Category: Entrepreneurship

With Both Covid and Monkeypox, C.D.C. Wrongly “Tried to Maintain Control Over Testing”

(p. A14) Too often in a crisis, government officials look for easy solutions, with dramatic and immediate impact. But there are none for managing pandemics.

“A pandemic is by definition a problem from hell. You’re vanishingly unlikely to be able to remove all of its negative consequences,” said Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health.

Instead, he added, officials should bet on combinations of imperfect strategies, with an emphasis on speed over accuracy.

In both the coronavirus pandemic and the monkeypox outbreak, for example, the C.D.C. at first tried to maintain control over testing, instead of disseminating the responsibility as widely as possible. The move led to limited testing, and left health officials blind to the spread of the viruses.

The Food and Drug Administration was slow to help academic labs develop alternatives for testing, and encouraged the highest quality of diagnosis. It may be reasonable for officials to ask which test is faster or which one produces the least errors, Dr. Hanage said, but “all of them are better than not doing anything.”

For the full commentary, see:

Apoorva Mandavilli. “Unprepared for Covid and Monkeypox. And the Next Outbreak, Too.” The New York Times (Saturday, October 1, 2022): A14.

(Note: the online version of the commentary was updated Sept. 30, 2022, and has the title “New Infectious Threats Are Coming. The U.S. Probably Won’t Contain Them.”)

M.R.I. Inventor and Entrepreneur Earned Patent, But Was Denied Nobel Prize

(p. B10) Dr. Raymond Damadian, who built the first magnetic resonance imaging scanner, which revolutionized doctors’ ability to diagnose cancer and other illnesses — but who, to his dismay, saw the Nobel Prize for the science behind it go to two others — died on Aug. 3 [2022] at his home in Woodbury, N.Y.

. . .

The vision of scanning the human body without radiation came to Dr. Damadian in the late 1960s, he said, when he was working on nuclear magnetic resonance spectroscopy — which, until then, had been used to identify the chemical makeup of the contents of a test tube — at Downstate Medical Center (now SUNY Downstate Health Sciences University) in Brooklyn.

Working with rats, he discovered that when tissues were placed in a magnetic field and hit with a pulse of radio waves, cancerous ones emitted distinctly different radio signals than healthy ones.

He published his findings in 1971 in the journal Science and was granted a patent three years later for an “apparatus and method for detecting cancer in tissue.” It took 18 months to build the first M.R.I., originally known as a nuclear magnetic resonance scanner, or N.M.R. Its first scan, on July 3, 1977, was of Lawrence Minkoff, one of Dr. Damadian’s assistants — a vivid and colorful image of his heart, lungs, aorta, cardiac chamber and chest wall.

“Having birthed the original idea of the N.M.R. body scanner, we were intent on being the first to accomplish it,” Dr. Damadian said in the book “Gifted Mind: The Dr. Raymond Damadian Story, Inventor of the M.R.I.,” published in 2015, which he wrote with Jeff Kinley. “Failing to do so meant we might be denied the recognition for the original idea.”

But the technology behind the M.R.I. had several fathers.

Acknowledging that he was inspired by Dr. Damadian’s work, Paul C. Lauterbur of the State University of New York at Stony Brook had figured out how to translate the radio signals bounced off tissue into images. And Peter Mansfield of the University of Nottingham in England had developed mathematical techniques for analyzing the data, making the process more practical.

Employing the techniques he pioneered, Dr. Damadian’s company, Fonar, based in Melville, N.Y., produced the first commercial scanner in 1980.

. . .

While working at Downstate and later at Fonar, Dr. Damadian was aware of Dr. Lauterbur, a chemist who was also working on M.R.I. imaging and with whom he shared the National Medal of Technology.

In “Gifted Mind,” Dr. Damadian acknowledged that Dr. Lauterbur “realized that the N.M.R. signal differences in diseased and normal tissues I discovered could be used to construct a picture (image).”

But in 2003, when Dr. Lauterbur and Dr. Mansfield won the Nobel Prize in Medicine for their contributions to the science of magnetic resonance imaging, Dr. Damadian was enraged.

. . .

A year later, Dr. Damadian received one of the two annual Bower Awards given by the Franklin Institute, a science museum in Philadelphia. He was cited for his business leadership.

“There is no controversy in this,” said Dr. Bradford A. Jameson, a professor of biochemistry at Drexel University who was the chairman of the committee that chose the winners. “If you look at the patents in this field, they’re his.”

