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FTR#1258 Pandemics, Inc., Part 8: Covid Update

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— George Orwell, 1946

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FTR#1258 This pro­gram was record­ed in one, 60-minute seg­ment.

Intro­duc­tion: Updat­ing the Covid-19 pan­dem­ic, this broad­cast explores trou­bling devel­op­ments in the admin­is­tra­tion of aspects of the pan­dem­ic.

NB: Mr. Emory is not an anti-vaxxer. When prop­er­ly man­u­fac­tured and vet­ted, they are fun­da­men­tal to the main­te­nance of pub­lic health.

The dis­turb­ing aspects of Biden’s vac­cine pol­i­cy sug­gest the pos­si­bil­i­ty that the reg­u­la­to­ry hand­i­cap­ping of the FDA advo­cat­ed by Trump backer Peter Thiel and his ide­o­log­i­cal fel­low trav­el­ers may have been imple­ment­ed, under the pres­sure of the pan­dem­ic.

That de-reg­u­la­tion of the FDA may have car­ried over into Avi­a­tor Glass­es Joe’s admin­is­tra­tion.

An inter­est­ing and trou­bling sto­ry con­cerns the FDA’s “thumbs down” on the John­son & John­son vac­cine because of a blood-clot­ting dis­or­der that affects 3.25 recip­i­ents per mil­lion. There have been a total of nine deaths from the dis­or­der out of 18 mil­lion recip­i­ents of the vac­cine.

The mRNA vac­cines, by way of con­trast, pro­duce a seri­ous con­di­tion called myocardi­tis in strong, healthy adults. That strikes eleven in every one hun­dred thou­sand recip­i­ents.

One must won­der why this con­clu­sion was reached. Is there Big Phar­ma prof­it-mak­ing con­sid­er­a­tions at play here? Or is the read­i­ly-adapt­able mRNA tech­nol­o­gy to new organ­isms that might be craft­ed as part of a bio­log­i­cal war­fare pro­gram loom­ing in the back­ground of such a deci­sion?

An even more dis­turb­ing, per­haps relat­ed, arti­cle con­cerns sub­stan­tive indi­ca­tions that the much-maligned John­son & John­son vac­cine is more effec­tive than its mRNA com­peti­tors.

It may pro­vide bet­ter pro­tec­tion against the Omi­cron vari­ant.

” . . . . By now, all the vac­cines seem to be per­form­ing about equal­ly well against coro­n­avirus infec­tions; in fact, John­son & John­son appears to be hold­ing up slight­ly bet­ter. . . . Over­all, then, the John­son & John­son vac­cine appeared to be some­what more pro­tec­tive against infec­tion than the two alter­na­tives. . . . . . The J.&J. vac­cine may pro­duce anti­bod­ies that decline more slow­ly than those pro­duced by the oth­er vac­cines, some research sug­gests. Or those anti­bod­ies may become more sophis­ti­cat­ed over time, through a bio­log­i­cal phe­nom­e­non called affin­i­ty mat­u­ra­tion. . . . Per­haps, some researchers sug­gest, the vac­cine offered a more robust defense against the Omi­cron vari­ant, respon­si­ble for the huge increase in infec­tions over the past few months. And stud­ies have shown that the vac­cine trains oth­er parts of the immune sys­tem at least as well as the oth­er two vac­cines. . . .”

Anoth­er stun­ning devel­op­ment con­cerns the FDA’s deci­sion to vet the next gen­er­a­tion of [mRNA] boost­ers with mouse tri­als, instead of human!

” . . . . ‘For the FDA to rely on mouse data is just bizarre, in my opin­ion,’ says John Moore, an immu­nol­o­gist at Weill Cor­nell Med­i­cine in New York. ‘Mouse data are not going to be pre­dic­tive in any way of what you would see in humans.’ . . . .”

WHY?

Peter Thiel favored “kneecap­ping the FDA” in order to bring Big Phar­ma’s prod­ucts to mar­ket soon­er, in full aware­ness of the col­lat­er­al dam­age that would result from this.

” . . . . For Food and Drug Admin­is­tra­tion com­mis­sion­er, he [Thiel] attempt­ed to nom­i­nate can­di­dates who shared his belief that the FDA’s main role—regarding tri­als for drugs—was unnec­es­sary. One of Thiel’s allies in this cru­sade, and his top pick to lead the FDA, was Bal­a­ji Srini­vasan, the Stan­ford com­put­er sci­ence lec­tur­er and cryp­tocur­ren­cy entre­pre­neur who’s invest­ed along­side Thiel in Cur­tis Yarvin’s com­pa­ny and shared Thiel’s views. . . . ‘For every thalido­mide,’ he tweet­ed, “many dead from slowed approvals.” . . . . Thiel had argued much the same. . . .”

Note that the FDA’s reg­u­la­to­ry “red light” on the use of thalido­mide saved the U.S. from the birth defects night­mare expe­ri­enced by Europe.

We note in that regard that Thiel comes from an “I.G.” back­ground, to coin a term. As not­ed in FTR #718, Thiel’s father was a chem­i­cal engi­neer from Frank­furt, the cap­i­tal of I.G.

After the pan­dem­ic, Thiel seemed pleased at that event, main­tain­ing that it had pro­ject­ed us into the future. ” . . . . ‘COVID-19 cre­at­ed a shift. There used to be this feel­ing that the future was being held back some­how. Changes that should have tak­en place long ago did not come because there was resis­tance. Now the future is set free.’ He was, it seemed, wel­com­ing the pan­dem­ic as a chance to reset soci­ety accord­ing to his ideals and plans. . . .”

Joe Biden’s pol­i­cy vis a vis Covid may well be eugeni­cist in its ori­en­ta­tion. Return­ing to “nor­mal,” in most respects, but allow­ing the virus to cir­cu­late, plac­ing seniors–no longer in the workforce–at risk

We have not­ed that Biden’s social poli­cies appear to be exten­sions of his nation­al secu­ri­ty pol­i­cy. He has stat­ed that com­pet­ing with Chi­na is a pri­or­i­ty.

In that regard, trim­ming expens­es, includ­ing the rel­a­tive­ly expen­sive social pro­grams need­ed to care for the elder­ly, is appar­ent­ly on the front burn­er. 

Bot­tom line: old folks don’t work.

” . . . . ‘And the ques­tion I have is, how much death are we OK with?’ she asks. ‘Have we decid­ed this is OK? And if so, why?’ . . . . Covid-19 has always been a dis­ease of the elder­ly, defined almost more by its age skew of mor­tal­i­ty than by any of its oth­er char­ac­ter­is­tics, with risk dou­bling rough­ly every eight years and octo­ge­nar­i­ans hun­dreds of times more at risk of death than young adults. . . .”

Indica­tive of Biden’s cyn­i­cism on social and eco­nom­ic pol­i­cy is his selec­tion to serve on the Social Secu­ri­ty Admin­is­tra­tion:

” . . . . Defend­ers of Social Secu­ri­ty on Tues­day urged the U.S. Sen­ate to block Pres­i­dent Joe Biden’s lit­tle-noticed nom­i­na­tion of Andrew Big­gs — an Amer­i­can Enter­prise Insti­tute senior fel­low with a his­to­ry of sup­port­ing Social Secu­ri­ty pri­va­ti­za­tion — to serve on the inde­pen­dent and bipar­ti­san Social Secu­ri­ty Advi­so­ry Board. . . . Biden was vice pres­i­dent when for­mer Pres­i­dent Barack Oba­ma pro­posed a ‘grand bar­gain’ with the GOP that would have entailed cuts to Social Secu­ri­ty. Big­gs, too, has a long record of advo­cat­ing Social Secu­ri­ty cuts. As Cun­ning­ham-Cook wrote last month, ‘For years, Big­gs has been a vocal crit­ic of expand­ed Social Secu­ri­ty and work­ers’ right to a secure, sta­ble retire­ment free from the vagaries of the stock mar­ket.’. . .”

1a.

In a new­ly filed law­suit, Mod­er­na asserts that the Pfizer/BioNTech mRNA coro­n­avirus vac­cines are infring­ing on Moderna’s patents. What’s eye­brow-rais­ing in this law­suit is the time­frame of Moderna’s claims. The com­pa­ny is argu­ing that Pfizer’s vac­cine copied work Mod­er­na had already done on coro­n­avirus vac­cines involv­ing human tri­als going back to 2015 and 2016. Beyond that, Mod­er­na asserts the full-sequence coro­n­avirus spike pro­tein used in Pfizer’s vac­cine was devel­oped by Mod­er­na years before the pan­dem­ic.

Per­haps the biggest set of ques­tions that might be answered in this law­suit involve Moderna’s pos­si­ble col­lab­o­ra­tive role in the broad­er US-gov­ern­ment-fund­ed gain-of-func­tion research being lead by the Eco­HealthAl­liance in col­lab­o­ra­tion with labs around the world like Shi Zhengli’s lab at the Wuhan Insti­tute of Virol­o­gy (WIV) and Ralph Baric’s lab at UNC Chapel Hill. As we’ve seen, Ralph Bar­ic was work­ing on devel­op­ing coro­n­avirus ther­a­peu­tics back in 2017 using gain-of-func­tion-cre­at­ed coro­n­avirus­es in col­lab­o­ra­tion with Shi Zhengli’s lab at the WIV. And Bar­ic also helped test the Mod­er­na covid vac­cine in 2020. So was Mod­er­na – which was fund­ed by DARPA – at all involved in this oth­er NIH-fund­ed coro­n­avirus-relat­ed gain-of-func­tion work? The cir­cum­stan­tial evi­dence sure points in that direc­tion.

Above all, there’s the part of the law­suit claim­ing that Pfiz­er effec­tive­ly stole the full-sequence coro­n­avirus spike pro­tein sequence Mod­er­na had worked out years ear­li­er.

This is a con­fus­ing part of the law­suit since, as we’ve been told, it was the SARS-CoV­‑2 spike pro­tein sequence that was at the heart of the mRNA COVID vac­cine devel­oped in record-break­ing time back in Jan­u­ary of 2020.

What is Mod­er­na talk­ing about when claim­ing that it already devel­oped a coro­n­avirus spike pro­tein years ear­li­er? Recall how Mod­er­na was crit­i­cized back in 2020 over its deci­sion to file a patent in Feb 2020 for a “Beta­coro­n­avirus vac­cine” – a broad-spec­trum vac­cine designed for non-COVID coro­n­avirus­es – with­out acknowl­edg­ing the US gov­ern­ments role in that researchPfizer/BioNTech filed a patent for a sim­i­lar “uni­ver­sal coro­n­avirus vac­cine” back in June.

It appears that’s what Mod­er­na is refer­ring to when it claims to have devel­oped a coro­n­avirus spike pro­tein sequence years before the pan­dem­ic. That rais­es the obvi­ous ques­tion: was Mod­er­na part of the whole Eco­HealthAl­liance gain-of-func­tion research on coro­n­avirus­es back in their 2015–2016 peri­od?

Gain-of-func­tion research was tech­ni­cal­ly banned in the US from 2014 until the Trump admin­is­tra­tion lift­ed it in 2017. Recall, also, how Baric’s gain-of-func­tion work that was start­ed before the mora­to­ri­um was put into place was allowed to con­tin­ue under a spe­cial exemp­tion.

If Moderna’s coro­n­avirus vac­cine devel­op­ment involved the use of virus­es being gen­er­at­ed by Bar­ic under an exemp­tion to the gain-of-func­tion mora­to­ri­um, that would obvi­ous­ly be a very sen­si­tive area of research.

There’s anoth­er facet of this sto­ry to keep in mind: recall that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics – which require numer­ous shots over years – to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set­backs. And yet observers were forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als.

There is no men­tion of coro­n­avirus-relat­ed research at all in that arti­cle, while there is men­tion of work on things like a Zika virus vac­cine.

Yet, in the new law­suit, Mod­er­na claims it suc­cess­ful­ly car­ried out human tri­als on a coro­n­avirus vac­cine as far back as 2015. It would seem that Moderna’s coro­n­avirus-relat­ed vac­cine research was being kept under wraps dur­ing this peri­od.

We have to ask if the extreme secre­cy around its work dur­ing this peri­od may have been dri­ven by the con­tro­ver­sial nature of devel­op­ing coro­n­avirus vac­cines using gain-of-func­tion coro­n­avirus­es gen­er­at­ed by the Eco­HealthAl­liance net­work. Cir­cum­stan­tial evi­dence points in that direc­tion. 

Mod­er­na is appar­ent­ly suing over patents it devel­oped dur­ing its most­ly-still-secret DARPA col­lab­o­ra­tion. Col­lab­o­ra­tion that might be direct­ly relat­ed to the most­ly-still-secret US-gov­ern­ment-financed inter­na­tion­al col­lab­o­ra­tion ded­i­cat­ed to mak­ing and study­ing nov­el coro­n­avirus­es. Law­suits have a ten­den­cy to unin­ten­tion­al­ly reveal secrets. Thereis clear­ly an abun­dance of secrets still wait­ing to be revealed about Moderna’s coro­n­avirus vac­cine research.

Again, we empha­size the fol­low­ing very inter­est­ing detail in Moderna’s com­plaint: the com­pa­ny is assert­ing that Pfiz­er and BioN­Tech copied Moderna’s full-length spike pro­tein for­mu­la­tion for a coro­n­avirus, which Mod­ern claims to have cre­at­ed years before the emer­gence of COVID-19.

Recall how the shar­ing of the genet­ic sequence of SARS-CoV­‑2 by Chi­nese researchers with the glob­al com­mu­ni­ty allowed for Mod­er­na to and its NIH col­lab­o­ra­tors to design the vac­cine in just two days with just that spike pro­tein sequence infor­ma­tion.

Once again, Mod­er­na is suing Pfiz­er over the alleged theft of a coro­n­avirus spike pro­tein sequence devel­oped years ear­li­er, we have to ask whether or not this part of the law­suit is relat­ed to the “uni­ver­sal coro­n­avirus” vac­cine Pfiz­er and BioN­Tech start­ed test­ing back in June.

Note, again, that Mod­er­na caught flack back in August of 2020 after it filed patents relat­ed to the coro­n­avirus vac­cine that didn’t dis­close the bil­lions in dol­lars in DARPA mon­ey, includ­ing DARPA involve­ment in the devel­op­ment of a broad spec­turm “Beta­coro­n­avirus” vac­cine that Mod­er­na had filed a patent for in Feb­ru­ary 2020.

That, again, returns us to ques­tions regard­ing Moderna’s involve­ment with the pre-pan­dem­ic gain-of-func­tion coro­n­avirus research car­ried out by the Eco­Health Alliance and col­lab­o­ra­tors like the WIV. Because as we’ve seen, the cre­ation of a broad-spec­trum coro­n­avirus vac­cine was part of the pre-pan­dem­ic work done by the Eco­HealthAl­liance, the WIV, and Ralph Baric’s lab at UNC Chapel Hill.

Was Mod­er­na involved in that broad-spec­trum coro­n­avirus vac­cine research? It appears to have been the case.

“Mod­er­na Sues Pfiz­er and BioN­Tech Over Covid Vac­cine” By Jen­ny Gross and Rebec­ca Rob­bins; The New York Times; 08/26/2022

The law­suit, filed Fri­day, claims that the com­pa­nies’ Covid vac­cine vio­lat­ed Moderna’s mRNA patents.

The vac­cine man­u­fac­tur­er Mod­er­na sued Pfiz­er and BioN­Tech on Fri­day, claim­ing that its rivals’ Covid-19 shot vio­lates its patents pro­tect­ing its ground­break­ing tech­nol­o­gy.

Mod­er­na said in a state­ment that Pfiz­er and BioN­Tech infringed on patents filed between 2010 and 2016 that cov­ered its mRNA tech­nol­o­gy. Mod­er­na, which is based in Cam­bridge, Mass., sued in U.S. Dis­trict Court in Mass­a­chu­setts and the Region­al Court of Düs­sel­dorf in Ger­many, where BioN­Tech is based.

Christo­pher Rid­ley, a spokesman for Mod­er­na, said the com­pa­ny did not have an esti­mate for the amount of dam­ages it was seek­ing.

Pfiz­er and its devel­op­ment part­ner BioN­Tech were “sur­prised by the lit­i­ga­tion,” said Jer­i­ca Pitts, a spokes­woman for Pfiz­er. She added that the com­pa­nies “remain con­fi­dent in our intel­lec­tu­al prop­er­ty sup­port­ing the Pfizer/BioNTech vac­cine and will vig­or­ous­ly defend against the alle­ga­tions of the law­suit.”

Mes­sen­ger RNA, or mRNA, is the genet­ic script that car­ries DNA instruc­tions to each cell’s pro­tein-mak­ing machin­ery and has been used in the pro­duc­tion of coro­n­avirus vac­cines.

“We are fil­ing these law­suits to pro­tect the inno­v­a­tive mRNA tech­nol­o­gy plat­form that we pio­neered, invest­ed bil­lions of dol­lars in cre­at­ing, and patent­ed dur­ing the decade pre­ced­ing the Covid-19 pan­dem­ic,” said Stéphane Ban­cel, Moderna’s chief exec­u­tive. “This foun­da­tion­al plat­form, which we began build­ing in 2010, along with our patent­ed work on coro­n­avirus­es in 2015 and 2016, enabled us to pro­duce a safe and high­ly effec­tive Covid-19 vac­cine in record time after the pan­dem­ic struck.”

Mod­er­na, which received close to $10 bil­lion in tax­pay­er fund­ing to devel­op the vac­cine, test it and pro­vide dos­es to the fed­er­al gov­ern­ment, had said in fall 2020 that it would not enforce its Covid-relat­ed patents while the pan­dem­ic con­tin­ued. But on March 7, the com­pa­ny said that said that it was updat­ing its pledge, since vac­cine sup­ply was no longer an issue out­side the poor­est coun­tries. It said it expect­ed man­u­fac­tur­ers out­side the 92 poor­est coun­tries to respect the company’s intel­lec­tu­al prop­er­ty. At the time, it also said that it was expand­ing its patent pledge to nev­er enforce Covid patents for 92 low- and mid­dle-income coun­tries.

Mod­er­na said on Fri­day that it was not seek­ing dam­ages for activ­i­ties before March 8 and that none of the patents relate to intel­lec­tu­al prop­er­ty gen­er­at­ed dur­ing Moderna’s col­lab­o­ra­tion with the Nation­al Insti­tutes of Health on Covid-19, which it said began only after patent­ed tech­nolo­gies were proven suc­cess­ful in 2015 and 2016.

Mod­er­na said that Pfiz­er copied two fea­tures of its patent­ed tech­nol­o­gy. First, Pfiz­er took four vac­cine can­di­dates into clin­i­cal test­ing, but ulti­mate­ly pro­ceed­ed with a vac­cine with the same mRNA tech­nol­o­gy as the Mod­er­na vac­cine. Mod­er­na said it was the first com­pa­ny to val­i­date this tech­nol­o­gy in human tri­als in 2015, and that nei­ther Pfiz­er nor BioN­Tech had its lev­el of expe­ri­ence in devel­op­ing mRNA vac­cines for infec­tious dis­eases.

Sec­ond, Mod­er­na claims that Pfiz­er and BioN­Tech copied its full-length spike pro­tein for­mu­la­tion for a coro­n­avirus, which Mod­er­na had cre­at­ed years before Covid-19 emerged. Coro­n­avirus­es refer to a large fam­i­ly of virus­es that cause mild to mod­er­ate upper res­pi­ra­to­ry tract ill­ness­es, accord­ing to the N.I.H. The more seri­ous ones include SARS, MERS and Covid-19.

Mod­er­na said it was not seek­ing to remove Pfiz­er and BioNTech’s vac­cines from the mar­ket, and was not ask­ing for an injunc­tion to pre­vent their future sale, giv­en the need for access to coro­n­avirus vac­cines. . . .

1b. An inter­est­ing and trou­bling sto­ry con­cerns the FDA’s “thumbs down” on the John­son & John­son vac­cine because of a blood-clot­ting dis­or­der that affects 3.25 recip­i­ents per mil­lion. There have been a total of nine deaths from the dis­or­der out of 18 mil­lion recip­i­ents of the vac­cine.

The mRNA vac­cines, by way of con­trast, pro­duce a seri­ous con­di­tion called myocardi­tis in strong, healthy adults. That strikes eleven in every one hun­dred thou­sand recip­i­ents.

One must won­der why this con­clu­sion was reached. Is there Big Phar­ma prof­it-mak­ing con­sid­er­a­tions at play here? Or is the read­i­ly-adapt­able mRNA tech­nol­o­gy to new organ­isms that might be craft­ed as part of a bio­log­i­cal war­fare pro­gram loom­ing in the back­ground of such a deci­sion?

“FDA lim­its use of John­son & Johnson’s Covid-19 vac­cine, cit­ing clot­ting risk” by Helen Bran­swell; STAT News; 05/05/2022

. . . . Peter Marks, the FDA’s vac­cines lead, told STAT the agency reached its deci­sion after a recent review of the data on the vac­cine revealed anoth­er per­son in this coun­try had died after receiv­ing it — the ninth such death — in the first quar­ter of the year. The vac­cine is made by J&J’s vac­cines divi­sion, Janssen.

“If we see deaths and there is an alter­na­tive vac­cine that is not asso­ci­at­ed with deaths but is asso­ci­at­ed with sim­i­lar effi­ca­cy … we felt it was time at this point to make a state­ment on the [product’s] fact sheet that this was not a first-line vac­cine,” said Marks, who is direc­tor of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research.

The clot­ting dis­or­der, called throm­bo­sis with throm­bo­cy­tope­nia or TTS, is rare, occur­ring at a rate of about 3.25 cas­es per mil­lion dos­es admin­is­tered. But the con­di­tion can be fatal or life-alter­ing if an indi­vid­ual sur­vives. With one death for every 2 mil­lion dos­es giv­en in this coun­try, the FDA decid­ed that is a risk most peo­ple don’t need to take, Marks said. . . .

. . . . He acknowl­edged the lat­est announce­ment won’t change much on the ground in the Unit­ed States, where few vac­ci­na­tion sites stock the J&J vac­cine at this point. But it could have impli­ca­tions abroad, where coun­tries still strug­gling to vac­ci­nate their pop­u­laces could be influ­enced by the U.S. deci­sion. . . .

———

2. An even more dis­turb­ing, per­haps relat­ed, arti­cle con­cerns sub­stan­tive indi­ca­tions that the much-maligned John­son & John­son vac­cine is more effec­tive than its mRNA com­peti­tors.

It may pro­vide bet­ter pro­tec­tion against the Omi­cron vari­ant.

” . . . . By now, all the vac­cines seem to be per­form­ing about equal­ly well against coro­n­avirus infec­tions; in fact, John­son & John­son appears to be hold­ing up slight­ly bet­ter. . . . Over­all, then, the John­son & John­son vac­cine appeared to be some­what more pro­tec­tive against infec­tion than the two alter­na­tives. . . . . . The J.&J. vac­cine may pro­duce anti­bod­ies that decline more slow­ly than those pro­duced by the oth­er vac­cines, some research sug­gests. Or those anti­bod­ies may become more sophis­ti­cat­ed over time, through a bio­log­i­cal phe­nom­e­non called affin­i­ty mat­u­ra­tion. . . . Per­haps, some researchers sug­gest, the vac­cine offered a more robust defense against the Omi­cron vari­ant, respon­si­ble for the huge increase in infec­tions over the past few months. And stud­ies have shown that the vac­cine trains oth­er parts of the immune sys­tem at least as well as the oth­er two vac­cines. . . .”

“As Virus Data Mounts, the J.&J. Vac­cine Holds Its Own” By Apoor­va Man­davil­li; The New York Times; 03/15/2022

Rough­ly 17 mil­lion Amer­i­cans received the John­son & John­son Covid vac­cine, only to be told lat­er that it was the least pro­tec­tive of the options avail­able in the Unit­ed States. But new data sug­gest that the vac­cine is now pre­vent­ing infec­tions, hos­pi­tal­iza­tions and deaths at least as well as the Pfiz­er-BioN­Tech and Mod­er­na vac­cines.

The rea­sons aren’t clear, and not all experts are con­vinced that the vac­cine has vin­di­cat­ed itself. But the accu­mu­lat­ing data nonethe­less offer con­sid­er­able reas­sur­ance to recip­i­ents of the vac­cine and, if con­firmed, have broad impli­ca­tions for its deploy­ment in parts of the world.

In Africa, for exam­ple, dis­tri­b­u­tion of a sin­gle-dose vac­cine that can be refrig­er­at­ed for months is by far the most prac­ti­cal option.

John­son & John­son has at least tem­porar­i­ly shut down the only plant mak­ing usable batch­es of the vac­cine. But the South Africa-based Aspen Phar­ma­care is gear­ing up to sup­ply large quan­ti­ties to the rest of the con­ti­nent. Only about 13 per­cent of Africans are ful­ly vac­ci­nat­ed, and only about 1 per­cent have received a boost­er dose. . . .

. . . . But the notion that the vac­cine is infe­ri­or has grown out­dat­ed, some experts said: More recent data sug­gest that it has more than held its own against its com­peti­tors.

“We’ve been aware that J.&J. has been kind of down­grad­ed in people’s minds,” Dr. Gail-Bekker said. But “it punch­es above its weight for a sin­gle-dose vac­cine.”

Until last June, the cumu­la­tive data from the C.D.C. showed that immu­niza­tion with the Mod­er­na vac­cine result­ed in the low­est rates of break­through infec­tions; those who got John­son & John­son saw the high­est rates, with Pfiz­er-BioN­Tech some­where in the mid­dle.

Dur­ing the sum­mer months, the gaps — par­tic­u­lar­ly between J.&J. and Pfiz­er — began to nar­row. By now, all the vac­cines seem to be per­form­ing about equal­ly well against coro­n­avirus infec­tions; in fact, John­son & John­son appears to be hold­ing up slight­ly bet­ter.

As of Jan. 22, the lat­est data avail­able, unvac­ci­nat­ed peo­ple were 3.2 times as like­ly to become infect­ed as those who received the sin­gle-dose John­son & John­son vac­cine; they were 2.8 times as like­ly to become infect­ed as those who received two dos­es of the Mod­er­na vac­cine and 2.4 times as like­ly as those with two dos­es of Pfiz­er-BioN­Tech. Over­all, then, the John­son & John­son vac­cine appeared to be some­what more pro­tec­tive against infec­tion than the two alter­na­tives. . . . . .

. . . . The find­ings indi­cate that the J.&J. vac­cine deserves a clos­er look, said Dr. Lar­ry Corey, an expert in vac­cine devel­op­ment at the Fred Hutchin­son Can­cer Research Cen­ter in Seat­tle.

“This vac­cine plat­form may have some sur­pris­ing char­ac­ter­is­tics that we hadn’t antic­i­pat­ed,” he said. The data “is inter­est­ing, provoca­tive, and we should spend more time under­stand­ing it.”

