Re: Vaccine hesitancy: an interview with Stanley Plotkin, rubella vaccine developer
Dear Editor
I disagree with Stanley Plotkin [1]: the public understand very well why they might wish to be protected against infectious diseases but the issue is whether the products are safe, and when they doubt they may have both personal experience and negative scientific information which could be bearing upon their judgment. Notably, when Plotkin wrote with Heidi Larson and Paul Offit to BMJ Rapid Responses earlier this year the troubling absence of rigorous pre-marketing double-blind safety trials was raised by Profs David Healy, Christopher Exley and myself [2].
The public are constantly regaled with claims of safety, relative safety (i.e. “the benefits outweigh the risks”), the importance of herd immunity etc., but the fact that people who report harms are shunned and disparaged does not in itself inspire confidence. Citing how many ordinary citizens have succeeded in suing the US government [1] may also not be very meaningful when in the same space three-quarters of a million cases have accumulated on the Vaccine Adverse Event Reporting System (VAERS) [3] and this is a passive reporting system which may only represent a small fraction events.
One issue Plotkin might like to address is the continuing use of aluminium adjuvants despite widespread scientific condemnation [4-25]. It is not the only vaccine safety issue but the obliviousness of global and governmental health organisations to it is perhaps indicative of a wider apparent indifference.
The lack of spontaneous public enthusiasm for vaccine lobby hegemony is perhaps well represented by the saga of Voices for Vaccines [1] which was discussed by me and Peter Doshi in the Rapid Responses to his article “The unofficial vaccine educators: are CDC funded non-profits sufficiently independent?” [26,27], and quite evidently the independence of vaccine science should be just as critical as any other.
[1] Elisabeth Mahase, 'Vaccine hesitancy: an interview with Stanley Plotkin, rubella vaccine developer', BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6926 (Published 23 December 2019)
[4] Jørgensen L, Gøtzsche PC, Jefferson T.'The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias', BMJ Evid Based Med. 2018 Oct;23(5):165-168. doi: 10.1136/bmjebm-2018-111012. Epub 2018 Jul 27
{5] Lars Jørgensen, Peter Doshi, Peter Gøtzsche, Tom Jefferson, 'Challenges of independent assessment of potential harms of HPV vaccines', BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3694 (Published 24 September 2018)
[6] Emma Shardlow, Matthew Mold and Christopher Exley, 'Unraveling the enigma: elucidating the relationship between the physicochemical properties of aluminium-based adjuvants and their immunological mechanisms of action,', 7 November 2018, Allergy, Asthma & Clinical Immunology201814:80 https://doi.org/10.1186/s13223-018-0305-2
[7] Lee SH, 'Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil, J Inorg Biochem. 2012 Dec;117:85-92. doi: 10.1016/j.jinorgbio.2012.08.015. Epub 2012 Aug 30.
[8] Lee SH, 'Melting profiles may affect detection of residual HPV L1 gene DNA fragments in Gardasil®.', Curr Med Chem. 2014 Mar;21(7):932-40.
