Category: Regulations

Covid-19 Patents Provide Funding for Development of Future Vaccines

(p. A25) South Africa and India have petitioned the World Trade Organization to suspend some intellectual property protections from Covid-19 drugs, vaccines and diagnostic technologies. In support of the effort, Doctors Without Borders began a social media campaign urging governments to “put lives over profits,” warning of “pharma profiteering” and urging support for “#NoCovidMonopolies.”

. . .

Intellectual property rights, including patents, grant inventors a period of exclusivity to make and market their creations. By affording these rights to those who create intangible assets, such as musical compositions, software or drug formulas — people will invent more useful new things.

Development of a new medicine is risky and costly. Consider that scientists have spent decades — and billions of dollars — working on Alzheimer’s treatments, but still have little to show for it. The companies and investors who fund research shoulder so much risk because they have a shot at a reward. Once a patent expires, generic companies are free to produce the same product. Intellectual property rights underpin the system that gives us all new medicines, from psychiatric drugs to cancer treatments.

. . .

Eroding patent protections has far-reaching consequences.

Take “messenger RNA,” the technology platform that supports the vaccines from Pfizer-BioNTech and Moderna. Ozlem Tureci and Ugur Sahin, the wife-and-husband team at the helm of BioNTech, began exploring the use of mRNA more than 25 years ago and founded their company in 2008. Theoretically, mRNA can instruct the body to engineer proteins, including ones that increase immunity against infectious pathogens, cancers and rare genetic conditions. But the Covid-19 vaccines are the first truly successful applications of this technology. Scientists eager to explore future uses of mRNA will struggle to find investment if intellectual property protections are snatched away when others deem it necessary.

For the full commentary, see:

Thomas Cueni. “The Risk in Suspending Vaccine Patent Rules.” The New York Times (Saturday, December 12, 2020): A25.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Dec. 10, 2020, and has the same title as the print version.)

Can the Methods of ACT UP Bring Quicker Cures for Other Maladies?

Amar Bhidé has a thought-provoking article in which he asks the public choice question of how to overcome government regulators who slow the development of breakthrough drugs. He holds up, as a main example to ponder, the AIDs ACT UP movement that is often given credit for winning concessions from the FDA that spurred the availability of a drug cocktail that greatly extended and improved the lives of AIDs patients. The passages quoted below are from a review of a book that may be a promising source for learning more about what ACT UP did and how they did it.

(p. C3) In her 2012 book, “The Gentrification of the Mind,” Sarah Schulman delved into the silence still surrounding AIDS in America.

. . .

Schulman has gone from witness to a sort of living archive. She is a former member of AIDS Coalition to Unleash Power, the influential direct-action group committed to ending AIDS. Her new book, “Let the Record Show,” is based on 17 years of interviews she conducted with nearly 200 members of the organization.

. . .

The effect is rather like standing in the middle of that large room, where anyone could speak up and share an idea. Everyone is talking; small stories branch off, coalesce pages later. Speakers shade in one another’s stories, offer another angle, disagree passionately. You turn a page, and the same people have their arms linked together at a protest. Shadows start to fall; in squares of gray text, deaths are marked, moments for remembrance. So many people leave the room.

. . .

This is not reverent, definitive history. This is a tactician’s bible.

The organizational brilliance of ACT UP emerged out of necessity. The group was founded in 1987, incited by Larry Kramer’s famous call to action. The members were infected, their lovers were sick and dying. There wasn’t time to obsess over process, to contest every comma in a letter. The anarchistic framework asked only that members be “committed to direct action to end the AIDS crisis.”

. . .

When Schulman herself returns to the individual, it is to think again about the figure of the bystander. Why did these particular people rise to the moment and not others?

What thread connected an H.I.V.-positive stockbroker, a retired chemist from Queens, addicts, art students, lifelong activists, people who just happened to be in the next room at the center and wandered in, What was going on in there? For some it was their first experience of gay community; for others it was where they went when the community began to vanish. All of them became autodidacts in drug research, policy, media relations.

For the full review, see:

Parul Sehgal. “Remembering Those Who Stood Up.” The New York Times (Wednesday, May 5, 2021): C3.

