I am grateful to Dr Batarseh [1] for enlarging on the issue I raised in my letter of 16 April [2]. The question still arises why if this was known it was not included in public information at the time of roll out. The duties of disclosure with regard to informed consent in the United Kingdom in relation to both the Montgomery ruling and GMC guidance were for example discussed in these columns last autumn [3]. It is evident that the rarity of risk would not be an adequate reason for not mentioning it. Jay Ilangaratne, for example, quoted paragraph 89 of the Montgomery ruling [4]:
“89…..First, it follows from this approach that the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient.”
What was the position of the MHRA in relation to the AstraZeneca product - had it done due diligence but not alerted the public (noting the previous problem with anaphylaxis and PEG in relation to the Pfizer [5])?
[1] Dr. Kareem I. Batarseh, ‘ Venous Thromboembolism and Thrombocytopenia Associated With Adenoviral Vector-Based COVID-19 Vaccines: An Explanation of the Anomaly’, 19 April 2021, https://www.bmj.com/content/373/bmj.n961/rr
Competing interests:
AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
Rapid Response:
Had the MHRA done due diligence?
Dear Editor
I am grateful to Dr Batarseh [1] for enlarging on the issue I raised in my letter of 16 April [2]. The question still arises why if this was known it was not included in public information at the time of roll out. The duties of disclosure with regard to informed consent in the United Kingdom in relation to both the Montgomery ruling and GMC guidance were for example discussed in these columns last autumn [3]. It is evident that the rarity of risk would not be an adequate reason for not mentioning it. Jay Ilangaratne, for example, quoted paragraph 89 of the Montgomery ruling [4]:
“89…..First, it follows from this approach that the assessment of whether a risk is material cannot be reduced to percentages. The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available, and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive also to the characteristics of the patient.”
What was the position of the MHRA in relation to the AstraZeneca product - had it done due diligence but not alerted the public (noting the previous problem with anaphylaxis and PEG in relation to the Pfizer [5])?
[1] Dr. Kareem I. Batarseh, ‘ Venous Thromboembolism and Thrombocytopenia Associated With Adenoviral Vector-Based COVID-19 Vaccines: An Explanation of the Anomaly’, 19 April 2021, https://www.bmj.com/content/373/bmj.n961/rr
[2] John Stone, ‘Re: Covid-19: Rare immune response may cause clots after AstraZeneca vaccine, say researchers’, 16 April 2021, https://www.bmj.com/content/373/bmj.n954/rr-2
[3] Responses to Daniel Sokol ‘New guidance from the GMC: what constitutes meaningful dialogue?, https://www.bmj.com/content/371/bmj.m3933/rapid-responses
[4] Jay Ilangaratne, ‘ Re: New guidance from the GMC: what constitutes meaningful dialogue?’, 3 November 2020, https://www.bmj.com/content/371/bmj.m3933/rr-8
[5] John Stone, ‘ PEG in the Pfizer vaccine: not a good start’, 10 December 2020, https://www.bmj.com/content/371/bmj.m4654/rr-28
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance