‘What Do You Have to Lose?’ How Trump Has Promoted Malaria Drug

By BY THE NEW YORK TIMES from NYT U.S. https://ift.tt/2xFzPK1

It is known as a malaria drug, and it’s been around for a long time. And it’s very powerful, but the nice part is it’s been around for a long time, so we know that if things don’t go as planned, it’s not going to kill anybody. And it’s shown very encouraging very, very encouraging early results. There’s a possibility — a possibility — and I say it: What do you have to lose? I’ll say it again, what do you have to lose? Take it. I really think they should take it. But it’s their choice, and it’s their doctor’s choice or the doctor’s and the hospital. But hydroxychloroquine, try it if you’d like. It will be, not a game changer because that’s not a nice enough term — it will be wonderful. It’ll be so beautiful. It’ll be a gift from heaven. If it works that would be great. If it doesn’t work, we know for many years — malaria, it’s incredible what it’s done for malaria. It’s incredible what it’s done for lupus. But it doesn’t kill people. But if it was somebody else other than President Trump that put it forward, if some other person put it forward that said, “Oh, let’s go with it, you know, what do you have to lose?”

In briefing after briefing with reporters at the White House, Mr. Trump defied the voices of medical experts and some of his own top advisers — including Dr. Anthony S. Fauci, the nation’s top infectious disease specialist and an adviser to the coronavirus task force. They 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.

At the end of March, a division of Novartis, a leading pharmaceutical company, donated 30 million doses of hydroxychloroquine sulfate to the health department’s stockpile for the possible use of treating Covid-19. Mr. Trump heralded the announcement a few days later, saying that the drug “may work, then again, it may not work.”

But in mid-April, a small drug trial in Brazil was halted after some patients developed irregular heart rates. Then a study this week of 368 V.A. patients, which has not been peer-reviewed, found that it did not help patients avoid the need for ventilators, and that the use of the drug alone was associated with an increased risk of death.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 , 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.

In his statement, Dr. Bright did not directly name Mr. 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 favor 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,” Dr. 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 H.H.S. 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.”

But Trump administration officials painted a different picture of Dr. Bright’s tenure.

Dr. Bright and Dr. Robert Kadlec, the assistant health secretary for preparedness and response, clashed repeatedly, according to those officials. While Dr. Bright followed careful procedures, they said, he was a polarizing figure within the Department of Health and Human Services, where concerns had circulated about a management style that was described as confrontational.

Those officials said that there had been discussions about removing Dr. Bright for many months, and that they came to a head after emails were leaked to Reuters last week detailing internal discussions about chloroquines.

A senior administration official said that Alex M. Azar II, the secretary of the Department of Health and Human Services, told the coronavirus task force members in their meeting on Wednesday about Dr. Bright’s departure from BARDA, describing it as a promotion to the vice president. Officials left the meeting and learned of Dr. Bright’s public statement.

In a statement, Caitlin Oakley, a spokeswoman for the Department of Health and Human Services, said that “Dr. Bright has departed BARDA to N.I.H., where he’ll work on development and deployment of novel point-of-care testing platforms.”

She added: “As it relates to chloroquine, it was Dr. Bright who requested an Emergency Use Authorization from the Food and Drug Administration for donations of chloroquine that Bayer and Sandoz recently made to the Strategic National Stockpile for use on Covid-19 patients. The E.U.A. is what made the donated product available for use in combating Covid-19.”

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

“I never heard of him,” the president told reporters. “You just mentioned 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’d have to hear the other side. I don’t know who he is.”

A career government official who has led BARDA since 2016, Dr. 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,” Dr. Bright said. He went on to describe what he said 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 Dr. Bright’s account said that Dr. Bright was pressured to rush access to the drug after the president and Larry Ellison, the chairman and chief technology officer of Oracle, had a conversation about chloroquines. Dr. 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 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.

And inside the White House, the drug still has its true believers, including Peter Navarro, a trade adviser who has been put in charge of procuring protective gear and other medical supplies to fight the virus. Mr. Navarro is relentless with anyone in the West Wing who will listen, encouraging the government to keep stockpiling the drug and dismissing the recent studies as “deeply flawed.”

The Brazil study gave doses of hydroxychloroquine in excess of the levels recommended by the Food and Drug Administration, Mr. Navarro said in an interview. The veterans study administered the medicine too late and focused narrowly on an older population with high incidences of cardiac failure, diabetes and lung disease, among other issues, he insisted.

“None of this was reported by a mainstream media which appears incapable of reading anything more than study headlines,” he said. “To date, almost 40 studies have reported apparent usefulness of hydroxychloroquine or chloroquine in shortening length of hospital stay, improving symptoms, and resolving lung lesions as seen on X-rays.”

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

Dr. William W. 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,” Dr. O’Neill said. “But we have to be careful about jumping to conclusions either way.”

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

Dr. Bright is represented by two lawyers who work with whistle-blowers, and who represented Christine Blasey Ford, who testified against the nomination of Judge Brett M. Kavanaugh to the Supreme Court, accusing him of sexual misconduct decades ago, a claim he denied.

In a statement, they called Dr. Bright’s change in position “retaliation, plain and simple” and said they planned to ask for an investigation.

Michael D. Shear reported from Washington, and Maggie Haberman from New York. Katie Thomas contributed reporting from Chicago, and Kenneth P. Vogel and Ana Swanson from Washington