(Note: ellipses added. In the original, the words NOT italicized above, were the only words that WERE italicized.)

(Note: the online version of the review has the date May 4, 2021, and has the title “A New Testament to the Fury and Beauty of Activism During the AIDS Crisis.”)

The book under review is:

Schulman, Sarah. Let the Record Show: A Political History of ACT UP New York, 1987-1993. New York: Farrar, Straus and Giroux, 2021.

The article mentioned above by Bhidé is:

Bhidé, Amar. “Constraining Knowledge: Traditions and Rules That Limit Medical Innovation.” Critical Review 29, no. 1 (Jan. 2017): 1-33.

Xi Jinping Only Pays “Mere Lip Service” to “Private Enterprise and Innovation”

(p. A23) Ant Group, China’s biggest fintech conglomerate, was preparing last November for its initial public offering. Analysts projected it would raise $34 billion, the largest sale of shares in history. The company, founded by Jack Ma, had become synonymous with financial innovations, which are often risky.

In the run-up to the I.P.O., Chinese regulators trying to assess financial risks on Ant’s books had been brushed off by Mr. Ma. In an audacious speech, he criticized regulators as too cautious and pilloried state-owned banks for their “pawnshop” mentality of providing loans only to borrowers who could post collateral.

Even oblique attacks on China’s government rarely go unpunished. This was a direct provocation. Yet such was Mr. Ma’s aura, and his apparent imperviousness to government strictures, that domestic and foreign investors were unconcerned.

. . .

Then it all fell apart. Two days before Ant’s shares were to begin trading on the Hong Kong and Shanghai exchanges, the government blocked the I.P.O.

. . .

It seemed that, in bringing the hammer down on the company, the government aimed to limit its growing economic and political power.

But in so doing, the government spooked investors. Suddenly, President Xi Jinping’s pledges to encourage private enterprise and innovation looked like mere lip service.

For the full commentary, see:

Eswar Prasad. “Jack Ma Paid for Taunting China.” The New York Times (Friday, April 30, 2021): A23.

(Note: ellipses added.)

(Note: the online version of the commentary has the date April 28, 2021, and has the title “Jack Ma Taunted China. Then Came His Fall.”)

Those Lacking Degrees Are Cheaper, More Loyal, and Often Equally Able

(p. B5) Millions of jobs requiring a four-year college degree can be done without that level of education, some corporate leaders say.

To address inequalities in business and society, some executives suggest that companies shake up their approach to hiring and consider unconventional candidates. Black Americans in particular are often left unprepared by the U.S. education system, and companies could help by hiring workers without a degree and giving them training, Kenneth Frazier, CEO of Merck & Co., said Tuesday at The Wall Street Journal’s CEO Council Summit.

“It’s really important for us to recognize that because people haven’t had an opportunity early in their lives, it doesn’t mean that they can’t make a real contribution to your company,” Mr. Frazier said.

. . .

“We get many people who are cheaper, they’re just as good, they’re very loyal because this gives them an opportunity,” he said. “For those of us who are insiders now by virtue of our success and our positions in companies, we need to extend ourselves and reach out, and bring in people who may not be the people that we’re comfortable with, and may not be the first person that we think of.”

For the full story, see:

Chip Cutter. “Some CEOs Suggest Hiring More People Without Degrees.” The Wall Street Journal (Thursday, May 6, 2021): B5.

(Note: ellipsis added.)

(Note: the online version of the story has the date May 5, 2021, and has the title “Some CEOs Suggest Dropping Degree Requirements in Hiring.”)

Some Oil and Gas Landmen Seamlessly Transition to Being Wind and Solar Landmen

(p. A1) Carter Collum used to spend mornings shoulder to shoulder with competitors in the record rooms of East Texas courthouses, hunting for the owners of underground natural-gas deposits. At night, he made house calls, offering payments and royalties for permission to drill.

Mr. Collum worked as a landman, tracking the owners of oil and gas trapped in rock layers thousands of feet beneath the earth’s surface and getting their signatures, a job about as old as the American petroleum industry.

. . .

