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Institute of Medicine Chokes On the Epistemological Obscenity

Iom logoBy Dan Olmsted

It isn't worth spending much time and energy to take on the new Institute of Medicine report on vaccine safety concerns-- bought and paid for by the Department of Health and Human Services -- except to note that as the Feds continue trying to bottle up the truth about the autism epidemic, it keeps leaking out everywhere else. The Vaccine Court rulings this week, uncovered by the outstanding reporting of David Kirby and validated over and over by the Unanswered Questions report of EBCALA, are far more important in the long run than the dying yelps of the medical-industrial complex.

In other words, the fact that vaccines are the main driver of the autism epidemic, validated every day by families across the county and now in the world, is far more important than the ginned-up claim by the special interests that they don't cause autism, or autoimmune disorders, or asthma, or ADHD, or juvenile diabetes, and etcetera and etcetera and etcetera.

But one interesting sign of desperation does shine through in this report. My fellow AOA editor and book-coauthor Mark Blaxill has called it the Epistemological Obscenity -- the idea that the total health outcomes of vaccinated versus unvaccinated groups simply cannot be determined. It's like some mad extrapolation of Heisenberg's Uncertainty Principle to the macro-atomic level. You just can't measure it!

The EO is a two-part equation. First, you cannot ethically do a prospective study of vax v unvax. Paul Offit has been whining about this for years and he'll just love the IOM report, which says:

"Although randomized controlled trials are the gold standard for clinical research, such a trial cannot be safely and efficiently performed to compare health outcomes among vaccinated and unvaccinated or differently immunized children, the committee concluded.  Among other reasons, children placed in the study group that does not receive vaccines in a timely fashion would be exposed to greater risk for contracting illnesses.  Many parents who refuse immunization may object to their children being randomly assigned to the group that gets vaccines."

So, it's prospectively unethical. OK, then what about a study of people who are already unvaccinated -- you know, the Amish, homeschoolers, the HomeFirst practice in Chicago? Chiropractors, Christian Scientists, Bushmen, Waldorfers, Spenglerians, Hippie-Dippies (not my term!) in Ashland.

No way. The report says: "Some people have suggested comparing vaccinated children with children in "naturally occurring" populations of unimmunized individuals, such as certain religious communities.  With less than 1 percent of the American population refusing all immunizations, however, it would be very difficult to recruit enough willing unvaccinated participants, the committee concluded.  It can take tens of thousands of study participants to discover uncommon health problems.  Moreover, these populations tend to be much less diverse ethnically, racially, socio-economically, and genetically than the general population, and because such factors can influence health, it would be difficult to determine if differences between the study groups are the result of vaccines or these other factors.  The costs of conducting this kind of study or a randomized controlled trial likely would be prohibitive."

Even people with no noses should smell a rat here. As readers of AOA know, a study funded by Our Side, but rigorously independent, is already under way at Jackson State among homeschoolers. How in God's name did such a study ever get approval if this idea is so impossible? Please, please, oh please, let this be the moment that journalists with an ounce of skepticism say, wait a second.

In our book, The Age of Autism, Mark and I addressed this approach:

"A very simple test goes right to the heart of the vaccine controversy. What is the difference in total health outcomes, including autism, between vaccinated and unvaccinated populations? We would argue that we've uncovered a number of natural experiments in human populations that suggests we should should be seriously concerned over the ever-increasing load of childhood vaccinations, especially in the United States. At the same time, we'd argue that the right approach to what we often call the 'vax/unvax' issue is not a single study but a body of science. Oddly, when it comes to doing such studies in human populations, and studying the autism levels in the Amish, the homeschooled, or philosophical objectors, vaccine industry proponents resist mightily.

"Conducting human vax/unvax studies in existing unvaccinated groups would be so fraught with metholodical problems that they are 'retrospectively impossible.' As for controlled studies, they would be so burdened with permission probelems that they would be 'prospectively unethical.' In short, the resistance to the proposal to do vax/unvax work has not only taken the attitude of 'we already know the answers,' but 'we should not seek to know.' It's pretty hard to make scientific progress in the face of this kind of epistemological nihilism."

