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The IOM and "completely expressed concerns"

11 Sep

If you’ve read my previous posts Dr. Bernadine Healy, you know I have some pretty serious concerns about how she represented the way the Institute of Medicine operated when they produced their report on Vaccines and Autism.  Those statements were made in interviews with Sharyl Attkisson.  Again, if you’ve been reading, you realize that Ms. Attkisson’s methods were a cause of concern for me as well.  I have voiced these concerns with CBS news via fax.

Dr. Healy made some pretty bold assertions, and Ms. Attkisson failed to even attempt to follow up on them.

The prime example is when Dr. Healy proposed that

…“There is a completely expressed concern that they don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. “First of all,” Healy said, “I think the public’s smarter than that. The public values vaccines. But more importantly, I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show.”

I’ve noted before, that a statement of that magnitude, calling into question the very methods and motives of the IOM deserved followup by Ms. Attkisson.  When someone makes a claim that an organization we all depend on to be independent and unbiased may have acted improperly, and unbiased reporter should make sure of the facts by checking with the real source before going ahead with the story.

Well, bloggers sometimes do the work that reporters fail to do.  In this case, AutismLibrary asked the IOM for comment on some of the way the IOM and its process in handling the 2004 Vaccines and Autism report have been portrayed.  Below (with permission) is the response that AutismLibrary received and blogged:

Thank you for your recent and very thoughtful message. As you know, the IOM’s Immunization Safety Review Committee most certainly did not suggest that scientific inquiry into the role of vaccines in autism should cease because the results could affect public perception of the value of childhood vaccinations. The public deserves better than that.

The committee’s 2004 report, Vaccines and Autism, states:

Determining causality with population-based methods such as epidemiological analyses requires either a well-defined at-risk population or a large effect in the general population. Absent biomarkers, well-defined risk factors, or large effect sizes, the committee cannot rule out, based on the epidemiological evidence, the possibility that vaccines contribute to autism in some small subset or very unusual circumstances. However, there is currently no evidence to support this hypothesis either.

After a paragraph in which the report follows that sentence with a discussion of the sparse literature regarding subsets of autism and the theoretical possibility of a vaccine-susceptible subpopulation, the report states:

While the committee strongly supports targeted research that focuses on better understanding the disease of autism, from a public health perspective the committee does not consider a significant investment in studies of the theoretical vaccine-autism connection to be useful at this time. The nature of the debate about vaccine safety now includes a theory that genetic susceptibility makes vaccinations risky for some people, which calls into question the appropriateness of a public health, or universal, vaccination strategy. However the benefits of vaccination are proven and the hypothesis of susceptible populations is presently speculative. Using an unsubstantiated hypothesis to question the safety of vaccination and the ethical behavior of those governmental agencies and scientists who advocate for vaccination could lead to widespread rejection of vaccines and inevitable increases in incidence of serious infectious diseases like measles, whooping cough, and Hib bacterial meningitis.

The committee urges that research on autism focus more broadly on the disorder’s causes and treatments for it. Thus, the committee recommends a public health response that fully supports an array of vaccine safety activities. In addition the committee recommends that available funding for autism research be channeled to the most promising areas.

Some readers have apparently failed to appreciate the full meaning and intent of the committee’s carefully written text. The report, as supported by the above-quoted paragraphs, clearly acknowledges the possibility that new information in support of hypotheses about susceptible subpopulations could emerge, at which time significant new research efforts might be appropriate. Whether the recent information about mitochondrial dysfunction will be the foundation for a major new research direction remains to be seen. The committee’s comment on the untoward consequences of discouraging vaccination was offered as an elaboration of their concerns about the unsubstantiated vaccine-autism hypothesis and not as support for their recommendations about an appropriate research agenda for understanding autism.

The scientists and clinicians on this committee evaluated the then-available scientific data in an unbiased manner. They reached their conclusions based on where the evidence led them. This principle—making recommendations only if supported by the evidence—guides all studies that IOM undertakes. I reiterate that the committee most certainly did not urge caution about pursuing the vaccine-autism connection in order to avoid frightening the public away from immunizations. The IOM stands ready to re-examine this issue should sufficient and relevant evidence emerge.

I almost put the entire last paragraph in bold for emphasis. Instead I’ll pull two lines out:

I reiterate that the committee most certainly did not urge caution about pursuing the vaccine-autism connection in order to avoid frightening the public away from immunizations

and

The IOM stands ready to re-examine this issue should sufficient and relevant evidence emerge

I read this as: there were no “completely expressed concerns” that affected the IOM’s study and that although they recommended rejecting the vaccine/autism hypotheses (thimerosal and MMR), they haven’t “turned their backs” on the subject. Should good research come forward (as with any subject in science) they will look again.

I do have one simple question: Shouldn’t Sharyl Attkisson approached the IOM for comment before going forward with this story?

Another fax for Ms. Couric

9 Sep

Note: I didn’t do my homework–Ms. Attkisson has discussed the Hornig paper. She manages to do exactly what we would expect: toe the ThoughtfulHouse line. The blog piece by Ms. Attkisson was posted while I was finishing my fax, given the time stamp.

As you will read below, I didn’t find Sharyl Attkisson’s recent blog post to be what I expected. OK, I wasn’t expecting her to be convinced by the recent study by Hornig et al., (paper here) but I at least expected her to comment on it. Instead, she dodged the issue completely. Worse yet, her post boils down to (a) assuming that the government doesn’t do vaccine safety research then (b) apparently implying that she and Dr. Bernadine Healy are somehow responsible for a “new” effort by the government to study vaccine safety.

So, CBS news has two new pages in their fax machine (to go along with a previous fax). In an effort to save their staffers the time of forwarding the fax, I quote it below.

