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) Cite this as: BMJ 2019;367:l6926
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It is The BMJ's policy to require authors to declare any competing interests they may have. In this article, Stanley Plotkin was the subject and not the author and therefore was not required to complete a competing interest form. However, our journalist was alert to Plotkin's competing interests, which is why she reported that he "consults for many pharmaceutical and biotech companies, as well as non-profits." Our judgement is that a list of company names would not have added value to this piece.
Competing interests: No competing interests
Dear Editor,
Stanley Plotkin has been hugely influential on global vaccination practice and policy during his long vaccine industry-funded career.
As this article notes, Plotkin "...consults for many pharmaceutical and biotech companies, as well as non-profits...".[1]
There must be more transparency for the conflicts of interest of vaccine industry-associated people such as Stanley Plotkin. More detailed information should have been included in this BMJ feature authored by Elisabeth Mahase, which provides Plotkin with a platform to espouse his views on 'vaccine hesitancy', and his endorsement of mandatory vaccination to counter scepticism about safety, i.e. "I have to say that it works - even though there's a lot of opposition - because the US maintains high coverage".
Stanley Plotkin's conflicts of interest were discussed when he was questioned by US lawyer Aaron Siri during a deposition for a vaccine court case in January 2018.[2] Details of the extent of his industry conflicts of interest were elicited from him by Mr Siri, e.g. Plotkin's consultancy work for Sanofi, Merck, Glaxo and Pfizer, and his association with Dynavax Technologies, MyMetics, Inovio, CureVac AG, SynVaccine, GeoVax Labs, GlycoVaxyn AG, Adjuvance Technologies, BioNet-Asia, Abcombi Biosciences, and Hookipa Biotech. (See pp. 84-93 of the deposition transcript, details in reference 2 below.)
Subsequently, Plotkin himself briefly summarised his conflicts of interest in an article he had published describing his experience during this deposition, i.e. 'How to Prepare for Expert Testimony on the Safety of Vaccination', published in the Pediatrics journal in April 2019.[3]
In the interests of providing some transparency for Stanley Plotkin's conflicts of interest, here is Financial Disclosure and Potential Conflict of Interest information provided in his Pediatrics article, i.e. "Dr Plotkin is a paid consultant to Sanofi Pasteur, GlaxoSmithKline, Merck, Pfizer, Inovio Pharmaceuticals, Variations Bio, Takeda Pharmaceutical Company, Dynavax Technologies, Serum Institute of India, CureVac, Valneva SE, Hookipa Pharma, and NTxBio. Vaxconsult gives advice to vaccine developers." I suggest this brief information still does not do justice to Stanley Plotkin's lengthy history of conflicts of interest.
There is growing awareness that conflicts of interest are undermining trust in healthcare professionals. This was discussed in a previous BMJ news article by Elisabeth Mahase, when she reported that the Royal College of General Practitioners' council "will call on the General Medical Council to ensure that all doctors registered in the UK have declared their conflicts of interest, as part of a mandatory scheme". This move comes after the college 'overwhelmingly' passed a motion on 23 November 2019 which said that "declaring interests must be a condition of registering with the GMC, that declarations must be reviewed "at least annually", and must be held on a publicly available register".[4]
According to Mahase, "The council said that it believes that all healthcare professionals should make similar declarations of interest, and any associated costs for implementing this should be met by the government".
This is not just a UK matter. We urgently need an international system and ethos which ensures that people involved in healthcare, and influencing health policy, properly disclose their conflicts of interest, including a history of their conflicts of interest.
For further information on Stanley Plotkin's conflicts of interest and other vaccine related matters, interested readers should seek out the transcript of Stanley Plotkin's deposition.[2]. Video of the deposition is accessible via this YouTube link: https://www.youtube.com/watch?v=DFTsd042M3o
References:
1. Elisabeth Mahase. Vaccine hesitancy: an interview with Stanley Plotkin, rubella vaccine developer. BMJ 2019;367I6926 doi: 10.1136/bmj.I6926 (Published 23 December 2019).
2. Transcript of videotaped deposition of Stanley A. Plotkin, M.D. New Hope, Pennsylvania. January 11, 2018. State of Michigan in the Circuit Court for the County of Oakland Family Division. Lori Matheson f/k/a Lori Ann Schmitt, Plaintiff vs. Michael Schmitt, Defendant. Case No. 2015-831539-DM. Available here: https://s3.amazonaws.com/content.sitezoogle.com/u/392970/3c2a804699eeff7...
3. Stanley A. Plotkin. How to prepare for expert testimony on the safety of vaccination. Pediatrics Volume 143, number 4, April 2019:e20183578.
4. Elisabeth Mahase. RCGP calls on GMC to introduce mandatory and public declaration of interests register. BMJ 2019;367:I6695 doi: 10.1136/bmj.I6695 (Published 26 November 2019).