Of course, progress is not what these folks are interested in. They are heavily invested in the status quo, in which autism is a mystery, whether it is increasing is a real fun debate to have, and more and more and more and more genes are kinda implicated in one way or the other. Meanwhile, the IOM suggests looking at the CDC's very-own Vaccine Safety Database if anyone has any more annoying questions -- an idea already knocked down by a Congressionally mandated, NIH-appointed panel.

So this is what the last gasps of a dying beast sound like, gagging on the Epistemological Obscenity.

Here is the IOM press release and links:

IOM Report Details Strategy for Monitoring Safety of Childhood Immunization Schedule

WASHINGTON -- A review of the available evidence underscores the safety of the federal childhood immunization schedule, says a new report from the Institute of Medicine.  Should signals indicate the need for investigation of the schedule, however, the report offers a framework for conducting safety research using existing or new data collection systems. 

Roughly 90 percent of American children receive most childhood vaccines advised by the federal immunization schedule by the time they enter kindergarten, noted the committee that wrote the report.  However, some parents choose to spread out their children's immunizations over a different time frame than recommended by the schedule and a small fraction object to having their children immunized at all.  Their concerns arise in part from the number of doses that children receive; the schedule entails 24 immunizations by age 2 given in amounts ranging from one to five injections during a pediatric visit.  Some critics of immunization policies have called for studies comparing health outcomes among vaccinated and unvaccinated children and for research to determine if subgroups exist that are predisposed to experiencing harmful health effects from the vaccines.

Studies have repeatedly shown the health benefits associated with the recommended schedule, including fewer illnesses, deaths, and hospital stays, the report notes.  Every new vaccine is tested for safety and evaluated in the context of the entire schedule before it is added.  And the systems designed to detect possible harmful effects of immunization have worked well at discovering occasional problems with individual vaccines, such as a rare intestinal disorder linked to a now-discontinued rotavirus vaccine.  However, the elements of the schedule -- the number, frequency, timing, order, and age at which vaccines are given -- are not well-defined in existing research and should be improved.

Until newer and bigger data collection systems can be harnessed, the Vaccine Safety Datalink (VSD) is the best available tool for exploring questions about the immunization schedule should the need arise, the committee concluded.  This database contains information on the immunization histories of more than 9 million people covered by nine participating managed care organizations.  Researchers can identify individuals who were vaccinated according to alternative schedules as well as any diagnoses, medical procedures, and outcomes they have experienced.  VSD also contains data on race, age, gender, and other factors that help researchers do better comparisons and account for factors that might affect participants' health.  Already a research team has tapped VSD to explore patterns among children in the Kaiser Permanente Colorado system who are defined as undervaccinated.

However, VSD tracks people from only eight states and looks at a smaller percentage of low-income and minority people than is in the U.S. population as a whole.  Moreover, VSD's usefulness depends on the continuing involvement of participating health plans.  The U.S. Department of Health and Human Services and its partners should maintain their commitment to funding VSD and consider bringing in additional health plan members to enhance the data and make it more representative of the full U.S. population, the report says.

Newer data collection and surveillance systems offer great potential to monitor rare adverse events that may be associated with the childhood immunization schedule, the committee said.  When fully implemented, the Sentinel Initiative program being developed by the U.S. Food and Drug Administration to monitor the safety of approved drugs and other medical products will complement existing passive vaccine surveillance systems, the report says.  FDA's new Post-License Rapid Immunization Safety Monitoring Program is amassing a large amount of health data, offering the potential to analyze vaccine exposures and adverse events with a greater degree of statistical power.

Although randomized controlled trials are the gold standard for clinical research, such a trial cannot be safely and efficiently performed to compare health outcomes among vaccinated and unvaccinated or differently immunized children, the committee concluded.  Among other reasons, children placed in the study group that does not receive vaccines in a timely fashion would be exposed to greater risk for contracting illnesses.  Many parents who refuse immunization may object to their children being randomly assigned to the group that gets vaccines.

