FDA Should Approve Faster Clinical Trials for Boosters to Block New Covid-19 Variants

(p. A17) . . . , it is essential to design clinical trials that can be completed within several months, to avert potential outbreaks of new variants. It’s fast, but given today’s scientific capabilities that could be enough time to do the required trials.

Take the South African variant known as B1351. The existing trials will be used to establish that the current vaccines provide clinical protection against Covid disease. But to prove the new versions targeting B1351 work as well as the current vaccines, the FDA can measure the antibody levels in the plasma from patients who have recovered from B1351 and establish a benchmark for the number of antibodies needed to neutralize that virus. Then the FDA can use those antibody levels as a proxy to evaluate whether updated vaccines are able to generate sufficient levels of protection.

This could allow vaccine makers to test new boosters in clinical trials that enroll 300 or 400 patients rather than 40,000, an enormous savings in cost and time. Larger and longer studies can be started at the same time, including ones that follow vaccinated patients.

For the full commentary, see:

Scott Gottlieb. “Another Promising Vaccine, This One From Johnson & Johnson.” The Wall Street Journal (Monday, February 1, 2021): A17.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date January 31, 2021, and has the same title as the online version.)

Naps Aid Immunity, Energy, Alertness, Memory, and Mood

(p. D4) Sara E. Alger, a sleep scientist at the Walter Reed Army Institute of Research in Silver Spring, Md., has been a public advocate for naps, particularly in the workplace, except in cases of insomnia. Along the way, she has had to fight anti-nap prejudice.

“Naps in general have a stigma attached to them as something you only do when you’re lazy or when you’re sick,” Dr. Alger said.

Wrapped inside nap phobia in the United States is often a message reminding us to be productive during what we now think of as normal working hours, although that concept is relatively new.

Modern attitudes about napping go back to the Industrial Revolution, according to Matthew J. Wolf-Meyer, an anthropologist at Binghamton University in New York and the author of “The Slumbering Masses: Sleep, Medicine, and Modern American Life.”

“For a long time, people had flexible sleep schedules,” Dr. Wolf-Meyer said. Farmers and tradespeople had some autonomy over their time. They could choose to rest in the hottest part of the day, and might take up simple tasks during a wakeful period in the middle of the night, between two distinct bouts of sleep.

As the 1800s went on, more and more Americans worked in factories on set shifts that were supervised by a foreman. “They work for a total stranger, and a nap becomes totally nonnegotiable,” he said.

Staying awake all day and getting one’s sleep in a single long stretch at night came to be seen as normal. With that came a strong societal expectation that we ought to use our daylight hours productively.

. . .

Although there are no hard data so far on whether naps have been on the rise during 2020, sleep scientists like Dr. Alger think it’s likely. The many people who now work remotely no longer need to worry about the disapproving eyes of their colleagues if they want a brief, discreet period of horizontality in the afternoons.

If most offices reopen next year, as now seems possible, perhaps greater tolerance toward the adult nap will be one of the things salvaged from the smoking wreckage of the working-from-home era. (In a tweet last week, Dr. Wolf-Meyer called the pandemic “the largest (accidental) experiment with human #sleep ever conducted.”) . . .

Experts say that people who get seven to nine hours of sleep a day are less prone to catching infectious diseases, and better at fighting off any they do catch. Afternoon sleep counts toward your daily total, according to Dr. Alger.

This immunity boost, she said, is in addition to other well-known dividends of a good nap, like added energy, increased alertness, improved mood and better emotional regulation.

Included under the last rubric is a skill that seems especially useful for dealing with families, even if you never get closer to your relatives this year than a “Hollywood Squares”-style video grid: “Napping helps you be more sensitive to receiving other people’s moods,” Dr. Alger said. “So you’re not perceiving other people as being more negative than they are.”

Napping also helps you remember facts you learned right before nodding off. Given the way things have been going lately, of course, you may not see this as a plus. You could look at it from the reverse angle, though: Every hour before Jan. 1 that you spend napping is another hour of 2020 you won’t remember.

For the full commentary, see:

Pete Wells. “This Thanksgiving, Nap Without Guilt.” The New York Times (Wednesday, November 25, 2020): D1 & D4.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Nov. 24, 2020, and has the title “This Thanksgiving, It’s Time to Stop Nap-Shaming.”)

