WFMU-FM is podcasting For The Record–You can subscribe to the podcast HERE.
You can subscribe to e‑mail alerts from Spitfirelist.com HERE.
You can subscribe to RSS feed from Spitfirelist.com HERE.
You can subscribe to the comments made on programs and posts–an excellent source of information in, and of, itself, HERE.
Mr. Emory’s entire life’s work is available on a 32GB flash drive, available for a contribution of $65.00 or more (to KFJC). Click Here to obtain Dave’s 40+ years’ work.
Please consider supporting THE WORK DAVE EMORY DOES.
FTR #1134 This program was recorded in one, 60-minute segment.
Introduction: As indicated by the title of the program, this broadcast updates various articles and book excerpts concerning Covid-19.
A Daily Mail Online [UK] article sets forth two bogus papers contending that the SARS CoV‑2 virus was genetically engineered by the Chinese as a bioweapon in a laboratory and that it “escaped.” Note the championing of one of the papers by a former head of MI6 and the authorship of the second by The Epoch Times, the paper of the Falun Gong cult. Linked to CIA, Steve Bannon’s anti-China milieu and the Trump administration, the organization is a fascist mind control cult discussed in numerous shows, including FTR #‘s 1089 and 1090.
- “A former MI6 chief was yesterday accused by Government officials of peddling ‘fanciful claims’ that coronavirus was accidentally created in a Chinese laboratory. British security agencies believe Covid-19 is not a man-made virus and is ‘highly likely’ to have occurred naturally and spread to humans through animals. And Health Secretary Matt Hancock has said there is ‘no evidence’ to back up the theory that it originated in a laboratory. But Sir Richard Dearlove, who was head of the MI6 from 1999 to 2004, cited a recent report claiming the disease was accidentally manufactured by Chinese scientists.
- “ ‘I do think that this started as an accident,’ Sir Richard told The Daily Telegraph’s ‘Planet Normal’ podcast. ‘It raises the issue: if China ever were to admit responsibility, does it pay reparations? I think it will make every country in the world rethink how it treats its relationship with China.’ He added: ‘Look at the stories... of attempts by the [Beijing] leadership to lock down any debate about the origins of the pandemic and the way people have been arrested or silenced.’ . . . . The paper – co-authored by Professor Angus Dalgleish, a renowned oncologist and vaccine researcher who works at St George’s Hospital, University of London, and Birger Sorensen, a Norwegian virologist – contains none of the stark allegations that originally stunned its reviewers.
- “The initial paper that triggered wild rumours failed stringent tests of verification and is understood to have been rejected in April by eminent international journals such as Nature and the Journal of Virology. Biomedical experts from the Francis Crick Institute and Imperial College London are said to have refuted its conclusions. Then one of the paper’s co-authors, Dr John Fredrik Moxnes, chief scientific adviser to the Norwegian military, asked for his name to be withdrawn. This week, after numerous rewrites, the paper was published by the Quarterly Review of Biophysics Discovery. And those original world-shaking conclusions have now withered to innuendo. No accusation of Chinese manipulation appears. . . .”
- “. . . . Back in April, a slickly produced investigative documentary, Tracking Down The Origin Of The Wuhan Coronavirus, was released online. It claimed conclusive proof that the Covid-19 virus had been created as a biological ‘weapon of mass destruction’ in a Chinese lab. . . .”
- “At first sight, it seemed a shockingly convincing piece of journalism. On behalf of this newspaper, I cross-checked every claim: The experts it cited and the factual evidence unearthed. I also researched the backgrounds of its makers. I then approached some of the world’s best independent scientific authorities to ask their opinion. They all agreed – this enticingly spicy story just didn’t stand up.”
- “It had been produced by a US based anti-Chinese government media organisation called the Epoch Times. Its ‘experts’ were veteran hard-Rightists. Most damningly, its scientific ‘facts’ were twisted out of shape.So much, then, for the Chinese-manufactured coronavirus conspiracy . . .”
Steve Bannon is at the epicenter of the anti-China effort and–to no one’s surprise–never really left the Trump White House.
When assessing Bannon as a political animal, one should never forget that among the important ideological influences on him is Julius Evola, an Italian fascist who found Mussolini too moderate and ultimately took his cues from the Nazi SS, who were financing his work by the end of World War II.
” . . . . Donald Trump’s lightning-rod 2016 campaign boss and former White House chief strategist who was banished from the West Wing in 2017 has quietly crept back into 1600 Pennsylvania Ave., reestablishing ties to staffers, particularly with regard to his pet issues of China and immigration. . . . Another former administration official told The Post that Bannon never really left the White House after he was fired, maintaining contacts and keeping up regular channels of communications with officials there. . . .”
In addition, as discussed in FTR #‘s 1111 and 1112, Bannon is part of a network that includes J. Kyle Bass and Tommy Hicks, Jr. This nexus involves asymmetrical investing with regard to the Hong Kong and Chinese economies and the inter-agency governmental networks involved in both overt and covert anti-China policies implemented by Team Trump. As will be seen below, they also are networking with the mis-named “Scientists to Stop Covid-19.” In that regard, they are also helping steer policy that controls development of treatment and vaccines for Covid-19. The management of drug and vaccine development, in turn, doubles back to market-driving investment dynamics.
An interesting summation of characteristics of a “deliberate” epidemic are evaluated against the finding that New York City was the epicenter of the U.S. Covid-19 outbreak:
Potential epidemiological clues to a deliberate epidemic:
Clue no. 1–A highly unusual event with large numbers of casualties: Check!
Clue no. 2–Higher morbidity or mortality than is expected. Check!
Clue no. 3–Uncommon disease. Check!
Clue no. 4–Point-source outbreak. Check!
Clue no. 5–Multiple epidemics. Check! (Global pandemic)
–Z. F. Dembek, et al., “Discernment Between Deliberate and Natural Infectious Disease Outbreaks”
The prevailing view of the Covid-19 outbreak contends that the American outbreak spread outward from New York City. The strain of SARS CoV‑2 that appeared in New York came, in turn, from Europe.
This doesn’t make sense. There were confirmed cases of the virus on the West Coast that did not come from New York. A European strain of the virus transmitted to New York City would have come in via air. In such an event, there would have been a well-documented outbreak of Covid-19 among flight attendants, who operate in close contact with passengers in cramped circumstances, as well as experiencing jet lag, which compromises the immune system.
Next, we review an aspect of the 2001 anthrax attacks. We highlighted the 2001 anthrax attacks in connection with the Covid-19 outbreak in New York City in FTR #1128.
We note that the Anthrax attacks appear to have operated in overlapping contexts, including justification for the war in Iraq.
The 2001 anthrax attacks appear to have served as a provocation that justified a ten-fold increase in spending for biological warfare development. The number of BSL‑4 labs (having dual civilian and military use) increased from two in 2001, to a dozen in 2007.
This increase occurred while Donald Rumsfeld was George W. Bush’s secretary of defense. He went to that position from being Chairman of the Board of Directors for Gilead Sciences, the manufacturer of remdesivir.
We will delve into the politics of the anthrax attacks in the future.
In the context of the above article, note that the National Institutes of Health have also partnered with CIA and the Pentagon, as underscored by an article about a BSL‑4 lab at Boston University. Note that Europe and the U.S. have twelve BSL4 labs apiece. Taiwan has two. China has one:
- As the article notes, as of 2007, the U.S. had “more than a dozen” BSL4 labs–China commissioned its first as of 2017. a tenfold increase in funding for BSL4 labs occurred because of the anthrax attacks of 2001. Those attacks might be seen as something of a provocation, spurring a dramatic increase in “dual use” biowarfare research, under the cover of “legitimate” medical/scientific research. In FTR #1128, we hypothesized about the milieu of Stephen Hatfill and apartheid-linked interests as possible authors of a vectoring of New York City with Sars COV2: ” . . . . Before the anthrax mailings of 2001, the United States had just two BSL4 labs—both within the razor-wire confines of government-owned campuses. Now, thanks to a tenfold increase in funding—from $200 million in 2001 to $2 billion in 2006—more than a dozen such facilities can be found at universities and private companies across the country. . . .”
- The Boston University lab exemplifies the Pentagon and CIA presence in BSL‑4 facility “dual use”: ” . . . . But some scientists say that argument obscures the true purpose of the current biodefense boom: to study potential biological weapons. ‘The university portrays it as an emerging infectious disease lab,’ says David Ozonoff, a Boston University epidemiologist whose office is right across the street from the new BSL4 facility. ‘But they are talking about studying things like small pox and inhalation anthrax, which pose no public health threat other than as bioweapons.’ . . . The original NIH mandate for the lab indicated that many groups—including the CIA and Department of Defense—would be allowed to use the lab for their own research, the nature of which BU might have little control over. . . .”
Pivoting to discussion and review of the political, financial and corporate connections to the development of medicinal treatments for, and vaccines to prevent, Covid-19, we recap details relevant to the extraordinary timing of a 4/29 announcement of favorable results for a trial of remdesivir. That announcement drove equities markets higher and was beneficial to the stock of Gilead Sciences.
We present a Stat News article on the internal deliberations behind the decisions to modify the NIAID study. Of particular significance is the DSMB deliberation. Note the timeline of the DSMB deliberation, combined with the announcement on 4/29 that drove the markets higher.
- The decision was made to cut it short before the question of remdesivir’s impact on mortality could be answered: ” . . . .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. 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. . . .”
- In addition, patients scheduled to receive placebo received remdesivir, instead. ” . . . . 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. . . .”
- Steven Nissen was not alone in his criticism of the NIAID’s decision. ” . . . .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. . . .”
- Not only was the administration of remdesivir instead of placebo prioritized, but the NIAID study itself was attenuated! ” . . . . 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. . . .”
- The performance of the DSMB for the remdesivir study is noteworthy: ” . . . . 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. . . .”
- The DSMB meeting on 4/27 determined the switch from placebo to remdesivir. Of paramount importance is the fact that this was JUST BEFORE the 4/29 announcement that drove the markets higher and the same day on which key Trump aide–and former Gilead Sciences lobbyist Joe Grogan resigned! ” . . . . . 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. . . .”
- Dr. Ethan Weiss gave an accurate evaluation of the NIAID study: ” . . . . ‘We’ve squandered an incredible opportunity to do good science,’ [Dr. Ethan] 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.’ . . . .”
The remarkable handling of the NIAID study, the timing of the announcement of the altogether limited success of the attenuated trial and the rise in equities as a result of the announcement may be best understood in the context of the role played in Trump pandemic decision-making by an elite group of billionaires and scientists–including convicted felon Michael Milken (the “junk bond king”).
- ” . . . . Calling themselves ‘Scientists to Stop COVID-19,’ the collection of top researchers, billionaires and industry captains will act as an ‘ad hoc review board’ for the torrent of coronavirus research, ‘weeding out’ flawed data before it reaches policymakers, the Wall Street Journal reported on Monday. They are also acting as a go-between for pharmaceutical companies seeking to build a communication channel with Trump administration officials. The group . . . . has advised Nick Ayers, an aide to Vice President Mike Pence, as well as other agency heads, in the past month. Pence is heading up the White House coronavirus task force. . . .”
- ” . . . The brainy bunch is led by Thomas Cahill, a 33-year-old doctor who became a venture capitalist . . . . Cahill’s clout comes from building connections through his investment firm, Newpath Partners, with Silicon Valley’s Peter Thiel, the founder of PayPal, and billionaire businessmen Jim Palotta and Michael Milken. . . .”
Note that Peter Thiel played a dominant role in bankrolling Newpath Partners, and the other financial angel who elevated Cahill–Brian Sheth–introduced him to Tommy Hicks, Jr., the co-chairman of the RNC. In FTR #‘s 1111 and 1112, we looked at Hicks’ networking with Steve Bannon associate J. Kyle Bass, as well as his role in the inter-agency networks driving the anti-China effort.
