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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.

 

The New, New Anti Semitism

Tuesday, January 15th, 2019

The following is this disturbing  report of widespread antisemitism in the left wing, progressive movement in America. I was alerted to it by my dear friend & colleague, Stephen Dubel.

NATIONAL REVIEW

The New, New Anti-Semitism

By Victor Davis Hanson

January 15,2019

 

The old anti-Semitism was mostly, but not exclusively, a tribal prejudice expressed in America up until the mid 20th century most intensely on the right. It manifested itself from the silk-stocking country club and corporation (“gentlemen’s agreement”) to the rawer regions of the Ku Klux Klan’s lunatic fringe.

While liberals from Joe Kennedy to Gore Vidal were often openly anti-Semitic, the core of traditional anti-Semitism, as William F. Buckley once worried, was more rightist. And such fumes still arise among the alt-right extremists.

Yet soon a new anti-Semitism became more insidious, given that it was a leftist phenomenon among those quick to cite oppression and discrimination elsewhere. Who then could police the bigotry of the self-described anti-bigotry police?

The new form of the old bias grew most rapidly on the 1960s campus and was fueled by a number of leftist catalysts. The novel romance of the Palestinians and corresponding demonization of Israel, especially after the 1967 Six-Day War, gradually allowed former Jew-hatred to be cloaked by new rabid and often unhinged opposition to Israel. In particular, these anti-Semites fixated on Israel’s misdemeanors and exaggerated them while excusing and downplaying the felonies of abhorrent and rogue nations.

Indeed, evidence of the new anti-Semitism was that the Left was neutral, and even favorable, to racist, authoritarian, deadly regimes of the then Third World while singling out democratic Israel for supposed humanitarian crimes. By the late 1970s, Israelis and often by extension Jews in general were demagogued by the Left as Western white oppressors. Israel’s supposed victims were romanticized abroad as exploited Middle Easterners. And by extension, Jews were similarly exploiting minorities at home.

Then arose a relatively new mainstream version of Holocaust denial that deprived Jews of any special claim to historic victim status. And it was a creed common among World War II revisionists and some American minorities who were resentful that the often more successful Jews might have experienced singularly unimaginable horror in the past. The new anti-Semitism that grew up in the 1960s was certainly in part legitimized by the rise of overt African-American bigotry against Jews (and coupled by a romantic affinity for Islam). It was further nursed on old stereotypes of cold and callous Jewish ghetto storeowners (e.g., “The Pawnbroker” character), and expressed boldly in the assumption that black Americans were exempt from charges of bias and hatred.

Anti-Semitic blacks assumed that they could not be credibly charged with bigotry and were therefore free to say what they pleased about Jews. Indeed, by the 1970s and 1980s, anti-Semitism had become the mother’s milk of a prominent post–Martin Luther King Jr. black-activist leadership, well beyond Malcolm X and the Black Panthers — even though Jews had been on the forefront of the civil-rights movements and had been recognized as such by an earlier generation of liberal black leaders.

Soon it became common for self-described black leaders to explain, to amplify, to contextualize, or to be unapologetic about their anti-Semitism, in both highbrow and lowbrow modes: James Baldwin (“Negroes are anti-Semitic because they’re anti-white”), Louis Farrakhan (“When they talk about Farrakhan, call me a hater, you know what they do, call me an anti-Semite. Stop it. I am anti-termite. The Jews don’t like Farrakhan, so they call me Hitler. Well, that’s a great name. Hitler was a very great man”), Jesse Jackson (“Hymietown”), Al Sharpton (“If the Jews want to get it on, tell them to pin their yarmulkes back and come over to my house”), and the Reverend Jeremiah Wright (“The Jews ain’t gonna let him [Obama] talk to me”).

Note that Jesse Jackson and Al Sharpton both ran as Democratic candidates for president. Sharpton officially visited the Obama White House more than 100 times, and Wright was the Obamas’ longtime personal pastor who officiated at the couple’s wedding and the baptism of their daughters and inspired the title of Obama’s second book.