Some people have suggested comparing vaccinated children with children in "naturally occurring" populations of unimmunized individuals, such as certain religious communities.  With less than 1 percent of the American population refusing all immunizations, however, it would be very difficult to recruit enough willing unvaccinated participants, the committee concluded.  It can take tens of thousands of study participants to discover uncommon health problems.  Moreover, these populations tend to be much less diverse ethnically, racially, socio-economically, and genetically than the general population, and because such factors can influence health, it would be difficult to determine if differences between the study groups are the result of vaccines or these other factors.  The costs of conducting this kind of study or a randomized controlled trial likely would be prohibitive.

The report was sponsored by the U.S. Department of Health and Human Services.  Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The Institute of Medicine, National Academy of Sciences, National Academy of Engineering, and National Research Council together make up the private, nonprofit National Academies.  For more information, visit http://national-academies.org or http://iom.edu.   

--

Dan Olmsted is Editor of Age of Autism.

 

Comments

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So why don't they study this [VSD] data? Take a whole bunch of people and compare their vaccine histories with their health histories and see how the unvaxed, partially vaxed, and fully vaxed compare?

They HAVE. Simpsonwood was the result.

http://childhealthsafety.wordpress.com/2009/01/13/secret-british-mmr-vaccine-files-forced-open-by-legal-action/#US_CDC_No_Trust

"Although randomized controlled trials are the gold standard for clinical research, such a trial cannot be safely and efficiently performed to compare health outcomes among vaccinated and unvaccinated or differently immunized children, the committee concluded."

We have HAD the next best thing.

"In New Delhi, India, prior to 2000, ASD/PDD (autism spectrum disorder/pervasive developmental disorder) symptoms were rare – typically only occurring in children who were vaccinated abroad. However, after the Indian pediatricians began recommending, in 2000, the addition of triple-dose Thimerosal-preserved Hib (Haemophilis influenza B) and Hep B (hepatitis B) vaccination programs to the existing Thimerosal-preserved triple dose DTP (diphtheria toxin, tetanus toxin and pertussis toxins) vaccination program recommended by the Government of India, the incidence of a childhood ASD/PDD diagnosis increased to 2 % to 4 % of vaccinated New Delhi children.” Doctor Paul King PhD

http://savemylifedrrima.com/thimerosal-preserved-vaccines-are-major-cause-of-current-chronic-condition-%E2%80%98autism%E2%80%99-epidemic/

Folks the epidemiological vaccination evidence coming out of India is TOTALLY damning. Please take a little time to read this extensive paper if you have any doubt about the evils of vaccination. India is being introduced to the needle in a big way to prepare them to accept the MASSIVE vaccinations that will be MANDATED during our World Wide Political Pandemic.

I think the so called ant- vaccine crowd(myself and my wife) have our own studies.

We have two completely vaccinated adults one low functioning autistic aged 15 years with school assessed age of “around 2 years old on a good day”..Both who have medical files from the doctor proving illness that fill a large filling cabinet…..

We also have a boy and a girl totally un-vaccinated with any pharma shit nothing..and they have never been to the doctors and have NO medical files whatsoever apart from a registration of birth….

We are not alone,We were not ant-vaccine but we are now and proud OFFITT…SHAME ON PHARMA

So why is the medical community afraid of doing the vax vs unvax study? Simple. They don't want to be labeled as the real infection promoters because such methodology would require them to INFECT the uninfected and the unvaccinated deliberately. Take shingles for example, in order to establish the risk factor, the subjects MUST be either infected naturally or inoculated intentionally with VZV. Hence it would be genuinely unethical if they were the one caught doing the first harm. The theme "leaving the unvaccinated unprotected" is an appeal to ignoranc

'So why don't they study this data? Take a whole bunch of people and compare their vaccine histories with their health histories and see how the unvaxed, partially vaxed, and fully vaxed compare?'

Twyla, very good question. Does anyone think they haven't already done this? Even with the large database from the Danish study do you think they haven't crunched the numbers to see how at least the partially vaccinated fare? They have their answer. Because you haven't heard noise from them, this indicates its not a good answer.

