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Thursday, October 29, 2020

5, 4, 3, 2, 1...

My wife and I voted early by absentee ballots about two weeks ago, hand-delivered to our Election Board downtown Baltimore location. We've both gotten confirmation that our ballots were received and processed, and our votes recorded. 

Don't wait until Election Day if you can avoid it.

apropos, two recent reads of mine:

Sobering. What will we be thinking in a week?


My latest Science Magazine arrived.

U.S. scientists use words like disastrous, damaging, and catastrophic to describe the performance of President Donald Trump during his 45 months in office, citing his handling of the COVID-19 pandemic, his repeated public dismissals of scientific expertise, and his disdain for evidence. But there are other aspects of the administration's overall record that elicit a more positive response, including sustained funding for most research agencies and the high quality of many of the people he has chosen to manage those programs. On the eve of the 3 November presidential election, Science takes a close look at Trump's complicated legacy in science…

Haven't read this issue yet. Stay tuned.


“…Trump’s psychology might be understood through the lens of the coronavirus itself. He has met a foe that he cannot bluff into submission or wear down with insults. A virus is a physical force, like gravity or fire. It has no intention. It is not alive, and it cannot think. It can only react to its immediate environment. It can thrive only when it can invade functioning, living cells nearby. The virus forces entry and makes thousands of copies of itself and, having no further use for the cell, destroys it and abandons the remains.

All of the flaws in Trump’s character and psychology have come to light through this virus. He reacts to immediate circumstances. He hijacks, pillages, and moves on. He has done this to America’s public-health institutions, which are wobbling and could topple under the continued weight of his negligence. He presides over a country where people are dying all around him, and he appears to see this only as a messaging issue.

If Trump were to win a second term, he has made clear how this pandemic would play out. He is to have no moment of revelation. Americans would continue to die by the thousands. The president would devote his time and energy not to lowering that number, but to denying its existence. He has said the virus would disappear, and he would cling to that narrative regardless of the body count. If we joined him in this ignorance, the pathology would be ours.”James Hamblin, MD


Tuesday, October 27, 2020

Will new SCOTUS Justice Amy Coney Barrett provide the Obamacare death vote?

SCOTUS will hear the latest Obamacare repeal case the week after the November 3rd election. The actual ruling will probably not come until many months thereafter.

For the record, that is not a literal quote, but an allusive snarky smack at her hardline "textualism" schtick.

I may have to write a new song, I guess. That one just tumbled out of my head in about 10 minutes the day SCOTUS upheld the PPACA in 2012.

Womens' reproductive rights are also now at significant risk, in light of Justice Barrret's "Personhood-at-Conception" views.


My old 2009 health policy reform posts on another of my blogs

Eleven years ago, when Obamacare was in the legislative oven (these posts likely have some "link rot" by now). I've been pondering this stuff for quite a while.

Sunday, October 25, 2020

#COVID19: "We're rounding the corner. It's going away."

225,000 dead Americans were unavailable for comment.



Friday, October 23, 2020

"You're going to have such great health care..."

I've been following Trump's BS on health care since he was a candidate. "...such great health care, at a tiny fraction of the cost..." Yeah, coming to a decade near you soon.



Update: During the 2nd Trump-Biden debate, the President again claimed that Covid19 is "going away," and that "we're turning the corner."

apropos, I just finished this illuminating book.

While he and his circle have regular, daily testing for coronavirus, he has done everything he can to hinder it for the rest of us and convince us the virus is not so bad. Beyond that, he has tried to destroy the Affordable Care Act (also known as Obamacare), which has insured tens of millions of people, made false promises about some imaginary health care policy that would guarantee insurance for preexisting conditions, imposed tariffs that hurt American consumers, tried to dismantle the Consumer Financial Protection Bureau, which has recouped billions of dollars for citizens scammed by financial institutions, and threatened cuts to Medicare, Medicaid, and Social Security.

Res, Barbara A.. Tower of Lies: What My Eighteen Years of Working With Donald Trump Reveals About Him (pp. 139-140). Graymalkin Media, LLC. Kindle Edition.