In the past ten years, however, we have seen an emerging new, new anti-Semitism. It is likely to become far more pernicious than both the old-right and new-left versions, because it is not just an insidiously progressive phenomenon. It has also become deeply embedded in popular culture and is now rebranded with acceptable cool among America’s historically ignorant youth. In particular, the new, new bigotry is “intersectional.” It serves as a unifying progressive bond among “marginalized” groups such as young Middle Easterners, Muslims, feminists, blacks, woke celebrities and entertainers, socialists, the “undocumented,” and student activists. Abroad, the new, new bigotry is fueled by British Labourites and anti-Israel EU grandees.

Of course, the new, new anti-Semitism’s overt messages derive from both the old and the new. There is the same conspiratorial idea that the Jews covertly and underhandedly exert inordinate control over Americans (perhaps now as grasping sports-franchise owners or greedy hip-hop record executives). But the new, new anti-Semitism has added a number of subtler twists, namely that Jews are part of the old guard whose anachronistic standards of privilege block the emerging new constituency of woke Muslims, blacks, Latinos, and feminists.

Within the Democratic party, such animus is manifested by young woke politicians facing an old white hierarchy. Progressive activist Linda Sarsour oddly singled out for censure Senate majority leader Charles Schumer, saying, “I’m talking to Chuck Schumer. I’m tired of white men negotiating on the backs of people of color and communities like ours.”

In attacking Schumer, ostensibly a fellow progressive, Sarsour is claiming an intersectional bond forged in mutual victimization by whites — and thus older liberal Jews apparently either cannot conceive of such victimization or in fact are party to it. With a brief tweet, Alexandra Ocasio-Cortez dismissed former Democratic senator Joe Lieberman’s worry over the current leftward drift of the new Democratic party. “New party, who dis?” she mocked, apparently suggesting that the 76-year-old former Democratic vice-presidential candidate was irrelevant to the point of nonexistence for the new progressive generation.

Likewise, the generic invective against Trump — perhaps the most pro-Israel and pro-Jewish president of the modern era — as an anti-Semite and racist provides additional cover. Hating the supposedly Jew-hating Trump implies that you are not a Jew-hater yourself.

Rap and hip-hop music now routinely incorporate anti-Semitic lyrics and themes of Jews as oppressors — note the lyrics of rappers such as Malice, Pusha T, The Clipse, Ghostface Killah, Gunplay, Ice Cube, Jay-Z, Mos Def, and Scarface. More recently, LeBron James, the Los Angeles Lakers basketball legend, tweeted out the anti-Semitic lyrics of rapper 21 Savage: “We been getting that Jewish money, everything is Kosher.” LeBron was puzzled about why anyone would take offense, much less question him, a deified figure. He has a point, given that singling out Jews as money-grubbers, cheats, and conspirators has become a sort of rap brand, integral to the notion of the rapper as Everyman’s pushback against the universal oppressor. The music executive and franchise owner is the new Pawnbroker, and his demonization is often cast as no big deal at best and at worst as a sort of legitimate cry of the heart from the oppressed.

Note that marquee black leaders — from Keith Ellison to Barack Obama to the grandees of the Congressional Black Caucus — have all had smiling photo-ops with the anti-Semite Louis Farrakhan, a contemporary black version of Richard Spencer or the 1980s David Duke. Appearing with Farrakhan, however, never became toxic, even after he once publicly warned Jews, “And don’t you forget, when it’s God who puts you in the ovens, it’s forever!”

Temple professor, former CNN analyst, and self-described path-breaking intellectual Marc Lamont Hill recently parroted the Hamas slogan of “a free Palestine from the river to the sea” — boilerplate generally taken to mean that the goal is the destruction of the current nation of Israel. And here, too, it’s understandable that Hill was shocked at the ensuing outrage — talk of eliminating Israel is hardly controversial in hip left-wing culture.

The Democratic party’s fresh crop of representatives likewise reflects the new, new and mainlined biases, camouflaged in virulent anti-Israeli sentiment. Or, as Princeton scholar Robert George recently put it:

The Left calls the tune, and just as the Left settled in on abortion in the early 1970s and marriage redefinition in the ’90s, it has now settled in on opposition to Israel – not merely the policies of its government, but its very existence as a Jewish state and homeland of the Jewish people.

