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Comment on: Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate Model: Assessments of Neurodevelopment, Learning, and Social Behavior.

21 Feb

There is a common myth one hears from one group of autism parents: there is no research on autism and vaccines being performed. Usually this is combined with the insinuation that the government is scared of vaccine/autism research. The claims are often made by people who should (and likely do) know better.

One of the few places one can find a discussion of the ongoing vaccine/autism work is here at Left Brain/Right Brain. In a post last year I address the question of Why won’t the government fund vaccine/autism research?, which was really a post about how there is work being funded. In case the title was unclear, I also wrote More of that vaccine/autism research that doesn’t exist. Other articles include What projects are being funded in autism research? Part 1: vaccines and GI issues.

In one of those articles I wrote:

There’s a study by Gene Sackett’s group, A PRIMATE MODEL OF GUT, IMMUNE, AND CNS RESPONSE TO CHILDHOOD VACCINES. This appears to be a follow on project to the Laura Hewitson studies that were discussed a great deal online a few years ago.

And, guess what? A study by Gene Sackett, together with Laura Hewitson and others, has just been published: Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate Model: Assessments of Neurodevelopment, Learning, and Social Behavior. It may not be the study referenced above as that study was government funded, but this new study addresses some of the concerns raised by previous studies published by Laura Hewitson’s team. If you wonder what I mean by “addressed”, here’s the last phrase of the abstract: the study “…provided no consistent evidence of neurodevelopmental deficits or aberrant behavior in vaccinated animals.”

No evidence of harm.

Gene Sackett was a collaborator on one of those previous studies by Laura Hewitson: Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine: influence of gestational age and birth weight. This study was discussed a great deal by those promoting the vaccine/autism link (say here, here, here and elsewhere. It was called a “blockbuster” study by Mark Blaxill (then of SafeMinds, now of the Canary Party, both groups who promote the failed idea that the rise in autism diagnoses was caused by thimerosal in vaccines) on the Age of Autism blog. Dan Olmsted (of the same blog) called the results “explosive”. They both downplayed the preliminary nature of the study and the small sample size and way overplayed the importance of the results.

And as this new study clarifies, both were wrong. Both spread guilt and fear: one can still find parents talking online about how their child was delayed in one of the reflexes discussed in the study and, thus, was harmed by thimerosal in vaccines. Just an example of the harm the people pushing the idea that vaccines and autism are linked have caused.

As noted above, this new study clears up the concerns raised by the earlier studies. If history is any guide, Mr. Olmsted and Mr. Blaxill will not demonstrate the courage needed to admit their mistakes nor try to correct the damage they have caused. I would love to be wrong and have to write an apology to them.

Here is the abstract to Examination of the Safety of Pediatric Vaccine Schedules in a Non-Human Primate Model: Assessments of Neurodevelopment, Learning, and Social Behavior.

Abstract
BACKGROUND:
In the 1990s, the mercury-based preservative, thimerosal, was used in most pediatric vaccines. While there are currently only two thimerosal-containing vaccines (TCVs) recommended for pediatric use, parental perceptions that vaccines pose safety concerns are affecting vaccination rates, particularly in light of the much expanded and more complex schedule in place today.
OBJECTIVES:
The objective of this study was to examine the safety of pediatric vaccine schedules in a non-human primate model.
METHODS:
We administered vaccines to 6 groups of infant male rhesus macaques (n=12-16/group) using a standardized thimerosal dose where appropriate. Study groups included the recommended 1990s pediatric vaccine schedule, an accelerated 1990s primate schedule with or without the measles-mumps-rubella (MMR) vaccine, the MMR vaccine only, and the expanded 2008 schedule. We administered saline injections to age-matched control animals (n=16). Infant development was assessed from birth-12 months of age by examining the acquisition of neonatal reflexes, the development of object concept permanence (OCP), computerized tests of discrimination learning, and infant social behavior. Data were analyzed using ANOVAs, multi-level modeling, and survival analyses, where appropriate.
RESULTS:
There were no group differences in the acquisition of OCP. During discrimination learning animals receiving TCVs had improved performance on reversal testing, although some of these same animals performed poorer in subsequent learning set testing. Analysis of social and non-social behaviors identified few instances of negative behaviors across the entire infancy period. While some group differences in specific behaviors were reported at 2 months of age, by 12 months all infants, irrespective of vaccination status, had developed the typical repertoire of macaque behaviors.
CONCLUSIONS:
This comprehensive five-year, case-control study, which closely examined the effects of pediatric vaccines on early primate development, provided no consistent evidence of neurodevelopmental deficits or aberrant behavior in vaccinated animals.

