Category: Regulations

“Unanticipated Tragedies Are Unpreventable, No Matter How Many Regulations”

(p. A15) Dr. Offit acknowledges the limits of regulatory fixes, noting that, while regulatory guidelines are important, “unanticipated tragedies are unpreventable, no matter how many regulations, training programs, fines, and penalties are put in place.” He contrasts the tragic death in 1999 of 18-year-old Jesse Gelsinger in an early gene-therapy study—aimed at remediating a rare enzyme deficiency—with the triumphant experience of Emily Whitehead, a girl with leukemia treated 11 years later at the same university with genetically manipulated T-cells. Gelsinger’s death has been ascribed to protocol deficiencies, conflicts of interest and inadequate regulation, but “a closer look,” Dr. Offit writes, “shows that the only difference between the outcomes of Emily Whitehead and Jesse Gelsinger were luck and timing.” The specific supportive approach used by Whitehead’s doctors to address a life-threatening complication of her T-cell infusion stemmed directly from the lessons learned during Gelsinger’s ordeal. We recognize successes, Dr. Offit laments, but “never the failures that made those successes possible.”

One anxiety suffusing every page of “You Bet Your Life” is what to make of the Covid-19 vaccines. Dr. Offit, a member of the FDA’s vaccine advisory committee, has been described in The Wall Street Journal as “an outspoken advocate of the science and value of vaccinations,” including the Covid-19 vaccine. He has described its clinical-trial data as “enormously reassuring” and has seen little evidence of “a very rare, serious side effect that would be something that would cause a long term problem.” Yet his review of the history of vaccination and of its complexities evokes surprising empathy for the vaccine-hesitant. He recounts the early days of the Salk polio vaccine, which saved lives yet also tragically transmitted the disease to some patients when the product was inadequately prepared by one of its manufacturers. He notes that “the first vaccines aren’t always the best, safest, and last” and regrets the “disturbing show of hubris” by the Covid vaccine developers.

Ultimately, Dr. Offit emphasizes, we need to come to terms with the fact that all medical technologies carry risk—as does the decision not to avail oneself of them. “A choice not to get a vaccine is not a risk-free choice,” Dr. Offit notes. Either way, he says, “you’re gambling”—so “choose the lesser risk.”

For the full review, see:

David A. Shaywitz. “BOOKSHELF; The Dangers Of Finding a Cure.” The Wall Street Journal (Tuesday, Nov. 09, 2021): A15.

(Note: the online version of the review has the date November 8, 2021, and has the title “BOOKSHELF; ‘You Bet Your Life’ Review: The Dangers of Finding a Cure.”)

The book under review is:

Offit, Paul A. You Bet Your Life: From Blood Transfusions to Mass Vaccination, the Long and Risky History of Medical Innovation. New York: Basic Books, 2021.

Climate Change Infrastructure Subsidies Mainly Benefit the Rich

(p. A9) Mr. Biden has insisted that at least 40 percent of the benefits of federal climate spending will reach underserved places, which tend to be low income, rural, communities of color, or some combination of the three.

But historically, it is wealthier, white communities — with both high property values and the resources to apply to competitive programs — that receive the bulk of federal grants. And policy experts say it’s unclear whether, and how quickly, federal bureaucracy can level the playing field.

. . .

The new climate provisions in the infrastructure bill inject billions of dollars into competitive grant programs. These are pots of money that towns, cities and counties can access only by submitting applications, which federal agencies then rank, with funds going to applicants with the highest scores.

That system is designed to ensure that funding goes to the most worthwhile projects.

But it also hinges on something outside the control of the federal government: The ability of local officials to use sophisticated tools and resources to write successful applications. The result is a process that has widened the gap between rich communities and their less affluent counterparts, experts say.

The disparity begins even before the application process begins. That’s because local governments must be aware of the grant programs in the first place, which means having dedicated staff to track those programs. Then they need to design proposals that will score highly, and correctly complete the reams of required paperwork.

Even if they are awarded a grant, communities are required to pay a share of the project — often 25 percent, which is unaffordable for many struggling towns and counties.

Governments that can clear those obstacles face a final hurdle: Demonstrating that the value of the property that would be protected is greater than the cost of the project. That rule often excludes communities of color and rural areas, where property values are usually lower than in white communities.

. . .

The Biden administration has touted the program, called Building Resilient Infrastructure and Communities, or BRIC, as a model that should be expanded. The infrastructure bill provides billions more to the program.

But most of the first round winners were wealthy, predominantly white areas in a handful of coastal states, federal data show.

