Gardasil safety and efficacy – debunking the HPV vaccine myths

Gardasil safety and efficacy

There was an article published in Pediatrics that described how educating either teenagers or their parents about HPV vaccinations had little effect on the overall vaccination rate for the vaccine. Essentially, the researchers found that it was a 50:50 probability that any teen would get the vaccine, regardless of their knowledge of HPV and the vaccine itself. Some of the reasons why the HPV vaccine uptake is so low is a result of several myths about Gardasil safety and efficacy.

So I thought about why that Pediatrics study found that education about HPV and Gardasil didn’t move the needle on vaccination uptake. It’s possible that the benefits of the vaccine is overwhelmed by two factors–first, that there’s a disconnect between personal activities today vs. a disease that may or may not show up 20-30 years from now; and second, that the invented concerns about the HPV quadrivalent vaccine, promulgated by the usual suspects in the antivaccination world, makes people think that there is a clear risk from the vaccine which is not balanced by preventing cancer decades from now. It’s frustrating. Continue reading “Gardasil safety and efficacy – debunking the HPV vaccine myths”

HPV vaccine side effects – unrelated to chronic fatigue syndrome

HPV vaccine side effects

The list of HPV vaccine side effects is long and, on the surface, very troubling. But study after study, some of them with millions of patients, have found that the vaccine is extremely safe, and the side effects attributed to the vaccine occur at the same rate between vaccinated and unvaccinated individuals.

Now, there is a large new study in Norway that examined another hypothetical side effect that has been claimed to be associated with the HPV vaccine. And what did the study find? No link.

We’re going to examine the new study on potential HPV vaccine side effects, which will tell us more about the safety of the vaccine. Continue reading “HPV vaccine side effects – unrelated to chronic fatigue syndrome”

Vaccines cause diabetes – another myth refuted and debunked

vaccines cause diabetes

If you cruise around the internet, engaging with the antivaccination cult (not recommended), you will pick up on their standard tropes, lies, and other anti-science commentary. One that has always bothered me, not because that it was a lie, but because I had enough evidence floating in my brain that I was wondering if it were true–that vaccines cause diabetes, especially the Type 1 version.

A lot of the vaccine deniers believe that vaccines cause a lot of everything, and several claim that vaccines cause Type 1 diabetes (or here), based on little evidence. As far as I can tell, this myth is based on the “research” from  J. Barthelow Classen, M.D., who has pushed the idea that vaccines causes type 1 diabetes, through some magical process that has never been supported by other independent evidence.

In another example of the antivaccination world’s cherry picking evidence to support their a priori conclusions, they ignore the utter lack of plausibility supporting any link between vaccines and Type 1 diabetes.

Moreover, Classen seems to come to his beliefs based on population-wide correlations that rely on post hoc fallacies, rather than actually showing causality between vaccines and diabetes. It’s like finding that a 5% increase in consumption of Big Macs is correlated with Republican wins in elections. They may happen at the same time, but it would take a laughable series events to show any relationship.

Continue reading “Vaccines cause diabetes – another myth refuted and debunked”

Appeal to false authority – who is Tetyana Obukhanych

There are so many annoying issues about the antivaccination cult, that most of us can’t even keep up with it. If only they would provide evidence published in high quality, peer reviewed journals (yes, a high standard, but if we’re talking about public health, a high standard is required), the fake debate would move into a real scientific discussion. One of their favorite feints against real evidence is to push people, like Tetyana Obukhanych, who appear to have great credentials, but once you dig below the surface, not much is there.

One of the most irritating problems I have with the antivaccination movement  is their over-reliance on false authorities, where they trumpet the publications or commentary from someone who appears to have all of the credentials to be a part of the discussion on vaccines, but really doesn’t. Here’s the thing – it simply does not matter who the authority is or isn’t, all that matters is the evidence.

For example, Christopher Shaw and Lucija Tomljenovic, two researchers in the Department of Ophthalmology at the University of British Columbia, have, for all intents and purposes, sterling credentials in medicine and science. However, they publish nonsense research (usually filled with the weakest of epidemiology trying to show population level correlation between vaccines and adverse events) in low ranked scientific journals.

Now the anti-vaccine world has a new hero – Tetyana Obukhanych. Continue reading “Appeal to false authority – who is Tetyana Obukhanych”

European court vaccine ruling – the vaccine deniers think they won

European court vaccine ruling

On 21 June 2017, the European Court of Justice ruled in favor of the plaintiffs in a case that examined whether Sanofi-Pasteur’s hepatitis B vaccine caused multiple sclerosis (MS) in a patient. Although the ruling might, on the surface, be considered bad for vaccines, we need to look more carefully at that European court vaccine ruling.

There are several questions that we need to answer. First, what did the court actually rule? What can courts say about science? And, is there any evidence that the hepatitis B vaccine causes multiple sclerosis? Continue reading “European court vaccine ruling – the vaccine deniers think they won”

European court vaccine decision – a legal analysis

European court vaccine decision

On June 21, 2017 the European Court of Justice (ECJ) decided a product liability case (N.W. et al v. Sanofi Pasteur MSD SNC, C-621/15) described by news articles as allowing plaintiffs to be compensated for alleged vaccine harms, even when there is no scientific evidence of a causal connection (in the most extreme versions, “with no proof”). This description is incorrect. More nuanced analyses were provided by Orac and Steve Novella, but I think they, too, did not exactly capture what the decision does. This post explains the European court vaccine decision.

