Seeking Cure for Covid-19, Scientist in Elite Group Identifies the FDA as “the Problem Here”

(p. A1) A dozen of America’s top scientists and a collection of billionaires and industry titans say they have the answer to the coronavirus pandemic, and they found a backdoor to deliver their plan to the White House.

The eclectic group is led by a 33-year-old physician-turned-venture capitalist, Tom Cahill, who lives far from the public eye in a one-bedroom rental near Boston’s Fenway Park. He owns just one suit, but he has enough lofty connections to influence government decisions in the war against Covid-19.

. . .

(p. A6) Brian Sheth, co-founder of private-equity firm Vista Equity Partners, and a Democrat, had been watching the effort gather steam from his home in Austin, Texas. He was an early investor in Dr. Cahill’s fund and had been on the first call. His expertise was technology, though, not immunology.

He had become friendly with Thomas Hicks Jr., the Dallas businessman and co-chairman of the Republican National Committee. Mr. Sheth introduced Mr. Hicks to Dr. Cahill’s group.

The connection cinched ties between a group of mostly liberal scientists from left-leaning institutions with a Republican stalwart who hunts birds with Donald Trump Jr.

In his first chat with the group, Mr. Hicks said, “I’m not a scientist. Make it clear enough for me, and then tell me where the red tape is.”

A major concern of the scientists was the FDA. The scientists had in their research identified monoclonal antibody drugs that latch onto virus cells as the most promising treatment. But to make the medicine in sufficient quantities, one drugmaker, Regeneron Pharmaceuticals Inc., would have to shift some of its existing manufacturing to Ireland. FDA rules required a monthslong wait for approval.

Mr. Scolnick, who had tussled with bureaucracy during the AIDS epidemic, tried reaching the FDA. The call ended poorly after the bureaucrats told the group they already had the pandemic under control. In a group call afterward, one of the scientists said, of the FDA: “They’re the problem here.”

Dr. Cahill got in touch with Mr. Ayers. Once the group briefed the vice president’s aide on the bottleneck, Mr. Ayers said he knew who to call. That evening, March 27, Regeneron received a call from the FDA. They had permission, starting immediately, to shift production to Dublin.

For the full story, see:

Rob Copeland. “Scientists, Billionaires Mount Manhattan Project for Covid-19.” The Wall Street Journal (Tuesday, April 28, 2020): A1 & A6.

(Note: ellipsis added.)

(Note: the online version of the article has the date April 27, 2020, and the title “The Secret Group of Scientists and Billionaires Pushing a Manhattan Project for Covid-19.”)

“For Every Scientist Employed by the F.D.A., There Are Three Lawyers”

(p. 5) Imagine that the fateful day arrives. Scientists have created a successful vaccine. They’ve manufactured huge quantities of it. People are dying. The economy is crumbling. It’s time to start injecting people.

But first, the federal government wants to take a peek.

That might seem like a bureaucratic nightmare, a rubber stamp that could cost lives. There’s even a common gripe among researchers: For every scientist employed by the F.D.A., there are three lawyers. And all they care about is liability.

For the full commentary, see:

Stuart A. Thompson. “How Long Will a Vaccine Really Take?” The New York Times, SundayReview Section (Sunday, May 3, 2020): 4-5.

(Note: the online version of the commentary was updated April 30, 2020 and has the same title as the print version.)

Hydroxychloroquine Clinical Trials Suspended on Basis of Lancet Article Containing “Major Inconsistencies”

(p. A11) A group of scientists who raised questions last week about a study in The Lancet about the use of antimalarial drugs in coronavirus patients have now objected to another paper about blood pressure medicines in the New England Journal of Medicine, which was published by some of the same authors and relied on the same data registry.

Moments after their open letter was posted online Tuesday morning [June 2, 2020], the editors of the N.E.J.M. posted an “expression of concern” about the paper, and said they had asked the paper’s authors to provide evidence that the data are reliable.

The Lancet followed later in the day with a statement about its own concerns regarding the malarial drugs paper, saying that the editors have commissioned an independent audit of the data.

. . .

In their letter to the N.E.J.M., critics of the work wrote: “Serious, and as yet unanswered, concerns have been raised about the integrity and provenance of these data.”

The letter points out “major inconsistencies” between the number of coronavirus cases recorded in some countries during the study period and the number of patient outcomes reported by the researchers over the same period.

. . .

