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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

The CDC advised states to stop confirming cases of H1N1 back in July, presumably because it was a waste of resources when H1N1 had already been declared to be at epidemic levels. The assumption was that everyone who presented with flu-like illness was ill with H1N1.

CBS News asked the CDC to release data on the confirmed cases, and when the CDC did not respond to their request immediately they filed a Freedom of Information Act (FOIA) request for the data, and concurrently undertook a three-month, state-by-state inquiry concerning data of confirmed cases prior to the CDC’s recommendation to stop confirming H1N1 via laboratory test.

CBS found that the states were confirming swine flu in about 1%-17% of cases of persons sick with flu-like illness. The majority of the other flu-like illnesses were caused by non-influenza causes (83%-97%), although there were small amounts of cases confirmed to be seasonal influenza.

And of course during this time the presumption is that all these cases are swine flu, making it seem far more prevalent than it really is.  CBS cites the case of a recent “outbreak” of 250 students at Georgetown University, where the presumption is that there are 250 cases of H1N1, when in reality, those cases have not been confirmed and it is nothing more than a counting of students who went to the unversity’s health service with flu-like symptoms.  It’s very likely that few of those 250 students actually have swine flu.

This has problematic implications for vaccination recommendations as well (setting aside the question of whether the vaccine is safe and effective).  The CDC recommends that unless you have had a laboratory-confirmed H1N1 diagnosis you should get the swine flu vaccine, which means that some people who have actually been ill with swine flu will be getting an unnecessary jab, and people who think they have been ill with H1N1 will mistakenly assume that they are immune.

A new report in the British Medical Journal is bound to ruin the day of company officials (and shareholders) of the current human papilloma virus (HPV) vaccine manufacturer, Merck, who were undoubtedly pleased that an FDA committee recently recommended that the government agency okay the use of Gardasil in males against genital warts.

An economic analysis of the cost effectiveness of vaccinating boys for HPV in order to prevent cervical cancer caused by certain HPV variants in girls was done at the Harvard School of Public Health.  The researchers concluded that vaccinating girls resulted in a cost of $50,000 per quality adjusted life year (QALY), which means that for every additional year of perfectly healthy life that is gained via the vaccine, the cost is $50,000.00.  The cost for including boys in the HPV vaccination efforts raised the cost of one QALY to over $100,000, which “…exceeds conventional thresholds of good value for money,” the researchers said.

The researchers made the calculations assuming 75% vaccination coverage rate, and also assumed that the immunity to the cancer-causing variants of HPV that the vaccine is supposed to confer lasts a lifetime, which is of course unknown at this stage, since the vaccines in question have only been in use for a few years.

The immunity conferred by every other vaccine appears to wane over time, so until we have evidence to the contrary, it is rational to assume that any immunity conferred by Gardasil and Cervarix will wane as well.  If repeated vaccination is necessary, this will raise the cost of each QALY even further.

Nonetheless, it seems likely that the current push to recommend the use of HPV vaccines in males will continue with a simple shift in focus on genital warts instead of cervical cancer.

The two currently FDA approved vaccines for human papilloma virus are manufactured by Merck & Co.  (Gardasil, ) and GSK, GlaxoSmithKlein (Cervarix).

I was reading a New York Times article this moring about the State of New York’s recent mandate that all healthcare workers receive the swine flu vaccine.

It was shocking to learn that hospitals incent healthcare workers to get vaccines by offering them time off work or the chance to win a vacation or holiday trip. It reminds me of parents offering their children ice cream if only they eat their broccoli.

It’s probably more appropriate in a non-paternalistic state to offer healthcare workers good reasons to have the shots than to offer them bribes.  Good reasons would include: 1)  evidence that the shot is necessary (meaning that we have good reason to believe that this strain of flu is particularly dangerous or virulent),  2) evidence that the shots are effective, and 3) evidence that the shots have been adequately tested and are safe.

The article also says that workers who decline vaccines even when they are “voluntary” are often punished by having notes concerning their noncompliance with the vaccine recommendations put into their personnel file or else they are forced to wear face masks at all times.

The FDA announced today that it approved four Swine Flu (H1N1) vaccines manufactured by Sanofi Pasteur, Novartis, MedImmune and CSL Limited and expects that the vaccines will be  available in approximately four weeks.  Vaccines will be available both with and without thimerosal.

Last week the two of the four companies who manufacture the approved vaccines had findings published in the New England Journal of Medicine:   CSL Limited and Novartis.

The worrying aspect of all of this rush to make H1N1 vaccines available is the seemingly small numbers of people on whom the vaccines are being tested before they are approved.

Details from the website of the National Institute of Allergy and Infectious Disease at the National Institute of Health detail five clinical trials taking place under the support of the NIAID in addition to trials that are being (or have been) undertaken by the manufacturers.