September 8, 2008

Katie Couric, Managing Editor
CBS Television Network
524 West 57th Street
6th Floor
New York, NY 10019-2902

VIA FACSIMILE

Dear Ms. Couric,

I have faxed you recently about my concerns with the reporting of Ms. Attkisson. I would love to be writing you now with word that things have improved. But, sadly, they have not.

Ms. Attkisson appears to have avoided the key story of the week (if not month) in vaccines and autism: the study by Hornig et al. which shows (again) a lack of a link between autism and the MMR vaccine. Instead, Ms. Attkisson ran a blog piece that perpetuates the myth that vaccine safety is not a high priority for the nation’s health researchers.

Hornig et al. is precisely the sort of study that Dr. Bernadine Healy (in an interview by Ms. Attkisson) claimed the research establishment was “afraid” to perform: a study looking not at large populations, but specifically at children with autism. In this paper, the study group critera were very narrow: children with autism who regressed and have significant GI problems. The study sought to answer questions raised by Dr. Wakefield’s flawed study, which has caused much distress in the autism community for 10 years. The study found that MMR is not linked to autism: a conclusion accepted by autism advocate Rick Rollens, one of the most vocal spokespeople for the autism/vaccine link.

You can imagine that, yes, I expected Ms. Attkisson to address this study in her blog or reporting. Instead I read with dismay her blog piece on September 4th, “Vaccine Watch”. In her introduction, she references her interviews with Dr. Healy, but avoids the issue of the Hornig MMR study. Instead, she discusses recent NIH grant solicitations in the area of vaccine safety, and presents them as though vaccine safety research is something new. As noted above, this perpetuates the myth that vaccine safety is not being studied.

In addition to the Hornig et al. study, there is another study soon to be released on autism and thimerosal containing vaccines. Again, a targeted study looking at the exact population of interest. I would hope that this one doesn’t escape Ms. Attkisson’s attention. Also, one need look no further than clinicaltrials.gov to find ongoing studies on vaccine safety and adverse events. It is difficult to find a way that will not appear sarcastic to point out that the CDC’s Vaccine Safety Office is a very clear example of the government’s ongoing commitment to tracking vaccine safety.

If you have any question of how important the Hornig study is in the autism community, take a look at the comments on Ms. Attkisson’s own blog post. You will find that, even though Ms. Attkisson avoided the study, the autism community considered the Hornig study to be the news of the week, not the NIH grant solicitations.

Accusations of media bias are often applied too quickly by readers who disagree with the stances taken on certain stories. However, in the case of Ms. Attkisson, I find it difficult to understand how she could avoid a story which not only was so important to the community, but also answered the precise questions she has posed in her previous reporting.

I appreciate your time in this matter, and will gladly clarify any statements above that may not be clear.

Sullivan
Autism Parent
LeftBrainRightBrain.co.uk
SullivansJourney@gmail.com

Strategic Plan: when should I be concerned?

5 Sep

No, I’m not asking “when should I be concerned about the Strategic Plan”. Instead, I am taking parts of the Plan and posting them here. The full Plan is 34 pages long. Don’t let that slow you down! It really isn’t that long, and I found it a good read. But, it is hard to discuss the whole thing as a blog post.

Another point I see–there are six sections.  It may be tough to sit down at one time and write a response to all six.  If you think that may keep you from commenting, follow these posts and comment as you go.  It sounds like they would prefer you to write one single email, but I am all for anything that gives them more feedback–especially feedback that encourages using a strong scientific approach to selecting research projects.

With apologies to the people who wrote the Strategic Plan, I am going to only post the sections on “Research Opportunities” and “Short Term Objectives” and “Long Term Objectives”.  Read them and ask, “Is this how I want research dollars and research time spent?”.  If so, send them email and show support for the parts you like.  If not, email them and let them know your concerns.

With that intro, for the section, “When Should I be Concerned”, we have:

Research Opportunities

• ASD screening instruments and approaches for use in community settings to identify individuals who require diagnostic evaluation.

• Sensitive and efficient clinical diagnostic tools for diagnosing ASD in widely diverse populations, including underrepresented racial and ethnic groups, females, younger and older age groups.

• ASD measures that are easy to administer and that are sensitive to incremental changes in both core and associated ASD symptoms. Such measures can be used to help track the clinical course of individuals with ASD, monitor responses to interventions, and provide information about the broader autism phenotype.

• Detailed criteria for specific ASD sub-types in order to better describe the variations in symptoms and severity and study how these variations relate to underlying pathology, intervention strategies, and outcomes.

• ASD subpopulations and associated biobehavioral markers that provide early indication of ASD risk and opportunities for early intervention.

• Protocols for genetic testing in routine clinical practice in order to identify individuals at risk for ASD. Identification of individuals with genetic variations associated with ASD will facilitate intensive studies of ASD subpopulations with shared genetic risk factors to characterize common phenotypic and biological features.


Short-Term Objectives

• Develop, with existing tools, at least one efficient diagnostic instrument (e.g., briefer, less time intensive) that is valid in diverse populations for use in large-scale studies by 2011.

• Validate and improve the sensitivity and specificity of existing screening tools for detecting ASD through studies of the following community populations that are diverse in terms of age, socio-economic status, race, ethnicity and level of functioning by 2012.
o School aged children
o General population (vs. clinical population)

Long-Term Objectives

• Validate a panel of biomarkers that separately, or in combination with behavioral measures, accurately identify, before age 2, one or more subtypes of children at risk for developing ASD by 2014.

• Develop five measures of behavioral and/or biological heterogeneity in children or adults with ASD, beyond variation in intellectual disability, that clearly relate to etiology and risk, treatment response and/or outcome by 2015.

