Category: Regulations

Instead of Centralizing With C.D.C., the Need for Speed Requires “Clinical and Commercial Labs to Create and Deploy Tests”

(p. A22) The faulty coronavirus testing kits developed by the Centers for Disease Control and Prevention in the early weeks of the pandemic were not only contaminated but had a basic design flaw, according to an internal review by the agency.

Health officials had already acknowledged that the test kits were contaminated, but the internal report, whose findings were published in PLOS ONE on Wednesday, also documented a design error that caused false positives.

. . .

The C.D.C.’s test was designed to detect three distinct regions, or target sequences, of the virus’s genetic material. The test kits contain a set of what are known as primers, which bind to and make copies of the target sequences, and probes, which produce a fluorescent signal when these copies are made, indicating that genetic material from the virus is present.

The primers and probes need to be carefully designed so that they bind to the target sequences and not to each other. In this case, that did not happen. One of the probes in the kit sometimes bound to one of the primers, producing the fluorescent signal and generating a false positive.

“It’s something that should have been caught in the design phase,” said Susan Butler-Wu, a clinical microbiologist at the Keck School of Medicine of the University of Southern California. “That’s one thing that you check for.”

. . .

The bigger lesson, Dr. Butler-Wu said, is that the responsibility for developing diagnostic tests should be distributed more widely during a public health emergency. Rather than relying on the C.D.C. to be the sole test developer, officials could also enlist clinical and commercial labs to create and deploy tests.

“It’s great that there’s all these additional checks in place, but what are you going to do when there’s a new emerging pathogen and we need to respond quickly?” she said. “I don’t think that’s a viable model for responding to a pandemic.”

For the full story, see:

Emily Anthes. “C.D.C. Finds Design Error In Testing Kits It Distributed.” The New York Times Thursday, December 16, 2021): A22.

(Note: ellipses added.)

(Note: the online version of the story has the date Dec. 15, 2021, and has the title “C.D.C. Virus Tests Were Contaminated and Poorly Designed, Agency Says.”)

The PLOS ONE article mentioned above is:

Lee, Justin S., Jason M. Goldstein, Jonathan L. Moon, Owen Herzegh, Dennis A. Bagarozzi, Jr., M. Steven Oberste, Heather Hughes, Kanwar Bedi, Dorothie Gerard, Brenique Cameron, Christopher Benton, Asiya Chida, Ausaf Ahmad, David J. Petway, Jr., Xiaoling Tang, Nicky Sulaiman, Dawit Teklu, Dhwani Batra, Dakota Howard, Mili Sheth, Wendi Kuhnert, Stephanie R. Bialek, Christina L. Hutson, Jan Pohl, and Darin S. Carroll. “Analysis of the Initial Lot of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel.” PLOS ONE 16, no. 12 (Dec. 15, 2021). DOI: 10.1371/journal.pone.0260487.

Due to B Cells, Covid-19 Infection Creates Longer-Lasting Immunity than Does Just Vaccination

(p. D4) . . . among the vaccinated and boosted, getting infected with the Omicron variant also appears to be contributing to a psychological shift, as people realize they have probably gained at least a short-term natural boost to their immune system. Scientists call it “hybrid immunity,” which results from the combined protection of pre-existing vaccine antibodies and natural antibodies from a breakthrough infection.

. . .

A recent study showed that vaccinated health care workers with breakthrough infections had significantly higher levels of antibodies compared to a vaccinated control group that had not had natural infections. Fikadu Tafesse, an immunologist at Oregon Health & Science University who helped conduct the research, said that although the study was done before the Omicron wave, the findings suggest a drastically elevated level of protection after a breakthrough infection.

“Super immunity is maybe an overreach, but we know the most recent studies show there’s hybrid immunity, really due to immune players known as memory B cells,” said Anita Gupta, an adjunct assistant professor of anesthesiology and critical care medicine at Johns Hopkins University School of Medicine. “When some of the short-lived immune cells go away, these memory B cells are going to last a while.”