More than half the money went to California, New Jersey and Washington State. The largest single recipient was a $68 million flood-control project in Menlo Park, Calif., where the median household income is more than $160,000, the typical home costs more than $2 million and only one in five residents are Black or Hispanic. The project is in line to get $50 million from FEMA.

For the full story, see:

Christopher Flavelle. $50 Billion Conundrum: Who Gets Climate Protection?” The New York Times (Saturday, December 4, 2021): A9.

(Note: ellipses added.)

(Note: the online version of the story has the date Dec. 3, 2021, and has the title “Billions for Climate Protection Fuel New Debate: Who Deserves It Most.”)

New Nuclear Designs Are “Cheap, Efficient, Extremely Reliable”, “Nearly Carbon-Free” and Much Safer

(p. A17) Jacopo Buongiorno, a nuclear-engineering professor at the Massachusetts Institute of Technology, has calculated that over the life cycle of power plants, which includes construction, mining, transport, operation, decommissioning and disposal of waste, the greenhouse-gas emissions for nuclear power are 1/700th those of coal, 1/400th of gas, and one-fourth of solar. Nuclear also requires 1/2,000th as much land as wind and around 1/400th as much as solar. For any given power output, the amount of raw material used to build a nuclear plant is a small fraction of an equivalent solar or wind farm. Although nuclear waste is obviously more difficult to dispose of, its volume is 1/10,000th that of solar and 1/500th of wind. This includes abandoned infrastructure and all the toxic substances that end up in landfills. One person’s lifetime use of nuclear power would produce about a half-ounce of waste. Even including the Chernobyl disaster, human mortality from coal is 2,000 to 3,000 times that of nuclear, while oil claims 400 times as many lives.

Although the federal government tends to resist nuclear power, many nuclear technologies are being investigated and funded by private capital including molten-salt reactors, liquid-metal reactors, advanced small modular reactors, microreactors and much more. More than 70 development projects are under way in the U.S., with many designs intended to create assembly-line construction facilities to simplify and standardize testing, licensing and installations. One appealing approach is to replace large-scale facilities with many smaller but safer, cheaper and more-manageable ones. The $10 billion 10-year planning and implementation cycle for a large nuclear plant can be cut in half with a small modular reactor and another half with a microreactor.

. . .

Nuclear power is cheap, efficient, extremely reliable and nearly carbon-free. New designs, including smaller reactors, drastically reduce the risk of large-scale radioactive contamination.

. . .

Sacrifice isn’t always the path to progress.

For the full commentary, see:

Andrew I. Fillat and Henry I. Miller. “Nuclear Power Is the Best Climate-Change Solution by Far.” The Wall Street Journal (Friday, Nov. 5, 2021): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date November 4, 2021, and has the same title as the print version.)

“Precautionary Principle Would Have Vastly Slowed” Anesthesia, Antibiotics, Chemotherapy and Other Medical Innovations

(p. 15) In his new book, “You Bet Your Life,” Paul A. Offit wants to understand the failures and tragedies that help pave the way to medical innovation. For most of human history, anesthesia did not exist. Patients had to be forcibly restrained while their limbs were amputated and their cancers were removed, typically amid piercing screams and unbearable agony. Things did not start to change until the 1840s, when a carnival barker named Gardner Colton charged people 25 cents to sniff “laughing gas,” also known as nitrous oxide, which made them fall down in hysterics and then go to sleep for a few minutes. On Dec. 10, 1844, a dentist named Horace Wells attended Colton’s show. Soon after inhaling the gas (and making a fool of himself), he told a friend that a person could probably “have a tooth extracted or a limb amputated and not feel any pain.”

Wells sought out Colton immediately after the show, and the very next day, he became the first person to use nitrous oxide as an anesthetic: He asked a fellow dentist to extract one of his own teeth. The procedure was painless. Over the following weeks, Wells used nitrous oxide on 15 of his patients. It worked every time. In January 1845, he asked if he could demonstrate his method to specialists in a large amphitheater at the Massachusetts General Hospital. The demonstration failed. Wells gave too little of the anesthetic to his patient, who woke up during the extraction, in intense pain and screaming. Members of the audience shouted out, “Humbug!” Wells was disgraced.

. . .

Offit is a good storyteller, and he has some terrific stories to tell. He also draws important lessons. In the domain of medical innovation, tragedies cannot be prevented, no matter how many regulations we put in place. Science moves forward in fits and starts, with blunders, failures and losses along the way. New discoveries are rarely immediate; we inevitably learn more over time. Ours is not a risk-free world, which means that we need to choose the lesser risk. New technologies are always a gamble.

