What Could Possibly Go Wrong? Outbreaks of Injustice Linked by Two Different Dobbs.

BY MIKE MAGEE

Under the definition for the noun, epidemic, there are two main (and distinctly different) definitions. I know this fact because it was the beginning point of my preparations earlier this summer for a Fall course on “The History of Epidemics in America” at the Presidents College at the University of Hartford. 

The entry reads:

Epidemic noun

ep·​i·​dem·​ic | \ ˌe-pə-ˈde-mik  \

Definition of epidemic (Entry 2 of 2)

1: an outbreak of disease that spreads quickly and affects many individuals at the same time : an outbreak of epidemic disease

2: an outbreak or product of sudden rapid spread, growth, or development; an epidemic of bankruptcies

In my course, sessions 1, 2, and 4 will be devoted to the first (and classical, microbe-centric) definition. But my third session will focus on “manmade” epidemics which fall under definition two.

I thought long and hard about this choice. The deciding factor was reading New York Times best selling author, Adam Cohen’s book, “Imbeciles.” It details the shameful story of “The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck.”

More on that tale in a moment, but in commentary on the book, Cohen states, “…in many ways, I believe you can learn more about an institution and more about an ideal like justice if you look at where it’s gone wrong rather than where it’s gone right.”

The tale of Carrie Buck is instructive, and sheds a damning light on our current Supreme Court and its’ recent decision, Dobbs v. Jackson Women’s Health Organization. In that case, Jackson Women’s Health Organization, Mississippi’s only abortion clinic, sued Mississippi state health officer, Thomas E. Dobbs, for relief from the state law prohibiting abortion after the 15th week of pregnancy. 

Chief Justice John Roberts sided with the minority in this recent case. That decision to let the Mississippi law stand unearthed a bucket of repressive state laws with more likely to come. But we have been their before. All one need do is view the portrait of Chief Justice Robert’s hero, Justice John Marshall Harlan, which can be found on the wall to the left of the fireplace in the Justices Conference Room in the U. S. Supreme Court.

Of Justice Harlan’s many wise decisions, none is quoted more often than Jacobson v. Massachusetts (1905).I that decision, which supported fining one Methodist Minister who refused to comply with mandatory Smallpox vaccination, Justice Harlan wrote:

“Real liberty for all could not exist under the operation of a principle which recognizes the right of each individual person to use his own, whether in respect of his person or his property, regardless of the injury that may be done to others.”

For most progressive policy elites, this was a “slam dunk.” What could possibly go wrong here? Of course, they had not fully considered the “unintended consequences,” let alone the presence of zealots committed to advantaging the narrow opening created by the new decision.

At the time, President Wilson and others were focused on “strengthening the American stock.” This involved a two-prong attack on “the enemy without” and “the enemy within.”

The Immigration Act of 1824, signed by President Calvin Coolidge, was the culmination of an attack on “the enemy without.” Quotas for immigration were set according to the 1890 Census which had the effect of advantaging the selective influx of Anglo-Saxons over Eastern Europeans and Italians. Asians (except Japanese and Filipinos) were banned.

As for “the enemy within,” rooters for the cause of weeding out “undesirable human traits” from the American populace had the firm support of premier academics from almost every elite university across the nation. This came in the form of new departments focused on advancing the “Eugenics Movement,” an excessively discriminatory, quasi-academic approach based on the work of Francis Galton, cousin of Charles Darwin.

Isolationists and Segregationists picked up the thread and ran with it focused on vulnerable members of the community labeled as paupers, mentally disabled, dwarfs, promiscuous or criminal. 

In a strategy eerily reminiscent of that employed by Mississippi Pro-Life advocates in Dobbs v. Jackson Women’s Health Organization in 2021, Dr. Albert Priddy, activist director of the Virginia State Colony for Epileptics and Feebleminded, teamed up with radical Virginia state senator Aubrey Strode to hand pick and literally make a “federal case” out of a young institutionalized teen resident named Carrie Buck.

Their goal was to force the nation’s highest courts to sanction state sponsored mandated sterilization, and thus allow the spread of the practice nationwide. This required a test case and a defense attorney for the victim, who was hired by Dr. Priddy. Carrie Buck was chosen as the target. 

In a strange twist of fate, the Dobbs name was central to this case as well. That is because Carrie Buck was under the care of foster parents, John and Alice Dobbs, after Carrie’s mother, Emma, was declared mentally incompetent. At the age of 17, Carrie, after having been removed from school after the 6th grade to work as a domestic for the Dobbs, was raped by their nephew and gave birth to a daughter, Vivian. This lead to her mandated institutionalization, and subsequent official labeling as an “imbecile.” 

