My "When I Knew More Than Hayek" celebrates 2020 as the 75th anniversary of the publication of Hayek's most important paper: "The Use of Knowledge in Society."
Posted by Arthur Diamond on Thursday, December 31, 2020
Category: Health
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:
(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.”)
“Normal” Human Temperature May Be Lower When Baseline Inflammation Is Lower
When I was a child my mother would hand me an oral thermometer to take my temperature and often the temperature would come out below 98.6 degrees. She would be annoyed and hand it back to me, saying that I should put it in right this time. I would painfully jab the thermometer back under my tongue, discouraged that I would never figure out what I was doing wrong. So several decades later, I smiled when I read the commentary quoted below. (Hey mom, maybe I was doing it OK all along.)
(p. A2) Nearly 150 years ago, a German physician analyzed a million temperatures from 25,000 patients and concluded that normal human-body temperature is 98.6 degrees Fahrenheit.
That standard has been published in numerous medical texts and helped generations of parents judge the gravity of a child’s illness.
But at least two dozen modern studies have concluded the number is too high.
The findings have prompted speculation that the pioneering analysis published in 1869 by Carl Reinhold August Wunderlich was flawed.
Or was it?
In a new study, researchers from Stanford University argue that Wunderlich’s number was correct at the time but is no longer accurate because the human body has changed.
Today, they say, the average normal human-body temperature is closer to 97.5 degrees Fahrenheit.
. . .
“Wunderlich did a brilliant job,” Dr. Parsonnet said, “but people who walked into his office had tuberculosis, they had dysentery, they had bone infections that had festered their entire lives, they were exposed to infectious diseases we’ve never seen.”
For his study, he did try to measure the temperatures of healthy people, she said, but even so, life expectancy at the time was 38 years, and chronic infections such as gum disease and syphilis afflicted large portions of the population. Dr. Parsonnet suspects inflammation caused by those and other persistent maladies explains the temperature documented by Wunderlich and that a population-level change in inflammation is the most plausible explanation for a decrease in temperature.
For the full commentary, see:
(Note: ellipsis added.)
(Note: the online version of the commentary has the date January 17, 2020, and has the title “THE NUMBERS; 98.6 Degrees Fahrenheit Isn’t the Average Anymore.”)
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:
(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:
(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:
(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:
Even Chimps Seek Cool Comfort
Some humans reject air conditioning. Chimps are unable to create air conditioning. But when they discover a cool cave in a hot summer, they spend time in the cave.
(p. D2) Everyone needs to cool off on a scorching summer day, even chimpanzees. Where do the primates go on sizzling days when woodlands and forests don’t provide respite from the heat?
Caves.
. . .
In southeastern Senegal, temperatures spike to 110 degrees Fahrenheit and fires burn large parts of the landscape over a seven-month dry season. Several natural cave formations pock the terrain, and they can be up to 55 degrees cooler than the surrounding grasslands.
For the full story, see:
(Note: ellipsis added.)
(Note: the online version of the story was updated on August 6, 2020, and has the same title as the print version.)
See also:
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:
(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.
Scientists Shocked to Discover a New Structure in Human Body
Some have claimed that we have picked all the low-hanging fruit and that there is little yet to be discovered. But if we remain curious, alert to serendipitous inconsistencies or surprises, we still have a lot to be learned. The default is to not see, or at least to soon forget, when we see the unexpected. To see and remember is hard enough. In the passages quoted below the researchers saw, remembered, and followed up. (Another example would be when Nick Steinsberger saw, remembered, and followed-up on the unexpected positive effects of the accidentally too watery fracking mixture injected into a well.)
(p. D5) A team of researchers in the Netherlands has discovered what may be a set of previously unidentified organs: a pair of large salivary glands, lurking in the nook where the nasal cavity meets the throat. If the findings are confirmed, this hidden wellspring of spit could mark the first identification of its kind in about three centuries.