Dr. Corey said the results jibe with his expe­ri­ence in H.I.V. research with the ade­n­ovirus that forms the back­bone of the John­son & John­son vac­cine. “It has much longer dura­bil­i­ty than almost any oth­er plat­form that we’ve ever worked with,” he said.

Sci­en­tists are only begin­ning to guess why the vaccine’s pro­file is improv­ing with the pass­ing months.

Lev­els of anti­bod­ies sky­rock­et in the first few weeks after immu­niza­tion, but then rapid­ly wane. The J.&J. vac­cine may pro­duce anti­bod­ies that decline more slow­ly than those pro­duced by the oth­er vac­cines, some research sug­gests. Or those anti­bod­ies may become more sophis­ti­cat­ed over time, through a bio­log­i­cal phe­nom­e­non called affin­i­ty mat­u­ra­tion.

Per­haps, some researchers sug­gest, the vac­cine offered a more robust defense against the Omi­cron vari­ant, respon­si­ble for the huge increase in infec­tions over the past few months. And stud­ies have shown that the vac­cine trains oth­er parts of the immune sys­tem at least as well as the oth­er two vac­cines. . . .

3. Anoth­er stun­ning devel­op­ment con­cerns the FDA’s deci­sion to vet the next gen­er­a­tion of [mRNA] boost­ers with mouse tri­als, instead of human!

” . . . . ‘For the FDA to rely on mouse data is just bizarre, in my opin­ion,’ says John Moore, an immu­nol­o­gist at Weill Cor­nell Med­i­cine in New York. ‘Mouse data are not going to be pre­dic­tive in any way of what you would see in humans.’ . . . .”

WHY?

“What’s behind the FDA’s con­tro­ver­sial strat­e­gy for eval­u­at­ing new COVID boost­ers” by Rob Stein; npr.org; 8/18/2022.

The U.S. Food and Drug Admin­is­tra­tion is using a con­tro­ver­sial strat­e­gy to eval­u­ate the next gen­er­a­tion of COVID-19 boost­ers.

The approach is stir­ring debate as the agency works to make new, hope­ful­ly improved, boost­ers avail­able in Sep­tem­ber to help pre­vent severe dis­ease and save lives in the fall and win­ter.

For the first time, the FDA is plan­ning to base its deci­sion about whether to autho­rize new boost­ers on stud­ies involv­ing mice instead of humans. 

“For the FDA to rely on mouse data is just bizarre, in my opin­ion,” says John Moore, an immu­nol­o­gist at Weill Cor­nell Med­i­cine in New York. “Mouse data are not going to be pre­dic­tive in any way of what you would see in humans.” . . . .

But oth­ers defend the approach, argu­ing that the coun­try has had enough expe­ri­ence with the vac­cines at this point to be con­fi­dent the shots are safe and that there’s not enough time to wait for data from human stud­ies.

“We have 500 peo­ple a day dying of coro­n­avirus right now. Those num­bers sad­ly might very well rise in the fall and the win­ter. The ques­tion is: ‘Can we do some­thing bet­ter?’ ” says Dr. Ofer Levy, a pedi­atrics and infec­tious dis­ease researcher at Har­vard Med­ical School who also advis­es the FDA. “And I think the answer is: ‘We can, by imple­ment­ing this approach.’ ” . . .

. . . . But the big con­cern is the boost­ers may not work as well as the mouse data might sug­gest. Mouse exper­i­ments are noto­ri­ous­ly unre­li­able. . . .

. . . . “We need to make sure that we have sol­id immuno­genic­i­ty data in peo­ple to show that you have a dra­mat­i­cal­ly greater neu­tral­iz­ing anti­body response against BA.4, BA.5,” says Dr. Paul Offit of the Uni­ver­si­ty of Penn­syl­va­nia, who also advis­es the FDA. “I think any­thing short of that is not accept­able.” . . .

4. Peter Thiel favored “kneecap­ping the FDA” in order to bring Big Phar­ma’s prod­ucts to mar­ket soon­er, in full aware­ness of the col­lat­er­al dam­age that would result from this.

” . . . . For Food and Drug Admin­is­tra­tion com­mis­sion­er, he [Thiel] attempt­ed to nom­i­nate can­di­dates who shared his belief that the FDA’s main role—regarding tri­als for drugs—was unnec­es­sary. One of Thiel’s allies in this cru­sade, and his top pick to lead the FDA, was Bal­a­ji Srini­vasan, the Stan­ford com­put­er sci­ence lec­tur­er and cryp­tocur­ren­cy entre­pre­neur who’s invest­ed along­side Thiel in Cur­tis Yarvin’s com­pa­ny and shared Thiel’s views. . . . ‘For every thalido­mide,’ he tweet­ed, “many dead from slowed approvals.” . . . . Thiel had argued much the same. . . .”

Note that the FDA’s reg­u­la­to­ry “red light” on the use of thalido­mide saved the U.S. from the birth defects night­mare expe­ri­enced by Europe.

We note in that regard that Thiel comes from an “I.G.” back­ground, to coin a term. As not­ed in FTR #718, Thiel’s father was a chem­i­cal engi­neer from Frank­furt, the cap­i­tal of I.G.

The Con­trar­i­an by Max Chafkin; Pen­guin Press [HC]; Copy­right 2021 by Max Chafkin; ISBN 9781984878533; p9. 253–254.

. . . . For Food and Drug Admin­is­tra­tion com­mis­sion­er, he [Thiel] attempt­ed to nom­i­nate can­di­dates who shared his belief that the FDA’s main role—regarding tri­als for drugs—was unnec­es­sary.

The con­sen­sus view among drug devel­op­ers, even many in Sil­i­con Val­ley, has been that “you don’t want to put indi­vid­u­als at risk,” said Zach Wein­berg, the cofounder of Flat­iron Health, a Sil­i­con Val­ley-backed med­ical research firm that is now owned by the phar­ma­ceu­ti­cal giant Roche. “Peter Thiel’s view is that will slow things down. His whole game is if a few peo­ple get hurt and that cre­ates progress, he’s will­ing to take that trade.” 

One of Thiel’s allies in this cru­sade, and his top pick to lead the FDA, was Bal­a­ji Srini­vasan, the Stan­ford com­put­er sci­ence lec­tur­er and cryp­tocur­ren­cy entre­pre­neur who’s invest­ed along­side Thiel in Cur­tis Yarvin’s com­pa­ny and shared Thiel’s views. . . . 

 . . . . “For every thalido­mide,” he tweet­ed, “many dead from slowed approvals.” . . . .

Thiel had argued much the same. . . .

. . . . the agency’s [FDA] refusal in the ear­ly 1960’s to approve thalido­mide, a sleep­ing pill, is regard­ed as one of the great admin­is­tra­tive suc­cess sto­ries. In Europe, where a less-reg­u­lat­ed mar­ket allowed thalido­mide to be pre­scribed to preg­nant women, thou­sands of babies were born with­out ful­ly formed limbs. . . .

. . . . Thiel’s oth­er choice to run the FDA was Jim O’Neill, who’d run the Thiel Foun­da­tion and had since worked as an investor at Mithril, Ajay Royan’s ven­ture cap­i­tal firm . . . . He also believed in rolling back the FDA man­dates about drug effi­ca­cy. . . .

5. After the pan­dem­ic, Thiel seemed pleased at that event, main­tain­ing that it had pro­ject­ed us into the future. ” . . . . ‘COVID-19 cre­at­ed a shift. There used to be this feel­ing that the future was being held back some­how. Changes that should have tak­en place long ago did not come because there was resis­tance. Now the future is set free.’ He was, it seemed, wel­com­ing the pan­dem­ic as a chance to reset soci­ety accord­ing to his ideals and plans. . . .”

The Con­trar­i­an by Max Chafkin; Pen­guin Press [HC]; Copy­right 2021 by Max Chafkin; ISBN 9781984878533; p9. 327–328.

. . . . How could any­one devot­ed to life exten­sion not be moved by so many pre­ventable deaths? By late March more than 550,000 Amer­i­cans had died from Covid, mak­ing the pan­dem­ic dead­lier than U.S. casu­al­ties in World War I and World War II com­bined. The Unit­ed States has suf­fered one of the worst per-capi­ta mor­tal­i­ty rates in the world. How had those grim fig­ures not moved him to break with Trump or to at last spend more ambi­tious­ly to help? . . . .

. . . . Thiel spoke to Die Welt­woche, a Swiss news­pa­per whose edi­tor Roger Kop­pel is a mem­ber of the country’s nation­al-con­ser­v­a­tive People’s Par­ty. Dur­ing an inter­view with Kop­pel, Thiel char­ac­ter­ized the dis­ease as a men­tal pathol­o­gy rather than a phys­i­cal one. “I see it as a psy­cho­log­i­cal indi­ca­tor that peo­ple know deep down: There is no way back to the old nor­mal,” he said.

He con­tin­ued: “COVID-19 cre­at­ed a shift. There used to be this feel­ing that the future was being held back some­how. Changes that should have tak­en place long ago did not come because there was resis­tance. Now the future is set free.” He was, it seemed, wel­com­ing the pan­dem­ic as a chance to reset soci­ety accord­ing to his ideals and plans. . . .

6. In an alto­geth­er spec­u­la­tive ele­ment, we review dis­cus­sion of Nazi chem­i­cal giant I.G. Far­ben’s influ­ence in the phar­ma­ceu­ti­cal busi­ness, the pro­gram access­es infor­ma­tion about the tran­quil­iz­er thalido­mide. When pre­scribed for preg­nant women in the ear­ly 1960’s, it led to hor­ri­bly deformed babies. A new book claims that the drug was actu­al­ly invent­ed by the Nazis and test­ed in con­cen­tra­tion camps dur­ing World War II.

“Thalido­mide ‘Cre­at­ed by Nazis’ ” [TimesOn­line]; The Aus­tralian; 2/08/2009.

“The morn­ing sick­ness drug thalido­mide, which caused preg­nant women to give birth to babies with­out arms and legs, was first devel­oped by the Nazis, prob­a­bly as part of their chem­i­cal weapons pro­gramme, accord­ing to new research.

Two sep­a­rate aca­d­e­mics have revealed the dis­cov­ery of doc­u­ments indi­cat­ing that the drug did not orig­i­nate with Chemie Grunen­thal, the post-war Ger­man chem­i­cal firm, as has always been claimed.

If, as their research sug­gests, thalido­mide was first devel­oped by sci­en­tists work­ing in wartime Ger­many, it could have impli­ca­tions for the lia­bil­i­ty of the Ger­man gov­ern­ment. So far it has giv­en com­pen­sa­tion only to Ger­man vic­tims, although the drug was dis­trib­uted in 46 coun­tries.

Thou­sands of the drug’s vic­tims are still bat­tling for increased finan­cial aid to help them cope with its lega­cy. There are 457 thalido­miders remain­ing in the UK; 2,700 in Ger­many; and a total of up to 6,000 worldwide.s

Moth­ers pre­scribed it between its launch in 1957 and 1961, when it was removed from the mar­ket, gave birth to chil­dren who lacked prop­er arms, legs, hands and feet. Some had also suf­fered brain dam­age and oth­er dis­abil­i­ties.

Dr Mar­tin John­son, direc­tor of the Thalido­mide Trust which pro­vides help for sur­viv­ing vic­tims in the UK, has writ­ten a paper detail­ing evi­dence sug­gest­ing that the drug had been devel­oped before Grunen­thal secured a patent in 1954.

The com­pa­ny has always main­tained that thalido­mide was cre­at­ed by chance in 1953 by sci­en­tists who had tried to cre­ate an anti­his­t­a­mine but end­ed up with a tran­quil­liz­er.

John­son sus­pects that it was actu­al­ly first pro­duced as a pos­si­ble anti­dote to nerve tox­ins such as sarin, which was devel­oped by Otto Ambros, a Nazi sci­en­tist who joined Grunen­thal after the war.

‘It is now appear­ing increas­ing­ly like­ly that thalido­mide was the last war crime of the Nazis,’ said John­son.

One doc­u­ment unearthed by the Thalido­mide Trust shows that Grunen­thal appar­ent­ly pur­chased the trade name of the drug — Con­ter­gan — and there­fore prob­a­bly the sub­stance itself, from a French firm, Rhone-Poulenc, which was under Nazi con­trol dur­ing the war years.

A con­fi­den­tial let­ter sent from Astra, which held the Swedish licence to dis­trib­ute thalido­mide, to its Nor­we­gian sub­sidiary in 1958 states: ‘Unfor­tu­nate­ly we can’t use the name Con­ter­gan in the Scan­di­na­vian coun­tries, since Grunen­thal obtained the name exclu­sive­ly for the Ger­man mar­ket through an agree­ment with Rhone-Poulenc.’

From 1942 onwards Rhone-Poulenc reg­is­tered 14 sim­i­lar drugs, all end­ing with the same ‘ergan’ suf­fix, a char­ac­ter­is­tic unique to the firm. Many of the drugs shared prop­er­ties with thalido­mide, such as affect­ing the ner­vous sys­tem.”

7. Joe Biden’s pol­i­cy vis a vis Covid may well be eugeni­cist in its ori­en­ta­tion. Return­ing to “nor­mal,” in most respects, but allow­ing the virus to cir­cu­late, plac­ing seniors–no longer in the workforce–at risk

We have not­ed that Biden’s social poli­cies appear to be exten­sions of his nation­al secu­ri­ty pol­i­cy. He has stat­ed that com­pet­ing with Chi­na is a pri­or­i­ty.

In that regard, trim­ming expens­es, includ­ing the rel­a­tive­ly expen­sive social pro­grams need­ed to care for the elder­ly, is appar­ent­ly on the front burn­er. 

Bot­tom line: old folks don’t work.

” . . . . ‘And the ques­tion I have is, how much death are we OK with?’ she asks. ‘Have we decid­ed this is OK? And if so, why?’ . . . . Covid-19 has always been a dis­ease of the elder­ly, defined almost more by its age skew of mor­tal­i­ty than by any of its oth­er char­ac­ter­is­tics, with risk dou­bling rough­ly every eight years and octo­ge­nar­i­ans hun­dreds of times more at risk of death than young adults. . . .”

“Endem­ic Covid-19 Is Look­ing Bru­tal” by David Wal­lace-Wells; The New York Times; 7/24/2022.

. . . . More than 300 Amer­i­cans have been dying near­ly every day for months; the num­ber is today above 400, and grow­ing.

Right now, [Dr. Trevor] Bed­ford says, around 5 per­cent of the coun­try is get­ting infect­ed with the coro­n­avirus each month and he expects that pat­tern to large­ly con­tin­ue. What would that imply death-wise, I ask? As a ball­park esti­mate, he says, going for­ward we can expect that every year, around 50 per­cent of Amer­i­cans will be infect­ed and more than 100,000 will die. . . .

. . . . A hun­dred thou­sand deaths is more than the annu­al toll of any oth­er infec­tious dis­ease and would make Covid-19 a top-10 cause of death in the coun­try — a major and nov­el cause of wide­spread death cloud­ing the Amer­i­can hori­zon with anoth­er dark lay­er of mor­bid­i­ty we had nev­er known before. It’s a few mul­ti­ples of a typ­i­cal flu sea­son and more than die each year from dia­betes, pneu­mo­nia or kid­ney dis­ease. It is what this news­pa­per once called, in an immor­tal front-page ban­ner, “an incal­cu­la­ble loss.”

How do you cal­cu­late a loss 10 times as high? How can you reck­on with that lev­el of dying, each year, going for­ward? Accord­ing to Céline Gounder, an infec­tious dis­ease epi­demi­ol­o­gist and a senior fel­low at the Kaiser Fam­i­ly Foun­da­tion, that fig­ure is actu­al­ly the low end — the ball­park, she says, runs from 100,000 to 250,000. That’s not her esti­mate of this year’s toll but of the annu­al con­tin­u­ing mor­tal­i­ty bur­den rolling for­ward indef­i­nite­ly into the future. “And the ques­tion I have is, how much death are we OK with?” she asks. “Have we decid­ed this is OK? And if so, why?” . . . .

. . . . Covid-19 has always been a dis­ease of the elder­ly, defined almost more by its age skew of mor­tal­i­ty than by any of its oth­er char­ac­ter­is­tics, with risk dou­bling rough­ly every eight years and octo­ge­nar­i­ans hun­dreds of times more at risk of death than young adults. But in a time of wide­spread vac­ci­na­tion and almost uni­ver­sal infec­tion, that gap may well expand.

[Dr. Michael] Mina com­pares the build­ing of immu­ni­ty to the learn­ing of a lan­guage. “It’s a fact of the biol­o­gy of immu­ni­ty that it’s real­ly hard to build a brand-new mem­o­ry and keep it if you’re old,” he says. “And so I do think that for quite a while our elder­ly pop­u­la­tion is going to keep hav­ing real­ly big prob­lems because they just can’t retain these new mem­o­ries.” Peo­ple exposed today, who will become 80 years old in 25 years or so, won’t have the same prob­lem, Mina says, because they will have built their immune mem­o­ry at a younger age. . . .

8. Indica­tive of Biden’s cyn­i­cism on social and eco­nom­ic pol­i­cy is his selec­tion to serve on the Social Secu­ri­ty Admin­is­tra­tion:

” . . . . Defend­ers of Social Secu­ri­ty on Tues­day urged the U.S. Sen­ate to block Pres­i­dent Joe Biden’s lit­tle-noticed nom­i­na­tion of Andrew Big­gs — an Amer­i­can Enter­prise Insti­tute senior fel­low with a his­to­ry of sup­port­ing Social Secu­ri­ty pri­va­ti­za­tion — to serve on the inde­pen­dent and bipar­ti­san Social Secu­ri­ty Advi­so­ry Board. . . . Biden was vice pres­i­dent when for­mer Pres­i­dent Barack Oba­ma pro­posed a ‘grand bar­gain’ with the GOP that would have entailed cuts to Social Secu­ri­ty. Big­gs, too, has a long record of advo­cat­ing Social Secu­ri­ty cuts. As Cun­ning­ham-Cook wrote last month, ‘For years, Big­gs has been a vocal crit­ic of expand­ed Social Secu­ri­ty and work­ers’ right to a secure, sta­ble retire­ment free from the vagaries of the stock mar­ket.’. . .”

“Biden’s Nom­i­nee for Social Secu­ri­ty Board” by Jake John­son [Com­mon Dreams]; Con­sor­tium News; 7/6/2022.

The advo­ca­cy group Social Secu­ri­ty Works is urg­ing the Sen­ate to block Andrew Big­gs’ appoint­ment by high­light­ing his role in the George W. Bush administration’s failed attempt to pri­va­tize the New Deal pro­gram in 2005.

Defend­ers of Social Secu­ri­ty on Tues­day urged the U.S. Sen­ate to block Pres­i­dent Joe Biden’s lit­tle-noticed nom­i­na­tion of Andrew Big­gs — an Amer­i­can Enter­prise Insti­tute senior fel­low with a his­to­ry of sup­port­ing Social Secu­ri­ty pri­va­ti­za­tion — to serve on the inde­pen­dent and bipar­ti­san Social Secu­ri­ty Advi­so­ry Board.

Social Secu­ri­ty Works, a pro­gres­sive advo­ca­cy group, is lead­ing the charge against Big­gs, high­light­ing his role in the George W. Bush administration’s failed attempt to pri­va­tize the New Deal pro­gram in 2005. At the time, Big­gs worked on Social Secu­ri­ty as an asso­ciate direc­tor of Bush’s Nation­al Eco­nom­ic Coun­cil.

“Andrew Big­gs has advo­cat­ed for Social Secu­ri­ty cuts through­out his career. And now, he’s been nom­i­nat­ed to over­see Social Secu­ri­ty,” Social Secu­ri­ty Works tweet­ed on Tues­day.

The group, whose pres­i­dent cur­rent­ly serves on the Social Secu­ri­ty Advi­so­ry Board (SSAB), is also shar­ing a sam­ple call script for those who wish to con­tact their rep­re­sen­ta­tives about Big­gs.

“The Sen­ate can, and must, block this ter­ri­ble nom­i­na­tion,” the orga­ni­za­tion wrote. “Please call your sen­a­tors at 202–224-3121 and tell them to vote NO on Andrew Big­gs.”

The White House announced Big­gs’ nom­i­na­tion to the SSAB in May, a move that drew lit­tle notice at the time.

Last month, The Lever‘s Matthew Cun­ning­ham-Cook called atten­tion to the president’s pick and warned it sug­gests “there could soon be a coor­di­nat­ed push in Wash­ing­ton to cut the Social Secu­ri­ty pro­gram, which pro­vides retire­ment, dis­abil­i­ty, and sur­vivor ben­e­fits to 66 mil­lion Amer­i­cans.”

While Biden vowed on the cam­paign trail to back an expan­sion of Social Secu­ri­ty, he has pre­vi­ous­ly sup­port­ed cut­ting the program’s ben­e­fits. Biden was vice pres­i­dent when for­mer Pres­i­dent Barack Oba­ma pro­posed a “grand bar­gain” with the GOP that would have entailed cuts to Social Secu­ri­ty.

Big­gs, too, has a long record of advo­cat­ing Social Secu­ri­ty cuts. As Cun­ning­ham-Cook wrote last month, “For years, Big­gs has been a vocal crit­ic of expand­ed Social Secu­ri­ty and work­ers’ right to a secure, sta­ble retire­ment free from the vagaries of the stock mar­ket.”

“He has dis­missed the retire­ment cri­sis as a non-issue and as recent­ly as 2020 blamed prob­lems with the Social Secu­ri­ty sys­tem on ‘old­er Amer­i­cans’ game of chick­en,’” he added. “While the seat on the bipar­ti­san board is by tra­di­tion assigned to a Repub­li­can, Biden could have cho­sen a mod­er­ate can­di­date — or even leaned on prece­dent to avoid the nom­i­na­tion process alto­geth­er. For­mer Pres­i­dent Don­ald Trump rou­tine­ly refused to nom­i­nate Democ­rats for seats on boards and com­mis­sions.”

Sim­mer­ing out­rage over Big­gs’ nom­i­na­tion to serve on the SSAB, which was formed in 1994 to advise the pres­i­dent and Con­gress on Social Secu­ri­ty, comes as pro­gres­sives are demand­ing an expan­sion of the program’s mod­est ben­e­fits — while Repub­li­can law­mak­ers, per usu­al, eye cuts.

Last month, Sens. Bernie Sanders (I‑Vt.) and Eliz­a­beth War­ren (D‑Mass.) led the intro­duc­tion of the Social Secu­ri­ty Expan­sion Act, which would lift the cap on income sub­ject to the Social Secu­ri­ty pay­roll tax and boost the program’s annu­al ben­e­fits by $2,400.

“At a time when half of old­er Amer­i­cans have no retire­ment sav­ings and mil­lions of senior cit­i­zens are liv­ing in pover­ty, our job is not to cut Social Secu­ri­ty,” Sanders said at the time. “Our job must be to expand Social Secu­ri­ty so that every senior cit­i­zen in Amer­i­ca can retire with the dig­ni­ty they deserve and every per­son with a dis­abil­i­ty can live with the secu­ri­ty they need.”

Discussion

4 comments for “FTR#1258 Pandemics, Inc., Part 8: Covid Update”

  1. Every­one has one choice when it comes to the COVID pan­dem­ic: take the mRNA vac­cines or not. That’s obvi­ous­ly not true. There are plen­ty of non-mRNA COVID vac­cines cur­rent­ly avail­able. But it’s hard to ignore how the under­ly­ing mes­sage to the pub­lic in the US about COVID vac­cines has large­ly been to take the mRNA vac­cines or not get vac­ci­nat­ed at all. The non-mRNA vac­cines have effec­tive­ly been ‘unper­son­ed’ in the cov­er­age of the pan­dem­ic.

    That’s been the case from the very begin­ning of the pan­dem­ic. But it may have been tak­en to a new absurd lev­el in the fol­low­ing arti­cle in the Atlantic about a rare side-effect from mRNA recent­ly report­ed: A Bel­gian immu­nol­o­gist long involved in study­ing new med­i­cines, includ­ing the mRNA vac­cines, had to report an unfor­tu­nate find­ing. And a very per­son­al find­ing at that. Short­ly after get­ting an mRNA boost­er, Gold­man’s case of lym­phoma grew dra­mat­i­cal­ly worse right around the spot of the injec­tion.

    And while Gold­man is just a sin­gle case, the data points were quite com­pelling. Gold­man’s angioim­munoblas­tic T‑cell lym­phoma affects fol­lic­u­lar helper T cells, and research has already found that mRNA vac­cines are par­tic­u­lar­ly effec­tive at pro­vid­ing an extra ‘oomph’ to the body’s fol­lic­u­lar helper T cells. Also, Gold­man’s tumor has a muta­tion known to pre­dis­pose T‑cells to go rogue.

    But that research show­ing mRNA vac­cine specif­i­cal­ly pro­vide an extra ‘oomph’ to T‑cells also poten­tial­ly relates to that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics — which require numer­ous shots over years — to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set backs. And yet observers were just forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als. It was one of the high­ly con­ve­nient aspects of the whole mRNA vac­cine sit­u­a­tion: the side effects from the LNP deliv­ery vehi­cle just might be desir­able and have an adju­vant-like effect in the con­text of a vac­cine if those side effects end up revving up the immune sys­tem. So it should­n’t be par­tic­u­lar­ly sur­pris­ing when we learn that there might be rare side effects involv­ing an over­ly-revved-up immune sys­tem. The extra immuno­log­i­cal ‘oomph’ from the mRNA vac­cines was tout­ed as a sell­ing point, after all.

    So we have to ask: is the extra immuno­log­i­cal ‘oomph’ tar­get­ing fol­lic­u­lar ‘helper’ T‑cells trig­gered specif­i­cal­ly by mRNA vac­cines — and which may have exac­er­bat­ed Gold­man’s lym­phoma — at all relat­ed to the side-effects observed by the LNP deliv­ery vehi­cles? It’s the kind of ques­tion we had bet­ter hope researchers are ask­ing. But that brings us to anoth­er part of this sto­ry: as the arti­cle describes, the med­ical estab­lish­ment is basi­cal­ly inca­pable of real­ly study­ing these rel­a­tive­ly rare side effects. If some­thing can’t be sta­tis­ti­cal­ly con­firmed with a ran­dom­ized con­trolled tri­al (RCT), the med­ical estab­lish­ment is high­ly prone to ignore it. And rare side-effects are very often going to be too rare to set up an RCT.

    But then there’s the fact that immuno­log­i­cal dis­or­ders can man­i­fest in all sorts of ways. We should­n’t expect just a sin­gle type of symp­tom to show up if, for exam­ple, T‑cells are being turned rogue. So even if rare side-effects have a com­mon under­ly­ing immuno­log­i­cal cause we’re going to be poised to miss it.

