Category: Regulations

Fauci’s Office Rejected Protocol for a Voluntary COVID Human Challenge Trial That Could Have Tested Therapies and Vaccines Faster

(p. 2) . . . the first Covid-19 human challenge study [was] just completed in Britain, where young, healthy and unvaccinated volunteers were infected with the coronavirus that causes Covid while researchers carefully monitored how their bodies responded.

. . ., there were those who decried deliberately infecting or “challenging” healthy volunteers with disease-causing pathogens. It violates the medical principle of “do no harm.” The trade-off is a unique opportunity to discover the causes, transmission and progression of an illness, as well as the ability to more rapidly test the effectiveness of proposed treatments.

. . .

Dr. [Matthew] Memoli [the director of the Laboratory of Infectious Diseases Clinical Studies Unit at the National Institute of Allergy and Infectious Diseases] has conducted numerous influenza challenge studies, and he prepared a protocol for a Covid challenge trial that the National Institute of Allergy and Infectious Diseases rejected last year because it was felt that not enough was known about the virus and that there were no effective rescue therapies, according to a statement from the office of the director, Dr. Anthony Fauci.

The consortium formed to run Britain’s Covid challenge trial, which included scientists who trained at the Common Cold Unit, had access to the British National Health Service’s robust, real-time data on Covid hospitalizations and deaths. The researchers designing the study said they felt confident that there was little risk to the healthy unvaccinated 18-to-30-year-old volunteers they recruited for the trial. There were no severe adverse events in the 36 people who participated, and they will continue to be monitored over the next year.

The aim of the study was to identify the lowest amount of virus to safely and reliably infect someone, so researchers can later easily test the efficacy of vaccines or antivirals on future challenge trial volunteers.

. . .

Dr. Fauci’s office said the institute has no plans to fund Covid-19 human challenge trials in the future. Many bioethicists support that decision. “We don’t ask people to sacrifice themselves for the good of society,” said Jeffrey Kahn, director of the Johns Hopkins Berman Institute of Bioethics. “In the U.S., we are very much about protecting individual rights and individual life and health and liberty, while in more communal societies it’s about the greater good.”

But Josh Morrison, a co-founder of 1Day Sooner, which advocates on behalf of more than 40,000 would-be human challenge volunteers, argues it should be his and other people’s right to take risks for the greater good. “Most people aren’t going to want to be in a Covid challenge study, and that’s totally fine, but they shouldn’t project their own choices on other people,” he said.

. . .

As one participant in Britain’s Covid human challenge trial put it: “You know the phrase ‘one interesting fact about yourself’ that strikes terror into everyone? That’s now solved forever. I did something that made a difference.”

For the full commentary, see:

Kate Murphy. “Are Human Challenge Trials Ethical?” The New York Times, SundayReview Section (Sunday, October 17, 2021 [sic]): 2.

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

(Note: the online version of the commentary has the date Oct. 14, 2021 [sic], and has the title “Britain Infected Volunteers With the Coronavirus. Why Won’t the U.S.?”)

Allowing the Sale of Hearing Aids Over-the-Counter (O.T.C.) Results in “Increased Innovation and Lower Prices”

(p. D3) A year ago, the Food and Drug Administration announced new regulations allowing the sale of over-the-counter hearing aids and setting standards for their safety and effectiveness.

. . .

Some background: In 2020, the influential Lancet Commission on Dementia Prevention, Intervention and Care identified hearing loss as the greatest potentially modifiable risk factor for dementia.

Previous studies had demonstrated a link between hearing loss and cognitive decline, said Dr. Frank Lin, an otolaryngologist and epidemiologist at Johns Hopkins and lead author of the new research.

“What remained unanswered was, If we treat hearing loss, does it actually reduce cognitive loss?” he said. The ACHIEVE study (for Aging and Cognitive Health Evaluation in Elders) showed that, at least for a particular group of older adults, it could.

. . .

A small study recently published in JAMA Otolaryngology found that patients who were given a commercially available, self-fitting hearing aid in a clinical trial could, after six weeks, hear as well as patients fitted with the same device by audiologists.

. . .

The United States is the first country to develop a regulated O.T.C. hearing aid market, and “the tech companies and the retailers are still experimenting,” Dr. Lin pointed out. He predicts increased innovation and lower prices ahead.

For the full commentary, see:

Paula Span. “THE NEW OLD AGE; A Challenging Over-the-Counter Market for Hearing Aids.” The New York Times (Tuesday, October 31, 2023): D3.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Oct. 30, 2023, and has the title “THE NEW OLD AGE; Hearing Aids Are More Affordable, and Perhaps More Needed, Than Ever.”)

