Brazilian President Jair Bolsonaro has gone all in on hydroxychloroquine to help his coronavirus-ravaged country beat COVID-19. He has pushed his government to make the malaria drug widely available and encouraged Brazilians to take it, both to prevent the disease and to treat it.
Now the far-right populist is putting his convictions to the ultimate test: Bolsonaro on Tuesday announced that he had tested positive for the disease and was taking hydroxychloroquine.
Bolsonaro said in a televised interview that he had taken an initial two doses, in conjunction with the antibiotic azithromycin, and felt better almost immediately. His only regret, he said, was not using it sooner.
"If I had taken hydroxychloroquine preventively, I would still be working" instead of heading into quarantine, Bolsonaro said.
Later, in a separate video, he gulped down a third pill. He said he was aware of other treatments, but noted none of them had been proven to work.
"I trust in hydroxychloroquine," he said. "And you?"
Bolsonaro's illness is a potent symbol of his government's botched response to the outbreak. More than 1.7 million people in Brazil have tested positive for coronavirus and nearly 68,000 have died. Only the United States has performed worse.
A forceful critic of stay-at-home measures, Bolsonaro, 65, has largely shunned masks and derided the coronavirus as a "little flu." Instead, he has placed his faith in hydroxychloroquine and chloroquine, turning them into the centerpiece of his government's virus-beating playbook.
The two medications are often used against malaria, while hydroxychloroquine is also used to treat certain automimmune diseases. Some countries authorized the drugs to be tried on COVID-19 patients, and some doctors anecdotally have reported encouraging results.
Still, evidence is mounting that these drugs have no benefit for hospitalized patients. The U.S. Food and Drug administration in June, for example, revoked its emergency use authorization for hydroxychloroquine and chloroquine, saying it was no longer likely that the medications were effective at treating COVID-19 in these patients.
Bolsonaro has been undeterred by such pronouncements. He has pushed his Health Ministry to expand access to the drugs and dispensed with two Health Ministers - Luiz Henrique Mandetta and Nelson Teich - who had urged a more cautious approach.
Eduardo Pazuello - an active-duty Army general, who took over on an interim basis on May 15, and remains in the job to this day - has proven more obedient. Under his watch, the ministry has broadened access to the drugs, and public sector doctors are now allowed to prescribe them for almost anyone who has tested positive for the coronavirus, not just the sickest patients. They can even be used by pregnant women and children with certain health conditions.
The president's office declined to comment for this article, directing questions to the Health Ministry. The Health Ministry did not respond.
To understand how Bolsonaro's administration embraced this unconventional strategy, Reuters interviewed more than two dozen people, including current and former health officials involved in the federal response, as well as physicians, scientists and public health experts. What emerged was a picture of a leader worried about the crippling effects of lockdowns imposed by governors and mayors across Brazil, and eager for a quick fix to re-open the economy.
Bolsonaro was initially inspired by his political idol, U.S. President Donald Trump, who was an early advocate of hydroxychloroquine, a dozen sources said. But Bolsonaro has gone much further than his U.S. counterpart.
At his command, the Army has drastically ramped up production of chloroquine.
His new-look Health Ministry, now led by soldiers and Bolsonaro loyalists, has eagerly promoted the antimalarials as the best hope against COVID-19.
And Brazilian public entities, such as state governments and federal ministries, have snapped up the drugs on the open market. So far this year, they have spent a total of 2.3 million reais ($429,706) on hydroxychloroquine - up 6,592% compared with the total amount spent in 2019, according to a Reuters review of government data. These bodies have also spent 1.51 million reais on chloroquine so far in 2020, compared with 626,472 reais in 2019.
At the center of all this stands Bolsonaro.
Mandetta, the Health Minister fired by Bolsonaro in April, said the president's drumbeat of support for the drugs had hampered efforts to impose stay-at-home measures and slow the spread of the virus in Brazil.
"That made many people believe that the cure was ready, that it already existed, that you didn't need to worry, that you could just take this medicine, that would solve the problem," Mandetta told Reuters.
Teich, Mandetta's replacement who resigned after less than a month on the job, did not respond to requests for comment.
Since leaving, he has said publicly that he resigned due to disagreements with Bolsonaro, who was pressuring him to broaden access to hydroxychloroquine and chloroquine. Exclusive Reuters reporting reveals that Teich hoped to persuade Bolsonaro to wait for results from a fast-tracked hydroxychloroquine trial, but was unable to convince the president, according to four people familiar with the situation.
Marcia Castro, a native Brazilian and professor at the Harvard T.H. Chan School of Public Health, said it was a "totally absurd" strategy to prioritize unproven drugs over reliable tools such as testing, tracing and social distancing.