. . .

Dr. Damadian continued to innovate. He created open M.R.I. machines, which alleviate the claustrophobia patients can experience during scans when they are moved slowly through a tight tunnel, as well as mobile and stand-up scanners.

In recent years, he was focused on research that included imaging cerebral spinal fluid as it flowed to the brain.

For the full obituary, see:

Richard Sandomir. “Raymond Damadian, 86, Is Dead; Creator of the First M.R.I. Scanner.” The New York Times (Thursday, August 18, 2022): B10.

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

(Note: the online version of the obituary was updated Aug. 19, 2022, and has the title “Raymond Damadian, Creator of the First M.R.I. Scanner, Dies at 86.” Where there is a minor difference between the online and print versions, the passages quoted above follow the online version.)

Damadian’s biography mentioned above is:

Kinley, Jeff, and Raymond Damadian. Gifted Mind: The Dr. Raymond Damadian Story, Inventor of the MRI. Green Forest, AZ: Master Books, 2015.

Deregulation of Hearing Aids Will Lower Costs and Increase Innovation

(p. A1) The Food and Drug Administration decided on Tuesday to allow hearing aids to be sold over the counter without a prescription to adults, a long-sought wish of consumers frustrated by expensive exams and devices.

The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans from buying the devices. Health experts say that untreated hearing loss can contribute to cognitive decline and depression in older people.

Under the F.D.A.’s new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October, without being required to see a doctor for an exam to get a prescription.

. . .

“This could fundamentally change technology,” said Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.”

. . .

The change has been percolating for years. In 2016, a proposal for the F.D.A. to approve over-the-counter hearing aids for adults with mild to moderate hearing was released in a report by the National Academies of Science, Engineering and Medicine. The following year, Senators Chuck Grassley, a Republican of Iowa, and Elizabeth Warren, a Democrat of Massachusetts, introduced a bill enabling the agency to make the change. Congress approved the legislation and President Trump signed it into law.

Finalizing regulations has moved slowly since then, with some conflict over details, like how the federal rule would interact with state laws on hearing aid returns or warranty policies and how much the devices should amplify sound.

Mr. Biden issued an executive order last July calling for greater competition in the economy, which urged the F.D.A. to take action “to promote the wide availability of low-cost hearing aids.”

For the full story, see:

Christina Jewett. “F.D.A. Decides to Allow Over-the-Counter Sales of Hearing Aids.” The New York Times (Wednesday, August 17, 2022): A1 & A23.

(Note: ellipses added.)

(Note: the online version of the story was updated Aug. 23, 2022, and has the title “F.D.A. Clears Path for Hearing Aids to Be Sold Over the Counter.”)

Israel’s “Bold’ Creativity Yields Wine from Negev Desert

(p. A4) As growers in more established wine-producing areas of Europe and elsewhere in the world battle unpredictable, extreme weather, including scorching heat waves, Israelis have found themselves at the vanguard of dry-weather wine production, testing approaches that might soon find more global application.

And the work is being done in the Negev, home to hundreds of technology start-ups and a futuristic solar tower — and long a laboratory for experimentation in Israel.

“It is in the Negev that the creativity and pioneering vigor of Israel shall be tested,” read an inscription on the cafe’s wall — an iconic quote from David Ben-Gurion, Israel’s founding prime minister, who lived out his last years about 50 yards away, in an austere wooden cabin.

. . .

“To succeed in the Negev, you have to be bold and experiment,” said David Pinto, a vintner who planted his family plot with vines about three years ago.

. . .

With some 325 days of sunshine and little annual rainfall, the desert vines depend on drip irrigation, an innovation developed by another Negev collective in the 1960s that allows the farmer to tightly control the amount of water.

Desert vineyards also come with some natural advantages.

At night the temperatures drop steeply, even in midsummer, benefiting the vines. With low humidity, the Negev vines are exposed to few pests and fungi and require little pesticide spraying, making much of the wine production close to organic.

While artificial irrigation is frowned upon in traditional winegrowing regions in Europe, and is even banned in some locales, it may become more of a necessity.

And in a global wine industry that must adapt to climate change, Israel could be a role model, said Aaron Fait, an expert in desert research and agriculture at Ben-Gurion University of the Negev.

For the full story, see:

Isabel Kershner. “An Unexpected Vintage Grows in Israel’s Negev Desert.” The New York Times (Wednesday, September 7, 2022): A4.