Three take-home points are important:

  1. If there is no scientific consensus as to whether a vaccine causes a particular kind of injury, member state courts can allow plaintiffs to use circumstantial evidence to prove a vaccine injured them. Defendants, of course, can use scientific evidence to counter the plaintiff’s circumstantial evidence. This decision does not mean that science doesn’t matter in the courts or that anti vaccine activists can win even when the science is against them.
  2. Member courts cannot treat circumstantial evidence as creating a presumption of causation. The plaintiff bears the burden of proving the vaccine cause the injury, and each case must be examined on its facts.  For example, a temporal connection alone does not automatically mean there’s causation.
  3. In a referral like this, the ECJ does not reexamine the facts. It is answering the specific questions of law, and basing its decision on the description of the facts sent up from below. The ECJ was acting on a mistaken premise that the science, in this case, was unclear. That premise came from the lower courts, and the ECJ did not err in following it: it did not reexamine the facts, and did not decide the case in front of it, it only addressed a specific legal question. In the lower courts that now will be expected to rule according to the ECJ’s decision, Sanofi Pasteur – the defendant – should provide the scientific evidence, and we can hope the court, as did the Court of Appeals who ruled on the case last, will follow it. It’s unclear how the case will end.

This is a complex decision. To explain it, I will start with some background on product liability law and European Union law with respect to the European court vaccine decision. Then I will address this case, and then the ruling itself. If you are short of time you can skip the background and go directly to the case, but I think those who want to really understand this will benefit from it. Continue reading “European court vaccine decision – a legal analysis”

Vaccine informed consent – mandates and liability

vaccine informed consent

Several people have asked me whether having school mandates is in tension with the idea of vaccine informed consent . The answer is no. While school mandates have some effect on parental autonomy, the doctrine of informed consent should not be conflated with autonomy.

For a somewhat different reason, imposing sanctions on those who do not vaccinate is also not a violation of informed consent. Continue reading “Vaccine informed consent – mandates and liability”

Vaccine injury compensation and mitochondrial disorders

Vaccine injury compensation and mitochondrial disorders

This post examines the treatment by the National Vaccine Injury Compensation Program (NVICP) of the first of two claims (see second one here) heard from those claiming vaccines cause more injuries than acknowledged in recent days. This article will focus on vaccine injury compensation and mitochondrial disorders – while the second one will cover an NVICP decision with respect to a form of an autoimmune syndrome.

The Special Master’s decisions – as many decisions in NVICP are – are long, complex, and examine the evidence closely and in detail. They address factual debates, expert disagreements specific to the case and expert disagreements on the science.

This post won’t cover them – that’s not my goal. All I will address are the Special Master’s conclusion about two hypotheses raised by those who believe vaccines injured their child (and also promoted by anti-vaccine organizations).

The NVICP (commonly called the Vaccine Court) is a no-fault program created by Congress to serve two goals: to protect the vaccine supply by offering limited liability protections to vaccine manufacturers and providers and to help those injured by vaccines – or even those who may have been so injured – be compensated more easily than in the regular courts.

As I addressed in the past, NVICP provides petitioners – as claimants are called – with substantial breaks compared to the regular courts. Petitioners do not have to prove a product defect or any kind of fault; the requirements for proving causation are relaxed; evidentiary rules are relaxed, allowing the introduction of evidence and experts that would not be allowed in a regular court.

NVICP is not, however, a benefits program. Its goal is not providing any parent with a child with a problem support. The United States certainly needs to offer more support to families of children with disabilities, but NVICP’s aim is different: it focuses on compensating injuries that may, at least, have been caused by vaccines.

To be compensated by an NVICP decision a petitioner does need to meet minimal standards suggesting a possible connection between a vaccine and an injury (a settlement does not require similar proof; parties settle for all kinds of reasons, including a view that the case isn’t worth litigating). At the very least a petitioner needs to show an injury, and provide expert testimony (expert testimony is generally needed when someone claims medical causation in the courts as well – that a medical act, device, drug etc. caused harm – with very narrow exceptions).

Continue reading “Vaccine injury compensation and mitochondrial disorders”

Chickenpox vaccine and shingles – the nuanced facts

chickenpox vaccine and shingles

There are a lot of nuanced facts and evidence about vaccines. The so-called “pro-vaccine” crowd looks at the body of evidence, then concludes that it saves children’s lives by stopping vaccine preventable diseases. The “anti-vaccine” side seems to rely on anecdotes, cherry picking bad studies published in really bad journals, and read anti-science websites, just to support their preconceived conclusions. And now there is a lot of junk science with respect to chickenpox vaccine and shingles, much of which we need to debunk.

One of the enduring myths of the antivaccine cult is that chickenpox vaccine will increase the rate of shingles, especially in older adults. A recent published article examines chickenpox vaccine and shingles – and like everything in science, it’s the nuanced data that makes the story. Not the headlines.

Continue reading “Chickenpox vaccine and shingles – the nuanced facts”