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SafeMinds Review of Autism-Like Outcomes from Vaccinations in a Non-Human Primate Model

SafeMindsSafeMinds Review of Autism-Like Outcomes from Vaccinations in a Non-Human Primate Model

Findings identify distortion in public reporting and argue need for full disclosure of study documents.
 
Does published research always reflect the truth? A research paper came out last month in the prestigious Proceedings of the National Academy of Sciences with this title: Administration of thimerosal-containing vaccines to infant rhesus macaques does not result in autism-like behavior or neuropathology. The paper, by Bharathi Gadad, Laura Hewitson and colleagues, concluded that "administration of TCVs and/or the MMR vaccine to rhesus macaques does not result in neuropathological abnormalities, or aberrant behaviors, like those observed in ASD."

This paper was preceded earlier this year by another based on the same primate model of vaccine administration and autism and was led by the same primary investigators. It too was published in a prestigious journal, Environmental Health Perspectives. It also "provided no consistent evidence of neuro-developmental deficits or aberrant behavior in vaccinated animals."

Pretty strong conclusions. Case closed, no? Well, not so fast. The Medical literature is rife with misreported investigations and selective reporting. What is published in journals is only a small piece of the entire body of any investigation's work, and some investigations are not published at all, so a large part of the evidence base may remain largely invisible to the scientific community or to the public. What's ultimately published may reflect bias, intentional or not.

SafeMinds partially funded this investigation of vaccine administration and autism-like outcomes in a non-human primate model. We have been following it since its inception in 2003, have had regular internal updates from and interaction with various investigators, and have read all the public documents that have appeared from this decade-long, complex placebo-controlled experiment. Based on our knowledge, SafeMinds has serious concerns about the validity of the conclusions of the two most recent papers.  Read the full article at SafeMinds.

Comments

Carol

"The Purkinje cells are extremely important as an autism indicator. Purkinje cell loss and damage is a reliable indicator of autism. Over 90% of human autistics have a substantial loss of Purkinje cells, at least in some areas (lobes) of the cerebellum.

Purkinje cells were not counted in all the subjects, which is suspicious. For example, the 2008 group had 12 subjects, but Purkinje cells were counted in only 8. Why 4 subjects from this group were not included was not explained. The TVC and MMR groups contained 12 and 15 subjects respectively, but only 5 from each of these groups had Purkinje cells counted. This was also not explained.

Gadad reported average (mean) numbers of Purkinje cells, not individual-level data. This is a serious mistake because averaging will conceal the presence of outliers with unusual numbers of Purkinje cells. Gadad instead should have reported the number of individuals diagnosable with autism or with high Purkinje cell loss, not the averaged Purkinje cell numbers on the group-level.

If 2% of a population suffers autism with -20% Purkinje cell loss (a typical amount, at least in specific lobes of the cerebellum), the effect on the group level average is -0.4% which will be very difficult to observe in group-level averages and totally impossible to observe in this study. So what we really need is individual-level data, not these averages.

Another suspicious aspect of Gadad’s Purkinje cell number reporting is the use of the 'standard error of the mean' (SEM), instead of standard deviation (SD). The use of the SEM by Gadad is improper and misleading. SEM and SD are very different:

SEM: Indicates how far the measured average is likely to be from the true average
SD: Indicates how widely scattered the individual measurements are.

Since the SEM merely reports the error of the average, it doesn’t tell us anything about the possible existence of outliers with very low Purkinje cell numbers (i.e., brain-damaged monkeys). Its the SD that gives us that type of information.

The use of the SEM has been widely criticized in the scientific literature since it is sometimes used to deceive rather than inform. The SEM is always smaller than the SD, so it creates the false impression that the data is 'cleaner' than it really is. SEM has sometimes been used deceptively to conceal unusual or undesirable data that does not fit a model or hypothesis. I think that is the case with Gadad...."

http://vaccinepapers.org/gadad-et-al-2015-pnas-journal/

D

@Linda1 - Off topic, but I think you need to see the film, "Project Nim", about Nim Chimpsky and the Columbia language experiments: http://www.imdb.com/name/nm1769198/

Regarding your comments, I'd say that while I understand why people support and engage in such research, particularly given the desperation that we face to extricate ourselves from this problem, I also think that the willingness to do this to animals is part of the very hubris that has gotten us into the predicament we are in. Having spent a long time looking at this, I no longer feel that the questions are safety and efficacy are really the issue. I think there is some kind of deep moral defect that has gotten us here. We seem to think we can design the world to our convenience. That pretty much anything we do is acceptable in that quest; and when it comes to these vaccines, what we're doing can only be described as ghoulish.