    But when there’s plen­ty of non-mRNA COVID vac­cine options avail­able, the ques­tion of whether or not the risks of the mRNA vac­cines for lym­phoma patients are worth the cost/benefit trade­offs in the face of unknown risks is kind of beside the point. Just give the can­cer patients one of the non-mRNA vac­cines instead. And that brings us to the tru­ly bizarre aspect of this sto­ry. Because as we’re going to see, while Michel Gold­man appears to be gen­uine­ly torn as to whether or not he’s will­ing to take a sec­ond mRNA COVID boost­er shoot after the expe­ri­ence he had with the first shot, he does­n’t appear to have con­sid­ered at all the pos­si­bil­i­ty of tak­ing one of the non-mRNA vac­cines. Like it just does­n’t even come up as an option in the entire arti­cle.

    It’s the lat­est exam­ple of this bizarre hyper-pref­er­ence for what are still exper­i­men­tal mRNA vac­cines. We’ve already seen how the mRNA boost­ers are being approved based on mouse tri­al data alone. We also saw how the FDA issued a warn­ing about the John­son & John­son vac­cine back in May for a very rare side effect despite the fact that those vac­cines appeared to actu­al­ly have the best effi­ca­cy against vari­ants. And as we’re going to see the arti­cle, even Gold­man him­self was com­ment­ing on how the AstraZeneca vac­cine side-effects were far less of a risk than the risk of COVID itself. Gold­man, who resides in Europe, pre­sum­ably has access to that vac­cine. But he’s not tak­ing it. It’s mRNA vac­cines or noth­ing for Michel Gold­man. For rea­sons that remain entire­ly unex­plained to this day:

    The Atlantic

    Did a Famous Doctor’s COVID Shot Make His Can­cer Worse?

    A life­long pro­mot­er of vac­cines sus­pects he might be the rare, unfor­tu­nate excep­tion.

    By Rox­anne Kham­si
    Sep­tem­ber 24, 2022, 8 AM ET

    On Sep­tem­ber 22 of last year, Michel Gold­man, a Bel­gian immu­nol­o­gist and one of Europe’s best-known cham­pi­ons of med­ical research, walked into a clin­ic near his house, rolled up his sleeve, and had a boost­er shot deliv­ered to his arm. He knew he’d need it more than most.

    Just a few weeks ear­li­er, Michel, 67, had been to see his younger broth­er, Serge, the head of nuclear med­i­cine at the hos­pi­tal of the Uni­ver­sité Libre de Brux­elles, where both men are pro­fes­sors. Michel was hav­ing night sweats, and he could feel swollen lymph nodes in his neck, so his broth­er brought him in for a full-body CT scan. When the images came through to Serge’s com­put­er they revealed a smat­ter­ing of inky spots, bunched near Michel’s left armpit and run­ning up along his neck. It was can­cer of the immune system—lymphoma.

    Giv­en his own area of exper­tise, Michel under­stood this meant he’d soon be immuno­com­pro­mised by chemother­a­py. With anoth­er win­ter on the way—and per­haps anoth­er wave of SARS-CoV­‑2 infections—that meant he had just a nar­row win­dow of oppor­tu­ni­ty in which his body would respond in full to COVID vac­ci­na­tion. Hav­ing received two dos­es of Pfiz­er the pri­or spring, Michel quick­ly went to get his third. If he was about to spend months absorb­ing poi­son as he tried to beat a dead­ly can­cer, at least he’d have the most pro­tec­tion pos­si­ble from the pan­dem­ic.

    With­in a few days, though, Michel was some­how feel­ing even worse. His night sweats got much more intense, and he found himself—quite out of character—taking after­noon naps. Most wor­ry­ing­ly, his lymph nodes were even more swollen than before. He con­ferred with Serge again, and they set up anoth­er body scan for Sep­tem­ber 30, six days before Michel was sched­uled to start his can­cer treat­ment. Once again he sat in the radi­ol­o­gy wait­ing room while his broth­er wait­ed for the pic­tures to appear on his com­put­er.

    Serge’s bushy eye­brows fur­rowed when he spoke with Michel after hav­ing seen the scans. (“I will always remem­ber his face, it was just incred­i­ble,” Michel told me.) The pic­tures showed a brand-new bar­rage of can­cer lesions—so many spots that it looked like some­one had set off fire­works inside Michel’s body. More than that, the lesions were now promi­nent on both sides of the body, with new clus­ters bloom­ing in Michel’s right armpit in par­tic­u­lar, and along the right side of his neck.

    When Michel’s hema­tol­o­gist saw the scan, she told him to report direct­ly to the near­est hos­pi­tal phar­ma­cy. He’d have to start on steroid pills right away, she told him. Such a swift pro­gres­sion for lym­phoma in just three weeks was high­ly unusu­al, and he could not risk wait­ing a sin­gle day longer.

    As he fol­lowed these instruc­tions, Michel felt a gnaw­ing wor­ry that his COVID boost­er shot had some­how made him sick­er. His broth­er was har­bor­ing a sim­i­lar con­cern. The asym­met­ri­cal clus­ter of can­cer­ous nodes around Michel’s left armpit on the ini­tial scan had already seemed “a bit dis­turb­ing,” as his broth­er said; espe­cial­ly giv­en that Michel’s first two dos­es of vac­cine had been deliv­ered on that side. Now he’d had a boost­er shot in the oth­er arm, and the cancer’s asym­me­try was flipped.

    The broth­ers knew this might be just an eerie coin­ci­dence. But they couldn’t shake the feel­ing that Michel had expe­ri­enced what would be a very rare yet life-threat­en­ing side effect of COVID vac­ci­na­tion. For a doc­tor who had spent four decades study­ing and advo­cat­ing for new med­i­cines, that feel­ing would unfold into many months of delib­er­a­tion and self-doubt. Michel used to run an insti­tute for vac­cine-tech­nol­o­gy research, and he’s spo­ken out to reas­sure the pub­lic about the safe­ty of the COVID vac­cines, and of the mRNA vac­cines in par­tic­u­lar. In Decem­ber 2020, he told an inter­view­er that “if there was a real prob­lem with the tech­nol­o­gy, we’d have seen it before now for sure.” His “main con­cern,” he con­tin­ued, was that peo­ple would use the mere pos­si­bil­i­ty of side effects “as an argu­ment not to be vac­ci­nat­ed.”

    But now that pos­si­bil­i­ty appeared to be splat­tered all across his med­ical charts. Michel Gold­man, cham­pi­on of the mRNA vac­cines, sus­pect­ed that he was their unlucky vic­tim.

    I hap­pened to speak with Michel by phone in April 2021, months before his can­cer diag­no­sis. I’d called him to dis­cuss anoth­er poten­tial side effect of COVID vac­ci­na­tion, one asso­ci­at­ed in par­tic­u­lar with the shot made by AstraZeneca. By that point, 220 peo­ple who’d received that vac­cine had devel­oped an unusual—and very dangerous—blood-clotting syn­drome, which was char­ac­ter­ized by an atyp­i­cal low platelet count. At least sev­en peo­ple in the U.K. alone had died of the com­pli­ca­tion. Michel patient­ly laid out the dif­fer­ent mech­a­nisms that might explain this strange con­di­tion. But he was quick to add that the mRNA COVID vac­cines were built in a way that could mit­i­gate the risk of this par­tic­u­lar prob­lem.

    Michel cur­rent­ly leads the I3h insti­tute, a uni­ver­si­ty hub aimed at assist­ing in drug-design projects; in an ear­li­er post­ing, he head­ed a $2 bil­lion Euro­pean endeav­or to accel­er­ate the research of new med­i­cines. As such, he’s spent many years attend­ing to the pos­si­ble risks—even tiny ones—of nov­el med­ical treat­ments. He has raised aware­ness about the iron over­load that used to afflict dial­y­sis patients before the advent of a drug known as ery­thro­poi­etin, for exam­ple; and looked for signs of “cytokine storms” in kid­ney-trans­plant recip­i­ents who received mon­o­clon­al-anti­body treat­ments. So when a pletho­ra of new vac­cines for COVID emerged in the first year of the pan­dem­ic, he was watch­ing very close­ly.

    When we talked about the poten­tial side effects of the AstraZeneca vac­cine last year, Michel made it clear that, in the big pic­ture, any chance of seri­ous com­pli­ca­tions from the shots would be orders of mag­ni­tude small­er than the chance of com­pli­ca­tions from the pan­dem­ic ill­ness itself. If COVID vac­cines caused clot­ting dis­or­ders or myocardi­tis in a tiny per­cent­age of those who received them, he assured me, COVID would lead to stroke or heart inflam­ma­tion in a much larg­er group.

    The risks and ben­e­fits for each vac­cine should be weighed against each oth­er, he con­tin­ued. If AstraZeneca were the only option, then its pro­tec­tion might be worth the very small risk of devel­op­ing a rare blood dis­or­der. But giv­en the avail­abil­i­ty of Pfiz­er, Mod­er­na, and oth­er COVID vac­cines, many peo­ple could opt for a safer alter­na­tive.

    Now that risk-ben­e­fit cal­cu­la­tion has been thrust upon him in a per­son­al and ter­ri­fy­ing way. By the time we spoke again, he’d become a can­cer patient who sus­pect­ed that his mRNA vac­cine might have made things worse. Michel is reserved by nature, prone to mak­ing mat­ter-of-fact remarks rather than emo­tive mus­ings. In this case, I found him more guard­ed than ever, and I could tell he’d strug­gled over how he should describe his own experience—or, indeed, whether he should even be describ­ing it at all. Per­haps his hypoth­e­sis was wrong, and the course of his can­cer had had noth­ing to do with the shots. Or maybe the can­cer and the mRNA vac­cine were con­nect­ed, but the risk of get­ting immu­nized was still just a tiny speck beside the ben­e­fits. Apply­ing the same log­ic that he’d used before, he decid­ed it made sense to go pub­lic with this the­o­ry. If oth­er peo­ple with the same lym­phoma felt the need to hedge their bets, they might con­sid­er hold­ing off on the Pfiz­er and Mod­er­na shots.

    Michel knew that by speak­ing out about anoth­er poten­tial rare effect—especially with­out hard proof—he’d be intro­duc­ing a dif­fer­ent kind of risk. Recent years had already seen a rise in anti-vac­cine dis­in­for­ma­tion, and pro­test­ers have thrown men­stru­al blood at state leg­is­la­tors and issued death threats to pub­lic-health offi­cials. Fear­mon­gers have made the prob­lem worse by cit­ing scary-sound­ing data from the Vac­cine Adverse Event Report­ing Sys­tem, a U.S. gov­ern­ment data­base of pos­si­ble side effects from immu­niza­tions, with insuf­fi­cient con­text. In Europe, French police used tear gas to dis­perse anti-vac­cine pro­test­ers who were aim­ing fire­works at offi­cers in July of 2021; a vac­ci­na­tion cen­ter was set ablaze in Poland a few weeks lat­er. Michel was well aware of all this trend; in fact, he’d been sound­ing the alarm about the spread of vac­cine mis­in­for­ma­tion online before the. If he shared his own expe­ri­ence of can­cer, might that make the prob­lem worse?

    This was not a rea­son to remain silent, Michel even­tu­al­ly decid­ed. It was a rea­son to speak care­ful­ly.

    ...

    Michel’s can­cer was the kind that attacks the body’s T cells, which coor­di­nate the immune response to invad­ing pathogens. T‑cell lym­phomas come in rough­ly 30 dif­fer­ent sub­types; Michel’s, known as angioim­munoblas­tic T‑cell lym­phoma, affects what are called fol­lic­u­lar helper T cells, which hang out in the ton­sils and the lymph nodes, among oth­er tis­sues.. Fol­lic­u­lar helper T cells serve a cru­cial role in the cas­cade of events to pro­tect the body after dan­ger­ous invaders have arrived. That process begins with den­drit­ic cells, which iden­ti­fy a virus or oth­er pathogen and present exam­ples of it to the rest of the immune sys­tem. The helper T cells do just as their name sug­gests: They help pass that mes­sage along to B cells, which end up mak­ing pro­tec­tive anti­bod­ies against the virus.

    Michel had recent­ly learned that mRNA vac­cines, such as the Pfiz­er shots he had received, are espe­cial­ly effec­tive at gen­er­at­ing that mes­sage, and spurring its pas­sage through the helper T cells. Some researchers argue that the COVID vac­cines from Pfiz­er and Mod­er­na have been more pro­tec­tive than oth­ers for exact­ly this rea­son: They rev up those cells with extra oomph. Now Michel began to won­der whether that oomph could, in ultra­rare cas­es, turn out to be a lia­bil­i­ty. Per­haps the shots gave such a jolt to his helper T cells that they went berserk. If they were prone to form­ing tumors, or if they were already can­cer­ous, then over­stim­u­la­tion could have made the prob­lem even worse.

    As the days went by, Michel found oth­er clues sug­gest­ing that the link was real, and that the mRNA vac­cines might be risky for a spe­cif­ic sub­set of the pop­u­la­tion. He learned that body scans of some of those who get vac­cines, includ­ing can­cer patients, have shown height­ened activ­i­ty in the lymph nodes near the armpit on the side where the shot was received. He also came across anoth­er, very impor­tant clue. In 2018, a team of researchers based at Colum­bia University’s Insti­tute for Can­cer Genet­ics had pub­lished an intrigu­ing study using mice with a pair of gene muta­tions that, when they co-occur, pre­dis­pose T cells to go rogue. (Michel’s tumor, which had been sequenced by this point, showed the same two muta­tions.) When these mice were inject­ed with sheep red-blood cells—as an exper­i­men­tal stand-in for invad­ing microbes—the ani­mals devel­oped the sub­type of lym­phoma that was diag­nosed in Michel.

    Now Michel had a the­o­ry to explain the bleak coin­ci­dence that had befall­en him. Serge agreed that it made sense. The broth­ers had co-writ­ten research papers in the past, includ­ing ones on the use of stem cells for heart repair and den­drit­ic-cell vac­cines for can­cer. It was time for them to write anoth­er.

    On Octo­ber 20 of last year, Hans-Georg Eich­ler, a clin­i­cal phar­ma­col­o­gist and for­mer senior med­ical offi­cer for the Euro­pean Med­i­cines Agency, opened up his email to find a mes­sage from Michel. The two have known each oth­er for more than a decade. “I hope that you are well,” the mes­sage start­ed, “which is not real­ly my case ...” Michel had past­ed in a link to a med­ical report, not yet pub­lished. “I am curi­ous to hear your thoughts,” he wrote.

    The paper, titled “Rapid Pro­gres­sion of Angioim­munoblas­tic T Cell Lym­phoma Fol­low­ing BNT162b2 mRNA Vac­cine Boost­er Shot” and cred­it­ed to Serge Gold­man, Michel Gold­man, and six of their Bel­gian col­leagues, would run in the jour­nal Fron­tiers in Med­i­cine a few weeks lat­er. (Michel is that journal’s edi­tor in chief; he recused him­self from the process of edit­ing and peer review.) It begins by describ­ing “a 66-year-old man with no sig­nif­i­cant med­ical his­to­ry” who had been diag­nosed with lym­phoma that wors­ened fol­low­ing a boost­er dose of COVID-19 vac­cine. The Gold­mans’ unusu­al con­nec­tion to the data—the fact that the 66-year-old man in ques­tion was Michel—comes across oblique­ly in the text. An ethics state­ment, print­ed at the end of the case report, includes the line: “Being one of the authors, the patient con­sent­ed to the pub­li­ca­tion.”

    Eich­ler, who had close­ly fol­lowed the furor over vac­cine-asso­ci­at­ed blood-clot dis­or­ders the pre­vi­ous spring, replied that evening: “I have read the paper and am very impressed … It is the most respon­si­ble and coura­geous thing you could do under the worst pos­si­ble cir­cum­stances.”

    “I would say that 95 per­cent of the reac­tions were extreme­ly friend­ly,” Michel told me lat­er. But as he’d feared, anti-vac­cine activists picked up on the sto­ry. “The lymph nodes of those who have tak­en these shots are explod­ing, bur­geon­ing, and bulging with this tox­ic bioweapon,” a right-wing influ­encer named Jane Ruby wrote on Telegram beneath a screen­shot of Michel’s CT scans, which had appeared in his pub­lished paper (and are repro­duced in this arti­cle). “LYMPHOMA — That’s right… Can­cer of the lym­phat­ic sys­tem … STOP THIS FROM GETTING INTO BABIES AND CHILDREN!!!!!” Ruby’s claims were ampli­fied on Nat­ur­al News, among oth­er anti-vac­ci­na­tion sites where, again, the very images that Michel’s broth­er had used to diag­nose his ill­ness were pre­sent­ed as shock­ing evi­dence of vaccination’s dan­gers. “PHOTOS: LYMPHOMA CANCER EXPLODING IN THE BOOSTED,” one web­site said.

    When I told Michel about these online posts, he shook his head in dis­ap­point­ment. “They’re look­ing for any­thing to sup­port their crazy vision,” he said. “It makes me sad about the world in which we are liv­ing.” That’s not to say he was sur­prised. Michel knew, for instance, that med­ical experts have dis­pelled false rumors about vac­cines infect­ing peo­ple with COVID-19. He told me that he’d obsessed over get­ting the tone of the man­u­script exact­ly right, so as not to fuel vac­cine skep­ti­cism. He was care­ful, for exam­ple, to describe the vac­cine as pos­si­bly “induc­ing” the “pro­gres­sion” of his cancer—rather than “caus­ing” it to sur­face. “I spent hours and hours,” he said. “I’ve nev­er spent so much time on details in a paper.”

    Extreme­ly rare cas­es like Michel’s cre­ate a tricky ter­rain for sci­ence com­mu­ni­ca­tion. Even a clin­i­cal tri­al with thou­sands of par­tic­i­pants might nev­er turn up a sin­gle case of some­one’s can­cer wors­en­ing after vac­ci­na­tion. In that con­text, experts can’t assign a sta­tis­ti­cal esti­mate of the risk across the wider pop­u­la­tion. Sci­ence jour­nal­ists may be wary of report­ing on the sto­ry for that rea­son. In fact, when Michel first told me about his can­cer and about the paper he’d writ­ten with his broth­er, I said that I couldn’t write about it. I was wor­ried that some read­ers would mis­in­ter­pret my arti­cle, and mis­tak­en­ly see it as a rea­son not to get vac­ci­nat­ed. As I write this, I’m still con­cerned that you might do exact­ly that.

    But the sci­en­tif­ic lit­er­a­ture is sprin­kled with odd cas­es like Michel’s that have puz­zled doc­tors. The Gold­mans’ paper fol­lows ear­li­er iso­lat­ed reports sug­gest­ing a pos­si­ble link between COVID-19 vac­ci­na­tion and lym­phoma. Aaron Man­gold, who heads the divi­sion of clin­i­cal der­ma­tol­ogy at the Mayo Clin­ic in Ari­zona, co-authored a paper pub­lished in May 2021 about a patient whose rare skin lym­phoma recurred after his ini­tial Pfiz­er shot. The tumor­ous ulcer appeared in the armpit of the same arm in which the man had received the injec­tion, and then regressed spon­ta­neous­ly. A sec­ond shot of the vac­cine, deliv­ered three weeks lat­er, pro­duced no fur­ther lesions, Man­gold told me, and the whole ordeal could have sim­ply been a coin­ci­dence. He felt that he’d been “thread­ing the nee­dle” to go pub­lic with the case report giv­en that uncer­tain­ty.

    Ladan Zand, a nephrol­o­gist at the Mayo Clin­ic in Rochester, Min­neso­ta, faced the same conun­drum when she co-authored a paper last year detail­ing five patients who had a relapse of kid­ney dis­ease fol­low­ing mRNA COVID vac­ci­na­tion. Her team also doc­u­ment­ed eight patients who were new­ly diag­nosed with the dis­ease, known as glomeru­lonephri­tis, after receiv­ing the shot. But Zand cau­tions that those patients might have had under­ly­ing kid­ney dis­ease and not been aware of it. Peo­ple infect­ed with the nov­el coro­n­avirus also show high­er rates of kid­ney-func­tion decline over time. “I spend half of my vis­its now ask­ing patients to get vac­ci­nat­ed,” she said. “If you were to com­pare the risks and ben­e­fits, the ben­e­fits of the vac­cine way out­weigh the risk of rare enti­ties that, for the most part, seem to be self-lim­it­ing.”

    William Mur­phy, an immu­nol­o­gist at UC Davis, told me that Michel’s before-and-after CT scans were fas­ci­nat­ing in the con­text of the mouse study from Colum­bia. The cancer’s behav­ior cer­tain­ly appeared to be relat­ed to the vac­cine, he said, “giv­en the huge dif­fer­ence in the scans of the tumor pro­gres­sion in a very short peri­od of time.” But one can’t be cer­tain, how­ev­er strik­ing the data. It’s just a case report, he added—one patient.

    The Gold­mans’ paper, for its part, notes that it would be “pre­ma­ture” to extrap­o­late the find­ings from Michel to oth­er patients with the same kind of can­cer, and that the link, even if it were proved, should not dis­cour­age gen­er­al uptake of “much-need­ed vac­cines.” An unusu­al para­graph tacked onto the bot­tom of the arti­cle under­scores the point. Marked “Patient Per­spec­tive,” and writ­ten in the third per­son, it notes that Michel him­self “remains con­vinced that mRNA vac­cines rep­re­sent very effi­cient prod­ucts with a favor­able ben­e­fit-risk ratio,” and that he hopes the report will encour­age fur­ther research.

    In mid-Feb­ru­ary, Michel spiked a sud­den fever. COVID had final­ly caught up with him.

    Giv­en that he was immuno­com­pro­mised by six rounds of can­cer chemother­a­py, Michel knew that his doc­tors would need to act quick­ly. He soon received an infu­sion of the mon­o­clon­al-anti­body drug sotro­vimab, and man­aged to recov­er with­out inci­dent; his lymph nodes stayed bless­ed­ly qui­et, and there was no resur­gence of his can­cer. Now he’s eli­gi­ble for a sec­ond boost­er shot, but he’s not sure whether he should take it. “I don’t know what I will do,” he said.

    Would anoth­er dose of the vac­cine cause anoth­er round of can­cer lesions? Michel and the sci­en­tists who have been in touch with him are still mulling the evi­dence about whether his orig­i­nal can­cer flare was sim­ply a fluke. Steven Hor­witz, a med­ical oncol­o­gist at Memo­r­i­al Sloan Ket­ter­ing who focus­es on the care of patients with lym­phoma, has looked more close­ly at vac­cine side effects since hear­ing about Michel’s case, and feels reas­sured by what he’s found. “Of our patients who received mRNA COVID vac­cines, we have not seen any clear­ly relat­ed and doc­u­ment­ed relaps­es or pro­gres­sions,” he told me via email. Mean­while, lym­phomas and the treat­ments giv­en for them can weak­en the immune sys­tem, putting affect­ed patients at high­er risk of severe COVID-19 if infect­ed. “Vac­ci­na­tion remains the most effec­tive way to mit­i­gate that risk,” he said.

    I reached out to the mak­ers of the mRNA COVID vac­cines to ask about Michel’s case. A rep­re­sen­ta­tive for Pfiz­er not­ed that the com­pa­ny takes such reports “very seri­ous­ly” but that, “to date, there has been no iden­ti­fied cor­re­la­tion between the vac­cine and can­cer.” Moderna’s chief med­ical offi­cer, Paul Bur­ton, told me that the com­pa­ny keeps care­ful track of safe­ty data and has not found any rela­tion­ship between vac­ci­na­tion and lym­phoma. He also point­ed to the case of a 61-year-old woman with can­cer of the sali­vary gland whose tumor shrank to about one-quar­ter of its orig­i­nal size in the month after she received a sec­ond dose of the Mod­er­na vac­cine. “Now, did it real­ly regress because the per­son got a mes­sen­ger RNA vac­cine?” he asked. “I don’t know. I think biol­o­gy is tru­ly a remark­able thing.”

    While Michel remains unsure about his fourth shot, he has con­tin­ued to be out­spo­ken on the ben­e­fits of vac­ci­na­tion over­all, and often speaks to Bel­gian media on the top­ic. At the same time, he has become a stronger advo­cate for broad­er track­ing of adverse events from vaccines—an endeav­or he and oth­ers in drug devel­op­ment call “phar­ma­covig­i­lance.” “We need to make sure that some phar­ma­covig­i­lance pro­grams are pow­ered to detect very, very rare side effects,” Michel told me. Eich­ler, who was involved in drug reg­u­la­tion for the Euro­pean Med­i­cines Agency, said that while some doc­tors may be “afi­ciona­dos” of ran­dom­ized con­trolled tri­als as the only valid source of med­ical evi­dence, oth­er types of infor­ma­tion are need­ed. Michel’s case shows why: You’ve got a patient “who is a pro­fes­sor of med­i­cine, who expe­ri­ences the side effects and says, ‘Okay, this must be a side effect,’” Eich­ler said. That “rings the bells. Could Michel have ever come up in an RCT? My answer is prob­a­bly not.”

    ...

    Around the time of his Feb­ru­ary fol­low-up, Michel received a mes­sage from a doc­tor who had read his self-ref­er­en­tial case report. The doctor’s moth­er had been diag­nosed with the same sub­type of lym­phoma that Michel has fol­low­ing a COVID boost­er shot. More recent­ly, he got an email from a woman whose sis­ter had been vac­ci­nat­ed and received that diag­no­sis the fol­low­ing month. Again, these could be coin­ci­dences. Or maybe they are the sec­ond and third data points in a grow­ing set. The pos­si­ble con­nec­tion between Michel’s lym­phoma flare and his COVID-19 vac­ci­na­tion occu­pies much of his think­ing these days. “If it exists, it must be very rare,” he said. But he doesn’t regret going pub­lic with his case. “I’m still con­vinced it was the right thing to do.”

    ———–

    “Did a Famous Doctor’s COVID Shot Make His Can­cer Worse?” By Rox­anne Kham­si; The Atlantic; 09/24/2022

    “As he fol­lowed these instruc­tions, Michel felt a gnaw­ing wor­ry that his COVID boost­er shot had some­how made him sick­er. His broth­er was har­bor­ing a sim­i­lar con­cern. The asym­met­ri­cal clus­ter of can­cer­ous nodes around Michel’s left armpit on the ini­tial scan had already seemed “a bit dis­turb­ing,” as his broth­er said; espe­cial­ly giv­en that Michel’s first two dos­es of vac­cine had been deliv­ered on that side. Now he’d had a boost­er shot in the oth­er arm, and the cancer’s asym­me­try was flipped.”

    It was cause-and-effect hypoth­e­sis that was hard ignore: Michel Gold­man’s lym­phoma got dra­mat­i­cal­ly worse almost imme­di­ate­ly after get­ting the shot. But that was just the start of the evi­dence. The dots were thee to con­nect: Gold­man’s angioim­munoblas­tic T‑cell lym­phoma affects fol­lic­u­lar helper T cells, and research has already found that mRNA vac­cines are par­tic­u­lar­ly effec­tive at pro­vid­ing an extra ‘oomph’ to the body’s fol­lic­u­lar helper T cells. And Gold­man’s tumor has a muta­tion known to pre­dis­pose T‑cells to go rogue. Gold­man’s cas­es is only one data point, but a pret­ty com­pelling data point.