Let’s repeat that conclusion for emphasis: This comprehensive five-year, case-control study, which closely examined the effects of pediatric vaccines on early primate development, provided no consistent evidence of neurodevelopmental deficits or aberrant behavior in vaccinated animals.

The full paper is available online. In it you can read this:

This data is in contrast to our previous pilot study in which a delay in the acquisition of the root, suck, and snout survival reflexes were reported for primate infants following exposure to the birth dose of the thimerosal containing Hep B vaccine (Hewitson et al. 2010a). This discrepancy is most likely due to the larger number of animals in the present study providing more accurate estimates. Furthermore, in the present study reflexes were examined from birth to 21 days of age, during which some animals received multiple TCVs (not just a single Hep B vaccine as was used in the previous 23 study), and yet no detrimental effects on the acquisition of survival reflexes were reported for these animals.

Hewitson 2010a is Delayed acquisition of neonatal reflexes in newborn primates receiving a thimerosal-containing hepatitis B vaccine: Influence of gestational age and birth weight. This is the “blockbuster” study according to Mark Blaxill. Ironically, Mr. Blaxill’s article links to the first publication of the “blockbuster”, the version that was retracted.

The first thing that people who promote the vaccine/autism link would do with a study like this, one that doesn’t find a link between vaccines and harm, is claim that it isn’t “independent” and the authors and/or funding agencies are too biased. So, let’s look at the authors

Britni Curtis,1 Noelle Liberato,1 Megan Rulien,1 Kelly Morrisroe,1 Caroline Kenney,1 Vernon Yutuc,1 Clayton Ferrier,1 C. Nathan Marti,2 Dorothy Mandell,3 Thomas M. Burbacher,1,4 Gene P. Sackett,1,5 and Laura Hewitson1,6,7

1Infant Primate Research Laboratory (IPRL), Washington National Primate Research Center, and Center on Human Development and Disability (CHDD), Seattle, Washington, USA; 2Abacist Analytics, LLC, Austin, Texas, USA; 3Independent Consultant, Austin, Texas, USA; 4Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington, USA; 5Department of Psychology, University of Washington, Seattle, Washington, USA; 6The Johnson Center for Child Health and Development, Austin, Texas, USA; 7Department of Psychiatry, University of Texas Southwestern, Dallas, Texas, USA

Laura Hewitson was the lead researcher in the previous macaque studies, the ones often quoted as providing evidence of a link between thimerosal and autism. Her organization (The Johnson Center for Child Health and Development) was formerly referred to as Thoughtful House and was directed in that time by Andrew Wakefield. Thomas Burbacher and Gene Sackett have also been involved with previous animal studies on thimerosal, including this one often cited again as evidence of a link between vaccines and autism.

The funding?

This work was supported by The Ted Lindsay Foundation, SafeMinds, National Autism Association, the Vernick family, and the Johnson family. This work was also supported by WaNPRC Core Grant RR0166 and CHDD Core Grant HD02274.

Both SafeMinds and the National Autism Association are strong proponents of the idea that vaccines cause autism.

Under competing financial interests we read:

Competing financial interests: Drs. Marti and Mandell provided consulting services as independent contractors in regards to the data analyses. Neither person has provided services to pharmaceutical companies that manufacture vaccines or their representatives, nor have they been an expert witness in thimerosal, or similar suits. The other authors declare they have no actual or potential competing financial interests.

