One of the limitations constraining those of us who do human subjects research is that ethical considerations often prevent us from designing our clinical trials in what would be, from a strictly scientific standpoint, in the most methodologically rigorous way. For example, we can't intentionally infect human beings with known inocula of deadly bacteria in order to cause a reproducible severity of disease to be treated with a new antibiotic.
One thing that antivaccinationists seem unable to understand is this very point with respect to vaccine trials. They will call for a "vaxed versus unvaxed" study in which children are randomized to receive the full vaccine schedule or saline placebo. Of course, such a design would be highly unethical because the placebo control group would be left unprotected from potentially deadly vaccine-preventable diseases, which violates the all-important principle of clinical equipoise, which mandates that there be genuine scientific uncertainty over which group is receiving the more efficacious and/or safer treatment. Obviously, leaving half of the children in a "vaxed-unvaxed" study would grossly violate that principle. Heck, even from the warped viewpoint of an antivaccinationist, such a trial would violate clinical equipoise, because an antivaccinationist would believe it was the vaccinated group that would be receiving the harmful interventions. Some of the less clueless antivaccine activists have enough understanding of this concept to grudgingly accept that a randomized trial of this sort is totally unethical and therefore cannot be done. As a result they'll call for an epidemiological study of vaccinated versus unvaccinated children, not realizing that such a study is methodologically far more complex than it sounds, would be enormously expensive, and would likely require nearly as many unvaccinated children as there are in the United States. Such a study would require compelling evidence to justify it, and, as we all know, the evidence that vaccines cause autism, asthma, GI issues, neurodevelopmental disorders, sudden infant death syndrome, or the other problems antivaccinationists blame them for is at best not compelling and at worst nonexistent.
One way to try to get answers when you can't use humans is to use animals. However, this approach has problems as well, because, depending on the animal model and the disease, the relevance of such experiments can be questioned. One way to try to maximize the relevance to human physiology is to use nonhuman primates, but such experiments are incredibly expensive to do and must be held to very high ethical standards given how human-like they are. I mention these considerations for two reasons. First, one of the most infamous experiments trying to prove that vaccines cause autism—and failed, of course—using Rhesus Macaque monkeys. It was an experiment done by Laura Hewitson, who was at the University of Pittsburgh at the time. Ever since then, periodically, investigators have done experiments with nonhuman primates looking for neurodevelopmental disorders due to vaccines. For instance, Laura Hewitson followed up her first study with another one in 2009 and yet another in 2010. All were bad science. All were preliminary studies at best. All claimed to relate the pediatric vaccine schedule to neurodevelopmental disorders. All were touted by antivaccinationists. One was withdrawn.
Finally, the other day, a good monkey study was released by Gadad et al in PNAS entitled Administration of thimerosal-containing vaccines to infant rhesus macaques does not result in autism-like behavior or neuropathology. Even stranger, Laura Hewitson is one of the authors. Unfortunately, part of the justification for the study were the previous monkey studies that purported to show a link between vaccines and neurodevelopmental disorders. Indeed, so bad were those previous studies that personally I consider this study to be highly unethical to have done, given that there is no compelling evidence to justify subjecting 79 macaque monkeys to a bunch of injections and killing a large fraction of them to study their brains, all in the service of testing the long discredited hypothesis that vaccines cause autism or other neurodevelopmental disorders. I mean, seriously. The University of Washington IACUC, which approved this study, should be ashamed of itself. Ethically, the study is a travesty. It was also a waste of a lot of money, again, because this question did not need to be studied yet again. Despite the lack of a compelling scientific rationale for the study, it was nonetheless done, and done competently; so we have to consider its results which—surprise! surprise!—were completely negative. Let's take a look at the details.
The design was quite simple. There were 79 infant macaque monkeys subjected to six different vaccination schedules: (i) Control (n = 16), in which animals received saline injections in place of vaccines; (ii) 1990s Pediatric schedule (n = 12), in which animals received vaccines following the pediatric schedule recommended in the 1990s; (iii) 1990s Primate (n = 12), in which animals received vaccines recommended in the 1990s but on an accelerated schedule; (iv) thimerosal-containing vaccines (TCV, n = 12), in which animals received all TCVs but no MMR vaccines following the accelerated schedule; (v) MMR (n = 15), in which animals only received the MMR vaccine but no TCVs following the accelerated schedule; and (vi) 2008 (n = 12), in which animals received vaccines recommended in 2008 but on an accelerated schedule. Infants were assigned to a peer group of four animals, with multiple study groups being tested each year for neurodevelopmental outcomes.
The investigators then assessed social behavior, with testing being carried out by a social tester blinded to the experimental group. The testers were well-trained and experienced; they were also tested for reliability and used standard testing methods:
Infants underwent testing as follows: from birth to 20 d, infants were assessed for the development of neonatal reflexes and perceptual and motor skills; from postnatal day 14 to ∼3.5 mo of age, infants were examined for the development of OCP; from ∼3 to 6 mo of age, animals underwent discrimination learning assessments; from ∼5 to 8 mo of age, animals were assessed for learning set development; and from 30 d to 12 mo of age, animals underwent assessments of behavior before group living. These developmentally appropriate tests are measures of neurodevelopment, learning, cognitive abilities, and social behavior in young macaques (45). At ∼13 mo of age, animals were transferred to juvenile caging where they were group housed (n = 4 males per group) with animals from within their peer group for the duration of the study. All subsequent behavioral data were collected while animals were in their home cage.
Behaviors were defined as passive, exploring, playing, sex, aggression, withdrawal, fear-disturbed, rock-huddle-stop-clasp (strong clasping/grasping of another monkey without play behavior, or self-clasping with arms, legs, hands, or feet, without locomotion and no active inspection of own or other’s body), and stereotypy (repetitive body movements, with or without locomotion, requiring three or more consecutive, repetitive movements). It might be a cliche, but there were no statistically significant differences detected in any of the behaviors measured in any of the experimental groups.