All of those claims are true, but I think that Offit also pulls out an even deeper and more provocative moral from this history. In life and in public policy, many people in Europe and the United States are drawn to the “precautionary principle,” which essentially calls for a high degree of risk aversion: Whenever an innovation threatens to cause harm, we should be exceedingly cautious before we allow it. Offit’s examples, and the history of medical advances, demonstrate that in its most extreme forms, the precautionary principle is self-defeating. Simply put, precautions kill. Whether we are speaking of anesthesia, heart transplants, antibiotics, chemotherapy or blood transfusions, the precautionary principle would have vastly slowed down innovations that, yes, carried serious risk and led to real harm, but were ultimately a great boon to humanity.

For the full review, see:

Cass R. Sunstein. “Side Effects.” The New York Times Book Review (Sunday, October 17, 2021): 15.

(Note: ellipsis added.)

(Note: the online version of the review was updated Oct. 25, 2021, and has the title “A History of Medical Innovation That Doesn’t Ignore the Side Effects.”)

The book under review is:

Offit, Paul A. You Bet Your Life: From Blood Transfusions to Mass Vaccination, the Long and Risky History of Medical Innovation. New York: Basic Books, 2021.

California Labor and Environment Policies Reduce Nimble Response to Supply Chain Backups

(p. A17) The backup of container ships at the Long Beach and Los Angeles ports has grown in recent weeks despite President Biden’s intervention to get terminal operators to move goods 24/7.

. . .

The two Southern California ports handle only about 40% of containers entering the U.S., mostly from Asia. Yet ports in other states seem to be handling the surge better. Gov. Ron DeSantis said last month that Florida’s seaports had open capacity. So what’s the matter with California? State labor and environmental policies.

Some 20 business groups recently asked Gov. Gavin Newsom to declare a state of emergency and suspend labor and environmental laws that are interfering with the movement of goods. Opening the Port of Los Angeles 24 hours a day “alone will do little without immediate action from the state to address other barriers that have created bottlenecks at the ports, warehouses, trucking, rail, and the entire supply chain,” they wrote.

One barrier is a law known as AB5. Before its enactment in 2019, tens of thousands of truck drivers worked as independent contractors, which gave them more autonomy and flexibility than if they were employees. As contractors, truck drivers can work for multiple companies, which allows them to nimbly respond to surges in demand.

. . .

Another problem: a shortage of storage space. “There is absolutely no available capacity in the warehousing sector due to the difficulty in developing any new capacity,” the businesses noted in their letter. The vacancy rate for warehouses near the Los Angeles and Long Beach ports was a mere 1%, compared with 3.6% nationwide.

If warehouses don’t have space in their facilities or parking lots to unload goods, drivers can’t make deliveries. Some truck drivers are leaving container boxes along with the chassis outside storage facilities and are picking them up later, but that results in a shortage of chassis at the ports. (About half of chassis are leased to truckers from a common pool supplied by private companies.)

. . .

. . . in California warehouse growth ignited opposition from environmental groups, which complain of pollution and noise. Many cities have limited new logistics facilities.

For the full commentary, see:

Allysia Finley. “California Is the Supply Chain’s Weakest Link.” The Wall Street Journal (Friday, Nov. 5, 2021): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date November 4, 2021, and has the same title as the print version.)

N.I.H. Funded EcoHealth Wuhan Research to Make Coronaviruses More Infective and Virulent

(p. A21) EcoHealth Alliance has come under scrutiny because of its collaboration on coronavirus research with researchers at the Wuhan Institute of Virology, which is situated in the city where the pandemic began.

. . .

Last month, The Intercept, an online publication, posted 900 pages of materials related to the N.I.H. grants to EcoHealth Alliance for the research. The materials provided details about experiments designed to provide new insights into the risk that bat coronaviruses have for sparking new pandemics.

In some of their experiments, the researchers isolated genes from bat coronaviruses that encode a surface protein, called spike. Coronaviruses use the spike protein to bind to host cells, the first step to an infection. The spike protein latches onto a cell-surface protein called ACE2.

According to the materials published, the researchers then engineered another bat virus, called WIV1, to carry spike proteins from other bat coronaviruses. They then conducted experiments to see if the engineered WIV1 viruses became better at attaching to ACE2 on cells.

. . .

Dr. Lawrence Tabak, the principal deputy director of the N.I.H., wrote in the letter to Representative Comer that the agency determined that the research proposed by EcoHealth Alliance did not meet the criteria for additional review . . .

. . .

Dr. Tabak noted that in one line of research, the researchers had produced mice genetically engineered to produce the human version of the ACE2 protein on their cells. Infecting these animals with coronaviruses could potentially provide a more realistic sense of the risk that the viruses have of infecting humans than just using dishes of cells.