These days, the jobs are going dry. Landmen, after riding the highs of the boom, face weakened demand for fossil fuels and investor indifference to shale companies after years of poor returns. Instead of oil and gas (p. A10) fields, some landmen are securing wind and solar fields, spots where the sun shines brightest and the wind blows hardest.

The difference is shale wells eventually empty and, in good times, that keeps landmen on the prowl for new land and new contracts. Wind and solar energy never run out, limiting demand for new leases as well as landmen.

For the full story, see:

Rebecca Elliott. “Oil-and-Gas Landmen Now Hunt for Wind and Sun.” The Wall Street Journal (Monday, April 19, 2021): A1 & A10.

(Note: ellipsis added.)

(Note: the online version of the story has the date April 18, 2021, and has the title “Landmen Who Once Staked Claims for Oil and Gas Now Hunt Wind and Sun.”)

Musk Confronts or Ignores Regulators Who Block Innovation

(p. A1) He’s become one of the world’s most successful entrepreneurs by reinventing industries from electric cars to rockets. Along the way, he’s also rewritten the rules of engagement with U.S. regulators.

Elon Musk has emerged a winner in a series of run-ins with a range of regulatory agencies that have watched as he sidestepped rules or ignored enforcement attempts. He has overmatched an alphabet-soup of agencies that oversee financial markets and safety in the workplace, on highways and in space flight.

Most chief executives try to avoid regulators—or at least stay in their good graces. Many accused of overstepping have paid fines or agreed to make improvements.

Mr. Musk, revered by some investors for his iconoclastic approach, has taken a different tack on his way to becoming one of the richest men in the world, not letting regulations hinder his goals to revolutionize transportation with Tesla Inc.’s electric cars or colonize Mars using SpaceX rockets.

Federal agencies say he’s breaking the rules and endangering people. Mr. Musk (p. A10) says they’re holding back progress.

. . .

The Federal Aviation Administration criticized SpaceX for launching a rocket in December [2020] without a proper FAA license. Mr. Musk ridiculed the FAA space division in a tweet as “fundamentally broken.”

. . .

When asked to comment on the specifics of this article, Mr. Musk replied with a “poop” emoji. Asked to elaborate, Mr. Musk declined to provide any input on his interactions with federal agencies or his view toward regulation. In a tweet Tuesday, Mr. Musk said he agrees with regulators “99.9% of the time.” He added that when they disagree, it “is almost always due to new technologies that past regulations didn’t anticipate.”

. . .

After the FAA delayed a January [2021] test launch, Mr. Musk accused the agency of holding back progress and argued that its regulations were outdated. “Their rules are meant for a handful of expendable launches per year from a few government facilities,” he tweeted on Jan. 28. “Under those rules, humanity will never get to Mars.”

. . .

The National Labor Relations Board ruled in March that Tesla had violated U.S. labor law by hindering unionization and ordered Mr. Musk to delete a tweet discouraging employees from unionizing. Tesla this month appealed the decision, saying the NLRB’s ruling was “contrary to law.”

Mr. Musk’s tweet remains online. The NLRB declined to comment.

For the full story, see:

Ben Foldy, Rebecca Elliott, Susan Pulliam. “Elon Musk’s War With Regulators.” The Wall Street Journal (Thursday, April 29, 2021): A1 & A10.

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

(Note: the online version of the story has the date April 28, 2021, and has the title “Elon Musk’s War on Regulators.”)

New Regulations Pushed by Union Allied with de Blasio Will Limit New NYC Hotels

(p. A8) Mayor Bill de Blasio and other New York City leaders are pushing a controversial plan to drastically restrict hotel development, a move that the mayor’s own experts fear could endanger the city’s post-pandemic recovery and cost billions in lost tax revenue.

. . .

The Council is expected to approve the plan in time for Mr. de Blasio to see it become law before he leaves office this year. Once it is in place, developers fear that few, if any, new hotels would be built.

. . .

“We flag that to continue with this proposal could be seen as contrary to economic recovery principles and sound planning,” Marisa Lago, the director of the planning department, wrote last year in the memo to City Hall.

But Mr. de Blasio’s views hew closer to those of another group: the hotel workers union that endorsed his 2020 presidential campaign, pouring $440,000 into ads to bolster his ill-fated candidacy.

