Ousted HHS boss: Push for hydroxychloroquine 'distracted' us from saving lives

Dr. Rick Bright testifies before a House panel May 14, 2020 (screenshot CSPAN)

At a hastily assembled hearing Republicans charged was conducted by the wrong committee and without prior distribution of relevant documents, ousted federal vaccine official-turned whistleblower Dr. Rick Bright testified Thursday that without a "comprehensive" national plan to combat the coronavirus pandemic, America could face the "darkest winter in modern history."

Bright, a vaccine expert who led a biodefense agency in the Department of Health and Human Services, contends he was booted from his high-level post after the Trump administration resisted his science-based warnings.

He has filed a 63-page whistleblower complaint charging, among other things, that Trump appointees pressured health officials to rush approval of the politically charged hydroxychloroquine treatment and that senior leaders ignored his warnings about mask shortages and repeatedly missed opportunities to effectively combat the pandemic.

Bright was joined at the session of the House Energy and Commerce Committee by his attorney, Debra Katz, who is known for representing Christine Blasey Ford, the chief accuser of Supreme Court Justice Brett Kavanaugh during his confirmation hearings. Ford, in fact, initially brought her accusation against Kavanaugh to the chairman of the House Energy and Commerce Committee, Rep. Anna Eshoo, D-Calif., who was presiding over the hearing Thursday.

Republican Rep. Richard Hudson of North Carolina said that while any whistleblower should be respected, the hearing was not about a whistleblower complaint.

"It's about undermining an administration during a national global crisis," he charged.

Hudson added that the hearing was being held in "the wrong subcommittee well before the Office of Special Counsel has completed its work" with the whistleblower complaint.

"It's a lesson in what not to do," he said, describing the hearing as an example of "an abuse of whistleblower complaints for political expediency."

'We're in deep sh--'

Among the moments that drew the most attention Thursday was Bright's citation of emails in late January from an executive for the medical supply company Prestige Ameritech, Mike Bowen, who informed him the N95 mask supply had been "completely decimated."

Bright, who was director of the Biomedical Advanced Research and Development Authority, recounted Brown saying: "We're in deep sh--. 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 claimed. "From that moment I knew that we were going to have a crisis for our health care workers because we were not taking action. We were already behind the ball."

On their way to Pennsylvania on Thursday to visit a factory impacted by the coronavirus lockdown, President Trump and HHS Secretary Alex Azar shot back at Bright's claims.

A visibly angry Azar said, "Everything he's complaining about was achieved."

The secretary cited a "Manhattan project for vaccines" that is underway, noting it was Bright's job to lead the development of vaccines.

"While we're launching at warp speed, he's not showing up for work," Azar said.

The White House's program to quickly produce, distribute and administer a vaccine once it becomes available is called "Operation Warp Speed."

During the hearing, Rep. Markwayne Mullins, R-Okla., noted Bright's absence from work, pointing out he has continued to collect his $285,000 salary while initially on sick leave for high blood pressure – caused by his work situation, Bright testified – and now on vacation.

"You're too sick to go into work, but you're well enough to come here while getting paid," said Mullin. "I have a hard time understanding that.”

Regarding hydroxychloroquine, Azar said, "Dr. Bright literally signed the application for FDA authorization."

"His allegations do not hold water," he said. "They do not hold water."

Trump, describing Bright as a "disgruntled employee," noted many doctors have reported a "tremendous response" to the hydroxychloroquine, azithromycin and zinc protocol.

"I watched this guy for a little while this morning," he said. "There are a lot of people who do not like the job he did."

'Centralized' plan

Bright's primary complaint is that he was ousted for battling Trump appointees over science.

But along with complaints by employees about his leadership reported by Politico, he appears to have fundamental philosophical and policy differences with the Trump administration.

In his testimony, Bright called repeatedly for a "standard, centralized, coordinated" plan "that includes all Americans." The White House, meanwhile, has presented federal guidelines and advice, acknowledging the constitutional authority for dealing with the outbreak lies with the governors.

