Category: Regulations

F.A.A. Can Take Many Years to Certify Innovative Aviation Technologies

(p. 6) Despite the excitement about e-planes, the Federal Aviation Administration has never certified electric propulsion as safe for commercial use. Companies expect that to change in the coming years, but only gradually, as safety concerns are worked out.

. . .

The consensus within the industry is that the F.A.A., which regulates half the world’s aviation activity, is several years from certifying urban air mobility.

“It’s a big burden of proof to bring new technology to the F.A.A. — appropriately so,” Mr. Clark said. Currently the certification process for a new plane or helicopter takes two to three years on average. For an entirely new type of vehicle, it could be considerably longer. (One conventionally powered aircraft that can take off and land without a runway had its first flight in 2003. It remains uncertified.)

For the full story, see:

Ben Ryder Howe and Tristan Spinski. “Covid Patient In Shanghai Describes Life In Isolation.” The New York Times, SundayBusiness Section (Sunday, April 17, 2022): 1 & 6-7.

(Note: ellipsis added.)

(Note: the online version of the story was updated April 18, 2022, and has the title “The Battery That Flies.”)

“Byzantine Health Care System” Slowed Rollout of Effective COVID Anti-Viral Medication Paxlovid

(p. A16) GREENBELT, Md. — Last month, the owner of a small pharmacy here secured two dozen courses of Pfizer’s new medication for treating Covid-19, eager to quickly provide them to his high-risk customers who test positive for the virus.

More than a month later, the pharmacy, Demmy’s, has dispensed the antiviral pills to just seven people. The remaining stock is sitting in neatly packed rows on its shelves here in the suburbs of Washington, D.C. And the owner, Adeolu Odewale, is scrambling to figure out how to get the medication, Paxlovid, to more people as cases have increased over 80 percent in Maryland in recent days.

“I didn’t expect that I was still going to be sitting on that many of them,” he said of the pills he still has on hand. “It’s just that people need to know how to get it.”

. . .

But with the medication now more abundant, pharmacists, public health experts and state health officials say that encouraging the right people to take it, and making it easier for them to access, could help blunt the effects of another Covid wave.

State health officials say that many Americans who would be good candidates for Paxlovid do not seek it out because they are unaware they qualify for it, hesitant about taking a new medication, or confused by the fact that some providers interpret the eligibility guidelines more narrowly than others.

Since the medication has to be prescribed by a doctor, nurse practitioner or physician assistant, people have to navigate an often byzantine health care system in search of a prescription, then find a pharmacy that carries the treatment, all within five days of developing symptoms. The medication, prescribed as three pills taken twice a day for five days, is meant to be started early in the course of infection.

. . .

More than 630,000 courses of the drug — roughly a third of the supply distributed to date — are currently available, and the federal government has been sending 175,000 courses to states each week, according to federal data.

. . .

Giving pharmacists prescribing power could help people get the treatment much more quickly and easily, public health experts say. But regulators at the F.D.A. and other federal health officials believe there is reason to not allow pharmacists to prescribe Paxlovid themselves, even though some Canadian pharmacists can do so. The treatment can interfere with certain medications and should be prescribed at a lower dose for people with kidney impairment, which is measured with a blood test.

Pharmacists say that they are highly trained and well equipped to conduct such screening themselves. Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said pharmacists could get Paxlovid to patients faster if they could prescribe it, “without having to call a physician’s office and wait for a call back, and hope it happens within five-day period.”

For the full story, see:

Noah Weiland. “Plenty of Covid Pills, Not Many Prescriptions.” The New York Times (Wednesday, April 27, 2022): A16.

(Note: ellipses added.)

(Note: the online version of the story has the date April 26, 2022, and has the title “With Supply More Abundant, Pharmacies Struggle to Use Up Covid Pills.” The online version says that the article appeared on p. A18 of the print version, but in my National edition of the print version, it appeared on p. A16.)

Art Diamond Discusses “Policy Hurdles in the Fight Against Aging” on Caleb Brown’s Cato Daily Podcast

Caleb Brown, of the Cato Institute, posted an interview with me yesterday (May 27, 2022) on his “Cato Daily Podcast.” The topic, “Policy Hurdles in the Fight against Aging,” is related to a chapter in my book-in-progress on medical entrepreneurship that is to be entitled Less Costs, More Cures: Unbinding Medical Entrepreneurs.

Sugarman Spent $500,000 in a Losing Fight Against a $100,000 FTC Fine

(p. A12) Though many of his wackier ideas bombed, Mr. Sugarman came up with a big winner now and then, including pocket calculators in the early 1970s and his BluBlocker sunglasses, designed to filter out ultraviolet and blue light waves, starting in the 1980s.

. . .