I will leave you with the final paragraph of the new study

In summary, we did not find evidence of an adverse impact of vaccination status on early neurodevelopmental measures, including the acquisition of neonatal reflexes and the development of object permanence. This was true for animals receiving TCVs, as well as animals in the 2008 group, which received the expanded pediatric vaccine schedule that remains very similar to the currently recommended schedule. Although some animals receiving TCVs performed better in the reversal phase of discrimination learning compared to controls, this association was not consistent across all study groups with thimerosal exposure. Furthermore, learning set performance appeared to be poorest for animals in the TCV group but this observation was not mirrored in the 1990s Primate group. Finally, all infants, irrespective of vaccine status, developed the typical social behaviors for this age of animal, with very few instances of negative behaviors reported. While the data as a whole does not support a consistent adverse effect of TCVs on primate development, factors that may modulate the toxicokinetics and toxicodynamics of thimerosal, such as genetics, gender, birth weight, gestational age, maternal health, and chemical co-exposures, should be thoroughly investigated.


By Matt Carey

National Geographic, “The War on Science”, includes discussion of vaccines and autism

19 Feb natgeo

I just got my copy of the March 2015 issue of National Geographic a couple of days ago. Imagine my reaction when I saw this cover (click to enlarge):

natgeo

In case you are having trouble imagining my reaction–it includes a big THANK YOU to National Geographic.

Yes, they put “vaccinations can lead to autism” up there with “evolution never happened” and “the moon landing was fake”.

This paragraph includes references to Jenny McCarthy (anti-vaccine activist and actress Jenny McCarthy) and Andrew Wakefield’s Lancet article.

Doubting science also has consequences. The people who believe vaccines cause autism—often well educated and affluent, by the way—are undermining “herd immunity” to such diseases as whooping cough and measles. The anti-vaccine movement has been going strong since the prestigious British medical journal the Lancet published a study in 1998 linking a common vaccine to autism. The journal later retracted the study, which was thoroughly discredited. But the notion of a vaccine-autism connection has been endorsed by celebrities and reinforced through the usual Internet filters. (Anti-vaccine activist and actress Jenny McCarthy famously said on the Oprah Winfrey Show, “The University of Google is where I got my degree from.”)


By Matt Carey

CNN: The money behind the vaccine skeptics

6 Feb

CNN Money has a short video up that makes a point that a few of us have been making for the past few years: much of the vaccine antagonistic message is funded by a few wealthy people. A good discussion can be found at A Snapshot of the Deep Pockets of the Anti-Vaccine Movement on Haprocrates Speaks. The CNN piece is called “The money behind the vaccine skeptics“. I can’t get the video to embed here, but one can find it here.

Here’s a screenshot from CNN showing the organizations, people and money that CNN discusses (click to enlarge)

cnn money

CNN points out that the self-styled National Vaccine Information Center and others (such as Chris Shaw’s group at the University of British Columbia) get a lot of money from the Dwoskin family. The Dwoskin Family Foundation told CNN that they are not antivaccine but are, instead, advocates for safer vaccines. It’s a story we hear a lot.

Claire Dwoskin is or was a board member of the NVIC and made this statement about vaccines. John Stossel had aired a piece about how his daughter had fought off a whooping cough infection and in her response to one of his producers she stated:

What his daughter went through is NOTHING compared to what the families of autistic children go through every day of their lives. No disease can match this record of human devastation. Vaccines are a holocaust of poison on our children’s brains and immune systems. Shame on you all.

I’m not sure how that sentiment fits in with being “advocates for safer vaccines”. One has to accept that vaccines are safe before advocating for safer vaccines.

Also mentioned is Barry Segal who funds Focus Autism (now Focus for Health) and A Shot of Truth. And Generation Rescue’s JB Handley and Jenny McCarthy. Both Focus Autism and Generation Rescue are noted for funding Andrew Wakefield’s “Strategic Autism Initiative”. All these groups are discussed in previous articles here at Left Brain/Right Brain.