For the full story, see:

Dani Blum. “Your New ‘Hybrid Immunity’ Isn’t a Superpower.” The New York Times (Thursday, January 27, 2022): D4.

(Note: ellipses added.)

(Note: the online version of the story was updated Jan. 21, 2022, and has the title “I Had Breakthrough Covid. Can I Start Living Like It’s 2019?”)

The “recent study” mentioned above is:

Bates, Timothy A., Savannah K. McBride, Bradie Winders, Devin Schoen, Lydie Trautmann, Marcel E. Curlin, and Fikadu G. Tafesse. “Antibody Response and Variant Cross-Neutralization after Sars-Cov-2 Breakthrough Infection.” JAMA 327, no. 2 (Jan. 11, 2022): 179-81.

FDA Only Approves Drugs That Fight Diseases and FDA Does Not See Aging as a Disease

(p. R2) Will people eventually routinely live—and live healthily—longer? That’s the vision of the burgeoning field of aging research, where scientists are trying to extrapolate tantalizing life-prolonging findings from animal experiments into medicines that slow, prevent or even reverse the aging process for humans.

Leading candidates for stanching aging include two familiar drugs—metformin, a front-line diabetes treatment, and rapamycin, long used to prevent transplant patients from rejecting donated organs. Both have been shown to increase longevity in animal studies and both target molecular processes linked to the aging of cells.

Another approach is a new class of drugs called senolytics, which clear the body of so-called senescent cells, old cells that stop dividing but don’t die. They accumulate in tissues throughout the body and secrete factors that damage other cells. They are linked to such aging conditions as frailty, cognitive impairment and lack of physical resilience.

Also in the mix is a strategy called cellular reprogramming in which scientists are seeking to turn back the clock on aging cells, restoring functions characteristic of younger cells.

. . .

. . ., the Food and Drug Administration doesn’t recognize aging as a disease to be treated, meaning there isn’t a clear path to approval for a drug that targets the biology of aging. Researchers instead have to design trials that can quantify whether a drug improves health or extends survival in a specific age-related disease. A pill that a large and generally healthy population would take, perhaps for decades, would have to clear a high safety bar.

. . .

Researchers are working to develop biomarkers in blood or other bodily sources that can quantify the aging process and serve as drug targets or as proxies to indicate a drug is working or not. Without validated biomarkers, it could take 20 or 30 years in some cases to run a randomized trial to prove whether a drug safely extended life.

For the full story, see:

Ron Winslow. “A Pill to Turn Back the Clock.” The Wall Street Journal (Thursday, Jan. 13, 2022): R2.

(Note: ellipses added.)

(Note: the online version of the story has the date January 11, 2022, and has the title “Can You Fight Aging? Scientists Are Testing Drugs to Help.”)

Diamond to Give “How to Cure Cancer” Talk at Gustavus Adolphus College

I appreciate Marta Podemska-Mikluch’s perseverance over the long pandemic in arranging my conversations with Gustavus Adolphus College students on some of my current research on medical entrepreneurship. I am looking forward to my visit!

Majority of Economists Say Price Controls Would Fail to “Successfully” Reduce Inflation

(p. B1) America’s recent inflation spike has prompted renewed interest in an idea that many economists and policy experts thought they had long ago left behind for good: price controls.

The federal government last imposed broad-based limits on how much private companies could charge for their goods and services in the 1970s, when President Richard M. Nixon ushered in wage and price freezes over the course of a few years. That experiment was widely regarded as a failure, and ever since, the phrase “price controls” has, at least for many people, called to mind images of product shortages and bureaucratic overreach. In recent decades, few economists have bothered to study the idea at all.

. . .