” . . . . At the helm of the effort: The 33-year-old and very-much-under-the-radar venture capitalist Tom Cahill, who leads life sciences-focused Newpath Partners. Cahill completed his M.D. and PhD at Duke University a mere two years ago before landing at blue-chip investment firm Raptor Group through a friend. He went on to found Newpath with some $125 million after impressing well-connected names like venture capitalist Peter Thiel and Vista Equity Partners co-founder Brian Sheth. . . . It was through Sheth, for example, that Scientists to Stop Covid-19 connected with the co-chairman of the Republican National Committee, Thomas Hicks Jr. . . .”
The federal government’s extreme focus on remdesivir has been shaped, in large measure, by the influence of “Scientists to Stop COVID-19”:
- “Scientists to Stop Covid-19” is shepherding remdesivir: ” . . . . Scientists to Stop COVID-19 recommends that in this phase, the U.S. Food and Drug Administration (FDA) should work to coordinate with Gilead pharmaceuticals to focus on expediting the results of clinical trials of remdesivir, a drug identified as a potential treatment for COVID-19. The group also recommends administering doses of the drug to patients in an early stage of infection, and notes remdesivir will essentially be a placeholder until a more effective treatment is produced.
- The group is doing so by attenuating the regulatory process for coronavirus drugs: “Government entities and agencies appear to adhere to the recommendations outlined by the group, with the Journal reporting that the FDA and the Department of Veterans Affairs (VA) have implemented some of the suggestions, namely relaxing drug manufacturer regulations and requirements for potential coronavirus treatment drugs. . . .”
We conclude discussion of the remdesivir machinations with a piece about the timing of the announcement of Grogan’s departure.
” . . . . Grogan has served as the director of the White House Domestic Policy Council since February 2019, overseeing a broad array of policy issues including health care and regulation. . . . Grogan was one of the original members of the White House coronavirus task force launched in late January. . . . Grogan worked as a lobbyist for drug company Gilead Sciences before joining the Trump administration. . . .”
The departure was announced in the Wall Street Journal on the morning of Wednesday, April 29, the same day we got our first public reports of the NIAID clinical trial of remdesivir that was positive enough to show it shortened the time to recovery and the same day the FDA granted remdesivir emergency use status.
Note, again, the timing of the DSMB’s actions, as well as the influence of “Scientists to Stop Covid-19.”
In FTR #1130, we noted that Moncef Slaoui–formerly in charge of product development for Moderna–was chosen to head Trump’s “Operation Warp Speed.” He will be working with Four-Star General Gustave Perna, chosen by Chairman of the Joint Chiefs of Staff General Mark Milley.
Even after agreeing to sell his Moderna stock, Moncef Slaoui’s investments raise alarming questions–note that he is a “venture capitalist” and a longtime former executive at Glaxo-Smithkline:
- The circumstances of his appointment will permit him to avoid scrutiny: ” . . . . In agreeing to accept the position, Dr. Slaoui did not come on board as a government employee. Instead, he is on a contract, receiving $1 for his service. That leaves him exempt from federal disclosure rules that would require him to list his outside positions, stock holdings and other potential conflicts. And the contract position is not subject to the same conflict-of-interest laws and regulations that executive branch employees must follow. . . .”
- He will retain a great deal of Glaxo-Smithkline stock: ” . . . . He did not say how much his GSK shares were worth. When he left the company in 2017, he held about [500,000 in Western Print Edition] 240,000 shares and share equivalents, according to the drug company’s annual report and an analysis by the executive compensation firm Equilar. . . .”
- Further analysis of Slaoui’s position deepens concern about the integrity of the process: ” . . . . ‘This is basically absurd,’ said Virginia Canter, who is chief ethics counsel for Citizens for Responsibility and Ethics in Washington. ‘It allows for no public scrutiny of his conflicts of interest.’ Ms. Canter also said federal law barred government contractors from supervising government employees. . . . Ms. Canter, a former ethics lawyer in the Obama and Clinton administrations, the Securities and Exchange Commission and other agencies, pointed out that GSK’s vaccine candidate with Sanofi could wind up competing with other manufacturers vying for government approval and support. ‘If he retains stock in companies that are investing in the development of a vaccine, and he’s involved in overseeing this process to select the safest vaccine to combat Covid-19, regardless of how wonderful a person he is, we can’t be confident of the integrity of any process in which he is involved,’ Ms. Canter said.In addition, his affiliation with Medicxi could complicate matters: Two of its investors are GSK and a division of Johnson & Johnson, which is also developing a potential vaccine. . . .”
Next, we turn to Moderna’s animal trial for the messenger RNA vaccine it is developing. There are several considerations to be weighed in connection with the Moderna vaccine.
- Again, the chairman of Trump’s “Warp Speed” vaccine development program–Moncef Slaoui–was in charge of Moderna’s product development operation.
- Moderna’s trial with mice was positive with regard to generating antibody levels high enough to prevent ADE.
- Antibody Dependent Enhancement (ADE), is a phenomena where low levels of ineffective antibodies latch onto the virus and exacerbate an overactive immune response that leads to the deadliest symptoms likes cytokine-storms. This danger was seen with SARS and attempts to create a SARS vaccine so it’s a reasonable fear with SARS-CoV‑2.
- The Phase III (human) trial is going to be started in July, involving 30,000 people. Alarmingly, those 30,000 people will all be receiving the exact same dosage, 100 micrograms, and that means the phase III trial won’t be testing sub-optimal dosages. The big Phase III trial won’t be testing for ADE in humans.
- We may have a nightmare situation where political pressure gives undo weight to animal safety results, leapfrogging over the necessity of testing for side effects.
- The animal trials have been severely criticized: ” . . . . ‘This is the barest beginning of preliminary information,’ said Dr. Gregory Poland, an immunologist and vaccine researcher at the Mayo Clinic who has seen the paper, which has yet to undergo peer-review. Poland said the paper was incomplete, disorganized and the numbers of animals tested were small. . . . Poland, who was not involved with the research, said the paper leaves out ‘important parameters’ that could help scientists judge the work. . . .”
- We MIGHT create a vaccine that protects those who get a strong immune response while endangering those with sub-protective responses–a “eugenic” vaccine.
- ” . . . . ‘This is the barest beginning of preliminary information,’ said Dr. Gregory Poland, an immunologist and vaccine researcher at the Mayo Clinic who has seen the paper, which has yet to undergo peer-review. Poland said the paper was incomplete, disorganized and the numbers of animals tested were small. . . . Poland, who was not involved with the research, said the paper leaves out ‘important parameters’ that could help scientists judge the work. . . .”
- The phase II clinical trials on humans are still underway and won’t be completed before November. Phase III is going to be getting underway in July. The Human clinical trials are already underway at the same time the animal safety trials have yet to be completed.
- Side effects can take a while to manifest.
We provided detailed critical comments on Moderna’s Phase I trial in FTR #1132.
We conclude with a New York Times article sets forth a “Vaccine October Surprise” scenario for this fall.
” . . . . In a desperate search for a boost, he could release a coronavirus vaccine that has not been shown to be safe and effective as an October surprise. Oct. 23, 2020, 9 a.m., with 10 days before the election, Fox New releases a poll showing President Trump trailing Joe Biden by eight percentage points. Oct. 23, 2020, 3 p.m., at a hastily convened news conference, President Trump announces that the Food and Drug Administration has just issued an Emergency Use Authorization for a coronavirus vaccine. Mr. Trump declares victory over Covid-19, demands that all businesses reopen immediately and predicts a rapid economic recovery. Given how this president has behaved, this incredibly dangerous scenario is not far-fetched. In a desperate search for a political boost, he could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective. . . .”
1. A Daily Mail Online [UK] article sets forth two bogus papers contending that the SARS CoV‑2 virus was genetically engineered by the Chinese as a bioweapon in a laboratory and that it “escaped.” Note the championing of one of the papers by a former head of MI6 and the authorship of the second by The Epoch Times, the paper of the Falun Gong cult. Linked to CIA, Steve Bannon’s anti-China milieu and the Trump administration, the organization is a fascist mind control cult discussed in numerous shows, including FTR #‘s 1089 and 1090.
- “A former MI6 chief was yesterday accused by Government officials of peddling ‘fanciful claims’ that coronavirus was accidentally created in a Chinese laboratory. British security agencies believe Covid-19 is not a man-made virus and is ‘highly likely’ to have occurred naturally and spread to humans through animals. And Health Secretary Matt Hancock has said there is ‘no evidence’ to back up the theory that it originated in a laboratory. But Sir Richard Dearlove, who was head of the MI6 from 1999 to 2004, cited a recent report claiming the disease was accidentally manufactured by Chinese scientists.
- “ ‘I do think that this started as an accident,’ Sir Richard told The Daily Telegraph’s ‘Planet Normal’ podcast. ‘It raises the issue: if China ever were to admit responsibility, does it pay reparations? I think it will make every country in the world rethink how it treats its relationship with China.’ He added: ‘Look at the stories... of attempts by the [Beijing] leadership to lock down any debate about the origins of the pandemic and the way people have been arrested or silenced.’ . . . . The paper – co-authored by Professor Angus Dalgleish, a renowned oncologist and vaccine researcher who works at St George’s Hospital, University of London, and Birger Sorensen, a Norwegian virologist – contains none of the stark allegations that originally stunned its reviewers.
- “The initial paper that triggered wild rumours failed stringent tests of verification and is understood to have been rejected in April by eminent international journals such as Nature and the Journal of Virology. Biomedical experts from the Francis Crick Institute and Imperial College London are said to have refuted its conclusions. Then one of the paper’s co-authors, Dr John Fredrik Moxnes, chief scientific adviser to the Norwegian military, asked for his name to be withdrawn. This week, after numerous rewrites, the paper was published by the Quarterly Review of Biophysics Discovery. And those original world-shaking conclusions have now withered to innuendo. No accusation of Chinese manipulation appears. . . .”
- “. . . . Back in April, a slickly produced investigative documentary, Tracking Down The Origin Of The Wuhan Coronavirus, was released online. It claimed conclusive proof that the Covid-19 virus had been created as a biological ‘weapon of mass destruction’ in a Chinese lab. . . .”
- “At first sight, it seemed a shockingly convincing piece of journalism. On behalf of this newspaper, I cross-checked every claim: The experts it cited and the factual evidence unearthed. I also researched the backgrounds of its makers. I then approached some of the world’s best independent scientific authorities to ask their opinion. They all agreed – this enticingly spicy story just didn’t stand up.”
- “It had been produced by a US based anti-Chinese government media organisation called the Epoch Times. Its ‘experts’ were veteran hard-Rightists. Most damningly, its scientific ‘facts’ were twisted out of shape.So much, then, for the Chinese-manufactured coronavirus conspiracy . . .”
A former MI6 chief was yesterday accused by Government officials of peddling ‘fanciful claims’ that coronavirus was accidentally created in a Chinese laboratory.
British security agencies believe Covid-19 is not a man-made virus and is ‘highly likely’ to have occurred naturally and spread to humans through animals.
And Health Secretary Matt Hancock has said there is ‘no evidence’ to back up the theory that it originated in a laboratory.
But Sir Richard Dearlove, who was head of the MI6 from 1999 to 2004, cited a recent report claiming the disease was accidentally manufactured by Chinese scientists.
‘I do think that this started as an accident,’ Sir Richard told The Daily Telegraph’s “Planet Normal” podcast.
‘It raises the issue: if China ever were to admit responsibility, does it pay reparations? I think it will make every country in the world rethink how it treats its relationship with China.’ He added: ‘Look at the stories... of attempts by the [Beijing] leadership to lock down any debate about the origins of the pandemic and the way people have been arrested or silenced.’