The book by Wolf-Meyer, mentioned above, is:

Wolf-Meyer, Matthew J. The Slumbering Masses: Sleep, Medicine, and Modern American Life. Minneapolis, MN: University of Minnesota Press, 2012.

Fauci Lied on Herd Immunity Until His “Gut Feeling” Told Him U.S. Was Ready for the Truth

(p. A6) In the pandemic’s early days, Dr. Fauci tended to cite the same 60 to 70 percent estimate that most experts did. About a month ago, he began saying “70, 75 percent” in television interviews. And last week, in an interview with CNBC News, he said “75, 80, 85 percent” and “75 to 80-plus percent.”

In a telephone interview the next day, Dr. Fauci acknowledged that he had slowly but deliberately been moving the goal posts. He is doing so, he said, partly based on new science, and partly on his gut feeling that the country is finally ready to hear what he really thinks.

For the full story, see:

Donald G. McNeil Jr. “How Can We Achieve Herd Immunity? Experts Are Quietly Upping the Number.” The New York Times, First Section (Sunday, December 27, 2020): A6.

(Note: the online version of the story has the date Dec. 24, 2020, and has the title “How Much Herd Immunity Is Enough?”)

“Celebrities Have Access to Better Care Than Ordinary People”

As the passages quoted below suggest, Trump’s friends may have had access to drugs that not everyone had access to. But it also should be acknowledged that Trump was pushing for Covid-19 drugs to be available sooner and with fewer restrictions.

(p. A25) Both the Regeneron and Eli Lilly therapies are meant for people who are at risk of getting sick enough with Covid to be hospitalized, not those who are hospitalized already. The emergency use authorization for the Regeneron treatment specifically says that it is “not authorized” for “adults or pediatric patients who are hospitalized due to Covid-19.”

A physician with experience administering the new monoclonal antibodies, who didn’t want to use his name because he’s not authorized by his hospital to speak publicly, said giving them to Giuliani “appears to be an inappropriate use outside the guidelines of the E.U.A. for a very scarce resource.” Very scarce indeed: According to the Department of Health and Human Services, as of Wednesday the entire country had about 77,000 total doses of the Regeneron cocktail and almost 260,000 doses of Eli Lilly’s monoclonal antibody treatment. That’s less than you’d need to treat everyone who’d tested positive in just the previous two days.

Right now, the criteria for distributing these drugs can be murky. Robert Klitzman, co-founder of the Center for Bioethics at Columbia, said that the federal government allocates doses to states, states allocate them to hospitals and hospitals then decide which patients among those most at risk will get treated. Some states have developed guidelines for monoclonal antibody treatment, “but my understanding is that most states have not yet done that,” Klitzman said.

Hospitals try to come up with ethical triage frameworks, but Klitzman told me there are often workarounds for V.I.P.s. He said it helps to know someone on the hospital’s board. Such bodies typically include wealthy philanthropists. Often, he said, when these millionaires and billionaires ask hospital administrators for special treatment for a friend, “hospitals do it.”

Why? “Hospitals have huge financial problems, especially at the moment with Covid,” he said. They’ve had to shut down profitable elective surgeries and treat many people without insurance. More than ever, he said, they “need money that is given philanthropically from potential donors.”

In other words, Giuliani was right: Celebrities have access to better care than ordinary people. “When someone is in the public eye, or if someone is a potential donor, or has already been a donor to a hospital, then there’s folks in the hospital hierarchy, in the administration, who are keenly aware if they’re coming in, if they’re present, if they need something,” said Shoa Clarke, a cardiologist and professor at Stanford University School of Medicine. Covid, which is leading to rationing of medical resources, only magnifies this longstanding inequality.

For the full commentary, see:

Michelle Goldberg. “Why Trump Cronies Get Covid Meds.” The New York Times (Saturday, December 12, 2020): A25.

(Note: the online version of the commentary has the date Dec. 10, 2020, and has the title “Covid Meds Are Scarce, but Not for Trump Cronies.” The passage quoted above includes several sentences, and a couple of words, that appear in the online, but not in the print, version of the commentary.)

Federal Sugar Quotas Increase Demand for Corn Syrup, Increasing Suffering from Gout

Corn syrup is a substitute for sugar. Federal sugar import quotas increase the price of sugar. As a result, the demand for corn syrup increases. The result, as affirmed in the article quoted below, is an increase in Americans suffering from gout.