Any modern anatomy book will show just three major types of salivary glands: one set near the ears, another below the jaw and another under the tongue. “Now, we think there is a fourth,” said Dr. Matthijs Valstar, a surgeon and researcher at the Netherlands Cancer Institute and an author on the study, published last month in the journal Radiotherapy and Oncology.
The study was small, and examined a limited patient population, said Dr. Valerie Fitzhugh, a pathologist at Rutgers University who wasn’t involved in the research. But “it seems like they may be onto something,” she said. “If it’s real, it could change the way we look at disease in this region.”
Even without a direct therapeutic application, Dr. Yvonne Mowery, a radiation oncologist at Duke University, said she “was quite shocked that we are in 2020 and have a new structure identified in the human body.”
Dr. Valstar and his colleagues, who usually study data from people with prostate cancer, didn’t set out on a treasure hunt for unidentified spit glands.
. . .
While perusing a set of scans from a machine that could visualize tissues in high detail, the researchers noticed two unfamiliar structures dead center in the head: a duo of flat, spindly glands, a couple of inches in length, draped discreetly over the tubes that connect the ears to the throat.
Puzzled by the images, they dissected tissue from two cadavers and found that the glands bore similarities to known salivary glands that sit below the tongue. The new glands were also hooked up to large draining ducts — a hint that they were funneling fluid from one place to another.
It’s not completely clear how the glands eluded anatomists. But “the location is not very accessible, and you need very sensitive imaging to detect it,” said Dr. Wouter Vogel, a radiation oncologist at the Netherlands Cancer Institute and an author on the study.
. . .
Dr. Fitzhugh added that it should be easier to spot the camera-shy glands with traditional techniques “now that they know to look for it.”
For the full story, see:
(Note: ellipses added.)
(Note: the online version of the story was updated on Oct. 21, 2020, and has the title “Doctors May Have Found Secretive New Organs in the Center of Your Head.”)
The academic article mentioned above is:
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:
(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.”)
Invading Mussels Gave Lake Michigan Sparkling Clarity
(p. 12) Having just moved back to Chicago from Mexico, she had seen Lake Michigan with fresh eyes. “Have you noticed how blue the lake is now?” she asked me one day. I had not. “It’s, like, Caribbean blue,” she said. The next time I went down to the lakeside I noticed what she meant. The lake of my childhood had always vacillated somewhere between a slate blue and the gray found in the seams of an old tennis ball. But suddenly it had taken on a kind of hyperclarity; it sparkled. The lake was so clean, I read online, that passing airplanes could see shipwrecks resting on the lake bottom. Thanks to climate change, the lake was approaching Caribbean temperatures, as well; it hit 80 degrees one recent July, when it would normally be in the high 50s. I remember feeling pleased by this change, but also slightly unsettled, the same way we feel on an unseasonably warm winter’s day. It was too good to be good.
And so it came as a revelation to me to read Dan Egan’s deeply researched and sharply written “The Death and Life of the Great Lakes.” Dipping into this book was like opening the secret diary of a mercurial and mysterious parent. I learned that the reason the lake had become so clear was that it had been invaded by a dastardly pair of bivalves — the zebra and quagga mussels — which had hitched a ride on a shipping barge from either the Black or Caspian Seas and then quietly but ceaselessly colonized the lake. They set about cleaning up the water with hyperactive single-mindedness, eventually sucking up 90 percent of the lake’s phytoplankton. The water is now three times clearer than it was in the 1980s.
For the full review, see:
Robert Moor. “Five Alive.” The New York Times Book Review (Sunday, May 28, 2017): 12.
(Note: the online version of the review has the date May 23, 2017, and has the title “April’s Book Club Pick: ‘The Death and Life of the Great Lakes,’ by Dan Egan.”)
The book under review is:
Egan, Dan. The Death and Life of the Great Lakes. New York: W. W. Norton & Company, 2017.