Category: Regulations

Insurers Are Paid More When They Negotiate HIGHER Prices for Patients

(p. A1) This year, the federal government ordered hospitals to begin publishing a prized secret: a complete list of the prices they negotiate with private insurers.

The insurers’ trade association had called the rule unconstitutional and said it would “undermine competitive negotiations.” Four hospital associations jointly sued the government to block it, and appealed when they lost.

They lost again, and seven months later, many hospitals are simply ignoring the requirement and posting nothing.

But data from the hospitals that have complied hints at why the powerful industries wanted this information to remain hidden.

It shows hospitals are charging patients wildly different amounts for the same basic services: procedures as simple as an X-ray or a pregnancy test.

And it provides numerous examples of major health insurers — some of the world’s largest companies, with billions in annual profits — negotiating surprisingly unfavorable rates for their customers. In many cases, insured patients are getting prices that are higher than they would if they pretended to have no coverage at all.

. . .

(p. A14) Customers judge insurance plans based on whether their preferred doctors and hospitals are covered, making it hard for an insurer to walk away from a bad deal. The insurer also may not have a strong motivation to, given that the more that is spent on care, the more an insurance company can earn.

Federal regulations limit insurers’ profits to a percentage of the amount they spend on care. And in some plans involving large employers, insurers are not even using their own money. The employers pay the medical bills, and give insurers a cut of the costs in exchange for administering the plan.

. . .

People carefully weighing two plans — choosing a higher monthly cost or a larger deductible — have no idea that they may also be picking a much worse price when they later need care.

Even for simple procedures, the difference can be thousands of dollars, enough to erase any potential savings.

It’s not as if employers can share that information at open enrollment: They generally don’t know either.

“It’s not just individual patients who are in the dark,” said Martin Gaynor, a Carnegie Mellon economist who studies health pricing. “Employers are in the dark. Governments are in the dark. It’s just astonishing how deeply ignorant we are about these prices.”

. . .

Health economists think of insurers as essentially buying in bulk, using their large membership to get better deals. Some were startled to see numerous instances in which insurers pay more than the cash rate.

. . .

“The worrying thing is that the third party you’re paying to negotiate on your behalf isn’t doing as well as you would on your own,” said Zack Cooper, an economist at Yale who studies health care pricing.

. . .

(p. A15) Hospitals and insurers can also hide behind the contracts they’ve signed, which often prohibit them from revealing their rates.

“We had gag orders in all our contracts,” said Richard Stephenson, who worked for the Blue Cross Blue Shield Association from 2006 until 2017 and now runs a medical price transparency start-up, Redu Health. (The association says those clauses have become less common.)

Mr. Stephenson oversaw a team that made sure the gag orders were being followed. He said he thought insurers were “scared to death” that if the data came out, angry hospitals or doctors might leave their networks.

. . .

The new price data is often published in hard-to-use formats designed for data scientists and professional researchers. Many are larger than the full text of the Encyclopaedia Britannica.

And most hospitals haven’t posted all of it. The potential penalty from the federal government is minimal, with a maximum of $109,500 per year. Big hospitals make tens of thousands of times as much as that; N.Y.U. Langone, a system of five inpatient hospitals that have not complied, reported $5 billion in revenue in 2019, according to its tax forms.

For the full story, see:

Sarah Kliff, Josh Katz and Rumsey Taylor. “Hospital Data Reveals Secrets Behind Billing.” The New York Times (Monday, August 23, 2021): A1 & A14-A15.

(Note: the online version of the story has the date Aug. 22, 2021, and has the title “Hospitals and Insurers Didn’t Want You to See These Prices. Here’s Why.”)

FASTA Is Not Faster at Untangling Red Tape to Sell Surplus Federal Property

(p. B6) The plan sounded simple enough.

The federal government has long owned more real estate than it knows what to do with — buildings that sit empty and sites that are underdeveloped — but it must jump through hoops before it can sell its holdings. So surplus properties languish while taxpayers foot the bill for maintenance.

The solution, springing from legislation passed in 2016, was an independent agency that would quickly identify underused properties and expedite their disposal.