Two Republican lawmakers who also are physicians challenged Bright's handling of the controversy over making the anti-inflammatory drug hydroxychloroquine available as a treatment for COVID-19.

Reps. Michael Burgess of Texas and Larry Bucshon of Indiana both said they had heard from many doctors who have reported success treating patients with protocols of hydroxychloroquine and azithromycin, and sometimes zinc.

"They are recording significant benefits if it is used early enough in the course," Burgess said.

Bright told the committee he had not heard of hydroxychloroquine – which has been used successfully for 70 years to treat malaria as well as auto-immune diseases such as rheumatoid arthritis – until it was brought to his attention in March by Dr. Janet Woodcock, director of the Food and Drug Administration Center for Drug Evaluation and Research.

Bright pushed back on a request by Azar to make hydroxychloroquine available for COVID-19 patients, according to the whistleblower complaint. Azar want to make it available under an "expanded access" protocol, also called "compassionate use," allowing patients with severe illnesses to try unapproved drugs when no other treatments are available. But Bright said a compromise was struck, and the FDA granted "emergency use authorization," allowing doctors in hospitals, under certain conditions, to prescribe hydroxychloroquine for patients with the respiratory disease caused by the coronavirus.

Bright testified to the committee Thursday he became aware of "the anecdotal reports" of hydroxychloroquine's efficacy with COVID-19 but said it hasn't shown in randomized studies "an overwhelming level of evidence that it has benefit."

Bucshon, however, noting he is a cardiovascular and thoracic surgeon who has been in health care for 30 years, said doctors "across the country will use drugs off-label in a circumstance where they don't have or they don't see a viable alternative."

He acknowledged the need for double blind studies, but "in this situation, I think a little bit of understanding and leeway from the federal government is in order."

"We do want to ensure the safety," he said, but hydroxychloroquine "has been proven safe for many, many years in appropriate doses."

He acknowledged it can lead to cardiac arrhythmias if not used properly.

"But when states tried to stop doctors from using [hydroxychloroquine], there was such a backlash they had to back away from it, because the physicians in the community wanted to use it," Bucshon said.

"So doctors like me out in the real world, if things are working, even anecdotally, they're not going to wait for the government bureaucracy to approve it," he said.

"This is why doctors are using it."

The data eventually will show whether or not it should be used for COVID-19, he said, but lives are on the line now.

"If two years from now we have the studies, and we say, 'Hey, that stuff really would have worked, and the government stopped that from being used,' if I was the family of a person that was stopped from getting hydroxychloroquine, I'd be pretty mad," the Indiana lawmaker said.

Bright's agency scrapped plan for mask-making machine

Regarding the supply of personal protective equipment, Bucshon said there's plenty of blame on both sides of the aisle, noting the supply of masks was not replenished after the H1N1 outbreak during the Obama administration.

The congressman confronted Bright with his agency's handling of the opportunity to facilitate the building of a machine that could rapidly produce masks during a pandemic.

HHS alloted $3.3 million in 2015, he said, to have the company O&M Halyard build the machine. But according to a CNBC report in 2018, the machine was never built.

Despite a $1.5 billion budget, BARDA said it didn't have the money for it.

Noting Bright was in charge of BARDA at the time, Bucshon wanted to know why the project was scrapped.

Bright, speculating that the agency's "technical team" must have vetted it and found it wanting, claimed he never saw the proposal.

"I find that surprising, but I'll take your word for it," Bucshon said.

The Indiana lawmaker concluded his allotted time by returning to the hydroxychloroquine issue.

"To doctors across America, it's easy for us to sit here in Washington, whether we're members of Congress or whether we're agencies, and talk in the abstract about people dying in our intensive care units," he said.

"But when you're a physician at the bedside, and there's a medication that has promise and that had a safety profile that we understand, doctors will use this medication offline," he said.

"And that's what's happened.

"Whether that's right or wrong, that may take us years to prove, but in the meantime people can die."