The piece is short and perhaps that’s why they don’t mention Generation Rescue’s hundreds of thousands of dollars spent on full page ads claiming vaccines cause autism, or their poorly performed phone survey on vaccines. Lots of money spent on promoting fear and distrust of vaccines.

I’ve never seen evidence of these groups actually funding work into safer vaccines. I’ve never seen, say, funding for research into a new vaccine or even something simple like improved storage and transportation for vaccines into the developing world to reduce the use of thimerosal, a preservative these groups claim (without good evidence) cause autism and other disabilities.


Matt Carey

Jenny McCarthy tells the story two different ways…again

29 Jan

Yep, this doesn’t have anything to do with autism. Well, aside from the fact that we will discuss how one public face for autism is once again showing that her stories don’t match over time. You see, Jenny McCarthy has a reality TV show now and the story of her divorce presented in that show doesn’t match what she wrote in her book 8 years ago. I found the new story in a recent article in the Washington Post: Jenny McCarthy tries to mend her anti-vaccine reputation with reality TV. It’s too little, too late in which Emily Yahr writes:

The show is filled with such heart-to-hearts, with McCarthy recounting her ordeals as a single mom, starting with her ex filing for divorce in 2005 the same week that Evan was diagnosed with autism.

Now, it’s been a while since I read Jenny McCarthy’s “Louder than words” book. A long while, but that statement didn’t strike me as consistent with what she wrote in her book. The sentiment is the same: harsh on her kid’s father while putting herself in a good light, but the details didn’t match.

What did she say in her 2007 book? She says that she asked for the divorce. She was the mommy warrior, taking charge in that book. Now in her reality show she’s the object of sympathy, dumped by her husband just when she needed him most.

LTW-divorce

In fact, if you read the book, she talks about thinking about divorce for some time before she finally asked for it. Because that whole “same week as the diagnosis” thing in the TV show isn’t what she wrote in 2007 either. Between the autism diagnosis and her asking for a divorce, there are weeks, if not months of stories in her book. Stories that include Ms. McCarthy asking her husband to leave, and him refusing.

Who knows what the actual story was. All we hear is the story that fits the image she wants to portray at the moment. Her ex husband is taking the high road and not returning fire.

Oh, and if you are worried about how her son took the divorce, don’t. According to Ms. McCarthy, autism renders one incapable “emotionally connecting” with such events.

LTW-downplay-evan-reaction

Sorry to be sarcastic there. But, really, Ms. McCarthy? Autism renders one incapable of emotionally connecting with what was going on? Couldn’t be that the kid was unable to understand why his mother was making his father leave, just as any kid would?

No real surprises here. Ms. McCarthy has been inconsistent over the years. She had multiple stories of her first encounter with Barbara Walters when Ms. McCarthy was a guest on The View. She has informed us that her son is no longer autistic. Then, a few years later, she tells us that he is. (Jenny McCarthy Slams Rumor That Her 11-Year-Old Son Evan Doesn’t Have Autism). She hammers away at vaccines, but tells us she’s pro-vaccine. And to cap it all, she heads an autism charity that focuses on treatment, but won’t speak out against the faux treatments (like bleach enemas) that are promoted at her orgs conventions.


by Matt Carey

Measles are back but where is Jenny McCarthy?

28 Jan

It takes a lot of courage to stand up and make yourself heard on unpopular topics. But it’s only really courageous if you are willing to accept responsibility for being wrong. Jenny McCarthy stood up. She made herself heard. In the process she got a lot of media attention, led a march on Washington (the Green Our Vaccines rally), and sold a lot of books. That was years ago. Now we are seeing the outbreaks of disease that so many, even Ms. McCarthy, predicted based on the path she set. Back then she at least had the guts to say, “it’s not my fault” (I disagree). Now she’s just absent from the public’s eye on this topic. Instead we get her new reality show.

