French court hands down a ludicrous decision about Gardasil

Marie-Oceane-Bourguignon-gardasil-France-lawsuiteA few months ago, I covered a story about a French teenager who had filed a lawsuit against a French vaccine manufacturer, Sanofi Pasteur (but the patents and trademarks are owned by Merck), along with French health regulators. The lawsuit claimed that side-effects from the HPV quadrivalent vaccine, known as Gardasil (or Silgard), induced multiple sclerosis (MS), a neurological disease that results from inflammation of neurons, in a teenage girl.

As with most of these antivaccination stories and tropes, I analyze them, debunk them, and then move on. I didn’t even bother check up to see if there was a legal decision, mainly because my French reading skills barely go beyond reading a menu and ordering a croque-monsieur at a sidewalk café in Lyon (headquarters of Sanofi Pasteur). But mostly, I just assumed it was one of those silly stories where the antivaccination cult tries to make a mountain out of a tiny pebble on the beach.

Well, I misjudged the desperation of the antivaccination world. Around 8 months ago, the court actually did hand down a decision about this case, but recently the vaccine fear mongering, anti-science websites are starting to push the story. I have no clue why these vaccine refusers are pushing this story eight months later, but it’s probably because they are desperate for anything that makes them relevant, given how irrelevant most of their ideas can be.

The lawsuit involved a plaintiff, Marie-Océane Bourguignon, a 15 year old girl (at the time of Gardasil immunization), who claimed that the HPV vaccine induced multiple sclerosis (MS), a neurological disease that results from inflammation of neurons. The best available evidence states that MS is caused by a combination of genetics and viral infection, which someday may someday be prevented by a vaccine. Nevertheless, according to the translated court decision, the French judge placed 50% of the blame for the MS on Gardasil using a rather complex analysis. His decision was based on the testimonies of two independent medical professionals, the treating physician, Madame Bourguignon and her parents, and Sanofi Pasteur. Nowhere in the decision are there comments or documents that show that the court actually examined any actual scientific evidence that could possibly link Gardasil to multiple sclerosis, if there are any. Maybe because there is no evidence.

Before the vaccine deniers start spouting off about how some random court in France has proclaimed Gardasil to cause multiple sclerosis, let’s look at the decision more carefully. And thoroughly analyze any logic that might have supported this decision.

  1. The first and major point that must be stated is that courts are not made to make a scientific pronouncement. Scientific consensus is usually developed over time and includes substantial evidence to support it. Court decisions have a lower bar for quality of evidence, incorporate a false balance between the plaintiffs and defendants, and include a fair amount of emotion and sympathy. Courts are frequently terrible evaluators of scientific data.
  2. If the French Academy of Medicine proclaimed that Gardasil causes MS, that would be powerful. They haven’t, and a court just doesn’t have that ability. Of course, Daniel Floret, the chairman of one of France’s leading medical authorities, states “none of the international medical safety controls has showed up any link between this vaccine and any kind of auto-immune disease, and millions of doses have been administered.”
  3. Gardasil has been shown to be extraordinarily safe in two different and large epidemiological studies, one with over 700,000 doses and the other with over 350,000 doses. No causal links were shown between the HPV quadrivalent vaccine and multiple sclerosis, despite examining over 1 million patients in two continents.
  4. Teenagers are at risk of many chronic diseases that are coincidental to vaccines. For example, the rate for MS in some general populations in Europe is close to 200 per 100,000. Without any substantial and incontrovertible evidence that the HPV vaccine is linked to MS, and with substantial evidence that MS is caused by viruses and is fairly prevalent in Europe, one can only conclude scientifically that this child had a coincidental MS attack.
  5. There is just no evidence that vaccines cause autoimmune diseases, which is implicated in the judge’s decisions about Madame Bourguignon’s condition.
  6. The medical experts’ testimony was unable to establish a direct causal link with Gardasil, stating “that there are no scientific grounds to incriminate Gardasil as the only causal factor for the demyelinating inflammatory pathologies of the central nervous system.” However, the experts did state that “the vaccine-induced demyelinating inflammatory cascade from which the plaintiff suffers presents all the objective characteristics of medical and legal imputability,” although this could have been coincidental rather than causal. And considering there is no evidence that Gardasil actually is involved, it’s hard to see how they developed this conclusion.
  7. Speaking of the medical experts, neither (one a neurologist and the other a pathologist) are experts in immunology, autoimmune diseases, vaccines, or any other area of research that a typical person would consider to be an actual expert in the scientific basis of vaccines and multiple sclerosis.
  8. The Bourguignon family has a substantial family history of genetic vulnerability making her susceptible to the potential onset of a dysfunctional immune demyelination of the central nervous system. And again, there is absolutely no scientific evidence supporting that Gardasil induced the start of this immune demyelination. There’s certainly no plausible physiological pathway to support it.

sanofi_pasteur_msd_gardasil

And of course, the fear-mongering websites that proclaim they care about lives, but are just money-making fronts for antivaccination deception, forget that Gardasil saves lives by preventing cancer. The HPV quadrivalent vaccine specifically targets subtypes 16 and 18, that cause not only approximately 70% of cervical cancers, but they also cause most HPV-induced anal (95% linked to HPV), vulvar (50% linked), vaginal (65% linked), oropharyngeal (60% linked) and penile (35% linked) cancers. It also targets HPV6 and HPV11, which account for approximately 90% of external genital warts. The viruses are generally passed through genital contact, almost always as a result of vaginal, oral and anal sex. I’m not sure how to be clearer, than to say Gardasil prevents cancers–serious, life threatening cancers.