Linda1

To add to my last post about _Next of Kin_, it has been at least a decade since I read the book. I went to Amazon and read some of the reviews was reminded of a part that I had forgotten, summarized in this excerpt of an Amazon review by Duane Williams on April 10, 1999:

"While in Oklahoma, Fouts came in contact with an autistic child and his work with Washoe led him to a remarkable discovery. He realized that the child might not be able to coordinate his auditory experience with his visual experience and that might be why he couldn't communicate with others. So Fouts tried teaching sign language to the autistic child and in a couple of months the child was communicating with others for the first time in his life. His behavior also changed. He stopped screaming and rocking and started making eye contact with people. More remarkably, a few weeks after he started learning ASL, he started to speak in English. This led Fouts to begin theorizing about the origins of language, which is discussed at some length in this book."

http://www.amazon.com/Next-Kin-My-Conversations-Chimpanzees/dp/0380728222

Linda1

Washoe, raised as a human in an American experiment by psychologists, was not a monkey. She was a chimpanzee. In the book, _Next of Kin: My Conversations With Chimpanzees_, psychologist Roger Fout tells how she on her own volition would use a broom to sweep her cage floor to keep it clean, how she signed her desire to have a baby and to raise and be a mother to her baby, how she on her own learned to curse appropriately, calling someone who she deemed to be a bad person "dirty" (which was the word she used to describe feces), and how she asked one of the graduate students working with her who had been pregnant, what happened to the woman's baby. Upon being told that the baby had died, Washoe signed that she was sorry and sad to hear that.

If I remember correctly, Washoe at one point also lived at the Washington State Primate facility (can't remember the exact name), which is really a prison for animals held in captivity and kept from experiencing the joy of life they were meant to have.

The animals that the Safeminds experiment abused and killed were not chimpanzees, but we have no reason to believe that monkeys are any less deserving of their lives. Certainly they think, learn, experience joy, pain and understand loss. In order to settle a political, not even scientific argument, about the cause of human autism, what right has anyone to rob a monkey mother of her healthy baby and that baby his relationship with his mother, his health and ultimately his own life? I hope that Safeminds will rethink their participation in this horrific senseless exercise and will vow to protect all animals as well as humans in any future endeavors.

Betty Bona

I forgot to mention that this is Texas based research. I don't mean to put down all Texas research, but maybe there is a pattern and past history of applying pressure and obtaining results from applying pressure in certain institutions.

Betty Bona

When I look at this research and try to figure how an honest researcher can proceed to publish this paper, I am reminded of Garth Nicolson's problems in Texas with his finding of a weaponized mycoplasma being tested in Texas prisons and found in Gulf War Illness patients. He was working at the University of Texas at MD Anderson center in Houston and his wife was at Baylor. His boss and several others were killed when the findings were about to be disclosed. I think some institutions bow to pressure more than others. And maybe some institutions have a history of doing the bidding of the moneyed interests or government. But maybe the pressure is just to great to overcome.

For Cherry

The strategy that needs to happen now is, since the Peds or docs won't come to the schools, we need to bring the schools to them. You can't film the horror show that are the schools now but you can do a film of teachers talking about their day and what kind of kids they have in their classes. They will tell you of ESL that is no longer just ESL anymore, it's ESL/autism or ESL/severe ADHD etc.
A school I work at has several staff ready to walk. Grade 1 students defecating in classroom, violent out of co trol behavior. The schools are in crisis. This is in Canada. We need to gather the teachers' stories.

