Mark Blaxill and Boyd Haley Respond to Pichichero et. al. Thimerosal Mercury Excretion Study

Comment from Boyd Haley:

...Attached is a letter Mark Blaxill and I prepared and sent to the Pediatrics Journal in response to a Pichichero et al. study which claimed thimerosal (or ethyl mercury) left the body to fast to be toxic. Pediatrics refused to publish it which showed a total lack of support for any scientific debate in this journal for items concerning mercury toxicity causing autism. This same Pediatrics journal rejected the Nataf paper showing abnormal urinary porphyrin profiles in autistic children indicating they were mercury toxic. What the paper shows is that using Pichichero’s own data on fecal mercury excretion there was a definite retention of mercury in children receiving the normal vaccine schedule. Boyd Haley

From The Lancet 2002:

Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study.

Pichichero ME, Cernichiari E, Lopreiato J, Treanor J.

Department of Microbiology/Immunology, University of Rochester, Rochester, New York, NY, USA. michael_pichichero@urmc.rochester.edu

BACKGROUND: Thiomersal is a preservative containing small amounts of ethylmercury that is used in routine vaccines for infants and children. The effect of vaccines containing thiomersal on concentrations of mercury in infants' blood has not been extensively assessed, and the metabolism of ethylmercury in infants is unknown. We aimed to measure concentrations of mercury in blood, urine, and stools of infants who received such vaccines. METHODS: 40 full-term infants aged 6 months and younger were given vaccines that contained thiomersal (diptheria-tetanus-acellular pertussis vaccine, hepatitis B vaccine, and in some children Haemophilus influenzae type b vaccine). 21 control infants received thiomersal-free vaccines. We obtained samples of blood, urine, and stools 3-28 days after vaccination. Total mercury (organic and inorganic) in the samples was measured by cold vapour atomic absorption. FINDINGS: Mean mercury doses in infants exposed to thiomersal were 45.6 microg (range 37.5-62.5) for 2-month-olds and 111.3 microg (range 87.5-175.0) for 6-month-olds. Blood mercury in thiomersal-exposed 2-month-olds ranged from less than 3.75 to 20.55 nmol/L (parts per billion); in 6-month-olds all values were lower than 7.50 nmol/L. Only one of 15 blood samples from controls contained quantifiable mercury. Concentrations of mercury were low in urine after vaccination but were high in stools of thiomersal-exposed 2-month-olds (mean 82 ng/g dry weight) and in 6-month-olds (mean 58 ng/g dry weight). Estimated blood half-life of ethylmercury was 7 days (95% CI 4-10 days). INTERPRETATION: Administration of vaccines containing thiomersal does not seem to raise blood concentrations of mercury above safe values in infants. Ethylmercury seems to be eliminated from blood rapidly via the stools after parenteral administration of thiomersal in vaccines.

Blaxil and Haley's submission to Pediatrics:

Infant stool eliminates vaccinal mercury slowly suggesting high retention in tissue

To the editor,

In a study in The Lancet, Pichichero et al 1 argued that ethylmercury administered to infants through vaccines is eliminated rapidly from the blood and effectively excreted in stool. Our analysis of this data, combined with a more recent analysis2 of mercury excretion in baby hair suggests a more worrisome interpretation, one that offers support for the hypothesis3 linking early mercury exposures with autism.

Our calculations suggest that Pichichero et al. overstated the significance of their excretion findings. Although their data support a rapid rate of ethylmercury elimination from blood, instead of similarly rapid stool elimination, their findings demonstrate slow stool excretion in many infants, suggesting that significant amounts of ethylmercury from vaccines may be retained in infant tissue.

Most methyl mercury is eliminated from the body through stool and ethyl mercury from vaccines most likely follows the same path. Both mercury species must pass out of the blood to allow excretion in feces or (in lesser amounts) hair. 4 Nevertheless elimination from blood also allows for mercury transport into tissue, without prompt excretion. Our analysis of mercury excretion in autistic and control baby hair demonstrated that, although mercury was excreted at high rates in hair of normal infants, hair of autistic infants contained very little mercury, only 0.47 mcg/g versus 3.63 mcg/g in controls. This finding raises the possibility of increased mercury retention in the tissue of autistic infants, who also had higher rates of prenatal mercury exposure.

Pichichero et al provide data specific to infant mercury excretion through feces. They measured mercury concentrations in stool of 22 normal infants exposed to thimerosal in vaccines, ages two and six months, and found a range of 23-141 nanograms of mercury per gram of stool (dry weight). The authors interpreted these levels, mere parts per billion, as positive evidence of mercury elimination.

But these mercury concentrations are extremely low, not nearly enough to allow rapid excretion. Infant dry weight stool volumes have been measured at between 1-3 grams per kilogram (kg) per day.5 Based on the 50th percentile weight progression from 3.5-8 kg in the zero-six month period, infant stool volumes may be expected to range from 6-18 grams (dry weight) per day. Taking the stool concentration range for mercury from Pichichero et al, we calculated the time required for an infant to excrete the ethylmercury (187.5 mcg) that U.S. infants received by six months of age during the 1990s.

Stool Hg concentration Daily Hg excretion Days to excrete 187.5 mcg
(ng/g) (mcg/day) (days)

Minimum: 23 0.14-0.41 457-1,339
Maximum: 140 0.84-2.52 74-223

In the case of maximum excretion, early vaccine exposures are eliminated within the time period of exposure, but for those children with stool concentrations at the low end of the range, the infant elimination rate rises to nearly four years. For autistic infants, with evidence of reduced excretion in hair and additional fetal exposures2 (from maternal amalgam filling, fish consumption and Rho D immunoglobulin injections) these excretion times were likely far longer.

Our analysis contradicts the optimism expressed by Pichichero et al and suggests that low mercury excretion rates in some infants may underlie the link between mercury exposures and autism.

Mark F. Blaxill
Director, Safe Minds

Boyd E. Haley, PhD
Professor of Chemistry and Department Chairman
University of Kentucky


References:
1. Pichichero ME, Cernichiari E, Lopreiato J, Treanor J. Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study. Lancet. 2002;360(9347):1737-1741
2. Holmes AS, Blaxill MF, Haley BE. Reduced levels of mercury in first baby haircuts of autistic children. Int J Toxic. 2003;111(4):277-285
3. Bernard S, Enayati A, Redwood L, Roger H, Binstock T. Autism: a novel form of mercury poisoning. Med Hypotheses. 2001;56:462-471
4. Clarkson TW. The three modern faces of mercury. Environ Health Perspect. 2002;110 Suppl 1:11-23
5. Chou C, Studies on the use of soybean food in infant feeding in China and the development of formula 5410. Food Nutr Bull. 1983;5(1) :10-11 http://www.unu.edu/unupress/food/8F051e/8F051E00.htm - Contents

Like Its Predecessor RotaShield, Offit's Rotateq May Be Linked To Intussusception

Potential conflicts of interest: Ginger Taylor is the mother of a child with vaccine induced autism who has gotten to the point where she cringes at hearing the name Paul Offit because of his ridiculously irresponsible overstatements of vaccine safety on media outlet after media outlet while always failing to disclose his conflict of interest that he is a vaccine patent holder on Merck's RotaTeq vaccine. (Did you know that babies can theoretically handle 100,000 vaccines in one sitting? It's true! Paul Offit says so!)

If there is such thing as a science grudge match, this qualifies, as I can't imagine that the authors of this study feel any differently about Offit than I do.

However, let's let the article speak for itself. It finds that like the last rota virus vaccine to be removed from the market, Offit's vaccine may be causing Intussusception, a nasty, life threatening disorder where the intestine actually turns inside out and starts folding in on itself like a a telescope collapses.

Rota Teq is on the CDC's vaccine schedule.

If this bears out, let's hope it is yanked even more quickly than RotaShield was.

RotaTeq vaccine adverse events and policy considerations

David A. Geier, Paul G. King, Lisa K. Sykes, Mark R. Geier

The Institute of Chronic Illnesses, Inc., CoMeD, Inc., The Genetic Centers of America,

Potential conflicts of interest: David A. Geier has been a consultant in vaccine/biologic cases before the no-fault National Vaccine Injury Compensation Program (NVICP) and in civil litigation. Mark R. Geier has been a consultant and expert witness in vaccine/biologic cases before the no-fault NVICP and in civil litigation. Paul G. King and Lisa K. Sykes have no conflicts of interest.

Background: Rotavirus is the leading cause of severe gastroenteritis in children <5 years-old worldwide. On February 3, 2006, the US Food and Drug Administration licensed RotaTeq™ (Merck and Co.), a bioengineered combination of five human-bovine hybridized reassortment rotaviruses. In August of 2006, the Advisory Committee on Immunization Practices recommended RotaTeq for routine vaccination of US infants administered orally at the ages 2, 4, and 6 months. Material/Methods: An evaluation of data reported to VAERS following the fi rst fi ve quarters of post-marketing surveillance of RotaTeq was undertaken. Trends in adverse events reported following RotaTeq and cost effectiveness calculations of RotaTeq in the context of the disease burden of rotavirus in the US were examined. Results: From February 3, 2006 through July 31, 2007, a total of 160 (of the 165 reported) intussusception and 11 (of the 16 reported) Kawasaki disease adverse event reports were identifi ed when RotaTeq was administered or co-administered with other vaccines. Time-trend analyses showed that there were signifi cant increases in the total number of intussusception and Kawasaki disease adverse events entered into VAERS in comparison to previous years. Conclusions: These observations, coupled with limited rotavirus disease burden, cost-effectiveness, and potential contact viral transmission concerns, raise serious questions regarding the use of RotaTeq in the US. Healthcare providers should diligently report adverse events following RotaTeq vaccination to VAERS, and those who have experienced a vaccine-associated adverse event should be made aware that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program (NVICP). key words: gastroenteritis • gastrointestinal hemorrhage • rotavirus infection • vaccine adverse event reporting system

The Effects of Hyperbaric Oxygen Therapy on Oxidative Stress,

The Effects of Hyperbaric Oxygen Therapy on Oxidative Stress,
Inflammation, and Symptoms in Children with Autism: an Open-Label
Pilot Study

Daniel A Rossignol, Lanier W Rossignol1, S Jill James, Stepan Melnyk and
Elizabeth Mumper

International Child Development Resource Center, University of
Arkansas for Medical Sciences, Department of Pediatrics, Arkansas Children's Hospital Research Institute, Advocates for Children

Background: Recently, hyperbaric oxygen therapy (HBOT) has increased in popularity as treatment for autism. Numerous studies document oxidative stress and inflammation in individuals with autism; both of these conditions have demonstrated improvement with HBOT, along with enhancement of neurological function and cognitive performance.
In this study, children with autism were treated with HBOT at atmospheric pressures and oxygen concentrations in current use for this condition. Changes in markers of oxidative stress and inflammation were measured. The children were evaluated to determine clinical effects and safety.

Methods: Eighteen children with autism, ages 3–16 years, underwent 40 hyperbaric sessions of 45 minutes duration each at either 1.5 atmospheres (atm) and 100% oxygen, or at 1.3 atm and 24% oxygen. Measurements of C-reactive protein (CRP) and markers of oxidative stress, including plasma oxidized glutathione (GSSG), were assessed by fasting blood draws collected before and after the 40 treatments. Changes in clinical symptoms, as rated by parents, were also assessed. The children were closely monitored for potential adverse effects.

Results: At the endpoint of 40 hyperbaric sessions, neither group demonstrated statistically significant changes in mean plasma GSSG levels, indicating intracellular oxidative stress appears unaffected by either regimen. A trend towards improvement in mean CRP was present in both groups; the largest improvements were observed in children with initially higher elevations in CRP. When all 18 children were pooled, a significant improvement in CRP was found (p = 0.021). Pre- and post-parental observations indicated statistically significant improvements in both groups, including motivation, speech, and cognitive awareness (p < 0.05). No major adverse events were observed.

Conclusion: In this prospective pilot study of children with autism, HBOT at a maximum pressure of 1.5 atm with up to 100% oxygen was safe and well tolerated. HBOT did not appreciably worsen oxidative stress and significantly decreased inflammation as measured by CRP levels. Parental observations support anecdotal accounts of improvement in several domains of autism. However, since this was an open-label study, definitive statements regarding the efficacy of HBOT for the treatment of individuals with autism must await results from double-blind, controlled trials.

MMR + Chicken Pox Vaccine = More Seizures

Getting the Merck MMRV (Measles, Mumps, Rubella, Chicken Pox combo vaccine), rather than the MMR and separate Chicken Pox vaccine, results in "slightly more" or more than double the seizures, depending on how you want to spin the story:

"It found a rate of febrile seizure of nine per 10,000 vaccinations among MMRV recipients, and four per 10,000 among children who got separate MMR and chicken pox shots. Of 166 children who had febrile seizures after either type of vaccination, 26 were hospitalized and none died, the CDC said."

So CDC removes its preference for the MMRV vaccine, but does not change it's preference to the MMR and separate chicken pox vaccine. It just does not state a preference. Because half the seizures is not worth stating a preference?!

This does not just call for a preference, it seems to make the MMRV obsolete. What they had before the MMRV was safer.

Is the CDC's priority the health of children or the health of Merck's bottom line?

WASHINGTON (Reuters) - Children who get a combined vaccine against measles, mumps, rubella and chicken pox are slightly more likely to have seizures compared to those getting two separate shots for the same diseases, U.S. officials said on Thursday.

The seizures are not usually life-threatening and the U.S. Centers for Disease Control and Prevention said it was no longer expressing a preference that children get the so-called MMRV combined vaccine rather than two shots -- the MMR vaccine against measles, mumps and rubella (German measles) and a separate one against varicella (chicken pox).

The CDC said it made the change after seeing evidence that children who got the combined MMRV vaccine faced an elevated, but still very small, risk of suffering febrile seizures after vaccination compared to those who got the two shots.

A febrile seizure is a convulsion in young children associated with an increase in body temperature, often from an infection. While frightening, the seizures are not usually dangerous and only a small percentage of children who experience one go on to develop epilepsy.

Dr. John Iskander, the acting director of the CDC's Immunization Safety Office, said it remained very important that parents get their children vaccinated against these diseases.

"These are vaccines that have had enormous public health benefits," Iskander said.

The CDC said the availability of the MMRV vaccine, made by pharmaceutical company Merck, already was limited in the United States because of manufacturing constraints unrelated to vaccine safety, and was not expected to be widely available until 2009.

The CDC said a study examined the risk for febrile seizures seven to 10 days after vaccination among 43,353 children ages 12 months to 23 months who received the MMRV vaccine and 314,599 children of the same age who received the MMR vaccine and chicken pox vaccine administered separately.

It found a rate of febrile seizure of nine per 10,000 vaccinations among MMRV recipients, and four per 10,000 among children who got separate MMR and chicken pox shots. Of 166 children who had febrile seizures after either type of vaccination, 26 were hospitalized and none died, the CDC said.

Today Show Part 2: AAP President Tells Giant Easily Disprovable Mistruth

Yesterday, in a segment on autism and vaccines on the Today Show, Dr. David Tayloe, President Elect of the American Academy of Pediatrics, was asked the following question:

"Do you believe that all vaccines should be used on every child?"

His complete response:

"Yes. I think any of the vaccines we have today have been tested and proven to be safe, and the credible studies don't show any relationship between vaccines and permanent injury. So we favor this and we know that unless we have vaccination rates that are in the 90 to 95% range we are not going to prevent epidemics from coming into this country of measles, of polio, from countries where these diseases are still endemic. So its very important that we vaccinate all our children."

Repeating: No "relationship between vaccines and permanent injury".

This is probably the most glaring falsehood that I have heard in the vaccine debate yet, stated by the chief pediatrician in the US, to whom all other pediatricians look to for guidance in how to treat their patients.

Has Dr. Tayloe has never heard of the Federal Program called the Vaccine Injury Compensation Program, the sole purpose of which it to compensate people for the permanent injuries that they sustain from approved vaccines?

From the VICP section of the HRSA web site that shows the vaccine injuries that are covered:

"The Vaccine Injury Table (Table) makes it easier for some people to get compensation. The Table lists and explains injuries/conditions that are presumed to be caused by vaccines. It also lists time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccine. If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found. For example, if you received the tetanus vaccines and had a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found."

A quick rundown of a few of the covered reactions:

DTaP, Tdap, DTP-Hib, MMR, MR, R - Anaphylactic shock, encephalopathy, any accute complication or sequela of above events(including death).

Rubella vaccines - Chronic arthritis, any acute complication or sequela (including death) of above event.

Measles vaccines - Thrombocytopenic purpura, Mealses, any acute complication or sequela (including death) of above event.

Live Virus Polio vaccines - Polio.

Inactivated Virus Polio vaccines - Anaphylactic shock, any acute complication or sequela of above events(including death).

I am pretty sure that "Death" could be considered permanent injury.

Additionally, Dr. Tayloe has apparently never read a package insert in a box of vaccine.

Here is a random sample of insert quotes. Let's start with the one that sent my two week old Chandler into three months worth of fevers and crying and two years of constipation:

ENGERIX-B, Hepatitis B Vaccine -

"Multiple Sclerosis: Although no causal relationship has been established, rare instances of exacerbation of multiple sclerosis have been reported following administration of hepatitis B vaccines and other vaccines. In persons with multiple sclerosis, the benefit of immunization for prevention of hepatitis B infection and sequelae must be weighed against the risk of exacerbation of the disease."

"Carcinogenesis, Mutagenesis, Impairment of Fertility: ENGERIX-B has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility."

"Postmarketing Reports: Additional adverse experiences have been reported with the commercial use of ENGERIX-B. Those listed below are to serve as alerting information to physicians.

Hypersensitivity: Anaphylaxis; erythema multiforme including Stevens-Johnson syndrome; angioedema; arthritis. An apparent hypersensitivity syndrome (serum sickness–like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses, and erythema nodosum (see CONTRAINDICATIONS).
Cardiovascular System: Tachycardia/palpitations.
Respiratory System: Bronchospasm including asthma-like symptoms.
Gastrointestinal System: Abnormal liver function tests; dyspepsia.
Nervous System: Migraine; syncope; paresis; neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell’s palsy, transverse myelitis; optic neuritis; multiple sclerosis; seizures.
Hematologic: Thrombocytopenia.
Skin and Appendages: Eczema; purpura; herpes zoster; erythema nodosum; alopecia.
Special Senses: Conjunctivitis; keratitis; visual disturbances; vertigo; tinnitus; earache."

"CONTRAINDICATIONS - Hypersensitivity to any component of the vaccine, including yeast, is a contraindication. This vaccine is contraindicated in patients with previous hypersensitivity to any hepatitis B-containing vaccine."

(Even though my baby, in no uncertain terms, showed "hypersensitivity", his doctors continued to administer the vaccine to him until his regression at 18 months).