(p. B2) Artificially holding down prices leads to shortages, inefficiencies or other unintended consequences, like an increase in black-market activity. And while some economists say price controls on specific products can make sense in specific situations — to prevent price-gouging after a natural disaster, for example — most argue that they are a poor tool for fighting inflation, which is a broad increase in prices.

In a recent survey of 41 academic economists conducted by the University of Chicago’s Booth School of Business, 61 percent said that price controls similar to those imposed in the 1970s would fail to “successfully reduce U.S. inflation over the next 12 months.” Others said the policy might bring down inflation in the short-term but would lead to shortages or other problems.

“Price controls can of course control prices — but they’re a terrible idea!” David Autor, an economist at the Massachusetts Institute of Technology, wrote in response to the survey.

. . .

“It sounds good: Your wages are going to be higher, and your prices are going to be the same,” said Lawrence H. Summers, a Harvard University economist. “Unless there is a mechanism for producing more stuff, it’s just going to result in longer queues.”

For the full story, see:

Ben Casselman and Jeanna Smialek. “A Throwback Idea Returns As Inflation Rears Its Head.” The New York Times (Monday, January 17, 2022): B1-B2.

(Note: ellipses added.)

(Note: the online version of the story was updated Jan. 13, 2022, and has the title “Price Controls Set Off Heated Debate as History Gets a Second Look.”)

“Fission Is in Fashion” and Is Over-Regulated

(p. A15) Fission is in fashion as drawbacks of intermittent wind and solar power emerge.

. . .

Regulatory limits on annual exposure around nuclear plants are less than a year’s background radiation from rocks and cosmic rays. Radiation scientists now know that people can safely absorb that much radiation every day because DNA is repaired and cells are replaced constantly in living beings. Yet regulators’ mandated limits, at a thousandth of what’s really harmful, create fright of all radiation. No one needed to be evacuated at Fukushima or around Chernobyl, places where thousands died from unwarranted fear and relocation stress.

For the full commentary, see:

Robert Hargraves. “If You Want Clean Power, Go Fission.” The Wall Street Journal (Thursday, January 27, 2022): A15.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date Jan. 26, 2022, and has the same title as the print version.)

Socialist Mayor’s Environmental Bicycles Turn Paris Streets into Risky Chaos

(p. 4) PARIS — On a recent afternoon, the Rue de Rivoli looked like this: Cyclists blowing through red lights in two directions. Delivery bike riders fixating on their cellphones. Electric scooters careening across lanes. Jaywalkers and nervous pedestrians scrambling as if in a video game.

Sarah Famery, a 20-year resident of the Marais neighborhood, braced for the tumult. She looked left, then right, then left and right again before venturing into a crosswalk, only to break into a rant-laden sprint as two cyclists came within inches of grazing her.

“It’s chaos!” exclaimed Ms. Famery, shaking a fist at the swarm of bikes that have displaced cars on the Rue de Rivoli ever since it was remade into a multilane highway for cyclists last year. “Politicians want to make Paris a cycling city, but no one is following any rules,” she said. “It’s becoming risky just to cross the street!”

The mayhem on Rue de Rivoli — a major traffic artery stretching from the Bastille past the Louvre to the Place de la Concorde — is playing out on streets across Paris as the authorities pursue an ambitious goal of making the city a European cycling capital by 2024.

Mayor Anne Hidalgo, who is campaigning for the French presidency, has been burnishing her credentials as an ecologically minded Socialist candidate. She has earned admirers and enemies alike with a bold program to transform greater Paris into the world’s leading environmentally sustainable metropolis, reclaiming vast swaths of the city from cars for parks, pedestrians and a Copenhagen-style cycling revolution.

For the full story, see:

Liz Alderman. “PARIS DISPATCH; Europe’s New Cycling Capital, or a Pedestrian’s Nightmare?” The New York Times, First Section (Sunday, Oct. 3, 2021): 4.

(Note: the online version of the story was updated Oct. 4, 2021, and has the title “PARIS DISPATCH; As Bikers Throng the Streets, ‘It’s Like Paris Is in Anarchy’.”)