{9] Peter Doshi, Tom Jefferson, Mark Jones, Kyungwan Hong, Larissa Shamseer, Haeyoung Lee, O’Mareen Spence, Florence Bourgeois, 'Call to action: RIAT restoration of a previously unpublished methodology in Gardasil vaccine trials', 11 January 2019, https://www.bmj.com/content/346/bmj.f2865/rr-7
[10] Gerwyn Morris, Basant K. Puri, and Richard E. Frye, ‘The putative role of environmental aluminium in the development of chronic neuropathology in adults and children. How strong is the evidence and what could be the mechanisms involved?’ Metab Brain Dis. 2017; 32(5): 1335–1355. Published online 2017 Jul 27. doi: 10.1007/s11011-017-0077-2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5596046/
[12] M.S. Petrik, M.C. Wong, R.C. Tabata, R.F. Garry, C.A. Shaw, 'Aluminum adjuvant linked to Gulf War Illness induces motor neuron death in mice', Neuromolecular Med., 9 (no.1) (2007)
83-100. Https://www.Ncbi.nlm.nih.gov/pubmed/17114826
[13] G. Crépeaux, R.K. Gherardi, F.J. AuthierAsia, 'Chronic fatigue syndrome, and selective low dose neurotoxicity of aluminum adjuvants' J. Allergy Clin. Immunol. Pract., 6 (no.2) (2018), p. 707 Https://doi. Org/10.1016/j. Jaip.2017.10.039. Https://www.Ncbi.nlm.nih.gov/pubmed/29525002. Mar - Apr 2018
[14] R.K. Gherardi, G. Crépeaux, F.J. Authier, 'Myalgia and chronic fatigue syndrome following immunization : macrophagic myofasciitis and animal studies support linkage to aluminum adjuvant persistency and diffusion in the immune system'
Autoimmun. Rev., 18 (no.7) (2019), pp. 691-705 Https://doi. Org/10.1016/j. Autrev.2019.05.006. Https://www.Ncbi.nlm.nih.gov/pubmed/31059838
[15] J.D. Masson, G. Crépeaux, F.J. Authier, C. Exley, R.K. Gherardi 'Critical analysis of reference studies on the toxicokinetics of aluminum-based adjuvants',
J. Inorg. Biochem., 181 (04) (2018), pp. 87-95, Https://doi. Org/10.1016/j. Jinorgbio.2017.12.015. Https://www.Ncbi.nlm.nih.gov/pubmed/29307441
[16] G. Crépeaux, H. Eidi, M.O. David, Y. Baba-Amer, E. Tzavara, B. Giros, F.J. Authier, et al., 'Non-linear dose-response of aluminium hydroxide adjuvant particles: selective low dose neurotoxicity',Toxicology, 375 (2017), pp. 48-57 Https://doi. Org/10.1016/j. Tox.2016.11.018. Https://www.Ncbi.nlm.nih.gov/pubmed/27908630
[17] M. Rigolet, J. Aouizerate, M. Couette, N. Ragunathan-Thangarajah, M. Aoun-Sebaiti, R.K. Gherardi, J. Cadusseau, F.J. Authier, 'Clinical features in patients with long-lasting macrophagic myofasciitis', Front. Neurol., 5 (2014), p. 230
Https://doi. Org/10.3389/fneur.2014.00230. Https://www.Ncbi.nlm.nih.gov/pubmed/25506338
[18] S.K.S. Sheth, Y. Li, C.A. Shaw, 'Is exposure to aluminium adjuvants associated with social impairments in mice? A pilot study', J. Inorg. Biochem., 181 (2018), pp. 96-103,
Https://doi. Org/10.1016/j. Jinorgbio.2017.11.012. Https://www.Ncbi.nlm.nih.gov/pubmed/29221615
[19] D.R. Fanni, R. Ambu, C. Gerosa, S. Nemolato, N. Iacovidou, P. Van Eyken, V. Fanos, M. Zaffanello, G. Faa, 'Aluminum exposure and toxicity in neonates: a practical guide to halt aluminum overload in the prenatal and perinatal periods',World J. Pediatr., 10 (no.2) (2014)
101-7. Https://doi. Org/10.1007/s12519-014-0477-x. Https://www.Ncbi.nlm.nih.gov/pubmed/24801228
[20] A. Strunecka, R.L. Blaylock, J. Patocka, O. Strunecky, 'Immunoexcitotoxicity as the central mechanism of etiopathology and treatment of autism spectrum disorders: A possible role of fluoride and aluminum',Surg. Neurol. Int., 9 (2018), p. 74
Https://doi. Org/10.4103/sni. Sni_407_17. Https://www.Ncbi.nlm.nih.gov/pubmed/29721353
[21] R.K. Gherardi, G. Crépeaux, F.J. Authier, L. Lujan, 'Animal studies are mandatory to investigate the poorly understood fate and effects of aluminum adjuvants administered to billions of humans and animals worldwide', Autoimmun. Rev., 17 (no.7) (2018), pp. 735-737
Https://doi. Org/10.1016/j. Autrev.2018.02.005. Https://www.Ncbi.nlm.nih.gov/pubmed/29729447
[22] J. Lyons-Weiler, R. Ricketson, 'Reconsideration of the immunotherapeutic pediatric safe dose levels of aluminum',
J. Trace Elem. Med. Biol., 48 (2018), pp. 67-73
Https://doi. Org/10.1016/j. Jtemb.2018.02.025. Https://www.Ncbi.nlm.nih.gov/pubmed/29773196