But nothing has been simple about the Public Buildings Reform Board, as the little-known agency is called.

It took three years for the five existing board members to be sworn in, and two empty seats remain, including that of the chairman. The Government Accountability Office reported that the board did not adequately document how it went about selecting properties for sale. The board was sued when it sought to sell a Seattle building that is a repository of important tribal records. The General Services Administration, the agency that disposes of most federal properties, has flouted the board’s advice.

And so far, only a single property that the board has recommended for sale has actually been sold.

. . .

The board’s tribulations are a reminder of how difficult it can be to untangle government red tape.

. . .

In the federal government’s 2015 fiscal year, agencies reported more than 7,000 excess or underutilized properties, according to the Government Accountability Office.

Attempts have been made, through Republican and Democratic administrations, to remedy the problem. A bipartisan breakthrough came in 2016 with the passage of the Federal Assets Sale and Transfer Act, known as FASTA, . . .

. . .

But so far, only eight of the FASTA properties have been put up for auction; of these, a parking lot in Idaho Falls, Idaho, has been sold for $268,000.

For the full story, see:

Jane Margolies. “Surplus Property for Sale, Red Tape Included.” The New York Times (Wednesday, September 15, 2021): B6.

(Note: ellipses added.)

(Note: the online version of the story has the date Sept. 14, 2021, and has the title “Plan to Sell Unused Federal Property Becomes ‘Arm-Wrestling Contest’.”)

Chinese Proletariat Yells: “Evergrande, Give Back My Money I Earned With Blood and Sweat!”

(p. B1) When the troubled Chinese property giant Evergrande was starved for cash earlier this year, it turned to its own employees with a strong-arm pitch: Those who wanted to keep their bonuses would have to give Evergrande a short-term loan.

Some workers tapped their friends and family for money to lend to the company. Others borrowed from the bank. Then, this month, Evergrande suddenly stopped paying back the loans, which had been packaged as high-interest investments.

Now, hundreds of employees have joined panicked home buyers in demanding their money back from Evergrande, gathering outside the company’s offices across China to protest last week.

Once China’s most prolific property developer, Evergrande has become the country’s most in-(p. B7)debted company. It owes money to lenders, suppliers and foreign investors. It owes unfinished apartments to home buyers and has racked up more than $300 billion in unpaid bills. Evergrande faces lawsuits from creditors and has seen its shares lose more than 80 percent of their value this year.

Regulators fear that the collapse of a company Evergrande’s size would send tremors through the entire Chinese financial system. Yet so far, Beijing has not stepped in with a bailout, having promised to teach debt-saddled corporate giants a lesson.

. . .

As rumors rippled through the Chinese internet that Evergrande might go bankrupt this month, Mr. Jin and some of his colleagues gathered in front of provincial government offices to pressure the authorities to step in.

In the southern city of Shenzhen, home buyers and employees crowded into the lobby of Evergrande’s headquarters last week and shouted for their money back. “Evergrande, give back my money I earned with blood and sweat!” some could be heard yelling in video footage.

For the full story, see:

Alexandra Stevenson and Cao Li. “Workers Had To Lend Cash To China Firm.” The New York Times (Saturday, September 20, 2021): B1 & B7.

(Note: ellipsis added.)

(Note: the online version of the story was updated Sept. 22, 2021, and has the title “Evergrande Gave Workers a Choice: Lend Us Cash or Lose Your Bonus.”)

French Regulators Ban Hardy Grapes that Thrive in Global Warming

(p. A4) BEAUMONT, France — The vines were once demonized for causing madness and blindness, and had been banned decades ago. The French authorities, brandishing money and sanctions, nearly wiped them out.

But there they were. On a hillside off a winding mountain road in a lost corner of southern France, the forbidden crop was thriving. Early one recent evening, Hervé Garnier inspected his field with relief.

In a year when an April frost and disease have decimated France’s overall wine production, Mr. Garnier’s grapes — an American hybrid variety named jacquez, banned by the French government since 1934 — were already turning red. Barring an early-autumn cold snap, all was on track for a new vintage.

