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FTR #1151 Bio-Psy-Op Apocalypse Now, Part 11: Covid-19 Updates, Part 2

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FTR #1151 This pro­gram was record­ed in one, 60-minute seg­ment [5].

[6]Intro­duc­tion: Con­tin­u­ing our inquiry into the Covid-19 pan­dem­ic, this pro­gram con­tin­ues analy­sis of the dis­ease as a pandemic–a bio­log­i­cal war­fare man­i­fes­ta­tion that is one part act of war, one part domes­tic ter­ror­ism, and a major “psy-op.”

The wide­ly pub­li­cized inter­view Trump gave [7] to Bob Wood­ward, in which Trump can­did­ly assessed the lethal nature of SARS Cov‑2 has been mis­un­der­stood. Trump’s pol­i­cy on the virus has been just exact­ly what he and the inter­ests for which he fronts desire.

The Pan­dem­ic is a por­tal for the real­iza­tion of the goals of the Under­ground Reich for which Trump is a front man and enabler. These issues either have been or will be dis­cussed at greater length.

  1. The virus is the Wealth Con­cen­tra­tion Virus.
  2. It is the Wealth-Destroy­ing Virus for areas and insti­tu­tions that the Trump inter­ests oppose.
  3. It is the Urban Area Destruc­tion Virus.
  4. It is the White Suprema­cist Virus–hitting peo­ple of col­or much hard­er, due to health and socio-eco­nom­ic fac­tors.
  5. It is the Eugenic Virus–killing old­er peo­ple and peo­ple with com­pli­cat­ing med­ical con­di­tions.
  6. It is the Edu­ca­tion-Destroy­ing Virus, dras­ti­cal­ly and neg­a­tive­ly affect­ing pub­lic schools and col­leges.
  7. It is the Pub­lic Tran­sit Destroy­ing Virus.
  8. It is the Divide and Con­quer Virus–separating the old from the young and–potentially–women from men.
  9. The pan­dem­ic is the “Bio-Psy-Op Apoc­a­lypse” Virus, rav­aging the psy­ches of indi­vid­u­als and groups.
[8]

Trump kept a copy of this by his bed­side for late-night read­ing.

The Covid-19 pan­dem­ic is dri­ving what might be termed a right-wing ide­o­log­i­cal wet dream in a num­ber of dif­fer­ent respects. Here, we note that the dam­age done by the virus is seen as fur­ther­ing a cor­po­ratist agen­da, mas­querad­ing under the com­mon rhetor­i­cal cam­ou­flage of “lib­er­tar­i­an” phi­los­o­phy.

An impor­tant piece in The Guardian [9] details how plu­to­crats terming them­selves “anar­cho-cap­i­tal­ists” see the pan­dem­ic as forc­ing regions–from nations to municipalities–to con­form to the demands of dom­i­nant, mobile blocks of cap­i­tal by elim­i­nat­ing the essen­tials of the pro­gres­sive social agen­da.

  1. ” . . . . They spy oppor­tu­ni­ty in the cri­sis, and wager that we might be able to ride the wave of the pan­dem­ic into a new tomor­row, where the virus shat­ters the glob­al map – and under­mines the pow­er of demo­c­ra­t­ic nation states. The US is ground zero for this type of think­ing. . . .”
  2. ” . . . . In an analy­sis released at the end of April, Arthur Laf­fer and Stephen Moore, two of Trump’s clos­est eco­nom­ic con­fi­dants and authors of the book on ‘Trumpo­nom­ics’, pre­dict­ed that ‘blue’ Demo­c­ra­t­ic states would be slow­er than ‘red’ states to recov­er, because of what they saw as their pre-exist­ing excess of reg­u­la­tions and tax­es. . . .”
  3. ” . . . .Their analy­sis divid­ed the US map into ‘lag­gard anti-growth’ states and ‘momen­tum pro-growth’ states. The for­mer have min­i­mum wages, pro-union laws and state income tax; the lat­ter are free of such reg­u­la­tions. In the estab­lished mode of dis­as­ter cap­i­tal­ism, Laf­fer and Moore’s analy­sis appears to see the pan­dem­ic as a way to com­pel ‘anti-growth’ states to adopt ever low­er tax rates in order to attract mobile cap­i­tal and labour. It sug­gests those who resist will not be bailed out by redis­tri­b­u­tion from the cen­tral gov­ern­ment, but left to lan­guish in a deserved eco­nom­ic depres­sion. The effect is rem­i­nis­cent of social Dar­win­ism, applied as a phi­los­o­phy of gov­ern­ment. . . .”
  4. ” . . . . As nations are divid­ed into dif­fer­ent zones accord­ing to their respec­tive stages of viral and eco­nom­ic recov­ery, the well-off could fol­low Elon Musk’s recent threat to relo­cate from Cal­i­for­nia to Texas, vot­ing with their feet for loca­tions that elude redis­trib­u­tive tax­a­tion. In our post-pan­dem­ic future, the flight to safe­ty, away from con­ta­gious ‘red zones’, could be a flight from the nation state as we know it. . . .”
[10]

U.S. Army Med­ical Research Insti­tute of Infec­tious Disease–located at Ft. Det­rick and closed by the CDC for safe­ty vio­la­tions in August, 2019.