This is given to babies that are hours old. And remember, the head of the AAP says, even though the package insert says differently, that the vaccine is safe for every child and no permanent injury will occur.

Fluvirin, Flu Vaccine

"Controlled studies on FLUVIRIN® have not been conducted to demonstrate safety in pregnant women."

"CONTRAINDICATIONS
INFLUENZA VIRUS IS PROPAGATED IN EGGS FOR THE PREPARATION OF INFLUENZA VIRUS VACCINE. THUS, THIS VACCINE SHOULD NOT BE ADMINISTERED TO ANYONE WITH A HISTORY OF HYPERSENSITIVITY (ALLERGY) TO CHICKEN EGGS, CHICKEN, CHICKEN FEATHERS OR CHICKEN DANDER.
THE VACCINE IS ALSO CONTRAINDICATED IN INDIVIDUALS HYPERSENSITIVE TO ANY COMPONENT OF THE VACCINE INCLUDING THIMEROSAL (A MERCURY DERIVATIVE) (SEE ADVERSE REACTIONS). EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE SHOULD AN ACUTE ANAPHYLACTIC REACTION OCCUR DUE TO ANY COMPONENT OF THE VACCINE.
IMMUNIZATION SHOULD BE DELAYED IN PERSONS WITH AN ACTIVE NEUROLOGICAL DISORDER
CHARACTERIZED BY CHANGING NEUROLOGICAL FINDINGS, BUT SHOULD BE CONSIDERED WHEN THE
DISEASE PROCESS HAS BEEN STABILIZED.
THE OCCURRENCE OF ANY NEUROLOGICAL SYMPTOMS OR SIGNS FOLLOWING ADMINISTRATION OF ANY
VACCINE IS A CONTRAINDICATION TO FURTHER USE.
THE VACCINE SHOULD NOT BE ADMINISTERED TO PERSONS WITH ACUTE FEBRILE ILLNESSES UNTIL THEIR TEMPORARY SYMPTOMS AND/OR SIGNS HAVE ABATED."

WARNINGS
Influenza Virus Vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless, in the judgment of the physician, the potential benefits clearly outweigh the risk of administration.
Patients with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have a reduced antibody response in active immunization procedures.

But if Dr. Tayloe is right, the package insert should be changed to read:

"CONTRAINDICATIONS
None."

"WARNINGS
None."

P.S.:

"No studies regarding the simultaneous administration of inactivated influenza vaccine and other childhood vaccines have been conducted."

One more... Merck's MMR vaccine:

"CONTRAINDICATIONS
Hypersensitivity to any component of the vaccine, including gelatin.
Do not give M-M-R II to pregnant females; the possible effects of the vaccine on fetal development are unknown at this time. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females and PRECAUTIONS, Pregnancy).
Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin).
Febrile respiratory illness or other active febrile infection. However, the ACIP has recommended that all vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper respiratory infection with or without low-grade fever, or other low-grade febrile illness.
Patients receiving immunosuppressive therapy. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.
Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other alignant neoplasms affecting the bone marrow or lymphatic systems.
Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses;41-43 cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis60 (MIBE), pneumonitis61 and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine.
Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is emonstrated."

"WARNINGS
Due caution should be employed in administration of M-M-R II to persons with a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided. The physician should be alert to the temperature elevation which may occur following vaccination (see ADVERSE REACTIONS).
Hypersensitivity to Eggs Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of chick embryo antigen. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases. Such individuals may be vaccinated with extreme caution, having adequate treatment on hand should a reaction occur"

"The AAP states, "Persons who have experienced anaphylactic reactions to topically or systemically administered neomycin should not receive measles vaccine."

Now that Dr. Tayloe is running the AAP, will they remove that statement from the insert?

I have not even gotten to the sections on Adverse Reactions yet, but I have already made my point.

Oh, yeah... and then last week the Hannah Poling case broke.

It is factual to say that in come cases, approved vaccines DO result in permanent injury and that not all vaccines are safe for all children.

Dr. Tayloe is wrong.

Either he knows about the things which I have written above, in which case he has lied to the American public and he has no place being the head of the AAP, or he does not know the things which I have written above, in which case he is incompetent to be the head of the AAP.

... and there is not a chance in hell that he does not know about all that I have written here.

Additionally, allow me to draw your attention to the second half of Dr. Tayloe's statement:

"So we favor this and we know that unless we have vaccination rates that are in the 90 to 95% range we are not going to prevent epidemics from coming into this country of measles, of polio, from countries where these diseases are still endemic. So its very important that we vaccinate all our children."

Note the goal of his vaccination policy, not to serve the best interest of your individual child, but to protect this country of a viral epidemic.

Keep in mind, that when your are in the pediatricians office and he is looking at your child and making decisions on how to treat him, the AAP, his professional organization has taught him that your baby is not his client. That 'society' is his client. And that depending on how ethical he is or how sharp his critical thinking skills are, he may not actually be serving your child, but "the greater good".

We have been lobbying the AAP to reevaluate vaccines and move in a more cautious direction in making recommendations for their doctors.

If the election of Dr. Tayloe and his criminal pronouncements are the response to the AAP of parents increasingly loud protestations of their destructive direction, then it is time to start ignoring the AAP.

There are many, many pediatrician out there who genuinely want to work in the best interests of their patients, and as difficult as it was for me and Honey to hear Dr. Tayloe lie on tv, it must have been more difficult for them to have heard. They know that serious vaccine reactions exist, and they just watched the man that represents them tell a very stupid lie to the entire country.

(please excuse any typos, etc, as I have not had a chance to proof this. I reserve the right to make corrections)

Dr. Poling Responds To Autism/Vaccine Nay Sayers

Dr. Stephen Novella on his blog NeuroLogica has posted his evaluation of the Poling case and why he believes it does not support the vaccine autism connection.

Dr. Jon Poling has responded as seen on The Age of Autism countering the arguement and expanding on the information that has been available publicly on the case.

It is a discussion between two neurologists and I will need to read them each 5 times before I can even begin to comment on the conversation.

But I will note two things.

First, I am impressed that Dr. Poling lists his potential conflicts of interest at the end of his letter. I think that every medical professional should do that as a part of their signature (For example I would sign Ginger Taylor, B.S., M.S., Mother of regressive autistic child who suspects vaccines had a causal relationship to ASD, Has Google Ads on her autism blog).

Second, for all of his in depth analysis of the medical facts in this case, Dr. Novella failed to correctly discern the sex of the child in question. He refers to Hannah several times as "he" and "the child", never as a female. He criticizes David Kirby's articles about the case, but did not read them thoughtfully enough to see that Mr. Kirby was clearly talking about a girl.

I will reserve this space for further comment as I come to understand this case further.

I will post both pieces:

Has the Government Conceded Vaccines Cause Autism?
Published by Steven Novella

No. But David Kirby and other anti-vaccinationist ideologues and members of the so-called mercury militia would like you to think so. For background, the Autism Omnibus refers to a set of hearings before the Vaccine Injury Compensation Program regarding claims by about 5000 parents that their childrens’ autism was caused by vaccines. These claims are primarily based upon the various hypotheses that the MMR vaccine, or thimerosal in some vaccines (but not MMR), or the combination of both, is a cause of autism.

So far there have been hearings, but only one final decision. In November the US government settled one case in favor of the petitioner. This is the case those who have supported the failed hypothesis that vaccines cause autism now point to as admission that they were right all along (or at least as a means of stoking the flames of fear about vaccines.) But the US government did not admit vaccines cause autism - they conceded one case that is highly complex and not necessarily representative of any other case and cannot be reasonably used to support the vaccine/autism connection.

David Kirby, author of Evidence of Harm, wrote a highly misleading article the other day in the Huffington Post on this issue. Orac has already done an excellent job of tearing down Kirby’s claims. He points out that legal cases are often decided for legal - not necessarily scientific - reasons. That the government only conceded that “compensation is appropriate.” That is all - they conceded nothing about the larger question of vaccines and autism. Orac also points out that if this case were a concession of a connection why would the petitioner’s lawyers settle and give away a case that could win them all their other cases?

David Kirby has also written a follow up article, where he publishes verbatim the US government’s decision. Kirby asks his readers:

If you feel this document suggests that some kind of link may be possible, you might consider forwarding it to your elected representatives for further investigation.

But, of course, if you feel that this document in no way implicates vaccines, then let’s just keep going about our business as usual and not pay any attention to all those sick kids behind the curtain.

I think Kirby is hoping that most people will not have the patience or medical background to read and understand the entire document, and that they will come away with a vague notion that there must be something to all this vaccine fear-mongering. What does the document really tell us?

To summarize the case history, the child in the case appeared normal and healthy, except for chronic otitis media, until about 20 months of age at which time he had a series of vaccines according to the routine vaccination schedule. Two days later the child had a fever to 102.3, was lethargic, irritable, and would arch his back when he cried. The child then developed a rash. It was later determined that the child had: “encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness.” The child regressed and developed symptoms similar to those of autism spectrum disorder. However, the child does not have autism - he has a regressive neurological disorder that includes blood and muscle abnormalities not seen in autism, and any clinical resemblance to autism is not a reflection of a common cause.

Six years after symptoms began the child also developed partial temporal lobe epilepsy that required treatment.

During this time the child also had an extensive workup, which discovered:

A CSF organic acids test, on January 8, 2002, displayed an increased lactate to pyruvate ratio of 28,1 which can be seen in disorders of mitochondrial oxidative phosphorylation.

