Thread by @BBuchman_CNS

Today Dr. Rick Bright, chief vaccine expert for the Health & Human Services Dept. is prepared to tell Congress his advocacy of science and safety not only went ignored by the Trump admin but prompted retaliation with dangerous consequences.
Live-tweet starts @ 10AM ET.
Excerpt⤵️

While I live-tweet Dr. Bright's testimony before Congress for @CourthouseNews, a stream will be available here: and here: c-span.org/video/?471986-…

It has been less than 30 days since Bright was removed from the director role at the Biomedical Advanced Research and Development Authority, or BARDA, an HHS offshoot funding companies to build out diagnostics and vaccines. He was abruptly transferred to a more modest role at NIH

In his complaint w/OSC, Bright alleged Bob Charrow, US Health & Human Srvcs general counsel, gave him a directive to set protocols expanding access to chloroquine well past what the FDA authorized for emergency use to treat Covid-19.
Via @KlasfeldReports: courthousenews.com/fired-head-of-…

Bright says he resisted broadly calls to 'flood' NY & NJ w/ uninspected chloroquine & hydroxychloroquine from Pakistan and India even as "the administration promoted it as a panacea"
You can read Dr. Bright's whistleblower complaint here:
documentcloud.org/documents/6890…
@CourthouseNews

Dr. Rick Bright's testimony will get underway shortly.
c-span.org/video/?471986-…
@CourthouseNews

And away we go.
Chairman @RepAnnaEshoo begins:
"Our country is in pain, Americans are afraid, they are sick, hungry and jobless and 80,000 souls have been lost. And the government that was supposed to protect them has failed."

"We are the greatest country on earth and yet we have the greatest deaths of anywhere in the world, why?"
Eshoo: The basic delay at the start of this year is what cost lives... because of incompetence, denial, delay and a disorganized response.

.@RepAnnaEshoo: "Frankly, I'm tired of those who bear the responsibility accepting none of it while deflecting blame on others, the previous administration, @WHO, the Wuhan lab, anywhere but where the blame belongs."

Dr Bright's complaint was not only ignored but fired for being right, Eshoo says.
His whistleblower complaint was "one of the most troubling I have ever seen" she adds.
documentcloud.org/documents/6890…

This subcommittee chaired by Eshoo has jurisdiction over FDA, NIH, CDC and BARDA.
Secy Azar, Assistant Secretary for Response and Preparedness Kadlec and Peter Navarro have all "refused to testify"
Eshoo then asked for a moment of silence for the 80k Americans dead.

Debra Katz, Dr. Bright's attorney is seated next to Dr. Bright today.

Ranking member Michael Burgess, R-TX, in his opening remarks asks "why is this the first official hearing we are having on this topic?"
"I'm concerned it took five months to have a hearing on this novel coronavirus," he says, literally, between light clearing of his throat.

"We stand on the sidelines instead of becoming fully engaged," Burgess says, but moments later adds whistleblowers must have their claims investigated fairly. He runs through a litany of "procedural fouls" that led to the hearing while also mulling the timeline of Bright's cmplnt

Chairman Eshoo says Burgess may recall she called for a hearing on Jan. 30 with Kadlec, Fauci, all the heads of the health agencies and it was Secy Azar that said they could not come.

Chairman of the full committee Energy and Commerce Committee @FrankPallone speaking now:
This is a national emergency that requires every aspect of government to work together to reduce the spread of this virus.

Four laws have been enacted to provide economic assistance but new laws are not enough, Pallone says.
POTUS has failed to provide consistent and stable leadership to guide the U.S. through this crisis.

.@FrankPallone says Trump has delivered mixed messages to the public and "instead of showing leadership, the administration has abdicated responsibility and forced states to fend for themselves and find their own way out of this pandemic."
@CourthouseNews

Pallone on Trump's recent statement that 'we have met the moment and we have prevailed'... "could not be further from the truth, Mr. President," the chairman says.

We will next hear from the ranking member of the full health committee, Rep. Greg Walden, R-Oregon, who is first raising questions about having a government witness with private counsel at the witness table and with a microphone.

Eshoo says this is a first.
When Bright came in with an attorney, she requested a mic. So, as a courtesy, she received one, but she is not a witness and she will not field any questions.
"she's simply accompanying her client."