“There’s really no reason for its prohibition,” Mr. Garnier said. “Prohibited? I’d like to understand why, especially when you see the prohibition rests on nothing.”

Mr. Garnier is one of the last stragglers in a long-running struggle against the French wine establishment and its allies in Paris. The French government has tried to rip the jacquez and five other American vine varieties out of French soil for the past 87 years, arguing that they are bad for human physical and mental health — and produce bad wine.

But in recent years, the hardiness of the American varieties has given a lift to guerrilla winemakers like him, as climate change wreaks havoc on vineyards across Europe and natural wines made without the use of pesticides have grown in popularity.

. . .

With France awash in wine, lawmakers urgently addressed the problem around Christmas in 1934. To reduce overproduction, they outlawed the six American vines — including hybrids like the jacquez and pure American grapes like the isabelle — mainly on the grounds that they produced poor wine. Production for private consumption would be tolerated, but not for commercial sale.

The government had planned to follow up with bans on other hybrids but stopped because of the backlash to the initial ban, Mr. Lacombe said. Then the war provided another reprieve.

It was only in the 1950s — when hybrids were still cultivated on a third of all French vineyards — that the government really began cracking down on the six forbidden grapes, Mr. Lacombe said. It offered incentives to rip out the offending vines, then threatened growers with fines.

It then condemned the American grapes as harmful to body and sanity with arguments “not completely honest to try to quell a situation that was slipping away from the government,” Mr. Lacombe said.

“In fact, the present defenders of these vines are right in underlining all the historical and government inconsistencies,” he added.

. . .

Originally from northeastern France, Mr. Garnier, now 68, was once a longhaired high school student who traveled to see Jimi Hendrix, The Who and Janis Joplin perform in concert.

. . .

Some years later, he got into winemaking almost by accident. Two elderly brothers asked him to harvest their jacquez grapes in return for half of the wine production. He learned the history of the forbidden vines and eventually bought the brothers’ vineyards.

Today, he makes 3,400 bottles a year of his deeply colored, fruity “Cuvée des vignes d’antan,” or wine from vines of yesteryear. He got around the ban by creating a cultural, noncommercial association, “Memory of the Vine.” A membership fee of 10 euros, or about $12, yields a bottle.

With the growing threat of climate change and the backlash against the use of pesticides, Mr. Garnier is hoping that the forbidden grapes will be legalized and that France’s wine industry will open up to a new generation of hybrids — as Germany, Switzerland and other European nations already have.

“France is a great wine country,” he said. “To remain one, we have to open up. We can’t get stuck on what we already know.”

For the full story, see:

Norimitsu Onishi. “Guerrilla Winemakers Want France to Yield.” The New York Times (Monday, August 30, 2021): A4.

(Note: ellipses added.)

(Note: the online version of the story was updated Sept. 16, 2021, and has the title “For France, American Vines Still Mean Sour Grapes.”)

E.U. Blocks Innovations in Charger Port Technology

(p. B1) The European Union unveiled plans on Thursday [September 23, 2021] to make USB-C connectors the standard charging port for all smartphones, tablets and other electronic devices sold across the bloc, an initiative that it says will reduce environmental waste but that is likely to hit Apple the hardest.

The move would represent a long-awaited yet aggressive step into product-making decisions by the European Commission, the bloc’s executive arm. Apple, whose iPhones are equipped with a different port, has long opposed the plan, arguing that it would stifle innovation and lead to more electronic waste as all current chargers that are not USB-C would become obsolete.

. . .

(p. B6) European Union officials and lawmakers at the European Parliament have been advocating a common charger since 2009, when there were more than 30 charging options on the market, now down to three. They have argued that fewer wires would be more convenient for users and better for the environment, as mobile phone chargers are responsible for 11,000 tons of electronic waste per year across the bloc, according to estimates by the European Commission.

But Apple has also argued that if the European Union had imposed a common charger in 2009, it would have restricted innovation that led to USB-C and Lightning connectors. In a statement, Apple said that although it welcomed the European Commission’s commitment to protecting the environment, it favored a solution that left the device side of the charging interface open for innovation.

