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.

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Polio vaccine causes cancer – just a myth

polio vaccine causes cancer

Apparently, the “polio vaccine causes cancer” zombie meme has been reanimated by the antivaccination cult. Lacking evidence for their beliefs, retreading old debunked memes is their standard operating procedure.

The interesting thing about social media (Facebook, Twitter, blogs, Google, reddit) is that it’s fairly easy to push pseudoscientific beliefs. The first problem is that many people read the headlines, and never the underlying discussion. If it can be said in 140 characters, or a misleading infographic, many individuals will share that across the internet as a “fact”. So, if you see an claim that “Polio vaccines infected 98 million Americans with a cancer virus,” many people will immediately see that an accept it without much criticism.

Of course, this leads to a second problem. To refute this claim takes a lot more than 140 characters. The refutation is often complex, nuanced and highly scientific, and may take 2000 words or more to blast the claim into orbit. It’s highly emotional to claim a vaccine can cause cancer. On the other hand, to say it is not isn’t emotional–it’s coldly logical. And takes a lot of words.

And the third problem is that is that social media fallacies have multiple lives, so when someone reads one of these memes a year from now, they think “yeah, this is great information”, and pass it along as if it’s the Truth. Killing zombie memes are just as difficult as killing zombies in real life, or at least, on a TV show. Debunking these zombie memes is a full-time job. And, once it’s been debunked, we move back to the first problem again, again, and again.

Continue reading “Polio vaccine causes cancer – just a myth”

Flu vaccine ingredients – not so scary using simple math

flu vaccine ingredients

When dealing with those pushing pseudoscience, like the antivaccination cult, the most frustrating thing is that they tend to ignore and deny the most basic tenets of science. If denying the fact of gravity would further their goals of “proving” vaccines are neither effective nor safe, they would do so. And now that it’s flu season, they’re producing zombie tropes about flu vaccine ingredients.

If the antivaccination movement didn’t lead to epidemics of long-gone diseases, which can harm and kill children, the conversation would be over. I would just put the vaccine deniers in the same group as evolution deniers (creationists) or gravity deniers (there has to be some, somewhere). I would mock their pseudoscience, and move on. Of course, their denialism does lead to deaths of children, so we have to do what is right, and stop their lies, misinformation and ignorance in every forum we can.

We have to appeal to scientific values, and despite the fact that antivaccination pushers don’t share those values, we must continue to try. I have gotten enough emails and comments from people that they have started to vaccinate because of what I have written, so maybe some child’s life is better because all of us who support vaccines are heard.

Continue reading “Flu vaccine ingredients – not so scary using simple math”

Glyphosate causes cancer? The IARC did not have all the evidence

glyphosate causes cancer

In 2015, the  International Agency for Research on Cancer (IARC) reviewed research data regarding Monsanto’s glyphosate weed killer, also known as RoundUp. The IARC, at that time, concluded that glyphosate causes cancer.

The IARC, one of the intergovernmental agencies within the World Health Organization, is widely respected for their research into the causes of cancer. And with respect to glyphosate, the IARC concluded that:

There was limited evidence in humans for the carcinogenicity of glyphosate. Case-control studies of occupational exposure in the USA, Canada, and Sweden reported increased risks for non-Hodgkin lymphoma that persisted after adjustment for other pesticides.

The AHS cohort did not show a signifi cantly increased risk of non-Hodgkin lymphoma. In male CD-1 mice, glyphosate induced a positive trend in the incidence of a rare tumour, renal tubule carcinoma.

A second study reported a positive trend for haemangiosarcoma in male mice. Glyphosate increased pancreatic islet-cell adenoma in male rats in two studies. A glyphosate formulation promoted skin tumours in an initiation-promotion study in mice. Glyphosate has been detected in the blood and urine of agricultural workers, indicating absorption.

Glyphosate and glyphosate formulations induced DNA and chromosomal damage in mammals, and in human and animal cells in vitro. One study reported increases in blood markers of chromosomal damage (micronuclei) in residents of several communities after spraying of glyphosate formulations.

The Working Group classified glyphosate as “probably carcinogenic to humans” (Group 2A).

When I looked at their conclusions from a couple of years ago, I argued that there was significant evidence that glyphosate was not correlated or causal to any of the 200 or so cancers. And I wasn’t alone in that assessment.

 

Glyphosate causes cancer – IARC lacked evidence

Unfortunately, when the IARC made its decision two years ago, there was one major problem. According to an extensive article by Kate Kelland in Reuters, one of the members of the IARC’s study group looking at glyphosate knew of recently published data that showed no link between the weed killer and cancer. Aaron Blair, an epidemiologist from the US National Cancer Institute, never mentioned this new data to the study group examining whether glyphosate causes cancer. So the IARC made its decision without all of the available evidence.

Reuters obtained information that lead it to state that:

Previously unreported court documents reviewed by Reuters from an ongoing U.S. legal case against Monsanto show that Blair knew the unpublished research found no evidence of a link between glyphosate and cancer. In a sworn deposition given in March this year in connection with the case, Blair also said the data would have altered IARC’s analysis. He said it would have made it less likely that glyphosate would meet the agency’s criteria for being classed as “probably carcinogenic.”