• Identify and develop measures to assess at least three continuous dimensions of ASD symptoms and severity that can be used to assess response to intervention for individuals with ASD across the lifespan by 2016.

• Effectively disseminate at least one valid and efficient diagnostic instrument (e.g., briefer, less time intensive) in general clinical practice by 2016

Again, ask yourself, “Is this how I want research dollars and research time spent?”. If so, send them email and show support for the parts you like. If not, email them and let them know your concerns.

Autism's False Prophets

5 Sep
Autism's False Prophets. Bad science, risky medicine and the search for a cure - Dr Paul Offit

Autism's False Prophets. Bad science, risky medicine and the search for a cure - Dr Paul Offit

Available now – Amazon UK, Amazon US, Amazon Canada.

NB – Dr Offit is donating all profits from this book to autism research.

So. Here’s the short review: holy shit, this is a good book, you need to buy it and pass it on. Make your local library stock a copy or three.

Here’s the longer review.

The book begins – after a dedication that made me grin from ear to ear – with a quote so acutely apposite that its like Professor Szasz said it to perfectly sum up the book and the last ten years:

When religion was strong and science weak,
men mistook magic for medicine.
Now, when science is strong and religion weak,
men mistake medicine for magic.

I knew Dr Offit got a lot of hate mail. What I didn’t know was the extent and the utter viciousness of it. From the books prologue:

Whilst sitting in my office, I got a phone call from a man who said that he and I shared the same concerns. We both wanted what was best for our children. He wanted what was best for his son, giving his name and age. And he presumed I wanted what was best for my children, giving their names and ages and where they went to school. His implication was clear. He knew where my children went to school. Then he hung up.

I can empathise. I’ve had cowards directly or indirectly threaten my kids too. We know who I’m referring to.

Offit refuses to feel sorry for himself and goes on to describe in painstaking detail the circumstances surrounding the rise and fall of the two main vaccine/autism ideas: MMR and thimerosal. He paints a vivid and (in my experience) completely accurate portrait of Andrew Wakefield as a vainglorious but weak king who simply doesn’t have the courage to admit his own wrongdoing. Offit recounts an anecdote from one time Wakefield supporter, John March. The setting is a meeting between March, lawyer Richard Barr and Andrew Wakefield, called to discuss their litigation strategy.

[March]…presented his data….he told them there was no difference between the children with autism and controls, he suddenly found that the meeting had moved on to a different subject. It was a Damascene conversion for him. He realised that Wakefield could not hear negative results.

Offit (rightly) does not spare Wakefield at all. This is the man who is literally, the architect of the whole idea that vaccines cause autism. Offit quotes Wakefield in an interview with US show ’60 minutes’ in 2001:

I would have enormous regrets if [my theories] were wrong and there were complications or fatalities from measles.

In Feb this year, the Gaurdian reported:

There were 971 cases of measles in England and Wales in 2007 in contrast to 740 the previous year — a rise of over 30% and the highest jump since records began in 1995, said the Health Protection Agency (HPA).

Two teenagers have died of measles in the UK. One in 2006. One in 2008. Are there any signs of Wakefield’s profound regrets?

Offit goes on to study the thiomersal hypothesis from the beginning of the noughties to 2007 and the Cedillo hearings.

It is a strange feeling reading an account of events that you have been so intimately involved in talking about for the last five years. From the bizarre Bernard et al paper and the outright insistence of certain writers and founders of autism/anti-vaccine groups that autism was just another name for mercury poisoning, through Kathleen’s demolition of the Geier’s credibility and science, all the way to Jenny McCarthy’s Oprah showboating.

The main feeling I got was how much a lot of this was now _history_ – as Offit clearly and devastatingly argues, the science has spoken. Vaccines don’t cause autism. And as I blogged about recently, it seems pretty clear that the US public are (rightly) more concerned about the possible resurgence of killer diseases such as measles than they are to keep flogging the dead horse of autism anti-vaccinationism.

But my all time favourite part of the book was the final section. My friends were interviewed at length and the clearest feeling I had from this section was – you threw everything at us. Your money, your influence, your political power. We’re still standing. You threatened us with legal action – we’re still standing. You called us and our children names and threatened their well being. We’re still standing.

Paul Offit has written a real page-turner of a book here. One that should matter to every single autistic person and every single parent of an autistic person. Ultimately, its a book written to support autistic people. Why? because it seeks to close the door on a debate with no scientific merit. Will it do that? Possibly not, we are not dealing with rational people by and large. But what it will do is once and for all dispel the notion that ‘the parents’ who believe vaccines cause autism must be listened to solely because they are parents. Amen to that.

"I don't believe that"

29 Aug

To promote his new book ‘Autism’s False Prophets. Bad science, risky medicine and the search for a cure’ (Amazon UK, Amazon US, Amazon Canada) – and look for a review here very, very soon – Dr Paul Offit went on the US radio show Talk of the nation ‘Science Friday’ earlier today.

It turned into a microcosm of exactly the sort of scenario that those of us who have blogged about this for some time have come to expect. A question, a reasoned response and then a flat statement of denial.

The show began with the show host (who’s name I didn’t catch) asking why people weren’t vaccinating. Offit gave the answers we all know.

Then the show took a turn into what could’ve been a blog argument on any one of a number of blogs – including this one. A caller called Chantelle/Chantal came on the line and essentially asked Dr Offit how it could possibly be safe for a newborn to receive up to 1250micrograms of Aluminium and that there hadn’t been any studies on how Aluminium could affect a child. She said –

that is why I will not follow the CDC’s guidelines….my child will be vaccinated on my own schedule.

