You are currently browsing the tag archive for the ‘thimerosal’ tag.

I have noticed that a lot of visitors to my blog have come from searches that make it apparent they are looking for information on whether the swine flu vaccines contain thimerosal/mercury, so I thought I would collate the information from the package inserts for each of the available shots here for easy reference.

Novartis, Influenza A (2009) Monovalent Vaccine -Licensed for persons 4 years of age and older

  • 0.5 ml prefilled single dose syringe contains less than or equal to 1 microgram mercury per dose (residual mercury from manufacturing process)
  • 5 ml multidose vial contains 25 micrograms of mercury per 0.5 ml dose (as preservative)

Sanofi Pasteur, Influenza A (2009) Monovalent Vaccine – Licensed for persons 6 months of age and older

  • Prefilled syringe, 0.25 mL, for 6 through 35 months of age – contains no mercury (no mercury used in manufacturing process) – distinguished by a pink syringe plunger rod
  • Prefilled syringe, 0.5 mL,  for 36 months of age and older – contains no mercury (no mercury used in manufacturing process)
  • Single-dose vial, 0.5 mL, for 36 months of age and older – contains no mercury (no mercury used in the manufacturing process)
  • Multi-dose vial, 5 mL, for 6 months of age and older, 25 micrograms of  mercury per 0.5 ml shot (as preservative).

CSL Limited, Influenza A (H1N1) 2009 Monovalent Vaccine – licensed for persons 18 years of age and older

  • 0.5 mL single-dose, pre-filled syringe – no mercury (no mercury used in manufacturing process)
  • 5 mL multi-dose vial  each 0.5 mL dose contains 24.5 micrograms of mercury

MedImmune LLC,  Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
– (Live, Attenuated Intranasal Vaccine – LAIV) Licensed for persons from 2 years to 49 years

  • Prefilled single-dose intranasal sprayer containing 0.2 mL suspension (0.1 ml per nostril) – no mercury

I’ve been noticing that there’s a recent new(ish) complaint against people that are concerned about safety of vaccines.  I’ve seen it in some blog posts, and seen it almost constantly in the online comment sections following various news articles and blog articles about vaccines.

The complaint is that people who question vaccines have been changing the nature of their argument over time.  According to this complaint it started with people being concerned about mercury and thimerosal in vaccines.  Over time, as thimerosal was removed (or reduced, as some critics would say) from vaccines, and as a corresponding decrease in autism was not apparent, the “anti-vaccine” people changed their argument. Now they claim that aluminum, formaldehyde and polysorbate 80, etc. are the basis for concern about vaccines.

Apparently some people find this to be some fatal flaw, and from this it apparently follows that any criticism of vaccines is trumped automatically.  But I don’t see that this point has (or should have) any weight.

First of all, points in scientific discussion and debates change over time.  Not only do they change, they ought to change in response to advances in knowledge and to changes in thinking.  Anyone who stays wedded to the first idea they had is either truly perfect, or is a little too invested in being correct.

Consider the medical quest to treat ulcers.  Physicians and researchers considered excess stomach acid production to be the cause of ulcers for decades.  They even tried crazy things like freezing the lining of the stomach to try and reduce acid production until gastric linings started sloughed off and causing lots of bleeding.  I’m glad no one got in their way and said that they couldn’t change their theory halfway through, or was upset because they modified their position in light of further experience.

Furthermore, at least with regards to asthma, allergies and autism, it is reasonable to have a heightened and continuing sense of concern about vaccines, since they are direct attempts to alter the immune system.  Lots of children with autism seem to have immunological problems, and asthma and allergies are both dysfunctions of the immune system.  I’m not remotely suggesting there is evidence of anything causal because of this, but I do think it means it is well worth thinking about and looking at vaccines carefully, since we’re manipulating the immune system in ways that are not well understood, and we’ve got a lot of children appearing with immune problems.

Secondly, the increases in neurological problems, asthma/allergies, ADD and ADHD, bipolar disorder and autistic spectrum disorders in children ARE happening concomitantly with the increases in the number of vaccines that children get.  This is obviously another concern NOT causative on its face, but why does that then make it somehow crazy to want to examine vaccines more closely, as well as their constituent parts?