Sir Richard cited a report by Professor Angus Dalgleish, from St George’s Hospital, University of London, and Norwegian virologist Birger Sorensen, which claims the virus was manufactured in a laboratory, saying the study was a ‘very important contribution to a debate which is now starting about how the virus evolved and how it got out and broke out as a pandemic.’
The study claims to have identified ‘inserted sections’ on the surface of the Covid-19 virus that were ‘significantly different’ from any other similar bug they had studied.
But the Prime Minister’s spokesman slapped down Sir Richard’s comments, saying: ‘We’ve seen no evidence the virus is man-made.’ And a Government official added: ‘These are fanciful claims. World leading scientists in the UK, US and the World Health Organisation have said numerous times... the virus was natural in its origin and likely moved into the human population through natural transfer from animals – not through a specific accident or man-made incident.’ . . . .
. . . . Back in April, a slickly produced investigative documentary, Tracking Down The Origin Of The Wuhan Coronavirus, was released online. It claimed conclusive proof that the Covid-19 virus had been created as a biological ‘weapon of mass destruction’ in a Chinese lab.
At first sight, it seemed a shockingly convincing piece of journalism.
On behalf of this newspaper, I cross-checked every claim: The experts it cited and the factual evidence unearthed. I also researched the backgrounds of its makers.
I then approached some of the world’s best independent scientific authorities to ask their opinion. They all agreed – this enticingly spicy story just didn’t stand up.
It had been produced by a US based anti-Chinese government media organisation called the Epoch Times. Its ‘experts’ were veteran hard-Rightists. Most damningly, its scientific ‘facts’ were twisted out of shape.
So much, then, for the Chinese-manufactured coronavirus conspiracy... Well, not quite. Around the time I was researching the film, I became aware of rumours emerging about a ‘blockbuster’ piece of biological science by British and Norwegian investigators to be published in a reputable journal.
Experts who were sent the paper for ‘peer review’ prior to publication were astounded because it claimed to have established ‘beyond reasonable doubt that Covid-19 is an engineered virus’.
The authors alleged the Covid-19 virus had ‘unique fingerprints’ that could not have evolved naturally, and were ‘indicative of purposive manipulation’.
In other words, someone had manufactured this virus. Who exactly? The paper reportedly concluded Covid-19 should correctly be called the ‘Wuhan virus’.
When the paper was finally published this week, it sparked global headlines, largely thanks to former head of MI6, Sir Richard Dearlove. In a newspaper podcast interview he claimed the research was smoking-gun evidence the virus pandemic had ‘started as an accident’ when a man-made virus escaped from a Chinese lab.
The paper – co-authored by Professor Angus Dalgleish, a renowned oncologist and vaccine researcher who works at St George’s Hospital, University of London, and Birger Sorensen, a Norwegian virologist – contains none of the stark allegations that originally stunned its reviewers.
The initial paper that triggered wild rumours failed stringent tests of verification and is understood to have been rejected in April by eminent international journals such as Nature and the Journal of Virology. Biomedical experts from the Francis Crick Institute and Imperial College London are said to have refuted its conclusions.
Then one of the paper’s co-authors, Dr John Fredrik Moxnes, chief scientific adviser to the Norwegian military, asked for his name to be withdrawn. This week, after numerous rewrites, the paper was published by the Quarterly Review of Biophysics Discovery. And those original world-shaking conclusions have now withered to innuendo. No accusation of Chinese manipulation appears.
The rewritten paper describes the virus as a ‘chimera’ – this means it contains the viral genetic material of more than one virus. This may occur naturally when two viruses infect a living creature at the same time.
It is the reason leading investigators believe that the Covid-19 virus acquired its pandemic powers by jumping between species.
The other definition of a ‘chimera virus’ is one that has been created in a lab as a bioweapon, but the published paper only vaguely implies foul play. In conclusion, the paper argues that: ‘A comprehensive analysis of the aetiology of the target virus is prerequisite, not optional’. ‘Aetiology’ is defined in medical terms as ‘the cause or origin’. In other words, Professor Dalgleish and his colleague are demanding to know where Covid-19 came from. . . .
2. Steve Bannon is at the epicenter of the anti-China effort and–to no one’s surprise–never really left the Trump White House.
When assessing Bannon as a political animal, one should never forget that among the important ideological influences on him is Julius Evola, an Italian fascist who found Mussolini too moderate and ultimately took his cues from the Nazi SS, who were financing his work by the end of World War II.
” . . . . Donald Trump’s lightning-rod 2016 campaign boss and former White House chief strategist who was banished from the West Wing in 2017 has quietly crept back into 1600 Pennsylvania Ave., reestablishing ties to staffers, particularly with regard to his pet issues of China and immigration. . . . Another former administration official told The Post that Bannon never really left the White House after he was fired, maintaining contacts and keeping up regular channels of communications with officials there. . . .”
. . . . Donald Trump’s lightning-rod 2016 campaign boss and former White House chief strategist who was banished from the West Wing in 2017 has quietly crept back into 1600 Pennsylvania Ave., reestablishing ties to staffers, particularly with regard to his pet issues of China and immigration.
“He does have relationships there. No question about it,” a person with knowledge of the situation told The Post. “You know who runs the trade and China policy work in the White House. You know who runs the immigration side of things, those are the people Steve is talking to.” . . . .
. . . . Another former administration official told The Post that Bannon never really left the White House after he was fired, maintaining contacts and keeping up regular channels of communications with officials there. . . .
3. An interesting summation of characteristics of a “deliberate” epidemic are evaluated against the finding that New York City was the epicenter of the U.S. Covid-19 outbreak:
Potential epidemiological clues to a deliberate epidemic:
Clue no. 1–A highly unusual event with large numbers of casualties: Check!
Clue no. 2–Higher morbidity or mortality than is expected. Check!
Clue no. 3–Uncommon disease. Check!
Clue no. 4–Point-source outbreak. Check!
Clue no. 5–Multiple epidemics. Check! (Global pandemic)
–Z. F. Dembek, et al., “Discernment Between Deliberate and Natural Infectious Disease Outbreaks”
4. The prevailing view of the Covid-19 outbreak contends that the American outbreak spread outward from New York City. The strain of SARS CoV‑2 that appeared in New York came, in turn, from Europe.
This doesn’t make sense. There were confirmed cases of the virus on the West Coast that did not come from New York. A European strain of the virus transmitted to New York City would have come in via air. In such an event, there would have been a well-documented outbreak of Covid-19 among flight attendants, who operate in close contact with passengers in cramped circumstances, as well as experiencing jet lag, which compromises the immune system.
New York City’s coronavirus outbreak grew so large by early March that the city became the primary source of new infections in the United States, new research reveals, as thousands of infected people traveled from the city and seeded outbreaks around the country.
The research indicates that a wave of infections swept from New York City through much of the country before the city began setting social distancing limits to stop the growth. That helped to fuel outbreaks in Louisiana, Texas, Arizona and as far away as the West Coast.
The findings are drawn from geneticists’ tracking signature mutations of the virus, travel histories of infected people and models of the outbreak by infectious disease experts. . . .
5. We note that the Anthrax attacks appear to have operated in overlapping contexts, including justification for the war in Iraq.
The 2001 anthrax attacks appear to have served as a provocation that justified a ten-fold increase in spending for biological warfare development. The number of BSL‑4 labs (having dual civilian and military use) increased from two in 2001, to a dozen in 2007.
This increase occurred while Donald Rumsfeld was George W. Bush’s secretary of defense. He went to that position from being Chairman of the Board of Directors for Gilead Sciences, the manufacturer of remdesivir.
We will delve into the politics of the anthrax attacks in the future.
We highlighted the 2001 anthrax attacks in connection with the Covid-19 outbreak in New York City in FTR #1128.
“The Message in the Anthrax” by Don Foster; Vanity Fair; October 2003; pp. 188–200.
. . . . Patrick’s B.g. sample was purified to a trillion spores per gram — near the theoretical limit — and better than anything ever produced by Iraq, South Africa, or the Soviet Union. An untrained eye could not differentiate it from the anthrax powder that Patrick had produced in 1959. The purpose of the exercise at Dugway, however, was defensive: to prepare our nation for a bioterror attack.
In April 1999, Patrick told Fox News that in two years there will be an attack with a sophisticated agent manufactured overseas. His prediction was not far off the mark.
By October 12, 2001, the press was reporting that Bob Stevens (case 5), the 63-year old tabloid photo editor at American Media Inc. in Boca Raton, Florida, who had mysteriously succumbed to inhalational anthrax on October 5, had been infected at work. (Inhalational anthrax comes from breathing in spores, and is far deadlier than the cutaneous form of the disease, which is usually contracted through cuts and scratches in the skin.) Spores were found throughout the A.M.I. building, with hot spots in the mailroom and on the victim’s keyboard. . . .
. . . . Powder samples from both the Brokaw and Daschle letters were couriered to Fort Detrick, headquarters of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), in Frederick, Maryland. The USAMRIID scientists were alarmed by what they discovered. It was the same stuff that had killed Bob Stevens, the tabloid photo editor, in Florida: the Ames strain, used in the U.S. biodefense program. The distribution of Ames, regulated by USAMRIID, was limited to about a dozen labs under tight security controls. Moreover, the anthrax had been weaponized, refined to its most lethal particle size of one to three microns. Most astonishing was its purity: the powder had been concentrated to a trillion spores per gram. . . .
. . . . Several of America’s bioweaponeers have said, for the record, that the anthrax attack has an upside. The killings have forced long-awaited F.D.A. approval of the Bioport anthrax vaccine facility and prompted increased federal spending on biodefense — by $6 billion in 2003 alone. But the anthrax offender also diverted law-enforcement resources when we needed them most and wreaked havoc on the U.S. Postal Service. He has shown the world how to disrupt the American economy with minimal expense, and how to kill with minimal risk of being caught.
Now that it“s been done once, it seems likely to happen again. . . .
6. In the context of the above article, note that the National Institutes of Health have also partnered with CIA and the Pentagon, as underscored by an article about a BSL‑4 lab at Boston University. Note that Europe and the U.S. have twelve BSL4 labs apiece. Taiwan has two. China has one:
- As the article notes, as of 2007, the U.S. had “more than a dozen” BSL4 labs–China commissioned its first as of 2017. a tenfold increase in funding for BSL4 labs occurred because of the anthrax attacks of 2001. Those attacks might be seen as something of a provocation, spurring a dramatic increase in “dual use” biowarfare research, under the cover of “legitimate” medical/scientific research. In FTR #1128, we hypothesized about the milieu of Stephen Hatfill and apartheid-linked interests as possible authors of a vectoring of New York City with Sars COV2: ” . . . . Before the anthrax mailings of 2001, the United States had just two BSL4 labs—both within the razor-wire confines of government-owned campuses. Now, thanks to a tenfold increase in funding—from $200 million in 2001 to $2 billion in 2006—more than a dozen such facilities can be found at universities and private companies across the country. . . .”
- The Boston University lab exemplifies the Pentagon and CIA presence in BSL‑4 facility “dual use”: ” . . . . But some scientists say that argument obscures the true purpose of the current biodefense boom: to study potential biological weapons. ‘The university portrays it as an emerging infectious disease lab,’ says David Ozonoff, a Boston University epidemiologist whose office is right across the street from the new BSL4 facility. ‘But they are talking about studying things like small pox and inhalation anthrax, which pose no public health threat other than as bioweapons.’ . . . The original NIH mandate for the lab indicated that many groups—including the CIA and Department of Defense—would be allowed to use the lab for their own research, the nature of which BU might have little control over. . . .”
“High-Stakes Science” by Jeneen Interlandi; Newsweek; 12/05/2007.
