Category: Covid-19

Our Government Sends 19-Year-Olds to War but Does Not Allow Them to Try High-Risk, High-Reward Covid-19 Drugs and Vaccines

(p. A11) “Many drug programs are suspended or not pursued at all—not because of flaws in the science but because of commercial and strategic reasons,” Mr. Milken says. Researchers screen those programs, and he calls in his partners either to fund the ideas or promote their development at other companies if the inventors make them available.

It’s a niche in the pharmaceutical world that public funding can’t fill. Mr. Milken sustains a model “where a person could just give me a five-page summary and get a meeting. Government isn’t going to fund that, but philanthropy does.” “These little companies,” he adds—“they’re not Johnson & Johnson, they’re not Novartis, they’re not Amgen. They need financial capital.”

. . .

Mr. Milken’s deals not tinged by controversy, such as his 1983 issuance of bonds to finance telecom company MCI’s long-distance network, show the same preference that shapes his philanthropy: high risk for a high reward.

. . .

A perennial struggle for Mr. Milken has been to convince regulators to share that urgency. He says drug trials generally are too rigid: “We send 19-year-olds into war zones knowing that no matter what we do, some number—greater than zero—will lose their lives or their limbs. But we tell a patient who is going to die not to try something because it could be dangerous.”

Nonetheless, the partners he’s made in his search for cures prove that imagination and activity are still scattered through the country. Discussing the coronavirus with biotech founders and Nobel Prize winners, Mr. Milken says he’s been “thrust back into the 1970s and early ’80s, where any time someone had a new idea—a new company, a passion for something—I had set aside time every day to listen.” On the day a vaccine or effective cure for Covid-19 is finally announced, Americans will owe thanks to such risk takers, who Mr. Milken says “invest in where the world is going, not where it is.”

For the full interview, see:

Mene Ukueberuwa, interviewer. “THE WEEKEND INTERVIEW; What Would You Risk for a Faster Cure?” The Wall Street Journal (Saturday, May 2, 2020): A11.

(Note: ellipses added.)

(Note: the online version of the interview has the date May 1, 2020, and has the same title as the print version.)

Former FDA Research Virologist Suggests “Accelerated Approvals” of Covid-19 Vaccines

(p. A15) Covid-19 is a genuine emergency. Drug and biotech companies and academic institutions are doing their part, and regulators need to, as well. Having been a research virologist who spent 15 years at the FDA as the agency’s “biotechnology czar,” I have some suggestions:

. . .

• The FDA should issue “accelerated approvals” after testing in only limited populations. Additional subgroups—children, pregnant women, etc.—can be tested after approval. The accelerated approvals should be granted before the duration of postvaccination immunity has been ascertained. More-comprehensive trials can then confirm safety, efficacy and the length of time that immunity lasts.

• Establish reciprocity of approvals between the FDA and trusted counterparts in certain foreign countries (Australia, Canada, New Zealand, Japan, the Scandinavian countries and the European Medicines Agency), so that if one of them approves a vaccine, it is automatically approved in the other countries.

For the full commentary, see:

Henry I. Miller. “A Covid Vaccine: Faster, Please.” The Wall Street Journal (Thursday, April 23, 2020): A15.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date April 22, 2020, and has the title “A Coronavirus Vaccine: Faster, Please.”)

Fauci Criticizes Russia for Allowing Citizens to Take Covid-19 Vaccine After Passing Phase 2 Safety Trials

Milton Friedman thought that, at the very least, the FDA should allow Americans the freedom to choose to take drugs or vaccines after their safety has been established (basically meaning after passing the Phase 2 safety trials). Isn’t it strange that in the FDA’s United States, citizens may not do so, but in Putin’s authoritarian Russia, citizens are allowed that choice?

(p. A4) In a panel discussion, Dr. Anthony S. Fauci, the nation’s top infections disease expert, criticized Russia’s rushed clearance of a coronavirus vaccine. The vaccine, called Sputnik V, was approved without evidence that Phase 3 clinical trials had been completed, an essential part of the development pipeline to prove a product is safe and effective in people.

. . .

Dr. Fauci called attention to the many other coronavirus vaccines vying for eventual clearance, including several that are in Phase 3 trials in the United States. The process for testing vaccines can last months and usually involves thousands of people.

“So if we wanted to take the chance of hurting a lot of people or giving them something that doesn’t work, we could start doing this, you know, next week if we wanted to,” Dr. Fauci said. “But that’s not the way this works.”

