WASHINGTON (Reuters) – In mid-March, President Donald Trump personally pressured federal health officials to make malaria drugs available to treat the new corona virus, even though they had not been tested for COVID-19, two sources told Reuters.
Shortly thereafter, the federal government published very unusual guidance informing physicians that they had the opportunity to prescribe the drugs, with key dose information based on unattributed anecdotes rather than scientifically reviewed science.
While Trump, in a series of tweets and press comments, had made his views on the drugs, chloroquine and hydroxychloroquine, well known, he has not previously reported on the backstage intervention. The guidance, published by the Centers for Disease Control and Prevention, has received barely a message outside of medical circles.
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“The president shortens the process with his gut feelings,” said Jeffrey Flier, a former dean of Harvard Medical School. “We are in an emergency and we have to trust our government to make sure all these potential therapies are being tested in the most effective and objective way.”
In a statement to Reuters, the White House said the president had not started a “press campaign” but was taking appropriate action.
“The highest priority of the president is the health and safety of the American people, which is why he has brought together the federal government and the private sector, including doctors, scientists and medical researchers, for outstanding cooperation to accelerate vaccine development,” said the statement, which did not address Reuters questions about the CDC guidance.
Administration supporters say the CDC document, which marks alternatives, makes sense at a time of medical accident without proven treatment. And they note, chloroquine and hydroxychloroquine have been prescribed for years with known risks. Some potential risks for coronavirus patients are worth considering for the health crisis.
“In a perfect situation, you would never do this,” said a public health specialist who recently left the government. “But if you know the safety disadvantage, and the patient is ready to try it, it’s worth a try.”
It has long been known that in some patients, and in long-term use, hydroxychloroquine and chloroquine can cause a broken heartbeat or a heartbeat, the medical literature shows. A new research document states that these “may pose a particular risk to critically ill persons.”
In a series of conversations last month, President Trump personally instructed the top officials at the Centers for Disease Control, the Food and Drug Administration and the National Institute of Health to focus on the two drugs as potential therapies, said two sources familiar with the president’s efforts.
After seeking a medical breakthrough to the global crisis, Trump had contacted Dr. Stephen Hahn, the FDA administrator and other top health officials, questioned whether they were moving fast enough to make the drugs more widely available, a source said. “He wasn’t happy because of the bureaucracy.”
Trump did not raise his voice or express anger, but emphasized the “urgency” of fast-tracking access to the drugs, the other source said. A cascade of federal measures soon followed to make the drugs more accessible, including the federal government’s grant of emergency permits to supply them nationwide.
A NIH spokeswoman said the agency was “not the source of the content” of the CDC compiled document. The CDC said it presented guidance to physicians at the request of a coronavirus working group, which called for rapid action.
An FDA spokesman declined to discuss the president’s press service or to test the CDC-issued guidance. The agency said in a statement to Reuters that it acted appropriately when, in March, it issued an emergency order for the drugs to be prescribed and distributed.
“It was established, based on available scientific evidence, that it is reasonable to believe that the specific drugs may be effective in the treatment of COVID-19, and given that there are no adequate, approved or available alternative treatments, the known and potential benefits for treating this serious or life-threatening virus outweigh the known and potential risks, ”the FDA statement says.
The first official action came March 21, at the height of the president’s efforts, when the CDC prepared a document, Information for Clinics on Treatment Options for COVID-19 Patients, which contained a section on antimalarial drugs.
The document describes possible prescription information for coronavirus patients and at the same time suggests hydroxychloroquine and chloroquine as an alternative in coronavirus treatment. It was the first time the federal government’s Office for Disease Control officially got the idea.
“Although optimal dosage and duration of hydroxychloroquine for the treatment of COVID-19 is unknown,” the document states, “some US clinics have reported anecdotally” on various hydroxychloroquine doses.
The document does not name the clinics, say whether their treatment was successful or explain the paper’s purchase.