A muscle biopsy test for oxidative phosphorylation disease revealed abnormal results for Type One and Three.

In February 2004, a mitochondrial DNA (”mtDNA”) point mutation analysis revealed a single nucleotide change in the 16S ribosomal RNA gene (T2387C)

It if often difficult or impossible to draw firm conclusions from a single case, so I will lay out what I see as all the possible alternative hypotheses to explain this information.

1) One possibility is that the child was perfectly normal prior to the vaccines, which caused an encephalitis (inflammation of the brain) which caused brain damage, including the later seizures. The metabolic disorder and mutation may be a red herring and have no bearing on the child’s clinical condition.

2) The mitochondrial disorder predisposed the child to have a reaction from the vaccines, resulting in encephalitis. The subsequent neurological regression was due to some combination of the vaccine-induced encephalitis and the underlying mitochondrial disorder.

3) The child’s mitochondrial mutation is the primary cause of their neurological regression, but that this regression was exacerbated by the vaccine-induced encephalitis (this seems to be the US government’s conclusion).

4) The child has a mitochondrial encephalopathy which is the sole cause of all of the child’s neurological signs and symptoms. The reaction to the vaccines may have played no role at all in the subsequent regression, and the child’s current neurological condition is exactly what it would have been had they never been vaccinated. It is even possible that the encephalitis was merely the first manifestation of the mitochondrial disorder and the timing after the vaccines was merely coincidental.

That lays out the spectrum of possibilities in this case. At this point in time we do not have (or at least I am not privy to) sufficient scientific information to say definitively where along this spectrum the truth lies. The US government’s decision was based partly on this uncertainty - erring on the side of compensating the child and family.

But we can discuss the plausibility of each scenario. Kirby dismisses anything resembling option 4, but his dismissal is naive and unjustified. In fact the patient’s clinical syndrome resembles what is called a mitochondrial encephalopathy - with increased lactic acid, abnormal muscle biopsy, neurological regression, appropriate age of onset, even seizures. It is probably not a coincidence that the child has a point mutation in a gene that has been previously linked to these very mitochondrial disorders. Kirby incorrectly argues:

While it’s true that some inherited forms of Mt disease can manifest as developmental delays, (and even ASD in the form of Rhett Syndrome) these forms are linked to identified genetic mutations, of which T2387C is not involved. In fact little, if anything, is known about the function of this particular gene.

This is misleading. Kirby refers to “this particular gene” which makes me think that he believes T2387C is a gene. It’s not - it describes a point mutation (at location 2387 a thymidine has replaced a cytosine). The gene is the 16S ribosomal RNA gene. Mutations in this gene have been identified to cause mitochondrial encephalopathy. So Kirby is just wrong. It is true that I could not find that this specific mutation has been identified before, but that is common in genetics - a disease is linked to point mutations in a specific gene (or perhaps specific regions of a gene) but most or all families identified have their own specific mutation.

This makes option 4 very plausible - it would be an incredible coincidence if this child just happened to have a mutation in a gene that was known to cause their exact constellation of neurological signs and symptoms and yet the mutation was not the sole or primary cause of those symptoms.

But it does not rule out option 3 - that the mitochondrial disorder was the primary cause of the child’s neurological disorder but that a reaction to the vaccines worsened the ultimate symptoms. Therefore the government’s decision was reasonable - but is absolutely not a concession about any claim made by the petitioners concerning a link between vaccines an autism.

It does, however, make any hypothesis resembling option 1 or 2 extremely unlikely. Further testing regarding the physiological effects of this child’s specific mutation would be helpful, and such testing may be under way but I could find nothing published to date. It is theoretically possible that the identified mutation does not cause a change in the gene product or mitochondrial function, and is therefore just a coincidence. But this is unlikely given the clinical features in this case are a good match to known mutations of that gene.

Kirby, however, apparently wants to wring as much fear and confusion out of these events as he possibly can. So now he speculates wildly that maybe children diagnosed with autism really have this mitochondrial disorder combined with vaccines (he has to keep vaccines in the loop). Given the rarity of such mutations, and the fact that there were specific features in this case that would likely be uncovered in the routine evaluation of a child with autism (like an elevated lactic acid), it is highly unlikely that there are many children with vaccine-triggered mitochondrial encephalopathy mimicking autism out there.

It has been found that some children with autism have mitochondrial dysfunction - one study found that 7.2% of subjects with autism had “definite mitochondrial respiratory chain disorder.” Poling et al, in response to this child’s case, did a retrospective study of children with autism and with other neurological disorders and found that “Aspartate aminotransferase was elevated in 38% of patients with autism compared with 15% of controls.” Such findings are preliminary - the only conclusions that can be drawn is that the association between autism and metabolic disorders requires further investigation. However, these studies did not look at the incidence of suspicious mitochondial mutations in autism, and these findings may not be relevant to this case.

Kirby also wildly speculates that perhaps the evil toxins in vaccines caused the mutation in the first place. He writes:

Use of the AIDS drug AZT, for example, can cause Mt disorders by deleting large segments of mitochondrial DNA. If that is the case, might other exposures to drugs or toxins (i.e., thimerosal, mercury in fish, air pollution, pesticides, live viruses) also cause sporadic Mt disease in certain subsets of children, through similar genotoxic mechanisms?

Among stiff competition, this is perhaps the most absurd and scientifically ignorant thing Kirby has every written. AZT does NOT cause a genetic disorder. AZT blocks DNA replication (it blocks the copying of DNA) - that is its mechanism as an anti-retroviral drug. In patients it can also block mitochondrial DNA replication, thereby causing mitochondrial depletion. This results in there being too few mitochondria (the energy factories of cells) in some cell populations and causes dysfunction in tissue that is especially susceptible to the effects of this dearth of mitochondria. This is a side effect of AZT and also other retrovirals because of sustained use at doses designed to inhibit DNA replication. This does result in some effects that are similar to mitochondrial genetic disorders - because both result in insufficient mitochondrial activity. But that is the only similarity. AZT does not cause a disseminated somatic mutation, which is the incredible analogy that Kirby is making.

What Kirby is suggesting is that in infants and toddlers toxins can cause the same point mutation in millions of different cells throughout the body. Toxin-induced mutations do not cause genetic diseases, unless they occur in a germ cell in which case a mother or father can pass the mutation onto their children. If it occurs in the womb then large cell populations may be affected (whatever cells derive from the cell that had the mutation). But in a child a point mutation would affect only one cell and any cells that derive from it. A toxic mutagen would cause different random point mutations in different cells. This could not cause the mitrochondrial encephalopathy in this child. It can increase the risk of cancer, because cancer can develop from a single mutation in a single cell that causes it to become neoplastic.

Conclusion

This is a unique and idiosyncratic case that raises more questions than it answers. In my opinion as a neurologist, with the information provided, the child has a mitochondrial encephalopathy. The role of the vaccines is unclear, but at worst a rare vaccine reaction exacerbated the underlying mitochondrial disorder. This case has no clear implication for the larger question concerning vaccines and autism, which is likely why both sides agreed to settle.

Yet those who insist, despite the evidence, on claiming that vaccines or mercury are linked to autism are likely to add this permanently to their litany of misinformation and fear-mongering.

Note: I am searching for any follow up information pertinent to this case and will post any addendum here.

DR. JON POLING TO DR. STEVEN NOVELLA ON AGE OF AUTISM

PolingsBy Dr. Jon Poling, father of Hannah Poling.

OPEN LETTER TO DR. STEVEN NOVELLA
IN RESPONSE TO "Has the Government Conceded Vaccines Cause Autism?"

Dr. Novella,

Thank you for generating interesting discussion regarding my little girl, Hannah Poling. I would like to give you additional information in order to generate further productive discussions on this matter amongst the neurology community. This information should assist you, Dr. DiMauro, and Dr. Trevethan, who have also commented publicly, to formulate better theories as to the significance of Hannah’s mitochondrial dysfunction in relation to her autism.

1. Mito Dysfunction or Mito Disease? Chicken or Egg?

To begin with, I would like to point out that the spectrum of mitochondrial dysfunction is probably considered more broad and complex than the spectrum of neurobehavioral abnormalities seen with autism. Dysfunction of the mitochondria, specifically dysfunction of the oxidative phosphorylation pathway, most likely contributes, but may not be the cause of many diseases—including Parkinson’s disease, Friedreich’s Ataxia, Alzheimer disease, etc. Thus, it is probably incorrect to refer to mitochondrial dysfunctional and mitochondrial disease interchangeably. Indeed, the role of the dysfunctional mitochondrial are yet to be clarified in these diseases. Thus, I will refer to Hannah’s metabolic condition as a mitochondrial dysfunction, not a mitochondrial disease.

2. Mito Genetic Finding? Mito mtDNA ‘red herring’ ?

ADDITIONAL GENETIC TESTING NOT AVAILABLE IN THE J CHILD NEUROL CASE REPORT: Dr. Shoffner performed genetic testing on both Hannah’s muscle and her mother’s leukocytes subsequent to our case report. Hannah (muscle mtDNA) and her mother (leukocyte mtDNA) were both found to be HOMOPLASMIC for the mtDNA T2387C transition mutation.
Our analysis of this genetic finding in the mtDNA was significantly different than those of other physicians that I’ve seen in scientific blogs or commentary. I suspect it would have been fatal to both Hannah and her mother if this homoplasmic mutation was pathogenic since (as I am sure you are aware) the mutation is on the 16S ribosomal subunit which is highly conserved. Thus, this mutation probably represents a benign polymorphism rather than pathogenic mutation. It is unlikely, but possible, that the mutation is significant to Hannah, but in such a case, it must work in concert with other nuclear genes to cause her mitochondrial dysfunction. To our knowledge, this point mutation has not been reported in cases similar to Hannah’s.