Cherry Misra

Many of you may recall this, but I think it is appropriate to mention it for those who do not follow this issue closely. The esteemed mercury toxicologist professor Dr. Boyd E. Haley said long ago something like " What would be surprising would be if mercury in vaccines DIDNT cause health problems in children "
Was not this study a waste of funds by Safeminds? Dont the dozens and dozens of studies that show how toxic mercury is tell us enough.? It seems to me that they need a new strategy. The research information that we have already plus the precautionary principle are enough to condemn Thimerosal in vaccines. People need to be educated about the fact that mercury is still found in flu vaccines given to pregnant women and young children. Most Americans dont even know that much

Jeannette Bishop

Thanks, Bayareamom, for highlighting Christina's highlight of David Foster's enlightening Newsweek comment. Thank you, John Stone for more clarification. I think I've got things straightened out now (I have to confess on a first skim-read I was thinking how interesting it was to learn that Bayareamom was a programmer for UCSD ...which really was info from David Foster about him...hopefully I'm not confusing things more).

Also, thank you, SafeMinds.

John Stone

Bayareamom

Just to clarify, the comment appeared under Lyn Redwood's blog on 5 October:

http://www.safeminds.org/blog/2015/10/05/why-arent-i-surprised-that-the-media-got-it-wrong-again/

and Christina was just recycling a comment by David Foster on Newsweek. I don't think it was ever intended as a challenge to Safeminds: the intention appears to have been to bring to light a number flaws, issues etc in the paper, and David includes what Safeminds has said at the time - the comment about cherry-picking. In context David was addressing Dorit Reiss, Matt Carey etc. not challenging Safeminds. I think you have simply misread the comment.

John

Bayareamom

Meaning no disrespect, John, but no...they didn't (as Christina so rightfully pointed out). She stated in her comment that it was somewhat 'problematic' as to the language used by Safe Minds re the final abstract/language used when that research came out.

We'll just have to agree to disagree, here. I can see I'm not going to get a response from Safe Minds on this issue and neither is Christina. Safe Minds didn't bother to respond to Christina's comment over on their own website, so can't imagine they would respond HERE, either.

It's a decent question and deserves a REAL answer.

Birgit Calhoun

About Wakefield, it is important to remember that the Wakefield paper was not a study. It was a "case series". When you see an article like that you are basically given a description of a number, in this case 12, of sick children with similar symptomatology. The Wakefield paper was mainly pointing out how similar these cases were. At the end the question is asked: Could the autism in these children be something other than coincidence that they all had recently received the MMR vaccine.

The SafeMinds study was not a case series. SafeMinds describes how the preliminary results did not match what was reported in the end. The fraudulent nature of the final product of that work is quite noticeable. I trust what SafeMinds is saying. The small size of the cohort relates to how expensive the study subjects are. And when preliminary indications are wiped away because of different numbers there has to be an explanation.

Sadly I am not surprised that this is happening. Truth in science is harder and harder to come by when corporate greed is involved. Universities are not immune to lure of the mighty dollar.

Patience (Eileen Nicole) Simon

I responded yesterday on the safeminds website, and on AoA October 6.

Cells in the cerebellum and hippocampus were looked at because abnormalities were reported years ago by Courchesne and Bauman and Kemper in human cases of autism.

In 2011 Lukose and Kulesza reported malformation of the superior olive in the auditory pathway in 9 brains from autistic subjects. Then they subjected laboratory rats to valproic acid (Depakote) during gestation, and found the same neuropathology.

They looked at the superior olive because Patricia Rodier in 1996 reported malformation of the superior olive in a 21-year-old woman whose autism was attributed in part to prenatal exposure to alcohol and other drugs.

I think the inferior colliculus in the auditory pathway should also be examined in vaccine research with primates. This small area in the midbrain auditory pathway has higher blood flow than any other area of the brain, and was prominently damaged in primates subjected to asphyxia at birth.

I have tried and will continue to try to point out the vulnerability of the auditory system in the brain, to toxic substances as well as asphyxia.

John Stone

Bayareamom

The fact is that they covered these topics when you said they didn't.

Bayareamom

John,

Again - I am asking SafeMinds for their response. I'm not looking for conjecture or looking to speculate ON MY OWN, here.

Thanks anyway. Hopefully, we may have an answer from someone at SafeMinds here at this forum.

John Stone

Bayareamom:

"Why was there a total lack of discussion of differences which can easily be seen in these behaviorlal graphs?"

