More Gaslighting on COVID-19 Vaccine Harms

Michael Hiltzik published this article in the LA Times on October 24, 2023:

“Why anti-vaxers are pretending a flawed study on vaccine deaths has been vindicated”

In January 2023 the peer reviewed article I authored was published in BMC Infectious Diseases.  The study included an estimate of COVID-19 vaccine fatalities based on survey data.  Because estimated fatalities were substantial, complaints came to the journal, which triggered a re-review and ultimately retraction.  Complaints also came to my university regarding whether I conducted the study in accordance with ethical standards, which triggered an investigation.  Seven months later my university’s investigation came to a close, finding that I had followed ethical standards.  I also revised the paper, submitted it to another peer reviewed journal, and it was republished.

Mr. Hiltzik’s article relies heavily on a blog post by David Gorski.  From the tone of Gorski’s flailing post, he seems unhinged about the news of my being exonerated and the article being republished.  The editor (James Lyons-Weiler, Ph.D.) of the journal in which my article was republished provides a useful response to Gorski.  My republished article can be found here.

The controversial component of my article is that it includes a projection from the survey data to the general population on potential vaccine deaths. It is standard practice for researchers to draw inferences from survey data to a population. The ruckus is that the projected number of fatalities was large and contradicts the official narrative.  It is fair to say that for most other research topics, what I did and reported would not be controversial.

Hiltzik’s article is completely biased, but what is even more troubling than the content is what he chose to exclude.  In the process of writing his article, Hiltzik reached out to me by e-mail and I provided a response with some information.  It is instructive to read Hiltzik’s article and then look at the verifiable information on COVID-19 vaccine harms I shared as shown below. He chose not to report on the growing evidence of COVID-19 vaccine harms.

Judging by the very low COVID-19 vaccine booster uptake this fall (less than 3%), it appears that most people are seeing through the smoke. They explicitly or intuitively understand that that the COVID-19 vaccines are ineffective and unsafe.  I sense desperation in both the Hiltzik article and the Gorski post…as if they are scrambling to keep the lid on a pressure cooker that is about to blow. Perhaps the narrative of COVID-19 vaccine safety is fragile if survey research is receiving this kind of attention. I hope there is a breakthrough and relief soon so that the vaccine injured can get the medical and financial assistance they need.  Journalists have a duty to the people to give a full unbiased accounting lest they mislead the public.

See below for my e-mail message to Michael Hiltzik on October 23, 2023:

Hi Michael,

BMC Infectious Diseases has not reinstated the retracted article. Rather, the paper was revised and submitted to Science, Public Health Policy, and the Law where it underwent another review process and was published.

If I may, I’d like to share a few resources with you:

1. Perhaps you have seen the Op Ed by Dr. Pierre Kory and Mary Beth Pfeifer that appeared in USA Today on August 11, 2023, “More Young Americans Are Dying – and It’s not COVID. Why Aren’t We Searching for Answers?”  Kory and Pfeifer point to insurance data and ask why so many young people are dying. COVID doesn’t explain why Gen Z, millennials are dying. What does? (usatoday.com)
2. REACT19: 3,400 COVID Vaccine Publications and Case Reports (https://react19.org/1250-covid-vaccine-reports/#respond)

“Collection of 3,400 peer reviewed case reports and studies, across 24 general health categories, citing adverse effects post COVID vaccination.Researching Covid vaccine adverse events can be daunting in part due to a broad myriad of factors. Primarily, the information is incredibly challenging to find. Here, we share an ever growing list of peer-reviewed studies specific to Covid vaccine adverse events. This list is curated and maintained by our dedicated staff of injured PhDs and medical professionals.”

3. A recent survey by Rasmussen Reports: COVID-19 Virus Deaths vs. Vaccine Deaths (https://www.rasmussenreports.com/public_content/politics/public_surveys/covid_19_virus_deaths_vs_vaccine_deaths) (March 2023

“Nearly as many Americans believe someone close to them died from side effects of the COVID-19 vaccine as died from the disease itself. The latest Rasmussen Reports national telephone and online survey finds that 11% of American Adults say a member of their household died from COVID-19, while 86% answer no. Ten percent (10%) say a member of their household has died whose death they think may have been caused by side effects of COVID-19 vaccines, while 85% say there were no such deaths in their household.” 

Did BMC Infectious Diseases follow the guidelines provided by the Committee of Publications regarding retraction?  Here are the guidelines followed by my interpretation:

According the COPE guidelines, retraction is appropriate under the following conditions (with my reaction below each condition):

1. They have clear evidence that the findings are unreliable, either as a result of major error (eg, miscalculation or experimental error), or as a result of fabrication (eg, of data) or falsification (eg, image manipulation)

The editorial board cited no major error or miscalculation. They found no fabrication or falsification.

2. It constitutes plagiarism

The editorial board found no plagiarism.

3. The findings have previously been published elsewhere without proper attribution to previous sources or disclosure to the editor, permission to republish, or justification (ie, cases of redundant publication)

The paper had not been published elsewhere.

4. It contains material or data without authorisation for use

Not a problem either.

5. Copyright has been infringed or there is some other serious legal issue (eg, libel, privacy)

No copyright infringement.

6. It reports unethical research

No unethical research was conducted.

7. It has been published solely on the basis of a compromised or manipulated peer review process

To my knowledge, there was no compromised or manipulated peer review.

8. The author(s) failed to disclose a major competing interest (a.k.a. conflict of interest) that, in the view of the editor, would have unduly affected interpretations of the work or recommendations by editors and peer reviewers.

No problem with competing interest was cited in the retraction. I disclosed the funder of the $11,000 survey expense in the manuscript.