Dr. Priddy applied for official permission for forced surgical sterilization of the girl, and had his hand-selected defense attorney oppose his actions in court. His intent was to force the case all the way to the Supreme Court where a positive outcome would validate nationalizing the practice. 

To bolster his case for sterilization, Priddy enlisted the aid of a well-known Eugenics Professor, Harry Laughlin, who testified during the trial that Carrie suffered from “…social and economic inadequacy; has a record during life of immorality, prostitution, and untruthfulness; has never been self-sustaining; has had one illegitimate child, now about 6 months old and supposed to be a mental defective.”

In his majority decision supporting Dr. Priddy, Buck v. Bell,  Supreme Court Chief Justice Oliver Wendall Holmes leaned heavily on precedent. Reflecting his extreme bias, he wrote: “The principle that supports compulsory vaccination is broad enough to cover the cutting of Fallopian tubes (Jacobson v. Massachusetts 197 US 11). Three generation of imbeciles are enough.” Carrie Buck underwent tubal ligation against her will at the institution on October 19, 1927.

What followed was predictable. By 1930, 24 states had passed their own laws allowing involuntary sterilizations. Between 1927 and 1974, 60,000 Americans were sterilized including 7,500 victims in the state of Virginia. That state’s sterilization law was repealed in 1974, and in 1980 an ACLU suit forced to make reparations. On May 2, 2002, Virginia Gov. Mark Warner publicly apologized for Virginia’s eugenics program.

Carrie Buck lived to age 76, had no mental illness, and read the Charlottesville, VA newspaper every day, cover to cover. There is no evidence that her mother Emma was mentally incompetent. Her daughter Vivian was an honor student, who died in the custody of John and Alice Dobbs at the age of 8.

Mike Magee MD is a Medical Historian and the author of “CODE BLUE: Inside the Medical Industrial Complex.”

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It’s Time for No

BY KIM BELLARD

We all – well, most of us – try to be agreeable.  It’s usually a better social lubricant to say “yes” than “no.”  It’s widely considered to be better for your career to be the one who always says “yes” instead of being the troublesome worker who often says “no.”  “Yes, dear” is a safer marital strategy than “no” or “not again.”  But, like most conventional wisdoms, these deserve to be challenged. 

I’ve read several articles recently where “no” is the suggested strategy, and I think there’s something there.  Especially for healthcare.  

————–

The first is a fun, fascinating, possibly far-reaching article in Nature, “Why four scientists spent a year saying no.”  The authors are “a group of mid-career environmental social scientists” who felt they were saying “yes” to too many commitments.  As a result, they decided to not only be more deliberate about saying no but also to track it.  Their goal was to collectively decline 100 work-related requests, which they hit in March 2022. 

It’s harder than you might think; as the authors warn: “It involves rethinking priorities and empowering ourselves and our colleagues to set boundaries.”  They had to forget FOMO (fear of missing out) and embrace JOMO (joy of missing out), in order to create more room for intentional “yes.” 

They offer four insights about the learned skill of saying “no”:

• Tracking helped make “no” an option;
• Say no more often ad to larger asks;
• Saying no is emotional work;
• Practice makes “no” easier.

It’s often so tempting to just say “yes,” but we’ve all only got so much time and energy.  Sometimes “no” is the best answer.  

————-

Sometimes, though, the saying “no” is not out loud; sometimes we say no by our actions.  Which leads me to a new trend: “quiet quitting.”  

This is another TikTok trend, started by one user (@zkchillin) in July and quickly going viral.  The mainstream press is all over it, with articles in WSJ, NYT, NPR, and CNN, among others.  Despite what it sounds like, quiet quitting isn’t ghosting your employer, just walking away from your job without resignation or other declaration of leaving.  In fact, it doesn’t involve quitting at all. 

Quiet quitting rejects the notion that workers are supposed to always try to go above and beyond.  It rejects the notion that work life is more important than life outside work. It encourages people to say “no’ more at work inside of automatically saying “yes” to requests that they take on more tasks or longer hours.  It doesn’t mean doing the bare minimum required to keep your job, but it insists on only doing the things the job requires and pays them to do, during the hours they’re supposed to be doing them.  

It’s a Gen Z thing.  One 24-year-old TikToker, Zaid Khan, said: “You’re quitting the idea of going above and beyond. You’re no longer subscribing to the hustle-culture mentality that work has to be your life.” 

Healthcare, of course, shudders at the thought of quiet quitting.  What would happen if nurses wouldn’t work all those extra shifts?  What would have happened if doctors and other medical professionals had refused to see COVID-19 patients when PPE was lacking and no one quite knew how dangerous COVID was or how to treat it?  What would happen if primary care doctors stopped trying to fit 26 hours of work into a “normal” workday?  What would happen if physicians said it’s ridiculous that they have to spend two hours a day outside work hours on EHR tasks?  

