Rick Bright, Bloomberg via Getty Images

De­posed BAR­DA chief blasts Trump ad­min­is­tra­tion on pro­mot­ing un­proven drugs as Covid-19 panacea: 'Science — not pol­i­tics or crony­ism — has to lead the way'

A day af­ter news broke that the head of BAR­DA, the gov­ern­ment agency at the cen­ter of a na­tion­al ef­fort to de­vel­op vac­cines and treat­ments for Covid-19, had been re­moved from his post, the now for­mer di­rec­tor is speak­ing out against the Trump ad­min­is­tra­tion, say­ing that he was forced out for re­sist­ing po­lit­i­cal pres­sure to fund un­proven drugs that have been pushed by the pres­i­dent and his al­lies.

In a lengthy state­ment first ob­tained by The New York TimesRick Bright said that he was re­moved for re­sist­ing pres­sure to in­vest the agency’s re­sources in­to hy­drox­y­chloro­quine, a malar­ia treat­ment that Pres­i­dent Trump has pushed over the ad­vice of pub­lic health of­fi­cials, in­clud­ing the NIH, who say it is un­proven and in some cas­es can be harm­ful. Bright’s de­par­ture was first re­port­ed by STAT. 

“I be­lieve this trans­fer was in re­sponse to my in­sis­tence that the gov­ern­ment in­vest the bil­lions of dol­lars al­lo­cat­ed by Con­gress to ad­dress the Covid-19 pan­dem­ic in­to safe and sci­en­tif­i­cal­ly vet­ted so­lu­tions, and not in drugs, vac­cines and oth­er tech­nolo­gies that lack sci­en­tif­ic mer­it,” Bright said.

“I am speak­ing out be­cause to com­bat this dead­ly virus, sci­ence — not pol­i­tics or crony­ism — has to lead the way.”

A lit­tle-known gov­ern­ment agency that was formed in the af­ter­math of 9/11 and the an­thrax scare, the Bio­med­ical Ad­vance Re­search and De­vel­op­ment Au­thor­i­ty has emerged as the lead­ing agency fund­ing the ef­forts to de­vel­op treat­ments and vac­cine against Covid-19. Last week, the agency an­nounced an up-to $483 mil­lion agree­ment with Mod­er­na to help ush­er its vac­cine to ap­proval and scale up man­u­fac­tur­ing. That came af­ter an agree­ment with J&J to put $1 bil­lion — split be­tween the gov­ern­ment and the phar­ma com­pa­ny — be­hind their vac­cine ef­fort. The agency put out a call for ap­pli­ca­tions for fund­ing for drugs and oth­er med­ical prod­ucts for use against Covid-19 in March.

Bright’s sud­den de­par­ture yes­ter­day – com­ing just af­ter Con­gress had al­lo­cat­ed new funds to the agency – shocked pub­lic health ex­perts and again raised ques­tions about po­lit­i­cal med­dling that have cloud­ed the ad­min­is­tra­tion’s re­sponse to the cri­sis. In­fec­tious dis­ease ex­perts around the ad­min­is­tra­tion, most no­tably NI­AID chief An­tho­ny Fau­ci, have pushed back against the pres­i­dent’s fre­quent en­dorse­ment of the malar­ia drug, but be­fore Bright, none had in­di­cat­ed they were pres­sured to di­vert fed­er­al mon­ey to sup­port the un­proven com­pound.

Asked about Bright’s state­ment at Wednes­day’s White House press brief­ing, Trump said: “I nev­er heard of him. If a guy says he was pushed out of a job, maybe he was, maybe he wasn’t. You’d have to hear the oth­er side. I don’t know who he is.”

Bright, who joined the agency in 2010 and has led it since 2016, was moved to an un­spec­i­fied po­si­tion at the NIH de­vel­op­ing Covid-19 di­ag­nos­tics. We’ve re­pro­duced his state­ment in full be­low:

WASH­ING­TON – “Yes­ter­day, I was re­moved from my po­si­tions as the Di­rec­tor of the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty (BAR­DA) and HHS Deputy As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse by the Ad­min­is­tra­tion and in­vol­un­tar­i­ly trans­ferred to a more lim­it­ed and less im­pact­ful po­si­tion at the Na­tion­al In­sti­tutes of Health. I be­lieve this trans­fer was in re­sponse to my in­sis­tence that the gov­ern­ment in­vest the bil­lions of dol­lars al­lo­cat­ed by Con­gress to ad­dress the COVID-19 pan­dem­ic in­to safe and sci­en­tif­i­cal­ly vet­ted so­lu­tions, and not in drugs, vac­cines and oth­er tech­nolo­gies that lack sci­en­tif­ic mer­it. I am speak­ing out be­cause to com­bat this dead­ly virus, sci­ence – not pol­i­tics or crony­ism – has to lead the way.