I suggest you look at pages 12-14

Or page 6:

"PHASE II RESULTS
Same Data/Opposite Results on Hippocampus CA1 Size"

Not obvious to me that they are pulling their punches. It struck me when I read it that it was a hard hitting review documenting scientific fraud. In order to do this they don't necessarily have to make exactly the same points in exactly same way as other people.

Bayareamom

So - the questions put forth to SafeMinds would go something like this:

"Why was there no mention by SafeMinds as to the difference in certain lobes in the cerebellum, i.e., the lobes which were found to be SMALLER, which are precisely the lobes which neuropsychologists would expect to be impacted, given their functional associations?"

"Why was there no mention by SafeMinds as to the RED graphs (B and D), where you can absolutely see there is something very strange occurring with the vaccinated primates?"

"Why was there a total lack of discussion of differences which can easily be seen in these behaviorlal graphs?"

Again, I would respectfully ask a representative of SafeMinds their response to the above questions.

Bayareamom

...and by the by, I just now took another look at the graphs Christina is talking about. She is SPOT ON...

Bayareamom

@John Stone,

I understand that, John, but I would still appreciate an answer from someone at SafeMinds regarding the precise queries presented to them, by Christina.

She asks EXTREMELY VALID and cogent questions and certainly deserves an answer (as do the rest of us).

John Stone

Bayareamom

I am not replying on behalf Safeminds but I can see they wanted to take care over their response, and document it in detail. BTW I believe Christina was reporting the comments of David Foster.

no-vac

Very likely, the authors of this phase II study were either bribed or frightened or blackmailed by pharma mafia to produce the results contradictory to their phase I study. Let's face it, science is corrupted and dead now, and all which counts is the parental experience, which overwhelmingly shows direct vaccine-autism link.

Bayareamom

As regards my earlier comment regarding this other primate study, I would respectfully ask a representative of SafeMinds to respond to the queries written within the comment posted "Christina."

Why WEREN'T these issues pointed out by SafeMinds when this study came out?

Bayareamom

"...This paper was preceded earlier this year by another based on the same primate model of vaccine administration and autism and was led by the same primary investigators..."

The below comment was written after an article appeared in SafeMinds explaining the results of an earlier primate study:

Comment:

"...Here is the full study:

http://www.pnas.org/content/early/2015/09/24/1500968112.full.pdf

Go to this link, and look at the graphs presented which show the relationship between various behaviors and the different groups. Notice that in Figures B and D, there is something rather peculiar happening with the RED group (vaccinated with the Pediatric 1990's schedule)...do these look like there is no effect of vaccination? Even in Figure B all of the "vaccinated" groups have the opposite trend than the placebo group. Why is none of this even discussed?

Enough on the behavioral data, lets look at the brain volumetric morphometry they present in this paper. They tell us that because previous research found differences between autistic and non-autistic children in cerebellar morphometry, they analyzed the cerebellum and found that there were no differences between groups in cerebellar hemisphere volume.

What I find interesting is that some of the previous research they mention was done by Dr. Eric Courchesne and Dr. Terry L. Jernigan at UCSD, and I was the programmer who wrote the programs which did the volumetric analyses. Hypoplasia of cerebellar vermal lobules VI and VII in autism.

http://www.ncbi.nlm.nih.gov/pubmed/3367935

We found differences in the cerebellum, yes, but only in certain lobes of the cerebellum, and interestingly enough the lobes which were found to be smaller were precisely the ones neuropsychologists would expect to be impacted, given their known functional associations.

The differences were in regions populated by purkinje cells, and it is well known that mercury damages purkinje cells specifically and the cerebellum generally: Neuron loss in cerebellar cortex of rats exposed to mercury vapor: a stereological study.

http://www.ncbi.nlm.nih.gov/pubmed/10912926

Another general finding of Courchesne's research was that the overall brain and cerebellar volumes in very young autistic children tended to be larger than controls. This difference tended to normalize as the autistic children got older. So what does a finding of no difference between overall cerebellar hemisphere volume between mercury-exposed and control infant primates tell us?

Precisely NOTHING. They did not find differences because they weren't looking in the right place..."