As an intro­duc­tion, we review key aspects of a very impor­tant arti­cle [11] by Whit­ney Webb, set­ting forth exten­sive DARPA research into bat-borne coro­n­avirus­es, poten­tial­ly geno­ci­dal gene-dri­ving tech­nol­o­gy and over­lap­ping research into vac­cine devel­op­ment, as well as the pos­si­bil­i­ty that such research may have been involved with the CDC’s shut­down of Fort Det­rick­’s USAMRIID in ear­ly August of 2019.

In numer­ous pro­grams, we have not­ed remde­sivir and how it has driven–very pos­si­bly with insid­er advanced knowl­edge and trading–the stock mar­ket. We have cov­ered remde­sivir and Gilead Sci­ences in detail in FTR #‘s 1132 [12], 1134 [13], and 1138 [14].

The FDA–now head­ed by the Hoover Insti­tute’s Stephen Hahn, a for­mer can­cer spe­cial­ist with no expe­ri­ence in infec­tious diseases–has expand­ed [15] the approved use of remde­sivir. Experts are warn­ing that the FDA pro­vid­ed no data jus­ti­fy­ing the move [15] and now the drug is going to be in even short­er sup­ply for the sick­est patients.

The remain­der of the pro­gram focus­es on fast-track­ing of vac­cines.

Among the gam­bits being dis­cussed as pos­si­ble vehi­cles for Trump to gain a sec­ond term is the roll­out of a Covid-19 vac­cine. The CDC has told states [16] to pre­pare for such a devel­op­ment. Many crit­ics have cit­ed the pre­ma­ture nature of such a pos­si­bil­i­ty and the lack of ade­quate test­ing.

Next, we present an inter­view of the head of the FDA, Stephen Hahn, about his will­ing­ness to fast-track a vac­cine. The way Hahn puts it, the cri­te­ria for his deci­sion to fast track is sim­ply as long as the ben­e­fits out­weigh the risks [17].

Hahn comes from the Hoover Insti­tute. His med­ical expe­ri­ence is in the field of can­cer treat­ment. He has no expe­ri­ence in infec­tious dis­eases.

As crit­ics point out, even if ear­ly results are over­whelm­ing­ly pos­i­tive that doesn’t pre­clude the pos­si­bil­i­ty of dan­ger­ous side effects tak­ing longer to man­i­fest. In addi­tion, end­ing the tri­al ear­ly reduces oppor­tu­ni­ty to recruit more peo­ple from groups cur­rent­ly under-rep­re­sent­ed in tri­als, such as blacks and His­pan­ics. End­ing the tri­als ear­ly due to very pos­i­tive ini­tial results might hide dele­te­ri­ous results down the line, par­tic­u­lar­ly for the non-whites that Trump and his base despise.

Antho­ny Fau­ci has indi­cat­ed the pos­si­bil­i­ty [18] of such an ear­ly autho­riza­tion.

Next, we present an inter­view with a pre­vi­ous FDA chief, Scott Got­tlieb, who sits on the board of Pfizer–along with Mod­er­na, lead­ing the race to get a vac­cine to mar­ket.

One sce­nario he saw as fea­si­ble [19] for a pre-elec­tion vac­cine release: if clin­i­cal tri­als demon­strate that the vac­cine is high­ly effec­tive in the mid­dle of a new “dense” wave of cas­es.

1a. The wide­ly pub­li­cized inter­view Trump gave to Bob Wood­ward, in which Trump can­did­ly assessed the lethal nature of SARS Cov‑2 has been mis­un­der­stood. Trump’s pol­i­cy on the virus has been just exact­ly what he and the inter­ests for which he fronts desire.

The pan­dem­ic is a por­tal for the real­iza­tion of the goals of the Under­ground Reich for which Trump is a front man and enabler. These issues either have been or will be dis­cussed at greater length.

  1. The virus is the Wealth Con­cen­tra­tion Virus.
  2. It is the Wealth-Destroy­ing Virus for areas and insti­tu­tions that the Trump inter­ests oppose.
  3. It is the Urban Area Destruc­tion Virus.
  4. It is the White Suprema­cist Virus–hitting peo­ple of col­or much hard­er, due to health and socio-eco­nom­ic fac­tors.
  5. It is the Eugenic Virus–killing old­er peo­ple and peo­ple with com­pli­cat­ing med­ical con­di­tions.
  6. It is the Edu­ca­tion-Destroy­ing Virus, dras­ti­cal­ly and neg­a­tive­ly affect­ing pub­lic schools and col­leges.
  7. It is the Pub­lic Tran­sit Destroy­ing Virus.
  8. It is the Divide and Con­quer Virus–separating the old from the young and–potentially–women from men.
  9. The pan­dem­ic is the “Bio-Psy-Op Apoc­a­lypse” Virus, rav­aging the psy­ches of indi­vid­u­als and groups.

“Neg­li­gence with Amer­i­can Lives” Edi­to­r­i­al; New York Times;  9/10/2020; p. A22 [West­ern Edi­tion]. [7]

On Feb. 7, dur­ing a taped inter­view with Bob Wood­ward, Pres­i­dent Trump acknowl­edged that the coro­n­avirus could be trans­mit­ted through the air, that it was very dan­ger­ous and that it would be dif­fi­cult to con­tain. “This is dead­ly stuff,” he told [20] the inves­tiga­tive jour­nal­ist.