Competing interests: No competing interests
Dear Editor
John Stone asks “Why does open discourse about vaccine safety never happen ? “.
Perhaps there is too much at stake ?
Regular readers of the BMJ will realise that John Stone and like minded sceptical observers of the vaccination scene, who are all pro child wellbeing, and pro informed consent, are given a cautious welcome on this website. Despite very rare dissenting voices, we nevertheless enjoy a ban on our contributions appearing in the print edition.
Conversely, senior doctors are allowed free rein in the print edition, to categorise, often unkindly, those who do not share their inclination to vaccinate every susceptible child, with every available vaccine.
The obligation, placed on all doctors by the Montgomery judgement in 2015, to fully explain the variable benefits, as well all the serious adverse effects, however rare, of any proposed treatment, has thus to be erased from medical consciousness, when the parents of young children are asked to consent to vaccination.
No senior doctor will be drawn into discussion of how the Montgomery judgement applies to informed consent for vaccination.
A clear request to Dr David Oliver and like minded colleagues, to do just that, drew no reply. (1)
We thus have a situation where the BMJ will not, in it’s print edition, mention the confirmation on this website that there have been no safety studies of the vaccines on the UK childhood schedule (2,3), not it’s disinclination to print the views of Professor Exley, aluminium biotoxicity expert, on that subject.(4) A 30 year failure of the USA HHS to fulfil it’s governance role of the vaccine industry was also unremarked.(5). Not forgetting the association between Bexsero and Kawasaki disease. (6) How often are parents advised about that ?
Regarding effectiveness, the well recognised poor immunity from the mumps vaccine makes a simple childhood illness more dangerous in young adults. The Hepatitis B vaccine, with aluminium adjuvant, will confer at best, less than 50% immunity when a teenager’s sexual behaviour or IV drug use makes infection more likely. That teenager, as a one year old has already had three injections of Hep B vaccine, to prevent an infection that is clearly not a childhood risk. (7)
All these possible problems, and many more, will be familiar to readers of this website. They should be discussed with parents, if the Montgomery judgement is respected.
Many times in recent years the dysfunctional UK consent system for vaccination, following from neglect of the Montgomery judgement, has been described on this website. (8)
No vaccine apologist has commented, far less demurred.
Meanwhile, in the UK, parents are very likely, not given full information, children are very likely, vaccinated after invalid consent.
John Stone is right to expect open discourse, which others avoid.
1 https://www.bmj.com/content/365/bmj.l2244/rr-18
2 https://www.bmj.com/content/365/bmj.l4291/rr-0
3 https://www.bmj.com/content/365/bmj.l4291/rr-13
4 https://www.bmj.com/content/365/bmj.l2359/rr-4
5 https://www.bmj.com/content/362/bmj.k3244/rr
6 https://www.bmj.com/content/367/bmj.l6447/rr-2
7 Paul Thomas M.D. & Jennifer Margulis, Ph.D, The Vaccine Friendly Plan,
Ballantine Books, NY, 2016. p60.
8 https://www.bmj.com/content/364/bmj.l739/rr-1
Competing interests: No competing interests
Dear Editor
Before turning on "the vaccine hesitant" might it be suggested that vaccine apologists need to address substantive questions about their science [1,2]. Without this the argument goes by default and they only have themselves to blame [3]. As with anything else people should have a right to ask questions, and if they are met with silence they can only draw their own conclusions. Where are the emperor's clothes?
[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] Response to Mahase , 'Vaccine hesitancy: an interview with Stanley Plotkin, rubella vaccine developer', https://www.bmj.com/content/367/bmj.l6926/rapid-responses
[3] John Stone, 'Re: New power versus old: to beat antivaccination campaigners we need to learn from them—an essay by Kathryn Perera, Henry Timms, and Jeremy Heimans', 2 December 2019, https://www.bmj.com/content/367/bmj.l6447/rr-8
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
Dear Editor
What is “misinformation” [1]? Stanley Plotkin, himself, expressed considerable uncertainty about the effectiveness of measles vaccination in his recent article ‘Is There a Correlate of Protection for Measles Vaccine?’ [2], and many of the issues about long term effectiveness and mutated strains are matters that I have already raised in BMJ Rapid Responses in recent months [3].
Equally, if measles vaccine offers a lesser immunity than the naturally occurring virus - which until 50 years ago nearly everyone caught in early childhood - there may be a question of the long term benefit to the population.
Indeed, a new and troubling possibility has by implication been raised in a just published article on the BBC website by Prof. Jonathan Ball of University of Nottingham. Ball writes [4]:
“So, what's stopping animal morbilliviruses cropping up in humans?
