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Final Forms/Counting Death

Wednesday, July 29th, 2020

Given the terrible times we are having today, as COVID-19 ravage the Earth, the death rate increases. It is important to know if a death is due to the virus or of other maladies that plague mankind. I thought that the following article would be of interest.

Dept. of Public Health

April 7, 2014 Issue of The New Yorker

Final Forms

What death certificates can tell us, and what they can’t

By Kathryn Schulz

March 31, 2014

We have developed a vast, macabre bureaucracy to answer the question of why we die.I

 

llustration from Oxford Science / Getty

It starts with a dead body, as so many mysteries do. A middle-aged man is found unconscious and rushed to a hospital. For four days, he lingers in a coma; on the fifth, he dies. The clues are few and dark and point in different directions. The man was a drug addict. He was diabetic. Some of his family members say that he acted strangely the last time they saw him conscious. Others disagree. The lab tests are inconclusive. Everything is inconclusive. If this were a mystery of the Conan Doyle kind, there would be a detective, and there would be a solution. In the event, there is neither. Instead, there is a young doctor, in her first year on the job, and there is a single piece of paper: a death certificate, on which she is meant to record, precisely and for posterity, why this person died.

Not every mystery involves a dead body, but every dead body is a mystery. Death is an assassin with infinite aliases, and the question of what kills us is tremendously complex. It is also tremendously labile. We ask it with clinical curiosity and keen it in private grief; we pose it rhetorically and inquire specifically; we address it to everyone from physicians to philosophers to priests. It is as bare as bone and as reverberant as bell metal: Why do we die?

For millennia, our answers to that question were sharply constrained. Lacking any real understanding of the physiological causes of death, we pointed instead to the entities we knew could make things happen: conscious (or putatively conscious) agents. Sometimes that agent was us. We killed one another, obviously; we hexed one another, allegedly; we brought about mortality in general—from Prometheus to Eve, through hubris and through sin. Alternatively, sometimes the agent was death itself. Many early cosmologies include a Grim Reaper, give or take a costume change: Thanatos in Greek mythology, the Hindu Yama, the Angel of Death in the Bible. As a rule, these were agents in the other sense as well: mere instruments of a higher power. For most of history, no matter how we died, we did so at the bidding of God or of the gods.

A correlative of all this agency was passivity. If an omnipotent being wants to kill you, there’s not much you can do about it except beg for mercy—a popular strategy even today. Only after we started looking to the physical world to determine why we die did premodern fatalism begin to fade. Sentient agents yielded to disease agents, divine intercession to medical intervention. Today, “Why do we die?” is one of the fundamental questions of epidemiology, and we have developed a vast and macabre bureaucracy to answer it.

The atomic unit of that bureaucracy is the death certificate. Of all the ways we have ever devised to grapple with our mortality, it is the strangest, least elegiac, and by far the most ambitious. It emerged by an accident of history and evolved to serve two different masters. In part, it is a public-health measure—though even the doctors who deal with death certificates often forget that, regarding them instead as one more piece of paperwork. In part, it is a form of personal identification: the saddest of diplomas, the most mysterious of passports.

And, in part, it is a clue. Of the roughly fifty million people who will die this year, approximately half will get a death certificate. That figure includes every fatality in every developed nation on earth: man, woman, child, infant. The other half, death’s dark matter, expire in the world’s poorest places, which lack the medical and bureaucratic infrastructures for end-of-life documentation. Yet, even with so many people unaccounted for, this number represents the spread of a remarkable idea: that death should be accounted for—that by documenting every single decedent and every possible cause we can solve its mystery.

The antecedent of the modern death certificate emerged in early-sixteenth-century England, in a form known as a Bill of Mortality. The antecedent of the Bill of Mortality does not exist. No earlier civilization we know of kept systematic track of its dead: not ancient Egyptians, for all their elaborate funerary customs; not the Greeks; not the Romans, those otherwise assiduous centralized bookkeepers.

Even Christianity, one of the world’s most successful purveyors of ideas about death, seldom attended to the specifics of why we die. Churches did traditionally keep records of baptisms and burials—and, practically speaking, those serve as a good proxy for births and deaths. But, as a philosophical matter, they are tellingly different: the church was interested in the fate of the soul, not the body. If the goal of life is to gain access to heaven, and death is in God’s hands, there’s no point, and no grace, in dwelling on the particulars of how we die.

That cosmological indifference coincided with scientific ignorance. Early medicine relied more on folklore than on physiology, and its practitioners were not in the habit of examining bodies, living or dead. Well into the nineteenth century, the limits of medical knowledge were such that doctors sometimes didn’t even know if someone had died, let alone how. The widespread terror of being buried alive, which today seems like a dark little wiggle of the id, once reflected a genuine possibility. In the absence of any scientific way to confirm the end of life, it sometimes happened that those consigned to coffins were only mostly dead.

Compounding all this was political irrelevance. Early states had neither the means nor the motive to track individual deaths—or, for that matter, individual anything. Low literacy rates made individual documentation on a broad scale impractical, and reigning administrative practices made it unnecessary. You don’t need a tax I.D. number if taxes are levied on your entire town, and you don’t need a draft card if conscription is collective. Only in exceptional cases did everyday people need to be able to identify themselves—there was, for instance, the vexing premodern problem of how to tell true messengers from false ones—and, accordingly, individual documentation was rare.

The modern death certificate owes its existence to the cosmological, scientific, and political revolutions that eventually overturned this entire world order. But its prototype emerged in response to something else: death itself, on an epic and horrifying scale. In 1347, the Black Death broke out in Europe. By 1351, a third or more of all Europeans were dead. With a huge percentage of the remaining population infectious and the rest of it terrified, the plague turned the formerly private experience of death into a matter of (extreme) public concern. Italy responded by passing the first modern quarantine laws, tracking the living. England took a different route, and began tracking the dead.

Thus the Bills of Mortality: weekly lists of the plague dead, broken down by parish. The earliest known bill is a single handwritten document, thought to date from 1512, which states that in the city of London, between the sixteenth and the twenty-third of November, thirty-four people died of “the plague” and thirty-two of unspecified “oder dyseases.” No information about the dead appeared on early bills, not even their names. And the bills themselves appeared only sporadically: cropping up when the plague did, fading away again when the crisis passed. Their intended purpose seems to have been to help the healthy steer clear of the most infectious parts of town.

Many of history’s great inventions are really great appropriations—middling ideas if used as intended, brilliant when reoriented or co-opted. In their original form, Bills of Mortality were not a particularly powerful or inspired device. But, in the hundred years after their introduction, two modifications altered both the function of the bills and the future of public health. In 1603, the bills began appearing weekly rather than episodically, and did so continuously for the next two hundred and thirty-three years. In 1629, during a lull in the plague, the court of King James I ordered parish clerks to begin listing deaths from other causes as well. The first change turned the Bills of Mortality into one of history’s richest data sets. The second turned them into a global first: a state-mandated system for recording why we die.

