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 Times, Rick 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.

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”