3. Encephalitis? Metabolic Encephalopathy? Or “Regressive Encephalopathy with Features of Autism Spectrum Disorder”

The other interesting term you used was encephalitis rather than encephalopathy. We are not sure that she had an “-itis” but we did clearly document a regressive encephalopathy based on not only our parental reporting, but also based on the pediatrician’s documents, affidavits from other family members, and the growth curve measurements (injury pattern). Early on in the regression we did note back arching (opisthotonus), fever, and disrupted sleep. Although fever occurred a lumbar puncture was not performed.

An interesting developing story in autism research is the immune/inflammatory connection. In her senior resident thesis, Dr. Anne Comi, a former JHU colleague, along with Dr. Andy Zimmerman, reported, the increased prevalence of autoimmune disease in families of autistic offspring. Interesting, Hannah also has a maternal family history of autoimmune disease. Dr. Carlos Pardo, another one of my former chief residents, along with Andy and Dr. Vargas, published a beautiful study in the Archives of Neurology, demonstrating neuroinflammation on autopsy of brain samples and inflammation cytokine markers in the CSF of individuals with Autism. The interesting thing was that inflammation was demonstrated in autopsy specimens from adults as old as 44 years of age. The conclusion was that further research would be required to determine if inflammation was a primary disorder in autism or; alternatively, if inflammation and microglial activation was secondary to neurodegeneration. Dr. Sudhir Gupta at UC Irvine has a nice model of how the two pathways of neuroinflammation and mito dysfunction may not be mutually exclusive. This remains to be seen; however, study of mitochondrial dysfunction and neuroinflammation hold the promise of treatment development. The two avenues of research deserve funding at the highest levels.

4. How many Hannah Polings are out there?

The short answer is that nobody knows. However, there is emerging data to suggest that she is not alone.

Dr. Shoffner will be presenting his experience with 37 patients with combined autism and mitochondrial dysfunction at the AAN meeting in Chicago this April. 65% of his referrals are positive for mitochondrial dysfunction. Of course, his yield is subject to referral bias as a mito expert, so the prevalence of mitochondrial dysfunction in Autism is surely less than 65%.

The best estimate to date of the prevalence of mitochondrial dysfunction in autistic patients comes from Oliviera et al. in a population of 120, 5 of 69 (or 7.2%) showed mitochondrial dysfunction. If this is generalized to the US estimate of 1 million patients with ASDs, then the number of kids like Hannah could be 72,000! Isn’t this worth further study?

Dr. Shoffner furthermore advocates, along with us, that vaccination is important even for kids with mitochondrial dysfunction. I would argue that you should not give nine at one time and that none of them should contain Thimerosal (mercury).

5. Thimerosal—On or Off the Table?

I don’t want to dwell on mercury, as this theory is not why HHS conceded Hannah’s case (imo). Dr. DiContanzo just wrote an interesting blog about how his opinion of mercury in vaccines has changed (http://drugs.about.com/b/2008/03/08/mercury-in-vaccines-and-autism-the-burden-of-proof-may-shift.htm).

My opinion is that mercury is a potent neurotoxin. Therefore, don’t inject it into kids! Interestingly, basic research studies have shown that Thimerosal toxicity occurs through mitochondrial pathways. Officials point to the large epidemiology studies as proof that there is no link between thimerosal and autism. However, these studies are not powered to disprove the null hypothesis when considering that the mitochondrial autistic population may be just a small percent of the case totals. Remember that while the CDC sponsored Verstraten study is hyped as a negative study, it DID find a statistically significant increase in childhood tics in those exposed to higher doses of thimerosal.

6. Hannah was destined to regress? Or was she?

Some experts have already stated that ‘mitochondrial disease’ is degenerative so the vaccine reaction was just the start of an inevitable decline. This was neither the opinion of Dr. Richard Kelley at KKI nor Dr. John Shoffner. In fact, the markers that led us down the mitochondrial trail (inc AST but not ALT, low serum bicarbonate, and slight increased CK, increase in the alanine to lysine ratio on PAA) are no longer present. Furthermore, in our pilot study (unpublished but mentioned in the J child neurol paper), Dr. Frye (the statistician for our study and also a child neurologist) found a non-significant trend that AST decreased toward normal with increasing age. With further studies we hoped to examine the hypothesis that this abnormality may be representative of a developing/immature biochemical pathway present in some children.

7. Triple Hit Hypothesis—#1Underlying genetic susceptibility #2Insult must occur during specific developmental period #3 A certain vaccination or combination thereof is the environmental trigger (?vaccine component like thimerosal ?direct immune stim/fever reaction ?live virus reaction?)

The implication is that Hannah’s type of autism requires a genetic susceptibility and properly timed insult to manifest disease. We have not subjected Hannah to another muscle biopsy or re-examined ox phos functional assays that were published in the paper. I can inform your readers though that the serum biochemical markers have resolved, growth resumed and continues along a normal trajectory, and there have been no other episodes of regression since 2000. We are however left with autism and later in 2006, epilepsy.
It is recommended that studies be initiated immediately to screen siblings of cases to identify biochemical markers so as to identify potential screening tests.

I agree with the mainstream that my daughter’s case has raised many intelligent discussions and questions. I’m very proud of her for starting this discussion. Our hope is that further research into this case and others like it, we will be also to find screening tests to prevent what happened to my daughter from happening to anybody else.

(Dr. Poling acknowledges the editorial comments and insightful suggestions of Dr. Richard E. Frye. He also would like to declare his conflicts of interest. First of all, he is the father of Hannah Poling. Dr. Poling has also accepted consultancy or speakers honoraria from Pfizer, Eisai, Ortho-McNeil, Biogen, Teva, Immunex (now Amgen), and Allergan.)

PS While I thought it useful to clarify some of the neurological issues raised by the government's concession of my daughter's case, please understand that I will not be able to respond to individual comments posted. Thank-you. Jon

Toxic Levels of Mercury in Chinese Infants Eating Fish Congee

More evidence of the link that does not exist:

"A boy aged 2 years and 10 months presented with delayed speech and some autistic features. Since weaning, he had eaten fish (barramundi, sea perch, salmon and rock cod) up to eight times a week. He had no history of herbal medicine use, and his thyroid function, blood lead level, and a DNA screen for fragile X syndrome were normal. The child’s blood mercury level was 350 nmol/L and urine Hg/Cr ratio was 14 nmol/mmol (NR, < 10 nmol/mmol*)."

Toxic Levels of Mercury in Chinese Infants Eating Fish Congee

Stephen J Corbett and Christopher C S Poon

MJA 2008; 188 (1): 59-60

To the Editor: We report elevated mercury levels in three infants, each the only child of Chinese parents living in Sydney. All three children had eaten fish congee (a rice and fish porridge) as a weaning food and ate fish regularly as toddlers. Their parents had sought medical advice for either developmental delay or neurological symptoms in the children.

A 2-year-old boy had demonstrated increasingly aggressive behaviour for the past 6 months. A general practitioner had diagnosed mercury poisoning in the boy’s father 2 months earlier, following investigation for complaints of allergies, rashes, abdominal pain and diarrhoea. The family ate fish (usually salmon, barramundi or snapper) at least five times a week, and had used unspecified herbal medicines in the past. The child had eaten fish regularly since weaning. The boy’s blood mercury level was 158 nmol/L (normal range [NR], < 50 nmol/L), a random urine mercury/creatinine (Hg/Cr) ratio was 9 nmol/mmol (NR, < 6 nmol/mmol*), and his hair mercury level was 1.42 mg% (NR, < 0.18 mg%). The boy’s father and mother (who was pregnant) also had elevated hair mercury levels, of 4.3 mg% and 6.0 mg%, respectively. The father and child were treated with chelation therapy elsewhere.

* The two laboratories reported different normal ranges for the urine Hg/Cr ratio.

A boy aged 2 years and 10 months presented with delayed speech and some autistic features. Since weaning, he had eaten fish (barramundi, sea perch, salmon and rock cod) up to eight times a week. He had no history of herbal medicine use, and his thyroid function, blood lead level, and a DNA screen for fragile X syndrome were normal. The child’s blood mercury level was 350 nmol/L and urine Hg/Cr ratio was 14 nmol/mmol (NR, < 10 nmol/mmol*). The boy’s father did not eat fish, and his blood mercury level was 19 nmol/L. The child’s mother did eat fish, and had a blood mercury level of 27 nmol/L. Two weeks after removing fish from the diet, the child’s blood mercury level had fallen to 99 nmol/L and his urine Hg/Cr ratio to 7 nmol/mmol. However, his behaviour did not improve, and he was subsequently diagnosed with classical autism.

A 15-month-old boy presented with delayed development since birth. Fish had been introduced to his diet at 8 months of age, and he had since continued to consume fish four to five times a week. He had recently eaten either ling or salmon. The boy’s mother had consumed ling three to four times a week after the fifth month of her pregnancy. The child’s thyroid function, DNA screen for fragile X syndrome, chromosome karyotype, and urinary metabolic screen were normal. His blood mercury level was 143 nmol/L, but fell to 19 nmol/L over a period of 1 year after ceasing fish intake. His longer-term developmental status is unknown.

