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EPA Study: Autism Boom Began in 1988, Environmental Factors Are Assumed

Posted: 04/23/10 01:10 PM ET

If it seems like most of the people you know with autism are 22 or younger, that's because most people diagnosed with autism were born after 1987. A recent US EPA study has found a distinct "changepoint" year - or spike - in autism in California and elsewhere and concludes that it would be "prudent to assume that at least some portion of this increase is real and results from environmental factors."

"In the Danish, California, and worldwide data sets, we found that an increase in autism disorder cumulative incidence began about (the birth cohort years) 1988-1989," wrote the authors Michael E. Mc Donald and John F. Paul, of the EPA's National Health and Environmental Effects Research Laboratory.

"Although the debate about the nature of increasing autism continues," they added, "the potential for this increase to be real and involve exogenous (external) environmental stressors exists."

But it was the distinct timing in the increase of autism - the birth of an epidemic, as many believe - that was most notable, and which "may help in screening for potential candidate environmental stressors."

"The calculated year was determined to be significant," the EPA scientists said. The rate of increase before 1988 "was significantly different" than the rate after that year (the "postchangepoint," in epidemiology parlance). In California, the rate spiked from 5.7-per-10,000 before the changepoint, to 20.8-per 10,000 in its wake, and the worldwide dataset showed a similar jump (from 6.0 to 24.2). In Denmark, the rise was even more dramatic, though total incidence was only a fraction of that in the US: from 0.6 to 6.6.

(A study in Japan from 1988-1996 showed continuously increasing autism rates, but no calculable changepoint year - please see the full report for a discussion on study limitations).

So why would rates more than triple in California kids born before and after 1988? Is it just the result of better diagnostics and better reporting, as many have insisted? Or did something drastic change in these children's environment, beginning in 1988?

The EPA officials doubt it was the former. They noted a recent study suggesting that changing diagnostic criteria may account for only a "2.2-fold higher cumulative incidence of autism, relative to the seven-fold increase" reported in California over 11 years. Likewise, they said, "diagnostic substitution," or switching kids from the mental retardation to autism category, "could not account for increased autism from 1987 to 1994."

As they wrote:

Although artifacts associated with observed increases in various studies cannot be ruled out, from a precautionary standpoint, it seems prudent to assume that at least some portion of this increase in incidence is real and results from environmental factors interacting with susceptible populations. As such exposure is potentially preventable, identification of relevant candidate environmental factors should be a research priority.

Meanwhile, the scientists were surprised to find such similar changepoint years in California, Denmark and the worldwide dataset, although they conceded the data were consistent with similar studies done in Minnesota and Sweden, and a third US nationwide study which found, "the greatest increase in ASD prevalence occurring in cohorts born between 1987 and 1992."

There are many external factors that could be associated with autism, the authors said, so knowing when the explosion in cases began should help narrow down the long list of suspects.

"Future studies should examine for novel or increasing exposures to environmental factors from gestation to at least age three for our calculated 1988-1989 birth cohorts," the authors wrote. "Assuming a dose-response relationship, a candidate factor would have continued to increase in the environment from the late 1980s through at least the mid-1990s."

But what could it (or they) be? According to the EPA:

  • Any candidate must be a substance or substances whose exposure level dramatically increased in developed countries beginning at the 1988 changepoint.
  • The candidate will likely be something whose exposure level was greater in California than in Denmark between 1988 and 1997.
  • The candidate is likely something that was introduced in developing countries later than California, Japan and Denmark. For example, a recent Hong Kong study "is suggestive of a rise in autism, but beginning more recently than our calculated changepoints."
  • The candidate "would need to be disruptive to early human neural development."
  • The candidate would need to have a route of exposure "consistent with bioavailability to fetuses and infants."
  • The candidate would need to have increasing levels of US exposure between 1988 and at least 1995.
  • The potential for exposure to a variety of environmental factors "acting synergistically on susceptible populations also cannot be ruled out."

The authors suggested an initial toxicological screening for potential autism-trigger candidates using the CDC's Agency for Toxic Substances and Disease Registry or similar data sets.

The EPA officials did not offer a list of substances that should be looked at, though they did note that studies on MMR vaccine and the mercury-based vaccine preservative thimerosal, "did not support a relationship with autism," including a 2004 report from the Institute of Medicine.

