Flop? Data from first randomized clinical trial suggests Gilead's "miracle drug" remdesivir is a bust

Flop? Data from first randomized clinical trial suggests Gilead's "miracle drug" remdesivir is a bust

All the hydroxychloroquine true believers got their comeuppance a few days ago and now the remdesivir true believers like me are getting their comeuppance today. That doctor from Harvard tried to warn us that the positive buzz for remdesivir so far was largely anecdotal, but did I listen?

This is what I get for daring to entertain a hopeful thought in the middle of this waking farking nightmare.

I’m going to go hibernate for the next year. Wake me up if they find a “miracle drug” that holds up to even one round of trials.

A potential antiviral drug for the coronavirus has flopped in its first randomised clinical trial, disappointing scientists and investors who had high hopes for remdesivir, according to draft documents published accidentally by the World Health Organization and seen by the Financial Times.

The Chinese trial showed remdesivir — developed by California-based Gilead Sciences — did not improve patients’ condition or reduce the pathogen’s presence in the bloodstream. Researchers studied 237 patients, giving the drug to 158 and comparing their progress with the remaining 79. The drug also showed significant side effects in some, which meant 18 patients were taken off it.

According to Stat, 13.9 percent of Chinese patients who received remdesivir died within a month versus 12.8 percent of the control group, a statistically insignificant difference. At *best*, the drug didn’t help. At worst, it actually hastened death.

Gilead’s shares are down more than six percent today as I write this. But wait, the company says: You’re all jumping the gun.

Gilead spokesperson Amy Flood said the company believes “the post included inappropriate characterization of the study.” Because the study was stopped early because it had too few patients, she said, it cannot “enable statistically meaningful conclusions.” However, she said, “trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”

The data (for details, see screenshot below) will be closely scrutinized but are also likely imperfect. The study was terminated prematurely, which could have affected the results. The context that would be provided by a full manuscript is missing, and the data have not been reviewed as normally occurs before publication.

“Trends in the data”? What does that mean? Well, there’s a clinical trial of the drug going on right now at the University of Nebraska Medical Center that’s backed by the NIH. Results are expected “any day,” according to NBC. Maybe Gilead has seen those results and is teasing some good news to come to counter today’s grim report about the Chinese trial. The company has also said that it’s still working on ways to speed up production of remdesivir, which is difficult to synthesize; if they had reason to believe the drug was a bust, one would think they wouldn’t bother devoting more resources to it. So maybe they know something encouraging that we don’t.

Or, more pessimistically, maybe they have preliminary reason to believe it’s a bust but want to be in position to produce massive amounts just in case some of the other studies ongoing turn up better results. One expert told Stat that the Chinese trial was large enough that a bad result there bodes ill for the drug, even if the trial was incomplete: “If there is no benefit to remdesivir in a study this size, this suggests that the overall benefit of remdesivir in this population with advanced infection is likely to be small in the larger Gilead trial.” The drug may not work for patients who are far gone — but note again what the Gilead rep said about “patients treated early in disease.” It would make sense that the drug would work better the earlier it’s used, since it’s designed to inhibit RNA replication by viruses. A patient who’s far gone may already have too much of the virus in their system for remdesivir to do much about it. A patient who’s earlier in the course of the disease might be different.

Anyway, feel free to bookmark this post and throw it back at me when the next remdesivir trial shows it doesn’t do anything for patients treated early either. Until then, it’s on to the next miracle drug:

If that one doesn’t work, we’ll continue to hold out hope that somehow Oxford University’s going to deliver an effective vaccine in one-half or even one-third the time that every scientist in the world thinks it’ll take to produce a vaccine. And if that doesn’t work, there’s a long longshot possibility that we can beat back this virus with an item that just so happens to be available in every convenience store in America. One word, my friends: Cigarettes.

By the way, the only reason we know the results of this Chinese trial of remdesivir is because our friends at the WHO “accidentally” posted them publicly on their website, before the full report was ready. Do we think that was an honest mistake? I have no theory that it wasn’t, but (a) I don’t trust anything that the Chinese stooges at the WHO do and (b) it seems like quite a coincidence that the one study that ended up being published prematurely on the website was the one having to do with the world’s most hotly anticipated potential coronavirus treatment.

Update: Now here’s a thought.

Was the buzz a week ago about the encouraging data on remdesivir in Chicago part of some pump-and-dump scheme by an insider who knew the new Chinese data was coming? Last to chance to cash in on the drug before the hype collapsed!

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David Strom 8:41 PM on January 30, 2023