(Her emphasis)

Dr Offit answered with a brief overview of Aluminium’s role in a vaccine is and then told Chantal the simple truth – one that I blogged about fairly recently – there’s more Aluminium in between 50 days to a years worth of breast milk than in the entire vaccine schedule:

We live on the planet Earth. If we choose to live on the planet Earth that means we’re going to be exposed to light metals like Aluminium and heavy metals like mercury.

Chantal then seemed (I wasn’t entirely clear) to want to compare kids with kidney issues (who clearly need to be careful with Aluminium) with _all_ kids. As Dr Offit stated – that’s hardly a valid or real-world comparison.

Then the host asked a great question:

Chantal, is there anything Dr Offit could tell you that would change your mind

.

The answer: “Absolutely not”.

And there we have it. That is the rock bottom of every single argument the autism/antivax brigade peddle. Screw the science, screw the facts. I just don’t want to hear it and I will put my fingers in my ears and make ‘la-la’ noises until you go away.

Chantal then goes on to justify this ridiculous stance by saying (a la Jenny McCarthy) that there is no independent science supporting vaccine safety. This is tosh. A study this is submitted for peer review to a science journal is peer reviewed by independent experts from the relevant field all over the world. And then, the ultimate test of impartiality takes place – the science is either replicated or it isn’t. Replicated science _has to be_ by definition be independent of its author. How could it not be? If we want to see the opposite of reproducible science, then that can be arranged.

Chantal goes on to say that Dr Offit ‘makes millions’ from speaking about the safety of vaccines. A bizarre claim that I’m pretty sure is not true. He then goes on to describe the ‘high bar’ that vaccine studies must pass. Studies with tens of thousands of participants.

Next, Chantal tries the ‘too many too soon’ dogma that we’ve become recently familiar with. She claims ‘six at one time is absurd’. Dr Offit gives Chantal some facts to play with on that score too:

…the bacteria that live on their nose [a newborn], or the surface of their throat are literally in the trillions. Those bacteria have between 2,000 and 6,000 immunological components and consequently our body makes grams of antibody to combat these bacteria….The number of immunological challenges contained in vaccines is not figuratively, it is literally a drop in the ocean of what you encounter every day.

(Emphasis his, slight paraphrasing)

Chantal then got a bit snappy.

So tell me…how many studies have been done on vaccine loading, which means five or six vaccines at one time. How many?

Dr Offit’s answer:

Somewhere in the vicinity of the high hundreds to low thousands.

Chantal:

I don’t believe that.

Boom! There it is again – she simply doesn’t believe it. Screw the facts, screw the evidence, my fingers are going right back in my ears…la-la-la-la…I can’t hear you…

Dr Offit explains further that any vaccine in the US has to undergo something called a ‘concomitant use study’. These are to establish that vaccines work OK together.

You have to show that vaccine does not interfere with the immune response or the safety of existing vaccines and similarly that existing vaccines don’t interfere with the immune response or the safety of the new vaccine

Dr Offit said ‘high hundreds to low thousands’ of studies (Chantal didn’t believe that remember). A simple Google search reveals over 1,800 results for that phrase. Searching PubMed for ‘concomitant vaccine’ returns over 700.

Dr Offit closes the interview by saying he doesn’t believe all parents are as close minded as Chantal. He uses a nicer phrase than that as he’s a gentleman but that’s how I see it. Close minded to the point of obstinate stupidity.

For some people, it truly doesn’t matter what the facts are, or what the science is. They just stick their fingers in their ears.

La-la-la.

John McCain starting to back away from vaccines?

28 Aug

I’m a bit hesitant to blog about political figures from other countries. I don’t know an awful lot about John McCain other than he was a Vietnam (I think) veteran and was a POW for awhile. I know the Bush team sledged him pretty badly in the run up to Bush’s current term and I know he tries hard to cultivate a old-fashioned-take-no-shit-youngster attitude. I neither like him nor dislike him.

However, back in February he did irritate me quite a lot when he said:

[Autism]….is on the rise amongst children, the question is what’s causing it. And we go back and forth and there’s strong evidence that indicates that it’s got to do with a preservative in vaccines.

It irritated me because firstly, there’s no evidence its ‘on the rise’ in the sense I think he meant it. There’s no way of scientifically telling from current studies if it is or not. In fact, the best science done so far on the issue (Shattuck, 2006) states:

The mean administrative prevalence of autism in US special education among children ages 6 to 11 in 1994 was only 0.6 per 1000, less than one-fifth of the lowest CDC estimate from Atlanta (based on surveillance data from 1996). Therefore, special education counts of children with autism in the early 1990s were dramatic underestimates of population prevalence and really had nowhere to go but up. This finding highlights the inappropriateness of using special education trends to make declarations about an epidemic of autism, as has been common in recent media and advocacy reports.

In other words, because autism has not been tracked well up until now, there is no way we can say with any degree of confidence that is increasing. It may be, but most scientists think that instead of an _increase in autism_ , we are seeing an increase in _accurate diagnosis_ of autism.

Secondly, McCain’s statement irritated me because, of course, there is _no_ evidence, strong or otherwise, that indicates autism is caused by preservatives in vaccines. And certainly McCain totally failed to provide any kind of evidence for this silly statement.

However, as election time draws nearer, it seems McCain’s statements are growing a bit more (he said with no trace of irony) conservative. Maybe someone explained the facts of life to him: after having someone of less than stellar brain power in office for the last eight years, it might be a good idea to evaluate things properly, rather than just sound off and come across as Dubya Part II.

Here’s what he said recently:

We don’t know what causes [autism]. There’s a huge debate going on now about vaccinations. And I’ve read and studied and gotten briefings, and I don’t know all the answers.

