Category: Covid-19

“Real World Evidence” on Effectiveness of Experimental Drugs Can Be Extracted From Electronic Health Records

(p. A7) . . . analysis of compassionate-use data, about the experimental drug remdesivir from Gilead Sciences Inc. published in the New England Journal of Medicine, came under criticism. Scientists pointed out that the Covid-19 patients received the drug in centers around the world where care may have differed, data on some patients was incomplete and there was no comparison group.

That study’s first author, Jonathan Grein, of Cedars-Sinai Medical Center in Los Angeles, said given how little is known about the coronavirus and how to treat it, “I think at this point any information is potentially helpful.” He said the study, funded by Gilead Sciences, noted the findings were limited and preliminary. “It is a starting point, an opportunity to aggregate our initial experiences,” he said.

. . .

The FDA . . . has worked closely with companies trying to extract “real world evidence” about patients’ experiences with new or experimental drugs from sources such as electronic health records.

For the full story, see:

Amy Dockser Marcus. “Hundreds Get Plasma in National Study.” The Wall Street Journal (Wednesday, April 22, 2020): A7.

(Note: ellipses added.)

(Note: the online version of the story has the date April 21, 2020, and has the title “Hundreds Receive Plasma From Recovered Coronavirus Patients in National Study.”)

Blacks Deficient in Vitamin D Are at Greater Risk of Cytokine Storm from Covid-19

(p. A15) Black Americans are dying of Covid-19 at a higher rate than whites. Socioeconomic factors such as gaps in access to health care no doubt play a role. But another possible factor has been largely overlooked: vitamin D deficiency that weakens the immune system.

Researchers last month released the first data supporting this link. Based on a link between levels of the inflammatory marker C-reactive protein and severe cases of Covid-19, they estimate that tens of thousands of lives could be saved world-wide by normalizing vitamin D levels, through its modulation of the inflammatory cascade.

Vitamin D is produced by a reaction in the skin to the ultraviolet rays in sunlight. Many Americans are low in vitamin D, but those with darker skin are at a particular disadvantage because melanin inhibits the vitamin’s production.

For the full commentary, see:

Vatsal G. Thakkar. “Vitamin D and Coronavirus Disparities.” The Wall Street Journal (Friday, April 17, 2020): A15.

(Note: the online version of the commentary has the date April 16, 2020, and has the same title as the print version. Where the wording of the online and print versions differs, the passages quoted above follow the online version.)

The research working paper mentioned above, is:

Daneshkhah, Ali, Vasundhara Agrawal, Adam Eshein, Hariharan Subramanian, Hemant Kumar Roy, and Vadim Backman. “The Possible Role of Vitamin D in Suppressing Cytokine Storm and Associated Mortality in Covid-19 Patients.” (April 30, 2020).

Art Diamond Interviewed on Curing Covid-19

On Monday, May 4, Jim Blasingame, the host of his nationally syndicated “The Small Business Advocate” radio show, interviewed me on issues related to my book Openness to Creative Destruction, and “Free to Choose a Possible Cure,” my April 17 op-ed piece on the web site of the American Institute for Economic Research. You can click on the links below to listen to each segment of the interview.

EPA Brags of Taking Weeks to Approve Soft-Pack Packaging for Scarce Disinfectant Wipes

New York (CNN)The coronavirus pandemic has made all kinds of virus-busting home cleaning products nearly impossible to find.

Disinfectant wipes, especially, are in high demand with consumers clearing out shelves just as quickly as stores restock them.

But now, one of the biggest makers of private-label wipes says tens of millions more wipes are expected to hit store shelves.

Rockline Industries, which makes Good & Clean wipes and store brand products for major retailers, said the wipes will be available at stores later this month.

. . .

Rockline was able to increase its wipes production because of a packaging tweak.

Cleaning wipes are predominantly packaged in hard plastic canisters, unlike baby wipes, which usually come in soft-packs.

. . .

But the unprecedented demand for household disinfectant wipes led to Rockline maxing out its canister production. It needed a different solution to be able to quickly and significantly increase the volume of packaged wipes to meet demand.

. . .

Given how quickly the disinfectant wipes supply is depleting in the market in response to the pandemic, Rockline, in February [2020], started exploring different ways to expedite supply, including alternative packaging formats.

The disinfectant wipes products are registered with the Environmental Protection Agency, which oversees the category and approves new products, new ingredients and packaging changes for individual companies.

So, several weeks ago, Rockline had talks with the EPA about putting its disinfectant wipes in soft-packs in addition to canisters as a way to get even more product into stores. Clorox and Lysol already sell some wipes in soft-packs.

“Typically the approval could take several months,” Dresselhuys said. Rockline was able to get the approval in just a matter of weeks.

The EPA said it’s in its interest to ensure Americans have access to approved surface disinfectant products effective against the novel coronavirus.

“To this end, the agency is expediting disinfectant product reviews and identifying regulatory flexibilities to avoid supply chain disruptions, including ingredient sourcing changes, manufacturing location additions or changes, and packaging changes,” the agency said in a statement to CNN Business.