And finally, if the concerns about vaccines, and their components are so ridiculous and ill-founded, then why aren’t the easy rebuttals just trotted out instead of crying not fair, they changed the game?  For myself, I’d prefer that to all these pointless charges of fallacious argument, and I’m sure there are lots of others who are listening for that as well.

David Kirby, the famous journalist who had leaked the details of the Hannah Poling case in the media in the US, spoke in the United Kingdom last night, at Regent Hall, Oxford Street, London.

I turned up a bit early: 6:10 for a 6:30 pm start, thinking that I wanted to make sure that I got a seat, expecting the room would be quite full, but I was wrong.

The talk began slightly late at about 6:45 pm, and by that time there were about fifty people there, at most.  I was amazed that in a country where there are higher rates of autism than in most of the US that so few people bothered to turn up to hear what this man had to say.

Kirby gave an excellent talk.

I wasn’t sure what to expect since I had seen his work ridiculed on the some of the pro-vaccinationist websites, although I had never read his book or his work at The Huffington Post.  I suppose to be completely fair, I should point out that they don’t call themselves pro-vaccinationists, they tend to call themselves skeptics, or “science-based” or “evidence-based”, implying of course that people who are skeptical about vaccines and who look at evidence don’t exist, or that it is some sort of oxymoron.  It reminds me a bit of being at university where a scholar would refer to her theory as the ‘rich, complex model’ and the theory of someone who disagreed with her as the ‘impoverished, superficial model’.

When Kirby began his talk, he made it clear that he’s not anti-vaccine, nor is he a crusader and that above all, he is a journalist who leaves the science to the scientists.  He pointed out that when he goes home at night, he forgets all about autism; he has no stake in this game and no children.  Along with this topic, he is also working on a project concerning factory-farming of animals, and is writing a book, and none of it has anything to do with autism.

He further pointed out that he doesn’t care whether it is the vaccines that are causing autism or not.  He says that he began researching this area to figure out what was happening that was causing these huge rises in autism cases, and whether it is vaccines or something else doesn’t matter to him, because he is simply working to try and uncover the cause, hoping once discovered the autism epidemic will be able to be stopped.

Kirby began by considering facts and studies that supported the idea that vaccines and autism were not related, and then he turned to those that did suggest a relationship.  He discussed the major studies that are generally considered to be evidence that vaccines are safe, and pointed out all the areas in which these epidemiological studies had methodological problems that directly called the results of the study into question – in many cases by the authors of the studies themselves.  I had already read all the studies he discussed, so I didn’t hear a lot that I didn’t already know, but it was very interesting to have all the information from these studies presented back-to-back so that one could see that as a body of evidence it wasn’t terribly convincing.

But the most amazing part of this talk was that there was no one from the press there.

Well, there was one woman, who said she was a journalist, and that she tried to get someone to commission her to attend the event and write about it, but no one was willing, so she came out of her own interest.  She  pointed out that a notification about the talk had been disseminated among the usual channels in the journalistic community, and that she was certain that the lack of press had nothing to do with people not being aware of the talk.

Meanwhile Hannah Poling is big news in the states and people are now realising that many more children seem to have the markers of mitochondrial dysfunction than the US government originally claimed.   In spite of initial comments by the government health offices that Hannah had an extremely rare inherited condition (in fact Kirby said that the test case intended to replace the Hannah Poling case turned out to have all the same markers and condition as Hannah did, although I haven’t yet confirmed this myself) that the settlement did not mean that the government believed that vaccines cause autism.

But in the midst of this big news that lots of parents are following very closely online, things in the press here are strangely, almost bizarrely silent on this matter.  David Kirby even mentioned that he had a BBC interview scheduled which was canceled, and The Daily Mail commissioned him to write a piece on this subject, which he did, which they then decided not to print.

