Category: Regulations

Epidemic Showed Limits of China’s “Government-Driven, Top-Down Solutions”

(p. B1) WULONGQIAO, China — A devastating disease spreading from China has wiped out roughly one-quarter of the world’s pigs, reshaping farming and hitting the diets and pocketbooks of consumers around the globe.

China’s unsuccessful efforts to stop the disease may have hastened the spread — creating problems that could bedevil Beijing and global agriculture for years to come.

. . .

The epidemic shows the limits of China’s emphasis on government-driven, top-down solutions to major problems, sometimes at the expense of the practical. It has also laid bare the struggle of a (p. B6) country of 1.4 billion people to feed itself.

. . .

When the swine fever began to spread 16 months ago, the Ministry of Agriculture told the country’s local governments to cull all pigs in herds if there was even one sick animal, and to compensate the farmers. The ministry authorized local governments to pay up to $115 for the largest pigs, a cap later raised to $170. Before the epidemic, however, many pigs sold for $250 or more apiece, particularly breeding sows, according to government data. With the epidemic, the price has soared to $600 or more.

To get that partial reimbursement, many farmers had to deal with tightfisted local officials. The ministry said it would reimburse local governments only for between 40 percent and 80 percent of their costs. Local governments also had to provide proof, often including laboratory tests, that pigs died of African swine fever and not some other ailment.

As a result, culling has been slow. Official data show only 1.2 million pigs, or less than 0.3 percent of the country’s herds, have been culled. It is not clear where the rest of the country’s vanished herds went, but food experts say many were likely butchered and turned into food. That would worsen the spread, because the disease can lurk in meat for months.

For the full story, see:

Keith Bradsher and Ailin Tang. “China Flubs Effort to Halt Lethal Turn of Pig Illness.” The New York Times (Thursday, December 26, 2019): B1 & B6.

(Note: ellipses added.)

(Note: the online version of the story has the date Dec. 17, 2019, and has the title “China Responds Slowly, and a Pig Disease Becomes a Lethal Epidemic.”)

For California Electricity Regulator: “Safety Is Not a Glamorous Thing”

(p. A1) PG&E’s collapse has exposed the California Public Utilities Commission’s failure to hold the utility accountable on safety. The CPUC (p. A12) for years focused attention elsewhere, on setting rates and pushing for cleaner power.

Now, the agency tasked with regulating utility safety is struggling to refocus on the issue while also grappling with its failure to prevent the state’s second electricity crisis in two decades.

. . .

From the early 2000s, the commission’s focus was on setting rates and implementing Sacramento’s renewable-energy goals. Starting in 2002, three consecutive governors, two Democrats and a Republican, signed bills ratcheting up the percentage of wind and solar power utilities had to buy.

These mandates required investor-owned utilities such as PG&E to change their mix of generation, effectively phasing out burning coal and lowering reliance on natural gas while signing contracts to buy electricity from new solar and wind farms. The CPUC oversaw these deals, as well as figuring out how to integrate thousands of new rooftop solar installations.

“Was there a considerable amount of resources placed on policy? Yeah, there was,” says Timothy Alan Simon, a commissioner between 2007 and 2012 and now a utilities consultant. “It’s a challenge to balance between the safety aspects and the need for policy deliberation.”

Michael Peevey, a former Southern California Edison president, and CPUC president between 2002 and 2014, was a vocal champion of renewable-energy policies. Now retired, he says the regulator was large enough to focus on safety and renewables simultaneously but that it was tough to get Sacramento lawmakers excited about funding safety.

When compared with eliminating coal and adding solar energy, he says, “Safety is not a glamorous thing.”

For the full story, see:

Ruth Simon. “PG&E Regulators Failed to Stop Crisis.” The Wall Street Journal (Saturday, December 9, 2019): A1 & A12.

(Note: ellipsis added.)

(Note: the online version of the story has the date December 8, 2019, and has the title “‘Safety Is Not a Glamorous Thing’: How PG&E Regulators Failed to Stop Wildfire Crisis.”)

