This morning, STAT News reported:
A government-run study of Gilead’s remdesivir, perhaps the most closely watched experimental drug to treat the novel coronavirus, showed that the medicine is effective against Covid-19, the disease caused by the virus.
Gilead made the announcement in a statement Wednesday, stating: “We understand that the trial has met its primary endpoint.” The company said that the National Institute of Allergy and Infectious Diseases, which is conducting the study, will provide data at an upcoming briefing.
The finding — although difficult to fully characterize without any data for the study — would represent the first treatment shown to improve outcomes in patients infected with the virus that put the global economy in a standstill and killed at least 218,000 people worldwide.
I’ve been staying on the sidelines this morning, watching the Tweets pile up on this. I often choose to chime in when I think I might contribute something that no one else will. The wisdom of the crowds may have this one covered. Some email and social media reactions follow.
One of the nation’s leading public health journalists wrote to me:
I know that STAT’s business model is implicitly pro-pharma but even given that, this story is a press release.
In other words, that leading journalist didn’t view this as journalism but as PR – public relations.
A former Boston hospital CEO, Paul Levy, retweeted what STAT story co-author Adam Feuerstein had tweeted. Philadelphia Inquirer journalist Tom Avril chimed in.
STAT’s Helen Branswell, another of the nation’s leading public health journalists, tweeted:
Data to follow, apparently from NIAID. Unusual way to release critical results; can’t kick tires.
The New York Times, in a Gina Kolata quickie, published a story, “Gilead claims ‘positive data’ to come from NIH trial of remdesivir.” The sub-headline was: Neither the company nor the institutes discussed the data. Previous results for the potential coronavirus treatment have been inconclusive.
Journalism professor Michael Balter tweeted, in response:
It might be good to go public with this when data are available, not when it is good PR for the company.
This kind of tweet doesn’t help, but it’s what you get in the cacophony of rushing research results into public consumption:
Ok, I don’t get the deal with Remdesivir.
First they tell us it’s awesome. Then they tell us it doesn’t work at all. Today it’s awesome again.
What the HELL is going on?
— Bill Mitchell (@mitchellvii) April 29, 2020
So what has happened before 10 a.m. Central time today is that there has been considerable criticism of a government health agency’s PR, of a drug company’s PR, and of a leading news organizations’s coverage of same. It would be helpful for news consumers if we could break this cycle.
This post may be updated later today and/or in days to come.
Today, The Lancet published a paper, Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. (Complete paper is behind a paywall.) Excerpt: “In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits.”
Later today, Bloomberg and many other news organizations reported:
The U.S. government’s top infectious-disease expert said that early results of a closely watched clinical trial offered “quite good news” regarding a potential Covid-19 therapy made by the biotechnology company Gilead Sciences Inc.
Anthony Fauci, the head of National Institute of Allergy and Infectious Diseases, which is conducting the study, said at a White House meeting … that the trial showed a significant positive effect in treating the virus.
Last week, the market swooned after apparently discouraging results from a Chinese trial that was halted early after researchers struggled to enroll patients were accidentally posted on a World Health Organization web page. Data confirming those more downbeat results were published in the U.K. medical journal The Lancet on Wednesday. Fauci said at the White House Wednesday that that trial was “not an adequate study.”
One of those Bloomberg journalists tweeted:
This “release” of remdesivir data by $GILD is the biggest mess I have seen in almost three decades of covering drug development. And I have seen some shit shows. What does it mean? No damn idea.
— Michelle Fay Cortez (@FayCortez) April 29, 2020
Some in the financial world seem to be suggesting a double standard with Dr. Fauci touting his own agency’s unpublished study (NIAID) as “quite good news” while criticizing the Chinese paper in The Lancet. Just one example: Stocks Soar On Fauci-Touted Remdesivir Study Despite Marginal Survival Benefit, Snubs Lancet Findings.
It’s a randomized, double-blind, placebo-controlled, multi-center peer-reviewed and published study, with all data available, in The Lancet. Versus a US federal health agency study, the results of which have not yet been published in peer-reviewed literature, but which were touted by the head of that agency in a White House meeting – while he was criticizing the Lancet paper.
Maybe the best social media recap I saw was this one:
-Gilead has a crap week last week.
-Releases no-data “positive” news before market open
-Gets news amplified in single-source story
-Sees its stock soar
-Data turn out to be: no real effect on death, 4 days less to hospital discharge
– Contradictory study w/in hours https://t.co/8WlupVqnRG
— Maryn McKenna (@marynmck) April 29, 2020
April 30: Since yesterday a growing number of observers have shown concern that the NIAID trial’s endpoints were changed two weeks ago. It’s like starting off with the goal line 100 yards away, but then, in mid-game, you shift the goal line to only 50 yards away. Many are addressing this on Twitter. Here is some of what Dr. Walid Gellad of the University of Pittsburgh wrote:
Since NIH remdesivir trial is in the news…
— Walid Gellad, MD MPH (@walidgellad) April 29, 2020
Quick summary: Breathe. Go slowly in jumping to any conclusions. Caveat lector.