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On Wednesday, Rep. Carolyn Maloney (D-NY) and Rep. Christopher Smith (R-NJ) called on HHS Secretary Kathleen Sibelius to dedicate between 1.6% and 6.6% of the $300 million in federal stimulus funds earmarked for the purchase and distribution of vaccines to fund a major study of health outcomes -- including autism -- among vaccinated and unvaccinated people.
The move comes just one week after the federal government's National Vaccine Advisory Committee also unanimously voted to recommend a feasibility study on conducting the controversial investigation.
Some federal officials have balked at doing a vaccinated-unvaccinated study, citing its high cost -- which Maloney and Smith said would fall in the $5-$20 million range.
"Indeed, this was part of the rationale provided by Dr. Thomas Insel, Director of the National Institute of Mental Health, when he obtained a reversal of a previous vote," backing the study at the Federal Interagency Autism Coordinating Committee, which Dr. Insel chairs, the lawmakers wrote.
But, they noted, "The American Recovery and Reinvestment Act has authorized $300 million in new funding to promote the purchasing and distribution of vaccines. Surely, dedicating resources to fundamental safety research should command as high a priority as increasing our already generous purchasing practices for childhood vaccines."
Another obstacle often cited by opponents, Maloney and Smith said, is that the number of unvaccinated children in the United States is "too small or too different to permit a valid study."
But as they noted, Duane Alexander, Director of the National Institute of Child Health and Human Development (who also supports more vaccine-autism research), has said that the National Children's Study -- with its 100,000 children in the sample -- "may itself contain several thousand unvaccinated children." And, they added, children such as the home schooled and the Amish, "with known reduced vaccination rates" could be recruited to gain higher numbers.
As for "differences" among the unvaccinated, Maloney and Smith wrote that, "refusals are rising among the most affluent, educated and professional parents," many of whom, Maloney noted, live in her Manhattan district. "Indeed, it is the rise of such refusals that lends urgency to the need to investigate the safety of our current childhood vaccine program," the lawmakers said.
Maloney and Smith are cosponsors of the House "Comprehensive Comparative Study of Vaccinated and Unvaccinated Populations Act," which they will reintroduce in the coming weeks. They wrote to Secretary Sibelius seeking her "support in furthering the goals" of the bill.
Just last week, the National Vaccine Advisory Committee recommended asking an expert panel, such at the Institute of Medicine, to weigh in on the strengths, weaknesses, ethical issues and costs of studying and comparing vaccinated, unvaccinated, and "alternatively vaccinated" groups of children for a number of disorders -- including autism.
Prospective clinical trials, where children would be randomized into vaccinated and placebo groups, would be unethical. But NVAC suggested one publicly submitted idea to conduct an "observational study" looking at, "natural variation in vaccination schedules, including some children where vaccination is declined through parental intent."
The recommendation was made to Sibelius's DHHS.
The Obama Administration has now been asked -- on the record -- to weigh in on two key controversies in the ongoing vaccine-autism debate. Also this week, the US Supreme Court asked the Administration for its opinion on whether autism families should be able to file thimerosal lawsuits against drug companies in civil court or not.
These are two big, looming decisions, and the autism world will be watching very intently.
Will the Obama people come down in favor of federal preemption for pharmaceutical products over the legal rights of families? And will they ignore the advice of their own National Vaccine Advisory Committee and try to shut down research to close a wide gap in our knowledge of immunization safety?
We will find out soon enough.
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ON A SIDE NOTE: SEVEN STUDIES TO WATCH
Yesterday, I wrote that US officials had approved or recommended seven new studies somehow related to autism and vaccination, including a major new prospective study by several NIH agencies.
I have listed them here on one page, for readers who might want to share it with medical personnel, family members, elected officials, members of the media and anyone else who tells them that the vaccine-autism debate is over and done with.
Anyone complaining about parents asking for more research should direct their ire at the following US Government agencies and affiliated groups, who concur that many gaps in vaccine-safety research remain:
US Department of Health and Human Services
US Environmental Protection Agency
US Centers for Disease Control and Prevention
National Institutes of Health
National Institute of Environmental Health Sciences
National Institute of Mental Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute of Neurological Disorders and Stroke
National Vaccine Advisory Committee
APPROVED STUDIES:
1) The National CADDRE Study -- This 5-year project of the CDC's Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) Network will "help identify what might put children at risk for autism," the CDC says. Among those risk factors: "specific mercury exposures, including any vaccine use by the mother during pregnancy and the child's vaccine exposures after birth."
