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FTR #1134 Bio-Psy-Op Apocalypse Now, Part 9: Covid-19 Updates

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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

  1. “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.
  2. “ ‘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.
  3. “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. . . .”
  4. “. . . . 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. . . .”
  5. “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.”
  6. “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: 

Bit­ten: The Secret His­to­ry of Lyme Dis­ease and Bio­log­i­cal Weapons by Kris New­by; Harper­Collins [HC]; Copy­right 2019 by Kris New­by; ISBN 9780062896728; p. 185.

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:

  1. 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. . . .”
  2. 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.

  1. 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. . . .”
  2. 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. . . .”
  3. 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. . . .”
  4. 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. . . .”
  5. 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. . . .”
  6. 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. . . .”
  7. 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”).

  1. ” . . . . 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 pol­i­cy­mak­ersthe 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. . . .”
  2. ” . . . 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”:

  1. “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.
  2. 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:

  1. 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. . . .”
  2. 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. . . .”
  3. 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.

  1. Again, the chair­man of Trump’s “Warp Speed” vac­cine devel­op­ment program–Moncef Slaoui–was in charge of Mod­er­na’s prod­uct devel­op­ment oper­a­tion.
  2. Mod­er­na’s tri­al with mice was pos­i­tive with regard to gen­er­at­ing anti­body lev­els high enough to pre­vent ADE.
  3. 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.
  4. 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. 
  5. 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. 
  6. 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. . . .”
  7. We MIGHT cre­ate a vac­cine that pro­tects those who get a strong immune response while endan­ger­ing those with sub-pro­tec­tive responses–a “eugenic” vac­cine.
  8. ” . . . . ‘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. . . .”
  9. 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.
  10. 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

  1. “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.
  2. “ ‘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.
  3. “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. . . .”
  4. “. . . . 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. . . .”
  5. “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.”
  6. “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 . . .”

“Spy chief in coro­n­avirus storm: Down­ing Street hits out at for­mer MI6 boss Richard Dearlove’s ‘fan­ci­ful’ claims that Covid-19 was made in a lab” by Lar­isa Brown; The Dai­ly Mail; 6/4/2020.

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. . . .”

“Steve Ban­non Is Qui­et­ly Creep­ing Back into the White House” by Jon Levine; The New York Post; 5/9/2020.

. . . . 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: 

Bit­ten: The Secret His­to­ry of Lyme Dis­ease and Bio­log­i­cal Weapons by Kris New­by; Harper­Collins [HC]; Copy­right 2019 by Kris New­by; ISBN 9780062896728; p. 185.

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.

“Trav­el From New York City Seed­ed U.S. Out­breaks” by Bene­dict Carey and James Glanz; The New York Times; 5/7/2020.

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:

  1. 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. . . .”
  2. 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.

  1. 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. . . .”
  2. 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. . . .”
  3. 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. . . .”
  4. 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. . . .”
  5. 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. . . .”
  6. 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. . . .”
  7. 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.’ . . . .”

“Inside the NIH’s con­tro­ver­sial deci­sion to stop its big remde­sivir study” by Matthew Her­p­er; Stat News; 05/11/2020

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”).

  1. ” . . . . 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 pol­i­cy­mak­ersthe 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. . . .”
  2. ” . . . 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. . . .”

“Sci­en­tists, bil­lion­aires team up to aid White House in coro­n­avirus bat­tle” by Mark Moore; New York Post; 04/28/2020

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. . . .”

“The ven­ture cap­i­tal­ist at the cen­ter of the coro­n­avirus fight” BY LUCINDA SHEN; For­tune; 04/28/2020

7d. The fed­er­al gov­ern­men­t’s extreme focus on remde­sivir has been shaped, in large mea­sure, by the influ­ence of “Sci­en­tists to Stop COVID-19”:

  1. “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.
  2. 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. . . .”

“Elite group of sci­en­tists and bil­lion­aires are work­ing togeth­er to fight the coro­n­avirus pan­dem­ic” by Alexan­dra Kel­ley; The Hill; 04/28/2020

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:

  1. 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. . . .”
  2. 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. . . .”
  3. 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. . . .”

“Trump’s Vac­cine Chief Has Vast Ties to Drug Indus­try, Pos­ing Pos­si­ble Con­flicts” by Sheila Kaplan, Matthew Gold­stein and Alexan­dra Steven­son; The New York Times; 5/21/2020.

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. . . .”

“Mod­er­na COVID-19 vac­cine appears to clear safe­ty hur­dle in mouse study” by Julie Steen­huy­sen; Reuters; 06/12/2020.

 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.

“Mod­er­na Plans To Start Phase 3 Test­ing of its COVID-19 Vac­cine Can­di­date in July” by Alice Park; Time; 06/11/2020

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. 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. . . .”

“Could Trump Turn a Vac­cine Into a Cam­paign Stunt?” by Ezekiel J. Emanuel and Paul A. Offit; The New York Times; 06/08/2020

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. . . .

 

 

Discussion

3 comments for “FTR #1134 Bio-Psy-Op Apocalypse Now, Part 9: Covid-19 Updates”

  1. 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:

    ABC7 WJLA

    Army germ lab shut down by CDC in 2019 had sev­er­al ‘seri­ous’ pro­to­col vio­la­tions that year

    by Diana DiGan­gi
    Wednes­day, Jan­u­ary 22nd 2020

    FREDERICK, Md. — In 2019, an Army lab­o­ra­to­ry at Fort Det­rick that stud­ies dead­ly infec­tious mate­r­i­al like Ebo­la and small­pox was shut down for a peri­od of time after a CDC inspec­tion, with many projects being tem­porar­i­ly halt­ed.

    The lab itself report­ed that the shut­down order was due to ongo­ing infra­struc­ture issues with waste­water decon­t­a­m­i­na­tion, and the CDC declined to pro­vide the rea­son for the shut­down due to nation­al secu­ri­ty con­cerns.

    ABC7 has received doc­u­ments from the CDC out­lin­ing vio­la­tions they dis­cov­ered dur­ing a series of inspec­tions that year, some of which were labeled “seri­ous.”

    Ear­li­er that year, the US Army Med­ical Research Insti­tute had announced an exper­i­ment at the Fort Det­rick lab­o­ra­to­ry that would involve infect­ing rhe­sus macaque mon­keys with active Ebo­la virus to test a cure they were devel­op­ing.

    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.

    Select agents are defined by the CDC as “bio­log­i­cal agents and tox­ins that have been deter­mined to have the poten­tial to pose a severe threat to pub­lic health and safe­ty, to ani­mal and plant health, or to ani­mal or plant prod­ucts.”

    ...

    OBSERVATION 1

    Sever­i­ty lev­el: Seri­ous

    The CDC report­ed that an indi­vid­ual par­tial­ly entered a room mul­ti­ple times with­out the required res­pi­ra­to­ry pro­tec­tion while oth­er peo­ple in that room were per­form­ing pro­ce­dures with a non-human pri­mate on a necrop­sy table.

    “This devi­a­tion from enti­ty pro­ce­dures result­ed in a res­pi­ra­to­ry occu­pa­tion­al expo­sure to select agent aerosols,” the CDC wrote.