Healthcare as we know it would fall apart…as maybe it should.

————-

Last but not least, sometimes healthcare professionals should be saying “no” loud and clear, as suggested in a NEJM Perspective by Matthew K. Wynia, M.D., M.P.H.:Professional Civil Disobedience — Medical-Society Responsibilities after Dobbs

The core question, Dr. Wynia, posits, is: “What should medical professionals do when a law requires them to harm a patient?”  He is referring, of course, to restrictions on medical practice imposed by various state abortion laws in the wake of the Dobbs decision.  He then asks the corollary question: “When these laws directly and immediately threaten the health of patients, should physicians collectively disobey them — that is, should they engage in professional civil disobedience?”

Healthcare has plenty of organizations that collectively claim to advocate for its constituents – the AMA, various specialty organizations, the American Nurses Association, and so on. Cynically, these are often used to argue to higher pay and/or better working conditions, rather than for the best interests of patients.  Sometimes they do take moral stances, including (as Dr. Wynia points out) their concerns about the implications of Dobbs.  But actually taking action, of threating work stoppages or boycotts?  That’s a step they rarely take, and one Dr. Wynia believes it is time for.

“Too often,” he laments, “organized medicine has failed to fulfill its duty to protect patients when doing so required acting against state authority.”  Dr. Wynia wonders: “How long could a dangerous state law survive if the medical profession, as a whole, refused to be intimidated into harming patients, even if such a refusal meant that many physicians might go to jail?”  

Not long, I’d bet.

The danger, he warns, is that: “…when a society takes a wrong turn and medical professionals go along, mistrust in medicine grows and either social change must be driven by other groups or the society fails.” In other words, time for the medical profession to say no, at least when it comes to any restrictions that impact the best care of their patients.

——————

Normally, I’m someone who is intrigued by new ideas, who is excited about innovation, who wants to see change – all things that signal saying “yes.”  But saying “yes” to too many things often effectively means implicitly saying no to most of them; we can only do so much at once, we can only accept so much change at a time.  Saying “no” more often, and more strategically, allows us to focus on the things we must say “yes” to.

In healthcare, patients are too often forced to accept “yes” to things they’d really like to say “no”
 to.  Physicians and other healthcare professionals are often forced to agree to work practices and restrictions that they know they should say “no” to.  And both patients and healthcare professionals are finding that legislators are acting in ways that are at odds with our best interests.

Time to say “no.”

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.

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Amazon’s Coitus Interruptus: In or out?

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

Meanwhile, it’s time for Matthew’s tidbits and of course given their recent news-making I am going to focus on Amazon in health care. The news is of course that they are in health care in a big way, buying One Medical. The news is also of course is that they are out–shutting down Amazon Care.

This reminds me of the famous criticism delivered in the British parliament by one MP about another back the last time (in the 1970s) there was a vote about leaving the EU. “The Honourable gentleman can’t make up his mind. First he’s in, then he’s out. In, out. In, out. This is the politics of coitus interruptus.” After a moment a voice from the backbenches shouted “Withdraw.”

So is Amazon in or out?

They are out of their 4 year effort to build a hybrid telehealth-to-home medical group that helps mainstream employers manage their costs. This is despite stating their intent just a few months back to add new clinics and this year adding a decent number of employer clients including Hilton hotels–before that they only really had a few of their own employees as clients. Interestingly enough, it was the development of this platform that convinced Amazon that they didn’t need Haven–their alliance with JP Morgan and Berkshire Hathaway which was developing a similar offering.

They are in to the business of One Medical to the tune of a $3Bn acquisition as well as putting in $300m extra cash so far, and likely a lot more later. Like Amazon Care, One Medical has a hybrid telehealth and clinic approach (though no home visits as yet). When Amazon said they were killing Amazon Care, they suggested that a lack of employer uptake was the biggest problem. One Medical does have employer clients. But these aren’t mainstream low or medium wage employers to whom they are delivering capitated care at a worksite. In One Medical terms that means an employer pays their employees’ $200 per member annual fee, after which the employee can see a One Medical doctor. And curiously enough by far their biggest employer client is Google.

One Medical says that they lower overall costs for their employer clients, but to use another British political line, “they would say that wouldn’t they.” In reality One Medical does very little specialty or hospital care management, and via its relationships with local high-priced health systems is able to charge insurers very high prices for primary care which they seem to actually pay! (And yes I have lots of personal experience here..). Putting aside the fact that One Medical somehow is contriving to still lose loads of money–a big reason why it put itself up for sale–it is not an organization trying to manage costs for employers in value-based care arrangements, unlike say Firefly Health or even Crossover Health (of which Amazon is a big client for its lower paid workers).