Below, from The New Yorker: 

How Trump Became the Pro-Infection Candidate

Nine months into the pandemic, it’s a truism to say that America’s response has been politicized. Even so, with an election looming, the virus surging, and President Trump and others in government recently infected, our divisions now stand out with a startling, even brutal, clarity. There have always been two basic ways of looking at the coronavirus crisis. The first sees the minimization of death as a paramount goal; the second holds that significant death is inevitable and acceptable. Those who take the first view, including most medical and public-health professionals, advocate a temporary, science-driven restructuring of society, designed to save lives; those who take the second view, including the President and those in his circle, say that people die all the time, from car crashes, drug addictions, diseases, and the like, and argue that we don’t stop living to prevent them from dying. “Many people every year, sometimes over 100,000, and despite the Vaccine, die from the Flu,” the President tweeted, earlier this month, after he was discharged from the hospital. “Are we going to close down our Country?” (Twitter flagged the tweet as misinformation since, in fact, far fewer than a hundred thousand people die from the flu each year.)

There are different ways of holding the we-all-gotta-go-sometime view. Someone who grasps it lightly might incline a little more toward risk-taking than caution in her personal choices. But over the course of the pandemic, the President and many of his followers have come to cling to it tightly, even triumphantly, brandishing it as a kind of ideology… 

The U.S. is now entering what seems to be a new wave of infection; over the past week, the country saw, on average, more than sixty thousand new cases a day. In many states, covid-19 wards are filling up again, and some places are seeing record-high hospitalizations; the Midwest is experiencing its largest growth in cases since the start of the pandemic. According to some models, the U.S. could experience nearly four hundred thousand covid-19 deaths before the next President is sworn in. Despite all this, Trump would likely interpret reëlection as a validation of his approach. We could find ourselves living even more deeply in two incompatible worlds: a medical world, in which doctors, hospitals, scientists, and public-health professionals continue doing their best to grapple with the virus, and a political one, in which wishful thinking and pseudoscience rule. Of course, it doesn’t have to be this way. We could move, together, into a single, fact-based world—one in which we confront reality and work to improve it.


Click the image.



Thursday, October 22, 2020

Where is the love?

Vote on or (preferably) before November 3rd.

Friday, October 16, 2020

Salus populi suprema lex esto?

I wonder whether Trump "Texualist" SCOTUS nominee Amy Coney Barrett would disagree?

Came to this timely book by way of the author's NY Times OpEd (prior post). Finished it straight away. Compelling. Kudos, John Fabian Witt, PhD, JD.



Chapter 1: The Sanitationist State 

Chapter 2: Quarantinism in America 

Chapter 3: Civil Liberties in an Epidemic? 

Chapter 4: New Sanitationisms / New Quarantinisms 

Chapter 5: Masked Faces toward the Past 

Afterword: Viral Protests 


Suggested Reading 




Salus populi suprema lex esto. (The health of the people is the supreme law.)

—Cicero, De legibus 

Not long ago, and for most of American history, infection was an everyday crisis. Infectious diseases like smallpox, bubonic plague, yellow fever, polio, cholera, typhoid fever, malaria, and influenza helped produce many of the defining features of the modern world: street cleaning, the shape of city neighborhoods, the clean water piped to our kitchens, and the pediatrician visits that mark the lives of our young children. Even how people behave in the bedroom in their most intimate moments reflects the risk of infectious disease. 

Less tangibly, perhaps, but just as profoundly, laws and government have shaped and been shaped by recurrent crises of infectious disease. Epidemics have offered vast powers to state officials. They have produced new ideas about individual rights and basic civil liberties. They have raised questions about equality, since infections have not targeted Americans equally. And they have demanded that we create institutions capable of protecting important values while aggressively fighting the risks of infection and disease. 

This book is a citizen’s guide to the ways in which American law has shaped and responded to the experience of contagion. In the months after COVID-19 arrived in the United States in January 2020, Americans began immediately replaying patterns from the past. Even new responses were powerfully conditioned by history. And how could it have been otherwise? As Karl Marx once wrote, people make their own history, “but they do not make it just as they please.”1 We produce the future out of history’s ingredients. But we are not doomed to repeat it, either as unnecessary tragedy or as ignorant farce. If the past is a guide, how our law responds to contagion now and in the future will help decide the course of our democracy. Historically, the law of epidemics has prompted Americans to make choices about basic values. People who know their history make better choices…

Witt, John Fabian. American Contagions (pp. 8-9). Yale University Press. Kindle Edition. 