. . . . Before the anthrax mailings of 2001, the United States had just two BSL4 labs—both within the razor-wire confines of government-owned campuses. Now, thanks to a tenfold increase in funding—from $200 million in 2001 to $2 billion in 2006—more than a dozen such facilities can be found at universities and private companies across the country. . . .
. . . . But some scientists say that argument obscures the true purpose of the current biodefense boom: to study potential biological weapons. “The university portrays it as an emerging infectious disease lab,” says David Ozonoff, a Boston University epidemiologist whose office is right across the street from the new BSL4 facility. “But they are talking about studying things like small pox and inhalation anthrax, which pose no public health threat other than as bioweapons.” And when it comes to terrorism, Ozonoff says, more labs will only increase the threat of an attack. “There has been one serious bioterror incident,” he says. “That was anthrax, and it came from a biodefense lab.” While the university has repeatedly stated that the new facility will not house bioweapons research, that might not be a promise it can keep. The original NIH mandate for the lab indicated that many groups—including the CIA and Department of Defense—would be allowed to use the lab for their own research, the nature of which BU might have little control over. . . .
7a. Pivoting to discussion and review of the political, financial and corporate connections to the development of medicinal treatments for, and vaccines to prevent, Covid-19, we recap details relevant to the extraordinary timing of a 4/29 announcement of favorable results for a trial of remdesivir. That announcement drove equities markets higher and was beneficial to the stock of Gilead Sciences.
We present a Stat News article on the internal deliberations behind the decisions to modify the NIAID study. Of particular significance is the DSMB deliberation. Note the timeline of the DSMB deliberation, combined with the announcement on 4/29 that drove the markets higher.
- The decision was made to cut it short before the question of remdesivir’s impact on mortality could be answered: ” . . . .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. 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. . . .”
- In addition, patients scheduled to receive placebo received remdesivir, instead. ” . . . . 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. . . .”
- Steven Nissen was not alone in his criticism of the NIAID’s decision. ” . . . .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. . . .”
- Not only was the administration of remdesivir instead of placebo prioritized, but the NIAID study itself was attenuated! ” . . . . 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. . . .”
- The performance of the DSMB for the remdesivir study is noteworthy: ” . . . . 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. . . .”
- The DSMB meeting on 4/27 determined the switch from placebo to remdesivir. Of paramount importance is the fact that this was JUST BEFORE the 4/29 announcement that drove the markets higher and the same day on which key Trump aide–and former Gilead Sciences lobbyist Joe Grogan resigned! ” . . . . . 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. . . .”
- Dr. Ethan Weiss gave an accurate evaluation of the NIAID study: ” . . . . ‘We’ve squandered an incredible opportunity to do good science,’ [Dr. Ethan] 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.’ . . . .”
7b. The remarkable handling of the NIAID study, the timing of the announcement of the altogether limited success of the attenuated trial and the rise in equities as a result of the announcement may be best understood in the context of the role played in Trump pandemic decision-making by an elite group of billionaires and scientists–including convicted felon Michael Milken (the “junk bond king”).
- ” . . . . Calling themselves ‘Scientists to Stop COVID-19,’ the collection of top researchers, billionaires and industry captains will act as an ‘ad hoc review board’ for the torrent of coronavirus research, ‘weeding out’ flawed data before it reaches policymakers, the Wall Street Journal reported on Monday. They are also acting as a go-between for pharmaceutical companies seeking to build a communication channel with Trump administration officials. The group . . . . has advised Nick Ayers, an aide to Vice President Mike Pence, as well as other agency heads, in the past month. Pence is heading up the White House coronavirus task force. . . .”
- ” . . . The brainy bunch is led by Thomas Cahill, a 33-year-old doctor who became a venture capitalist . . . . Cahill’s clout comes from building connections through his investment firm, Newpath Partners, with Silicon Valley’s Peter Thiel, the founder of PayPal, and billionaire businessmen Jim Palotta and Michael Milken. . . .”
7c. Note that Peter Thiel played a dominant role in bankrolling Newpath Partners, and the other financial angel who elevated Cahill–Brian Sheth–introduced him to Tommy Hicks, Jr., the co-chairman of the RNC. In FTR #‘s 1111 and 1112, we looked at Hicks’ networking with Steve Bannon associate J. Kyle Bass, as well as his role in the inter-agency networks driving the anti-China effort.
” . . . . At the helm of the effort: The 33-year-old and very-much-under-the-radar venture capitalist Tom Cahill, who leads life sciences-focused Newpath Partners. Cahill completed his M.D. and PhD at Duke University a mere two years ago before landing at blue-chip investment firm Raptor Group through a friend. He went on to found Newpath with some $125 million after impressing well-connected names like venture capitalist Peter Thiel and Vista Equity Partners co-founder Brian Sheth. . . . It was through Sheth, for example, that Scientists to Stop Covid-19 connected with the co-chairman of the Republican National Committee, Thomas Hicks Jr. . . .”
7d. The federal government’s extreme focus on remdesivir has been shaped, in large measure, by the influence of “Scientists to Stop COVID-19”:
- “Scientists to Stop Covid-19” is shepherding remdesivir: ” . . . . Scientists to Stop COVID-19 recommends that in this phase, the U.S. Food and Drug Administration (FDA) should work to coordinate with Gilead pharmaceuticals to focus on expediting the results of clinical trials of remdesivir, a drug identified as a potential treatment for COVID-19. The group also recommends administering doses of the drug to patients in an early stage of infection, and notes remdesivir will essentially be a placeholder until a more effective treatment is produced.
- The group is doing so by attenuating the regulatory process for coronavirus drugs: “Government entities and agencies appear to adhere to the recommendations outlined by the group, with the Journal reporting that the FDA and the Department of Veterans Affairs (VA) have implemented some of the suggestions, namely relaxing drug manufacturer regulations and requirements for potential coronavirus treatment drugs. . . .”
7e. We conclude discussion of the remdesivir machinations with a piece about the timing of the announcement of Grogan’s departure.
” . . . . Grogan has served as the director of the White House Domestic Policy Council since February 2019, overseeing a broad array of policy issues including health care and regulation. . . . Grogan was one of the original members of the White House coronavirus task force launched in late January. . . . Grogan worked as a lobbyist for drug company Gilead Sciences before joining the Trump administration. . . .”
The departure was announced in the Wall Street Journal on the morning of Wednesday, April 29, the same day we got our first public reports of the NIAID clinical trial of remdesivir that was positive enough to show it shortened the time to recovery and the same day the FDA granted remdesivir emergency use status.
Note, again, the timing of the DSMB’s actions, as well as the influence of “Scientists to Stop Covid-19.”
“Top Trump policy adviser Joe Grogan to leave post” by Morgan Chalfant; The Hill; 04/29/2020
8a. In FTR #1130, we noted that Moncef Slaoui–formerly in charge of product development for Moderna–was chosen to head Trump’s “Operation Warp Speed.” He will be working with Four-Star General Gustave Perna, chosen by Chairman of the Joint Chiefs of Staff General Mark Milley.
Even after agreeing to sell his Moderna stock, Moncef Slaoui’s investments raise alarming questions–note that he is a “venture capitalist” and a longtime former executive at Glaxo-Smithkline:
- The circumstances of his appointment will permit him to avoid scrutiny: ” . . . . In agreeing to accept the position, Dr. Slaoui did not come on board as a government employee. Instead, he is on a contract, receiving $1 for his service. That leaves him exempt from federal disclosure rules that would require him to list his outside positions, stock holdings and other potential conflicts. And the contract position is not subject to the same conflict-of-interest laws and regulations that executive branch employees must follow. . . .”
- He will retain a great deal of Glaxo-Smithkline stock: ” . . . . He did not say how much his GSK shares were worth. When he left the company in 2017, he held about [500,000 in Western Print Edition] 240,000 shares and share equivalents, according to the drug company’s annual report and an analysis by the executive compensation firm Equilar. . . .”
- Further analysis of Slaoui’s position deepens concern about the integrity of the process: ” . . . . ‘This is basically absurd,’ said Virginia Canter, who is chief ethics counsel for Citizens for Responsibility and Ethics in Washington. ‘It allows for no public scrutiny of his conflicts of interest.’ Ms. Canter also said federal law barred government contractors from supervising government employees. . . . Ms. Canter, a former ethics lawyer in the Obama and Clinton administrations, the Securities and Exchange Commission and other agencies, pointed out that GSK’s vaccine candidate with Sanofi could wind up competing with other manufacturers vying for government approval and support. ‘If he retains stock in companies that are investing in the development of a vaccine, and he’s involved in overseeing this process to select the safest vaccine to combat Covid-19, regardless of how wonderful a person he is, we can’t be confident of the integrity of any process in which he is involved,’ Ms. Canter said.In addition, his affiliation with Medicxi could complicate matters: Two of its investors are GSK and a division of Johnson & Johnson, which is also developing a potential vaccine. . . .”
8b. Next, we turn to Moderna’s animal trial for the messenger RNA vaccine it is developing.
Mice were given Moderna’s vaccine in a range of doses, included doses expected to elicit sub-protective response. Recall that the interaction of COVID-19 with sub-protective immune responses (so low levels of antibodies that can’t prevent the disease) is one of the key safety issues to test given the possibility of Antibody Dependent Enhancement (ADE), a phenomena where low levels of ineffective antibodies latch onto the virus and exacerbate an overactive immune response that leads to the deadliest symptoms likes cytokine-storms. This danger was seen with SARS and attempts to create a SARS vaccine so it’s a reasonable fear with SARS-CoV‑2
They’re still conducting The phase II clinical trials with people and phase III is going to be getting underway in July. But that’s part of what’s kind of alarming about the situation: the Human clinical trials are already underway at the same time the animal safety trials have yet to be completed. The phase II trial is going to follow people for the next year so it won’t be completed before November. Side effects can take a while to manifest.
We may have a nightmare situation where political pressure gives undo weight to animal safety results, leapfrogging over the necessity of testing for side effects.
We MIGHT create a vaccine that protects those who get a strong immune response while endangering those with sub-protective responses–a “eugenic” vaccine.
” . . . . ‘This is the barest beginning of preliminary information,’ said Dr. Gregory Poland, an immunologist and vaccine researcher at the Mayo Clinic who has seen the paper, which has yet to undergo peer-review. Poland said the paper was incomplete, disorganized and the numbers of animals tested were small. . . . Poland, who was not involved with the research, said the paper leaves out ‘important parameters’ that could help scientists judge the work. . . .”
A series of studies in mice of Moderna Inc’s COVID-19 lent some assurance that it may not increase the risk of more severe disease, and that one dose may provide protection against the novel coronavirus, according to preliminary data released on Friday.
Prior studies on a vaccine for SARS – a close cousin to the new virus that causes COVID-19 – suggests vaccines against this type of virus might have the unintended effect of causing more severe disease when the vaccinated person is later exposed to the pathogen, especially in individuals who do not produce an adequately strong immune response.
Scientists have seen this risk as a hurdle to clear before vaccines can be safely tested in thousands of healthy people.
While the data released by the U.S. National Institutes of Allergy and Infectious Disease (NIAID) and Moderna offered some assurance, the studies do not fully answer the question.
“This is the barest beginning of preliminary information,” said Dr. Gregory Poland, an immunologist and vaccine researcher at the Mayo Clinic who has seen the paper, which has yet to undergo peer-review.
Poland said the paper was incomplete, disorganized and the numbers of animals tested were small.
The authors said they have submitted the work to a top-tier journal. Moderna’s vaccine is in midstage testing in healthy volunteers. Moderna said on Thursday it plans to begin final-stage trials enrolling 30,000 people in July.
In the animal studies, mice received one or two shots of a variety of doses of Moderna’s vaccine, including doses considered not strong enough to elicit a protective immune response. Researchers then exposed the mice to the virus.
Subsequent analyses suggest “sub-protective” immune responses do not cause what is known as vaccine-associated enhanced respiratory disease, a susceptibility to more severe disease in the lungs.