No studies have been done on other vaccine ingredients and autism risk, however, nor on the entire vaccine schedule.

If no candidate pans out as the culprit, they wrote, "perhaps most of the observed increases are not caused by an environmental factor, but result from study artifacts that produce false increases or from the current levels being correct but not a true increase."

Either way, the current caseload is going to cost a fortune. People with autism in California born between 1988 and 1997 will incur a mean lifetime care cost between $2.7 billion and $4.0 billion, and "these costs likely have continued to grow in recent years."

I am hopeful that this information will finally spark the mad-dash that this country desperately needs to make to identify the environmental factors in autism. We require a Manhattan-Project style operation spearheaded by the Federal government, and we needed it ten years ago. This crisis is too serious to ignore in mild complacency any longer.

Here are just some of the areas where science is looking:

AIR POLLUTION - A few studies have linked increased risk of autism to environmental toxins - such as mercury - in air pollution, including a CDC funded study from the San Francisco Bay Area, a study of Superfund Cleanup sites in Minnesota, and a study of children living in proximity to mercury-emitting coal fired power plants in Texas.

ENDOCRINE DISRUPTORS - These ubiquitous chemicals and other "early life immune insults," or ELIIs, "are important factors in childhood and adult chronic diseases," says one study from Cornell University. "However, prenatal and perinatal environmentally induced immune alterations have yet to be considered in depth in the context of autism and autism spectrum disorders."

PESTICIDES - One study presented at the 2008 International Meeting for Autism Research in London reported that mothers who used pesticide-based shampoos on pets doubled the risk of having an ASD child, compared to mothers who did not. Another study in the agriculturally intensive Central Valley of California reported that autism risk increased "with the poundage of organochlorine pesticides applied, and decreased with distance from field sites."

MERCURY IN FISH - At least one tiny study, from Australia, showed elevated mercury levels in three infants weaned on congee (a rice and fish porridge) and fed fish regularly as toddlers. Their parents had sought medical advice for developmental delay and neurological symptoms, including symptoms of autism spectrum disorder.

RETROVIRUSES - In October, researchers from the University of Nevada, the National Cancer Institute and The Cleveland Clinic announced the startling discovery of antibodies to a little known retrovirus in 95 percent of patients with Chronic Fatigue Syndrome. One of the researchers reported finding the same pathogen in 40 percent of autsim children tested. The work has been disputed by other scientists.

PREMATURE BIRTH AND EARLY BIRTH WEIGHT - Between 1990 and 2000, late preterm births in the US increased by 13 percent, and the rate of low birth-weight babies increased by 24 percent. Toxicologists calculate exposure rates to toxins based on kilograms of body weight.

VACCINES AND UNDERLYING DISORDERS - In January of this year, the Institute of Medicine's Committee to Review Adverse Effects of Vaccines issued its "Working list of adverse events to be considered." Included in the adverse events associated with the DTaP and MMR vaccines were "autism" and "Autism Spectrum Disorders (ASD)/Pervasive Developmental Disorders (PDD)." Interestingly, the IOM Committee said it would consider investigating so-called "Secondary" autism, or "autistic features arising from chronic encephalopathy, mitochondrial disorders and/or other underlying disorders." In other words, vaccines don't cause autism, but they might cause brain disease in certain predisposed kids, and that might lead to autism.

VACCINES AND IMMUNE STRESS - As for "Primary" autism, the IOM has been asked by the Federal Vaccine Injury Compensation Program (VICP, or Vaccine Court) to consider reviewing all the medical literature since the 2004 IOM report that found no link. "In particular, VICP is interested in the Committee's review on more recent theories of 'neuroinflammation' and 'hyperarousal/overexcitation of the immune system via multiple simultaneous antigenic stimulation." In other words, getting too many shots at once might cause an inappropriate neuro-immune response, such as that sometimes reported in autism.

VACCINES AND VIRAL PARTICLES - A brand new study reported finding pig and monkey viral particles in a number of vaccines. In the MMR II and Varivax (Chicken Pox) vaccines, researchers detected human endogenous retrovirus K, or HERV-K. The retrovirus was a "consequence of their manufacture using human cell lines." A 2001 study of genes and autism reports on the development of "frozen blocks of DNA" caused by imperfect gene duplication. "It appears that human endogenous retroviruses (HERV) and
HERV fragments are involved," the authors wrote. "The long version of the C4 gene, for
example, results from the integration of an HERV-K."