"It's a profoundly lamentable situation, and it's no coincidence that we now have more than 60,000 deaths," she said.
'MIRACULOUS CURE'
Bolsonaro's interest in hydroxychloroquine and chloroquine has its roots in early reports from China and France about the drugs' potential to help COVID-19 victims, according to six people who spoke with Reuters.
In mid-February, Chinese state-run media reported that health experts there had "confirmed" chloroquine "has a certain curative effect." Around that time, a French microbiologist, Didier Raoult, also began to laud the drugs.
Raoult's advocacy of hydroxychloroquine and chloroquine was picked up by right-wing bloggers and libertarian thinkers. Then, on March 19, Trump waded into the debate. "I think it could be a game changer," said Trump, who claims to have briefly taken hydroxychloroquine as a prophylactic.
Bolsonaro was particularly swayed by Trump's comments, six people said. Bolsonaro had met with the U.S. leader earlier that month at Trump's Mar-a-Lago resort in Florida, and several members of the Brazilian entourage returned sick to Brazil.
"It's the idea of a miraculous cure," said one recently departed cabinet minister, speaking on condition of anonymity. "(Bolsonaro) believes in those magic solutions. And I also think, in part, it is to copy Trump."
The White House pointed Reuters to a statement on May 31, when it announced it had sent 2 million doses of hydroxychloroquine to Brazil "as a demonstration of ... solidarity" between two countries which share a "longstanding collaboration on health issues."
On March 21, two days after Trump's comments, Bolsonaro announced he was ordering the Army Chemical and Pharmaceutical Laboratory to ramp up chloroquine production in Brazil for use as a COVID-19 treatment. Following that directive, the lab, located in Rio de Janeiro, has manufactured 2.25 million 150-milligram chloroquine pills, the Army told Reuters.
By comparison, the lab produced a total of 265,000 tablets in the previous three years combined, according to production data obtained through a freedom of information request filed by opposition lawmaker Ivan Valente and viewed by Reuters.
Brazil's armed forces have used chloroquine to ward off malaria in the nation's jungles for decades, and Bolsonaro, a former Army captain, has put military men in key positions. At least 27 current or former soldiers have recently joined the Health Ministry, replacing experienced public health officials, according to a Reuters tally. Meanwhile, current or former soldiers make up nearly half of Bolsonaro's 23-seat cabinet.
Five sources told Reuters that the longstanding usage of the drugs by members of the armed forces helped allay safety fears among Bolsonaro's military advisors.
"The majority of them served in the Amazon," said Osmar Terra, Bolsonaro's former Citizenship Minister, who has informally advised the government during the crisis. "All of them have used hydroxychloroquine for a long time."
Brazil's Army did not respond to a request for comment.
The Health Ministry said it has distributed 4.4 million chloroquine tablets to the states. It is unclear how widely they are being administered, as Brazil's physicians are free to prescribe the drugs as they see fit. But a huge number of Brazilians probably have access to them, officials, physicians and public health experts said.
Thaysa Drummond, an infectologist treating COVID-19 patients at the Eduardo de Menezes Hospital in Belo Horizonte, said a lot of patients arriving - either from primary care clinics, or other hospitals - had previously been given the drugs.
"In practice, lots of doctors are prescribing it," she said. Her hospital was not, she added, "because there is no robust, quality scientific evidence that supports their use."
Potential side effects of hydroxychloroquine and chloroquine include vision loss and heart rhythm problems.
NEW VOICES
Health Ministry officials initially expressed caution about the drugs, wanting to wait for credible clinical trial data, according to a dozen people familiar with the situation.
So Bolsonaro turned to outside medical professionals who shared his enthusiasm.
They included a São Paulo-based oncologist named Nise Yamaguchi. Virtually unknown in epidemiology and public-health circles, Yamaguchi said she took an early interest in hydroxychloroquine due to Raoult's work and the Chinese studies. She had appeared on Brazilian radio and television touting the potential promise of these treatments. Bolsonaro took notice, and on April 3 he dispatched an Air Force plane to bring her to the capital for a chat, Yamaguchi told Reuters. The president's office declined to comment on Yamaguchi's account.
At their meeting, Yamaguchi told Reuters that Bolsonaro showed her press reports about Raoult's hydroxychloroquine study. He wanted to know "why it couldn't be used more widely" in Brazil, she said. Yamaguchi said she told the president she was concerned about a lack of supply, in part because India, one of the world's biggest suppliers of generic medicine, had imposed a March export ban on hydroxychloroquine to meet its own domestic demand.