The N.I.H. required that EcoHealth Alliance notify the agency if the engineered viruses turned out to grow 10 times faster or more than WIV1 would without their new spike proteins.

In some experiments, it turns out, that viruses did grow quickly.

“EcoHealth failed to report this finding right away, as required by the terms of the grant,” Dr. Tabak wrote.

The N.I.H. also sent Representative Comer a final progress report that EcoHealth Alliance submitted to the agency in August [2021].

In the report, the researchers describe finding that WIV1 coronaviruses engineered to carry spike proteins were more virulent. They killed infected mice at higher rates than did the WIV1 virus without spikes from the other coronaviruses.

The filing had been submitted late, the N.I.H. said, nearly two years beyond the grant-specified deadline of 120 days from completion of the work. “Delayed reporting is a violation of the terms and condition of N.I.H. grant award,” Renate Myles, a spokeswoman for the agency, said.

Jesse Bloom, a virologist at the Fred Hutchinson Cancer Center who has called for more research into the origins of the pandemic, said the revelations raised serious questions about the risks of investigating viruses originating from animals, known as zoonotic viruses.

For the full story, see:

Carl Zimmer and Benjamin Mueller. “N.I.H. Says Bat Studies Were Not Submitted Promptly.” The New York Times (Friday, October 22, 2021): A21.

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

(Note: the online version of the story was updated October 28, 2021, and has the title “Bat Research Group Failed to Submit Virus Studies Promptly, N.I.H. Says.”)

CDC Intentionally Overestimated Risk of Heterosexual Spread of AIDS

(p. A17) ‘Follow the science,” we’ve been told throughout the Covid-19 pandemic. But if we had paid attention to history, we would have known that once a disease becomes newsworthy, science gets distorted by researchers, journalists, activists and politicians eager for attention and power—and determined to silence those who challenge their fear-mongering.

When AIDS spread among gay men and intravenous drug users four decades ago, it became conventional wisdom that the plague would soon devastate the rest of the American population.

. . .

In reality, researchers discovered early on that transmission through vaginal intercourse was rare, and that those who claimed to have been infected that way were typically concealing intravenous drug use or homosexual activity. One major study estimated the risk of contracting AIDS during intercourse with someone outside the known risk groups was 1 in 5 million. But the CDC nonetheless started a publicity campaign warning that everyone was in danger. It mailed brochures to more than 100 million households and aired dozens of public-service announcements, like a television ad with a man proclaiming, “If I can get AIDS, anyone can.”

The CDC’s own epidemiologists objected to this message, arguing that resources should be focused on those at risk, as the Journal reported in 1996. But they were overruled by superiors who decided, on the advice of marketing consultants, that presenting AIDS as a universal threat was the best way to win attention and funding. By those measures, the campaign succeeded. Polls showed that Americans became terrified of being infected, and funding for AIDS prevention surged—much of it squandered on measures to protect heterosexuals.

Scientists and public officials sustained the panic by wildly overestimating the prevalence of AIDS. Challenging those numbers was a risky career move, as New York City’s health commissioner, Stephen C. Joseph, discovered in 1988 when he reduced the estimated number of AIDS cases in the city by half. He had good reasons for the reduction—the correct number turned out to be much lower still—but he soon needed police protection. Activists occupied his office, disrupted his speeches, and picketed and spray-painted his home.

Another victim of 1980s-style cancel culture was Michael Fumento, who meticulously debunked the scare in his 1990 book, “The Myth of Heterosexual AIDS.” It received good reviews and extensive publicity, but it was unavailable in much of the country because local bookstores and national chains succumbed to pressure not to sell it. Mr. Fumento’s own publisher refused to keep it in print, and he was forced out of two jobs—one as an AIDS analyst in the federal government.

The AIDS fear-mongers suffered few consequences for their mistakes.

For the full commentary, see:

John Tierney. “Unlearned AIDS Lessons for Covid.” The Wall Street Journal (Monday, October 4, 2021): A17.

(Note: ellipsis added.)

(Note: the online version of the commentary was updated October 3, 2021, and has the same title as the print version.)

Former Teacher Union President Says Charter Schools Give Black and Hispanic Children “Access to a Quality Education”

(p. A21) When I became a teacher, it seemed natural to become an advocate for the profession. Somewhere along the way I became more of a union leader than an educational leader.

. . .

I used to oppose charter schools, not because they were bad for kids, but because they were bad for unions.

. . .

I served as president of the Washington Teachers’ Union for six years and recognize the added value unions can bring in securing fair compensation and safe working conditions for teachers. I’m still a union member. But I now work on behalf of charter schools.

