Trump's push for risky malaria drugs disrupts coronavirus response

“It’s not the right thing to throw the sink – also Oracle-led – on patients in the middle of a pandemic,” said Arthur Caplan, bioethicist at NYU.

Scientists are trying to answer some of the gaping questions about chloroquine: the World Health Organization is launching a global study of the drug and other possible treatments, while New York State enrolls patients in its own study this week.

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“Using untested drugs without the right evidence will raise false hopes and even do more harm than good – and a shortage of essential medicines needed to treat other diseases,” said Tedros Adhanom Ghebreyesus, director general of the World Health Organization.

In the United States, where Trump promoted chloroquin’s “very strong” capabilities in press conferences, President and Vice President Mike Pence is promoting off-label use because the drug is already approved for certain diseases. While this means that doctors can prescribe it to their patients, they don’t have to report harmful side effects or even if the drug was effective.

Health experts warn that the confusion will have tragic consequences. An Arizona man died after taking chloroquine phosphate, a treatment for sick fish. He believed it was the drug Trump was referring to. “I saw it sitting on the back shelf and I thought, ‘Hey, isn’t that the stuff you’re talking about on TV?'” his wife told NBC News. “Trump kept saying it was basically a cure.”

Meanwhile, government health officials fear that hydroxychloroquine care for lupus and arthritis patients who have been using the drug for years may be running low. For example, The Virginia Department of Health urged doctors on Wednesday to adhere to regulations “consistent with evidence of their use.”

The FDA is working with federal officials and academic centers to collect data on hydroxychloroquine and a range of therapies, spokesman Michael Felberbaum told POLITICO. However, policy experts are increasingly concerned that high-ranking officials like Pence, who promote off-label use rather than litigation, will do more harm.

Meanwhile, meetings with Oracle health officials to set up the Oracle database are held daily, Agus said. Amy Abernethy, the FDA’s deputy chief commissioner, who was partially recruited by Flatiron, a medical record company, to integrate more real-world data and technology into the agency, has been heavily involved in the effort, he said. A senior HHS official said Abernethy has been involved in a number of data collection projects related to the coronavirus, but there is concern that the chloroquine effort will “over-attest”.

And while health authorities are running to create a drug tracking system, the president continues to promote them as a potential panacea.

“I don’t think anyone takes what he says about drugs literally, but he does create discourse – and I like that,” said Agus.

There is a “desperate effort” worldwide to find an answer, said Soumya Swaminathan, WHO chief scientist. “This leads to widespread use of these drugs – for example chloroquine – [when] We don’t know that it will benefit anyone. “

The president initially referred to chloroquine during a press conference last week in which he promised that the FDA would open the door to the use of promising drugs. Interest in chloroquine has grown rapidly in the research community: Scientists in Wuhan, China, suggested in February that it could be helpful in combating their severe outbreak after weeks of use. A few weeks later, a group of researchers in France released data from a small preliminary study – although some have now questioned the research, it was found that peer review was carried out within a day and the lead researcher was previously accused of fraud. Later published a Chinese study in The Lancet suggested no benefit from the pills.

The drug’s popularity exploded online, touted by a mix of venture capitalists and questionable personalities. Bitcoin investor Gregory Rigano released a Google document advocating the drug – reinforced by prominent voices like Elon Musk, who shared it with his 32 million Twitter followers – and appeared in Fox News to describe it as ” Heilmittel ”for host Tucker Carlson.

Health researchers immediately asked questions about Rigano’s claims, and Stanford University said that he had no affiliation there and that nobody and the university were involved in his work. But within a day of Rigo’s appearance on Carlson’s show, Trump called chloroquine “very powerful” in his daily meeting at the White House.

“The nice thing is that this has been around for a long time, so we know that if things don’t go as planned, it won’t kill anyone,” said the president.

FDA Commissioner Stephen Hahn and leading infectious disease expert Anthony Fauci stood next to Trump at the briefing and seemed to mitigate Trump’s expectations of anti-malarial drugs.

“We need to make sure that the sea of ​​new treatments receives the right medication for the right patients, at the right dosage and at the right time,” said Hahn last week. “It is therefore important that our specialists examine these therapeutic developments.”

Fauci took a clear line the next day, even when the president pushed back. “You have to be careful when you say” pretty effective. “It has never been done in a clinical trial. People have been given who felt it might have worked.”

“I’m a smart guy. I feel good about it, ”said Trump. “Let’s see what happens. We have nothing to lose.”

But even the pharmaceutical companies behind chloroquine, some of which have already donated millions of tablets to the US government, are careful when they simply prescribe their medicines to people who want them.

German drug maker Bayer, who held the original chloroquine patent, was the first to get involved when Chinese officials turned to the company when the nation’s outbreak raged in early February. The experience provided lessons for dealing with the drug, said Matthias Berninger, a Bayer manager for public affairs. This is how it works best when given to people shortly after infection, rather than waiting for them to be hospitalized in an intensive care unit and forced to use a respirator.

Now, with 60 percent of new US coronavirus infections, New York is the emerging frontline of the pandemic. Bayer has donated three million tablets to the German government, confident from China’s experience that the drug could reduce the number of people who need to go to the hospital – as long as the right patients are available.

“Scientists at the forefront and the president’s willingness play an important role in ensuring a coordinated therapy strategy,” he said. But if there are too many off-label recipes, “the people who need it most won’t get it.”

Public health experts continue to warn against raising hopes for one or two unproven drugs. “For the corona virus, I doubt that the solution to this pandemic will be a new drug,” said Richard Besser, who served as CDC director during the 2009 swine flu outbreak. “It’s great to have hope. I like to promise too little and hopefully deliver too much.”

“The real problem isn’t finding a miracle cure,” said bioethicist Caplan, whose university in New York City is now surrounded by the outbreak. “I wish the administration would find out how to get equipment and protective gear to where the outbreak is worst. If we had tests, it would be far more than just finding out if this antimalarial drug can kill the coronavirus. “

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