Trouble came in 1979 when the Federal Trade Commission accused him of violating a rule requiring firms to send out mail-order items promptly or notify customers of delays. Mr. Sugarman said the delays were caused by blizzards and a computer breakdown. The FTC proposed a $100,000 fine.

Mr. Sugarman counterattacked with a pamphlet, “The Monster That Eats Business,” an indictment of the FTC illustrated with cartoons in the style of Mad magazine. He accused FTC officials of hounding him over trivial lapses. After six years of fighting, he agreed to a settlement requiring him to pay a fine of $115,000 over four years. Mr. Sugarman said he had spent $500,000 on legal fees and added that “we are completely innocent of the charges.”

The success of BluBlocker sunglasses dug him out of that hole. Mr. Sugarman had a home on Maui, where he published a weekly newspaper. He flew small airplanes. He drove a Ferrari Testarossa. He looked dapper in his BluBlockers.

For the full obituary, see:

James R. Hagerty. “Marketing Guru Survived His Flops and Found Hits.” The Wall Street Journal (Saturday, April 2, 2022): A12.

(Note: ellipsis added.)

(Note: the online version of the obituary has the date March 29, 2022, and has the title “Marketing Maverick Survived Flops, Found Hits.”)

Imposing Permanent Daylight Savings Time Is Like Imposing Permanent Jet Lag

(p. A19) . . . when the U.S. Senate recently passed a bill to make daylight-saving time permanent, sleep experts became more alarmed.

Legislators picked the wrong time, they say.

Our internal clocks are connected to the sun, which aligns more closely with permanent standard time, says Muhammad Adeel Rishi, a pulmonologist and sleep physician at Indiana University. When the clocks spring forward, our internal clocks don’t change but are forced to follow society’s clock rather than the sun. DST is like permanent social jet lag.

Dr. Rishi is one of the authors of a 2020 position statement from the American Academy of Sleep Medicine, a professional society, supporting making standard time—not daylight-saving time—permanent.

. . .

One of the big problems with permanent DST, objectors note, is that in the winter the sun will rise later and many schoolchildren will be walking to school in the dark.

On the western edge of the eastern time zone in Indiana, for instance, the sun won’t rise in the winter until about 9 a.m., notes Dr. Rishi. “You’re basically putting these kids two hours off from their circadian biology,” he says.

For the full commentary, see:

Sumathi Reddy. “YOUR HEALTH; Body Clock Needs Sun In Morning.” The Wall Street Journal (Thursday, March 24, 2022): A19.

(Note: ellipses added.)

(Note: the online version of the commentary has the date March 23, 2022, and has the title “YOUR HEALTH; Why Permanent Daylight-Saving Time Is Seen as Bad for Your Health.”)

Pre-Covid Federal Pandemic Plans Did Not Include Lockdowns

(p. A19) California Gov. Gavin Newsom announced the first statewide U.S. stay-at-home order on March 19, 2020. All U.S. states and most other countries have long since abandoned lockdowns as oppressive, ineffective and exorbitantly expensive. But why did free countries adopt such a strategy to begin with?

. . .

Stay-at-home orders weren’t part of the script in pre-Covid federal pandemic plans. The idea of “flattening the curve” through what are known as “layered non-pharmaceutical interventions” can be traced to an influential 2007 Centers for Disease Control and Prevention guidance paper, updated in 2017. Contemplating a severe pandemic with a 2% case fatality rate, the CDC recommended now-familiar strategies, such as masking, surface disinfection and temporary school closings.

Yet aside from suggesting limits on mass gatherings, the CDC paper makes no mention of closing workplaces. Instead, it concludes that such a severe pandemic could warrant recommending that employers “offer telecommuting and replace in-person meetings in the workplace with video or telephone conferences.” The closest it comes to lockdowns is recommending “voluntary home quarantine” for people with an infected family member.

. . .

When Western nations were confronted with Covid-19, they seemed to believe the Communist Party’s unproven claims about the efficacy of lockdowns. In the end, every other country got some variant of the virus and some variant of China’s official response. The world has learned to live with the former, as politically accountable leaders found they couldn’t maintain draconian restrictions forever. The people of China will be forced to endure the latter indefinitely.

For the full commentary, see:

Eugene Kontorovich and Anastasia Lin. “Covid Lockdowns Were a Chinese Import.” The Wall Street Journal (Thursday, March 24, 2022): A19.

(Note: ellipses added.)

(Note: the online version of the commentary has the date March 23, 2022, and has the same title as the print version.)

