"I'm Just A Bill"

As the Schoolhouse Rock song goes, the NJ bill to ban thimerosal in vaccines (A1324/S618) is moving along, finally out of committee today.

I'm just a bill.
Yes, I'm only a bill.
And I'm sitting here on Capitol Hill.
Well, it's a long, long journey
To the capital city.
It's a long, long wait
While I'm sitting in committee,
But I know I'll be a law some day
At least I hope and pray that I will
But today I am still just a bill.
- "I'm Just A Bill" (Frishberg/Sheldon, 1975)

A1324, sponsored by Assemblyman Peter Biondi (R-Somerset) is officially titled, "Eliminates use of vaccines containing mercury over three years." It effectively removes thimerosal, the ethyl mercury preservative, from all vaccines after a phase-out period. I had the great privilege of testifying in support of the bill when it was first introduced in committee in March, and to be there again today in Trenton when it was voted out of the Assembly Health and Senior Services Committee. While thimerosal has not been conclusively linked to autism, there is data that connects the mercury preservative to clear biological disruption. And no one has, or ever will, prove it is completely safe. Below, I've listed the salient points from my testimony.
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1.
Thimerosal (aka thiomersal, merthiolate) is an organic ethyl mercury compound, used since the 1930’s as a preservative for vaccines. Toxicity studies done in animals prior to human use resulted in tremendous morbidity and mortality, and there are no records available of “any (human) clinical studies formally evaluating the safety of thimerosal before its initial marketing.”(1) In fact, all subjects in the first report of human use (1931, 22 adults with meningitis) subsequently died. If it were proposed for FDA approval today, it would be ridiculed.
2.
According to the CDC’s ATDSR (Agency for Toxic Substances and Disease Registry): “The nervous system is very sensitive to all forms of mercury…Very young children are more sensitive to mercury than adults. Mercury in the mother's body passes to the fetus and may accumulate there. It can also pass to a nursing infant through breast milk.”(2)
3.
Thimerosal, even in micro molar amounts, has been demonstrated in multiple studies to result in significant disruption in cellular metabolism, leading to immune dysregulation, neurotoxicity and cell death. (7-19)
4.
The American Academy of Pediatrics, in a 1999 joint statement with the US Public Health Service Agencies, declared that “because any potential risk is of concern, the US Public Health Service (USPHS), the American Academy of Pediatrics (AAP), and vaccine manufacturers agree that thimerosal-containing vaccines should be removed as soon as possible.”(3)
5.
In 2000, the AAP and associated groups reaffirmed their commitment to the above statement, commenting, “The AAFP, AAP, and the PHS in consultation with the ACIP reaffirm the goal set in July 1999 to remove or greatly reduce thimerosal from vaccines as soon as possible for the following reasons: 1) the removal or substantial reduction of thimerosal from vaccines is feasible, 2) the progress in removal which has been made to date is substantial, 3) the discussions between the Food and Drug Administration and the vaccine manufacturers in removing thimerosal are ongoing, and 4) the public concern about the use of mercury of any sort remains high. Based on information from the FDA and manufacturers, the PHS projects that the United States will complete its transition to a secure routine pediatric vaccine supply free of thimerosal as a preservative by the first quarter of 2001.”(4)
6.
In 2001, the AAP issued two relevant reports. The first, a technical report titled “Mercury in the Environment,”(5) concluded that “mercury in all of its forms is toxic to the fetus and children, and efforts should be made to reduce exposure to the extent possible to pregnant women and children as well as the general population.” The second, “An Assessment of Thimerosal Use in Childhood Vaccines,”(1) discusses consequences of toxic reactions to thimerosal, including neurotoxicity and nephrotoxicity, and points out that “some infants may be exposed to cumulative levels of mercury… that exceed EPA recommendations. Exposure of infants to mercury in vaccines can be reduced or eliminated by using products formulated without thimerosal as a preservative.”
7.
Even though most routinely recommended pediatric vaccines are now thimerosal-free, which demonstrates that manufacturers can produce adequate supplies, the advised flu vaccine schedule will results in millions of children receiving thimerosal in excess of government standards. The EPA limit is 0.1 mcg/kg(6), which means that the 12.5 mcg in infant doses (0.25 ml, for those under 3 yrs old) is safe if you’re a baby weighing 275 pounds or more. Furthermore, the first time a child receives a flu under 9 years old, they are advised to get a second dose one month later. That’s 25 mcg total for those between 6 months and 3 years old, safe for any child weighing 550 pounds or more. Children between 3 and 9 years old will receive either 25 mcg (1 dose) or 50 mcg (2 doses for first timers), the latter considered safe for any child weighing 1100 pounds or more. We can produce thimerosal-free flu vaccine, and all new vaccines introduced in the past two years are thimerosal-free. In any case, A1324 allows for use of thimerosal in case of catastrophic emergency to insure vaccine supply.
8.
Opponents to A1324 claim that passing this legislation will result in reduced confidence in vaccine policy and supply, thereby leading to reduced compliance with immunization. It is my opinion, based on conversations with many families and primary care physicians that this legislation will result in increased trust and confidence in our ability to produce optimally safe vaccines, and will ultimately lead to increased compliance with immunization policy.
9.
In summary, data and published statements support the legislative ban of thimerosal for human use. While we do not have, and are unlikely to have, conclusive evidence that human disease can be directly linked to vaccines containing thimerosal, we do not have, nor will we ever have, proof that thimerosal is safe for biological use. As a pediatrician, a parent, and a proud citizen of New Jersey, I urge you, in the strongest terms, to support A1324.

