Natural Solutions Foundation
The Voice of Global Health and Food Freedom(TM)
www.HealthFreedomUSA.org and www.GlobalHealthFreedom.org
September 14, 2010
Permalink: http://drrimatruthreports.com/?p=6652
Action Item to Oppose S. 510 and S. 3767 NOW: http://salsa.democracyinaction.org/o/568/p/dia/action/public/?action_KEY=4613
Set up your tax deductible donation to the Natural Solutions Foundation here: http://drrimatruthreports.com/?page_id=189
I really like the work that the Environmental Working Group does and often applaud them publicly. Until today.
Today, this environmental and social policy group took a giant step backwards and fell off the cliff into the filth below,as far as I am concerned.
I read with distress and disgust that they were supporting the passage of S. 510, the phony “PHUDE” “Safety” Bill and decided that I had to urge them to review and revise their anti-health, anti-freedom, pro totalitarian policy in support of S. 510.
Shortly after I wrote and sent it, I saw that another group, NJPRIG, is also endorsing this awful bill. Having just spell checked this one, I had it ready to go.
Please feel free to use this letter, or the material contained in it, to send letters to persons and organizations endorsing these bills, to modify so that they become letters to the Editor, etc. Use it or we ALL lose it!
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
To EWG on the occasion of their support of S. 510
Dear EWG,
I am disappointed and deeply concerned that your organization has decided to support the draconian, dangerous and destructive fake Food “Safety” Bill, S. 510. The estimated cost of first year implementation will be $825,000,000 (Section 401).
Since factory food, not local, organic and family farm food, is responsible for the atrocious level of food safety in the US food supply, it is the de-industrialization of our food supply which will protect our health and increase food safety, not the reverse. The bill, of course, gives more power to the FDA to abuse, more money to that organization to spend on policies which have shown no success in the past in controlling food-borne illnesses and new resources to damage clean food source operations and their ability to remain in business legally.
The bill also brings into force the complete HARMonization of the US with Codex Alimentarius, an international body led by the US demands for corporitization and industrialization of the global food supply to the degradation of that food supply through irradiation, chemical contamination and unproven, unsafe GMOs.
Specifically, the bill as written, in effect, incorporates the “HARMonization” provisions of the discredited “Dietary Supplement Safety Act” S.3002 and actually calls upon the FDA to recommend harmonization of American nutritional freedoms with Codex Alimentarius’ restrictions.
– Section 404: “Nothing in this Act… shall be construed in a manner inconsistent with… any …treaty or international agreement to which the United States is a party.”
– Section 306(c)(5): “Recommendations on whether and how to harmonize requirements under the Codex Alimentarius.”
While I concur that the amendment re: BPA is a good idea, the bill to which it is attached will not increase food safety, but rather will cataclysmically diminish food safety by industrializing the entire US food supply.
Small, local and organic farmers, whose food is not the source of food-born illnesses, will be forced out of business if they cannot meet the expensive, ineffective and unnecessary standards of reporting, seed sorting facilities and other equipment requirements and so forth which Agribiz is capable of meeting.
For example, the ancient, and vital practice of seed saving to improve stock will only be possible under this bad bill if there is a facility devoted to each species of plant, say, one for tomato, one for broccoli, one for eggplant, on the farmer’s property: each such facility will cost between $1M and $1.5M. Clearly, this is a purposeful maneuver to make the act of seed saving a crime for the small farmer.
The bill as written threatens small farm, home, local/organic and community food production with onerous rules that, while perhaps appropriate for industrialized food production, will create impossible “barriers against entry” that will rapidly destroy such local and natural production. No protective language is included in the Senate bill that satisfies these concerns.
Heretofore, food and drug regulations in the United States have been public documents of record and, as such, available to the public. S. 510 changes that and in Section 106 provides in part for the regulations issued to be kept secret from the public, “In the interest of national security, the Secretary … may determine the time and manner in which the guidance documents issued under paragraph (1) are made public…”
As the Medical Director of the Natural Solutions Foundation, www.HealthFreedomUSA.org and www.GlobalHealthFreedom.org, the world’s largest health freedom organization, and as a personal supporter of your previous work and positions, I must urge you to carefully reconsider the position your organization has taken on this dangerous, unnecessary, expensive and destructive bill.
Rather than support it, the Natural Solutions Foundation has urged Health Freedom Advocates and Activists to correspond with their Senators and other decision makers to oppose this legislation, making sure that it is NOT passed by Unanimous Congressional Consent or by any other means. Our Action Item is here: Stop S.510! http://salsa.democracyinaction.org/o/568/p/dia/action/public/?action_KEY=4613
To date, our supporters have sent 358,700 emails urging the defeat of S. 510.
We invite you to revise your organizational policy and urge your supporters to join ours in doing the same.
Please feel free to contact me for additional information or dialogue on this vitally important and timely issue.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
Natural Solutions Foundation Emergency eAlert – 09.12.10 [1:00 PM EDT]
Hacked Again! Multiple Web Sites Hacked To Keep You From Defeating S. 510!
Permalink: http://drrimatruthreports.com/?p=6628
ACT NOW, Forward Widely!
Major Hack Attack Just When We Need Your Action the Most! Coincidence? NOT!
These Action Items are So Important That We, AND Oracle Broadcasting, Just Got Knocked Off the Internet To Keep You From Taking Action!
Defeat S. 510 to prevent the total industrialization of Food: http://salsa.democracyinaction.org/o/568/p/dia/action/public/?action_KEY=4613
Donate to Help Health Freedom Stay Online (Clearly, We Need Higher Security Servers!): http://drrimatruthreports.com/?page_id=189
If you were listening to our Dr. Rima Reports broadcast, www.Oraclebroadcasting.com, or www.HealthFreedomPortal.org, this morning, you know:
1. Natural Solutions Foundation’s main websites, www.HealthFreedomUSA.org, and www.GlobalHealthFreedom.org, were nowhere to be found
2. www.HealthFreedomPortal.org, our live chat and show access page for the show, was not available since it, too, was hacked
3. Our massively important Action Item against S. 510 was unavailable so you were blocked from taking action to prevent the total destruction and industrialization of the US food supply and the triumph of Codex Alimentarius in America. Your emails have successfully stopped passage of this bill, which has been called “Monsanto’s wet dream bill”, since last November. The globalist controllers, apparently, are growing impatient.
4. Because of this hacking episode you could not make a tax deductible donation through our “donate” tab as you usually can do.
5. The internet radio station, www.OracleBroadcasting.com, which we broadcast through lost its sound capacity during our show so listeners to the Dr. Rima Reports suddenly found that the only way they could listen to the show was through the call in line, 512-904-8014! Most of them, obviously, simply lost the show.
Health and Food Freedom websites are under attack and were taken off the internet about 11 AM this morning, near the start of the Dr. Rima Reports Internet Radio Program. As in past hack attacks, this occurs at a critical moment as we seek to overcome the false letter sent late Friday aftteroon from the heads of FDA and HHS to the members of the US Senate, trying to stampede them into passing the fake “food safety” bill, S.510.
During the show, Ralph Fucetola, JD, Counsel and Trustee, set up an emergency link on the so-far-unhacked site, www.drrima.net, so that you can, in fact, take action. In less than 1 hour, more than 500 people did so, generating 2500 emails to Congress and other decision makers. That is not good enough.
The emergency page linked below is posted on the Dr Rima Network to allow access to urgent action items and updates in this battle.
Please also check here for updates:
http://www.drrima.net/emergency-links.php
MUST ACT NOW TO STOP S.510!
This link takes you directly to the Action Item:
http://salsa.democracyinaction.org/o/568/p/dia/action/public/?action_KEY=4613
Take it once for each member of your family and then send it to everyone you can reach electronically. They all eat. They all can come down with the chronic diseases of under nutrition. It is their issue, too. Ask each of them to take the action once for each member of their family and then send it out to their contacts, asking those contacts to repeat those steps, etc.
Next, go to this site to find your US Senators’ phone numbers:
http://www.contactingthecongress.org/
Please, after sending your email above, get the phone number and CALL
your US Senator’s office, leave a strong message!
You may want to tell them in your message that the language in S.510:
1. Will close down family and organic farms because it requires them to have hugely
expensive machinery that they cannot afford;
2. Will create a monopoly over industrialized food for Big Agrabiz;
3. Will NOT stop tainted food problems because the bad stuff comes from
Big Agribiz where they already have the machinery and mechanisms required but still produce factory farm food;
4. Has language that opens the door for Codex restrictions to be implemented in the US despite the will of the people, current law and current regulation
5. The law contains language that allows bureaucrats to create secret regulations;
6. Will put the Homeland Security in charge of food delivery systems around the country
– politicizing same since any state in disagreement with the Feds will have
problems receiving food;
7. Because S. 510 so strongly favors Big Agrabiz, companies like Monsanto will more easily be able to push its GM agenda; and
8. Will cost at least $825 million in the first year…
We MUST take off the white gloves, take the Action Item and then call their Senators on Monday to rage about this Bill. S. 510 could come up as early as Monday and probably will, sometime this week. We are looking for a couple of Senators who are willing to fight it on the floor so it will be delayed – if delayed to the end of the year, it is dead – but the Globalists are seriously pushing this now… and they want YOU dead!