It was both a short step and a long time from there to the modern death certificate. As an epidemiological document, the death certificate would have to wait for disease to more fully migrate from the metaphysical to the material realm. As personal identification, it would have to wait for the political revolutions of the eighteenth century, which, by reconfiguring the relationship between the individual and the state, made documenting the lives and deaths of every citizen newly desirable. The flip side of democracy is bureaucracy: if everyone counts, everyone must be counted. The flip side of equality is equality: the pauper gets a driver’s license, the President needs one, and you wait in line at the D.M.V. And the flip side of representation is surveillance: by 1851, the French political theorist Pierre-Joseph Proudhon could observe that “to be governed is to be noted, registered, enumerated, accounted for, stamped, measured, classified, audited, patented, licensed, authorized, endorsed, reprimanded, prevented, reformed, rectified, and corrected, in every operation, every transaction, every movement.”

By the time Proudhon wrote those words, the Bills of Mortality were all but extinct. A numeric tally of the anonymous dead had evolved into a list of the named dead, one person per line, and then into a dedicated form: one decedent per page. This was the death certificate, the grave end of cradle-to-grave documentation. Bureaucratically speaking, that ex-post personal identification represented the death certificate’s ultimate end. But, for public-health purposes, the name of the dead didn’t matter. What mattered, and what had evolved as well, was the cause of death.

In the Unetanneh Tokef, a Jewish liturgical poem thought to have been composed in the eleventh century A.D., the poet notes that, at the beginning of every year, it will be determined who shall perish in the coming months, and how:

who by water and who by fire

who by sword and who by beast

who by famine and who by thirst

who by earthquake and who by plague

who by strangling and who by stoning.

That poem nicely captures the way the premodern world parsed death: into a few coarse causes, all reducible to God’s will. “And You shall apportion the destinies of all Your creatures,” the poet writes.

By the time of the Bills of Mortality, the list of things we thought could kill us had expanded dramatically. Yet, reading those bills today, you could be forgiven for failing to recognize them as an advance in public health. It was possible, in seventeenth- and eighteenth-century England, to die of Bleach and of Blasted, of Cramp and of Itch, of Sciatica and of Lethargy. You could be carried off by Cut of the Stone, or King’s Evil, or Planet-struck, or Rising of the Lights. You could succumb to Overjoy, which sounds like a decent way to go, or be Devoured by Lice, which does not. You could die of Stopping of the Stomach, or Head-Ach, or Chin-cough, or Teeth. You could die of HorseshoeHead, though don’t ask me how. You could die of being a Lunatick. You could die of, basically, death: “Suddenly”; “Killed by several Accidents”; “Found dead in the Streets.” You could die of Frighted, and of Grief.

If what we are after is a revolution in our understanding of death, this does not seem like an entirely promising start. But in the mid-seventeenth century a haberdasher named John Graunt got interested in the question of why we die. That interest was neither medical nor philosophical but actuarial. Like many successful shopkeepers, Graunt was a meticulous accountant, and he realized that he could use the Bills of Mortality to crunch the numbers on death. By trawling through twenty years of those bills, Graunt compiled a list of eighty-one causes of death, which he divided into four main categories: chronic diseases, epidemic diseases, conditions that killed children, and “outward griefs”—that is, injuries. With information like that available for the first time, “it becomes necessary to discuss the problem—can lifetime be prolonged by a knowledge of the causes that cut it short?”

The man who asked that question was Graunt’s most important successor, William Farr, one of the founders of epidemiology. In 1836, when Farr was twenty-eight, England replaced the Bills of Mortality with what would become the global prototype of a modern death-registration system, and created the General Register Office to manage it. The office opened in 1837, and Farr became its first Compiler of Abstracts.

Unlike Graunt, Farr was in the game not to keep books but to save lives, and he realized that vital statistics were the language in which public-health questions could be asked and answered—and, crucially, changed. In 1853, at the behest of the newly formed International Statistical Congress, he helped compile a comprehensive list of causes of death, for use in standardizing mortality data worldwide. The resulting classification contained a hundred and thirty-nine ways to die, divided into seven categories, from “Deaths from accident or violence” to “Deaths from old age.” There were still a few ringers on this list—you could die of laryngitis, and of teething—but it was a long way from Blasted and Itch.

The definitive advance, however, came forty years later, when the classification was revised by a committee headed by the French statistician and demographer Jacques Bertillon. Bertillon doubled the categories of the earlier list from seven to fourteen, expanded causes of death from a hundred and thirty-nine to a hundred and sixty-one, and organized them, as we still do today, by anatomical systems: “Diseases of circulatory system,” “Diseases of respiratory system,” and so forth. The result was published in 1893, as the International List of Causes of Death.

A hundred and twenty years later, that list is still with us. Today, it is managed by the World Health Organization, and is known as the International Statistical Classification of Diseases and Related Health Problems—or, more commonly, the ICD-10. The ICD still reflects Bertillon’s original structure, but it has expanded prodigiously in the course of ten revisions. As its new name suggests, that is partly because it now includes entries for nonfatal diseases. (And much more besides. Beginning after the Second World War, the W.H.O. bowed to the desire of hospitals and insurance companies to use the ICD for billing purposes; as a result, it now contains entries for every imaginable health-care interaction, from well visits to warts. That shift displeases some epidemiologists, since, as a report by the Centers for Disease Control has pointed out, public-health priorities no longer drive the management of the list.)

But, even if you strip the classification of everything that can’t kill you, you are left with a staggering number of things that can. The ICD-10 comes in three forest-green volumes (or as a download, or on CD-rom), can be purchased for $562.82 through Barnes & Noble, and runs to twenty-two hundred pages. The first cause of death that it lists is A00.0, “Cholera due to Vibrio cholerae 01.” The last is Y89.9, “Sequelae of unspecified external cause.” Arrayed between them are more than eight thousand other officially sanctioned ways to die. Taken together, those ICD entries are used to code and standardize the causes of death on death certificates.

Contemplating all this, one suspects that we have got about as far as possible from the premodern relationship to death. A single reason for death, divine will, has mutated into ever more numerous and narrow causes; sixty-six anonymous deaths in sixteenth-century London have grown to twenty-five million death certificates per year. Yet the why of death remains elusive—practically, philosophically, above all emotionally. And, the more extensively we attempt to document it through death certificates, the stranger and more troubled that project comes to seem.