For the full story, see:

Barron, James. “Coronavirus Update.” The New York Times (Thursday, August 11, 2020): A4.

(Note: ellipsis added.)

(Note: the online version of the story was updated August 14, 2020, and has the title “U.S. Coronavirus Death Toll Reflects Sun Belt Outbreaks.” Where there are slight differences in wording between the versions in the passages quoted, the online version appears above. The online version does not list an author. I cite James Barron, who is listed as the author in the print version.)

Environmentalism Is a “Substitute Religion” Offering “Purpose and Transcendence”

(p. A13) There is a recurring puzzle in the history of the environmental movement: Why do green activists keep promoting policies that are harmful not only to humans but also to the environment? Michael Shellenberger is determined to solve this problem, and he is singularly well qualified.

He understands activists because he has been one himself since high school, when he raised money for the Rainforest Action Network. Early in his adult career, he campaigned to protect redwood trees, promote renewable energy, stop global warming, and improve the lives of farmers and factory workers in the Third World. But the more he traveled, the more he questioned what Westerners’ activism was accomplishing for people or for nature.

He became a different kind of activist by helping start a movement called ecomodernism, the subject of “Apocalypse Never: Why Environmental Alarmism Hurts Us All.” He still wants to help the poor and preserve ecosystems, but through industrialization instead of “sustainable development.” He’s still worried about climate change, but he doesn’t consider it the most important problem today, much less a threat to humanity’s survival—and he sees that greens’ favorite solutions are making the problem worse.

. . .

Mr. Shellenberger makes a persuasive case, lucidly blending research data and policy analysis with a history of the green movement and vignettes of people in poor countries suffering the consequences of “environmental colonialism.” He realizes, though, that rational arguments alone won’t convince devout environmentalists. “I was drawn toward the apocalyptic view of climate change twenty years ago,” he writes. “I can see now that my heightened anxiety about climate reflected underlying anxiety and unhappiness in my own life that had little to do with climate change or the state of the natural environment.”

For him and so many others, environmentalism offered emotional relief and spiritual satisfaction, giving them a sense of purpose and transcendence. It has become a substitute religion for those who have abandoned traditional faiths, as he explains in his concluding chapter, “False Gods for Lost Souls.” Its priests have been warning for half a century that humanity is about to be punished for its sins against nature, and no matter how often the doomsday forecasts fail, the faithful still thrill to each new one.

For the full review, see:

John Tierney. “BOOKSHELF; False Gods for Lost Souls.” The Wall Street Journal (Monday, June 22, 2020): A13.

(Note: ellipsis added.)

(Note: the online version of the review has the date June 21, 2020, and has the title “BOOKSHELF; ‘Apocalypse Never’ Review: False Gods for Lost Souls.”)

The book under review is:

Shellenberger, Michael. Apocalypse Never: Why Environmental Alarmism Hurts Us All. New York: HarperCollins Books, 2020.

Viruses Mutate More Nimbly Than Therapies Hobbled by FDA Regulations

(p. A7) In a laboratory in New York City, researchers coaxed a key piece of the coronavirus — its infamous outer “spike” — to mutate so that it became invisible to disease-fighting antibodies, according to a new study that has not yet been published in a scientific journal.

The provocative finding should not set off alarm bells, experts said. The altered spikes were not attached to the real coronavirus, which mutates at a much slower pace than most laboratory viruses. But the study does underscore the need for treatments and vaccines that attack the virus in different ways, so that if the pathogen manages to evade one approach, another will be waiting in the wings.

“It’s an old story for virology,” said Dr. Sallie Permar, a virologist and pediatrician at Duke University who was not involved in the study. “If you only target one little region, that virus is going to find a way to get away from it. It’s why viruses are so successful in this world.”

. . .

Several types of monoclonal antibodies are now in clinical trials. If all goes well, such concoctions might not only treat coronavirus infections but also prevent them. That could help millions of people, especially as the world awaits a vaccine, said Akiko Iwasaki, an immunologist at Yale University who was not involved in the study.

But the new findings also hint that single-antibody formulations “may not be as successful,” Dr. Taylor said, at least in the long term. Developing a cocktail containing a diverse blend of antibodies could be a safer bet.

Such mixtures would also more accurately mimic the body’s natural response to the coronavirus. In the study, viruses flushed with samples of convalescent plasma — fractions of blood donated by people who have recovered from Covid-19 — struggled to infect cells.