“You just breathe the air, and that’s how it’s passed,” the pres­i­dent warned.

Despite his appar­ent under­stand­ing of the sever­i­ty of the dis­ease and its method of trans­mis­sion, over the next month [21], in five cities around the coun­try, Mr. Trump held large indoor ral­lies, which were attend­ed by thou­sands of his sup­port­ers.

Mr. Trump spent weeks insist­ing in pub­lic that the coro­n­avirus was no worse than a sea­son­al flu. It would “dis­ap­pear” when the sea­sons changed, he promised in late Feb­ru­ary [22]. “We’re doing a great job,” he said in ear­ly March.

Why lie to the Amer­i­can peo­ple? Why — as the admin­is­tra­tion accus­es the Chi­nese gov­ern­ment of doing — lie to the world about the sever­i­ty of what was declared a pan­dem­ic only days lat­er? . . . .

1b. The Covid-19 pan­dem­ic is dri­ving what might be termed a right-wing ide­o­log­i­cal wet dream in a num­ber of dif­fer­ent respects. Here, we note that the dam­age done by the virus is seen as fur­ther­ing a cor­po­ratist agen­da, mas­querad­ing under the com­mon rhetor­i­cal cam­ou­flage of “lib­er­tar­i­an” phi­los­o­phy.

An impor­tant piece in The Guardian details how plu­to­crats terming them­selves “anar­cho-cap­i­tal­ists” see the pan­dem­ic as forc­ing regions–from nations to municipalities–to con­form to the demands of dom­i­nant, mobile blocks of cap­i­tal by elim­i­nat­ing the essen­tials of the pro­gres­sive social agen­da.

  1. ” . . . . They spy oppor­tu­ni­ty in the cri­sis, and wager that we might be able to ride the wave of the pan­dem­ic into a new tomor­row, where the virus shat­ters the glob­al map – and under­mines the pow­er of demo­c­ra­t­ic nation states. The US is ground zero for this type of think­ing. . . .”
  2. ” . . . . In an analy­sis released at the end of April, Arthur Laf­fer and Stephen Moore, two of Trump’s clos­est eco­nom­ic con­fi­dants and authors of the book on ‘Trumpo­nom­ics’, pre­dict­ed that ‘blue’ Demo­c­ra­t­ic states would be slow­er than ‘red’ states to recov­er, because of what they saw as their pre-exist­ing excess of reg­u­la­tions and tax­es. . . .”
  3. ” . . . .Their analy­sis divid­ed the US map into ‘lag­gard anti-growth’ states and ‘momen­tum pro-growth’ states. The for­mer have min­i­mum wages, pro-union laws and state income tax; the lat­ter are free of such reg­u­la­tions. In the estab­lished mode of dis­as­ter cap­i­tal­ism, Laf­fer and Moore’s analy­sis appears to see the pan­dem­ic as a way to com­pel ‘anti-growth’ states to adopt ever low­er tax rates in order to attract mobile cap­i­tal and labour. It sug­gests those who resist will not be bailed out by redis­tri­b­u­tion from the cen­tral gov­ern­ment, but left to lan­guish in a deserved eco­nom­ic depres­sion. The effect is rem­i­nis­cent of social Dar­win­ism, applied as a phi­los­o­phy of gov­ern­ment. . . .”
  4. ” . . . . As nations are divid­ed into dif­fer­ent zones accord­ing to their respec­tive stages of viral and eco­nom­ic recov­ery, the well-off could fol­low Elon Musk’s recent threat to relo­cate from Cal­i­for­nia to Texas, vot­ing with their feet for loca­tions that elude redis­trib­u­tive tax­a­tion. In our post-pan­dem­ic future, the flight to safe­ty, away from con­ta­gious ‘red zones’, could be a flight from the nation state as we know it. . . .”

“How the lib­er­tar­i­an right plans to prof­it from the pan­dem­ic” by Quinn Slo­bo­di­an; The Guardian [U.K.]; 6/1/2020. [9]

Dis­as­ter cap­i­tal­ists dream of dis­as­sem­bling nation states for post-viral exploita­tion

When coro­n­avirus crept across the world in ear­ly Feb­ru­ary, talk of how dif­fer­ent nations were deal­ing with the virus came to resem­ble the Olympics for state capac­i­ty. Which coun­try had the author­i­ty, the sup­plies and the exper­tise to “crush the curve”? A bal­ance sheet of nation­al progress marked out a bleak race to the hori­zon, enu­mer­at­ed in case num­bers and death fig­ures.

Although the focus over recent months has remained on lead­ers in cri­sis mode and the cen­tral agen­cies deliv­er­ing fore­casts and quar­an­tine mea­sures, local author­i­ties have also played a promi­nent role dur­ing the pan­dem­ic. Chi­nese may­ors, US gov­er­nors and Indi­an chief min­is­ters have coor­di­nat­ed local respons­es, tak­ing respon­si­bil­i­ty for pop­u­la­tions and even lock­ing horns with nation­al politi­cians.

