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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

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Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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Clay Siegall, Morphimmune CEO

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

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Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

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