Rick Bright arrives to testify before the House Energy and Commerce Subcommittee on Health on May 14, 2020, in Washington, DC. (Greg Nash, POOL/AFP via Getty Images)

Rick Bright de­tails mis­man­aged pan­dem­ic re­sponse, warns of drugs, vac­cine sup­ply prob­lems down the road; HHS push­es back

In wide-rang­ing con­gres­sion­al tes­ti­mo­ny, the oust­ed head of an agency at the cen­ter of the fed­er­al gov­ern­ment’s Covid-19 vac­cine and treat­ment re­sponse crit­i­cized the Trump ad­min­is­tra­tion for a slow-foot­ed fed­er­al re­sponse that could re­sound through­out the course of the pan­dem­ic.

“I be­lieve we could have done bet­ter,” Rick Bright, for­mer chief of the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty (BAR­DA), told a House sub­com­mit­tee. “We don’t have the right lead­er­ship for this re­sponse and we don’t have the right plan for this re­sponse.”

Bright, who has head­ed BAR­DA since 2016, was re­moved from his post in April. Sev­er­al days lat­er, he ac­cused HHS of re­as­sign­ing him be­cause he op­posed ef­forts to put sig­nif­i­cant funds be­hind Covid-19 drugs not sup­port­ed by da­ta, in­clud­ing the an­ti-malar­i­al hy­drox­y­chloro­quine. Bright sub­se­quent­ly filed a whistle­blow­er com­plaint de­tail­ing a long his­to­ry of po­lit­i­cal in­ter­fer­ence at the agency, set­ting up a much-an­tic­i­pat­ed con­gres­sion­al hear­ing on Thurs­day.

Thurs­day morn­ing, in the lead­up to Bright’s tes­ti­mo­ny, Pres­i­dent Trump dis­missed Bright on Twit­ter as a “dis­grun­tled em­ploy­ee” who he had nev­er heard of. And HHS re­leased a lengthy re­but­tal to the whistle­blow­er com­plaints, set­ting the stage for some of the line of ques­tion­ing Re­pub­li­cans used dur­ing the hear­ing.

“Mr. Bright has not yet shown up for work, but con­tin­ues to col­lect his $285,010 salary, while us­ing his tax­pay­er-fund­ed med­ical leave to work with par­ti­san at­tor­neys who are politi­ciz­ing the re­sponse to COVID-19,” a spokesper­son said in an emailed state­ment. “His whistle­blow­er com­plaint is filled with one-sided ar­gu­ments and mis­in­for­ma­tion.”

The Of­fice of Spe­cial Coun­sel, a gov­ern­ment watch­dog, how­ev­er, pre­lim­i­nar­i­ly de­ter­mined to­day there was ev­i­dence back­ing Bright’s claims and that he should be re­in­stat­ed.

Alex Azar

Un­strap­ping a black cloth mask to tes­ti­fy, Bright point­ed to mis­man­age­ment at HHS from the ear­ly days of the pan­dem­ic. He said he tried to se­cure a sam­ple of the virus in Jan­u­ary to help ex­pe­dite the de­vel­op­ment of vac­cines, treat­ments and di­ag­nos­tics, but the agency was not able to ac­quire one un­til Feb­ru­ary. He at­tempt­ed to get fund­ing for vac­cines and coun­ter­mea­sures in his first meet­ing with HHS sec­re­tary Alex Azar, he said, but Azar was puz­zled by his ques­tion, he said, and over the months his con­tin­ued calls for ur­gency led to him be­ing shut out.

“I was told that my urg­ings caused a com­mo­tion and I was re­moved from those meet­ings,” Bright said.

He point­ed to emails, men­tioned from his whistle­blow­er com­plaint, he re­ceived in Jan­u­ary from Mike Bowen, the head of mask man­u­fac­tur­er Pres­tige Ameritech, of­fer­ing N95s and warn­ing the US had in­suf­fi­cient do­mes­tic sup­ply.

“He said ‘we’re in deep shit, the world is, and we need to act’ and I pushed that for­ward to the high­est lev­els I could in HHS and got no re­sponse,” Bright said. “From that point I knew we were go­ing to have a cri­sis.”

In their state­ment, HHS said Bright was not re­spon­si­ble for masks and said Bright’s “as­sump­tion that oth­ers were not con­cerned with and work­ing on var­i­ous work­streams re­lat­ed to COVID-19 pre­pared­ness is bizarre and false.”