Nationwide protests in late May and June 2020 arose just as the United States tried to reopen after two months of widespread COVID-19 shutdowns. The death of an African American man named George Floyd at the hands of Minneapolis police produced an outpouring of dissent and anger like none seen since at least the mass protests of 1968. 

Protesters aimed to bring an end to some of the same inequities the law of epidemics had made visible over the past several centuries. From the earliest seventeenth-century settler-colonial quarantines to the yellow fever policies of the late eighteenth and nineteenth centuries to the border inspections in Texas and California to the virus of the spring of 2020 and beyond, American legal responses to epidemics have targeted the poor, people at the border, and nonwhites. America’s record on infectious disease is filled with discriminations and authoritarianisms. Each new infection presents a risk of entrenching existing inequities. 

On the other hand, epidemics have repeatedly offered a vantage from which to see deep into basic structures of inequality and injustice in the American legal order. As the nineteenth-century jurisprudence of hygiene made apparent, calamity can be an occasion for making intolerable social conditions visible—and for reforming them. Progressive sanitarians turned contagion risks into opportunities for lifting up the poor. Savvy political leaders grasped the ways in which public health could sometimes align the interests of rich and poor, white and Black, citizen and immigrant. Disease specialists found ways to connect civil liberties and collective welfare. 

America has two histories: one ugly, the other far more appealing. In the months and years ahead, Americans will hold the power to choose between them. Let’s make the right choice. [pp. 84-85]

IMO, it's a safe bet that we will be struggling against the Covid19 pandemic well into 2021. I could not recommend this concise yet thorough book more highly. We could well continue to make myriad wrong choices. As of this evening, US Covid19 fatalities exceed 218k. Daily new cases continue to rise.

VOTE on November 3rd.


...For centuries, American constitutional law granted state governments broad public health powers. “Salus populi suprema lex,” the old saying went: The health of the people is the supreme law. Such authority went back to the beginning of the Republic. In the famous 1824 case of Gibbons v. Ogden, Chief Justice John Marshall defended the “acknowledged power of a State to provide for the health of its citizens.” States, he explained, were empowered to enact “inspection laws, quarantine laws” and “health laws of every description”…

The basic outlines of this approach remained in place for more than two centuries. Today, however, the tradition of salus populi is in collapse. In state and federal courts alike, Republican-appointed and Republican-elected judges are upsetting the long-established consensus.

This month, a bare majority of four Republican-appointed justices on the Michigan Supreme Court struck down the state’s 75-year-old emergency powers law as an “unlawful delegation of legislative power to the executive.” In dissent, Chief Justice Bridget McCormack (who was endorsed by Democrats when she campaigned for election to the court) correctly identified the majority’s reasoning as “armchair history” that set aside decades of precedent.

Last month, a federal district judge in Pennsylvania appointed by President Trump struck down the state’s business closure rules and its limits on gatherings. The judge in the case, William Stickman, revived hoary ideas about freedom of contract and laissez-faire economic policy that once led the courts to strike down protective labor legislation like wage and hour laws.

And back in the spring, four justices connected to the Republican Party on the Wisconsin Supreme Court overturned their state’s common-sense emergency Covid-19 rules over the dissents of three colleagues…


Also called "Ouija Board Jurisprudence."

The theory is that the only things that matter are the exact words in the Constitution and what they were understood to mean by the citizens at the time of adoption. Need I really enumerate the questions begged?
  • Which citizens? Only landed, literate white males (their contemporary "epistocrats")?
  • What if they left no unambiguous writings? (Ouija Board Seance time?)
  • What of vagueness, ambiguities, and contradictions?
  • Finally, what is the purpose of a "constitution?" Jousting lexical / semantic pedantry or moral intent?

No-nuance, reflexive Textualism is a fatuous theory, promulgated most ostentatiously by the late legend-in-his-own-mind Antonin Scalia (Judge Barrett's mentor). He explictly differentiated himself from the "Original Intent" advocates. He said he didn't care about "intent," only the final-cut-ratified words as "understood" at the time of Signing (again, by whom?). But, overarching moral intent matters. Y'know, like, say, those in the Preamble?

BTW, some words and phrases not found anywhere in our Constitution:
  • "Checks and balances"
  • "Co-equal branches"
  • "Separation of Powers"
Props to esteemed ConLaw Professor Garrett Epps

Where does stuff like that leave us?