Do vaccines and vaccine ingredients belong on the list of candidates? Many people say no, but the IOM and the VICP say yes.

I agree with the experts. And now that we have a "changepoint" of 1988, we should go back and look at vaccine exposures both pre- and post- changepoint. Between 1988 and 1996, the following vaccines were added to the US schedule for children in the first 15 months of life:

  • HiB - Improved Hib conjugate vaccine licensed in December 1987, and single dose added to childhood schedule in 1988.
  • DTaP - Additional dose at younger age added around 1990.
  • HiB - Three additional doses added to schedule in 1991.
  • Hep B - Three doses - Added to childhood schedule in 1992.

  • Chicken Pox - Approved in 1995, added to schedule in 1996

1988 was a very interesting year, and those children have a lot to tell us. Let's listen.

David Kirby is author of Evidence of Harm - Mercury in Vaccines and the Autism Epidemic and, most recently, Animal Factory: The Looming Threat of Industrial Pig, Dairy and Poultry Farms to Humans and the Environment - Both from St.. Martin's Press

 
 
 
If it seems like most of the people you know with autism are 22 or younger, that's because most people diagnosed with autism were born after 1987. A recent US EPA study has found a distinct "changepoi...
If it seems like most of the people you know with autism are 22 or younger, that's because most people diagnosed with autism were born after 1987. A recent US EPA study has found a distinct "changepoi...
 
 
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HUFFPOST SUPER USER
carolh
Water Resources Civil Engineer
09:53 AM on 05/11/2010
What changed dramatically in the 1980's, was the move from giving children aspirin to Tylenol. A study of children given Tylenol after their vaccine and subsequent shots, showed that these kids were SIX TIMES more likely to develop autism.

http://www.foodconsumer.org/newsite/Non-food/Drug/tylenol_linked_to_autism_0805100913.html

Tylenol is known to deplete glutathione, and one of the genes for autism is for making glutathione. Also in these vaccines is free glutamic acid in the hydrolyzed gelatin. Glutamate ALSO depletes glutathione by interfering with cysteine metabolism. Both hydrolyzed gelatin AND Tylenol will make children with this gene deficient in glutathione - which LEADS to mercury poisoning, because their little bodies can't naturally get rid of it from any source. By the way, the kids who got Advil were not at risk. We should take note - ibuprofen happens to be a glutamate BLOCKER.

So... who was right in the end? Everyone. And no one. Mercury is a symptom - not the cause. The genes are the start, but the glutathione killing Tylenol is the trigger. We have to immediately stop giving kids Tylenol with their vaccines and take out free glutamic acid from the vaccines. Testing glutathione levels and taurine levels - which are also affected - will be a great way to separate out the kids who need to permanently avoid Tylenol and watch their diets, like kids with PKU.
05:14 PM on 05/05/2010
wanna know the truth? the real truth? it's in the catalytic converter in automobiles, look at what changes were made to automobile exhaust in the mid 80's and you'll see, I don't care about anything but fixing it
HUFFPOST SUPER USER
mom2luke
10:06 PM on 05/02/2010
What about inducing pregnancies? What's in that IV? Any aluminum or Hg?
Wondering b/c I read that 70 percent of children w/ autism were induced at birth (including my son).
Did that pertossin (?) administration during labor start becoming SOP/ more prevalent in 1988 to avoid long labors??
just a theory.
HUFFPOST SUPER USER
sdtech
12:45 AM on 05/01/2010
“Unused or expired vaccines are considered hazardous if they contain mercury (such as thimerosal) or cresol-based preservatives. These are most commonly found in multidose vials and some pre-filled syringes. Any vial that is not empty and contains vaccine with a mercury or cresol-based preservative must be managed as hazardous waste per North Dakota’s Pharmaceutical Waste Guidance”

See http://www.ndflu.com/Vaccine/Disposal%20of%20MDV.pdf .
11:47 PM on 04/28/2010
It is very unfortunate that some in the liberal community view the scientific community as being in bed with profiteers or the right wing political organizations.