Chris Rock on Covid-19, Blackface, and Cancel Culture

(p. 7) [Rock:] Part of the reason we’re in the predicament we’re in is, the president’s a landlord. No one has less compassion for humans than a landlord. [Laughs.] And we’re shocked he’s not engaged.

Did you ever see that movie “The Last Emperor,” where like a 5-year-old is the emperor of China? There’s a kid and he’s the king. So I’m like, it’s all the Democrats’ fault. Because you knew that the emperor was 5 years old. And when the emperor’s 5 years old, they only lead in theory. There’s usually an adult who’s like, “OK, this is what we’re really going to do.” And it was totally up to Pelosi and the Democrats. Their thing was, “We’re going to get him impeached,” which was never going to happen. You let the pandemic come in. Yes, we can blame Trump, but he’s really the 5-year-old.

Put it this way: Republicans tell outright lies. Democrats leave out key pieces of the truth that would lead to a more nuanced argument. In a sense, it’s all fake news.

. . .

[Itzkoff:] Jimmy Fallon drew significant criticism this past spring for a 20-year-old clip of himself playing you in blackface on “Saturday Night Live.” How did you feel about that segment?

[Rock:] Hey, man, I’m friends with Jimmy. Jimmy’s a great guy. And he didn’t mean anything. A lot of people want to say intention doesn’t matter, but it does. And I don’t think Jimmy Fallon intended to hurt me. And he didn’t.

. . .

[Itzkoff:] There’s been a wider push to expunge blackface from any movies or TV shows where it previously appeared. Have people taken it too far?

[Rock:] If I say they are, then I’m the worst guy in the world. There’s literally one answer that ends my whole career. Blackface ain’t cool, OK? That’s my quote. Blackface is bad.

For the full interview, see:

Dave Itzkoff, interviewer. “Chris Rock’s New Universe.” The New York Times, Arts&Leisure Section (Sunday, September 20, 2020): 6-7.

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

(Note: the online version of the interview was updated Sept. 24, 2020, and has the title “Chris Rock Tried to Warn Us.”)

2016 Law Requires FDA to Move to Mining Real-World Data and Away from Costly and Slow Clinical Trials

(p. A1) Drugmakers are trying to win drug approvals by parsing vast data sets of electronic medical records, shifting away from lengthy, and costly, clinical trials in patients.

. . .

For the companies, the use of real-world data can cut costs and shorten drug-development times. Instead of finding trial subjects, companies simply mine hospital and doctor files for cases where patients already took a drug in routine medical care, looking for changes in blood pressure, tumor size and other readings to see if the medicine is helping or causing a side effect.

. . .

(p. A2) . . . for rare diseases especially, it can take a while to even enroll enough patients in studies. And their cost can limit the number of trials that companies can fund, drugmakers say.

A 2016 law required the FDA to explore greater use of real-world data, and the agency is developing standards to assess the reliability of different data sources and which kinds of decisions the data support.

“Real-world evidence should not be a means toward dropping standards, but rather a mechanism to have more efficiency in evidence generation while maintaining standards,” said FDA Principal Deputy Commissioner Amy Abernethy, a former executive at health-data firm Flatiron Health.

A market has emerged in recent years for digital drug-use information. Iqvia Inc., which tracks prescription and health data, has about a dozen projects under way, said Nancy Dreyer, the company’s chief scientific officer of real-world evidence.

For the full story, see:

Peter Loftus. “Drugmakers Mine Data to Avoid Clinical Trials.” The Wall Street Journal (Tuesday, Dec. 24, 2019): A1-A2.

(Note: ellipses added.)

(Note: the online version of the story was updated Dec. 23, 2019, and has the title “Drugmakers Turn to Data Mining to Avoid Expensive, Lengthy Drug Trials.”)

How “Single-Payer” Socialized Medicine Works for American Indians

(p. A1) EAGLE BUTTE, S.D.—Kate Miner walked into the Indian Health Service hospital, seeking help for a cough that wouldn’t quit.