The retraction note can be found here:

“The editors have retracted this article as concerns were raised regarding the validity of the conclusions drawn after publication. Post-publication peer review concluded that the methodology was inappropriate as it does not prove causal inference of mortality, and limitations of the study were not adequately described. Furthermore, there was no attempt to validate reported fatalities, and there are critical issues in the representativeness of the study population and the accuracy of data collection. Lastly, contrary to the statement in the article, the documentation provided by the author confirms that the study was exempt from ethics approval and therefore was not approved by the IRB of the Michigan State University Human Research Protection Program.”

Here are my thoughts on the reasons given for retraction:

• Post-publication peer review concluded that the methodology was inappropriate as it does not prove causal inference of mortality, and limitations of the study were not adequately described.

THE ORIGINAL ARTICLE DOES NOT CLAIM CAUSAL INFERENCE AND THIS LIMITATION WAS ACKNOWLEDGED IN THE ORIGINAL STUDY, WHICH WAS KNOWN BY THE ORIGINAL REVIEWERS AND EDITORS.

• Furthermore, there was no attempt to validate reported fatalities, and there are critical issues in the representativeness of the study population and the accuracy of data collection.

THE RESEARCH WAS BASED ON AN ANONYMOUS SURVEY AND THUS IT IS NOT POSSIBLE TO VALIDATE REPORTED FATALITIES.  THIS LIMITATION WAS ACKNOWLEDGED IN THE ORIGINAL STUDY. THE EDITORS WERE AWARE OF THIS WHEN THE ARTICLE WAS ORIGINALLY PUBLISHED.

A COMPARISON BETWEEN SUMMARY STATISTICS FROM THE SURVEY AND THE POPULATION CENSUS SHOW A VERY CLOSE MATCHING.  REGARDING ACCURACY OF DATA COLLECTION, NO ONE EXAMINED THE DATA TO DETERMINE WHETHER THERE WAS AN ISSUE WITH ACCURACY.

• Lastly, contrary to the statement in the article, the documentation provided by the author confirms that the study was exempt from ethics approval and therefore was not approved by the IRB of the Michigan State University Human Research Protection Program.

THIS LAST ISSUE RELATES TO YOUR QUESTION.  FROM THIS STATEMENT IT WOULD APPEAR THAT I VIOLATED SOME ETHICAL GUIDELINE.  I DID NOT.  BEFORE THE SURVEY WAS ADMINISTERED, I SUBMITTED THE SURVEY AND CONSENT FORM TO MY UNIVERSITY’S IRB.  THE IRB THEN GAVE ME THE GO AHEAD TO ADMINISTER THE SURVEY BY DETERMINING THE STUDY WAS EXEMPT FROM STRICT OVERSIGHT AND PROTOCOLS. THE STUDY IS BASED ON A SURVEY, WHICH WAS DEEMED TO POSE LITTLE RISK OF HARM TO SURVEY PARTICIPANTS. 

HOWEVER, THE PAPER INDICATES THAT THE IRB “APPROVED” THE STUDY RATHER THAN SAY THE STUDY WAS “APPROVED BY WAY OF EXEMPTION DETERMINATION”.

I SHARED WITH THE EDITORIAL BOARD THAT ALL THE SURVEY BASED RESEARCH CITED IN THE ARTICLE INDICATED THAT THE RESPECTIVE IRB’S “APPROVED” IN THE STUDIES, INCLUDING THIS STUDY THAT I COAUTHORED WHICH WAS PUBLISHED IN THE SISTER JOURNAL BMC PUBLIC HEALTH:

Shupp R, Loveridge S, Skidmore M, Green B, Albrecht D. Recognition and stigma of prescription drug abuse disorder: personal and community determinants. BMC Public Health. 2020 Jun 22;20(1):977. doi: 10.1186/s12889-020-09063-z. Erratum in: BMC Public Health. 2023 Oct 19;23(1):2049. PMID: 32571263; PMCID: PMC7310116.

BMC THEN EVALUATED WHETHER THE RESEARCH FOR THAT ARTICLE WAS CONDUCTED IN AN ETHICAL MANNER.  IN THIS CASE, BMC DECIDED THAT THE LANGUAGE COULD BE REVISED.

“The original publication of this article contained an incorrect exemption statement in the method section. The incorrect and correct information is listed in this correction article.

 Incorrect:

 The Prescription Drug Abuse survey took place between July 6 and July 16, 2016 (IRB approved October 1, 2014 by Michigan State University Human Research Protection Program).

 Correct:

 The Prescription Drug Abuse survey took place between July 6 and July 16, 2016 (IRB approved as exempt October 1, 2014 by Michigan State University Human Research Protection Program).”

THUS, THIS ARTICLE WAS NOT RETRACTED. RATHER, TWO WORDS WERE ADDED “as exempt” AND IT WAS ALLOWED TO STAND.

By my reading, the only item among the reasons that would be a clear basis for retraction is the ethical consideration.  However, BMC decided not to retract the other article with the same language issue (and shouldn’t have).  Last, my own university has now cleared me of any ethical violations.

With many journals, when there is controversy a research note describing critique(s) is encouraged.  The author is then allowed to provide a response.  In this way, discourse and debate is engendered. We all can learn something from the debate.

Michael, my article is one piece of evidence among many that the COVID-19 vaccines have resulted in injury and death.  In my opinion, there should be discourse and debate.  My hope in conducting the research was to bring attention to the issue and engender discussion. There are many vaccine injured who need medical and financial assistance.  You could help them by asking whether further investigation is warranted.

Best regards,

Mark