So you must act now; forward this widely!
Of course, our donation page is down too, but you can donate through PayPal via www.DrRima.net
(donation button on lower right). Please help! We urgently need funds now!
We need to migrate our sites to much more secure servers!
Yours in health and freedom,
The Trustees of the Natural Solutions Foundation
Maj. Gen. Albert N. Stubblebine III (US Army, Ret.)
President
Rima E. Laibow, MD
Medical Director
Ralph Fucetola, JD
Counsel and Trustee
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———————————————
Our question to the FDA and CDC agents who check our web site is: What are the psychiatric and ethical labels that can be applied to a society that allows a 10,000 fold increase in a devastating childhood condition and responds to it with denial, cover-up and persecution? No doubt you believe you will never be held accountable for ignoring your obligations as public servants. In that we trust you are as wrong as you are about the “safety and efficacy” of vaccines!
CoMeD Inc
http://mercury-freedrugs.org/
Review of recent publications that show Thimerosal-preserved vaccines are major cause of current chronic-condition ‘autism’ epidemic – Rev. 1
by Paul G. King, PhD, CoMeD Science Advisor, Science Advisor to the National Coalition of Organized Women (NCOW), and a Science Advisor to StS and other groups
Recent publications by several research groups, and myself, in several areas have all combined to further establish that Thimerosal-preserved vaccines, which have not been banned from use in the USA and are widely used in much of the rest of the world today, are a major causal factor in the US epidemics of chronic childhood medical conditions, especially “autism”, which have incidence rates today of at least 1 in 100.
Examples include:
. Children with a diagnosis of an autism spectrum disorder/pervasive development disorder [ASD/PDD], which has a USA survey incidence of
about “1 in 100”, and . Childhood asthma, where the US incidence reportedly exceeds 1 in 10 children.
However, prior to the mid 1970s, these childhood diseases were either unknown in the USA (e.g., childhood type 2 diabetes) or were rare (i.e., having incidence rates of about 1 in 10,000; e.g., “autism”).
Similarly, but displaced forward by more than a decade in time, 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.
Moreover, that Thimerosal-preserved vaccines are the cause of the New Delhi, India ASD/PDD epidemic is confirmed by the apparent “doubling” in ASD/PDD incidence that occurred in a New Delhi, India nursery school’s population after these Indian pediatricians reduced the recommended completion date for the 9-Thimerosal-preserved vaccine doses (3 DTP, 3 Hep B, and 3 Hib) from 6 months in 2000 to 3.5
months in the mid-2000s.
Hopefully, the abstracts, keywords, and brief notes by this reporter for each of the 9 articles that are important but, for the most part, have been ignored by the major media and many “autism groups” (e.g., Autism Speaks) that apparently have no interest in informing the public of the scientifically sound evidence linking Thimerosal-preserved vaccines to ASD/PDD and other childhood neurodevelopmental, developmental, and behavioral disorders, syndromes, and diseases that were, until 1980, unknown (e.g., childhood type 2 diabetes) or rare (e.g., asthma) but are common today.
However, this reporter would be remiss if he did not again warn the reader that no one, other than the researchers conducting the study (not necessarily the persons writing the articles) and God, knows whether or not a published account, peer-reviewed or sworn
to, or not, is a sound, valid, straightforward recounting of the observations made, the studies performed, and the outcomes reported.
Further, this reporter reminds the reader that independent reviews of many of the recent published peer-reviewed articles bearing on pharmaceutical safety and effectiveness issues have found that the studies reviewed were:
. Ghost written by other than the named authors;
. Perverted by those conducting them;
. Designed not to study what the article claimed to have studied;
. Statistically manipulated to reduce the certainty in the adverse effects below the legal level of concern
. Misleading or false in their design, execution and reporting because the study was never actually conducted but was fabricated by an author;
. Otherwise flawed; and/or
. Some combination of the preceding.
With the preceding caveats in mind, this reporter will now present those published articles that directly or indirectly establish Thimerosal-preserved vaccines are major causal factors for the epidemics of childhood chronic medical conditions (childhood disorders, syndromes and diseases) that beset the American public and the world today.
In general, this reporter will add underlining and/or double underlining to emphasize the important points in each publication.
Further, as with all of this reviewer’s publications, should any reader find significant factual errors in this editorial, then please send the author (at paulgkingphd@gmail.com) your proposed changes along with e-mail attachments that contain copies of the published documents that provide the proofs needed to substantiate your claims.
Then, as has been the case in the past, after verifying the validity of your concerns, the confirmed factual errors will be corrected and an appropriately “revised document” posted as widely as the initial document was.
If you find spelling, grammar or textual errors, please also send them in so that this document can be appropriately revised and reposted as an “updated document”.
Finally, this reviewer has suggested corrections in red bracketed text (e.g., [correction]) in instances where such are required or seem to be important to include.
With the preceding in mind, this reviewer/reporter will begin this review with the paper that was published on-line in June of 2010.
1. Kern JK, Geier DA, Adams JB, Geier MR. A biomarker of
mercury body-burden correlated with diagnostic domain specific
clinical symptoms of autism spectrum disorder Biometals 2010,
published online “09 June 2010”; DOI 10.1007/s10534-010-
9349-6.
[http://www.springerlink.com/content/100146/?Content+Status=Accepted&sort=p_OnlineDate&sortorder=desc&v=condensed&o=10]
“Abstract The study purpose was to compare the quantitative results from
tests for urinary porphyrins, where some of these porphyrins are known
biomarkers of heavy metal toxicity, to the independent assessments from a
recognized quantitative measurement, the Autism Treatment Evaluation
Checklist (ATEC), of specific domains of autistic disorders symptoms
(Speech/Language, Sociability, Sensory/ Cognitive Awareness, and
Health/Physical/Behavior) in a group of children having a clinical diagnosis
of autism spectrum disorder (ASD). After a Childhood Autism Rating Scale
(CARS) evaluation to assess the development of each child in this study and
aid in confirming their classification, and an ATEC was completed by a
parent, a urinary porphyrin profile sample was collected and sent out for
blinded analysis. Urinary porphyrins from twenty-four children, 2–13 years
of age, diagnosed with autism or PDD-NOS were compared to their ATEC
scores as well as their scores in the specific domains (Speech/Language,
Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior)
assessed by ATEC. Their urinary porphyrin samples were evaluated at
Laboratoire Philippe Auguste (which is an ISO-approved clinical
laboratory). The results of the study indicated that the participants’ overall
ATEC scores and their scores on each of the ATEC subscales
(Speech/Language, Sociability, Sensory/Cognitive Awareness, and
Health/Physical/Behavior) were linearly related to urinary porphyrins
associated with mercury toxicity. The results show an association between
the apparent level of mercury toxicity as measured by recognized urinary
porphyrin biomarkers of mercury toxicity and the magnitude of the specific
hallmark features of autism as assessed by ATEC.
Keywords Toxicity, Mercury, CARS, ATEC, ASDs, Asperger’s, Autism”
Simply put, this case study demonstrated that there was a linear correlation
between the levels of the mercury-associated urinary-toxicity indicating porphyrins and
the degree of impairment observed in 24 children with a diagnosis of an ASD. Thus, the
children’s mercury-toxicity burden was shown to correlate with the degree of impairment
observed as measured by the ATEC Test and various ATEC Subscales.
2. Kern JK, Geier DA, Adams JB, Mehta JA, Grannemann BD,
Geier MR. Toxicity Biomarkers in Autism Spectrum Disorder: A
Blinded Study of Urinary Porphyrins. Pediatrics International
2010. Accepted Article: “09 June 2010”; doi: 10.1111/j.1442-
200X.2010. 03196.x.
[http://www3.interscience.wiley.com/journal/123573454/abstract]
“Abstract
Background: Recent studies suggest children diagnosed with an autism
spectrum disorder (ASD) have significantly increased levels of urinary
porphyrins associated with mercury (Hg) toxicity, including penta-
carboxyporphyrin (5cxP), precoproporphyrin (prcP), and coproporphyrin
(cP), compared to typically developing controls. However, these initial
studies were criticized because the controls were not age- and gender-
matched to the children diagnosed with an ASD.
Methods: Urinary porphyrin biomarkers in a group of children (2-13 years of
age) diagnosed with an ASD (n=20) were compared to matched (age, gender,
race, location, and year tested) group of typically developing controls (n=20).
Results: Participants diagnosed with an ASD had significantly increased
levels of 5cxP, prcP, and cP in comparison to controls. No [statistically]
significant differences were found in non-Hg associated urinary porphyrins
(uroporphyrins, hexacarboxyporphyrin, and heptacarboxyporphyrin). There
was a significantly increased odds ratio for an ASD diagnosis relative to
controls among study participants with precoproporphyrin (odds ratio=15.5,
p<0.01) and coproporphyrin (odds ratio=15.5, p<0.01) levels in the second
through fourth quartiles in comparison to the first quartile.
Conclusion: These results suggest that the levels of Hg-toxicity-associated
porphyrins are higher in children with an ASD diagnosis than controls.
Although the pattern seen (increased 5cxP, prcP, and cP) is characteristic of
Hg toxicity, the influence of other factors, such as genetics and other
metals[,] cannot be completely ruled-out.
