by an analyst for J.P. Morgan.

Another front-runner in the vaccine race, Pfizer, made a similarly terse announcement on Saturday: The company is proposing to expand its clinical trial to include thousands more participants, but it gave few other details about its plan, including how it would determine the effectiveness of the vaccine in its larger study.

It’s standard for drug companies to withhold details of clinical trials until after they are completed, tenaciously guarding their intellectual property and competitive edge. But these are extraordinary times, and now there is a growing outcry among independent scientists and public health experts who are pushing the companies to be far more open with the public in the midst of a pandemic that has already killed more than 193,000 people in the United States.

These experts say American taxpayers are entitled to know more since the federal government has committed billions of dollars to vaccine research and to buying the vaccines once they’re approved. And greater transparency could also help bolster faltering public confidence in vaccines at a time when a growing number of Americans fear President Trump will pressure federal regulators to approve a vaccine before it is proved safe and effective.

“Trust is in short supply,” said Dr. Harlan Krumholz, a cardiologist and health care researcher at Yale University in New Haven, Conn., who has spent years prodding companies and academic researchers to share more trial data with outside scientists. “And the more that they can share, the better off we are.”

Last week, nine pharmaceutical companies, including AstraZeneca and Pfizer, pledged to “stand with science” and rigorously vet any vaccine for the coronavirus — an unusual pact among competitors. But the researchers said that missing from the joint statement was a promise to share more critical details about their research with the public and the scientific community.

None of the three companies with coronavirus vaccines in advanced clinical trials in the United States have made public the protocols and statistical analysis plans for those trials — the detailed road maps that could help the independent scientists better understand how the trials were designed, and hold the companies accountable if they were to deviate from their plans. In some cases, crucial details about how the trials have been set up — such as at what points an independent board can review early study results, or under what conditions a trial could be stopped early — have not been made public.

“We’ve never had such an important clinical trial — or series of clinical trials — in recent history,” said Dr. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, Calif., and a longtime expert on clinical trials. “Everything should be transparent.”

Public confidence in the drug companies’ findings and federal regulators’ rigor will be critical in persuading Americans to get vaccinated. A growing number of people are skeptical. A poll by the Kaiser Family Foundation this past week found that nearly two-thirds of Americans — 62 percent — are worried that the Food and Drug Administration will rush to approve a coronavirus vaccine without making sure it is safe and effective, under political pressure from Mr. Trump.

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Credit…Hans Pennink/Associated Press

Pharmaceutical companies are counting on their vaccine research to help them rebuild reputations that have been tarnished by soaring drug prices and the industry’s role in fueling the opioid epidemic.

In an effort to restore public trust, senior regulators at the F.D.A. took the highly unusual step of promising in a USA Today op-ed piece on Thursday to uphold the scientific integrity of the process of evaluating treatments and vaccines, and to maintain the agency’s independence.

Representatives for the three companies with vaccine candidates in large, advanced trials in the United States — Moderna, Pfizer and AstraZeneca — said they had released many details about the trials.

Pfizer said in a statement that the novelty of the virus and the fast-moving nature of the coronavirus crisis had meant that the protocol had to be flexible “to enable us to enhance the evaluation of the potential vaccine’s safety and efficacy.” The company said it would publish the full protocol from the trial as part of its submission to a medical journal “that will include results, enrollment criteria and final number of participants enrolled.”

On Saturday, Pfizer said it would ask the F.D.A. for permission to expand its trial to 44,000 participants, from its initial target of 30,000. But the announcement raised new questions about how the company would be able to know the results by its goal of the end of October, with so many new participants. A Pfizer spokeswoman, Amy Rose, said, “We are not going to speak to timing or specifics of any interim analyses.”

AstraZeneca did not initially report that a participant’s illness had halted its clinical trials around the world. The studies were paused last Sunday, but not reported until the news was broken by STAT on Tuesday. The company still has not disclosed the patient’s illness that led to the pause, even though it has discussed the medical condition of another participant who developed multiple sclerosis in July, which led to another brief halt of the trial. That illness was determined to be unrelated to the vaccine.