'President's obsession'

Democratic Rep. Ben Ray Lujan of New Mexico asked Bright to comment on President Trump's optimism about hydroxychloroquine as a treatment for COVID-19.

The lawmaker cited Trump saying the drug had "shown very, very encouraging early results."

"Was the president's statement accurate?" Luhan asked.

"I do not think that was the best informed statement," Bright replied.

Luhan pressed further, opining that "every hour spent on hydroxychloroquine was an hour you and your team couldn't spend on working on this virus."

"Did the president's obsession with this issue distract you and others on your team from your mission of saving lives?" he asked.

"The directive we received to prioritize and put an expanded access protocol in place within 48 hours was extremely distracting to dozens of federal scientists who were focused on the coronavirus outbreak," Bright said. "They had to set aside all other work to try to put together this protocol im the 48 hour directed time period.

"It distracted from their efforts in developing other drugs."

Studies show

However, peer-reviewed studies published from January through April 20 indicated hydroxychloroquine benefited COVID-19 patients, especially when used early.

The Phoenix-based Association of American Physicians and Surgeons argued in a letter urging Arizona Gov. Doug Ducey to reverse his ban on the use of the treatment that more than 90% of a total of 2,333 patients treated with hydroxychloroquine and azithromycin in studies in China, France, South Korea, Algeria and the U.S. improved clinically.

"The antiviral properties of these drugs have been studied since 2003. Particularly when combined with zinc, they hinder viral entry into cells and inhibit replication. They may also prevent overreaction by the immune system, which causes the cytokine storm responsible for much of the damage in severe cases," the doctors explained.

Some studies show a decrease in the number of days in which a patient is contagious, a reduction in the need for ventilators and a shortened time to clinical recovery.

In early April, a poll of 6,200 physicians in 30 countries found hydroxychloroquine to be the best drug available to treat COVID-19.

At the same time, renowned infectious disease specialist Dr. Stephen Smith declared he had seen 100% success in his treatment of 72 seriously ill COVID-19 patients with hydroxchloroquine and azithromycin.

"I think this is the beginning of the end of the pandemic," he said in an April 1 interview with Fox News host Laura Ingraham. "I'm very serious."

"It's a game-changer. An absolute game-changer."

Weeks later, opponents of the drug's use for COVID-19 spotlighted a study by University of Virginia School of Medicine opthamology professor Dr. Jayakrishna Ambati that concluded there was no benefit for coronavirus patients in U.S. veterans hospitals.

Smith, in an April 28 interview with Ingraham, called the study a "sham."

"I've no idea why [Ambati] delved into this study, which isn't a study. It's a sham," Smith said. "I can't believe anyone took this seriously. There's not one dosage listed, cumulative or daily, of hydroxychloriquine or azithromycin. And people call this a study."

Published in the medRxiv online depository, the study was not peer-reviewed. It analyzed the medical records of 368 male veterans hospitalized with confirmed coronavirus infection at Veterans Health Administration medical centers who died or were discharged by April 11.

About 28% of patients who were given hydroxychloroquine in addition to the usual care died compared to 11% who received routine care alone.

But Smith argued that "not one person in that paper saw one COVID patient.

"Only three are MDs [and] all [those] are ophthalmology trained," Smith said of the research. "It's a sham. It's a shame on UVA. I sent an email to the dean of the medical school at UVA. I have not heard back from them. It is an embarrassment that UVA allows this thing to be called a study."

In mid-April, media, beginning with the New York Times, seized on a small study of 81 patients funded by the Brazilian state of Amazonas. The study was widely reported to have been halted when patients developed irregular heart rates.

There were several errors or distortions, however, in the reporting of the study on the "Trump-touted" drug.

For one, the study was not stopped. For another, it tested the more toxic drug chloroquine, not hydroxychloroquine.

Significantly, according to the abstract, it was only patients who were given three times the recommended dosage who experienced heart arrhythmias. The researchers said in their abstract that they stopped recruiting patients for the high-dosage arm of the study.