    OBSERVATION 2

    Sever­i­ty lev­el: Seri­ous

    The CDC report­ed that the lab did not ensure that employ­ee train­ing was prop­er­ly ver­i­fied when it came to tox­ins and select agents.

    “These fail­ures were rec­og­nized through video review of lab­o­ra­to­ri­ans’ work­ing in BSL3 and ABSL3 labs,” their report said. “[These] indi­cate the [lab]’s means used to ver­i­fy per­son­nel under­stood the train­ing had not been effec­tive, lead­ing to increased risk of occu­pa­tion­al expo­sures.”

    The CDC went on to spec­i­fy that a lab­o­ra­to­ri­an who was not wear­ing appro­pri­ate res­pi­ra­to­ry pro­tec­tion was seen mul­ti­ple times “par­tial­ly enter­ing” a room where non-human pri­mates that were infect­ed with [redact­ed] were “housed in open caging.” They also observed a lab­o­ra­to­ri­an dis­pos­ing of waste in a bio­haz­ardous waste bin with­out gloves on.

    OBSERVATION 3

    Sever­i­ty lev­el: Mod­er­ate

    In this vio­la­tion obser­va­tion, the CDC went into more detail on the inci­dent of the work­er not wear­ing gloves while dis­pos­ing of bio­haz­ardous waste, writ­ing that “biosafe­ty and con­tain­ment pro­ce­dures must be suf­fi­cient to con­tain the select agent or tox­in.”

    The cor­rec­tive action they rec­om­mend­ed was to con­firm that rel­e­vant per­son­nel have been trained to wear gloves to pre­vent expo­sure to haz­ardous mate­ri­als.

    OBSERVATION 4

    Sever­i­ty lev­el: Seri­ous

    In this obser­va­tion, the CDC notes that the Unit­ed States Army Med­ical Research Insti­tute of Infec­tious Dis­eases had “sys­tem­at­i­cal­ly failed to ensure imple­men­ta­tion of biosafe­ty and con­tain­ment pro­ce­dures com­men­su­rate with the risks asso­ci­at­ed with work­ing with select agents and tox­ins.”

    The vio­la­tion specif­i­cal­ly observed involved “enti­ty per­son­nel [...] prop­ping open” a door while remov­ing “large amounts of bio­haz­ardous waste” from an adja­cent room, “[increas­ing] the risk of con­t­a­m­i­nat­ed air from [the room] escap­ing and being drawn into the [redact­ed]” where the peo­ple work­ing “typ­i­cal­ly do not wear res­pi­ra­to­ry pro­tec­tion.”

    OBSERVATION 5

    Sever­i­ty lev­el: Mod­er­ate

    The CDC report­ed that the lab­o­ra­to­ry failed to safe­guard against unau­tho­rized access to select against. They wrote that per­son­al pro­tec­tive equip­ment worn while decon­t­a­m­i­nat­ing some­thing con­t­a­m­i­nat­ed by a select agent had been stored in open bio­haz­ard bags, in an area of the facil­i­ty that the CDC has redact­ed for secu­ri­ty rea­sons.

    “By stor­ing reg­u­lat­ed waste in this area, the enti­ty did not lim­it access to those with access approval,” they wrote.

    OBSERVATION 6

    Sever­i­ty lev­el: Mod­er­ate

    The CDC reports that some­one at the lab did not main­tain an accu­rate or cur­rent inven­to­ry for a tox­in.

    OBSERVATION 7

    Sever­i­ty lev­el: Low

    The CDC reports that a build­ing at the Fort Det­rick lab­o­ra­to­ry didn’t have a “sealed sur­face to facil­i­tate clean­ing and decon­t­a­m­i­na­tion.” This includ­ed cracks around a con­duit box, cracks in the ceil­ing, and a crack in the seam above a bio­log­i­cal safe­ty cab­i­net.

    ————

    “Army germ lab shut down by CDC in 2019 had sev­er­al ‘seri­ous’ pro­to­col vio­la­tions that year” by Diana DiGan­gi; ABC7 WJLA; 01/22/2020

    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:

    ...
    Ear­li­er that year, the US Army Med­ical Research Insti­tute had announced an exper­i­ment at the Fort Det­rick lab­o­ra­to­ry that would involve infect­ing rhe­sus macaque mon­keys with active Ebo­la virus to test a cure they were devel­op­ing.

    ...

    Select agents are defined by the CDC as “bio­log­i­cal agents and tox­ins that have been deter­mined to have the poten­tial to pose a severe threat to pub­lic health and safe­ty, to ani­mal and plant health, or to ani­mal or plant prod­ucts.”
    ...

    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:

    ...
    OBSERVATION 2

    Sever­i­ty lev­el: Seri­ous

    The CDC report­ed that the lab did not ensure that employ­ee train­ing was prop­er­ly ver­i­fied when it came to tox­ins and select agents.

    “These fail­ures were rec­og­nized through video review of lab­o­ra­to­ri­ans’ work­ing in BSL3 and ABSL3 labs,” their report said. “[These] indi­cate the [lab]’s means used to ver­i­fy per­son­nel under­stood the train­ing had not been effec­tive, lead­ing to increased risk of occu­pa­tion­al expo­sures.”

    The CDC went on to spec­i­fy that a lab­o­ra­to­ri­an who was not wear­ing appro­pri­ate res­pi­ra­to­ry pro­tec­tion was seen mul­ti­ple times “par­tial­ly enter­ing” a room where non-human pri­mates that were infect­ed with [redact­ed] were “housed in open caging.” They also observed a lab­o­ra­to­ri­an dis­pos­ing of waste in a bio­haz­ardous waste bin with­out gloves on.

    OBSERVATION 3

    Sever­i­ty lev­el: Mod­er­ate

    In this vio­la­tion obser­va­tion, the CDC went into more detail on the inci­dent of the work­er not wear­ing gloves while dis­pos­ing of bio­haz­ardous waste, writ­ing that “biosafe­ty and con­tain­ment pro­ce­dures must be suf­fi­cient to con­tain the select agent or tox­in.”

    The cor­rec­tive action they rec­om­mend­ed was to con­firm that rel­e­vant per­son­nel have been trained to wear gloves to pre­vent expo­sure to haz­ardous mate­ri­als.
    ...

    Then there’s the vio­la­tions involv­ing fail­ing safe­guard against unau­tho­rized access to “select agents” and fail­ing to main­tain an accu­rate inven­to­ry:

    ...
    OBSERVATION 5

    Sever­i­ty lev­el: Mod­er­ate

    The CDC report­ed that the lab­o­ra­to­ry failed to safe­guard against unau­tho­rized access to select against. They wrote that per­son­al pro­tec­tive equip­ment worn while decon­t­a­m­i­nat­ing some­thing con­t­a­m­i­nat­ed by a select agent had been stored in open bio­haz­ard bags, in an area of the facil­i­ty that the CDC has redact­ed for secu­ri­ty rea­sons.

    “By stor­ing reg­u­lat­ed waste in this area, the enti­ty did not lim­it access to those with access approval,” they wrote.

    OBSERVATION 6

    Sever­i­ty lev­el: Mod­er­ate

    The CDC reports that some­one at the lab did not main­tain an accu­rate or cur­rent inven­to­ry for a tox­in.
    ...