[23] G McFarland G, E La Joie E, P Thomas, J Lyons-Weiler, 'Acute exposure and chronic retention of aluminum in three vaccine schedules and effects of genetic and environmental variation, Journal of Trace Elements in Medicine and Biology, Volume 58, March 2020, 126444, https://www.sciencedirect.com/science/article/pii/S0946672X19305784
[25] Emma Shardlow, Matthew Mold, Christopher Exley, 'The interaction of aluminium-based adjuvants with THP-1 macrophages in vitro: Implications for cellular survival and systemic translocation', Journal of Inorganic Biochemistry
Volume 203, February 2020, 110915, https://www.sciencedirect.com/science/article/pii/S0162013419305719
[26] Peter Doshi, 'The unofficial vaccine educators: are CDC funded non-profits sufficiently independent?', BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j5104 (Published 07 November 2017)
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
Rapid Response:
Re: Vaccine hesitancy: an interview with Stanley Plotkin, rubella vaccine developer
Dear Editor
I disagree with Stanley Plotkin [1]: the public understand very well why they might wish to be protected against infectious diseases but the issue is whether the products are safe, and when they doubt they may have both personal experience and negative scientific information which could be bearing upon their judgment. Notably, when Plotkin wrote with Heidi Larson and Paul Offit to BMJ Rapid Responses earlier this year the troubling absence of rigorous pre-marketing double-blind safety trials was raised by Profs David Healy, Christopher Exley and myself [2].
The public are constantly regaled with claims of safety, relative safety (i.e. “the benefits outweigh the risks”), the importance of herd immunity etc., but the fact that people who report harms are shunned and disparaged does not in itself inspire confidence. Citing how many ordinary citizens have succeeded in suing the US government [1] may also not be very meaningful when in the same space three-quarters of a million cases have accumulated on the Vaccine Adverse Event Reporting System (VAERS) [3] and this is a passive reporting system which may only represent a small fraction events.
One issue Plotkin might like to address is the continuing use of aluminium adjuvants despite widespread scientific condemnation [4-25]. It is not the only vaccine safety issue but the obliviousness of global and governmental health organisations to it is perhaps indicative of a wider apparent indifference.
The lack of spontaneous public enthusiasm for vaccine lobby hegemony is perhaps well represented by the saga of Voices for Vaccines [1] which was discussed by me and Peter Doshi in the Rapid Responses to his article “The unofficial vaccine educators: are CDC funded non-profits sufficiently independent?” [26,27], and quite evidently the independence of vaccine science should be just as critical as any other.
[1] Elisabeth Mahase, 'Vaccine hesitancy: an interview with Stanley Plotkin, rubella vaccine developer', BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6926 (Published 23 December 2019)
[2] Responses to Iacobucci,'Vaccine safety: British are less sceptical than Europeans, but younger people need assurance', https://www.bmj.com/content/365/bmj.l4291/rapid-responses
[3] NVIC Medalerts, 749,842 reports, https://www.medalerts.org/vaersdb/findfield.php
[4] Jørgensen L, Gøtzsche PC, Jefferson T.'The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias', BMJ Evid Based Med. 2018 Oct;23(5):165-168. doi: 10.1136/bmjebm-2018-111012. Epub 2018 Jul 27
{5] Lars Jørgensen, Peter Doshi, Peter Gøtzsche, Tom Jefferson, 'Challenges of independent assessment of potential harms of HPV vaccines', BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3694 (Published 24 September 2018)
[6] Emma Shardlow, Matthew Mold and Christopher Exley, 'Unraveling the enigma: elucidating the relationship between the physicochemical properties of aluminium-based adjuvants and their immunological mechanisms of action,', 7 November 2018, Allergy, Asthma & Clinical Immunology201814:80 https://doi.org/10.1186/s13223-018-0305-2
[7] Lee SH, 'Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil, J Inorg Biochem. 2012 Dec;117:85-92. doi: 10.1016/j.jinorgbio.2012.08.015. Epub 2012 Aug 30.