    And again, recall that fas­ci­nat­ing Sep­tem­ber 2016 STAT News arti­cle that described how Mod­er­na had shift­ed its focus from mRNA ther­a­peu­tics — which require numer­ous shots over years — to mRNA vac­cines. It was seen as as dis­ap­point­ment by indus­try observers and sign that Mod­er­na was run­ning into undis­closed set­backs involv­ing side effects trig­gered by the lipid nanopar­ti­cle (LNP) deliv­ery vehi­cle for the mRNA. But as we saw, Mod­er­na was insist­ing at the time that it was expe­ri­enc­ing no such set backs. And yet observers were just forced to take their word because the com­pa­ny was being so secre­tive and releas­ing almost no infor­ma­tion about its inter­nal tri­als. It was one of the high­ly con­ve­nient aspects of the whole mRNA vac­cine sit­u­a­tion: the side effects from the LNP deliv­ery vehi­cle just might be desir­able and have an adju­vant-like effect in the con­text of a vac­cine if those side effects end up revving up the immune sys­tem. So it should­n’t be par­tic­u­lar­ly sur­pris­ing when we learn that there might be rare side effects involv­ing an over­ly-revved-up immune sys­tem. The extra immuno­log­i­cal ‘oomph’ from the mRNA vac­cines was tout­ed as a sell­ing point, after all:

    ...
    Michel’s can­cer was the kind that attacks the body’s T cells, which coor­di­nate the immune response to invad­ing pathogens. T‑cell lym­phomas come in rough­ly 30 dif­fer­ent sub­types; Michel’s, known as angioim­munoblas­tic T‑cell lym­phoma, affects what are called fol­lic­u­lar helper T cells, which hang out in the ton­sils and the lymph nodes, among oth­er tis­sues.. Fol­lic­u­lar helper T cells serve a cru­cial role in the cas­cade of events to pro­tect the body after dan­ger­ous invaders have arrived. That process begins with den­drit­ic cells, which iden­ti­fy a virus or oth­er pathogen and present exam­ples of it to the rest of the immune sys­tem. The helper T cells do just as their name sug­gests: They help pass that mes­sage along to B cells, which end up mak­ing pro­tec­tive anti­bod­ies against the virus.

    Michel had recent­ly learned that mRNA vac­cines, such as the Pfiz­er shots he had received, are espe­cial­ly effec­tive at gen­er­at­ing that mes­sage, and spurring its pas­sage through the helper T cells. Some researchers argue that the COVID vac­cines from Pfiz­er and Mod­er­na have been more pro­tec­tive than oth­ers for exact­ly this rea­son: They rev up those cells with extra oomph. Now Michel began to won­der whether that oomph could, in ultra­rare cas­es, turn out to be a lia­bil­i­ty. Per­haps the shots gave such a jolt to his helper T cells that they went berserk. If they were prone to form­ing tumors, or if they were already can­cer­ous, then over­stim­u­la­tion could have made the prob­lem even worse.

    As the days went by, Michel found oth­er clues sug­gest­ing that the link was real, and that the mRNA vac­cines might be risky for a spe­cif­ic sub­set of the pop­u­la­tion. He learned that body scans of some of those who get vac­cines, includ­ing can­cer patients, have shown height­ened activ­i­ty in the lymph nodes near the armpit on the side where the shot was received. He also came across anoth­er, very impor­tant clue. In 2018, a team of researchers based at Colum­bia University’s Insti­tute for Can­cer Genet­ics had pub­lished an intrigu­ing study using mice with a pair of gene muta­tions that, when they co-occur, pre­dis­pose T cells to go rogue. (Michel’s tumor, which had been sequenced by this point, showed the same two muta­tions.) When these mice were inject­ed with sheep red-blood cells—as an exper­i­men­tal stand-in for invad­ing microbes—the ani­mals devel­oped the sub­type of lym­phoma that was diag­nosed in Michel.

    Now Michel had a the­o­ry to explain the bleak coin­ci­dence that had befall­en him. Serge agreed that it made sense. The broth­ers had co-writ­ten research papers in the past, includ­ing ones on the use of stem cells for heart repair and den­drit­ic-cell vac­cines for can­cer. It was time for them to write anoth­er.
    ...

    And yet, as this arti­cle describes, the med­ical estab­lish­ment does­n’t seem to be very well equipped for iden­ti­fy­ing and hon­ing in on these kinds of rare events. Even reporters are wary of report­ing on such events unless they can be sta­tis­ti­cal­ly estab­lished across a larg­er patient pop­u­la­tion which sim­ply may not be pos­si­ble for a lot of rare con­di­tions. That’s part of the sto­ry here: risks that can’t be stud­ied via a ran­dom­ized-con­trolled clin­i­cal tri­als (RCTs) are sys­tem­at­i­cal­ly ignored. And yet, if mRNA vac­cines are poten­tial­ly caus­ing immune sys­tems to go hay­wire in some patients, we can’t expect that to man­i­fest as a sin­gle dis­ease. Out of con­trol immune sys­tems man­i­fest in all sorts of ways. So you could have a shared under­ly­ing cause man­i­fest­ing as all sorts of dif­fer­ent rare events that we sys­tem­at­i­cal­ly over­look:

    ...

    Extreme­ly rare cas­es like Michel’s cre­ate a tricky ter­rain for sci­ence com­mu­ni­ca­tion. Even a clin­i­cal tri­al with thou­sands of par­tic­i­pants might nev­er turn up a sin­gle case of some­one’s can­cer wors­en­ing after vac­ci­na­tion. In that con­text, experts can’t assign a sta­tis­ti­cal esti­mate of the risk across the wider pop­u­la­tion. Sci­ence jour­nal­ists may be wary of report­ing on the sto­ry for that rea­son. In fact, when Michel first told me about his can­cer and about the paper he’d writ­ten with his broth­er, I said that I couldn’t write about it. I was wor­ried that some read­ers would mis­in­ter­pret my arti­cle, and mis­tak­en­ly see it as a rea­son not to get vac­ci­nat­ed. As I write this, I’m still con­cerned that you might do exact­ly that.

    But the sci­en­tif­ic lit­er­a­ture is sprin­kled with odd cas­es like Michel’s that have puz­zled doc­tors. The Gold­mans’ paper fol­lows ear­li­er iso­lat­ed reports sug­gest­ing a pos­si­ble link between COVID-19 vac­ci­na­tion and lym­phoma. Aaron Man­gold, who heads the divi­sion of clin­i­cal der­ma­tol­ogy at the Mayo Clin­ic in Ari­zona, co-authored a paper pub­lished in May 2021 about a patient whose rare skin lym­phoma recurred after his ini­tial Pfiz­er shot. The tumor­ous ulcer appeared in the armpit of the same arm in which the man had received the injec­tion, and then regressed spon­ta­neous­ly. A sec­ond shot of the vac­cine, deliv­ered three weeks lat­er, pro­duced no fur­ther lesions, Man­gold told me, and the whole ordeal could have sim­ply been a coin­ci­dence. He felt that he’d been “thread­ing the nee­dle” to go pub­lic with the case report giv­en that uncer­tain­ty.

    Ladan Zand, a nephrol­o­gist at the Mayo Clin­ic in Rochester, Min­neso­ta, faced the same conun­drum when she co-authored a paper last year detail­ing five patients who had a relapse of kid­ney dis­ease fol­low­ing mRNA COVID vac­ci­na­tion. Her team also doc­u­ment­ed eight patients who were new­ly diag­nosed with the dis­ease, known as glomeru­lonephri­tis, after receiv­ing the shot. But Zand cau­tions that those patients might have had under­ly­ing kid­ney dis­ease and not been aware of it. Peo­ple infect­ed with the nov­el coro­n­avirus also show high­er rates of kid­ney-func­tion decline over time. “I spend half of my vis­its now ask­ing patients to get vac­ci­nat­ed,” she said. “If you were to com­pare the risks and ben­e­fits, the ben­e­fits of the vac­cine way out­weigh the risk of rare enti­ties that, for the most part, seem to be self-lim­it­ing.”

    ...

    While Michel remains unsure about his fourth shot, he has con­tin­ued to be out­spo­ken on the ben­e­fits of vac­ci­na­tion over­all, and often speaks to Bel­gian media on the top­ic. At the same time, he has become a stronger advo­cate for broad­er track­ing of adverse events from vaccines—an endeav­or he and oth­ers in drug devel­op­ment call “phar­ma­covig­i­lance.” “We need to make sure that some phar­ma­covig­i­lance pro­grams are pow­ered to detect very, very rare side effects,” Michel told me. Eich­ler, who was involved in drug reg­u­la­tion for the Euro­pean Med­i­cines Agency, said that while some doc­tors may be “afi­ciona­dos” of ran­dom­ized con­trolled tri­als as the only valid source of med­ical evi­dence, oth­er types of infor­ma­tion are need­ed. Michel’s case shows why: You’ve got a patient “who is a pro­fes­sor of med­i­cine, who expe­ri­ences the side effects and says, ‘Okay, this must be a side effect,’” Eich­ler said. That “rings the bells. Could Michel have ever come up in an RCT? My answer is prob­a­bly not.”
    ...

    But then we get to the tru­ly inex­plic­a­ble aspects of this sto­ry: if the dan­ger asso­ci­at­ed with the COVID vac­cines are asso­ci­at­ed with the effect on T‑cells induced by specif­i­cal­ly mRNA vac­cines, what about all the non-mRNA COVID vac­cine options for patients like Gold­man? Can’t he just take the AstraZeneca vac­cine instead? Or the John­son & John­son vac­cine? How about the new­ly-approved Novavax vac­cine? There are plen­ty of non-mRNA options. And Gold­man him­self even empha­sized how the risks found with these oth­er vac­cines were vast­ly out­weighed by the risks of COVID:

    ...
    I hap­pened to speak with Michel by phone in April 2021, months before his can­cer diag­no­sis. I’d called him to dis­cuss anoth­er poten­tial side effect of COVID vac­ci­na­tion, one asso­ci­at­ed in par­tic­u­lar with the shot made by AstraZeneca. By that point, 220 peo­ple who’d received that vac­cine had devel­oped an unusual—and very dangerous—blood-clotting syn­drome, which was char­ac­ter­ized by an atyp­i­cal low platelet count. At least sev­en peo­ple in the U.K. alone had died of the com­pli­ca­tion. Michel patient­ly laid out the dif­fer­ent mech­a­nisms that might explain this strange con­di­tion. But he was quick to add that the mRNA COVID vac­cines were built in a way that could mit­i­gate the risk of this par­tic­u­lar prob­lem.

    ...

    When we talked about the poten­tial side effects of the AstraZeneca vac­cine last year, Michel made it clear that, in the big pic­ture, any chance of seri­ous com­pli­ca­tions from the shots would be orders of mag­ni­tude small­er than the chance of com­pli­ca­tions from the pan­dem­ic ill­ness itself. If COVID vac­cines caused clot­ting dis­or­ders or myocardi­tis in a tiny per­cent­age of those who received them, he assured me, COVID would lead to stroke or heart inflam­ma­tion in a much larg­er group.

    The risks and ben­e­fits for each vac­cine should be weighed against each oth­er, he con­tin­ued. If AstraZeneca were the only option, then its pro­tec­tion might be worth the very small risk of devel­op­ing a rare blood dis­or­der. But giv­en the avail­abil­i­ty of Pfiz­er, Mod­er­na, and oth­er COVID vac­cines, many peo­ple could opt for a safer alter­na­tive.
    ...

    And yet, despite Gold­man’s assur­ances about the safe­ty of the AstraZeneca vac­cine, we find that he’s appar­ent­ly still try­ing to decide whether or not to get anoth­er mRNA boost­er shot or no vac­cine at all. WTF!?!?! Why?! Why not just take one of the non-mRNA vac­cines? It’s tru­ly bizarre:

    ...
    The Gold­mans’ paper, for its part, notes that it would be “pre­ma­ture” to extrap­o­late the find­ings from Michel to oth­er patients with the same kind of can­cer, and that the link, even if it were proved, should not dis­cour­age gen­er­al uptake of “much-need­ed vac­cines.” An unusu­al para­graph tacked onto the bot­tom of the arti­cle under­scores the point. Marked “Patient Per­spec­tive,” and writ­ten in the third per­son, it notes that Michel him­self “remains con­vinced that mRNA vac­cines rep­re­sent very effi­cient prod­ucts with a favor­able ben­e­fit-risk ratio,” and that he hopes the report will encour­age fur­ther research.

    In mid-Feb­ru­ary, Michel spiked a sud­den fever. COVID had final­ly caught up with him.

    Giv­en that he was immuno­com­pro­mised by six rounds of can­cer chemother­a­py, Michel knew that his doc­tors would need to act quick­ly. He soon received an infu­sion of the mon­o­clon­al-anti­body drug sotro­vimab, and man­aged to recov­er with­out inci­dent; his lymph nodes stayed bless­ed­ly qui­et, and there was no resur­gence of his can­cer. Now he’s eli­gi­ble for a sec­ond boost­er shot, but he’s not sure whether he should take it. “I don’t know what I will do,” he said.

    Would anoth­er dose of the vac­cine cause anoth­er round of can­cer lesions? Michel and the sci­en­tists who have been in touch with him are still mulling the evi­dence about whether his orig­i­nal can­cer flare was sim­ply a fluke. Steven Hor­witz, a med­ical oncol­o­gist at Memo­r­i­al Sloan Ket­ter­ing who focus­es on the care of patients with lym­phoma, has looked more close­ly at vac­cine side effects since hear­ing about Michel’s case, and feels reas­sured by what he’s found. “Of our patients who received mRNA COVID vac­cines, we have not seen any clear­ly relat­ed and doc­u­ment­ed relaps­es or pro­gres­sions,” he told me via email. Mean­while, lym­phomas and the treat­ments giv­en for them can weak­en the immune sys­tem, putting affect­ed patients at high­er risk of severe COVID-19 if infect­ed. “Vac­ci­na­tion remains the most effec­tive way to mit­i­gate that risk,” he said.

    ...

    Around the time of his Feb­ru­ary fol­low-up, Michel received a mes­sage from a doc­tor who had read his self-ref­er­en­tial case report. The doctor’s moth­er had been diag­nosed with the same sub­type of lym­phoma that Michel has fol­low­ing a COVID boost­er shot. More recent­ly, he got an email from a woman whose sis­ter had been vac­ci­nat­ed and received that diag­no­sis the fol­low­ing month. Again, these could be coin­ci­dences. Or maybe they are the sec­ond and third data points in a grow­ing set. The pos­si­ble con­nec­tion between Michel’s lym­phoma flare and his COVID-19 vac­ci­na­tion occu­pies much of his think­ing these days. “If it exists, it must be very rare,” he said. But he doesn’t regret going pub­lic with his case. “I’m still con­vinced it was the right thing to do.”
    ...

    So best of luck to Michel Gold­man in his bat­tle with lym­phoma. A bat­tle that hope­ful­ly won’t involve any new bouts of COVID. And/or any new rare side-effects that get sys­tem­at­i­cal­ly ignored.

    Posted by Pterrafractyl | September 26, 2022, 4:01 pm
  2. Here’s an arti­cle from a few weeks ago fol­low­ing up on one of the more dis­turb­ing sto­ries to emerge from the COVID pan­dem­ic. The sto­ry also poten­tial­ly relates to Metabio­ta and the devel­op­ment of pan­dem­ic insur­ance prod­ucts:

    Recall how Palan­tir man­aged to get gov­ern­ment con­tracts to help mon­i­tor the COVID out­break. And not just with the CDC in the US. As of April of 2020, Palan­tir was work­ing with over a dozen gov­ern­ments in assist­ing their COVID response, includ­ing the UK’s Nation­al Health Ser­vice (NHS). Palan­tir’s NHS con­tract involved using Palan­tir’s Foundry plat­form to help the NHS deter­mine cur­rent occu­pan­cy lev­els at hos­pi­tals, down to the num­ber and type of beds, as well as the capac­i­ty of acci­dent and emer­gency, depart­ments and wait­ing times. Palan­tir was get­ting access to some pret­ty gran­u­lar UK med­ical data. The kind of data that could pre­sum­ably be very handy for any com­pa­ny involved with pre­dict­ing and track­ing emerg­ing pan­demics. And with the NHS putting up a new £360 mil­lion con­tract com­ing for ten­der for a major new data plat­form, it sounds like Palan­tir is very keen on get­ting that con­tract and tak­ing steps to make it hap­pen. Steps like hir­ing key NHS offi­cials.

    And now we’re learn­ing that Palan­tir has plans to expand its foot­print in the UK health sys­tem. Secret plans. Well, for­mer­ly secret plans. Plans to avoid pub­lic scruti­ny by buy­ing expand­ing in this mar­ket indi­rect­ly. Instead of Palan­tir direct­ly offer­ing ser­vices to UK health data firms, the com­pa­ny is going on a buy­ing spree instead, tar­get­ing small health data firms across the UK.

    Intrigu­ing­ly, it sounds like Palan­tir is offer­ing the founders of these firms extra sweet deals if the founders agree to shift their data and ser­vices to Palan­tir’s Foundry. In oth­er words, Palan­tir real­ly wants to get its hands on that data. This is par­tic­u­lar­ly inter­est­ing giv­en that, as we’re going to see, the exist­ing NHS con­tracts with Palan­tir are explic­it that “the data con­trol stays with the own­er of the data, not with Palan­tir.” So at the same time Palan­tir appears to be poised to place itself at the heart of the NHS’s health­care data, but not nec­es­sar­i­ly with ‘con­trol’ over that data, the com­pa­ny is simul­ta­ne­ous­ly going around buy up small UK health data firms in a push to get as much of that data into Palan­tir’s inter­nal Foundry plat­form as pos­si­ble.

    And this is all, of course, hap­pen­ing under the watch of a UK gov­ern­ment that appears to be ani­mat­ed by the ghost of Ayn Rand. That’s the broad­er con­text here: the cur­rent right-wing UK gov­ern­ment is keen on hand­ing as much of the pub­lic sec­tor over to the pri­vate sec­tor as pos­si­ble. Out­sourc­ing the NHS’s health data ser­vices to a fas­cist like Peter Thiel just makes sense. Fas­cist sense, but that’s the kind of sense guid­ing the UK these days, which is why we should prob­a­bly start ask­ing what oth­er kind of fas­cist goals might be achiev­able once you hand a nation’s health care data over to one of the world’s lead­ing fas­cists:

    Finan­cial Times

    Palan­tir gears up to expand its reach into UK’s NHS
    US data ana­lyt­ics group hires health ser­vice exec­u­tives in bid to secure £360mn con­tract

    Mad­hu­mi­ta Mur­gia and Sarah Neville in Lon­don
    June 8 2022

    US data ana­lyt­ics group Palan­tir is gear­ing up to become the under­ly­ing oper­at­ing sys­tem for the UK’s Nation­al Health Ser­vice, poach­ing senior NHS offi­cials as part of a bid to win a £360mn con­tract to man­age the data of mil­lions of patients across Eng­land.

    The com­pa­ny, best known for its ties to the secu­ri­ty, defence and intel­li­gence sec­tors, has been the NHS’s go-to data ana­lyt­ics provider dur­ing its Covid-19 cri­sis response. Its Foundry soft­ware was used in the man­age­ment of ven­ti­la­tors and PPE equip­ment, deliv­ery of the nation­wide vac­ci­na­tion pro­gramme and help­ing to tack­le the back­log of 6mn patients wait­ing for elec­tive care.

    The secre­tive com­pa­ny, co-found­ed by Peter Thiel, an ear­ly investor in Face­book and promi­nent sup­port­er of for­mer US pres­i­dent Don­ald Trump, is now manoeu­vring to expand its reach into the NHS over the next decade.

    That push has prompt­ed pri­va­cy activists and some with­in the NHS to voice con­cerns about Palantir’s suit­abil­i­ty to run nation­al health sys­tems as well as the dan­gers of the NHS rely­ing on a sin­gle pri­vate com­pa­ny for its key func­tions.

    Over the next few months, Palan­tir will bid for the five-year £360mn con­tract for the pro­posed Fed­er­at­ed Data Plat­form (FDP), a new data tool to con­nect and inte­grate patient and oth­er data sources from across the health sys­tem, so real-time deci­sions can be made effec­tive­ly by clin­i­cians and bureau­crats. The con­tract is due to be award­ed in Novem­ber this year.

    “This would be the veins through which patient data would flow, very much the oper­at­ing sys­tem for data in the NHS,” said Phil Booth, founder of health data advo­ca­cy group med­Con­fi­den­tial. “This is clear­ly a core ele­ment of the NHS’s entire dig­i­tal trans­for­ma­tion pro­gramme.”

    To help its chances, Palan­tir has hired two senior NHS offi­cials in recent months — Indra Joshi, the NHS’s for­mer head of arti­fi­cial intel­li­gence, and Har­jeet Dhali­w­al, for­mer deputy to Ming Tang, NHS England’s data chief, who is respon­si­ble for the FDP con­tract and for Palantir’s pre­vi­ous con­tracts with the NHS.

    A for­mer senior health offi­cial said that eye­brows with­in the ser­vice had been raised by “the revolv­ing door between gov­ern­ment, NHS and Palan­tir”.

    The UK is a key mar­ket for Palan­tir, which employs more than 600 peo­ple — its largest sin­gle office — and plans to hire an addi­tion­al 250 staff this year. The com­pa­ny already process­es sen­si­tive nation­al secu­ri­ty data for UK pub­lic author­i­ties, includ­ing the Min­istry of Defence and cab­i­net office.

    “Palan­tir has said this is a must-win deal for them,” said a per­son with knowl­edge of Palantir’s expan­sion plans in the UK. “This is a five-year con­tract, with an option for an exten­sion for two years. [Many peo­ple] think it’s real­ly £1bn over 10 years. Once Palan­tir is in, how are you going to remove them?

    The move comes as Palantir’s growth slows sig­nif­i­cant­ly. Its sales in the first quar­ter of this year rose 31 per cent, com­pared with a rise of 49 per cent in the same peri­od last year.

    Although the com­pa­ny has said it wants to piv­ot to doing more com­mer­cial work, gov­ern­ment con­tracts still have a big impact on its finan­cial health. Gov­ern­ment rev­enue was up 16 per cent year on year in the first quar­ter, com­pared with a 76 per cent increase the year before.

    Accord­ing to sev­er­al fig­ures at the NHS and at its sup­pli­ers, Palan­tir is viewed as the fron­trun­ner for the FDP con­tract, which runs until 2027. The plat­form will be used for the nation­al man­age­ment of vac­cines and immu­ni­sa­tion pro­grammes, pop­u­la­tion health, elec­tive wait­ing lists and med­i­cines and equip­ment sup­ply chains, among oth­er appli­ca­tions.

    In an infor­ma­tion pack pro­vid­ed to poten­tial sup­pli­ers by the NHS, and seen by the Finan­cial Times, Palantir’s tech­nol­o­gy was laud­ed as a mod­el. “The cur­rent plat­form (Foundry) is . . . deliv­er­ing huge ben­e­fits and was crit­i­cal to the suc­cess of the vac­ci­na­tion and PPE pro­grammes.”

    Rolling out this type of sys­tem across the rest of the health ser­vice “has the poten­tial to deliv­er £3.6bn ben­e­fits over 10 years”, the doc­u­ment said.

    One senior NHS offi­cial said Palan­tir was well-placed to win the bid, par­tic­u­lar­ly when its work was assessed against fail­ures else­where in the Covid response, notably defi­cien­cies in the pro­gramme to test and track con­tacts of infect­ed peo­ple.

    “If you were to com­pare the [suc­cess­ful] work that Palan­tir did in vac­cines and PPE, with the work that Palan­tir didn’t do, which was test and trace . . . [Palan­tir] hasn’t let us down,” he said.

    Oth­er poten­tial bid­ders could include con­sult­ing firms such as Accen­ture, PwC and KPMG, who have tech­nol­o­gy part­ners such as Ora­cle and Microsoft.

    ...

    NHS Eng­land said the pro­cure­ment process would start in ear­ly July and that it would be an open pro­cure­ment to allow all sup­pli­ers a chance to bid.

    “The NHS should not be com­mis­sion­ing a sin­gle sup­pli­er to be the provider of its oper­at­ing sys­tem for data for Eng­land. We need to be build­ing the capac­i­ty to do that our­selves,” said Booth of med­Con­fi­den­tial. “What­ev­er sup­pli­er is con­tract­ed should be com­plete­ly trans­par­ent, but Palan­tir is a black box.”

    Palantir’s involve­ment in the NHS has been par­tic­u­lar­ly con­tro­ver­sial among civ­il lib­er­ties groups. Last July, a group of pri­va­cy cam­paign­ers led by tech jus­tice group Fox­glove launched the “No Palan­tir in Our NHS” cam­paign owing to its work with the US immi­gra­tion ser­vice and close links to nation­al secu­ri­ty agen­cies.

    While a senior NHS offi­cial acknowl­edged the ques­tion of data secu­ri­ty was “com­plete­ly valid”, he said NHS Eng­land had “gone into this in a lot of depth” and believed that Palan­tir was “one of the few com­pa­nies that can actu­al­ly address those con­cerns legit­i­mate­ly”. Under the licence agree­ments that the NHS has pre­vi­ous­ly entered into with the com­pa­ny, “the data con­trol stays with the own­er of the data, not with Palan­tir”, he not­ed.

    Not all are con­vinced. “Many are already con­cerned about com­mer­cial inter­ests hav­ing involve­ment at all, let alone a com­pa­ny that helped Don­ald Trump with his ICE deten­tions at the Mex­i­can bor­der,” said Booth. “Is this a prop­er cor­po­rate enti­ty to be work­ing at the heart of the NHS?”

    ————

    “Palan­tir gears up to expand its reach into UK’s NHS” by Mad­hu­mi­ta Mur­gia and Sarah Neville; Finan­cial Times; 06/08/2022

    Over the next few months, Palan­tir will bid for the five-year £360mn con­tract for the pro­posed Fed­er­at­ed Data Plat­form (FDP), a new data tool to con­nect and inte­grate patient and oth­er data sources from across the health sys­tem, so real-time deci­sions can be made effec­tive­ly by clin­i­cians and bureau­crats. The con­tract is due to be award­ed in Novem­ber this year.”