The company said that Mr. Soriot’s appearance at the J.P. Morgan meeting was part of a long-planned event, and that he largely discussed the company’s business outlook, with a few questions about the trial. The New York Times has reported that the patient developed symptoms consistent with transverse myelitis, or inflammation of the spinal cord.

A spokeswoman for AstraZeneca, Michele Meixell, said that while trial sponsors were required to notify the doctors operating clinical trial sites if an “unexplained event” occurred, “it is not common practice for those pauses to be communicated beyond the clinical community involved in a trial — including the media — in order to protect the privacy of individual participants and maintain the integrity of the trial.”

There is precedent for greater transparency. The large Recovery trial being run by the University of Oxford in Britain — which helped determine that the steroid dexamethasone reduces deaths in patients with Covid-19 — has published its trial protocol and statistical analysis plans.

While the broad outlines of the vaccine trial designs have been made available — including on a federal clinical trial registry — crucial details remain a mystery.

For example, Pfizer’s chief executive has said the company could apply to the F.D.A. for emergency authorization of its vaccine as early as October. But the company has not said how many times — and at what point in the trial — it will allow an independent review board to examine its study data to evaluate whether the evidence of safety and efficacy is strong enough that it can stop the trial early and apply for an emergency approval from federal regulators.

And none of the companies have published the criteria they will use to determine when these outside boards would advise stopping the trial, which could happen if the vaccine showed overwhelming efficacy, if it showed that it did not protect against Covid-19 or if it was linked to serious safety issues.

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Credit…Jeenah Moon/Getty Images

These so-called interim analyses are the subject of intense interest, because they are the only way that late stage trials could be halted early.

Company executives have provided some trial details when they have spoken on discussion panels or at investor conferences, or in news releases. But researchers looking for clues have had to comb through transcripts, videos and articles posted online, rather than to examine documents that the companies provided.

The lack of transparency is unacceptable, several researchers said, given that the federal government has billion-dollar deals with each of the companies.

“Look, we paid for it,” said Saad B. Omer, the director of the Yale Institute for Global Health. “So it’s reasonable to ask for it.”

A federal clinical trial registry details the number of trial participants, who should be included and excluded from the study, and the main outcomes. But it only skims the surface, Dr. Krumholz said. “The protocols are much more detailed.”

Peter Doshi, who is on the faculty at University of Maryland School of Pharmacy in Baltimore and an editor with The BMJ, a medical journal, said he recently requested the protocols from Pfizer, Moderna and AstraZeneca. None of the companies shared them, he said.

“I imagine most of the public would like to believe scientists are all sharing their data, that this process is open to scrutiny among the scientific community,” said Dr. Doshi, who has helped pressure drug makers to share trial records with researchers. “Just not true.”

Dr. Doshi said the protocols could help researchers answer important questions about the studies, and possibly to critique them. For example, can the trials determine whether the vaccine can prevent Covid-19 and complications in high-risk groups like older adults? When the researchers test for the coronavirus, how do they account for false results?

Other independent scientists said they were eager to examine the trials’ statistical analysis plans, which would guide them in analyzing the results.

“Frankly, I would love to know what they’re planning to do, and how they’re planning to do it,” said Dr. Judith Feinberg, the vice chairwoman for research in medicine at West Virginia University in Morgantown.

By making these documents public, outside experts said they would be able to hold the companies accountable if they changed the way they analyzed the results.

“There’s no downside” to sharing the documents, said Dr. Paul A. Offit, a professor at the University of Pennsylvania in Philadelphia who serves on the F.D.A. advisory committee that will review coronavirus vaccines. “People are skittish about these vaccines. I think it helps to be transparent.”

Dr. Omer said he was in favor of the companies releasing the protocols and analysis plans, but he said he also worried that, in the wrong hands, the technical documents could be misinterpreted.