“Subprotective doses did not prime mice for enhanced immunopathology following (exposure),” Dr. Barney Graham of the Vaccine Research Center at NIAID and colleagues wrote in the manuscript, posted on the bioRxiv website.
Further testing suggested the vaccine induces antibody responses to block the virus from infecting cells.
The vaccine also appeared to protect against infection by the coronavirus in the lungs and noses without evidence of toxic effects, the team wrote.
They noted the mice that received just one dose before exposure to the virus seven weeks later were “completely protected against lung viral replication,” suggesting a single vaccination prevented the virus from replicating in the lungs.
“At first glance, it looks promising in inducing neutralizing antibody protection in mice,” Dr. Peter Hotez, a researcher at Baylor College of Medicine said in an email. He had not reviewed the paper in detail.
Poland, who was not involved with the research, said the paper leaves out “important parameters” that could help scientists judge the work. . . .
8c. The Phase III trial is going to be started in July, involving 30,000 people. Alarmingly, those 30,000 people will all be receiving the exact same dosage, 100 micrograms, and that means the phase III trial won’t be testing sub-optimal dosages. The big Phase III trial basically won’t be testing ADE in humans.
The Phase II trial is ongoing, but will not be completed before November.
We provided detailed critical comments on Moderna’s Phase I trial in FTR #1132.
On June 11, biotech company Moderna announced it had finalized plans for phase 3 testing of its COVID-19 vaccine candidate. The late-stage trial will include 30,000 participants and is expected to begin in July.
The trial will test just one dose level of the vaccine, 100 micrograms, given in two shots. . . .
The phase 2 study is ongoing, and is enrolling 600 healthy people who will be followed for a year after their injections. This stage will continue to look at the vaccine’s safety as well as collect further data on its effectiveness. This study will include more people who might be a high risk of exposure to COVID-19, such as health care workers and residents in long-term care facilities.
In June, Moderna became one of five vaccine developers chosen to be part of President Trump’s Operation Warp Speed program to speed development of a COVID-19 vaccine. The selection qualifies Moderna to receive federal government funding to continue development of vaccine, conduct tests, as well as scale up manufacturing to meet the goal of beginning to inoculate 300 million people beginning early next year. Moderna said it plans to deliver 500 million to 1 billion doses a year beginning in 2021.
8d. A New York Times article sets forth a “Vaccine October Surprise” scenario for this fall.
” . . . . In a desperate search for a boost, he could release a coronavirus vaccine that has not been shown to be safe and effective as an October surprise. Oct. 23, 2020, 9 a.m., with 10 days before the election, Fox New releases a poll showing President Trump trailing Joe Biden by eight percentage points. Oct. 23, 2020, 3 p.m., at a hastily convened news conference, President Trump announces that the Food and Drug Administration has just issued an Emergency Use Authorization for a coronavirus vaccine. Mr. Trump declares victory over Covid-19, demands that all businesses reopen immediately and predicts a rapid economic recovery. Given how this president has behaved, this incredibly dangerous scenario is not far-fetched. In a desperate search for a political boost, he could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective. . . .”
In a desperate search for a boost, he could release a coronavirus vaccine that has not been shown to be safe and effective as an October surprise.
Oct. 23, 2020, 9 a.m., with 10 days before the election, Fox New releases a poll showing President Trump trailing Joe Biden by eight percentage points.
Oct. 23, 2020, 3 p.m., at a hastily convened news conference, President Trump announces that the Food and Drug Administration has just issued an Emergency Use Authorization for a coronavirus vaccine. Mr. Trump declares victory over Covid-19, demands that all businesses reopen immediately and predicts a rapid economic recovery.
Given how this president has behaved, this incredibly dangerous scenario is not far-fetched. In a desperate search for a political boost, he could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective. . . .
. . . . By comparison, the Phase III effectiveness trial for one rotavirus vaccine, RotaTeq, to prevent diarrhea involved about 70,000 infants from 2001 to 2004 and another rotavirus vaccine trial, Rotarix, involved 63,000 infants, from 2003 to 2006.
Researchers are expecting that it will be likely to take at least another eight to 12 months to determine whether these coronavirus vaccines are effective. Scientists have to wait until a sufficient number of patients are exposed to coronavirus to see if the vaccine really reduces the infection rate, as well as how many people develop uncommon side effects. For comparison, the effectiveness trial for the rotavirus vaccines took about four years and the human papillomavirus vaccine studies to prevent cervical cancer took seven years.
So could Mr. Trump really pull an “October Surprise” with a vaccine less than five months from today? . . .
. . . . There is another scenario that is far more ominous: Three months after the N.I.H. trials begin in July — so, mid October — studies reveal many patients are developing high levels of antibodies to the coronavirus without severe side effects. As the White House did with its relentless promotion of hydroxychloroquine as a cure, it would badger the F.D.A. to permit use of the vaccine. More pressure would come from drug companies, some of whom may spend up to $1 billion on research and are intensely competing for prestige and glory. They are planning to begin manufacturing their vaccine candidates at-risk — that is, before completed studies showing their vaccine is actually effective.
Cognizant of the fate of Rick Bright — the head of the Biomedical Advanced Research and Development Authority, who was summarily demoted when he resisted the president’s wishes to ramp up purchase of hydroxychloroquine — the F.D.A. could issue an Emergency Use Authorization for one or more vaccines. These authorizations only require that the F.D.A. finds it “reasonable to believe” that a vaccine “may be effective” in preventing a life-threatening disease for it to be put on the market, without being formally licensed.
An emergency authorization would allow Mr. Trump to hold his news conference and declare victory. But like President George W. Bush’s “Mission Accomplished” proclamation, it has the potential to be a travesty. Millions of vaccines could be distributed without proof that the vaccine can prevent disease or transmission.
No vaccine since the 1950s has been approved and licensed without completing large, prospective, placebo-controlled studies of safety and effectiveness.
Even if a vaccine generates antibodies, it does not prove that the vaccine is effective at preventing infection; it only makes it more likely that the vaccine would be effective. Indeed, about half of the vaccines for other diseases that work and are on the market actually lack clear immunological correlates for protection, meaning they are effective but patients’ antibodies, immune cells or other markers do not identify whether a patient is protected. Even with the initial trials, we are likely to have scant data on whether older people will mount an immune reaction and be protected.
Giving people a false sense of being protected will most likely lead to serious outbreaks of the disease as people reduce their compliance with physical distancing and other public health measures.
If only 20,000 participants receive the vaccine, serious but rare side effects might be missed. If such harms eventually arise, it could further erode a fragile vaccine confidence and threaten the ability to get enough people vaccinated to establish herd immunity. That would be a disaster. . . .
. . . . The F.D.A. must require more than the production of antibodies to approve a vaccine, even for an emergency authorization, much less licensing. Only when the independent data safety and monitoring board composed of physicians, researchers and biostatisticians reviews the accumulated trial data to assess the safety and effectiveness of the vaccines, should the F.D.A. be allowed to decide on approval. . . .
Uncle Sam and The Swastika
Here’s a set of articles about the nature of the safety violations that got Fort Detrick shut down by the CDC last year and the steps taken to fix the problems that raise all sorts of interesting questions about whether or not the SARS-CoV‑2 could have originated from a Fort Detrick lab escape.
But whether or not the virus was released from Fort Detrick, the pair of articles also point to the kind of incredible security risks that are being undertaken in the US’s military biological warfare research that mirror those found in story of Edward Snowden, where the widespread use of contractors essentially outsourced major national security concerns to for-profit contractors. Yes, in addition to routinely giving all sorts of contractors access to incredible treasure troves of NSA state secrets that Edward Snowden was able to easily pilfer, it turns out the majority of the Fort Detrick’s laboratory staff are contractors.
Don’t forget that the only real purpose for using contractors is that they’re useful for converting government services (including biowarfare research) into profit centers for the politically-connected owners of these private contracting firms. Sometimes that profit it maximized by grossly overpaying for the contractors and skimming profits off the top. But sometimes that profit gets maximized by skimping on the background checks and training. So those profit-driven security risks were at work for Fort Detrick’s staff too.
And as we’ll see, the safety violations found by CDC include not securing access to “select agents”, which is a term for the kinds of nasty infectious diseases they were working with in the facility. So large numbers of contractors had access to the kinds of viruses found in that facility that they shouldn’t have had access to. That was the situation at Fort Detrick found in the first half of 2019...and it sounds like that’s how things were long run at the facility so who knows how many contractors have had access to all sorts of nightmare viruses found in that lab for years.
So what were the revealed details about the nature of the safety violations that got the facility shut down? Well, in January of this year, a local news outlet, ABC7, got access to CDC documents describing seven observed violations. Part of what makes these violations interesting in relation to the possibility that SARS-CoV‑2 escaped from the lab is that several of the violations involved “non-human primates” infected with a redacted “select agent” and personnel not wearing proper respiratory gear and/or opening doors that could have allowed air from rooms where these primates infected with the “select agent” were being housed or dissected to flow into areas where other personnel weren’t wearing respiratory gear. So violations involving the risk of airborne diseases were part of the reason the facility got shut down.
Another class of violation in the document involves the disposal of biological waste without wearing gloves. Recall how we’ve now learned that SARS-CoV‑2 can be spread in feces so if that biological waste involved primate feces from primates infected with SARS-CoV‑2 that would be another opportunity for infecting the staff.
Something to keep in mind regarding the nature of these mystery “select agents” is that while we know that they were infecting rhesus monkeys with Ebola in 2019 to test a possible cure, one of the violations about a non-human primate and the risk of airborne “select agents” involved BSL‑3 labs and ABSL‑3 (animal BSL‑3) labs. And as we’ve seen, Ebola research requires BSL‑4 conditions but coronaviruses only need BSL‑3. So the complaint about airborne exposure risks involving BSL‑3 and ABSL‑3 lab presumably didn’t involve Ebola. Were any of these primates being used to test remdesivir on, say, SARS or MERS (or chimeric “gain-of-function”-generated coronaviruses)?
Oh, and guess what the Ebola treatment was that they were working on with these primates: remdesivir. The trial was being conducted with Gilead. It sounds like the trial was intended to grant FDA approval for the efficacious use of remdesivir in humans for Ebola using the FDA’s Animal Rule, where the FDA may grant approval for use in humans based on data from animals when obtaining efficacy data from human patients is deemed to be not ethical or feasible. In other words, since they can’t reasonable expose people to Ebola to test the effectiveness of remdesivir for Ebola treatments rhesus monkeys can be used instead. It sounds like Gilead was still responsible for demonstrating remdesivir’s safety in humans and the Animal Rule is only being used for establishing efficacy against Ebola.
Keep in mind that remdesivir was originally developed to treat Ebola so it makes sense that remdesivir was the Ebola therapy they were testing. On the other hand, hasn’t it been tested with limited success in human Ebola patients for years? There were literally reports about testing remdesivir and other drugs on Ebola patients during an outbreak in Congo in October of 2018. So it seems pretty unnecessary to rely on the Animal Rule. But as we’ll see, part of the excitement about the rhesus monkey study was the fact that it was seen as a model for using the Animal Rule the testing for drug testing on emerging diseases. As Col. Gary Wheeler, USAMRIID commander, is quoted saying in the USAMRIID press release announcing the experiment, “For years, development of Ebola virus medical countermeasures has been subject to regulatory uncertainties regarding which models, if any, would be acceptable to the FDA as a foundation for evaluating efficacy under the Animal Rule. The study design and data-quality posture USAMRIID adopted for the Ebola virus NHS sets a precedent that has the potential to be useful for medical countermeasure development efforts targeting other similar human pathogens, such as Marburg or Sudan viruses.” So months before Fort Detrick got shut down it proudly announced a plan to infect rhesus monkeys with Ebola to get FDA approval for remdesivir use in humans under the FDA Animal Rule as a model for developing drugs for use in humans against other highly dangerous pathogens.
