Those advocating vaccines and mandates appeal to science, primarily RCTs that supposedly offer gold standard evidence.
The vaccine RCTs were run by Contract Research Organizations, who subcontracted to other CROs, who subcontracted to other CROs. We know that paperwork in CRO centres was fudged, and people who were injured and died went missing (1). We also know the regulators have not seen and do not have access to the raw data from these trials.(2) Nor do the public health, government ministers and others who advocate mandates.
We know that the trials were ghostwritten, and even though dead patients went missing, likely preferentially among those taking the vaccine, we know that there was a clear excess of trial volunteers dying on the Pfizer vaccine than on placebo.(3)
The supposed miraculous benefits we have heard about centre on fewer infections. There may have been just the same number of infections with the injections damping symptoms, making the vaccinated more likely to spread the virus and kill vulnerable others. We simply don't know if this was the case.
Is it possible MHRA or FDA would approve a treatment that didn’t work? The answer is yes. If they knew it didn’t work, would they tolerate articles in prestigious journals claiming it did work. The answer is yes - MHRA and FDA have a track record here that they cannot escape (4).
We are told the real-world evidence shows that it is the unvaccinated who are dying in hospitals. This apparent mismatch with the trial evidence needs to be reconciled. The onus though is on those advocating mandates who claim RCTs offer the gold-standard evidence to engage with the issue. CDC and MHRA have also had several-fold more reports of deaths immediately after vaccination in one year from Covid vaccines than from all other vaccines combined over a decade.(5) These too need taking into account.
I hesitate hoping you will listen to my reasons and help reduce the number of deaths stemming from the pandemic of overtreatment we have. Life Expectancy was falling pre Covid in the US and UK almost certainly because of an across the board trial data sequestration and ghost writing of trials, which allows a hyping of treatment benefits and a hiding of harms - and overtreatment as a result (6).
In the name of science, whose norms require data access, we should refuse all treatments until companies make all data fully accessible, allowing us to work out a policy that makes most sense.
Lots of medical advocates for mandates talk in terms of moral injury. I see lots of patients seriously injured by the vaccines and families of people who have died. They are gaslighted, told they have mental health problems, and face a wall of anger if they ask about a possible vaccine input.
Although I risk being struck off for mentioning these things, this response is not anonymous
1. Thacker P. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ 2021;375:n2635
2. Healy D, Le Noury J, Wood J. Children of the Cure. Samizdat Press, Toronto 2020.
3. Naik R. Summary Basis for Regulatory Action. November 8, 2021 https://www.fda.gov/media/151733/download
4. Healy. Did regulators fail over selective serotonin reuptake inhibitors. BMJ 2006, 333, 92-95.
5. Center for Disease Control: https://wonder.cdc.gov/vaers.html; Medicines and Healthcare products Regulatory Agency: www.gov.uk/mhra
6. Healy D. Shipwreck of the Singular. Healthcare’s Castaways. Samizdat Press, Toronto 2021.
Competing interests:
I have a pre-vaccine rollout position on these issues, with which in August 2020 most healthcare staff would likely have agreed.
Johnson RM, Doshi P, Healy D (2020). Covid-19: Should doctors recommend treatments and vaccines when full data are not publicly available? BMJ 2020;370:m3260 http://dx.doi.org/10.1136/bmj.m3260
Rapid Response:
A Reason for Hesitancy
Dear Editor
Those advocating vaccines and mandates appeal to science, primarily RCTs that supposedly offer gold standard evidence.
The vaccine RCTs were run by Contract Research Organizations, who subcontracted to other CROs, who subcontracted to other CROs. We know that paperwork in CRO centres was fudged, and people who were injured and died went missing (1). We also know the regulators have not seen and do not have access to the raw data from these trials.(2) Nor do the public health, government ministers and others who advocate mandates.
We know that the trials were ghostwritten, and even though dead patients went missing, likely preferentially among those taking the vaccine, we know that there was a clear excess of trial volunteers dying on the Pfizer vaccine than on placebo.(3)
The supposed miraculous benefits we have heard about centre on fewer infections. There may have been just the same number of infections with the injections damping symptoms, making the vaccinated more likely to spread the virus and kill vulnerable others. We simply don't know if this was the case.
Is it possible MHRA or FDA would approve a treatment that didn’t work? The answer is yes. If they knew it didn’t work, would they tolerate articles in prestigious journals claiming it did work. The answer is yes - MHRA and FDA have a track record here that they cannot escape (4).
We are told the real-world evidence shows that it is the unvaccinated who are dying in hospitals. This apparent mismatch with the trial evidence needs to be reconciled. The onus though is on those advocating mandates who claim RCTs offer the gold-standard evidence to engage with the issue. CDC and MHRA have also had several-fold more reports of deaths immediately after vaccination in one year from Covid vaccines than from all other vaccines combined over a decade.(5) These too need taking into account.
I hesitate hoping you will listen to my reasons and help reduce the number of deaths stemming from the pandemic of overtreatment we have. Life Expectancy was falling pre Covid in the US and UK almost certainly because of an across the board trial data sequestration and ghost writing of trials, which allows a hyping of treatment benefits and a hiding of harms - and overtreatment as a result (6).
In the name of science, whose norms require data access, we should refuse all treatments until companies make all data fully accessible, allowing us to work out a policy that makes most sense.
Lots of medical advocates for mandates talk in terms of moral injury. I see lots of patients seriously injured by the vaccines and families of people who have died. They are gaslighted, told they have mental health problems, and face a wall of anger if they ask about a possible vaccine input.
Although I risk being struck off for mentioning these things, this response is not anonymous
1. Thacker P. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ 2021;375:n2635
2. Healy D, Le Noury J, Wood J. Children of the Cure. Samizdat Press, Toronto 2020.
3. Naik R. Summary Basis for Regulatory Action. November 8, 2021 https://www.fda.gov/media/151733/download
4. Healy. Did regulators fail over selective serotonin reuptake inhibitors. BMJ 2006, 333, 92-95.
5. Center for Disease Control: https://wonder.cdc.gov/vaers.html; Medicines and Healthcare products Regulatory Agency: www.gov.uk/mhra
6. Healy D. Shipwreck of the Singular. Healthcare’s Castaways. Samizdat Press, Toronto 2021.
Competing interests: I have a pre-vaccine rollout position on these issues, with which in August 2020 most healthcare staff would likely have agreed. Johnson RM, Doshi P, Healy D (2020). Covid-19: Should doctors recommend treatments and vaccines when full data are not publicly available? BMJ 2020;370:m3260 http://dx.doi.org/10.1136/bmj.m3260