The IARC acts in a manner that it appears to develop a scientific consensus about what may increase the risks of cancer. As I have mentioned many times, the scientific consensus is a powerful tool in providing us with the collective conclusions of top scientists in a field. However, this consensus must be based on evidence, not opinion or belief. And if a consensus is “proclaimed” without consideration of all of the high quality evidence, then it’s hard to put much value in it.

Now there wasn’t a grand conspiracy that blocked the IARC from considering this new evidence. Blair himself was a senior researcher on the study that showed no link between cancer and glyphosate. The reason the research wasn’t included was simple – the IARC only uses published data to come to its consensus about cancer risk, and Blair’s research could not be included in the discussion. This leads to increased transparency and reduces the risk of claims of “secret evidence” that may lead to accusations of bias.

Now, this rule may seem onerous to some, it does keep the discussion to peer-reviewed data, ignoring data that hasn’t been vetted. This probably works both ways, leaving out data that may move a chemical into a cancer causing category or not.

But this decision by the IARC had some significant consequences. First, it’s hard to read anything about GMO foods, agriculture, or food without someone spouting off that “glyphosate causes cancer.” In fact, there’s a class action lawsuit in California, with 184 individual plaintiffs, who use the IARC analysis on glyphosate, claiming that exposure to the chemical gave them cancer. The plaintiffs allege Monsanto failed to warn consumers of the risks of RoundUp, which Monsanto fiercely denies.

Monsanto claims that the fresh data should have been published in time for use in IARC deliberations on glyphosate. Or, at the minimum, the preliminary data should have been evaluated, considering Blair’s involvement with both the IARC and the new research.

Again, according to Reuters,

The company also goes beyond saying the fresh data should have been published. It told Reuters the data was deliberately concealed by Blair, but provided no specific evidence of it being hidden.

So this gets a bit more troubling.

What did Aaron Blair do? And why?

This is what is troubling to me. Actually, the data that mostly refuted the hypothesis that glyphosate causes cancer was available two years before the IARC assessment meeting. Now, science does move slowly, but that’s glacial.

According to Blair, the data was not published in a timely manner because there was too much data to fit into one scientific paper (which seems like a lame excuse to this writer). Reuters actually asked whether “he deliberately did not publish it to avoid it being considered by IARC.” Of course, Blair denied it. Furthermore, the National Cancer Institute also stated that “space constraints” was one of the reasons why the new data on glyphosate was not published in a timely manner.

Of course, the absence of Blair’s data was a critical oversight – the IARC ended the meeting by concluding that the weed killer is a “probably human carcinogen.”

In fact, the statement based its findings on “limited evidence” of carcinogenicity in humans, but “sufficient evidence” in animal research models. It specifically stated that there was a “positive association” between glyphosate and non-Hodgkin lymphoma, a cancer of the blood.

Beyond the litigation mentioned above, the IARC had all kinds of negative consequences. For example, some countries have pending decisions regarding whether to relicense or ban sales of glyphosate. Some countries have even restricted glyphosate’s use in home gardens and on crops immediately prior to harvest.

And back to the class action lawsuit in California, Reuters reports that:

… (the) California judge took the IARC assessment into account in a separate legal case in March when ruling that the state can require RoundUp to carry a warning label that it may cause cancer. Monsanto is now facing further litigation from hundreds of plaintiffs across the United States who say glyphosate gave them or their loved ones non-Hodgkin lymphoma, citing the IARC assessment as part of their claims.

All, because of an apparently flawed decision without all of the high quality evidence considered. This is frustrating from a scientific standpoint.

What is in Blair’s study?

This unpublished research, and it’s still unpublished, came from the Agricultural Health Study, a large multi-center study led by scientists at the National Cancer Institute. The researchers examined agricultural workers and their families, in the USA, who were exposed to various agricultural chemicals, including glyphosate. Blair himself agreed that the unpublished data showed “no evidence of an association” between exposure to glyphosate and non-Hodgkin lymphoma.

In fact, a review by Acquavella et al., published in 2016, examined the body of research regarding glyphosate and non-Hodgkin lymphoma. The authors concluded that, “overall, our review did not find support in the epidemiologic literature for a causal association between glyphosate and non-Hodgkin lymphoma or multiple myeloma.” That’s a pretty powerful finding with regards to the IARC decision.

Additionally, Robert Tarone also published a paper in 2016 that took IARC’s decision regarding glyphosate to task. He concluded that,

It is shown that the classification of glyphosate as a probable human carcinogen was the result of a flawed and incomplete summary of the experimental evidence evaluated by the Working Group. Rational and effective cancer prevention activities depend on scientifically sound and unbiased assessments of the carcinogenic potential of suspected agents. Implications of the erroneous classification of glyphosate with respect to the IARC Monograph Working Group deliberative process are discussed.