Then, at the conclusion of the experiment, brains from monkeys in the control (N=12), 1990s (N=12), and 2008 groups (N=8) were sectioned for histological and immunohistological examination. The authors examined the brains for neuropathology in parts of the brain previously shown in humans to have changes in autism: the cerebellum, hippocampus, and amygdala. Try as they might to find differences, Gadad et al failed to find any differences between controls and either of the two vaccinated groups examined. There were no changes in the neurons in these regions. There were no changes in protein levels. Basically, there were no differences from control in the two experimental groups in the volume of the cerebellar hemispheres, the number or density of Purkinje cells in the cerebellum. There was no difference in the size of the Purkinje cells. Western blots (a means of detecting proteins with antibodies) failed to find differences in certain Purkinje-cell associated proteins calbindin, GAD-67, and proteins that are markers for different cell types, such as Iba1 (a microglial marker) and GFAP (astrocyte marker). Again, these were all negative. Gadad et al measured these proteins up, down, right, left, and sideways (so to speak), but failed to find any differences.
Why, you might ask, didn't Gadad et al examine the brains from the monkeys in the other experimental groups? The authors justify this decision thusly:
The neuroanatomical analyses were first performed in brains from the 1990s Primate and 2008 groups, as animals in these groups received the highest amount of EtHg exposure (1990s Primate) or the most extensive vaccine exposure (2008). Because no neuronal differences were found in either of these vaccine groups compared with the control group, no additional vaccine groups were fully studied.
This is a reasonable compromise. If the groups that received the most extensive thimerosal exposure and the highest vaccine exposure showed no detectable differences in brain structure in regions relevant to autism pathophysiology, then there really isn't a good reason to kill the rest of the monkeys to look at their brains. Even with that compromise, 36 monkeys paid for this information with their lives (16 control + 12-1990s schedule, and 8-2008 schedule) and brains. Basically, this study's results are inconsistent with the three main "hypotheses"—after all the disconfirming data calling them "hypotheses" really is doing them too much honor—that thimerosal-containing vaccines, MMR vaccines, or and "too many [vaccines] too soon" cause autism. Each hypothesis is represented by an experimental group. Sadly, 36 monkeys paid for these answers with their lives (16 control + 12-1990s schedule, and 8-2008 schedule) and brains, while the rest received at least unnecessary injections and other interventions.
Indeed, Dr. Paul Offit, after listing all the studies that have failed to find a correlation between vaccines and autism, alluded to a similar same concern in an accompanying editorial, although characteristically he was nowhere near as blunt as I am. Characteristically, he refrained from calling the study unethical and a waste of money and tried to find something good about this waste of money and primates:
One could reasonably wonder whether it is necessary to continue to spend more money chasing this fruitless, dead-end hypothesis. However, the constant drumbeat of negative studies has made a difference. Unlike 10 y ago, the media no longer covers the vaccine– autism controversy by telling both sides of the story when only one side is supported by the science; for the most part, they have chosen perspective over false balance. Legislators are also stepping up; both California and Vermont recently eliminated their philosophical exemptions to vaccination.
I will admit that Dr. Offit has a point. There certainly is a value in negative studies. No one, least of all I, would dispute that. The question—and reasonable scientists can disagree over the answer to this question—is: What is the point where we can say that enough is enough, that the question being studied has settled to a sufficient degree of certainty that it is no longer worth spending large sums of money on or killing intelligent primates to ask and study the question yet again? An animal study like this might be considerably less expensive and complex than large epidemiological studies, but it's still an animal study. It's not a human study. Human epidemiological studies, on the other hand, are much more expensive and require controlling for confounders that don't need to be controlled for in the highly controlled world of animal studies.
Unfortunately, I would argue that the relentless drumbeat of negative studies about vaccines and autism has probably played less of a role in how the press has changed its tune in the way it covers vaccine-autism pseudoscience to a far less credulous one than the discrediting of the chief architect of the MMR-autism scare, Andrew Wakefield, did. As much as I really, really wish it were the science alone that finally turned the tide and persuaded reporters and much of the general public that vaccines do not cause autism, I tend to think that was less of a factor than Wakefield's disgrace. From my perspective, seeing Wakefield lose his medical license, be dismissed as the medical director of the quack clinic he used to run in Texas, have his Lancet paper that launched the MMR scare retracted, and be shown to have been a scientific fraud practicing what Brian Deer so aptly called "Piltdown medicine" probably played a far greater role in changing public perception. Add to that the string of outbreaks of vaccine-preventable diseases that culminated in the Disneyland measles outbreak early this year. These things, more than anything else, were likely what shifted public opinion. That's why it's my opinion that, barring new compelling evidence that demands that we study the question further, studies such as this one are unnecessary.
Particularly annoying to me was the way that the authors of this study basically twisted themselves into pretzels to justify doing the study. For example:
Several epidemiological studies sought to determine whether TCVs resulted in neurodevelopmental disorders including autism; however, both nonsignificant and significant associations have been reported (8–12). Significant associations have been reported by Thompson et al. (11), who investigated the association between TCVs and immune globulins early in life and neuropsychological outcomes in children at 7–10 y of age. The data included the evaluation of 1,047 children and their biological mothers and 24 neuropsychological tests. The only variable that was statistically significant was tics; children who were exposed to higher doses of thimerosal were more likely to exhibit tics. In a follow-up study by Barile et al. (12) examining a subset of the data from Thompson et al. (11), they found a significant association between thimerosal dosage and tics, but only in boys. They found no statistically significant associations between thimerosal exposure from vaccines early in life and six of the seven neuropsychological constructs examined.