The “small study” mentioned above is:

De Sousa, Karina C., Vinaya Manchaiah, David R. Moore, Marien A. Graham, and De Wet Swanepoel. “Effectiveness of an over-the-Counter Self-Fitting Hearing Aid Compared with an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial.” JAMA Otolaryngology–Head & Neck Surgery 149, no. 6 (2023): 522-30.

“The Economic Mobility That Springs From Property Ownership”

(p. C9) Mr. Husock, a senior fellow at the American Enterprise Institute, traces the progress of a seemingly sensible but ultimately destructive idea: that “low-income neighborhoods built by ordinary builders were exploitative, overcrowded, and dangerous.”

. . .

What these reformers failed to understand, Mr. Husock contends, is that the poor neighborhoods of large cities provided what planned and subsidized neighborhoods never could: tightly knit communities, a sense of belonging and attendant political participation, ethnic character and the economic mobility that springs from property ownership.

. . .

The unreformers, Mr. Husock writes, “understood something fundamental: Community develops when keeping one’s property becomes part of a positive conspiracy of shared self-interest.”

For the full review, see:

Barton Swaim. “The Tragedy of the Progressive City.” The Wall Street Journal (Saturday, Oct. 30, 2021 [sic]): C9.

(Note: ellipses added.)

(Note: the online version of the review has the date October 29, 2021 [sic], and has the title “Politics: When the Lights Go Down in the City.”)

The book under review is:

Husock, Howard A. The Poor Side of Town: And Why We Need It. New York: Encounter Books, 2021.

Mandated Fukushima Evacuations Killed 1,600; Radiation Killed 0

Berkeley scientist Noah Whiteman’s Most Delicious Poison argues that often chemicals that are therapeutic at low doses are poisons at high doses. The commentary quoted below provides evidence that what Whiteman argues is true of many chemicals, is also true of radiation.

(p. D3) This spring [2015], four years after the nuclear accident at Fukushima, a small group of scientists met in Tokyo to evaluate the deadly aftermath.

No one has been killed or sickened by the radiation — a point confirmed last month by the International Atomic Energy Agency. Even among Fukushima workers, the number of additional cancer cases in coming years is expected to be so low as to be undetectable, a blip impossible to discern against the statistical background noise.

But about 1,600 people died from the stress of the evacuation — one that some scientists believe was not justified by the relatively moderate radiation levels at the Japanese nuclear plant.

. . .

“The government basically panicked,” said Dr. Mohan Doss, a medical physicist who spoke at the Tokyo meeting, when I called him at his office at Fox Chase Cancer Center in Philadelphia. “When you evacuate a hospital intensive care unit, you cannot take patients to a high school and expect them to survive.”

Among other victims were residents of nursing homes. And there were the suicides. “It was the fear of radiation that ended up killing people,” he said.

Most of the fallout was swept out to sea by easterly winds, and the rest was dispersed and diluted over the land. Had the evacuees stayed home, their cumulative exposure over four years, in the most intensely radioactive locations, would have been about 70 millisieverts — roughly comparable to receiving a high-resolution whole-body diagnostic scan each year. But those hot spots were anomalies.

By Dr. Doss’s calculations, most residents would have received much less, about 4 millisieverts a year. The average annual exposure from the natural background radiation of the earth is 2.4 millisieverts.

How the added effect of the fallout would have compared with that of the evacuation depends on the validity of the “linear no-threshold model,” which assumes that any amount of radiation, no matter how small, causes some harm.

Dr. Doss is among scientists who question that supposition, one built into the world’s radiation standards. Below a certain threshold, they argue, low doses are harmless and possibly even beneficial — a long-debated phenomenon called radiation hormesis.

. . .

Life evolved in a mildly radioactive environment, and some laboratory experiments and animal studies indicate that low exposures unleash protective antioxidants and stimulate the immune system, conceivably protecting against cancers of all kinds.

. . .

. . ., a study of radon by a Johns Hopkins scientist suggested that people living with higher concentrations of the radioactive gas had correspondingly lower rates of lung cancer. If so, then homeowners investing in radon mitigation to meet federal safety standards may be slightly increasing their cancer risk. These and similar findings have also been disputed.

. . .

There is more here at stake than agonizing over irreversible acts, like the evacuation of Fukushima. Fear of radiation, even when diluted to homeopathic portions, compels people to forgo lifesaving diagnostic tests and radiotherapies.

We’re bad at balancing risks, we humans, and we live in a world of continual uncertainty. Trying to avoid the horrors we imagine, we risk creating ones that are real.