The IARC’s decision that glyphosate causes cancer seems to be under attack by serious researchers.

Blair admitted, while being deposed by Monsanto lawyers, that IARC’s review of whether glyphosate causes cancer would have been different if the Agricultural Health Study data were included. According to Blair, the addition of the missing data would have  “driven the meta-relative risk downward.” In non-scientific terms, that means meta-data would have shown a reduced correlation between glyphosate and non-Hodgkin lymphoma.

Essentially, the IARC review ignored a huge body of robust data from a comprehensive study on exposure to glyphosate, and it’s relationship to cancers. This is a major oversight of the IARC decision.

And it’s just shocking to note that one person, Aaron Blair, was on the IARC review committee and had insider access to high quality data that refuted the IARC’s claims of correlation (and causation) between glyphosate and cancer.

Reuters took the data (which, as I stated, still has not been published, although the NCI told Reuters that they are currently working on an updated analysis) to two statistical experts to determine what it may say about whether glyphosate causes cancer. Neither of the experts had seen the data, and neither had a conflict of interest with respect to glyphosate or Monsanto.

The experts came to two key conclusions after examining the data:

  1. There was “no apparent scientific preseason for not publishing the data” from the large study. In other words, absent some issue like bias or bad study design, they felt that the data was publishable in its current form.
  2. The data shows no evidence that glyphosate causes cancer, especially non-Hodgkins lymphoma.

Of course, you’d think that the IARC would reconsider it’s decision about glyphosate, relying upon all the science, not just what they had already decided. Apparently, that’s not going to happen.

Reuters wrote to the IARC about Blair’s new data and whether they would reconsider their position. They responded by email,

IARC declined to say whether Blair informed IARC staff about the unpublished data, whether he should have, and whether that data might have changed IARC’s evaluation of glyphosate had it been published in time. The agency said it had no plans to reconsider its assessment of the chemical.

That’s not very scientific. The consensus must change with new, high quality data. It seems like the IARC is being stubborn about their decision rather than looking at more robust evidence that contradicts their conclusions.

 

Glyphosate causes cancer – the Summary

As I wrote in 2015, without the data from the Agricultural Health study, I, and other researchers, felt that the IARC decision was suspect. It seemed to rely upon very weak associations between glyphosate and non-Hodgkin lymphoma, while ignoring high quality evidence that showed no correlation.

With this data, as yet unpublished, the IARC’s decision about the carcinogenicity of glyphosate just doesn’t pass scientific credibility.

I hope that when Blair’s study finally gets published, the IARC will review its findings and follow the science to a more defensible conclusion. What should trouble the IARC is that many scientists are starting to look askance at their decisions regarding carcinogens. The evidence just doesn’t support their conclusions on glyphosate, but what if their decisions about other chemicals is also this badly done?

I’m convinced that we overstate the risk of cancers for lots of reasons. But there are really only a handful of ways to prevent cancer – avoiding glyphosate isn’t one of them.

Glyphosate causes cancer? The body of scientific evidence seems to say no.

Key citations

 
 

Monsanto glyphosate causes cancer – so do apples

Monsanto glyphosate

Monsanto glyphosate (Roundup)  is a broad-spectrum systemic herbicide used to kill weeds, especially annual broadleaf weeds and grasses that are known to compete with commercial crops grown around the world. It has several advantages over many herbicides in that it breaks down in the soil into non-toxic organic molecules, reducing or eliminating contamination of groundwater and lower soils.

Monsanto has developed genetically modified (GMO) grains that are resistant to glyphosate, so that agriculture can apply the herbicide to kill the competitive weeds while not harming the crop. This allows farmers to suppress the weeds while allowing better production out of the grain crop.

Whatever the benefits of Monsanto glyphosate, GMOs and the herbicide are tied together in many minds. And there has been an ongoing effort by many people to claim that glyphosate causes cancer. But let’s look at the science, because maybe we’ll get some information.

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Anti-vaccine doctors – naming names and listing lists

Anti-vaccine doctors

Recently, the vaccine deniers have pushed a list of anti-vaccine doctors, which gets copy-pasted from one website to another, and are similar to those lists of “scientists” who deny Darwinian evolution or climate change. But is this really made up of respected physicians and researchers? Does it really contain doctors who are experts or authorities on vaccines?

Well, thanks to Zared Schwartz, a senior at the University of Florida studying microbiology, cell science and neurobehavioral, who took it upon himself to look up each of these individuals and see if they’ve got anything to offer in the discussions about vaccines. Guess what? It doesn’t appear so.

So if you run across this list of anti-vaccine doctors and researchers, wondering if any of them speak from authority, just check them out on this list.

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HPV and prostate cancer – meta-analysis shows link

HPV and prostate cancer

It has been well established that human papilloma virus (HPV) is closely linked to numerous cancers. Recently, evidence has been uncovered that show a link between HPV and prostate cancer. This provides us with more evidence that preventing these infections with the HPV vaccine can lead to a reduction in many types of cancers in both men and women.

 

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