FDA Takes “Several Months” to Approve Manufacturers’ “Rapid” Test Applications

(p. A1) As rising Covid-19 infections stoked demand for tests across the U.S. in December, California-based LumiQuick Diagnostics Inc. shipped 100,000 rapid tests to a hospital customer—in Germany.

LumiQuick didn’t receive authorization from the Food and Drug Administration to sell Covid-19 tests domestically after waiting several months for a decision.

Some public-health experts said the relatively strict review process is part of a broader failure by U.S. officials and manufacturers to make and distribute enough rapid tests to track the pandemic adequately. Nearly two years into the pandemic, people have struggled to find tests during the holiday season as infections surge again, fueled by the highly infectious Omicron variant.

. . .

(p. A4) “We’ve never gotten the testing situation well instituted in our country,” said Ezekiel Emanuel, co-director of the Healthcare Transformation Institute at the University of Pennsylvania, and a former member of the Biden administration’s disbanded coronavirus advisory board.

. . .

Some U.S. manufacturers said the FDA’s slow review of new rapid tests discouraged them from making products that they weren’t sure they would be able to sell in the U.S. “Without approval we cannot commit,” said Frank Wang, chief executive officer of BioMedomics Inc., a North Carolina manufacturer that applied for authorization in March. The company has sold some tests outside the U.S.

Another test maker, Kaya17 Inc., said it has been waiting on FDA approval for months. “The FDA has to up their game and move faster,” said Sulatha Dwarakanath, the company’s CEO.

For the full story, see:

Austen Hufford and Brianna Abbott. “Slow Test Approvals Blamed for Shortage.” The Wall Street Journal (Friday, Dec. 31, 2021): A1 & A4.

(Note: ellipses added.)

(Note: the online version of the story has the date December 30, 2021, and has the title “Covid-19 Rapid Test Shortages Tied to Slow Federal Action.” The online version says that the title of the print version is “Tests in Short Supply as Approvals Lag.” But my print version (probably the Central Edition) has the title “Slow Test Approvals Blamed for Shortage.”)

Biden Daycare Proposal Would Act Like $27,000 Tax on Many Middle-Class Families

(p. A17) Child care is already a major expense for parents, and President Biden pledges to reduce its cost with his multitrillion-dollar Build Back Better bill. Yet while some of those who receive government subsidies may see reduced costs, millions of other working parents could see their child-care costs double. The new program would act like a $20,000 to $30,000 annual tax on middle-income families.

The bill’s latest draft proposes to reinvent child care with a trifecta of cost-increasing forces. First, it would remove much of the incentive to offer lower-cost care.

. . .

Second, providers would need extra staff to comprehend and comply with all the new statutes, certifications and agency rules.

. . .

Third, the bill imposes “living wage” regulations on staff pay.

. . .

. . ., Build Back Better could increase costs by more than 120%. For a family with an infant and a 4-year old, that would be an additional annual expense of up to $27,000 if they don’t qualify for subsidies. In 2022, when the subsidy is only available to those earning no more than their state’s median income, that would be half of families currently using child care. Even in 2024 when the subsidies would be more generous, more than a quarter of families using such child care would be paying more than double of what they do now.

For the full commentary, see:

Casey Mulligan. “Biden Would Make Daycare Even Pricier.” The Wall Street Journal (Friday, Dec. 10, 2021): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date December 9, 2021, and has the title “Biden Would Make Daycare Even More Expensive.”)

Regulators Allow U.S. Carmakers to Offer Consumers the Same Safer Adaptive Driving Beam Headlights Already Allowed in Europe

(p. B5) I am driving in the California hills high above Malibu, in a deep-blue electric Audi E-tron, and I turn onto a pitch-black winding road. Instinctively, I reach to turn on the high beams. But before I have a chance to do so, the low beams automatically rise and spread out like a hand fan, filling the entire roadway with light and projecting it far into the distance.