The following day, Bolsonaro announced publicly he had asked Indian Prime Minister Narendra Modi to loosen restrictions. Three days later, amid growing international pressure, India relaxed its export ban. Modi's office did not respond to a request for comment. In India, which now has the world's third-worst coronavirus outbreak after Brazil, doctors have also widely prescribed hydroxychloroquine.
Bolsonaro soon tasked Yamaguchi with designing guidelines to steer Brazilian doctors on how to use the antimalarials, a task usually reserved for government health officials, three former Health Ministry sources said.
On April 16, Bolsonaro fired Mandetta, the health minister. The two had been sparring publicly for weeks over Bolsonaro's aversion to stay-at-home measures and support of hydroxychloroquine and chloroquine.
That same day, Brazil's Federal Medical Council (CFM), which is in charge of medical licensing and ethics, agreed on guidelines for how and when doctors could prescribe the drugs.
Bolsonaro replaced Mandetta with Teich, an oncologist with no public health experience. By mid-May, Bolsonaro was publicly pushing Teich to deliver a new protocol to allow doctors to prescribe hydroxychloroquine and chloroquine for early-stage patients.
Teich was reluctant to do so without more evidence that the drug was effective and safe for this use, according to four people familiar with the situation. So his team crafted a plan to win over the president - a domestic hydroxychloroquine study that would provide partial results within weeks, according to the people.
They reached out to Álvaro Avezum, a São Paulo cardiologist who was part of a coalition conducting robust clinical trials into possible COVID-19 treatments, the people said. One of those studies was investigating whether patients with less severe symptoms could use hydroxychloroquine to prevent hospitalization. Teich's team thought research that could potentially confirm the benefits of such early intervention might appeal to Bolsonaro, who has sought to make Brazilians less fearful of contracting COVID-19 so they can get back to work, the people said.
On the condition of Health Ministry support, Avezum agreed to fast-track the study, two sources said. Avezum declined to comment on those talks, but said the aim was to be as efficient as possible.
In public, Bolsonaro was ratcheting up the pressure on his health minister to sign off on the new protocol.
"It's not whether Teich likes it or not, ok? It's what's happening," Bolsonaro said to reporters on May 13. "We've got hundreds of deaths a day. If there's a possibility to lower that number with chloroquine, why not use it?"
The following day, Teich met with Bolsonaro to discuss the hydroxychloroquine clinical trial. The encounter did not go well. Bolsonaro told Teich he wanted the drug approved for wider use, and he wanted it now.
"I'm the one who makes decisions," the president said, according to two sources with knowledge of that meeting.
Teich resigned the following day.
VIRULENT TIMES
Hydroxychloroquine and chloroquine are now flashpoints in Brazil's polarized politics. People's views of the drugs have become something of a referendum on their president, much like masks in the United States.
Brazilian physician Marcus Lacerda got caught in the turmoil. In late March, he began a randomized trial in the northern rainforest city of Manaus to investigate the safety and efficacy of two different doses of chloroquine - one high, and one low - on hospitalized patients with severe COVID-19.
When the trial's monitoring group noticed an increased lethality in the high-dosage group, it halted the study. Sixteen people taking higher chloroquine doses died, compared with six in the low-dosage group.
The results were quickly rejected by the drug's supporters. Bolsonaro's son Eduardo, a federal lawmaker, tweeted that the study had been designed to "disqualify chloroquine," and he accused the investigators of being leftist partisans.
Lacerda said his life became a nightmare. Bolsonaro fans, angered by results from a study which appeared to portray the president's favored drug as lethal, sent a deluge of messages to his Facebook account. They called him an "assassin," a "monster" and a "pseudo-scientist."
"Your time will come," one Facebook user warned.
Because of death threats, Lacerda required armed guards for a few weeks. Life has gradually returned to normal, but he remains shaken by the online hate. "It has an incalculable effect on people's lives," he told Reuters.
Bolsonaro's age places him at risk from COVID-19. Still, given the fact that Brazil's current mortality rate is less than 5%, and Bolsonaro, as president, will have access to high-quality medical care, he stands a good chance of recovering.
If he does, many expect him to credit hydroxychloroquine for his survival.
Wildo Araujo, a former Health Ministry official who co-authored one of Brazil's first major COVID-19 studies, said such a claim would further politicize the drug. It would also be baseless, he added, as the efficacy of drugs can only be proved with large, randomized, placebo-controlled trials.
"The statement of one individual doesn't prove anything," he said. "(Bolsonaro) will use ... that narrative. But from a scientific point of view, it doesn't have any value at all."
($1 = 5.3525 reais)