Cede any part of your life to the state, no matter how profound, and soon enough it will hold its own in the bureaucratic triathlon of tedium, arcana, and complexity. Consider: a death certificate is a single piece of paper, one-sided. The official instructions for how to fill it out include the “Physicians’ Handbook on Medical Certification of Death” (fifty-seven pages), the “Funeral Directors’ Handbook on Death Registration and Fetal Death Reporting” (sixty pages), and the “Medical Examiners’ and Coroners’ Handbook on Death Registration and Fetal Death Reporting” (a hundred and thirty pages). This is to say nothing of various supplementary guidelines, such as “Instructions for Completion of Death Certificates in the Aftermath of a Hurricane” and “Completing the Cause-of-Death Section of the Death Certificate for Injury and Poisoning.”

Why does a one-page document require two hundred and fifty pages of instructions? The most generous answer is that death certificates are legitimately difficult to fill out. In the United States, the task of doing so often falls to interns or residents—newly minted M.D.s, in their first year or two on the job. (Death certificates, like all paperwork, obey the law of occupational gravity, and residents are on the bottom.) You have already met one of those M.D.s. Sasha Swartzman, a resident in internal medicine at the Oregon Health and Science University, was the doctor on duty when the man at the beginning of this story met his mysterious end. She describes the process of filling out death certificates as “sort of like doing your own taxes. Shouldn’t I be smart enough to know how to do this?”

A nine-year-old is smart enough to fill out ninety per cent of a death certificate. The difficulties arise almost exclusively in the cause-of-death section, which consists of just four lines. On the first, doctors are instructed to enter the “immediate cause” of death, defined on the form as the “final disease or condition resulting in death.” (If you are already pausing to consider the relationship between “immediate” and “final”: let it go.) On the second line, doctors enter whatever caused the condition on the first line, and on the third line they enter whatever caused the condition on the second line. The last line is reserved for the “underlying cause of death”: “the disease or injury that initiated the chain of morbid events that led directly and inevitably to death.” It is this line that will get turned into an ICD code and identified as the thing that killed you.

The National Center for Health Statistics provides this example of how to correctly complete those lines:

Rupture of myocardium (the immediate cause)

Acute myocardial infarction

Coronary artery thrombosis

Atherosclerotic coronary artery disease (the underlying cause).

Clear enough, even if you don’t know a thrombosis from a bass drum. But real death, like real life, is complicated, as Swartzman’s experience with the diabetic drug user shows. In that case, the immediate cause was obvious: the man died of anoxia, lack of oxygen to the brain. But why? He could have gone hypoglycemic. He could have had a seizure. He could have suffered sudden cardiac arrest. He could have overdosed, accidentally or on purpose. “At some point,” Swartzman says, “you just have to make an educated guess as to what might have happened and go with it.”

As that suggests, death certificates, again like tax returns, do not always scrupulously reflect the truth. From the beginning, they have been compromised both by the limits of medical knowledge and by dodgy reporting practices. In 1662, John Graunt complained that syphilis was underreported as a cause of death because medical investigators failed to recognize it “after the mist of a Cup of Ale, and the bribe of a two-grout fee.” Similar treatment befell other causes of death viewed as morally damning or unmentionable in polite company: tuberculosis, breast cancer, alcoholism, aids, suicide. To protect the reputations of the deceased and the sensibilities of survivors, doctors sometimes upgraded those socially awkward deaths to more acceptable ones—issuing, in essence, vanity death certificates. That practice was sufficiently common in nineteen-thirties New York that the city began issuing a confidential medical report of death: a second, separate document stating the real cause of death.

The practice of bowdlerizing death certificates has faded (although not disappeared), but other reporting problems persist. In 2010, researchers from St. Luke’s–Roosevelt Hospital Center and Columbia University surveyed five hundred and twenty-one doctors in thirty-eight residency programs across New York City. Only a third believed death certificates to be accurate. Nearly half reported knowingly listing an inaccurate cause of death, and that number rose to almost sixty per cent among residents with the most experience. Those who intentionally list inaccurate causes typically choose familiar ones, with the result that common causes of death appear even more common, and rare ones more rare. The Framingham Heart Study, an ongoing longitudinal study in Massachusetts, found that death certificates overstate coronary-heart disease as a cause of death by as much as twenty-four per cent in the general population and by a far greater percentage in the elderly.

Why do residents fudge these forms? Part of the problem is inadequate training; in the New York study, only two in five reported receiving any instruction in how to fill out a death certificate, and only one in five had taken the city’s ostensibly mandatory training module. But, when asked, they also pointed to other issues. Sometimes the death-registration system would not accept the cause they felt was correct. Sometimes a hospital administrator overrode them. Sometimes they had never met the patient. Under three per cent reported ever correcting a death certificate in light of new information. Reading about all this, I recalled how a doctor friend of mine had responded when I told her I was interested in death certificates and found myself thinking of them partly as a genre. “Yes,” she snorted. “Fiction.”

The errors that creep into death certificates from inadequate training and other systemic issues are troubling. They overstate leading causes of death, obscure emerging ones, and distort the data we use to allocate funds for research, education, prevention, and treatment. But bad answers are only part of the issue. A more interesting and difficult problem is how we decide what counts as a good answer.

That problem is wonderfully illustrated by a passage from “Huckleberry Finn,” which enlivens an otherwise arid report by the C.D.C. One afternoon, while chatting with the Wilks sisters, the ever-inventive Huck spontaneously invents a new disease—a form of mumps so virulent that, he claims, a neighbor is in danger of dying from it. But mumps can’t kill you, Susan Wilks protests. Oh, yes, this kind can, Huck insists, because it is all “mixed up with other things,” from “yaller janders” to “brain-fever.” Fine, Susan retorts, but in that case it’s not the mumps that will kill the neighbor: “A body might stump his toe, and take pison, and fall down the well, and break his neck, and bust his brains out, and somebody come along and ask what killed him, and some numskull up and say, ‘Why, he stumped his toe.’ ”

This is precisely the problem posed by death certificates: when filling them out, how far back should we chase the causal chain? If a stubbed toe initiates a fatal sequence of events, is it the underlying cause? Alternatively, how far forward should we chase it? If we are someday able to parse “rupture of myocardium” into its sequential parts, will it cease to be a final cause? And how many causal chains should we chase? To the annoyance of statisticians, it is perfectly possible to die of multiple causes; indeed, as more people live into extreme old age, multifactorial deaths might well become the norm. But multiple causes of death do messy things to mortality data—reporting that one person died of three causes makes it look like three hundred per cent of your population died—and death certificates are not optimized for that kind of recording.

Problems like these have troubled philosophers for centuries. It is formidably difficult to distinguish beyond doubt a cause from a non-cause, or a proximal cause from a distal cause, or which of six rock-throwing hoodlums smashed your picture window. Yet in everyday life we draw such distinctions constantly. That is not imprudent. It is expedient. Causal reasoning is motivated reasoning; we do it not to discover the fundamental make-it-happen mechanisms of the world but to achieve some ends. And that is why the stumped-toe problem matters. We identify the causes we care about—and, conversely, we care about the causes we identify.