The union, the Hotel Trades Council, has long pushed to limit the construction of new hotels, which are often nonunion. Its calculation has been that limiting the development of such hotels, which typically offer less-expensive lodging than existing full-service hotels, would tend to increase hotel room prices generally and bolster the higher-end hotels where many of its workers are employed.

. . .

In most of the city, developers are free to build hotels in areas that are zoned for such use. Under a special approval process, building hotels would become far more challenging, said Moses Gates, vice president of housing and neighborhood planning at the Regional Plan Association, an influential nonprofit planning group. No other type of routine development currently gets the kind of scrutiny that Mr. de Blasio is proposing for hotels, he said.

“Hotels would be the only common land use which would always need City Council approval to be built, no matter what,” Mr. Gates said.

. . .

The Hotel Trades Council’s support of a special permit process for new hotels may seem counterintuitive, since it is effectively opposing the growth of jobs in the industry that it represents. Union hotel jobs in New York City provide one of the few pathways to the middle class for workers with no college education.

“Labor generally is in favor of employment and of growth, but especially jobs in their own sector,” said Harry C. Katz, a professor of collective bargaining at Cornell University.

But mid-market hotels that serve middle-class tourists are hard to unionize, union and industry experts say. If citywide special permits are adopted, as is expected, the hotel union would most likely use its political leverage to pressure Council members to only accept new hotels that use union labor.

For the full story, see:

Dana Rubinstein and J. David Goodman. “A Plan to Limit New Hotels in New York Meets Resistance.” The New York Times (Wednesday, April 28, 2021): A8.

(Note: ellipses added.)

(Note: the online version of the story has the date April 27, 2021, and has the title “A $7 Billion Mistake? New York Seeks to Curb New Hotels.”)

The research co-authored by Stone and mentioned above was described in:

Stone, Brian, Jr., Evan Mallen, Mayuri Rajput, Carina J. Gronlund, Ashley M. Broadbent, E. Scott Krayenhoff, Godfried Augenbroe, Marie S. O’Neill, and Matei Georgescu. “Compound Climate and Infrastructure Events: How Electrical Grid Failure Alters Heat Wave Risk.” Environmental Science & Technology (published online in advance of print on April 30, 2021).

French Central Planners Say Crepe Makers Are “Essential” but Desk Lamps Are Not

(p. A11) PARIS — Three French lockdowns, and counting, over the past 13 months have been many things, among them a rare opportunity for the formidable national bureaucracy of about 5.6 million public servants to display their gift for the complication of lives.

With the announcement of the third Paris lockdown last month to try to control the spread of the coronavirus, an apotheosis of the absurd was reached.

. . .

How to get your head around hairdressers, vendors of electronic cigarettes, video game outlets and chocolatiers being deemed essential stores, and so allowed to open, but shoe shops, beauty salons, clothing boutiques and department stores being forced to close?

Familiarity with the labyrinthine thought processes of the French functionary was clearly needed. France, as one former prime minister, Georges Clemenceau, observed, “is an extremely fertile country: You plant functionaries and taxes grow.”

. . .

Despite the reforming ambition of successive presidents — Jacques Chirac spoke of the “obesity of the state” in 1986 — the number of functionaries has grown by over one million in the last 30 years and now represents 22 percent of the entire work force. They are resilient.

. . .

I recently rented an apartment and needed to furnish it.

. . .

This was how I learned more about essential vs. nonessential items under the lockdown. I could buy electric cheese-heating raclette makers in a dozen different models. I could buy toasters galore, pans in all shapes, any form of home stereo equipment — but not a desk lamp.

At Boulanger, an electronics store, smoothie makers and vacuum cleaners were available for sale, but not refrigerators, stoves or other large appliances that had been roped off.

How this comported with controlling the coronavirus — over 100,000 people in France have died from it, and more than five million have been infected — was not immediately clear.

The sheer intricacy of the bureaucratic obtuseness overwhelmed me. I could not help wondering whether some fraction of the many hours devoted to coming up with such regulations might have been better used speeding the vaccines to more people. France has up to now underwhelmed in getting its population vaccinated.

. . .