The Daily Mail did however choose to publish this poorly researched article by Barney Calman about biomedical interventions for autism.  Calman is a journalist who seems to have unfortunately joined forces with Michael Fitzpatrick, a GP who repeatedly and zealously denies that vaccines do any harm or that they have any link to autism.  Fitzpatrick has a son with autism (a teenager who is institutionalised), which he takes special care to mention whenever he speaks or writes, as if this somehow makes his claims weightier.  In fact, Fitzpatrick was at the Kirby talk yesterday, and after Kirby presented his material and then asked for questions, Fitzpatrick hurried not to make any substantive rebuttal of anything Kirby presented, but instead to ask how it could be the case that vaccines contributed to autism when there weren’t any GPs, paediatricians or pediatric gastroenterologists who believed it.

So it would seem that the press in the UK is only willing to publish pieces that are pro-vaccine, and against biomedical treatment for autism.  It doesn’t seem to matter if those articles are even remotely factually correct, or if the primary proponents make sophomoric claims from authority that something must be true because a bunch of doctors think it’s true.

Surely if work like that is worthy of any journalistic effort, then Hannah Poling deserves her own newspaper – and yet she gets nothing in this country.  For myself, I find the silence of the press completely deafening, and I am happy to see people around the country taking notice.

http://www.nytimes.com/2008/03/21/us/21vaccine.html

I saw this article in the New York Times recently about a small measles outbreak in San Diego. In some ways that article was a typical pro-vaccine article, using certain techniques in order to give a slightly skewed view of the truth to make a stronger point. For example they cited statistics from around the world (242,000 children die annually from measles) instead of giving us statistics relevant to our lives. If children in third world countries are dying from measles, you could very reasonably conclude that this might not tell you much about what your child’s risk might be. There are obviously differences in circumstances, and at least some of those children might not have access to the healthy food, good sanitation and the excellent palliative care that we generally have available in the US. But there were two parts of the article I found more interesting than the rhetoric: the comment that many pediatricians view people who don’t vaccinate their children as “…parasites, of a sort, benefiting from an otherwise inoculated majority.” I suppose that they got a lot of mileage from calling people parasites instead of free riders, since it’s obviously a more upsetting, pejorative term. The other thing that was interesting was the fact that they got a mother to admit that she was more concerned about her child’s well being than those of other children.

But the most amazing thing about the article was the vitriol contained in the comments by people who think that vaccination should be forced on all children by the government. These people did a lot of name-calling of those who disagree with them, using inflammatory terms like “unscientific”, “poorly educated”, and claiming that non-vaccinators are unable to evaluate validity of reasoning because they don’t share the opinion of the particular comment’s author. It’s an important lesson for all of us to pay very little attention to the authority with which people speak on important matters, but instead to focus on the evidence which they present. This is especially true when the opinion is full of inflammatory, emotional language and is mostly rhetoric rather than evidenced reasoning, as are most of the comments after the article. If I didn’t know better, I would think it was a fervent flame war over religion and not a scientific disagreement.

Let me state my position point-blank, before I go any further: every person making a comment there that makes it seem as though this is a simple problem with an obvious answer (in either direction) does not know what they are talking about. That includes all the physicians and nurses who think that giving people shots for thirty years somehow confers upon them complex, otherwise-unknown scientific truths that have amazingly eluded everyone else. There is a reason that well-educated people around the world disagree in this problem-space: no one knows what the truth is. I maintain that anyone who tells you otherwise hasn’t looked at the problem and the studies very carefully, or has some sort of interest in the conclusion. And that interest may be as benign (and simultaneously malignant) as just assuming that when a lot of credentialed people say something is true, it must be.

Now, let me begin by saying something that I thought would be obvious to everyone: vaccines damage some children. (and this has nothing to do with the recent Hannah Poling case) It is pretty much true that everyone who knows about public health already knows this. This is the reason that vaccine court exists, and the reason that each shot costs a little bit more than it would otherwise; the money gets put into a fund to pay off those that have been hurt by vaccines. Again, it’s called PUBLIC health – it’s not about your child; it’s about the promotion of the healthy well-being of the society at large, knowing that along the way some people will probably be hurt. This is very simple public policy stuff about which it appears lots of people have their heads in the sand.

