US President Donald Trump
US President Donald Trump speaks during a news conference at the White House in Washington, DC, US, on Wednesday, April 22, 2020. Image Credit: Bloomberg

Washington: The doctor who led the US federal agency involved in developing a coronavirus vaccine said Wednesday that he was removed from his post after he pressed for rigorous vetting of hydroxychloroquine, an anti-malaria drug embraced by President Donald Trump as a coronavirus treatment, and that the administration has put “politics and cronyism ahead of science.”

Dr Rick Bright was abruptly dismissed this week as director of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, and removed as deputy assistant secretary for preparedness and response. He was given a narrower job at the National Institutes of Health.

In a scorching statement, Bright assailed the leadership at the health department, saying he was pressured to direct money toward hydroxychloroquine, one of several “potentially dangerous drugs promoted by those with political connections” and repeatedly described by the president as a potential “game changer” in the fight against the virus.

“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,” he said in his statement. “I am speaking out because to combat this deadly virus, science - not politics or cronyism - has to lead the way.”

Doubts about the use of hydroxychloroquine as a treatment for the coronavirus and the lack of evidence about the drug’s effectiveness - including some small studies that indicated patients could be harmed - appear to have dampened Trump’s enthusiasm for it.

As the seriousness of the pandemic became clearer in mid-March, the president seized on anecdotal reports about victims of the coronavirus who recovered quickly after using the drug. Desperate for good news as he watched the death toll climb and the stock market plummet, Trump could hardly contain his excitement.

In a post on Twitter on March 21, the president urged federal officials to quickly approve the use of hydroxychloroquine with an antibiotic called azithromycin - a combination that he believed could work on the coronavirus.

“Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents) be put in use IMMEDIATELY,” he tweeted. “PEOPLE ARE DYING, MOVE FAST, and GOD BLESS EVERYONE!”

Insufficient data

In briefing after briefing with reporters at the White House, Trump defied the voices of medical experts and some of his own top advisers - including Dr Anthony Fauci, the nation’s top infectious disease specialist and an adviser to the coronavirus task force - who cautioned that hydroxychloroquine, which is used to treat autoimmune diseases like rheumatoid arthritis and lupus as well as malaria, needed to undergo the same kind of rigorous evaluation that other drugs do.

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In mid-April, a small trial in Brazil was halted after some patients developed irregular heart rates. Then a study this week of 368 Veterans Affairs patients, which has not been peer-reviewed, found that it did not help patients avoid the need for ventilators and that the use of the drug alone was associated with an increased risk of death. And this week, a panel of the government’s own experts at the National Institute of Allergy and Infectious Diseases said there was “insufficient data” to recommend taking it to treat symptoms from the virus.

The president has not talked much since then about hydroxychloroquine.

Searing language

In his statement, Bright did not directly name Trump. But the searing language he used left little doubt that he viewed the administration’s support for the drug as pressure to ignore scientific facts in favour of politics.

“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,” Bright wrote. “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 into vaccines and supplies critical to saving American lives. I also resisted efforts to fund potentially dangerous drugs promoted by those with political connections,” he said, adding that hydroxychloroquine was “promoted by the administration as a panacea, but which clearly lack scientific merit.”

‘I never heard of him’

Asked about Bright and his transfer Wednesday at the daily White House briefing, Trump said he did not know who he was.

“I never heard of him,” the president told reporters. “You mention the name; I never heard of him. When did this happen? I never heard of him. The guy says he was pushed out of a job. Maybe he was. Maybe he wasn’t. I don’t know who he is.”

A career government official who has led BARDA since 2016, Bright pointed specifically to the initial efforts to make chloroquine and hydroxychloroquine widely available before it was scientifically tested for efficacy with the coronavirus.

“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,” Bright said, describing what ultimately happened: “I insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician.”

A person familiar with Bright’s account said that he was pressured to rush access to the drug after the president and Larry Ellison, chairman and chief technology officer of Oracle, had a conversation about chloroquines. Bright was then directed to put in place a nationwide expanded access program to make the drugs available on a broad basis without specific controls in place, according to the person familiar with his account.

Medical experts say that it is still not known whether hydroxychloroquine might yet emerge as an effective treatment for the most devastating symptoms of COVID-19, the disease caused by the coronavirus. The studies in Brazil and at the Department of Veterans Affairs were small and limited. Comprehensive, peer-reviewed studies have yet to be completed, and while hospitals are using the drug, many doctors acknowledge they are doing so only because they have few other tools to help dying patients.

Doctors hopeful

Some doctors around the country are still hopeful that more complete tests of the drug might still yield some positive news.

Dr. William O’Neill, a cardiologist at the Henry Ford Health System in Detroit who is organizing a large randomized study using the drug as a preventive medication in health care workers and emergency medical workers, said he had “cautious optimism” but urged the public to avoid drawing premature conclusions.

“Everybody is desperate to find out all the answers,” O’Neill said. “But we have to be careful about jumping to conclusions either way.”

Bright said his superiors at the Department of Health and Human Services were doing exactly that.

He is represented by the lawyers who represented Christine Blasey Ford, who testified against the nomination of Judge Brett Kavanaugh to the Supreme Court, accusing him of sexual misconduct decades ago, a claim he denied.

A spokeswoman for Alex Azar, secretary of the Department of Health and Human Services, did not immediately respond to an email seeking comment.

Medical publication Stat reported Tuesday that Bright had clashed with Dr. Robert Kadlec, assistant health secretary for preparedness and response. A former administration official disputed that Bright expressed significant opposition to the drug and insisted that he was moved out of his position because of long-standing concerns about his job performance.