By Sandy Gottstein
Editor's Note: Sandy Gottstein of Vaccinations News is a pioneer in the struggle to get public health officials to study autism in never-vaccinated children. At our invitation, she describes her long and courageous effort to bring this common-sense idea to life. Sandy, who does not have an affected child, deserves a vote of thanks from the autism community for her perseverance and clarity on this fundamental issue.
A tree fell in a forest, but no one was there to hear it. Did it really happen?
Who doesn't know the story of the proverbial, fallen tree? Who really cares, though? Isn't it just a fun, arguable, almost silly riddle?
I care, and here's why. We're living the teaser in the guise of never-studied, never-vaccinated children. For if never-vaccinated children rarely, if ever, get autism, allergies, asthma, cancer, SIDS, chronic and autoimmune disease, etc. but they are not studied, in essence, there is no one to hear about it.
The "experts" would have us believe that the things we don't know about don't exist. They would have us believe that the alleged absence of evidence is evidence of absence.
Of course, this is nonsense. Ignorance may indeed feel like bliss, but in the real, material world, knowing has nothing to do with being. But will we ever know the truth?
If the "experts" have anything to say about it, heck, no. If people like me have anything to say about it, hell, yes.
The fact that never-vaccinated children have not been studied has long been my focus and concern.
I've been embroiled in the vaccine issue ever since 1982, when my first child was born. By the time my second was 6 months old in early 1987, I was pretty much done with vaccinations. (Although I had serious misgivings, they did each later get a booster tetanus shot.)
No more vaccines, even though neither of my children had any known vaccine damage. No more vaccines, even though the number was almost nothing compared to what children are being injected with today.
What drove that decision? Three main things: a) numerous studies indicating there have been serious problems associated with and likely caused by vaccination; b) the fact that after reading hundreds of studies, not one of them used the only proper comparison group, never-vaccinated children, as controls, and c) the fact that virtually everything we "know" about vaccine safety has been bought and paid for by the vaccine manufacturers.
I also educated myself about the diseases and their seriousness in developed nations like ours, as well as doing everything I knew to improve my children's immune status. That included nursing my sons until they were at least 4 years old.
I first wrote about the "controls" problem in the late 80s during my extended effort to get a philosophical exemption bill passed in Alaska. Surely common sense would prevail, I foolishly thought, given the state of the evidence. But I seriously underestimated the fear factor and over-reliance (in my opinion) on so-called expert opinion.
When it became apparent that nothing was going to happen vis à vis exemptions, and some legislative interest was voiced for it, I decided to take a stab at the information part of informed choice. The main mechanism was to require vaccination records for all deaths of children 7 and under. (Few children older than that were being vaccinated at that time.) Drs. Archie Kalokerinos and Arthur Zahalsky flew to Alaska to help me meet with some of the movers and shakers in the state. Most seemed interested, but in the end it failed because "Public Health" aggressively fought it.
Public Health fought getting information and won. Sounds painfully familiar, eh?
My next formal attempt at getting attention focused on the never-vaccinated issue was in 1993, when I testified to the Institute of Medicine:
"In the 1991 IOM review, the Committee quite fairly pointed out that it had been handicapped by the lack of adequate studies, including the poor design of many. The Committee also properly concluded that the absence of appropriate studies meant that there was insufficient evidence to indicate whether or not there was a causal relationship between many of the adverse reactions being studied and vaccination. Imponderably, however, similarly flawed information was cited as evidence AGAINST causality in their report in a number of instances.
The Committee's conclusions concerning SIDS and DPT vaccine are a case in point. Although they admitted in their review, and I quote, 'Prior to the 1960's, little was known about the epidemiology of sudden infant death syndrome (SIDS)', they concluded, and again I quote, 'Studies showing a temporal relation between these events are consistent with the expected occurrence of SIDS over the age range in which DPT immunization typically occurs'. Without information on the background rate of SIDS in historically, socioeconomically, and otherwise comparable never vaccinated groups, data on the expected frequency of SIDS merely reflects its incidence among vaccinated populations, rather than absent vaccinations, and cannot be considered accurate or meaningful. Given that such background information was not presented by the Committee, conclusions about the absence of a relationship between SIDS and vaccination were not justified.
Nor were any studies cited - in fact, to my knowledge none exist - in which the only proper control group, never vaccinated children, was used. If, as is the case in most studies, 'less recently', but nonetheless vaccinated, children were used as controls, and an adverse event can be either a delayed or long-term consequence of vaccination, one would EXPECT to find no differences between the study groups, even if vaccination HAD caused an adverse event. Conclusions about causality drawn from any study with such serious limitations are not justified.
The fact is, all controls are not equal. More importantly, many groups are improperly designated as controls. The 1991 IOM statement that a nontreatment group, i.e., control, might be one using an established alternate vaccine, is an example of an improper definition of a control. In no way can any form of vaccination, whether 'established' or less recently administered, be considered lack of intervention. The extent to which various established vaccines and times since administration of vaccine are similar to non-vaccination should be studied, not assumed. Only a placebo, which in the case of vaccination studies equals the absence of vaccination, is appropriate.