(p. 32) As the British and American historians Roy Porter and George Sebastian Rousseau write in “Gout: The Patrician Malady” (1998), the disease, cast by some as “a quasi-deity born of the union of Bacchus and Venus,” appeared to reach epidemic proportions in 18th-century England as more people attained affluence.

. . .

The disease has not been banished to the past, nor is it any longer the exclusive insignia of rich white men (if it ever really was). From the 1960s to the 1990s, the number of sufferers more than doubled in the United States, and that’s continued to rise.

. . .

According to data collected by the National Health and Nutrition Examination Survey (NHANES), as of 2016, around 9.2 million American adults, 5.9 million men and 3.3 million women, were living with the disease, making up 3.9 percent of the adult population, and another 32.5 million (14.6 percent) exhibited hyperuricemia, elevated levels of uric acid, putting them at risk.

. . .

Some scientists point (p. 34) to the dramatic rise in rates of obesity — from 13.4 percent of adults in 1980 to 42.4 percent in 2017-18, again per the NHANES — since excess weight depresses kidney efficiency, and to the likely not unrelated introduction, in 1967, of high-fructose corn syrup, which can cause the body to produce higher levels of uric acid, and its wholesale embrace in the early 1980s by the American food industry and then the world.

. . .

(p. 35) The disease remains mysterious in its onset. Beyond genetic factors, high-fructose corn syrup poses a greater danger than a lobe of foie gras, cutting across class lines.

For the full story, see:

Ligaya Mishan. “The Disease of Kings.” The New York Times Style Magazine (Sunday, November 15, 2020): 32 & 34-35.

(Note: ellipses added.)

(Note: the online version of the story was updated Nov. 14, 2020, and has the title “Once the Disease of Gluttonous Aristocrats, Gout Is Now Tormenting the Masses.”)

“When I Knew More Thank Hayek” AIER YouTube Video

The American Institute for Economic Research (AIER) premiered on Mon., Jan. 4, 2020, a neat YouTube video they created based on a shortened version of my article “When I Knew More Than Hayek.” [Hayek, Covid & The Use of Knowledge in Society | Kate Wand via @youtube] #Hayek #localknowledge

2016 Law Requires FDA to Move to Mining Real-World Data and Away from Costly and Slow Clinical Trials

(p. A1) Drugmakers are trying to win drug approvals by parsing vast data sets of electronic medical records, shifting away from lengthy, and costly, clinical trials in patients.

. . .

For the companies, the use of real-world data can cut costs and shorten drug-development times. Instead of finding trial subjects, companies simply mine hospital and doctor files for cases where patients already took a drug in routine medical care, looking for changes in blood pressure, tumor size and other readings to see if the medicine is helping or causing a side effect.

. . .

(p. A2) . . . for rare diseases especially, it can take a while to even enroll enough patients in studies. And their cost can limit the number of trials that companies can fund, drugmakers say.

A 2016 law required the FDA to explore greater use of real-world data, and the agency is developing standards to assess the reliability of different data sources and which kinds of decisions the data support.

“Real-world evidence should not be a means toward dropping standards, but rather a mechanism to have more efficiency in evidence generation while maintaining standards,” said FDA Principal Deputy Commissioner Amy Abernethy, a former executive at health-data firm Flatiron Health.

A market has emerged in recent years for digital drug-use information. Iqvia Inc., which tracks prescription and health data, has about a dozen projects under way, said Nancy Dreyer, the company’s chief scientific officer of real-world evidence.

For the full story, see:

Peter Loftus. “Drugmakers Mine Data to Avoid Clinical Trials.” The Wall Street Journal (Tuesday, Dec. 24, 2019): A1-A2.

(Note: ellipses added.)

(Note: the online version of the story was updated Dec. 23, 2019, and has the title “Drugmakers Turn to Data Mining to Avoid Expensive, Lengthy Drug Trials.”)

“Normal” Human Temperature May Be Lower When Baseline Inflammation Is Lower

When I was a child my mother would hand me an oral thermometer to take my temperature and often the temperature would come out below 98.6 degrees. She would be annoyed and hand it back to me, saying that I should put it in right this time. I would painfully jab the thermometer back under my tongue, discouraged that I would never figure out what I was doing wrong. So several decades later, I smiled when I read the commentary quoted below. (Hey mom, maybe I was doing it OK all along.)

(p. A2) Nearly 150 years ago, a German physician analyzed a million temperatures from 25,000 patients and concluded that normal human-body temperature is 98.6 degrees Fahrenheit.

