To be continued…discussion, articles, references and more!

Gardasil trials update–“New Medical Conditions”

Gardasil trials update–“New Medical Conditions”

By Cynthia A. Janak

…I found an interesting document on the FDA website about my favorite topic, Gardasil.

Subject: Clinical Review of Biologics License Application Supplement for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil®) to extend indication for prevention of vaginal and vulvar cancers related to HPV types 16 and 18.

Dated September 11, 2008


This document is 187 pages long and I was scanning this document for adverse events. I did find something interesting starting on their page 132; it was Table 73, titled “New Medical Conditions” Days 1–15…

The total study participants were 5088 for Gardasil and 3790 for the Placebo. (Now let us remember that this group includes the Alum and carrier solution placebos.) The participants that they were able to follow-up with were 5012 for Gardasil and 3725 for the Placebo group.

What caught my eye with this table was the fact that these participants did not have these conditions prior to the study. I surmise this because of the title “New Medical Conditions”. So in essence these individuals were probably healthy average people with active lives and families.

Here is what I found.


Gardasil trials update–“New Medical Conditions”

Gardasil trials update–“New Medical Conditions”

Deirdre Imus: How Do I Find a Green Pediatrician?

Deirdre Imus: How Do I Find a Green Pediatrician?

…Today I found a great link at Deirdre Imus’ website to the “Integrative Pediatrics Council” HERE which provides a list of “green” pediatricians throughout America (and one in Canada.)

The Pentagon — A Voice of Reason on Vaccines and Autism?

The Pentagon — A Voice of Reason on Vaccines and Autism?

David Kirby

Recently, several documents have been brought to my attention which, when viewed together, suggest that the Department of Defense has legitimate concerns about vaccine injuries and their possible connection to autism, perhaps more so than other branches of the Federal Government.

These documents raise several questions that I am currently trying to get answered from DOD officials:

1) Autism may be an “adverse event” of Tripedia (DTaP) use

According to the website of the Vaccine Healthcare Centers Network, run by DOD and CDC, autism is listed as an “adverse event” associated with use of the Tripedia triple vaccine for diphtheria, tetanus and pertussis.

My questions are: Why does autism appear here? Does VHC consider autism to be a possible adverse event of DTaP use, or has it simply been reported that way by parents?

2) Patients who have bad vaccine reactions should avoid multiple vaccines in the future

According to this VHC slide, any patient who has a “Systemic Event” following immunization – defined as “symptoms and signs of illness after vaccination” and “any reaction that does not involve the injection site” – should avoid multiple vaccines in the future, if possible.

My questions are: Is that standard DOD policy? Is there an alternative schedule for these patients? Does this advice apply to children of service members as well? Why is this information not shared with civilian doctors and pediatricians?

3) Patients who develop serious neurological diseases might need vaccine exemptions in the future

This VHC slide says that a patient who develops a severe neurologic disease following vaccination might need temporary or permanent exemption from future vaccines. Such diseases include peripheral neuropathy, encephalopathy (including autism, presumably) Guillain-Barré syndrome and progressive focal neurologic disease. Such patients should be given temporary exemptions from future vaccinations.

Meanwhile, risks for recurrent reactions should be assessed before additional doses are given, and “permanent vaccine exemption may be required.”

Again, is this DOD policy? Are such exemptions given? Because autism is listed as a “severe neurological disease,” would those patients (ie, children of service members) also be exempt from future vaccinations? And, on a related note, does VHC consider autism to be a “neurological disease,” as opposed to a developmental/behavioral disorder?

4) Mercury, and possibly thimerosal may cause autism and dementia

According this slide (#22) on the vaccine preservative thimerosal, from the Armed Forces Institute of Pathology (AFIP), “exposure to mercury in utero and children may cause mild to severe mental retardation and mild to severe motor coordination impairment.” The slide also seems to indicate that autism and dementia might questionably be “health effects” of mercury or thimerosal exposure.

My question is: Why does autism appear on a list of health effects on a slide about thimerosal, even if it is followed by a question mark?

5) Alternative biomedical treatments may be prescribed for thimerosal exposure

The same slide says that “treatments” for thimerosal exposure include: “Methyl-B12, ointment DMPS, & glutathione (GSH).” These are all alternative (some would say fringe, radical and dangerous) treatments being used today by thousands of autism parents and their children’s physicians, with varying degrees of success (including reports of full recovery).

Methyl-B12 – has been shown to repair damage to the process of methylation, and to restore methionine and glutathione levels in patients with autism to within normal ranges.

DMPS – is a sulfur-based amino acid used in the process of chelation – in which sulfur molecules bind with heavy metals such as mercury, and eliminate them from the system.

Glutathione – is a sulfur-based protein that binds with heavy metals and eliminates them from the system. It is also a powerful anti-oxidant. Many children with autism show signs of glutathione depletion, heavy metal accumulation and oxidative stress.

My questions are: Was the speaker simply refering to treatments that some people have tried, or is the AFID endorsing these treatments for thimerosal toxicity and/or autism? On what evidence is this based? Are Methyl B-12 and GSH, like chelation, considered standard of care in the military for mercury toxicity? Can you explain why autism families in the military have these treatments covered, (at thousands of dollars a year), even if they also have an autism diagnosis? Is this why military insurance will pay for visits to doctors in the Defeat Autism Now network, which advocates the use of these non-traditional treatments?

I eagerly await the replies from VHC and AFID officials, and will update this blog as soon as I hear anything.

Meanwhile, regardless of the Pentagon’s positions on the above questions, we know for certain that DOD is concerned about the risk of injury from multiple vaccines.

In fact, it may even need to reconsider the practice.