For the full commentary, see:

Elian Peltier. “E.U. Aims to Require USB-C Ports.” The New York Times (Friday, Sept. 24, 2021): B1 & B6.

(Note: ellipsis, and bracketed date, added.)

(Note: the online version of the commentary has the date Sept. 23, 2021, and has the title “In a setback for Apple, the European Union seeks a common charger for all phones.”)

Facebook and Twitter Colluded with Government to Censor Free Speech

(p. A17) The media has panned Donald Trump’s First Amendment lawsuits against Facebook, Twitter and YouTube: “sure to fail,” “as stupid as you’d think,” “ridiculous.”

. . .

But the central claim in Mr. Trump’s class-action lawsuit—that the defendants should be treated as state actors and are bound by the First Amendment when they engage in selective political censorship—has precedent to back it up. Their censorship constitutes state action because the government granted them immunity from legal liability, threatened to punish them if they allow disfavored speech, and colluded with them in choosing targets for censorship.

. . .

A growing body of evidence suggests that social media companies have voluntarily worked with Democratic officials to censor content the latter disfavor. In Brentwood Academy v. Tennessee Secondary School Athletic Association (2001), the high court held that state action exists if the private party’s conduct results from “significant encouragement, either overt or covert,” or if the private party is a “willful participant in joint activity with the State or its agents.”

According to allegations in other pending lawsuits, Twitter formed “trusted partner” relationships with state officials to remove content identified by the officials as election misinformation—when in reality the content was simply critical of state policies.

In September 2020 Mr. Zuckerberg acknowledged that Facebook “works with” the Centers for Disease Control and Prevention to remove Covid-related content. The company’s official policy states that it is “advised” by public-health authorities about what Covid content should be blocked. For months, while officials including Anthony Fauci proclaimed that the Wuhan lab-leak theory was “debunked” and a “conspiracy theory,” Facebook blocked any mention of that theory as “misinformation.”

But after Dr. Fauci and the administration retreated from this position, Facebook almost immediately lifted its ban. Recently published email exchanges between Mr. Zuckerberg and Dr. Fauci reveal no evidence of direct instruction from the government on this point but make a case for Facebook’s willful participation in a joint activity with the government.

For the full commentary, see:

Vivek Ramaswamy. “Trump Can Win His Case Against Tech Giants.” The Wall Street Journal (Monday, July 12, 2021): A17.

(Note: ellipses added; italics in original.)

(Note: the online version of the commentary has the date July 11, 2021, and has the same title as the print version.)

Disney’s Imagineers “Brain Trust” Leaving California for Florida’s “Business Friendly Climate”

(p. B3) Disney executives told roughly 2,000 workers in Southern California—including many members of its famed Imagineers force—that their jobs would be moving to a new campus in Orlando.

. . .

Though Disney’s narrative on Wall Street has lately focused on its streaming efforts, any change to the parks that are beloved by consumers and protected by employees carries symbolic resonance.

That is especially true for the Imagineers, which have become one of Disney’s most revered and mysterious workforces. Since their founding in the mid-20th century, the Imagineers have been credited by fans and Walt Disney himself with innovating some of the signature touches found in Disney theme parks, including beyond traditional entertainment.

. . .

The costly nature of Disney’s new office points to the sophistication of the tech operations moving there. The Imagineers in particular have come to be known as a Disney brain trust, with new employees joining from Google Inc. or the National Aeronautics and Space Administration.

As the scope of Disney’s parks division has grown, smaller groups of Imagineers have been based in Florida, Shanghai and other parts of the world. With this most recent announcement, the largest concentration of Imagineers will no longer be based in Southern California for the first time since their founding.

Imagineer projects have included the Haunted Mansion and Soarin’ Around the World as well as newer additions such as the Avengers Campus and a “Zootopia”-themed land. Employees are immersed in the Imagineer way: to constantly “plus” their work—that is, make every detail a bit better—and think of each project in a “blue sky” way with no limitations.

