Gary Schwitzer is the founder of HealthNewsReview.org and has been its publisher for 14 years. He tweets as @garyschwitzer or as @HealthNewsRevu
This is what STAT reported in what they labeled an “Exclusive” last evening.
Early peek at data on Gilead coronavirus drug suggests patients are responding to treatment
Fox News picked up on the STAT story, but added its own caveats:
“Partial data from an ongoing clinical trial is by definition incomplete and should never be used to draw conclusions about the safety or efficacy of a potential treatment that is under investigation,” said a spokeswoman for University of Chicago Medicine, in a statement emailed to Fox News.”In this case, information from an internal forum for research colleagues concerning work in progress was released without authorization. Drawing any conclusions at this point is premature and scientifically unsound.”
A Gilead spokeswoman told Fox News that the totality of data need to be analyzed in order to draw any conclusions from the trial. “Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19,” she said, in an emailed statement. “We expect the data from our Phase 3 study in patients with severe COVID-19 infection to be available at the end of this month, and additional data from other studies to become available in May.”
“We are grateful for all of the efforts of investigators and patients participating in our studies and look forward to sharing the results from the complete dataset,” the spokeswoman added.
Gilead Sciences Inc’s shares surged 16% in after hours trading on Thursday following a media report detailing encouraging partial data from trials of the U.S. company’s experimental drug remdesivir in severe COVID-19 patients.
CNBC also had news for investors, but with a different perspective: Investors should be cautious on the potential for Gilead’s drug Remdesivir, analysts say.
A new report from STAT News on Gilead’s experimental drug Remdesivir serves as an encouraging update on the drug’s potential to fight Covid-19, however analysts argue it’s largely anecdotal and should be interpreted with caution.
Covid-19 patients who are getting an experimental drug called remdesivir have been recovering quickly, with most going home in days, STAT News reported Thursday after it obtained a video of a conversation about the trial.”
It took CNN 10 paragraphs to get to the caveats:
However, the trial does not include what’s known as a control group, so it will be difficult to say whether the drug is truly helping patients recover better. With a control arm, some patients do not receive the drug being tested so that doctors can determine whether it’s the drug that is really affecting their condition.
Strong cautions from the company that make the drug aren’t reported until the very end of the story.
Scientist and former pharmaceutical executive Rick Wobbe wrote on one of the journalist’s Facebook page:
I hope the optimism is justified. Thus far, preliminary statements regarding uncontrolled studies haven’t withstood further scrutiny very well.
Overnight on Twitter, oncologist Vinay Prasad starting addressing this and has continued today:
I want remdesivir to succeed
Today’s report from Chicago is not proof of benefit
Rct of remdesivir v standard of care endpoint survival OR
Rct remdesivir v placebo endpoint 7pt scale
If you dont produce this data, many will remain critical
We want Rx that work not snakeoil
— Vinay Prasad (@VPrasadMDMPH) April 17, 2020
Michigan cardiologist Venk Murthy, MD, on Twitter:
Great thread by @jeremyfaust unpacking claims by aweful article giving unauthorized info from remdesivir trial.
Short answer: don’t jump to any conclusions yet. https://t.co/6ejwTaH1yC
— Venk Murthy (@venkmurthy) April 17, 2020
That is emergency medicine physician Jeremy Faust, MD whose thread Dr. Murthy praised. Faust also tweeted:
You could spin it as GREAT NEWS (“Only two people died so far out of 113!”). Or you can spin it to be TERRIBLE NEWS (“Holy shit, two people died, and probably ZERO should have!”).
— Jeremy Faust MD MS (@jeremyfaust) April 17, 2020
Penn research ethicist Steven Joffe, MD, on Twitter:
Preliminary, partial, should never have been leaked. Violation of trial integrity.
There are also clear questions about journalism ethics, basing a story in the middle of a pandemic on a pirated copy of a video of a researcher sharing her unpublished findings with faculty colleagues.
We will add to this post in the days to come.
Addendum:
Later on April 17, the two STAT journalists, Adam Feuerstein and Matthew Herper, hosted a one-hour Zoom chat which they called, “What we know about Gilead’s remdesivir data.”
6 days later, on April 23, STAT reported, “New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope.” The remdesivir rollercoaster rides on.
Opinions on other issues in news, journals, PR, advertising, marketing
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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