    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:

    ...
    OBSERVATION 4

    Sever­i­ty lev­el: Seri­ous

    In this obser­va­tion, the CDC notes that the Unit­ed States Army Med­ical Research Insti­tute of Infec­tious Dis­eases had “sys­tem­at­i­cal­ly failed to ensure imple­men­ta­tion of biosafe­ty and con­tain­ment pro­ce­dures com­men­su­rate with the risks asso­ci­at­ed with work­ing with select agents and tox­ins.”

    The vio­la­tion specif­i­cal­ly observed involved “enti­ty per­son­nel [...] prop­ping open” a door while remov­ing “large amounts of bio­haz­ardous waste” from an adja­cent room, “[increas­ing] the risk of con­t­a­m­i­nat­ed air from [the room] escap­ing and being drawn into the [redact­ed]” where the peo­ple work­ing “typ­i­cal­ly do not wear res­pi­ra­to­ry pro­tec­tion.”
    ...

    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:

    WDVM

    Army lead­er­ship share details on changes made to reopen Fort Det­rick labs

    by: Jas­mine Pelaez
    Post­ed: Oct 9, 2019 / 06:18 PM EDT
    Updat­ed: Oct 9, 2019 / 06:18 PM EDT

    FREDERICK, Md. (WDVM) — Octo­ber marks three months since the clo­sure of U.S. Army med­ical research lab­o­ra­to­ries at Fort Det­rick.

    ...

    Army lead­er­ship from Fort Det­rick report­ed to mem­bers of the Con­tain­ment Lab­o­ra­to­ry Com­mu­ni­ty Advi­so­ry Com­mit­tee Tues­day to address the sus­pen­sion of biosafe­ty lev­el 3 and 4 labs at the Unit­ed States Army Med­ical Research Insti­tute of Infec­tious Dis­eases (USAMRIID).

    “We’ve had to make adjust­ments. We can’t keep doing things the way we’ve always done it,” explained Com­mand­ing Gen­er­al for Med­ical Research and Devel­op­ment Com­mand at Fort Det­rick, Brigadier Gen­er­al Mike Tal­ley

    The labs were closed down on July 18 after a cease and desist order by the Cen­ter for Dis­ease Con­trol and Pre­ven­tion (CDC) after find­ing mechan­i­cal issues and human error in treat­ing lab­o­ra­to­ry waste­water.

    ...

    Tal­ley out­lined that CDC per­son­nel have been embed­ded in the labs. Progress includes review­ing about 31 stan­dard oper­at­ing pro­ce­dures, and adding more non-com­mis­sioned offi­cer involve­ment.

    “A major­i­ty of our lab­o­ra­to­ry work­ers are contractors–putting teeth in the con­tracts to ensure they’re fol­low­ing the shalls, wills and musts are things we’ve done in the inter­im,” said Tal­ley.

    Train­ing is a main focus mov­ing forward–Talley explains that per­son­nel work­ing with­in the high­er-lev­el labs will go through cer­ti­fi­ca­tion.

    “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,” Tal­ley explained.

    May­or Michael O’Connor says the plans do sound promis­ing to ensure com­mu­ni­ty safe­ty, but com­mu­ni­ca­tion is key.

    “The ongo­ing com­mu­ni­ca­tion is what’s real­ly crit­i­cal. When there’s any kind of inci­dent at the Fort that the com­mu­ni­ty could learn about, it’s impor­tant for us in lead­er­ship to hear about that before we read about it in the news­pa­per,” O’Connor said.

    Army lead­er­ship aims to con­struct a new steam ster­il­iza­tion plant at Fort Det­rick. This will be put out for bid world­wide.

    ————

    “Army lead­er­ship share details on changes made to reopen Fort Det­rick labs” by Jas­mine Pelaez; WDVM; 10/09/2019

    “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:

    http://www.usamriid.army.mil

    FOR IMMEDIATE RELEASE: CONTACT: Caree Van­der Lin­den
    March 28, 2019 (301) 619‑2285 Fort Det­rick, MD teresa.l.vanderlinden.civ@mail.mil

    USAMRIID Research Pro­vides Reg­u­la­to­ry Frame­work for Devel­op­ing Ebo­la Virus Ther­a­peu­tic under FDA “Ani­mal Rule”

    The U.S. Army Med­ical Research Insti­tute of Infec­tious Dis­eases (USAMRIID) today announced that, for the first time, the U.S. Food and Drug Admin­is­tra­tion (FDA) has pro­vid­ed for­mal reg­u­la­to­ry agree­ment for use of an ani­mal mod­el to sup­port devel­op­ment of a drug can­di­date, remde­sivir, for treat­ing dead­ly Ebo­la virus (EBOV)infections. This agree­ment was made pos­si­ble through a 2018 Nat­ur­al His­to­ry Study (NHS) of Ebo­la virus con­duct­ed by USAMRIID in close col­lab­o­ra­tion with Gilead Sci­ences, Inc., the spon­sor of remde­sivir devel­op­ment, and The Gene­va Foun­da­tion (Gene­va), and fund­ed by the Joint Project Man­ag­er for Med­ical Coun­ter­mea­sure Sys­tems (JPM-MCS), a com­po­nent of the U.S. Depart­ment of Defense’s Joint Pro­gram Exec­u­tive Office for Chem­i­cal, Bio­log­i­cal, Radi­o­log­i­cal and Nuclear Defense.

    Specif­i­cal­ly, FDA agreed that the rhe­sus macaque, infect­ed by intra­mus­cu­lar (IM) injec­tion, is a rel­e­vant and ade­quate­ly char­ac­ter­ized mod­el of Ebo­la virus dis­ease to sup­port fil­ing under the FDA Ani­mal Rule. In addi­tion, the agency agreed that the rhe­sus IM/EBOV dis­ease mod­el is suf­fi­cient as a sin­gle ani­mal mod­el for ther­a­peu­tic prod­uct devel­op­ment. Notably, FDA also agreed that a spe­cif­ic delayed time-to-treat approach is appro­pri­ate for future non­clin­i­cal stud­ies aimed at char­ac­ter­iz­ing the effi­ca­cy of remde­sivir.

    Spon­sors must demon­strate effi­ca­cy before a med­ical prod­uct can be approved by the FDA; how­ev­er, for cer­tain prod­ucts, when obtain­ing effi­ca­cy data from human patients is not eth­i­cal or fea­si­ble, the FDA may grant approval under the Ani­mal Rule. Such approval would be based on effi­ca­cy data from well-con­trolled stud­ies in ade­quate­ly char­ac­ter­ized ani­mal model(s), when the results of those stud­ies estab­lish that the drug can­di­date is rea­son­ably like­ly to pro­duce clin­i­cal ben­e­fit in humans. The spon­sor must still demon­strate the product’s safe­ty in humans.

    “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,” said COL Gary Wheel­er, USAMRIID com­man­der. “The study design and data-qual­i­ty pos­ture USAMRIID adopt­ed for the Ebo­la virus NHS sets a prece­dent that has the poten­tial to be use­ful­for med­ical coun­ter­mea­sure devel­op­ment efforts tar­get­ing oth­er sim­i­lar human pathogens, such as Mar­burg or Sudan virus­es.

    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.