For the full story, see:

Kavilanz, Parija. “No One Can Get Disinfectant Wipes. One Company Found a Clever Solution to Put Them on Shelves.” In CNN Business, Fri., May 1, 2020, URL: https://www.cnn.com/2020/05/01/business/disinfectant-wipes-shortage-coronavirus/index.html.

(Note: ellipses added.)

Chinese Scientists “Withdrew” Research Paper That Noted Proximity of Shi Bat Lab to Wuhan Market

(p. A11) For the past 15 years, Chinese scientist Shi Zhengli has warned the world—in English, Chinese and French—that bats harbor coronaviruses that pose serious risks to human health.

The flying mammals are a likely culprit in the pandemic now sweeping the globe, and Dr. Shi and her laboratories in Wuhan, where the outbreak was first identified, have attracted suspicion.

. . .

Dr. Shi’s experience—and her large set of reference material—helped her determine that the new coronavirus loose in Wuhan had most likely come from a bat. In fact, a sample her team collected in Yunnan province in 2013 was about 96% identical to the genetic sequence of the virus that causes Covid-19.

All of that has raised questions about whether the virus could have somehow escaped from one of Dr. Shi’s labs and infected Wuhan’s population.

In a February [2020] research paper, Chinese scientists pointed out that the Wuhan market, where the coronavirus began spreading late last year, was close to her labs as well as those of another local scientist who has worked on bats at the Wuhan Municipal Centers for Disease Control and Prevention.

The authors withdrew their paper as “speculation” after it got widespread international notice.

For the full story, see:

James T. Areddy. “‘Bat Woman’ Draws Scrutiny.” The Wall Street Journal (Wednesday, April 22, 2020): A11.

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

(Note: the online version of the story has the date April 21, 2020, and has the title “China Bat Expert Says Her Wuhan Lab Wasn’t Source of New Coronavirus.”)

Early Promising Results from Gilead-Sponsored Study on Remdesivir

(p. B3) A doctor in Chicago told colleagues that Gilead’s drug remdesivir appeared to help many patients enrolled in a clinical trial site at the University of Chicago Medicine hospital, according to a news report in online health publication STAT, which cited a video of the remarks. The doctor said that the hospital had enrolled 125 patients in two remdesivir studies sponsored by Gilead, and that most had been discharged from the hospital, and two had died.

. . .

“Partial data from an ongoing clinical trial is by definition incomplete and should never be used to draw conclusions about the safety or efficacy of a potential treatment that is under investigation,” a University of Chicago spokeswoman said in an email. “Drawing any conclusions at this point is premature and scientifically unsound.”

. . .

Last week, Gilead reported in the New England Journal of Medicine that remdesivir showed encouraging results in treating 53 patients with severe Covid-19 symptoms. The patients were given the drug under so-called compassionate use, which allows for doctors to request unapproved drugs for patients in emergency situations.

Of the 53 compassionate use patients who received remdesivir, nearly half were discharged from the hospital and seven patients died, or 13% of the total, according to the New England Journal paper. Of 30 patients using breathing tubes connected to ventilators, 17 had their tubes disconnected after remdesivir treatment.

For the full story, see:

Joseph Walker. “Gilead Shares Up 9.7% On Encouraging Signs In Covid-19 Drug Trial.” The Wall Street Journal (Saturday, April 18, 2020): B3.

(Note: ellipses added.)

(Note: the online version of the story has the date April 17, 2020, and has the title “Coronavirus Drug Report, Though Inconclusive, Sends Gilead Higher.” Where the versions differ, the passages quoted above follow the somewhat longer online version.)

Chinese Communists Censor Academic Articles on Origins of Covid-19

(p. A21) Beijing has claimed that the virus originated in a Wuhan “wet market,” where wild animals were sold. But evidence to counter this theory emerged in January [2020]. Chinese researchers reported in the Lancet Jan. 24 that the first known cases had no contact with the market, and Chinese state media acknowledged the finding. There’s no evidence the market sold bats or pangolins, the animals from which the virus is thought to have jumped to humans. And the bat species that carries it isn’t found within 100 miles of Wuhan.

Wuhan has two labs where we know bats and humans interacted. One is the Institute of Virology, eight miles from the wet market; the other is the Wuhan Center for Disease Control and Prevention, barely 300 yards from the market.

Both labs collect live animals to study viruses. Their researchers travel to caves across China to capture bats for this purpose. Chinese state media released a minidocumentary in mid-December following a team of Wuhan CDC researchers collecting viruses from bats in caves. The researchers fretted openly about the risk of infection.

. . .

While the Chinese government denies the possibility of a lab leak, its actions tell a different story. The Chinese military posted its top epidemiologist to the Institute of Virology in January. In February Chairman Xi Jinping urged swift implementation of new biosafety rules to govern pathogens in laboratory settings. Academic papers about the virus’s origins are now subject to prior restraint by the government.

For the full commentary, see:

Tom Cotton. “Coronavirus and the Laboratories in Wuhan.” The Wall Street Journal (Wednesday, April 22, 2020): A21.

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

(Note: the online version of the commentary has the date April 21, 2020, and has the title “ON BUSINESS; Airbnb Defied the Odds of Startup Success. How Will It Survive a Pandemic?”)