Lawrence D. Rosen, MD, FAAP
May 11, 2006

Scientific References:
1. Ball LK, et al: An assessment of thimerosal use in childhood vaccines. Pediatrics 107: 114-1154, 2001.
2. ATSDR ToxFAQs™ for Mercury: http://www.atsdr.cdc.gov/tfacts46.html
3. CDC: Thimerosal in vaccines: a joint statement of the American Academy of Pediatrics and the Public Health Service. MMWR 49: 563-565, 1999. Also published as AAP Committee on Infectious Diseases and Committee on Environmental Health: Thimerosal in vaccines – an interim report to clinicians. Pediatrics 104: 570-574, 1999.
4. Joint Statement Concerning Removal of Thimerosal from Vaccines, June 22, 2000: http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/joint_statement_00.htm
5. Goldman LR, et al: Technical Report: Mercury in the environment: implications for pediatricians. Pediatrics 108: 197-205, 2001.
6. U.S. Environmental Protection Agency on Mercury: http://www.epa.gov/mercury/exposure.htm
7. Herdman ML, et al: Thimerosal Induces Apoptosis in a Neuroblastoma Model Via the cJun N-Terminal Kinase Pathway. Toxicol Sci. 2006 Apr 19; [Epub ahead of print]
8. Yel L, et al: Thimerosal induces neuronal cell apoptosis by causing cytochrome c and apoptosis-inducing factor release from mitochondria. Int J Mol Med. 2005: 16(6):971-7
9. Chang HT, et al: Thimerosal-induced cytosolic Ca2+ elevation and subsequent cell death in human osteosarcoma cells. Pharmacol Res. 2005 Oct; 52(4):328-33.
10. Humphrey ML, et al: Mitochondrial mediated thimerosal-induced apoptosis in a human neuroblastoma cell line (SK-N-SH). Neurotoxicology. 2005 Jun; 26(3):407-16.
11. Parran DK, et al: Effects of thimerosal on NGF signal transduction and cell death in neuroblastoma cells. Toxicol Sci. 2005 Jul; 86(1):132-40.
12. Ueha-Ishibashi T, et al: Flow-cytometric analysis on cytotoxic effect of thimerosal, a preservative in vaccines, on lymphocytes dissociated from rat thymic glands. Toxicol In Vitro. 2005 Mar; 19(2):191-8.
13. Baskin DS, et al: Thimerosal induces DNA breaks, caspase-3 activation, membrane damage, and cell death in cultured human neurons and fibroblasts. Toxicol Sci. 2003 Aug; 74(2):361-8.
14. Makani S, et al: Biochemical and molecular basis of thimerosal-induced apoptosis in T cells: a major role of mitochondrial pathway. Genes Immun. 2002 Aug; 3(5):270-8.
15. Burbacher TM, et al: Comparison of blood and brain mercury levels in infant monkeys exposed to methylmercury or vaccines containing thimerosal. Environ Health Perspect 113: 1015-1021, 2005.
16. Goth SR, et al: Uncoupling of ATP-mediated calcium signaling and dysregulated IL-6 secretion in dendritic cells by nanomolar thimerosal. Environ Health Perspect, April 2006, in press.
17. Hornig M et al: Neurotoxic effects of postnatal thimerosal are mouse strain dependent. Mol Psychiatry 9: 833-845, 2004.
18. James SJ, et al: Thimerosal neurotoxicity is associated with glutathione depletion: protection with glutathione precursors. NeuroToxicology 26: 1-8, 2005.
19. Waly M, et al: Activation of methionine synthase by insulin-like growth factor-1 and dopamine: a target for neurodevelopmental toxins and thimerosal. Mol Psychiatry 9: 358-370, 2004.

Comments

[MaryH]

Thank you so much for giving your testimony, Dr. Rosen! You are setting a great example for pediatricians to learn to care about the whole child.
Mary Hernandez