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.

 

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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!