Covid Policy Should Have Taken Account of Costs of Lockdowns and Mandates

(p. A17) Reducing the incidence of disease isn’t necessarily desirable if excessive prevention, in the form of lockdowns or school closures, is more costly to society than the damage done by an illness. We don’t close highways to minimize accidental deaths, despite the existence of dangerous drivers. Yet this is exactly what we’re doing when the government intervenes to limit the spread of communicable diseases by, for instance, mandating vaccines that don’t prevent transmission.

. . .

In early 2020, University of Chicago economists estimated that about 80% of the total damage from Covid came from prevention efforts that hindered economic activity, and only 20% from the direct effects of the disease itself. This analysis motivated me and others to recommend that initial efforts to stop the spread should focus on older people, who are at higher risk of severe illness and not as active in the economy as younger people. This would allow younger people to keep the economy going while limiting the spread of the disease among those most at risk from it. Some in the public-health community, like the signers of the Great Barrington Declaration, eventually saw the light.

My Chicago colleague Casey B. Mulligan has found that total monthly Covid-related harms fell from 2020 to 2021, even as the number of deaths rose. In tax terms, this is an effect not unlike that of the Laffer curve—a lower rate may increase revenue because of growth in the tax base. Similarly, vaccines and treatments reduced the costs associated with getting sick—call it the “disease tax”—but also increased social and economic activity, allowing the infection to spread. Even if the disease tax is paid by more people, the costs are outpaced by the overall benefit derived from the subsequent tsunami of economic activity.

For the full commentary, see:

Tomas J. Philipson. “An Economic Evaluation Of Covid Lockdowns.” The Wall Street Journal (Saturday, January 20, 2022): A17.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date January 19, 2022, and has the same title as the print version.)

During Pandemic, Delayed Medical Procedures Rose from 4.6 to 6 Million in England’s Socialized Healthcare System

(p. A8) LONDON — Lara Wahab had been waiting for more than two years for a kidney and pancreas transplant, but months had passed without any word. So last month she called the hospital, and got crushing news.

There had been a good match for her in October [2021], the transplant coordinator told her, which the hospital normally would have accepted. But with Covid-19 patients filling beds, the transplant team could not find her a place in the intensive care unit for postoperative care. They had to decline the organs.

“I was just in shock. I knew that the N.H.S. was under a lot of strain, but you don’t really know until you’re waiting for something like that,” she said, referring to the National Health Service. “It was there, but it sort of slipped through my fingers,” she added of the transplant opportunity.

Ms. Wahab, 34, from North London, is part of an enormous and growing backlog of patients in Britain’s free health service who have seen planned care delayed or diverted, in part because of the pandemic — a largely unseen crisis within a crisis. The problems are likely to have profound consequences that will be felt for years.

The numbers are stark: In England, nearly 6 million procedures are currently delayed, a rise from the backlog of 4.6 million before the pandemic, according to the N.H.S. The current delays most likely impact more than five million people — a single patient can have multiple cases pending for different ailments — which represents almost one-tenth of the population. Hundreds of thousands more haven’t been referred yet for treatment, and many ailments have simply gone undiagnosed.

For the full story, see:

Megan Specia. “In Britain, an Ever-Growing Backlog of Non-Covid Care.” The New York Times (Thursday, January 27, 2022): A8.

(Note: bracketed year added.)

(Note: the online version of the story was updated January 27, 2022, and has the title “‘I Feel Really Hopeless’: In U.K., Millions See Non-Covid Health Care Delayed.”)

Natural Immunity Is Stronger and Lasts Longer Than Immunity from Covid Vaccines

(p. A17) Public-health officials ruined many lives by insisting that workers with natural immunity to Covid-19 be fired if they weren’t fully vaccinated. But after two years of accruing data, the superiority of natural immunity over vaccinated immunity is clear. By firing staff with natural immunity, employers got rid of those least likely to infect others. It’s time to reinstate those employees with an apology.

For most of last year, many of us called for the Centers for Disease Control and Prevention to release its data on reinfection rates, but the agency refused. Finally last week, the CDC released data from New York and California, which demonstrated natural immunity was 2.8 times as effective in preventing hospitalization and 3.3 to 4.7 times as effective in preventing Covid infection compared with vaccination.

Yet the CDC spun the report to fit its narrative, bannering the conclusion “vaccination remains the safest strategy.” It based this conclusion on the finding that hybrid immunity—the combination of prior infection and vaccination—was associated with a slightly lower risk of testing positive for Covid. But those with hybrid immunity had a similar low rate of hospitalization (3 per 10,000) to those with natural immunity alone. In other words, vaccinating people who had already had Covid didn’t significantly reduce the risk of hospitalization.