There's concerns by other lawmakers about any potential whistleblower testimony being offered without being under oath. Eshoo says all witnesses know it is illegal to lie to Congres but in this subcommittee, unlike in ONI, they don't swear people in.

Walden begins by acknowledging that there has been long simmering problems around the national stockpile of critical equipment needed to fight a pandemic.
While Walden lauds Trump, he says there is still much more to do.

We have asked for and will hold hearings on the need to reform the strategic national stockpile, Walden says.

We must find new ways to provide access to mental health and support healthcare workers, including those furloughed because their hospitals are closed, he adds.

Walden then laments the procedural set up of the hearing.

The views are my own and not those of the Dept of Health and Human Services, Dr. Bright says as he begins.

Today the world is confronting a public health emergency unlike any we have seen in a century.

“The health care system is being taxed to the limit, our economy is spiraling downward, leading to mass unemployment & our population is being paralyzed by fear stemming from the lack of a coordinated response & a dearth of accurate, clear communications about the path forward"

On Tuesday, Dr. Fauci delivered a message that was clear and trustworthy. We should listen to him and other scientists sharing their expertise, Bright says.
Background:
courthousenews.com/rushing-back-w…

While waiting for a cure or a vaccine, which I believe will come, there are things we must do:
Increase public education about the basics, masks, handwashing etc.
We need to ramp up production of supplies, incl. raw components as well.

Shortages of these increase the risk for front line health care workers, Bright says. We need to facilitate equitable distro of supplies. And we need a national testing strategy.

Bright: "The virus is here. It is everywhere. We need to be able to find it, isolate it and stop it. We need to have the right testing for everyone who needs it. We need to be able to trace and quarantine properly as we strive for a cure."

Initially, our nation was not as prepared as it could have been. Some scientists raised early warning signals that were overlooked and pages from our pandemic playbook were overlooked. There will be time to look back and assess so we can improve, but right now we must go forward.

What does he mean when he says it will be the darkest winter in modern history, Eshoo asks.
Bright: The window is closing to address this pandemic because we still do not have a standard, centralized coordinated plan to take our nation through this response.

Bright: With proper leadership, the best science leading the way, we can devise a comprehensive strategy, we can devise a plan that includes all Americans and help them help us guide us through the pandemic. (Continues)

Bright: "But time is running out because the virus is still spreading everywhere, people are getting restless to leave their homes and we have to make critical decisions about how to balance the economy and the science."

About Dr. Bright's push to obtain early virus samples from China to develop treatment solutions:
He met "frustration and dismissal" when he raised the request for the samples with Secy Azar on January 23 and again during what he describes as a "strong push" on Jan 27.

Eshoo asks if there was any action taken on remdesivir, any pushing for development. She doesn't mention chloroquine yet.

There was no action to develop or distribute that once we had scientific data showed this might help those with the virus, Bright says of remdesivir.

Dr. Rick Bright says he was told his urgent warnings about concerns over vax options and PPE needs were "causing a commotion" and he was removed from meetings.

Ranking member Burgess, R-TX, notes that drugs similar to chloroquine and hydroxychloroquine passed Bright's sniff test at BARDA.

Bright says his concerns around the safety of chloro. were based on "limited data available"
So they proposed ID'ing a source the drug so NIH could conduct a randomized controlled study.
They did this with remdesivir.

Bright begins to say something about the database app created by a California-based tech enterprise Oracle, co-founded by Larry Ellison, a billionaire informally advising Trump in recent weeks as he donates to the president’s reelection campaign.

But Burgess cuts in.

Burgess says "this isn't a hearing about chloroquine."

And then a moment later, anecdotally: "But I've spoken to a lot of doctors who report 'significant benefit' if it's used early enough."

Bright told the OSC the push to use drugs untested for Covid-19 was not motivated by medical ethics, but rather, instruction on arranging a private-public partnership between the federal government and Oracle

More on that later, I'm sure.

But we move onto the urgent need for funding at the outset of a pandemic.