Josh D’Amaro, the Disney executive overseeing the relocation, recently ended a parks presentation with a clip of Imagineers watching a walking robotic “Groot” from the film “Guardians of the Galaxy.” And then he wielded a “Star Wars” lightsaber.

“It’s real,” he added, two words that sent online fandoms into frantic speculation over what the Imagineers were cooking up. Patent applications routinely stream out of the division, many dissected by parks disciples for clues about what changes might be afoot.

In announcing the change, Mr. D’Amaro, head of Disney’s parks, experiences and products division since May 2020, said the decision didn’t come lightly since he had moved his own family across the country while climbing Disney’s ranks. He cited Florida’s business-friendly climate in announcing the move and pointed out to employees that the state offered a lower cost of living with no state income tax.

For the full story, see:

Erich Schwartzel “Disney Magic Makers to Relocate.” The Wall Street Journal (Saturday, July 24, 2021): B3.

(Note: ellipses added.)

(Note: the online version of the story has the date July 23, 2021, and has the title “Disney Looks to Relocate Its Theme-Park Magic Makers to Florida.” Where there is a slight difference in wording, the quotes above follow the online version.)

RSV and Other Common Viruses Now Surge as Unintended Consequence of Covid-19 Masks, Distancing, and Lockdowns

(p. A6) Doctors in France are calling it the immunity debt: When people avoided each other during the pandemic, they failed to build up the immunity against viruses that comes from normal contact.

As regular life resumes, society may find payments on that debt coming due, in the form of worse-than-normal viral disease outbreaks.

. . .

Figures recently released in Japan show the profound effect exposure to viruses such as flu and RSV can have on a nation’s health.

Deaths caused by pneumonia—a common complication of viral infections—last year in Japan fell by more than 17,000, far outweighing the 3,466 deaths attributed to Covid-19. As a result, Japan’s overall mortality fell for the first time in more than a decade.

It may have been borrowing from the future by creating greater room for viruses to run rampant later. Robert Cohen, a professor at a pediatric research center near Paris called Activ, calls this “immunity debt.”

Dr. Cohen said the hygiene measures adopted during the pandemic bring “an immediate and indisputable benefit” because common illnesses have been suppressed. But at some point almost all children are going to get RS virus, chickenpox and viruses that cause colds, which could mean larger outbreaks when the bugs make up for lost time, he said.

For the full story see:

Miho Inada. “Common Viruses Make a Comeback.” The Wall Street Journal (Tuesday, June 29, 2021): A6.

(Note: ellipsis added.)

(Note: the online version of the story has the date June 28, 2021, and has the title “Post-Covid-19, World Risks an ‘Immunity Debt’.”)

Center-Left Biothreat Expert Says Many Scientists Rejected Wuhan Lab Origin, Not Due to Evidence, but Due to Trump

(p. A13) A few months before Covid-19 became a pandemic, Filippa Lentzos started reading about unusual flu cases in Wuhan, China. Ms. Lentzos, a social scientist who studies biological threats, belongs to an email group she describes as consisting of “ex-intelligence, bioweapons specialists, experts, former State Department diplomats” and others “who have worked in arms control, biological disarmament.”

As Chinese authorities struggled to contain the outbreak, she recalls, the expert circle asked questions about the pathogen’s origin: “Is this security related? Is it military? Is there something dodgy going on? What information are we not getting here?”

. . .

. . . in February 2020, a group of scientists had published a statement in the Lancet calling out “conspiracy theories suggesting that COVID-19 does not have a natural origin.” The New York Times and Washington Post dutifully attacked Mr. Cotton as unhinged. Media, with an assist from some virologists, dismissed the lab-leak theory as “debunked.”

Ms. Lentzos, who places her own politics on the Swiss “center left,” thought that conclusion premature and said so publicly. In May 2020, she published an article in the Bulletin of the Atomic Scientists weighing whether “safety lapses in the course of basic scientific research” caused the pandemic. While acknowledging there was, “as of yet, little concrete evidence,” she noted “several indications that collectively suggest this is a serious possibility that needs following up by the international community.”

. . .