You’ll notice that I am conveniently ignoring the Iora Health part of One Medical which they inexplicably bought last year. Iora focuses on capitated services for Medicare Advantage plans, and it is trying to manage costs. Though given the amount it’s losing, that effort isn’t going so well either.

It’s possible that Amazon is going to surprise us and try to turn Iora + One Medical into a capitated giant to work with and steal the margin of the big Medicare Advantage plans. Then later, move that strategy into mainstream employers.

But if they were going to try that it would probably have been easier and more culturally aligned to merge Iora with Amazon Care. My suspicion is that Amazon means what it says and is finding it too hard to manage costs for employers. My guess is it will jettison Iora, keep using Crossover and others to manage costs for its own lower-paid employees, and try to turn One Medical into a Whole Foods-like national brand for the cost- unconscious top 25% of Americans….and somehow make it profitable.

If they manage that it would be great for Amazon’s business. But it would be very disappointing for those of us hoping that Amazon was going to have a serious go at providing a low-cost, innovative service that was trying to lower overall health care costs for employers and make a serious dent in the market power of America’s high priced, under-delivering hospital systems.

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THCB Gang Episode 102, Thursday August 25

Joining Matthew Holt (@boltyboy) for the 100th #THCBGang on Thursday August 4 are Suntra Modern Recovery CEO JL Neptune (@JeanLucNeptune); Queen of all employer benefits Jennifer Benz (@jenbenz); Special guest this week is Olympic rower for 2 countries and all around dynamo Jennifer Goldsack, (@GoldsackJen), and Ryan Vega, CIO of Veterans Affairs.

You can see the video below & if you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels.

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#HealthTechDeals Episode 43 | Happy Ring, Upfront, PatientBond, Nitra, Digital Diagnostic, Ubie

On this episode of HTD, Jess and I check out Akili Interactive: at least it’s still worth more than Pear Therapeutics. And by the way, what do we think will happen between Amazon and Signify? Tune in to find out! We also look at some new deals in health tech: Happy Ring raises $60 million; Upfront buys PatientBond, raising $20 million; Nitra raises $62 million; Digital Diagnostic raises $75 million; Ubie raises $26.2 million.

-Matthew Holt

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“Virgin-Soil Epidemics” Covers a Multitude of Sins

BY MIKE MAGEE

Epidemics don’t appear in isolation of geography, social status, race or economics.

In a recent Kaiser Family Foundation article, the authors reviewed case numbers and death rates organized by race/ethnicity. It will come as no surprise that the most vulnerable populations death rate is nearly three times greater than the least vulnerable. But what may surprise you is that the population at greatest risk was neither self-identified as Black or Hispanic, but Native American.

Sadly, this is not a new story, but in the analogs of American history, it has been papered over by a partially true, but incomplete, narrative. That storyline was largely popularized by the book, “Guns, Germs, and Steel.” Published in 1997, author Jared Diamond explained that European colonists, arriving in the Caribbean islands in the late 15th century, carried with them a variety of diseases like smallpox and measles, and transmitted them to indigenous people that had no prior exposure to these deadly microbes.

Two years ago, University of Oregon Professor of History Jeffrey Ostler recently challenged the “virgin-soil” hypothesis in an article in The Atlantic. In his words, “Although the virgin-soil-epidemic hypothesis may have been well-intentioned, its focus on the brief, if horrific, a moment of initial contact consigns disease safely to the distant past and provides colonizers with an alibi. Indigenous communities are fighting more than a virus.”

Students of American history are already more than familiar with the impact of infectious diseases on the natives of Saint-Dominique (now Haiti) in the late 18th century, but also the advance of disease northward that followed and eventually enveloped our own Native Americans. 

Best known among the documented tragedies of the 19th century is the Cherokee Trail of Tears. While immunologic susceptibility unquestionably played a role in the event, the forced expulsion of the Cherokees from Georgia, North Carolina, and Tennessee, in three phases was a complex and multi-faceted disaster.

It began with the U.S. Army destroying native homes and detaining our earliest Americans in concentration camps or holding pens for several months. Without decent shelter and sanitation, and limited food and water, disease thrived. Of the 16,000 contained, 2000 immediately perished primarily from dysentery, but also diseases like measles, whooping cough, and malaria.

Severely weakened, the forced march west that followed as a second phase, resulted in an additional 1500 deaths. Finally, the early months of relocation in Oklahoma, sacrificed an additional 500 souls. In all then, 4,000 of the original 16,000 died. 