William Thompson, as you might recall, is the "CDC whistleblower," and the above is a total cherry pick job on Thompson's studies. While Thompson's 2007 study did show a statistically significant association between thimerosal-containing vaccines and ticks, what Gadad et al totally fail to mention is that the study didn't correct for multiple comparisons and that it also showed positive associations between thimerosal-containing vaccines and positive outcomes. That's why the overall conclusion is that the pattern of associations was most consistent with random statistical noise. Funny how Thompson (and Gadad et al) mention the ticks but ignore the seemingly positive associations.
In the abstract, studies like this one do have value—to a point. Given the evidence we have and what we already know about the relationship between vaccines and autism (namely that there isn't one), however, I really have to question the very necessity for such a study. Sure, it shows what every other well-designed study asking whether vaccines, be they thimerosal-containing or not, are associated with autism, but surely the investigators must have known before they started that that's what it would show. Worse, I can predict exactly what the antivaccine faithful will say about it. They'll dismiss it as an animal experiment and continue to call for either an experiment even more unethical than this one (a randomized trial of "vaxed versus unvaxed") or an epidemiological study of "vaxed versus unvaxed" children that they can dismiss because it's an epidemiological study prone to all of the confounders that epidemiological studies are prone to.
At least I can hope that after this study no more primates need die in the service of a dead, discredited hypothesis. A bigger challenge will be preventing children from dying because belief in this discredited hypothesis leads parents not to vaccinate their children against deadly diseases.
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Or invoke a chunky, canned concept soup in which (1) pure placebo studies don't exist, (2) the magic study is retrospective, and yet (3) countervailing epidemiological* studies are inexplicably dismissed out of hand.
* AoA seems to be leaning toward "population studies" instead these days, but the why and when don't strike me as particularly interesting questions.
It's not the EtHg, duh!
& no, I'm not a colleague of Professor Jeff Reimers or Dr Luc Montagnier infamous for his teleporting DNA!
I can't believe you of all people would resort to a straw man argument ...
AVers like Wakefield, Sears, the Australian Vaccination-Skeptics Network (formerly the Australian Vaccination Network), and the US-based National Vaccine Information Center (NVIC) will not care a whit for this study. They will continue to call for a completely unethical--an also unnecessary-- RCT for a vaccinated versus unvaccinated study in infants. That will never happen, and even if it did, when the results came back supporting the null hypothesis, the AVers would not accept the conclusion of the study. They won't accept the conclusion of any study that doesn't support what they *just know*, which is their deranged belief that vaccines cause autism. There is no convincing them--ever.
As you mentioned, Wakefield has been largely neutralized due loss if his medical license, retraction of his 1998 Lancet paper, and hisdismissal as head of a dubious clinic he tried to run in the US. The Australian Vaccination-Skeptics Network has been greatly weakend by government rulings that they: (1) change their name (from formerly the very misleading AVN), (2) cannot raise money as a non-profit, and (3) have to post on their website extremely strong warning that their AV advice is dangerous to the public.
Wakefield's downfall came in the UK and has continued in the US. the Australian Vaccination-Skeptics Network's downfall came in Australia. Meanwhile in the US we have Sears (as an AV pediatrician with a large following) and the NVIC (with it's misleading name an even bigger following) spewing dangerous lies unfettered. Sears has no rebuke from his state medical board and continues as a member in good standing with the American Academy of Pediatrics. The NVIC continues to function as a non-profit in the US, continues to be allowed its very misleading name and continues to be listed as a United Way charity. Very much so did the Disneyland measles outbreak open the eyes of California legislators to the danger of increasingly low vaccination rates in their state--resulting in the passage of SB277. i can't help but suspect, however, that a lot of the increasing vaccine-preventable disease outbreaks in the US could have been prevented had certain medical boards (California's) , national medical academies (the AAP), governmental agencies (Congress) and charities (the United Way) done something very early on about Sears and the NVIC. Metaphorically pulling the teeth from Sears and the NVIC would go a long way towards showing vaccine-hesitant parents that neither Sears nor the NVIC are legitimate in their absurd claims. Instead, we continue to do studies that preach to the choir and literally de-brain primates t o prove a point proven many studies ago.
^ And it's rarely a bad time to invoke Prometheus.
Yep, that one was a classic, although it's dated because it cites autism prevalence as 1 in 150.
Where is PETA when you need them?
Yeah. PETA goes wild over legitimate, ethically and scientifically justifiable animal research, such as some cardiac experiments going on at my own institution, but when it comes to really egregious studies like this one...silence. My guess is that it's crank magnetism in action, with animal rights protesters having a high affinity for antivax views as well.
As much as I loathe the anti-vaccine mindset, I'm just not cruel enough to sic PETA on them. Not to mention PETA wouldn't bother about sound logic behind why the study should not have been done, and their propensity to aggressively target all animal researchers even when the research is justified.
As to this study, I already saw a couple people yesterday dismissing it without having even read it. One simply dismissed "bad science" but didn't say why this study was bad. And then there was Marcella Piper-Terry, who tweeted:
Apparently, 79 monkeys in groups of ~12 is too small, but a case series of 12 kids is just fine. Also, Marcella seems not to have read the study, as the authors did not find anything about tics. They merely mentioned tics in passing with reference to the Thompson and Barile papers.
Then Marcella bravely blocked me.
@ Chris Hickey"
" The NVIC continues to operate as a non-profit in the US"
Unfortunately, all of the major woo-fraught sites I survey- including AoA and TMR- have charity status, even those which are profitable enterprises not merely megaphones for alt med nonsense.
I don't know the law but how did something like AoA manage to get approved as a charity?
This happened recently I believe.
What is the point where we can say that enough is enough?
Do vaccines cause regressive autism?