The USAMRIID announcment in March about this remdesivir study also mentions that the facility was audited by the FDA in January of 2019 and no objectionable conditions or practices were found. So it sounds like the FDA might need to audit their auditing practices. Or else either the practices at the facility suddenly got really bad later in 2019. Given how many of the observed violations involving infected non-human primates it’s hard to say which scenario we should expect.
So while we don’t have any specific information indicating that SARS-CoV‑2 was being researched at Fort Detrick last year, based on what we know from this CDC report we can be pretty confident that if SARS-CoV‑2 research was indeed taking placing there was a very real risk of it escaping:
“Several of the laboratory violations the CDC noted in 2019 concerned “non-human primates” infected with a “select agent”, the identity of which is unknown — it was redacted in all received documents, because disclosing the identity and location of the agent would endanger public health or safety, the agency says. In addition to Ebola, the lab works with other deadly agents like anthrax and smallpox.”
Violations involving “non-human primates” infected with mystery “select agents”. That appears to be what actually got the facility shut down by the CDC and not simply issues with the filter decontamination system like we were initially told. And these violations involving “non-human primates” follow announcements earlier in 2019 by USAMRIID that they would be infecting rhesus macaque monkeys with Ebola to test a cure they were developing which, as we’ll see below, was really an FDA efficacy trial of remdesivir that was intended to prove the efficacy of remdesivir for Ebola patients in humans using monkeys as a proxy. So while we don’t know what exactly the “select agents” were that the “non-human primates” were being infected with in these safety violations we do know it may have involved Ebola:
But as “Observation 2” describes in the CDC report, the failures of employees to follow proper training, like wearing respiratory protection when entering a room housing infected primates “in open caging” or wearing gloves while disposing of biohazardous waste, were seen in BSL‑3 and ABSL‑3 labs. That doesn’t sound like Ebola:
Then there’s the violations involving failing safeguard against unauthorized access to “select agents” and failing to maintain an accurate inventory:
Finally, note how Observations 4 hints a violations that go far beyond what was observed, saying that USAMRIID had “systematically failed to ensure implementation of biosafety and containment procedures commensurate with the risks associated with working with select agents and toxins.” So these ‘observations’ are really just examples of what was apparently a much more serious and pervasive culture of routine safety violations:
Ok, now here’s an article from October 2019 about the US Army’s plans for the changes at the facility after all these violations were discovered. And as we learn in the article, a majority of the lab workers their are contractors and –putting teeth in the contracts to ensure they’re following the shalls, wills and musts.” As they describe it, only “those personnel that have been certified through the training are going to be allowed to go back into the laboratories, and there is a solid sustainment plan to keep their skills up– we haven’t done this before.” So it sounds like certifying that these contractors having actually been trained and are actually following the training is something new for Fort Detrick:
“Training is a main focus moving forward–Talley explains that personnel working within the higher-level labs will go through certification.”
So personnel working within the “higher-level” labs will go through certification. That’s progress, although it’s not clear why the “lower-level” lab workers should be getting certified. And given all the issues with unauthorized access let’s hope these contractors are getting meaningful background checks regardless of whether or they’re working in lower-level or higher-level labs.
Finally, here’s that March 2019 USAMRIID announcement about the rhesus monkey Ebola experiments. Experiments that were intended to get FDA approval for remdesivir’s use with human Ebola patients using the Animal Rule loophole. As the letter proudly notes, the FDA audited the facility and January of 2019 and found no problems:
“USAMRIID and Gilead Sciences, Inc. worked in close partnership to develop the study plan for conducting the IM/EBOV NHS in rhesus monkeys, analyze the study outcome and submit data to the FDA. A team of over 100 USAMRIID and Geneva personnel, representing the divisions of Molecular and Translational Sciences, Virology, Telemetry, Pathology, Veterinary Medicine, Advanced Research Studies and Quality Assurance participated in the study, which was conducted in a Biosafety Level 4 (BSL‑4) laboratory under maximum containment conditions. Importantly, this project was the first-ever study to be completed in compliance with Good Laboratory Practice (GLP) standards in a BSL‑4 laboratory. In January 2019, FDA auditors visited USAMRIID to conduct a data quality and integrity inspection of USAMRIID’s GLP facilities and processes. The results of the audit were reported as “No Action Indicated,” a classification that occurs when no objectionable conditions or practices were found during the inspection.”
“No Action Indicated”. That was the result of the FDA’s inspection of the facilities. Given all the problems found by the CDC in the BSL‑3 labs you have to wonder if the FDA limited their inspection to the BSL‑4 facilities where the Ebola experiments would take place. Either way, it sounds like this was some sort of precedent-setting experiment with a study design that could be applied to the development of therapies for other highly infectious viruses like Marburg or Sudan viruses that also require BSL‑4 labs:
So if this study design could be used for BSL‑4 viruses like Ebola, what about viruses that require BSL‑3 like SARS or MERS? We know there were studies in 2018 involving remdesivir as a therapy for SARS and MERS. There would obviously be ethical issues with infecting people with those viruses too in order to test the efficacy of different drugs, so might there have been some interest using primates to test any drugs for the coronavirus family of viruses too later on in 2019?
Finally, since it sounds like the big problems found by the CDC were in BSL‑3 labs, it raises a question regarding SARS-CoV‑2 that we couldn’t really answer easily back in December when the pandemic was discovered: Based on what we know now about the SARS-CoV‑2 virus today, and all of its various dangers and ability to spread, would BSL‑3 be enough? It’s the kind of question that applies to “gain-of-function” research in general: how would researchers know in advance if the ‘gained functions’ make the virus so much more dangerous that it needs to be studied in a more secure facility? That seems like a pretty huge inherent challenge with this area of research. A pretty huge challenge on top of the general challenge of running a highly secure biowarfare facility that was clearly already overwhelming Fort Detrick in the months before this pandemic.
Here’s a pair of STAT News articles that add some important context for that United States Army Medical Research Institute of Infectious Diseases (USAMRIID) study at Fort Detrick that was announced in March of 2019 where rhesus monkeys were infected with Ebola to test the efficacy of remdesivir in humans (using the monkeys as a proxy for humans):
It turns out remdesivir was part of a human clinical trial in 2019 of four different Ebola therapies. The trial also tested the ZMAPP — a cocktail of monoclonal antibodies produced in plants that’s been previously tested on Ebola patients — and two new therapies based on monoclonal antibodies: REGN-EB3, a cocktail of three monoclonal Ebola antibodies made by Regeneron Pharmaceuticals, and mAb114, a single monoclonal antibody developed by the National Institute of Allergy and Infectious Diseases (NIAID). The two new monoclonal antibody therapies did the best and remdesivir performed by far the worst of the four.
The clinical trial originally involved enrolling 725 patients but as the data poured evidence that the monoclonal antibodies were performing much better than both remdesivir and ZMAPP. So the trial’s data and safety monitoring board modified the trial to just compare the two new antibody therapies. They also removed remdesivir and ZMAPP from the drugs being handed out for compassionate use for patients not enrolled in the trial. In other words, it was so obvious early on in the trial that remdesivir and ZMAPP were performing so poorly compared to the competition that they felt ethnically compelled to modify the trial and only give patients the new monoclonal antibodies.
The clinical trial was started in November of 2018, in the midst of an Ebola outbreak in parts of Africa. It was expected that the study would have to be a rolling study over multiple outbreaks in order to enroll enough patients to get an adequate sample size for a meaningful statistical comparison of the therapies. But it turns out there were more than enough patients to answer that question. It’s a notable outcome given that, as we saw, the decision to use the FDA’s Animal Rule as a justification for conducting efficacy tests of remdesivir against Ebola in humans using rhesus monkeys as a proxy at Fort Detrick was based on idea that animal models were an acceptable proxy when testing on human patients weren’t ethical or feasible. And as this clinical trial demonstrates it was very feasible find human Ebola patients.
How did the therapies perform? Well, early results in August of 2019 show mortality rates of 49% in people treated with ZMapp, 53% in those who received remdesivir, 34% in people treated with mAb114, and 29% for people who received REGN-EB3. The fatality rate for the outbreak as a whole was 67%. Later results released in November of 2019 based on more data that compared just mAb114 and REGN-EB3 showed patients of the monoclonal antibody treatments had around a 35% mortality rate, but it drops to around 10% in people who had relatively low viral loads when they first received the treatment. In addition, it turns out that REGN-EB3 monoclonal antibodies weren’t harvested from human Ebola patients. They were harvested from mice, which makes this the kind of treatment that could be much easier to produce at scale (although manufacturing in plants like ZMAPP is ideal).
Here’s part of what makes this story extra interesting in the context of remdesivir as a treatment for COVID-19 in the context of ‘gain-of-function’ experiments: the fact that these monoclonal antibodies perform so much better than remdesivir isn’t particularly surprising because remdesivir has long been viewed as a ‘broad spectrum’ antiviral drug whereas monoclonal antibodies are specifically designed for certain viruses. So there’s a cost and benefit to specificity and efficacy. A broad spectrum anti-viral drug simply isn’t going to be as potent as a monoclonal antibody for a given disease but it has the advantage of potentially working moderately well for a large number of viruses, especially novel emerging viruses for which we don’t already have a vaccine or monoclonal antibodiy therapy available. So remdesivir, if it works, is likely at best ‘better than nothing’ tool that’s readily available for a broad class of emerging viruses. And as this pandemic makes clear, ‘better than nothing’ is a lot better nothing. But how would we evaluate that a drug has broad spectrum antiviral capabilities against emerging viruses when they haven’t emerged yet? Well, ‘gain-of-function’ experiments would obviously be one approach to developing broad spectrum drugs. Instead of waiting for the novel viruses to pop up in the wild researchers preemptively create new viruses and test therapies against them. So the pursuit of broad spectrum drugs is part of the justification for ‘gain-of-function’ research.
Also recall how part of the excitement about the Fort Detrick remdesivir rhesus monkey trial was how it was precedent-setting and could leading to the use of animal proxies for future drug development against other diseases...a precedent that would be incredibly useful for testing drugs against ‘gain-of-function’ synthetic viruses. After all, if someone developed SARS-CoV‑2 in a lab, you can’t ethically just give that to humans but you could conceivably get approval to give it to a non-human primate as a proxy. So the system of using monkeys as human proxies is actually crucial if ‘gain-of-function’ experiments can be used for broad spectrum drug development.
And that, in turn, suggests that the worse remdesivir performs against targeted therapies like monoclonal antibodies the greater the incentive by Gilead to demonstrate its ‘broad spectrum’ efficacy’ to justify its approval for use with emerging viruses. So it would be interesting to know if the poor performance of remdesivir in this Ebola clinical trial actually made Gilead more interested in ‘gain-of-function’ research that could establish remdesivir’s broad spectrum antiviral activity because it’s clearly not the therapy of choice for Ebola at this point:
“That analysis showed REGN-EB3 was performing better than ZMapp at statistically significant rates, doing well enough that it crossed a pre-established threshold that requires altering the protocol of the study. Close behind was mAb114, which will be developed by Ridgeback Biotherapeutics. The antiviral drug remdesivir, made by Gilead, underperformed ZMapp.”
Remdesivir comes in last place. It’s better than nothing, but not so much worse than the new monoclonal antibodies that they dropped it from the trial and ended it for “compassionate use”. But Gilead assured the world that its still studying remdesivir for Ebola and other emerging diseases. It really is a ‘solution looking for a problem’:
And note the surprising abundance of Ebola patients. You have to wonder if all these patients were readily available when the Fort Detrick rhesus monkey trial to test remdesivir in Ebola patients was approved as a proxy for humans based on a lack of available human patients:
Finally, note the incredibly good news that these monoclonal antibodies could be generated in mice and not just humans:
Ok, now here’s a November 2019 STAT News article following up on the results of the clinical trial after remdesivir and ZMAPP were dropped and it just focused on the two monoclonal antibodies. The results were similar to the preliminary results, with ~35% mortality rate for patients on either therapy. But it’s when the therapy is started early that it gets really remarkable: around a 10% mortality rate.