Many of the scientists who first raised concerns about the database are involved in clinical trials of chloroquine and hydroxychloroquine, and they were forced to pause the studies for safety reviews after The Lancet study was published.

James Watson, a senior scientist with MORU Tropical Health Network, said his unit had to immediately suspend work on a large randomized clinical trial to see if chloroquine or hydroxychloroquine can protect health care workers exposed on the job to the coronavirus from infection.

“I saw very quickly this paper didn’t hold up to much scrutiny at all,” he said. “We started wondering, ‘Who’s been collecting this data, and where did it come from?’ We were quite surprised to see a global study with only four authors listed and no acknowledgment of anyone else.”

. . .

David Glidden, a professor of biostatistics at University of California, San Francisco, who reads all new publications about Covid-19 antiviral therapies as a member of a National Institutes of Health clinical guidelines panel, said he was immediately struck by the vagueness of the descriptions in both papers.

For the full story, see:

Roni Caryn Rabin. “Scientists Question Medical Data From Single Company Used in Two Studies.” The New York Times (Wednesday, June 3, 2020): A11.

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

(Note: the online version of the article was updated June 2, 2020, and had the title “Scientists Question Medical Data Used in Second Coronavirus Study.”)

Disillusioned Cuban Communist Became Entrepreneur

(p. 7) . . . , Ms. Limonta’s faith in the revolution had been absolute. Born just three weeks after Fidel Castro started his uprising by beaching an old American yacht called Granma in a mangrove swamp on Cuba’s southern shore in 1956, she had fully embraced his promise to wipe out inequality and create a new Cuba.

. . .

As the revolution aged, contradictions grew harder to ignore. As her job took her around the country, she saw that the hospitals most Cubans went to were shabby reflections of the one where her mother was treated. Other Cubans waited months, sometimes years, for a wheelchair. They couldn’t count on oxygen being available. Vital equipment broke down. Medicines ran out. Doctors and nurses expected to be bribed.

The stark differences weighed on Ms. Limonta, weakening her revolutionary spirit as well as her heart. She was just 48 when she was rushed to the mediocre hospital to which she, as a resident of Guanabacoa, was assigned. But once doctors found out who she was, they insisted on transferring her to Cuba’s top cardiology center.

She got the pacemaker she needed, but the speedy treatment only deepened her doubts. Bound by a strict sense of social justice, she finally forced herself to see the truth. She and her mother had been pampered in their time of need not because they were equal to other Cubans. Not because they were socialists. Not because they loved Fidel. But because they were more important.

The surgery caused a nearly mortal infection in her heart. Emergency open-heart surgery left her scarred and uncertain about her life. She decided to quit her job, hand in her party membership, give back her state car and even renounce the Santería religion she had been practicing.

Standing before a mirror one day, she cried. The scars on her body made her look like she had been torn apart and sewn back together, which was how she felt about her life. She had turned her back on everything she once believed in and had no idea how to go on. She was not like her friend Lili, who led the neighborhood Committee for the Defense of the Revolution and whose faith in Communism was unshakable. Like many other Cubans whose support for the revolution lagged, Ms. Limonta had few options. She could dissent openly and invite harassment or persecution. She could throw herself into a raft and hope the sea breezes blew her to Florida. Or she could keep her thoughts to herself and focus on surviving.

Even with the subsidized rice and beans every Cuban receives, her $12 monthly pension guaranteed only misery. She needed to remake her life and found inspiration in the old treadle sewing machine that her mother had given her for graduation. Using discarded hotel sheets, she sewed crib sets for newborns that she covertly sold for a few dollars apiece. In 2011, when Raúl Castro cautiously allowed Cubans to start their own small businesses, Ms. Limonta became one of Cuba’s first legal capitalists.

Eventually, with help from a church-sponsored business incubator, she created her own company, rented space for a workshop, hired seamstresses and started turning out clothing of her own design. When President Barack Obama visited Havana in 2016 to see for himself how Cuba was responding to the opening he had set in motion, Ms. Limonta was among the Cuban entrepreneurs who met with him.

. . .

. . . , the old men who run Cuba cannot deny that they’ve lost even individuals like Ms. Limonta who once embraced the revolution. Cubans are not in the streets protesting, but they have no loyalty toward the men who took Fidel Castro’s place or the political system they keep propping up.

For the full commentary, see:

Anthony DePalma. “How Cubans Lost Faith in Revolution.” The New York Times, SundayReview Section (Sunday, May 24, 2020): 10.

(Note: ellipses added.)