Similarly, the National Institutes of Health repeatedly has dismissed natural immunity by arguing that its duration is unknown—then failing to conduct studies to answer the question. Because of the NIH’s inaction, my Johns Hopkins colleagues and I conducted the study. We found that among 295 unvaccinated people who previously had Covid, antibodies were present in 99% of them up to nearly two years after infection. We also found that natural immunity developed from prior variants reduced the risk of infection with the Omicron variant. Meanwhile, the effectiveness of the two-dose Moderna vaccine against infection (not severe disease) declines to 61% against Delta and 16% against Omicron at six months, according to a recent Kaiser Southern California study. In general, Pfizer’s Covid vaccines have been less effective than Moderna’s.

The CDC study and ours confirm what more than 100 other studies on natural immunity have found: The immune system works. The largest of these studies, from Israel, found that natural immunity was 27 times as effective as vaccinated immunity in preventing symptomatic illness.

None of this should surprise us. For years, studies have shown that infection with the other coronaviruses that cause severe illness, SARS and MERS, confers lasting immunity.

For the full commentary, see:

Marty Makary. “The High Cost of Disparaging Natural Immunity.” The Wall Street Journal (Thursday, January 27, 2022): A17.

(Note: the online version of the commentary has the date January 26, 2022, and has the title “The High Cost of Disparaging Natural Immunity to Covid.”)

The Israeli preprint study mentioned above is:

Gazit, Sivan, Roei Shlezinger, Galit Perez, Roni Lotan, Asaf Peretz, Amir Ben-Tov, Dani Cohen, Khitam Muhsen, Gabriel Chodick, and Tal Patalon. “Comparing Sars-Cov-2 Natural Immunity to Vaccine-Induced Immunity: Reinfections Versus Breakthrough Infections.” medRxiv (2021): doi: https://doi.org/10.1101/2021.08.24.21262415.

Middle Class Hurt by California Mandate for New Home Batteries and Solar Panels

(p. B1) This month, state regulators updated California’s building code to require some new homes and commercial buildings to have solar panels and batteries and the wiring needed to switch from heaters that burn natural gas to heat pumps that run on electricity. Energy experts say it is one of the most sweeping single environmental updates to building codes ever attempted by a government agency.

But some energy and building experts warn that California may be taking on too much, too quickly and focusing on the wrong target — new buildings, rather than the much larger universe of existing structures. Their biggest fear is that these new requirements will drive up the state’s already high construction costs, putting new homes out of reach of middle- and lower-income families that cannot as easily afford the higher upfront costs of cleaner energy and heating equipment, which typically pays for itself over years through (p. B3) savings on monthly utility bills.

. . .

Adding solar panels and a battery to a new home can raise its cost by $20,000 or more. While that might not matter to somebody buying a million-dollar property, it could be a burden on a family borrowing a few hundred thousand dollars to buy a home.

“You’re going to see the impact in office rents. You’re going to see it in the cost of the milk in your grocery store,” said Donald J. Ruthroff, a principal at Dahlin Group Architecture Planning in Pleasanton, Calif. “There’s no question this is going to impact prices across the board.”

. . .

The Sycamore Square townhouses were the last ones developed in San Bernardino before the solar mandate took effect last year. Glenn Elssmann, a partner in the project who hired Mr. Marini’s company as the contractor, said the added cost of the solar requirement would have made construction of the development impossible. Homes in Sycamore Square started at $340,000 for the four-bedroom, three-bath units and reached as high as $370,000.

Jimmie Joyce, 44, who works in payroll at the Los Angeles County Department of Public Health, will soon close on the purchase of a house in Sycamore Square after trying for almost a year to buy closer to Inglewood, a city near the Los Angeles International Airport where he lives now. His commute will likely increase from about 40 minutes to an hour and a half.

“I, for one, didn’t even plan on moving out that far,” Mr. Joyce said. “The way the market is, people are just overbidding to just try to get in things.” He said he made an offer $10,000 to $15,000 higher than the asking price on a home that ended up with more than 70 bids, including one that was $60,000 more than his.

His new home is already expensive for him, he said, and adding $10,000 to $20,000 more for solar, a battery and other amenities “would make that much more challenging.”

The changes regulators adopted this month will also require most new commercial buildings, including schools, hotels, hospitals, office buildings, retailers and grocery stores, and apartment buildings and condos above three stories to include solar and batteries. And regulators will require single-family homes to have wiring that will allow them to use electric heat pumps and water heaters, rather than ones that burn natural gas. About 55 percent of California’s homes use electric heat and 45 percent use natural gas.

For the full story, see:

Ivan Penn. “Greener Buildings, for a Lot of Green.” The New York Times (Monday, August 30, 2021): B1 & B3.

(Note: ellipses added.)

(Note: the online version of the story was updated Sept. 9, 2021, and has the title “California’s Plan to Make New Buildings Greener Will Also Raise Costs.”)