The article also notes that researchers were puzzled that ZMAPP hadn’t performed better overall because it produced a mortality rate of around 22% in an earlier clinical trial but had around 50% in this trial. Since ZMAPP is also based on monoclonal antibodies it was suggested that this finding could indicate that the performance of monoclonal antibodies might vary from outbreak to outbreak, which wouldn’t be surprising since viruses evolve. It underscores that there really is real value in having readily available broad spectrum antivirals like remdesivir which also means the incentives for establishing the efficacy of remdesivir doesn’t necessarily go away even when it dramatically underperforms the antibody therapies:
““It was a substantial decrease [in mortality],’’ said Dr. Anthony Fauci, director of NIAID, which designed and helped conduct the trial. “When you look at people who have a low viral load,” — people who hadn’t yet progressed to severe illness when they began treatment — “it’s even more impressive. It goes down to 10%, 11%.””
A 10% mortality rate for Ebola. It’s quite impressive. But there was still reason for caution, like the fact that ZMAPP had such wildly different performance compared to a 2014–2016 trial. It raises the question of how well these new monoclonal antibodies would work against future different strains:
And regarding the reference to some antibodies found to work against all species of Ebola viruses, recall that one of the visions for the future of vaccination is using DNA vaccines that insert new genes into certain long-living cells in the body that encode for these kinds of broad spectrum antibodies in order to confer quasi-permanent protection against a range of viruses. It’s a reminder that in addition to broad spectrum drugs there’s also a race for broad spectrum antibodies. And don’t forget that broad spectrum antibody development is another type of research that would find the use of ‘gain-of-function’ experiments to generate a broad range of novel viruses and primates as proxies for human efficacy testing.
So that’s all something to keep in mind regarding the 2019 Fort Detrick remdesivir efficacy trial using rhesus monkeys as a proxy for human patients: the remdesivir is going to find its profitable niche it’s going to be have to be as a broad spectrum drug that’s better than nothing but probably not nearly as good as a targeted therapy. And one way to establish that broad spectrum status is to create a whole bunch of new viruses and then test them on primates. When it comes to drug development for viruses, a ‘solution looking for a problem’ can take on troubling incentive structures when one of the potential ‘problems’ is novel emerging viruses that we now know how to make.
We finally have the magic numbers: Gilead just released the price of remdesivir. At least the prices for COVID-19 patients in the US that will be charged to the hospitals. It’s going to costs about $5,700 for a 10-day course for private insurance patients and $3,120 for a shorter five-day course. For Medicare and Medicaid patients, hospitals will be charged $4,300 and $2,340 for the 10 and five-day courses.
For uninsured patients, the hospitals will be paid through a special fund the Trump administration set up to pay hospitals directly for the costs of coverage COVID-related treatments for the uninsured. Recall how the Trump administration refused to reopen Obamacare enrollment windows for the pandemic emergency and instead is forcing all uninsured people to rely on a hastily arranged program to pay hospitals directly for COVID treatments but there are already reports that hospitals are having a difficult time getting the Trump administration to pay for the range of treatments potentially necessarily for more severe cases and patients are getting stuck with massive bills. So it’s that troubled pool of money that’s hopefully going to be paying at least some of the costs for remdesivir for the uninsured.
It also looks like Gilead’s price decision was influenced the Institute for Clinical and Economic Review (ICER), the private non-profit that’s become the de facto drug pricing agency for the US market. Recall how the ICER is primarily funded by the health insurance industry and conservative mega-donors. Back in early May, the ICER was estimating a price of $4,500 for a 10-day trial. Then, last week, the ICER issued an update that rose the estimated price range $4,580-$5,080, but with a major caveat: that if the promising value of dexamethasone pans out in clinical trials, the price of remdesivir should drop to $2,520 — $2,800. So Gilead’s announced price range is basically a premium on top of on the high end of the ICER’s fair value estimates.
But also recall that ICER report in May that concluded that remdesivir should only cost around $4,500 per patient for a 10-day trial if its found to be effective at reducing mortality. But if it’s not found to be effective at reducing mortality the drug should cost around $390 per patient. And yet, as we’ve seen, there’s been one study that found that remdesivir appears to shorten the time to recovery for severely ill patients (from 15 to 11 days) but the study wasn’t statistically significant and the mortality rates didn’t appear to improve with the drug. Also recall a later study that found no statistically significant difference between a 5 day and 10 day course on the drug, which was the kind of result that raised real question as to whether or not the drug was helping at all. So at this point there’s a still a very real question as to whether or not the drug is actually helping patients survive, which seems like the kind of scenario that should lead to a much lower price, but nope, we’re getting the the higher price. So Gilead’s $5,700 for a 10-day course is not as high as the $10k prices some analysts were suggesting earlier but still a lot higher than the $390 the ICER suggested for a drug that doesn’t actually improve surivival rates.
Now, in terms of how much this could cost actual patients, the good-ish news is that Medicare patients will have to pay a $1,400 deductible before the rest of the expenses are covered and thanks to an annual out-of-pocket expense caps created by Obamacare there’s a maximum of $7,300 per person that can be charged annually for people with private insurance. So there’s a good chance people with private insurance will pay thousands of dollars for remdesivir but they probably won’t pay the entire cost because the overall cost of a 10 day hospital stay with remdesivir will be far more than $7,300 and include much more than the price of remdesivir alone.
As the following Vox article describes, there’s also logistical questions raised by the fact the Gilead is charging different prices for private insurance vs Medicare/Medicaid patients because hospitals usually buy drugs in bulk without known which patients will receive them. According to one expert, Peter Bach at Memorial Sloan Kettering, this decision could reflect a cynical strategy on the part of Gilead: Medicare generally pays hospitals one bulk amount for each diagnosis but sometimes it created a separate line of a payament known as a “new tech add-on payment”, or NTAP for new treatments. Bach speculates that Gilead could be hoping that by charging a lower price for Medicare patients the company is enticing the Trump administration into setting up an NTAP for remdesivir. This would mean that hospitals would be paid separately for the costs of remdesivir treatments when treating patients instead of having those costs covered by the bundled price Medicare pays per patient diagnosis, thus encouraging hospitals to prescribe more remdesivir to patients overall. In other worlds, Gilead might have the expectation that it can maximize profits by maximizing the volume of sales by setting a price point for Medicare/Medicaid patients that encourages the government to set up an NTAP and remove the hospitals’ cost concerns about prescribing the drug. Isn’t the US drug pricing system fun?
Perhaps the biggest shock in this story is that it sounds like a number of drug pricing experts were surprised by the price. Specifically, surprising by how cheap it is and speculating that it didn’t choose a higher price point because it didn’t want bad press. This is $5,700 for a drug that arguably doesn’t do anything but maybe shortens the time to recovery...maybe...and that’s considered surprising cheap by the standards of the US drug pricing systems:
” As the Wall Street Journal covered, the sales price to hospitals will be about $5,700 for a private insurance patient getting the longer 10-day course, and that $3,120 price tag for the shorter one. For patients covered by Medicare and other government programs, the price will be a little bit lower: $2,340 for the shorter treatment and about $4,300 for the longer one.”
It’s not the most expensive price analysts were predicted but this certainly isn’t on the cheap end either. And the primary benefit patients are getting from the drug appears to shorter hospital stays. And this is the price Gilead chose despite dexamethasone performing even better in clinical trials at reducing hospital stays and really being readily available and quite cheap. What would Gilead’s price have been without those dexamethasone clinical trial results:
And yet the lower price Gilead chose for Medicare/Medicaid was apparently so much less than expected that one expert, Peter Bach, speculated that it could be a strategy intended to entice the Trump administration into setting up an NTAP for the drug to encourage hospitals to prescribe it more often for Medicare and Medicaid patients. Will the administration also set up an NTAP for dexamethasone or other cheaper alternatives if the clinical trials pan out for those therapies? We’ll see but that’s also going to be something to watch:
Finally, note the one piece of actual good-ish news: the out-of-pocket annual expense caps created by Obamacare are going to be limiting the total hospital-stay costs for people with private insurance. But as Bach reminds us, it’s not like those costs aren’t being felt by individual patients. They just end up being indirectly paid costs that are still leaching money out of the economy. It’s a big reason hospital stays are so wildly expensive in the US — that’s part of how these indirect costs are paid realized:
And that points to one of ultimate irony question about the cost of remdesivir: the clinical justification for paying the high price of the drug is the possible shortening of the hospital stay and reducing the outrageously high price of in-patient hospital care in the US which, in turn, is heavily driven by the broken US health care system and drug pricing that creates all sort indirect hidden costs.
To summarize, Gilead managed to find a price that’s vastly more than it probably should charge based on the available clinical evidence and yet it still much cheaper than analysts expected when compared to the cost of other drugs in the US. So there is some good news, but it’s limited to Obamacare’s annual expense caps and the existence of dexamethasone.
There was some new research on the SARS-CoV‑2 virus that appears to confirm many of the suspicions raised by previous studies and could have big implications on the hope of tracing the origins and history of this outbreak:
A team working for the La Jolla Institute for Immunology and the Coronavirus Immunotherapy Consortium just published a study in Cell that builds on the earlier work out of Los Alamos National Laboratory. Recall how the Los Alamos team found that a strain of the virus that contained the D614G mutation — a mutation to the genome of the virus that also changes the amino acid structure of virus’s spike protein — and discovered that the strains of the virus with the newer G‑mutation appeared to spread have much better than the earlier D‑strains. The G‑strain is so much better that when this form of the virus moves into an area that already had a widespread D‑strain outbreak the G‑strain would complete overtake it. It was the kind of study that had big possible implications in terms of developing a vaccine because vaccines are likely to target the spike-protein and viruses with varying spike proteins might be more vaccine-resistant. But it also had big potential implications in terms of tracing the history of the viral outbreak because the ability of the G‑strain to overtake earlier D‑strain outbreaks means that traces of those earlier outbreaks using phylogenetic tree analysis would be effectively wiped out.
This new study basically confirms the findings and suspicions of that Los Alamos study. They found that the G‑strain does indeed spread more effectively than the D‑strain because it somehow reproduces more rapidly in the upper-respiratory tract. The researchers quantified that the G‑strain is about 3–9 times more infectious than the D‑strain. Interestingly, though, it doesn’t appear to be more lethal. So the number of viral copies in the upper-respiratory tract doesn’t make the virus ultimately more deadly which is is surprising but at least it’s a rare pleasant SARS-CoV‑2 surprise.
Crucially for the goal of vaccine development, they found that antibodies from patients in San Diego who previously contracted the older D‑strain were just as effective, if not more effective, at neutralizing the newer G‑strain. This is seen as a test of whether or not modifications to the spike protein might break the effectiveness of vaccines that are going to be targeting the spike protein. More good news.
Finally, they confirmed that the G‑strain is basically the virus at this point. It has virtually completely overtaken the D‑strain almost everywhere. But there are a few exceptions like Santa Clara County, California, where the D‑strain still survives somehow and Iceland where the G‑strain never arrived. That makes Santa Clara County a potentially invaluable region for exploring earlier outbreaks in the US. In theory, if you sampled a large number of viral strains from Santa Clara patients you should be able to construct a phylogenetic tree showing the evolution of outbreak in the area that could allow you to estimate how long it’s been circulating in the area, something that’s no longer possible everywhere else where all of the viral samples gathered are going to come from the new G‑strain that arrived in the US from Europe.
