Category: Regulations

Electrical Vehicle (EV) Chargers Are “Often on the Fritz”

(p. A1) One of the biggest roadblocks to the mass adoption of electric vehicles is the troubled business model for the commercial chargers that power them.

The government is pouring billions of dollars into developing a national highway charging network. But businesses aren’t sure how they will make money, and the nascent industry looks messy.

Utility companies and gas stations are at war with each other over who will own and operate EV chargers. Rural states say some charging stations could operate at a loss for a decade or more. (p. A10) New companies that provide charging gear and services are contending with the equipment’s spotty reliability.

. . .

Equipment is often on the fritz. Communications can break down between the car and the charger, the charger and the company operating the charging network, and with payment systems. On occasion, a wasp crawls into the gear and builds a nest. Vandals can strike, sticking gum in the credit card readers and bashing the machines.

. . .   A 2022 study led by the University of California, Berkeley tested all 657 public EV fast chargers in the greater San Francisco Bay Area and found more than a quarter didn’t work.

For the full story, see:

Jennifer Hiller. “Electric Cars Have A Charging Problem.” The Wall Street Journal (Wednesday, Nov. 30, 2022): A1 & A10.

(Note: ellipses added.)

(Note: the online version of the story has the date November 29, 2022, and has the title “Why America Doesn’t Have Enough EV Charging Stations.”)

Some Gain-of-Function Bat Coronavirus Research in Wuhan Was Done in Level 2 Biosafety Lab (Instead of Higher Level 3 or 4)

(p. A1) Some scientists and officials in the Biden administration are pushing for more oversight, globally, of risky bioresearch. One focus is laboratory work that enhances a pathogen or endows it with new properties—sometimes called “gain-of-function” research—which is often done to assess its potential to infect humans.

. . .

(p. A12) Scientists and government officials have debated the risks of gain-of-function research since at least 2011, when virologists genetically modified the deadly H5N1 avian-flu virus so it could spread among ferrets.

. . .

Dr. Collins and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said the risks could be mitigated, and the information might accelerate efforts to develop vaccines or stop outbreaks.

. . .

Then in 2014, the U.S. government declared a pause to gain-of-function research on certain dangerous viruses and set out to develop a new set of rules following incidents including an unintentional exposure of lab workers to anthrax bacteria and a discovery of some decades-old overlooked vials of smallpox virus.

Some research was allowed to continue: work seeking to identify coronaviruses that might jump to humans. Ralph Baric at the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill and colleagues published a study of a bat virus closely related to SARS, or Severe Acute Respiratory Syndrome, a disease that emerged in 2002 and killed nearly 800 people.

. . .

They inserted a portion of the bat virus into a SARS virus adapted for lab tests in mice—creating a novel pathogen—and sought to see whether it would infect human cells. It did, and in mice it caused disease, though less deadly than SARS.

Then, he and his colleagues published research showing that another virus closely related to SARS infected both mice and human airway cells in the lab. They warned it was “poised for human emergence.”

Dr. Baric has said he thinks SARS-CoV-2 most likely evolved naturally to infect humans, yet he joined the scientists who in May [2021] called for serious investigation of the lab-accident hypothesis as well.

Researchers in Wuhan used techniques similar to his to test whether eight SARS-like bat coronaviruses had the potential to infect human cells, according to a paper they published in 2017. It was part of an effort to find out how SARS-like bat viruses might make changes that would render them a danger to humans.

Biosafety levels in laboratory research range from 1—used in high-school or college labs for work that doesn’t pose a disease risk to humans—to 4, reserved for the most dangerous pathogens.

At least some of the bat-coronaviruses work at Wuhan was done in a level-2 lab, which some U.S. scientists say is too low a safety level for that kind of work.

For the full story, see:

Betsy McKay and Amy Dockser Marcus. “Virus Research Explodes, Igniting Worry.” The Wall Street Journal (Saturday, Sept. 25, 2021): A1 & A12.

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

(Note: the online version of the story has the date September 24, 2021, and has the title “Virus Research Has Exploded Since Covid-19 Hit. Is It Safe?”)

Regulation of Truckers’ Driving Hours Caused Higher Speeds and More Fatalities

(p. A13) Falling asleep at the wheel is deadly. “It is obvious that a man cannot work efficiently or be a safe driver if he does not have an opportunity for approximately 8 hours sleep in 24,” the Interstate Commerce Commission declared in 1937. Ever since, federal rules have limited the work hours of interstate truckers. Also ever since, truckers, their employers and their customers have circumvented the rules when they stand in the way of making money.

Congress tackled the problem in 2012 by requiring long-distance truckers to track their hours with an “electronic logging device” connected to the engine. The mandatory rest breaks and the limits on drivers’ daily and weekly hours didn’t change, but the Transportation Department estimated that monitoring compliance with an ELD would avoid 1,844 crashes and save 26 lives annually.  . . .