On death certificates, the causes we identify are constrained in one specific way: to the immediate physical breakdown that triggered the events that killed you. “If someone dies of a heart attack,” Harvey Fineberg, the president of the Institute of Medicine, says, “you don’t say he died of high cholesterol, sedentary life style, and a forty-pack-year history of smoking.” For that matter, he notes, we no longer say that “you died of despair, you died of poverty, you died of heartbreak. But certainly those are all pretty clear risks for premature death.”

That point has been made, and contested, many times before. In a now famous 1993 paper called “Actual Causes of Death in the United States,” the epidemiologists William Foege and Michael McGinnis showed that roughly half of all deaths in the United States in 1990 could be attributed to nine factors not listed on death certificates: tobacco, diet and physical activity, alcohol, microbial agents, toxic agents, firearms, sexual behavior, motor vehicles, and illicit use of drugs. Omitting such causes mattered, they argued, because the conditions listed on death certificates get the lion’s share of U.S. health-care allocations. Yet the non-listed causes might make better investments; the earlier you intervene on a causal chain the easier and cheaper the intervention tends to be. Consider the relative costs, literal and figurative, of anti-smoking campaigns versus smoking-cessation programs versus lung-cancer treatment.

We could, in theory, redesign death certificates to capture more distant links in the causal chain. But it is not clear that we should. For one thing, a harried young doctor completing a death certificate is unlikely to have access to the desired information. For another, there is an inherent trade-off to adding more fields to any form. Thomas Frieden, the director of the C.D.C., puts it concisely: “The quality of the data you collect is inversely proportional to the amount of data you collect from each reporter.” That is, if you increase the number of questions you ask on a death certificate, you decrease the accuracy of the answers. “There’s lots more information, different information, better information I’d love to have,” Frieden acknowledges. “But whether the juice is worth the squeeze is the question.”

In Bernard Malamud’s short story “Take Pity,” a census-taker named Davidov asks a man named Rosen how an acquaintance of his died. When Rosen shrugs off the question, the census-taker grows irritable:

“How did he die?” Davidov spoke impatiently. “Say in one word.”

“From what he died?—he died, that’s all.”

“Answer, please, this question.”

“Broke in him something. That’s how.”

“Broke what?”

“Broke what breaks.”

Thus does the mandate of data collection—say it in one word—meet the mystery of dying. That encounter is improbable, uncomfortable, and, as exemplified by death certificates, one of the most felicitous in history. In the past two centuries, global life expectancy has more than doubled, from twenty-eight years to seventy-one. In the United States, the infant-mortality rate in 1900 hovered around one in three; today, it is barely six in a thousand. Death certificates did not bring all this about unilaterally, of course. But it is a measure of their importance that, without them, we wouldn’t even know these numbers.

Still, that importance, like a life, has a limit. The C.D.C. will tell you that a death certificate, in addition to its primary functions, “provides family members closure, peace of mind, and documentation of the cause of death.” But death certificates and family members are like Davidov and Rosen. Both may ask why someone died, but the causes that count as good answers are irreconcilably different. As the bereaved, we ask because we want to know if a loved one suffered or was at peace, or if her death was meaningful, or whether we could have prevented it, or how the universe could have permitted it.

On all those questions, a death certificate is mute. Instead, it provides the pathological basis of death, determined by some combination of fact, convention, and guesswork, and described in terms that most non-doctors struggle to understand. That is the kind of answer it should give; a death certificate is not Auden’s elegy for Yeats, meant to both solemnize and lift our grief.

Nor is a death certificate likely to provide peace of mind in its other capacity. Among forms of personal identification, the death certificate is the one that undoes the work of all the rest, removing someone we love from Social Security rolls and voting registers and all the other ranks of the living. That process might be necessary, but it is hardly soothing. The bureaucratization of death that began with the Bills of Mortality has evolved over time into a massively complex checkpoint at the border between the living and the dead: Charon’s T.S.A. At its behest, we supply death certificates to cell-phone companies to induce them to terminate contracts; to airlines to release frequent-flier miles; to Netflix, no kidding, to cancel accounts. We track down fax machines to send copies to six separate government offices, and send another to an attorney via registered mail. In short, we spend vast amounts of energy using death certificates to convince various entities of what is, to us, the most devastatingly obvious fact in the world: that someone we love is no more.

The primary purpose of a death certificate is to explain why we die. But when we are in the pitch of grief—or, for that matter, in the full sunshine of joy—what form, what blank, what cause, whether final, immediate, or underlying, could possibly answer that question to anyone’s satisfaction? Why do we die? For all the medical advances of modernity, there is a sense in which the ancient fatalists had it right. Broke what breaks. We die because we were born; because we are mortal; because that is, after all, life. ♦

Published in the print edition of the April 7, 2014, issue of The New Yorker.

 

NIH Stops Remdesivir Study

Thursday, May 21st, 2020

STAT

5/21/20

Inside the NIH’s controversial decision to stop its big remdesivir study

By Matthew Herper @matthewherper

May 11, 2020

The drug maker Gilead Sciences released a bombshell two weeks ago: A study conducted by a U.S. government agency had found that the company’s experimental drug, remdesivir, was the first treatment shown to have even a small effect against Covid-19.

Behind that ray of hope, though, was one of the toughest quandaries in medicine: how to balance the need to rigorously test a new medicine for safety and effectiveness with the moral imperative to get patients a treatment that works as quickly as possible. At the heart of the decision about when to end the trial was a process that was — as is often in the case in clinical trials — by turns secretive and bureaucratic.

The National Institute of Allergy and Infectious Diseases has described to STAT in new detail how it made its fateful decision: to start giving remdesivir to patients who had been assigned to receive a placebo in the study, essentially limiting researchers’ ability to collect more data about whether the drug saves lives — something the study, called ACTT-1, suggests but does not prove. In the trial, 8% of the participants given remdesivir died, compared with 11.6% of the placebo group, a difference that was not statistically significant.

 

EGGS

A top NIAID official said he had no regrets about the decision. “There certainly was unanimity within the institute that this was the right thing to do,” said H. Clifford Lane, NIAID’s clinical director. “While I think there might’ve been some discussion, [because] everyone always tries to play devil’s advocate in these discussions, I think there was a pretty uniform opinion that this was what we should do.”

From the standpoint of the agency, he said, the study had answered the question it was designed to answer: The median time that hospitalized Covid-19 patients on remdesivir took to stop needing oxygen or exit the hospital was, at 11 days, four days shorter than those who were on placebo. “How many patients would we want to put at risk of dying,” he asked, for that last little bit of proof? Remdesivir, he noted, was not a home run, but is probably better than nothing.

Steven Nissen, a veteran trialist and cardiologist at the Cleveland Clinic, disagreed that giving placebo patients remdesivir was the right call. “I believe it is in society’s best interest to determine whether remdesivir can reduce mortality, and with the release of this information doing a placebo-controlled trial to determine if there is a mortality benefit will be very difficult,” he said. “The question is: Was there a route, or is there a route, to determine if the drug can prevent death?” The decision is “a lost opportunity,” he said.