So it’s going to be interesting to see if there’s an extra effort to identify and aggressively sample the virus in Santa Clara County or any other areas that are found to still harbor the D‑strain. Keep in mind that recent analysis by Tom Squitieri in the American Prospect where he found a strong correlation between infections at US military bases and the basses that housed the military athletes who attended the 2019 Military World Games in Wuhan. It hinted at older outbreaks of the less aggressive D‑strain that could be circulating around all sorts of military bases. But those older strains won’t be circulating for much longer with the new G‑strain having almost entirely replaced it. And that’s all what makes this new research potentially so significant: it tells us something about what to expect in terms of future vaccine development but also tells us something about what to expect in terms of our current ability to retrospectively examine how and where the outbreak ultimately started:
“This is now the virus.”
This is now the virus. That’s how wildly successful that D‑to‑G mutation has been. Virtually all of the new cases are the G‑strain, even in areas where the D‑strain was already prevalent. Except Santa Clara County for some reason:
And this new research isn’t just looking at statistics and making inferences. They tested the virus in the lab and found that, yes, the G‑strain really is more infectious and that appears to be due to faster reproduction in the upper respiratory tract. And yet this mutation doesn’t appear to make it more deadly. Crucially, the mutation doesn’t appear to inhibit the antibodies developed to fight the older D‑strain. In fact, D‑strain antibodies appear to be even better at neutralizing the G‑strain virus. So a change in the spike protein that made the virus more effective at spreading didn’t break the ability of an older antibody to kill it. In terms of vaccine development prospects that’s exceptionally good news:
So as we can see, there’s plenty of the good news and bad news coming out of this study. Intertwined bad and good news: it’s bad news that the virus managed to mutate in a manner that made it so much better at spreading that this new strain has almost entirely overtaken the old strain. And it’s bad news that this way this new strain spreads more effectively is by reproducing more rapidly in the upper respiratory tract. And it’s very bad news that this mutation took place on the spike protein. And yet it’s great news that the G‑strain of the virus doesn’t appear to be any deadlier despite producing more copies of the virus. And it’s incredibly good news that antibodies against the D‑strain are just as effective if not more effective against the G‑strain. It’s hard to say whether or not it was net-good or net-bad news but it could clearly be worse.
Is there another major global pandemic on the way? That’s the warning we just got from a team of Chinese researchers who have reportedly discovered a strain of swine flu similar to the strain behind the 2009 swine flu outbreak. And while it doesn’t sound like there have been any human-to-human transmissions with this new strain, which the researchers call G4 EA H1N1, the researchers have detected signs of recent infections when they looked at data on Chinese abattoir and swine industry workers from 2011 to 2018. So this virus is circulating in an environment where it repeatedly has opportunities to evolve greater abilities to infect humans.
At least that was the initial report from these Chinese researchers. As we’ll see in the second article below, the Chinese agriculture ministry has already come out in opposition to the study after holding a seminar in the G4 virus. Or at least opposition to how the study has led to all sorts of warnings in the media about a new virus emerging from China. The ministry announced that the study is too small to be representative and that it lacks adequate evidence to show the virus now the dominant strain among pigs. In addition, the ministry asserts that this strain has been monitored continuously by the World Health Organization (WHO) and related agencies since 2011. In addition, the ministry issued a statement saying authors of the study agreed the that G4 virus does not effectively replicate in the human body and cause disease.
So we have a team of Chinese researchers who are warning that they’ve found evidence of a strain of the H1N1 that’s been repeatedly infecting humans since 2011 and is very well positioned to become a future human global pandemic followed by the Chinese agriculture ministry downplaying those concerns by pointing out that the WHO has been monitoring this strain the whole time and there’s no evidence it’s a full-blown human-infecting virus yet. The take home message being that we shouldn’t panic quite yet about the potential pandemic but we should definitely be preparing to panic:
“While it is not an immediate problem, they say, it has “all the hallmarks” of being highly adapted to infect humans and needs close monitoring.”
It’s not a nightmare virus yet, but it has all of the hallmarks of being a future viral nightmare. It’s already demonstrated an ability to infect human cells that line human airways and has already been infecting humans potentially for close to a decade now:
The good news is that at least it sounds like a vaccine should be relatively easy to create for it. In addition, the 2009 strain was less deadly than feared apparently because older people have been previously exposed to similar strains that were already circulating and had built up a degree of immunity. So the good news is ironically that humanity has been flirting with this pandemic long enough that some degree of immunity already exists in the populace:
But the Chinese agriculture ministry had a decidedly defensive response to this study. The ministry held a seminar of experts to discuss the dangers posed by the virus and concluded that there was no new threat posed that wasn’t already understood and being monitored:
“The participants concurred that the G4 virus is not new, the statement said. Furthermore, such a strain has been monitored continuously by the World Health Organization (WHO) and related agencies in China since 2011, the statement said, citing a senior WHO official.”
It’s an interesting rebuttal to the warnings of a new potential pandemic: the virus isn’t actually new and the WHO has been monitoring it since 2011. On the one hand, it’s reassuring to hear that Chinese and global authorities have indeed been keeping an eye on this virus since 2011. On the other hand, the fact that this virus is been sporadically infecting humans since at least 2011 sounds like exactly the kind of scenario that would give the virus time and opportunity to evolve the features required to become the nightmare virus we’re being warned about.
All in all, this is certainly going to be a virus to keep in eye on. Or at least keep an eye on the institutions tasked with keeping an eye on this virus. And that’s part of what makes this story so significant: this new G4 virus is a great candidate to develop better systems for monitoring and detecting emerging viral outbreaks. We know the virus is widely circulating in swine and can already infect humans. Will humanity detect the seemingly inevitable G4 outbreak in time? And will it make a difference even if it is detected early on? As the SARS-CoV‑2 experience is teaching us, when a virus is infectious enough it’s basically impossible to eliminate it without a vaccine once it’s already circulating widely enough and that means early detection is crucial.
And then there’s the obvious nightmare scenario about engineered forms of G4 getting strategically released, a scenario that only got more tempting after China’s agriculture ministry downplayed the seriousness of this warning. It’s a scenario that points towards one step China, and the rest of the world, can take right now to reduce the odds of a future viral outbreak, whether natural or strategically man-made: end the kind of industrial scale factory farming that is exactly the kind of environment where we would expect a nightmare virus to emerge. There’s already plenty of other reasons to end factory farming. But as all the questions about the origins of the SARS-CoV‑2 virus has amply demonstrated, we are now living the age of synthetic biology and man-made viruses. If a group wants to sabotage China in a massive way and a trigger new global depression, releasing some sort of engineer G4 virus near a Chinese hog farm is an obvious play at this point and relatively cheap and easy to do. But it’s not limited to Chinese hog farms. Any country with large-scale factory farming industry (like the US) is a country vulnerable to both the viruses that inevitably emerge under factory-farming conditions but also man-made viruses that can be plausibly released near a factory farm. Factory farming is quite simply an invitation for both natural pandemics and bio-economic-warfare. So when the G4 virus or one of its viral cousins does eventually trigger an outbreak it’s going to be important to keep in mind that emerging viral pandemics, whether natural or man-made, are just one of the many costs of factory farmed meat and it’s an optional cost humanity is choosing to pay.
The New York Times had a recent piece detailing the work done by Steve Bannon and Guo Wengui to effectively create a Chinese COVID-19 ‘whistleblower’, Dr. Li-Meng Yan. Dr. Yan, an infectious disease expert who was involved with the Chinese study of the initial coronavirus outbreak in December, although she doesn’t appear to be an actual coronavirus expert. In mid-January, Yan reached out to Wang Dinggang, a YouTube host and close associated of Guo. Yan reportedly initially reached out to Wang about the rumors she had been hearing rumors about the Chinese government downplaying the severity of the virus. Within days, Wang was telling his audience of around 100,000 that he was in contact with a Chinese whistleblower who informed him the virus was deliberately released by the Chinese government. Interestingly, Wang also appears to be the first person to seed the rumor that Hunter Biden is involved with child sex trafficking, so he’s appears to be the kind of propagandist that specializes in making up hyper-salacious stories for his audience. Wang and Guo have joined Bannon in his crusade to convince the public the 2020 election was rigged
Wang’s January show about Dr. Yan apparently caught the attention of Steve Bannon. A few months later, Wang was telling Yan she needed to flee to Hong Kong for her safety. Guo was going to pay for her travel, first class. On April 28, she left from the airport and a couple weeks later she surfaced in the US, where Bannon and Guo immediately set out to train her to become a public ‘whistleblower’ for English-speaking audiences. On July 10, Yan revealed her identity for the first time during a 13-minute interview on the Fox New website. After thing, Yan began what is described as a whirlwind tour of right-wing media, culminating in a September 15 interview on Tucker Carlson’s show on Fox News, the most watched show on cable news. By this point the story was mainstreamed. During that interview, Carlson ask Yan if the Chinese government deliberately released the virus and she said, of course, yes China released it intentionally.
All in all, it’s a familiar sounding story of how the right-wing disinfotainment complex operates and builds myths and narratives. But the article also makes a point that hints at this right-wing disinfotainment complex becoming a much bigger influence on Chinese-language audiences in coming years: Due to the fact that most Chinese language media content is controlled by the Chinese government, there isn’t really a large non-Chinese-government-controlled media available to fact-check the growing alliance between Chinese dissidents and Western far right media figures. The global Chinese-language audience is going to be subjected to the same kind of fact-free anything-goes make-it-up-as-you-go media environment that has long captivated conservative audiences in the West. It’s a psychosocial mega-disaster in the making:
“Mr. Wang, who was a businessman in China before moving to the United States for unknown reasons, is part of a growing group of commentators that have emerged on the Chinese-language internet. Their shows, which mix punditry, serious analysis and outright rumor, cater to a diaspora that often does not trust Chinese state media and has few reliable sources of news in its native language.”
There’s a Chinese-language media credibility vacuum and figures like Wang Dinggang and Guo Wengui are filling it. In coordination with Steve Bannon. The merger of English-language and Chinese-langauge disinfotainment. It’s the larger emerging story here the promises to provide all sorts of future stories of coordinated disinformation campaigns. Disinformation campaigns like proudly presenting Dr. Yan as the world class coronavirus expert despite her not actually having studied coronaviruses before the outbreak:
And disinformation campaigns that aren’t limited to podcasts on the internet but are propelled by major media outlets like Fox News. When Yan was interviewed by Tucker Carlson in September she was being interviewed on the most watched show on cable news. You can’t get more mainstream than that:
And this joint-disinformation effort between the Western far right and Chinese dissidents is a two-way street. Increasingly, Chinese-language audiences are being fed US far right media content. And yet, Wang Dinggang is also the guy who reportedly first floated the meme that Hunter Biden was involved in child sex-trafficking. It’s like cross-cultural disinformation synergy:
It’s that two-way street nature of this relationship that also raises a significant question for English-language audiences: Assuming Trump leaves office — and proceeds to set up his own right-wing media empire as many expect — what kind of role with figures like Guo and Wang have in Trump’s future media empire? And what kind of impact will the fusion of Chinese dissidents with the American far right have on the politics of Chinese-American community? Are we watching the slow-motion mainstreaming of the radicalization of the Chinese-American community?
And in the short term, what role is the Chinese dissident community media — including Trump-allied the Epoch Times — going to have in US politics over the next four years during and ostensible Biden administration? As we’ve seen, The Epoch Times is now a leading source of information for American conservatives. What type of role will the Chinese dissident media in US politics? Are we also watching the beginning of the rise of Chinese dissident media as a major source of American conservative media content going forward? It’s a grimly fascinating question. There is clearly a shared interest and the financial resources to cultivate these kind of disinfotainment media outlets for years to come. That’s a recipe for a lot of synergistic malicious myth-making.