Right back at "intent," as it bears on rational resolution the issues faced by living Americans, by those appointed or elected to represent them on the courts.
During her recent Senate Judiciary Committee confirmation hearing, Judge Barrett told of a "textualism" course taught at her Notre Dame Law School entitled "Scalia vs Thomas" (Justice Clarence Thomas). What more do you need to know? Seriously? Dueling obtuse "No True Scotsman" debates? "Well, (harrumphingly), no True Textualist believes that..."

abstract. Judges generally begin their interpretive task by looking for the ordinary meaning of the language of the law. And they often end there—out of respect for the notice function of the law or deference to the presumed intent of the lawmaker. 

Most everyone agrees on the primacy of the ordinary meaning rule. Yet scholars roundly be- moan the indeterminacy of the communicative content of the language of the law. And they pivot quickly to other grounds for interpretation…

Interesting read.

"When we speak of ordinary meaning we are asking an empirical question—about the sense of a word or phrase that is most likely implicated in a given linguistic context. Linguists have developed computer-aided means of answering such questions. We propose to import those methods into the law’s methodology of statutory interpretation. And we consider and respond to criticisms of their use by lawyers and judges."

Hmmm... My 2017 post on AI/NLP?


YTD seven-day moving-average curve-fit through daily confirmed cases

CNN graphic.


Wednesday, October 14, 2020

The Covid19 pandemic appears to again be escalating

Current US Covid19 deaths are more than 216k (10/14), 21% of world fatalities from 4.3% of world population. Not having the underlying Hopkins data, I just dropped in some linear slope segments estimates by hand.

78 days to year's end. We could readily have 300k US fatalities by New Year's Day. "Pandemic fatigue" is not helping matters.


Link to the Biden-Harris plan here.

VOTE, on or before Nov. 3rd.


A disturbing NY Times OpEd (click the title, may be paywalled).
Alongside growing controversy over judicial nominations, court reform and Covid-19 policies, American law is in the midst of a little-noticed paradigm shift in courts’ treatment of public health measures.

The Republican Party’s campaign to take over the federal and state courts is quietly upending a long and deeply embedded tradition of upholding vital public health regulations. The result has been a radically novel and potentially catastrophic sequence of decisions blocking state responses to the coronavirus pandemic...
That led me to his book, which I've just started.

“Professor Witt’s book is an original and thoughtful contribution to the interdisciplinary study of disease and American law. Although he covers the broad sweep of the American experience of epidemics from yellow fever to COVID-19, he is especially timely in his exploration of the legal background to the current disaster of the American response to the coronavirus. A thought-provoking, readable, and important work.”—Frank Snowden, author of Epidemics and Society.
Stay tuned...

Sunday, October 11, 2020

"The doctor who fooled the world."

And, no he's not Walter Reed's Sean Conley, who's not fooling anyone outside the MAGA cult. 

My latest Science Magazine hardcopy arrived. 

A book review of timely interest therein:

Flawed research and its enduring repercussions

On 26 February 1998, the Royal Free Hospital in London held a press conference to announce that a study conducted by one of the hospital's clinicians would be published in The Lancet, one of the world's oldest and most prestigious medical journals. Sitting at the front of the room was the senior author, Andrew Wakefield, who explained that the combination measles-mumps-rubella (MMR) vaccine could cause developmental delays, including autism. Wakefield argued that the MMR vaccine suppressed the immune system in some children, freeing the measles vaccine virus to damage the intestine, which allowed encephalopathic proteins to enter the circulation, cross the blood-brain barrier, and destroy brain cells. He called for MMR vaccinations to cease until more research could be conducted.

Wakefield became an international hero. A biopic starring British actor Hugh Bonneville portrayed him as a courageous man willing to speak truth to power. In the United States, Wakefield testified before the Congressional Committee on Government Reform and appeared on 60 Minutes with Ed Bradley. Then along came Brian Deer, an investigative reporter working for The Sunday Times. Deer would become the first to expose the clinician's undisclosed financial associations and unearth troubling problems with the Lancet paper. In The Doctor Who Fooled the World, Deer recounts in vivid detail how he came to learn that Wakefield and his study were not what they appeared to be…

As a consequence of these and other revelations, The Lancet retracted the paper, and Wakefield lost his license to practice medicine. Subsequent studies have shown that children who receive the MMR vaccine are at no greater risk of developmental delays than those who do not receive it.