Most peo­ple would read the pan­dem­ic as a sign that pop­u­la­tions and nation states should band togeth­er, and for the peo­ple “at the head of the rope” to pull even hard­er, to use the metaphor favoured by the French pres­i­dent, Emmanuel Macron. But there are oth­ers who see mat­ters quite dif­fer­ent­ly. They spy oppor­tu­ni­ty in the cri­sis, and wager that we might be able to ride the wave of the pan­dem­ic into a new tomor­row, where the virus shat­ters the glob­al map – and under­mines the pow­er of demo­c­ra­t­ic nation states.

The US is ground zero for this type of think­ing. Across the coun­try, regions have bro­ken up into “com­pacts”, with states com­pet­ing against each oth­er for life-sav­ing ven­ti­la­tors and PPE. The atmos­phere is one of com­pet­i­tive fed­er­al­ism, where states are recon­fig­ured as eco­nom­ic units bid­ding in a mar­ket­place. Washington’s state gov­er­nor, Jay Inslee, accused Trump of “foment­ing domes­tic rebel­lion” for his calls to “lib­er­ate” indi­vid­ual states; gov­er­nor Gavin New­som termed Cal­i­for­nia a “nation-state.” One Mary­land gov­er­nor con­fessed to keep­ing Covid-19 tests in an undis­closed loca­tion under armed guard, in part to pre­vent their seizure by cen­tral state author­i­ties.

Although North America’s econ­o­my is grad­u­al­ly reopen­ing, the virus is still ram­pag­ing through its pop­u­la­tion. What will eco­nom­ic recov­ery look like in the midst of a pan­dem­ic? The president’s eco­nom­ic advis­ers have some ideas. In an analy­sis released at the end of April, Arthur Laf­fer and Stephen Moore, two of Trump’s clos­est eco­nom­ic con­fi­dants and authors of the book on “Trumpo­nom­ics”, pre­dict­ed that “blue” Demo­c­ra­t­ic states would be slow­er than “red” states to recov­er, because of what they saw as their pre-exist­ing excess of reg­u­la­tions and tax­es.

Their analy­sis divid­ed the US map into “lag­gard anti-growth” states and “momen­tum pro-growth” states. The for­mer have min­i­mum wages, pro-union laws and state income tax; the lat­ter are free of such reg­u­la­tions. In the estab­lished mode of dis­as­ter cap­i­tal­ism, Laf­fer and Moore’s analy­sis appears to see the pan­dem­ic as a way to com­pel “anti-growth” states to adopt ever low­er tax rates in order to attract mobile cap­i­tal and labour. It sug­gests those who resist will not be bailed out by redis­tri­b­u­tion from the cen­tral gov­ern­ment, but left to lan­guish in a deserved eco­nom­ic depres­sion. The effect is rem­i­nis­cent of social Dar­win­ism, applied as a phi­los­o­phy of gov­ern­ment.

The most artic­u­late cheer­leader for this kind of post-pan­dem­ic lib­er­tar­i­an­ism is Bal­a­ji Srini­vasan, the elec­tri­cal engi­neer and for­mer gen­er­al part­ner at Sil­i­con Val­ley ven­ture cap­i­tal fund Andreesen Horowitz. Since the pan­dem­ic began, Srini­vasan has fore­told a redi­vi­sion of the world map into “green zones” that have con­trolled and con­tained the virus and “red zones”, which have not.

“We are enter­ing this frac­tal envi­ron­ment,” Srini­vasan recent­ly told a vir­tu­al sum­mit organ­ised by the Start­up Soci­eties Foun­da­tion, “in which the virus breaks cen­tralised states”. The virus does not stop at the bor­der, so nor will this process of frag­men­ta­tion. As regions seal them­selves off to pre­vent con­ta­gion, “you can drill down to the state, or even the town or coun­ty lev­el”, Srini­vasan observed, not­ing that any state with­out the virus under con­trol will “face defec­tion” in an inten­si­fied con­test for tal­ent and cap­i­tal. After the pan­dem­ic has passed, “nations are going to turn into effec­tive­ly ven­dors and entre­pre­neurs and rel­a­tive­ly mobile peo­ple will be appli­cants”, he pre­dict­ed.

It’s easy to imag­ine how a par­tic­u­lar breed of investor could see this pan­dem­ic as an oppor­tu­ni­ty that will accel­er­ate exist­ing trends. The loose attach­ments that investors feel towards this or that nation will grow even loos­er as cap­i­tal becomes more mobile, and a sort­ing process will sep­a­rate the pro­duc­tive few nations from the malin­ger­ing many. States that don’t fall in line with the demands of this investor class will be starved by the vol­un­tary expa­tri­a­tion of the wealthy, with their assets and abil­i­ties in tow.

If you assume this is mere­ly a pes­simistic vision, you’d be wrong. In fact it accords with a long-cul­ti­vat­ed ide­ol­o­gy that Srini­vasan shares with a group of like-mind­ed ven­ture cap­i­tal­ists and entre­pre­neurs, who sub­scribe to vari­a­tions of the rad­i­cal lib­er­tar­i­an phi­los­o­phy known as “anar­cho-cap­i­tal­ism”. The idea at its root is that a wealthy class of investors and entre­pre­neurs should be free to exit nation states and form new com­mu­ni­ties whose mem­bers can choose which rules (and tax laws) they’re gov­erned by – as if those rules were prod­ucts on a store shelf.