In my opinion, the non-static characteristics of immunity may never allow a point where we can say "enough is enough".
Has anyone found a macaque monkey with regressive autism? Of course not....
In my opinion, vaccine research on macaque monkeys to determine if they cause autism is just plain monkey business.
In other words, there will never be enough research to convince you that vaccines do not cause autism. Thank you for admitting what I already knew about antivaccinationists.
The claim that this study is statistically underpowered isn't completely absurd. OTOH, it's called the autism spectrum for a reason. Presumably there are cases where the subject has some symptoms of autism, but not severe enough to merit a diagnosis of ASD. (I would not be surprised to find myself in that category.) If there is no evidence that vaccines push subjects in that direction, then there is no compelling reason to perform this or any further animal studies.
Were this a rational world, we would be long past that point. Unfortunately, the vaccines-cause-autism crowd are so invested in that viewpoint that no amount of evidence will persuade them. They will insist on more studies, ethics be damned. Once in a while they'll get a spurious correlation (that's where people like Thompson come in) and seize on that. So we'll have to do more studies, just to demonstrate that the false positive is indeed false. Until we can figure out a way to stop the media from running with opinions-differ-regarding-shape-of-earth stories, we're stuck with the need for rebuttal studies.
Even Dr. Oz now concedes that vaccines don't cause autism...
In other words, there will never be enough research to convince you that vaccines do not cause autism. Thank you for admitting what I already knew about antivaccinationists.
This is the first time you said "Thank you" to me so thank you!
Yes, I am against vaccine research on macaque monkeys because monkeys can't get vaccine induced regressive autism based on DMS-V diagnostic criteria.
In a companion article published last June by some of this paper's authors, Hewitson and her colleagues concluded, "We found no 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 [thimerosal-containing vaccines,] as well as animals in the 2008 group, which received the expanded pediatric vaccine schedule that is very similar to the currently recommended schedule."
They also wrote, "These data are in contrast to our previous pilot study... This discrepancy is most likely due to the larger number of animals in the present study providing more accurate estimates." [Curtis B, Liberato N, Rulien M et al. Examination of the safety of pediatric vaccine schedules in a non-human primate model: assessments of neurodevelopment, learning, and social behavior. Environ Health Perspect. 2015 Jun;123(6):579-89.]
Matt Carey blogged about the remarkable and profoundly dishonest silence maintained by Mark Blaxill, Age of Autism, and SafeMinds (the study was in part funded by SafeMinds!) in comparison to the attention that they lavished on the sketchy preliminary work that these more recent studies emphatically contradict:
I don't see any sign of it at Guidestar or the IRS website. But maybe they incorporated under another name or something.
WRT to the law generally, education is a legitimate exempt activity, as is advocacy, within certain limits.
I know. But it's broadly defined, because First Amendment.
TMR actually appears to be part 501(c)(3) (Team TMR, Inc.) and part taxable entity (TTMR, LLC -- ie, the website).
There are numerous potential issues there -- eg, if the exempt org is paying rent for office space or other facilities that the LLC also uses for for-profit purposes, and so on -- but the (c)(3) doesn't appear to have filed any 990s, so it's impossible to say if any of them are real and problematic.
FWIW, charities cannot be LLCs. Nor can they be part of LLCs. (Technically. For some reason, there was an Abramoff charity that was, IIRC. But that was probably just an oversight.)
I do see that Lisa Goes is president of the charity and head of PR for the LLC, and that Helen Conroy is executive director of the charity and president of the LLC.
But in itself, that just means that the potential exists. It's not really uncommon.
You can never win trying to appease antivaxers with science.I know this blog post is supposed to be just about this macaque study,but there is no way you can write about this study without mentioning a few external points that have been brought up in the past in this blog.Our friend Sullivan over at leftbrainrightbrain has done a number of blog posts about all of the vaxed VS unvaxed studies that disprove Saint Andrew.MJD's comment @ #10 demonstrates that there will never be enough studies to satisfy the antis.Researchers need to stop trying.JB Handley has a lengthy screed/manifesto floating around the internets that was published recently,that has been sent to me by a number of people on Facebook.Basically he says all science that says vaccines do not cause autism is bogus,because all scientists are paid off pharma shills doing the equivalent of "tobacco science".So no science can ever be trusted.Same as it ever was.
What antivaxers may not realize is that they have done their own vaxed VS unvaxed study,better than anyone else could ever do.Most antivax families who have subsequent children,and do not vaccinate these children.Many of these younger siblings are born autistic.I think this might make for a very interesting meta-analysis one day.Of course the antis now have an explanation for this,too.The vaccines a mother gets as a child are so powerful as to cause epigenetic changes that gave their kids autism.Another case of "I don't think you know what that means." in regards to epigenetics,just like with MTHFR.
There is another thing that I say over and over again,that people like MJD,Anne Daschel,and the rest do not seem to grasp,since he brought up regressive autism,which I have.In true regressive autism,regression is rarely a one time thing.It is something that happens over and over again,every time there is a febrile illness,for the rest of the person's life.
Most regressive autism is due to congenital mitochondrial and metabolic diseases,of which I have some of both.Treat the underlying diseases,the regressions stop,immune deficiencies are corrected,and the autism improves dramatically.Antivaxers have called me a liar,but I have lived this,they have not.The science also proves me out,but the antis don't believe the science,and will not read it.So what are you going to do with the hardcore antivaxers other than to say screw 'em,and move on,which is what science needs to do.
Well, of course I've written about many of those points before, which is why I included so many links to old posts of mine. :-)
Keep in mind, too, that there is generally a pretty big lag between when an entity files their 990s and when it shows up on Guidestar.
The funny thing is antivaxxers are the tobacco companies in this story. They use the same false arguments against epidemiological studies and defame the scientists doing the studies exactly like the tobacco companies did.
