|
?:reviewBody
|
-
On 10 March 2016, a nondescript Wordpress blog post reporting that autism was now disclosed and acknowledged as an adverse event reported for use of DTaP (Diphtheria, Tetanus, and acellular Pertussis) vaccine was published by an anonymous blogger. The item primarily consisted of a sensationalist title (which suggested a new development in 2016), along with the following text and image: Predictably, it wasn't long before the blog post began popping up in anti-vaccine circles on social media under headlines such as FDA announces vaccines cause autism and Now it’s official: FDA announced that vaccines are causing autism! Readers didn't need to scan past the misleading titles to catch the thrust of the claims: The headlines insinuated that autism had recently been added to the list of known adverse affects asssociated with the DTaP, quietly confirming what science-based medical information had supposedly denied for so long. It was true that the photograph appended to that article matched the insert available for Tripedia, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) as shown on the Food and Drug Administration (FDA)'s web site [PDF]: Also true was the fact that visible selective emphasis highlighted information favorable to anti-vaxxers while failing to include crucial context (namely that the listed effect was a post-approval, unverified user-reported one that does not establish a causal relationship to components of Tripedia vaccine): We contacted UC Hastings law professor and immunization law expert Dorit Rubenstein Reiss about the claim, who directed us to a related passage in the Tripedia insert. While the blog highlighted Sudden Infant Death Syndrome (SIDS) alongside autism as reported adverse effects, directly beneath the referenced passage was information that the rate of SIDS was lower among vaccinated infants than among unvaccinated ones: Another aspect of the vaccine excerpt reproduced above was that automobile accidents and drownings were included among the causes of reported deaths that occurred after vaccination, which underscores that the nature of such statistics is an inclusive one encompassing adverse events which clearly have no causal relationship with vaccine. Reiss also pointed us to the FDA's guidance on adverse event-related drug labeling [PDF], which states: When we asked Reiss whether adverse event labeling included all documented reports whether or not they were linked to the drug in question, she confirmed that the insert lists events reported even if causation evidence is sketchy. It actually says so. Those who read down to the bottom of the eleven-page Tripedia/DTaP insert might have noticed another relevant portion: The insert information was labeled current as of December 2005, which first would mean its sudden discovery by an anonymous blogger over a decade later was of questionable (if not negligible) import. But the age of the documentation was important for a second reason: the prominent medical journal The Lancet didn't formally retract a controversial 1998 research paper which falsely advanced the belief that vaccines were linked to autism until February 2010. While that retraction was significant and definitive, twelve years passed between the paper's publication and The Lancet's disavowal of it: A 2 February 2010 article published in the British Medical Journal explained how the process of gathering accurate information to counter Wakefield's claims took years: That article also alluded to the immediate and lasting effects of the initial publication of Wakefield's now-discredited research: An April 2011 article in the Indian Journal of Psychiatry summarized in a timeline the havoc wreaked by Wakefield's 1998 paper, noting that a journalistic investigation, rather than academic vigilance led to the long-awaited retraction: So while it was true autism was listed among the reported adverse events in the Tripedia/DTaP vaccine's insert, that same insert explained that all adverse events were listed, regardless of evidence of causation. Furthermore, the insert was current as of 2005, and was therefore hardly a novel finding in 2016. Five years after the Tripedia insert was printed, The Lancet formally retracted the 1998 paper to which fears about vaccines and autism were largely attributed, but by that point, the advancement of that idea had already left a palpable mark on public health in both the United States and in the UK. However, as FDA adverse events reporting standards dictate, all adverse reports recorded in association with drugs are included in such documents, no matter how likely (or unlikely) it was that the drug had caused them.
(en)
|
![[This page as RDF]](http://data.gesis.org/claimskg/static/rdf-icon.gif){kind=icon}