Peter Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, agreed with Nissen. “The core understanding of clinical research participation and clinical research conduct is we run the trial rigorously to provide the most accurate information about the right treatment,” he said. And that answer, he argued, should ideally have determined whether remdesivir saves lives.

The reason we have shut our whole society down, Bach said, is not to prevent Covid-19 patients from spending a few more days in the hospital. It is to prevent patients from dying. “Mortality is the right endpoint,” he said.

Most experts contacted by STAT expressed opinions that fell between Nissen and Lane, believing that the decision was a difficult case, with several defending the NIAID.

“I think it was a really tough call,” said Janet Wittes, a prominent statistician and the president of Statistics Collaborative.

When the remdesivir results were announced, the NIH said the data came from an “interim” analysis. This means that a study was stopped early because a drug’s benefit was so undeniable that it would be unethical to continue the study. But Lane said this was incorrect. The data come from a preliminary final analysis, a point at which the study would normally end.

Related:

With remdesivir, Gilead finds itself at strategic crossroads, with its reputation (and far more) at stake

The ACTT study (short for Adaptive Covid-19 Treatment Trial) began in late February. The first patient dosed in the study was an American repatriated from the Diamond Princess, a British cruise ship where there was an outbreak of more than 800 Covid-19 cases. By the terms of the study, hospitalized patients were randomly assigned to receive either intravenous remdesivir or a placebo. On day 15, the study would score patients on a scale from 1 (dead) to 8 (not hospitalized, with no restrictions on activities).

As results from other Covid-19 studies conducted in China started to trickle in, Lane and his team began to worry that looking at the outcome on only the 15th day could lead the study to fail even if the drug was effective. On March 22, with only 77 patients enrolled in the study, members of the NIAID team had a conference call on which they decided to change the measure that would be used. Instead of measuring patients on an eight-point scale on one day, the study would measure the time until the patients scored one of the best three outcomes on the scale. This decision was finalized on April 2; it was posted to clinicaltrials.gov, a government registry of clinical trials, on April 16.

Ironically, Lane said, the study would still have been positive if the change had not been made. But the change in the study’s main goal also changed the way the study would be analyzed. Now, the NIAID decided, the analysis would be calculated when 400 patients out of the 1,063 patients the study enrolled had recovered. If remdesivir turned out to be much more effective than expected, “interim” analyses would be conducted at a third and two-thirds that number.

The job of reviewing these analyses would fall to a committee of outside experts on what is known as an independent data and safety monitoring board, or DSMB. Though they generally go unseen, DSMBs are among the most important and powerful forces in medical research. They are allowed to analyze the data from a trial while it’s ongoing, even as drug companies, doctors, and patients are kept from knowing who is getting the medicine and who is getting placebo. These boards have two jobs: to make sure that patients aren’t being harmed by the experimental drug, and to ensure that it’s not already clear beyond a doubt that a medicine is effective.

Those decisions bring moments of triumph, despair, and, occasionally, confusion.

When Merck decided to withdraw the painkiller Vioxx in 2004, it was because a DSMB had recommended stopping a study of the drug when it became clear the medicine increased the risk of heart attacks and strokes. In 2014, when a study of the cancer immunotherapy Opdivo first proved that drug extended survival in melanoma, it was because a DSMB had found the result incontrovertible and recommended stopping the study.

But the DSMB for the remdesivir study did not ever meet for an interim efficacy analysis, Lane said. All patients had been enrolled by April 20. The data for a DSMB meeting was cut off on April 22. The DSMB met and, on April 27, it made a recommendation to the NIAID.

That recommendation was not about whether the patients on placebo should receive remdesivir. Instead, the DSMB recommended that in the next phase of the study, testing Eli Lilly’s arthritis drug Olumiant against remdesivir, there was no need for a placebo-only group.

That decision, Lane said, led the NIAID to conclude that patients who had been given placebo should be offered remdesivir, something that started happening after April 28.

This is where Nissen and Bach disagree. There were 1,063 patients in the study, but only 480 had recovered at the time of the analysis. Researchers could have collected more data, they argue, and perhaps have learned if remdesivir saves lives. They were already close, both note. Results are considered “significant” if a measure called a p-value is less than 0.05; the value for mortality in the preliminary analysis was 0.059. “How many patients would we want to put at risk of dying to get that 0.01 on the p-value,” Lane retorted.

Marc Pfeffer, a cardiologist at the Brigham and Women’s Hospital in Boston, said he believes NIAID made the right call. He said that he was “very sympathetic” to the fact that researchers were getting this study done during a pandemic. “If you make the decision that remdesivir should be part of everybody’s therapy in the next phase, then those volunteers taking the risks in the current trial should be switched to the active therapy now considered effective,” he said.

Should this decision have been left to the DSMB, not the NIAID? DSMBs are technically only advisory panels, said Richard Chaisson, a professor at the Johns Hopkins Bloomberg School of Public Health.

Chaisson remembers running an NIH-funded study of a preventative treatment for tuberculosis. The DSMB recommended continuing the trial, but he decided not to, because it was putting patients at too much risk. “The NIH had no problem with me not following the DSMB’s advice, and were even relieved I made the decision I did,” he said.

Wittes, of Statistics Collaborative, said she is glad she wasn’t on this DSMB, adding, “I don’t know where I would have come out.” And she said that when full results of the study are available, she would be “shocked” if the NIAID had not done things properly.

“I think there are groups of people who you’d really respect who would not have stopped a study like this without a mortality benefit,” Wittes said. “And I think you can argue that both ways.”

But she also worried that the evidence might not be strong enough to make the decision society is now making: that every new Covid-19 treatment must be given with or compared to remdesivir.

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“The danger is now it’s the treatment for everybody,” she said. “Now this is the base drug and everything is going to be that plus something or the control. I think we don’t know if it’s strong enough for it to be the standard of care. I don’t think we know who should be treated.”

Steven Joffe, an ethics expert at the University of Pennsylvania, said he believes the NIAID likely took the right steps in making its decision to give remdesivir to the placebo patients. But he worries about deciding to use time to improvement, not death, as the measure of success, in the first place.

“I don’t find this endpoint very compelling, and to me the real issue is the decision to design the trial around the endpoint of time to recovery defined in the way they defined recovery,” Joffe said. “To me, the decisions that are this weighty ought to be based on clinically important endpoints.”

All of this would normally wait until the full results were published, at which point the roster of the DSMB may be revealed. (Lane would not share their names.) But what is unusual in this case is that, before the data are even fully analyzed, the FDA has authorized remdesivir’s use. A Chinese study, meanwhile, failed to show remdesivir had a benefit. Several more studies of the drug expected to read out soon.