For the full commentary, see:

George Johnson. “RAW DATA; When Radiation Isn’t the Risk.” The New York Times (Tuesday, Sept. 22, 2015 [sic]): D3.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sept. 21, 2015 [sic], and has the title “RAW DATA; When Radiation Isn’t the Real Risk.”)

The recent book by Whiteman mentioned above is:

Whiteman, Noah. Most Delicious Poison: The Story of Nature’s Toxins―from Spices to Vices. New York: Little, Brown Spark, 2023.

The study of radon mentioned above is:

Thompson, Richard E. “Epidemiological Evidence for Possible Radiation Hormesis from Radon Exposure: A Case-Control Study Conducted in Worcester, Ma.” Dose-Response 9, no. 1 (2011): 59-75.

“A Richer World Is Much More Resilient Against Weather Extremes”

(p. A15) A new peer-reviewed study of all the scientific estimates of climate-change effects shows the most likely cost of global warming averaged across the century will be about 1% of global gross domestic product, reaching 2% by the end of the century. This is a very long way from global extinction.

Draconian net-zero climate policies, on the other hand, will be prohibitively costly. The latest peer-reviewed climate-economic research shows the total cost will average $27 trillion each year across the century, reaching $60 trillion a year in 2100. Net zero is more than seven times as costly as the climate problem it tries to address.

. . .  A richer world is much more resilient against weather extremes. In the short term, therefore, policymakers should focus on lifting the billions of people still in poverty out of it, both because it will make them more resilient against extreme weather and because it will do so much good in a myriad of other ways.  . . .

Careful science can inform us about the problem of climate change, but it can’t tell us how to solve it. Sensible public debate requires all the facts, including about the costs of our choices. Some of the most popular climate policies will have costs far greater than climate change itself. When politicians try to shut down discussion with claims that they’re “following the science,” don’t let them.

For the full commentary, see:

Bjorn Lomborg. “‘Follow the Science’ Leads to Ruin.” The Wall Street Journal (Thursday, March 14, 2024): A15.

(Note: ellipses added.)

(Note: the online version of the commentary has the date March 13, 2024, and has the same title as the print version.)

The “new peer-reviewed study” mentioned above is:

Tol, Richard S. J. “A Meta-Analysis of the Total Economic Impact of Climate Change.” Energy Policy 185 (Feb. 2024): 113922.

The “latest peer-reviewed climate-economic research” mentioned above is:

Tol, Richard S. J. “Costs and Benefits of the Paris Climate Targets.” Climate Change Economics 14, no. 04 (2023): 2340003.

Federal and State Regulatory Thicket Thwarts “Permitting, Siting, Construction and Operation” of New Energy Infrastructure and Technology

(p. C5) Environmentalists have long argued that tackling climate change will require regulations to discourage fossil-fuel use, such as a carbon tax or a cap-and-trade program. In reality, there is no plausible path to a low-carbon economy without a serious deregulatory program. Today’s thicket of environmental regulation at the federal and state levels thwarts permitting, siting, construction and operation of virtually every class of new infrastructure and technology. There are simply too many veto points and opportunities for obstruction, at too many procedural and jurisdictional levels, to conceivably embark on a rapid mission to remake the nation’s energy economy.

. . .

The U.S. can no longer continue to neglect its compounding infrastructure and clean-energy needs. We aren’t going to regulate our way to a thriving low-carbon economy and a more stable climate. America needs to get back to building again.

For the full commentary, see:

Ted Nordhaus. “For a Clean-Energy Future, We Need Deregulation.” The Wall Street Journal (Saturday, February 19, 2022 [sic]): C5.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date February 17, 2022 [sic], and has the same title as the print version.)

Most Illegal Immigrants to the U.S. Correctly Believe That They Will Be Able to Stay Forever

(p. A1) Today, people from around the globe are streaming across the southern border, most of them just as eager to work. But rather than trying to elude U.S. authorities, the overwhelming majority of migrants seek out border agents, sometimes waiting hours or days in makeshift encampments, to surrender.

. . .

In December [2023] alone, more than 300,000 people crossed the southern border, a record number.

It is not just because they believe they will be able to make it across the 2,000 mile southern frontier. They are also certain that once they make it to the United States they will be able to stay.

Forever.

And by and large, they are not wrong.

For the full commentary, see:

Miriam Jordan. “Most Migrants Arrive Believing They Can Stay.” The New York Times (Thursday, February 1, 2024): A1 & A13.

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

(Note: the online version of the commentary has the date Jan. 31, 2024, and has the title “One Big Reason Migrants Are Coming in Droves: They Believe They Can Stay.”)