The science is very clear on this issue, and the bulk of the research is completely disconnected from any profit motivated company. The vaccine autism-connection is just not there.

By continuing in this conspiracy theory fallacy, one wastes resources which could be focused on pursuing the real cause of autism disorders and viable treatment options. Instead we have this continuing waste of resources based on conspiracy theories, not based on science.

And it does a terrible injustice to the thousands of dedicated medical researchers and health care professionals to falsely accuse them of either being ignorant or in on the conspiracy.

Ignorance of the actual science and what the scientific evidence tells us is the true tragedy here, not the conspiracy parents imagine.
02:14 AM on 04/29/2010
skeptigirl

Just like cowboys and Indians, eh?
02:26 AM on 04/29/2010
I'm sorry but I don't understand your comment.
HUFFPOST SUPER USER
sdtech
02:11 PM on 04/29/2010
Google Poul Thorsen.

Read "Changing the Course of Autism" by Bryan Jepson.

Read "Evidence of Harm" by David Kirby.

Most "journalists" are too lazy to read and think critically--but you can.
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HUFFPOST SUPER USER
dugmaze
Any man's death diminishes me
09:56 PM on 04/27/2010
Frontline is coming on--vaccine debate.

They should have Sheldon on there. He is the masterdebater!
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HUFFPOST SUPER USER
Sheldon101
sheldon101blog.blogspot.com Wakefield transcripts
06:02 PM on 04/28/2010
Doug, thanks for reminding me of high school and high school humor.
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HUFFPOST SUPER USER
dugmaze
Any man's death diminishes me
10:10 PM on 04/29/2010
Somebody always gets offended when I tell a joke! You just can't please everyone.
11:35 AM on 04/27/2010
From the CDC website:

"During 1989-1991, a major resurgence of measles occurred in the United States. More than 55,000 cases and greater than 120 measles-related deaths were reported....These efforts [to increase vaccination coverage], coupled with ongoing implementation of the two-dose MMR recommendation, reduced reported measles cases from 2,237 in 1992 to 312 in 1993 (9)...."

Additionally, the 1989 vaccination schedule recommends that in counties with more than 5 cases of measles among preschoolers, the first dose of measles vaccine be given at 9 mos and a second dose at 15 mos.

It seems likely that to counter the 1989 measles outbreak, measles vaccinations were given to some 9-month-olds followed by revaccination at 15 mos. The regular 1989 schedule calls for the first measles vaccination in the form of MMR to be given at 15mos. (Since MMR was not recommended for children under one year of age, 9-month-olds were probably given monovalent measles vaccine.)
HUFFPOST SUPER USER
mom2luke
10:13 PM on 05/02/2010
there you have it. it seems to be the combination and "catch up" vax administered to children w/ reoccuring ear infections (thus antibiotics/already over taxed immune systems) who seem the most vunerable to descending into regressive autism. parents trust the dr. who says vaccines are good (administered at "well baby") appts...even if the child has a slight fever (also on CDC website that this is Ok as long as it is below 101 degrees!)
defies common sense. and only after the descent to autism do parents connect the dots.
personally, I have records of the time I had to take off work after my son became sick after every single vaccine.
But i was too ignorant to realize what was happening. Then. Not now.
HUFFPOST SUPER USER
sdtech
11:55 PM on 04/26/2010
The 2010 Environmental Science and Technology paper says “As such exposure is potentially preventable, identification of relevant candidate environmental factors should be a research priority”

See page 2116, http://www.all.org/pdf/McDonaldPaul2010.pdf .

Next, look at the 2009 CDC report. The CDC document authors state that, based on 2006 data from a selected county (or counties) in 11 states, the estimated overall average ASD 2006 Prevalence is “9.0 per 1,000 children, or approximately 1 in 110 children.”

It also says that, based on a rate of 4 million children born in the United States every year, “… approximately 36,500 children from each birth cohort eventually will be diagnosed with an ASD.”


See pages 8 and 23, http://cdc.gov/ncbddd/autism/states/ADDMCommunityReport2009.pdf .

The birth cohort for the year when vaccines contain NO Thimerosal could be this year—if the CDC would do its job and immediately ban thimerosal.

