March 15, 2008

AIA: Now With Email Subscriptions

So I had email subscribers back in the day, until blotlet went outta business.

I am happy to announce that I am replacing it with Feedblitz. So sign up already:

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March 14, 2008

Jenny In Canada

Cute Baby Alert!

Something (very happily) not about autism.

This is my beautiful friend Heather and her o-so-cute baby Cassius. Check him out... he knows that he is cute!

Pharma Insider?

An interesting comment on Dr. Gupta's blog (let's get you guys on the record already!):

I work for a drug company, pharma companies pay big money and lobby over many years to get their vaccines on the schedule, its the dirty truth.

The other truth is that vaccines are developed in separate silos from one another by different companies. They are not clinically tested as a given group -- in other words, where are the clinical studies that mimic the real world dosage schedule and I will start to believe the CDC's position that no harm is caused by vaccines.

Where is the statistical analysis of safety and side effects in the real world for combined dosing of vaccines? Drug companies use these points to sell the efficacy of their individual vaccines but, when combined as groups, no data has been shown to tell parents for sure that vaccines combined from different companies for different diseases will meet the safety threshold as a group given over sustained periods of
time in the first two years of life.

The vaccine discussion must continue because new vaccines are being lobbied everyday to be added to the CDC list of mandated vaccines. As parents we have an obligation
to educate ourselves and understand how vaccines get on the market. We are the voice of our children. If the scientists and clinicians can not answer our questions and have an honest debate over it, then we have nothing but a shell game going on.

There is no doubt that vaccines can save lives on an individual disease basis and prevent massive outbreaks of fatal disease. However, the CDC has an obligation to public safety and should force the drug companies to do the work to understand the interaction of vaccine dosing schedules, active and inert ingredients used in the manufacture of vaccines, and importantly answer supply chain questions (the recent heparin debate with ingredients sourced from China) should have made this issue crystal clear.

I do not want to hear that removal of thimerosal did not reverse autism rates, you can slice data to your advantage there. The fact is the number of vaccines given since thimerosal was removed has probably risen. Where is the data that charts the number of vaccines given under two years old against the number of autism cases? Where are our good scientific minds to think this through?

Can I Get The Flu Shot While Pregnant?

(I have noticed a lot of people coming to my blog from the "Can I get the flu shot while pregnant" search term. They have been referred to another post of mine, "Did You Get The Flu Shot While Pregnant". Feel free to visit that post, which is on mom's reports of long term damage done to their kids from getting the flu shot, but I thought I should write something that more directly speaks to this question:)

The CDC and it's Advisory Committee on Immunization Practices (ACIP) recommends the flu shot for pregnant women.

However, I believe that this is an irresponsible recommendation as the flu shot has not been safety tested on pregnant women.

And despite the fact that some of these flu vaccines are not for use in children, the CDC and ACIP have not issued a warning for pregnant women not to have them.

Additionally, despite repeated requests from parents of vaccine injured children, the CDC and ACIP will not state a preference for pregnant women to receive only Thimerosal free flu shots.

From the vaccine package inserts:

Fluarix (Thimerosal free):
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with FLUARIX. It is not known whether FLUARIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLUARIX should be given to a pregnant woman only if clearly needed. The ACIP has issued recommendations regarding the use of the influenza virus vaccine in pregnant women.

Nursing Mothers: It is not known whether FLUARIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUARIX is administered to a nursing woman. The ACIP has issued recommendations regarding the use of the influenza virus vaccine in nursing mothers.

Pediatric Use: FLUARIX IS NOT INDICATED FOR USE IN CHILDREN.


Flulaval (Contains Thimerosal):
Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with FLULAVAL. It is also not known whether FLULAVAL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLULAVAL should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether FLULAVAL is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLULAVAL is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of FLULAVAL in pediatric patients have not been established.


Flumist (Thimerosal Free):
Pregnancy: Pregnancy Category C Animal reproduction studies have not been conducted with FluMist. It is not known whether FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FluMist should be given to a pregnant woman only if clearly needed.
The effect of the vaccine on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rats receiving the frozen formulation. Groups of animals were administered the vaccine either once (during the period of organogenesis on gestation day 6) or twice (prior to gestation and during the period of organogenesis on gestation day 6), 250mcL/rat/occasion (approximately 110-140 human dose equivalents based on TCID50), by intranasal instillation. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or preweaning development were observed. There were no vaccine related fetal malformations or other
evidence of teratogenesis noted in this study.