As to the notion that it is unethical to withhold vaccination due to 'widespread acceptance' of vaccination, I would submit that to the contrary, if anything, it is unethical to administer vaccinations of unknown safety and efficacy. It is unsound to argue we can't withhold vaccines because of 'widespread acceptance', as the 1991 IOM Committee did, when the reason there is such widespread acceptance of vaccinations is that we have been told the vaccines are safe and effective. Their argument is particularly ironic given their finding that serious consequences can result from the two vaccines, and lament about the absence of adequate information. To the contrary, the conclusion that must be drawn from their review is that randomized, long-term, placebo-controlled, prospective clinical trials are urgently needed, in spite of ethical concerns about ADMINISTERING vaccines of unknown safety. Indeed, no reassuring claims about the infrequency of any linked adverse event should be made until and unless the false premises underlying study designs and the many study design flaws, including the lack of reasonable and time appropriate controls, and reporting system inadequacies, are corrected."
We all know where that went.
After taking a long break from the issue in complete discouragement, the autism crisis reared its ugly head. I had always feared that little would happen until there was a lot of obvious, likely vaccine damage. Those fears, it appeared, were being realized – both the widespread damage and resultant growing interest in the topic.
The Internet was also gaining in use and prominence and it occurred to me that we now had a way to compete with the extensive and expensive propaganda of the multinational drug companies. (Judging by the recent JAMA article on the subject, I may have been on to something!) To that end, my news and information website, Vaccination News (now a non-profit) was launched, in the hopes of providing a means for the public to educate itself and become politically motivated to support better information and the right to choose. After getting a welcome nudge from my friend Nicholas Regush, I also began writing my column Scandals, where the absence of proper controls in vaccination research was a frequent topic of discussion. (Another column, "Out of Control", I never really got off the ground; but it obviously dealt with the issue as well.)
I also had a rally and later gave a slightly revised version of that speech, in which the importance of using never-vaccinated subjects as controls featured prominently. (The newspaper didn't even cover the cold April afternoon rally at which there were around 50 attendants, and at which a mother of a government compensated vaccine-damaged child was one of the speakers.)
But while the political clout of angry parents was growing, little was happening on the never-vaccinated research front.
Then what seemed like a miracle occurred. I was in Washington for a conference unrelated to vaccination and was lucky enough to be free on a day Congressman Burton was holding hearings on autism research funding. So I sat myself in the front row, listening with rapt attention to the unhappy truth about the lack of agency interest in meaningfully studying the issue. Congressman Shays had taken over the hearing, when he suddenly announced that for the first time questions would be taken from the audience. Being in the front row, my wildly waving hand was noticed and I was included in the list of five.
Here is what transpired, and my later response to their comments:
Ms. Mintz. Hi. My name is Sandy Mintz. I am from Anchorage, AK. I am lucky enough not to have a child who has been injured by a vaccine.
My question is, is NIH ever planning on doing a study using the only proper control group, that is, never vaccinated children?
Dr. Foote. I am not aware of--but note carefully what I said, that I am not aware of--a proposed study to use a suitably constructed group of never vaccinated children. Now CDC would be more likely perhaps to be aware of such an opportunity.
Dr. Boyle. The study that I mentioned earlier that we are doing in collaboration with Denmark compares children who received the MMR vaccine versus children who did not receive MMR.
Ms. Mintz. But I am saying never vaccinated with any vaccine. That assumes that other vaccines don't cause autism, which is what needs to be studied, not assumed.
Mr. Shays. Let me just say that if you would turn off your mic, I am happy to have you do the followup, if you would respond to it.
Ms. Mintz. I'm sorry.
Mr. Shays. No, you don't need to apologize. And we will go to the next. Do you have any other comment based on that? The point that is being made, any vaccination. Could we just suggest that you take this under advisement?
Ms. Wharton. The difficulty with doing such a study in the United States, of course, is that a very small portion of children have never received any vaccines, and these children probably differ in other ways from vaccinated children. So performing such a study would, in fact, be quite difficult.
The Denmark study was a study that, in fact, could not have been done in the United States, although, of course, these children did potentially receive some other vaccines, but simply hadn't received MMR.
Mr. Shays. I will invite anyone who is here to speak to staff or me afterwards if they want to augment a comment."
While I wasn't able to 'augment my comment' right after the meeting, here's the gist of what I later e-mailed to Beth Clay, the professional committee staff member who was present at the hearing:
1) There are more than enough never vaccinated children in the states which allow philosophical exemptions to conduct a proper study.
2) If children who have not been vaccinated are different in ways that prevent them from getting autism, wouldn't we want to know that?
Well, wouldn't we?"
Nothing I did or said seemed to make a difference, though. Then another miracle occurred in the form of Dan Olmsted. His examination of the Amish and a clinic in Chicago brought attention to the issue like never before, even resulting in Representative Carolyn Maloney introducing a bill to do just such a study.
As we are sadly learning, however, so far that effort has also led to nothing of substance.
And nothing it will remain, unless more and more of us get involved.
It is hard not to feel completely disheartened, especially being so far away from everyone deeply involved in the issue. My health has definitely suffered because of it. Sometimes, many times, I have wanted to forget the whole thing.
But then I think of the precious children already harmed by vaccines, and my fear that nothing will happen until there are more of them. I think of those we may prevent from being harmed in the future. And I think of the families struggling in ways I never will have to.
I think of all this and more. And the only conclusion I can draw is that there is no turning (my) back.
So continue to face it I will. I can't help but hope, though, that when the never-vaccinated tree falls it is heard far and wide.