An X-ray taken of Ms. Miner’s lungs that day, Oct. 19, 2016, found signs of cancer.

What exactly the IHS doctor said to Ms. Miner about her exam remains in dispute. Notations in her medical file indicate the doctor told her to come back for a lung scan the next day. Her family says they never were given such instructions and weren’t told of the two masses the X-ray revealed.

What is clear is that no further tests were done. And no IHS provider followed up when Ms. Miner returned twice more to the hospital, the only one on the Cheyenne River Reservation, over the next six months, medical records show.

Finally, on May 7, 2017, as the 67-year-old Ms. Miner lay crumpled on a hospital cot, the right side of her body shaking, a physician assistant ordered a CT scan, after her family insisted, according to the records and family members.

“You have two very large masses in your right lung. It’s probably a malignancy,” Ms. Miner’s daughter Kali Tree Top recalled the physician assistant saying.

Ms. Miner reached for her daughter’s hand and started to cry.

Ms. Miner’s encounters with the IHS, and her family’s repeated efforts to get her help there, illustrate how the federal agency can fail the patients who need it most.

For the full story, see:

Dan Frosch. “A Tragic Journey Through the Indian Health Service.” The Wall Street Journal (Tuesday, December 24, 2019): A1 & A8.

(Note: the online version of the story was updated December 23, 2019, and has the title “Kate Miner’s Tragic Journey Through the U.S. Indian Health Service.”)

Opposed by China and WHO, Trump Administration Declared Covid-19 Public Health Emergency on January 31, 2020

(p. A1) The U.S. imposed entry restrictions on foreign nationals and quarantines on Americans returning from the Chinese province at the center of the coronavirus outbreak, as markets tumbled over fears about the impact on global growth.

Health and Human Services Secretary Alex Azar declared a public health emergency Friday [Jan. 31, 2020]. He said foreign citizens who have traveled anywhere in China within the past 14 days would be denied U.S. entry, while Americans who visited Hubei province would be quarantined for up to two weeks.

. . .

(p. A8) “Many countries have offered China support in various means. In sharp contrast, certain U.S. officials’ words and actions are neither factual nor appropriate,” Chinese Foreign Ministry spokeswoman Hua Chunying said. “Just as the WHO recommended against travel restrictions, the U.S. rushed to go in the opposite way.”

For the full story, see:

Alex Leary and Brianna Abbott. “U.S. Curbs Entry to Combat Virus.” The Wall Street Journal (Saturday, February 1, 2020): A1 & A8.

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

(Note: the online version of the story has the date January 31, 2020, and has the title “U.S. Imposes Entry Restrictions Over Coronavirus.”)

Wasteful Administrative Health Care Costs

The study quoted from below suggests that the main cure for wasteful administrative costs is a “single payer” system, which is a politically correct euphemism for socialized medicine. I suggest that a better cure would be to eliminate the government middle-man, and make the patient be the payer. The patient as payer would seek and buy low-cost cures or therapies, which would shift efforts at healthcare innovation toward lower cost innovations. As has been suggested for education, vouchers could provide poor patients with the means to pay for basic care.

(p. B4) Even a divided America can agree on this goal: a health system that is cheaper but doesn’t sacrifice quality. In other words, just get rid of the waste.
A new study, published Monday [October 7, 2020] in JAMA, finds that roughly 20 percent to 25 percent of American health care spending is wasteful. It’s a startling number but not a new finding. What is surprising is how little we know about how to prevent it.

. . .

Teresa Rogstad of Humana and Natasha Parekh, a physician with the University of Pittsburgh, were co-authors of the study, which combed through 54 studies and reports published since 2012 that estimated the waste or savings from changes in practice and policy.

. . .

The estimated waste is at least $760 billion per year. That’s comparable to government spending on Medicare and exceeds national military spending, as well as total primary and secondary education spending.

. . .

The largest source of waste, according to the study, is administrative costs, totaling $266 billion a year. This includes time and resources devoted to billing and reporting to insurers and public programs. Despite this high cost, the authors found no studies that evaluate approaches to reducing it.