Key words: toxicity, mercury, Hg, heavy metal, ASD, autism, porphyrins”
[Underlining emphasis added.]
Simply put, this cases-matched-controls study demonstrated that there was a
elevation in the levels of the urinary-mercury-toxicity-indicating porphyrins in children
with a ASD diagnosis as compared to the levels of those urinary-mercury-toxicity-
indicating porphyrins in the matched (age, gender, race, location and year tested) control
children studied. There was no similar elevation for the other urinary porphyrins in either
the case or the control groups. To be fair, the researchers reported:
“Although the pattern seen ... is characteristic of Hg toxicity, the influence
of other factors, such as genetics and other metals[,] cannot be completely
ruled-out”.
3. King PG. Parallels in New Delhi, India: An Epidemic Induced
By Added Doses Of Thimerosal-Preserved Vaccines. Published
on-line 11 July 2010.
[http://dr-king.com/docs/100711_ParallelsinNewDelhiIndia_AnEpidemic_b.pdf]
The importance of this report is that it clearly established that the year 2000
addition of six (6) Thimerosal-preserved vaccine doses (3 each for Hep B and Hib) to the
three doses of Thimerosal-preserved DTP vaccines that New Delhi, India children were
already receiving in their pediatrician-recommended vaccination program increased the
observed incidence of “ASD”-symptomatic children from <1 in about 2200 to 2 to 4%
when the completion date for the Thimerosal-preserved DTP and added Hib and Hep B
vaccinations was “by 6 months of age”.
That the Thimerosal-preserved vaccines are the casual factor is confirmed by a
doubling in the incidence of affected children to about 5 to 8 % after the Indian
pediatrician reduced completion age for the nine Thimerosal-preserved vaccine doses
from 6 months to 3.5 months.
Thus, the principal source of the observed post-vaccination mercury-poisoning
symptoms and post-vaccination clinical diagnosis outcomes in this instance is the
Thimerosal-preserved vaccines is supported by the reality that these New Delhi, India
children and their families are vegetarians – they do not eat fish.
As we shall see, this reality also impacts the other reported study involving
children in India.
4. Priya MDL, Geetha A. Level of Trace Elements (Copper, Zinc,
Magnesium and Selenium) and Toxic Elements (Lead and
Mercury) in the Hair and Nail of Children with Autism. Biol
Trace Elem Res 2010, published online July 2010 (11 pages).
[http://www.unboundmedicine.com/medline/ebm/record/20625937/abstract/Level_of_
Trace_Elements__Copper_Zinc_Magnesium_and_Selenium__and_Toxic_Elements__
Lead_and_Mercury__in_the_Hair_and_Nail_of_Children_with_Autism_]
“Abstract Autism is a multi-factorial pathology observed in children with
altered levels of essential and elevated levels of toxic elements. There are
also studies reporting a decrease in nutritional trace elements in the hair and
nail of autistic children with healthy controls; moreover, bioelements have
been shown to play an important role in the central nervous system.
Therefore, the purpose of the present study was to assess the levels of trace
elements like copper (Cu), zinc (Zn), magnesium (Mg), and selenium (Se)
and toxic elements like mercury (Hg), and lead (Pb) in the hair and nail
samples of autistic children and to evaluate whether the level of these
elements could be correlated with the severity of autism. The subjects of the
study were 45 autistic children with different grades of severity (low (LFA),
medium (MFA), and high (HFA) functioning autism) according to Childhood
Autism Rating Scale, n=15 children in each group and 50 healthy children
(age and sex matched). The boys and girls ratio involved in this study was
4:1, and they were 4-12 years of age. The study observed a valid indication
of Cu body burden in the autistic children. The children with different grades
of autism showed high significance (p<0.001) in the level of copper in their
hair and nail samples when compared to healthy controls. The level of Cu in
the autistic children could be correlated with their degree of severity (more
the Cu burden severe is autism). The study showed a significant elevation
(p<0.001) in the levels of toxic metals Pb and Hg in both hair and nail
samples of autistic children when compared to healthy control group. The
elevation was much pronounced in LFA group subjects when compared
among autistic groups MFA and HFA. The levels of trace elements Mg and
Se were significantly decreased (p<0.001) in autistic children when
compared to control. The trace element Zn showed significant variation in
both hair and nails of LFA group children when compared to control group
and other study groups. The significant elevation in the concentration of Cu,
Pb, and Hg and significant decrease in the concentration of Mg and Se
observed in the hair and nail samples of autistic subjects could be well
correlated with their degrees of severity.
Keywords Autism . Hair . Nail . Trace elements . Degrees of severity”
Simply put, this is a case-matched-control study of the comparative levels of key
“trace” metals, both beneficial (Cu, Mg, Se, and Zn) and toxic (Pb and Hg), in the case
group to those in the matched control group.
In addition, the correlation between the degree of severity (as assessed by CARS
evaluations) in the “autism” group and these metals was assessed.
The samples assessed were nape-of-the-neck hair and fingernail clippings.
The observation of a 4:1 male-to-female ratio in the case group again points to a
causal factor that is related to the child’s sex in a manner that males are several times
more likely to be affected than females – mercury poisoning is one of the few types of
poisoning that exhibits this type of sex ratio
Here it is again important to remember that dietary mercury from fish is not a
contributor to the elevated levels of mercury observed because the children and their
families do not eat fish, fish-meal-fed animals, or fish-derived foods as a general rule.
Thus, given the preceding, Thimerosal (vaccine-mercury) from Thimerosal-
preserved vaccines is the most logical major post-natal source – though there may be
contributions from the child’s mother or mother’s milk when the child is breastfed, in
instances where the mother has “silver-mercury” (amalgam) fillings or, typically in older
children, the placement of amalgam dental fillings in the child.
In general, statistically significant between-group differences were observed for
cases and the matched controls for all of the metals measured when the cases were
classified by CARS as Low-Functioning (LFA) and between the LFA and the High-
functioning (HFA) cases.
In addition, highly statistically significant (p <0.001) correlations were found
between all measures in the case group and their CARS scores.
Based on this reviewer’s assessment of the data, it would seem that, between hair
and nail samples, that the copper (Cu), Magnesium (Mg), Selenium (Se), Zinc (Zn)
essential elements and Lead (Pb) and mercury (Hg) toxic elements and the Cu/Zn ratio
(not reported but discussed) in nail samples should be used as the basis for an
independent measure of severity in assessing neurodevelopmental impairment in children
with an ASD diagnosis independent of the children’s mercury body burden (which should
still be assessed using a valid urine prophyrin profile analysis).
Since there are ISO-17025, CLIA-certified clinical laboratories that have an ICP-
MS system set up to assess the levels of the range of elements accessible to an ICP-MS
system using a single prepared nail sample, it would seem that a follow-up study would
explore all of the available elements in nail samples to assess the correlation of all of the
available metals as a measure of severity in those diagnosed with an ASD as well as a
discriminator between those who are not in the ASD spectrum and those who are.
Since only the Pb levels in the LFA group were statistically significant compared
to the controls in the nail samples, while the Hg levels were statistically significant for
the hair and nail samples in all case groups (LFA, MFA and HFA), these results seem to
point to a probably much higher degree of mercury intoxication in the children with an
ASD diagnosis than lead intoxication.
However, the appropriate urinary porphyrin profile analyses and red-blood-cell
Hg and Pb levels would be needed in the case group using fresh urine, blood, and nail
samples to assess how the levels being excreted match both the body burden (as
measured by the urinary porphyrins) and the circulating levels of Pb and Hg (as measured
by the levels in the patient’s red blood cells).
Further, the most important toxic metal, in the USA, that was left out is arsenic
and a full ICP-MS scan would shed light on this missing piece of the puzzle.
Finally, the researchers’ closing remarks are important to relate here:
“The limitation of the study is that we have measured the levels of only few trace
elements like Cu, Zn, Mg, and Se and toxic elements like Pb and Mg, whereas there are
also other essential trace elements which may be just or even more important for life and
other toxic elements which may be just or even more threatening to life. So the study can
be extended to evaluate the other trace and toxic elements in autistic children with
different grades of severity.”
5. Majewska MD, Urbanowicz E, Rok-Bujko P, Namyslowska I,
Mierzejewski P. Age-dependent lower or higher levels of hair
mercury in autistic children than in healthy controls. Acta
Neurobiol Exp 2010, 70(2): 196–208. [http://www.ane.pl/pdf/7024.pdf]
“An association between autism and early life exposure to mercury is a hotly
debated issue. In this study, 91 autistic Polish children, male and female, 3-4
and 7-9 years old, were compared to 75 age- and sex-matched healthy
children with respect to: demographic, perinatal, clinical and developmental
measures, parental age, birth order, morphometric measures, vaccination
history, and hair mercury content. In demographic and perinatal measures[,]
there were no consistent differences between the autistic and control groups.
Autistic children had a significantly greater prevalence of adverse reactions
after vaccinations and abnormal development than controls. Between 45%
and 80% of autistic children experienced developmental regress[ion].
Autistic children significantly differed from healthy peers in the
concentrations of mercury in hair: younger autistics had lower levels, while
older – higher levels than their respective controls. The results suggest that
autistic children differ from healthy children in metabolism of mercury,
which seems to change with age”.
