Checking social media for vaccination misinformation: five minutes with . . . Claire Milne
BMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l2351 (Published 28 May 2019) Cite this as: BMJ 2019;365:l2351
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I sincerely hope that Claire Milne when fact checking the claims she ascribes to the third group is mindful of the fact that ADR’s are not always confined to a “small group of people” and although not linked to a vaccine at the outset, can later be shown to be. It does not follow that because a link between a vaccine and a condition hasn’t been established to the satisfaction of the regulatory authorities, that it does not exist. What starts as a temporal link between a vaccine and a problem can go on to be a recognised causal link.
The Pandemrix vaccine is an excellent example of how a serious ADR can be missed in trials, and initially dismissed when the subject of numerous ADR reports, but later acknowledged retrospectively.
Pandemrix was granted an EU Marketing Authorisation in May 2008, and by 23rd September 2010, was the subject of an EMA press release.
“The Committee concluded that the available evidence was insufficient to determine whether there is any link between Pandemrix and reports of narcolepsy, and that further studies were necessary to fully understand this issue”(1).
By March 2013 Health Protection Agency data supported a link between Pandemrix and narcolepsy (2) and the licence was not renewed after it expired on 13th August 2015.
Not only was narcolepsy not listed as a possible side effect of the vaccine, the response to the initial ADR reports concluded that there was insufficient data to determine a link between the two.
NICE defines an adverse drug reaction as an unexpected and previously unrecognised hazard requiring prompt attention yet years passed between the original ADR reports involving narcolepsy and the link being recognised.
“Any drug may produce unwanted or unexpected adverse reactions. Rapid detection and recording of adverse drug reactions is of vital importance so that unrecognised hazards are identified promptly and appropriate regulatory action is taken to ensure that medicines are used safely.”(3)
The clinical trials did not detect narcolepsy as a possible side effect of the vaccine. A study involving 1000 children (between the ages of 6 m and 12 years) commencing in September 2009 carried out by the Oxford Vaccine Group under Study Director, Andrew Pollard (4) did not detect narcolepsy in recipient children. On the contrary, the study determined that “the administration of a seasonal influenza vaccine was safe and immunogenic and confirmed the superiority of the Pandemrix vaccine” (5)
It is perhaps worthy of remembering that adverse reactions and side effects are two entirely different things with a side effect being an undesired effect which occurs following the administration of a medication (6) and an ADR, “any unexpected or dangerous reaction to a drug/an unwanted effect caused by the administration of a drug” (7)
Stemming the tide of misinformation is the right thing to do but censorship cannot legitimately include all personal stories of vaccine experiences where recipients allege vaccine induced reactions whether in the form of side effects or adverse reactions. Side effects are recognised events following vaccination and are not misinformation however harmful acknowledging them may be to the overall acceptance of vaccination. ADR’s can and do exist, they aren’t necessarily reserved to a small number of people and can at anytime during the marketing of a vaccine, be determined as vaccine induced, even when not considered so at the outset. Not every article, story or report involving an ADR can be safely air brushed into oblivion during fact checking on the basis that it is spreading vaccine misinformation. Pandemrix is an example of this.
(1) https://www.ema.europa.eu/en/news/european-medicines-agency-updates-revi...
(2) https://www.pharmaceutical-journal.com/news-and-analysis/hpa-data-suppor...
(3) https://bnf.nice.org.uk/guidance/adverse-reactions-to-drugs.html
(4) https://clinicaltrials.gov/ct2/show/NCT00980850
(5) Impact case study (REF3b) PREVENTING THE SPREAD OF H1N1: IMMUNISATION TRIALS IN UK CHILDREN
(6) https://www.pharmacytimes.com/contributor/shelby-leheny-pharmd-candidate...
(7) https://www.rxlist.com/script/main/art.asp?articlekey=26227
Competing interests: No competing interests
Well Miss Milne should have no problem recognising the myriad falsehoods being perpetrated by the UK Government not least of which being that all vaccines are safe for everyone. This misinformation is freely available including in the BMJ. I very much look forward to reading her report of these issues.
Competing interests: My research group investigates vaccine safety and recently has been funded by the MRC, CMSRI and Bencard Allergie.
Standard media outlets are dominated by vaccine officialdom
I've never trusted social media like Facebook and have never signed on to any of them. My source of vaccine news is Google's "News" category, where I type in "vaccines." My strong impression is that this news source is dominated by hard-line vaccine authorities: CDC AAP, various public health departments and their media outlets. The never-ending campaign for annual flu shots is one example. Overwhelming support of vaccine mandates and opposition to non-medical exemptions is another. The current measles outbreak is being used to lobby not only for measles vaccination but for pushing mandates for every other vaccine on the immunization schedule. In the US at least the "Vaccine Industrial Complex" is still very much in charge.
ALLAN S. CUNNINGHAM 2 June 2019
Competing interests: No competing interests