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.
Everyday we are flooded with a tsunami of news about the race to test COVID-19 vaccines in thousands – tens of thousands – of people. When you hear about such large trials of 30,000 or more, you might be surprised by the following.
Today I pause to reflect on the very low level of evidence in very small numbers of people that might be used to try to advance coronavirus drugs or vaccines.
This week, former Harvard Medical School professor William Haseltine wrote, “Beware of COVID-19 vaccine trials designed to succeed from the start.” Excerpt:
Both Pfizer and Moderna have touted the large number of participants in their trials, at upwards of 30,000 participants slated for each. But while the full trial sizes might be large, the protocols suggest that efficacy can be proved in an initial test group of just 106 for the Moderna vaccine and in a group of 64 for Pfizer. But keep in mind only half of each group receives the vaccine; the other half receives a placebo.
The protocols suggest that successful initial interim trials for the Moderna and Pfizer vaccines would show efficacy among 74 percent and 76.9 percent of participants, respectively. This means if 39 of those who receive the vaccine do not get sick, Moderna will consider the vaccine a success. For Pfizer, the number is 25.
At this point, the Food and Drug Administration could grant emergency-use authorization. In other words, the two vaccines could hinge on the combined results of 64 people.
Haseltine concludes:
If — or perhaps when — positive early results from these trials are announced, keep my warnings in mind. These protocols seem designed to get a drug on the market sooner rather than later, on a timeline arguably based more on politics than public health. The lives of millions are at risk; we can and should demand better.
That was about vaccine trials. How about an attempt to rush into use a drug tested in just 21 people?
EndPoints News, founded by biotech journalist-analyst John Carroll, reports that a small biotech company is asking the FDA for emergency use authorization (EUA) for its drug, aviptadil, based on the results of just 21 people.
University of Minnesota virologist David Boulware emailed EndPoints News: “Their reported results are very good but not earth shattering. Without a randomized control group, what the true actual effect is unknown. If highly effective, then a small randomized clinical trial should be able to quickly confirm these initial results.”
The story notes, “The only other company to discuss their intention to file for an EUA, Eli Lilly, did so after results came back from a randomized control study testing their antibody in over 450 patients.”
I’ve been meaning to write about news coverage of that Lilly announcement from last week.
Carroll of Endpoints News wrote about that Lilly antibody drug, “Analysts are quick to pan Eli Lilly’s buzzing first cut of positive clinical data for its COVID-19 antibody.” He described the scope of one reported outcome as “tiny.”
But, you see, these Lilly results were not published in a journal. They were announced in a company PR news release. And many journalists reporting on such announcements do not have the specialization or experience of someone like Carroll or his website.
Predictably, there was a broad spectrum in the quality of news coverage of this PR announcement.
Focusing on speed dumps us into the political arena, in which it was reported that:
President Trump said a plan by the Food and Drug Administration to issue tough new standards for emergency approval of a coronavirus vaccine “sounds like a political move” and warned that the White House might reject it.
History is being made. How will we look back on these days a year from now?
Opinions on other issues in news, journals, PR, advertising, marketing
We’ve written about the hype of liquid biopsies for years (see link in comment below). And now this…. https://www.statnews.com/2022/01/12/medicare-shouldnt-cover-liquid-biopsies-early-cancer-detection/
Case counts still matter. “(There) are stories that may not be told adequately if only hospitalizations and deaths are emphasized.” @garyschwitzer interviewed by @dbauder of @AP. https://apnews.com/article/omicron-changing-news-outlets-covid-data-da9272f7c4c8a109c3bfb56bed9e9c76
My friend Gary @garyschwitzer wrote to his city council representative in a Minnesota town about a Viva Las Vegas event scheduled for January.
The response he got seems to perfectly capture where we are now.
https://www.healthnewsreview.org/2021/12/2021-ends-with-covid-craziness-in-sports-and-politics/
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Comments are closed.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like