This complex intermingling of disease and severely compromised and susceptible human hosts played out again and again in the years following the 1830 Indian Removal Act. That federal legislation directed the forced relocation of all Native peoples east of the Mississippi River to ‘Indian Territory’ – the future Oklahoma and Kansas.)

Forced migration, accompanied by exposure to the elements, malnutrition, and violent warfare attacks along the way, created a deadly brew – and that was before disease intervened. The Cherokees were not the only victims in the two decades between 1830 and 1850. A partial list of other tribes includes Creeks, Seminoles, Chickasaws, Choctaws, Senecas, Wyandots, Potawatomis, Sauks and Mesquakies, Ojibwes, Ottawas, Miamis, Kickapoos, Poncas, Modocs, Kalapuyas, and Takelmas.

The trial of the Sauks and Mesquakies from western Illinois to Oklahoma occurred in four segments, with a staggering 85% mortality rate. During their migration, dislocation, and for years after their relocation, fertility rates plummeted and maternal-infant mortality soared.

Professor Ostler does acknowledge the value of the “virgin-soil” hypothesis, but with caveats. As he wrote, “The virgin-soil-epidemic hypothesis was valuable in countering earlier theories that attributed Native American population decline to racial inferiority, but its singular emphasis on biological difference implied that population collapses were nothing more than historical accidents.” And, as is commonly claimed, “History repeats!”

Of native Americans, it has been fairly said: “They are contending with the ongoing legacy of centuries of violence and dispossession… Countering the invisibility of Native peoples, of course, means greater awareness of how COVID-19 is affecting them and enhanced efforts to provide resources to help them combat the current outbreak…”

On the broader issue of epidemics in America, past and present, it is useful to be reminded, it is as much about us as it is the about the microbes we are forced to encounter.

Mike Magee MD is a Medical Historian and the author of “CODE BLUE: Inside the Medical Industrial Complex.”

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The Shocking Impact of an Ancestor’s Secret Abortion

BY MICHAEL MILLENSON

When my siblings and I were young, we were fascinated by my father’s Uncle Byron. Handsome and confident, he drove a big, 1960s-era Chrysler Imperial, had a glamorous job — an executive at a Baltimore radio station — and radiated panache.

He also was part of a small family mystery. His father, Louis, was married three times, and Byron was raised by Wife № 3. But he was the biological child of Wife № 2, who died just a few years after his birth from an unknown cause.

Thanks to some persistent genealogical research, I recently discovered that cause: Annie Millenson had a botched abortion, and it killed her. It also destroyed her surviving family.

Following the Supreme Court’s Dobbs decision and the resulting deluge of state anti-abortion laws, I took a closer look at my family story. I not only found unsettling signs of how the past can, indeed, be prologue, I also discovered why abortion could be an integral part of your family’s story, too ­– you just don’t know it.

In the last part of the 19th century and the first part of the 20th, with contraception unreliable and childbirth dangerous, women of all social classes and religions (including Catholics) sought abortions. With an estimated two million abortions each year, “abortion was part of life,” writes Leslie J. Reagan, a University of Illinois professor, in the 1979 book, When Abortion Was a Crime: Women, Medicine and Law in the United States, 1867–1973.

That abortion had relatively recently become illegal did not deter those who were desperate, as Annie Millenson surely would have been. When she married Louis Millenson, she was a widow who already had four young children (two girls and two boys). She, first husband Max and family had moved to Denver to be near a renowned Jewish hospital that could treat his “consumption,” as tuberculosis was then known. It didn’t work.

Max died in 1907. In June, 1909 Annie married Louis, a cigarmaker seven years older and, like her, a European Jewish immigrant. Byron was born in December, 1911. When Annie became pregnant again in late 1914 or early 1915, the family of seven was barely scraping by with help from Louis’s younger brother, who ran a large local butcher shop. Also, Annie was 40 years old.

“Therapeutic” abortions to save the life of the mother were often an exception to a state’s abortion ban. (Nineteenth and early 20th-century abortion opponents were actually less extreme than many current ones.) Annie’s abortion was performed by a respected Denver doctor, but he was neither a gynecologist nor surgeon. Did his connections confer tacit legal protection?

In any event, something went very wrong. There was bleeding and an infection that developed into the deadly condition we now call sepsis. After lingering for a few weeks, Annie died on April 11, 1915.

Annie’s death left Louis with unpaid medical bills of $200, a crushing debt at a time when a skilled cigarmaker might earn $35 in a week. I don’t know what Louis would do today if he lived in a state where abortion was criminalized and he had no money to feed his children. But the decision he made then was as shocking as it must have been agonizing.