Texas Is “One State” Whose “Streamlined Permitting Process Allows Wind, Solar and Battery Projects to Get Built and Connected”

(p. A1) Something unusual is happening in America. Demand for electricity, which has stayed largely flat for two decades, has begun to surge.

Over the past year, electric utilities have nearly doubled their forecasts of how much additional power they’ll need by 2028 as they confront an unexpected explosion in the number of data centers, an abrupt resurgence in manufacturing driven by new federal laws, and millions of electric vehicles being plugged in.

Many power companies were already struggling to keep the lights on, especially during extreme weather, and say the strain on grids will only increase. Peak demand in the summer is projected to grow by 38,000 megawatts nationwide in the next five years, according to an analysis by the consulting firm Grid Strategies, which is like adding another California to the grid.

“The numbers we’re seeing are pretty crazy,” said Daniel Brooks, vice president of integrated grid and energy systems at the Electric Power Research Institute, a nonprofit organization.

In an ironic twist, the swelling appetite for more electricity, driven not only by electric cars but also by battery and solar factories and other aspects of the clean-energy transition, could also jeopardize the country’s plans to fight climate change.

To meet spiking demand, utilities in states like Georgia, North Carolina, South Carolina, Tennessee and Virginia are proposing to build dozens of power plants over the next 15 years that would burn natural gas. In Kansas, one utility has postponed the retirement of a coal plant to help power a giant electric-car battery factory.

. . .

(p. A15) At the same time, investment in American manufacturing is hitting a 50-year high, fueled by new federal tax breaks to lift microchip and clean-tech production. Since 2021, companies have announced plans to spend at least $525 billion on factories for semiconductors, batteries, solar panels and more.

In Georgia, where dozens of electric vehicle companies and suppliers are setting up shop, the state’s largest utility now expects 16 times as much growth in electricity demand this decade as it did two years ago.

Millions of Americans are also buying plug-in vehicles and electric heat pumps for their homes, spurred by recent federal incentives. In California, one-fifth of new cars sold are electric, and officials estimate that E.V.s could account for 10 percent of power use during peak hours by 2035.

. . .

So far, one state that has kept pace with explosive demand is Texas, where electricity use has risen 29 percent over the past decade, partly driven by things like bitcoin mining, liquefied natural gas terminals and the electrification of oil fields. Texas’s streamlined permitting process allows wind, solar and battery projects to get built and connected faster than almost anywhere else, and the state zoomed past California last year to lead the nation in large-scale solar power.

“Texas still has problems, but there’s a lot to learn from how the state makes it easier to build clean energy,” said Devin Hartman, director of energy and environmental policy at the R Street Institute.

For the full story, see:

Brad Plumer and Nadja Popovich. “Energy Appetite in U.S. Endangers Goals on Climate.” The New York Times (Monday, March 17, 2024): A1 & A15.

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

(Note: the online version of the story has the date March 14, 2024, and has the title “A New Surge in Power Use Is Threatening U.S. Climate Goals.”)

If Your Disease Has No “F.D.A.-Stamped” Cure, Try Rational Experiments Rather Than Give Up

(p. 9) My whole family was sick in March with Covid-like symptoms, and though the one test we obtained was negative, I’m pretty sure we had the thing itself — and my own symptoms took months rather than weeks to disappear.

But unlike many of the afflicted, I didn’t find the experience particularly shocking, because I have a prior long-haul experience of my own. In the spring of 2015, I was bitten by a deer tick, and the effects of the subsequent illness — a combination of Lyme disease and a more obscure tick-borne infection, Bartonella — have been with me ever since.

Lyme disease in its chronic form — or, per official medical parlance, “post-treatment Lyme disease syndrome” — is a fiendishly complicated and controversial subject, and what I learned from the experience would (and will, at some point) fill a book.

. . .

If you feel like you need something else to get better, some outside intervention, something more than just your own beleaguered body’s resources, be impatient — and find a way to go in search of it.

. . .

EXPERIMENT, EXPERIMENT, EXPERIMENT.

There is no treatment yet for “long haul” Covid that meets the standard of a randomized, double-blind, placebo-controlled trial, which means that the F.D.A.-stamped medical consensus can’t be your only guide if you’re trying to break a systemic, debilitating curse. The realm beyond that consensus has, yes, plenty of quacks, perils and overpriced placebos. But it also includes treatments that may help you — starting with the most basic herbs and vitamins, and expanding into things that, well, let’s just say I wouldn’t have ever imagined myself trying before I become ill myself.

