Thursday, September 17, 2009

What is FDA Thinking? Hep B Vaccine for New Borns Contains 10 Times the Allowed Level of Aluminum in IV Drugs

An article about a new study showing a correlation between Hep. B vaccine in new borns with elevated risk of Autism prompted me to do some research on the amount of aluminum in this vaccine. I was HORRIFIED! Read the article here.

The study most strongly implicated Energix brand with the elevated risk. According to NIH on the Energix Hepatitis B vacine, "Each 0.5-mL dose contains 10 mcg of hepatitis B surface antigen adsorbed on 0.25 mg aluminum as aluminum hydroxide." according to NIH http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10573

The conversion = .25mg equals 250 mcg

So that's a one time injection of 250 mcg aluminum in a new born baby. Now let's see what FDA says about aluminum exposure in hospital IVs.

"...FDA recommends that premature babies, and anyone with impaired kidney function, receive no more than 10 to 25 mcg of injected aluminum at any one time," according to Dr. Sears in his article "Is Aluminum the New Thimerosal?" http://www.mothering.com/health/aluminum-new-thimerosal

UNBELIEVABLE... Again 250mcg on day one of life in Engerix!

Also, according to Dr. Sears, “...The second document discusses aluminum content in IV feeding solutions, or Total Parenteral Nutrition (TPN) solutions. The FDA requires these solutions to contain no more than 25 mcg of aluminum per liter of solution. A typical adult in the hospital would get around 1 liter of TPN each day, thus about 25 mcg of aluminum.”

Again 250mcg on day one in Engerix vs a limit of 25mcg/liter in an IV solution for an adult! WHAT!!? How the hell does FDA justify this?

I didn’t even quote the study findings from Dr Sears article regarding nervous system damage caused by aluminum toxicity. If you haven’t read this article I highly recommend it. Here

There are no studies evaluating the safety of aluminum in vaccines.

The 16 studies the government always references, that supposedly prove vaccine don't cause autism, are all based on either one vaccine (MMR) or one ingredient (Thimersal/Mercury). These studies are all epidemiological and many, including Dr. Bernadine Healy, former Dir of NIH, say epidemiology will not find subsets of susceptible population. Here

So with regard to thimerosal (mercury), which was formerly in the Hep B vaccine at levels far exceeding EPA standards for one day exposure, Hep B contained an excessive amount (according to EPA standards) prior to sometime after 2002 (we don't know when stockpiles of thimerosal containing vaccine ran out.) Would this study not also potentially implicate thimerosal or the use of thimerosal with aluminum simultaneously?

Note: There are implications that Hep B vaccine may cause (autoimmune) Rheumatoid Arthiritis in a subset of the population
WHO - http://www.who.int/vaccine_safety/topics/hepatitisb/rheumatoid_arthritis/Dec_2007/en/index.html
Oxford Journals, Rhematology - http://rheumatology.oxfordjournals.org/cgi/content/abstract/38/10/978

4 comments:

Joseph said...

"...FDA recommends that premature babies, and anyone with impaired kidney function, receive no more than 10 to 25 mcg of injected aluminum at any one time," according to Dr. Sears in his article "Is Aluminum the New Thimerosal?"

Dr. Sears lied. The FDA regulation that he hints at deals only with aluminum concentration in IV solutions, and is not 25 mcg, but 25 mcg/L.

Also, our bodies excrete metals pretty effectively. Problems usually only arise when you're getting long-tern exposure, and when the rate of that exposure is greater than the rate of the body's excretion. For this reason, guidelines for long-term exposure are stricter than guidelines for single doses. So, it makes sense that the guideline for IV fluids is going to be stricter than the guideline for vaccines.

Also, the method of delivery is different. Intramuscular injections (i.e. vaccines) have a much slower absorption rate than IVs.

Anyways, I hope this information is helpful.

Thing1Thing2Mom said...

Joseph

Dr. Sears did not lie. I miss quoted him by leaving out the "/L". Even when calculating by body wight the roughly 350 to 12oo mcg of aluminum that an infant receives (based on combination of brands) in the 2, 4 and 6 month well baby visits FAR exceed 25mcg/L of body wieght.

The point remains the same. We do not have safety studies on injected aluminum. Also, you are incorrect in saying, "So, it makes sense that the guideline for IV fluids is going to be stricter than the guideline for vaccines." There are no guidelines for heavy metals in vaccines. Which is a problem and frankly OUTRAGEOUS!

You also state,
"...our bodies excrete metals pretty effectively. Problems usually only arise when you're getting long-tern exposure, and when the rate of that exposure is greater than the rate of the body's excretion."

We have inadequate scientific data comparing individual abilities to excrete heavy metals. It stands to reason that genetic susceptibility would leave some people with a less effective ability to detox.

And speaking of long term exposure, through childhood vaccines children receive up to 4,925 mcg aluminum by 18 months.

From Aluminum in Vaccines: A Neurological Gamble, "In 1997 the New England Journal of Medicine published data showing that premature babies injected with aluminum build up toxic
levels in the blood, bones and brain, and that aluminum toxicity can lead to neurological damage, including mental handicaps at 18 months of age."

For more on aluminum exposure in vaccines with scientific citation see, http://www.thinktwice.com/aluminum.pdf by Neil Z. Miller

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