“We have preliminary findings from one of our many on-going research studies that suggest a relationship between adverse events and multiple vaccinations exist,” US Army Colonel Renata J. M. Engler, MD, director of the VHC, (a “collaborative network” of the Defense Department and the CDC), wrote to Rep. Carolyn Maloney (D-NY). “These findings will require validation, but heighten our concern for the current clinical practice of multiple vaccinations.”

“The more drugs one is exposed to, the greater the likelihood of having an adverse event so as vaccine numbers increase, and (sic) we will see more people who have efficacy or safety issues,” Col. Engler said. “The standard of care (ie, in the context of mixing vaccines) is to minimize drug exposures because of the recognition that the more drugs being used, the greater the chance of a reaction and potentially a serious adverse event.”

I wonder when the CDC and America’s pediatricians will issue an equally thoughtful and cautionary statement, instead of their usual reassurance that small children can easily get 100,000 shots at once, without a single “serious adverse event” among them.


Age of Autism

VHCN  _the page that is now under revision you can view here.

Toy Warning

Some Products on Shelves this Holiday Season Will be Illegal to Sell in February

One in Three Children’s Toys Tested by http://www.healthytoys.org/ Found to have Significant Levels of Toxic Chemicals Including Lead, Flame Retardants, and Arsenic.

Lead was detected in 20% of the toys tested this year.  In fact, lead levels in some of the products were well above the 600 parts-per-million (ppm) federal recall standard used for lead paint, and will exceed the U.S. legal limit in February, according to the new Consumer Product Safety Commission (CPSC) regulations.  Levels of lead in many toys were significantly above the American Academy of Pediatrics recommended ceiling of 40 ppm of lead in children’s products.  Children’s jewelry remains the most contaminated product category, maintaining its spot at the top of HealthyToys.org’s “worst” list.

The CPSC regulations, which go into effect in February 2009, would make certain products on the shelf this holiday season illegal to sell two months from now.  Experts insist that these new regulations, while a good first step, do not go nearly far enough to protect our children.

“There is simply no place for toxic chemicals in children’s toys,” said Ecology Center’s Jeff Gearhart, who led the research. “Our hope is that by empowering consumers with this information, manufacturers and lawmakers will feel the pressure to start phasing out the most harmful substances immediately, and to change the nation’s laws to protect children from highly toxic chemicals.”

In addition to allowing parents to search by product name, brand, or toy type to see if certain toys have toxic chemicals, the newly-redesigned site also allows visitors to create a personalized holiday wish list that can be sent to family and friends, and a blog-friendly widget to quickly search the toy ratings.

Researchers tested for chemicals that have been associated with reproductive problems, developmental and learning disabilities, hormone problems and cancer; and for those that have been identified by regulatory agencies as problematic.  Babies and young children are the most vulnerable populations because their brains and bodies are still developing, and because they frequently put toys into their mouths.  The testing was conducted with a screening technology – the portable X-Ray Fluorescence (XRF) analyzer – that identifies the elemental composition of materials on or near the surface of products.

Highlights from the HealthyToys.org 2008 findings:

  • Lead is Still in Toys – HealthyToys.org found lead in 20% of all the products tested this year, including 54 products (3.5%) that exceed the current 600 ppm recall threshold for lead-based paint, and the soon-to-be national standard for all children’s products.  When children are exposed to lead, the developmental and nervous system consequences can be irreversible.  The American Academy of Pediatrics has recommended a level of 40 parts per million (ppm) of lead as the maximum that should be allowed in children’s products.
  • It’s Not Just China – HealthyToys.org has not found a consistent correlation between the country of manufacture and the presence of toxic chemicals in toys.  21% of toys from China and 16% of those from all other countries had detectable levels of lead in 2008.  17 toys manufactured in the U.S. were sampled and 35% of those had detectable levels of lead.  Two toys had levels above 600 ppm.  Among the highest lead levels detected in HealthyToys.org (190,943 ppm) was in a Halloween Pumpkin Pin made in the USA.
  • It’s Not Just Lead – HealthyToys.org found a significant number of toys containing cadmium, mercury, arsenic, and bromine.  2.9% (45 products) had bromine at concentrations of 1,000 ppm or higher.  This indicates the likely use of brominated flame retardants — chemicals that may pose hazards to children’s health.  Other toxic chemicals found in toys include arsenic, cadmium, and mercury.  Arsenic was detected at levels greater than 100 ppm in 22 or 1.4% of products; 289 (18.9%) of products contained detectable levels of arsenic.  Cadmium was found above 100ppm in 30 (1.9%) of products; 38 (2.4%) of products contained detectable levels of cadmium.  Mercury was found above 100 ppm in 14 (1%) of products; 62 (4.2%) of products contained detectable levels of mercury. 
  • Polyvinyl Chloride (PVC / Vinyl) – HealthyToys.org identified products made with PVC plastic by measuring their chlorine content.  PVC is a problematic plastic because it creates major environmental health hazards in its manufacture and disposal and may contain additives, including phthalates, that may pose hazards.  27% of toys (excluding jewelry) tested this year by HealthyToys.org were made with PVC.
  • Jewelry – Jewelry remains the most contaminated product category tested.  Children’s jewelry is five-times more likely to contain lead above 600 ppm than other products.  15% of jewelry samples (compared to 3% of other products) had lead levels above 600 ppm.  Overall, jewelry is twice as likely to contain detectable levels of lead as other products.  Numerous Hannah Montana brand jewelry items tested high for lead.  HealthyToys.org recommends that consumers avoid low cost children’s jewelry.
  • The Good News – The good news is that 62% (954) of the products tested contain LOW levels of chemicals of concern, and 21% (324) of all products contain NO chemicals of concern.  These products look and feel no different than other children’s products on the shelf.  These findings show that manufacturers can and should make toys free of unnecessary toxic chemicals.