Some scientists, including those at American biotechnology company Regeneron, are already attempting this combo approach, mixing two potent types of monoclonal antibodies into a single treatment.

But Dr. Iwasaki pointed out that antibody cocktails might be tougher to bring to market. “Every time you make a drug, you get approval for each component separately,” she said. . . .

The lesson of diversity might be even more powerful for vaccines, which can marshal a multifaceted immune response. Some immune cells and molecules will be tailored to home in on the spike, whereas others might prefer other parts of the virus. Vaccines that present the body with many pieces of the coronavirus, rather than the spike alone, could have a better shot at triggering a suite of these defenses, said Dr. Taia Wang, an immunologist at Stanford University who was not involved in the study.

For the full story, see:

Katherine J. Wu. “Experiment on Spike Protein Shows Obstacles of Mutation.” The New York Times (Wednesday, July 29, 2020): A7.

(Note: ellipsis added.)

(Note: the online version of the story has the date July 28, 2020, and has the title “The Coronavirus Could Dodge Some Treatments, Study Suggests.” The online version has an extra paragraph that does not appear in the print version. In my quotations above, I stick to the print version.)

Paper Towels Spread Fewer Germs Than Hot-Air Drying

(p. R1) In the age of coronavirus, handwashing can save lives. But proper hand-drying matters, too.

“It might sound pedantic, but it’s actually critical,” says John Gammon, professor of infection prevention and control at Swansea University in the U.K.

Prof. Gammon was the lead author of a review of hand-drying research and published his findings in the March 2019 issue of the Journal of Infection Prevention. His paper, “The Neglected Element of Hand Hygiene,” examined the effectiveness of paper towels, cloth towels and dryers that use hot air or high-velocity air.

In a clinical situation, such as a hospital, disposable paper towels are generally the quickest, most efficient and hygienic method of hand drying. “The mechanical action of rubbing with paper towels has an effect on reducing microorganisms on hands,” Prof. Gammon says. Paper towels are also less likely to spread germs into the surrounding environment than hot-air and high-velocity air dryers, he adds.

For the full story, see:

Beth DeCarbo. “The Best Way to Dry Your Hands.” The Wall Street Journal (Friday, April 3, 2020): R1.

(Note: the online version of the story was updated April 2, 2020, and has the title “You’ve Perfected Your Handwashing Technique. Here’s How to Dry Them.” Where there is a slight difference in wording between the versions, the passages quoted above follow the online version.)

Gammon’s academic paper, mentioned above, is:

Gammon, John, and Julian Hunt. “The Neglected Element of Hand Hygiene – Significance of Hand Drying, Efficiency of Different Methods and Clinical Implication: A Review.” Journal of Infection Prevention 20, no. 2 (March 2019): 66-74.

Disney Will Only Re-Open a Park When It Can “Cover Its Variable Costs”

(p. B14) Disney Chief Executive Officer Bob Chapek has maintained that the company wouldn’t reopen a park without at least the ability to cover its variable costs, but analysts expect more will be needed to get parks fully back into the black. Bernstein analyst Todd Juenger estimates Disney’s parks would need to be at 60% of their “normal run-rate attendance” to reach break-even on a pretax basis.

. . .

On Thursday, [June 25, 2020] UBS reported results of a survey of 2,000 U.S. consumers conducted earlier this month. In that survey, among the respondents who had cited worries about social distancing as keeping them from visiting, nearly two-thirds said they would only consider attending a Disney park once a vaccine is available.

For the full story, see:

Dan Gallagher. “The Magic Kingdom Is Losing Its Spell.” The Wall Street Journal (Saturday, June 27, 2020): B14.

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

(Note: the online version of the story has the date June 26, 2020, and has the title “Disney’s Parks Need a Cure.”)

After Age 65, Men Lose More “Antibody-Producing B Cells” Than Women Lose

(p. B5) By examining gender-based distinctions in the immune system, cell structure, brain and other systems, researchers are discovering how and why men and women grow older in clearly different ways.

Their findings could help explain why Covid-19 has had a greater impact on older men than older women. A recent study found that men, after the age of 65, lost important antibody-producing B cells in the blood, while women didn’t.

“It was surprising,” said Duygu Ucar, an associate professor who led the study at the Jackson Laboratory for Genomic Medicine in Farmington, Conn. The research team also found that men, as they age, experience greater inflammation in their blood, which has been associated with severe cases of Covid-19.

. . .