(Note: the online version of the commentary has the date May 23, 2020 and has the same title as the print version.)

DePalma’s commentary, quoted above, is related to his book:

DePalma, Anthony. The Cubans: Ordinary Lives in Extraordinary Times. New York: Viking, 2020.

SARS Taught Hong Kongers to Wear Masks

(p. A8) When Alex Lam types “SARS” into his iPhone, a face-mask emoji pops up, as it does for others in Hong Kong. It is a reminder of the infectious-disease crisis that disrupted life in his home city in the early 2000s.

“Everyone here remembers the hard times back in 2003” and doesn’t want to repeat them, said Mr. Lam, who contracted the earlier coronavirus, severe acute respiratory syndrome.

When the new coronavirus emerged, he quickly began wearing masks in public, washing his hands and avoiding crowds.

. . .

Social-distancing measures were also in place in Hong Kong soon after China introduced the first coronavirus lockdowns in January [2002]. Authorities shut schools and ordered the city’s thousands of civil servants to work from home in late January.

. . .

Residents grew accustomed to wearing masks, which many global experts believe help prevent those infected from spreading the disease to others.

For the full story, see:

Natasha Khan, Timothy W. Martin. “Past Outbreaks Helped Asia Tackle Crisis.” The Wall Street Journal (Thursday, May 7, 2020): A8.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the story was updated May 7, 2020 and has the title “Asia’s Lesson for Corralling Coronavirus? ‘Act Fast’.”)

Honoring the Heroes of Hong Kong and Tiananmen Square

I posted the entry below to Facebook on Thursday, June 4, 2020, the 31st anniversary of the day when the Chinese Communists massacred those protesting for democracy and freedom in Tiananmen Square.

At 8 PM I lit a candle to honor the heroes of Hong Kong who dared to gather today to honor the heroes of Tiananmen Square. #6431truth #HongKongFreedom

Posted by Arthur Diamond on Thursday, June 4, 2020

California Places the Regulatory “Final Straw” on Elon Musk’s Tesla

(p. A15) Informed by Democratic Gov. Gavin Newsom’s authorities that his factory in Fremont had to remain in lockdown, Mr. Musk tweeted: “Frankly, this is the final straw. Tesla will now move its HQ and future programs to Texas/Nevada immediately.”

The keyword here is “final straw,” suggesting that Mr. Musk’s cost-of-doing-business problems with California predate this virus. Hundreds of businesses already have relocated out of California, fleeing the uncountable regulatory straws the state has laid across the backs of anyone doing business there.

For the full commentary, see:

Daniel Henninger. “WONDER LAND; Elon Musk’s ‘Final Straw’.” The Wall Street Journal (Thursday, May 21, 2020): A15.

(Note: the online version of the commentary has the date May 20, 2020 and has the same title as the print version.)

In Most Red States, the Benefits of Opening Economies Exceed the Costs

(p. A4) Two-thirds of confirmed coronavirus cases are in states with Democratic governors. When states are measured by the sheer number of coronavirus cases, six of the top seven have Democratic governors. Together, those six blue states have about half of the nation’s cases, though only about a third of its population.

. . .

“A red-state governor is losing his business in exchange for blue-state lives,” said Angus Deaton, a Nobel Prize-winning economist at a Brookings Institution seminar last week. “So for him, opening up is a no-brainer, which is sort of why it is happening.”

He added: “It is a lot to ask those governors to kill their businesses and their GDP for people who live far away, and who they may not even like very much.”

For the full commentary, see:

Gerald F. Seib. “CAPITAL JOURNAL; Virus Exacerbates the Red-Blue Divide.” The Wall Street Journal (Tuesday, May 19, 2020): A4.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date May 18, 2020 and has the title “CAPITAL JOURNAL; Why Coronavirus Increasingly Exacerbates the Red-Blue Divide.”)

Deaton’s comments quoted above, are consistent with the central message of his co-authored book:

Case, Anne, and Angus Deaton. Deaths of Despair and the Future of Capitalism. Princeton, N.J.: Princeton University Press, 2020.

Matt Ridley Suspects Wuhan Lab Innocent of Creating Covid-19

(p. C5) RaTG13 is the name, rank and serial number of an individual horseshoe bat of the species Rhinolophus affinis, or rather of a sample of its feces collected in 2013 in a cave in Yunnan, China. The sample was collected by hazmat-clad scientists from the Institute of Virology in Wuhan that year. Stored away and forgotten until January this year, the sample from the horseshoe bat contains the virus that causes Covid-19.