2) The National Children's Study - This HHS-EPA joint effort will investigate "the effects of environmental influences on the health and development of more than 100,000 children across the United States," including autism. As part of their work researchers will track medical records, including vaccinations and their impact on neorodevelopment.
3) The Early Autism Risk Longitudinal Investigation (EARLI) - This network of NIH agencies (NIEHS, NICHD, NIMH, NINDS) and affiliated sites will follow 1,200 pregnant women who already have a child with autism, to identify the "earliest possible environmental risk factors and their interplay with genetic susceptibility during the prenatal, neonatal and early postnatal periods." Potential risk factors in the study include vaccines, thimerosal, and heavy metals.
RECOMMENDED STUDIES
On June 2, 2009, the Federal Government's National Vaccine Advisory Committee voted unanimously to recommend a sweeping list of vaccine safety studies, including four related to vaccines and autism. The CDC had previously proposed studying autism as a "clinical outcome" of vaccination, and NVAC concurred. The document can be viewed at:
4) Study the Feasibility of Comparing Vaccinated, Unvaccinated and Alternatively Vaccinated Children - NVAC recommended asking an expert panel, such at the Institute of Medicine, to weigh in on the strengths, weaknesses, ethical issues and costs of studying and comparing vaccinated, unvaccinated, and "alternatively vaccinated" groups of children for a number of disorders - including autism. Prospective clinical trials, where children would be randomized into vaccinated and placebo groups, would be unethical.
But NVAC suggested one publicly submitted idea to conduct an "observational study" looking at, "natural variation in vaccination schedules, including some children where vaccination is declined through parental intent."
5) Study Vaccine-Mitochondria-Autism Links - "Recent developments around mitochondrial dysfunction reinforce the importance of studies of vaccine adverse events in rigorously defined subsets of the ASD spectrum," the NVAC wrote. The rate of mitochondrial dysfunction in autism has been estimated at somewhere between 7%-to-30% of all ASD children. "Mitochondrial dysfunction carries an established risk of brain damage subsequent to infectious disease," the NVAC wrote. "Thus, a small and specific subset of the general population (such as those with mitochondrial dysfunction) may be at elevated risk of reduced neurological functioning, possibly including developing ASD, subsequent to live virus vaccination."
6) Study Vaccines and Regressive Autism - "In the context of vaccination research, the ASD clinical subset of particular interest is regressive autism" the NVAC wrote. Estimates of ASD regression range from about 15 to 50% of all ASD cases, depending on the definition used. "Regressive autism does fit the recommendations of the IOM (immunization) committee for further research in rigorously defined subsets of ASD," the NVAC said. Such studies might entail, "prospective vaccination response profiling in siblings of children with regressive ASD, a subpopulation who are at higher risk."
7) Study Vaccine Injuries and the Risk of Autism - Another autism subpopulation that should be included in vaccine studies is what the NVAC called "the intersection of ASD cases with (clearly defined vaccine outcomes) such as fever, febrile seizure, or hypotonic-hypo-responsive episode (HHE)." Do these adverse effects correlate with ASD? "It would be worthwhile to assess," the NVAC wrote. "On a molecular level, it might be feasible to compare ASD cases with history of adverse events following immunization against cognitively normal controls with a similar history of adverse events, to assess whether there are significant differences in immune response profiles between groups."
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This sounds like what we call a "fishing expedition". There is no hypothesis here. There is no probable cause. Just tens of millions of dollars thrown at a problem to assuage a few misguided concerns about vaccines. People (such as David Kirby) first blamed thimerosal. When this was removed and autism diagnoses only went up, they simply moved the goal posts. Now it could be any of the "many" ingredients in vaccines.
It is a bit like sending someone to the moon just to make absolutely sure that it isn't made of cheese. Nevermind that most credible astronomers can tell its composition from here.
Ironically I feel that vaccines are a victim of their own success. Now that small pox and polio are more or less unheard of, people think autism is the worst that could possibly happen to their child. It used to be children were lucky to make it to their 5th birthday.