That standard has been published in numerous medical texts and helped generations of parents judge the gravity of a child’s illness.

But at least two dozen modern studies have concluded the number is too high.

The findings have prompted speculation that the pioneering analysis published in 1869 by Carl Reinhold August Wunderlich was flawed.

Or was it?

In a new study, researchers from Stanford University argue that Wunderlich’s number was correct at the time but is no longer accurate because the human body has changed.

Today, they say, the average normal human-body temperature is closer to 97.5 degrees Fahrenheit.

. . .

“Wunderlich did a brilliant job,” Dr. Parsonnet said, “but people who walked into his office had tuberculosis, they had dysentery, they had bone infections that had festered their entire lives, they were exposed to infectious diseases we’ve never seen.”

For his study, he did try to measure the temperatures of healthy people, she said, but even so, life expectancy at the time was 38 years, and chronic infections such as gum disease and syphilis afflicted large portions of the population. Dr. Parsonnet suspects inflammation caused by those and other persistent maladies explains the temperature documented by Wunderlich and that a population-level change in inflammation is the most plausible explanation for a decrease in temperature.

For the full commentary, see:

Jo Craven McGinty. “THE NUMBERS; 98.6 Degrees Is No Longer the Body’s Norm.” The Wall Street Journal (Saturday, January 18, 2020): A2.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date January 17, 2020, and has the title “THE NUMBERS; 98.6 Degrees Fahrenheit Isn’t the Average Anymore.”)

How “Single-Payer” Socialized Medicine Works for American Indians

(p. A1) EAGLE BUTTE, S.D.—Kate Miner walked into the Indian Health Service hospital, seeking help for a cough that wouldn’t quit.

An X-ray taken of Ms. Miner’s lungs that day, Oct. 19, 2016, found signs of cancer.

What exactly the IHS doctor said to Ms. Miner about her exam remains in dispute. Notations in her medical file indicate the doctor told her to come back for a lung scan the next day. Her family says they never were given such instructions and weren’t told of the two masses the X-ray revealed.

What is clear is that no further tests were done. And no IHS provider followed up when Ms. Miner returned twice more to the hospital, the only one on the Cheyenne River Reservation, over the next six months, medical records show.

Finally, on May 7, 2017, as the 67-year-old Ms. Miner lay crumpled on a hospital cot, the right side of her body shaking, a physician assistant ordered a CT scan, after her family insisted, according to the records and family members.

“You have two very large masses in your right lung. It’s probably a malignancy,” Ms. Miner’s daughter Kali Tree Top recalled the physician assistant saying.

Ms. Miner reached for her daughter’s hand and started to cry.

Ms. Miner’s encounters with the IHS, and her family’s repeated efforts to get her help there, illustrate how the federal agency can fail the patients who need it most.

For the full story, see:

Dan Frosch. “A Tragic Journey Through the Indian Health Service.” The Wall Street Journal (Tuesday, December 24, 2019): A1 & A8.

(Note: the online version of the story was updated December 23, 2019, and has the title “Kate Miner’s Tragic Journey Through the U.S. Indian Health Service.”)

Opposed by China and WHO, Trump Administration Declared Covid-19 Public Health Emergency on January 31, 2020

(p. A1) The U.S. imposed entry restrictions on foreign nationals and quarantines on Americans returning from the Chinese province at the center of the coronavirus outbreak, as markets tumbled over fears about the impact on global growth.

Health and Human Services Secretary Alex Azar declared a public health emergency Friday [Jan. 31, 2020]. He said foreign citizens who have traveled anywhere in China within the past 14 days would be denied U.S. entry, while Americans who visited Hubei province would be quarantined for up to two weeks.

. . .

(p. A8) “Many countries have offered China support in various means. In sharp contrast, certain U.S. officials’ words and actions are neither factual nor appropriate,” Chinese Foreign Ministry spokeswoman Hua Chunying said. “Just as the WHO recommended against travel restrictions, the U.S. rushed to go in the opposite way.”

For the full story, see:

Alex Leary and Brianna Abbott. “U.S. Curbs Entry to Combat Virus.” The Wall Street Journal (Saturday, February 1, 2020): A1 & A8.

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

(Note: the online version of the story has the date January 31, 2020, and has the title “U.S. Imposes Entry Restrictions Over Coronavirus.”)