"the Vaccine Safety Datalink (VSD) is the best available tool for exploring questions about the immunization schedule should the need arise, the committee concluded."
Should the need arise? They don't think there's a need yet?

"This database contains information on the immunization histories of more than 9 million people covered by nine participating managed care organizations. Researchers can identify individuals who were vaccinated according to alternative schedules as well as any diagnoses, medical procedures, and outcomes they have experienced. VSD also contains data on race, age, gender, and other factors that help researchers do better comparisons and account for factors that might affect participants' health."
So why don't they study this data? Take a whole bunch of people and compare their vaccine histories with their health histories and see how the unvaxed, partially vaxed, and fully vaxed compare?

Thanks so much for sharing that study,Rachel.
That is great information for all of us to review.

Here's another angle on the vaxed vs. unvaxed question:

As Jennifer Vanderhorst Larson said in her rebuttal to Brian Deer, "To my knowledge, there is no case of a completely unvaccinated child developing normally and then spontaneously, dramatically regressing into autism."

Why haven't we made more of this powerful fact? Let the vaccine defenders produce such a child if he or she exists - the burden is on them. We can produce plenty of vaccinated children who regressed into autism.

Addendum from http://www.autismresourcefoundation.org/info/info.1860-1979.html to my earlier comment:

April 24, 1930
An Eli Lilly intra-office memo from Retter to Rhodebamel stated:
•"...in view of our experience with the merthiolate solution, we have to know pretty definitely what to expect from merthiolate ointment and jelly before they are put on the market...Can we expect to have the stronger ointment and jelly used without complaint which attended the use of solution in the same strengths?...Our experience with the solution ought to serve as a warning and certainly in the face of that warning we ought not to advocate the use of the stronger products without some pretty definite evidence that we will not repeat our solution experience."

Merthiolate was the name used for Thimerosal way-back-when until the '70s.

There is, of course, always a fundamental strategy which is that they become impossibly fastidious when it doesn't suit them and push through any despicable junk when it does - all of it wrapped in bureaucratic pomposity and weasel protestations of the public good.

wait a minute-let me get this straight-they can track 9 million people who are vaccinated -some fully and some with different schedules and look at the illnesses and outcomes and no doubt they come from different socio-economic groups--so why can't they track 100,000 non-vaccinated individuals, from different socio-economic backgrounds and check for outcomes and illnesses??yep, even people without brains can understand a conspiracy.
maurine

Would the IOM also object on ethical grounds to doing real scientific double blind tests comparing solutions containing just the vehicle water with all the adjuvants plus Thimerosal without the actual vaccine being present (against the placebo destilled water) on animals such as rabbits or mice or rats as Eli Lilly did around 1929? Tests like that would not be as good as actual complete vaccines, but they would show how dangerous Thimerosal is.

Please click the link below and comment on ABC news story about this:

"Childhood Vaccine Schedule Safe, IOM Says" -ABC news

http://abcnews.go.com/Health/childhood-vaccine-schedule-safe-iom/story?id=18228922

With all due respect, you forgot to mention the parasites(not my term) after the hippie dippies.
Maurine

Offit probably wrote the IOM report..can see his grubby,stubby, fingers all over it..SHAME ON HIM...

What a strange report-brief. The IOM determined that the CDC's recommended vaccine schedule was safe because it has always been safe. I thought that vaccines were unavoidably unsafe. I guess they determined if you put a whole bunch of them together vaccines become safer.
The reason they gave for considering looking into vaccine safety to begin with was due the "attitude" of worried parents whom don't trust the government. They were happy to calm the worries of parents that vaccines are obviously safe so that they were not at this time going to pursue studies that they were requested to do by the public.
They ended excited and anxious to add more vaccines to this growing childhood schedule.
I noticed that there is a scheduled meeting at the end of this month to go over the new vaccines that they want to add to the schedule (Phase II, committee only). No wonder why they were in such a hurry to wrap this vaccine safety issue up.

http://www.iom.edu/Reports/2013/The-Childhood-Immunization-Schedule-and-Safety/Report-Brief011613.aspx