Well said Seldon. Regardless if any of these studies will be performed, they will not be good enough if they further support the extensive body of work showing a lack of association with autism and vaccines
You will also be attacked shortly for suggesting vaccines work by the usual suspects.
"When this was removed and autism diagnoses only went up..."
Do you have a link to this evidence?
Are you saying that all kids diagnosed after the reduction of thimerosal from preservative level to trace level vaccines(see next paragraph) were preschool children? How could you know? In the study of the Minnesota Somali autism cluster presented by the MDH with the aid of the CDC, it was pointed out that there is no definitive data for this age goup.
Preservative level infant vaccines did not expire until January 2003. Trace level vaccines took a few year after that to expire - Hep-B vaccines manufactured up until Jan 08 still contain 600 ppb hg and have not expired yet. As for older kids, some meningitis and tetanus for kids 7 and older contain preservative level hg. There are not enough mercury free flu shots available to cover even half of the infants whose parents choose them. In Minnesota, 6,578 kids born BEFORE 2003 were labeled with autism for school services AFTER 2003. The rate for kids recieving autism services in public schools in Minnesota between the ages of 7 and 13 is now around 1 in 66.
I offer the following additional suggestions for those who wish to be proactive while waiting for study results.
I do not know the causes of autism, but suspect it may be a combination of a genetic predisposition in conjunction with one or more environmental toxins including foods.
I encourage all studies on the subject. I am driven to help people now in the prevention and treatment of health issues, and have little patience to wait for peer-reviewed studies that may turn out to be severely flawed.
My approach in the non-existent field of autism prevention: Counsel women who wish to become pregnant to devote 1 to 2 years prior to conception following a natural low-toxin eating plan, and a detoxification program to reduce their burden of heavy metals and organic compounds. It is too early in this nascent study to report results. Details are in my book: "The Wellness Project" I will donate a copy to your local library if you wish to read about the plan. All of my work is self-funded.
My current approach to treatment: Support treatment of children using a variety of detoxification and antifungal protocols that have been continuously refined over the years to minimize harm. There have been remarkable and repeatable results in some children and not others. I attend conferences where hundreds of parents report the results of various protocols, and the ones I mentioned consistently score at the top for efficacy.
Roy Mankovitz, Director
www.Montec
roy, again I must point out that the studies arent there yet to support your claims of these treatments. please provide published peer-reviewed account instead of anecdotes.
your previous posts suggested medicine is useless if one has a nutritionally balanced diet, neither stands as a complete preventative for disease.
You raise excellent points.
I agree the studies are not there yet to formally support my claims for these treatments. Out of frustration with the medical community's progress, I developed a hypothesis some years ago based on correlations I have seen between diet, detox, and illness in adults and kids. As you know, all hypotheses begin as an educated guess. The next steps are to refine it and formally test it, which requires participants, funds, and lots of time to run the tests. Then, reports are published and peer-reviewed.
A few months ago, I decided that in parallel with the formal approach I would take a chance and publish my hypotheses and the unusual research to support it. It is not specific to autism and is based on the "genetics plus toxins" approach that I believe applies to many chronic illnesses. My goal was to get the information out to the public now. My hope is that if just a few people read about it and experiment with some of it (it is a simple self-directed program), and it improved the health of at least one person, it would be worth it. I first tried the program on myself (10 plus years), then family and friends to gain confidence, with good results, all anecdotal. Now, some progressive MDs are beginning to incorporate it into their practice, but no results yet.
I realize most folks want to wait for formal review, but some others are interested in experimenting.
http://www
Lead in ginkgo pills. Arsenic in herbals. Bugs in a baby's colic and teething syrup. Toxic metals and parasites are part of nature, and all of these have been found in "natural" products and dietary supplements in recent years.
yeah, that contamination you're talking about is accidental. We can't stop some of that from happening- and there is a hygiene hypothesis that says we do need a certain amount of exposure to germs/foreign objects to prime our immune system. BUT, with vaccination you have a very purposeful exposure to MANY ingredients, wihich, to be honest with you, have not ever been effectively tested for safety.
Just because vaccination has such a noble intent doesn't mean it can't be harmful to babies; it also doesn't make it exempt from rigorous, objective scrutiny. The stakes (our children) are too high.