So far the lesson is that the pro- and anti-vaccine people agree about this general fact, and they’re now arguing about numbers. Pro-vaccine people think that you’re at much higher risk for being injured by illnesses, and the anti-vaccine people think you are at more risk for being harmed by vaccines. The anti-vaccine people are concerned that autoimmune diseases, allergies and autism are caused, at least in part, by vaccines and/or their component parts (meaning live viruses, adjuvants and/or preservatives, mainly) and that many of the illnesses for which we vaccinate are not serious. The pro-vaccine people think that vaccines alone keep us from reverting to the days when hospitals were full of people suffering and dying from diseases that we can now sidestep entirely because effective vaccines have been invented.

I have personally read all of the studies claiming to show that there is no connection between vaccines and autism, and would have read the studies showing that vaccines were evaluated in the long term, had anyone done those sorts of studies. And by that I mean that I have read the studies in their entirety, which means that I did not rely on information that I read about them in Time magazine, I did not have a conversation with someone (an MD or DO, or a medical student – lots of whom commented on the NY Times article) who claimed to have read the study, and lastly (and most importantly) I did not just glance at the abstract and pretend that I read the whole study, considered the methodology carefully and agree that the study actually demonstrates what it claims to show.

And even with all this study of the primary literature it’s the case that I still don’t understand what people are talking about when they say that vaccines have been proven to not cause autism. There are some epidemiological studies, but when I learned about biostatistics and scientific studies, population-based studies were used solely to help define more specific questions that could be investigated via experimental research. They are where one begins to define a medical inquiry, and are almost never used to prove/disprove anything (and certainly are not used to approve drugs or medical devices) because they fall prey to too many confounding factors.

The prior objection about the population-based studies doesn’t even begin to raise the questions about the legitimacy of the particular population studies that were done, and cited by the Institute of Medicine. In one case the children in the country where the study was done were administered half the thimerosal as children in the US, but somehow the study is still cited as perfectly applicable to US children. There was another study, done in the US, but it had a minor difficulty in that all the data that was analysed was “lost” (although individuals have testified that they were instructed to destroy the data), which would under any other circumstance result in the study being disregarded. High standards of proof in medicine usually require that the information used is available so that the results of the analysis can be checked and verified by other parties. In fact, the famous Wakefield study (that claimed an association between autism and measles vaccines by isolating measles in the gut of autistic children) is commonly discredited in this way. But somehow this protocol has been eschewed for studies on only one side of this debate. All this makes me feel a bit as though I’m living in the twilight zone; there’s one standard of proof when you’re discussing the claim that vaccines have no relation to autism, and a separate, more stringent standard of proof for the other side of the debate, and everything else.

But in spite of all these difficulties, every day people claim that there is no association between vaccines and autism. Go ahead and go back and count the number of comments after the New York Times article that claimed that the association between autism and vaccines has been disproven (bonus points for how many times this was said by physicians and med school students). These are the standards of proof being used by these commenters. (assuming they’ve read the studies at all and aren’t just relying on press releases or the likes of sciencedaily’s rubbish summaries that bear no relation to the study in question)

I believe that if someone could show people that do not vaccinate that vaccines were actually safe they might well reconsider; I think the uptake rates on vaccines would increase dramatically if people felt that they were safe and effective. So let me share some ideas that I have for things that could be done to get to get non-vaxers to reconsider, instead of using the brute force of law or personal attack, which a lot of the commenters seemed to be advocating.

Admit that no one has done any long-term study of vaccinations, and that certainly NO ONE has done a study to determine what happens when you give the many shots of the US recommended schedule in a short period of time (other than generate a lot of revenue).

