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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
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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.

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.

I come across stories about what the press likes to call “vaccine-preventable diseases” rather frequently. There are often warnings about the clusters of illness caused by people who choose not to vaccinate. They point to mini-epidemics of whooping cough, measles and mumps, and lament how all this wreaks havoc even for those who have been vaccinated (since vaccines are not 100% effective). There’s always an outbreak here or there, and if you search the archives of any major newspaper you will get quite a few hits.

But I can’t remember the last time I saw the press covering a severe vaccine reaction, or death. I suspect it has something to do with my observation that when there is a temporal relationship between a vaccine and an illness or death, we are reminded that temporal relationships are not the same thing as causality, and that it is a coincidence that a problem occurred shortly after vaccination. But in the amazingly rare instances that a child dies of a vaccine-preventable illness, like measles, the temporal relationship takes priority, and we are told that the child died of measles, even if the child was taking azathioprine or other immune-suppressive drugs to shut down their immune system due to other ailments or organ transplant.

Whatever the reason, today I can stop complaining about the lack of coverage for vaccine reactions, because I came across a story this morning about a healthy three month old infant who received an MMR vaccine, developed a fever, and seemed generally unsettled, who then died the following day. Of natural causes.

Consultant forensic pathologist, Dr Charles Wilson, told the hearing that he believed the baby had died of pneumonia.

He said: “Kenzie had the early stages of a lung infection, the kind you tend to see with bacteria. It was the earliest stage of pneumonia. It was an entirely natural, tragic and unforeseeable cause of death.”

I’m glad the pathologist mentioned that the pneumonia was the type you tend to see with bacteria. That would (phew!) completely rule out any involvement of the vaccine then, since it is comprised of three live-attenuated viruses. I’m a little surprised though, that he thought the pneumonia was the type that one tends to see with bacteria. Didn’t he check the infected lung tissue? I’m surprised he doesn’t know what pathogen was in the lungs.

I’m going to confess now that I find this a bit odd. Do children who seem fine and healthy often die in the very beginning stages of pneumonia, before anyone knows they are ill? Maybe this is truly so common that there is no need to raise an eyebrow, or to send some lung tissue to histopath.

In order to take this article, and the pathologist, at face value we have to believe: 1) the child was absolutely fine at the healthcare visit where he had received the MMR, and that there was no sign of pneumonia that a clinician should have noticed, even if the child was going to die of it about 30 hours later, 2) the administration of the MMR was strictly coincident in time with the unrelated fatal illness, 3) healthy children die rapidly in the early stages of infections, even when it is sufficiently early that there are no symptoms of any concern, and 4) that #3 happens often enough that no one bothers to send infected tissue for histopathological assessment. Apparently the coroner agrees this is reasonable:

Coroner Jennifer Leeming recorded a verdict of death by natural causes.

For myself, I remain slightly skeptical.

I was rather foolishly unable to keep myself from reading yet another New York Times Op-Ed about mercury and vaccines, this one authored by Paul Offit, well-known vaccine advocate who works for the Children’s Hospital of Philadelphia, and has previously served on the CDC’s Advisory Committee on Immunization Practices (ACIP). He has perhaps more famously consulted for Merck, who gave him a $350,000 grant to develop the RotaTeq rotavirus vaccine which is now recommended by the CDC for infants in the US at 2, 4 and 6 months of age (he shares the patent for this vaccine and therefore financially profits whenever the vaccine is given). Rotavirus was killing about 60 infants a year in the US, but hopefully millions of vaccinations will now lower that figure since Rotateq is allegedly quite effective (98% according to New Scientist).

This latest offering by Offit is entitled “Inoculated Against Facts”, and appeared in the NYT on the of 31st of March in response to the media frenzy surrounding the Hannah Poling vaccine court settlement. Offit is obviously worried that the Poling case is going to have fewer people vaccinating, because he spends a lot of time trying to make it seem as though the decision to settle this case was nonsensical, and that the underlying health problem for Hannah Poling (even though no one knows if it existed before the vaccines or not) is extremely rare. He even goes so far as to as to say the “…vaccine court judges have turned their back on science by dropping preponderance of evidence as a standard.” He complains that now petitioners need only “propose a biologically plausible mechanism” in order to prevail in vaccine court. Thankfully, the Polings (who are a physician, lawyer and nurse between them) seem quite committed to setting the record straight on both medical and legal fronts, and have done so here, as a rebuttal to this op-ed in the New York Times, and in the Atlanta Journal-Constitution, (text at the end of this post).

As usual, there is some (junk) food for thought in the comments, courtesy of the New York Times faithful, intelligent, well-educated readers. I’m getting a little hardened to all the tedious rhetoric in those comments, by people who clearly just repeat the propaganda, with very little understanding of what it means. But the best one is this one, from JJ, from Boulder, Colorado. Here’s a partial quote:

It’s called “public health” for a reason: the health of the public is put first, and for good reason. I say this as a parent of a 3 yr old who has received all shots on time; I asked appropriate questions about those shots as they came up (re. thimerosal, etc.) but never questioned whether I would vaccinate, because I believe in something called civic responsibility.

I was absolutely gobsmacked. Do you think that if JJ had gotten his/her child vaccinated, and s/he stopped speaking and lost all eye contact within a week, that they’d be together at pro-vaccine demonstrations these days, with their kid in an over-sized, disabled child’s stroller, with a big sign proclaiming the pride in the sacrifice of their child for the benefit of everyone else? The only persons confident enough to moralize about people not risking their children’s well-being for the greater good are those who have already made the “sacrifice” and emerged unscathed. Those who are not so lucky have a very different perspective.

