Strange India All Strange Things About India and world


A miracle cure must have sounded pretty good.

On March 19, the president conducted a press conference, and it was really weird.

This is where he started pitching hydroxychloroquine. “It’s shown very encouraging—very, very encouraging early results. And we’re going to be able to make that drug available almost immediately,” the president said. The FDA was all in too: “They’ve gone through the approval process; it’s been approved.”

This was untrue in most respects. Few results were in. The president might have meant that hydroxychloroquine was approved for malaria, lupus, and rheumatoid arthritis, and that clinicians could prescribe it off-label. He might also have been talking about Boulware’s trial, which had also been approved by the FDA. It’s certainly possible the president got confused.

The president introduced FDA commissioner Stephen Hahn, who treaded cautiously. Chloroquine was worth considering for use against Covid-19, Hahn said. “Again,” he said, “we want to do that in the setting of a clinical trial—a large, pragmatic clinical trial.”

That wasn’t what the White House was pushing for behind the scenes, though. At that same moment, the administration was allegedly pressuring Rick Bright, responsible for vaccine development as the head of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (Barda), to get on the hydroxychloroquine train. According to Bright’s eventual whistle-blower report, the general counsel for HHS told Bright’s team that the White House wanted an Investigational New Drug protocol for chloroquine to accommodate a soon-to-come donation of millions of doses from Bayer. Bright managed to talk his bosses down to an emergency use authorization, a less full-throated support of the drug’s efficacy. “When I resisted efforts to promote and enable broad access to an unproven drug, chloroquine, to the American people without transparent information on the potential health risks, I was removed from Barda,” Bright told a subcommittee of the House Energy and Commerce Committee.

On March 27, the FDA announced an emergency use authorization for hydroxychloroquine and chloroquine to treat Covid-19, freeing up the drugs for use on sick patients. Prescriptions skyrocketed, mostly from physicians who’d never prescribed it before. Many people who volunteer for clinical trials do so out of community spirit; some also hope to get access to a potentially crucial drug—risking the chance that they might instead get randomized to the placebo group. Widespread availability of hydroxychloroquine meant nobody needed to be in a trial to get it. The authorization had the counterintuitive effect of undercutting the effort to find out if the drug was actually worth taking.

Back in Minneapolis, Boulware suddenly found he couldn’t enroll enough people to get the statistical power his protocol needed to give a definitive answer. The research was on outpatients, people who weren’t hospitalized, all over the country—they could volunteer from anywhere. And the emails just stopped coming. Boulware read all the same news reports as everyone else. He could understand why. “Half of the people think it’s an unethical trial because it clearly works,” he told me in April, “and the other half thinks it’s clearly dangerous and we shouldn’t do it.”

They had 1,200 people enrolled. They only needed 180 more. They were so close.

The president’s advocacy added another, hyper-partisan political layer of difficulty. Trump supporters began to see the use of hydroxychloroquine, like the avoidance of wearing masks, as a badge of political allegiance. Even gentle cautions about potential bad health outcomes from hydroxychloroquine came to signal disloyalty. Drug companies weren’t pushing for trials. (Sandoz, a drugmaker with a business in generic, off-patent drugs like hydroxychloroquine, tried to mount a trial but canceled it for lack of participation.) The government wasn’t pushing for one, as it had for remdesivir. All of that left Boulware’s team hanging. Even his volunteers were telling him how they felt. “By mid-April, people had formed an opinion,” he says. “Either it worked or it was dangerous, and our enrollment was minimal.”



Source link

Leave a Reply

Your email address will not be published. Required fields are marked *