Key words: autism, mercury, hair, thimerosal, vaccines, development
Abbreviations: THIM – thimerosal”
Simply put, this is another case-matched-control study where the matching has
been extended to address multiple potentially confounding factors (age- and sex-matched
healthy children with respect to: demographic, perinatal, clinical and developmental
measures, parental age, birth order, morphometric measures, vaccination history, and
hair-Hg content).
In addition, a two-level design (GROUP I; children 3-4 years of age and GROUP
II, children 7-9 years of age) was adopted to ascertain if there were differences between
the age groups.
In general, all of these children (case and control) had the “same” (not statistically
different) vaccination exposures by 2 years of age, except for the females in the 7-9 group
(who, on average, received about four (4) less vaccine doses by 2 years of age than either
the male or the female controls).
The differences seen are strictly linked to diagnostic difference (“ASD excluding
Asperger’s” for the cases and “normal” for the controls) and not to any other factor.
The paper’s Table III and Figure 1 shown below clearly summarize the real
differences between the cases and the controls as follows:
Table III
Comparison of combined groups of autistic and control children
Autistic (M+F)
Groups I + II
Controls (M+F)
Groups I + II
p
Vaccine complications (%)
20.4*
6.5
p=0.009
Abnormal development (%)
40.9*
3.9
p<0.001
Caesarian or pathological birth (%)
32
29
NS
Epilepsy (%)
5.5
1.2
NS
Potential Rh conflict (%)
8
12
NS
Genetic load (%)
12
5
NS
Nonparametric measures: Comparison of nonparametric measures between combined groups of autistic and
control children. Information about epilepsy, potential genetic load and potential Rh conflict is based on
parental interviews. M = males, F = females. Statistically significant differences are denoted by (*).
Fig. 1 Different levels of mercury in hair of autistic and healthy children from age groups
I and II. The histogram shows mean values ± SEM. Statistically significant differences
between autistic and control groups are denoted by (*), (p=0.01). Crossing lines point to
divergent developmental trends of change in hair mercury levels between the autistic and
control groups.
Significantly, there was no statistically significant difference between cases and
controls attributable to: a) “Caesarian or pathological birth”, b) “Epilepsy”, c) “Potential
Rh conflict”, and d) “Genetic load”.
The only parameters that were significantly different were: 1) Vaccine
complications (20% in the overall “autism” case group; and 6.5% in the overall control
group – a 3-fold difference) and 2) Abnormal development (40.9 % in the case group; 3.9
in the control group – a 13.6-fold difference).
In addition, as shown on the article’s “Fig. 1” above, in both age ranges (3-4 and
7-9), the average hair-mercury levels were significantly different between the case and
control sets.
Moreover, the controls had an average hair-mercury level that apparently
decreased as the Polish children matured; while the average hair-mercury level in the
case groups increased as the Polish children matured.
The researchers’ conclusion was:
“Autistic and healthy children differ in prevalence of abnormal development,
frequency of adverse reactions to vaccinations and concentrations of mercury in hair,
which change with development. The data indirectly imply vaccinations and mercurials
as potential factors in autism pathogenesis.”
Further, since:
. Thimerosal-preserved vaccines (DTP, Hib and Hep B) have not been removed
from the early childhood vaccines given by age 2;
. The Polish vaccination schedule has remained similar to the US vaccination
schedule in the late 1990s with respect to Thimerosal-preserved vaccines; and
. Most all of the children in the study were vaccinated similarly,
the factors causing the differences seen must be related to:
1. Differences in the genetic make-up/susceptibilities of the damaged children as
compared to the apparently undamaged controls and,
2. From the differences in the changes in the hair-mercury excretion patterns,
some aspects of the differential toxicity of the mercury that is not initially
excreted by the cases at the same rate as by the “fully” matched controls.
Since the vaccination histories for the cases and the controls are “matched”, it is
not the vaccinations per se or the level of Thimerosal exposure per se that account for the
significant differences seen but rather the significant differences reflect:
. How poorly some Polish children handle vaccination, in general, and/or,
based on the hair mercury data,
. How poorly these children handled sub-acute mercury detoxification of the
mercury in the multiple doses of Thimerosal-(49.55% mercury by weight)-
preserved vaccines that they received by two years of age.
Taken together, the findings indicate that the Thimerosal-preserved vaccines still
being administered in Poland to children from birth to 2 years of age are key factors in
“autism pathogenesis”.
6. Geier DA, Audhya T, Kern JK, Geier MR. Blood mercury levels
in autism spectrum disorder: Is there a threshold level? Acta
Neurobiol Exp 2010, 70(2): 177–186. [http://www.ane.pl/pdf/7022.pdf]
“Mercury (Hg) may significantly impact the pathogenesis of autism spectrum
disorders (ASDs). Lab results generated by Vitamin Diagnostics (CLIA-
approved), from 2003-2007, were examined among subjects diagnosed with
an ASD (n=83) in comparison to neurotypical controls (n=89). Blood Hg
levels were determined by analyzing Hg content in red blood cells (RBC)
using cold vapor analysis, and consistent Hg measurements were observed
between Vitamin Diagnostics and the University of Rochester. Adjusted
(age, gender, and date of collection) mean Hg levels were 1.9-fold
significantly (P<0.0001) increased among subjects diagnosed with an ASD
(21.4 µg/L) in comparison to controls (11.4 µg/L). Further, an adjusted
significant (P<0.0005) threshold effect (>15 µg/L) was observed for Hg
levels on the risk of a subject being diagnosed with an ASD in comparison to
controls (odds ratio=6.4). The weight of scientific evidence supports Hg as a
causal factor in subjects diagnosed with an ASD.
Key words: Asperger, autistic, body-burden, neurodevelopmental, PDD[,
mercury]”
Simply put, this is another case-matched-control study.
Here the matching factors used were age, gender and date of collection and the
study is a retrospective review of lab test results.
The results from this research clearly establish that the average level of mercury
in red blood cells of the case children is significantly elevated above the controls’ average
level.
In addition, based on the results found, a child with a red-blood-cell mercury level
above the lab’s blood-test’s level of 15 micrograms per liter has a significantly higher
statistical risk (odds ratio=6.4; where an odds ratio of “2” or more is considered legally
significant) of being diagnosed with an ASD than a child with a lower level of red-blood-
cell mercury.
Finally, all should carefully consider the researchers’ conclusions concerning their
finding here:
“The present study indicates that subjects diagnosed with an ASD have, on average,
significantly higher levels of Hg in their blood than controls. The neurotoxicity of Hg is
well-established, and it is known that even small amounts of Hg can cause neurological
injury similar to the brain pathology found in subjects diagnosed with an ASD (…). In
addition, recent research indicates subjects diagnosed with an ASD have a decreased
detoxification capacity for Hg (…). The weight of evidence provided by a variety of
different studies offers a compelling argument for the hypothesis that Hg is a causal
factor in the neuropathology reported in subjects diagnosed with an ASD.
It is recommended that further research should be conducted to evaluate the
consistency of the present results with those in other populations of subjects diagnosed
with an ASD. Investigators should also examine the potential correlation between
elevated Hg and other potential markers of adverse effects in subjects with an ASD
diagnosis, and physicians should consider treatment options that may be available for
Hg-intoxication in subjects diagnosed with an ASD.”
Based on the findings reported in the other articles, in this review set, and
previous articles, it is clear that Thimerosal-preserved vaccines have been clearly
established as a major factor in the “autism” epidemic.
Moreover, because Thimerosal-preserved flu shots are still the predominate
vaccines in terms of doses and are still allowed to be administered to pregnant women
and children from 6 moths of age until 18 years of age, Thimerosal-preserved vaccines
will continue to be a major factor in the USA, if not the major factor, in “autism” and
many other of the post-1988 epidemics of childhood chronic diseases, disorders and
syndromes that were unknown or rare in the 1970s.
7. Geier DA, Kern JK, Geier MR. The biological basis of autism
spectrum disorders: Understanding causation and treatment by
clinical geneticists. Acta Neurobiol Exp 2010, 70(2): 209–226.
[http://www.ane.pl/pdf/7025.pdf]
“Autism spectrum disorders (ASDs), also known as pervasive developmental
disorders (PDD), are a behaviorally defined group of neurodevelopmental
disorders that are usually diagnosed in early childhood. ASDs
disproportionately affect male children. Mercury (Hg), a heavy metal, is
widespread and persistent in the environment. Mercury is a ubiquitous source
of danger in fish, drugs, fungicides/herbicides, dental fillings, thermometers,
and many other products. Elevated Hg concentrations may remain in the
brain from several years to decades following exposure. This is important
because investigators have long recognized that Hg is a neurodevelopmental
poison; it can cause problems in neuronal cell migration and division, and
can ultimately cause cell degeneration and death. Case-reports of patients
have described developmental regressions with ASD symptoms following
fetal and/or early childhood Hg exposure, and epidemiological studies have
linked exposure to Hg with an elevated risk of a patient being diagnosed with
an ASD. Immune, sensory, neurological, motor, and behavioral dysfunctions
similar to traits defining or associated with ASDs were reported following
Hg intoxication with similarities extending to neuroanatomy,
neurotransmitters, and biochemistry. The sexual dimorphism of ASDs may
result from synergistic neurotoxicity caused by the interaction of testosterone
and Hg; in contrast, estrogen is protective, mitigating the toxicity of Hg.