[8] Lee SH, 'Melting profiles may affect detection of residual HPV L1 gene DNA fragments in Gardasil®.', Curr Med Chem. 2014 Mar;21(7):932-40.
{9] Peter Doshi, Tom Jefferson, Mark Jones, Kyungwan Hong, Larissa Shamseer, Haeyoung Lee, O’Mareen Spence, Florence Bourgeois, 'Call to action: RIAT restoration of a previously unpublished methodology in Gardasil vaccine trials', 11 January 2019, https://www.bmj.com/content/346/bmj.f2865/rr-7
[10] Gerwyn Morris, Basant K. Puri, and Richard E. Frye, ‘The putative role of environmental aluminium in the development of chronic neuropathology in adults and children. How strong is the evidence and what could be the mechanisms involved?’ Metab Brain Dis. 2017; 32(5): 1335–1355. Published online 2017 Jul 27. doi: 10.1007/s11011-017-0077-2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5596046/
[11] Matthew Mold, Dorcas Umar, Andrew King, Christopher Exley, ‘Aluminium in brain tissue in autism’, Journal of Trace Elements in Medicine and Biology Volume 46, March 2018, Pages 76-82, https://www.sciencedirect.com/science/article/pii/S0946672X17308763
[12] M.S. Petrik, M.C. Wong, R.C. Tabata, R.F. Garry, C.A. Shaw, 'Aluminum adjuvant linked to Gulf War Illness induces motor neuron death in mice', Neuromolecular Med., 9 (no.1) (2007)
83-100. Https://www.Ncbi.nlm.nih.gov/pubmed/17114826
[13] G. Crépeaux, R.K. Gherardi, F.J. AuthierAsia, 'Chronic fatigue syndrome, and selective low dose neurotoxicity of aluminum adjuvants' J. Allergy Clin. Immunol. Pract., 6 (no.2) (2018), p. 707 Https://doi. Org/10.1016/j. Jaip.2017.10.039. Https://www.Ncbi.nlm.nih.gov/pubmed/29525002. Mar - Apr 2018
[14] R.K. Gherardi, G. Crépeaux, F.J. Authier, 'Myalgia and chronic fatigue syndrome following immunization : macrophagic myofasciitis and animal studies support linkage to aluminum adjuvant persistency and diffusion in the immune system'
Autoimmun. Rev., 18 (no.7) (2019), pp. 691-705 Https://doi. Org/10.1016/j. Autrev.2019.05.006. Https://www.Ncbi.nlm.nih.gov/pubmed/31059838
[15] J.D. Masson, G. Crépeaux, F.J. Authier, C. Exley, R.K. Gherardi 'Critical analysis of reference studies on the toxicokinetics of aluminum-based adjuvants',
J. Inorg. Biochem., 181 (04) (2018), pp. 87-95, Https://doi. Org/10.1016/j. Jinorgbio.2017.12.015. Https://www.Ncbi.nlm.nih.gov/pubmed/29307441
[16] G. Crépeaux, H. Eidi, M.O. David, Y. Baba-Amer, E. Tzavara, B. Giros, F.J. Authier, et al., 'Non-linear dose-response of aluminium hydroxide adjuvant particles: selective low dose neurotoxicity',Toxicology, 375 (2017), pp. 48-57 Https://doi. Org/10.1016/j. Tox.2016.11.018. Https://www.Ncbi.nlm.nih.gov/pubmed/27908630
[17] M. Rigolet, J. Aouizerate, M. Couette, N. Ragunathan-Thangarajah, M. Aoun-Sebaiti, R.K. Gherardi, J. Cadusseau, F.J. Authier, 'Clinical features in patients with long-lasting macrophagic myofasciitis', Front. Neurol., 5 (2014), p. 230
Https://doi. Org/10.3389/fneur.2014.00230. Https://www.Ncbi.nlm.nih.gov/pubmed/25506338