    “To date, there are no FDA-approved ther­a­peu­tics for treat­ment of Ebo­la virus dis­ease. Both the cur­rent out­break in the Demo­c­ra­t­ic Repub­lic of Con­go and the 2014–2016 West Africa out­break, the largest in his­to­ry, high­light the urgent need for antivi­ral ther­a­py to com­bat this dead­ly dis­ease. We are com­mit­ted to devel­op­ing our inves­ti­ga­tion­al antivi­ral agent, remde­sivir, for the treat­ment of Ebo­la virus infec­tion using the Ani­mal Rule or oth­er appro­pri­ate reg­u­la­to­ry path­way based on feed­back from FDA,” said John McHutchi­son, AO, MD, Chief Sci­en­tif­ic Offi­cer and Head of Research and Devel­op­ment, Gilead Sci­ences, Inc. Remde­sivir is an inves­ti­ga­tion­al agent and is not approved by any reg­u­la­to­ry agency glob­al­ly. Its safe­ty and effi­ca­cy have not been estab­lished.“

    This project is a tes­ta­ment to the effi­cien­cy of pub­lic-pri­vate part­ner­ship to accel­er­ate the devel­op­ment of crit­i­cal­ly need­ed med­ical coun­ter­mea­sures,” said COL David Ham­mer, Joint Project Man­ag­er for Med­ical Coun­ter­mea­sure Sys­tems. “We can advance prod­ucts more quick­ly when we work togeth­er to lever­age the skills of mul­ti­ple orga­ni­za­tions.”

    The NHS was con­duct­ed as part of the over­all remde­sivir devel­op­ment plan, and prod­uct-inde­pen­dent qual­i­fi­ca­tion of the rhe­sus IM/EBOV mod­el through the FDA Ani­mal Mod­el Qual­i­fi­ca­tion Pro­gram has not been sought or obtained.

    ...

    —————

    “USAMRIID Research Pro­vides Reg­u­la­to­ry Frame­work for Devel­op­ing Ebo­la Virus Ther­a­peu­tic under FDA “Ani­mal Rule”” by Caree Van­der Lin­den; http://www.usamriid.army.mil; 03/28/2019

    “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:

    ...
    Specif­i­cal­ly, FDA agreed that the rhe­sus macaque, infect­ed by intra­mus­cu­lar (IM) injec­tion, is a rel­e­vant and ade­quate­ly char­ac­ter­ized mod­el of Ebo­la virus dis­ease to sup­port fil­ing under the FDA Ani­mal Rule. In addi­tion, the agency agreed that the rhe­sus IM/EBOV dis­ease mod­el is suf­fi­cient as a sin­gle ani­mal mod­el for ther­a­peu­tic prod­uct devel­op­ment. Notably, FDA also agreed that a spe­cif­ic delayed time-to-treat approach is appro­pri­ate for future non­clin­i­cal stud­ies aimed at char­ac­ter­iz­ing the effi­ca­cy of remde­sivir.

    Spon­sors must demon­strate effi­ca­cy before a med­ical prod­uct can be approved by the FDA; how­ev­er, for cer­tain prod­ucts, when obtain­ing effi­ca­cy data from human patients is not eth­i­cal or fea­si­ble, the FDA may grant approval under the Ani­mal Rule. Such approval would be based on effi­ca­cy data from well-con­trolled stud­ies in ade­quate­ly char­ac­ter­ized ani­mal model(s), when the results of those stud­ies estab­lish that the drug can­di­date is rea­son­ably like­ly to pro­duce clin­i­cal ben­e­fit in humans. The spon­sor must still demon­strate the product’s safe­ty in humans.

    “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,” said COL Gary Wheel­er, USAMRIID com­man­der. “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 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.

    Posted by Pterrafractyl | June 24, 2020, 3:01 pm
  2. 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:

    STAT News

    For the first time, clin­i­cal tri­al results show Ebo­la drugs improve sur­vival rates

    By Helen Bran­swell
    August 12, 2019

    A his­toric clin­i­cal tri­al has shown that two ther­a­pies made from Ebo­la anti­bod­ies appear to be improv­ing sur­vival rates among peo­ple who receive them, health offi­cials announced Mon­day. The announce­ment marks the first time a clin­i­cal tri­al has suc­cess­ful­ly shown that an Ebo­la ther­a­py improves sur­vival in peo­ple who have been infect­ed.

    Two oth­er ther­a­pies used in the clin­i­cal tri­al per­formed less well and will be dis­con­tin­ued.

    The ther­a­pies that have improved sur­vival rates are 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, part of the Nation­al Insti­tutes of Health. The clin­i­cal tri­al will con­tin­ue com­par­ing these two drugs in Ebo­la treat­ment cen­ters in the Demo­c­ra­t­ic Repub­lic of the Con­go.

    “It means that we do have now what looks like treat­ments for a dis­ease which not too long ago we real­ly had no ther­a­peu­tic approach at all,” said Dr. Antho­ny Fau­ci, direc­tor of NIAID.

    “We feel that with agents such as these … that we may be able to improve the sur­vival of peo­ple with Ebo­la and … might even make peo­ple more enthu­si­as­tic about com­ing for care,” he said. “Because when you have some­thing to offer an indi­vid­ual, it makes it much more like­ly that you might get to them ear­ly. And the ear­li­er the bet­ter, as in any dis­ease.”

    A num­ber of clin­i­cal tri­als were start­ed near the end of the 2014–2016 West African Ebo­la out­break, but they either revealed that pro­posed ther­a­pies did not work or failed to reach a result before the out­break end­ed.

    One of the drugs test­ed in West Africa, ZMapp, had shown a sig­nal that it was improv­ing sur­vival, but the out­break end­ed before the tri­al could con­clude. In the cur­rent clin­i­cal tri­al, called the PALM study — the acronym stands for Pamo­ja Tulinde Maisha, which is Swahili for Togeth­er Save Lives — three ther­a­peu­tics were test­ed against ZMapp.

    The orig­i­nal plan for the tri­al involved enrolling 725 patients. But the trial’s data and safe­ty mon­i­tor­ing board, which has con­duct­ed spo­radic reviews of the data, ana­lyzed find­ings based on 499 patients late last week.

    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.

    The board decid­ed the tri­al should be revamped to test REGN-EB3 and mAB114 against each oth­er. Remde­sivir and ZMapp have been dropped from the tri­al.

    The clin­i­cal tri­al was con­duct­ed at Ebo­la treat­ment cen­ters in Beni, Kat­wa, Butem­bo, and Mang­i­na, all hotspots at var­i­ous points in the out­break. Patients who are cared for in treat­ment cen­ters that are not involved in the tri­al have been receiv­ing the drugs under com­pas­sion­ate use pro­to­cols. Going for­ward, only the two drugs will be used in those cir­cum­stances as well.

    Dr. Sumathi Siva­palasingam, Regeneron’s med­ical lead on the REGN-EB3 project, said the com­pa­ny was in a state of shock. They had expect­ed the drug to work, she said, but were still sur­prised at how well it per­formed vis-à-vis the oth­er ther­a­pies.

    There were only lim­it­ed and pre­lim­i­nary data avail­able at this point. But they showed 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 the Regen­eron cock­tail. The fatal­i­ty rate for the out­break as a whole is 67%.