    It’s a mas­sive prize: a five-year £360mn con­tract to build a new data plat­form that will con­nect a myr­i­ad of health data sources. And a con­tract that’s almost guar­an­teed to be extend­ed for at least anoth­er five years and prob­a­bly indef­i­nite­ly. And based on insid­er com­ments, it sounds like Palan­tir is the like­ly choice for this con­tract when the gov­ern­ment ulti­mate­ly makes that deci­sion next month. Yes, Palan­tir — a com­pa­ny found­ed by an open fas­cist and financed by the CIA — is poised to get embed­ded at the heart of the NHS oper­a­tions for the fore­see­able future:

    ...
    The com­pa­ny, best known for its ties to the secu­ri­ty, defence and intel­li­gence sec­tors, has been the NHS’s go-to data ana­lyt­ics provider dur­ing its Covid-19 cri­sis response. Its Foundry soft­ware was used in the man­age­ment of ven­ti­la­tors and PPE equip­ment, deliv­ery of the nation­wide vac­ci­na­tion pro­gramme and help­ing to tack­le the back­log of 6mn patients wait­ing for elec­tive care.

    ...

    That push has prompt­ed pri­va­cy activists and some with­in the NHS to voice con­cerns about Palantir’s suit­abil­i­ty to run nation­al health sys­tems as well as the dan­gers of the NHS rely­ing on a sin­gle pri­vate com­pa­ny for its key func­tions.

    ...

    “Palan­tir has said this is a must-win deal for them,” said a per­son with knowl­edge of Palantir’s expan­sion plans in the UK. “This is a five-year con­tract, with an option for an exten­sion for two years. [Many peo­ple] think it’s real­ly £1bn over 10 years. Once Palan­tir is in, how are you going to remove them?

    ...

    Accord­ing to sev­er­al fig­ures at the NHS and at its sup­pli­ers, Palan­tir is viewed as the fron­trun­ner for the FDP con­tract, which runs until 2027. The plat­form will be used for the nation­al man­age­ment of vac­cines and immu­ni­sa­tion pro­grammes, pop­u­la­tion health, elec­tive wait­ing lists and med­i­cines and equip­ment sup­ply chains, among oth­er appli­ca­tions.

    In an infor­ma­tion pack pro­vid­ed to poten­tial sup­pli­ers by the NHS, and seen by the Finan­cial Times, Palantir’s tech­nol­o­gy was laud­ed as a mod­el. “The cur­rent plat­form (Foundry) is . . . deliv­er­ing huge ben­e­fits and was crit­i­cal to the suc­cess of the vac­ci­na­tion and PPE pro­grammes.”

    Rolling out this type of sys­tem across the rest of the health ser­vice “has the poten­tial to deliv­er £3.6bn ben­e­fits over 10 years”, the doc­u­ment said.

    One senior NHS offi­cial said Palan­tir was well-placed to win the bid, par­tic­u­lar­ly when its work was assessed against fail­ures else­where in the Covid response, notably defi­cien­cies in the pro­gramme to test and track con­tacts of infect­ed peo­ple.

    “If you were to com­pare the [suc­cess­ful] work that Palan­tir did in vac­cines and PPE, with the work that Palan­tir didn’t do, which was test and trace . . . [Palan­tir] hasn’t let us down,” he said.
    ...

    But as good as its chances are, Palan­tir isn’t tak­ing any chances with the hir­ing of key NHS offi­cials in recent months. The mes­sage is clear: NHS offi­cials can expect cushy job offers from Palan­tir in exchange for this con­tract:

    ...
    To help its chances, Palan­tir has hired two senior NHS offi­cials in recent months — Indra Joshi, the NHS’s for­mer head of arti­fi­cial intel­li­gence, and Har­jeet Dhali­w­al, for­mer deputy to Ming Tang, NHS England’s data chief, who is respon­si­ble for the FDP con­tract and for Palantir’s pre­vi­ous con­tracts with the NHS.

    A for­mer senior health offi­cial said that eye­brows with­in the ser­vice had been raised by “the revolv­ing door between gov­ern­ment, NHS and Palan­tir”.
    ...

    Final­ly, note the key assur­ance we’re hear­ing about data pri­va­cy con­cerns: The data processed by Palan­tir’s sys­tems for the NHS Under the pre­vi­ous licens­ing agree­ments came with the stip­u­la­tion that “the data con­trol stays with the own­er of the data, not with Palan­tir.” So if they sta­tus quo is main­tain, Palan­tir could end up at the heart of the NHS’s health data pro­cess­ing while not actu­al­ly hav­ing con­trol of the data. It would be inter­est­ing to know what exact­ly that kind of arrange­ment entails in terms of real world data pri­va­cy impli­ca­tions. Because whether or not Palan­tir ‘con­trols’ the data, it pre­sum­ably needs to be able to access it if it’s going to be offer­ing these ser­vices:

    ...
    Palantir’s involve­ment in the NHS has been par­tic­u­lar­ly con­tro­ver­sial among civ­il lib­er­ties groups. Last July, a group of pri­va­cy cam­paign­ers led by tech jus­tice group Fox­glove launched the “No Palan­tir in Our NHS” cam­paign owing to its work with the US immi­gra­tion ser­vice and close links to nation­al secu­ri­ty agen­cies.

    While a senior NHS offi­cial acknowl­edged the ques­tion of data secu­ri­ty was “com­plete­ly valid”, he said NHS Eng­land had “gone into this in a lot of depth” and believed that Palan­tir was “one of the few com­pa­nies that can actu­al­ly address those con­cerns legit­i­mate­ly”. Under the licence agree­ments that the NHS has pre­vi­ous­ly entered into with the com­pa­ny, “the data con­trol stays with the own­er of the data, not with Palan­tir”, he not­ed.

    Not all are con­vinced. “Many are already con­cerned about com­mer­cial inter­ests hav­ing involve­ment at all, let alone a com­pa­ny that helped Don­ald Trump with his ICE deten­tions at the Mex­i­can bor­der,” said Booth. “Is this a prop­er cor­po­rate enti­ty to be work­ing at the heart of the NHS?”
    ...

    And that ‘data con­trol’ arrange­ment brings us to the lat­est update we got on Palan­tir’s plans for expand­ing its NHS foot­print. Secur­ing that £360mn con­tract is just the one part of this expan­sion. The more pub­lic part. There’s a qui­et part too: Palan­tir has been try­ing to qui­et­ly ‘hoover up’ all sorts of UK health data firms. The idea is that by buy­ing firms out­right, Palan­tir can avoid some of the polit­i­cal resis­tance it faces with things like NHS con­tracts.

    And then we get to this inter­est­ing detail: it also sounds like Palan­tir has been sweet­en­ing the buy­out deals for these small firms if the founders of the firms agree to move their data and ser­vices over to Palan­tir’s Foundry. That sure sounds like a recipe for gain­ing con­trol over that data. So what have to ask, what else is Palan­tir plan­ning on using this data for? Pan­dem­ic insur­ance-relat­ed data analy­sis is one pos­si­bil­i­ty that comes to mind but it’s just one exam­ple of the array of pos­si­ble appli­ca­tion for this kind of data. That’s part of what makes this sto­ry some­thing to watch: Palan­tir does­n’t just want those NHS con­tracts. The com­pa­ny wants that health data and it’s ‘hoover­ing up’ firms across the UK to get it:

    Bloomberg

    Peter Thiel’s Palan­tir Had Secret Plan to Crack UK’s NHS: ‘Buy­ing Our Way In’

    * US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals
    * Sil­i­con Val­ley data firm bid­ding for £360 mil­lion NHS con­tract

    By Olivia Solon
    Sep­tem­ber 30, 2022 at 12:00 AM CDT

    Palan­tir Tech­nolo­gies had a secret plan to deep­en its rela­tion­ship with the UK’s Nation­al Health Ser­vice with­out pub­lic scruti­ny.

    The US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals that already had an exist­ing rela­tion­ship with the NHS, accord­ing to emails and strat­e­gy doc­u­ments seen by Bloomberg. This approach would hope­ful­ly allow Palan­tir to avoid fur­ther scruti­ny in work­ing with one of the largest depos­i­to­ries of health data.

    Palantir’s region­al head Louis Mosley described the strat­e­gy in an email enti­tled “Buy­ing our way in…!” sent in Sept. 2021, which out­lined “hoover­ing up” small busi­ness­es serv­ing the NHS to “take a lot of ground and take down a lot of polit­i­cal resis­tance.”

    The NHS, one of the world’s largest employ­ers with a recent annu­al bud­get close to £190 bil­lion ($208 bil­lion), has become a key client for Palan­tir. It hired the US tech firm to help with its Covid-19 response, and cur­rent­ly has a £360 mil­lion con­tract com­ing up for ten­der — a deal Palan­tir is hop­ing to win.

    While Palan­tir has so far been unsuc­cess­ful in buy­ing up NHS sup­pli­ers, the doc­u­ments seen by Bloomberg show how Palan­tir hopes to deep­en its busi­ness with a key client, both by mak­ing key hires from the NHS and via poten­tial acqui­si­tions.

    Palan­tir has con­sis­tent­ly faced crit­i­cism in coun­tries includ­ing the US and UK from civ­il lib­er­ties groups, who have been con­cerned by its track record for pro­vid­ing tools to gov­ern­ment agen­cies that help enable broad sur­veil­lance of pop­u­la­tions, for exam­ple by US Cus­toms and Enforce­ment to find undoc­u­ment­ed migrants for depor­ta­tion. Law­mak­ers in the UK have also voiced con­cern over Palantir’s tech­nol­o­gy.

    ...

    ‘Start Scop­ing’

    Co-found­ed in 2003 by Face­book Inc. board mem­ber Peter Thiel, Palan­tir quick­ly won the atten­tion and finan­cial back­ing of In-Q-Tel, the ven­ture invest­ing arm of the U.S. Cen­tral Intel­li­gence Agency. The start­up count­ed the CIA among its first cus­tomers, and cul­ti­vat­ed an ear­ly rep­u­ta­tion for secre­cy.

    Named for the all-see­ing stones used in J.R.R. Tolkien’s fic­tion­al The Lord of the Rings tril­o­gy, Palan­tir now counts dozens of US gov­ern­ment agen­cies as cus­tomers, with a a sig­nif­i­cant num­ber in the nation­al secu­ri­ty and defense space. Palan­tir lead­er­ship has for­sworn doing busi­ness in Chi­na and oth­er regions not aligned with US inter­ests, ele­vat­ing the impor­tance of UK deals. How­ev­er, despite pre­dict­ing $1.9 bil­lion in rev­enue for 2022, the firm has strug­gled to turn a prof­it. It’s share price is down about 56% so far this year.

    Accord­ing to Mosley’s email to col­leagues, suit­able UK takeover tar­gets were those with cred­i­ble lead­er­ship, annu­al rev­enue of between £5 mil­lion and £50 mil­lion, and already sell­ing soft­ware ser­vices to the NHS. Founders would be offered a “v. gen­er­ous buy­out sched­ule (say 10x, espe­cial­ly if all stock),” he wrote.

    Palan­tir would offer com­pen­sa­tion to founders for their equi­ty stake if they shift­ed all of their ser­vices into Palantir’s main data han­dling plat­form, Foundry, which was designed to orga­nize data from dis­parate sources.

    “I doubt any­body else is like­ly to come along and offer them some­thing as gen­er­ous as we would (we might even be their only real exit option),” Mosley wrote.

    Ear­ly in the Covid-19 pan­dem­ic, Foundry was used by the NHS to track the take-up of vac­cines and, more recent­ly, to man­age the back­log of patients wait­ing for elec­tive surg­eries. Since 2020, Palan­tir secured more than £37 mil­lion in con­tracts with the NHS and the Depart­ment of Health and Social Care, accord­ing to pub­lic spend­ing track­er Advice­Cloud.

    One of the com­pa­nies Palan­tir sought to acquire, short­ly before Mosley emailed his plan, was Beau­ti­ful Infor­ma­tion, an NHS-pri­vate part­ner­ship that gen­er­ates real-time infor­ma­tion for hos­pi­tals to use for bal­anc­ing resources with patient demand. Palan­tir lost out to Cana­di­an health-tech firm Vital­Hub Corp, which announced it bought Beau­ti­ful Infor­ma­tion for £1.55 mil­lion in Jan­u­ary.

    “I’m keen to start scop­ing more acqui­si­tion tar­gets like [Beau­ti­ful Infor­ma­tion],” Mosley wrote, adding that he had “a kit­ty,” a British term for a pot of mon­ey.

    Late in 2021, Palan­tir was also in advanced talks to invest more than £21 mil­lion into British data-ana­lyt­ics firm Sen­syne, in a deal code­named “Project Gon­dor” — a ref­er­ence to a fic­tion­al king­dom depict­ed in The Lord of the Rings — in return for Sen­syne using Palantir’s Foundry, accord­ing to an inter­nal doc­u­ment seen by Bloomberg.

    “There is noth­ing unusu­al about a com­pa­ny explor­ing invest­ments or acqui­si­tions,” Palantir’s spokesman said. He said the com­pa­ny had been approached with “two such oppor­tu­ni­ties” in 2021. “We declined to pro­ceed with either and have not acquired any com­pa­nies that work with the NHS,” he said.

    ...

    Palan­tir was also part of a group of sev­er­al investors that con­tributed $230 mil­lion to sup­port Baby­lon Hold­ings Ltd. going pub­lic in 2021, as part of a longer-term part­ner­ship between the two com­pa­nies that saw Baby­lon migrate some of its data to Palantir’s Foundry plat­form, Bloomberg report­ed.

    Lob­by Efforts

    Deals and takeovers were only part of Palantir’s approach, how­ev­er, the mes­sages seen by Bloomberg show. At the same time as the Baby­lon part­ner­ship, Palan­tir urged indus­try lob­by group TechUK to encour­age gov­ern­ment agen­cies to buy com­mer­cial off-the-shelf prod­ucts, such as Foundry, instead of build­ing their own bespoke tools.

    ...

    Palan­tir hired Glob­al Coun­sel — the strate­gic advi­so­ry firm co-found­ed by Peter Man­del­son, a British Lord and for­mer lead­ing advis­er to ex-Prime Min­is­ter Tony Blair — to help lob­by UK gov­ern­ment. It also recent­ly hired Indra Joshi and Har­jeet Dhali­w­al, key fig­ures from the NHS.

    “Glob­al Counsel’s work for Palan­tir is a mat­ter of pub­lic record,” a spokesper­son said in an emailed state­ment. “The rel­e­vant dec­la­ra­tions to statu­to­ry reg­is­ters and the NHS in rela­tion to this work have been made.”

    Crit­ics have chal­lenged the NHS’s lack of trans­paren­cy over hasti­ly exe­cut­ed deals dur­ing the pan­dem­ic. Palan­tir was paid a nom­i­nal £1 fee in March 2020 to run a Covid-19 data store to help the NHS allo­cate resources more effi­cient­ly, but has used the work as a case study in pitch­es for oth­er NHS con­tracts, accord­ing to two senior NHS offi­cials who were not autho­rized to speak to the media.

    Ahead of that deal, Palan­tir spent months woo­ing NHS chiefs, the Bureau of Inves­tiga­tive Jour­nal­ism report­ed in Feb­ru­ary 2021. In Decem­ber 2020, Palan­tir was grant­ed a new con­tract to con­tin­ue the data-store work in a £23.5 mil­lion deal that was not sub­ject to a pub­lic ten­der process.

    Palan­tir declined to com­ment, but NHS Eng­land said in a state­ment at the time that it had “always act­ed in accor­dance with its legal respon­si­bil­i­ties.”

    Despite hir­ing Glob­al Coun­sel, Palan­tir received crit­i­cism from law­mak­ers over their deep­en­ing rela­tion­ship with the NHS.

    “Patient trust is vital to our NHS, so for­eign tech com­pa­nies such as Palan­tir, with their his­to­ry of sup­port­ing mass sur­veil­lance, assist­ing in drone strikes, immi­gra­tion raids and pre­dic­tive polic­ing, must not be placed at the heart of our NHS,” British law­mak­er David Davis, a mem­ber of the Con­ser­v­a­tive Par­ty and for­mer Sec­re­tary of State for Exit­ing the Euro­pean Union, said dur­ing a House of Com­mons debate in June 2021.

    Inde­pen­dent media com­pa­ny Open­Democ­ra­cy sued the UK gov­ern­ment with the sup­port of legal non­prof­it Fox­glove for award­ing busi­ness to Palan­tir with­out a pub­lic ten­der process. The gov­ern­ment agreed not to extend the con­tract beyond Covid with­out a pub­lic con­sul­ta­tion. The push-back con­tin­ued in Sept. 2021, when the Depart­ment of Health and Social Care end­ed anoth­er data deal with Palan­tir, Bloomberg report­ed.

    Cori Crid­er, found­ing direc­tor of Fox­glove, said there are “real con­cerns” about whether Palan­tir offers the NHS val­ue for mon­ey, “or whether there is just a ‘shiny dash­board’ think­ing infect­ing some offi­cials.”

    It’s not known when the NHS will make a deci­sion for its upcom­ing £360 mil­lion ten­der. Oth­er poten­tial bid­ders include major con­sult­ing firms as well as large US tech com­pa­nies.

    “Foundry as a piece of soft­ware is entire­ly com­pe­tent,” said Phil Booth, coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial, adding that he did not have con­cerns about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry.

    How­ev­er, he said that Palantir’s his­to­ry as a “Peter Thiel-backed, CIA-ini­ti­at­ed com­pa­ny” could deter patients from shar­ing their data. “We should get rid of Palan­tir and build our own open-source soft­ware,” he said.

    ———–

    “Peter Thiel’s Palan­tir Had Secret Plan to Crack UK’s NHS: ‘Buy­ing Our Way In’” By Olivia Solon; Bloomberg; 09/30/2022

    “The US data-ana­lyt­ics com­pa­ny aimed to buy up small­er rivals that already had an exist­ing rela­tion­ship with the NHS, accord­ing to emails and strat­e­gy doc­u­ments seen by Bloomberg. This approach would hope­ful­ly allow Palan­tir to avoid fur­ther scruti­ny in work­ing with one of the largest depos­i­to­ries of health data.

    You can see why Palan­tir is keen on this strat­e­gy: instead of deal­ing with all the headaches and pub­lic rela­tions chal­lenges of hav­ing Palan­tir direct­ly get new con­tracts with the UK’s NHS, just have Palan­tir buy up com­pa­nies that are already work­ing with NHS data. As long as Palan­tir can man­age to “hoover up” enough small com­pa­nies it’s only a mat­ter of time before its foothold is secured:

    ...
    Palantir’s region­al head Louis Mosley described the strat­e­gy in an email enti­tled “Buy­ing our way in…!” sent in Sept. 2021, which out­lined “hoover­ing up” small busi­ness­es serv­ing the NHS to “take a lot of ground and take down a lot of polit­i­cal resis­tance.”

    ...

    While Palan­tir has so far been unsuc­cess­ful in buy­ing up NHS sup­pli­ers, the doc­u­ments seen by Bloomberg show how Palan­tir hopes to deep­en its busi­ness with a key client, both by mak­ing key hires from the NHS and via poten­tial acqui­si­tions.

    ...

    Ear­ly in the Covid-19 pan­dem­ic, Foundry was used by the NHS to track the take-up of vac­cines and, more recent­ly, to man­age the back­log of patients wait­ing for elec­tive surg­eries. Since 2020, Palan­tir secured more than £37 mil­lion in con­tracts with the NHS and the Depart­ment of Health and Social Care, accord­ing to pub­lic spend­ing track­er Advice­Cloud.
    ...

    But buy­ing the UK health data firms was just the first step. The sec­ond step is to con­vince the new­ly-pur­chased firms to move all of their ser­vices to Palan­tir’s Foundry plat­form. It’s a reminder that Big Data giants have a lot of ways of get­ting their hands on pre­cious data. It’s also the kind of episode that rais­es the ques­tion of how many oth­er health data firms from around the world may have already made this qui­et­ly deci­sion to move their data and ser­vices to Palan­tir’s Foundry. Mov­ing this data into Palan­tir qui­et­ly and with­out the pub­lic notic­ing is at the core of the plan, after all:

    ...
    Accord­ing to Mosley’s email to col­leagues, suit­able UK takeover tar­gets were those with cred­i­ble lead­er­ship, annu­al rev­enue of between £5 mil­lion and £50 mil­lion, and already sell­ing soft­ware ser­vices to the NHS. Founders would be offered a “v. gen­er­ous buy­out sched­ule (say 10x, espe­cial­ly if all stock),” he wrote.

    Palan­tir would offer com­pen­sa­tion to founders for their equi­ty stake if they shift­ed all of their ser­vices into Palantir’s main data han­dling plat­form, Foundry, which was designed to orga­nize data from dis­parate sources.

    “I doubt any­body else is like­ly to come along and offer them some­thing as gen­er­ous as we would (we might even be their only real exit option),” Mosley wrote.

    ...

    Late in 2021, Palan­tir was also in advanced talks to invest more than £21 mil­lion into British data-ana­lyt­ics firm Sen­syne, in a deal code­named “Project Gon­dor” — a ref­er­ence to a fic­tion­al king­dom depict­ed in The Lord of the Ringsin return for Sen­syne using Palantir’s Foundry, accord­ing to an inter­nal doc­u­ment seen by Bloomberg.

    “There is noth­ing unusu­al about a com­pa­ny explor­ing invest­ments or acqui­si­tions,” Palantir’s spokesman said. He said the com­pa­ny had been approached with “two such oppor­tu­ni­ties” in 2021. “We declined to pro­ceed with either and have not acquired any com­pa­nies that work with the NHS,” he said.

    ...

    Palan­tir was also part of a group of sev­er­al investors that con­tributed $230 mil­lion to sup­port Baby­lon Hold­ings Ltd. going pub­lic in 2021, as part of a longer-term part­ner­ship between the two com­pa­nies that saw Baby­lon migrate some of its data to Palantir’s Foundry plat­form, Bloomberg report­ed.
    ...

    And then there’s the oth­er angle to Palan­tir’s strat­e­gy: lob­by­ing gov­ern­ment offi­cials and/or hir­ing them for lucra­tive jobs. It’s a strat­e­gy that has clear­ly already worked, as the £23.5 mil­lion deal Decem­ber 2020, con­tract to con­tin­ue the Palan­tir’s COVID-relat­ed work that was not sub­ject to a pub­lic ten­der process. Lob­by­ing works:

    ...
    Deals and takeovers were only part of Palantir’s approach, how­ev­er, the mes­sages seen by Bloomberg show. At the same time as the Baby­lon part­ner­ship, Palan­tir urged indus­try lob­by group TechUK to encour­age gov­ern­ment agen­cies to buy com­mer­cial off-the-shelf prod­ucts, such as Foundry, instead of build­ing their own bespoke tools.

    ...

    Palan­tir hired Glob­al Coun­sel — the strate­gic advi­so­ry firm co-found­ed by Peter Man­del­son, a British Lord and for­mer lead­ing advis­er to ex-Prime Min­is­ter Tony Blair — to help lob­by UK gov­ern­ment. It also recent­ly hired Indra Joshi and Har­jeet Dhali­w­al, key fig­ures from the NHS.

    “Glob­al Counsel’s work for Palan­tir is a mat­ter of pub­lic record,” a spokesper­son said in an emailed state­ment. “The rel­e­vant dec­la­ra­tions to statu­to­ry reg­is­ters and the NHS in rela­tion to this work have been made.”

    Crit­ics have chal­lenged the NHS’s lack of trans­paren­cy over hasti­ly exe­cut­ed deals dur­ing the pan­dem­ic. Palan­tir was paid a nom­i­nal £1 fee in March 2020 to run a Covid-19 data store to help the NHS allo­cate resources more effi­cient­ly, but has used the work as a case study in pitch­es for oth­er NHS con­tracts, accord­ing to two senior NHS offi­cials who were not autho­rized to speak to the media.

    Ahead of that deal, Palan­tir spent months woo­ing NHS chiefs, the Bureau of Inves­tiga­tive Jour­nal­ism report­ed in Feb­ru­ary 2021. In Decem­ber 2020, Palan­tir was grant­ed a new con­tract to con­tin­ue the data-store work in a £23.5 mil­lion deal that was not sub­ject to a pub­lic ten­der process.

    ...

    Inde­pen­dent media com­pa­ny Open­Democ­ra­cy sued the UK gov­ern­ment with the sup­port of legal non­prof­it Fox­glove for award­ing busi­ness to Palan­tir with­out a pub­lic ten­der process. The gov­ern­ment agreed not to extend the con­tract beyond Covid with­out a pub­lic con­sul­ta­tion. The push-back con­tin­ued in Sept. 2021, when the Depart­ment of Health and Social Care end­ed anoth­er data deal with Palan­tir, Bloomberg report­ed.

    Cori Crid­er, found­ing direc­tor of Fox­glove, said there are “real con­cerns” about whether Palan­tir offers the NHS val­ue for mon­ey, “or whether there is just a ‘shiny dash­board’ think­ing infect­ing some offi­cials.”
    ...

    Final­ly, note the rather laugh­able assur­ances we’re get­ting, of all places, the coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial: we should­n’t be con­cerned about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry. Yes, because we should all be super assured that Foundry — a plat­form built by a com­pa­ny long financed by the CIA’s In-Q-Tel — would­n’t spy on any data inap­pro­pri­ate­ly. That’s the appar­ent atti­tude held by the peo­ple tasked with cham­pi­oning patient data:

    ...
    It’s not known when the NHS will make a deci­sion for its upcom­ing £360 mil­lion ten­der. Oth­er poten­tial bid­ders include major con­sult­ing firms as well as large US tech com­pa­nies.

    “Foundry as a piece of soft­ware is entire­ly com­pe­tent,” said Phil Booth, coor­di­na­tor of British data-pri­va­cy cam­paign orga­ni­za­tion med­Con­fi­den­tial, adding that he did not have con­cerns about unau­tho­rized peo­ple access­ing patient data as that would be “sui­ci­dal” for Foundry.

    How­ev­er, he said that Palantir’s his­to­ry as a “Peter Thiel-backed, CIA-ini­ti­at­ed com­pa­ny” could deter patients from shar­ing their data. “We should get rid of Palan­tir and build our own open-source soft­ware,” he said.
    ...

    This is prob­a­bly a good time to recall that one of fas­cis­m’s best friends is a col­lec­tive sense of “we could­n’t imag­ine they would do things like that.” And also a good time to start imag­in­ing what a fas­cist might want to do with all of that data.

    Posted by Pterrafractyl | October 18, 2022, 3:48 pm
  3. The biotech indus­try has expe­ri­enced noth­ing less than a rev­o­lu­tion in recent years. Includ­ing an appar­ent rev­o­lu­tion in the speed at which new vac­cines and ther­a­peu­tics can be brought to mar­ket as evi­denced by the recent deci­sion to release the new mRNA Omi­cron-tar­get­ing boost­er vac­cines based entire­ly on mouse tri­al data. As we’ve seen from all the sto­ry about the ‘gain-of-func­tion’ exper­i­ments on coro­n­avirus and test­ing their lethal­i­ty on mice, a mouse’s immune sys­tem can behave very dif­fer­ent­ly from humans. But that’s the deci­sion that reg­u­la­tors made.