“You cannot kid around with this kind of stuff,” he said. In the long run, however, he said it was to the companies’ advantage to allow qualified researchers to evaluate the plans.

If independent researchers agreed the trials were set up properly — and Dr. Omer said he expected that would be the case — that could help enhance their credibility. They can say: “Hold your horses. No need to jump up and down.”

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FDA revokes emergency authorization for chloroquine and hydroxychloroquine in COVID-19 treatment

The U.S. Food and Drug Administration (FDA) has revoked an emergency use authorization (EUA) that it previously issued for chloroquine and hydroxychloroquine, two anti-malarial drugs also used in the treatment of chronic rheumatoid arthritis (via Washington Post). These are the drugs that Trump famously touted as effective in COVID-19 treatment, despite major concerns raised with the scientific validity of early medical investigations that showed they were potentially effective agains the infection beyond the ongoing global pandemic.

Subsequent studies showed conflicting results, including when one team of researchers ended elements of its clinical study into the drugs’ use early due to excess fatalities. The FDA had issued its EUA for use of chloroquine and hydroxychloroquine in late March, prompting criticism from many in the medical and pharmaceutical research community since evidence seemed very mixed in terms of its potential efficacy and risks. Then following those deaths in that subsequent clinical study, it issued a statement of precaution regarding the use of the drugs.

The FDA grants EUAs in circumstances where it deems the benefits outweigh the risks of expediting a provisional authorization for the use of therapies and devices that haven’t undergone its full, rigorous approval process for drugs and equipment. The COVID-19 pandemic has resulted in the FDA releasing many more EUAs than is typical, especially as it pertains to testing equipment used for diagnostic of the infection and SARS-CoV-19, its preceding and causal virus.

Trump irresponsibly touted the value of chloroquine and hydroxychloroquine, and later professed to be taking the medicine himself as a precaution he wrongly believed would stave off infection. The drug’s supply subsequently experienced a number of stresses due to increased demand, which had potentially dire consequences for people with a legitimate need for its consumption due to conditions for which it is approved and clinical shown to be effective, including lupus and chronic arthritis.

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Johnson & Johnson to End Talc-Based Baby Powder Sales in North America

Johnson & Johnson is discontinuing North American sales of its talc-based baby powder, a product that once defined the company’s wholesome image and that it has defended for decades even as it faced thousands of lawsuits filed by patients who say it caused cancer.

The decision to wind down sales of the product is a huge concession for Johnson & Johnson, which has for more than a century promoted the powder as pure and gentle enough for babies.

The company said on Tuesday that it would allow existing bottles to be sold by retailers until they ran out. Baby powder made with cornstarch will remain available, and the company will continue to sell talc-based baby powder in other parts of the world.

Johnson & Johnson has often said that faulty testing, shoddy science and ill-equipped researchers are to blame for findings that its powder was contaminated with asbestos. But in recent years, thousands of people — mostly women with ovarian cancer — have said that the company did not warn them of potential risks that the company was discussing internally.

Even as it announced the withdrawal of its baby powder, the company said that it “will continue to vigorously defend the product” in court. But Johnson & Johnson acknowledged that demand for the talc-based version had slumped as consumer habits changed and concerns about the product spread.

For decades, baby powder’s main ingredient was talc, a mineral known for its softness. Sold in an iconic white bottle, its fragrance is said to be one of the most recognizable in the world.

It was only in 1980, after consumer advocates raised concerns that talc contained traces of asbestos, a known carcinogen, that the company developed a cornstarch alternative.

Krystal Kim, a Philadelphia woman who has survived two bouts of ovarian cancer that she blames on her lifelong use of the powder, said the decision to remove the product was a victory. Ms. Kim was one of a group of women who won a lawsuit against Johnson & Johnson in 2018.

“It means no more little girls are going to go through what we went through,” said Ms. Kim, who started using baby powder when she was 10 years old. “This stops now. That monster is off the shelves.”