    Leah Lip­sich, Regeneron’s vice pres­i­dent for strate­gic pro­gram direc­tion, said the com­pa­ny believes it has ade­quate sup­plies of REGN-EB3, with cur­rent stock “in the high hun­dreds” of dos­es, with anoth­er round of pro­duc­tion about to start.

    The NIH has about 300 dos­es of mAb114 at the moment, Fau­ci said, with addi­tion prod­uct com­ing avail­able in ear­ly Sep­tem­ber.

    To date more than 1,400 peo­ple have received one of the exper­i­men­tal ther­a­pies.

    The results put into ques­tion the future of ZMapp, the first mon­o­clon­al anti­body prepa­ra­tion to be used to fight Ebo­la.

    ...

    A state­ment from Gilead said the com­pa­ny remains com­mit­ted to study­ing remde­sivir as a pos­si­ble treat­ment for Ebo­la and oth­er emerg­ing viral dis­eases. “A full analy­sis of the PALM tri­al data will help to inform future study [and] use of remde­sivir. Poten­tial learn­ings may include insight into the impact of viral strain and sever­i­ty of dis­ease pro­gres­sion on treat­ment strate­gies and the poten­tial for both sin­gle agent and com­bi­na­tion treat­ment approach­es,” it said.

    The new results are based on a tri­al that was start­ed last Novem­ber. At the time, it was thought that it might take mul­ti­ple Ebo­la out­breaks before researchers had enough data. It was designed to be a rolling tri­al that could incor­po­rate data from future out­breaks in oth­er coun­tries, if need­ed.

    But the ongo­ing out­break in the Demo­c­ra­t­ic Repub­lic of the Con­go, now in its sec­ond year, has been so large there were enough patients enrolled to come up with answers.

    The out­break, occur­ring in the north­east­ern provinces of North Kivu and Ituri, is the sec­ond largest on record. To date, 2,831 peo­ple have been infect­ed with the virus, and near­ly 1,900 have died.

    Dr. Jean-Jacques Muyem­be, direc­tor of DRC’s Nation­al Insti­tute of Bio­med­ical Research, and the first sci­en­tist to pro­pose using blood from Ebo­la sur­vivors to help peo­ple suf­fer­ing from the dis­ease, said for years he could not have imag­ined the devel­op­ment announced Mon­day, pre­dict­ing thou­sands of lives will be saved in future Ebo­la out­breaks.

    — An ear­li­er ver­sion of this sto­ry report­ed the anti­bod­ies from both of the suc­cess­ful treat­ments were derived from Ebo­la sur­vivors. In fact the Regen­eron anti­bod­ies were gen­er­at­ed in mice.

    ————-

    “For the first time, clin­i­cal tri­al results show Ebo­la drugs improve sur­vival rates” by Helen Bran­swell; STAT News; 08/12/2019

    “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’:

    ...
    The orig­i­nal plan for the tri­al involved enrolling 725 patients. But the trial’s data and safe­ty mon­i­tor­ing board, which has con­duct­ed spo­radic reviews of the data, ana­lyzed find­ings based on 499 patients late last week.

    ...

    The board decid­ed the tri­al should be revamped to test REGN-EB3 and mAB114 against each oth­er. Remde­sivir and ZMapp have been dropped from the tri­al.

    The clin­i­cal tri­al was con­duct­ed at Ebo­la treat­ment cen­ters in Beni, Kat­wa, Butem­bo, and Mang­i­na, all hotspots at var­i­ous points in the out­break. Patients who are cared for in treat­ment cen­ters that are not involved in the tri­al have been receiv­ing the drugs under com­pas­sion­ate use pro­to­cols. Going for­ward, only the two drugs will be used in those cir­cum­stances as well.

    ...

    There were only lim­it­ed and pre­lim­i­nary data avail­able at this point. But they showed 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 the Regen­eron cock­tail. The fatal­i­ty rate for the out­break as a whole is 67%.

    Leah Lip­sich, Regeneron’s vice pres­i­dent for strate­gic pro­gram direc­tion, said the com­pa­ny believes it has ade­quate sup­plies of REGN-EB3, with cur­rent stock “in the high hun­dreds” of dos­es, with anoth­er round of pro­duc­tion about to start.

    ...

    A state­ment from Gilead said the com­pa­ny remains com­mit­ted to study­ing remde­sivir as a pos­si­ble treat­ment for Ebo­la and oth­er emerg­ing viral dis­eases. “A full analy­sis of the PALM tri­al data will help to inform future study [and] use of remde­sivir. Poten­tial learn­ings may include insight into the impact of viral strain and sever­i­ty of dis­ease pro­gres­sion on treat­ment strate­gies and the poten­tial for both sin­gle agent and com­bi­na­tion treat­ment approach­es,” it said.
    ...

    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:

    ...
    The new results are based on a tri­al that was start­ed last Novem­ber. At the time, it was thought that it might take mul­ti­ple Ebo­la out­breaks before researchers had enough data. It was designed to be a rolling tri­al that could incor­po­rate data from future out­breaks in oth­er coun­tries, if need­ed.

    But the ongo­ing out­break in the Demo­c­ra­t­ic Repub­lic of the Con­go, now in its sec­ond year, has been so large there were enough patients enrolled to come up with answers.
    ...

    Final­ly, note the incred­i­bly good news that these mon­o­clon­al anti­bod­ies could be gen­er­at­ed in mice and not just humans:

    ...
    — An ear­li­er ver­sion of this sto­ry report­ed the anti­bod­ies from both of the suc­cess­ful treat­ments were derived from Ebo­la sur­vivors. In fact the Regen­eron anti­bod­ies were gen­er­at­ed in mice.
    ...

    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:

    STAT News

    Two Ebo­la treat­ments yield ‘sub­stan­tial decrease’ in mor­tal­i­ty, land­mark tri­al shows

    By Helen Bran­swell
    Novem­ber 27, 2019

    Final data from a land­mark clin­i­cal tri­al of four Ebo­la ther­a­pies con­duct­ed in the cur­rent out­break in the Demo­c­ra­t­ic Repub­lic of the Con­go show two of the drugs dra­mat­i­cal­ly reduced the risk of dying from the dis­ease, espe­cial­ly in peo­ple who start­ed treat­ment quick­ly after onset of their ill­ness.

    Find­ings of the PALM tri­al, pub­lished in the New Eng­land Jour­nal of Med­i­cine on Wednes­day, show that two treat­ments based on Ebo­la anti­bod­ies led to a sur­vival rate of about 65% in treat­ed patients, com­pared to 33% in the out­break over­all.

    Put anoth­er way, about 35% of the patients treat­ed with a mon­o­clon­al anti­body cock­tail called REGN-EB3 made by Regen­eron Phar­ma­ceu­ti­cals and a sin­gle mon­o­clon­al anti­body devel­oped by the Nation­al Insti­tute for Aller­gy and Infec­tious Dis­eases called mAb114 suc­cumbed to their infec­tions. The over­all mor­tal­i­ty rate in the out­break, which enters its 17th month next week, stands at 67%.

    “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%.”

    The tri­al test­ed the two treat­ments against a third anti­body prod­uct, ZMapp, and the antivi­ral drug remde­sivir, made by Gilead Sci­ences. They did not per­form as well, sav­ing only about half of the patients who were treat­ed with one of those two ther­a­pies.