The article barely made a ripple. “If you look at the argumentation that’s used today, it’s exactly the same basically as what I laid out, which was, accidents happen,” she says. “We know that they’re having questions around safety. We know they were doing this field work. We see videos where they’re in breach of standard biosafety protocol. We know China is manipulating the narrative, closing down information sources—all of that stuff. All of that is in there. But it didn’t get much traction.”

. . .

American liberals—including many scientists—conflated open-mindedness about the question with support for Mr. Trump. Ms. Lentzos was one of the few who could separate their distaste for him from their analysis of the pandemic.

. . .

The most significant problem came from the scientific community. “Some of the scientists in this area very quickly closed ranks,” she says, and partisanship wasn’t their only motive: “Like most things in life, there are power plays. There are agendas that are part of the scientific community. Just like any other community, there are strong vested interests. There were people that did not talk about this, because they feared for their careers. They feared for their grants.”

Ms. Lentzos counsels against idealizing scientists and in favor of “seeing science and scientific activity, and how the community works, not as this inner sacred sanctum that’s devoid of any conflicts of interests, or agendas, or any of that stuff, but seeing it as also a social activity, where there are good players and bad players.”

Take Peter Daszak, the zoologist who organized the Lancet letter condemning lab-leak “conspiracy theories.” He had directed millions of dollars to the Wuhan Institute of Virology through his nonprofit, EcoHealth Alliance. A lab mistake that killed millions would be bad for his reputation. Other researchers have taken part in gain-of-function research, which can make viruses deadlier or easier to transmit. Who would permit, much less fund, such research if it proved so catastrophic? Yet researchers like Marion Koopmans, who oversees an institution that has conducted gain-of-function research, had an outsize voice in media. Both she and Mr. Daszak served on the World Health Organization’s origin investigation team.

. . .

Ms. Lentzos has experience working with United Nations agencies, including the World Health Organization. “It was incredibly exciting to finally go in. And then you become more disillusioned when you see how things operate, how things don’t operate,” she says. “Like any large organization, they are slow, and inflexible, and bureaucratic.”

For the full interview see:

Adam O’Neal, interviewer. “THE WEEKEND INTERVIEW; A Scientist Who Said No to Covid Groupthink.” The Wall Street Journal (Saturday, June 12, 2021): A13.

(Note: ellipses added.)

(Note: the online version of the interview has the date June 11, 2021, and has the same title as the print version.)

Dog Sniffs Identify Covid-19 Faster, Cheaper, and More Accurately than Antigen Tests

(p. A6) A growing body of research by scientists and dog trainers from the U.S. to the United Arab Emirates suggests that dogs can use their powerful sense of smell to sniff out Covid-19 infections, including in people without symptoms.

With more than 300 million scent receptors (compared with roughly five million in humans), dogs can do this with a high degree of accuracy by detecting compounds the human body releases in secretions like sweat and saliva as it reacts to the coronavirus, according to scientists.

Dogs have long been trained to detect odors associated with drugs or explosives and have also been used to identify diseases such as cancer, malaria and diabetes.

. . .

One dog can screen 250 to 300 people a day, according to the WHO.

Prof. Grandjean calculated that dog screenings in France could cost as little as one euro, equivalent to about $1.20, per person, as opposed to roughly €75 for a polymerase chain reaction, or PCR, test, a highly accurate test that involves a nasal swab.

. . .

Studies have shown that dogs can be trained to identify Covid-19 infections with roughly 82% to 99% sensitivity and 84% to 98% specificity, Prof. Grandjean said. A test’s sensitivity indicates its ability to correctly detect an infection, while its specificity shows how well it can avoid giving false positives.

Researchers at the University of Veterinary Medicine in Hannover, Germany, trained eight dogs for one week to detect respiratory secretions from infected patients with an average detection rate of 94%, according to a study published recently in the journal BMC Infectious Diseases

In a study of 21 dogs led by Prof. Grandjean, 15 of the animals were able to detect Covid-19 with a sensitivity of 90% or more, with six dogs showing a sensitivity of 71% to 87%. The study was published in April in the Open Access Journal of Veterinary Science and Research.

