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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

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Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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