Fish congee, made with either freshwater species or locally caught fish, is a common weaning food in coastal regions of southern China and South-East Asia.1 Adding fish to the weaning diet has health benefits,1,2 such as reducing anaemia, and is actively promoted. However, fish, particularly the large pelagic (open ocean) species more likely to be bought in Australia, may also contain mercury. Excessive consumption of mercury has been associated with neurological impairment.3-5

The Box shows that the consumption by infants of fish congee made from portions of large fish species may exceed the provisional tolerable weekly intake (PTWI)7 for methylmercury of 1.6 μg/kg bodyweight/week (the limit considered sufficient to protect a developing fetus). Food Standards Australia New Zealand’s most recent risk assessment concluded that median-level consumers of fish are unlikely to exceed the PTWI for methylmercury,6 but frequent consumers might if all their consumption is of predatory or long-lived fish species, which tend to acccumulate higher concentrations of mercury.

It has been previously noted in the Journal that public health policy regarding fish consumption needs to balance the health benefits for cardiovascular disease and anaemia with the possible ill effects of mercury on neurological development in infants.8

We recommend that multilingual information about fish and mercury be made available to pregnant women and mothers, especially targeting groups who are likely to be frequent consumers of fish and who use fish in weaning and infant foods. Regulatory and health promotion activities could also be informed by surveillance of blood or hair mercury levels in infants from ethnic groups at high risk of mercury intoxication, and of the frequency of fish consumption in this age group (by type of fish).

Estimated weekly mercury intake in infants consuming fish congee

Evidence of Mitochondrial Dysfunction in Autism and Implications for Treatment

I am really tired of hearing "No Link".

Evidence of Mitochondrial Dysfunction in Autism and Implications for Treatment

Daniel A. Rossignol, J. Jeffrey Bradstreet
International Child Development Resource Center, 3800 W. Eau Gallie Blvd., Suite 105,
Melbourne, FL 32934

Abstract: Classical mitochondrial diseases occur in a subset of individuals with autism and are usually caused by genetic anomalies or mitochondrial respiratory pathway deficits. However, in many cases of autism, there is evidence of mitochondrial dysfunction (MtD) without the classic features associated with mitochondrial disease. MtD appears to be more common in autism and presents with less severe signs and symptoms. It is not associated with discernible mitochondrial pathology in muscle biopsy specimens despite objective evidence of lowered mitochondrial functioning. Exposure to environmental toxins is the likely etiology for MtD in autism. This dysfunction then contributes to a number of diagnostic symptoms and comorbidities observed in autism including: cognitive impairment, language deficits, abnormal energy metabolism, chronic gastrointestinal problems, abnormalities in fatty acid oxidation, and increased oxidative stress. MtD and oxidative stress may also explain the high male to female ratio found in autism due to increased male vulnerability to these dysfunctions.
Biomarkers for mitochondrial dysfunction have been identified, but seem widely under-utilized despite available therapeutic interventions. Nutritional supplementation to decrease oxidative stress along with factors to improve reduced glutathione, as well as hyperbaric oxygen therapy (HBOT) represent supported and rationale approaches. The underlying pathophysiology and autistic symptoms of affected individuals would be expected to either improve or cease worsening once effective treatment for MtD is implemented.

Its Not Just The Mercury: Aluminum Hydroxide In Vaccines

When parents began suspecting that their children's autism was triggered by their vaccines, and those parents in the scientific professions began to look at the plausibility of the vaccine/autism connection, one ingredient jumped out at them as the most likely culprit. Mercury. Excessive mercury. So much mercury in one typical shot (25mg)that according to EPA guidelines a person must weigh 550lbs to safely process the amount of mercury that was being injected into a child. And they often got more than one shot at a time.

After all mercury is the most toxic substance on earth that does not set off a geiger counter.

It has taken more than a decade, but the public and scientific community is finally on the same page on the idea that it does not belong in vaccines. And yet is it still in vaccines. We continue to work on the problem.

But now that the mercury message is out there, it is time for the scientific community to begin to turn their attention to the other three well known dangers that are in vaccines. Aluminum, Monosodium Glutamate, and Formaldehyde.

Today we are going to give Aluminum a look.

Aluminum is known to be associated with degenerative, fatal neurological conditions like Parkinson's, ALS (Lou Gehrig's) and Alzheimer's. And yet according to the CDC, it is in the following vaccines:

Anthrax, DTaP (all brands), DT (all brands), Hib/Hep B (Comvax), Hep A (all brands), Hep B (all brands), HPV (Gardasil), Pneumococcal (Prevnar), Rabies (Biorab), Td (all brands), and Tdap (all brands).

That is most of the vaccines on the CDC's list.

The reason that aluminum is in our vaccines is because it is an adjuvant.

Generally speaking, the way vaccines work is that they contain a virus and substances called ‘adjuvants’ (like mercury and aluminum) that kick the immune system into high gear so that they go on the hunt for the viruses, eat ‘um up, and create antibodies against further infection.

In people with typical immune systems, the body then stands down from high alert. But in some people, it doesn’t, and the immune system begins to behave like early 20th century Germany and attacks what ever is in sight. The result, autoimmune disorders.

A few examples of autoimmune disorders: When the immune system attacks the connective tissue, you get arthritis, when it attacks the mylon sheath around the nerves, you get Guillain-Barré Syndrome (a known side effect of the flu shot that causes paralysis), and when it attacks the pancreas you have Type 1 Diabetes. And on and on.

Because autism was first seen as a psychiatric problem caused by bad parenting, it has taken decades for it to be properly medically investigated, and for the autoimmune features of the disorder (i.e. cytokines in the brain causing swelling leading to cognitive dysfunction) to be recognized. (Which is why even mild anti inflammatory agents like fish oil improve communication skills of so many people with autism, and why parents report that children’s autistic symptoms seem to improve when their kids are sick.)

(When Chandler was diagnosed and we had his immune system tested, viola… hyper drive. I just thought he had rough skin… turns out it was mild eczema. When I started him on fish oil and his rough skin turned back into baby skin and his eye contact and verbal skills improved.)

So the reason that aluminum needs as hard a look as a vaccine component as mercury does, is because we are learning that it also causes cell death. A lot of cell death. In the brain.

Canadian neuroscientist Chris Shaw did not set out to shake confidence in vaccination, but what he and his team found when testing Aluminum Hydroxide, the form used most often in vaccines, really upset them.

"No one in my lab wants to get vaccinated," he said. "This totally creeped us out. We weren't out there to poke holes in vaccines. But all of a sudden, oh my God-we've got neuron death!"

Vaccines Show Sinister Side
By Pieta Woolley
Straight.com
March 23, 2006

If two dozen once-jittery mice at UBC are telling the truth postmortem, the world's governments may soon be facing one hell of a lawsuit. New, so-far-unpublished research led by Vancouver neuroscientist Chris Shaw shows a link between the aluminum hydroxide used in vaccines, and symptoms associated with Parkinson's, amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease), and Alzheimer's.

Shaw is most surprised that the research for his paper hadn't been done before. For 80 years, doctors have injected patients with aluminum hydroxide, he said, an adjuvant that stimulates immune response.

"This is suspicious," he told the Georgia Straight in a phone interview from his lab near Heather Street and West 12th Avenue. "Either this [link] is known by industry and it was never made public, or industry was never made to do these studies by Health Canada. I'm not sure which is scarier."

Similar adjuvants are used in the following vaccines, according to Shaw's paper: hepatitis A and B, and the Pentacel cocktail, which vaccinates against diphtheria, pertussis, tetanus, polio, and a type of meningitis.

To test the link theory, Shaw and his four-scientist team from UBC and Louisiana State University injected mice with the anthrax vaccine developed for the first Gulf War. Because Gulf War Syndrome looks a lot like ALS, Shaw explained, the neuroscientists had a chance to isolate a possible cause. All deployed troops were vaccinated with an aluminum hydroxide compound. Vaccinated troops who were not deployed to the Gulf developed similar symptoms at a similar rate, according to Shaw.

After 20 weeks studying the mice, the team found statistically significant increases in anxiety (38 percent); memory deficits (41 times the errors as in the sample group); and an allergic skin reaction (20 percent). Tissue samples after the mice were "sacrificed" showed neurological cells were dying. Inside the mice's brains, in a part that controls movement, 35 percent of the cells were destroying themselves.

"No one in my lab wants to get vaccinated," he said. "This totally creeped us out. We weren't out there to poke holes in vaccines. But all of a sudden, oh my God-we've got neuron death!"

At the end of the paper, Shaw warns that "whether the risk of protection from a dreaded disease outweighs the risk of toxicity is a question that demands our urgent attention."

He's not the only one considering that.

The charge that there's a sinister side to magic bullets isn't new. With his pen blazing, celebrity journalist Robert F. Kennedy Jr. popularized vaccine scepticism with his article arguing that mercury in vaccines causes autism, which ran in the June 2005 Rolling Stone and on-line at Salon.com. So did last year's vaccines-linked-to- autism bestseller, Evidence of Harm by David Kirby (St. Martin's Press). But there's a potential public-health cost to all the controversy, according to the B.C. Centre for Disease Control.

"Vaccines have been a victim of their own success," spokesperson Ian Roe told the Straight in a telephone interview from Ottawa. Diseases such as polio, which killed his father-in-law, are almost eradicated and therefore no longer serve as a warning to parents. But the epidemic threat is still real. "If everyone decided to not get vaccinated, we'd live in a very different world."