Bright says it was outlined early that we needed millions to develop vaccines.
In his early days with Azar, Bright asked for funding to get vax started and it took some time, he said, but what BARDA did was look internally at other contracts and programs to redirect funding

They did this at BARDA as early as January and were able to set up some contracts.
"Because of those actions, that is why we have made some progress now" he says and adds that the U.S. is now a placeholder for companies developing the vaccines.

"We did everything we could to make sure those companies were going to build capacity in the U.S," Dr. Bright says."We had to get in line first even if we didn't have the money for it."

Rep Walden asks Bright about when he was trying to obtain a sample of the virus and from where.
Walden: Why were the strains not sent to him though they were available to the U.S. government.

Bright says he was asking for viruses in January and became available on Feb. 6, Bright says.
They were distro'ed to labs.
Some viruses came from NIH that rec'd the initial seed from CDC, Bright says.

Walden says people at NIH indicated that the real key was to get the DNA sequence that China would eventually come to share.
In terms of going after the vax, it was the sequencing that mattered most to get started, he says.

Walden says other scientists have argued the delay in getting the sample didn't set them back. Does Bright disagree that the sequencing mattered most but getting the virus first did not set them back?

China posted 1st sequence Jan 10/11; some companies can get started with that information Bright notes, and NIH began efforts on a vax candidate even before the point it rec'd the sequence.

But when we're spending billions on drugs, diagnostics, we want to have the most credible information possible, Bright says.

Next question from Rep Eliot Engel, D-NY.
"When can we expect a vaccine?"

Optimistically experts point to 12-18 months for vax but Bright says "this is an aggressive schedule" and barring any mistakes or delays.
"When we say 12-18 months, that's not an FDA approved vax, that's to have sufficient data on the efficacy to use on an emergency basis."

His concerns over chloroquine escalated when he was pushed by those inside of the administration asking him to shill the drug beyond authorized use, Bright tells the committee.

Rep Brett Guthrie asks Bright about his meeting with Peter Navarro and Mick Mulvaney and Robert Kadlec and raises a question about 33 exhibits that were in his complaint but not provided to the committee.
These included HHS emails which, since removal, he doesn't have access to

Rep GK Butterfield, D-NC asks about the issues Bright raised at BARDA about transport of supplies including a stock of swabs that were manufactured in Italy where an outbreak was raging.

"I was quite alarmed to learn from CDC dir. Rober Redfield that we were going to experience a shortage of swabs and I was surprised our national stockpile did not have any of those in supply," Bright says.

"So my urgency to find a solution to that was supported by FDA," Bright says.
Once he confirmed the shortage, it was critical to find a solution, so they partnered with DoD who worked with BARDA for Ebola response years before.

When he raised the swab shortage concern with Azar, he was told by the secretary "I don't want to deal with swabs right now."

So, Bright went to Navarro to request assistance with transport from DoD and he got it, to Navarro's credit, Butterfield acknowledges.

Rep. Morgan Griffith, R-VA says it "seems to me" when you have few or no options, and don't have time to run a double blind study, then it wouldn't be out of bounds to consider chloroquine.
What was the great hesitancy to let doctors try? Wouldnt you need that to do the test?

Bright: We want to make sure the drugs we consider are safe & effective. The highest priority is safety. Many studies/third party reports did not have safety vetting. Many drugs were repurposed. We knew of those safety concerns & didnt know how it would impact people w/the virus.

Bright notes how this virus affects multiple organs and can cause organ failure.
Griffith: You're not worried about an irregular heartbeat if you dont have one at all. Here was the first drug that showed some promise. Why wouldnt we want to try this?

Bright: We have to do it carefully, sir.... We were thinking outside of the box. We are being careful and using clinical data to determine risk."

The inaction and delay has caused harm to health care workers across the U.S. and when we reopen and if it is done so unsafely, Bright argues, it will put these same people at risk again.

Rep Matsui asks if the admin put politics ahead of science and concern for public health.
Bright: There were some attempts to bypass the rigorous vetting process that caused me great concern and increased the tension between me and Dr. Kadlec.

Without the scientific vetting, it does increase the risk of a drug being evaluated or supported without safety in mind, Bright argues.

Rep Kathy Castor, D-Fla., is up. Are N95 respirators necessary to protect those on the front lines?
Yes, they are considered frontline equipment to keep health care workers from getting infected.
She notes:
latimes.com/california/sto…