Early lawsuits against Johnson & Johnson claimed the talc itself caused ovarian cancer, though the scientific evidence on that was never conclusive. Plaintiffs’ lawyers later shifted their focus, arguing that traces of asbestos — an indisputable and much-feared carcinogen — were present in talc and capable of causing cancer even in microscopic amounts.

Asbestos contamination can occur when talc is mined, because both minerals can be intermingled underground, and internal memos and reports unearthed during litigation revealed that the company had been concerned for at least 50 years about the possibility of traces of asbestos in its talc. Asbestos was first linked to ovarian cancer in 1958.

The revelation of these company documents also prompted inquiries by the Justice Department and Securities and Exchange Commission, as well as congressional committees and authorities in Mississippi and New Mexico.

As of late March, Johnson & Johnson faced 19,400 lawsuits related to talc body powders, many of them involving complicated science. A federal judge ruled in April that plaintiffs’ scientific experts could testify with some exceptions, a blow to Johnson & Johnson, which had been pushing to exclude the testimony in hopes of shutting down thousands of cases.

The legal record has been mixed so far. Several juries have decided against Johnson & Johnson, in one case awarding $4.7 billion to 22 women including Ms. Kim in 2018. But the company has prevailed in other cases and is appealing nearly all of the cases it has lost.

Johnson & Johnson’s talc supplier, Imerys Talc America, filed for Chapter 11 bankruptcy protection last year.

In October, Johnson & Johnson recalled 33,000 bottles of baby powder after the Food and Drug Administration said it discovered evidence of chrysotile asbestos in a bottle purchased from an online retailer. Soon after, the company said that multiple tests of the same bottle came up clean.

Nathan A. Schachtman, a lawyer who defends product liability cases and spent decades handling asbestos-related claims, said that companies often agreed to settle lawsuits or discontinue products that they believed were safe in an attempt to soothe shareholders and win back public confidence — to “buy peace,” he said.

“At some point, the shareholders don’t care whether the science is on your side,” said Mr. Schachtman, who said he was not involved in the Johnson & Johnson talc cases. “Companies have to make very practical and hard decisions about withdrawing products that they don’t think are bad products, or dropping cases because they know they can’t win them all and it’s expensive to defend them.”

On Tuesday, Johnson & Johnson said that baby powder made up half a percent of its total consumer health business in the United States and that demand for the talc-based version had slumped. The decision to discontinue the product stemmed from a re-evaluation of its product portfolio, the company said.

Mark Lanier, a lawyer who represents thousands of cancer survivors and their families who are suing Johnson & Johnson, said the company had made “the right move.”

“They can give all the reasons they want — I’m just thankful the stuff is off the market. I do believe this will save untold misery and lives,” Mr. Lanier said.

Though Johnson’s Baby Powder has long been advertised for infants and is stocked on the baby aisle along with diapers and baby shampoo, adult women have been the main purchasers in recent decades, using it on their perineum and to prevent chafing between the legs.

Thousands of women who developed ovarian cancer after long-term use of the product blamed the powder and sued the company, while a smaller number sued after developing mesothelioma, a rare and particularly vicious cancer that develops in the linings of the lungs and abdomen and is considered a signature disease of asbestos.

And groups that have advocated the removal of other talc-based cosmetics from the market seized on Johnson & Johnson’s decision to call for more companies to do the same.

In a statement, the Environmental Working Group advocacy organization urged other cosmetic companies to stop using talc in loose powders. The group said that it commissioned tests that last week found asbestos in two eye shadow palettes made with talc, marketed to children and sold on Amazon.

Amazon did not immediately respond to a request for comment.

The F.D.A. issued several alerts last year warning that asbestos had been discovered in several talc cosmetics products, including eye shadow sold at Claire’s, a retailer focused on teenagers.