For the full commentary, see:

Austin Frakt. “THE NEW HEALTH CARE; Up to 25% of Health Costs Called Wasteful.” The New York Times (Tuesday, October 8, 2019): B4.

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

(Note: the online version of the commentary has the date Oct. 7, 2019, and has the title “THE NEW HEALTH CARE; The Huge Waste in the U.S. Health System.”)

The print version of the academic article in JAMA mentioned above is:

Shrank, William H., Teresa L. Rogstad, and Natasha Parekh. “Waste in the Us Health Care System: Estimated Costs and Potential for Savings.” JAMA 322, no. 15 (Oct. 15, 2019): 1501-09.

WHO “Expert” Committee Took Four Months to Endorse Widespread Mask-Wearing

(p. A1) GENEVA—Sylvie Briand landed in China looking for answers. Nearly a month had passed since word of a mysterious pneumonia had emerged. It was now late January and the World Health Organization was struggling to learn more about it.

Frustrated with mounting cases and limited information from China, the WHO’s top brass, including Dr. Briand, flew to Beijing to resolve a burning question: How easily did this new disease spread?

They met with President Xi Jinping. They had a phone call with local WHO staff just back from the Wuhan epicenter, quarantined after one developed a cough. Dr. Briand, the agency’s director of global infectious hazard preparedness, drew up a list of questions for Chinese health officials.

By the time the WHO received answers, the Covid-19 pandemic was stumbling into emergency rooms on three continents. Its spread around the world had already begun on Jan. 30 [2020] when the WHO declared a global public-health emergency, its one and only level of alert.

. . .

(p. A10) “Now is the moment for all countries to be preparing themselves,” Director-General Tedros Adhanom Ghebreyesus declared on Feb. 4, when the WHO reported more than 20,600 cases in 25 countries.

But that same day, the WHO also asked nations not to close borders—following its standard protocol, as such restrictions might discourage governments from reporting outbreaks. Within weeks, the virus landed on the agency’s doorstep, turning Geneva into a hot spot.

. . .

To write its recommendations, the WHO solicits outside experts, which can be a slow process. It took those experts more than four months to agree that widespread mask-wearing helps, and that people who are talking, shouting or singing can expel the virus through tiny particles that linger in the air. In that time, about half a million people died.

. . .

A review of the WHO’s initial response to the pandemic, based on interviews with current and former WHO staff, public-health experts advising it and officials who work with it, suggests that the agency’s bureaucratic structure, diplomatic protocol and funding were no match for a pandemic as widespread and fast-moving as Covid-19.

. . .

On Jan. 3 [2020], representatives of China’s National Health Commission arrived at the WHO office in Beijing. The NHC acknowledged a cluster of pneumonia cases, but didn’t confirm that the new pathogen was a coronavirus, a fact Chinese officials already knew. That same day, the NHC issued an internal notice ordering laboratories to hand over or destroy testing samples and forbade anyone from publishing unauthorized research on the virus.

China’s failure to notify the WHO of the cluster of illnesses is a violation of the International Health Regulations, said Lawrence Gostin, professor of global health law at Georgetown University who has advised the WHO on international health regulation matters. “Once a government knows that there is a novel virus that fits within the criteria, which China did, it’s obliged to report rapidly,” he said.

China also flouted the IHR by not disclosing all key information it had to the WHO, said David Fidler, an expert on global health and international law at the Council on Foreign Relations. The regulations call for member states to provide the WHO with “timely, accurate and sufficiently detailed public health information available to it on the notified event.”

For the full story, see:

Betsy McKay and Drew Hinshaw. “Doctors Split on Best Way To Treat Coronavirus Cases.” The Wall Street Journal (Saturday, August 29, 2020): A1 & A10.

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

(Note: the online version of the story has the date August 28, 2020, and has the title “How Coronavirus Overpowered the World Health Organization.”)