The French Court did not provide us with any evidence that causes us to overturn the scientific consensus about Gardasil. None.

The consensus agrees, based on over 1 million doses in controlled studies, the HPV vaccine is incredibly safe. The scientific consensus agrees that the HPV vaccine prevents the virus that causes some serious, deadly cancers. There is no plausible physiological pathway or evidence that an HPV vaccine can cause multiple sclerosis. The current scientific understanding is that multiple sclerosis is probably caused by a virus that one day will be prevented by a vaccine developed by real scientists.

Gardasil saves lives. And that’s not a belief based on a legal ruling, it’s based on medical and scientific evidence provided to us by the best epidemiologists, immunologists, microbiologists, virologists, biomedical researchers, and public health specialists in the world. Not by a judge who has none of that knowledge.

 

Visit the Science-based Vaccine Search Engine.

 

Key citations:

The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor

Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!


  • Pingback: Your one stop shop for real science and myth debunking about Gardasil()

  • Pingback: Mumps vaccine effectiveness and waning immunity()

  • lilady R.N.

    I’m going to go out on a limb here (in the absence of Professor Rubinstein-Reiss), to offer up my amateur legal opinion.

    I’ve never heard of a vaccine injury decision which puts 50 % of the blame for a purported “injury” on a vaccine.

    • kellymbray

      You are right, it is strange. It is either the cause or not the cause.

      • lilady R.N.

        I’ve heard of contributory negligence on the part of the plaintiff, which cuts down on your payment for injury and negligence being apportioned out to two or more defendants, but this award is weird, IMO.

    • Boris Ogon

      It is always extraordinarily dangerous to extrapolate local legal principles to foreign jurisdictions (indeed, extrapolations to Louisiana are dangerous, because of foundations outside of English common law).

      This decision, in and of itself, doesn’t tell you much of anything. There appears to be an element of what would be called a warning defect over here. Liability apparently hinges on articles 1386-1 and 1386-4 of the French Code civil. This is indeed products liability, and it’s strict liability.

      OK, but now where does ONIAM come in if this is a straight tort? One may recall that the Bocca case had nothing to do with causation, which was conceded; it was about who was going to pay for the compensation. Is there a similar question here? It’s hard to tell without a competent English reference on French public health law.

      But – and here we’re in the realm of rank speculation – one may note that there was a civil appeal. This suggests that it went through a CRCI (mandatory vaccinations may go straight to ONIAM), where there is a “more than 24% disability” rule, first, so such assessments aren’t exactly uncommon.

      The take-away point is that this isn’t a regular court decision.

      There’s a (too brief) overview of ONIAM here (PDF).

      • I did not want to delve into the mysteries of French civil law. As President Bartlett once said, “But let’s go down, way down, to the Deep South and the humid bayou of Louisiana and its nine electoral votes. What manner of man it must take to win the state, which, by the way, is the only one operating under the Napoleonic Code of France. And I still don’t know what that’s all about.”

        Interestingly, the Napoleonic code bases law on facts and written law that must come from an elected body. English Common Law is based on precedent and prior judicial decisions. I believe that France doesn’t use the Napoleonic code anymore. Just Quebec and Louisiana. Maybe a few other places.

        Irrelevant. I focused this article on how it’s ignorant to use it as evidence that Gardasil causes harm. For me, whether the court though it was 100% correct or not, if it followed the law and precedent or not, was irrelevant. They were wrong scientifically, and that’s that.

    • I think it happens quite a bit. But I’m not at all familiar with French tort law. If only I lived in Louisiana, I might. 🙂

  • Ben Fairbanks

    Whenever I am tempted to complain about the American or Australian judicial system, I take a deep breath and consider my fortune that I don’t live in France or Italy.

  • Dan Kegel
    • lilady R.N.

      Not germane to this discussion about an implausible link between HPV vaccines and the onset of multiple sclerosis.

      http://www.cdc.gov/vaccinesafety/Concerns/h1n1_narcolepsy_pandemrix.html

      “…..Pandemrix is manufactured by GlaxoSmithKline in Europe and was specifically produced for pandemic 2009 H1N1 influenza. It was not used before 2009, and has not been used since the influenza pandemic season (2009-2010). It contains an oil-in-water emulsion adjuvant called ASO3. Adjuvants are substances added to a vaccine to increase the body’s immune response to that vaccine.