Ethan Weiss, a cardiologist at the University of California, San Francisco, who traveled to New York two weeks ago to treat Covid-19 patients, said that he does worry that we have missed “a fleeting opportunity” to understand how well remdesivir works. “It is sad to me that we’re not going to get a complete answer about it.”  But he said he also thinks the issue is “inside baseball.” Remdesivir, as several experts have pointed out, is not a game changer.

The real problem, Weiss said, is not the handling of this particular study but that there aren’t more like it.  He said he wished the U.S. had built the infrastructure needed to do more studies like this when the pandemic in New York was at its height. He wished there were more studies, with more DSMBs.

“We’ve squandered an incredible opportunity to do good science,” Weiss said. “If we could ever go back and do something all over, it would be the infrastructure to actually learn something. Because we’re not learning enough.”

 

About the Author

Matthew Herper has covered medical innovation ––––for two decades chronicling the rise of genetic medicine and the ballooning cost of new drugs. Along the way he profiled major figures from Martin Shkreli to Bill Gates. From 2000 to 2018, he covered science and medicine for Forbes, writing 17 covers and building the Forbes Healthcare Summit into an industry leading event.

 

Weird Galactic Connections

Tuesday, November 12th, 2019
There’s Growing Evidence That the Universe Is Connected by Giant Structures

Scientists are finding that galaxies can move with each other across huge distances, and against the predictions of basic cosmological models. The reason why could change everything we think we know about the universe.

By Becky Ferreira Nov 11 2019, 8:00am
ABSTRACT THREADS. IMAGE: ANDRIY ONUFRIYENKO/GETTY IMAGES

The Milky Way, the galaxy we live in, is one of hundreds of billions of galaxies strewn across the universe. Their variety is stunning: spirals, ring galaxies shaped like star-studded loops, and ancient galaxies that outshine virtually everything else in the universe.

But despite their differences, and the mind-boggling distances between them, scientists have noticed that some galaxies move together in odd and often unexplained patterns, as if they are connected by a vast unseen force.

Galaxies within a few million light years of each other can gravitationally affect each other in predictable ways, but scientists have observed mysterious patterns between distant galaxies that transcend those local interactions.

These discoveries hint at the enigmatic influence of so-called “large-scale structures” which, as the name suggests, are the biggest known objects in the universe. These dim structures are made of hydrogen gas and dark matter and take the form of filaments, sheets, and knots that link galaxies in a vast network called the cosmic web. We know these structures have major implications for the evolution and movements of galaxies, but we’ve barely scratched the surface of the root dynamics driving them.

Scientists are eager to acquire these new details because some of these phenomena challenge the most fundamental ideas about the universe.

“That’s actually the reason why everybody is always studying

these large-scale structures,” said Noam Libeskind, a cosmographer at the Leibniz-Institut for Astrophysics (AIP) in Germany, in a call. “It’s a way of probing and constraining the laws of gravity and the nature of matter, dark matter, dark energy, and the universe.”

Why are distant galaxies moving in unison?

Galaxies tend to form gravitationally bound clusters that belong to even larger superclusters. Earth’s long-form cosmic address, for instance, would have to note that the Milky Way is part of the Local Group, a gang of several dozen galaxies. The Local Group is inside the Virgo supercluster, containing more than 1,000 galaxies.

On these more “local” scales, galaxies frequently mess with each other’s spins, shapes, and angular velocities. Sometimes, one galaxy even eats another, an event known as galactic cannibalism. But some galaxies show dynamic links across distances too great to be explained by their individual gravitational fields.

For instance, a study published in The Astrophysical Journal in October found that hundreds of galaxies were rotating in sync with the motions of galaxies that were tens of millions of light years away.

“This discovery is quite new and unexpected,” said lead author Joon Hyeop Lee, an astronomer at the Korea Astronomy and Space Science Institute, in an email. “I have never seen any previous report of observations or any prediction from numerical simulations, exactly related to this phenomenon.”

Lee and his colleagues studied 445 galaxies within 400 million light years of Earth, and noticed that many of the ones rotating in a direction toward Earth had neighbors that were moving toward Earth, while those that were rotating in the opposite direction had neighbors moving away from Earth.

“The observed coherence must have some relationship with large-scale structures, because it is impossible that the galaxies separated by six megaparsecs [roughly 20 million light years] directly interact with each other,” Lee said.

Lee and his colleagues suggest that the synchronized galaxies may be embedded along the same large-scale structure, which is very slowly rotating in a counter-clockwise direction. That underlying dynamic could cause the kind of coherence between the rotation of the studied galaxies and the motions of their neighbors, though he cautioned that it will take a lot more research to corroborate his team’s findings and conclusions.

While this particular iteration of weirdly synced up galaxies is novel, scientists have observed odd coherences between galaxies at even more mind-boggling distances. In 2014, a team observed curious alignments of supermassive black holes at the cores of quasars, which are ancient ultra-luminous galaxies, that stretch across billions of light years.

Led by Damien Hutsemékers, an astronomer at the University of Liège in Belgium, the researchers were able to observe this eerie synchronicity by watching the universe when it was only a few billion years old, using the Very Large Telescope (VLT) in Chile. The observations recorded the polarization of light from nearly 100 quasars, which the team then used to reconstruct the geometry and alignment of the black holes at their cores. The results showed that the rotation axes of 19 quasars in this group were parallel, despite the fact that they were separated by several billion light years.

The discovery, which was published in the journal Astronomy & Astrophysics, is an indicator that large-scale structures influenced the dynamics of galaxies across vast distances in the early universe.

“Galaxy spin axes are known to align with large-scale structures such as cosmic filaments but this occurs on smaller scales,” Hutsemékers said in an email, noting that theoretical studies have proposed some tentative explanations of this process.

“However, there is currently no explanation why the axes of quasars are aligned with the axis of the large group in which they are embedded,” he noted.

The truth behind synchronized galaxies could change everything

The secret of these synchronized galaxies may pose a threat to the cosmological principle, one of the basic assumptions about the universe. This principle states that the universe is basically uniform and homogenous at extremely large scales. But the “existence of correlations in quasar axes over such extreme scales would constitute a serious anomaly for the cosmological principle,” as Hutsemékers and his colleagues note in their study.

However, Hutsemékers’ cautioned that more of these structures would need to be spotted and studied to prove that this is a serious wrinkle in the cosmological principle. “Other similar structures are needed to confirm a real anomaly,” he said.

For the moment, the dynamics behind these quasar positions are not well understood because there are few observational techniques to refine them. “As far as large-scale alignments are concerned, we are essentially waiting for more data,” Hutsemékers’ said. “Such studies are statistical and a step forward would require a large amount of polarization data, not easy to gather with current instrumentation.”

Future radio telescopes, such as the Square Kilometre Array, might be able to probe these mysterious alignments in more detail.