Linda Reinstein, whose husband died of asbestos-induced mesothelioma and who now heads the Asbestos Disease Awareness Organization, called the company’s move a public health victory but said several chemical companies continued to use asbestos in manufacturing and had blocked an outright ban on it. “We can’t wait for them to follow Johnson & Johnson,” she said.

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Everlywell gains first FDA authorization for a standalone, at-home, COVID-19 test sample collection kit

Everlywell was one of the first startups to announce that it was working on a self-administered, at-home COVID-19 diagnostic kit, but it initially sought out to ship kits before regulators made clear that this was not in line with its guidelines. Everlywell then became intent on working with the FDA to secure a proper Emergency Use Authorization for its kits before sending any to consumers, and that approach has paid off with the U.S. drug regulator issuing an EUA for Everlywell’s tech today.

Everlywell‘s COVID-19 Test Home Collection Kit is the first standalone sample collection kit to be granted a proper EUA by the FDA. Other kits have been in use through physician-prescribed and directed collection, and others still have been authorized specifically for use with one test (where provider of both kit and test are the same). This approval is unique because Everlywell is offering its sample kit independent of any specific testing lab, and can work with a variety of labs to potentially provide a broader testing footprint.

The test kits are then sent to one of two labs currently authorized under separate EUAs for COVID-19 testing, and the administration notes that this could expand to other test providers in future should they file for an EUA and provide the requisite data that goes along with the verification required for that emergency approval. The FDA cites Everlywell’s work in collecting and presenting data from studies including those supported by the Bill and Melinda Gates Foundation to show that samples collected at home using its nasal swab collection method remain stable during shipping.

That data is also now available to others looking to provide similar test kit offerings, the FDA notes, which should reduce the burden of proof on anyone looking to gain authorization for a competing product. That could potentially open up testing even further, reducing a bottleneck that many public health professionals see as one of the key drivers of a successful recovery.

“The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health in a statement provided to TechCrunch. “Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”

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Employers Rush to Adopt Virus Screening. The Tools May Not Help Much.

Bob Grewal recently began testing a new health-screening setup for workers at a Subway restaurant he owns in Los Angeles near the University of Southern California.

When he stepped inside the employee food prep area, a fever-detection and facial recognition camera service, PopID, quickly identified him by name and gauged his temperature. Then a small tablet screen underneath the camera posted a message that cleared him to enter.

“Thank you Bob, you have a healthy Temp. of 98.06,” the screen said. “PopID aims to create a safe environment and stop the spread of Covid-19.”

Mr. Grewal is one of many business leaders racing to deploy new employee health-tracking technologies in an effort to reopen the economy and make it safer for tens of millions of Americans to return to their jobs in factories, offices and stores. Some employers are requiring workers to fill out virus-screening questionnaires or asking them to try out social-distancing wristbands that vibrate if they get too close to each other. Some even hope to soon issue digital “immunity” badges to employees who have developed coronavirus antibodies, marking them as safe to return to work.

But as intensified workplace surveillance becomes the new normal, it comes with a hitch: The technology may not do much to keep people safer.

Public health experts and bioethicists said it was important for employers to find ways to protect their workers during the pandemic. But they cautioned there was little evidence to suggest that the new tools could accurately determine employees’ health status or contain virus outbreaks, even as they enabled companies to amass private health details on their workers.

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Credit…Tag Christof for The New York Times

“I think employers need to look carefully before they jump into any of this,” said Michael T. Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “Some companies are embarking upon things that are not going to help and may actually set us back.”

Over the past month, companies have started marketing a slew of employee-tracking tools to combat the virus.

PwC, the financial services firm, has developed a contact-tracing app to help employers “provide a lower-risk workplace for employees.It will automatically log proximity between employees and can be used to help identify people who may have been exposed to the virus at work.

Salesforce, the giant software company, is offering a new tool, Work.com, to help employers “safely reopen.” Among other things, it will enable companies to create online employee health surveys and map the workplace locations visited by employees with coronavirus infections.