Thats quite a lot more circumspect than ‘there’s strong evidence that indicates that it’s got to do with a preservative in vaccines’. A simple statement of facts. After all, its true – we _don’t_ know what causes autism. And there _is_ a debate going on about vaccinations. And guess what? John McCain _doesn’t_ know all the answers.

I’m guessing McCain’s team have suggested to him that if he doesn’t want to be known as the also-ran who hyped up unfounded fears of vaccinations in the middle of a measles epidemic sweeping through the country he’s attempting to lead then it would be a good idea to engage his brain before opening his mouth.

Busy day at the Trib for vaccines

27 Aug

According to the Chicago Tribune’s “On This Day In History“, on this day in “1906 Albert Sabin, the Polish-American doctor who developed a polio vaccine, was born”.

Coincidentally, the Tribune had a couple of pieces on vaccines in the past few days. The main story, Kids’ vaccinations face risky resistance discusses how fears over vaccines and autism are causing a drop in uptake. This is worrying doctors given this year’s outbreak of measles in the U.S. The authors note:

Doctors say worried parents tend to find scientific data less persuasive than the horror stories they hear about vaccine side effects online or from friends. One expert said attitudes are likely to change eventually, but only after children start dying again of diseases parents have come to think of as obsolete.

Or, to put it another way:

“I think people have a hard time separating out what’s reliable information and what’s not reliable,” Dr. Ruben Rucoba, a Wheaton pediatrician. “What gets attention is not the statistics, but the story. All it takes is one friend of a cousin of a neighbor who they can point to who says, ‘My child got an immunization, and now he has a problem.’ “

Another page listed “Common Vaccine Beliefs“. Number one on the list being:

1. Vaccines cause autism.

The issue usually raised is thimerosal, a mercury-based preservative formerly common in vaccines. It has since been removed from most shots to reduce children’s exposure to mercury. Also, because signs of autism may appear about the same time children receive the measles, mumps and rubella vaccine, some parents think there is a connection. Many studies, including a report by the Institute of Medicine, have concluded there is no association between autism and vaccines that contain thimerosal or the MMR vaccine.

The Trib has included some good links on vaccine information.

Bloggers respond to news. No big deal there. But, I find it is interesting to see one of the Trib’s own bloggers responding to Trib stories. Especially since the blogger, Julie Deardorff, as you can imagine if you know her blog, doesn’t agree with the Trib.

Ms. Deardorff has a number of pieces on vaccines and autism. She also is one of the AutismOne convention’s panelists on the media. She’s the one that AutismNewsBeat caught on video complaining that she isn’t allowed to “attack” vaccines.

Ms. Deardorff’s piece is “Why some parents question vaccines.” A statement towards the end makes it clear some of the mindset of Ms. Deardorff:

Vaccines represent social health without regard to individuals. That’s how they work.

Ah. Yeah. It’s hard to comment well on such rubbish, other than to thank Ms. Deardorff for actually putting that in a public place so we can understand her position. OK, I’ll add this comment–that’s not how vaccines work. She would do well to peruse the links her own organization has provided for some education on how vaccines do, in fact, work.

Scrolling back to the beginning of her piece, we see her actual thesis:

In the past, most parents didn’t question childhood vaccinations because they inherently trusted medical officials and feared common childhood diseases.

She then goes on to discuss that this trust has eroded. She takes no credit for her small part in contributing to this erosion of confidence (nor does she mention any of the other people and groups actively working to erode confidence). Instead she places the blame on public health community:

But the real crisis is not that some parents skip or delay vaccination because they believe vaccines might pose health risks or are linked to autism. It’s that they’re losing confidence in public health officials and policy, partly because vaccines are being forced on them, regardless of their personal desires or beliefs.

She then, without any indication that she sees the irony, lists a number of events and adds her own odd interpretations in order to erode confidence. I pick a few out for example:

In Maryland, parents who didn’t vaccinate their children against chickenpox and Hepatitis B were threatened with jail time and fines.

This is a grand example of Ms. Deardorff facilitating the misinformation campaign of the vaccine rejectionists. Here is the form that people in Maryland have to submit on their children’s vaccine status in order to enter the children in school. The same form has the exemption clause. In other words–the parents could have avoided any and all pressure by filling out that form. Instead, the vaccine rejectionist parents decided to make a political statement by not submitting the forms in order to gain publicity.

The AAP issued a sample letter to pediatricians suggesting that physicians tell parents who refuse to vaccinate that they have a “self-centered and unacceptable attitude” since their child is getting protection from others who have chosen to vaccinate. Parents who absolutely refuse to vaccinate could be booted from your pediatrician’s practice.

I haven’t asked our pediatrician what his policy is on vaccine rejectionist clients. I hope that when I brought my children in at 1 month, 2 months, etc., that they weren’t being exposed to vaccine-preventable infectious diseases like some of the children in San Diego’s recent measles outbreak. Yes, some children caught measles in doctor’s waiting rooms. I have zero problem with pediatricians telling vaccine rejectionist parents to find vaccine rejectionist pediatricians.

I really hadn’t intended to discussing all her points. I started with just one. The one that really caught my eye was this:

Research suggests that America might be over-vaccinating its kids and that we might want to re-evaluate and adjust the immunization schedule. But not because of health concerns; the vaccines might just be unnecessary and waste a lot of money according to the study by researchers with Oregon Health & Science University published in the New England Journal of Medicine.

The article she is referring to (I believe) is a favorite of rejectionists groups and websites. The abstract is here, and the full paper is available free.