(Note: ellipses added.)

(Note: the online version of the story has the same date as the print version, and has the title “Desert Winemaking ‘Sounds Absurd,’ but Israeli Vineyards in Negev Show the Way.”)

Senate Cedes Sovereignty on Air Conditioning HFC Regulation

(p. A17) WASHINGTON — The Senate voted on Wednesday to approve an international climate treaty for the first time in 30 years, agreeing in a rare bipartisan deal to phase out of the use of planet-warming industrial chemicals commonly found in refrigerators and air-conditioners.

. . .

Many American manufacturers had a business incentive to support the amendment. Under the pact, nations that do not ratify the amendment will have restricted access to expanding international markets starting in 2033.

Some Republicans from states with many chemical manufacturers supported the Kigali deal.

. . .

Americans for Prosperity, a political action committee founded by the billionaire Koch brothers, sent a letter to lawmakers last week saying that ratifying the Kigali Amendment would be an “abdication of U.S. sovereignty over environmental regulation” to the United Nations. The group also argued it would raise the price of air-conditioning, refrigeration and industrial cooling for American consumers.

For the full story, see:

Lisa Friedman and Coral Davenport. “Senate Ratifies Global Pact to Curb HFCs, Used in Cooling.” The New York Times (Thursday, September 22, 2022): A17.

(Note: ellipses added.)

(Note: the online version of the story has the date Sept. 21, 2022, and has the title “Senate Ratifies Pact to Curb a Broad Category of Potent Greenhouse Gases.” Where there is a minor difference between the online and print versions, the passages quoted above follow the online version.)

Netherlands Dairy Farmers “No Longer Allowed To Exist” Due to “Climate Tyranny”

(p. 6) WOUDENBERG, Netherlands — The dairy farmers of the Netherlands have had enough.

They have set fire to hay and manure along highways, dumped trash on roads to create traffic jams, and blockaded food distribution centers with their tractors, leading to empty shelves in supermarkets. Across the country, upside down flags wave from farmhouses in protest.

The anger of the farmers is directed at the government, which has announced plans for a national 50 percent reduction of nitrogen emissions by 2030, in line with European Union requirements to preserve protected nature reserves, that they believe unfairly targets them. Factories and cars also emit large amounts of nitrogen and have not been targeted, they say, although the government said that cuts associated with both polluters would be addressed in the future.

Agriculture is responsible for the largest share of nitrogen emissions in the Netherlands, much of it from the waste produced by the estimated 1.6 million cows that provide the milk used to make the country’s famed cheeses, like Gouda and Edam.

To realize those planned cuts, thousands of farmers will be required to significantly reduce livestock numbers and the size of their farming operations. If they cannot meet the cuts the government demands of them, they may be forced to close their operations altogether.

The Dutch government has set aside about 25 billion euros, about $26 billion, to carry out its plan, and some of that money will be used to help farmers build more sustainable operations — or buy them out, if possible.

“My livelihood and my network is being threatened,” said Ben Apeldoorn, whose farm in the province of Utrecht has about 120 cows producing milk for making cheese. “You’re just no longer allowed to exist,” said Mr. Apeldoorn, 52, who has been a farmer for 30 years.

. . .

Prime Minister Mark Rutte, who this month became the country’s longest-serving prime minister and has grappled with what is known in the Netherlands as “the nitrogen crisis,” has condemned the protests, calling them “unacceptable.”

. . .

Helma Breunissen, 47, a dairy farmer who with her husband also runs a veterinarian’s office, attended one of the meetings with Mr. Rutte to make her anger known.

“If half of the cattle needs to disappear, then my veterinary’s office will also end,” Ms. Breunissen said by telephone. “I don’t want a bag of money from the government, I just want to do my job.”

. . .

While many Dutch support the aims of a greener Netherlands, some right-wing groups have expressed support for the Dutch farmers as a way of opposing climate activism. The right-wing Forum for Democracy has declared that “there is no climate crisis” and opposes the government’s plans.

And the Dutch farmers have also received some support from abroad.

“Farmers in the Netherlands — of all places — are courageously opposing the climate tyranny of the Dutch government, can you believe it?” former President Donald J. Trump said at a rally last month.

For the full story, see:

Claire Moses. “Emission Cuts in the Netherlands Have Dairy Farmers Up in Arms.” The New York Times, First Section (Sunday, August 21, 2022): 6.