Canada's last national immunization conference, in December 2004, heard a report that vaccine coverage is sometimes low. For diphtheria, the Public Health Agency of Canada found that just 75 percent of two-year-olds are immunized; the target is 99 percent. For tetanus, just 66 percent of 17-year-olds are immunized, compared to a target of 97 percent.

Dr. Ronald Gold, the former head of the infectious-disease division at Toronto's Hospital for Sick Children, told the conference that "we will never be without an anti-vaccine movement," but "in reality, there is no scientific evidence for these myths."

Can I just stop here for a second and point out that in the middle of offering you scientific evidence for the theory that vaccines cause serious and permanent brain damage that I AGAIN have to be faced with someone in medical authority saying, "NO LINK"! How many studies have to find a link before they will stop saying it, "no link"?

There are hundreds of studies, but they don't want to look at them.

I will start writing more about them.

The collective denial is staggering.

Shaw acknowledges that there's a lot of pressure on parents to vaccinate their children. "You're considered to be a really bad parent if you don't vaccinate," he said-and your child can't attend public school. "But I don't think the safety of vaccines is demarcated. How does a parent make a decision based on what's available? You can't make an intelligent decision."

Conservatively, he said, if one percent of vaccinated humans develop ALS from vaccine adjuvants, it would still constitute a health emergency.

It's possible, he said, that there are 10,000 studies that show aluminum hydroxide is safe for injections. But he hasn't been able to find any that look beyond the first few weeks of injection. If anyone has a study that shows something different, he said, please "put it on the table. That's how you do science."

Neuroscience research is difficult, Shaw said, because symptoms can take years to manifest, so it's hard to prove what caused the symptoms.

"To me, that calls for better testing, not blind faith."

He pointed out that George W. Bush passed legislation that opens the door for the USA to order a nationwide anthrax immunization campaign, with the threat of bioterrorism.

Shaw's paper is currently undergoing a peer review.

Despite the fact that Shaw announced his study in March of 2006, only three months ago, Melinda Wharton, Deputy Director of the National Center of Immunization and Respiratory Diseases at CDC, gave an interview to Jaye Watson of WXIA TV in Atlanta and here is what she said about the dangers of aluminum content:

Q. Aluminum is used in vaccines. This is a question I bring with me from attending the conference and seeing a panel of 3 doctors or so talk about aluminum and the amount in vaccines. One said that the aluminum exposures for the vaccine’s recommended of the 2 month visit exceed the suggested safety limits set by the FDA. Has the CDC tested the toxicity of aluminum in vaccines?

A. The vaccines are licensed by the FDA, and the vaccines meet FDA standards, so no, CDC hasn’t looked at that particular issue, but that is handled by the Food and Drug Administration’s part of vaccine licensing.

Q. So, that would almost be counter productive….

A. It wouldn’t be licensed if it was toxic.

Because we all know that the FDA would never license something that was harmful to people. (Thalidomide is currently an FDA approved drug? What the hell?!)

Shaw's study completed peer review, it was published in in 2207 in Neuromolecular Medicine:

Aluminum adjuvant linked to gulf war illness induces motor neuron death in mice.
Neuromolecular Med. 2007;9(1):83-100.
Petrik MS, Wong MC, Tabata RC, Garry RF, Shaw CA.

Department of Ophthalmology and Program in Neuroscience, University of British Columbia, Vancouver, British Columbia, Canada.

Gulf War illness (GWI) affects a significant percentage of veterans of the 1991 conflict, but its origin remains unknown. Associated with some cases of GWI are increased incidences of amyotrophic lateral sclerosis and other neurological disorders. Whereas many environmental factors have been linked to GWI, the role of the anthrax vaccine has come under increasing scrutiny. Among the vaccine's potentially toxic components are the adjuvants aluminum hydroxide and squalene. To examine whether these compounds might contribute to neuronal deficits associated with GWI, an animal model for examining the potential neurological impact of aluminum hydroxide, squalene, or aluminum hydroxide combined with squalene was developed. Young, male colony CD-1 mice were injected with the adjuvants at doses equivalent to those given to US military service personnel. All mice were subjected to a battery of motor and cognitive-behavioral tests over a 6-mo period postinjections. Following sacrifice, central nervous system tissues were examined using immunohistochemistry for evidence of inflammation and cell death. Behavioral testing showed motor deficits in the aluminum treatment group that expressed as a progressive decrease in strength measured by the wire-mesh hang test (final deficit at 24 wk; about 50%). Significant cognitive deficits in water-maze learning were observed in the combined aluminum and squalene group (4.3 errors per trial) compared with the controls (0.2 errors per trial) after 20 wk. Apoptotic neurons were identified in aluminum-injected animals that showed significantly increased activated caspase-3 labeling in lumbar spinal cord (255%) and primary motor cortex (192%) compared with the controls. Aluminum-treated groups also showed significant motor neuron loss (35%) and increased numbers of astrocytes (350%) in the lumbar spinal cord. The findings suggest a possible role for the aluminum adjuvant in some neurological features associated with GWI and possibly an additional role for the combination of adjuvants.

(One note on what Apoptosis is. It is basically when a cell self destructs.

Apoptosis is also the process that is taking place, via mitochondrial dysfunction, when Thimerosal is administered, that came to our attention when Dr. Jon Poling discussed the details of his daughter Hannah's case.

Hanna was the first case of an autistic child paid from the US Vaccine Injury Compensation Fund to be made public, although details are coming to light that she is at least the 10th such child. The other families are currently working to make their cases known.)

So here is the questions that parents are currently beginning to ask: as thimerosal has been in the process of removal from vaccines, have manufacturers replaced it with higher doses of aluminum to added to make up for the adjuvant properties lost when mercury was no longer present? How do we know what a safe level of aluminum is for our children? Does the CDC even care?

Developmental Regression and Mitochondrial Dysfunction in a Child With Autism

After David Kirby's disclosure of the court papers in the Hannah Poling case last week, it became clear that the child in this study was the same child whose autism claim was conceded by the DOJ to be paid by the Vaccine Injury Compensation Fund.

What I didn't know until today was that her father, Jon Poling, MD, PhD, was the lead author on the paper.

For your consideration:

Developmental Regression and Mitochondrial Dysfunction in a Child With Autism
Jon S. Poling, MD, PhD
Department of Neurology and Neurosurgery Johns Hopkins Hospital Baltimore, MD

Richard E. Frye, MD, PhD
Department of Neurology Boston Children's Hospital Boston, MA

John Shoffner, MD
Horizon Molecular Medicine Georgia State University Atlanta, GA

Andrew W. Zimmerman, MD
Department of Neurology and Neurosurgery Johns Hopkins Hospital Kennedy Krieger Institute Baltimore, MD, zimmerman@kennedykrieger.org


Autistic spectrum disorders can be associated with mitochondrial dysfunction. We present a singleton case of developmental regression and oxidative phosphorylation disorder in a 19-month-old girl. Subtle abnormalities in the serum creatine kinase level, aspartate aminotransferase, and serum bicarbonate led us to perform a muscle biopsy, which showed type I myofiber atrophy, increased lipid content, and reduced cytochrome c oxidase activity. There were marked reductions in enzymatic activities for complex I and III. Complex IV (cytochrome c oxidase) activity was near the 5% confidence level. To determine the frequency of routine laboratory abnormalities in similar patients, we performed a retrospective study including 159 patients with autism (Diagnostic and Statistical Manual of Mental Disorders-IV and Childhood Autism Rating Scale) not previously diagnosed with metabolic disorders and 94 age-matched controls with other neurologic disorders. Aspartate aminotransferase was elevated in 38% of patients with autism compared with 15% of controls (P < .0001). The serum creatine kinase level also was abnormally elevated in 22 (47%) of 47 patients with autism. These data suggest that further metabolic evaluation is indicated in autistic patients and that defects of oxidative phosphorylation might be prevalent. (J Child Neurol 2006;21:170—172; DOI 10.2310/7010.2006.00032).

New Study Implicates Mercury In The Development Of Autism

The American Journal of Biochemistry and Biotechnology has published this study out of Rutgers and UMDNJ that exposed mercury to animals and found "neurobehavioral alterations" such as impaired social interaction, cognition and motor behavior. They also found that they improved when given vitamin E, suggesting that oxidative stress is at work in this process.

This is no surprise to any of us who have been treating our autistic kids for mercury toxicity and oxidative stress for years, but the big surprise in this study is in the credits.

The shocker is that this study is brought to you by Autism Speaks.

IMHO Autism Speaks has finally said something worth saying.

So... will we see this article in the press? Will the AAP recognize it and start looking at Vit. E as a helper for their patients with autism? Will CDC start taking another look at vaccines? Will Autism Speaks start coming around now that their own studies are implicating mercury as a factor in the development of autism?

Or will they all continue to proffer the lie that there is no convincing evidence linking vaccines to autism, while ignoring all the studies that are piling up on the hard drives of parents across the country?