Al­though Bright’s com­plaint pinned his ouster on his op­po­si­tion to hy­drox­y­chloro­quine, jour­nal­ists point­ed out that Bright’s sig­na­ture was on the doc­u­ments au­tho­riz­ing the emer­gency use of the pill for Covid-19 pa­tients. In their state­ment, HHS called Bright the “spon­sor” of the hy­drox­y­chloro­quine ef­fort who “cel­e­brat­ed” when the gov­ern­ment was able to se­cure the sup­ply.

Bright told the House that he had been “di­rect­ed to” file those au­tho­riza­tions by the Trump ad­min­is­tra­tion. He ar­gued the sup­ply was nec­es­sary for clin­i­cal tri­als but not out­side it. Along­side oth­er gov­ern­ment sci­en­tists, he said, he had worked to push back on ad­min­is­tra­tion ef­forts to set up an ex­pand­ed ac­cess pro­to­col by which peo­ple — in­clud­ing those who hadn’t test­ed pos­i­tive to Covid-19 — could have ac­cess to the po­ten­tial­ly dan­ger­ous drug out­side of a hos­pi­tal. “We had to come up with an al­ter­nate so­lu­tion that the ad­min­is­tra­tion would ac­cept,” he said.

While ini­tial­ly suc­cess­ful, Bright said, he then learned of and spoke out against a sub­se­quent gov­ern­ment plan to “flood” New York and New Jer­sey with the an­ti-malar­i­al, lead­ing to his ouster.

“That was the straw that broke the camel’s back,” Bright re­called, “and ex­pe­dit­ed my re­moval.”

Turn­ing to­ward more re­cent con­tro­ver­sy, Bright said a chaot­ic gov­ern­ment re­sponse has en­dan­gered pa­tients and could im­pede the re­sponse go­ing for­ward. Over the week-and-a-half since the FDA au­tho­rized the use of remde­sivir as the first drug shown to have ef­fi­ca­cy against Covid-19, doc­tors have sharply crit­i­cized the gov­ern­ment for how they’ve dis­trib­uted the Gilead an­tivi­ral, with no clear cri­te­ria an­nounced and some hos­pi­tals with larg­er num­bers of pa­tients un­able to se­cure a sup­ply.

Bright was no longer at BAR­DA when remde­sivir was au­tho­rized, but he said no plan had been put in place to pre­pare for when it was.

“There was nev­er ac­tion tak­en on the ur­gency to come up with a plan for ac­qui­si­tion of lim­it­ed dos­es,” Bright said, “nor to dis­trib­ute the lim­it­ed dos­es of remde­sivir.”

Now, Bright said, sim­i­lar prob­lems loom for po­ten­tial vac­cines, once they’re shown to work. Al­though BAR­DA and the lead­ing vac­cine com­pa­nies have put sig­nif­i­cant funds in­to scal­ing up man­u­fac­tur­ing, an ap­proved vac­cine will still come in batch­es rather than all at once, pos­ing a need to eq­ui­tably dis­trib­ute the dos­es un­til they are avail­able. Bright re­vealed that the gov­ern­ment had se­cured ac­cess to some of those dos­es with their fund­ing agree­ments, but he said there’s lit­tle plan for how to give them out.

“It’s go­ing to be a lim­it­ed sup­ply,” Bright said. “We need to have a strat­e­gy and a plan in place now. We don’t have that yet and it is a sig­nif­i­cant con­cern.”

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

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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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Bill Hinshaw, Axcella CEO

UP­DAT­ED: Say­ing good­bye to R&D chief, Flag­ship-backed Ax­cel­la drops PhII pro­gram as it fo­cus­es on long Covid, NASH

In its bid to be one of the first biotechs to develop a drug for long Covid, which impacts as many as 1 in 4 elder Americans, Axcella said Thursday it has completed enrollment in a Phase IIa study looking at fatigue-related lingering symptoms of the pandemic disease.

But the company will have to make progress with its long Covid and NASH mid-stage programs without its president of R&D, Alison Schecter. She stepped down immediately yesterday to “pursue other opportunities” after 14 months with the Flagship-founded biotech, according to an SEC filing, and Axcella doesn’t currently have plans to replace her, CEO Bill Hinshaw told Endpoints News in an emailed statement.

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.