“I have spent my en­tire ca­reer in vac­cine de­vel­op­ment, in the gov­ern­ment with CDC and BAR­DA and al­so in the biotech­nol­o­gy in­dus­try. My pro­fes­sion­al back­ground has pre­pared me for a mo­ment like this – to con­front and de­feat a dead­ly virus that threat­ens Amer­i­cans and peo­ple around the globe. To this point, I have led the gov­ern­ment’s ef­forts to in­vest in the best sci­ence avail­able to com­bat the COVID-19 pan­dem­ic. Un­for­tu­nate­ly, this re­sult­ed in clash­es with HHS po­lit­i­cal lead­er­ship, in­clud­ing crit­i­cism for my proac­tive ef­forts to in­vest ear­ly in vac­cines and sup­plies crit­i­cal to sav­ing Amer­i­can lives. I al­so re­sist­ed ef­forts to fund po­ten­tial­ly dan­ger­ous drugs pro­mot­ed by those with po­lit­i­cal con­nec­tions.

“Specif­i­cal­ly, and con­trary to mis­guid­ed di­rec­tives, I lim­it­ed the broad use of chloro­quine and hy­drox­y­chloro­quine, pro­mot­ed by the Ad­min­is­tra­tion as a panacea, but which clear­ly lack sci­en­tif­ic mer­it. While I am pre­pared to look at all op­tions and to think “out­side the box” for ef­fec­tive treat­ments, I right­ly re­sist­ed ef­forts to pro­vide an un­proven drug on de­mand to the Amer­i­can pub­lic. I in­sist­ed that these drugs be pro­vid­ed on­ly to hos­pi­tal­ized pa­tients with con­firmed COVID-19 while un­der the su­per­vi­sion of a physi­cian.  These drugs have po­ten­tial­ly se­ri­ous risks as­so­ci­at­ed with them, in­clud­ing in­creased mor­tal­i­ty ob­served in some re­cent stud­ies in pa­tients with COVID-19.

“Sidelin­ing me in the mid­dle of this pan­dem­ic and plac­ing pol­i­tics and crony­ism ahead of sci­ence puts lives at risk and stunts na­tion­al ef­forts to safe­ly and ef­fec­tive­ly ad­dress this ur­gent pub­lic health cri­sis.

“I will re­quest that the In­spec­tor Gen­er­al of the De­part­ment of Health and Hu­man Ser­vices in­ves­ti­gate the man­ner in which this Ad­min­is­tra­tion has politi­cized the work of BAR­DA and has pres­sured me and oth­er con­sci­en­tious sci­en­tists to fund com­pa­nies with po­lit­i­cal con­nec­tions as well as ef­forts that lack sci­en­tif­ic mer­it. Rush­ing blind­ly to­wards un­proven drugs can be dis­as­trous and re­sult in count­less more deaths. Sci­ence, in ser­vice to the health and safe­ty of the Amer­i­can peo­ple, must al­ways trump pol­i­tics.

“I am very grate­ful for the bi­par­ti­san sup­port from Con­gress and their con­fi­dence in my lead­er­ship of BAR­DA as re­flect­ed in the gen­er­ous ap­pro­pri­a­tion to BAR­DA in the CARES 3 Act. It is my sin­cere hope that the ded­i­cat­ed pro­fes­sion­als at BAR­DA and through­out HHS will be al­lowed to use the best sci­en­tif­ic acu­men and in­tegri­ty to con­tin­ue their ef­forts to stop the pan­dem­ic with­out po­lit­i­cal pres­sure or dis­trac­tions. Amer­i­cans de­serve no less.”

Dr. Bright’s at­tor­neys, De­bra Katz and Lisa Banks, state that “the Ad­min­is­tra­tion’s re­moval of Dr. Bright from his po­si­tion as di­rec­tor of BAR­DA is re­tal­i­a­tion plain and sim­ple. The re­sults from the Ad­min­is­tra­tion’s re­fusal to lis­ten to the ex­perts and to side­line those like Dr. Bright who point out any er­rors in the gov­ern­ment’s re­sponse will con­tin­ue to be cat­a­stroph­ic for the Amer­i­can peo­ple. We will re­quest that the Of­fice of Spe­cial Coun­sel seek a stay of Dr. Bright’s ter­mi­na­tion and that Dr. Bright be per­mit­ted to re­main in his po­si­tion pend­ing the OSC and IG’s in­ves­ti­ga­tion of this un­law­ful forced trans­fer.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month to discuss the development and authorization of Covid-19 vaccines, the chairwoman won’t be there.

Hana El Sahly has recused herself from the expert panel’s review of the topic, citing her role as a lead investigator in Moderna’s Phase III trial, Reuters reported. An associate professor of virology and microbiology at Baylor College of Medicine in Houston, El Sahly was appointed the chairwoman last year.