Category: Covid-19

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.”)

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’.”)

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

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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).

Trump Walks the Walk on Hydroxychloroquine

(p. A6) WASHINGTON—President Trump said he is taking hydroxychloroquine, an antimalarial drug that he has cited as a possible defense against the novel coronavirus but that some scientists have cautioned needs further study and could be dangerous.

“I happen to be taking it, hydroxychloroquine,” he told reporters at the White House on Monday. He said he had consulted with the White House doctor and suggested he is taking the drug as a preventive measure. Mr. Trump said he has been checked regularly for Covid-19, has tested negative and has no symptoms. He said he has been taking hydroxychloroquine for about a week and a half.

. . .

On Monday [May 18, 2020], Mr. Trump continued to stress anecdotal evidence in favor of the drug and told reporters, “I was just waiting to see your eyes light up when I said this.” He also expressed confidence in the drug’s safety. “I’m not going to get hurt by it. It’s been around for 40 years for malaria, for lupus, for other things.”

For the full story, see:

Catherine Lucey, Jared S. Hopkins. “President Trump Says He Is Taking Hydroxychloroquine as Preventive.” The Wall Street Journal (Tuesday, May 19, 2020): A6.

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

(Note: the online version of the story has the date May 18, 2020, and has the title “Trump Says He Takes Contested Drug for Prevention.”)

The key reference on advocates of a drug who take it first themselves, without confirmation from randomized double-blind clinical trials, is:

Altman, Lawrence K. Who Goes First?: The Story of Self-Experimentation in Medicine. Berkeley, CA: University of California Press, 1998.

China Sent Fewer Masks to World Than Claimed

(p. A6) This spring, Beijing energetically promoted its exports and overseas donations of medical supplies and asked foreign politicians to thank China publicly for the shipments. But a study released on Tuesday [May 6, 2020] found that the shipments were slow to get started.

. . .

The tonnage of China’s net exports of respirators and surgical masks was down 5 percent in March from the same month a year earlier, according to an analysis by Chad Bown, a trade specialist at the Peterson Institute for International Economics in Washington.

The analysis, based on Beijing’s own customs data, also found that China cut way back on exports of medical supplies in January and February and stepped up imports in those months.

For the full story, see:

“Top British Doctor Quits After Violating Lockdown.” The New York Times (Wednesday, May 6, 2020): A6.

(Note: ellipsis added.)

(Note: the online version of the story was updated May 21 [sic], 2020 and has the title “Top U.K. Scientist Resigns Over Coronavirus Distancing Violation.” The print and online articles are a series of brief articles that are only related by being on some aspect of the Covid-19 pandemic. In the online version, all of the brief articles must be searched-for under the name of the top brief article.)

Sarilumab Showed “Hint” of Promise for Critically Ill Covid-19 Patients

(p. A10) . . . , preliminary results on treatments with . . . sarilumab, marketed as Kevzara and made by Regeneron and Sanofi, indicate that it does not help patients who are hospitalized but not using ventilators.

. . .

The patients fell into two groups — “severe,” meaning they required oxygen but did not need a ventilator or so-called high flow oxygen, and “critical,” those who needed a ventilator, high flow oxygen or were in intensive care.

. . .

The results for the critically ill patients are not conclusive but there is a hint that such patients may be helped, so the study will continue with only critically ill patients. More than 600 have been enrolled. Results are expected in early June [2020].

For the full story, see:

Gina Kolata. “Drug Shows Slim Promise For Critical Covid Cases.” The New York Times (Tuesday, April 28, 2020): A10.

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

(Note: the online version of the story has the date April 27, 2020, and has the title “Arthritis Drug Did Not Help Seriously Ill Covid Patients, Early Data Shows.”)