Young Doctor “Taken Aback” by Deaths Under Nationalized Medicine

(p. 26) Westaby’s book will be a balm to the hearts of curmudgeons everywhere. Sidestepping the contemporary hand-wringing about the lack of empathy in medicine, Westaby, a British surgeon, positions empathy as a threat to the surgical career: “Heart surgery,” he writes, “needs to be an impersonal, technical exercise.”

. . .

The deaths that truly madden him are those that could have been prevented by available technologies not then funded by the British National Health Service (N.H.S.), his employer.

. . .

As a young doctor who imagines nationalized medicine as a way toward comprehensive care for all my patients, I was taken aback.

For the full review, see:

Rachel Pearson. “SHORTLIST; Medical Memoirs.” The New York Times Book Review (Sunday, July 2, 2017): 26.

(Note: the online version of the review has the date June 27, 2017, and has the title “SHORTLIST; Four Timely Memoirs from the Halls of Medicine.”)

The book under review is:

Westaby, Stephen. Open Heart: A Cardiac Surgeon’s Stories of Life and Death on the Operating Table. New York: Basic Books, 2017.

Trump Administration Pushed FDA to Allow Citizens to Choose Vaccines Sooner

(p. A7) On Sept. 23 [2020], Dr. Stephen M. Hahn left a virtual meeting of the White House’s coronavirus task force to take a call from the president’s chief of staff, Mark Meadows.

Mr. Meadows was angry with Dr. Hahn, the head of the Food and Drug Administration, for pushing new guidelines for vaccine developers, according to two senior administration officials familiar with the call who requested anonymity because they were not authorized to discuss it. The F.D.A. wanted to require two months of follow-up data to make sure a vaccine was safe and effective, all but ensuring one would not be ready by Election Day as President Trump had promised.

Mr. Meadows told the commissioner the White House would not sign off on the guidance because it was unnecessary and would delay vaccine approval, so he should drop it, the officials said.

. . .

Mr. Meadows, Jared Kushner, the president’s son-in-law and senior adviser, and the president himself have called Dr. Hahn directly to urge him to speed up emergency authorization of vaccines and treatments, according to the two senior administration officials.

But despite the White House refusal to approve the new vaccine guidance document, the F.D.A. published the guidelines in briefing materials to an advisory committee that will discuss them on Thursday [October 22, 2020], effectively making them official.

For the full story, see:

Sheila Kaplan, Sharon LaFraniere, Noah Weiland and Maggie Haberman. “How the F.D.A. Stood Firm Against White House Pressure.” The New York Times (Wednesday, October 21, 2020): A7.

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

(Note: the online version of the story has the date Oct. 20, 2020, and has the title “How the F.D.A. Stood Up to the President.”)

Costs and Difficulties of Clinical Trials Delay “Most Promising Experimental Drugs”

(p. A6) As the coronavirus pandemic continues to wreak havoc in the United States and treatments are needed more than ever, clinical trials for some of the most promising experimental drugs are taking longer than expected.

Researchers at a dozen clinical trial sites said that testing delays, staffing shortages, space constraints and reluctant patients were complicating their efforts to test monoclonal antibodies, man-made drugs that mimic the molecular soldiers made by the human immune system.

As a result, once-ambitious deadlines are slipping. The drug maker Regeneron, which previously said it could have emergency doses of its antibody cocktail ready by the end of summer, has shifted to talking about how “initial data” could be available by the end of September [2020].

And Eli Lilly’s chief scientific officer said in June that its antibody treatment might be ready in September, but in an interview this week, he said he now hopes for something before the end of the year.

“Of course, I wish we could go faster — there’s no question about that,” said the Eli Lilly executive, Dr. Daniel Skovronsky. “I guess in my hopes and dreams, we enroll the patients in a week or two, but it’s taking longer than that.”

For the full story, see:

Katie Thomas. “Clinical Trials of Drugs For Virus Are Delayed By a Swamped System.” The New York Times (Saturday, August 15, 2020): A6.

(Note: bracketed year added.)

(Note: the online version of the story has the date Aug. 14, 2020, and has the title “Clinical Trials of Coronavirus Drugs Are Taking Longer Than Expected.”)