The court overseeing Annie’s estate approved a $250 payment for one-way railroad tickets to New York for the four children from Annie’s first marriage. They were to live with an aunt and uncle they’d never met, and reimburse the train fare to the estate when they became adults. The two boys also got new suits and caps for $4.75 each; there’s no record of the girls getting any new clothing.

I found out about Annie’s abortion only because I was able to track down Ann, the daughter of the oldest of those four children, on her 90th birthday. After she told me how Annie died, I asked whether her mother, aunt or uncles ever spoke of Louis. After six years of marriage to Annie, he was the only father the youngest siblings (ages three and five when Annie remarried) might clearly remember. They never mentioned him, Ann replied.

The four children did not end up living happily ever after. The family life they had previously known was shattered as the two girls lived for a time with relatives and then on their own, and the boys were sent to a transient hotel.

Yet to my surprise, Ann, named after her grandmother, told me the siblings had stayed in touch with Byron after he was grown and living in Baltimore. She even sent me a photo of Byron and his wife posing with Annie’s children and their spouses four decades after the family separation. I was taken aback. Byron’s daughters knew nothing about this “second family” that was as much their aunts, uncles and cousins as the offspring of Louis’s other marriages. (My family came from Wife № 1.) Like the abortion, this branch of the family tree was a tightly kept secret.

In a 2020 Vogue article, University of California, San Francisco professor Diana Greene Foster Greene presciently warned about the failure to discuss abortion “as a personal issue and instead view it as an abstract political debate.”

“Abortion was part of life.” How many families harbor a decades-old abortion story similar to ours ­– tragic and secret, or merely secret? How many more families, post-Dobbs, will be forced to take the same kind of risks Annie and Louis did and be forced, too, into silence about their “crime”?

Yes, abortion remains legal in many states, including Colorado. And yes, there are now pills for contraception and abortion, at least for those who can access them. Nonetheless, all signs point to a growing desperation among many women faced with a powerful segment of anti-abortion activists for whom the mother’s life seems to have little value.

As author, activist, consultant and a former Pulitzer-nominated journalist, Michael Millenson focuses professionally on making health care safer, better and more patient-centered.

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Zap Away

BY KIM BELLARD

Speaking as a sometimes forgetful “senior citizen,” when I found out that non-invasively zapping brains with electricity can result in measurable improvements in memory, that’s something I’m going to remember.

I hope.  

In research published in Nature Neuroscience by Grover, et. al., a team lead by Boston University cognitive neuroscientist Robert Reinhart produced improvements in both long-term and short-term (working) memory through a series of weak electric stimulation – transcranial alternating current stimulation (tACS). The authors modestly claim: “Together, these findings suggest that memory function can be selectively and sustainably improved in older adults through modulation of functionally specific brain rhythms.”

The study provided the stimulation using something that looks like a swimming cap with electrodes, applied for twenty minutes a day for four days.  The population was 150 people, broken up into three separate experiments, all ages 65 to 88.

The results were amazing.  “We can watch the memory improvements accumulate … with each passing day,” Dr. Reinhart marveled.  

Previous studies had suggested that long term and working memories had distinct mechanisms, in different parts of the brain, and this study seems to have demonstrated that fairly conclusively.  “We could improve either short-term or long-term memory separately,” Dr. Reinhart said. “And with this intervention across four consecutive days, we could change memory and watch the benefits accumulate over those days, which is striking.”  

Even more important, the gains persisted even a month later, with the greatest gains accruing to the participants who had the lowest cognitive function levels prior to the study. 

“That’s really one of the take home messages here—that it’s not just about stimulating a brain area, but it’s about stimulating a brain area at a specific frequency, so that it can then drive network communication,” Daniel Press, chief of the cognitive neurology unit at Beth Israel Deaconess Medical Center, told The Wall Street Journal.  (Dr. Press wasn’t involved in the research).

Other researchers not involved in the study were impressed.  “Their results look very promising,” says Ines Violante, a neuroscientist at the University of Surrey. “They really took advantage of the cumulative knowledge within the field.” 

“I was both impressed and surprised by this by this paper,” Simon Hanslmayr, a cognitive neuroscientist at the University of Glasgow,” said to Nature, with the results linked to “consistent and quite strong improvements in memory.”

“This is a really elegantly designed study,” Katharina Klink, a brain scientist at the University of Bern told StatNews. “These are such small currents that are being used, so to see effects on memory function after one month of not having any stimulation done to the brain, that’s quite impressive.”  