Dr. Lynn Goldman, dean of the Milken Institute School of Public Health at George Washington University, says she was surprised to read the document’s guidance, after Reuters pointed it out to her. “Oh my God!” She said. “No references, nothing! Why would the CDC publish anecdotes? It doesn’t make sense. This is very unusual. ”
Flier, the former Harvard dean, agreed. “It is a type of offering these drugs and suggesting that doctors can prescribe them when it is obviously not determined whether they are effective or harmful,” he said.
The CDC declined to specify the interaction between its director, Dr. Robert Redfield, with President Trump. In a statement, the agency said the guidance was prepared at the request of the coronavirus working group and physician who “requested the CDC to review the literature, compose and post the information as soon as possible.”
“The agency did that,” the statement said.
The CDC would not reveal the identity of the authors who prepared the document, nor specify its purchase. The document said it was under review by the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), the Department of Viral Diseases.
“BIGGEST GAME CHANGER”
Trump’s motive came after Fox News reported on March 16 a small French study highlighting the effectiveness of one of the drugs, hydroxychloroquine. Fox News interviewed a lawyer it said was involved, Gregory Rigano, who said “we have strong reason to believe that a preventive dose of hydroxychloroquine will prevent the virus from attaching to the body and just get rid of it completely.”
Rigano, who appeared on Fox News again two days later, said the president “has the power to approve the use of hydroxychloroquine against coronavirus immediately.”
Rigano did not respond to an email request for comment from Reuters.
On March 19, Trump promised to make the drugs more widely available. “It has proven very encouraging – very, very encouraging early results,” he said at a press conference. “And we will be able to make that drug available almost immediately. And this is where the FDA has been so good. They – they have gone through the approval process; it has been approved. And they did – they took it down from many, many months to immediate. ”
In fact, the drug had not undergone an FDA review process at that time. At the same press conference, FDA Administrator Hahn said regulators are “looking closer.”
“It’s a drug that the President has directed us to look into if an extended use of this can be done to actually see if it benefits patients,” Hahn said.
In a press release that day, the FDA emphasized that it was only investigating whether the drugs “can be used to treat patients with mild to moderate COVID-19 to potentially reduce the duration of symptoms.” Studies are ongoing, the FDA added, “to determine the effectiveness of using chloroquine to treat COVID-19.”
While the FDA approves drugs for the US market and oversees testing, the CDC is the most important agency that coordinates response to infectious diseases and provides information about them. At that time, the CDC had not produced the drugs.
Two days later, on March 21, the president personally pressed the health officials. The president also tweeted that the drugs should “be put to use immediately.” Trump, who cited the study, promised that the drugs showed “a real chance of being one of the biggest game changers in the history of medicine.”
That was when the CDC published its newer guidance to doctors and appeared to provide the stamp of approval to use hydroxychloroquine and chloroquine directly for COVID-19 patients. Although the document does not recommend the use of drugs, it does cite them as a possible alternative.
At the same time, the heads of bureaus in public began to change their attitude. After initially expressing caution, on March 23, the FDA’s Hahn told Fox News host Tucker Carlson that preliminary data showed that the drugs could really help treat the disease.
Millions of hydroxychloroquine and chloroquine pills are now on the way to the public, donated by pharmaceutical manufacturers including Novartis’ Sandoz, Bayer and Teva Pharmaceutical Industries Ltd. The FDA issued an emergency permit on March 28 to have them prescribed and distributed from Strategic National Warehouse.
A paper in Annals of Internal Medicine, the premier journal of internal medicine, this week warned of the dangers of tracing the drugs, given the unproven evidence and their potential lack of other uses, such as treatment for patients with lupus.
In a statement to Reuters, the magazine’s author, Drs. On the one hand, Jinoos Yazdany and Alfred H. J. Kim called the CDC document “direct and factual, if its purpose is to describe what we know.”
But they also expressed concern that the guidance could “leave the reader free to interpret this information depending on their bias. We believe that such a document should state more clearly what it means to caregivers.”
When they noted the president’s tweets in their report, the authors urged the medical community and the US government to send “clear messages” containing a correct interpretation of available information “to counteract misinformation, including misleading statements or” clickbait “material.”
Reporting by Aram Roston and Marisa Taylor in Washington. Editing by Ronnie Greene