“One of the great things about science is that you can have a model built with thousands of pieces of data but if one thing doesn’t stick it starts to crack. That crack either has to be sealed or it’s going to bring the whole house down.”

 

Quasar alignments are not the only hurdles that oddly synchronized galaxies have presented to established models of the universe. In fact, one of the most contentious debates in cosmology these days is centered around the unexpected way in which dwarf galaxies appear to become neatly aligned around larger host galaxies such as the Milky Way.

These satellite galaxies are currently a thorn in the side of what is known as the ΛCDM model, which is a theoretical timeline of the universe since the Big Bang. Simulations of the universe under the ΛCDM model predict that small satellite galaxies will end up in a swarm of random orbits around larger host galaxies.

But over the past decade, new observations have revealed that a huge chunk of the satellite galaxies around the Milky Way are synced up into one tidy orbital plane. At first, scientists wondered whether that simply meant something weird was going on with our own galaxy, but a similar plane of satellites was then observed around Andromeda.

The alarm bells really started ringing in 2015, when astronomers published observations of the same phenomenon a third time around Centaurus A, an elliptical galaxy about 10 million light years from the Milky Way.

This discovery “suggests that something is wrong with standard cosmological simulations,” according to a subsequent 2018 study in Science, led by Oliver Müller, an astronomer at the University of Strasbourg in France.

“At the moment, we have observed this at the three closest galaxies,” Müller said in a call. “Of course, you can always say that it’s only three, so it’s not statistical yet. But it shows that every time we have good data, we find it, so it could be universal.”

In a 2015 study, Libeskind and his colleagues suggested that filaments in the cosmic web might be guiding these organized galaxies, a process that could cohere with the ΛCDM model. Ultimately, though, there’s no conclusive answer to this dilemma yet.

“One of the great things about science is that you can have a model built with thousands of pieces of data but if one thing doesn’t stick it starts to crack,” said Libeskind. “That crack either has to be sealed or it’s going to bring the whole house down.”

The next generation of galaxy research

This tantalizing uncertainty has motivated astronomers like Marcel Pawlowski, a Schwarzschild Fellow at AIP and co-author on the 2018 Science study, to make this problem a focus of their research. Pawlowski is looking forward to data from the next generation of huge 30-meter class observatories that could show whether other big galaxies are surrounded by either isotropic or organized patterns of satellite galaxies.

“What we have to do now is expand our search to more distant satellite systems, and find satellite galaxies as well as measure their velocities,” said Pawlowski in a call.

“The field really advanced because of this debate going on in the literature,” Pawlowski added. “It’s been really good to see how the observational evidence became more and more solid.”

Whether it’s the strange motions of dwarf galaxies in our own galactic neighborhood or the eerie alignment of galaxies over millions or billions of light years, it’s clear that the dance moves of galaxies are an essential key to unlocking the large-scale structure of the universe.

The galaxies we see captured in static positions in beautiful deep-field shots are actually guided by many complex forces we don’t yet fully comprehend, including the cosmic web that undergirds the universe.

“What I really like about this stuff is just that we are still at the pioneering phase,” said Müller. “That’s super exciting.”

TAGGED: UNIVERSE, GALAXY, COSMOLOGY, MILKY WAY, GALAXIES, ANDROMEDA, COSMIC WEB, FILAMENTS, LARGE-SCALE STRUCTURES

 

The Horror Below : A Halloween Tale

Wednesday, October 30th, 2019

For this upcoming Halloween tomorrow, I thought it might be fun to put one of my Halloween short stories, which others have found both interesting and creepy. If anyone who visits my blog and reads it finds it interesting and creepy, I will be delighted.

The Horror Below

A Halloween Tale

It’s impossible for me to describe in detail all the events that led to my present state. As I sit here in the courtroom charged with what happened to Allen Hastings, I know that my testimony will be dismissed, and I will be executed. Perhaps that’s just as well. My dreams are haunted and I no longer wish to imagine what lurks in the dark corners of any room in which I reside.

It all started when I met Allen at the University –––– the class in Gothic literature. Our mutual interests in the gloomy settings, the grotesque and vile events, and the atmosphere of degeneration and decay of 12th and 13th century northern Europe, served as the basis for the development of a warm friendship. We shared many evenings in the local Rathskeller, drinking beer and feasting on bratwurst and sauerbraten. But with time, I began to have a sense of unease.

Outwardly jovial, but inwardly tortured, as I was later to learn, Allen expressed interest in the darkest aspects of medieval German literature, and especially the supposed long-lost book, Die Ubergeist, written by the mad necromancer, Gottfried Abendsturm.

Toward the end of the semester, he began ranting on and on, sometimes in unintelligible German, about the abominable creatures hidden all around us, and how the book could guide us to their hiding places and expose them.

I began to worry that he was losing his senses, and tried to deflect him from this obsession.  “Since you’ve never seen the book ––– it seems no one has –––– why waste your time agonizing about it?” I asked him.

He smiled…. no, he leered. “I’ve not only seen it, but I’ve read it.”

I laughed. “What nonsense. I dare you to show it to me.” These were the fatal words. I so wish I could bring back and smash that utterance into atomic pulp.

“Are you certain? Once you see it, read it, there’s no turning back,” he warned.

I shrugged. “Sure. After all, how often does one see a book that doesn’t exist.”

So, the next day, All Hallows Eve as it turned out, I went to his apartment, said hello to several of my friends and classmates as I entered the building, and foolishly told them I had come to visit Allen. I had never seen Allen’s flat, and I found it to be a strange and forbidding place. It was filled with death masks hanging from the walls, black curtains and furniture, and only a few electric lights ––– but dozens of candelabras with blood red candles. At that point I determined to leave as quickly as possible, after satisfying myself that Allen’s book did not exist.

He offered me a glass of wine and brought me into his study. He opened a safe that sat beside his desk. He reached in and brought out a huge book, richly embroidered with hideous gargoyles and satanic faces, and placed it on a table. “Well, here it is. Beautiful isn’t it? But be careful. The pages are so old that even the slightest injury will cause them to fragment into dust.”

I began to shiver as I turned the pages. It was written in medieval German, and throughout there were drawings of skulls, devil heads, corpses, and smiling rats with blood tinged teeth.

Allen now took over and turned to page 666. He then looked at me and said,  “Are you stouthearted enough to come with me where few have gone, where the sun does not shine, where the unspeakable resides?”

I hesitated and began to tremble uncontrollably. Oh, why didn’t I flee from this challenge? But being young and foolhardy, I was more afraid of seeming a coward than listening to my deep fears. I calmed myself and said, “Of course I’m ready. Where is this netherworld? In your kitchen?”  I laughed, perhaps a bit shrilly, and waited for his response.