_____________________h

By Jon S. Poling

For the Atlanta Journal-Constitution

Published on: 04/11/08

Autism in the U.S. has reached epidemic levels, at 1 in 150 children. Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention, has recently upgraded autism to “an urgent health threat.” The most contentious issue of the autism debate is the link to routine childhood vaccines. My daughter’s case, Hannah Poling v. U.S. Department of Health and Human Services, has changed this debate forever. Hannah has pointed us in a new and promising direction —- the mitochondria. On Nov. 9, 2007, HHS medical experts conceded through the Department of Justice that Hannah’s autism was triggered by nine childhood vaccinations administered when she was 19 months of age. This concession was granted without any courtroom proceedings or expert testimony, effectively preventing any public hearing discussing what happened to Hannah and why. Contrary to some reports, the Special Masters, “judges” who preside over the “vaccine court,” did not issue a decision. Four months later, on March 6, with trepidation my wife, Terry, and I stepped forward to announce this news —- providing hope and awareness to other families. The HHS expert documents that led to this concession and accompanying court documents remain sealed, though our family has already permitted release of Hannah’s records to those representing the almost 5, 000 other autistic children awaiting their day in vaccine court. Mitochondria key To understand Hannah’s case, it is important to understand mitochondria, which act like batteries in our cells to produce energy critical for normal function. Because the government’s concession hinged on the presence of Hannah’s underlying medical condition, mitochondrial dysfunction, some claim the decision is relevant to very few other children with autism. As a neurologist, scientist and father, I disagree. Emerging evidence suggests that mitochondrial dysfunction may not be rare at all among children with autism. In the only population-based study of its kind, Portuguese researchers confirmed that at least 7.2 percent, and perhaps as many as 20 percent, of autistic children exhibit mitochondrial dysfunction. While we do not yet know a precise U.S. rate, 7.2 percent to 20 percent of children does not qualify as “rare.” In fact, mitochondrial dysfunction may be the most common medical condition associated with autism. Biological markers Although unlikely, if the Portuguese studies are incorrect and mitochondrial dysfunction were found to be a rarity occurring in less than 1 percent of all autism, it would still impact up to 10,000 children (250,000 worldwide), based on current estimates that 1 million people in the U.S. (25 million worldwide) have autism. If, on the other hand, the research showing that 7.2 percent to 20 percent of children with autism have mitochondrial dysfunction is correct, then the implications are both staggering and urgent. Autism researchers do not currently understand whether mitochondrial dysfunction causes autism or is simply a secondary biological marker. Autism clearly has many different causes, and should really be separated into multiple autism(s). I propose that we clearly identify and research the subpopulation term of “mitochondrial autism,” which is distinguished by its unique biological, but not genetic, markers. Based on what we know now, it is time to follow the prestigious Institute of Medicine 2004 report regarding autism and vaccines: “Determining a specific cause (for autism) in the individual is impossible unless the etiology is known and there is a biological marker. Determining causality with population-based methods requires either a well-defined at-risk population or a large effect in the general population.” A paradigm shift When the IOM report was published, mitochondrial dysfunction defining an autistic subpopulation was not firmly established. Today there is no doubt that mitochondrial dysfunction represents a distinct autism subpopulation biological marker. I urge health officials and the IOM to embrace their own report and pursue this breakthrough in the science of autism. National public health leaders, including those at CDC, must now recognize the paradigm shift caused by this biological marker with regard to their current position of dispelling a vaccine-autism link. In light of the Hannah Poling concession, science must determine more precisely how large the mitochondrial autism subpopulation is: 1 percent, 7.2 percent, 20 percent? Based on the 2004 IOM analysis, if the mitochondrial autism subpopulation is found to be relatively uncommon, then all conclusions from prior epidemiological studies refuting an autism-vaccination link must be discarded. New studies then need to be performed exclusively with the mitochondrial subpopulation. If mitochondrial autism turns out to be common, then we could re-analyze the data from prior studies to determine if these studies were powered sufficiently based on a predicted effect size. If not powered appropriately, the conclusion refuting an autism-vaccine link would again have to be rejected. These statistical concepts are basic. The current vaccine schedule, co-sponsored by the CDC and the American Academy of Pediatrics, injures a small but significant minority of children, my daughter unfortunately being one of those victims. Every day, more parents and some pediatricians reject the current vaccine schedule. In an abundance of caution, meaningful reform must be performed urgently to prevent the re-emergence of serious diseases like polio or measles. Need for research As a neurologist, I have cared for those afflicted with SSPE (a rare but dreaded neurological complication of measles), paralytic polio and tetanus. If these serious vaccine-preventable diseases again become commonplace, the fault will rest solely on the shoulders of public health leaders and policymakers who have failed to heed the writing on the wall (scribbled by my 9-year old daughter). The mitochondrial autism scenario that my daughter has so eloquently painted has the CDC and public health experts logically cornered. Denial and fear tactics won’t close Pandora’s Box. Whether we find that mitochondrial autism is rare or common, there is urgent research left to be done to fully understand the interrelationship of vaccines, autism and mitochondria. Reform of the vaccine schedule will be an important part of the solution, whether vaccines play a major or minor role in autism. Our public health agencies and programs need a reconstruction plan. Day one of the reconstruction hopefully starts at the Vaccine Safety Advisory Committee’s Working Group, to be held at HHS headquarters today in Washington. > Dr. Jon S. Poling is a practicing neurologist in Athens and clinical assistant professor at the Medical College of Georgia.

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