Instead, this country has 65 million each one half milliliter doses, with a total volume of 8,500 gallons of vaccine with 250 times the USEPA concentration of 0.200 parts per million for liquid mercury hazardous waste, sanctioned for injection into children and pregnant women.

See http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=40&PART=261&SECTION=24&TYPE=TEXT .

Scientists agree that mercury kills brain cells.

MESSAGE TO ALL SCIENTISTS, DOCTORS, and ADMINISTRATORS IN THE CDC:

THIS IS A CRISIS. RESEARCH SHOWS MERCURY IS TOXIC TO HUMANS. TAKE MERCURY OUT OF ALL VACCINES NOW!!
HUFFPOST SUPER USER
sdtech
12:03 AM on 04/27/2010
See http://www.cdc.gov/flu/about/qa/vaxsupply.htm#table for CDC projected flu dose data.
HUFFPOST SUPER USER
sdtech
12:23 AM on 04/27/2010
See http://www.cdc.gov/FLU/ABOUT/QA/thimerosal.htm for CDC misinformation about Flu Vaccine Thimerosal safety for children 6 months and older and pregnant women.
HUFFPOST SUPER USER
mom2luke
10:16 PM on 05/02/2010
I like that. For other CDC misinformation, you can see from their website that it is indeed ok to give vax to child w/ "low grade" fever.
Nevermind that you have no idea whether that fever was planning to spike right after vax or whether that is mere coincident, or (dr's/nurse's favorite platitude to parents) "normal" reaction and you should give tylenol (another suspect in causing low glutothinone levels in kids w/ autism).
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HUFFPOST SUPER USER
Doybia
09:56 PM on 04/26/2010
http://www.abc.net.au/news/stories/2010/04/26/2883011.htm?section=justin

250 children who were made ill by the flu vaccine in Australia and reports are still coming in. So now we have a picture of how OBVIOUS vaccine problems have to be before doctors will pay attention. One child here and another child over there can be overlooked and dismissed, but when you have 50 kids turning up in the hospital that is a wake up call that cannot be ignored.

And unfortunately, this event will be waved around as an example of how the authorities are on top of vaccine problems and really pay attention.
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HUFFPOST SUPER USER
Doybia
10:02 PM on 04/27/2010
http://www.abc.net.au/news/stories/2010/04/28/2884576.htm

now another vaccine company is claiming that the manufacturer of the vaccine which caused the problems is too close to the government.

this is turning into a huge mess in Australia.
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HUFFPOST SUPER USER
Doybia
10:04 PM on 04/27/2010
and, specifically to people who say that the government response shows that vaccine problems are dealt with promptly, here is the story of a mom whose child had a reaction a few weeks ago.

quote:Five weeks ago Jodi Hahn's two-year-old son Jonah was rushed by ambulance to the Royal Brisbane Children's Hospital with convulsions and a high fever.

He had been given the children's swine flu vaccination less than 12 hours earlier.

Ms Hahn is now calling for a national register to report cases of adverse reactions to vaccines among children.
.

It was not until five weeks later, after speaking with the ABC, that Ms Hahn was contacted by the hospital to say that they would formally record Jonah's reaction as an adverse reaction to the swine flu vaccine.

Ms Hahn says at the time, she thought her son was dying.

"His whole body started to shake and his head threw back and his eyes rolled back in his head," she said.

Ms Hahn says when they arrived at hospital she told staff her son had just had the swine flu vaccination.

"Basically they said to us that it was a febrile convulsion and that they're reasonably common among children," she said.

"They let us go in the morning without really knowing what had caused it."

Ms Hahn says she found it almost impossible to report her son's case as a possible reaction to the vaccine.
02:58 AM on 04/29/2010
While we don't know what the current problem is in Australia, and it is important to get to the bottom of it, the H1N1 flu vaccine prevented thousands of pediatric deaths.

As far as the current events, look at the immediate response health care workers are taking in the situation. This is what we do. We look for problems, stop vaccines when there are problems and get to the bottom of it as soon as possible.

And yet, instead of recognizing the experience, the education, and the good intentions of the health care community, when we immediately address vaccine problems it is seen as evidence all vaccine are doing more harm than good.

The Big Pharma conspiracy theorists who ignore the entire health care community don't seem to notice that if we react like we do immediately to vaccine problems, we would do the same if the problems the conspiracy theorists believe we are overlooking were really occurring. But they are not.