Ten years ago the government set out to test herbal and other alternative health remedies to find the ones that work. After spending $2.5 billion, the disappointing answer seems to be that almost none of them do.
Echinacea for colds. Ginkgo biloba for memory. Glucosamine and chondroitin for arthritis. Black cohosh for menopausal hot flashes. Saw palmetto for prostate problems. Shark cartilage for cancer. All proved no better than dummy pills in big studies funded by the National Center for Complementary and Alternative Medicine. The lone exception: ginger capsules may help chemotherapy nausea.
http://www
What has happened to the quality of BigPharma trolls on this blog? I demand to know. I do not know what this is symptomatic of, if anything, but the quality of attacks against anti-vaccine zealots has become pathetic here of late:
NetDude: "there is no thimerosal in the vaccines of children anymore."
Dude, your own government web site, for crying out loud: http://www
kwombles: "the science shows no link between autism and vaccines."
I think you meant to say: "the science shows no link between autism and vaccines in the general population
Now go get some really good stuff and come back with strong arguments. Leave the woo at home.
Welcome to the debate Mr. Taylor!
I think it's cute how you frame anyone that doesn't agree with your opinions/p
I take no issue with further research into the causes of autism or looking once again, to see if there is any relation with vaccinations, I just worry that if it's conducted by anyone associated with NIH or the CDC that unless a connection is found, it'll just be one more study that is poo-poo'd by your community. I'm much more enthusiastic about the EARLI study.
I worry too, that money put into this is money that isn't used to study therapies that can help the children.
Mr. Taylor,
Got your knickers in a knot? No study has shown a link between vaccination and autism. A court ruling is not a study.
Not a sir, either, nor can I imagine why you assumed such, unless you were using BSG's use of sir for all persons in a position of authority. In that case, why thank you for recognizing said position of authority. Otherwise, it just adds to your portrait of a stuffy old, outraged busy-body. Which look do you prefer?
I assure you that the quality of my arguments is just fine, and if you don't like the arguments, provide counter arguments with scientific evidence to back it up rather than going pissy and outraged. It'll look better on you. No woo here and never will be, not from me; I am completely woo-free.A
Wow, did you just bad-mouth what appears to be your side? "anti-vaccine zealots"
So, you trashed everybody in one post and held yourself up to be what -- the barometer of reason and rationality?
Peakdavid,
By definition, the troll here is not us. A troll is “someone who posts controversial, inflammatory, irrelevant or off-topic messages in an online community, such as an online discussion forum or chat room, with the primary intent of provoking other users into an emotional response”
Please stick to the scientific discussion and less of the ad hominen attacks.
There is not thimerosal in the vaccines of young children. The flu shot is optional and available without thimerosal.
Find something new to blame. Just because someone has a point you don’t like, doesn’t make them “big pharma”. Read my posts and you’ll see my opinions on big pharma.
What has happened to the quality of antivax trolls on this blog? I demand to know.
The only thing "frivolous" in this debate is how drug companies laugh off being held accountable for the damage they do. They won't be sued out of existence, but we won't be buying their poison anymore.
I'm all for calling drug companies accountable and greater regulation, but drug discovery and manufacture is an expensive business and for someone to do it, will unfortunately be concerned about profit. we live in a capitalist society where some many things are ok to make profit from, but when it comes to anything remotely health based, its a sin to make some money from it?
vaccines have been one of the greatest worldwide achievements of mankind. the fact that these are not the profit making machine of other things the pharma industry makes says it all.
Dr. Ratner called vaccines the "bargain basement technology of the 20 th century." No, I don't think it should be a sin to make some money from something that people benefit from BUT it sure as heck should be proven safe. And I mean proven in a way that obviously most people find credible. As the Cochrane Collaborative Reviews show there is considerable bias in the pharma studies.
Thank you David for your tireless work. Where would we be without pioneers like you!
studying something legitimate as a cause for autism other than thimerosal?
yeah like aluminum, 2-phenyl bla bla bla and all the other neurotoxic ingredients, never mind the live viruses. But you must mean the really probable causes for autism like paternal and maternal age, refrigerator mothers, what alignment the planets were in and all that kind of thing...
You are a piece of work. Mr. David Kirby has performed tireless investigation and reporting on the studies reported on here. His work is one of the reasons the medical community--unlike you--is moving on. As they move on, BTW, they are still examining the role of thimerosal in autism.