A few seconds later, the headlights of an approaching vehicle set my headlights in motion; the high beams angle down as the light continually shape-shifts, changing patterns to avoid illuminating the oncoming car.

I had just experienced adaptive driving beam, or A.D.B., headlights, one of the most important advances in vehicle lighting technology in decades. With A.D.B. lighting, a vehicle’s headlights are essentially always on high beam, while cameras and software instruct them to constantly reshape the beam to avoid blinding oncoming drivers or shining in the rearview mirrors of those close ahead.

The bad news is that while widely used in Europe and Asia for over a decade, these smart headlights are illegal in the United States. On my demonstration drive, I was piloting a not-for-sale-here European model of the E-tron equipped with Audi’s futuristic digital matrix headlighting system.

The good news is that after years of unsuccessful attempts to allow the technology, A.D.B. lights will soon be on American cars and trucks, thanks to a section in the recently passed Infrastructure Investment and Jobs Act that mandates their use.

According to the infrastructure act, adaptive beam headlights must be approved for U.S. use within two years.

. . .

The changeover to A.D.B.-capable headlamps could be swift for some drivers who own Audi, BMW or Mercedes models with deactivated units. Once the A.D.B. standard is approved, it’s possible that a simple software upgrade will activate them.

Some owners who could not wait for legalization say they have figured out how to activate their matrix headlights, and at least one aftermarket service dealer in Southern California will turn them on for $900.

For the full commentary, see:

Eric A. Taub. “WHEELS: Coming Soon: The Perfect Glow on the Road.” The New York Times (Friday, January 14, 2022): B5.

(Note: ellipsis added.)

(Note: the online version of the commentary was updated Jan. 18, 2022, and has the title “WHEELS: Smart Headlights Are Finally on Their Way.”)

EU Plans to Color Nuclear and Natural Gas as “Green,” Allowing a “Nuclear Renaissance”

(p. B6) The European Union has drawn up plans to classify some nuclear power and natural gas plants as green investments that can help Europe cut planet-warming emissions, a landmark proposal that, if approved, could set off a resurgence of nuclear energy on the continent in the coming decades.

The European Commission said it had begun consultations with European Union countries on the proposal, which is intended to provide a common set of definitions of what constitutes a “sustainable investment” in Europe. Any final plan can be blocked by a majority of member states or by the European Parliament.

“The Commission considers there is a role for natural gas and nuclear as a means to facilitate the transition towards a predominantly renewable-based future,” the statement, released on Saturday [January 1, 2022] said.

. . .

. . ., the political tide has increasingly turned in favor of nuclear power as a low-carbon solution to mitigate climate change — especially a new generation of smaller, cheaper plants across the globe, said George Borovas, head of nuclear practice at the global law firm Hunton Andrews Kurth.

“There will be a nuclear renaissance,” he said. “It’s not going to be for everyone, but it will be for a number of countries.”

Investment money wouldn’t start flowing right away, noted Ms. Drew of Credit Suisse. Banks will need to update their sustainable investment governance for funds offered to clients, to include nuclear and gas alongside renewable energy sources like wind and solar power.

And small modular nuclear reactor projects, in particular, still need to get off the ground. “It’s early days. You have a few people with business plans looking for funding,” she noted.

But as the industry scales up, so will the investments. A number of companies, from Rolls-Royce to Westinghouse, are working on models that can be put together in factories and assembled on site at the fraction of the cost of traditional behemoth nuclear plants.

For the full story, see:

Liz Alderman and Monika Pronczuk. “Europe Prepares to Classify Nuclear and Natural Gas as Green.” The New York Times (Tuesday, January 4, 2022): B6.

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

(Note: the online version of the story was updated Jan. 4, 2022, and has the title “Europe Plans to Say Nuclear Power and Natural Gas Are Green Investments.”)