D'oh! I was going to mention the funding source:
Heheh. The funders of this grant must be very disappointed. One wonders if SafeMinds will write an article attacking it, given that it was one of the funders.
In any case, this study must have taken some serious scratch to do. I'd estimate that this study cost least several hundred thousand dollars, possibly even as much as a million dollars or more when you add in salaries of all the people involved, the care of the monkeys, and the supplies. That's serious cash that could have been used for a study that would have given us new knowledge and wouldn't have required the deaths of 36 primates.
One small positive might be if Laura Hewitson accepted and acknowledged the results and stopped doing these studies.
But, a quick Google search only came up with 3-5 year old writings about her earlier research and a pre-pub posting on this study.
So, not much chance of that.
Orac@21: That's a motley crew of funding sources. Is it normal to see published research supported by families (as opposed to family foundations)? Somehow, I don't think a family would have the means to vet proposed research that a foundation or a government agency would have. SafeMinds, as Orac notes, is a curious inclusion: were they hoping for a different result? Likewise the National Autism Association. Then there are two alphabet soup agencies I don't recognize. I can guess that WaNPRC is a state agency--aren't the taxpayers of Washington proud? (Washington is one of the states with no individual income tax, and it has a robust initiative process, so adequate funding of state government is a perennial issue there.) I have no idea without Googling what CHDD might be.
WaNPRC = Washington National Primate Research Center.
CHDD = Center on Human Development and Disability, which supports the WaNPRC's Infant Primate Research Laboratory.
So the University of Washington also funded this research in part.
At any rate, readers may contribute to AoA via PayPal or by sending money directly to Dan's house.
True, this is very recent, as Todd W. notes.
@ Sullivanthepoop (#20),
Interesting analogy, should the U.S. have a "National Smokers Injury Compensation Program (NSICP) wherein a dollar per cigarette package goes into the NSICP?
If an injured person can prove it came from smoking they can get compensated for their future medical and hardship expenses just like the National Vaccine Injury Compensation program (NVICP).
@MJD: I suppose *if* the person could prove the injury came from someone ELSE smoking, it would be fair. But given that we are well aware of smoking health hazards - AND that there is no medical benefit to anyone from smoking - either for themselves or those whom they expose to second-hand smoke - I wouldn't be willing to support compensation for them.
OTOH, vaccines have known *possible* negative effects, but do have positive personal and population effects. So it is only fair to compensate those persons who are injured in the cause of expanding medical health for themselves and others.
Also - smoking is a voluntary act with no greater medical benefit to the population. Vaccines benefit the person and others. NVIC is fair. NSICP would only be fair if it helps those who did NOT choose to smoke and were injured.
Correction (typing in a hurry...): vaccines have known negative effects that affect a small percent of those vaccinated. Smoking injures a far greater number of smokers. Vaccines do not injure those simply exposed to the vaccinated. Second-hand smoke is a known health hazard.
Some of the anti-vaxxers take the concept one step further... Clamoring for a vax vs. non-vax study utilizing ALL of the pediatric vaccine schedule. Can you imagine the magnitude of confounders???
RobRN@29: I can imagine the magnitude of the convulsive laughter coming from the IRB that is asked to approve such a study. They'll be rolling on the floor.
Somebody needs to remind the advocates of that study about the story of the man who, pointing to the chess board in front of him, asked for one grain of rice on the first square, two on the second square, and thereafter twice as many on the next square as on the previous square. It would take several decades of the entire world rice harvest to satisfy that request. The annual US birth cohort is approximately what would be needed to cover all of the options with N=1 and 22 yes-no choices. I don't know how many vaccines are on the pediatric schedule (I don't have kids), but I wouldn't be surprised if there were that many or more.
What 'non-static' characteristics are you speaking of, MJD? Be specific, and explain why these characterisitics preclude at some point concluding 'enough is enough'.
Funny--I'm against because not only is there is a complete lack of evidence that vaccines induce regressive autism in humnas but there also exists a large body of evidence rebutting the existence of such a casual association.
@23 "Is it normal to see published research supported by families (as opposed to family foundations)?"
The "Johnson family" = The Johnson Center for Child Health & Development. Laura Hewitson is the Scientific Director of the Johnson Center, which, before Andrew Wakefield's fall, was known as Thoughtful House. It's interesting to see press releases like this emerge from that former epicenter of the anti-vaccine movement:
BTW, the "Johnson family" seems to be connected to Johnson & Johnson and to the ownership of the New York Giants. They can apparently afford to support research projects.
And an absurdly high sales tax; the highest in the continental US, I think. It's a terribly regressive tax structure, which is odd, considering Washington's (somewhat well-deserved) socialist reputation. (Back when I was in college, I got a "Washington State Need Grant" which basically matched my Pell Grant. Thanks, WA!) Oregon's tax structure is the reverse, which is much more fair.
So, great: not only robbing from the poor to feed the rich, WA is robbing from the poor to fund stupid studies and kill monkeys.
^ Oh, I guess it's actually got the fifth highest sales tax in the US. It's in a group with Alabama, Tennessee, Louisiana and and Arkansas. It's always been puzzling to me.
It does seem like the crunchy natural types who make up PETA and friends have a higher percentage of AVers than the general population but I always thought that AVers are a minority everywhere but inside their echo chambers. I don't know what kind of percentage of animal researcher activists protest so I could be very wrong but might it just be that this one slipped their notice?
Yeah but this should have also been the reaction of the IRB that approved this study. Like Orac said, the University of Washington IACUC ought to be ashamed.
Sorry, "animal research" not "researcher".
In somewhat related news, the Society for the Promotion of Vaccine-Preventable Disease* (California Chapters) failed dismally to qualify a referendum to overturn California's new, very strict, vaccine mandate law, SB277.