. . .

. . . analysis shows that the most recent common ancestor of the human virus and the RaTG13 virus lived at least 40 years ago. So it is unlikely that the cave in Yunnan (a thousand miles from Wuhan) is where the first infection happened or that the culprit bat was taken from that cave to Wuhan to be eaten or experimented on.

Rather, it is probable that somewhere much closer to Wuhan, there is another colony of bats carrying the same kind of virus. Unless other evidence emerges, it thus looks like a horrible coincidence that China’s Institute of Virology, a high-security laboratory where human cells were being experimentally infected with bat viruses, happens to be in Wuhan, the origin of today’s pandemic.

. . .

Bats are sold in markets and supplied directly to restaurants throughout China and southeast Asia, but no direct evidence of their sale in Wuhan’s wet market has come to light. Also, horseshoe bats, which are much smaller than the tastier fruit bats, are generally not among the species eaten. The significance of the Yunnan cave sample is that it shows the bat virus didn’t need to recombine with viruses in other species in a market to be infectious to people. The role of the wet markets may be that other animals get infected there and produce much higher loads of virus than the bats would, amplifying the infection.

For the full commentary, see:

Matt Ridley. “The Bats Behind the Pandemic.” The Wall Street Journal (Saturday, April 11, 2020): C5.

(Note: ellipses added.)

(Note: the online version of the commentary was the date April 9, 2020 and has the same title as the print version.)

The New York Times Advises Its Readers How to Survive the Pandemic

(p. D3) BEST MAIL-ORDER ICE CREAM

Jeni’s Splendid Ice Cream

Shippable to all 50 states, the collections from Ohio’s hyper-popular (and woman-owned) ice cream company includes five pints, with flavors like Brambleberry Crisp and Salty Caramel (and even some lactose-free options for dairy-hesitant or vegan family members). It’s expensive, but Jeni’s unique flavors ad creamy consistency (thank you, butterfat) warrant the cost. $58 plus $13 shipping from Jeni’s Splendid

For the full story, see:

“The New Essentials: Family Fun.” The New York Times, AtHome Section (Sunday, May 24, 2020): 8.

(Note: all-cap heading, bolds, italics, and absence of period after italics, all in original.)

(Note: after a thorough search, as of 5/25/20, it appears that the New York Times did not post this article online.)

Methotrexate Hoped to Moderate Covid-19 Cytokine Storm

(p. A15) Today Dr. Frohman and his team of researchers believe one treatment for MS could do the same for seriously ill Covid-19 patients.

The drug is called methotrexate, and it’s already proven to calm the chaotic responses of panicked immune systems. “A blast of this drug, over a matter of hours . . . pulls the cord on the panic button and resets the immune system,” Dr. Frohman tells me.

The new research is set to be published as early as this week in the Journal of the Neurological Sciences. Methotrexate already has been approved by the Food and Drug Administration, meaning doctors treating Covid-19 patients could begin using it immediately. National Institutes of Health immunologist Avindra Nath said this week that combining methotrexate with remdesivir, an antiviral drug, may set a new standard for fighting the most serious Covid cases.

For the full commentary, see:

Peggy Wehmeyer. “A Covid Drug to Help Fight the Storm.” The Wall Street Journal (Thursday, May 14, 2020): A15.

(Note: ellipsis in original.)

(Note: the online version of the commentary has the date May 13, 2020 and has the same title as the print version.)

The Frohman research, mentioned above, is reported in:

Frohman, Elliot M., Esther Melamed, Roberto Alejandro Cruz, Reid Longmuir, Lawrence Steinman, Scott S. Zamvil, Nicole R. Villemarette-Pittman, Teresa C. Frohman, and Matthew S. Parsons. “Part I. Sars-Cov-2 Triggered ‘Panic’ Attack in Severe Covid-19.” Journal of the Neurological Sciences (in-press 2020).

Frohman, Elliot M., Roberto Alejandro Cruz, Reid Longmuir, Lawrence Steinman, Scott S. Zamvil, Nicole R. Villemarette-Pittman, Teresa C. Frohman, and Matthew S. Parsons. “Part II. High-Dose Methotrexate with Leucovorin Rescue for Severe Covid-19: An Immune Stabilization Strategy for Sars-Cov-2 Induced ‘Panic’ Attack.” Journal of the Neurological Sciences (in-press 2020).