. . .

In “Data Driven: Truckers, Technology, and the New Workplace Surveillance,” Karen Levy makes a provocative case against this approach.   . . .  Her concise and lively book will interest anyone concerned with the complicated business of regulation.

. . .

. . ., Ms. Levy raises important questions about regulation in general by examining the unintended effects of a well-meant initiative designed to address a serious safety problem. She reports on a 2021 study linking ELDs to greater compliance with regulations but no reduction in truck crashes. Fatalities in crashes involving large trucks actually increased, as drivers sped up to cover as many miles as they could during their permitted driving time.

For the full review, see:

Marc Levinson. “BOOKSHELF; Miles of Mandates.” The Wall Street Journal (Wednesday, Jan. 4, 2023): A13.

(Note: ellipses added.)

(Note: the online version of the review has the date January 3, 2023, and has the title “BOOKSHELF; ‘Data Driven’ Review: Miles of Mandates.”)

The book under review is:

Levy, Karen. Data Driven: Truckers, Technology, and the New Workplace Surveillance. Princeton, NJ: Princeton University Press, 2022.

FTX Fraudster Bankman-Fried Made $40 Million in Midterm Political Donations Which Mostly “Went to Democrats and Liberal-Leaning Groups”

(p. A1) FTX founder Sam Bankman-Fried oversaw one of the biggest financial frauds in American history, a top federal prosecutor said in charging that the former chief executive stole billions of dollars from the crypto exchange’s customers while misleading investors and lenders.

. . .

(p. A6) Mr. Bankman-Fried is also accused of defrauding the Federal Election Commission starting in 2020 by conspiring with others to make illegal contributions to candidates and political committees in the names of other people.

He and his associates contributed more than $70 million to election campaigns in recent years, The Wall Street Journal previously reported. He personally made $40 million in donations ahead of the 2022 midterm elections, most of which went to Democrats and liberal-leaning groups.

For the full story, see:

Corinne Ramey, James Fanelli, Dave Michaels, Alexander Saeedy and Vicky Ge Huang. “FTX Founder Is Charged With Fraud.” The Wall Street Journal (Saturday, Dec. 14, 2022): A1 & A6.

(Note: ellipsis added.)

(Note: the online version of the story was updated Dec. 13, 2022, and has the title “FTX’s Sam Bankman-Fried Charged With Criminal Fraud, Conspiracy.”)

As of January 2022, Koch Industries Had Invested $1.7 Billion into Renewable-Energy Infrastructure

(p. B10) Norwegian startup Freyr Battery and energy conglomerate Koch Industries Inc. are accelerating their plan to build a multibillion-dollar battery plant that will be among the largest to tap incentives in President Biden’s climate, tax and spending plan, Freyr said.

. . .

Koch has emerged as one of the biggest investors in batteries, a turnabout from its emphasis on fossil fuels. It has said it wants to benefit from the falling cost of renewable-energy technologies and help drive it down further. As of January [2022], it had invested a total of $1.7 billion into electric batteries, energy storage and solar-power infrastructure, according to its website.

The plan is unusual among battery projects in being dedicated primarily to the energy-storage market rather than electric vehicles.

For the full story, see:

Stephen Wilmot. “Koch Teams Up on Battery Plant.” The Wall Street Journal (Saturday, November 12, 2022): B10.

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

(Note: the online version of the story has the date November 11, 2022, and has the title “Koch Teams With Startup to Build Giant Battery Factory.”)

Unintended Consequences Make “Government-Provided Health Care” a “Fiscal and Regulatory Nightmare”

(p. A17) The private plans participating in Medicare’s prescription-drug program, known as Part D, currently draw on three sources of revenue to finance prescriptions: out-of-pocket payments from patients, premium payments made by plan members, and subsidies from the federal government. In 2025, under the Inflation Reduction Act, both government subsidies and out-of-pocket payments by patients are scheduled to be cut sharply. The difference will have to be made up by premiums. But the statute inhibits this third revenue source, which is also subsidized, from increasing more than 6%. That’s hardly enough to cover inflation, let alone compensate for the other two revenue losses.

. . .

Existing plans have room to cut benefits, although the original Part D statute limits their ability to do so. As plans are under no obligation to take a loss, their other choice is to exit the market, which from the patient’s perspective means that all the benefits disappear. In essence, the Inflation Reduction Act statute may prohibit Part D plans from being economically viable, even if it doesn’t explicitly ban them.

. . .

Welcome to the fiscal and regulatory nightmare known as government-provided health care, where those writing the rules don’t understand the consequences of what they do. Democrats hate that Medicare Advantage has been available as a pseudo-private alternative to original Medicare’s single-payer arrangement. Yet they have (unwittingly?) passed a law that so thoroughly disrupts traditional Medicare as to render it the worst of the Medicare options.