Such results mean dogs may be more precise than many rapid antigen tests, which correctly identify Covid-19 infections in an average of 72% of people showing symptoms and 58% of asymptomatic people, according to a recent review from Cochrane, a U.K.-based nonprofit that evaluates scientific research.

For the full story see:

Ruth Bender and Rachel Bachman. “Dogs Deployed to Sniff Out Covid.” The Wall Street Journal (Thursday, May 20, 2021): A6.

(Note: ellipses added.)

(Note: the online version of the story has the date May 19, 2021, and has the title “Your Next Covid-19 Test Could Be a Dog’s Sniff.”)

The articles mentioned in the passages above are:

Jendrny, Paula, Claudia Schulz, Friederike Twele, Sebastian Meller, Maren von Köckritz-Blickwede, Albertus Dominicus Marcellinus Erasmus Osterhaus, Janek Ebbers, Veronika Pilchová, Isabell Pink, Tobias Welte, Michael Peter Manns, Anahita Fathi, Christiane Ernst, Marylyn Martina Addo, Esther Schalke, and Holger Andreas Volk. “Scent Dog Identification of Samples from Covid-19 Patients – a Pilot Study.” BMC Infectious Diseases 20, no. 1 (2020). DOI:10.1186/s12879-020-05281-3

Grandjean, Dominique, Dana Humaid Al Marzooqi, Clothilde Lecoq-Julien, Quentin Muzzin, Hamad Katir Al Hammadi, Guillaume Alvergnat, Kalthoom Mohammad Al Blooshi, Salah Khalifa Al Mazrouei, Mohammed Saeed Alhmoudi, Faisal Musleh Al Ahbabi, Yasser Saifallah Mohammed, Nasser Mohammed Alfalasi, Noor Majed Almheiri, Sumaya Mohamed Al Blooshi, and Loïc Desquilbet. “Use of Canine Olfactory Detection for Covid-19 Testing Study on U.A.E. Trained Detection Dog Sensitivity ” Open Access Journal of Veterinary Science & Research (OAJVSR) 6, no. 2 (May 2021). DOI: 10.23880/oajvsr-16000210.

Dinnes, J., J. J. Deeks, S. Berhane, M. Taylor, A. Adriano, C. Davenport, S. Dittrich, D. Emperador, Y. Takwoingi, J. Cunningham, and et al. “Rapid, Point‐of‐Care Antigen and Molecular‐Based Tests for Diagnosis of Sars‐Cov‐2 Infection.” Cochrane Database of Systematic Reviews, no. 3 (2021). DOI: 10.1002/14651858.CD013705.pub2

Slow FDA Feeds Skepticism of mRNA Covid-19 Vaccines

(p. A19) In December 2020, the F.D.A. approved the distribution of mRNA coronavirus vaccines made by Pfizer and Moderna under the agency’s emergency use authorization provision, which permits an accelerated approval process for medications and treatments during a public health emergency.

. . .

In theory, full approval should be imminent, since Pfizer applied for full approval in early May, and Moderna asked for full approval on June 1. This process is often long, requiring the agency to inspect manufacturing plants and review considerable amounts of documentation for vaccine production. But in this case, because of the urgency of the pandemic, the vaccine makers began to submit this material, called a biologics licensing application, in late 2020, and they’ve continued to submit more information. The F.D.A. has already reviewed some of the submissions and has provided feedback to the manufacturers. The emergency authorizations were granted more than six months ago. That’s more than ample time for the agency to conduct plant inspections and review the applications.

. . .

Fortunately, two doses of the mRNA vaccines appear to provide nearly full protection from Covid-related hospitalization and death, and the shots substantially reduce infections.

The lives and health of millions of Americans rest on the F.D.A.’s decision to fully license these vaccines.

For the full commentary see:

Eric J. Topol. “Vaccines Need Full Approval.” The New York Times (Monday, July 5, 2021): A19.

(Note: ellipses added.)

(Note: the online version of the commentary has the date June 1, 2021, and has the title “It’s Time for the F.D.A. to Fully Approve the mRNA Vaccines.”)