Mercury exposure may significantly increase androgen levels, and as a result,
patients diagnosed with an ASD may significantly benefit from anti-
androgen therapy. Finally, the clinical geneticist has a wealth of biomarkers
to valuate and treat patients diagnosed with an ASD.
Key words: autistic, estradiol, ethylmercury, merthiolate, methylmercury,
Thimerosal[, testosterone, androgens]”
Simply put, this article starts by introducing the reader to the history of “autism”
in the USA and closes by noting:
“These epidemic rates for ASD diagnoses in the US have apparently coincided with a
sharp rise in fetal and infant exposures to mercury (Hg) …”
Next, the article reviews the history of mercury exposure and closes with:
“All told, researchers have reported that Hg exposures in early childhood from both
potential environmental and vaccine sources resulted in some infants receiving in
excess of 350 µg Hg during the first 6 months of life. It was estimated that about 50%
of the total Hg doses to which some infants were exposed came from routinely
recommended Thimerosal-containing childhood vaccines. The cumulative exposure
resulted in infants receiving doses of Hg in excess of Hg exposure limits established by
the US EPA, US CDC, US Food and Drug Administration (FDA), and Health Canada
during key developmental periods during the first year of life …”.
This paper then discusses mercury distribution and persistence following
exposure and closes with:
“Some researchers have described that Hg may have the potential to remain in the brain
from several years to decades following exposure (Sugita 1978).”
Next, this paper briefly reviews the biological plausibility of the mercury-
inducing symptoms used to diagnose an ASD (autism spectrum disorder) and closes with
the telling statement:
“Finally, a scientific consensus statement developed by the Collaborative on Health and
the Environment’s Learning Developmental Disabilities Initiative (2008) on
environmental agents associated with neurodevelopmental disorders declared there was
no doubt Hg exposure causes learning and developmental disorders including
conditions such as ASDs”.
Then, the article proceeds to discuss in some detail the independent and
reviewable evidence of a link between Thimerosal (49.55% mercury by weight) exposure
from Thimerosal-preserved vaccines and children having an ASD diagnosis. This
extended discussion of the mercury-ASD link closes with:
“Furthermore, Schweikert and others (2009) undertook an evaluation in the US, on a
state by state basis, of ASD prevalence among 3 to 5 year-old children from 2000 to
2006 and environmental Hg exposure levels from 1996 to 2006. These investigators
observed that Hg concentration in the environment among children 1 year-old or
younger had a significant association with ASD prevalence three years later.”
Turning form direct and indirect human evidence of a mercury-autism link, the
authors next briefly discuss various animal models of “ASD” symptoms or conditions
induced by mercury exposure from injected Thimerosal-preserved “vaccines” or “vaccine
surrogates” (mouse, rat, and hamster).
Next, the authors reviewed the clinical evidence of susceptibility and toxicity that
children with an ASD diagnosis exhibit and closes with:
“…potentially vulnerable sub-populations need to be identified and evaluated
independently because large population epidemiologic studies do not have the
sensitivity to detect minor high-risk subpopulations”
The article then proceeds to discuss the cellular mechanisms by which mercury
exposure induces the symptoms that are used to diagnose an ASD.
From there, the authors turn to an extensive discussion for the several-fold excess
of males to each female who has an ASD diagnosis in terms of not only mercury
exposure but also hormonal system effects and hormonal system disregulation by
mercury compounds. This extensive discussion closes with:
“In putting these pieces together, environmental exposures (particularly Hg exposure) that
adversely effect HST and the transsulfuration pathway can cause a cyclical biochemical
interaction pattern to develop between the transsulfuration and androgen pathways that
directly correlates with the biochemistry observed in those with an ASD diagnosis. As
expected, this interaction pattern and androgen elevations are consistent with the
behavioral/physical traits associated with or defining those who have an ASD diagnosis”
Next, the authors discuss how one should understand the treatment of hormonal
imbalances in children and adults having an ASD (or related behavioral disorder)
diagnosis. This discussion closes with:
“In evaluating the effects of leuprolide acetate administration to patients diagnosed with
an ASD, investigators have described their clinical experience following its
administration to nearly 200 patients with an ASD diagnosis. Leuprolide acetate
administration significantly lowered androgen levels and resulted in very significant
overall clinical improvements in socialization, sensory/cognitive awareness, and
health/physical/behavior skills, with few non-responders and minimal adverse clinical
effects to the therapy. It was also observed that leuprolide acetate administration
resulted in significant clinical ameliorations in hyperactivity/impulsivity, stereotypy,
aggression, self injury, abnormal sexual behaviors, and/or irritability behaviors …”.
Unfortunately, perhaps because of article size limitations, other than briefly
mentioning both cyproterone acetate, and spironolactone, the authors did not review their
use of these drugs in the treatment of hormonal imbalance in those with an ASD or with a related diagnosis.
Finally, in their conclusions, the authors present their conclusions and close with:
“Overall, it is apparent that many patients diagnosed with an ASD have significant
medical conditions that require evaluation and potential treatment. Table 1 summarizes
the specific types of biomarkers that a clinical geneticist may employ to help evaluate
and treatment patients diagnosed with an ASD …. It is clear that as additional research
is done, careful attention will be needed by the clinician to incorporate new testing and
treatment options for the benefit of their patients on the autism spectrum.”
Since the authors’ “Table I” presents a fairly comprehensive overview of the tests
for and some of the prescription drugs that are available to “treat” many of the damaged
biological pathways, that reviewer has provided a transcribed version of the original:
Table 1 [as in the text not “I” as at the top of the actual table]
A summary of clinically available lab testing and clinically available drugs to treat such conditions among biomarkers
associated with ASDs
Autism Biomarker
Clinical Laboratory Testing
[LabCorp Test#]1
Clinical Treatment Options
Porphyrins
Random Fractionated Urinary
Porphyrins [120980]
Detoxification Therapy
(DMSA, DMPS)
Transsulfuration
Homocysteine [706994], Cystathionine
[911032], GSH [853002], Taurine
[910844]
Methylcobalamin (vitamin B12),
Folinic Acid, Pyroxidine (Vitamin
B6)
Oxidative Stress/
Inflammation
Oxidative Stress Panel (Catecholamine,
GSH, Lipid Peroxides, GSH-Px, SOD)
[853047], Neopterin [140335]
ALDACTONE® (Spironolactone)
Hormones
Testicular Function Profile II
(FSH, LH, Testosterone, Free
Testosterone) [035113], DHEA
[004101], DHEA-S [004697],
Androstenedione [004705], Androstane
Diol Glucuronide [140442],
Dihydrotestosterone [500142], Estradiol
[140244], Estrone [004564], Total
Estrogens [004549]
LUPRON® (Leuprolide Acetate),
ANDROCUR® (Cypertyrone
Acetate), ALDACTONE®
(Spironolactone)
Mitochondria
Carnitine [706500], Pyruvic Acid
[004788], Lactic Acid [004770],
Ammonia [007054]
CARNITOR® (L-Carnitine)
Genetic
Blood Chromosomes [052019],
Chromosome Microarray [510002],
DNA Rett Syndrome [511180],
Angelman/Prader Willi Syndrome
Methylation Assay [511210], Fragile X
Syndrome [510065], MTHFR [511238],
APOE [822098]
Genetic Counseling
(Prenatal, Pediatric, Predictive)
(APOE) Apolipoprotein E; (DHEA) Dehydroepiandrosterone; (DHEA-S) Dehydroepiandrosterone-Sulfate; (DMP) 2,3-Dimercapto-1-propanesulfonic acid;
(DMSA) Meso 2,3-dimercaptosuccinic acid; (FSH) Follicle-stimulating hormone; (GSH) Glutathione; (GSHPx) Glutathione Peroxidase; (LH) Luteinizing
hormone; (MTHFR) Methylenetetrahydrofolate reductase; (SOD) Superoxide Dismutase
1 Laboratory testing described is available from the Laboratory Corporation of America (LabCorp), and is covered by most major insurance companies.
8. Hewitson L, Lopresti BJ, Stott C, Mason S, Tomko J. Influence
of pediatric vaccines on amygdala growth and opioid ligand
binding in rhesus macaque infants: A pilot study Acta Neurobiol
Exp 2010, 70(2): 147–164. [http://www.ane.pl/pdf/7020.pdf]
“This longitudinal, case-control pilot study examined amygdala growth in rhesus
macaque infants receiving the complete US childhood vaccine schedule (1994-
1999). Longitudinal structural and functional neuroimaging was undertaken to
examine central effects of the vaccine regimen on the developing brain. Vaccine-
exposed and saline-injected control infants underwent MRI and PET imaging at
approximately 4 and 6 months of age, representing two specific timeframes within
the vaccination schedule. Volumetric analyses showed that exposed animals did not
undergo the maturational changes over time in amygdale volume that was observed
in unexposed animals. After controlling for left amygdala volume, the binding of the
opioid antagonist [11C]diprenorphine (DPN) in exposed animals remained relatively
constant over time, compared with unexposed animals, in which a significant
decrease in [11C]DPN binding occurred. These results suggest that maturational
changes in amygdala volume and the binding capacity of [11C]DPN in the amygdala
was significantly altered in infant macaques receiving the vaccine schedule. The
macaque infant is a relevant animal model in which to investigate specific
environmental exposures and structural/functional neuroimaging during
neurodevelopment.