Really--did you not read that? It was The Early Autism Risk Longitudinal Investigation. It is looking at thimerosal, among other things.
Are you paying attention? Are you going to keep saying the same thing no matter what is reported and what is fact??
Do you not understand that unless you do something about your reading skills and willing to engage in these issues seriously that people think you just a knuckle-dragging Fox watcher?
Please stop doing this to yourself. It is painful to watch.
Great reporting, David. Really appreciate it.
And so far, only one petered-out troll was able to read what you wrote--including the dozens of possible risk factors being examined in these complex studies--and was able to utter the fateful words of yesteryear: "We have considerable evidence that thimerosal has little to do with autism."
Right. The study of the overall health effects of the current vaccine schedule is all about thimerosal.
Amazing--after all that these health agencies and doctors described that they were interested in studying, and all we get is "thimerosal and autism" line.
And then comes the head-rolling "courts of law cannot . . . should not be deciding scientific questions.
We need a better class of comment trolls on Friday nights!
Firstly, it was David Kirby who for many years made the claims regarding thimerosal and vaccines. He's gone a bit quiet all of a sudden now that the link has been shown not to exist. The goal posts have been shifted. That is why people bring this point up.
"cigarette smoking and cancer, asbestos and cancer, stuff that doesn't involve medical science at all" Secondly, , it was not lawyers who investigated and proved links between these. Science based medicine through clearly performed epidemiological studies demonstrated a link. without this evidence, law court rulings against to tobacco industries for example was not possible.
thirdly, lets say a study of vaccinated vs un-vaccinated children was performed (as unfeasible as this is), do you think that the results would be accepted if they did not show a link as ALL of the previous studies have done? or do you think we would get people like this picking fault in the study:
http://con
There are studies that show that they (the ones who did not want to find a link) did not prove a statistical significance between low thimerosal uptake or medium thimerosal uptake as causing autism in perfectly healthy high birth weight kids, but I am not aware of any study of U.S children using the recommended vaccine schedule of the 1990's that claims they could not rule out the link to autism in susceptable populations.
Please give us the actual citation from an actual study that shows the link to thimerosal "not to exist".
If I see a study from an independant source, not funded from those who benefit from the administration (AAP) production (PHarma) or promotion (CDC) of vaccines, on a group of children of all birth weights and real life health situations who have recieved the full vaccine schedule versus absolutely no vaccines prenatal or post natal, and considering where they live in regards to a significant mercury source I would be very willing to accept the study.
As we have seen in many studies however, what is in the summary and the conclusion of the study (what most doctors and even the Minnesota Commisioner of Health limit themselves to) is the most important.
Keep this in mind when you roll out the "14 studies" you plan to defend your comment on. I have read them and they do not say what you claim they say.
Would you mind reading a little closer?
Your first comment was about thimerosal. The studies David describes are examining far more than than largely removed ingredient. You ignored them and opted instead of the hoary old thimerosal bit. Admit that and move on.
David's question about who will make decisions on liability was a legal question, not a medical or scientific one. Of course scientists study scientific issues and courts make legal decisions. David was not suggesting that courts make scientific judgments. Courst sift through scientific judgments to make decisions.
You seem to have either poor reading skills or just don't take the time because all you are interested in is not discussing an issue but shouting a point of view.
This issue and the children involved deserve more.
40 vaccines and 48 months later- Aug 2007, our one twin sons dx'd with regressive ASD. Compare that to when my daughter received NINE vaccines by the time she hit 5 years old back in 1990... I kick myself every day... every day.
And now to face our insurance company that would rather put him on Ritalin than to provide him much needed THERAPY is absolutely appalling!
What is wrong with our country? And more importantly, what is wrong with the vamped up vaccine schedule or else on our kids these days?
This year, growing in my garden: A few flowers, weeds, our twins and a bit of Autism:
http://www
See Cameron toe walking there? He did not start out like this.. he regressed into this.
And it breaks my heart every day. I am the parent that had to him down for all those 40 vaccines.
Thank you David for your very hard work. It is appreciated as always.
We were lied to. It's not your fault or any parents fault. We all did what we thought was the proper thing to do at that time. If everything went alright, we wouldn't be second guessing ourselves.