France, . . ., still has a commissioner general for planning, as if the Soviet Union had never disappeared. The country proceeds with methodical purpose based on the analysis and forecasts of highly trained public servants, formed in elite schools.

Still, an overwhelming question grips my entire being: Why these apparently arbitrary rules?

I asked a Castorama store assistant to explain why, for example, the lamps I coveted were off limits while I could buy a crepe maker.

“I don’t really know,” she said. “But, of course, you can always use a candle.”

For the full commentary, see:

Roger Cohen. “France Is Locked Down, but Its Bureaucracy Is Thriving.” The New York Times (Tuesday, April 27, 2021): A11.

(Note: ellipses added.)

(Note: the online version of the commentary has the date April 26, 2021, and has the title “The Entangling, Ever-Extending Labyrinth of French Lockdowns.”)

Deregulation of Hearing Aids Will Lower Cost and Increase Innovation

(p. B5) Hearing aids typically cost thousands of dollars, require multiple visits to specialists and often aren’t covered by health insurance. Untreated hearing loss is associated with cognitive decline, dementia and other harms. Overcoming barriers to hearing treatment may significantly improve Americans’ health.

The federal government is poised to help. Congress in 2017 passed legislation that would let anyone buy hearing aids approved by the Food and Drug Administration without a prescription from an audiologist. The F.D.A. has missed a deadline to release draft guidelines for this new category of over-the-counter hearing aids.

Experts told me that when the F.D.A. moves ahead, it’s likely to lead to new products and ideas to change hearing aids as we know them.

. . .

It is already possible to buy a hearing helper — they can’t legally be called hearing aids — without a prescription. These devices, called personal sound amplification products or PSAPs, vary wildly in quality from excellent to junk.

. . .

Nicholas Reed, director of audiology at the Johns Hopkins Cochlear Center for Hearing and Public Health, told me that the F.D.A. process should provide a path for the best PSAPs to be approved as official over-the-counter hearing aids. He expects new companies to hit the market, too.

You may doubt that a gadget you buy next to the toilet paper at CVS could be a serious medical device. Dr. Reed’s research, however, has found that some hearing helpers for $350 or less were almost as good as prescription hearing aids for people with mild-to-moderate hearing loss.

Dr. Reed described the best lower-cost devices as the Hyundai of hearing help. (This was a compliment.) They aren’t flashy, but they will get many people safely and effectively where they need to go. He also imagines that the F.D.A. rules will create the conditions for many more people to buy hearing aids — both over the counter and by prescription.

. . .

Health care in the United States can often feel as if it’s stuck, and technology is usually not the solution. But with hearing aids, technology and a change in government policy could bring helpful health innovation.

For the full commentary, see:

Shira Ovide. “ON TECH; Affordable and Accessible Hearing Aids.” The New York Times (Monday, April 19, 2021): B5.

(Note: ellipses added.)

(Note: the online version of the commentary has the date April 12, 2021, and has the title “ON TECH; Hearing Aids for the Masses.”)

Reed’s research mentioned above is documented in:

Reed, Nicholas S., Joshua Betz, Nicole Kendig, Margaret Korczak, and Frank R. Lin. “Personal Sound Amplification Products Vs a Conventional Hearing Aid for Speech Understanding in Noise.” JAMA 318, no. 1 (July 4, 2017): 89-90.

SpaceX Is the Wikipedia of Space: Launch Quickly and Upgrade Quickly

SpaceX has a Wikipedia approach to space. Launch quickly; correct and upgrade quickly. This is similar to Google’s approach to hard drives: buy cheap, unreliable ones, have a lot of backups, and be ready to replace a lot of hard drives. Also the ethernet’s approach to packets: be ready to lose them and re-send. I argue these examples illustrate redundancy, and that we can and should have a robustly redundant labor market.

(p. B1) The Starlink project, owned by Mr. Musk’s Space Exploration Technologies Corp. or SpaceX, is authorized to send some 12,000 satellites into orbit to beam superfast internet to every corner of the Earth. It has sought permission for another 30,000.

Now, rival companies such as Viasat Inc., OneWeb Global Ltd., Hughes Network Systems and Boeing Co. are challenging Starlink’s space race in front of regulators in the U.S. and Europe. Some complain that Mr. Musk’s satellites are blocking their own devices’ signals and have physically endangered their fleets.

