Pandemic Update for 2022-02-11: Challenge — 7 Comments

  1. Very interesting human SARS-CoV-2 challenge study. I’m slightly curious as to what their acceptance criteria were to exclude over 99% of study volunteers. Wow! Also, seeing Eric Topol’s being quoted brought back a rush of memories to me. Eric was a participant in several CV programs I put together back in the late 80s and early 90s during meetings of the American College of Cardiology and the Heart Association. I was a regional Clinical Liaison for the old Dupont Pharmaceuticals, and worked closely with cardiology thought-leaders in presenting programs on several of our CV products. He was a pretty cool guy who loved expensive wine! He also “sold” a lot of drug for us. 😁 So. good to see him getting out front with this issue.

    • Eric Topol is one of a handful (well, maybe several dozen) of experts who gets quoted all the time in the popular media on pandemic subjects. As to the challenge study’s exclusion criteria: I made a copy of the decision flowchart from their paper. Click on the thumbnail here to open it in a new window.

      • Lazy me! I never looked further than the abstract on that study. However, looking at the flow chart, it appears that the 27,000 “candidates” is a false population. The 36 selected — 32 actually followed — was the true population. In reality, that’s way too small (I feel) to develop any reasonable clinical conclusions or extrapolations to the general population.

        Interestingly enough, two years after I did my final CV program for Dupont, I totally changed careers, transitioning rapidly from medical marketing to IT / QA project management. Talk about “presto-change”!

        Thanks for the response, Keith!

        • The initial call for volunteers, and the 27K respondents, were internet-based. It’s not a big surprise that many of them didn’t meet criteria. (Though from the flowchart I would bet that not all of the detailed criteria were spelled out in advance.)

          The study was approved for a cohort of up to 90 participants. And the approval process was probably the most rigorous in recent years. It took 10 months and involved boards and committees and academic trustees weighing the details of the proposed study against international criteria for ethical research, local laws, and their own moral sense. If the researchers had proposed a study population of 1,000 I seriously doubt their proposal would have been approved.

          • Yup! I’m sure the safety board was a little shaky about that protocol, too. Live, un-attenuated deadly virus!? Yikes!

          • Remember that when the researchers made their application, there was no vaccine. By the time it was approved and the study started, both vaccine and, more important to this study, monoclonal antibody treatments existed. So the risk of progression to severe disease, already low because of the age & condition of the volunteers, was rendered even lower. The protocols had strict criteria that would have triggered mAb treatment if any subject showed particular symptoms.

            In other words, the real risk to the participants was quite low. They exchanged 2 weeks of their lives, plus follow-up, for £4,500 and had little concern about it. Long Covid, what dat? But no bad outcomes were recorded.

  2. Another extremely helpful issue! (I know it’s a “post” but it has become a “publication” for me.)

    Ron’s career change reminds me that my first full-time job involved creating interactive multimedia lessons, and pharmaceutical companies were our biggest clients. I even joined American Medical Writers Association and in 1982-83 served as the chair of their Multimedia section. (During my term I had a breakdown for unrelated reasons, but still it was an honor.) Most of the AMWA members in multimedia were using laserdiscs for various interesting applications … ah, memories!

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