Today, a measles outbreak originating in Jenny McCarthy’s old backyard (southern California) has reached about 100 people infected (50 in the state, 23 more whose connection to the epicenter of the outbreak is unknown and more out of state). And, no comment from Ms. McCarthy. But she wasn’t always so quiet. Consider this statement from an interview in Time Magazine:

I do believe sadly it’s going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it’s their f___ing fault that the diseases are coming back. They’re making a product that’s s___. If you give us a safe vaccine, we’ll use it. It shouldn’t be polio versus autism.

The idea that somehow a resurgence of disease would lead to a change in vaccines didn’t make sense to me back then. It seemed like some nasty game of “chicken” where Ms. McCarthy was going to frighten enough people about vaccines that outbreaks would be possible. Frighten with statements like “they’re making a product that’s shit” and that the vaccines are not safe. Somehow, once this fear was instilled and the drop in vaccination rates happened, outbreaks would happen and these would prove her point that the vaccines are “shit” and the vaccines would be reinvented.

Apparently Ms. McCarthy realized that this logic wasn’t sound as she started distancing herself from the vaccine message years ago. Instead of being at the forefront of her movement today, ready to force the changes she predicted, she brings handlers to interviews to deflect questions on vaccines. She points people to her nonpology and nosplenation of her views in an op-ed published by the Chicago Sun Times, Jenny McCarthy: The gray area on vaccines

Here’s a defensive paragraph (and a straw man argument) in that op-ed:

“People have the misconception that we want to eliminate vaccines,” I told Time Magazine science editor Jeffrey Kluger in 2009. “Please understand that we are not an anti-vaccine group. We are demanding safe vaccines. We want to reduce the schedule and reduce the toxins.”

Here’s the thing. Many people have called out Jenny McCarthy over the years for her irresponsible statements about vaccines. She spread a lot of fear. One doesn’t read “They’re making a product that’s shit” or a correction of that view at the Sun Times. One doesn’t hear blanket statements that vaccines are all unsafe (“If you give us a safe vaccine, we’ll use it.”) One doesn’t read her statements that vaccines are behind the rise in diagnosed autism rates. One doesn’t hear her state that if she had another child, she wouldn’t vaccinate (a statement she made back when she was more vocal). No, all we get is her “grey area” on vaccines.

Also, not comment about the impending outbreaks.

Which brings me back to: where’s the courage in hiding and dodging the consequences of your actions, Ms. McCarthy? Are you going to point me back to your claim that “it’s not my fault” made on Larry King Live?

KING: Isn’t the problem here, Jenny, that people sometimes listen with one ear are going to panic. And not vaccine at all?

MCCARTHY: Probably. But guess what? It’s not my fault. The reason why they’re not vaccinating is because the vaccines are not safe. Make a better product and then parents will vaccinate.

I didn’t buy it then, I don’t buy it now.

And a similar sentiment

KING: Probably due to you, jenny, and programs like this, the percentage of children getting vaccinations is dropping.
Do you think that’s good?

MCCARTHY: I think it’s only good because it’s the only thing that’s going to shake up the CDC to do something about it.

Yes, they and others have been doing something about “it”. It being the drop in vaccination rates, not the alleged problems with vaccines you were intending. Many people have spent a lot of time trying to prevent or reduce the outbreaks we are seeing now. The question is why weren’t you working on avoiding this?

As I stated at the outset, it’s only courageous to stand up against prevailing opinion if you are willing to take responsibility and fix problems if/when you are proved wrong.

Ms. McCarthy, you were wrong. You were wrong to spread fear. And you can’t get out of it with a simple “it’s not my fault”. It is partly your fault that outbreaks are happening.

And are these outbreaks causing people to accept your position and make the changes you asked for?

No.

And all this doesn’t even touch on the problems of your promotion of unsafe “therapies” for autism, an issue much closer to my heart.


By Matt Carey

So, the National Vaccine Information Center has a Twitter bot?

20 Jan

Nonprofit organizations’ tax forms are public records. One can find them on many sites, and most nonprofits even host them on their own website. I was looking over the 2012 tax form for the National Vaccine Information Center recently and found something very interesting. The NVIC is one of the organizations that continues to push the failed idea that vaccines cause autism. This idea has caused a great deal of harm in the autism communities, but we get to be their hammer against vaccines.