Nursing Mothers: It is not known whether FluMist is excreted in human milk. Therefore, as some viruses are excreted in human milk and additionally, because of the possibility of shedding of vaccine virus and the close proximity of a nursing infant and mother, caution should be exercised if FluMist is administered to nursing mothers.

Pediatric Use: FluMist is not indicated for use in children <24 months of age. FluMist use in children <24 months has been associated with increased risk of hospitalization and wheezing in clinical trials [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].



Fluvirin (Contains Thimerosal)
Pregnancy: Pregnancy Category C
Animal reproduction studies have not been conducted with Influenza Virus Vaccine (FLUVIRIN®). It is also not known whether Influenza Virus Vaccine (FLUVIRIN®) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza Virus Vaccine (FLUVIRIN®) should be given to a pregnant woman only if clearly needed.
The clinical judgment of the attending physician should prevail at all times in determining whether to administer Influenza Virus Vaccine to a pregnant woman.

Pediatric Use: The safety and immunogenicity of FLUVIRIN® have been established in the age group 4 years to 16 years. The use of FLUVIRIN® in these age groups is supported by evidence from adequate and well-controlled studies of FLUVIRIN® in adults that demonstrate the immunogenicity of FLUVIRIN®. The safety and immunogenicity of FLUVIRIN® have not been established in children <4 years of age.



Fluzone (Comes in both Thimerosal Containing and Thimerosal Free):
PREGNANCY CATEGORY C
Animal reproduction studies have not been conducted with Influenza Virus Vaccine. It is not known whether Influenza Virus Vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza Virus Vaccine should be given to a pregnant woman only if clearly needed. For guidance regarding use in pregnant women, see INDICATIONS AND USAGE section.

PEDIATRIC USE: SAFETY AND EFFECTIVENESS OF FLUZONE VACCINE (SUBVIRION) IN INFANTS BELOW THE AGE OF 6 MONTHS HAVE NOT BEEN ESTABLISHED.

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.

NAA: Offering Grants For Marriage Counseling For Autism Parents

If you need counseling, apply.

If you don't, Donate. 100% of your donation here will go to NAA's Family First Fund.

From The National Autism Association:

WE ARE NOW ACCEPTING GRANT APPLICATIONS FOR OUR FAMILY FIRST PROGRAM.

BASED ON QUALIFICATIONS, GRANTS CAN NOW BE USED FOR LOCAL, FACE-TO-FACE MARRIAGE COUNSELING.

PLEASE SUBMIT ALL APPLICATIONS BEFORE JUNE 15TH, 2008.


FAMILY FIRST PROGRAM

The divorce rate within the autism community has been creeping up for quite some time. With the explosion in autism cases comes many more challenges with couples in our community. Family First was launched to provide couples within our community a way to access counseling on a 24/7 basis.

GOALS:
The four goals of the Family First Program are to:

1. Provide couples with access to counseling
2. Provide couples with financial aid for counseling
3. Raise awareness about the divorce rates within our community and around the country
4. Provide a solid support system for all autism couples

By focusing on these four objectives, our primary goal is to keep autism families together, which will open the door to a slew of other benefits for families including two-person income potential, less stress on just one parent, more time dedicated to therapy and treatments for the child, and the list goes on.

HOW YOU CAN HELP:

Create
There are so many ways we can help autism couples. Do you have a great idea that will work in your area? Here are some of the ways people from around the country are helping autism couples:

* Far Hills Community Church in Dayton, Ohio, offers a free “Date Nite” to autism couples. Could your church or support group do something similar in your area? See: http://farhills.org/events/datenight.html
* Free workshops are happening in places like Tennessee and North Carolina. Could you hold a free couples workshop in your area?


Donate
The National Autism Association is a non-profit, parent-run organization. The Family First Program is just one of the many projects we fund and coordinate to make a positive difference within the autism community. Through our voucher program, your donations would help us provide couples with the financial aid they need to obtain marital counseling. As always your donation is tax-deductible.