Stop pretending that the thousands of families who have had normally developing children who went for a series of vaccines one day, then screamed for 24 hours (a not-uncommon vax side-effect) and then never uttered another word are imagining it. Science at its heart is all about observation, not fancy journals; so when many people tell a very similar story it certainly warrants real scientific investigation instead of a castigation that people are all collectively imagining things, and that it is a coincidence. I find it astounding that the people of medical science expect people to believe this. When you dismiss the reports and the very observational basis of science and instead engage in heated denial, you are simply extending an open invitation to people to wonder about cover-ups and conspiracies.

Acknowledge that vaccines do not seem to provide the same sort of protection that natural immunity does. There are almost no infections that humans routinely get that are not caused through contact with mucosal or digestive surfaces (malaria being the major exception that comes to mind). In lay-speak, our immune systems have various “layers” of immune globulins that have different roles in immunity – when we inject vaccines, we bypass some levels of immune response, and there is a good chance that this big difference is a factor in the shorter duration of protection that vaccines offer. Because vaccinations don’t seem to confer long-lasting immunity there seems to be an emerging trend where illnesses that used to mainly affect children are now affecting older people (sometimes only in their 20s), and the result has been atypical forms of the illness (like measles) that seem to be more virulent than when the illness is typically contracted as a child. A slightly different problem with the short-lived effect of vaccines is the fact that women used to contract rubella as children, and later, when they became pregnant, their immunity to it was practically assured. Now that we vaccinate against rubella, the immunity that waned, or simply never occurred (via vaccine failure) means that more fetuses are at risk of birth defects due to perinatal rubella infections. Stop pretending that these problems are due to non-vaccinators when vaccines and their incomplete, short-lived immunity contribute to the problem as well.

Stop claiming that practically everyone in the world died of chicken pox and measles ten minutes before the vaccines were invented. Go look have a look at the first hand statistics instead of just mindlessly repeating the propaganda.

Dispense with the arguments from authority such as “I am a physician and I think x.” or “My doctor, who went to Yale, says y.” – people with decades of experience and education have been, and will always continue to be mistaken about things. What matters are the studies and methodologies, and not who said what and what their qualifications are. How many people die each year due to physician error? The Institute of Medicine report from 1999 claimed that the figure is approaching 100,000 people per year. Those people were killed by doctors who made mistakes. Please let’s stop perpetuating the myth that doctors have some extra-human access to anything – they are just people who trade in medicine, and they are sometimes right, and sometimes wrong.

Now let me point out that this debate could be solved with an actual study, devoid of biased funding, done by researchers whose livelihood does not depend on paychecks from the manufacturers of vaccines, investigating the points that I mentioned above. It will be difficult to blind an actual experimental investigation of this sort, because of moral concerns. But there are already plenty of families in the US that do not vaccinate, and comparing rates of the various allergies, ADHD, asthma and autism in children who were and were not vaccinated certainly is a good place to start.

Once some reasonable scientific work has been done in this area, I think we could be on the way to refining our thoughts and concerns. It’s the reluctance to actually discuss the shortcomings and unknowns of vaccination, and instead derail the debate with over-emotionalism and insults that holds both public health and the well being of children back.

And as a private reply to comment #383, B. Pirkle, R.N., San Francisco: Non-vaccinating parents all over will be struck by the irony of your comment. They know all too well that there is no such thing as a free lunch; that’s exactly what they’re trying to get YOU to see. You can’t just inject a bunch of untested stuff into the body, hope it effects the immune system in the way you intend, and assume that there is no cost or downside – that sounds like free lunch idealism at its best. Maybe you should consider taking a little of your own medicine.

There’s been a lot of buzz in the last month or so concerning this latest study by Michael Pichichero et al. from the University of Rochester which was purportedly published in the February issue of the medical journal Pediatrics a month ahead of schedule in order to combat what was thought to be unscientific autism-is-caused-by-vaccines rhetoric in a fictional television courtroom drama called Eli Stone.

And the media didn’t disappoint, there were lots of reports that latched right onto the “findings” of the study. Here are some examples from The Washington Post, Science Daily and Reuters.

You can begin to understand why the hubbub erupted after you look at the misleading abstract:

“The blood half-life of intramuscular ethyl mercury from thimerosal in vaccines in infants is substantially shorter that that of oral methyl mercury in adults.”