In that vein, Michigan’s new congresswoman, Rashida Tlaib, assumed she’d face little pushback from her party when she tweeted out the old slur that Jewish supporters of Israel have dual loyalties: Opponents of the Boycott, Divest, and Sanctions movement, which targets Israel, “forgot what country they represent,” she said. Ironically, Tlaib is not shy about her own spirited support of the Palestinians: She earlier had won some attention for an eliminationist map in her office that had the label “Palestine” pasted onto the Middle East, with an arrow pointing to Israel.

Similarly, Ilhan Omar (D., Minn.) — like Tlaib, a new female Muslim representative in the House — used to be candid in her views of Israel as an “apartheid regime”: “Israel has hypnotized the world, may Allah awaken the people and help them see the evil doings of Israel.” On matters of apartheid, one wonders whether Omar would prefer to be an Arab citizen inside “evil” Israel or an Israeli currently living in Saudi Arabia or Egypt.

Sarsour defended Omar with the usual anti-Israel talking points, in her now obsessive fashion. Predictably, her targets were old-style Jewish Democrats.  This criticism of Omar, Sarsour said, “is not only coming from the right-wing but [from] some folks who masquerade as progressives but always choose their allegiance to Israel over their commitment to democracy and free speech.” Again, note the anti-Semitic idea that support for the only functioning democracy in the Middle East is proof of lackluster support for democracy and free speech.

The unhinged Hank Johnson (D., Ga.) has derided Trump as a Hitler-like character, and Trump supporters as a doomed cadre of sick losers. He had once wondered whether too many U.S. Marines stationed on the shores of Guam might tip over the island and capsize it, so it was not too surprising when he also voiced the Farrakhan insect theme, this time in connection with apparently insidious Jewish destroyers of the West Bank: “There has been a steady [stream], almost like termites can get into a residence and eat before you know that you’ve been eaten up and you fall in on yourself.”

Out on the barricades, some Democrats, feminists, and Muslim activists, such as the co-founders of the “Women’s March,” Tamika Mallory and the now familiar Sarsour, have been staunch supporters of Louis Farrakhan (Mallory, for example, called him “the greatest of all time”). The New York Times recently ran a story of rivalries within the Women’s March, reporting that Mallory and Carmen Perez, a Latina activist, lectured another would-be co-leader, Vanessa Wruble, about her Jewish burdens. Wruble later noted: “What I remember — and what I was taken aback by — was the idea that Jews were specifically involved, and predominantly involved, in the slave trade, and that Jews make a lot of money off of black and brown bodies.”

Progressive icon Alice Walker was recently asked by the New York Times to cite her favorite bedtime reading. She enjoyed And the Truth Will Set You Free, by anti-Semite crackpot David Icke, she said, because the book was “brave enough to ask the questions others fear to ask” and was “a curious person’s dream come true.” One wonders which “questions” needed asking, and what exactly was Walker’s “dream” that had come “true.” When called out on Walker’s preference for Icke (who in the past has relied on the 19th-century Russian forgery The Protocols of the Elders of Zion, in part to construct an unhinged conspiracy about ruling “lizard people”), the Times demurred, with a shrug: It did not censor its respondents’ comments, it said, or editorialize about them.

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These examples from contemporary popular culture, sports, politics, music, and progressive activism could be easily multiplied. The new, new anti-Semites do not see themselves as giving new life to an ancient pathological hatred; they’re only voicing claims of the victims themselves against their supposed oppressors. The new, new anti-Semites’ venom is contextualized as an “intersectional” defense from the hip, the young, and the woke against a Jewish component of privileged white establishmentarians — which explains why the bigoted are so surprised that anyone would be offended by their slurs.

In our illiterate and historically ignorant era, the new, new hip anti-Semitism becomes a more challenging menace than that posed by prior buffoons in bedsheets or the clownish demagogues of the 1980s such as the once-rotund Al Sharpton in sweatpants. And how weird that a growing trademark of the new path-breaking identity politics is the old stereotypical dislike of Jews and hatred of Israel.

Victor Davis Hanson — NRO contributor Victor Davis Hanson is a senior fellow at the Hoover Institution and the author, most recently, of The Second World Wars: How the First Global Conflict Was Fought and Won. @vdhanson

 

 


William S. Frankl, MD, All Rights Reserved