He chuckled hoarsely, a cold, almost sinister sound, and then turned back to the book. He now proceeded to recite the poem on page 666 in a guttural, alien language:

“Ph’nglu mglw’nafh wgah’naglfhagn

Mzz’xetth mzz’etth ndd’rtth dz’ftthe

Wghtth’lleh mnw’ttghth zzfg’llenth

Tth’zcggmeh dzznth’emnth gdzdd’brgh.”

And when he finished, he smiled and closed the book. We stood staring at each other. His smile never left him. I began to feel lightheaded, and as I watched, the walls started to shake slowly, then violently, and the room disappeared. Now I found myself in an ancient church, in which, oddly enough, there were no religious ornaments. It’s difficult to describe how cold it was, and how unpleasant the smell of primeval decay. On what seemed to be the altar, I saw a long, raised stone slab above which hung a carved black bird with its wings spread out.

I stood transfixed until Allen turned to me and whispered, “Here.”  He had brought along two flashlights and two cell phones.. He handed me one of each and said, “Come, help me move that slab on the alter. Slowly, slowly, and with enormous effort, we were successful in uncovering an ingress into yawning blackness. The light from his flashlight revealed a long stone staircase leading down into what appeared to be infinite darkness. The smell that arose from the depths exceeded the most awful I have ever experienced ––– indescribable, except to say it caused me to retch over and over until, exhausted, I sank to the floor

Allen helped me up to a bench, and I tried to catch hold of myself. While doing so, I looked around at the church. Unimaginably old, perhaps several thousand years or more. Monstrous spider webs, encompassing all manner of dead insects, hung from the tall rafters. In the dark shadows surrounding us, I thought I saw movement, and then nothing. As I looked down away from my fear, I saw the skeletal remains of dead animals ––––rats, bats, birds. I shuddered and looked up at Allen.

“Where are we? In Hell?”

“Perhaps. But certainly a place where few have been and where I must finish my task. I need to go down into these catacombs. I must know what lies beneath this place. I’ll keep in touch with you via our cell phones.”  He turned and went to the opening.

“No, wait. I’m going with you. I can’t let you go down there alone.”  Sick with fear, but nevertheless unwilling to allow my friend to descend into that pit without me, I rose and started toward him.

“No!” he shouted. “No! You need to stay here. You can’t come with me.”

“Yes. I must. I insist.”

“If you try, I’ll call off this journey and we’ll leave. I’ll come back later. Alone. Won’t that be worse for me ? No one to contact?”

“All right. But for God’s sake, be careful.”

I sat down again, shivering, once more assessing the gloom where shadows moved and where I heard rustling and crunching as ghostly feet stepped upon the animal corpses. I shined the light in all directions, but failed to see the ghouls I sensed were all around me.

After what seemed like hours, my cell phone rang and I heard Allen’s voice. “Oh, my God. Oh, heavenly Father. What awful things I see. Ghastly! Dirty. Beastly. Ululating, demonic, blackest hell.”

“Allen, Allen, what is it? What are you seeing?”

“I can’t……. I can’t describe it. It’s too awful. You must get out! Get out!”

“No! I can’t leave you.”

“Yes. You must get out! But first move back the stone slab. For God’s sake push it back over the portal into this place beyond hell!” And then the screams began, high-pitched awful screams, Allen’s screams.

Breathing hard and sweating cold sweat, I barely managed to move the slab back over that doorway to the unspeakable. I ran to the entrance of the church, brushing past the slavering things that began to move out of the shadows, cackling, mumbling incomprehensible words.

I lunged out of the church into the night and into a crumbling graveyard. I began to scream as I ran toward lights I saw in the distance. After reaching what appeared to be a street leading to the university, I looked back, and the church was gone.

Shaking like some poor epileptic soul, I reached my apartment, tumbled into my room, and let out a strangled cry as I found Allen’s mutilated head on my bed. As I collapsed to the floor shrieking, the cellphone that I still clutched in my hand rang, and I heard harsh, croaking laughter, followed by a voice, deep, fiendish, savage, cruel, shout out,

“ Allen Hastings is dead and I am FREE! ”

 

 

 

 

 

 

 

 

 

Colin Kaepernick Falls Flat on Face Again

Sunday, July 7th, 2019

The Western Journal

CT Conservative Tribune

KAEP  humiliated as public learns Betsy Ross was part of masses anti-slavery group

Ryan Ledendecker

July 5, 2019

 

Former quarterback-turned-social-justice-warrior Colin Kaepernick caused a stir right before the July Fourth holiday after somehow convincing Nike’s top brass that a patriotic shoe it was set to release represented slavery.

In a last-minute move as the Air Max 1 Quick Strike “Betsy Ross flag” shoes were hitting store shelves, Nike pulled its release and immediately made national headlines.

And Ross’ name was subsequently dragged through the mud.

But before Kaepernick — a man who once donned socks that depicted police officers as “pigs” — continues to push the narrative that Ross’ 13-star flag somehow connects connects her to slavery, he might consider a quick lesson in U.S. history.

According to Biography, Ross was born as Elizabeth Griscom in Philadelphia, Pennsylvania, in January 1752, and grew up as a Quaker — a religious group also known as the Society of Friends.

What social justice warriors like Kaepernick are unaware of is that the Quakers were one of the first religious groups in America to condemn slavery both in the U.S. and abroad.

According to a history of Quakers and Slavery by Bryn Mawr College, “The Religious Society of Friends (Quakers) was the first corporate body in Britain and North America to fully condemn slavery as both ethically and religiously wrong in all circumstances.”

The Quakers also spent considerable time attempting to sway public opinion on the evils of slavery. They even provided education and resources for formerly slaves.

How much more anti-slavery can a group possibly be?

It’s unfortunate that no one at Nike did their homework before the company kowtowed to Kaepernick’s demands. It could have saved everyone else a lot of time.

Nike issued a ridiculous statement concerning the decision to cancel the shoe’s release, according to ESPN.

“We regularly make business decisions to withdraw initiatives, products and services. NIKE made the decision to halt distribution of the Air Max 1 Quick Strike Fourth of July based on concerns that it could unintentionally offend and detract from the nation’s patriotic holiday.”

Ironically, the company went against its own intentions of not detracting from July Fourth by making such a poor decision that caused a national stir.

Nike sure doesn’t seem proud of its American heritage, given the fact the company pulled a shoe that had no connection to slavery whatsoever.

If Kaepernick hadn’t told his followers to be offended by the shoe, they wouldn’t have been. It was just another attempt to create division in America — something Kaepernick’s proven to be a master at.

The 13-star flag represents the Revolutionary War and the courage it took for people in that era to give us the freedoms we currently enjoy.

Ross was an anti-slavery Quaker who should be respected by all Americans, politics aside. I won’t hold my breath waiting for an apology from the washed-up former football player, but he certainly owes one to Ross and every other American.

 


William S. Frankl, MD, All Rights Reserved