Nir Barzilai, director of the Institute for Aging Research at the Albert Einstein College of Medicine, looked at the blood of men and women between the ages of 65 and 95 and found protein levels changed at different rates. Less change means more stability, he said. Men’s levels changed far more than women’s, with 600 significant changes versus 277 for women, according to the study, published in December.

“The female biology seems to be more stable than men’s,” says Dr. Barzilai, the author of “Age Later” who specializes in geroscience.

For the full story, see:

Clare Ansberry. “Women and Men Age Differently—-And in More Ways Than Just Longevity.” The Wall Street Journal (Wednesday, July 15, 2020): A13.

(Note: ellipsis added.)

(Note: the online version of the story has the date July 14, 2020, and has the title “Women and Men Age Differently—in More Ways Than Just Longevity.” The last couple of paragraphs quoted above, appeared in the online, but not the print, version of the article.)

The “recent study” mentioned above is:

Márquez, Eladio J., Cheng-han Chung, Radu Marches, Robert J. Rossi, Djamel Nehar-Belaid, Alper Eroglu, David J. Mellert, George A. Kuchel, Jacques Banchereau, and Duygu Ucar. “Sexual-Dimorphism in Human Immune System Aging.” Nature Communications 11, Article #751 (Feb. 6, 2020): 1-17.

The book by Barzilai, mentioned above, is:

Barzilai, Nir. Age Later: Health Span, Life Span, and the New Science of Longevity. New York: St. Martin’s Press, 2020.

Reduce Spread of COVID-19 “With Plenty of Fresh Air” in Buildings

(p. B5) One way to reduce the spread of coronavirus is to maintain ventilation .

. . .

Modifications from equipment manufacturers such as Trane Technologies PLC, Carrier Global Corp. and Johnson Controls International PLC include filtering indoor air more thoroughly, drawing more outdoor air into buildings and deploying ultraviolet light against the virus inside ventilation systems.

“More fresh air and cleaner air are the direction that customers are going. This is top-of-mind for building owners and contractors,” said Jeff Williams, president of global products for Johnson Controls, maker of York-brand heating and air-conditioning equipment.

. . .

Research released this spring by the Department of Homeland Security found that coronavirus particles decay faster at a room temperature of 78 degrees Fahrenheit with a relative humidity of 50% than at lower temperatures and humidity. Add in a strong dose of ultraviolet light, and the virus decays by 90% in less than seven minutes, according to the department. Humans’ immune systems also are more effective against viruses in warmer, more humid conditions, according to a Yale University study published in May 2019.

“We can minimize the spread of the virus in the summer when there is plenty of sunlight and higher humidity. They’re actually effective in a defined space,” said Luke Leung, epidemic task force leader for the American Society of Heating, Refrigerating and Air-Conditioning Engineers, a trade association.

. . .

Recirculated air should include about 20% outdoor air to effectively dilute coronavirus particles, the Atlanta-based engineers’ society says. Many buildings’ air handlers were set up to draw less outdoor air, to maximize energy efficiency.

“The past few years there was a lot of emphasis on energy saving and there was less outside air in buildings,” said Seth Ferriell, chief executive of SSC Services for Education, a Tennessee-based company that manages ventilation systems for schools and universities. The firm has a contract to upgrade air handlers at Texas A&M University.

Mr. Ferriell estimated that increasing the amount of outdoor air in a building by 50% would drive up natural gas or electricity costs by as much as 15% a year because that additional air has to be cooled or heated to match the desired interior temperature.

For the full story, see:

Bob Tita. “Virus Spurs Ventilation Boost.” The Wall Street Journal (Thursday, July 9, 2020): B5.

(Note: ellipses added.)

(Note: the online version of the story has the date July 8, 2020, and has the title “Offices Try to Combat Coronavirus With More Fresh Air.” The last couple of paragraphs quoted above, appeared in the online, but not the print, version of the article.)

Masks “Absolutely Essential” to “Get Control of the Virus”

(p. 6A) Adm. Brett Giroir, a member of the White House coronavirus task force, called mask-wearing in public, which has been met with resistance in some U.S. states, “absolutely essential.”

Giroir, the assistant secretary at the Health and Human Services Department, told ABC’s “This Week” on Sunday [July 12, 2020] that “if we don’t have that, we will not get control of the virus.”

For the full story, see:

AP. “As U.S Wrestles With Virus Florida Sets Daily Record.” Omaha World Herald (Monday, July 13, 2020): A6.

(Note: bracketed date added.)