This sounds like great news, telling us that the mercury preservative in vaccines (still currently in most of the recommended children’s flu shots) is cleared from the blood of children much more quickly than the mercury found in seafood eaten by adults is cleared from their blood. “Maybe thimerosal IS safe,” you might think, if you didn’t actually bother to read the study, “and those people who were worried about injecting mercury into the bloodstream were alarmists.”

Of course, there are some relevant bits of information that were omitted from the abstract, such as where all the mercury cleared from the vaccinated children’s blood WENT. Pichichero doesn’t actually know, as his stated aim was to evaluate the similarity of methyl (fish) and ethyl (vaxes) mercury in order to determine whether current EPA guidelines that suggest maximum exposure to methyl mercury found in fish is suitable for application to ethyl mercury in some vaccinations. He analyzed urine, blood and feces, and so therefore can only report those findings; some inorganic mercury was excreted via a one-time fecal sample from the study subjects, which seems to indicate that at least some of mercury contained in the shots was excreted in this manner, but he doesn’t know how much of the mercury that was injected was excreted via feces. There was no significant excretion of mercury via urine.

Fortunately, Thomas Burbacher, et al. can make a good guess as to where some of the mercury from the injected infants went: their brains. Burbacher’s study reached a very similar result as Pichichero’s in that the half-life of ethyl mercury in the blood was significantly shorter than that of the methyl mercury. The difference is that Burbacher also examined the amount of mercury in the brains of infant macaques that had received either ethyl or methyl mercury, and found that blood mercury levels were not good indicators of brain mercury levels. Furthermore, while Burbacher’s results are similar to those of Pichichero’s in that there does not seem to be any accumulation of mercury in the blood after thimerosal exposure, there are concerns about the accumulation of mercury in the brain.

Burbacher found that absolute inorganic mercury concentrations in the brain were approximately twice as high in the thimerosal-exposed macaques than those exposed to methyl mercury in the diet. Inorganic mercury has a very long half-life in the brain, between 227 to 540 days, depending on which region of the brain in which the mercury is deposited.

When I read the Pichichero study, I couldn’t help but wonder why he so strenuously avoided any reference to the work Burbacher et al. had done; he had, in fact, cited that same study when he noted that “…ethyl mercury readily transports to all tissues but that it has a shorter half-life.” But then when interviewed by reporters concerning his recent study, as in the Reuters article linked above, he made claims such as “Now it’s obvious that ethyl mercury’s short half-life prevents toxic build-up from occurring. It’s just gone too fast.” Burbacher didn’t find it was gone too fast. He found it was going to the brain, and there was nothing in the Pichichero study that demonstrated that he knows where the mercury went when it left the blood. He knows it did not appear in the random urine sample, and that some of it appeared in a random fecal sample, but as far as he knows, a whole bunch of it might be sitting in some tissue in the body. So it is difficult to see his statement as anything more than pure conjecture, and unrelated to anything he knows to be true, in the usual scientific understanding of the word true, and certainly unrelated to anything he demonstrated in his study.

Burbacher and Pichichero did agree that the EPA guidelines for maximum exposure to methyl mercury should not be applicable to ethyl mercury, because both substances seem to be handled differently by the body. But they seem to be parting company on what this means. Burbacher recalls that inorganic mercury in the brain is associated with an increase in microglia and notes that a study has shown an increase in brain inflammatory processes including a large proliferation of microglia in the brains of autistic patients. Whereas Pichichero seems to be holding out hope when in the conclusion of the recent study he states: “Our results suggest that a new risk assessment regarding exposure to thimerosal…should be conducted in light of the demonstrated short half-life of ethyl mercury following vaccination.”

As always, I would gently suggest that you are as informed as possible before you inject substances into your children or yourself. And I further advocate the exercise of caution and extreme critical analysis when a person whose interests might be contrary to yours advocates that you do something based on purported research findings, particularly when the findings are actually outside the purview of the study. (It is interesting to have a look at the “Research Focus” heading here).

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