    The tri­al began in Novem­ber of last year, even­tu­al­ly enrolling 673 peo­ple who were ran­dom­ized to get one of the four treat­ments. It end­ed ear­ly, in August of this year, because an inter­im analy­sis showed the two drugs were sta­tis­ti­cal­ly bet­ter than ZMapp and remde­sivir. It was con­duct­ed under extra­or­di­nar­i­ly dif­fi­cult con­di­tions. The part of DRC where the out­break is occur­ring has been a con­flict zone for decades; two of the four Ebo­la treat­ment cen­ters where the tri­al was con­duct­ed were fire­bombed ear­li­er this year.

    Eri­ca Oll­mann Saphire, a sci­en­tist whose research focus­es on mon­o­clon­al anti­bod­ies for Ebo­la and oth­er dis­eases, was impressed by the study — and that it was even able to be con­duct­ed.

    “I think a lot of us were not sure that we would ever see this,” said Oll­mann Saphire, a pro­fes­sor at the La Jol­la Insti­tute for Immunol­o­gy.

    Under the topline find­ings were some inter­est­ing and even puz­zling results.

    The per­cent­age of patients in the tri­al who said they’d been vac­ci­nat­ed with Merck’s Ebo­la vac­cine was 25% — high­er than might be expect­ed giv­en the vac­cine is esti­mat­ed to be about 95% effec­tive. How­ev­er, at least half of those peo­ple had been vac­ci­nat­ed for few­er than 10 days when they became ill, sug­gest­ing the vac­cine hadn’t had time to gen­er­ate a pro­tec­tive response.

    Near­ly 40% of that group of patients — 60 patients in total — said they had been vac­ci­nat­ed more than 10 days before get­ting sick, at which point they should have been pro­tect­ed.

    But these are self-report­ed data. In an email, a World Health Orga­ni­za­tion spokes­woman said data like these can be sub­ject to recall bias; peo­ple may not accu­rate­ly remem­ber when they were vac­ci­nat­ed or know the dif­fer­ence between a vac­cine or a drug. “WHO’s analy­sis of vac­cine data … show vac­cine effi­ca­cy around 95% at 10 or more days after vac­ci­na­tion,” she said.

    The authors of the PALM study did not check the names of their patients against the mas­ter list of the more than 255,000 peo­ple who have been vac­ci­nat­ed in this out­break. To date, just over 3,300 peo­ple have been infect­ed and near­ly 2,200 have died.

    Data released last spring by the WHO sug­gest­ed that peo­ple who were vac­ci­nat­ed were less like­ly to die if they devel­oped Ebo­la. Fau­ci said the data in the PALM tri­al indi­cate the vac­cine may pro­vide a sur­vival advan­tage to peo­ple who lat­er con­tract Ebo­la, but the study was not designed to exam­ine that and can­not con­clude that defin­i­tive­ly.

    Oll­man Saphire said mAb114 per­formed bet­ter than she had expect­ed, giv­en that it is a sin­gle anti­body, not a cock­tail of sev­er­al anti­bod­ies. The fear with a sin­gle anti­body is that the virus will evolve to escape it, which is hard­er to do with a cock­tail of anti­bod­ies. She not­ed, though, that this will have to be mon­i­tored as the ther­a­py con­tin­ues to be used in this and in future out­breaks.

    ...

    Inter­est­ing­ly, the study authors not­ed the patients who ran­dom­ly received remde­sivir and ZMapp were gen­er­al­ly sick­er than those who received REGN-EB3 and mAb114 — which could have affect­ed the out­come.

    They flagged anoth­er fac­tor that may have con­tributed to poor­er per­for­mance of ZMapp and remde­sivir. Both were giv­en in treat­ments over a longer peri­od of time. REGN-EB3 and mAb114 were giv­en in a sin­gle dose. And because ZMapp is infused slow­ly, patients who came in late in the day who were ran­dom­ized to get it didn’t start treat­ment until the fol­low­ing day.

    The authors not­ed that it was puz­zling that ZMapp hadn’t per­formed as well in this tri­al as it did in a tri­al in West Africa dur­ing the 2014–2016 Ebo­la out­break. There, mor­tal­i­ty among peo­ple who received the anti­body cock­tail — made by Mapp Bio­phar­ma­ceu­ti­cals — was 22%. In the PALM tri­al, it was 50%. Fau­ci said more study is under­way to try to fig­ure out why the out­comes were so dif­fer­ent.

    Gary Kob­inger, the sci­en­tist who led the devel­op­ment of ZMapp, said that dif­fer­ence could be a red flag, sig­nal­ing that out­comes from the use of anti­body prepa­ra­tions may vary from out­break to out­break.

    Still, Kob­inger, direc­tor of the Infec­tious Dis­ease Research Cen­ter at Laval Uni­ver­si­ty in Que­bec, said the most impor­tant mes­sage of the study is that mon­o­clon­al anti­bod­ies are effec­tive in treat­ing Ebo­la. For years, sci­en­tists argued the oppo­site, he said.

    Going for­ward, it will be impor­tant to devel­op bet­ter anti­body prod­ucts, he said, not­ing some anti­bod­ies that work against all species of Ebo­la virus­es have been iden­ti­fied and their devel­op­ment should be fast-tracked. This out­break is caused by Zaire ebolavirus­es. Treat­ments that tar­get it alone would prob­a­bly not be effec­tive against Sudan ebolavirus­es or oth­ers in the fam­i­ly.

    “I think the take-home mes­sage is … the approach is good, it’s promis­ing. And there are bet­ter treat­ments,” Kob­inger said.

    ———–

    “Two Ebo­la treat­ments yield ‘sub­stan­tial decrease’ in mor­tal­i­ty, land­mark tri­al shows” by Helen Bran­swell; STAT News; 11/27/2019

    ““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:

    ...
    The authors not­ed that it was puz­zling that ZMapp hadn’t per­formed as well in this tri­al as it did in a tri­al in West Africa dur­ing the 2014–2016 Ebo­la out­break. There, mor­tal­i­ty among peo­ple who received the anti­body cock­tail — made by Mapp Bio­phar­ma­ceu­ti­cals — was 22%. In the PALM tri­al, it was 50%. Fau­ci said more study is under­way to try to fig­ure out why the out­comes were so dif­fer­ent.

    Gary Kob­inger, the sci­en­tist who led the devel­op­ment of ZMapp, said that dif­fer­ence could be a red flag, sig­nal­ing that out­comes from the use of anti­body prepa­ra­tions may vary from out­break to out­break.

    Still, Kob­inger, direc­tor of the Infec­tious Dis­ease Research Cen­ter at Laval Uni­ver­si­ty in Que­bec, said the most impor­tant mes­sage of the study is that mon­o­clon­al anti­bod­ies are effec­tive in treat­ing Ebo­la. For years, sci­en­tists argued the oppo­site, he said.

    Going for­ward, it will be impor­tant to devel­op bet­ter anti­body prod­ucts, he said, not­ing some anti­bod­ies that work against all species of Ebo­la virus­es have been iden­ti­fied and their devel­op­ment should be fast-tracked. This out­break is caused by Zaire ebolavirus­es. Treat­ments that tar­get it alone would prob­a­bly not be effec­tive against Sudan ebolavirus­es or oth­ers in the fam­i­ly.
    ...