      Pandemrix was not licensed for use in the United
      States. In fact, no adjuvanted influenza vaccines are licensed in the United States, and no adjuvanted influenza vaccines were used in the United States during the influenza pandemic or in any other influenza season.

      In response to the events in Europe, CDC reviewed data from the U.S. Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD)
      and to date have found no indication of any association between U.S.-licensed H1N1 or seasonal influenza vaccine and narcolepsy.

      CDC is currently sponsoring an international
      study on the associations between adjuvanted monovalent 2009 H1N1 influenza vaccines and narcolepsy. That study is expected to be completed in 2014….”

      That adjuvant, ASO3, has never been used in any vaccine marketed in the United States.

    • I don’t mean to be harsh, if you actually read the article, it clearly states what caused narcolepsy. Except, they didn’t show any causality, so I have no clue.

      But the presumptive evidence is adjuvant, as mentioned in another reply.

      If you want to play here, meaning participate in the discussion, you’re going to be thoroughly mocked unless your science is pretty solid. And trying to apply a conclusion in a relatively poor open source journal that doesn’t provide us with plausibility or causality, that is a wholly different vaccine, that’s just not going make for a pleasant conversation.

      • Side question (not about the subject at all), would you happen to know of any sites like the Cochrane Reviews for Global Warming?

        My interest is mainly in medicine – which is why I’m here, lol – but I was trying to explain to a Facebook friend why a primary study wasn’t any good for making his case that APG (do I have the acronym correct) is not the main cause of the warming. Of course, he’s also convinced that it is a leftist, Democrat scam, and the “science says it’s hidden volcanoes under Antarctica.” I looked into it, and this is what I found: http://dailycaller.com/2014/06/11/study-west-antarctic-glacier-melt-due-to-volcanoes-not-global-warming/
        Naturally, I clicked the link to this study: http://www.pnas.org/content/early/2014/06/04/1405184111.full.pdf+html?sid=5859c342-ec49-4de6-a82a-9b2c2c826b3e

        Other than this quote from the article: ““The combination of variable subglacial geothermal heat flow and the interacting subglacial water system could threaten the stability of Thwaites Glacier in ways that we never before imagined,” lead researcher David Schroeder said in a press release,” (the last 5 words, in particular), I didn’t find anything which would make me suspicious, but as I mentioned earlier, I’m more into the medical section of science rather than environmental. So, I’d appreciate it if you would be so kind as to guide me along my way.

        • lilady R.N.

          I know zero, nil, nada, zilch about global warming.

          Psssst, try googling “science blogs-global warming” and you’re sure to pick up some great science bloggers there.

          • I’m feeling a bit red-faced at the moment. I don’t know why that didn’t occur to me. Thank you.

        • Sorry, I should keep up with stuff. Go here:

          http://www.skepticalscience.com

          They break down every global warming deniers myth with scientific citations. So you can actually find the review articles for your specific myth. And there’s boatloads of them.

          I hope that helps.

          • Thank you very much, sir. It does indeed.

      • Dan Kegel

        Hey, relax, I’m a fan (see my site http://hpv.kegel.com). And I like having my science challenged; how else would I see my blind spots? But to play devil’s advocate:

        your point #5 talks about vaccines in general, not HPV vaccines (so saying ‘it’s not an HPV vaccine’ doesn’t disqualify it);

        your point #5 doesn’t specify US vaccines (so saying ‘that vaccine is not approved in the US’ doesn’t disqualify it);

        adjuvants are part of vaccines (so saying ‘it was the adjuvant’ doesn’t disqualify it).

        All I’m sayin’ is, it at least raises a real effect which is a plausible possible counterexample to the “vaccines do not cause autoimmune disease” claim.

        (Could also be bogus. http://psychiatry.stanford.edu/narcolepsy/articles/decreaseincidence.pdf seems to show a similar spike in a country that didn’t use Pandemrix. http://www.cdc.gov/vaccinesafety/Concerns/h1n1_narcolepsy_pandemrix.html has a few more links.)

    • ChadwicktheJones

      This may help clear some of your confusion about the article you linked.

      http://www.nature.com/news/narcolepsy-confirmed-as-autoimmune-disease-1.14413

      “But the results do not fully explain the Pandemrix mystery, because other flu vaccines contained the same proteins but did not lead to a spike in narcolepsy cases.”

      Also, according to this study, it’s related to the ASO3 adjuvant.

      http://www.bmj.com/content/346/bmj.f794

      Nevertheless, not relevant to this particular discussion.

      • Boris Ogon

        Also, according to this study, it’s related to the ASO3 adjuvant.

        Pet peeve: It’s AS03, even though “ASO” shows up in the literature (*koff*getsomerealcopyeditors*koff*). Hence “AS04.”

        • ChadwicktheJones

          HAH! Thanks for the correction. 🙂