Charter schools are also public schools. All of them. They provide more than three million students, mostly black and Hispanic, access to a quality public education. They are innovative and student-centered. They break down barriers that have kept families of color from the educational opportunities they deserve. Another two million children would attend charter schools if there were space for them. How could I work against these kids?

For the full commentary, see:

George Parker. “How My Mind Opened to Charter Schools.” The Wall Street Journal (Thursday, May 27, 2021): A21.

(Note: ellipses added.)

(Note: the online version of the commentary has the date May 26, 2021, and has the same title as the print version.)

FTC Slows Serendipitously Discovered Blood Test That Detects 50 Types of Cancer

(p. A13) Scientific breakthroughs are sometimes a matter of serendipity. Eight years ago Meredith Halks-Miller, a pathologist at the genetic-screening company Illumina, stumbled on something unusual while running prenatal blood tests for fetal chromosomal abnormalities. In some blood samples, the fetal genes were normal but the maternal DNA wasn’t. Illumina alerted pregnant women’s doctors to the finding. After further investigation, all the women were diagnosed with cancer, though none had symptoms when their blood was drawn.

This discovery led to the development of a blood test that can now detect 50 types of cancer and has the potential to save tens of thousands of lives a year if it becomes widely available. But regulators may slow the process.

The Federal Trade Commission last month wrapped up an administrative trial in which it seeks to block Illumina’s $8 billion acquisition of Grail, which makes the blood test.

. . .

Grail projects its test could prevent 90,000 to 100,000 cancer deaths each year if it were administered annually to all Americans 50 to 79. The sooner people get access to the test, the more lives will be saved. Illumina estimates that 10,000 lives will be saved over the following nine years for every year that it accelerates bringing the test to market. “By accelerating the global rollout of the test in the European Union, into Africa, into Asia, into Latin America, we believe we can save a lot more lives than that around the world,” Mr. deSouza says.

The company’s dominance in the DNA-testing market, however, attracted regulatory scrutiny. In March the FTC sued Illumina and Grail to block the acquisition, arguing that it would “lessen competition in the U.S. multi-cancer early detection (‘MCED’) test market by diminishing innovation and potentially increasing prices.”

Nonsense, Mr. deSouza says. “Today, there is nobody who is even starting the studies to develop a 50-cancer test like Grail, and once you start the study, it’s still a few years before you actually get the test. We think there will also be blood tests for single cancers, for colorectal cancer and other cancers. Those won’t compete with Grail. They will be complementary to Grail.”

For the full interview, see:

Allysia Finley, interviewer. “THE WEEKEND INTERVIEW; Regulatory Hurdles Block a Cancer Miracle.” The Wall Street Journal (Saturday, Oct. 9, 2021): A13.

(Note: ellipsis added.)

(Note: the online version of the interview has the date October 8, 2021, and has the same title as the print version.)

“The Best Recipe for Economic Growth Is” Freedom and Opportunity

(p. C3) Migration has been central to the American story since the beginning. In the early 19th century, New Englanders left the rocky soil of Massachusetts for the more fertile Ohio River valley. During the Dust Bowl of the 1930s, farmers fled Oklahoma for California. In the early 20th century, millions of African-Americans left the Jim Crow South to find work in the factories of northern cities. Through the 20th century, mobility was an American tradition: In every year between 1950 and 1992, according to the Current Population Survey, more than 6% of Americans moved across county lines.

In recent years, however, the engine of American migration has been grinding to a halt. People often move to get ahead, which makes mobility a reasonable measure of economic dynamism. So it’s a troubling sign that since 2007, geographic mobility has dropped by one-third, with fewer than 4% of Americans changing counties annually. The reason is clear: In the most prosperous cities and regions, insiders have figured out how to use regulations, laws and institutions to make life easier for themselves and harder for everyone else. In the process, they have made the U.S. a far less dynamic society.

. . .

Most important, we need to stop thinking of growth as a zero-sum game. Today, insiders worry about getting their share of the pie instead of growing the economy for everyone. The best recipe for economic growth is the traditional American one: freedom, combined with robust investment in opportunity for the least advantaged.

For the full commentary, see:

Edward Glaeser and David Cutler. “The American Housing Market Is Stifling Mobility.” The Wall Street Journal (Saturday, July 17, 2021): C3.

(Note: ellipses added.)

(Note: the online version of the commentary has the date September 2, 2021, and has the same title as the print version.)

The commentary quoted above is based on the authors’ book:

Glaeser, Edward L., and David Cutler. Survival of the City: Living and Thriving in an Age of Isolation. New York: Penguin Press, 2011.