Nonetheless, the damage was done. The Wakefield study helped to accelerate the antivaccination movement that has imperiled children and led to the resurgence of once-controlled diseases. 

Although many people think they know this now-infamous story, it is likely they are unaware of all its dramatic details. Curious lay readers and vaccine experts alike are sure to learn something worthwhile from Deer's well-chronicled account.

I've been aware of this Wakefield guy for a long time, e.g., via "Science Based Medicine."

Their Wakefield post archive contains hundreds of critical articles. They loathe him.    


From San Francisco to Shanghai, from Vancouver to Venice, controversy over vaccines is erupting around the globe. Fear is spreading. Banished diseases have returned. And a militant "anti-vax" movement has surfaced to campaign against children's shots.But why?

In The Doctor Who Fooled the World, award-winning investigative reporter Brian Deer exposes the truth behind the crisis. Writing with the page-turning tension of a detective story, he unmasks the players and unearths the facts. Where it began. Who was responsible. How they pulled it off. Who paid.

At the heart of this dark narrative is the rise of the so-called "father of the anti-vaccine movement": a British-born doctor, Andrew Wakefield. Banned from medicine, thanks to Deer's discoveries, he fled to the United States to pursue his ambitions, and now claims to be winning a "war."

In an epic investigation spread across fifteen years, Deer battles medical secrecy and insider cover-ups, smear campaigns and gagging lawsuits, to uncover rigged research and moneymaking schemes, the heartbreaking plight of families struggling with disability, and the scientific scandal of our time.

AntiVax lunacy is lethally dangerous. Particularly now. to wit:

PROLOGUE: Resurrection 

On the first night of the Donald Trump presidency, a video went up on the World Wide Web that sent a shudder through medicine and science. It featured a sixty-year-old man in a black tie and tuxedo, grinning into his phone under blue and white lights from a ballroom in Washington, DC.

“Sorry about that, guys,” he says, in a mellow British accent that would suit James Bond or a Harry Potter wizard. “I don’t know whether people are back on. Yeah?”

Then he repeats himself. “Sorry about that.” 

Below medium-brown hair, his face glistens with sweat. White light flashes on gray eyes. As he talks, he walks: first in brightness, then shadow, pursing full lips as if searching for a thought. Then raising a fist to cough. “Just looking round to see if there’s anyone important here,” he says, unzipping a smirk at his proximity to power. “If I can prevail upon them.” 

The picture is shaky and doesn’t last long: two-and-a-half minutes of sideways-turned images, streamed live on Periscope, a self-broadcasting app, from that night’s most exclusive event. A muffled beat thumps. Spotlights blaze. Secret Service agents take up positions. 

To some of us watching—as I was, from London—he looked like the perfect party guest. People once said he was “handsome,” even “hot,” with a sportsman’s physique, a charismatic charm, and a confidence that led others to trust him. That night, in a winged collar and pretied bow, he might have passed for a diplomat, a knighted stage actor, or a retired major league baseball star. 

But to others around the world, his appearance provoked gasps. You’d think the Prince of Darkness had stepped onto the dance floor. For this was Andrew Wakefield, a disgraced former doctor who’d been booted from his profession on charges of fraud, dishonesty, and a “callous disregard” for children’s suffering. 

“Too much to comprehend,” sneered a Texas gastroenterologist, in a flurry of Twitter posts fired that night. “I need anti-nausea meds,” moaned a chemist in Los Angeles. A Dutch autism researcher: “Scary times indeed.” A Brazilian biologist: “An administration for charlatans.” And from a PhD student on the North Island of New Zealand: “I hoped he’d just crawled under a rock.” 

No chance of that. This man reveled in infamy. His nature and predicament required it. Not since the 1990s and the arrest of one Harold Shipman—who serially murdered two hundred of his patients—had a British medical practitioner been so scorned. The New York Times described Wakefield as “one of the most reviled doctors of his generation.” Time magazine listed him among history’s “great science frauds.” And the Daily News spat that he’d been “shamed before the world,” under the headline: 

Hippocrates would puke 

His fall wasn’t recent, or easily missed by Trump’s team tasked to check the night’s guest list. By now, his disrepute was both acute and chronic, absorbed into popular culture. He’d been drawn as the villain in a cartoon strip (“The Facts in the Case of Dr. Andrew Wakefield”), sweated over by students in high school exams (“Was Dr. Wakefield’s report based on reliable scientific evidence?”), and his name embraced in public conversation as shorthand for one not to be believed. 