*because they are not anti-vaccine, of course, just pro-safer vaccines or natural immunity or something.
So the anti-vaccine, vaccines-cause-autism gang have just been handing two whopping losses: the study covered in this post, AND the hopes that they could overturn SB277.
I'm waiting for howls of outrage.
They're "Autism Age."
Society for the Promotion of Vaccine-Preventable Disease is actually quite apt. They promote the spread of VPD's. That's great news, thanks for the update.
In a companion article published last June by some of this paper’s authors, Hewitson and her colleagues concluded,
In passing they come out and dismiss Hornig's infamous "autistic mice" claims as an artefact of experimenter incompetence, useful only for showing other researchers what not to do:
I suspect that you underestimate the human capacity for willful ignorance and obliviousness.
re howls of outrage
Liz, one of Adams's minions, Julie Wilson, suspects that the lower-than-expected numbers of petitions submitted were because of ((shudder)) SABOTAGE! ( Natural News). Activists say so.
Right. Those pharma shills who rule under the Bear Flag could not tolerate an uprising by the health freedomists!
It would cause all the citizens to rally against them.
They're probably celebrated at the Bohemian Grove right now.
That might explain how this site redesign got approved.
Denice, the #SB277 petition organizers in Colusa, Glenn, Lake, Mendocino, Sierra, and Yuba counties missed the deadline, and tried to turn in petitions AFTER the deadline.
That's how competent the petition organizers were.
Reportedly, there were other counties in which no effort was made to turn in petitions.
If you want to follow along at home, you can go to this web page daily and check for updated counts.
Scroll down to the paragraph that reads:
The current count is for 9/30/2015.
Liz, they're squawking about counts in San Diego, San Bernadino, Orange and Sacramento.
It's a plot. It's always a plot, isn't it?
Denice: the whole opposition to SB277 + recall + referendum campaigns were a fuster-cluck from the very beginning. In real life, if the folks opposed to SB277 had the slightest grasp of how to do lobbying, the bill would have died in the first committee. They didn't -- or if they did, they could NOT discipline the minions to stick to the talking points.
Furthermore, the infighting and circular-firing-squad antics amongst the various wings for the Society for the Promotion of Vaccine-Preventable Disease has been both entertaining and informative.
Out of curiosity - what happens to the monkeys they didn't kill and autopsy?
Disappointing to know UW is involved, my daughter is finishing her biology degree there just now.
(And yay 8%+ sales tax. Great for us minimum wage folks.)
Mi Dawn @ 28
Don't forget "vaccine shedding".
Liz Ditz @ 38.
That made my day when Dr. Pan posted that on his Facebook page.
@Lisa J Hallett:
No idea, but they won't be getting measles any time soon. Or pertussis, or Hib, or...
Yah, get back to me at 10.25% plus a flat 3.75% income tax.
Hey, at least two-thirds of the Emerald Triangle may have gotten its sh*t together.
^ Or it might be a truly half-assed attempt to assess whether frequent visitors can actually be driven to the other, often wholly moribund, blogs by virtue of impairing the ability to follow comment threads.
Twenty quatloos say that SB LLC is fixing to wind up its affairs.
"Out of curiosity – what happens to the monkeys they didn’t kill and autopsy?"
They're being shipped over to AoA, to improve the quality of the conversation there.
DB owes me a new keyboard.
They're each given a typewriter and set to writing articles critical of vaccination for AoA.
Dang--didn't see DB's post
Dangerous Bacon and JGC:
What did monkeys ever do to you to justify such insults?
And speaking of AoA:
one of Orac's recent visitors. James Lyons-Weiler, is being featured there and is planning his own research institute.
Denice, our dear Dr. Hyphen has already started his own reserch institute, appointed himself CEO and maybe president too and is taking donations. The last time I checked he was up to 20 bucks.
Dr. Hyphen has already started his own reserch institute
Ah, I see he is aboard the OMICS scamwagon.
And hasn't bothered to update his employment I see.
It's quite interesting that he shows up here asking questions and then writes something displayed on AoA.
I wonder what "research institute" means in his dialect?
Notepads, a laptop and a phone?
That plus a nominal fee (depends on state; it's $50 for five years in New Hampshire) to register a trade name. I have had occasion to do this myself, except that I don't call myself a "research institute".
I have encountered a gentleman who lists his affiliation as the modestly named "Institute for Pure and Applied Research", the address of which, at the time, was a condo in Nashua, NH (and also, probably not coincidentally because the man doesn't drive, his home address). He's into alt-physics rather than alt-med, and he has some legitimate publications to his name--but he has also published several articles in Physics Essays, which looks to me like the physics version of Medical Hypotheses.
"What did monkeys ever do to you to justify such insults?"
Nothing personal, it's just that they can't all be writing Shakespeare
From Safeminds: But Sallie Bernard, president of SafeMinds, says she would at least like to see a re-analysis of the newest data. “We feel that embedded within these data sets there are animals that have potentially an adverse reaction to this vaccine schedule that would mirror what happens in human infants,” she says. “The majority who get vaccines are fine, but we believe there is a subset that have an adverse reaction to their vaccines. By looking at the raw data, not data in aggregate, we may be able to identify the subgroup that had that reaction.” http://www.newsweek.com/anti-vaxxers-accidentally-fund-study-showing-th…
says she would at least like to see a re-analysis of the newest data
If the data do not confess to the accusations, it is the researchers' fault for not torturing them sufficiently.
Oh, that story is hilarious. Maybe Brian Hooker is available to reanalyze the data.
Also, antivaccinationists' arguments are inconsistent. If 12 animals per experimental group (and 16 in the control, which they frequently forget to mention) are an insufficient number to rule out a difference then there's no way that you'd be able to do a subgroup analysis and find anything significant.