I have a lot of concerns with the above statement by Ms. Deardorff, but I will concentrate on this on this phrase: “…the vaccines might just be unnecessary and waste a lot of money…”

Which vaccines, Ms. Deardorff? Which vaccines? Your phrase is very vague. I am often vague and don’t use language accurately, but I don’t have the Chicago Tribune’s name behind me. You see, Ms. Deardorff, your statement makes it sound like it is the “vaccine schedule” that is in question. Not a fraction of it, as the actual research would suggest. Sloppy writing is one thing. When it supports your quest to “attack vaccines” it makes me question whether it should be attributed to mere sloppiness.

Let’s take a look at the story that was scary enough to be quoted by JABS. “Report: Vaccine booster shots may be unnecessary”.

So, it isn’t the schedule in whole, it isn’t even really the pediatric schedule for the most part, it’s the booster shots. What they found is that in adults–most of whom had immunity from infections, not from vaccines, by the way–kept immunity for a long time. Half-lives of immune cells were longer than human life-spans.

They measured half-lives for both people with natural immunity and for people with presumed vaccine immunity The group with the presumed vaccine-induced immunity was quite small, as noted in the supplemental information given online:

However, it is important to note that this is based on a very small sample size (n = 2-5 subjects) and more studies on a larger group of vaccinated individuals will be necessary to determine statistically significant antibody half-life measurements.

Thus the data on vaccine-induced immunity are quite limited. But, taking the data that we have, they don’t say “… the vaccines might just be unnecessary and waste a lot of money…” as Ms. Deardorff interprets them.

I found the study rather interesting, actually. I found it interesting since one of the tried and true arguments promoted by vaccine rejectionists is that vaccine immunity is short lived and “natural” immunity is somehow better. I find it interesting that JABS, GR (they host the paper on their website) and other groups latched on to this study, yet, they seem to neglect what it may actually teach.

What I also found interesting was some information I found searching for Dr. Slifka (the anchor author on that study). Turns out he wrote a review of Dr. Offit’s book “Vaccinated”. I’ll leave you with two quotes from that review:

More recently, unfounded concerns over theMMRvaccine and the use of mercury-containing preservatives have fueled a fiercely debated controversy over childhood vaccines and their suspected links to autism

and

Offit ends by emphasizing the power of preventive medicine and hopes that the great strides in vaccinology, in large part due to Maurice Hilleman, will not fall to complacency and ignorance.

Kelli Ann Davis doesn't get it

23 Aug

Over on Orac’s blog, a discussion is ongoing about (you guessed it) thiomersal.

One of the usual antivax canards is played beautifully by Kelli Ann Davis when she says:

So Phoenix Woman [another commenter], can you explain to me what the skull and crossbones is doing on the Material Safety Data Sheet (MSDS) if thimerosal is not a poison

This is top notch antivax stupidity. Not only does she entirely miss the point of ‘Phoenix Woman’s’ comment (which was not that thiomersal was not a poison) she also infers that the fact that thiomersal is a poison means that its automatically going to cause damage. She conveniently forgets – or doesn’t care – that the adage ‘the dose makes the poison‘ always applies.

And of course we have the scare tactic of mentioning the skull and crossbones.

Thing is, there are plenty of other Toxic substances used routinely in medicine. Lets have a look at Warafrin – which is at one level rat poison and at another level an anticoagulant. And hey – look at that – the MSDS sheet has a skull and crossbones on it.

Common clinical indications for warfarin use are atrial fibrillation, the presence of artificial heart valves, deep venous thrombosis, pulmonary embolism, antiphospholipid syndrome and, occasionally, after myocardial infarction.

And also

To this day, coumarins are used as rodenticides for controlling rats and mice in residential, industrial, and agricultural areas. Warfarin is both odorless and tasteless, and is effective when mixed with food bait, because the rodents will return to the bait and continue to feed over a period of days until a lethal dose is accumulated.

So, lets spell it out nice and slow for Kelli Ann – the dose makes the poison.

And so, lets have a look at the current dose levels of thiomersal in vaccine shall we?

For an ‘average’ person of 154 pounds, there is 6mg (miligrams) – or 6000 micrograms(µg)) of mercury occurring naturally in the body. So, roughly, a person of 25 pounds has 1mg (1000µg) of mercury (or, to put it another way, 1 pound of body mass gives us 40µg). A healthy newborn weighs on average about 7.5 pounds which gives a mercury body burden of approximately 303µg of mercury.

When we look at the FDA thimerosal content of vaccines currently mandated and add them all up we see that we get 239.2µg of mercury – way under what occurs naturally in the body of a healthy 7.5 pound newborn.

Now, this is not even a fair comparison. I have added up all the vaccines for a child of 6. Including doubling up on doses of a vaccine made by different manufacturers. Quite obviously a child won’t get a Td jab from two different manufacturers at one time. I have also included all the flu jabs – again, no one will get all flu jabs in a single flu season.

The maths is quite clear. There is more mercury existing naturally in our bodies – even those of a 7.5 pound newborn – than the combined total of every single thiomersal containing vaccine on the market.

Thimerosal and Autism on Trial: Closing statement by Mr. Matanoski

31 Jul

This is a portion of the government’s closing argument given by Mr. Matanoski. It is found on the audio from Dwyer called Day02-PM3.

First I want to point out on the specific causation … lawyers are kind of slick they move things around, they kind of play a shell game. When I heard the comments about a specific causation case it made it sound like respondent has a burden here to show what actually caused it. Actually the burden is on the petitioners to show that the vaccine caused autism. And respondent doesn’t have to show that it’s genetic in origin.