    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.

    Posted by Pterrafractyl | June 25, 2020, 4:27 pm
  3. 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:

    Vox

    Why a Covid-19 drug costs $3,100

    If you’re expe­ri­enc­ing some stick­er shock, don’t pan­ic — too much.

    By Dylan Scott
    Jun 29, 2020, 5:20pm EDT

    Remde­sivir, the antivi­ral drug that appears to reduce the recov­ery time for hos­pi­tal­ized Covid-19 patients, has a price tag: $3,120 for the typ­i­cal five-day reg­i­ment for a patient on pri­vate insur­ance. Gilead, the drug’s man­u­fac­tur­er, announced the news on Mon­day.

    The drug has been one of the most promis­ing treat­ments, reduc­ing the hos­pi­tal stay for Covid patients by sev­er­al days in ear­ly tri­als. Remde­sivir has been around for a while, but, as you might recall, drug dis­cov­ery experts have always thought this was the most promis­ing avenue for an effec­tive treat­ment to come on the mar­ket quick­ly: repur­pos­ing an exist­ing drug to fight Covid-19. The Food and Drug Admin­is­tra­tion autho­rized the emer­gency use of remde­sivir in May.

    But here in Amer­i­ca, where even peo­ple who have health insur­ance cov­er­age can often face high med­ical bills, the news of the drug’s promise was quick­ly fol­lowed by the ques­tion: Yeah, but what’s it going to cost?

    Now we have an answer — or the start of one, at least. Let’s get into it.

    How much are patients going to pay for remde­sivir?

    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.

    If you’re expe­ri­enc­ing some stick­er shock, don’t pan­ic — too much. These are the prices at which Gilead is sell­ing the drug to hos­pi­tals. Patients will gen­er­al­ly not be asked to pay the stick­er price, although their out-of-pock­et costs will depend on their health insur­er. (Unin­sured patients are sup­posed to have their costs cov­ered by the gov­ern­ment, although there are ques­tions about whether enough fund­ing is avail­able.)

    Med­ic­aid patients will be asked to pay very lit­tle, if any­thing. Medicare patients will have their treat­ment cov­ered by the program’s inpa­tient ben­e­fit, which has a $1,400 deductible before costs are ful­ly cov­ered. Deductibles vary for peo­ple with com­mer­cial health insur­ance, but because of the ACA, there is a hard cap (about $7,300 per per­son) on annu­al out-of-pock­et costs.

    So the bad news is, if you are in the hos­pi­tal for Covid-19, the cost of your med­ical care is like­ly to exceed those lim­its. Your bills would include not only any drugs you might receive, but also room charges, doc­tor fees, etc. Those typ­i­cal­ly add up to thou­sands of dol­lars on their own.

    But the good news is, because those out-of-pock­et lim­its are in place, you won’t bear the full brunt of those costs. The addi­tion of remde­sivir shouldn’t add much to your bot­tom line if you’re already being hos­pi­tal­ized.

    “In effect, this is good news for patients,” Sta­cie Duset­z­i­na, a health pol­i­cy pro­fes­sor at the Van­der­bilt Uni­ver­si­ty School of Med­i­cine, said. “There’s a treat­ment option, and if they find them­selves in this sce­nario, at least this won’t add a huge amount of addi­tion­al spend­ing to them.”

    Why is Gilead set­ting remde­sivir prices like this?

    While patients might side-eye the price tag for remde­sivir, Gilead’s pric­ing strat­e­gy could also be a headache for hos­pi­tals.

    For one, Peter Bach at Memo­r­i­al Sloan Ket­ter­ing point­ed out to me, it’s not at all clear how Gilead will charge sep­a­rate prices for gov­ern­ment insur­ers and pri­vate ones. Hos­pi­tals buy drugs in bulk, with­out know­ing which patients are going to receive them.

    “The cyn­ic in me thinks there’s two pos­si­bil­i­ties,” he said. One: “Gilead didn’t think through this.”

    But the sec­ond pos­si­bil­i­ty is “that this is a strat­e­gy.”

    Medicare gen­er­al­ly pays hos­pi­tals one bulk amount for each diag­no­sis. But some­times, it cre­ates a sep­a­rate line of pay­ment — known as a “new tech add-on pay­ment,” or NTAP — for new treat­ments. This has hap­pened before with nov­el can­cer ther­a­pies.

    So Gilead could be hop­ing the Trump admin­is­tra­tion, enticed by this dis­count­ed price, will set up an NTAP for remde­sivir. Oth­er­wise, hos­pi­tals would be asked to absorb the cost of remde­sivir as part of the bun­dled pay­ment they already receive from Medicare. That could dis­cour­age them from pre­scrib­ing the drug to as many patients as pos­si­ble, which would hurt Gilead’s bot­tom line and could, of course, hurt those peo­ple.

    And no mat­ter what hap­pens with Medicare, the same prob­lem is like­ly going to occur with Med­ic­aid patients.

    That’s because Med­ic­aid pay­ment rates for a hos­pi­tal stay — which, as with Medicare, cov­er all the nec­es­sary ser­vices — are typ­i­cal­ly set in advance, and when those rates were estab­lished for 2020, nobody knew that the Covid-19 pan­dem­ic would hap­pen or that remde­sivir would prove to be an effec­tive ther­a­py.

    ...

    Is this a fair price for remde­sivir as a Covid-19 ther­a­py?

    This was the bot­tom line for Duset­z­i­na: “I think this is a rea­son­able price and it’s a sur­pris­ing price.”

    We’re so used to price-goug­ing head­lines, in an Amer­i­can sys­tem that enables drug com­pa­nies with monop­o­lies to charge what­ev­er they want, that “rea­son­able” cer­tain­ly is a sur­prise.

    The sim­plest way to look at it is the Insti­tute for Clin­i­cal and Eco­nom­ic Review’s esti­mates of remdesivir’s val­ue as a Covid-19 treat­ment. ICER has come under crit­i­cism from drug­mak­ers (per­haps no sur­prise), but it is maybe the clos­est thing we have to the kind of inde­pen­dent arbiter of a drug’s val­ue that oth­er coun­tries like Aus­tralia have set up with­in their gov­ern­ment health sys­tems.

    ICER esti­mat­ed that if you account for the recent results show­ing anoth­er drug called dex­am­etha­sone reduces Covid-19 mor­tal­i­ty and is there­fore like­ly to become part of the stan­dard of care, remde­sivir has a cost-effec­tive­ness price bench­mark between $2,520 and $2,800. Gilead’s topline price was about $3,100. That’s pret­ty close to the ICER num­ber, espe­cial­ly as US drug prices go.

    The val­ue propo­si­tion is pret­ty sim­ple: Patients will spend less time in the hos­pi­tal. I asked about the pos­si­bil­i­ty of patients being kept longer to fin­ish the remde­sivir course if they would have oth­er­wise been sent home ear­li­er, but Bach told me that, think­ing of the sit­u­a­tion as a clin­i­cian, “if it’s reduc­ing viral load, it’s a good thing.” He said it would be “pret­ty nor­mal” to keep a patient under those cir­cum­stances — even if they said they felt well enough to leave.