(Note: The portion of this woman's comment, below, is the part of her comment that really struck me as I read thru it. Comment (respectfully) from SafeMinds?):

It is also problematic that representatives of Safe Minds, one of the organizations which helped fund this research, suggest that the findings in this study were "cherry picked". Given the lack of discussion of differences which can easily be seen in their behaviorlal graphs, and the fact that they do not mention previous significant findings, and even go so far as to include their emphatic findings in the very title of the paper, I think we can add this study to the very long list of bad science trumped as final proof that vaccines do not cause autism..."

Danchi

I doubt whether there was any specific timing involved in this instance.

I don't think the release was planned it was just a happy coincidence. However it serves a purpose doesn't it? If the latest study paid for by an anti-vaccine group shows that vaccines are not implicit in the rise in autism than there is no fear or reason for people to object to the hundreds of mandatory vaccine mandates that are being pushed across the US. People who have been researching the lack of science involved in vaccines know better however people who are just now questioning the status quo of the vaccine ritual, can be easily manipulated with this information. Add to this the upcoming fear mongering campaign of measles and whooping cough outbreaks that are sure to begin between now and March because of the back to school vaccinations that are still going -the CDC will use this to their advantage. After all, a game plan was written a couple of years ago: http://www.naturalnews.com/files/GSA-2013NAVPwhitepaper_final.pdf#search=roadmap%20to%20action

John Stone

Reader

1) Yes, people can draw their own conclusions about selective publication of data which is particularly blatant in this instance.

2) Of course, the size of the Wakefield paper was a red-herring: it was a small case series study. The issue was the distinctive pathology of a small group of patients, not how frequent they were. The criticism was particularly wicked because there was absolutely no good reason to deny these children medical investigation even if their symptoms were felt to be associated with a vaccine.

Nor do you expect a primate study to deal in vast numbers. There are of course statistical issues which were addressed the Safeminds review.

Danchi

I doubt whether there was any specific timing involved in this instance. The Jain study was apparently delayed from last summer (perhaps because of the Thompson story) and unleashed as a media event during critical votes over enforced mandates in the spring. The Curtis and Gadad papers had long been in the pipeline but not clear whether the timing of their release was micro-managed. It does look as if like the Jain study they are a deliberate waste of time.

Danchi

The purpose of the CDC and the vaccine makers was to throw out another study on the tail end of the Jain et al study hoping to reinforce the belief that vaccines are not responsible for autism. This, I believe,is also a distraction from the Jain et al study because many genuine researchers (not on someone's payroll) have questioned the validity of it. It's a continual reinforcement of the propaganda and they have the trolls out in force-especially their hired gun Dorit. Since pharma owns the media and the CDC does pharma bidding it's a challenge to get the message out that the study was another paid for by pharma/CDC, and has not only been cherry picked but manipulated. It's also difficult to deflate the message that SafeMind paid for a study that proved vaccines did not cause autism. This has been the headlines. I have written almost a dozen comments with quotes from SafeMind and specifics on what data was eliminated and what was changed but not one has been posted so pharma/CDC are trying to control the message by telling websites to censor any opposing arguments.

I think the only way to beat back pharam/CDC is for SafeMind to produce any documents that state specifically what they did and didn't pay for, the emails that requested information on why specific data was left out and the email from the lead researcher as to why they were told they could not explain or give reason to SafeMind why data was removed.

Reader

Two questions/points:
- isn't there a society of scientists precisely concerned with the issue of raw data availability being crucial to scientific integrity?
- why in this instance is a study of 12 so touted when normally they like to scream that Dr. Wakefield's case series had only 12 children ?

Lisa

I skimmed the review and am going to read it in depth when I finish my work day. However, it looks like a very rigorous review that raises very legitimate, serious concerns.

Something definitely stinks to high heaven. As I said before, I think administrators at the lead university -- University of Texas -- got cold feet and essentially decided to bail on this study. Who knows which big donors they were courting and were afraid of offending with a primate study linking vaccines to autism.

As they say, follow the money...

go rand

Have all the Presidential candidates been invited to the CDC rally ???

I would think they would want to stand with those attending, and stand against those who have trashed the lives of millions.

John Stone

Everyone needs to read the forensic dissection of the Curtis and Gadad papers and their back history in the Safeminds review:

http://www.safeminds.org/wp-content/uploads/2015/10/Review-of-Vaccine-autism-primate-research-vG.pdf

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