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Credit…Tag Christof for The New York Times

Clear, a security company that uses biometric technology to verify people’s identities at airports and elsewhere, plans this week to start marketing a health-screening service that can be used to vet and clear employees to enter workplaces. The service will take employees’ temperatures with a thermal camera, as well as verify the results of their medical tests for the virus, sharing the results with employers as color-coded scores like green or red.

Caryn Seidman-Becker, the chief executive of Clear, compared her company’s multilevel health-screening approach to airport security checks where a person who sets off a metal detector gets a pat-down.

“Nothing is foolproof,” Ms. Seidman-Becker said. “It’s putting them together that allows you to buy down risk and increase confidence.”

Companies are adopting new employee-tracking technologies partly in response to White House guidelines asking employers to monitor their “work force for indicative symptoms” and prohibit employees with symptoms from returning to workplaces unless a health provider has cleared them.

Yet many of the tools — including certain infrared thermometers and antibody tests that would be needed for employee “immunity” certificates — can be wildly inaccurate. Public health experts said the tools could create a false sense of security, leading workers to spread the virus inadvertently.

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Fever-screening devices, for example, could miss many of the up to one-quarter or more people infected with the virus who do not exhibit symptoms. Or they could inadvertently expose employees who are running higher temperatures because they are under stress or have other health conditions, issues the workers may have preferred to keep private.

Some law professors and bioethicists also warned that the idea of immunity certificates threatened to create a new class system for employment — one that could unfairly prevent certain people from working just because they had never contracted the virus.

“Do we really want a world where some people can go to work and others can’t based on their immunity status?” said Hank Greely, a professor at Stanford Law School who studies the social implications of new health technologies. “The people who can’t will say, ‘This is unfair,’ and they’ll be right.”

He and other experts said companies would be better off investing in a proven health intervention — lab testing for coronavirus — for their employees rather than shiny, new surveillance technologies.

Gabrielle Rejouis, a workers’ rights advocate at the Center on Privacy and Technology at Georgetown Law, said employers should be “providing free testing for their workers if they’re expecting them to come into work, and also making sure that they are paying sick leave and appropriate health benefits to make sure that workers aren’t coming to work sick and infecting their co-workers.”

Many of the worker-screening tools are being introduced with minimal government oversight — and with few details for employees about how companies are using and safeguarding their health data, or how long they plan to keep it.

To support emergency responses to the pandemic, the Food and Drug Administration is temporarily allowing companies to market infrared thermal camera systems that have not been vetted by health regulators for temperature checks in places like warehouses and factories. Similarly, the Equal Employment Opportunity Commission, which enforces antidiscrimination rules that generally prohibit employers from requiring employees to undergo medical exams, said in March that, given the coronavirus threat, employers may measure employees’ temperatures.

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Credit…Tag Christof for The New York Times

The federal law on patient privacy, the Health Insurance Portability and Accountability Act or HIPAA, also puts few restrictions on employers. Although the law protects employee health information collected by an employer for company-sponsored group health plans, it generally does not protect employee health data collected for other purposes, legal experts said.

As a result, companies are forging their own approaches to health-screening accuracy and privacy.

Some restaurants and warehouses, for instance, are using hand-held infrared devices to assess workers’ temperatures. PopID, the restaurant technology company behind the temperature-scanning system that Mr. Grewal is trying at his Subway franchises, uses wall-mounted thermal-imaging cameras that employees stop in front of for temperature checks.

The system records the date, time, employee name and temperature, creating a historical log for employers who want to check on worker compliance. Employers can choose to keep or delete that data.

“The decision to test temperature at a lot of these places has already been made,” said John Miller, the chief executive of the Cali Group, the parent company of PopID. “We’re just providing a better way to do it.”

PopID is also being used by some Taco Bell franchises, assisted living facilities and Lemonade, a California restaurant chain.

Mr. Grewal, whose family owns more than 50 Subway franchises, said he did not expect the temperature-scanning system to be a panacea. He simply views it as a tool to help employers better protect their workers and make consumers feel safer — much like the plexiglass he has installed to separate customers placing takeout orders from employees filling them, he said.