And I think that the comments about Dr Leventhal’s testimony on that point are a little off the mark. What Dr. Leventhal was saying, essentially, that most practitioners, most folks who study autism as a profession believe that it’s largely genetic in nature at that’s where the research has been directed and in fact it’s been fruitful in that regard. There’s still much more to do. But everything that has come out has pointed to genetics as very strongly associated with autism and most of the research that has been done has shown that autism would have a prenatal course. That it can essentially be seen, that the preconditions, if you will, for autism are in place beginning before birth, in most instances.

I think there also is a little bit of a misconception about what the force of Dr. Leventhal’s testimony was. He basically was saying that Colin’s case really is sadly no different than many of the cases that he sees, where there is a gradually emerging picture of difference, perhaps delays, but at least difference in the quality of behavior in the child as the child develops. It’s not necessarily apparent right from the start. That’s very rare. Most of the cases it’s apparent later and it may seem that a child has reached certain milestones has subsequently had trouble keeping those milestones. As the condition progresses there often is an improvement. That’s the natural course of the condition. What Dr. Leventhal was saying is, as time has gone on, more and more of the researchers have realized that if you look back in cases, that apparently seemed to have a normal trajectory and then there seemed to be a loss, that you see earlier signs and symptoms that all was not on a normal trajectory from the beginning.
That was the force of his testimony, and that testimony was backed up by other testimony by other testimony that the court has heard before he took the stand.
Dr. Lord who has specifically studied regressive autism made that point quite clear, that as this has progressed the concept of regressive autism has become more encompassing, that autism itself seems to have a progression where it appears that there is a loss but when one goes back, one sees that there is unusual, or differences in development earlier on in almost every case. And what Dr. Leventhal was saying is that as they gotten better, folks who do this for a living, folks who make their lives studying about studying autism they’ve realized that more and more of those cases they can see earlier on. And in very few instances when they’ve studied quite closely do they see that there isn’t some sign that the trajectory or the course is not the same as other children’s.

Dr. Mumper’s testimony which really wasn’t really much of the focus in the closing argument here. She seems to be relying on isolated lab results to come up to a conclusion that vaccines are the cause here. She’s been asked in this case and in other cases what would that pattern be, what do we need to look at? And in fact there doesn’t seem to be a particular pattern. In the King case certain test results were relied upon to draw the conclusion that thimerosal in vaccines were associated with autism in that case, or caused autism in that case. In the Mead case other results were looked at and thought to be, by Dr. Mumper, indicative that vaccines were causing, or evidence that vaccines were causing autism. And now in Colin’s case, we see yet a different pattern of test results being relied upon to reach that conclusion.

In fact those test results, with really no pattern, how can one say that there is any kind of clinical evidence from these test results that one can rely on to make that .. to draw those kinds of conclusions that Dr. Mumper is relying on.

And as you’ll see when you go through the testimony, we believe that she largely moved away from relying on any specific test result when questioned about each specific one she said that essentially that the mercury test result, the positive provocation, was really the only test that she had that showed that the mercury was there, and she was relying on to implicate thimerosal as a cause in this case, but then she admitted that she really didn’t know what the normal range would be for that test.
How can one say that this is an abnormal result when one doesn’t know what normal is?
Her testimony seems to be formed largely by the Defeat Autism Now world view which is that toxins and heavy metals are implicated in autism. And to use the example that Mr. Powers used of Tycho Brahe I think that comes to bear with her testimony as well. It doesn’t matter which test results she’s looking at it always comes back to a heavy metal or a toxin, when it could be that the acidosis that the lactic acid build up could be because the child was crying when the blood was taken. (35 min 30 sec)

…

I’m going to touch now on the general causation because that was a matter of some discussion by Mr. Williams. I see that the glutathione theory which is where we started with this general causation case seems to have dropped out. It wasn’t in the opening statement, it wasn’t in the closing statement. It seems that the theory of causation now is neuroinflammation and largely seems to be neuroinflammation alone. That was a theory that Dr. Kinsbourne recently advaced in this case. It obviously wasn’t present until just a couple of weeks before the trial in May.
This is something after six years in the making, this seems to have come up kind of at the very end.

Mr. Powers and Mr Williams have focused on the causation burden, and say that the information they have given on neuroinflammation meets that burden, that would be the causation burden under Althen and Grant, the specific criteria that they need to meet under that test that the court has articulated, the federal circuit’s has articulated.

Respondent starts a little earlier than that if you will in the calculation and that is about what evidence feeds into Althen and Grant. We start out with the analysis under Daubert about whether there is good scientific evidence to even meet that burden. So obviously the evidence that you have or the evidence that is being offered does not meet the criteria of good scientific or reliable evidence then you have nothing at all to test about whether you’ve met your legal burden under Althen.

Our position has been throughout this that the petitioners’ evidence that they have offered, the testimony that they’ve offered, fails to meet that standard of reliability that is set out under Daubert and that this court applies. Daubert stands for the proposition that there are not multiple kinds of scientific evidence. A kind for scientists to use and a kind for judges to use. There is only one kind of scientific evidence. It is the kind that scientists use. That is the kind that judges are supposed to be looking for as well. …

Kathleen Seidel’s neurodiversity weblog has more from the Dwyer case, including audio excerpts.

Elizabeth Mumper – Autism Omnibus, Dwyer vs HHS

When I heard Mr. Matanoski say, “when one doesn’t know what normal is,” it occurred to me that it could be used as a slogan or strapline for the autism/biomed organization that is led in part by Dr. Mumper.