“I believe this is the future of neurologic intervention, to help strengthen networks in our brains that may be failing,” Dr. Gayatri Devi, a clinical professor of neurology and psychiatry at the Zucker School of Medicine at Hofstra/Northwell, told CNN. “Additionally, treatment may be tailored to each person, based on that individual’s strengths and weaknesses, something pharmacotherapy is not able to do.”

“This was a very short intervention which produced both an immediate effect and a very durable one,” Marom Bikson, a neural engineer at the City College of New York, told MIT Technology Review. “More research is needed, but if this works out it could be in every doctor’s office … and it could eventually be something that people use at home.”  

Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic in the Center for Brain Health at Florida Atlantic University’s Schmidt College of Medicine, agrees, telling CNN: “In an ideal world, a portable at-home device that could offer this therapy would be the eventual goal.” 

I’d buy one of those…and one for my wife.

The study differed from previous efforts in a couple of significant ways.  One was applying the tACS over a period of days, rather than in a single session.  The second was targeting seniors rather than younger people, whose memory issues may be harder to identify or modify.  

Dr. Reinhart prefers to refer to tACS as brain modulation rather than brain stimulation, since the currents are too low to trigger brain cells to fire.  “They’re noninvasive, safe, extremely weak levels of alternating current,” he stresses.  Moreover, he adds: “When the current is running, you feel like a mild tingling or itching or poking or warming sensation.”  “Zap” may be too strong a word.

Study coauthor Shrey Grover told Nature that future areas of research include whether the tACS can impact other memory tasks, whether the improvements persist longer than a month, and whether it could help people with conditions like Alzheimer’s. “We’re hoping that we can extend upon this work in meaningful ways and contribute more information about how the brain works,” Dr. Grover says.

The study is more evidence that our brains are not as fixed as once thought.  “This plasticity is what allows the effects to be carried forward in time even when the stimulation has ended,” Dr. Grover told The Wall Street Journal.

We’re a long way from clinical trials or FDA approved devices for tACS, so if someone tries to sell you a brain stimulation cap, it’d be wise to be skeptical.  “It will take more work to turn this into something that could actually help people with memory impairments,” said University of New Mexico neuroscientist Vincent Clark, who was not involved in the study.

By contrast with tACS, deep brain stimulation (DBS) has been around for several years, with good success in treating conditions like Parkinson’s, dystonia, and, most recently, it had significant effects in treating depression in a small study from UTHealth Houston.  But, you know, DBS involves implanting electrodes in the brain, so that swimmer’s cap-like device looks a lot more appealing.

But at some point in the future, yeah, we’re likely to have options like that.  As Dr. Reinhart told StatNews: “People are just overwhelmingly interested in augmenting their abilities to provide any kind of cutting-edge advantage.  I can imagine a future potentially where people are using stimulation.”

In the meantime, keep doing your Wordle, taking those walks, or swallowing your favorite (prescription or OTC) nootropic to help keep your memory fresh, but keep your hopes alive that a more effective, more targeted solution may be on the way.  

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.

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Pharmacists Can Now Prescribe Paxlovid. Good idea?

BY ANISH KOKA

Apparently, the US Food and Drug Administration (FDA), that has long been charged with the safety and efficacy of drugs and devices now also controls who can prescribe drugs.

I was under the mistaken impression that in our highly rule based society you would need to pass a law to allow that to happen. Passing laws , of course, can be a long, messy, process that involves having to convince constituencies, and ruling by executive order is just way more efficient apparently.

So by decree of the FDA patients can now get Paxlovid, an anti-viral for the virus that causes COVID19, “directly from their state licensed pharmacist” if they so choose. Apparently, someone in government decided that there wasn’t enough Paxlovid being prescribed, and the major rate limiting step for many patients is not having access to a provider to prescribe the drug. I have to say provider now because physicians long ago lost the monopoly they enjoyed for prescribing medications to nurses with advanced degrees and physician assistants. The next obvious step is to cut out the ‘clinicians’ completely by allowing patients to get medications from a pharmacist without a prescription.

Its interesting because I’ve struggled with quite a few Paxlovid requests recently. About 5 weeks ago a long time elderly patient of mine with a history of coronary disease and a stroke called me during dinner because he had just contracted COVID. He had been more lethargic and a concerned wife took him to the ER, where he was found to be COVID positive. He was vaccinated and boosted, and we went back and forth about the different options. We finally decided to go ahead with Paxlovid. Paxlovid has a long list of interactions with a variety of drugs that make it unsuitable for many, but luckily he was only on a cholesterol lowering medication that we could hold for some time. Problem solved. So I thought.

