Transparency by drug corporations, scrutiny by journalists, very important in vaccine information

Pfizer’s chairman and CEO proclaimed in a Pfizer company news release: “Today is a great day for science and humanity.” In that PR news release – but only in that format – Pfizer announced early results of “a vaccine efficacy rate above 90%, at 7 days after the second dose.”
That’s about all we know – what Pfizer says about its own vaccine.  The data have not been published or publicly released – only that 90% number.
Regarding safety, the Pfizer company news release stated, “no serious safety concerns have been observed.”  Because no raw data have been released, we don’t know how “serious” was defined.
Pfizer did project: “We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
In an early story, STAT did a good job covering caveats and limitations. Excerpts:
“…key information about the vaccine is not yet available. There is no information yet on whether the vaccine prevents severe cases, the type that can cause hospitalization and death.
Nor is there any information yet on whether it prevents people from carrying the virus that causes Covid-19, SARS-CoV-2, without symptoms.

“If that headline really number really holds up, that is huge. That is much better than I was expecting and it will make a huge difference,” said Ashish Jha, the dean of the School of Public Health at Brown University. He cautioned, however, that it is always difficult to evaluate science via press release and that researchers will need to see the full results. He noted that side effects are something to watch, because even if there are no serious long-term complications, people feeling sick for a day or two could lead some to be hesitant to take a vaccine.

The story of how the data have been analyzed seems to include no small amount of drama. Pfizer, seeing an opportunity to both help battle a pandemic and demonstrate its research prowess, made decisions that were always likely to make its study the first of a Covid-19 vaccine to produce data.
The New York Times reported:
Pfizer…released only sparse details from its clinical trial.

Independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. And no one knows how long the vaccine’s protection might last.

(A senior Pfizer VP) sought to distance the company from Operation Warp Speed and presidential politics, noting that the company — unlike the other vaccine front-runners — did not take any federal money to help pay for research and development.
Vox was clear to include important caveats even with the limitations of a Twitter post:

Pfizer and BioNTech reported Monday that their Covid-19 vaccine is more than 90 percent effective in an early analysis.
Caveats:—The results came in a press release, not a study—They’re based on just 94 cases—The clinical trial isn’t complete
https://t.co/dKBaeHbdOT
— Vox (@voxdotcom) November 9, 2020

That level of scrutiny, especially with one of the first news stories out of the gate, is crucial. Not everyone met that standard.
When BuzzFeed headlined, “Pfizer’s coronavirus vaccine is more than 90% effective, early data says,” journalist Paul Thacker suggested a repair for that headline – “Pfizer’s Coronavirus Vaccine Is More Than 90% Effective, Says Incomplete Data That Has Not Been Validated By Independent Experts.” The story twice used the phrase “extremely promising.” Strunk and White, in The Elements of Style, suggested eliminating unnecessary words.  “Extremely” is unnecessary.  And “promising” is one of my longstanding seven words you shouldn’t use in medical news.
CNN had no independent perspective in its first story.
Fox News overpromised, stating: “FOX Business takes a look at the key data points investors and consumers should know.”  But there were no key data released – only the Pfizer announcement of “90% effective.”
Of course, much of the second wave of news already celebrates the leap in Pfizer stock, and in the stock market in general, in response to the Pfizer PR news release.
Scientist James Heathers tweeted:

I’ll believe plague vaccine news when it is accompanied by granular data. Press releases over the last seven months have not exactly worked out for us.
— ?James Heathers ? (@jamesheathers) November 9, 2020

Just last week, professors Jennifer Miller, Joseph Ross and Michelle Mello published on STAT, “Far more transparency is needed for COVID-19 vaccine trials.” Their concluding line:  “Transparency will help ensure this achievement is trusted.”  You be the judge whether today’s Pfizer PR news release met those trust and transparency standards.

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Glare on 2020: You may’t masks my actuality

It is deeply disheartening for me to reflect on how health care information was miscommunicated so often by so many different players in 2020.  In my 47-year career, I never saw a President, his Administration, some federal health agency leaders, many elected officials and so many others distort and deceive and mislead Americans so often on vital health care issues as I witnessed this past year.  Some news organizations and individual journalists rose to new heights in clarifying and analyzing to help the public.  But other corners of the journalism and public relations professions sunk to the bottom of the daily drumbeat of dreck – harming more than helping.
On this page I am posting links to each of the 44 articles I published on HealthNewsReview.org in 2020. I wrote all but four of them; the others were written by Mary Chris Jaklevic, who now writes for the Journal of the American Medical Association (JAMA).
Many of the lessons embedded in these posts are as valid today as they were even if published months ago.
January 15: A machine-versus-doctors fixation masks important questions about artificial intelligence.
January 17: How easy it is to be misled by Medicare Advantage marketing 
(The 2-month gap in publishing occurred when I thought it was safe to go on vacation. You can see that ended abruptly in March.) 
March 19: News release labeling to combat a global scourge of exaggerated claims 
March 20: Suffering sciatica! How 2 stories on same study reported with different emphases 
March 22:
The President and the pandemic: two months of dithering, deceit and distortion

