|2004P-0349 - Action on Products containing added Mercury|
|FDA Comment Number :||EC12|
|Submitter :||Mr. Jeff Sell||Date & Time:||09/23/2004 06:09:49|
|Organization :||Autism Society of America|
| We have an epidemic of Autism in this nation that must be addressed. We must leave no stone unturned in our efforts to understand its causes and prescribe proper treatments. The human toll and costs of this epidemic are staggering, and will worsen if we fail to direct the necessary attention and resources to this national problem.
The Department of Health and Human Services (HHS) issued an Autism A.L.A.R.M. earlier this years to the nation?s pediatricians urging them to conduct better screenings of children so that children with Autism and other developmental disabilities can be diagnosed earlier, and therefore interventions can
begin early. That ALARM stated that one out of every 163 children has an autism spectrum disorder.
While I am very supportive of our nation?s vaccine program, I also believe that we can do a much better job of monitoring the safety of our vaccines. We must engage in a more aggressive review of adverse reactions - both acute and chronic adverse reactions. This has been severely lacking for years.
That means continual monitoring for adverse reactions, specific research to understand why some children have adverse reactions, and ensuring independent oversight of vaccine safety research to ensure that this research is free from real and perceived conflicts of interest.
The agency with the greatest responsibility in monitoring for adverse vaccine reactions, the Centers for Disease Control, has significant conflict of interest that may inhibit their ability to conduct independent and unbiased research. Also, it appears that no federal agency has undertaken an aggressive enough research effort to help us better understand and avoid serious adverse reactions.
In July 1999, the U.S. Public Health Service and the American Academy of Pediatrics issued a joint statement, which was later endorsed by the American Academy of Family Physicians, proclaiming: ``[The] Public Health Service, the American Academy of Pediatrics, and vaccine manufacturers agree that thimerosal-containing vaccines should be removed as soon as possible.? As you know thimerosal is 50% ethylmercury.
In 2000 these groups reaffirmed this statement.
Then, in 2001, the Institute of Medicine concluded that ?exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders.? The IOM recommended that children not be given mercury-containing vaccines. Rather than implementing this policy immediately as was recommended by the IOM, this policy was gradually implemented, as mercury was phased-out. This phasing-out allowed many more children in the early part of this decade to receive high levels of mercury from pediatric vaccines. By early 2003, very few mercury containing childhood vaccines remained on the shelves.
-Mercury from childhood vaccines continues to be a possible culprit:
The CDC?s own study ? four years in the making - was unable to specifically exonerate mercury.
-Mercury is a neurotoxin and is particularly harmful to the developing central nervous system of fetuses and infants.
The Deth study, published in Molecular Psychiatry earlier this year showed that concentrations of thimerosal of 1nm were inhibitory of critical enzymes involved in neurodevelopment.
-Studies of children with Autism continue to show high levels of mercury ? chelation studies show that children with autism excrete high levels of mercury compared to normal controls, suggesting that these children might have a problem handling mercury.
Given these concerns about mercury and the possibility that vaccine exposures to mercury may have been a contributing factor in the epidemic of
| autism and neurodevelopmental disorders, it is critical that we err on the side of caution. We have the ability to eliminate this mercury exposure for infants and we should do so. Please use good sense.|