For like-mind­ed lib­er­tar­i­ans, the colour-cod­ed zones used in pub­lic health to con­trol the virus are the blue­print for a new polit­i­cal econ­o­my. Since Srini­vasan began dis­cussing the frame­work, colour-cod­ed zones have been rolled out to con­trol the virus in Malaysia, Indone­sia, North­ern Italy and France; the strat­e­gy was also con­sid­ered as a mod­el for bio­con­tain­ment in the White House in ear­ly April. As of ear­ly May, India has divid­ed its 1.3 bil­lion peo­ple into a patch­work of green, yel­low and red zones, with dif­fer­ent free­doms and restric­tions based on each.

The red-green zone schema has already informed the strate­gies of glob­al investors. In April, Hen­ley & Part­ners, the glob­al cit­i­zen­ship bro­ker, released its annu­al rank­ing of nation­al pass­ports for mobile investors, and pre­dict­ed that coro­n­avirus would spark a dra­mat­ic shift in glob­al mobil­i­ty. Its chief source fore­cast that “as the cur­tain lifts, peo­ple will seek to move from poor­ly gov­erned and ill-pre­pared ‘red zones’ to ‘green zones’, or places with bet­ter med­ical care.” In ear­ly May, it report­ed a 42% increase in appli­ca­tions for new nation­al­i­ties, com­pared with the pre­vi­ous year.

Nobody can tell what the world will look like after the pan­dem­ic. But what we can be sure of is that some investors appear to be already plac­ing their bets on a vision of the future where the wealthy are freed from tax con­straints. As nations are divid­ed into dif­fer­ent zones accord­ing to their respec­tive stages of viral and eco­nom­ic recov­ery, the well-off could fol­low Elon Musk’s recent threat to relo­cate from Cal­i­for­nia to Texas, vot­ing with their feet for loca­tions that elude redis­trib­u­tive tax­a­tion. In our post-pan­dem­ic future, the flight to safe­ty, away from con­ta­gious “red zones”, could be a flight from the nation state as we know it.

2. Ele­ments of a thought-pro­vok­ing and dis­turb­ing arti­cle about DARPA research into bat-borne dis­eases, includ­ing some caused by coronaviruses–are reviewed here.

As read­ers digest this infor­ma­tion, remem­ber that DARPA can bring to bear the twined tech­nolo­gies arti­fi­cial intel­li­gence and super-com­put­ers. It has the state of the art with respect to both. Com­bined with gene edit­ing, that tech­no­log­i­cal pair­ing offers the pos­si­bil­i­ty of tru­ly hor­ri­fy­ing syn­thet­ic virus­es.

Whit­ney Webb has pro­vid­ed us with trou­bling insight into Pen­ta­gon research–some of which remains clas­si­fied:

“Bats, Gene Edit­ing and Bioweapons: Rec­cent DARPA Exper­i­ments Raise Con­cerns Amid Coro­n­avirus Out­break” by Whit­ney Webb; The Last Amer­i­can Vagabond; 1/30/2020. [11]

3. In numer­ous pro­grams, we have not­ed remde­sivir and how it has driven–very pos­si­bly with insid­er advanced knowl­edge and trading–the stock mar­ket. We have cov­ered remde­sivir and Gilead Sci­ences in detail in FTR #‘s 1132 [12], 1134 [13], and 1138 [14].

The FDA–now head­ed by the Hoover Insti­tute’s Stephen Hahn, a for­mer can­cer spe­cial­ist with no expe­ri­ence in infec­tious diseases–has expand­ed the approved use of remde­sivir. Experts are warn­ing that the FDA pro­vid­ed no data jus­ti­fy­ing the move [15] and now the drug is going to be in even short­er sup­ply for the sick­est patients:

“‘With­out evi­dence’: Once again, FDA expands use of COVID-19 treat­ment with­out research to back it up” by Karen Wein­traub; USA TODAY; 08/28/2020 [15]

The U.S. Food and Drug Admin­is­tra­tion late Fri­day allowed the drug remde­sivir to be used on all patients hos­pi­tal­ized with COVID-19, although no pub­lished research sup­ports such wide­spread use.

The approval allows doc­tors free­dom to pre­scribe the antivi­ral ear­li­er. But it comes less than a week after the agency approved use of con­va­les­cent plas­ma with­out pub­lished sci­en­tif­ic sup­port, fuel­ing con­cerns the agency is yield­ing to polit­i­cal pres­sure.

“It seems to be a pat­tern of approval with­out sci­ence, with­out data, with­out evi­dence,” said Dr. Eric Topol, vice pres­i­dent for research at Scripps Research in La Jol­la, Cal­i­for­nia and a nation­al expert on the use of data in med­ical research.

In May, the FDA allowed remde­sivir to be used for hos­pi­tal­ized adults who need oxy­gen, but not those sick enough to require ven­ti­la­tion. A gov­ern­ment study pub­lished that month in the New Eng­land Jour­nal of Med­i­cine [36] found those patients recov­ered faster than those who hadn’t got­ten the drug, though there was no evi­dence that it saved lives.