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Protecting Public Trust in Immunization

28 Jul

That’s the title of a special article in Pediatrics:

Public trust in the safety and efficacy of vaccines is one key to the remarkable success of immunization programs within the United States and globally. Allegations of harm from vaccination have raised parental, political, and clinical anxiety to a level that now threatens the ability of children to receive timely, full immunization. Multiple factors have contributed to current concerns, including the interdependent issues of an evolving communications environment and shortfalls in structure and resources that constrain research on immunization safety (immunization-safety science). Prompt attention by public health leadership to spreading concern about the safety of immunization is essential for protecting deserved public trust in immunization.

It is quite bizarre that something that is overwhelmingly good for society and good for individuals should become the scapegoat for just about every ailment the modern world has. I’ve seen vaccines blamed for (aside from autism) asthma, AIDS, heart disease, obesity amongst other things and portrayed as part of a global Illuminati agenda to control the world population. I’ve seen people tie it in (or try anyway) to the events of 11th September 2001 and threaten scientists associated with their manufacture with death for them and their children. How the hell did we get here?

The paper from which I’ve included the Abstract above is an attempt to try and recognise how these things have happened and how the medical/science establishment can regain public trust in vaccination.

The paper opens with a little bit of self-chastisement:

Every time a mother holds her healthy infant to be immunized, she is demonstrating great faith in the potential benefit and safety of the vaccine and trust in the clinician who recommended it. Over past years, clinicians and public health leaders have taken for granted the magnitude of that act of trust. We also have basked in the praise that comes with being a participant in the success of immunization in dramatically reducing morbidity and mortality in childhood and changing the practice of
pediatrics.

For doctors, who are by and large subscribers to the scientific mentality, the benefits of vaccination are obvious. Their error has been to not notice that 99.99% of their case load are not subscribers to the scientific mentality and therefore they will not look at things with the same lack of emotion. It is in fact very difficult to do so. Particularly for something like vaccination when we are essentially treating our kids for things they haven’t got. Also difficult to see for emotional rather than scientific people are things like keeping up herd immunity:

“Vaccines are victims of their own success” is the shorthand now used to reflect the reality that, in the absence of vaccine-preventable disease, many parents fear vaccines more than the diseases known to them only vaguely.

Its true. Getting the message through that just because the vaccine-preventable disease is not right here right now doesn’t mean its gone for ever is difficult. And here is another place in which the scientific community have fallen down: they have not got the message through. Until very recently, they have not even tried.

Over the past 10 years the Internet, particularly the web, has grown to every corner of the globe and over the years, those who used to be anti-vaccine cranks have now become trusted gurus to the parents who think that looking on whale.to is the same as doing research. The scientific community has failed to keep up with this. Their solutions (the NHS website for example) whilst very informative are stilted, formal and do not speak to the emotional side/needs of parents.

The Pediatrics paper lists a number of ways for science to regain the trust of parents.

One area that needs increased investment is immunization-safety science;

…….

What is immunization-safety science? Or, more accurately, what are the sciences necessary for protecting public trust in the safety of vaccines? Most of the biological, social, and communication sciences have roles.

Some of these sciences are more central and obvious than others, such as allergy/immunology, epidemiology, and infectious diseases, but anthropology, ethics and political science also have important roles given the multiplicity of questions. Research on the short- and longer term risks and benefits of combinations and timing of multiple vaccines requires a different profile of disciplines than does the question of “what is the value of mandates in public immunization programs?”

Yes. Definitely. These are science based questions that need addressing.

Invest more in public awareness and genuine public engagement around immunization issues. Recognize the number and heterogeneity of publics to be served and the diversity and legitimacy of their questions and concerns.

? Educate the public on the elaborate, already existing US system for research and testing of vaccines, including the responsibilities of the vaccine industry and, particularly, the independent and interdependent functions of industry, the US Food and Drug Administration (FDA), the CDC, the Health Resources and Services Administration, and all their advisory bodies for prelicensure and postlicensure evaluation.
? Educate the public on the function, membership, and selection process for members of key advisory bodies.
? Increase the number and diversity of citizen members on advisory bodies without reducing scientific expertise.
? Give the public sufficient information and adequate time to understand the rationale for any new vaccines before embarking on immunization campaigns, which can be done without delaying protection.
? Engage local communities and parent groups as advocates of new vaccines.
? Avoid the hyperbolic marketing practices of overselling.
? Improve the communication skills of public and private health leaders to present information in perspective, including benefits, risks, and gaps in knowledge. Avoid obfuscation, admit gaps in knowledge, and be available and candid in answering the questions asked, building comfort even when the circumstances are uncomfortable. Take the time to explain changes in recommendations/policy. Such explanations are essential for reducing charges of waffling, indecision, and hidden agendas.
? Invest in research on what is truly driving parents’ questions and concerns and what may be needed to earn/keep their trust in vaccines.
? Decrease reliance on state mandates and in no case push for mandates before evaluating the results of voluntary immunization programs.

Yes, again, good points. However, to me, the key question is not being addressed. How do you intend to do this? What needs to change is how you get these things over to the general public. For example, parents of autistic people generally trust other parents of autistic people. I’m sure that there are some Paediatricians who are also parents of autistic people. Maybe they are even AAP members! Or work for the CDC. Give these people a voice.

Lets see some voxpop ‘interviews’ on YouTube. Nothing stilted, nothing formal, just people doing their job, speaking their minds. If there’s fault, let them admit it.

And you’re going to have to accept I think that there is a generation of parents here who are never going to see it your way. They’re lost. Concentrate on the new parents. If they’re having vaccinations, hold a Q&A but be ready for the hardcore anti-vaxxers. If they’re in for an autism assessment for their kids (or themselves) talk to them, don’t just diagnose and dismiss, let them express their fears. Yeah, it’ll take more time but it’ll be worth it in the long run.

Said the Brit, daring to comment on US health policy 😉

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