Key Words: rhesus macaques, Macaca mulatta, non-human primates, animal model,
neuroimaging, PET, MRI, amygdala, opioids, ethyl mercury, thimerosal,
neurotoxicity”
This primate case-control paper begins by introducing the reader to the region of
the primate brain known as the “amygdale”, “a complexly interconnected limbic system
structure located in the temporal lobe of the brain”.
That introduction closes with:
“The safety of the combined vaccine regimen per se, rather than that of individual
vaccines or vaccine components, is an important aspect of vaccine safety that has not
been examined. In order to more directly investigate the neurodevelopmental impact of
the complete US pediatric vaccine schedule (1994-1999), our model examined
structural and functional changes in the amygdala before and after vaccination in the
developing infant primate brain. Longitudinal development and functional
characteristics of the amygdala are reported in vaccinated (exposed) and unvaccinated
(unexposed) animals, and data on the novel application of [11C]DPN PET to the study
of macaque central nervous system (CNS) development are presented”.
The article then discusses the methods it used for the study in general – touching
on “Animal Assurances”, “Animal Husbandry”, “Study Design”, “Vaccine Dosing and
Administration”, “Magnetic Resonance (MR) Image Acquisition”, “Positron Emission
Tomography (PET)”, “Image Co-Registration and Volume-of-Interest (VOI)
Determination”, “PET Data Analyses”, and “Statistical Analysis”, with varying degrees
of specificity.
Next, the researchers discuss their findings under a heading titled, “RESULTS”.
The specific results categories initially discussed are “Volumetric analyses of the total
brain”, and “Volumetric analyses of the amygdala”, where the subcategories discussed
are: “Total Amygdala Volume”, “Right Amygdala Volume” and “Left Amygdala Volume”.
Then, the authors’ results’ reporting turned to “PET data analyses of region-
specific [11C]DPN binding in macaque brain” and their findings clearly showed significant
effects. Since figures speak volumes, this review has included the article’s “Fig. 3” here:
Fig. 3. [11C]DPN binding potential (BPND) values in the amygdalae. [11C]DPN binding
potential (BPND) values (raw mean+1 SD) in left, right and total amygdalae at T1 and T2 in
exposed and unexposed animals determined using the Logan Reference Plot and the cerebellar
cortex reference region rLP(CER).
Then, the authors proceed to report on: “[11C]DPN binding is influenced by vaccine
exposure and amygdala volume”, “Total Amygdala [11C]DPN Binding”, “Left Amygdala
[11C]DPN Binding”, and “Right Amygdala [11C]DPN Binding” in a series of brief
paragraphs and to end by summarizing their “[11C]DPN binding” findings as follows:
“In summary, at T1 there was a significant effect of exposure on total brain volume
(exposed > unexposed), but no difference in amygdala volume between groups.
Changes occurring between T1 and T2 include a differential change in total amygdala
volume between groups (a significant decrease in unexposed animals compared with a
non-significant increase in exposed animals) after adjustment for total brain volume,
and an increase in [11C]DPN binding in left amygdala compared with a decrease in
binding in unexposed animals, after adjusting for amygdala volume.”
Having presented their results, the authors next discussed their results in a passage
that ends with:
“If, for example, exorphines such as ß-caseomorphine have a role in this model, either
acting as partial or selective antagonists, or they exert a negative effect on endogenous
opioidergic systems (LaBella et al. 1985), they might inhibit a maturational decline in
opioid receptors and account for the sustained avidity of the amygdala for [11C]DPN in
exposed animals. How these effects could be potentially mediated by vaccine exposure
is not known. Additional histologic and molecular analyses of the amygdala may
provide mechanistic insights.”
Finally, these researchers present their conclusions as follows:
“In this pilot study, infant macaques receiving the recommended pediatric vaccine
regimen from the 1990’s displayed a different pattern of maturational changes in
amygdala volume and differences in amygdala-binding of [11C]DPN following the
MMR/DTaP/Hib vaccinations between T1 and T2 compared with non-exposed
animals. There was also evidence of greater total brain volume in the exposed group
prior to these vaccinations suggesting a possible effect of previous vaccinations to
which these animals had been exposed. Because primate testing is an important aspect
of pre-clinical vaccine safety assessment prior to approval for human use …, the results
of this pilot study warrant additional research into the potential impact of an interaction
between the MMR and thimerosal-containing vaccines on brain structure and function.
Additional studies are underway in the primate model to investigate the mechanistic
basis for this apparent interaction.”
This reviewer can only note that these researchers’ concluding remarks are simply
restating the findings of the observations in other papers as well as in human patient
work-ups where prior adverse vaccination history most certainly had a significant
negative impact on the outcomes observed following subsequent vaccinations.
9. DeSoto MC, Hitlan RT. Sorting out the spinning of autism: heavy
metals and the question of incidence. Acta Neurobiol Exp 2010,
70(2): 165–176. [http://www.ane.pl/pdf/7021.pdf]
“The reasons for the rise in autism prevalence are a subject of heated
professional debate. Featuring a critical appraisal of some research used to
question whether there is a rise in cases and if rising levels of autism are
related to environmental exposure to toxins (Soden et al. 2007, Thompson et
al. 2007, Barbaresi et al. 2009) we aim to evaluate the actual state of
scientific knowledge. In addition, we surveyed the empirical research on the
topic of autism and heavy metal toxins. Overall, the various causes that have
led to the increase in autism diagnosis are likely multi-faceted, and
understanding the causes is one of the most important health topics today.
We argue that scientific research does not support rejecting the link between
the neurodevelopmental disorder of autism and toxic exposures”.
Key words: autism, autism prevalence, heavy metals, mercury, toxins”
In simple terms, this article addresses the “spinning”(slanting/distorting),
intentional or not, of the probable causal links for the clinical symptoms that are used to
diagnose an “autism spectrum disorder” to obscure the realities that there has been an
epidemic increase in the incidence of children who have an ASD, related neuro-
developmental or related behavioral disorder, syndrome, or disease that has been caused,
and is being supported, by the use of Thimerosal-preserved vaccines that, at a given level
of sub-acute exposure, clinically mercury-poison some of those vaccinated, who are, for
whatever reasons (genetic, dietary, medical or environmental), sufficiently susceptible to
early developmental mercury poisoning by Thimerosal, an insidiously poisonous organic
mercury toxin, still used as a preservative in many vaccines repeatedly administered to
pregnant women and developing children.
Reviewer’s Concluding Observations
Given the scientific evidence in all of the preceding case and case-matched-
control studies as well as the other studies and review articles, Thimerosal (49.55%
mercury by weight) used as a preservative in vaccines has been, and still is, the iatrogenic
agent knowingly used by those, who profit from an increasing percentage of our
children’s having one or more chronic diseases, to intentionally injure an increasing
percentage of our children to increase their customer base, their profit and/or their profit
margins at the expense of the fiscal and physical health of ourselves and our children.
Given these additional findings, it is time to demand that all those who have
been, or are, involved in supporting the knowing use of Thimerosal as a preservative
in vaccines without proof of safety to the standard “sufficiently nontoxic …” (more
than 10 times below the lowest NOAEL for injected Thimerosal in the most susceptible
segment of the human population), as set forth in 21 CFR § 610.15(a)1, be prosecuted
under the “intent to defraud or mislead” provisions in 21 U.S.C. § Sec. 333(a)2.
1 Compliance with 21 CFR § 610.15(a) for Thimerosal-preserved vaccines is an absolute
nondischargeable duty that the makers of Thimerosal-preserved vaccines and other drugs have to
perform or else their Thimerosal-preserved vaccines are adulterated drugs under 21 U.S.C. §
351(a)(2)(B). Further, the introducing or causing the introduction of such adulterated drugs into
commerce is a Prohibited Act (see 21 U.S.C. § 331) and there are civil and criminal penalties that
apply to all those who are, in any responsible or accountable manner, engaged in violating 21 U.S.C. §
331 Prohibited Acts (see 21 U.S.C. § 333 Penalties [for § 331’s “Prohibited Acts” see § 331(a) “The
following acts and the causing thereof are prohibited: (a) The introduction or delivery for introduction
into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded”.]).
2 21 U.S.C. § 333(a)
“Violation of section 331 of this title; second violation; intent to defraud or mislead
(1) Any person who violates a provision of section 331 of this title shall be imprisoned for not
more than one year or fined not more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this section,(!1) if any person commits such
a violation after a conviction of him under this section has become final, or commits such a violation
with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or
fined not more than $10,000, or both. (!1) So in original. Words ‘of this section’ probably should not appear.”