Well, ya know, since we already know that vaccines have nothing to do with the COMMON childhood health problems, -Like, for example, we already PROVED that autism is not caused by vaccines, so we gotta look for the uncommon health problems, fer example, maybe vaccines are resulting in a few cases of Huntingtons or Lyme's disease or Behcets disease- or somethin' like that, so we gotta have tens of thousands of kids to do this kinda research on and maybe their parents would not like to do this or somethin', and we gotta be really careful about secrecy,oops I mean privacy, cuz that is very very important to us at the NIH, when we poke around looking for answers an' stuff cuz it is our job to help the children..... - Joe Orwellian , NIH staffer tells it like it is shortly before moving on to his new position at Merck

"It can take tens of thousands of study participants to discover uncommon health problems. Moreover, these populations tend to be much less diverse ethnically, racially, socio-economically, and genetically than the general population, and because such factors can influence health, it would be difficult to determine if differences between the study groups are the result of vaccines or these other factors."

This recommendations of this "committee" represent the perfect example of what President Obama meant when he formed a committee to restore "integrity" to the scientific community in the United States.

Less than 1% of the 4 to 5 million children born in the United States EVERY year .. who refuse vaccination .. would number in the "tens of thousands" .. which just happens to be the number the committee states would be needed for the study.

If "ethnicity, race, socio-economics, and genetics" are "factors" that can influence health .. how is it possible for public health officials to recommend and approve universal childhood vaccine polices based upon a "one size fits all" .. without any regard for those "health factors"?

Is the race and ethnicity of a newborn infant a factor to be considered by hospital staff BEFORE administering that infant a HEP B shot within hours of birth? If not ... why not?

In any event, this prestigious committee has done wonderful job explaining why they can't do their job .. which amounts to .. "it's just too darn hard".

Jeepers .. why didn't our crack intelligence agencies (CIA?) think of the "just too darn hard" excuse when asked to explain why .. after swearing under oath they KNEW that Saddam had weapons of mass destruction .. and .. to prove it .. they had satellite photos showing exactly where those weapons were being stored .. yet .. gosh darn it .. ten years later .. and those weapons have never been found?

A German study released in September 2011 of about 8000 UNVACCINATED children, newborn to 19 years, show vaccinated children have at least 2 to 5 times more diseases and disorders than unvaccinated children.

http://mnhopkins.blogspot.se/2013/01/vaccinated-kids-have-2-to-5-times-more.html

From the IOM press release: "However, the elements of the schedule -- the number, frequency, timing, order, and age at which vaccines are given -- are not well-defined in existing research and should be improved."

Well, Duh!! Isn't this the crux of what parents have been complaining about??? Aren't these elements the very things that should have been scrutinized by the IOM? IOM says: "A review of available evidence underscores the safety of the federal childhood immunization schedule, ..." in other words, they are to lazy to do the studies themselves. How can the IOM go public saying the the vaccine schedule is safe and then make a completely contradictory statement like the one above? Oh I guess they can do whateve they want they are the IOM.

IOM says, "It can take tens of thousands of study participants to discover uncommon health problems."

But isn't it the common health problems were primarily interested in (autism, ADHD, asthma, allergies, etc.)?

"Many parents who refuse immunization may object to their children being randomly assigned to the group that gets vaccines." Idiotic. Just have a blind study as opposed to double blind study. You'd have todo that anyway to respect many people who have religious objections besides GIVING vaccines does not equal a placebo. DUH!

Dr. Robert Sears describes the kind of vax/unvax study that should be done on pp. 227 of the second edition of the Vaccine Book: "This research could be done if families could volunteer for one group or the other. Given that there are hundreds of thousands of babies born each year in our country whose parents decide to delay or decline vaccines, it shouldn't be hard to find placebo volunteers. The parents would not be blinded, so their observations and opinions on their child's health would not be part of the study. The only people who would need to be blinded are those who test the children for signs of autism."
Why has it not been obvious to everyone that only the doctors examining the children would need to be blinded? OK, get official diagnoses of autism, allergies, asthma, bowel disease and so one, and eventually compare the incidence in the two groups. What's the hangup?

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