American Journal of Biochemistry and Biotechnology 4 (2): 218-225, 2008
ISSN 1553-3468
© 2008 Science Publications

Corresponding Author: George C. Wagner, Psychology, Busch Campus, Rutgers University, New Brunswick, NJ 08854
Tel: 732-445-4660 Fax: 732-445-2263


Evidence of Oxidative Stress in Autism Derived from Animal Models
1Xue Ming, 2Michelle A. Cheh and 2Carrie L. Yochum,
3Alycia K. Halladay and 2George C. Wagner
1Pediatric Neuroscience, UMDNJ, Newark, NJ
2Psychology, Rutgers University, New Brunswick, NJ
3Autism Speaks, Princeton, NJ

Abstract: Autism is a pervasive neurodevelopmental disorder that leads to deficits in social interaction, communication and restricted, repetitive motor movements. Autism is a highly heritable disorder, however, there is mounting evidence to suggest that toxicant-induced oxidative stress may play a role. The focus of this article will be to review our animal model of autism and discuss our evidence that oxidative stress may be a common underlying mechanism of neurodevelopmental damage. We have shown that mice exposed to either methylmercury (MeHg) or valproic acid (VPA) in early postnatal life display aberrant social, cognitive and motor behavior. Interestingly, early exposure to both compounds has been clinically implicated in the development of autism. We recently found that Trolox, a water-soluble vitamin E derivative, is capable of attenuating a number of neurobehavioral alterations observed in mice postnatally exposed to MeHg. In addition, a number of other investigators have shown that oxidative stress plays a role in neural injury following MeHg exposure both in vitro and in vivo. New data presented here will show that VPA-induced neurobehavioral deficits are attenuated by vitamin E as well and that the level of glial fibrillary acidic protein (GFAP), a marker of astrocytic neural injury, is altered following VPA exposure. Collectively, these data indicate that vitamin E and its derivative are capable of protecting against neurobehavioral deficits induced by both MeHg and VPA. This antioxidant protection suggests that oxidative stress may be a common mechanism of injury leading to aberrant behavior in both our animal model as well as in the human disease state.

After 30 Years AAP Finally Admits That Fiengold Diet Works For ADHD

Now will they instruct individual pediatricians to start prescribing dietary intervention to kids with ADHD or will they just stay on the Ritalin train?

Will take them 30 years for the AAP to face the fact that the GFCF diet is a viable treatment for Autism?

Now I don't expect a huge old organization like the AAP to turn on a dime, but 5 years should be plenty and 30 years is just plain malpractice. That is an entire generation of kids that were Ritalined when they could have instead just been fed healthy food.

HEY AAP! Study our recovering kids!!! I can control my son's behavior day to day by what he eats!!

From Fiengold.org:

The American Academy of Pediatrics -- the organization that sets practice parameters for pediatricians to follow -- has finally acknowledged that dietary intervention is a valid treatment for children with ADHD in the February 2008 issue of its publication, AAP Grand Rounds [full report attached]. We encourage parents to print this page and share it with their pediatricians, in case they have not seen the AAP's article.

After reviewing the British study published in the September 2007 Lancet, in which researchers found that food colorings and/or sodium benzoate increase hyperactive behavior in children, the AAP concludes with an Editors' Note and a commentary by Alison Schonwald, MD, FAAP, of the Developmental Medicine Center at Children’s Hospital in Boston. Dr. Schonwald writes:

"Despite increasing data supporting the efficacy of stimulants in preschoolers with attention deficit hyperactivity disorder (ADHD) parents and providers understandably seek safe and effective interventions that require no prescription. A recent meta-analysis of 15 trials concludes that there is "accumulating evidence that neurobehavioral toxicity may characterize a variety of widely distributed chemicals." [Schab DW, et al. J Dev Behav Pediatr. 2004;25:423–434] Some children may be more sensitive to the effects of these chemicals, and the authors suggest there is a need to better identify responders. In real life, practitioners faced with hyperactive preschoolers have a reasonable option to offer parents. For the child without a medical, emotional, or environmental etiology of ADHD behaviors, a trial of a preservative-free, food coloring–free diet is a reasonable intervention."(emphasis added)

And the Editors' Note which follows states:
"Although quite complicated, this was a carefully conducted study in which the investigators went to great lengths to eliminate bias and to rigorously measure outcomes. The results are hard to follow and somewhat inconsistent. For many of the assessments there were small but statistically significant differences of measured behaviors in children who consumed the food additives compared with those who did not. In each case increased hyperactive behaviors were associated with consuming the additives. For those comparisons in which no statistically significant differences were found, there was a trend for more hyperactive behaviors associated with the food additive drink in virtually every assessment. Thus, the overall findings of the study are clear and require that even we skeptics, who have long doubted parental claims of the effects of various foods on the behavior of their children, admit we might have been wrong." (emphasis added)

~ The following are PDF files. If you need a PDF reader, get it here.
Read AAP Grand Rounds article
Read Lancet study, full text
Read Behavior, Learning and Health: The Dietary Connection 2007
See more information at ADHDdiet.org

Eli Stone Compares Tobacco Safety Claims With Pharma Safety Claims

With all the vaccine safety claims by Med and Pharma flooding the media to counter the Eli Stone pilot, I thought it would be a good time to repost this from last summer:

Draw Your Own Analogies




Johnson & Johnson Clears Their Own Product of Autism Link

Critique of JnJ's Rhogam Study

If you don't want to find something, look where it is isn't.

Hey Kids, Get Vaxed!

UPDATE:

Scanning You Tube I found these, and these are not from that long ago:

NIMH Wants to Know What Direction Autism Research Should Go

... or at least they say they do.

I encourage you to write to them tomorrow and let them know what you would like looked at. Take a moment right now to put your thoughts down to be sure you get it in by the Jan 4th deadline.

From NAA:

Respond to NIMH's Request for Information about Autism Research Priorities


Due Tomorrow, January 4, 2008

Request for Information (RFI): Research Priorities for the Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorders (ASD)

The purpose of this time-sensitive RFI is to seek input from ASD stakeholders such as individuals with ASD and their families, autism advocates, scientists, health professionals, therapists, educators, state and local programs for ASD, and the public at large about what they consider to be high-priority research questions.

Background
The Combating Autism Act of 2006 (Public Law 109-416) re-established the Interagency Autism Coordinating Committee (IACC) and requires that the IACC develop a strategic plan for ASD research. The IACC includes both Federal and public members who are active in the area of ASD research funding, services, or advocacy. In its inaugural meeting on November 30, 2007, the IACC approved a process for developing the strategic plan that includes multiple opportunities for stakeholder input. This RFI is a first step in receiving broad input at the beginning stages of plan development.

To identify research priorities for possible inclusion in the strategic plan for ASD research, the IACC will convene several scientific workshops in January 2008. The responses received through this RFI will be collated, summarized, and provided to workshop participants. The scientific workshops will be organized around four broad areas of ASD research:

Treatment - includes ASD treatment, intervention, and services research that aim to reduce symptoms, promote development, and improve outcomes. This area includes the development and evaluation of medical, behavioral, educational, and complementary interventions for ASD. In addition, this area includes research studies that evaluate the effectiveness of treatments in real world settings, disparities in ASD treatment among specific subpopulations, practice patterns in ASD programs and services, and their cost-effectiveness.

Diagnosis - is concerned with the accurate and valid description of ASD (phenotype) both at the individual and the population level. The public health impact of ASD can be better understood by such studies. In addition, this area concerns itself with the diversity of what constitutes ASD and the characteristics of the condition over the lifespan.

Risk Factors - has to do with investigations of the factors that contribute to the risk of having an ASD in a given person or population. This includes genetic studies of clusters or sporadic occurrences of ASD, studies that focus on environmental factors, e.g., intrauterine events or exposure to toxins, which could lead to ASD, and the interaction between these factors that concentrate risk for ASD.

Biology -studies the underlying biological processes that lead to developmental and medical problems associated with ASD. This includes research in the area of neurosciences but does not confine itself to neurosciences. Therefore, research on other organ systems, interactions between organ systems, and/or other disease processes are included in this area.

The development of the strategic plan is expected to take approximately six months and will include several additional opportunities for public input.

Information Requested
We are interested in receiving your input and ideas about what are high-priority questions and issues for advancing research on ASD. We ask for your constructive and specific suggestions in the following areas (please refer to the above descriptions for each area).

What topics or issues need to be addressed to advance research on the:

1. Treatment of ASD?
2. Diagnosis of ASD?
3. Risk factors for ASD?
4. Biology of ASD?
5. Other areas of ASD research?

Responses
Please send responses to iacc@mail.nih.gov no later than January 4, 2008.

Please limit your response to two pages and mark it with this RFI identifier NOT-MH-08-103 in the subject line. The responses received through this RFI will be collated, summarized, and provided to scientific workshop participants in January 2008. Summarized results will also be made available to the public. Any proprietary information should be so marked. Respondents will receive an email confirmation acknowledging receipt of their response, but will not receive individualized feedback.

------------- end of NIMH message -------------

The following are suggested topics to cover:

* Highest priority should be on preventing new cases and treating individuals already affected.
* Congress made clear in the Combating Autism Act legislative history that NIH MUST investigate vaccines including preservatives as possible causes.
* A vaccinated vs. unvaccinated population study must be conducted.
* In order to better understand the mechanisms of autism onset, and consistent with new emphasis on early detection and treatment, a specific program should be undertaken, probably inpatient, to study newly diagnosed (suspected) cases of ASD to examine in vivo the specific processes and developmental mechanisms involved during onset.
* Documentation and publication of "recovered" cases.
* Evidence-based validation or rejection of treatments (behavioral and biomedical) currently being used to treat existing cases.

Process issues at NIH regarding autism research

* All workshops and workgroup meetings must be open to interested parties.
* Transparency and frequent opportunities for public input and feedback.
* The urgency of the epidemic demands all deliberate speed.
* Workgroup Chairmen must not have financial conflicts.
* Workgroups and workshops must have balance reflecting the diversity of views on cause and treatments for ASD, and not be biased toward past paradigms.
* The point of the Congressional mandate in the Combating Autism Act was to reprioritize and redirect research funding, not to simply repeat past funding hoping for a different outcome.