“"A major factor is likely to be pre-existing immunity, where natural infection or vaccination against measles provides a pool of antibodies, some of which cross-react and prevent infection by non-human morbilliviruses", explained Dr Bailey.
“But, as vaccination rates fall, we will continue to see major outbreaks of measles, and this will give other morbilliviruses, like CDV, the chance to explore a new human host.”
If vaccine immunity is not as good as natural immunity - and likely weakening - the potential threat to the species from the measles vaccine project, commenced sixty years ago [5], may be greater than any interim benefits. Perhaps, we would have done better focusing on supporting children as safely as possible through the natural infection rather than trying to preempt it?
These are I believe vital questions from which the general public has a right not to be excluded. If the public discussion of the safety of products has to be suppressed - dare one say it - should they ever have been marketed, let alone be made compulsory?
[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] Stanley A Plotkin, 'Is There a Correlate of Protection for Measles Vaccine?’, The Journal of Infectious Disease 1 November 2019, https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiz381/5...
[3] John Stone, 'Propaganda should not be allowed to overwhelm policy', 23 October 2019, https://www.bmj.com/content/367/bmj.l5995/rr-5
[4] Jonathan Ball, 'Could relatives of measles virus jump from animals to us?', BBC News: Science and Environment 1 January 2019, https://www.bbc.co.uk/news/science-environment-50839868
[5] Langmuir et al, 'THE IMPORTANCE OF MEASLES AS A HEALTH PROBLEM', American Journal of Public Health February 1962, https://ajph.aphapublications.org/doi/pdfplus/10.2105/AJPH.52.Suppl_2.1
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
Stanley Plotkin is a clinician-scientist of enormous accomplishment, but I wish he and other experts would be more candid about the very real problem of vaccine safety. Their attitude is illustrated by the following case:
On November 1, 2016 the Seattle Times reported the death from suspected AFM/acute flaccid myelitis of a 6 year-old boy from Bellingham, Washington at Seattle Children’s Hospital. His symptoms of paralysis first developed on October 15, seventeen days after receiving multiple vaccines for school, including a flu shot. The family suspected the vaccinations, but the possibility was dismissed by officials at the Hospital and the Washington State Department of Health. (Seattle Times, November 5)…..This case is similar to children with provocation paralysis, poliomyelitis that follows intramuscular injections with vaccines or antibiotics. It is not widely known that fewer than 1% of poliovirus infections result in paralysis, or that 80% of the cases of paralytic polio can be attributed to—“provoked by”—injections. (Kohler, Int J Epidem 2003;32:272. Strebel, NEJM 1995;332:500. Hill, BMJ 1950; July 1: page 1) The risk of paralysis occurs mainly within 30 days after an injection, and the risk is greatest 11 to 17 days following injection. The risk of paralysis increases progressively with the number of injections.
For some older clinician-scientists the similarities between AFM and paralytic polio are obvious. Polioviruses are enteroviruses, and the prime suspects in AFM are some of the more than 100 other enteroviruses. The scientists who showed how injections enable circulating polioviruses to attach to neuromuscular junctions and then travel to the spinal cord suggested that other enteroviruses could do the same thing. (Gromeier, J Virol 1998;72:5056. Dalakas, NEJM 1995;332:62. Ren, J Infect Dis 1992;166:747.)……The CDC is well aware of the possibility that vaccinations/injections could be co-factors in AFM cases, but they are not investigating the possibility. The CDC’s AFM Task Force seems to be focused exclusively on a search for viruses and the possibility of vaccine development. Like polio, AFM is a devastating illness; at least 90% of children are left with permanent disabilities, some of them quite severe. Prevention is extremely important and, based on experience with polio, might be substantially achieved by avoiding unnecessary injections.
Dr. Plotkin comments that the US Vaccine Court rarely gives awards for adverse reactions to vaccines. This fact has been confirmed by a legal scholar who has called for an overhaul of the National Childhood Vaccine Injury Act of 1986, including removal of the nearly insurmountable barriers to fair compensation for vaccine injuries. (Parasidis, Boston University Law Review 2017;97:2153)….I wonder what Dr. Plotkin or the Vaccine Court would say about the boy from Bellingham. Is his case, or the 601 AFM cases so far confirmed by the CDC (AFM Investigation, 3 December 2019), reason for vaccine hesitancy?
Dr. Plotkin suggests that vaccine authorities and the lay public do not understand each other. Is this really true? He suggests the need for more public vaccine education. What sort of education does he have in mind? Is mandatory vaccination the best response to public concern about vaccine safety?
ALLAN S. CUNNINGHAM 30 December 2019
Competing interests: No competing interests
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
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[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
Re: Vaccine hesitancy: an interview with Stanley Plotkin, rubella vaccine developer
Dear Editor
I note Rebecca Coombes’ response. I suppose it might be a question of what is incidental and what is thematic: different people might have different views.
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