So please don’t drink bleach, or believe everything you read on Goop.com. But if you find yourself decanting Chinese tinctures, or lying on a chiropractor’s table with magnets placed strategically around your body, or listening to an “Anti-Coronavirus Frequency” on Spotify, and you think, how did I end up here?, know that you aren’t alone, and you aren’t being irrational. The irrational thing is to be sick, to have no official treatment available, and to fear the outré or strange more than you fear the permanence of your disease.

. . .

. . . I believe that with enough time and experimentation, I will actually be well.

That belief is essential. Hold on to it. In the long haul, it may see you through.

For the full commentary, see:

Ross Douthat. “What to Do When Covid Doesn’t Go Away.” The New York Times, SundayReview Section (Sunday, August 9, 2020 [sic]): 9.

(Note: ellipses and bracketed year added. A few words in the original are italicized, but you cannot see that since my blog formatting has all quoted words italicized.)

(Note: the online version of the commentary has the date Aug. 8, 2020 [sic], and has the title “China Wants to Move Ahead, but Xi Jinping Is Looking to the Past.” The heading EXPERIMENT, EXPERIMENT, EXPERIMENT was in bold in both the online and print versions. In the print version it was all in caps. In the online version only the first letter of each word was capitalized.)

Douthat’s The Deep Places book can be viewed as a substantial elaboration of the commentary quoted above:

Douthat, Ross. The Deep Places: A Memoir of Illness and Discovery. New York: Convergent Books, 2021.

House Advances Bill to Senate, Asking Nuclear Regulatory Commission to Weigh Benefits as Well as Costs of Nuclear Power

(p. A19) The House this week overwhelmingly passed legislation meant to speed up the development of a new generation of nuclear power plants, the latest sign that a once-contentious source of energy is now attracting broad political support in Washington.

The 365-to-36 vote on Wednesday [Feb. 28, 2024] reflected the bipartisan nature of the bill, known as the Atomic Energy Advancement Act. It received backing from Democrats who support nuclear power because it does not emit greenhouse gases and can generate electricity 24 hours a day to supplement solar and wind power. It also received support from Republicans who have downplayed the risks of climate change but who say that nuclear power could bolster the nation’s economy and energy security.

. . .

The bill would direct the Nuclear Regulatory Commission, which oversees the nation’s nuclear power plants, to streamline its processes for approving new reactor designs. The legislation, which is backed by the nuclear industry, would also increase hiring at the commission, reduce fees for applicants, establish financial prizes for novel types of reactors and encourage the development of nuclear power at the sites of retiring coal plants.

. . .

Proponents of this change say it would make the N.R.C. more closely resemble other federal safety agencies like the Food and Drug Administration, which weighs both the risks and benefits of new drugs. In the past, critics say, the N.R.C. has focused too heavily on the risks.

For the full story, see:

Brad Plumer. “Once Pariah, Nuclear Power Finds Broad Political Support.” The New York Times (Saturday, March 2, 2024): A19.

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

(Note: the online version of the story has the same date as the print version, and has the title “U.S. Seeks to Boost Nuclear Power After Decades of Inertia.” The online version says that the print version appeared on p. A20. The Replica version said that the print version appeared on p. A19.)

FDA Delays Apple Offering Consumers Quick and Convenient Blood Pressure Readings

Doesn’t the FDA do harm by requiring that Apple watch blood pressure monitor be equal in accuracy to a standard clinical blood pressure monitor? Many people will not take the time and effort to get frequent readings from a standard blood pressure monitor in a clinic. But many of them would check their blood pressure conveniently on their watch. Isn’t a less accurate reading better than no reading at all?

(p. A1) Apple’s widening effort to turn its nine-year-old watch from a luxury timepiece into the ultimate all-in-one medical device is taking it into territory that is legally treacherous as well as potentially profitable.

. . .

(p. A2) “The studies that we’ve seen are not yet reassuring that they’re ready for prime time or for clinical use,” said Jordana Cohen, associate professor of medicine and epidemiology at the University of Pennsylvania.

To secure Food and Drug Administration clearance for selling a blood-pressure monitor, companies must demonstrate through the FDA’s 510(k) process that their device’s accuracy is comparable to an existing, already cleared device, she added.

Similarly, tracking glucose through noninvasive skin sensors is generally less precise than direct blood analysis, with factors such as skin tone and temperature affecting accuracy.

For the full story, see:

Dalvin Brown and Aaron Tilley. “Tech and Legal Hurdles Hinder Apple’s Quest for Medical Watch.” The Wall Street Journal (Friday, Dec. 29, 2023): A1-A2.

(Note: ellipsis added.)

(Note: the online version of the story has the date December 28, 2023, and has the title “Apple Keeps Chasing the Ultimate Health-Tracking Watch—but It Could Take Years.”)