You didn't fail as a parent. Sounds to me like your a good mom who spends plenty of time with her children. And that's the number one quality of a good parent, spending time with their children.
What if your twins were more "normal" or "mainstream"? How much time would you get to spend with them then? When our judgement day comes, we will reflect on all the times we had with our loved ones, not on superficial things we aquired throughout our life.
My wife was well on her career when my son was dx'd. We would have spent our whole lives working, rushing around, eating out instead of in. Just living the American dream. But now she's a homemaker, we homeschool, we eat together, laugh together, fight together, read together, fight together, and life really slowed down for us. My son is a blessing in disguise. He makes us see everything in a whole new light.
I went through every emotion possible when I learned about my son's autism. From shock to fear to anger. But now it's grateful. I'm so grateful. I truly hope you reach this level if you haven't already. Your family will always be in our prayers, Doug.
The vaccines arent to blame.
Doug,
That was very well and compassionately said. And you are absolutely right that no one is to blame for a child's autism, whatever the cause. However, you were not lied to. Nor was she, as the science shows no link between autism and vaccines. Regressive autism happens. And sometimes what looks like regressive autism is in appearance only. It takes time to notice developmental delays, especially if they are not overt and severe. For example, my own children's development appeared to be on track in terms of major developmental milestones, and it is only as they age that the disparity between them and their cohort becomes glaringly obvious. And in the case of my son, the distance between him and his peers developmentally becomes a huge chasm he will never cross.
Continued insistance on conspiracy theories and adherence to sites that promote this model of autism without offering support and assistance towards positive coping skills does the parents and the child far more harm than good.
I forgot to add that we can no longer afford NOT to seriously look at a vaccinated VS unvaccinated study for ADHD, asthma,seizures, learning disabilities, SIDS, aspergers, autism. These outcomes are way too costly to our system (never mind the heartache for the parents).
I don't need a study re: ADHD and learning disabilities - all I have to do is really dig a little into my husband and I's family trees to find the cause. Lots of incredibly bright folks with tons of *quirks* that were able to compensate their way through school despite issues that have now been "medicalized".
well I think the vaccinated
I hope that they do it soon because as time goes on the picture will become muddier as to what is a genetic effect and what is an environmental effect. When I had babies (I'm 49 now) I wasn't inundated with shots (back in the 60's and 70's). But, now the people of the 80's will be having babies and they have been given lots of vaccinations themselves, so maybe they have environmental exposures already that will be harder to tease out from "genetics.
I hope the vaccinated vs unvaccinated study will be done as soon as possilbe and use children who have already been vaccinated as opposed to those chilren who have never been vaccinated(and there are plenty). There is little time to start again with newborns.
Maurine Meleck
"Will the Obama people come down in favor of federal preemption for pharmaceutical products over the legal rights of families?"
Nice use of keywords. Alternative framing:
"Will the Obama people take a stand against frivolous lawsuits which could increase the specter of deadly epidemics by driving companies out of the vaccine-production business?"
We already have considerable evidence that thimerosal has little to do with autism. If we need to spend even more money for even more studies, as long as they are rigorous, so be it. But courts of law cannot and should not be deciding scientific questions.
no we don't have considerable evidence that thimerosal has little to do with autism. I, for one, wouldn't exactly apologize if the thimerosal specifically wasn't the thing that causes autism or seizures or learning disabilities or ADHD etc. Vaccines have ALOT of ingredients in them. I don't think the aluminum in the Gardasil is exactly good for the girls who receive it either. I hate to say it but you wait, if ,and when, they administer that Gardasil garbage to boys and they start dropping, the jig will be up.
there is no thimerosal in the vaccines of children anymore.
david kirby has even moved on from this, since if its not there and the autism rates have not dropped, it therefore shows its not the cause.
the mercury militia need to find a new target
Hopefully these new studies will answer our questions on vaccines and autism. We as a group need to be open to multiple findings of what causes austism.
Such an egregious crime to inject small children with these toxic poisons. To inject anyone period! Families should have the freedom to say no and not be questioned about it!
"Families should have the freedom to say no and not be questioned about it!"
They already do in most states, via vaccine exemptions.
"Such an egregious crime to inject small children with these toxic poisons."
Honestly, is the hyperbole necessary?
Is this study going to track paternal age in the autism families?
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