Oh Orac, please don't say that!
If Hooker gets involved we'll be subject to endless commentary by Jake, Barry and other partisans, an article, a retraction and then,
MAYBE, just maybe,
he'll secretly tape the monkey who decides to become a whistleblower.
One problem here is that macaques don't have special flowers that play soccer and hockey and drive crash tested minvans while texting activist rantings with their starbucks sippy cups. I love starbucks though, maybe their coffee causes autism???
Here is the comment I posted on the Newsweek article. Several folks including Matt and Dorit have chimed in numerous times, but no one has addressed the concerns raised about this study. Thought I might get a better audience here.
Here is the full study:
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 A, 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 C 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.
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.
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. And just so you know, animal research has replicated this finding of larger head and brain size, and can you guess what caused it? Exposure to mercury.
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.
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.
Several folks including Matt and Dorit have chimed in numerous times, but no one has addressed the concerns raised about this study. Thought I might get a better audience here.
Might I also recommend PubPeer as a good forum for expressing concerns about the statistical analysis part of published studies?
I say that without intending any judgement on the suitability of a RI comment thread as a forum.
I am glad that (as David tells us) mercury increases brain size.
This finding validates my practice of having a daily mercury cocktail after work. It has greatly enhanced my intellectual capacity, not to mention my bullshit detection capabilities.
Mercury vapor is a rather different toxicological animal from EtHg and MeHg.
How do you do from this:
Did you not make it to the first paragraph of the results section?
Of course "another general finding of Courchesne’s research" was that the neurodevelopmental changes that eventually produce autism begin by early in the second trimester of fetal development, long before the administration of the postnatal vaccinations that anti-vaxxers have long blamed for autism.
I suspect that while it might not be as hard for a programmer to keep up with the current evidence in medicine and biology as it is for me, someone who trained in medicine and biology, to keep up with developments in programming, it must be, still, rather difficult. (In fact, I really don't know shit about programming, so I wonder how much a programmer might know about the fields unrelated to programming to which I've devoted my adult life and that I do happen to understand.) Nonetheless, you seem to have missed many of the major developments in the field.
For example, an interesting article from a geneticist that I respect recently suggested that HALF of ASD cases are due to mutations that essentially trash the gene's protein product; half of these mutations are de novo (they occur during the development of the sperm or egg) but another half are transmitted from the parent (usually the mother, who is 'protected' from displaying the full spectrum of ASD that will become apparent in her (male) offspring. Of course, given the myriad regulatory elements that affect expression (amount and timing) of genes that may be related to ASD, an analysis that, as this recent work did, focuses on only the worst-case scenarios (mutations that disrupt the gene product) must necessarily miss many of of the effects that have previously been demonstrated to cause abnormal neurodevelopment--or programming,
-16 monkeys were in control group, so 63 were vaccinated, most following the schedule from 20-25 years ago, some did not receive MMR, some received MMR only. Only the last group of 12 monkeys got all the shots from 2008. If the autism rate is 1 in 68, how an they make a study on 12 monkeys only?
-Life expectancy of these monkeys is 30 years, so their 12-18 months is equivalent to human 30-45 months. Until that age, babies receive 25 or more shots, how can they compare them with monkeys who got none until 12-18 months?
-They killed all the monkeys from the control group? Killed unvxed ones to show they have no vaccine injured brain?
-How long did they wit after the shots? Children regress over longer period of time after they get the shots
Unrelated, because I'm not sure where to put this: The Supreme Court denied cert in Phillips v. New York today. That means the 2nd circuit's decision, upholding NY's narrow religious exemption and excluding unvaccinated kids during outbreaks, stands.
It's already received a devastating critique from AoA's resident microbiome expert:
"How absurd and speculative -- HALF of all AUTISM cases? LGD sounds like a lot of BS and another blame the MOTHER?"
So any whiff of 'blaming the mother'* research is rejected out-of-hand which is why teh vaxxeens is so steadfastly clung to.
*I trust we all know (here on Earth) how absurd blaming the mother for genetic aetiology of ASDs is.
@Narad - I saw that.....for whatever reason, AoA believes that any genetic component for autism is automatically going to be spun as "blame the parents / blame the mother."
I wonder if they blame the parents of children with Downs?
Until that age, babies receive 25 or more shots, how can they compare them with monkeys who got none until 12-18 months?
I recommend reading the paper, and following its links to the full information:
-How long did they wit after the shots?
Read the paper
Children regress over longer period of time after they get the shots
"Whatever the answer might be to my previous question, the human case is different."
Well, that was a complete waste of time, money, and monkeys.
Who do you think would win in a battle of the non-wits and outrageous screeching: PETA or SafeMinds?
"Who do you think would win in a battle of the non-wits and outrageous screeching: PETA or SafeMinds?"
Neither. But it might be entertaining nonetheless.
And the spinning and bleating at Safeminds has begun.
@ Rebecca Fisher:
" We explained that we had no preconceived notion of what the outcome of the study should have been but that we were quite perplexed that the recently published findings...."
Sure. Right. Of course.
"we had no preconceived notions, but we are surprised that the results don't match our preconceived notions!!!"
Note this comment. (Five quatloos on Waldman.)
And the spinning and bleating at Safeminds has begun
Outrageous! Conflict of interest! Scientists accepted funding from a source but did not shape their results and conclusions to fit that source's agenda!
Anne Dachel is giving them flying lessons.
ebohlman wins the Internetz.
Elsewhere, a poster by the name of Vaccinepapers (and who uses the Royal We) has turned up.
Hilarity is ensuing.
@ ChrisP, what a dumb shite he's turned out to be. Sadly, he really thought we would be impressed with his mad critical-thinking skillz and be bedazzled by his balance approach to the vaccine literature.
