The British Medical Journal got another chance — and missed again

In a recent post, I provided evidence of misclassification bias in those first studies from Israel about COVID vaccine effectiveness. As mentioned at the end of that post, I offered the British Medical Journal (BMJ) a short piece for their Analysis Section. They declined.

I tried again. This time I sent them a short letter to the editor in a format called Rapid Response. Check out the kind of material that is published there. I would say that the criteria are fairly loose.

My letter was a Rapid Response to this News item. (There is no requirement that a Rapid Response to an article be submitted within a specific timeframe.)

https://www.bmj.com/content/372/bmj.n567

Here is my letter:

Title: Vaccine effectiveness studies from Israel suffered from severe misclassification bias of the mortality endpoint

Dear Editor,

“Real world” studies from Israel of vaccine effectiveness against death from COVID have relied on official classification of the cause of death during the vaccination campaign.[1, 2] We now have solid evidence that those studies suffered from 50% misclassification of the mortality endpoint.

The Israel Central Bureau of Statistics (CBS) estimated excess deaths versus COVID deaths in various periods. Between December 2020 and March 2021 — the first vaccination campaign — the ministry of health reported 3,298 COVID deaths in Israel, but CBS estimated only 1,641 excess deaths. The CBS graph and table can be found elsewhere.[3]

You cannot post a figure in a Rapid Response. I provide it here again, for your convenience.

Evidently, half of reported COVID deaths at that time were not caused by COVID. They were part of background winter mortality in Israel, did not account for excess deaths, and could not have been prevented by a COVID vaccine. Therefore, those “real world” studies of vaccine effectiveness were subject to an unacceptable rate of misclassification of the mortality endpoint, and likely similar misclassification of correlated endpoints such as severe COVID and COVID hospitalization. As pointed out in an earlier response by Retsef Levi and Avi Wohl,[4] misclassification was probably differential (dependent on vaccination status).

Would reviewers have supported publication, had they known it back then?

Eyal Shahar, MD, MPH

Professor Emeritus

Footnotes

1. Dagan N, Barda N, Kepten E et al. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. N Engl J Med 2021; 384:1412–23

2. Hass, EJ, Angulo, FJ, McLaughlin, JM. et al. Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalizations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data, Lancet, 2021; 397:1819–29

3. https://medium.com/@shahar-26393/pfizer-vaccine-and-covid-mortality-a-call-for-retraction-of-publications-from-israel-15f5e67e6f7f

4. https://www.bmj.com/content/372/bmj.n567/rapid-responses

What was the fate of the letter?

The BMJ acknowledge receipt of a Rapid Response but does not inform about rejection. Here is part of their boilerplate acknowledgement message.

Unless a surprise is waiting for me in the near future, my letter was rejected. Why? Let’s try a multiple choice answer (choose one):

1. The editor found a fatal mistake in the argument

2. The editor decided that the topic was not of interest to their readers

3. The editor thought it would be too risky to publish anything that undermines the credibility of those studies

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Professor Emeritus of Public Health (University of Arizona); MD (Tel-Aviv University, Israel); MPH, Epidemiology (University of Minnesota)

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Eyal Shahar

Professor Emeritus of Public Health (University of Arizona); MD (Tel-Aviv University, Israel); MPH, Epidemiology (University of Minnesota)