    And as we’re going to see in the fol­low­ing Unlim­it­ed Hang­out piece by Whit­ney Webb from back in August, it appears that the reg­u­la­to­ry envi­ron­ment for biotech in the US is poised to get even ‘loosers’. At least that’s one of the main ambi­tions of Nation­al Resilience, a new com­pa­ny that only came into exis­tence in Novem­ber of 2020. As we’re going to see, this is a com­pa­ny with ‘juice’. Not only did the com­pa­ny score a major invest­ment by the gov­ern­ment of Cana­da last July in its Ontario facil­i­ties, but it turns out the genet­ic mate­r­i­al for Mod­er­na’s Omi­cron mRNA boost­ers is pro­duced by Nation­al Resilience.

    So what made Mod­er­na decide to out­source its mRNA sup­pli­er to a com­pa­ny that did­n’t exist even two years ago? Well, that’s where the com­pa­ny’s deep con­nec­tions to both the gov­ern­ment and indus­try come into focus. Because Nation­al Resilience is stacked with a ‘Who’s Who’ list of insid­ers. The com­pa­ny was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen. But as we’re going to see, Nel­son actu­al­ly attrib­ut­es the idea for Nation­al Resilience to a Luciana Borio, then the vice-pres­i­dent of In-Q-Tel. The CEO of In-Q-Tel, Chris Dar­by, also sites on the board of direc­tors, along with Palan­tir’s Joe Lons­dale. Recall the role Lons­dale played in get­ting Sau­di mon­ey invest­ed in Sil­i­con Val­ley. Anoth­er fig­ure on Nation­al Resilience’s board with expe­ri­ence in the pri­va­tized intel­li­gence sec­tor is Drew Oet­ting of Cer­berus, the own­er of Dyn­Corp. Oth­er notable indus­try fig­ures involved with the com­pa­ny include for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb and the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann.

    Also keep in mind the exten­sive role the US gov­ern­ment has already played in the devel­op­ment of Mod­er­na’s mRNA vac­cines. That long-stand­ing gov­ern­ment part­ner­ship came to light after Mod­er­na sued Pfiz­er claim­ing patent infringe­ment on a broad-spec­trum beta­coro­n­avirus vac­cine, with Mod­er­na assert­ing that it was con­duct­ing human mRNA vac­cine tri­als with US researchers as far back as 2015. Also recall how Mod­er­na ‘returned the favor’ for this gov­ern­ment sup­port by fil­ing patents that left out prop­er acknowl­edg­ment for the gov­ern­ment sci­en­tists work result­ing in gov­ern­ment law­suits. So we have Mod­er­na — a com­pa­ny that owes its exis­tence to major invest­ments from the US gov­ern­ment — decid­ing to out­source the genet­ic mate­ri­als for the new Omi­cron boost­ers to a brand new com­pa­ny stacked with peo­ple from the intel­li­gence world.

    But mak­ing the genet­ic mate­ri­als for mRNA ther­a­pies is far from Nation­al Resilience’s only ambi­tions. The com­pa­ny plans on becom­ing a key sup­pli­er of a vari­ety of bio­log­ics for the entire indus­try rang­ing from gene ther­a­pies, viral vec­tors, exper­i­men­tal vac­cines to oth­er “med­i­cines of tomor­row.”. In oth­er words, this com­pa­ny is plan­ning on spe­cial­iz­ing in exact­ly the kind of syn­thet­ic biol­o­gy tech­niques that are at the heart of mod­ern ‘dual use’ bio­log­i­cal war­fare research like what the Eco­HealthAl­liance was engaged in with ‘gain-of-func­tion’ coro­n­avirus­es. But Nation­al Resilience does­n’t appear to be plan­ning on car­ry­ing out this research on its own behalf. Instead, it wants to become the “AWS of biotech”, which sure sounds like a kind ‘gain-of-func­tion for-hire’ ser­vice.

    And then we get to per­haps the most dis­turb­ing ser­vice the com­pa­ny is plan­ning on offer­ing clients: “reg­u­la­to­ry sup­port”. That’s the term the com­pa­ny is using to describe ser­vices that sound like gov­ern­ment lob­by­ing designed to push prod­ucts through the reg­u­la­to­ry hur­dles faster. Again, don’t for­get that the lat­est Omi­cron boost­er were approved based on mouse tri­als alone. And it sounds like Nation­al Resilience is plan­ning on ensur­ing more deci­sions like that will hap­pen in the future:

    Unlim­it­ed Hang­out

    RNA for Moderna’s Omi­cron Boost­er Man­u­fac­tured by CIA-Linked Com­pa­ny
    Since late last year, mes­sen­ger RNA for Moderna’s COVID-19 vac­cines, includ­ing its recent­ly refor­mu­lat­ed Omi­cron boost­er, has been exclu­sive­ly man­u­fac­tured by a lit­tle known com­pa­ny with sig­nif­i­cant ties to US intel­li­gence.

    by Whit­ney Webb
    August 17, 2022

    Ear­li­er this week, the Unit­ed King­dom became the first coun­try to approve Moderna’s refor­mu­lat­ed ver­sion of its COVID-19 vac­cine, which claims to pro­vide pro­tec­tion against both the orig­i­nal form of the virus and the sig­nif­i­cant­ly less lethal but more trans­mis­si­ble Omi­cron vari­ant. The prod­uct was approved by the UK’s Med­i­cines and Health­care Prod­ucts Reg­u­la­to­ry Agency (MHRA) with the sup­port of the UK government’s Com­mis­sion on Human Med­i­cines.

    Described by UK offi­cials as a “sharp­ened tool” in the nation’s con­tin­ued vac­ci­na­tion cam­paign, the refor­mu­lat­ed vac­cine com­bines the pre­vi­ous­ly approved COVID-19 vac­cine with a “vac­cine can­di­date” tar­get­ing the Omi­cron vari­ant BA.1. That vac­cine can­di­date has nev­er been pre­vi­ous­ly approved and has not been the sub­ject of inde­pen­dent study. The MHRA approved the vac­cine based on a sin­gle, incom­plete human tri­al cur­rent­ly being con­duct­ed by Mod­er­na. The com­pa­ny pro­mot­ed incom­plete data from that tri­al in com­pa­ny press releas­es in June and July. The study has yet to be pub­lished in a med­ical jour­nal or peer reviewed. No con­cerns have been raised by any reg­u­la­to­ry agency, includ­ing the MHRA, regard­ing Moderna’s past his­to­ry of engag­ing in sus­pect and like­ly ille­gal activ­i­ty in past prod­uct tri­als, includ­ing for its orig­i­nal COVID-19 vac­cine.

    ...

    How­ev­er, unlike the company’s orig­i­nal COVID-19 vac­cine, the genet­ic mate­r­i­al, or mes­sen­ger RNA (mRNA), for this new vac­cine, includ­ing the new­ly for­mu­lat­ed genet­ic mate­r­i­al meant to pro­vide pro­tec­tion against the Omi­cron vari­ant, is being man­u­fac­tured, not by Mod­er­na, but by a rel­a­tive­ly new com­pa­ny that has received hard­ly any media atten­tion, despite its overt links to US intel­li­gence. Last Sep­tem­ber, it was qui­et­ly announced that a com­pa­ny called Nation­al Resilience (often referred to sim­ply as Resilience) would begin man­u­fac­tur­ing the mRNA for Mod­er­na COVID-19 vac­cine prod­ucts. Under the terms of the mul­ti-year agree­ment, “Resilience will pro­duce mRNA for the Mod­er­na COVID-19 vac­cine at its facil­i­ty in Mis­sis­sauga, Ontario, for dis­tri­b­u­tion world­wide.”

    “Rein­vent­ing Bio­man­u­fac­tur­ing”

    Nation­al Resilience was found­ed rel­a­tive­ly recent­ly, in Novem­ber 2020, and describes itself as “a man­u­fac­tur­ing and tech­nol­o­gy com­pa­ny ded­i­cat­ed to broad­en­ing access to com­plex med­i­cines and pro­tect­ing bio­phar­ma­ceu­ti­cal sup­ply chains against dis­rup­tion.” It has since been build­ing “a sus­tain­able net­work of high-tech, end-to-end man­u­fac­tur­ing solu­tions with the aim to ensure the med­i­cines of today and tomor­row can be made quick­ly, safe­ly, and at scale.” It fur­therplans to “rein­vent bio­man­u­fac­tur­ing” and “democ­ra­tize access to med­i­cines,” name­ly gene ther­a­pies, exper­i­men­tal vac­cines and oth­er “med­i­cines of tomor­row.”

    In pur­suit of those goals, the com­pa­ny announced it would “active­ly invest in devel­op­ing pow­er­ful new tech­nolo­gies to man­u­fac­ture com­plex med­i­cines that are defin­ing the future of ther­a­peu­tics, includ­ing cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins.” It was found­ed with the report­ed inten­tion “to build a bet­ter sys­tem for man­u­fac­tur­ing com­plex med­i­cines to fight dead­ly dis­eases” as a way to improve post-COVID “pan­dem­ic pre­pared­ness.”

    The com­pa­ny ini­tial­ly mar­ket­ed its man­u­fac­tur­ing capa­bil­i­ties as “the Resilience plat­form”, and offers prin­ci­pal­ly “RNA Modal­i­ties”, includ­ing RNA devel­op­ment for vac­cines, gene edit­ing and ther­a­peu­tics; and “Virus Pro­duc­tion”, includ­ing viral vec­tors, oncolyt­ic virus­es (i.e. a virus engi­neered to pref­er­en­tial­ly attack can­cer cells), virus­es for use in vac­cine devel­op­ment and gene-edit­ed virus­es for unspec­i­fied pur­pos­es. It is worth not­ing that, to date, many con­tro­ver­sial “gain-of-func­tion” exper­i­ments have jus­ti­fied mod­i­fy­ing virus­es for the same pur­pos­es as described by Nation­al Resilience’s Virus Pro­duc­tion capa­bil­i­ties. In addi­tion, Nation­al Resilience offers prod­uct for­mu­la­tions and oth­er modal­i­ties, such as bio­log­ics and cell ther­a­pies, to its clien­tele and the “Virus Pro­duc­tion” of its web­site has since been removed.

    Nation­al Resilience, being such a young com­pa­ny, has very few clients and there is lit­tle pub­licly avail­able infor­ma­tion on its man­u­fac­tur­ing capa­bil­i­ties aside from the company’s web­site. The firm only acquired its first com­mer­cial man­u­fac­tur­ing plant in March 2021, locat­ed in Boston, MA and pur­chased from Sanofi, fol­lowed short­ly there­after by the acqui­si­tion of anoth­er sep­a­rate plant locat­ed in Mis­sis­sauga, Ontario, Cana­da. Makeovers were announced for the plants, but lit­tle is pub­licly known about their progress. Pri­or to the acqui­si­tions, the com­pa­ny had been sub­leas­ing a Bay area facil­i­ty in Fre­mont, Cal­i­for­nia. Reporters were puz­zled at the time as to why a com­pa­ny with rough­ly 700 employ­ees at the time had acquired a total of 599,00 square feet of man­u­fac­tur­ing space after hav­ing only emerged from stealth less than 6 months pri­or.

    In April 2021, Nation­al Resilience acquired Olo­gy Bioser­vices Inc., which had received a $37 mil­lion con­tract from the US mil­i­tary the pre­vi­ous Novem­ber to devel­op an advanced anti-COVID-19 mon­o­clon­al anti­body treat­ment. This acqui­si­tion also pro­vid­ed Nation­al Resilience with its first Biosafe­ty Lev­el 3 (BSL‑3) lab­o­ra­to­ry and the abil­i­ty to man­u­fac­ture cell and gene ther­a­pies, live viral vac­cines and vec­tors and oncolyt­ic virus­es.

    Despite being in the ear­li­est stages of devel­op­ing its “rev­o­lu­tion­ary” man­u­fac­tur­ing capa­bil­i­ties, Nation­al Resilience entered into a part­ner­ship with the Gov­ern­ment of Cana­da in July of last year. Per that agree­ment, the Cana­di­an gov­ern­ment plans to invest CAD 199.2 mil­lion (about $154.9 mil­lion) into Nation­al Resilience’s Ontario-based sub­sidiary, Resilience Biotech­nolo­gies Inc. Most of those funds are des­tined for use in expand­ing the Ontario facil­i­ty that Resilience acquired last March and which is now man­u­fac­tur­ing the mRNA for Moderna’s COVID-19 prod­ucts. Canada’s Min­is­ter of Inno­va­tion, Sci­ence and Indus­try, François-Philippe Cham­pagne, assert­ed at the time that the invest­ment would “build future pan­dem­ic pre­pared­ness” and help “to grow Canada’s life sci­ence ecosys­tem as an engine for our eco­nom­ic recov­ery.” More recent­ly, in 2022, the com­pa­ny has announced a few new clients – Take­da, Opus Genet­ics and the US Depart­ment of Defense.

    Accord­ing to Nation­al Resilience’s exec­u­tives, the company’s ambi­tions appar­ent­ly go far beyond man­u­fac­tur­ing RNA and virus­es. For instance, Resilience CEO Rahul Singhvi has claimed that the com­pa­ny is seek­ing to build “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem.” Yet, Singhvi has declined to offer much in the way of specifics when it comes to exact­ly how the com­pa­ny plans to become the planet’s most elite bio­man­u­fac­tur­ing com­pa­ny.

    In an inter­view with The San Fran­cis­co Busi­ness Times, Singhvi states that Resilience is look­ing to fill its mas­sive man­u­fac­tur­ing plants with “tech­nolo­gies and peo­ple that can set and apply new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies as well as RNA-based treat­ments.” Pri­or to Resilience, Singhvi was CEO of NovaVax and an oper­at­ing part­ner at Flag­ship Pio­neer­ing, which played a major role in the cre­ation and rise of Mod­er­na.

    Singhvi has fur­ther insist­ed that Nation­al Resilience is “not a ther­a­peu­tics com­pa­ny, not a con­trac­tor and not a tools com­pa­ny” and instead aims “to boost pro­duc­tion using the new ther­a­peu­tic modal­i­ties” such as RNA-based treat­ments, which have become nor­mal­ized in the COVID-19 era. Where­as con­tract man­u­fac­tur­ers “are like kitchens, with pots and pans ready for any recipe,” “what we’re try­ing to do is fix the recipes,” Singhvi has explained. One mem­ber of Resilience’s board of direc­tors, for­mer FDA Com­mis­sion­er and Pfiz­er Board mem­ber Scott Got­tlieb, has described the com­pa­ny as seek­ing to act as the equiv­a­lent of Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try.

    Essen­tial­ly, Resilience bills itself as offer­ing solu­tions that will allow “futur­is­tic” med­i­cines, includ­ing mRNA vac­cines, to be pro­duced more quick­ly and more effi­cient­ly, with the appar­ent goal of monop­o­liz­ing cer­tain parts of the bio­man­u­fac­tur­ing process. It also appears poised to become the man­u­fac­tur­er of choice for mRNA vac­cines and exper­i­men­tal ther­a­peu­tics in the event of a future pan­dem­ic, which some pub­lic health “phil­an­thropists” like Bill Gates have said is immi­nent.

    Per­haps the company’s most note­wor­thy ambi­tion relates to their claims that they sup­port clients through the gov­ern­ment reg­u­la­to­ry process. Giv­en the company’s empha­sis on speedy mass pro­duc­tion of exper­i­men­tal gene ther­a­pies, its stat­ed inten­tion of get­ting the “futur­is­tic” med­ical prod­ucts it man­u­fac­tures to mar­ket as quick­ly as pos­si­ble seems at odds with the slow­er, tra­di­tion­al reg­u­la­to­ry process­es. Indeed, one could eas­i­ly argue that the approvals of mRNA vac­cines for the first time in human his­to­ry dur­ing the COVID-19 cri­sis were only pos­si­ble because of the major relax­ing of reg­u­la­to­ry pro­ce­durse and safe­ty test­ing due to the per­ceived urgency of the sit­u­a­tion.

    Resilience seems intent on see­ing that phe­nom­e­non repeat itself. As pre­vi­ous­ly men­tioned, the com­pa­ny claims to allow for the set­ting and appli­ca­tion of “new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies” and also says it plans to become a “tech­nol­o­gy-aggre­gat­ing stan­dards bear­er that helps ther­a­pies come to mar­ket more effi­cient­ly.” It pre­vi­ous­ly offered on its web­site “reg­u­la­to­ry sup­port” and “strat­e­gy con­sult­ing” to clients, sug­gest­ing that it would seek to medi­ate between clients and gov­ern­ment reg­u­la­tors in order to ful­fill its goal of hav­ing the prod­ucts it man­u­fac­tures tak­en to mar­ket more quick­ly. In addi­tion, upon launch, the com­pa­ny claimed it planned to obtain unspec­i­fied “reg­u­la­to­ry capa­bil­i­ties.” If so, it is cer­tain­ly notable that for­mer top Food and Drug Admin­is­tra­tion (FDA) offi­cials are either on the company’s board or, as will be not­ed short­ly, played a major role in the company’s cre­ation.

    The Peo­ple Behind Resilience

    Resilience was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen, who is known for lis­ten­ing “to science’s ear­li­est whis­pers, even when data are too ear­ly for just about any­one else.” Nelsen was one of the ear­li­est investors in Illu­mi­na, a Cal­i­for­nia-based gene-sequenc­ing hard­ware and soft­ware giant that is believed to cur­rent­ly dom­i­nate the field of genomics. As men­tioned in a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion, Illu­mi­na is close­ly tied to the DARPA-equiv­a­lent of the Well­come Trust known as Well­come Leap, which is also focused on “futur­is­tic” and tran­shu­man­ist “med­i­cines.” Nelsen is now chair­man of Nation­al Resilience’s board, which is a “Who’s Who” of big play­ers from the US Nation­al Secu­ri­ty State, Big Phar­ma and Phar­ma-relat­ed “phil­an­thropy.”

    How­ev­er, while Nelsen has been giv­en much of the cred­it for cre­at­ing Resilience, he revealed in one inter­view that the idea for the com­pa­ny had actu­al­ly come from some­one else – Luciana Borio. In July of last year, Nelsen revealed that it was while talk­ing to Borio about “her work run­ning pan­dem­ic pre­pared­ness on the NSC [Nation­al Secu­ri­ty Coun­cil]” that had “helped lead to the launch of Nelsen’s $800 mil­lion bio­log­ics man­u­fac­tur­ing start­up Resilience.”

    At the time of their con­ver­sa­tion, Borio was the vice pres­i­dent of In-Q-tel, the ven­ture cap­i­tal arm of the CIA that has been used since its cre­ation in the ear­ly 2000s to found a num­ber of com­pa­nies, many of which act as Agency fronts. Pri­or to In-Q-Tel, she served as direc­tor for med­ical and biode­fense pre­pared­ness at the Nation­al Secu­ri­ty Coun­cil dur­ing the Trump admin­is­tra­tion and had pre­vi­ous­ly been the act­ing chief sci­en­tist at the FDA from 2015 to 2017.

    Borio is cur­rent­ly a senior fel­low for glob­al health at the Coun­cil on For­eign Rela­tions, a con­sul­tant to Gold­man Sachs, a mem­ber of the Bill Gates-fund­ed vac­cine alliance CEPI, and a part­ner at Nelsen’s ven­ture cap­i­tal firm ARCH Ven­ture Part­ners, which funds Resilience. Nelsen’s ARCH pre­vi­ous­ly fund­ed Nanosys, the com­pa­ny of the con­tro­ver­sial sci­en­tist Charles Lieber. Around the time of her con­ver­sa­tion with Nelsen that led to Resilience’s cre­ation, Borio was co-writ­ing a pol­i­cy paper for the Johns Hop­kins Cen­ter for Health Secu­ri­ty that rec­om­mend­ed link­ing COVID-19 vac­ci­na­tion sta­tus with food stamp pro­grams and rent assis­tance as a pos­si­ble means of coerc­ing cer­tain pop­u­la­tions to take the exper­i­men­tal vac­cine.

    Borio is hard­ly Resilience’s only In-Q-Tel con­nec­tion, as the CEO of In-Q-Tel, Chris Dar­by, sits on the company’s board of direc­tors. Dar­by is also on the board of direc­tors of the CIA Offi­cers Memo­r­i­al Foun­da­tion. Dar­by was also recent­ly a mem­ber of the Nation­al Secu­ri­ty Com­mis­sion on Arti­fi­cial Intel­li­gence (NSCAI), where mem­bers of the mil­i­tary, intel­li­gence com­mu­ni­ty and Sil­i­con Valley’s top firms argued for the need to reduce the use of “lega­cy sys­tems” in favor of AI-focused alter­na­tives as a nation­al secu­ri­ty imper­a­tive. Among those “lega­cy sys­tems” iden­ti­fied by the NSCAI were in-per­son doc­tor vis­its and even receiv­ing med­ical care from a human doc­tor, as opposed to an AI “doc­tor.” The NSCAI also argued for the removal of “reg­u­la­to­ry bar­ri­ers” that pre­vent these new tech­nolo­gies from replac­ing “lega­cy sys­tems.”

    Anoth­er notable board mem­ber, in dis­cussing Resilience’s intel­li­gence ties, is Drew Oet­ting. Oet­ting works for Cer­berus Cap­i­tal Man­age­ment, the firm head­ed by Steve Fein­berg who pre­vi­ous­ly led the President’s Intel­li­gence Advi­so­ry Board under the Trump admin­is­tra­tion. Cer­berus is notably the par­ent com­pa­ny of Dyn­Corp, a con­tro­ver­sial US nation­al secu­ri­ty con­trac­tor tied to numer­ous scan­dals, includ­ing scan­dals relat­ed to sex traf­fick­ing in con­flict zones. Oet­ting is also part of the CIA-linked Thorn NGO osten­si­bly focused on tack­ling child traf­fick­ing that was the sub­ject of a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion.

    Oet­ting is also the co-founder of 8VC, a ven­ture cap­i­tal firm that is one of the main investors in Resilience. 8VC’s oth­er co-founder is Joe Lons­dale and Oet­ting “start­ed his career” as Lonsdale’s chief of staff. Lons­dale is the co-founder, along­side Peter Thiel and Alex Karp, of Palan­tir, a CIA front com­pa­ny and intel­li­gence con­trac­tor that is the suc­ces­sor to DARPA’s con­tro­ver­sial Total Infor­ma­tion Aware­ness (TIA) mass sur­veil­lance and data-min­ing pro­gram. In addi­tion, Oet­ting pre­vi­ous­ly worked for Bill Gates’ invest­ment fund.

    Also worth not­ing is the pres­ence of Joseph Robert Ker­rey, for­mer US Sen­a­tor for Nebras­ka and a for­mer mem­ber of the con­flict-of-inter­est-rid­den 9/11 Com­mis­sion, on Resilience’s board. Ker­rey is cur­rent­ly man­ag­ing direc­tor of Allen & Co., a New York invest­ment bank­ing firm which has host­ed an annu­al “sum­mer camp for bil­lion­aires” since 1983. Allen & Co. has long been a major play­er in net­works where orga­nized crime and intel­li­gence inter­sect, and is men­tioned repeat­ed­ly through­out my upcom­ing book One Nation Under Black­mail. For instance, Charles and Her­bert Allen, who ran the firm for decades, had con­sid­er­able busi­ness deal­ings with orga­nized crime king­pins and front­men for noto­ri­ous gang­sters like Mey­er Lan­sky, par­tic­u­lar­ly in the Bahamas. They were also busi­ness part­ners of Leslie Wexner’s men­tors A. Alfred Taub­man and Max Fish­er as well as asso­ciates of Earl Bri­an, one of the archi­tects of the PROMIS soft­ware scan­dal – which saw orga­nized crime and intel­li­gence net­works coop­er­ate to steal and then com­pro­mise the PROMIS soft­ware for black­mail and clan­des­tine intel­li­gence-gath­er­ing pur­pos­es. Allen & Co. was a major investor in Brian’s busi­ness inter­ests in the tech­nol­o­gy indus­try that Bri­an used in attempts to bank­rupt the devel­op­ers of PROMIS, Inslaw Inc. and to mar­ket ver­sions of PROMIS that had been com­pro­mised first by Israeli intel­li­gence and, lat­er, the CIA.

    In addi­tion to these intel­li­gence-linked indi­vid­u­als, the rest of Resilience’s board includes the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann; for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb; two for­mer exec­u­tives at John­son & John­son; for­mer pres­i­dent and CEO of Teva Phar­ma­ceu­ti­cals North Amer­i­can branch, George Bar­rett; Cal­Tech pro­fes­sor and board mem­ber of Alpha­bet (i.e. Google) and Illu­mi­na, Frances Arnold; for­mer exec­u­tive at Genen­tech and Mer­ck, Patrick Yang; and Resilience CEO Rahul Singhvi./b>.

    To Boost or Not to Boost

    It is cer­tain­ly telling that the nor­mal­ly pub­lic­i­ty hun­gry Mod­er­na has said so lit­tle about its part­ner­ship with Resilience and that Resilience, despite its ambi­tious plans, has also avoid­ed the media lime­light. Con­sid­er­ing Moderna’s his­to­ry and Resilience’s con­nec­tions, there may be more to this part­ner­ship that meets the eye and con­cerned mem­bers of the pub­lic would do well to keep a very close eye on Resilience, its part­ner­ships, and the prod­ucts it is man­u­fac­tur­ing.

    ...

    ———-

    “RNA for Moderna’s Omi­cron Boost­er Man­u­fac­tured by CIA-Linked Com­pa­ny” by Whit­ney Webb; Unlim­it­ed Hang­out; 08/17/2022

    How­ev­er, unlike the company’s orig­i­nal COVID-19 vac­cine, the genet­ic mate­r­i­al, or mes­sen­ger RNA (mRNA), for this new vac­cine, includ­ing the new­ly for­mu­lat­ed genet­ic mate­r­i­al meant to pro­vide pro­tec­tion against the Omi­cron vari­ant, is being man­u­fac­tured, not by Mod­er­na, but by a rel­a­tive­ly new com­pa­ny that has received hard­ly any media atten­tion, despite its overt links to US intel­li­gence. Last Sep­tem­ber, it was qui­et­ly announced that a com­pa­ny called Nation­al Resilience (often referred to sim­ply as Resilience) would begin man­u­fac­tur­ing the mRNA for Mod­er­na COVID-19 vac­cine prod­ucts. Under the terms of the mul­ti-year agree­ment, “Resilience will pro­duce mRNA for the Mod­er­na COVID-19 vac­cine at its facil­i­ty in Mis­sis­sauga, Ontario, for dis­tri­b­u­tion world­wide.””

