Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.
Among the most intense political debates in the U.S. right now is a behind-the-scenes fight over hydroxychloroquine and COVID-19. Some in the Trump administration—including the president himself—have been touting its efficacy despite limited evidence, but others are urging caution, arguing that the drug remains unproven.
That debate took center stage at a Saturday afternoon coronavirus task force meeting in the White House Situation Room, Axios reports.
When the meeting turned to hydroxychloroquine, economic adviser Peter Navarro handed out folders and said the drug has showed “clear therapeutic efficacy," Axios reported, citing a source familiar with the meeting. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, responded the evidence so far is anecdotal, prompting Navarro to turn "confrontational," one source told Axios.
After some back and forth, members of the task force agreed it was important to make the drug available in COVID-19 hot spots, according to the publication.
At Sunday’s press conference, a reporter asked Fauci about the drug, but President Donald Trump stopped him from answering. The U.S. has 29 million doses of the drug in the national stockpile, the president said at the briefing.
Like members of the task force, regulators also seem to be split on the drug. The U.S. FDA has issued an emergency use authorization for hydroxychloroquine and chloroquine, while regulators in Europe are holding out for more data. Instead, patients in Europe must access the drugs through clinical trials or national emergency use programs.
While Trump has said there’s low risk of trying the decades-old drug, Megan Ranney, an emergency physician at Brown University, told The New York Times side effects include psychiatric symptoms and cardiac problems. Plus, patients who’ve taken hydroxychloroquine for years have written to FiercePharma with concerns about their own supply of the medicine for proven uses, such as lupus.
Some of the confusion around hydroxychloroquine and COVID-19 stems from small, uncontrolled studies and the work of professor Didier Raoult in France. In a Los Angeles Times column, writer Michael Hiltzik outlined flaws with the professor's work. In one of Raoult's studies, six patients dropped out in the first six days; those patients either died, were transferred to the ICU, couldn't tolerate the drug or dropped out for another reason, Hiltzik wrote, so they weren't included in the final analysis.
But in a small controlled study from Wuhan, China, the drug did improve patient outcomes, according to the authors. Researchers there tested the drug in a 62-patient study in mild to moderate COVID-19. The entire group received standard care, while half of the group received standard care plus hydroxychloroquine for five days.
In the patients who received hydroxychloroquine, time to clinical recovery and body temperature recovery time were “significantly shortened," and those patients stopped coughing sooner, the authors said. They recommended the drug considering the lack of other options but said more research is needed.
With the pandemic raging, politicians, doctors and others are looking for any potential answers. Following the FDA's emergency authorization, members of the task force agreed the administration's stance should be that doctors and patients should decide whether the drug is the right route to take, Axios reports. Meanwhile, several drugmakers have bolstered manufacturing and pledged donated doses.
As the debate unfolds, Trump has repeatedly made his stance clear, but he's also cautioned that he's "not a doctor" and speaks about hydroxychloroquine based on his instinct.