    There could be a num­ber of rea­sons Gilead set a price low­er than some ana­lysts expect­ed. It might want to build some good­will with the pub­lic. It prob­a­bly would have been a pub­lic rela­tions cat­a­stro­phe to come in with a price that is seen as high for an effec­tive treat­ment to stave off a pan­dem­ic that has killed more than 125,000 Amer­i­cans and shut down much of the econ­o­my.

    “If you come out and you price real­ly aggres­sive high pric­ing here, you are gonna be in the crosshairs of the entire Amer­i­can pub­lic,” Duset­z­i­na said “The pres­i­dent, every­one.”

    Dex­am­etha­sone also might have played a part, because its clin­i­cal results are even more impres­sive than remdesivir’s. The lat­ter reduces recov­ery time by a few days; the for­mer reduced deaths by one-third in ven­ti­lat­ed patients.

    Know­ing it had anoth­er com­pet­i­tive prod­uct like­ly com­ing on the mar­ket, and that hos­pi­tals are feel­ing a finan­cial squeeze because of the issues described above, it may have behooved Gilead to set this “rea­son­able” price of its Covid-19 ther­a­py. Com­pe­ti­tion had the desired effect.

    Still, val­ue is all rel­a­tive and Amer­i­ca still has the high­est drug prices in the world. Now the country’s pri­vate insur­ance patients will face the high­est price for remde­sivir. And while their insur­ance ben­e­fits will lim­it their out-of-pock­et oblig­a­tion, the bill they receive in the mail, the whole sys­tem is still absorb­ing that price.

    Amer­i­ca does not have the kind of sys­tem that oth­er coun­tries do to extract the max­i­mum val­ue for a drug. If Gilead deliv­ered remde­sivir at a rea­son­able price, thanks to this con­flu­ence of PR and com­pet­i­tive pres­sure, it is real­ly an excep­tion to prove that rule.

    “We are still pay­ing for it. It’s just through a chain of var­i­ous inter­me­di­aries. It’s still all our mon­ey being leached out of our econ­o­my,” Bach told me. “Your tax­es are gonna go up, your ben­e­fits are gonna get skin­nied, your grand­kids are going to take on more debt. We’re talk­ing bil­lions of dol­lars here.”

    ————

    “Why a Covid-19 drug costs $3,100” by Dylan Scott; Vox; 06/29/2020

    ” 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:

    ...
    ICER esti­mat­ed that if you account for the recent results show­ing anoth­er drug called dex­am­etha­sone reduces Covid-19 mor­tal­i­ty and is there­fore like­ly to become part of the stan­dard of care, remde­sivir has a cost-effec­tive­ness price bench­mark between $2,520 and $2,800. Gilead’s topline price was about $3,100. That’s pret­ty close to the ICER num­ber, espe­cial­ly as US drug prices go.

    The val­ue propo­si­tion is pret­ty sim­ple: Patients will spend less time in the hos­pi­tal. I asked about the pos­si­bil­i­ty of patients being kept longer to fin­ish the remde­sivir course if they would have oth­er­wise been sent home ear­li­er, but Bach told me that, think­ing of the sit­u­a­tion as a clin­i­cian, “if it’s reduc­ing viral load, it’s a good thing.” He said it would be “pret­ty nor­mal” to keep a patient under those cir­cum­stances — even if they said they felt well enough to leave.

    ...

    Dex­am­etha­sone also might have played a part, because its clin­i­cal results are even more impres­sive than remdesivir’s. The lat­ter reduces recov­ery time by a few days; the for­mer reduced deaths by one-third in ven­ti­lat­ed patients.
    ...

    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:

    ...
    For one, Peter Bach at Memo­r­i­al Sloan Ket­ter­ing point­ed out to me, it’s not at all clear how Gilead will charge sep­a­rate prices for gov­ern­ment insur­ers and pri­vate ones. Hos­pi­tals buy drugs in bulk, with­out know­ing which patients are going to receive them.

    “The cyn­ic in me thinks there’s two pos­si­bil­i­ties,” he said. One: “Gilead didn’t think through this.”

    But the sec­ond pos­si­bil­i­ty is “that this is a strat­e­gy.”

    Medicare gen­er­al­ly pays hos­pi­tals one bulk amount for each diag­no­sis. But some­times, it cre­ates a sep­a­rate line of pay­ment — known as a “new tech add-on pay­ment,” or NTAP — for new treat­ments. This has hap­pened before with nov­el can­cer ther­a­pies.

    So Gilead could be hop­ing the Trump admin­is­tra­tion, enticed by this dis­count­ed price, will set up an NTAP for remde­sivir. Oth­er­wise, hos­pi­tals would be asked to absorb the cost of remde­sivir as part of the bun­dled pay­ment they already receive from Medicare. That could dis­cour­age them from pre­scrib­ing the drug to as many patients as pos­si­ble, which would hurt Gilead’s bot­tom line and could, of course, hurt those peo­ple.
    ...

    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:

    ...
    Med­ic­aid patients will be asked to pay very lit­tle, if any­thing. Medicare patients will have their treat­ment cov­ered by the program’s inpa­tient ben­e­fit, which has a $1,400 deductible before costs are ful­ly cov­ered. Deductibles vary for peo­ple with com­mer­cial health insur­ance, but because of the ACA, there is a hard cap (about $7,300 per per­son) on annu­al out-of-pock­et costs.

    So the bad news is, if you are in the hos­pi­tal for Covid-19, the cost of your med­ical care is like­ly to exceed those lim­its. Your bills would include not only any drugs you might receive, but also room charges, doc­tor fees, etc. Those typ­i­cal­ly add up to thou­sands of dol­lars on their own.

    But the good news is, because those out-of-pock­et lim­its are in place, you won’t bear the full brunt of those costs. The addi­tion of remde­sivir shouldn’t add much to your bot­tom line if you’re already being hos­pi­tal­ized.

    “In effect, this is good news for patients,” Sta­cie Duset­z­i­na, a health pol­i­cy pro­fes­sor at the Van­der­bilt Uni­ver­si­ty School of Med­i­cine, said. “There’s a treat­ment option, and if they find them­selves in this sce­nario, at least this won’t add a huge amount of addi­tion­al spend­ing to them.”

    ...

    Still, val­ue is all rel­a­tive and Amer­i­ca still has the high­est drug prices in the world. Now the country’s pri­vate insur­ance patients will face the high­est price for remde­sivir. And while their insur­ance ben­e­fits will lim­it their out-of-pock­et oblig­a­tion, the bill they receive in the mail, the whole sys­tem is still absorb­ing that price.

    Amer­i­ca does not have the kind of sys­tem that oth­er coun­tries do to extract the max­i­mum val­ue for a drug. If Gilead deliv­ered remde­sivir at a rea­son­able price, thanks to this con­flu­ence of PR and com­pet­i­tive pres­sure, it is real­ly an excep­tion to prove that rule.

    We are still pay­ing for it. It’s just through a chain of var­i­ous inter­me­di­aries. It’s still all our mon­ey being leached out of our econ­o­my,” Bach told me. “Your tax­es are gonna go up, your ben­e­fits are gonna get skin­nied, your grand­kids are going to take on more debt. We’re talk­ing bil­lions of dol­lars here.”
    ...

    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.

    Posted by Pterrafractyl | June 29, 2020, 4:36 pm

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