Ear­li­er this month, the Jour­nal of the Amer­i­can Med­ical Asso­ci­a­tion [37] pub­lished a study of less severe­ly ill hos­pi­tal­ized adults, show­ing that five days of treat­ment with remde­sivir was bet­ter than stan­dard care, though “the dif­fer­ence was of uncer­tain clin­i­cal impor­tance.”

No oth­er stud­ies have been pub­lished sup­port­ing more wide­spread use of remde­sivir. Yet the FDA said the data is now com­pelling enough to expand its use to all hos­pi­tal­ized patients, includ­ing chil­dren.

“The data show that this treat­ment has the poten­tial to help even more hos­pi­tal­ized patients who are suf­fer­ing from the effects of this dev­as­tat­ing virus,” FDA Com­mis­sion­er Dr. Stephen M. Hahn said in a pre­pared state­ment announc­ing the agency had grant­ed an emer­gency use autho­riza­tion [38] for remde­sivir. . . .

. . . . Topol said he was appalled by the expand­ed approval of the drug. “There are no data to sup­port wide use of remde­sivir,” he said. “This is extra­or­di­nary.”

The FDA announced the expand­ed use of remde­sivir at 5:20 p.m. ET on Fri­day, cit­ing the stud­ies pub­lished in May and August.

In a state­ment, Dr. Mer­dad Parsey, chief med­ical offi­cer of the Fos­ter City, Cal­i­for­nia-based Gilead Sci­ences Inc., said the com­pa­ny was pleased with the FDA’s deci­sion to expand use of the drug, which he referred to by its trade name. . . .

. . . . Hahn, a radi­a­tion oncol­o­gist and for­mer chief med­ical exec­u­tive of the MD Ander­son Can­cer Cen­ter in Hous­ton, has been FDA com­mis­sion­er only since Decem­ber, but this is the fourth time he has run afoul of the sci­en­tif­ic com­mu­ni­ty for his agency’s actions to com­bat the coro­n­avirus. . . .

. . . . Sun­day, Hahn and the pres­i­dent announced [39] the FDA would issue emer­gency approval for con­va­les­cent plas­ma, in which blood prod­ucts from recov­ered patients are admin­is­tered to those whose immune sys­tems haven’t built up enough anti­bod­ies to fight off the virus. . . .

. . . . The sci­en­tif­ic com­mu­ni­ty was hor­ri­fied by the autho­riza­tion of plas­ma and its char­ac­ter­i­za­tion by Hahn and the pres­i­dent.

Between that and Friday’s announce­ment for remde­sivir, Topol said the agency’s emer­gency approval process appears “far­ci­cal.”

4a. Among the gam­bits being dis­cussed as pos­si­ble vehi­cles for Trump to gain a sec­ond term is the roll­out of a Covid-19 vac­cine. The CDC has told states to pre­pare for such a devel­op­ment. Many crit­ics have cit­ed the pre­ma­ture nature of such a pos­si­bil­i­ty and the lack of ade­quate test­ing.

“C.D.C. Tells States How to Pre­pare for Covid-19 Vac­cine by Ear­ly Novem­ber” by Sheila Kaplan, Kather­ine J. Wu and Katie Thomas; The New York Times; 09/02/2020 [16]

The Cen­ters for Dis­ease Con­trol and Pre­ven­tion has noti­fied pub­lic health offi­cials in all 50 states and five large cities to pre­pare to dis­trib­ute a coro­n­avirus vac­cine to health care work­ers and oth­er high-risk groups as soon as late Octo­ber or ear­ly Novem­ber.

The new C.D.C. guid­ance is the lat­est sign of an accel­er­at­ing race for a vac­cine to great­ly ease a pan­dem­ic that has killed more than 184,000 Amer­i­cans. The doc­u­ments were sent out on the same day that Pres­i­dent Trump told the nation in his speech to the Repub­li­can Nation­al Con­ven­tion that a vac­cine might arrive before the end of the year.

Over the past week, both Dr. Antho­ny S. Fau­ci, the country’s top infec­tious dis­ease expert, and Dr. Stephen Hahn, who heads the Food and Drug Admin­is­tra­tion, have said in inter­views [17] with news orga­ni­za­tions [40] that a vac­cine may be avail­able for cer­tain groups before clin­i­cal tri­als have been com­plet­ed, if the data is over­whelm­ing­ly pos­i­tive.

Pub­lic health experts agree that agen­cies at all lev­els of gov­ern­ment should urgent­ly pre­pare for what will even­tu­al­ly be a vast, com­plex effort to vac­ci­nate hun­dreds of mil­lions of Amer­i­cans. But the pos­si­bil­i­ty of a roll­out in late Octo­ber or ear­ly Novem­ber has also height­ened con­cerns that the Trump admin­is­tra­tion is seek­ing to rush the dis­tri­b­u­tion of a vac­cine — or sim­ply to hype that one is pos­si­ble — before Elec­tion Day on Nov. 3.