To donate, please visit: http://www.nationalautismassociation.org/proddetail.php?prod=FamilyFirstDonation

March 13, 2008

The Beginning of the End of Vaccine/Autism Secrecy

If this does not signal the new direction that things are going... I don't know what does. The man overseeing the Vaccine Injury court is inviting David Kirby and possibly some of his detractors, to have a chat about autism and vaccines in front of lots and lots of judges.

The light shining on all this is getting brighter and brighter.

From David Kirby:

I have been contacted by Justice Gary Golkiewicz, the Chief Special Master of the US Court of Federal Claims, who personally called to invite me to speak at the Court’s Annual Judicial Conference, to be held on November 19 in Washington, DC.

I will be on a panel to discuss the Autism Omnibus Proceedings (I imagine by then there will be more Hannah Polings in the headlines by then) and its impact on the vaccine-autism debate in the country.

I think it’s safe to say that the court’s impact, so far, has been considerable.

Dr. Roy Grinker and Arthur Allen were mentioned as other possible panel members, and I welcome their participation at the conference. I imagine it will be a well-attended and interesting discussion.

I know it’s quite some time from now, but it just got confirmed and I thought you all might like to know.

PS: Stay tuned, there is another big news story coming out next week that should stir up the airwaves all over again.


Cheers

DK

March 12, 2008

Today Show Part 1: Autism Mom and Meningitis Mom Agree

...that not every vaccine is safe for every child.

Honey Renecella, mother of twins with vaccine induced autism and Suzanne Walter, mother of a girl whom she did not vaccinate who subsequently contracted meningitis, appeared together on The Today Show yesterday to tell their stories and talk about vaccine safety.

I am not sure if the show's bookers were expecting a cat fight, but what they got was anything but...



See The Today Show Part 2 to see Honey try to hold in her anger at the statements of head of the AAP who claims that all vaccines are for every child.

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)

CJR: The Wrong Debate Over Autism

IMHO: Mr. Juskalin misses the point a bit here.

Instead of "Why focusing on thimerosal misses a larger story", I think it would be more accurate to say, "Why focusing on thimerosal is the tip of a larger story"

Most autism looks to be derived from a toxic insult, of which vaccines are likely the worst offender, and of the ingredients of which mercury is most likely the worst offender.

The questions at the conclusion are important, but they have pretty much been answered. And those answers are leading to recovered children. It is hard to argue with results.


The Wrong Debate Over Autism
Why focusing on thimerosal misses a larger story

By Russ Juskalian Tue 11 Mar 2008 10:51 AM

Columbia Journalism Review

Back in 2005, CJR published a story by Daniel Schulman about media coverage of "whether a mercury-containing vaccine" preservative called thimerosal was to blame for an alarming spike in autism cases among a generation of children. Last summer, yet another study was released that showed no link between autism and vaccinations, and last week came news of a lawsuit settlement that required a girl's medical costs to be covered by the government after she was diagnosed with a rare mitchochondria disorder and autistic symptoms related to receiving nine vaccinations in one day. Clearly, the debate rages on, so we decided to take another look at the press-coverage landscape.

Schulman concluded in his piece that the media had been too quick to close the door on the potential link between thimerosal and autism. "[W]ith science left to be done and scientists eager to do it, it seems too soon for the press to shut the door on the debate," he wrote. He cited stories like a New York Times piece by Gardiner Harris and Anahad O'Connor in June of the same year, with the headline: "On Autism's Cause, It's Parents vs. Research".

Schulman, now an editor at Mother Jones, noted that while the vast majority of studies appeared to disprove a vaccine link to autism, there were serious researchers (notably Dr. Mady Hornig and Dr. Ezra Susser, both epidemiologists at Columbia's Mailman School of Public Health; Richard Deth, a Northeastern University pharmacologist; and Jill James, a professor of pediatrics at the University of Arkansas) who supported the possibility that environmental factors—and perhaps thimerosal in vaccinations—could at least be triggers for autism in predisposed populations that might otherwise not have developed the disorder.