Natural Solutions Foundation
The Voice of Global Health Freedom™
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www.GlobalHealthFreedom.org
Permalink: http://drrimatruthreports.com/?p=6098
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Half of All FDA Approved Drugs are Quietly Withdrawn Within 5 Years of Approval
“FDA approved” drugs means “safe”, right? Clinical trials show that drugs and vaccines are safe or they wouldn’t be allowed to be marketed, right? Drug companies have to report what actually happens in a clinical trial, right? Once a drug is approved by the FDA for market release it stays available for a long time, right?
Lethal and potentially lethal side effects from FDA approved drugs are rare, right?
The answer to these questions is one big collective, “NO!!!!!”
Here are the facts: Drug companies are free to suppress negative clinical trial information with impunity. That is not how the system is designed to work, at least on paper, but it is the way things work in the real world.
Drugs, all drugs and vaccines, enter Phase IV clinical trials when they are released for general use. Depending on how many people they kill, maim, blind or cause to suffer once doctors start prescribing the drug for whatever the FDA has approved it for, although they can use the drug for anything they want to (called “off label prescribing”). Even the callous, corrupt and conflict-of-interest-riddled FDA withdraws approximately 50% of all approved drugs within 5 years of approval because they are just too toxic to continue on the market.
How did they get approved in the first place? Well, as you will see when you read the articles below, drug companies disregard the requirements to be honest in reporting data as they choose. Given that it can cost up to a billion dollars (yes, you read that right, a billion US dollars) to research a drug and bring it to market, there is an enormous amount of pressure to get the drug into the patients’ hands by putting it in the doctor’s mind and getting it onto his/her prescription pad – no matter what.
One of the may ways drug companies accomplish what they want – drug sales, is to lie about how many people die or drop out in drug trials.
Another way is by literally purchasing the decision-makers for stock options, research grants and other inducements plucked fresh from the abundant and ever self-replenishing FDA Corruption Tree.
The results? Pharmaceutical Mayhem.
Drugs are the leading cause of death in the US and every other “developed” nation. But, not to worry, the FDA is on the job.! Oh, good. I was worried there for a moment!
You know, insultingly enough, the FDA expects you to believe that these deadly drugs released to the public to see what happens (and what happens is mayhem and murder much of the time) could possibly be an accident? Neither do I. Remember, these same drug companies are big players at Codex. They are the heirs and legatees of the German genocidalists who created Codex Alimentarius, now degrading the world’s food supply as a stepping side to “the Great Culling”, the death of 90% of the world’s population.
Bottom line, from where I stand? If you are not in an Emergency Room, there is, in my experience and belief, no reason to take drugs when inexpensive, gentle, effective and powerful natural options exist through orthomolecular medicine, homeopathy, naturopathy, chiropractic, acupuncture, Bio Acoustics, NeuroBioFeedback, Frequency Medicine, chelation, detoxification and a host of other helpful, safe techniques await your decision-making. But that is the very point, isn’t it? If you are an immensely powerful drug company and you know that your drugs are toxic, expensive, dangerous, poorly conceived and poorly tested, grossly dishonestly marketed what would you do? Jeopardize your cash bonus and tell the truth, wasting a billion bucks? Probably not. Probably you would do what the drug companies (and the BioTech companies which make GMOs and are usually one and the same as the drug companies!). You would lie, and lie big!
“These drugs are safe.” “The clinical trials show it.” “People do not get sick from our drugs.” “We followed the rules.” “You can trust us!”
Stuff and nonsense!
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
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Ana Cantu was a Human Guinea Pig in a Drug Trial for $4,800
Vera Hassner Sharav
Monday, 26 July 2010
“The study started out with 20 subjects…For about a week there were 14 subjects. Then they started dropping…Now, we’re down to 7.”
Below, a testimonial by Ana Cantu who was one of the healthy volunteers –“a human guinea pig” as she describes herself– in a month long study that tested the effects of Norvir, an HIV drug made by Abbott Laboratories, when coupled with the antidepressant Wellbutrin, made by GlaxoSmithKline.”
Her first-hand experience provides insight about the immense “pressure for positive results in clinical trials,” the level of discomfort a human subject is expected to endure from the adverse effects of the tested drug (or combination of drugs), and the dilemma for drug manufacturers whose drug causes adverse effects so severe, the test subjects in pre-marketing trials drop out in droves. The FDA accepts study results–even if only 7 of 20 subjects complete the study. Companies are loathe to scrap a negative study: they hold on to the last 7 subjects despite severe adverse effects. The “volunteers” suffer for the payment which they would forfeit if they quit.
Ana describes how and why corporate sponsors–in her case, GSK and Abbott Labs–conceal adverse event data that may damage a drug’s chances for approval.
Despite federal law requiring companies to fully disclose to the FDA all adverse events in pre-marketing clinical trials, drug companies have repeatedly violated the law with impunity: they have failed to include in their submission of data to the FDA, the worst adverse events suffered by subjects who, as a result, dropped out of the trials.
Her observations, published in The American Statesman (below) are disturbing and insightful:
“The study started out with 20 subjects, but 6 were eliminated during the in-patient stay by the drug company sponsoring the trial for various reasons (including drinking caffeine within 24 hours of check-in). For about a week, there were 14 subjects. Then they started dropping. The first one to go was a girl with a pronounced Texas twang named Denise, who had severe jaw and tooth pain. Then extreme nausea and emesis (the clinical term for vomiting, I discovered) claimed April. Jo Kay, Paula, Amy, Alyssa and Carrie went one after another. Now we’re down to 7.”
Ana experienced severe black outs–clearly an adverse effect of the experimental drug–but she was kept in the trial against her best interest:
“The day got off to a bumpy start when I started to black out while reporting my side effects. Darkness closed in from my peripheral vision and then I saw nothing but big colored spots.
“That morning, we were standing around in the cafeteria waiting to dose. All of a sudden, I couldn’t see and lost the ability to balance. If I hadn’t been standing between two of my fellow subjects, who grabbed me and held me up, I would’ve slammed into the floor. I knew I hadn’t fainted; I could still hear just fine, but all I heard was chaos as everyone around me freaked out. I dropped into the nearest chair and put my head between my legs while the study coordinator called the on-site paramedics. While the coordinator frantically called the staff doctor, a paramedic checked and re-checked me. I did fine as long as I wasn’t on my feet for too long. The doctor cleared me to keep dosing.”
Ana explains why her continued “participation” in the trial–disregarding the danger the black outs posed to her well-being–was to accommodate the sponsoring company’s need to maintain a minimum of 7 subjects in the trial:
“The drug company had a dilemma. To submit trial results to the FDA, the study couldn’t fall below seven participants. But, unfortunately, one showed signs of serious side effects and if those results were submitted, approval was highly unlikely. If my results were dropped, the FDA would never know about the problem and the drug company could start fresh with a third trial. However, the first clinical trial had to be scrapped because too many subjects dropped out as a result of their side effects, and it looked like the second study could soon follow the same path. To gather enough healthy volunteers who fit the protocol for a third trial would require a lot of time and money, and it wasn’t something the sponsor was willing to do. So, in the end, my results and I stayed in the study.”
“Because the trial ended with the magic number of seven volunteers, the results could be submitted for review and the FDA had the opportunity to see the data. But what happens in the trials in which drug companies drop some of the subjects with the worst side effects?”
Ana Cantu’s first-hand experience confirms the finding reported by FDA’s safety officer, Dr. Thomas Marciniak, who analyzed the raw data from GSK’s Avandia trial, and found that the company concealed from the FDA the worst adverse event data, resulting in its approval precipitating preventable heart attacks and deaths.
An editorial in today’s New York Times, calls upon the FDA to revoke its questionable approval of Avastin for breast cancer because it failed to extend patients’ lives while it caused serious side effects. The drug had gained “accelerated approval” without adequate testing.
~~~~~~~~~~~~~~~~~
Cantú: Anatomy of a drug trial
By Ana Cantú
AMERICAN-STATESMAN Friday, July 23, 2010
Exactly five years ago, in exchange for the most miserable month of my life, I got paid $4,800 to test the effects of a drug made by GlaxoSmithKline.
You know where you’ve heard the name GlaxoSmithKline recently, right? That’s the company on the verge of losing the approval of the Food and Drug Administration for the diabetes medication Avandia after regulators discovered omissions in a key clinical trial report. On Wednesday, the FDA ordered Glaxo to stop enrolling people in another Avandia trial.
According to a review reassessing the drug’s safety by the FDA’s Dr. Thomas Marciniak, a number of patients taking Avandia appeared to have serious heart problems that were not counted in the study’s tally of adverse events, otherwise known as side effects.
Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” he wrote.
It can cost hundreds of millions of dollars — in some cases, close to a billion — in research and development for a drug company to secure FDA approval.
By the time a drug gets to point where it can be tested in humans, the pressure for positive results in clinical trials is immense. And I found that out first-hand when as one of the healthy volunteers — a human guinea pig — in a study that tested the effects of Norvir, an HIV drug made by Abbott Laboratories, when coupled with the antidepressant Wellbutrin, made by GlaxoSmithKline.
In exchange for that $4,800 paycheck, I spent about a month going in and out of a blocky silver building in an office park not far from Austin-Bergstrom International Airport, the site of a contract research lab that conducts medical studies.
During the lab’s second clinical trial of the Norvir-Wellbutrin combination, which I chronicled in a personal blog, I was known only subject No. 40.