March 26: Federal health agencies block journalists’ access to COVID-19 experts & information. 
April 1: Strong caveats are lacking as news stories trumpet preliminary COVID-19 research
April 9: Self-promoting MDs hawk unproven COVID-19 pandemic treatments
April 16: ‘Love your lungs’? Exaggerated screening claims seem more out of step than ever
April 17: Slow down your giddy on Gilead news
April 21: NY Times “Well” column is unwell again – this time on pandemic running advice
April 23: Shining a light on super-spreaders of coronavirus misinformation
April 29: The COVID-19 research news rollercoaster is running again: STAT News + Gilead’s remdesivir
April 30:
What the public didn’t hear about the NIH remdesivir trial

May 3: The start of a study is often not newsworthy – even when you bring God into it
May 5: Thanks for missing HealthNewsReview.org, but it’s still here
May 5: Mutant coronavirus story upsets scientists about preprint journalism
May 7: Flubs and flaws in New York Times stories on llamas and coffee
May 19: Warning: early vaccine trial results don’t always stand test of time
May 20: 
Journalism in pandemic: online training for thousands of international journalists

May 21: Avoid single patient, single source COVID-19 stories – especially on “cures”
June 2:  60 Minutes promotes one hospital’s “promise of plasma”
June 3: Reuters report is another classic case study in how NOT to cover COVID-19 news
June 12: Same old, same old, with NY Times Well column – bisphosphonates for pneumonia this time
June 16: Following the dexamethasone COVID-19 drug news as it unfolds
June 17: Pharma PR appears as unvetted COVID-19 vaccine news in STAT newsletter
June 30: For breakfast, give me 2 observational studies and an anti-irritant 
July 3: Some global reaction to the news of US mass purchase of remdesivir 
July 13: Why make international news out of 9 vague patient reports on remdesivir?
July 17: Criticism of NY Times’ Coronavirus Drug and Treatment Tracker 
July 21: JAMA: Communicating Science in the Time of a Pandemic
JAMA: Communicating Science in the Time of a Pandemic

July 21:  One day of COVID-19 drug & vaccine news provides cautious reminders 
July 24:  HealthNewsReview.org in the news about COVID-19 
July 28: What you need to know about the Alzheimer’s test news
July 30: Things you should think about when you hear “vaccine by end of the year” 
August 5:  Drug company influence on journalism 
August 6: Crazy week of PR & news on studies should teach us how/what to ignore
August 24: Convalescent plasma: another controversial clash of politics & science
September 4:  It has come to this: ignore vaccines-in-animals drug industry PR & news
September 7:
Perfect storm of politics, PR, polluted messages to the public

September 24: How COVID-19 drug/vaccine decisions might be based on little evidence
November 9: Post-election health report: a time for healing 
November 9: Transparency by drug companies, scrutiny by journalists, vital in vaccine news
November 23:  “Investigating Health & Medicine” – Global Investigative Journalism Network Our contribution to a new global resource 

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Assist websites hype Apple Look ahead to COVID-19 prediction with out offering the proof

Milwaukee oncologist Michael Thompson, MD, wrote to me yesterday morning (February 10)  about an article – “New Study Suggests Apple Watch Heart Rate Sensor Can Predict COVID-19 Up to a Week Before a Swab Test” – promoted on Twitter by MacRumors.com. The story was about the so-called Warrior Watch Study at Mount Sinai Medical Center in New York.
MacRumors is a website that claims that it “attracts a broad audience of both consumers and professionals interested in the latest technologies and products. We also boast an active community focused on purchasing decisions and technical aspects of the iPhone, iPod, iPad, and Mac platforms.”
That broad audience may want to ask for more evidence and fewer rumors.  Dr. Thompson did, and didn’t like what he saw – or, rather, what he didn’t see.  He tweeted:

You should link to the primary data in @jmirpub . That primary source is not in your article or in Feb 9, 2021 @TechCrunch by @etherington. It is hard to review the data and understand how important this is without that. #scicomm
— Mike Thompson, MD, PhD, FASCO (@mtmdphd) February 10, 2021

MacRumors linked to a TechCrunch.com story which also didn’t link to the journal article describing the research.
The MacRumors editor responded on Twitter:

Wrong. The journal in question is, indeed, open access. They looked for the source article but couldn’t find it, but that didn’t stop them from making sensational claims based on something written by another news source.  Wow.
I didn’t have any difficulty finding the journal article online, nor did other MacRumors readers. One of them pointed out the limitations of the research acknowledged by the researchers, something MacRumors and TechCrunch ignored. Those limitations included:  a small sample size – which the researchers admit limits their ability to determine how predictive this may really be; only “sporadic collection” of relevant data by the Apple Watch; and the fact that the study relied on self-reported data, “precluding independent verification of COVID-19 diagnosis.”  Dr. Thompson pointed out that those who were COVID-infected in the study were relatively young and mainly women – so the data may not be generalizable to the broader population.
As always, when researchers acknowledge limitations of their work like these, it’s important for journalists to convey those limitations to readers before they run off to make their new Apple Watch purchase.
A late change to the story
A link to the journal article was added to the MacRumors story sometime after it was published.  The website shows that the original post was published at 1:27 am on February 10 with an edit at 5:27 am. But the Internet Archive Wayback Machine scan of the site at 10:06 am on February 10 did not show a link to the journal article, just as Dr. Thompson had stated. I wrote to the MacRumors editor on Twitter about this but have not yet received a response. Perhaps the change was made in response to reader criticism.
What’s wrong with this picture?
First, it’s weak journalism (can you even call it journalism?) to report a story based at least largely – if not solely – on what another technology website published. This was MacRumors basically scraping what TechCrunch reported (and not very well to begin with) and then throwing it up on their own website 10 hours later.
Second, this isn’t just the latest buzz about the Apple Watch.  It’s a story that makes a sensational claim related to early COVID-19 detection. And you’ll see below how some MacRumors readers were sucked in by the story’s claims – all without any data provided.
Third, as originally published, there was no link to – and no independent analysis of – the journal article that reports on the Apple Watch study findings. As Dr. Thompson tweeted, “It is hard to review the data and understand how important this is without that.” 
Fourth, it is not optimal web publishing practice to make a change (like adding a link to the journal article hours after publishing) without noting the change for readers.  Dr. Thompson, who is one of the most web-savvy physicians I know, wrote to me: “The guy could have just said. Oops, my bad. I added it. Thanks, man.”
Impact on readers
Several dozen reader comments were published on the MacRumors forum.
One reader commented:  “News flash. Apple Watch cures common cold and cancer. Quick run out and buy several.”
Another reader – apparently a physician who actually read the journal manuscript, wrote: “This headline (“New Study Suggests Apple Watch Heart Rate Sensor Can Predict COVID-19 Up to a Week Before a Swab Test”) is misleading. The watch CANNOT predict infection a week before the swab detects COVID.”
But another reader comment is exemplary of the other end of the spectrum:  “The Apple Watch could very well end up being one of the most significant medical devices ever made in human history.” Unless, of course, this comment was meant to be sarcastic. But there were other gee-whiz reactions from readers – spawned to some degree, in my view, by “journalism” like we saw in this case.
In addition to MacRumors and TechCrunch stories, 24/7 WallSt.com posted something that was based on the MacRumors article, which was based on the TechCrunch article.  Dizzy yet?  Unimpressed yet?
This wasn’t even news
A pre-print of the manuscript eventually accepted for publication by the Journal of Medical Internet Research was posted on the medRxiv.org website on November 7, 2020 – more than 3 months ago.
In mid-January of 2021 – about a month ago -stories based on that November pre-print were reported by CBS News, AppleInsider.com (based on the CBS story), Tom’sGuide.com, and 9to5Mac.com.
And stories by Bloomberg, USA Today and Forbes – about studies of wearable devices’ ability to predict COVID-19 infection –  were published seven to nine months ago.
Summary
If you really wanted to do a decent job on this topic this week, you could have had a reporter studying the November preprint for the past three months, getting many independent expert perspectives.  You could have included some of the perspectives reported at least seven to nine months ago about other research in the field.
Instead, readers didn’t get much at all this time around.

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June 24, 2021

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Gary Schwitzer is the founder and publisher of HealthNewsReview. He has covered health care news almost exclusively since 1973. Here is his online bio.  He tweets as @garyschwitzer or as @HealthNewsRevu.
Two new journalistic analyses of 2020-2021 pandemic news coverage were released this week.  I was interviewed in each of them.
Science journalist Faye Flam produced a new episode for her “Follow the Science” podcast, with funding from the Society for Professional Journalists. She interviewed me, David Leonhardt of the New York Times and David Wallace-Wells of New York Magazine.

And science journalist Jillian Mock quoted me and about a dozen other people she had interviewed in her piece for Medscape, ‘Dreck’ to Drama: How the Media Handled, and Got Handled, by COVID.

The journalism coverage was nothing short of “overwhelming:” For over a year, the COVID-19 pandemic has been the biggest story in the world, costing millions of lives, impacting a presidential election, and quaking economies around the world.https://t.co/myDYoRkh0g
— Medscape (@Medscape) June 24, 2021

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