If you give hundreds of thousands of children vaccines, some of them are going to have something happen that day, or soon after.
If you DON'T give hundreds of thousands of children vaccines, some of them are going to have something happen that day or soon after.

This is the thing these misguided parents don't get.
08:11 PM on 04/26/2010
Sheldon, isn’t the article above by David Kirby entitled “EPA Study: Autism Boom Began in 1988, Environmental Factors Are Assumed”? Let's discuss the issue at hand. This article is not about the GMC proceeding or Andrew Wakefield (at all). I’m sure there will be more articles about AJW and the GMC again. Here, we are trying to have a dialogue about an important question. Was there a “change point” in the prevalence rate of autism in the US in 1988? Could it be attributable to environmental factors? If so, which ones?
04:06 PM on 04/26/2010
Has anyone considered the increased use of ultrasound scans on pregnant women, or amniocentesis, or CVS? Also what about the use of fertility drugs such as clomid?

Increased use of these all about this era.
04:34 PM on 04/26/2010
Good questions as well.
03:20 PM on 04/26/2010
Did the HuffPost change the comments layout?
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HUFFPOST SUPER USER
dugmaze
Any man's death diminishes me
12:45 AM on 04/27/2010
It did for me. A little hard on the eyes.
04:16 AM on 04/27/2010
I though perhaps it was my computer at first!
04:36 AM on 04/26/2010
Answer for Sheldon101

I don't know what anyone will make of all that verbiage below. The GMC did not anyway go down this route in their findings against Drs Wakefield, Walker-Smith and Murch - they pretended that the generic ethical permission to take biopsies accorded Prof Walker-Smith designated 162-95 was the name of a project, which was no more true than their finding that the Lancet was a botched version of protocol 172-96.

As it was the practice of senior consultants in the UK at the time of Wakefield 'Lancet study' to retain biopsy samples for research from children investigated on clinical grounds the possibilty that you could review data and write it up subsequently is quite possible, and this was the kind of study the Lancet paper was: "an early report" based on consecutive referrals. It wasn't a formal study but the children needed investigation and treatment, and reviewing the data was worthwhile.
05:37 AM on 04/26/2010
The arcane considerations that Sheldon brings up insofar as they are intelligible in this context at all have nothing to do with basis on which the GMC came to their decision. We can go round and round in circles - which is presumably what Sheldon wants - but this is completely irrelevant to the case. The GMC says the doctors were in the wrong for one set of reasons and because their findings don't work - are at variance with the historical record - it is is evident that Sheldon has to find others.

Sheldon may be courteous but we can go on with his red-herring defence of the GMC for hundreds of posts and illuminate nothing.
HUFFPOST SUPER USER
sdtech
07:12 AM on 04/26/2010
Regarding the work by Dr. Wakefield et al, the parents sought help for their children and they responded and reported the results as a case study.

Now in contrast, consider the investigative work by Pichichero et al.

Despite a 1999 federal warning about Thimerosal, the Argentine investigators injected vaccines with thimerosal with 50 percent mercury into newborns in order to measure their mercury in blood levels.

Funding for this work included contracts with the US National Institutes of Health under the US Department of Health and Human Services.

USPHS statement:
“Because any potential risk is of concern, the AAP and the USPHS agree that the use of thimerosal-containing vaccines should be reduced or eliminated.”

See http://pediatrics.aappublications.org/cgi/content/full/104/3/570 , 1999.

Pichichero report:
“… all vaccines were administered by the investigators at the time of the enrollment visit.”

See pages 209 and 214 at http://pediatrics.aappublications.org/cgi/reprint/121/2/e208 , 2008.
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HUFFPOST SUPER USER
Sheldon101
sheldon101blog.blogspot.com Wakefield transcripts
06:22 PM on 04/26/2010
I have no idea why John Stone believes that 162-95 was important to the prosecution. I don't believe other Wakefield supporters have made this particular fallacious argument.