The C.D.C. plans lay out tech­ni­cal spec­i­fi­ca­tions for two can­di­dates described as “Vac­cine A” and “Vac­cine B,” includ­ing require­ments for ship­ping, mix­ing, stor­age and admin­is­tra­tion. The details seem to match the prod­ucts devel­oped by Pfiz­er and Mod­er­na, which are the fur­thest along in late-stage clin­i­cal tri­als [41]On Aug. 20, Pfiz­er said [42] it was “on track” for seek­ing gov­ern­ment review “as ear­ly as Octo­ber 2020.” . . . .

. . . . The guid­ance not­ed that health care pro­fes­sion­als, includ­ing long-term care employ­ees, would be among the first to receive the prod­uct, along with oth­er essen­tial work­ers and nation­al secu­ri­ty employ­ees. Peo­ple 65 or old­er, as well as Native Amer­i­cans and those who are from “racial and eth­nic minor­i­ty pop­u­la­tions” or incar­cer­at­ed — all com­mu­ni­ties known to be at greater risk of con­tract­ing the virus and expe­ri­enc­ing severe dis­ease — were also pri­or­i­tized in the doc­u­ments. . . .

. . . . It’s pos­si­ble to draw con­clu­sions soon­er “if there is an over­whelm­ing effect” in which vac­ci­nat­ed peo­ple appear to be far bet­ter pro­tect­ed from dis­ease, said Pad­mi­ni Pil­lai, a vac­cine researcher and immu­nol­o­gist at M.I.T. But data gath­ered ear­ly in a tri­al might not hold true months down the line. And researchers need time to test large num­bers of peo­ple from a vari­ety of back­grounds to deter­mine how well the vac­cine works in dif­fer­ent pop­u­la­tions — includ­ing the vul­ner­a­ble com­mu­ni­ties iden­ti­fied in the guide­lines.  . . 

4d. Next, we present an inter­view of the head of the FDA, Stephen Hahn, about his will­ing­ness to fast-track a vac­cine. The way Hahn puts it, the cri­te­ria for his deci­sion to fast track is sim­ply as long as the ben­e­fits out­weigh the risks [17].

Hahn comes from the Hoover Insti­tute. His med­ical expe­ri­ence is in the field of can­cer treat­ment. He has no expe­ri­ence in infec­tious dis­eases.

“FDA head says he is will­ing to fast-track Covid-19 vac­cine” by Kiran Stacey; The Finan­cial Times; 08/30/2020 [17]

The head of the US Food and Drug Admin­is­tra­tion has said he is will­ing to bypass the nor­mal approval process to autho­rise a Covid-19 vac­cine as soon as pos­si­ble — but has insist­ed he will not do so to please Pres­i­dent Don­ald Trump.

In an inter­view with the Finan­cial Times, Stephen Hahn said his agency was pre­pared to autho­rise a vac­cine before Phase Three clin­i­cal tri­als were com­plete, as long as offi­cials believed the ben­e­fits out­weighed the risks. But he defend­ed his embat­tled organ­i­sa­tion against accu­sa­tions that it was rush­ing the process to boost Mr Trump’s re-elec­tion prospects.

“It is up to the spon­sor [vac­cine devel­op­er] to apply for autho­ri­sa­tion or approval, and we make an adju­di­ca­tion of their appli­ca­tion,” Dr Hahn said. “If they do that before the end of Phase Three, we may find that appro­pri­ate. We may find that inap­pro­pri­ate, we will make a deter­mi­na­tion.” . . . .

. . . . Dr Hahn insist­ed there was a safe way to make a vac­cine avail­able before the end of Phase Three tri­als — poten­tial­ly by issu­ing an emer­gency autho­ri­sa­tion for use by cer­tain groups rather than a blan­ket approval. . . .

. . . . Last Sat­ur­day, Mr Trump accused “deep state” [43] ele­ments at the FDA of mov­ing too slow­ly in approv­ing new treat­ments for coro­n­avirus in an effort to harm him polit­i­cal­ly. A day lat­er, Dr Hahn and Mr Trump joint­ly announced emer­gency autho­ri­sa­tion for con­va­les­cent plas­ma, which uses the plas­ma of recov­ered Covid-19 patients as a treat­ment. But Dr Hahn was imme­di­ate­ly crit­i­cised for over­stat­ing its ben­e­fits. . . .

4e. As crit­ics point out, even if ear­ly results are over­whelm­ing­ly pos­i­tive that doesn’t pre­clude the pos­si­bil­i­ty of dan­ger­ous side effects tak­ing longer to man­i­fest. In addi­tion, end­ing the tri­al ear­ly reduces oppor­tu­ni­ty to recruit more peo­ple from groups cur­rent­ly under-rep­re­sent­ed in tri­als, such as blacks and His­pan­ics. End­ing the tri­als ear­ly due to very pos­i­tive ini­tial results might hide dele­te­ri­ous results down the line, par­tic­u­lar­ly for the non-whites that Trump and his base despise.

Antho­ny Fau­ci has indi­cat­ed the pos­si­bil­i­ty of such an ear­ly autho­riza­tion.

“Fau­ci Says COVID Vac­cine Tri­als Could End Ear­ly If Results Are Over­whelm­ing” by Liz Szabo; Kaiser Health News; 09/01/2020 [18]

A COVID-19 vac­cine could be avail­able ear­li­er than expect­ed if ongo­ing clin­i­cal tri­als pro­duce over­whelm­ing­ly pos­i­tive results, said Dr. Antho­ny Fau­ci, the nation’s top infec­tious dis­ease offi­cial, in an inter­view Tues­day with KHN.