    A com­pa­ny that did­n’t exist at the start of the pan­dem­ic, Nation­al Resilience, is going to be man­u­fac­tur­ing the actu­al genet­ic mate­r­i­al used for the new round of Omi­cron-tar­get­ing mRNA boost­ers. The same boost­ers that were approved for pub­lic use based on mouse data. So we prob­a­bly should­n’t be sur­prised to learn that Nation­al Resilience is stacked with fig­ures from the intel­li­gence com­mu­ni­ty. Or that it entered into a part­ner­ship with the gov­ern­ment of Cana­da in July of 2021, with a $154.9 mil­lion gov­ern­ment invest­ment in Nation­al Resilience’s Ontario sub­sidiary. This is a com­pa­ny with ‘juice’ when it comes to be the biotech world and gov­ern­ment. And Mod­er­na seems to be eager to hand over this cru­cial part of the man­u­fac­tur­ing sup­ply chain to this new com­pa­ny bristling with gov­ern­ment insid­ers.

    This is a good time to recall the exten­sive sup­port from the US gov­ern­ment Mod­er­na has received over the years. That long-stand­ing gov­ern­ment part­ner­ship came to light after Mod­er­na sued Pfiz­er claim­ing patent infringe­ment on a broad-spec­trum beta­coro­n­avirus vac­cine, with Mod­er­na assert­ing that it was con­duct­ing human mRNA vac­cine tri­als with US researchers as far back as 2015. Also recall how Mod­er­na ‘returned the favor’ for this gov­ern­ment sup­port by fil­ing patents that left out prop­er acknowl­edg­ment for the gov­ern­ment sci­en­tists work result­ing in gov­ern­ment law­suits. Mod­er­na has­n’t exact­ly been lack­ing grand ambi­tions of its own, which makes its deci­sion to hand over its mRNA sup­ply chain for its still-grow­ing vac­cine busi­ness to this new com­pa­ny all the more note­wor­thy:

    ...
    Described by UK offi­cials as a “sharp­ened tool” in the nation’s con­tin­ued vac­ci­na­tion cam­paign, the refor­mu­lat­ed vac­cine com­bines the pre­vi­ous­ly approved COVID-19 vac­cine with a “vac­cine can­di­date” tar­get­ing the Omi­cron vari­ant BA.1. That vac­cine can­di­date has nev­er been pre­vi­ous­ly approved and has not been the sub­ject of inde­pen­dent study. The MHRA approved the vac­cine based on a sin­gle, incom­plete human tri­al cur­rent­ly being con­duct­ed by Mod­er­na. The com­pa­ny pro­mot­ed incom­plete data from that tri­al in com­pa­ny press releas­es in June and July. The study has yet to be pub­lished in a med­ical jour­nal or peer reviewed. No con­cerns have been raised by any reg­u­la­to­ry agency, includ­ing the MHRA, regard­ing Moderna’s past his­to­ry of engag­ing in sus­pect and like­ly ille­gal activ­i­ty in past prod­uct tri­als, includ­ing for its orig­i­nal COVID-19 vac­cine.

    ...

    Despite being in the ear­li­est stages of devel­op­ing its “rev­o­lu­tion­ary” man­u­fac­tur­ing capa­bil­i­ties, Nation­al Resilience entered into a part­ner­ship with the Gov­ern­ment of Cana­da in July of last year. Per that agree­ment, the Cana­di­an gov­ern­ment plans to invest CAD 199.2 mil­lion (about $154.9 mil­lion) into Nation­al Resilience’s Ontario-based sub­sidiary, Resilience Biotech­nolo­gies Inc. Most of those funds are des­tined for use in expand­ing the Ontario facil­i­ty that Resilience acquired last March and which is now man­u­fac­tur­ing the mRNA for Moderna’s COVID-19 prod­ucts. Canada’s Min­is­ter of Inno­va­tion, Sci­ence and Indus­try, François-Philippe Cham­pagne, assert­ed at the time that the invest­ment would “build future pan­dem­ic pre­pared­ness” and help “to grow Canada’s life sci­ence ecosys­tem as an engine for our eco­nom­ic recov­ery.” More recent­ly, in 2022, the com­pa­ny has announced a few new clients – Take­da, Opus Genet­ics and the US Depart­ment of Defense.
    ...

    Adding to the remark­able nature of Nation­al Resilience’s sud­den rise is the com­pa­ny’s state ambi­tion: It’s out to “rein­vent bio­man­u­fac­tur­ing” with a focus on cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins. And based on its suc­cess in cap­tur­ing the Mod­er­na mRNA sup­ply con­tract, and the com­pa­ny’s deep indus­try con­tacts, we have every rea­son to sus­pect the com­pa­ny to become a major play­er in those sec­tors too. The com­pa­ny clear­ly has both gov­ern­men­tal and cor­po­rate ‘juice’:

    ...
    Nation­al Resilience was found­ed rel­a­tive­ly recent­ly, in Novem­ber 2020, and describes itself as “a man­u­fac­tur­ing and tech­nol­o­gy com­pa­ny ded­i­cat­ed to broad­en­ing access to com­plex med­i­cines and pro­tect­ing bio­phar­ma­ceu­ti­cal sup­ply chains against dis­rup­tion.” It has since been build­ing “a sus­tain­able net­work of high-tech, end-to-end man­u­fac­tur­ing solu­tions with the aim to ensure the med­i­cines of today and tomor­row can be made quick­ly, safe­ly, and at scale.” It fur­therplans to “rein­vent bio­man­u­fac­tur­ing” and “democ­ra­tize access to med­i­cines,” name­ly gene ther­a­pies, exper­i­men­tal vac­cines and oth­er “med­i­cines of tomor­row.”

    In pur­suit of those goals, the com­pa­ny announced it would “active­ly invest in devel­op­ing pow­er­ful new tech­nolo­gies to man­u­fac­ture com­plex med­i­cines that are defin­ing the future of ther­a­peu­tics, includ­ing cell and gene ther­a­pies, viral vec­tors, vac­cines, and pro­teins.” It was found­ed with the report­ed inten­tion “to build a bet­ter sys­tem for man­u­fac­tur­ing com­plex med­i­cines to fight dead­ly dis­eases” as a way to improve post-COVID “pan­dem­ic pre­pared­ness.”
    ...

    All of these gov­ern­ment ties make the heavy over­lap between Nation­al Resilience’s ambi­tions of cre­at­ing “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem” and the kind of ‘gain-of-func­tion’ research that Pen­ta­gon-financed groups like the Eco­HealthAl­liance all the more intrigu­ing. All signs point towards Nation­al Resilience plan­ning on car­ry­ing out that kind of research, or at least facil­i­tat­ing that kind of research for oth­ers as part of the “Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try” ser­vice mod­el they are try­ing to build. All of the pieces are in place for the cre­ation of a ‘AWS for biotech’ gov­ern­ment-backed monop­oly. A gov­ern­ment-backed monop­oly that the gov­ern­ment-backed Mod­er­na appears to be more than will­ing to help bring into exis­tence:

    ...
    The com­pa­ny ini­tial­ly mar­ket­ed its man­u­fac­tur­ing capa­bil­i­ties as “the Resilience plat­form”, and offers prin­ci­pal­ly “RNA Modal­i­ties”, includ­ing RNA devel­op­ment for vac­cines, gene edit­ing and ther­a­peu­tics; and “Virus Pro­duc­tion”, includ­ing viral vec­tors, oncolyt­ic virus­es (i.e. a virus engi­neered to pref­er­en­tial­ly attack can­cer cells), virus­es for use in vac­cine devel­op­ment and gene-edit­ed virus­es for unspec­i­fied pur­pos­es. It is worth not­ing that, to date, many con­tro­ver­sial “gain-of-func­tion” exper­i­ments have jus­ti­fied mod­i­fy­ing virus­es for the same pur­pos­es as described by Nation­al Resilience’s Virus Pro­duc­tion capa­bil­i­ties. In addi­tion, Nation­al Resilience offers prod­uct for­mu­la­tions and oth­er modal­i­ties, such as bio­log­ics and cell ther­a­pies, to its clien­tele and the “Virus Pro­duc­tion” of its web­site has since been removed.

    ...

    Accord­ing to Nation­al Resilience’s exec­u­tives, the company’s ambi­tions appar­ent­ly go far beyond man­u­fac­tur­ing RNA and virus­es. For instance, Resilience CEO Rahul Singhvi has claimed that the com­pa­ny is seek­ing to build “the world’s most advanced bio­phar­ma­ceu­ti­cal man­u­fac­tur­ing ecosys­tem.” Yet, Singhvi has declined to offer much in the way of specifics when it comes to exact­ly how the com­pa­ny plans to become the planet’s most elite bio­man­u­fac­tur­ing com­pa­ny.

    ...

    Singhvi has fur­ther insist­ed that Nation­al Resilience is “not a ther­a­peu­tics com­pa­ny, not a con­trac­tor and not a tools com­pa­ny” and instead aims “to boost pro­duc­tion using the new ther­a­peu­tic modal­i­ties” such as RNA-based treat­ments, which have become nor­mal­ized in the COVID-19 era. Where­as con­tract man­u­fac­tur­ers “are like kitchens, with pots and pans ready for any recipe,” “what we’re try­ing to do is fix the recipes,” Singhvi has explained. One mem­ber of Resilience’s board of direc­tors, for­mer FDA Com­mis­sion­er and Pfiz­er Board mem­ber Scott Got­tlieb, has described the com­pa­ny as seek­ing to act as the equiv­a­lent of Ama­zon Web Ser­vices for the biotech­nol­o­gy indus­try.

    Essen­tial­ly, Resilience bills itself as offer­ing solu­tions that will allow “futur­is­tic” med­i­cines, includ­ing mRNA vac­cines, to be pro­duced more quick­ly and more effi­cient­ly, with the appar­ent goal of monop­o­liz­ing cer­tain parts of the bio­man­u­fac­tur­ing process. It also appears poised to become the man­u­fac­tur­er of choice for mRNA vac­cines and exper­i­men­tal ther­a­peu­tics in the event of a future pan­dem­ic, which some pub­lic health “phil­an­thropists” like Bill Gates have said is immi­nent.
    ...

    Those deep gov­ern­ment ties also bring us to what could be the most omi­nous part of Nation­al Resilience’s busi­ness plans: offer­ing the ser­vice of sup­port­ing clients through the gov­ern­ment reg­u­la­to­ry process with a goal of get­ting prod­ucts to mar­ket more quick­ly. These ambi­tions are, of course, build­ing on the prece­dent of moves like the deci­sion to approve the lat­est mRNA boost­ers based entire­ly mouse data. In oth­er words, we should expect a lot more sto­ries about med­i­cines being approved based on mouse-tri­als-only if Nation­al Resilience is suc­cess­ful in deliv­er­ing these ser­vices:

    ...
    Per­haps the company’s most note­wor­thy ambi­tion relates to their claims that they sup­port clients through the gov­ern­ment reg­u­la­to­ry process. Giv­en the company’s empha­sis on speedy mass pro­duc­tion of exper­i­men­tal gene ther­a­pies, its stat­ed inten­tion of get­ting the “futur­is­tic” med­ical prod­ucts it man­u­fac­tures to mar­ket as quick­ly as pos­si­ble seems at odds with the slow­er, tra­di­tion­al reg­u­la­to­ry process­es. Indeed, one could eas­i­ly argue that the approvals of mRNA vac­cines for the first time in human his­to­ry dur­ing the COVID-19 cri­sis were only pos­si­ble because of the major relax­ing of reg­u­la­to­ry pro­ce­durse and safe­ty test­ing due to the per­ceived urgency of the sit­u­a­tion.

    Resilience seems intent on see­ing that phe­nom­e­non repeat itself. As pre­vi­ous­ly men­tioned, the com­pa­ny claims to allow for the set­ting and appli­ca­tion of “new stan­dards for man­u­fac­tur­ing cell ther­a­pies and gene ther­a­pies” and also says it plans to become a “tech­nol­o­gy-aggre­gat­ing stan­dards bear­er that helps ther­a­pies come to mar­ket more effi­cient­ly.” It pre­vi­ous­ly offered on its web­site “reg­u­la­to­ry sup­port” and “strat­e­gy con­sult­ing” to clients, sug­gest­ing that it would seek to medi­ate between clients and gov­ern­ment reg­u­la­tors in order to ful­fill its goal of hav­ing the prod­ucts it man­u­fac­tures tak­en to mar­ket more quick­ly. In addi­tion, upon launch, the com­pa­ny claimed it planned to obtain unspec­i­fied “reg­u­la­to­ry capa­bil­i­ties.” If so, it is cer­tain­ly notable that for­mer top Food and Drug Admin­is­tra­tion (FDA) offi­cials are either on the company’s board or, as will be not­ed short­ly, played a major role in the company’s cre­ation.

    ...

    And those grand ambi­tions of becom­ing the ‘AWS for biotech’ and a ‘bureau­cra­cy-whis­per­er’ that gets clients prod­ucts rapid­ly pushed through reg­u­la­to­ry review are made all the more alarm­ing when we learn that the idea for this com­pa­ny appar­ent­ly orig­i­nat­ed with Luciana Borio, then the vice pres­i­dent of In-Q-Tel. Nation­al Resilience does­n’t just have ‘juice’. It has CIA ‘juice’. You can’t get more con­nect­ed. This is the kind of com­pa­ny that could rede­fine this indus­try:

    ...
    Resilience was co-found­ed by Biotech ven­ture cap­i­tal­ist Robert Nelsen, who is known for lis­ten­ing “to science’s ear­li­est whis­pers, even when data are too ear­ly for just about any­one else.” Nelsen was one of the ear­li­est investors in Illu­mi­na, a Cal­i­for­nia-based gene-sequenc­ing hard­ware and soft­ware giant that is believed to cur­rent­ly dom­i­nate the field of genomics. As men­tioned in a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion, Illu­mi­na is close­ly tied to the DARPA-equiv­a­lent of the Well­come Trust known as Well­come Leap, which is also focused on “futur­is­tic” and tran­shu­man­ist “med­i­cines.” Nelsen is now chair­man of Nation­al Resilience’s board, which is a “Who’s Who” of big play­ers from the US Nation­al Secu­ri­ty State, Big Phar­ma and Phar­ma-relat­ed “phil­an­thropy.”

    How­ev­er, while Nelsen has been giv­en much of the cred­it for cre­at­ing Resilience, he revealed in one inter­view that the idea for the com­pa­ny had actu­al­ly come from some­one else – Luciana Borio. In July of last year, Nelsen revealed that it was while talk­ing to Borio about “her work run­ning pan­dem­ic pre­pared­ness on the NSC [Nation­al Secu­ri­ty Coun­cil]” that had “helped lead to the launch of Nelsen’s $800 mil­lion bio­log­ics man­u­fac­tur­ing start­up Resilience.”

    At the time of their con­ver­sa­tion, Borio was the vice pres­i­dent of In-Q-tel, the ven­ture cap­i­tal arm of the CIA that has been used since its cre­ation in the ear­ly 2000s to found a num­ber of com­pa­nies, many of which act as Agency fronts. Pri­or to In-Q-Tel, she served as direc­tor for med­ical and biode­fense pre­pared­ness at the Nation­al Secu­ri­ty Coun­cil dur­ing the Trump admin­is­tra­tion and had pre­vi­ous­ly been the act­ing chief sci­en­tist at the FDA from 2015 to 2017.

    Borio is cur­rent­ly a senior fel­low for glob­al health at the Coun­cil on For­eign Rela­tions, a con­sul­tant to Gold­man Sachs, a mem­ber of the Bill Gates-fund­ed vac­cine alliance CEPI, and a part­ner at Nelsen’s ven­ture cap­i­tal firm ARCH Ven­ture Part­ners, which funds Resilience. Nelsen’s ARCH pre­vi­ous­ly fund­ed Nanosys, the com­pa­ny of the con­tro­ver­sial sci­en­tist Charles Lieber. Around the time of her con­ver­sa­tion with Nelsen that led to Resilience’s cre­ation, Borio was co-writ­ing a pol­i­cy paper for the Johns Hop­kins Cen­ter for Health Secu­ri­ty that rec­om­mend­ed link­ing COVID-19 vac­ci­na­tion sta­tus with food stamp pro­grams and rent assis­tance as a pos­si­ble means of coerc­ing cer­tain pop­u­la­tions to take the exper­i­men­tal vac­cine.

    Borio is hard­ly Resilience’s only In-Q-Tel con­nec­tion, as the CEO of In-Q-Tel, Chris Dar­by, sits on the company’s board of direc­tors. Dar­by is also on the board of direc­tors of the CIA Offi­cers Memo­r­i­al Foun­da­tion. Dar­by was also recent­ly a mem­ber of the Nation­al Secu­ri­ty Com­mis­sion on Arti­fi­cial Intel­li­gence (NSCAI), where mem­bers of the mil­i­tary, intel­li­gence com­mu­ni­ty and Sil­i­con Valley’s top firms argued for the need to reduce the use of “lega­cy sys­tems” in favor of AI-focused alter­na­tives as a nation­al secu­ri­ty imper­a­tive. Among those “lega­cy sys­tems” iden­ti­fied by the NSCAI were in-per­son doc­tor vis­its and even receiv­ing med­ical care from a human doc­tor, as opposed to an AI “doc­tor.” The NSCAI also argued for the removal of “reg­u­la­to­ry bar­ri­ers” that pre­vent these new tech­nolo­gies from replac­ing “lega­cy sys­tems.”
    ...

    Beyond Luciana Borio, Nation­al Resilience’s intel­li­gence ties include Drew Oet­ting of Steve Fein­berg’s Cer­berus Cap­i­tal Man­age­ment and Palan­tir’s Joe Lons­dale. It’s worth recall­ing at this point how Lons­dale played a key role in get­ting Sau­di mon­ey into Sil­i­con Val­ley. And while “Nation­al Resilience” clear­ly has close ties to the US gov­ern­ment, its con­tracts with Cana­da also make clear that it’s not exclu­sive­ly oper­at­ing in the US. You have to won­der how much Sau­di mon­ey Lons­dale will end up get­ting direct­ed into this ven­ture:

    ...
    Anoth­er notable board mem­ber, in dis­cussing Resilience’s intel­li­gence ties, is Drew Oet­ting. Oet­ting works for Cer­berus Cap­i­tal Man­age­ment, the firm head­ed by Steve Fein­berg who pre­vi­ous­ly led the President’s Intel­li­gence Advi­so­ry Board under the Trump admin­is­tra­tion. Cer­berus is notably the par­ent com­pa­ny of Dyn­Corp, a con­tro­ver­sial US nation­al secu­ri­ty con­trac­tor tied to numer­ous scan­dals, includ­ing scan­dals relat­ed to sex traf­fick­ing in con­flict zones. Oet­ting is also part of the CIA-linked Thorn NGO osten­si­bly focused on tack­ling child traf­fick­ing that was the sub­ject of a pre­vi­ous Unlim­it­ed Hang­out inves­ti­ga­tion.

    Oet­ting is also the co-founder of 8VC, a ven­ture cap­i­tal firm that is one of the main investors in Resilience. 8VC’s oth­er co-founder is Joe Lons­dale and Oet­ting “start­ed his career” as Lonsdale’s chief of staff. Lons­dale is the co-founder, along­side Peter Thiel and Alex Karp, of Palan­tir, a CIA front com­pa­ny and intel­li­gence con­trac­tor that is the suc­ces­sor to DARPA’s con­tro­ver­sial Total Infor­ma­tion Aware­ness (TIA) mass sur­veil­lance and data-min­ing pro­gram. In addi­tion, Oet­ting pre­vi­ous­ly worked for Bill Gates’ invest­ment fund.

    Also worth not­ing is the pres­ence of Joseph Robert Ker­rey, for­mer US Sen­a­tor for Nebras­ka and a for­mer mem­ber of the con­flict-of-inter­est-rid­den 9/11 Com­mis­sion, on Resilience’s board. Ker­rey is cur­rent­ly man­ag­ing direc­tor of Allen & Co., a New York invest­ment bank­ing firm which has host­ed an annu­al “sum­mer camp for bil­lion­aires” since 1983. Allen & Co. has long been a major play­er in net­works where orga­nized crime and intel­li­gence inter­sect, and is men­tioned repeat­ed­ly through­out my upcom­ing book One Nation Under Black­mail. For instance, Charles and Her­bert Allen, who ran the firm for decades, had con­sid­er­able busi­ness deal­ings with orga­nized crime king­pins and front­men for noto­ri­ous gang­sters like Mey­er Lan­sky, par­tic­u­lar­ly in the Bahamas. They were also busi­ness part­ners of Leslie Wexner’s men­tors A. Alfred Taub­man and Max Fish­er as well as asso­ciates of Earl Bri­an, one of the archi­tects of the PROMIS soft­ware scan­dal – which saw orga­nized crime and intel­li­gence net­works coop­er­ate to steal and then com­pro­mise the PROMIS soft­ware for black­mail and clan­des­tine intel­li­gence-gath­er­ing pur­pos­es. Allen & Co. was a major investor in Brian’s busi­ness inter­ests in the tech­nol­o­gy indus­try that Bri­an used in attempts to bank­rupt the devel­op­ers of PROMIS, Inslaw Inc. and to mar­ket ver­sions of PROMIS that had been com­pro­mised first by Israeli intel­li­gence and, lat­er, the CIA.

    In addi­tion to these intel­li­gence-linked indi­vid­u­als, the rest of Resilience’s board includes the for­mer CEO of the Bill & Melin­da Gates Foun­da­tion, Susan Desmond-Hell­mann; for­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber, Scott Got­tlieb; two for­mer exec­u­tives at John­son & John­son; for­mer pres­i­dent and CEO of Teva Phar­ma­ceu­ti­cals North Amer­i­can branch, George Bar­rett; Cal­Tech pro­fes­sor and board mem­ber of Alpha­bet (i.e. Google) and Illu­mi­na, Frances Arnold; for­mer exec­u­tive at Genen­tech and Mer­ck, Patrick Yang; and Resilience CEO Rahul Singhvi..
    ...

    The sky is the lim­it for Nation­al Resilience. We’ll see how long it takes before the com­pa­ny man­ages to achieve some­thing close to a monop­oly sta­tus in dif­fer­ent parts of the biotech sup­ply-chain, both in the US and glob­al­ly. But it appears to be a mat­ter of time. Just as it also appears to be just a mat­ter of time before we are forced to learn nasty lessons about allow­ing com­pa­nies stacked with insid­ers to rush new biotech­nolo­gies to mar­ket. Nasty wild­ly prof­itable lessons that we will learn noth­ing from, no doubt.

    Posted by Pterrafractyl | October 27, 2022, 4:11 pm
  4. The new biva­lent mRNA COVID boost­ers — boost­ers designed with the spike pro­teins of both the orig­i­nal COVID19 strain as well as the new Omi­cron BA.5 vari­ant — haven’t been with­out their share of mys­ter­ies. For starters, there’s the fact that the genet­ic mate­r­i­al for the boost­ers is being pro­duced by a lit­tle-known recent­ly formed com­pa­ny, Nation­al Resilience, stacked with fig­ures from the intel­li­gence com­mu­ni­ty. Then there’s the deci­sion to issue the new mRNA biva­lent COVID boost­ers based on mouse-tri­al data, skip­ping the human safe­ty-tri­als. As we saw in that recent sto­ry about the ‘gain-of-func­tion’ exper­i­ments on hybrid COVID virus­es con­duct­ed at Boston Uni­ver­si­ty, the behav­ior of the mouse immune sys­tem can’t eas­i­ly be used as a proxy for how the human immune sys­tem might response. But the deci­sion to release the new biva­lent vac­cines based entire­ly on mouse data was made, with a goal of speed­ing up the deliv­ery of the new biva­lent vac­cine to the pub­lic in time for the fall, when COVID cas­es are expect­ed to rise again.

    That brings us to the fol­low­ing pair of arti­cles that should raise more ques­tions about the reg­u­la­to­ry process­es behind these deci­sions and the extent to which the pub­lic is reliant on data from Mod­er­na and Pfiz­er alone. First, it appears that these new biva­lent boost­ers don’t actu­al­ly demon­strate a sta­tis­ti­cal­ly sig­nif­i­cant improve­ment in anti­body lev­els over the orig­i­nal vac­cine. They aren’t worse than the orig­i­nal vac­cine, and even slight­ly bet­ter accord­ing to these stud­ies. Just not actu­al­ly bet­ter to the point of sta­tis­ti­cal sig­nif­i­cance.

    The ques­tion of whether or not the new biva­lent vac­cines are actu­al­ly bet­ter isn’t just an aca­d­e­m­ic area of inquiry. Again, the deci­sion to release the vac­cines based entire­ly on mouse data was ground­ed in a con­vic­tion that these were indeed bet­ter vac­cines for the newest strains and it was impor­tant to get them to the pub­lic as soon as pos­si­ble.

    But as we’re going to see, there are still mil­lions of read­i­ly avail­able orig­i­nal mRNA vac­cines that are sched­uled to expire in com­ing months. The mass expir­ing of those orig­i­nal vac­cines is obvi­ous­ly great new for Nation­al Resilience, which will have to fill in the gap with new vac­cines. But is it a good for the pub­lic? As the fol­low­ing arti­cle notes, The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill. And once those fed­er­al sup­plies are exhaust­ed (or expired), there will be no more free vac­cines in the US. With the GOP like­ly retak­ing con­trol of Con­gress next year it’s hard to imag­ine those stalled COVID fund­ing requests get­ting processed. Eschew­ing the orig­i­nal vac­cines that are about to expire while push­ing the new biva­lent vac­cines is basi­cal­ly a recipe for blow­ing through that fed­er­al sup­ply as soon as pos­si­ble. And that would be a poten­tial­ly jus­ti­fi­able deci­sion if the new biva­lent vac­cines are indeed more effec­tive. But if not, it’s just a recipe for pulling fed­er­al­ly-fund­ed free vac­cines out of the mar­ket soon­er rather than lat­er.

    That’s all part of the con­text of fol­low­ing pair of arti­cles. Two new stud­ies both sug­gest the biva­lent vac­cines basi­cal­ly per­form the same as the orig­i­nal. So how has the US fed­er­al gov­ern­ment respond­ed to those find­ings? Well, the White House­’s top COVID offi­cial, Dr. Ashish Jha , start­ed off by point­ing out that the two stud­ies had rel­a­tive­ly small sam­ple sizes. Jha then point­ed to upcom­ing stud­ies cur­rent­ly being con­duct­ed by Mod­er­na and Pfiz­er with more patients which he expects will indeed show a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence between the per­for­mance of the orig­i­nal vac­cine and the new biva­lent vac­cines. In oth­er words, the fed­er­al gov­ern­men­t’s response to these two new stud­ies is basi­cal­ly “let’s opti­misti­cal­ly wait for more data to come in before arriv­ing at con­clu­sions”.