@ ChrisP, what a dumb $hite he's turned out to be. Sadly, he really thought we would be impressed with his mad critical-thinking skillz and be bedazzled by his balance approach to the vaccine literature.
Sorry about the duplicate post.
Ms. Marcella Piper-Terry declared the study "bunk". http://vaxtruth.org/2015/10/macaquebunk/
Personally, I feel monkeys might be worth more than some human specimen? Why don't we just use pedophiles and other dirt to humankind, so they might have a purpose and save lifes, after destroying them instread of creatures that cause us no harm. By the way: if vaccines were all so great, why are people still getting ill in the first place. Personally I sort of get fed up by it. I am a non responder to many vaccines anyhow, so all you do is just making money on harming poor animals and not helping anybody. I am not against proven medical science, but I am against nonsense that makes people belief there is a cure for everything. If people come up with something that does not match your picture, you just break them down as frauds, instead of doing better investigation and inproving medicine.
To David Foster:
Quote: "Notice that in Figures A, 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?"
You might want to study the statistics behind the curves, discussed page 12499, last paragraph. Especially the part were they say that differences vanish after 6 Months. Curves alone without statistics can tell everything and nothing.
Quote: "Even in Figure C all of the “vaccinated” groups have the opposite trend than the placebo group." Yes, in the sense that they display *more* non-social passive behaviour. I.o.W. are less "autistic" than the control group.
Quote: "Neuron loss in cerebellar cortex of rats exposed to mercury vapor: a stereological study."
Mercury vapour is something completely different than Thiomersal. This argument is of the quality of "I stop using Salt on my table because it contains a biological weapon (Chlorine) used in WWI to gas allied troups."
Martine - if you have a problem with monkeys being used, perhaps you should complain to SafeMinds....since they funded the study.
Martine, let me fix a sentence of yours:
"By the way: if seatbelts were all so great, why are people still getting auto crash injuries in the first place."
And really, please, we beg you: direct your complaints about the animal studies to SafeMinds.
I am a non responder to many vaccines anyhow
Martine has no immune system? I am concerned.
Martine: Adult, free-living out-bred humans are not candidates for studies of neural development. Also, there are laws against this.
As stated before, please direct your ire at the use of these monkeys at SafeMinds.
Also, if you don't respond to vaccines it is likely that you would be unable to mount an appropriate immune response against the pathogen in question, in which case it is in your very best interest that everyone around you be vaccinated for your protection.
In other anti-vax news...
Whilst trudging through the muck ( AoA, TMR, Jake, etc), bored with the usual crap by Gamondes, Stagliano et al
I did chance upon something actually
at those fetes du twit ( #cdcwhistleblower, #hearthiswell) :
people we know! smart people! intentionally funny people!
tweeting there! What a concept!
Adult, free-living out-bred humans are not candidates for studies of neural development.
Fortunately we have Icelanders Tasmanians [insert deprecated regional population of choice].
Leave the Bohunks out of this!
Couldn't we legislate for a Compassionate Excemption clause to those laws, allowing science to experiment on PETA and AoA members instead? This would be much more humane: unlike monkeys, they've already proven themselves quite incapable of feeling.
How are monkey personalities valid when studying autism?
I'm not an anti vaxxer, I am grateful to not have Polio or Mumps. But no one I've ever known had a fatal case of HPV or Rotavirus. Or even varicella. The practice of delivering multi vaccines and their toxins to babies all at once is not natural! Viral and bacterial toxins are teratogens. Only vaccines for fatal or epidemic illness should be given.
I think they were more interested in behavior than personalities of the monkeys. And there is a difference.
Just curious, but did you raise the same objection when the original, preliminary results "showing" link were broadcast by anti-vaccine activists?
Which of the vaccine-preventable diseases can't be fatal?
Followed by an anti-vaccine rant.
I have known several young women who died from cervical cancer that occurred as a result of HPV infection. There are about 4,000 deaths from cervical cancer in the US each year. A vaccine would have saved most of those women from this fate.
L_A, you deny you are an anti-vaxxer, but you promptly recite antivaxx talking points (read lies).
Just because you don't personally know of deaths caused by those diseases doesn't mean they're harmless. ChrisP has already shot you down on HPV, so I'll look at the rest.
Rotavirus: from Wikipedia:
Varicella: Again from Wikipedia:
These diseases can, and all too often do, kill.
#112 "is not natural!"
Get off the f'ing computer then!
Stop driving a car, riding a bike, using a bus or train!
Stop cooking food!
Stop drinking tap water!
Stop wearing clothes!
Get out of your house!
Do I need to go on?
As the ever perspicacious Howard Devoto said: "I couldn't act naturally if I wanted to!"
HPV isn't fatal?
Tell that to my mother, who is currently fighting a battle against Cervical Cancer.....(caused by an HPV infection)
You don't know what that last word means, do you?
But no one I’ve ever known had a fatal case of ... Rotavirus
Why, when I think about it, none of my friends shat themselves to death in infancy either! L_A has a point there!
"The practice of delivering multi vaccines and their toxins to babies all at once is not natural! Viral and bacterial toxins"
...are found in "natural" infection and injure or kill millions of children around the world every year (vaccines prevent this from happening to many millions more kids). L_A needs to read up on basic microbiology.
Nobody I knew has died of varicella; several of them have been made utterly miserable by it, and one was told she might lose her hand.
If you would rather risk shingles--a disease with a significant chance of causing chronic neuropathic pain--than be vaccinated against it, you're a fool, but you're an adult fool so you have a right to take that chance.
"My guess is that it’s crank magnetism in action, with animal rights protesters having a high affinity for antivax views as well"
What is your correlation here? An anecdotal claim? Interesting. Do I hear ducks in the background?
Never the less-- stereotype away-- it's your blog.