Firm Founders “Learned to Cope With a Lot of Adversity and Have a Lot of Resilience”

(p. B6) I’m a sucker for good stories about the founding of companies.

Yvon Chouinard started apparel maker Patagonia in a chicken coop; James Dyson went through 5,000 prototypes on his way to inventing a bagless vacuum cleaner; Steve Ellis opened Chipotle burrito shops simply to earn enough money to start a gourmet restaurant (he never got that far).

Airbnb Inc.’s story takes the cake. In 2008, a couple entrepreneurial types living on Ramen noodles in San Francisco cooked up an online home-sharing scheme. They recruited a computer scientist, funded their idea in the early days by maxing out credit cards and selling politically-themed cereal boxes, and held on until their company shook up the entire lodging industry.

. . .

“There’s this crazy idealism that founders have,” Brian Chesky, one of those Airbnb founders and the company’s chief executive, told me this week in a video chat. “They’ve learned to cope with a lot of adversity and have a lot of resilience.”

For the full commentary, see:

John D. Stoll. “ON BUSINESS; Airbnb Defied the Startup Odds. Will It Survive a Pandemic?” The Wall Street Journal (Saturday, April 18, 2020): B6.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date April 17, 2020, and has the title “ON BUSINESS; Airbnb Defied the Odds of Startup Success. How Will It Survive a Pandemic?”)

Small Is Not Always Beautiful

(p. A16) Zaid Kurdieh has so many fava beans growing at his farm in upstate New York that he could send 4,000 pounds a week to the best chefs in New York City. In Kentucky, Robert Eversole and Thomas Sargent planted enough winter greens to fill the all the salad bars at the University of Kentucky and still have enough left over to feed fans at the state’s two major spring horse races.

But the coronavirus pandemic has postponed the Kentucky Derby and shut the university. And in New York, chefs who would normally be shelling Mr. Kurdieh’s fava beans for their spring menus have closed their restaurants.

So these small farmers, like many others across the country who spent decades building a local, sustainable agricultural system, are staring at their fields and wondering what to do now that the table has been kicked out from under the modern farm-to-table movement.

. . .

Farm-to-table — the term has become a fixture in the culinary lexicon — started in the 1970s, when Chez Panisse and a handful of other restaurants hatched what then seemed like a radical notion: Build menus from food grown by nearby farmers who are thoughtful about everything from the seeds they select and the soil they grow them in to the communities they feed.

That idea grew into a pipeline connecting farmers, ranchers and chefs that in 2019 had generated $12 billion in income for small-scale producers including cheesemakers and vintners. Governments, hospitals and schools have come to see the value in buying locally grown food. No Silicon Valley tech company worth its stock price would dare to design a cafeteria without local food.

Since the pandemic hit, that conduit has shut down. The loss in sales could run as high as $689 million, with much higher costs in jobs and other businesses that make up the farm-to-table economic ecosystem, according to a report compiled in March by the National Sustainable Agriculture Coalition.

For the full story, see:

Kim Severson. “Farm-to-Table Falters, and Growers Are in Limbo.” The New York Times (Friday, April 10, 2020): A16.

(Note: ellipsis added.)

(Note: the online version of the story has the date April 9, 2020, and has the title “The Farm-to-Table Connection Comes Undone.”)

An Informed Public Can Protect Themselves Better than Central Planners Can Protect Them

(p. A15) China teaches one thing: When a novel respiratory virus emerges, a free press is on balance an indispensable medical asset. The steps an informed public can take to protect itself are far more potent than any top-down action. Unknown is whether the new disease really originated in a meat market in Wuhan, as was first reported. But suppressing news of its outbreak once it was discovered was China’s most fatal mistake.

For the full commentary, see:

Holman W. Jenkins, Jr. “BUSINESS WORLD; Coronavirus Needs a Free Press.” The Wall Street Journal (Wednesday, February 12, 2020): A15.

(Note: the online version of the commentary has the date Feb. 11, 2020, and has the same title as the print version.)

A Map as Large as the Territory It Represents

(p. A4) As more reliable data comes in, said Dr. Spiegelhalter, “the Covid-19 pandemic is rapidly becoming a constrained problem.”

. . .

Statistical science, he said, “is a machine, in a sense, to turn the variability that we see in the world — the unpredictability, the enormous amount of scatter and randomness that we see around us — into a tool that can quantify our uncertainty about facts and numbers and science.”

But as he acknowledged in his book, “The Art of Statistics,” models “are simplifications of the real world — they are the maps not the territory.” (This is reminiscent of Jorge Luis Borges’s story, “On Exactitude in Science,” about a map growing as large as the territory it was meant to represent.)

For the full review, see:

Siobhan Roberts. “Embracing the Uncertainties of the Pandemic.” The New York Times (Wednesday, April 8, 2020): A4.

(Note: ellipsis added.)

(Note: the online version of the review has the date April 7, and has the title “Embracing the Uncertainties.”)

The Spiegelhalter book mentioned above, is:

Spiegelhalter, David. The Art of Statistics: How to Learn from Data. New York: Basic Books, 2019.