(It's a lot like the global warming debate in reverse: almost every major study said there was no credence to the autism-vaccine link, but there were, and still are, a few credible voices out there saying the case isn't closed.)

So, where are we now?

Last summer, a report on vaccinations and neurological problems in children was published in the New England Journal of Medicine and the vaccine-autism debate got a little more fuel. Depending on which side of the fence you stand, the argument can be made that coverage of this report was good or bad. Autism is a touchstone issue, so it was often mentioned in headlines and stories, even if only to note that the study itself was not focused on autism.

A sample of stories and headlines from September 27, 2007, paints a picture:

Newsday: "CDC: Vaccines are safe; Though autism was not a focus, study says mercury preservative in shots did not cause neurological problems"

Federal health officials yesterday reassured parents that childhood vaccines are safe and that kids who got routine immunizations a decade ago when shots contained a controversial mercury preservative are not at risk of neurological problems….An investigation examining autism and thimerosal, the preservative that once was added to common vaccines, is expected to be published within 12 months, scientists at the Centers for Disease Control and Prevention said yesterday.

The New York Times: "Vaccine Compound Is Harmless, Study Says, as Autism Debate Rages"

Yet another study has found that a controversial vaccine preservative appears to be harmless. But the study is unlikely to end the increasingly charged debate about vaccine safety.

The Globe and Mail (Canada): "Vaccine preservative can cause tics; But according to U.S. research, thimerosal does not appear harmful to kids' learning skills or physical abilities"

"The scientific literature to date does not support a causal link between autism and thimerosal, but it's important to say this study isn't of autism," she said. "There's a separate CDC study ongoing that's going to get at that question to provide more information."

Even more recently, the issue of an autism-vaccine link came up in response to a settlement involving the government and nine-year-old Hannah Poling. Poling started showing symptoms typical of autism shortly after receiving a bundle of vaccinations when she was a toddler. The government decided that Poling's vaccinations, given on top of a rare metabolic disorder, caused her problems.

The headlines this time covered broader ground: KHBS Fort Smith, "Vaccine-Autism Link Unproven By Controversial Georgia Case"; Atlanta Journal-Constitution, "Ga. girl helps link autism to childhood vaccines"; The New York Times, "Deal in an Autism Case Fuels Debate on Vaccine".

Not even John McCain could let this one go by as was noted by Benedict Carey in the Times, in a piece titled, "Into the Fray Over the Cause of Autism":

"It's indisputable that autism is on the rise among children," Senator John McCain said while campaigning recently in Texas. "The question is, What's causing it? And we go back and forth, and there's strong evidence that indicates that it's got to do with a preservative in vaccines."

With that comment, Mr. McCain marked his entry into one of the most politicized scientific issues in a generation.

It appears that Schulman was on to something when he claimed the media had taken too narrow a tack on the autism-vaccine link issue. But he, too, may have had his keyboard aimed in the wrong place.

The problem with the coverage was not that the few credible opposition voices didn't receive balanced coverage, but rather that the whole issue of whether vaccines containing thimerosal or mercury cause autism served as a distraction from the ongoing efforts to tease apart the causes of this enigmatic disorder. That's not to say the vaccine issue shouldn't be covered at all, but that there are many more important—if less emotionally driven—questions related to autism that deserve further investigation.

Is autism caused by environmental factors? Can it be triggered by these factors? How does epidemiology try to solve these riddles? Are some people genetically predisposed to respond to environmental factors (like mercury)? Can we find a way to screen for these predispositions (like Poling's metabolic condition)? What else is in our environment that poses a risk?

Lest we forget about the long list of environmental contaminants that have been pointed out going back to Rachel Carson's Silent Spring, the AP just released its own investigation that found a wide array of pharmaceuticals in tap water across America. A potent reminder that while important, the vaccination story is only one part of a bigger issue.

Schulman is right about one thing: when we simplify science to "yes" or "no" questions the repercussions can be dangerous. And simply because a few scientist are in the minority does not mean their careers and their work should be dismissed with the wave of a hand.

We may never find an answer to the autism-vaccine debate that satisfies everyone—and that's okay. Science pushes on, and the myriad questions about autism will continue to be researched long after the last mercury-containing inoculation is administered.

March 11, 2008

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