Six days later I got another panicked call, this time from an ER. Mr. X had been doing just fine until he starting having fevers and chills. He had finished his Paxlovid course the day before. Back in the hospital, testing revealed a positive covid antigen test. Luckily this hospital stay was just a 36 hour stay. No other infectious sources were found, though a bacterial antibiotic was started out of ‘caution’. Its hard to know exactly what happened but one possibility is a phenomenon known as COVID rebound – where the virus surges for unclear reasons after completion of the anti-viral course. Interestingly, this was an adverse event that the FDA and Pfizer, the maker of Paxlovid, were aware of. We know this because of a chart found in the FDA emergency use authorization documents that was not available in the peer reviewed paper that appeared in the New England journal of medicine.

Medicine is a complicated business and one of the factors I discussed with the patient and his wife when prescribing Paxlovid was the fact that he wasn’t very well represented in the trial that demonstrated a benefit for Paxlovid in treating COVID19. The impressive reduction in severe disease that Paxlovid demonstrated in the Table below is based on an earlier Sars-COV2 variant that infected unvaccinated individuals.

There is already plenty of evidence from the historical record that prior infections are protective against progression to severe disease from future infections (This is the literal basis for vaccination), and there is every reason to also believe that prior vaccinations may be protective as well. This is exactly what the Paxlovid trials that lead to FDA approval demonstrated as well. (Figure 1)

Patients in the trial with positive serology for the virus (i.e. those who had recovered from COVID) had a markedly smaller benefit with Paxlovid use. Ninety-eight percent of the patients who received a placebo in the trial did not progress to severe disease. The implications here are immense. Given that contact with Sars-COV2 is an inevitability for all the future offspring of Nick Cannon and Elon Musk, I could become a very rich man marketing my special version of camel urine as a treatment for COVID.

So there was every reason to believe at the time I was prescribing Paxlovid that I was exposing my patient to the adverse events of a drug with little to no benefit. Sure enough, two weeks later Pfizer released updated results of a study of Paxlovid use in patients that were vaccinated and found the reduction in hospitalization and death to be non-significant. From a sample of 721 vaccinated adults with at least one risk factor for progression to severe COVID, 3/361 who received Paxlovid progressed to severe COVID compared to 7/360 patients that received placebo. The statistically insignificant results don’t mean there was no benefit. Given that the drug inhibits viral replication, and the clinical context it was used in, the fewer number of patients who ended up severely ill who were given Paxlovid is unlikely to be a statistical fluke, but it does indicate any benefit of Paxlovid in a high risk, vaccinated population is very small. This is actually good news. Whether it be the newer variants circulating are more benign, or that vaccination against the original Sars-COV2 variant is providing robust protection, these results strongly suggest that doing nothing leads to a good result the vast majority of the time. The Pfizer press release differs a bit from this conclusion. Albert Bourla, CEO of Pfizer summarized the data in this fashion:

“Results from our Phase 2/3 EPIC-HR and EPIC-SR studies, as well as post-authorization experience, support the efficacy and safety profile for PAXLOVID in the treatment of mild-to-moderate COVID-19 patients with at least one risk factor for progressing to severe COVID-19, regardless of vaccination status,”

He isn’t technically wrong, but he is choosing to downplay the likely minimal benefit of the drug he manufactures for most people. He’s doing his job – which is to pump up the parts of the Paxlovid data that will result in more prescriptions of his drug. Later on in the press release we find this nugget :

The results from these additional analyses are not expected to impact Pfizer’s full-year 2022 revenue guidance.

Since this data has come out, I’ve received a number of other calls from patients who tested positive for COVID. Most of the calls are from young vaccinated patients that I wouldn’t have ever thought were appropriate for Paxlovid. Some have been from higher risk, but still vaccinated patients. The messages are, interestingly all about the same. “Patient tested positive for COVID, wants Paxlovid”. None of the subsequent conversations I have had have resulted in me prescribing Paxlovid. It turns out patients aren’t really excited about getting medications. The vast majority just want some reassurance from a professional that it’s ok to not take a drug.

That this is the context the FDA decided to roll out “pharmacist Paxlovid prescribing” says a lot more about what’s going on at the FDA than what’s going on with COVID and the therapies for COVID.

Here’s hoping the Pharmacists are a little more plugged in than the FDA is.

Anish Koka is a Cardiologist.

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#HealthTechDeals Episode 42: Incredible Health, Abridge, Interaxxon, Arine & Keycare

There are surprise profits in an overfunded sector, but then there are funding deals for staffing company Incredible Health ($80m), voice recorder Abridge ($12m), meditation company Interaxxon (Muse Headband) ($9m), medication company Arine ($29) & new virtual care medical group Keycare ($24)–Matthew Holt

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