   The Andrew Wakefield of biology 

   The Andrew Wakefield of politics 

   The Andrew Wakefield of transportation and planning 

Yet here he was at the Liberty Ball, on Friday, January 20, 2017, at a little after seven in the evening. Behind him, on Level 2 of the Walter E. Washington Convention Center, the first of the night’s revelers to pass through security rustled in their finery toward fluorescent-fronted bars. And Trump would later shuffle here with the first lady, Melania, to Frank Sinatra’s 1960s classic “My Way.” 

“So, uh, yeah, very, very exciting times,” Wakefield gushed. “I wish you could all be here with us.” 

Me too…

Deer, Brian (2020-09-28T23:58:59). The Doctor Who Fooled the World. Johns Hopkins University Press. Kindle Edition.

Interesting that Donald Trump, having now declared the arrival of "his" incipient Miracle Covid19 Vax by election day, now calls Joe Biden an "Anti-Vaxxer."

Click the cover image.

Also in the Science Magazine issue cited above:

Of abiding interest to me in light of my December 2019 Parkinson's dx.

It is becoming increasingly clear that amyloids are not necessarily the smoking gun of neuronal dysfunction and cognitive decline in neurodegenerative diseases. This is displayed in centenarians who have both apparently good cognitive health and brains populated with amyloids (1). Epidemiological data also point to the concept of cognitive reserve, where certain individuals appear more resilient to pathological changes in their brains (2). Hence, a challenge in neurodegeneration is to understand how certain aging brains successfully maintain proper neuronal function despite chronic amyloid buildup, whereas others do not. Several genetic studies have suggested that microglia, the primary tissue-resident macrophages of the brain, may be key in determining this success (3, 4). Emerging data in developing, adult, and diseased brains collectively suggest that microglia are critical to neuronal homeostasis and health. These observations raise the question of whether, and which, microglia-neuron interactions may be impaired in Alzheimer’s disease (AD) and Parkinson’s disease (PD) to confer neurodegeneration. Insight into this question will enable the development of methods to assess and modulate microglia-neuron interactions in the aging brain and allow for a desperately needed expansion of focus from clearing amyloids alone to monitoring neuronal health in biomarker and target engagement efforts…

Apologies to Little Feat.

Friday, October 9, 2020

The New England Journal of Medicine says #VoteHimOut

Covid-19 has created a crisis throughout the world. This crisis has produced a test of leadership. With no good options to combat a novel pathogen, countries were forced to make hard choices about how to respond. Here in the United States, our leaders have failed that test. They have taken a crisis and turned it into a tragedy.

The magnitude of this failure is astonishing…

Anyone else who recklessly squandered lives and money in this way would be suffering legal consequences. Our leaders have largely claimed immunity for their actions. But this election gives us the power to render judgment. Reasonable people will certainly disagree about the many political positions taken by candidates. But truth is neither liberal nor conservative. When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.

Read the entire blistering editorial. Signed by all of the Editors. #VoteHimOut, indeed.

"No, I don't take responsibility at all." —Donald Trump, March, 2020, White House Covid19 press conference.


Tuesday, October 6, 2020

DIY Covid19 vaccines R&D?

What could possibly go awry?

As the coronavirus disease 2019 (COVID-19) pandemic continues to sweep the globe, several groups have been working to develop and self-administer unapproved, unproven interventions that they describe as vaccines for COVID-19 (14). Some of the interest in these do-it-yourself (DIY) approaches apparently stems from a belief that self-experimentation is never subject to time-consuming ethics board review or regulation, such as by the U.S. Food and Drug Administration (FDA). This belief is legally and factually incorrect, and the misunderstanding has potentially important public health implications. Any failure by the FDA to regulate DIY vaccines would permit vaccines of dubious safety and effectiveness to endanger public health and would signal a lowering of standards that—in an age blighted by vaccine skepticism and during a highly politicized pandemic—could undermine public trust in all vaccines, however developed (5). Further, some self-experimentation can qualify as human subjects research that is required to undergo ethics review, by law or institutional policy. Even when ethics review is not required, citizen scientists must take seriously their heightened ethical responsibilities when promoting DIY interventions, especially those with potentially serious public health and societal effects, such as COVID-19 vaccines. Given the proliferation of citizen science efforts to fight COVID-19 and the general c onfusion (even among sophisticated scientists) that surrounds the regulation of DIY research, regulatory leadership is badly needed.