July 12: I check in tomorrow for 4 days. I’ll be taking an antidepressant and an AIDS drug in combination for about a month.
July 13: The facility is freezing. We’re still waiting on blankets. I should’ve brought a hat and gloves. You can tell the people who do studies regularly by their baggage — they bring extra pillows and blankets and huge rolling suitcases. The building is pretty new and it’s painted in all kinds of “modern” colors like bile, which complement the black-and-white tiled floors nicely. Subjects sleep 8 to a room in bunk beds, though there are only 3 people in my room. …
My first dose of Wellbutrin is tomorrow. I hear it gives you crazy dreams.
July 14: I’ve been stuck so many times today I feel like a junkie. I had to be up by 6:12 a.m. to check vital signs and get a pre-dose blood draw. Then I had breakfast, which I had to finish: two potato, egg and cheese tacos with pico de gallo and a carton of 2% milk, which I don’t like. I took the Wellbutrin at 7:27, so precisely every hour after that I’ve been having blood drawn. For the rest of the day, it’s blood draws only every 2 hours. I carry around a clipboard that has all my procedures and meals scheduled — everything has to be done exactly as it says on the sheet or they can dock pay off your study-completion bonus.
Amusing sign near the toilets: Please do NOT use cellphones in urine monitoring stations.
July 15: Dinner was decent — teriyaki chicken, rice, salad with Italian dressing, a hunk of zucchini bread and a sugar cookie. I tried the cookie and didn’t like the aftertaste so I hid it in a spare napkin and arranged everything else on the tray to conceal it. The cafeteria workers check how much of our food we eat — we’re supposed to finish at least 50% of everything. Sometimes it’s hard, like with yesterday’s trail mix. I hope we get a good snack, which I will take my first bite of at precisely 9:32 p.m.
About half of the subjects have done trials before and say that ours isn’t so bad, even with all the blood draws. Apparently, there are some where you have them every 15 minutes. …The people who usually play Monopoly switched to Uno.
July 18: Yesterday I had my first bad blood draw.
July 20: Tomorrow I start my doses of Norvir, the AIDS drug. Fun, fun.
July 23: I started on the AIDS drug on Thursday — 300 mg twice a day. The dosage gets upped to 400 mg tomorrow. I don’t feel bad yet, though I’m sleeping less than normal. And today my stomach objected to the egg facsimile we had to eat.
July 25: I was pretty excited that I didn’t get sick after my dosings. … I think the secret is to not drink the milk. And not to eat more than 50% of the food. I’m becoming an expert in artfully rearranging things on my plate so it looks like I’ve eaten. They (try to) make us eat after taking the giant AIDS pills, but since we get the same few meals over and over, it’s gotten really hard to do. Plus, there’s a chance you’ll get sick after so you really don’t want to see nasty food twice, if you get my meaning.
July 28: I discovered that I feel better if I don’t eat after taking the horse pills. This morning, I refused to eat the breakfast tacos and felt fine. So I followed the same strategy at dinner — I did eat the peas and carrots and drank some caffeine-free root beer, but most of the meal was untouched.
Over the course of the trial, as a result of a near-constant state of nausea, I lost about 10 percent of my body weight.
To keep up my strength, for lunch, I’d go to a fast-food restaurant and order the heaviest combo on the menu (double bacon cheeseburger, fries and a huge non-caffeinated beverage) and eat as much as I could before I started to feel sick again.
Every night, insomnia cut my sleep to three hours.
Aug. 1: The study started out with 20 subjects, but 6 were eliminated during the in-patient stay by the drug company sponsoring the trial for various reasons (including drinking caffeine within 24 hours of check-in). For about a week, there were 14 subjects. Then they started dropping. The first one to go was a girl with a pronounced Texas twang named Denise, who had severe jaw and tooth pain. Then extreme nausea and emesis (the clinical term for vomiting, I discovered) claimed April. Jo Kay, Paula, Amy, Alyssa and Carrie went one after another. Now we’re down to 7. In what I view as biological injustice, none of the males have shown noticeable symptoms.
Aug. 2: I had to go see an opthamologist today, just for my safety, since I reported a migraine with aura a few days ago. Unfortunately, I’m fine. Curses. I was hoping I could get medically excused from the study — that way I’d still get paid. But it looks like I’m going to have to finish it. Only 10 more days of dosing to go. My current side effects include oral numbness and tingling in my extremities.
Aug. 6: It’s another day in lockup: cloudy skies (I think) and cold air conditioning. The day got off to a bumpy start when I started to black out while reporting my side effects. Darkness closed in from my peripheral vision and then I saw nothing but big colored spots.
That morning, we were standing around in the cafeteria waiting to dose. All of a sudden, I couldn’t see and lost the ability to balance. If I hadn’t been standing between two of my fellow subjects, who grabbed me and held me up, I would’ve slammed into the floor. I knew I hadn’t fainted; I could still hear just fine, but all I heard was chaos as everyone around me freaked out. I dropped into the nearest chair and put my head between my legs while the study coordinator called the on-site paramedics. While the coordinator frantically called the staff doctor, a paramedic checked and re-checked me. I did fine as long as I wasn’t on my feet for too long. The doctor cleared me to keep dosing.
A few days after my first blackout episode, during a scheduled outpatient visit, one of the study coordinators said I had to be examined by the on-staff doctor. “Why?” “The sponsor is concerned about your side effects,” she said.
The drug company had a dilemma. To submit trial results to the FDA, the study couldn’t fall below seven participants. But, unfortunately, one showed signs of serious side effects and if those results were submitted, approval was highly unlikely. If my results were dropped, the FDA would never know about the problem and the drug company could start fresh with a third trial. However, the first clinical trial had to be scrapped because too many subjects dropped out as a result of their side effects, and it looked like the second study could soon follow the same path. To gather enough healthy volunteers who fit the protocol for a third trial would require a lot of time and money, and it wasn’t something the sponsor was willing to do. So, in the end, my results and I stayed in the study.
Aug. 21: So yesterday I had the exit screening/physical for my drug study. I had to have my blood pressure checked 3 times because it was low, even for me. The paramedic checked me, but I was asymptomatic. She asked how I was feeling. “Fine, especially now that I’m off the drugs.” She said, “Well, it was for the good of mankind.” “I guess … and the money.”
Because the trial ended with the magic number of seven volunteers, the results could be submitted for review and the FDA had the opportunity to see the data. But what happens in the trials in which drug companies drop some of the subjects with the worst side effects?
Actually, we’ve seen what happens — with Avandia.
~~~~~~~~~~~~~~~~~~
When a Drug Fails
THE NEW YORK TIMES July 25, 2010
The flameout of an enormously expensive drug to treat advanced breast cancer will pose a critical test for the Food and Drug Administration. Will the agency have the courage to reverse course when a medical treatment that it approved based on preliminary evidence flops badly in follow-up studies?
Two years ago, the F.D.A. gave Avastin, which is made by the Genentech unit of Roche, “accelerated approval” as a treatment for breast cancers that have spread to other parts of the body. Such cancers are essentially incurable so the best that current treatments can do is extend a patient’s life.
The hurry-up mechanism allows approval of a drug that has not yet been proved safe and effective in thorough clinical trials but has shown promise that it might benefit patients with life-threatening diseases. Rather than make such patients wait, they are treated with the drug while the manufacturer completes additional tests.
When Avastin was granted “accelerated approval” to treat advanced breast cancer, the primary evidence was a single clinical trial. It found that Avastin, when used with another drug, slowed progression of the disease but did not significantly extend patients’ lives.
Now two follow-up trials by the manufacturer have failed to confirm even those meager gains. In the initial trial, Avastin held tumor progression at bay for five and a half months. In the two new trials, pairing Avastin with different chemotherapy drugs, the delay in tumor worsening was much shorter: up to three months in one trial and less than a month in the other. The Avastin combinations also caused serious side effects.
Britain’s National Institute for Health and Clinical Excellence, a pace-setter in evaluating medical advances, issued draft guidance this month against using Avastin for advanced breast cancer patients in the National Health Service. It called the clinical trial data “disappointing” and the cost “too high for the limited and uncertain benefit it may offer patients.”
By a 12-to-1 vote last week, an F.D.A. advisory committee quite sensibly urged the agency to revoke Avastin’s approval for breast cancer. That would not affect its other approvals, gained through the standard regulatory process, for treating colon, lung, kidney and brain cancers. Avastin would remain available to doctors for off-label use against breast cancer. Many insurers, however, might refuse to cover an unapproved use.
The cost of Avastin has always seemed outrageously high for the medical benefits it confers. The wholesale price for a typical breast cancer patient is about $88,000 a year. Genentech has been capping annual spending at $57,000 for patients with incomes below $100,000.
The F.D.A. has rarely removed drugs that were given accelerated approval and sometimes has failed even to compel completion of follow-up studies. But there are signs it may get tougher. In June, the agency finally forced a leukemia drug off the market that had been given accelerated approval a decade ago, after a long- delayed follow-up study showed no clinical benefit and an increased risk of death. With Avastin, the follow-up studies were completed in a timely manner — with such meager results that withdrawal seems the right response.
http://www.theoneclickgroup.co.uk/news.php?start=3760&end=3780&view=yes&id=5045#newspost