(Note: ellipses added.)

(Note: the online version of the story has the date Aug. 20, 2022, and has the title “Dairy Farmers in the Netherlands Are Up in Arms Over Emission Cuts.” Where there is a minor difference between the online and print versions, the passages quoted above follow the online version.)

Since Adderall Is “Highly Regulated” Pharmacies and Patients Can’t “Quickly Pivot” in Response to Scarcity

(p. A13) The Food and Drug Administration has declared a nationwide shortage of Adderall, a medication used to treat A.D.H.D. that has had surging demand in recent years.

. . .

Adderall, which contains the stimulant amphetamine, is a controlled substance and highly regulated, so it is difficult for pharmacies to quickly pivot and carry new brands, analysts said.

. . .

While a number of companies make Adderall and generic versions, pharmacies may find it difficult to pivot to other suppliers because of amphetamine’s status as a controlled substance that typically includes restrictions on its use and monitoring of prescription orders. Any given pharmacy might risk raising red flags with the Drug Enforcement Administration by doubling its supply, said Erin Fox, an expert on drug shortages at the University of Utah.

“With a controlled substance, it’s harder for patients to call around and find a pharmacy that has product for them,” Ms. Fox said.

For the full story, see:

Christina Jewett. “F.D.A. Confirms Widespread Shortages of Adderall.” The New York Times (Friday, October 14, 2022): A13.

(Note: ellipses added.)

(Note: the online version of the story has the date Oct. 13, 2022, and has the title “F.D.A. Confirms Wide Shortage of Adderall.”)

Musk’s Private Starlink Infrastructure “Played a Crucial Role” in Saving Ukraine

(p. A6) KYIV, Ukraine—Elon Musk backtracked on his complaints over the cost of funding Starlink internet terminals in Ukraine and said his company would continue to pay for them, as explosions rocked the Russian-held city of Donetsk in eastern Ukraine on Sunday [Oct. 16, 2022].

Mr. Musk, the billionaire chief executive of SpaceX and Tesla, pledged to continue funding the Starlink service for Ukraine just a day after he said SpaceX couldn’t finance the service indefinitely on its own.

“The hell with it,” Mr. Musk tweeted on Saturday. “Even though Starlink is still losing money & other companies are getting billions of taxpayer $, we’ll just keep funding Ukraine govt for free.”

The 20,000 Starlink terminals estimated to be in operation across Ukraine have played a crucial role in maintaining the country’s communications during the war and are deployed at hundreds of Ukrainian military outposts where they allow commanders to call in artillery strikes or coordinate operations in areas where cell service is jammed by Russia.

For the full story, see:

Matthew Luxmoore. “Musk Says SpaceX to Cover Starlink Costs in Ukraine.” The Wall Street Journal (Monday, Oct. 17, 2022): A6.

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

(Note: the online version of the story was updated Oct. 16, 2022, and has the title “Elon Musk Says SpaceX Will Continue to Cover Starlink Costs in Ukraine.”)

Environmentalists Ignore “The Unintended Impacts of Policies”

(p. A1) Nicole Kramaritsch of Roxbury, N.J., has 46 bags just sitting in her garage. Brian Otto has 101 of them, so many that he’s considering sewing them into blackout curtains for his baby’s bedroom. (So far, that idea has gone nowhere.) Lili Mannuzza in Whippany has 74.

“I don’t know what to do with all these bags,” she said.

The mountains of bags are an unintended consequence of New Jersey’s strict new bag ban in supermarkets. It went into effect in May and prohibits not only plastic bags but paper bags as well. The well-intentioned law seeks to cut down on waste and single-use plastics, but for many people who rely on grocery delivery and curbside pickup services their orders now come in heavy-duty reusable shopping bags — lots and lots of them, week after week.

While nearly a dozen states nationwide have implemented restrictions on single-use plastic bags, New Jersey is the only one to ban paper bags because of their environmental impact. The law also bans polystyrene foam food containers and cups, and restricts restaurants from handing out plastic straws unless they’re requested.

Emily Gonyou, 22, a gig worker in Roselle Park who provides shopping services for people (p. A11) through Instacart, said she was surprised when she learned the delivery company had no special plans for accommodating the ban. “They pretty much said, ‘OK, do exactly what you’re doing, but with reusable bags,’” she said.