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Credit…Tag Christof for The New York Times

As part of the pilot test, he has asked employees to scan their temperatures four times a day — at the beginning and end of their work shifts, and before and after their break. The employee data is deleted every 30 days.

“People are going to adjust,” Mr. Grewal said. “They’re going to have to understand all the safety precautions that chains have taken.”

Even so, civil liberties experts said it was important for any virus-tracking of employees to be voluntary. Otherwise, by linking identification technologies like facial recognition to employees’ health status, employers could usher in an authoritarian, China-like system of surveillance and social control at workplaces.

“We are accepting encroachments on privacy here that we would not normally accept,” said Jay Stanley, a senior policy analyst at the American Civil Liberties Union. “We need to be vigilant to make sure that they don’t outlast this crisis.”

Four Republican senators recently said they would introduce a Covid-19 privacy bill to hold businesses accountable when they use people’s heath information to fight the pandemic.

As least for now, increased tracking and screening seem poised to become a fact of daily life not just for workers but also for consumers.

Clear, the biometric security company, already operates at sports arenas where fans can use their digital identities and faces to speed through fast-lane security checks. Now, said Ms. Seidman-Becker, Clear’s chief executive, restaurant groups, big-box retailers, sports teams, airlines and cruise ships are considering using Clear Health Pass, the company’s new identity verification and health-screening system, for both employees and customers.

“I really do think that this is ubiquitous,” she said.

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FDA reiterates risks of antimalarial drug use for COVID-19, as study into efficacy ends early due to deaths

The U.S. Food and Drug Administration (FDA) has issued a new warning about the known side effects of hydroxychloroquine and chloroquine, two antimalarial drugs (also used in the treatment of chronic rheumatoid arthritis and lupus), on the same day that a group of researchers published a paper in the Journal of the American Medical Association about their termination of a study investigating the potential of chloroquine as a potential COVID-19 treatment.

The drugs can have dangerous side effects, and the study written about in the AMA journal was ended early because the “primary outcome” was the death of study participants, with 22 deaths resulting. Before it was abruptly ended, the researchers found a lethality rate of 39% in the group of its subjects who took high dosages, and 15% in the low-dosage group, with an overall lethality rate of 27%.

“Our study raises enough red flags to stop the use of a high-dosage regimen, because the risks of toxic effects overcame the benefits,” the researchers said in their findings.

The FDA’s alert on April 24 doesn’t make specific mention of this study, but the 81-person phase II clinical trial represents one of the largest to date. The FDA notice does advise that reports they have received of deaths in COVID-19 patients receiving hydroxychloroquine, either alone or in tandem with other drugs, including an antibiotic known as azithromycin (which all patients in the investigation published in the AMA journal were taking), can result in “abnormal heart rhythms such as QT interval prolongation, dangerously rapid heart rate called ventricular tachycardia and ventricular fibrillation, and in some cases, death.”

Hydroxychloroquine and chloroquine gained widespread attention because Donald Trump advocated them as likely effective treatments for COVID-19, despite a lack of significant scientific evidence or any clinical studies done about their safety, likely due to early, small-scale investigations that showed they might have some potential. He repeatedly touted the drugs as proven safe, since they have been cleared for use previously in treating other medical conditions, but didn’t appear to grasp that this does not mean they aren’t dangerous or perhaps deadly when taken in the context of other conditions, or for individuals with other risk characteristics.

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Curative received FDA emergency use authorization for its novel COVID-19 tests

The diagnostics startup Curative has received an emergency use authorization from the Food and Drug Administration for its novel test to determine COVID-19 infection.

The company says that its tests have already been used by the City of Los Angeles since late March and have tested over 53,000 city residents.

Curative’s tests use an oral-fluid sample collected by having the subject cough to produce sputum, which release the virus from deep in the lungs, according to a spokesperson.