The NIAID-supported trials have tested two strengths of H1N1 vaccines made by CSL Limited and Sanofi Pasteur in 200 people, each receiving two doses of the vaccine given 21 days apart.  Half of the people tested were 65+ years old, the other half were between 18-64.

The other three NIAID trials are testing pediatric doses of the vaccine,  (these trials are expected to be completed in April of 2010), and the H1N1 vaccines given simultaneously and sequentially with the seasonal flu vaccine, both in adults and in children (these trials have the largest enrollment, up to 800 persons).

At the end, this means that 200 people between the ages of 18-64 were trialed with two doses of either the Sanofi Pasteur and CSL H1N1 vaccines, half of which got a larger dose of vaccine, and half of which got a smaller dose.  In CSL’s NEJM article, an additional 240 people were trialed (half less than 50 years old, half equal to or greater than 50 years old).

There was a good deal of the unsurprising injection-site tenderness, and symptoms like headache and pains, but no deaths and no serious adverse events.

But it’s not terribly surprising that there aren’t any serious adverse events showing up in very small group of people receiving a vaccine (100-200). The question is whether we will see any adverse events emerge in four weeks when the vaccines are made available to the public.

The UK Department of Health is gearing up to spend £400,000 to fund a media campaign to convince parents of young children to give their children the MMR, according to a story in PR Week.

I can’t help but wonder why they don’t take the money, and hold a large televised debate on the merits, completely open to the public.  Since the claim is that the MMR is emphatically not associated with autism, backed up by solid scientific study, why not publicly address parents’ concerns instead of trying to sell them with an advertising campaign?

Aren’t adverts for trying to convince someone to want something that they don’t really want?  Give the parents the discussion and an open forum where difficult questions are addressed with truthful and robust answers.  I suspect that people would really like to really assess the government claim that the risks of side effects of the vaccine-preventable diseases are much higher than the risks of side effects of the vaccines – instead of being “sold” on it by some PR experts.

There’s been a recent outbreak of whooping cough (pertussis) in Hunterdon County, NJ, and the last report I’ve seen puts the number of ill children at 32.  A separate news report stated that the ill children had been vaccinated,  and then another report confirmed that all the infected children had all of their recommended vaccines.

Most of the infected children were (29/32) between the ages of 7-12.  These children, if vaccinated according the CDC recommendations, had DTaP shots at ages 2 months, 4 months, 6 months, 15-18 months and 4-6 years.  That’s FIVE doses.  Five doses of the vaccine, and still this many children are not immune?

There’s been a recent addition of a SIXTH dose of pertussis in New Jersey near age 10, as there is concern that the temporary immunity to pertussis from the previous five doses wanes as quickly as ages 7-9.

Apparently when five doses of a vaccine aren’t sufficient to induce immunity the answer is to just keep giving more doses, as perhaps after the 10th, 25th or 33rd dose they will hit the jackpot.  If we’re lucky.

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.

“…my brother’s story also taught me about the loneliness of the visionary, the selfishness of our culture, and the arrogance that blinds many scientists.” – Christina Odone

Lorenzo Odone was a boy diagnosed at age 6 with the rare genetic disorder adrenoleukodystrophy (ALD), where an accumulation of fatty acids occurs in the body due to a missing transporter protein. This results in damage to the myelin sheaths that insulate the axons of nerve cells in the body, and signals can no longer be sent via these axons, resulting in increasing disability, such as losses of sight, hearing and movement.

Soon after his diagnosis, Lorenzo’s parents, Augusto and Michaela, were told by physicians that their son would soon be dead, and that there was nothing to be done.

But the Odones instead set about researching Lorenzo’s disease, and came upon a combination of acids (Lorenzo’s Oil) could stop the production of the fatty acids that were causing the problem. Once given to Lorenzo, the oils worked, and although they could not re-myelinate his already damaged cells, they greatly slowed the progression of the disease.

The Odones created an organization aimed at accelerating and supporting research into the repair of myelin and treatment of leukodystrophies and demyelinating disorders: The Myelin Project.

Lorenzo died just a couple of days ago, the 30th of May 2008, the day after his 30th birthday: 22 years later than the physicians predicted. And it was only in 2005 that research on the Odones’ patented Lorenzo’s Oil showed that young boys who had yet to display symptoms of ALD, who has the oils added to their diet, had a statistically lower chance of developing signs of the disease. And more research is being done.

It’s a lucky thing for Lorenzo that his parents persevered, and weren’t satisfied with the best answers that medical science had to offer. Today skeptical parents engage in similar acts of love and dedication to their children when they demand unbiased studies addressing the safety of the vaccine schedule, or they biomedically treat the medical problems borne by their autistic children, when physicians everywhere assure the public that yes, everything is safe, or no, nothing can be done, and anyone who says otherwise is a quack or a parent-in-denial. In spite of the “arrogance of scientists” that Lorenzo’s sister Christina Odone refers to in The Daily Mail, parents all over the world act against the advice of the medical establishment that said nothing could be done for Lorenzo.

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