“The FDA Can't Stop You”

In July 2020, six months after the first case of COVID-19 was confirmed in the United States, scientists associated with the Rapid Deployment Vaccine Collaborative (RaDVaC) reported administering to themselves a product of their own making that was intended to be a vaccine against the disease. As described in the group's white paper, the putative intranasal vaccine consists of synthetic peptides that mimic those of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and is designed to elicit only a local immune response (6).

By its own account, RaDVaC is engaged in “citizen science,” which broadly describes activities having a scientific aim that invite public participation. RaDVaC's chosen research path—which involves a homemade intervention, an evolving protocol, and unclear plans for collecting and analyzing outcomes data—is in contrast to traditional paths to vaccine development, which require randomized controlled trials (RCTs) with well-defined endpoints, such as demonstrated immune responses, and protocols concerning the retention and use of data.

Although some citizen scientists have antiregulatory leanings, RaDVaC has explained that it is not anti-FDA. Rather, its stated mission is a humanitarian one, animated by a belief that open, crowdsourced vaccine efforts will hasten the widespread availability of a potentially life-saving vaccine through development activities that it believes are not subject to FDA regulation (6). To that end, RaDVaC published on the internet instructions on how to self-manufacture and self-administer its DIY vaccine. RaDVaC also has provided materials for those activities, reporting as of several weeks ago the delivery of vaccine materials to 70 individuals (1). RaDVaC has made clear to potential users that its vaccine has not been reviewed or approved by the FDA. It also believes, as one of its leading scientists stated, “If you are just making it and taking it yourself, the FDA can't stop you” (1)…

Although many citizen scientists appear to take seriously the ethical responsibilities associated with their activities, it is important to recognize that those responsibilities expand when public health is at stake, such as with COVID-19 vaccine development. Characterizing or positioning research as self-experimentation does not eliminate risks to bystanders or the collective good. Given those potential risks, citizen scientists who are involved in open vaccine development and testing efforts outside of traditional scientific institutions should seek review by an independent IRB. The cost is not necessarily prohibitive for all projects and should be prioritized the same as critical safety equipment. Ethical and efficient development of a vaccine shown to be safe and effective against COVID-19, and broad dissemination of such a vaccine, are goals we all share and should be able to work together to achieve.

Click image for link.

DIY "biohacking" is not entirely "news."

WASHINGTON — As a teenager, Keoni Gandall already was operating a cutting-edge research laboratory in his bedroom in Huntington Beach, Calif. While his friends were buying video games, he acquired more than a dozen pieces of equipment — a transilluminator, a centrifuge, two thermocyclers — in pursuit of a hobby that once was the province of white-coated Ph.D.’s in institutional labs.

“I just wanted to clone DNA using my automated lab robot and feasibly make full genomes at home,” he said.

Mr. Gandall was far from alone. In the past few years, so-called biohackers across the country have taken gene editing into their own hands. As the equipment becomes cheaper and the expertise in gene-editing techniques, mostly Crispr-Cas9, more widely shared, citizen-scientists are attempting to re-engineer DNA in surprising ways.

Until now, the work has amounted to little more than D.I.Y. misfires. A year ago, a biohacker famously injected himself at a conference with modified DNA that he hoped would make him more muscular. (It did not.)

Earlier this year, at Body Hacking Con in Austin, Tex., a biotech executive injected himself with what he hoped would be a herpes treatment. (Verdict: No.) His company already had live-streamed a man injecting himself with a home-brewed treatment for H.I.V. (His viral load increased.)…

Don't anybody tell the MyPillow guy.

Seriously, garage-tinkerers and independent biotech startups and crowdsource funding have their places, but the public health stakes in these R&D domains are far too high for unfettered clinical libertarianism. 

Then there's this guy:


Thank you, sir.



to wit, see my prior Climate Change posts.