[18] S.K.S. Sheth, Y. Li, C.A. Shaw, 'Is exposure to aluminium adjuvants associated with social impairments in mice? A pilot study', J. Inorg. Biochem., 181 (2018), pp. 96-103,
Https://doi. Org/10.1016/j. Jinorgbio.2017.11.012. Https://www.Ncbi.nlm.nih.gov/pubmed/29221615
[19] D.R. Fanni, R. Ambu, C. Gerosa, S. Nemolato, N. Iacovidou, P. Van Eyken, V. Fanos, M. Zaffanello, G. Faa, 'Aluminum exposure and toxicity in neonates: a practical guide to halt aluminum overload in the prenatal and perinatal periods',World J. Pediatr., 10 (no.2) (2014)
101-7. Https://doi. Org/10.1007/s12519-014-0477-x. Https://www.Ncbi.nlm.nih.gov/pubmed/24801228
[20] A. Strunecka, R.L. Blaylock, J. Patocka, O. Strunecky, 'Immunoexcitotoxicity as the central mechanism of etiopathology and treatment of autism spectrum disorders: A possible role of fluoride and aluminum',Surg. Neurol. Int., 9 (2018), p. 74
Https://doi. Org/10.4103/sni. Sni_407_17. Https://www.Ncbi.nlm.nih.gov/pubmed/29721353
[21] R.K. Gherardi, G. Crépeaux, F.J. Authier, L. Lujan, 'Animal studies are mandatory to investigate the poorly understood fate and effects of aluminum adjuvants administered to billions of humans and animals worldwide', Autoimmun. Rev., 17 (no.7) (2018), pp. 735-737
Https://doi. Org/10.1016/j. Autrev.2018.02.005. Https://www.Ncbi.nlm.nih.gov/pubmed/29729447
[22] J. Lyons-Weiler, R. Ricketson, 'Reconsideration of the immunotherapeutic pediatric safe dose levels of aluminum',
J. Trace Elem. Med. Biol., 48 (2018), pp. 67-73
Https://doi. Org/10.1016/j. Jtemb.2018.02.025. Https://www.Ncbi.nlm.nih.gov/pubmed/29773196
[23] G McFarland G, E La Joie E, P Thomas, J Lyons-Weiler, 'Acute exposure and chronic retention of aluminum in three vaccine schedules and effects of genetic and environmental variation, Journal of Trace Elements in Medicine and Biology, Volume 58, March 2020, 126444, https://www.sciencedirect.com/science/article/pii/S0946672X19305784
[24] Christopher Exley, 'An aluminium adjuvant in a vaccine is an acute exposure to aluminium', Journal of Trace Elements in Medicine and Biology, Available on-line 18 September 2019, https://www.sciencedirect.com/science/article/pii/S0946672X19304201?via%...
[25] Emma Shardlow, Matthew Mold, Christopher Exley, 'The interaction of aluminium-based adjuvants with THP-1 macrophages in vitro: Implications for cellular survival and systemic translocation', Journal of Inorganic Biochemistry
Volume 203, February 2020, 110915, https://www.sciencedirect.com/science/article/pii/S0162013419305719
[26] Peter Doshi, 'The unofficial vaccine educators: are CDC funded non-profits sufficiently independent?', BMJ 2017; 359 doi: https://doi.org/10.1136/bmj.j5104 (Published 07 November 2017)
[27] Responses to Doshi, ' 'The unofficial vaccine educators: are CDC funded non-profits sufficiently independent?', https://www.bmj.com/content/359/bmj.j5104/rapid-responses
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