For the full commentary, see:

Casey B. Mulligan and Tomas J. Philipson. “The Inflation Reduction Act Comes for Medicare.” The Wall Street Journal (Tuesday, November 22, 2022): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date November 21, 2022, and has the same title as the print version.)

Project Entrepreneur Alex Oshmyansky Switched from Nonprofit to Profit to Raise Funds to Enable Project; Let Mark Cuban Take Credit for Project

(p. B1) DALLAS—When Mark Cuban got an email in 2018 from a stranger asking if he wanted to invest in a company dedicated to bringing down the cost of prescription drugs, he replied: “Tell me more.”

Today, the Dallas Mavericks owner and entrepreneur is helping steer the fledgling startup as it takes aim at high prescription drug prices and the industry middlemen who he says keeps them that way.

The Mark Cuban Cost Plus Drug Co. PBC, born from that brief email pitch from the company’s founder, Alex Oshmyansky, buys generic drugs from pharmaceutical manufacturers and sells them directly to patients online, rather than charging their insurance providers. By cutting out intermediaries and using a transparent pricing system, the pharmacy says it charges less than rivals for drugs: a 15% profit markup on a medicine’s cost, plus several dollars in fees for shipping and labor.

. . .

(p. B4) Several startups are attempting to reinvent parts of the pharmaceutical supply chain, removing costs by taking control of reimbursement, manufacturing and distribution.

Some firms, like ProvideGx and Civica Rx, are making drugs themselves so that they can control pricing and supply volumes. Others are selling directly to patients, bypassing the middleman known as pharmacy-benefit managers that traditionally handle drug coverage for health insurers.

A radiologist and former math prodigy, Dr. Oshmyansky received his undergraduate degree from the University of Colorado at Boulder at age 18, followed by an M.D. from Duke University and a Ph.D. in math from Oxford. He had the idea for a pharmacy after growing frustrated with pharmaceutical-industry pricing practices, such as companies hiking prices dramatically on decades-old drugs.

He planted the seed for the Cuban pharmacy in 2015 when he founded Osh’s Not-for-Profit Pharmaceuticals with a mission of manufacturing generic drugs and selling them to hospitals at a small markup on its costs.

He struggled to find investors to fund a nonprofit drug company, however, and eventually transitioned Osh’s into a for-profit entity. In 2018, he secured $1 million from investors through the Silicon Valley startup-incubator Y Combinator.

A few months later, in 2018, Dr. Oshmyansky emailed Mr. Cuban at his publicly available email address.

. . .

Eventually, Dr. Oshmyansky agreed to rename the company after Mr. Cuban in a bid to trade on his celebrity and attract free publicity.

For the full story, see:

Joseph Walker. “Mark Cuban Lands a Job at an Online Pharmacy.” The Wall Street Journal (Saturday, Dec. 10, 2022): B1 & B4.

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

(Note: the online version of the story has the date December 9, 2022, and has the title “Mark Cuban Has New Job: Working at Online Discount Pharmacy.”)

Firms Nimbly Shift Shipping Away from Unionized and Bottlenecked California Ports

(p. B1) Sharpie maker Newell Brands Inc. is opening distribution centers in Pennsylvania and North Carolina to lessen dependence on seaports in California. Abercrombie & Fitch Co. is moving more merchandise through New York and New Jersey to avoid West Coast bottlenecks. Air-conditioning manufacturer Trane Technologies PLC is sending most of its cargo this year through ports in the South, instead of the Los Angeles area.

The hierarchy of U.S. ports is getting shaken up. Companies across many industries are rethinking how and where they ship goods after years of relying heavily on the western U.S. as an entry point, betting that ports in the East and the South can save them time and money while reducing risk.

Their reasons range from fears of a dockworkers strike along the West Coast and a repeat of the bottlenecks that roiled supply chains early in the pandemic to a reduced dependence on Chinese production and the need to get products to all parts of the country faster.

In August [2022], Los Angeles lost its title as busiest port in the nation to the Port of (p. B6) New York and New Jersey as measured by the number of imported containers. It trailed its East Coast rival again in that measure during September and October, according to the Pacific Merchant Shipping Association and ports data.

The share of all U.S. containerized cargo handled by Los Angeles and a neighboring port in Long Beach fell through the first 10 months of the year to a combined 25% as measured by weight, according to census data analyzed by Jason Miller, interim chair of Michigan State University’s supply chain management department. That was their lowest level in nearly two decades, down from a height of 33%.

Other ports benefiting from this shift include Savannah, Ga., Houston and Charleston, S.C.

For the full story, see:

Paul Berger. “New Routes for Big Business.” The Wall Street Journal (Saturday, Dec. 10, 2022): B1 & B6.

(Note: bracketed year added.)

(Note: the online version of the story was updated Dec. 14, 2022, and has the title “California Long Ruled Shipping in U.S. Importers Look to East.”)

Share of Insulin Revenues Going to Middlemen Pharmacy Benefit Managers (PBMs) Increased by 155%

(p. B12) Pharmacy-benefit managers, or PBMs, have captured a growing slice of America’s world-leading drug spending during the past decade. The spotlight could soon shift to them.

. . .

While the three largest manufacturers of insulin—Eli Lilly, Novo Nordisk and Sanofi—charge more for their products in the U.S. than they do elsewhere, their take of overall spending has been decreasing in recent years as the relative power of middlemen has grown. PBMs have steadily gained negotiating clout by consolidating and merging with large insurance companies. The three largest PBMs are owned by CVS Health Corp. (which owns insurer Aetna), UnitedHealth Group Inc. and Cigna Corp.

. . .

. . . increases in recent years have mostly been passed on to PBMs in the form of heavy discounts that are hidden from public view.

A recent study by University of Southern California scholars showed that, between 2014 and 2018, the share of a hypothetical $100 insulin expenditure accruing to manufacturers decreased by 33%. During that same period, total U.S. spending on insulin hasn’t budged, but the share of insulin expenditures retained by PBMs has increased by 155%.

. . .

“What’s happening in this market is that the middlemen are making more and more money,” said University of Southern California professor Neeraj Sood, one of the authors of the study who has previously done consulting work for drug companies.

Yet the drug-pricing provisions in the recently passed Inflation Reduction Act singularly focused on what manufacturers charge while ignoring other players that take a slice of profits farther down the chain.

For the full commentary, see:

David Wainer. “HEARD ON THE STREET; Sanders, Musk Miss the Mark on Insulin.” The Wall Street Journal (Tuesday, November 22, 2022): B12.

(Note: ellipses added.)

(Note: the online version of the commentary has the date November 21, 2022, and has the title “HEARD ON THE STREET; Elon Musk, Bernie Sanders and Others Miss the Mark Over Pricey Insulin.”)

The academic study co-authored by Sood, and mentioned above, is:

Van Nuys, Karen, Rocio Ribero, Martha Ryan, and Neeraj Sood. “Estimation of the Share of Net Expenditures on Insulin Captured by Us Manufacturers, Wholesalers, Pharmacy Benefit Managers, Pharmacies, and Health Plans from 2014 to 2018.” JAMA Health Forum 2, no. 11 (2021), doi:10.1001/jamahealthforum.2021.3409.

Collins and Fauci Did Not Seek Open Debate on the Great Barrington Declaration

(p. A15) The Trump Twitter ban almost pales in comparison with the speech limitations routinely enforced on discussion of climate and Covid. Instead of “hate” or “violence,” the elastic pretext for speech restriction here is “settled science.”

The essence of science was once open debate. But that’s no longer true. In a now-infamous 2020 email, National Institutes of Health Director Francis Collins wrote Anthony Fauci that the Great Barrington Declaration, a dissent from Covid-lockdown policy, needed “a quick and devastating published take down,” which soon appeared in the press.

For the full commentary, see:

Henninger, Daniel. “WONDER LAND; They Want to Shut You Up.” The Wall Street Journal (Thursday, December 15, 2022): A15.

(Note: the online version of the commentary has the date December 14, 2022, and has the title “WONDER LAND; They Want to Shut You (and 303 Creative) Up.”)

Regulations Block CRISPR Cures

(p. 6) Scientists like me can now visualize an ideal scenario for the future of CRISPR medicines: When a 3-month-old starts to develop antibiotic-resistant infections, her primary care doctor orders a DNA test, and 48 hours later, ‌‌the faulty gene that is preventing the development of a normal immune system is identified. “Not a problem. We will refer your child for corrective CRISPR therapy,” says the physician to the devastated parents.

. . .

(p. 7) ‌To make CRISPR cures a reality, the biomedical community needs to start with regulation. For treatments developed for genetic diseases that affect tens of thousands of people (or, say, if a company tries to take on heart disease, which affects millions), the Food and Drug Administration has a well-established, yearslong review process. But the F.D.A. needs to consider a new regulatory process that could create a more streamlined path for bringing much-needed CRISPR medicine tailored to patients with a one-of-a-kind genetic typo. There is precedent for this: Starting in the late 1990s, the F.D.A. facilitated regulatory pathways for innovation of a then-new class of genomic medicines for cancer — CAR-T therapy — which is now widely used clinically. The same can be done for CRISPR.

For the full commentary, see:

Fyodor Urnov. “We Can Edit A Person’s DNA. So Why Don’t We?” The New York Times, SundayOpinion Section (Sunday, December 11, 2022): 6-7.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date Dec. 9, 2022, and has the title “We Can Cure Disease by Editing a Person’s DNA. Why Aren’t We?”)