Great post and I love your content! I was just wondering how do we know that the suspected cases were tested by PCR and most of them turned out to be negative? I was looking at FDA briefing document and all they mention is (PCR) ''unconfirmed COVID-19''. Does ''unconfirmed COVID-19'' = PCR negative for COVID-19?
Hi Karolina! Thanks for your comment. The trial protocol required patients with symptoms of COVID-19 to be tested for COVID-19, per this statement: "If, at any time, a participant
develops acute respiratory illness, an illness visit occurs. Assessments for illness visits include a nasal (midturbinate) swab, which is tested at a central laboratory using a reverse transcriptionpolymerase chain reaction (RT-PCR) test (e.g., Cepheid; FDA authorized under EUA), or other sufficiently validated nucleic acid amplification-based test (NAAT), to detect SARS-CoV-2."
There is a section in the Pfizer FDA briefing document that discusses "suspected, but unconfirmed" cases of COVID-19. Any of these suspected cases would have had to be treated as described above. An example is given in which a patient has symptoms that are similar to COVID-19 (as well as similar to a great number of other illnesses), but ultimately tests negative.
For a test to be "suspected, but unconfirmed," the illness would have had to have been reported and the PCR test would have had to come back negative, yes. Because any such reports were immediately referred to as "suspected," they continue to be reported that way, but since very many of them ultimately were unconfirmed (ie, tested negative per the protocol), it's not likely that even a large minority of these were actually COVID-19. Keep in mind that the case definition for the trial captures a whole lot of very minor symptoms as possible COVID-19, so a very wide net was being cast here. Some slight throat irritation would be enough to add a patient to the list of "suspected" cases.
Wow, I didn't realize that his PhD isn't in anything scientific or technical. I wonder how he became a professor of "pharmaceutical health services research" with those credentials.
I think Dr. Doshi has fallen into the intellectual version of the sunk cost fallacy from economics. It feels "expensive" to abandon your "investment" in a position you've defended and advocated, even when in reality you're better off just moving on.
Note that I haven't read his blog and am relying on your summary.
Great post and I love your content! I was just wondering how do we know that the suspected cases were tested by PCR and most of them turned out to be negative? I was looking at FDA briefing document and all they mention is (PCR) ''unconfirmed COVID-19''. Does ''unconfirmed COVID-19'' = PCR negative for COVID-19?
Hi Karolina! Thanks for your comment. The trial protocol required patients with symptoms of COVID-19 to be tested for COVID-19, per this statement: "If, at any time, a participant
develops acute respiratory illness, an illness visit occurs. Assessments for illness visits include a nasal (midturbinate) swab, which is tested at a central laboratory using a reverse transcriptionpolymerase chain reaction (RT-PCR) test (e.g., Cepheid; FDA authorized under EUA), or other sufficiently validated nucleic acid amplification-based test (NAAT), to detect SARS-CoV-2."
There is a section in the Pfizer FDA briefing document that discusses "suspected, but unconfirmed" cases of COVID-19. Any of these suspected cases would have had to be treated as described above. An example is given in which a patient has symptoms that are similar to COVID-19 (as well as similar to a great number of other illnesses), but ultimately tests negative.
For a test to be "suspected, but unconfirmed," the illness would have had to have been reported and the PCR test would have had to come back negative, yes. Because any such reports were immediately referred to as "suspected," they continue to be reported that way, but since very many of them ultimately were unconfirmed (ie, tested negative per the protocol), it's not likely that even a large minority of these were actually COVID-19. Keep in mind that the case definition for the trial captures a whole lot of very minor symptoms as possible COVID-19, so a very wide net was being cast here. Some slight throat irritation would be enough to add a patient to the list of "suspected" cases.
Huh. David Gorski pointed me to this:
https://www.skepticalraptor.com/skepticalraptorblog.php/anti-vaccine-peter-doshi-attacking-about-covid-19-vaccine-clinical-trials/
Doshi is borderline antivax, apparently.
Wow, I didn't realize that his PhD isn't in anything scientific or technical. I wonder how he became a professor of "pharmaceutical health services research" with those credentials.
Respectful Insolence: https://respectfulinsolence.com/2021/01/15/why-is-peter-doshi-still-an-editor-at-the-bmj/
I just read the column--he actually links back to this COVID Transmission (because, um, I sent him a link to it, I think).
Yes! It seems you have connected me with David Gorski, which I really appreciate :)
I think Dr. Doshi has fallen into the intellectual version of the sunk cost fallacy from economics. It feels "expensive" to abandon your "investment" in a position you've defended and advocated, even when in reality you're better off just moving on.
Note that I haven't read his blog and am relying on your summary.
That's what I thought too...until you posted that other comment.