Category: Regulations

YouTube, Vimeo, and Twitter Censor Firm Working on Ultraviolet Covid-19 Cure

(p. A15) Early in the Covid-19 pandemic, Aytu BioScience made a commitment to find ways to help. One of those ways came through our newly formed relationship with a prominent Los Angeles hospital.

On April 20 [2020] we put out a press release titled “Aytu BioScience Signs Exclusive Global License with Cedars-Sinai for Potential Coronavirus Treatment.” The treatment is called Healight, and it was developed by research physicians at the hospital’s Medically Associated Science and Technology Program. The technology, which has been in development since 2016, uses ultraviolet light as an antimicrobial and is a promising potential treatment for Covid-19.

Aytu and Cedars-Sinai have engaged with the Food and Drug Administration to pursue a rapid path to human use through an Emergency Use Authorization. But hardly anyone noticed—until Thursday, when President Trump mused, “. . . supposing you brought the light inside the body . . .”

My team and I knew the president’s comments could trigger a backlash against the idea of UV light as a treatment, which might hinder our ability to get the word out. We decided to create a YouTube account, upload a video animation we had created, and tweet it out. It received some 50,000 views in 24 hours.

Then YouTube took it down. So did Vimeo. Twitter suspended our account. The narrative changed from whether UV light can be used to treat Covid-19 to “Aytu is being censored.”

For the full commentary, see:

Josh Disbrow. “Ultraviolet Light Takes Political Heat.” The Wall Street Journal (Tuesday, April 28, 2020): A15.

(Note: bracketed year added, ellipses in original.)

(Note: the online version of the commentary has the date April 27, 2020, and the title “An Experimental Ultraviolet Light Treatment for Covid-19 Takes Political Heat.”)

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.)

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.

Cancer Mortality Declines Mainly Due to Less Smoking and Better Lung Cancer Treatment

(p. A12) . . . the American Cancer Society reported that the United States had experienced the sharpest one-year drop in cancer death rate ever recorded, . . . .

. . .

The society’s latest annual report on cancer statistics, released on Wednesday, noted that the death rate had dropped steadily over 26 years, from 1991 to 2017. The largest single-year decline ever reported, when the rate fell 2.2 percent, occurred from 2016 to 2017.

. . .

Experts attributed the decline in mortality to reduced smoking rates and to advances in lung cancer treatment. New therapies for melanoma of the skin have also helped extend life for many people with metastatic disease, or cancer that has spread to other parts of the body.

For the full story, see:

Michael Levenson. “Cancer Death Fell Sharply, And Trump Took Credit.” The New York Times (Monday, January 13, 2020): A12.

(Note: ellipses added.)

(Note: the online version of the story has the date Jan. 12, 2020 and has the title “Trump Took Credit for Lower Cancer Death Rates. Advocates Say Not So Fast.” Where there was a minor wording difference between the print and online versions, the quotation above follows the online version. )

The report from the American Cancer Society, mentioned above, is:

Siegel, Rebecca L., Kimberly D. Miller, and Ahmedin Jemal. “Cancer Statistics, 2020.” CA: A Cancer Journal for Clinicians 70, no. 1 (2020): 7-30.

Physicians Fighting Covid-19 Use Social Media “to Share Improvised Solutions”

(p. A9) In mid-March [2020], as U.S. hospitals scrambled for ventilators to treat a surge of coronavirus cases, a Vermont pulmonologist proposed a different treatment on a blog popular with emergency-medicine doctors.

Joshua Farkas observed in the post on the EMCrit blog that many Covid-19 patients seemed to benefit from less-invasive alternatives to help their breathing, including pressure therapy used to treat sleep apnea—sometimes referred to as CPAP, for continuous positive airway pressure.

. . .

The post helped galvanize an emerging theory about the treatment of Covid-19 patients, which in recent weeks has taken hold in U.S. hospitals. In New York City, where ventilators are in perilously short supply, doctors say they have since embraced CPAP and other treatments to improve breathing in Covid-19 patients.

The shift is one example of how health-care workers are writing the playbook for treating coronavirus patients on the fly, knowing they can’t wait for peer-reviewed articles or studies in established medical journals. Instead they are tapping into social media, podcasts, inside-baseball medical blogs and text-message groups to share improvised solutions to supply shortages and patient care, forcing hospitals to quickly re-evaluate their practices.

“This has been a rapidly evolving process,” said Dr. Farkas, who has treated Covid-19 patients in the intensive-care unit at the University of Vermont in Burlington. “As we struggle with how to treat a disease that so recently was totally unknown, this rapid exchange and updating of information is crucial.”

. . .

Last week, Michelle Romeo, a chief emergency-medicine resident at NYU Langone and Bellevue hospital in Manhattan, tweeted photos of a jury-rigged breathing device involving a mask used for BiPAP—an airway pressure therapy similar to CPAP.

At Mount Sinai Hospital in Manhattan, pulmonologists worked with the hospital’s sleep lab to figure out a way to use BiPAP machines like a ventilator. The result was posted on Reddit, and got “all kinds of different responses,” said Valerie Burgos-Kneeland, a registered nurse in the hospital’s Medical Intensive Care Unit. “It’s kind of been an opportunity for people to get creative.”

For the full story, see:

Rebecca Davis O’Brien. “Doctors Improvise, Share Treatments.” The Wall Street Journal (Friday, April 10, 2020): A9.

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

(Note: the online version of the story has the date April 9, 2020, and has the title “Doctors Are Improvising Coronavirus Treatments, Then Quickly Sharing Them.”)

“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.”)

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.)

“Masks Are Pilloried Until They Are Mandatory”

(p. 6) The surreal reality of American cities and towns also mirrors the half-remembered, half-empty approximations explored in sleep, ordered by the same pliable, foggy logic: Masks are pilloried until they are mandatory; liquor stores open early for sexagenarians only; an invisible plague makes people fall gravely ill seemingly at random; touching anything — everything — is banned.

For the full story, see:

Caity Weaver. “The Interpretation of Viral Dreams.” The New York Times, SundayStyles Section (Sunday, April 12, 2020): 6.

(Note: the online version of the story has the date April 11, 2020, and has the title “Why Am I Having Weird Dreams Lately?”)