. . .

The critics’ main argument is that Mr. Musk’s launch-first, upgrade-later principle, which made his Tesla Inc. TSLA +1.27% electric car company a pioneer, gives priority to speed over quality, filling Earth’s already crowded orbit with satellites that may need fixing after they launch.

“SpaceX has a gung-ho approach to space,” said Chris McLaughlin, government affairs chief for rival OneWeb. “Every one of our satellites is like a Ford Focus—it does the same thing, it gets tested, it works—while Starlink satellites are like Teslas: They launch them and then they have to upgrade and fix them, or even replace them alto-(p. B2)gether,” Mr. McLaughlin said.

For the full story, see:

Bojan Pancevski. “Rivals of SpaceX’s Satellites Cite Risk.” The Wall Street Journal (Tuesday, April 20, 2021): B1 & B2.

(Note: ellipsis added.)

(Note: the online version of the story has the date April 19, 2021, and has the title “Elon Musk’s Satellite Internet Project Is Too Risky, Rivals Say.”)

“As a Species, We’re Very Good At Adapting”

(p. A11) Barack Obama is one of many who have declared an “epistemological crisis,” in which our society is losing its handle on something called truth.

Thus an interesting experiment will be his and other Democrats’ response to a book by Steven Koonin, who was chief scientist of the Obama Energy Department. Mr. Koonin argues not against current climate science but that what the media and politicians and activists say about climate science has drifted so far out of touch with the actual science as to be absurdly, demonstrably false.

. . .

Mr. Koonin still has a lot of Brooklyn in him: a robust laugh, a gift for expression and for cutting to the heart of any matter. His thoughts seem to be governed by an all-embracing realism. Hence the book coming out next month, “Unsettled: What Climate Science Tells Us, What It Doesn’t, and Why It Matters.”

Any reader would benefit from its deft, lucid tour of climate science, the best I’ve seen. His rigorous parsing of the evidence will have you questioning the political class’s compulsion to manufacture certainty where certainty doesn’t exist. You will come to doubt the usefulness of centurylong forecasts claiming to know how 1% shifts in variables will affect a global climate that we don’t understand with anything resembling 1% precision.

. . .

Mr. Koonin is a practitioner and fan of computer modeling. “There are situations where models do a wonderful job. Nuclear weapons, when we model them because we don’t test them anymore. And when Boeing builds an airplane, they will model the heck out of it before they bend any metal.”

“But these are much more controlled, engineered situations,” he adds, “whereas the climate is a natural phenomenon. It’s going to do whatever it’s going to do. And it’s hard to observe. You need long, precise observations to understand its natural variability and how it responds to external influences.”

Yet these models supply most of our insight into how the weather might change when emissions raise the atmosphere’s CO2 component from 0.028% in preindustrial times to 0.056% later in this century. “I’ve been building models and watching others build models for 45 years,” he says. Climate models “are not to the standard you would trust your life to or even your trillions of dollars to.”

. . .

Let technology and markets work at their own pace. The climate might continue to change, at a pace that’s hard to perceive, but societies will adapt. “As a species, we’re very good at adapting.”

. . .

. . . , the mainstream climate community will try to ignore his book, even as his publicists work the TV bookers in hopes of making a splash. Then Mr. Koonin knows will come the avalanche of name-calling that befalls anybody trying to inject some practical nuance into political discussions of climate.

He adds with a laugh: “My married daughter is happy that she’s got a different last name.”

For the full interview, see:

Holman W. Jenkins, Jr., interviewer. “How a Physicist Became a Climate Truth Teller.” The Wall Street Journal (Saturday, April 17, 2021): A11.

(Note: ellipses added.)

(Note: the online version of the interview has the date April 16, 2021, and has the title “Mr. Humble and Dr. Butcher’ Review: A Heart in the Right Place.”)

Koonin’s climate book, discussed in the interview quoted above, is:

Koonin, Steven E. Unsettled: What Climate Science Tells Us, What It Doesn’t, and Why It Matters. Dallas, TX: BenBella Books, 2021.