The NVIC has a “vaccine ingredient calculator” or VIC (The NVIC Vaccine Ingredient Calculator: A disingenuous deceptive instrument of vaccine fear mongering).

Lately I’ve seen a lot of social media chatter where vaccine antagonistic people and groups are claiming that any opposition they see is being coordinated by “twitter bots”. Programs designed to create tweets.

So, imagine my response when I saw this on the NVIC 2012 tax form (click to enlarge):

NVIC tweet machine

Yes, the NVIC created a “Tweet Machine” which produced 8,760 tweets in one year. That’s one an hour over a 365 day year.

I am assuming that is this Twitter account.

VIC twit

See how they are still pounding the old, failed “autism is mercury poisoning” idea? That idea led to many kids being subjected to unnecessary chelation and other alternative treatments that range from useless to harmful.

Also, they want a stop to robocalls. Because that’s on topic for a vaccine discussion. And not at all ironic given the NVIC’s “Tweet Machine”


By Matt Carey

Unethical DAN doctor to be supervised by acupuncturist

31 Dec drusman1[1]

An Illinois doctor who subjects autistic children to “unwarranted, dangerous therapies” must have her work reviewed by an acupuncturist. The state medical board also fined Dr. Anju Usman $10,000, ordered her to take additional medical education classes, and placed her on probation for at least one year, as part of her plea agreement with state regulators.

The acupuncturist, Dr. Robert Charles Dumont, is a pediatrician, and a member of the faculty of the Integrative Medicine Department of Northwestern University School of Medicine. According to the consent decree, Usman “shall submit ten active patient charts on a quarterly basis” to Dumont. When asked if Usman is allowed to select which charts will be reviewed, a medical board spokesperson referred the reporter to the language in the consent decree.

Usman suggested to regulators the doctor who will be reviewing her charts, according to Usman’s attorney.

drusman

Usman is director of True Health Medical Center in Naperville, Illinois and owner of Pure Compounding Pharmacy. She a is regular presenter at Autism One, an annual gathering of vendors, providers, quasi-researchers and desperate parents.

The Illinois Department of Financial and Professional Regulation says Usman provided “medically unwarranted treatment that may potentially result in permanent disabling injuries” to a boy that Usman started seeing in the spring of 2002, when the child was not quite two years old. Records indicate Usman diagnosed the boy with a calcium-to-zinc imbalance, yeast, “dysbiosis”, low zinc, heavy metal toxicity, and abnormally high levels of aluminum, antimony, arsenic, cadmium, copper, lead, nickel, silver, tin, titanium and selenium. Usman prescribed chelation, a hormone modulator, and hyperbaric oxygen therapy, which regulators describe as an “extreme departure from rational medical judgment.”

The complaint against Usman was filed by the boy’s father in 2009. A year later, he sued Usman and Dr. Daniel Rossignol of Melbourne, Fla. for harming the child with “dangerous and unnecessary experimental treatments.” A Chicago-area lab, Doctor’s Data, was also sued. The plaintiff voluntarily dismissed the suit in 2014, but will reportedly reinstate it in 2015 or later.

Usman was the subject of a 2009 Chicago Tribune investigation into questionable medical practices aimed at treating autism. The article noted that Usman and Rossignol “are stars of Defeat Autism Now!, having trained thousands of clinicians…  They are listed on the group’s online clinician registry, a first stop for many parents of children with autism seeking alternative treatment.”

Usman’s name is also connected to the 2005 death of Tariq Nadama, a five-year-old boy who died at the hands of Dr. Roy Kerry. Usman diagnosed the boy with high aluminum levels, then referred him to Kerry, an ear-nose-throat specialist in Pennsylvania. Kerry treated the child for lead poisoning, even though his blood lead levels were below that which indicates the need for chelation.

Cross posted from Autism News Beat

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