Although two ongo­ing clin­i­cal tri­als of 30,000 vol­un­teers are expect­ed to con­clude by the end of the year, Fau­ci said an inde­pen­dent board has the author­i­ty to end the tri­als weeks ear­ly if inter­im results are over­whelm­ing­ly pos­i­tive or neg­a­tive.

The Data and Safe­ty Mon­i­tor­ing Board could say, “‘The data is so good right now that you can say it’s safe and effec­tive,’” Fau­ci said. In that case, researchers would have “a moral oblig­a­tion” to end the tri­al ear­ly and make the active vac­cine avail­able to every­one in the study, includ­ing those who had been giv­en place­bos — and accel­er­ate the process to give the vac­cine to mil­lions. . . .

. . . . Fau­ci, direc­tor of the Nation­al Insti­tute of Aller­gy and Infec­tious Dis­eases, said he trusts the inde­pen­dent mem­bers of the DSMB — who are not gov­ern­ment employ­ees — to hold vac­cines to high stan­dards with­out being polit­i­cal­ly influ­enced. . . .

Although the safe­ty board can rec­om­mend stop­ping a tri­al, the ulti­mate deci­sion to halt a study is made by the sci­en­tists run­ning the tri­al, Topol said.

A vac­cine man­u­fac­tur­er could then apply to the Food and Drug Admin­is­tra­tion for an emer­gency use autho­riza­tion, which can be grant­ed quick­ly, or con­tin­ue through the reg­u­lar drug approval process, which requires more time and evi­dence. . . .

. . . . Stop­ping tri­als ear­ly pos­es a num­ber of risks, such as mak­ing a vac­cine look more effec­tive than it real­ly is, Topol said.

“If you stop some­thing ear­ly, you can get an exag­ger­at­ed ben­e­fit that isn’t real,” because less pos­i­tive evi­dence only emerges lat­er, Topol said.

Stop­ping the stud­ies ear­ly also could pre­vent researchers from recruit­ing more minor­i­ty vol­un­teers. So far, only about 1 in 5 tri­al par­tic­i­pants are Black or His­pan­ic. Giv­en that Blacks and His­pan­ics have been hit hard­er than oth­er groups by the pan­dem­ic, Topol said, it’s impor­tant that they make up a larg­er part of vac­cine tri­als. . . .

. . . . A small­er, short­er tri­al could fail to detect impor­tant vac­cine side effects, which could become appar­ent only after mil­lions of peo­ple have been immu­nized, said Offit, direc­tor of the Vac­cine Edu­ca­tion Cen­ter at Children’s Hos­pi­tal of Philadel­phia.

4f. Next, we present an inter­view with Trump’s pre­vi­ous FDA chief, Scott Got­tlieb, who sits on the board of Pfizer–along with Mod­er­na, lead­ing the race to get a vac­cine to mar­ket.

One sce­nario he saw as fea­si­ble for a pre-elec­tion vac­cine release: if clin­i­cal tri­als demon­strate that the vac­cine is high­ly effec­tive in the mid­dle of a new “dense” wave of cas­es.

“Coro­n­avirus vac­cine before elec­tion unlike­ly — Dr. Got­tlieb on FDA chief’s pos­si­ble fast track” by Kevin Stankiewicz; CNBC; 08/31/2020 [19]

. . . . Got­tlieb said the only cir­cum­stance in which a vac­cine tri­al could offer suf­fi­cient effec­tive­ness data in Octo­ber would be if the U.S. coro­n­avirus out­break is “very dense,” mean­ing there is high trans­mis­sion rates through­out the gen­er­al pop­u­la­tion, and the vac­cines prove to be “very effec­tive” in those in tri­als.

“But that prob­a­bly wouldn’t leave enough time to issue an emer­gency use autho­riza­tion by Novem­ber, regard­less,” said Got­tlieb, who led the FDA in the Trump admin­is­tra­tion from May 2017 to April 2019 [44]. . . .

. . . . Got­tlieb, who pre­ced­ed Hahn at the FDA, said he was not exact­ly sure what Hahn’s com­ments meant [that the ben­e­fits out­weigh the risks–D.E.].

“It’s pos­si­ble what Dr. Hahn was refer­ring to was issu­ing an emer­gency use autho­riza­tion before the tri­als are ful­ly com­plete, inso­far as these are two-year tri­als. There’s going to be a two-year peri­od of safe­ty fol­low up on these clin­i­cal tri­als,” Got­tlieb said. . . .

. . . . Last week, at the Repub­li­can Nation­al Con­ven­tion, Trump said the U.S. “will pro­duce a vac­cine before the end of the year, or maybe even soon­er,” [45] set­ting off con­cerns again that the approval process could be influ­enced by polit­i­cal con­sid­er­a­tions instead of health and sci­ence.

Ear­li­er this month, Trump was asked in a radio inter­view whether a vac­cine could be ready before Nov. 3 [46], the date of the pres­i­den­tial elec­tion. “I think in some cas­es, it’s pos­si­ble before but right around that time,” he said in response. . . .