Here’s how the letter digitally signed by the FDA’s chief science officer, Denise Hinton, describes the Rucative test:

To use your product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab, and oral fluid specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using an authorized real-time (RT) PCR instrument. The Curative-Korva SARS-Cov-2 Assay uses all commercially sourced materials or other authorized materials and authorized ancillary reagents commonly used in clinical laboratories as described in the authorized procedures submitted as part of the EUA request. 

Curative, which was first covered by DotLA, is processing the tests in conjunction with Korva Labs, a testing facility associated with UCLA.

These tests hope to get around the supply chain shortages that constrain the number of tests the US can conduct. Currently, the US is still experiencing a shortage of test kits because the supply chain for critical components used in test kits has been disrupted by the global COVID-19 pandemic, the company said.

Curative is working to build alternatives to many of the sample collection and extraction kit components and what it calls more scalable RNA extraction methods that don’t rely on the use of magnetic silica beads.

The company was initially founded in January 2020 to focus on a novel test for sepsis, but pivoted to focus on COVID-19 testing as the disease swept across the globe.

“Our goal is to assemble an orthogonal supply chain to supply coronavirus test kits. Doing so will help us avoid buying materials that would constrain public health and CDC laboratories from ramping up production,” the company said on its website. “We are also working to partner with other operations looking to spin up testing facilities to help them source necessary reagents.”

Curative says that its test is better for two reasons. Its sampling method reduces the risk of exposure for healthcare workers and requires less Personal Protective Equipment and its use of an alternative supply chain means it can scale tests rapidly.

The company can already process roughly 5,000 tests per day and is manufacturing 20,000 test kits over the same period. Test results can be delivered in around 31 hours.

“Broad access to testing is critical to our nation’s response to COVID-19 and with this authorization, we can continue scaling and distributing our test nationwide,” said Fred Turner, the chief executive and founder of Curative Inc. “Our work with the Cities of Los Angeles and Long Beach has helped thousands of people access testing at drive-through facilities and we are fully equipped to expand that access to help thousands more across the country. At the same time, we are continuing to work with the FDA to validate our test for at-home collection, which would expand access even more.”

With the new authorization, the company is going to begin working with additional distributors around the country.

The Curative tests are already used by Los Angeles, Long Beach and through testing organized by LA County and the LA County Fire and Sherrif’s Department. The tests aren’t being sold directly to consumers and must be ordered by a physician, the company said.

Backed by the venture firm DCVC, Curative has already been the subject of some controversy when its investor sent a letter to limited partners indicating they’d be able to get access to the Curative tests upon request.

The firm wrote:

“… please let us know as soon as possible if you are experiencing COVID-19 symptoms and are unable to get tested. Through a unique relationship with one of our portfolio companies, we will expedite delivery of a test kit (simple, fast, safe saliva/cheek swab) that should provide results within 1-3 days via return by mail.”

In a subsequent blog post, the partners at DCVC explained their outreach.

With changes in regulations enabling telemedicine across state lines, we wanted to make sure everyone DCVC knows was aware of Carbon’s excellent care and full suite of testing. And yes, that includes people who work at our Limited Partners, who are making difficult decisions for themselves and their families in difficult times like the rest of us.

With Carbon moving at the pace they do with their fast, friendly electronic on-boarding, and with Curative’s testing capability likely ramping to 10,000+ tests a day in the next ten days, the combined health care firepower can indeed “expedite” care for everybody.

Was our language a little boastful? Yes, no excuses. And we’re sorry if folks got the wrong idea. No one is “jumping in line.” We will always strive to point out to our friends and community where they can get quick access to quality care as well as access to other cutting-edge technology in our portfolio.

Accurate testing remains the most important feature of any effort to contain the COVID-19 outbreak and a number of startup companies are working on novel diagnostics.

As Harvard University epidemiologist, William Hanage told Business Insider, “Figuring out what’s actually going on in the community is the key part of dealing with this pandemic.”

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