162-95 was the key to Wakefield's defense. In January 2010, Wakefield wrote: ":Myths: The Lancet Paper....did not have Ethics Committee (EC) approval False – The research element of the paper that required such an approval, detailed systematic analysis of children’s intestinal biopsies, was covered by the necessary EC approval (footnote 13)
footnote 13 Ethical Practices Committee approval 162/95. Date of approval September 5, 1995. Carroll, M. to Walker-Smith, J" . http://www.rescuepost.com/files/autismfile_us33-wakefield.pdf page 39

The panel specifically rejected the argument:
"The Panel has heard that ethical approval had been sought and granted for other trials and it has been specifically suggested that Project 172-96 was never undertaken and that in fact, the Lancet 12 children’s investigations were clinically indicated and the research parts of those clinically justified investigations were covered by Project 162-95. In the light of all the available evidence, the Panel rejected this proposition."

The rule the panel followed was the intent of the doctors, which is why we have the details of the communications between the doctors and parents in the period up to the admission of the child to the hospital and why http://vaccineswork.blogspot.com/2010/02/game-over-for-wakefield-at-start-of-gmc.html
12:30 AM on 04/26/2010
Very informative, thanks for the infos. :)
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HUFFPOST SUPER USER
Sheldon101
sheldon101blog.blogspot.com Wakefield transcripts
07:32 PM on 04/25/2010
Part 1
------
I've referenced my blog http://vaccineswork.blogspot.com/2010/04/left-out-hewitts-explanation-at-age-of.html for references showing that medical research is identified by intent. But John Stone writes: "No, you have made up a false definition of the rule (insofar as I can understand what you are saying at all), for which you cannot cite any authority..."

Wakefield freely admits the doctors put together a program to investigate the links between vaccination, damage to the gut and autistic type disorder. They are sunk if the rule for identifying research is the intent of the doctor to look beyond the patient before him, to generalize information.

For John Stone, Jacob Crosby, Martin Hewitt, Martin Walker, Dan Olmsted, David Kirby and anyone else who still believes or wants others to believe that medical research isn't identified by the intent of the doctors to generalize the information they are gathering, here are five references spanning three decades and three countries.

ONE
The landmark US 1979 Belmont report section 'Boundaries Between Practice and Research"
"By contrast, the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective." http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm#xethical
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HUFFPOST SUPER USER
Sheldon101
sheldon101blog.blogspot.com Wakefield transcripts
07:44 PM on 04/25/2010
Part 2
-------------
TWO
US Federal Regulations 45 CFR 46.102(d) Unchanged from at least 1991 to the present
(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
(http://www.hhs.gov/ohrp/references/comrulp2.pdf (1991)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102 (Current)

THREE
The Royal College of Physicians of London, August 1996."Guidelines on the practice of ethics committees in medical research involving human subjects"
"6.4. The distinction between medical research and innovative medical practice derives from the intent. In medical practice the sole intention is to benefit the individual patient consulting the clinician, not to gain knowledge of general benefit, though such knowledge may emerge from the clinical experience gained. In medical research the primary intention is to advance knowledge so that patients in general may benefit: the individual patient may or may not benefit directly."" http://briandeer.com/wakefield/research-intent.htm
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HUFFPOST SUPER USER
Sheldon101
sheldon101blog.blogspot.com Wakefield transcripts
07:46 PM on 04/25/2010
PART 3
----------

FOUR
What is the South African Medical Research Council's ethics policy? (2006)
2.1.1 Clinical practice
When an activity is undertaken with the sole intention of benefiting an individual patient, and where there is a reasonable chance of success, that activity may be considered to be part of clinical practice. The progressive modification of methods of investigation and treatment, in the light of a clinician's experience, is a normal feature of clinical practice and should not be considered as research.

2.1.2 Research
Research is a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalisable knowledge. Any such investigation raises ethical issues. The issues themselves may be small, but because studies may involve subordination of at least the immediate interest of the individual participant to the objective of the advancement of knowledge, they must be subject to ethics review.

2.1.3 Clinical practice and research
The distinction between clinical practice and research is often less clear than is suggested above, because both may be practised simultaneously on the same person. Any activity aimed at obtaining knowledge affecting a person in any way, and which is additional to ordinary clinical practice, is to be regarded as research .... A useful rule of thumb is that if this new knowledge is generalised or transferred to others, or presented at a scientific meeting, or submitted for publication or for a higher qualification, it is research.
http://www.sahealthinfo.org/ethics/ethicspolicy.htm