    Jha’s opti­mism was­n’t entire­ly unfound­ed. As we’re going to see in the sec­ond arti­cle excerpt below, Pfiz­er announced two weeks ago that it found the new boost­ers increased the neu­tral­iz­ing anti­bod­ies sev­en days after the shot against the BA.4 and BA.5 sub­vari­ants in a study involv­ing 80 vol­un­teers. Both Pfiz­er and Mod­er­na are expect­ed to release more data on their stud­ies in com­ing weeks, with Mod­er­na expect­ing to have sta­tis­ti­cal­ly pow­ered data by the end of the year.

    But as Dan Barouch of Har­vard Med­ical School, one of the authors of one of the two new stud­ies that did­n’t find a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence between the old and new vac­cines, points out, find­ing a “sta­tis­ti­cal­ly sig­nif­i­cant” dif­fer­ence in the per­for­mance of the vac­cines isn’t actu­al­ly the same as find­ing a clin­i­cal­ly sig­nif­i­cant dif­fer­ence. Don’t for­get that these new stud­ies did indeed find high­er lev­els of anti­bod­ies get­ting gen­er­at­ed by the new biva­lent vac­cines. But not much high­er. The dif­fer­ence was small enough that, giv­en the rel­a­tive­ly small sam­ple size, the researchers could­n’t claim to have found a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence in the anti­body lev­els. Sim­ply increas­ing the num­ber of peo­ple in these stud­ies will increase the sta­tis­ti­cal sam­pling pow­er and make it more and more like­ly that a “sta­tis­ti­cal­ly sig­nif­i­cant” find­ing will be arrived at. But it’s entire­ly pos­si­ble that stud­ies with more peo­ple will sim­ply con­firm the rel­a­tive­ly small boost in anti­bod­ies from the biva­lent vac­cines. Is a rel­a­tive­ly small boost actu­al­ly a mean­ing­ful dif­fer­ence in a clin­i­cal sense? That’s the dis­tinc­tion Barouch was mak­ing between “sta­tis­ti­cal­ly sig­nif­i­cant” dif­fer­ences and “clin­i­cal­ly sig­nif­i­cant” dif­fer­ences.

    But there’s anoth­er angle to this sto­ry: it turns out recent­ly pub­lished data on mice showed the new biva­lent vac­cines to be quite promis­ing and con­fer much bet­ter pro­tec­tion than the orig­i­nal vac­cines. So at the same time ear­ly stud­ies are find­ing no dif­fer­ence between the orig­i­nal and new vac­cines in humans, we’re get­ting stud­ies on mice sug­gest­ing the new vac­cines are actu­al­ly much bet­ter. And this all for vac­cines that are already avail­able based entire­ly on mouse data under the assump­tion that doing so is impor­tant to get the enhanced pro­tec­tion from the new vac­cines avail­able to the pub­lic as soon as pos­si­ble. Over­all, it’s the kind of sto­ry that under­scores just how much gam­bling and guess­work is involved in this whole process. Gam­bles, guess­work, and repeat­ed assur­ances from the indus­try that every­thing is going great:

    CBS News

    White House still expects new COVID boost­ers will offer bet­ter pro­tec­tion, but two new stud­ies cast doubt

    By Alexan­der Tin
    Updat­ed on: Octo­ber 28, 2022 / 1:28 PM

    The White House­’s top COVID-19 offi­cial says he still expects the pro­tec­tion against the Omi­cron BA.5 vari­ant offered by the new COVID vac­cine boost­ers will be bet­ter than their pre­de­ces­sors, despite two stud­ies that appear to ques­tion that assump­tion. In an inter­view with CBS News, Dr. Ashish Jha also said he does not think anoth­er immi­nent change to the COVID boost­ers will be need­ed.

    Jha’s com­ments come after researchers found, in two small­er groups of vol­un­teers, data sug­gest­ing that the updat­ed boost­ers pro­vide only sim­i­lar but not supe­ri­or anti­body boosts against BA.5, com­pared to the orig­i­nal vac­cine for­mu­la.

    “I do think that the pro­tec­tion against infec­tion is going to be bet­ter than if you were get­ting the orig­i­nal pro­to­type boost­er,” Jha told CBS News.

    Jha said he was not sur­prised about the new study results and praised the two sci­en­tists — Dan Barouch of Har­vard Med­ical School and David Ho of Colum­bia Uni­ver­si­ty — who led each of the research teams behind the pre­lim­i­nary find­ings.

    How­ev­er, he pre­dict­ed that the “well-con­trolled tri­als” with “larg­er sam­ples” now under­way from vac­cine mak­ers could yield more favor­able results about the boost­ers’ per­for­mance.

    The stud­ies did turn up high­er anti­body respons­es after the updat­ed boost­er, Jha said, even if they were too small to be sta­tis­ti­cal­ly sig­nif­i­cant.

    “I expect we’re going to see at least that size ben­e­fit, prob­a­bly big­ger, in the Pfiz­er and Mod­er­na stud­ies,” Jha said.

    Jha’s com­ments are in line with expec­ta­tions pre­vi­ous­ly voiced by fed­er­al health offi­cials from across the Biden admin­is­tra­tion, who have argued for months that the updat­ed boost­ers being rolled out this fall would out­per­form the orig­i­nal for­mu­la­tions.

    In a state­ment, the FDA’s top vac­cines offi­cial said data “from larg­er, well con­trolled stud­ies that are not sub­ject to the same lim­i­ta­tion of these small­er stud­ies are expect­ed to be avail­able in the near future” and urged Amer­i­cans to seek out an updat­ed boost­er.

    “Addi­tion­al­ly, even mod­est improve­ments in vac­cine response to the biva­lent boost­ers could have impor­tant pos­i­tive con­se­quences on pub­lic health,” said a state­ment from Dr. Peter Marks, head of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research.

    The new boost­ers are known as “biva­lent” because they include both a com­po­nent tar­get­ing the orig­i­nal “pro­to­type” strain and anoth­er aimed at the BA.4 and BA.5 vari­ants.

    Ear­ly data from ani­mals test­ed with the new shots had been promis­ing. Pre­vi­ous ver­sions tar­get­ing oth­er strains tri­aled on humans also sug­gest­ed a biva­lent for­mu­la­tion would also offer at least an “incre­men­tal” improve­ment, health author­i­ties con­clud­ed.

    ...

    “Mod­est and non­signif­i­cant”

    But this week, two stud­ies seemed to upend those expec­ta­tions.

    “There was no sig­nif­i­cant dif­fer­ence in neu­tral­iza­tion of any SARS-CoV­‑2 vari­ant test­ed between indi­vid­u­als who received a fourth mono­va­lent vac­cine and those who received a fourth dose of a biva­lent vac­cine,” con­clud­ed one study, which has yet to be peer-reviewed, post­ed by the team led by Ho.

    Sci­en­tists drew blood from peo­ple rough­ly a month after they had got­ten the new shot and test­ed their anti­body respons­es against “pseudovirus­es” — essen­tial­ly mock-ups of dif­fer­ent vari­ants, includ­ing BA.5.

    Barouch’s team per­formed a sim­i­lar exper­i­ment against BA.5. They turned up only “a mod­est and non­signif­i­cant” improve­ment from the updat­ed boost­ers in their study, which has also yet to be peer-reviewed.

    “If that very small dif­fer­ence holds up in a much larg­er study, then a much larg­er study might actu­al­ly say that’s a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence. The ques­tion is, is it clin­i­cal­ly rel­e­vant? And I don’t believe that that lev­el of dif­fer­ence is clin­i­cal­ly rel­e­vant,” Barouch said in an inter­view.

    Barouch said a phe­nom­e­non called immune imprint­ing may turn out to be the cul­prit for the dis­ap­point­ing immune response to the updat­ed boost­er.

    Immune imprint­ing, also known as “orig­i­nal anti­genic sin,” refers to the the­o­ry that the ini­tial expo­sure peo­ple had to an ear­li­er strain of the virus — either from infec­tion or vac­ci­na­tion — may hin­der the abil­i­ty of the body to pro­duce anti­bod­ies to new strains.

    Both the vac­cine com­pa­nies and health offi­cials had pre­vi­ous­ly down­played the hur­dle this phe­nom­e­non might pose to the new shots.

    Barouch acknowl­edged there was a pos­si­bil­i­ty that respons­es against BA.5 could improve after more weeks fol­low­ing the updat­ed boost­er, but cau­tioned that we have seen anti­bod­ies decline in the months after pre­vi­ous mRNA COVID shots.

    His team also mea­sured anoth­er part of the immune response from T cells. Those were “not sub­stan­tial­ly” boost­ed by addi­tion­al shots from either the biva­lent or orig­i­nal for­mu­la­tions.

    “We all talk about anti­bod­ies, the focus has been on anti­bod­ies, but there’s two sides to the immune sys­tem: anti­bod­ies and T cells. And we believe that both are impor­tant for pro­tec­tion against severe dis­ease,” said Barouch.

    Updat­ing the vac­cines

    The new stud­ies come as the Biden admin­is­tra­tion is prepar­ing for key deci­sions about the coun­try’s COVID-19 vac­cine sup­ply.

    Mil­lions of dos­es of the orig­i­nal mono­va­lent vac­cine, which is still being used for pri­ma­ry series shots, are due to expire over the com­ing months. Boost­ers also still need to be green­light­ed for the youngest age group: chil­dren down to 6 months old.

    The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill, which will prompt a shift to the pri­vate mar­ket.

    ...

    “We will have our BA.4/5 data by year end and ours will be sta­tis­ti­cal­ly pow­ered,” Mod­er­na spokesper­son Chris Rid­ley said in an email.

    Rid­ley also point­ed to results from a pre­vi­ous biva­lent for­mu­la­tion by Mod­er­na tar­get­ed at the BA.1 vari­ant, which was pub­lished in The New Eng­land Jour­nal of Med­i­cine a few weeks ago.

    Pfiz­er and their Ger­man part­ner BioN­Tech announced find­ing “pos­i­tive ear­ly data” from their updat­ed shots ear­li­er this month. Pfiz­er spokesper­son Steve Dane­hy said they expect to “have addi­tion­al data in com­ing weeks” on the shots.

    “We’re going to want to make pol­i­cy deci­sions based on more defin­i­tive, larg­er stud­ies, which are com­ing soon,” Jha said.

    ———-

    “White House still expects new COVID boost­ers will offer bet­ter pro­tec­tion, but two new stud­ies cast doubt” By Alexan­der Tin; CBS News; 10/28/2022

    “How­ev­er, he pre­dict­ed that the “well-con­trolled tri­als” with “larg­er sam­ples” now under­way from vac­cine mak­ers could yield more favor­able results about the boost­ers’ per­for­mance.”

    Dr. Ashish Jha clear­ly was­n’t dis­suad­ed from the con­vic­tion that the new biva­lent vac­cines are bet­ter. We just need to wait for the stud­ies from the vac­cine man­u­fac­tur­ers. Jha went on to point out that the two new stud­ies did find that new boost­ers pro­duced high­er anti­body lev­els. They’re just not high­er enough to reach the lev­el of sta­tis­ti­cal sig­nif­i­cance based on the rel­a­tive­ly small sam­ple sizes. Jha even pre­dict­ed that Mod­er­na’s and Pfiz­er’s bet­ter-pow­ered stud­ies will show a larg­er rel­a­tive advan­tage to the new boost­ers. We’ll see, but that’s what Jha is pre­dict­ing, which isn’t sur­pris­ing since the fed­er­al gov­ern­men­t’s deci­sion to release the new boost­ers on mouse data alone was based on a near cer­tain con­vic­tion that the new boost­ers would be bet­ter:

    ...
    Jha said he was not sur­prised about the new study results and praised the two sci­en­tists — Dan Barouch of Har­vard Med­ical School and David Ho of Colum­bia Uni­ver­si­ty — who led each of the research teams behind the pre­lim­i­nary find­ings.

    ...

    The stud­ies did turn up high­er anti­body respons­es after the updat­ed boost­er, Jha said, even if they were too small to be sta­tis­ti­cal­ly sig­nif­i­cant.

    “I expect we’re going to see at least that size ben­e­fit, prob­a­bly big­ger, in the Pfiz­er and Mod­er­na stud­ies,” Jha said.

    Jha’s com­ments are in line with expec­ta­tions pre­vi­ous­ly voiced by fed­er­al health offi­cials from across the Biden admin­is­tra­tion, who have argued for months that the updat­ed boost­ers being rolled out this fall would out­per­form the orig­i­nal for­mu­la­tions.

    In a state­ment, the FDA’s top vac­cines offi­cial said data “from larg­er, well con­trolled stud­ies that are not sub­ject to the same lim­i­ta­tion of these small­er stud­ies are expect­ed to be avail­able in the near future” and urged Amer­i­cans to seek out an updat­ed boost­er.

    “Addi­tion­al­ly, even mod­est improve­ments in vac­cine response to the biva­lent boost­ers could have impor­tant pos­i­tive con­se­quences on pub­lic health,” said a state­ment from Dr. Peter Marks, head of the FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research.
    ...

    In addi­tion, it appears that data on mice also found that the new boost­ers trig­gered high­er anti­body respons­es. It’s going to be inter­est­ing to see how dif­fer­ent the study results on mice and humans end up being for these boost­ers as bet­ter-pow­ered stud­ies are report­ed:

    ...
    Ear­ly data from ani­mals test­ed with the new shots had been promis­ing. Pre­vi­ous ver­sions tar­get­ing oth­er strains tri­aled on humans also sug­gest­ed a biva­lent for­mu­la­tion would also offer at least an “incre­men­tal” improve­ment, health author­i­ties con­clud­ed.
    ...

    And Jha’s pre­dic­tion that the Mod­er­na and Pfiz­er stud­ies will show not just a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence but a larg­er dif­fer­ence between the old and new boost­ers isn’t just Jha voic­ing opti­mism. AS Dr. Barouch, the author of one of two new stud­ies, points out, a sta­t­i­cal­ly sig­nif­i­cant dif­fer­ence may not be a clin­i­cal­ly sig­nif­i­cant dif­fer­ence. Which means it’s entire­ly pos­si­ble future bet­ter-pow­ered stud­ies will indeed reveal a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence, but still not a clin­i­cal­ly sig­nif­i­cant dif­fer­ence:

    ...
    But this week, two stud­ies seemed to upend those expec­ta­tions.

    “There was no sig­nif­i­cant dif­fer­ence in neu­tral­iza­tion of any SARS-CoV­‑2 vari­ant test­ed between indi­vid­u­als who received a fourth mono­va­lent vac­cine and those who received a fourth dose of a biva­lent vac­cine,” con­clud­ed one study, which has yet to be peer-reviewed, post­ed by the team led by Ho.

    Sci­en­tists drew blood from peo­ple rough­ly a month after they had got­ten the new shot and test­ed their anti­body respons­es against “pseudovirus­es” — essen­tial­ly mock-ups of dif­fer­ent vari­ants, includ­ing BA.5.

    Barouch’s team per­formed a sim­i­lar exper­i­ment against BA.5. They turned up only “a mod­est and non­signif­i­cant” improve­ment from the updat­ed boost­ers in their study, which has also yet to be peer-reviewed.

    “If that very small dif­fer­ence holds up in a much larg­er study, then a much larg­er study might actu­al­ly say that’s a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence. The ques­tion is, is it clin­i­cal­ly rel­e­vant? And I don’t believe that that lev­el of dif­fer­ence is clin­i­cal­ly rel­e­vant,” Barouch said in an inter­view.
    ...

    And that dis­tinc­tion between sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ences and clin­i­cal­ly sig­nif­i­cant dif­fer­ences get at the heart of the ques­tion over whether or not the fed­er­al gov­ern­ment is just wast­ing and throw­ing away the mil­lions of orig­i­nal vac­cines that are slat­ed to expire in com­ing months. With the fed­er­al gov­ern­ment get­ting out of the busi­ness of pro­vid­ing free vac­cines next year, this is arguably a deci­sion to toss away usable vac­cines and has­ten the end of freely avail­able vac­cines:

    ...
    The new stud­ies come as the Biden admin­is­tra­tion is prepar­ing for key deci­sions about the coun­try’s COVID-19 vac­cine sup­ply.

    Mil­lions of dos­es of the orig­i­nal mono­va­lent vac­cine, which is still being used for pri­ma­ry series shots, are due to expire over the com­ing months. Boost­ers also still need to be green­light­ed for the youngest age group: chil­dren down to 6 months old.

    The fed­er­al gov­ern­men­t’s sup­ply of the updat­ed boost­ers is on pace to run out next year as a result of a stalled COVID fund­ing request on Capi­tol Hill, which will prompt a shift to the pri­vate mar­ket.
    ...

    Inter­est­ing­ly, Barouch points to a known bio­log­i­cal phe­nom­e­na that could explain why the biva­lent vac­cines don’t improve respons­es as pre­dict­ed: “orig­i­nal anti­genic sin”, or the the­o­ry that the body tends to remem­ber the orig­i­nal ver­sion of a virus bet­ter than it adapts to new­er ver­sions. Note how Mod­er­na, Pfiz­er, and health offi­cials appeared to down­play this the­o­ry. It’s going to be very inter­est­ing to see if this the­o­ry pans out:

    ...
    Barouch said a phe­nom­e­non called immune imprint­ing may turn out to be the cul­prit for the dis­ap­point­ing immune response to the updat­ed boost­er.

    Immune imprint­ing, also known as “orig­i­nal anti­genic sin,” refers to the the­o­ry that the ini­tial expo­sure peo­ple had to an ear­li­er strain of the virus — either from infec­tion or vac­ci­na­tion — may hin­der the abil­i­ty of the body to pro­duce anti­bod­ies to new strains.

    Both the vac­cine com­pa­nies and health offi­cials had pre­vi­ous­ly down­played the hur­dle this phe­nom­e­non might pose to the new shots.

    Barouch acknowl­edged there was a pos­si­bil­i­ty that respons­es against BA.5 could improve after more weeks fol­low­ing the updat­ed boost­er, but cau­tioned that we have seen anti­bod­ies decline in the months after pre­vi­ous mRNA COVID shots.

    His team also mea­sured anoth­er part of the immune response from T cells. Those were “not sub­stan­tial­ly” boost­ed by addi­tion­al shots from either the biva­lent or orig­i­nal for­mu­la­tions.

    “We all talk about anti­bod­ies, the focus has been on anti­bod­ies, but there’s two sides to the immune sys­tem: anti­bod­ies and T cells. And we believe that both are impor­tant for pro­tec­tion against severe dis­ease,” said Barouch.
    ...

    Final­ly, note that Mod­er­na is pre­dict­ing its sta­tis­ti­cal­ly robust stud­ies by the end of the year. Pfiz­er already had some ini­tial pos­i­tive reports:

    ...
    “We will have our BA.4/5 data by year end and ours will be sta­tis­ti­cal­ly pow­ered,” Mod­er­na spokesper­son Chris Rid­ley said in an email.

    Rid­ley also point­ed to results from a pre­vi­ous biva­lent for­mu­la­tion by Mod­er­na tar­get­ed at the BA.1 vari­ant, which was pub­lished in The New Eng­land Jour­nal of Med­i­cine a few weeks ago.

    Pfiz­er and their Ger­man part­ner BioN­Tech announced find­ing “pos­i­tive ear­ly data” from their updat­ed shots ear­li­er this month. Pfiz­er spokesper­son Steve Dane­hy said they expect to “have addi­tion­al data in com­ing weeks” on the shots.

    “We’re going t want to make pol­i­cy deci­sions based on more defin­i­tive, larg­er stud­ies, which are com­ing soon,” Jha said.
    ...

    Will Mod­er­na actu­al­ly deliv­er that larg­er study on time? And will the pub­lic get to see all of the rel­e­vant data or will we just be asked to trust them? We’ll see.

    So let’s take a clos­er look at that ear­ly report from Pfiz­er. As we’re going to see, while the com­pa­ny has excit­ed­ly tout­ed the rel­a­tive­ly high­er anti­body lev­els that its new biva­lent vac­cine appeared to induce in a tri­al of 80 vol­un­teers, that com­pa­ny has yet to pub­licly release effi­ca­cy data. That data is pre­sum­ably com­ing. But it’s hard to get super excit­ed with only 80 peo­ple. That’s not exact­ly a huge sta­tis­ti­cal­ly robust sam­ple, espe­cial­ly when you con­sid­er­ing all the dif­fer­ent demo­graph­ic groups those 80 peo­ple could fall under. It sounds like Pfiz­er just broke it into two groups: ages 18–55, and 55+. So it was real­ly just ~40 peo­ple in each of those groups. Again, not exact­ly huge. So it’s going to be very inter­est­ing to see the details that Pfiz­er even­tu­al­ly releas­es on its full study. But the fact that they only have 80 peo­ple rais­es the pos­si­bil­i­ty that we’re going to see results from Pfiz­er and Mod­er­na that are very dif­fer­ent from these oth­er two stud­ies and yet don’t actu­al­ly have that much more sta­tis­ti­cal pow­er behind them. What will reg­u­la­tors do in that case?:

    Bloomberg

    Pfiz­er Says Boost­er Lifts Anti­bod­ies for Omi­cron Vari­ants

    * Com­pa­nies release ear­ly anti­body data on mod­i­fied vac­cine
    * Amid slow boost­er cam­paign, Amer­i­cans await effi­ca­cy data

    By Marthe Four­cade and Riley Grif­fin
    Octo­ber 13, 2022 at 6:18 AM CDT
    Updat­ed on Octo­ber 13, 2022 at 8:42 AM CDT

    Pfiz­er Inc. and its Ger­man vac­cine part­ner said their boost­er tai­lored to the lat­est omi­cron vari­ants raised more anti­bod­ies against the dom­i­nant strains of Covid-19 when com­pared with the orig­i­nal shot designed to fight the form of the virus.

    Blood from 80 vol­un­teers col­lect­ed sev­en days after the boost­er shot showed an increase in neu­tral­iz­ing anti­bod­ies against the BA.4 and BA.5 sub­vari­ants in a study, Pfiz­er and BioN­Tech SE said in a state­ment Thurs­day.

    The vac­cines were autho­rized with­out data show­ing their per­for­mance in humans. Pfiz­er and BioN­Tech plan to release addi­tion­al data in com­ing weeks mea­sur­ing immune respons­es one month fol­low­ing admin­is­tra­tion of the new biva­lent boost­er. They have not shared data on the shot’s effi­ca­cy, which would offer a bet­ter mea­sure of pro­tec­tion against wide­ly cir­cu­lat­ing vari­ants.

    “While we expect more mature immune-response data from the clin­i­cal tri­al of our omi­cron BA.4/BA.5‑adapted biva­lent vac­cine in the com­ing weeks, we are pleased to see encour­ag­ing respons­es just one week after vac­ci­na­tion in younger and old­er adults,” Pfiz­er Chief Exec­u­tive Albert Bourla said in the state­ment. “These ear­ly data sug­gest that our biva­lent vac­cine is antic­i­pat­ed to pro­vide bet­ter pro­tec­tion against cur­rent­ly cir­cu­lat­ing vari­ants than the orig­i­nal vac­cine, and poten­tial­ly help to curb future surges in cas­es this win­ter.”

    The vac­cine part­ners stud­ied two cohorts that had been giv­en the new vac­cine: one includ­ed those ages 18 to 55, and the oth­er includ­ing those 55 and up. The old­er cohort that demon­strat­ed a weak­er anti­body response against BA.4/BA.5 com­pared to the younger cohort, the com­pa­nies said.

    The US fall boost­er cam­paign has thus far fal­tered. Only 11.5 mil­lion Amer­i­cans have been admin­is­tered a new­ly mod­i­fied vac­cine from Pfiz­er-BioN­Tech or Mod­er­na Inc., a frac­tion com­pared to pre­vi­ous boost­er cam­paigns. On Wednes­day, US reg­u­la­tors expand­ed access to the new biva­lent boost­er shots to include chil­dren ages 5 and up.

    ...

    ———–

    “Pfiz­er Says Boost­er Lifts Anti­bod­ies for Omi­cron Vari­ants” By Marthe Four­cade and Riley Grif­fin; Bloomberg; 10/13/2022

    Blood from 80 vol­un­teers col­lect­ed sev­en days after the boost­er shot showed an increase in neu­tral­iz­ing anti­bod­ies against the BA.4 and BA.5 sub­vari­ants in a study, Pfiz­er and BioN­Tech SE said in a state­ment Thurs­day.”

    80 vol­un­teers is pre­sum­ably larg­er than the two new­ly released stud­ies that found no dif­fer­ence between the orig­i­nal and new boost­ers. And yet 80 peo­ple isn’t like some vast pool. And the small­er the dif­fer­ence you’re try­ing to mea­sure the greater the sta­tis­ti­cal pow­er that is required.

    But also note that Pfiz­er isn’t real­ly tell us how much high­er the anti­body lev­els are that are elicit­ed by the new vac­cine vs the orig­i­nal. Just that they are high­er. Well, that’s what those oth­er stud­ies found too: the new vac­cines did stim­u­late high­er anti­body lev­els. But not much high­er. The dif­fer­ence was so small that they could­n’t claim sta­tis­ti­cal sig­nif­i­cance. So is that what Pfiz­er found too? Or did the com­pa­ny see much greater dif­fer­ence? We have no idea. Just as we have no idea about the actu­al effi­ca­cy of the vac­cine. Pfiz­er isn’t report­ing that:

    ...
    The vac­cines were autho­rized with­out data show­ing their per­for­mance in humans. Pfiz­er and BioN­Tech plan to release addi­tion­al data in com­ing weeks mea­sur­ing immune respons­es one month fol­low­ing admin­is­tra­tion of the new biva­lent boost­er. They have not shared data on the shot’s effi­ca­cy, which would offer a bet­ter mea­sure of pro­tec­tion against wide­ly cir­cu­lat­ing vari­ants.
    ...

    If Pfiz­er find­ing one ‘break­through’ infec­tion after anoth­er? That might explain why it does­n’t want to report on the effi­ca­cy.

    Final­ly, notice the glar­ing data point miss­ing in all of this: non-mRNA COVID vac­cines. Sure, they exist. The J&J boost­er is still hypo­thet­i­cal­ly avail­able despite the US gov­ern­ments clear attempts to push every­one onto the mRNA vac­cines. And the Novavax boost­er just received approval. But almost no one is get­ting those shots. Where are the stud­ies com­par­ing these vac­cine tech­nolo­gies? Don’t for­get how the J&J vac­cine appeared to be the best per­former for long-term effi­ca­cy back in May right when the US gov­ern­ment advised against its use based on a rare blood­clot­ting issue. How can it be that there’s so lit­tle inter­est­ing in these com­par­isons? Who knows, but that’s the state of affairs. There is a clear and very strong gov­ern­men­tal pref­er­ence for the mRNA vac­cines over­all oth­er options. That’s abun­dant­ly clear. What isn’t clear is why that pref­er­ence exists and it’s get­ting less and less clear with each study, or lack there­of.

    Posted by Pterrafractyl | November 2, 2022, 4:44 pm

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