Ms. Gonyou said she goes through up to 50 reusable bags a day, many of which, she suspects, could end up in the garbage.

Compared to single-use plastics, the more durable reusable bags are better for the environment only if they are actually reused. According to Shelie Miller, a professor at the University of Michigan School for Environment and Sustainability, a typical reusable bag, manufactured from polypropylene, must be used at least 10 times to account for the additional energy and material required to make it. For cotton totes, that number is much higher.

. . .

Dr. Miller said the bag situation in New Jersey was emblematic of a lot of environmental policies. “If we don’t pay attention to the unintended impacts of policies such as the plastic waste ban, we run into the potential of playing environmental Whac-a-Mole,” she said. “We solve one environmental problem only to create or exacerbate another problem.”

For the full story, see:

Clare Toeniskoetter. “New Jersey Bag Ban’s Unforeseen Consequence: Too Many Bags.” The New York Times (Friday, September 2, 2022): A1 & A11.

(Note: ellipsis added.)

(Note: the online version of the story has the date Sept. 1, 2022, and has the title “Why Do Some People in New Jersey Suddenly Have Bags and Bags of Bags?”)

Regulators Slowed Development of Moderna Vaccine

How much credit for the Covid vaccines goes to government and how much to entrepreneurs? Loftus’s book focuses on Moderna, and makes the case that government deserves considerable credit, mostly for early funding. A case can be made that at least as much focus should be given to BioNTech. If BioNTech had been the focus, that case might have been harder to make.

(p. C5) In late 2019, just weeks before the world heard of Covid-19, scientists from the National Institute of Allergy and Infectious Diseases visited the new manufacturing plant of a small, 9-year-old biotechnology company called Moderna. The company’s leaders boasted that the new plant in Norwood, Mass., could make a batch of a newly designed vaccine in 60 days—rapid by standard timelines that usually take 12 months or more.

. . .

One Friday afternoon in August [2020], the company was expecting delivery of large air-handling units to help expand production at its factory. Moderna had hired construction cranes to lift the tractor-trailer-sized units onto the roof of its plant. But delivery was delayed because the supplier lacked all the state permits needed to transport oversize cargo from the Midwest to Massachusetts. If the units didn’t get there by Sunday, Moderna would lose the cranes and a week of production.

Frantic, Moderna executives called Warp Speed officials. They gave the job to an Army colonel, who leaned on state officials, who in turn sent state police with sirens blaring to escort the delivery to their state line and then hand off the convoy to a new escort. The precious cargo rolled into Moderna’s plant on Sunday morning, in time for the cranes.

The much larger and older Pfizer, meanwhile, mostly opted out of Operation Warp Speed for fear it would slow the company down. As for Moderna’s collaboration, it generated enough friction to make the company’s chief medical officer during 2020, Tal Zaks, question at times whether it was worth it to accept the federal assistance.

Dr. Zaks had wanted to use a private contract research organization to run the whole trial, but NIAID officials wanted their clinical-trial network involved. Eventually, Dr. Zaks backed off, and both entities participated. “I realized we were at an impasse, and I was the embodiment of the impasse,” Dr. Zaks said.

Next, when Moderna’s 30,000-person study began enrolling volunteers in July 2020, the subjects weren’t racially diverse enough. Moncef Slaoui, who led Warp Speed’s vaccine efforts, and Dr. Fauci began holding Saturday Zoom calls with Mr. Bancel and other Moderna leaders to “help coax and advise Moderna how to get the percentage of minorities up to a reasonable level,” Dr. Fauci recalled.

Drs. Fauci and Slaoui wanted Moderna to slow down overall enrollment, to give time to find more people of color. Moderna executives resisted at first. “That was very tense,” Dr. Slaoui said. “Voices went up, and emotions were very high.” Moderna ultimately agreed, and the effort worked, but it cost the trial about an extra three weeks. Later, Mr. Bancel called the decision to slow enrollment “one of the hardest decisions I made this year.”

For the full essay, see:

Peter Loftus. “The Partnership That Made the First U.S. Covid Vaccine.” The Wall Street Journal (Saturday, July 30, 2022): C5.

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

(Note: the online version of the essay has the date July 29, 2022, and has the same title as the print version.)

The essay quoted above is an adaptation from Loftus’s book:

Loftus, Peter. The Messenger: Moderna, the Vaccine, and the Business Gamble That Changed the World. Boston: Harvard Business Review Press, 2022.