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	a quiet place by peggy o'mara

Mercury Must Be Removed From Childhood Vaccines - Now!
Issue 125

You will face a difficult decision this fall when the influenza vaccine becomes part of the Recommended Childhood and Adolescent Immunization Schedule in the United States. As of April, the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the National Foundation for Infectious Diseases (NFID) have called for annual flu vaccination for all infants and toddlers 6 through 23 months of age, as well as for household contacts and out-of-home caregivers of all children under two. These new recommendations were published in the April 30 issue of the CDC's and on the AAP website.

These organizations want to vaccinate children broadly in order to reduce morbidity, but also as part of pandemic planning. Fear of viruses such as the avian flu fuels this recommendation. Children younger than two are the ones most likely to get a new virus and are also the ones most likely to shed it. For the last three years, these health groups have been encouraging physicians to recommend flu vaccine as routine for younger patients. They know from their experience with the varicella vaccine-which took eight years to reach 80 percent compliance-that it can take time to gain the cooperation of doctors and parents when a new vaccine is introduced.

Also of concern to these groups is the limited amount of flu vaccine that may ultimately be available. Unlike other vaccines, influenza vaccine is made from a new culture every year, and the demand must be estimated ahead of time. Often, we run out of flu vaccines and people panic. Conversely, if the public doesn't like a new vaccine, overproduction must be discarded, at a loss to the manufacturer.

Vaccine manufacturing is a complicated and risky business. Three companies-Aventis Pasteur, Evans, and MedImmune/Wyeth-currently manufacture flu vaccines. Only Aventis Pasteur is licensed to produce flu vaccines for children under two. The vaccine business was an $8 billion industry in 2002 and is expected to reach $25 billion before the end of the decade. Vaccine sales at Aventis are up 16 percent, with $1.58 billion in sales in 2002. The company has tripled its human vaccine sales during the last decade, thanks to strong growth in North America, where the company generates 50 percent of its sales. And in the kind of blurring of government/industry boundaries that critics decry, Aventis Pasteur has provided an unrestricted educational grant to the NFID for a pediatric influenza immunization initiative that will help implement the CDC's recommendations.

What is outstanding about these new recommendations is what they omit. They omit any mention of thimerosal. The CDC and the AAP did not recommend in their statements that parents choose thimerosal-free flu vaccines for their children, despite the fact that as early as 1999, the AAP recommended that all vaccines be thimerosal free. In fact, neither organization mentioned thimerosal at all in their public statements on the new flu vaccine recommendation.

These health agencies failed to mention thimerosal because they are more concerned about making sure that everyone gets the flu vaccine than ensuring a thimerosal-free supply. These agencies believe that the supply of the flu vaccine will be put in jeopardy if there is a preference for thimerosal-free vaccines, even though Aventis Pasteur said in an April 2, 2004, article that it could make sufficient thimerosal-free vaccines if given enough notice.

It is also problematic for these health agencies to suggest thimerosal-free vaccines because questioning the safety of thimerosal might jeopardize the development of international programs that export vaccines containing the mercury preservative to other countries.

What exactly is thimerosal? It is a powder that is nearly 50 percent mercury and is added to vaccines and other biologics as a preservative. Should you be worried about it? The EPA and the FDA are, but the health agencies that failed to suggest that parents choose thimerosal-free vaccines are not. They do not believe there is sufficient evidence to implicate the preservative in neurodevelopmental disorders, such as autism, especially in babies older than six months. And they do not think that the EPA standard for ingested mercury applies to injected mercury.

The EPA standard for ingested mercury was set in 1997, the same year Congress asked the FDA, in the Food and Drug Modernization Act, to compile a list of drugs and foods that contain intentionally introduced mercury compounds and to provide quantitative and qualitative analysis of the mercury compounds on the list. In December of that year, the EPA released the "Mercury Study Report to Congress" and set a reference dose of 0.1 µg/kg/day for ingested mercury.

What this means is that the maximum safe dose for ingested mercury is 0.1 microgram per kilogram of weight of the person ingesting the mercury per day. A kilogram is 2.2 pounds; so a 10-kilogram baby would weigh 22 pounds. The maximum ingested mercury dose for this 22-pound baby would be 1 microgram a day; for an 11-pound baby, it would be one-half microgram a day.

In July 1999, the EPA notified vaccine experts that if infants younger than six months receive a number of thimerosal-containing vaccines at the same time, their mercury levels could exceed the EPA's precautionary limit on mercury exposure. At her two-month visit, a 10-pound baby could get as much as 62.5 micrograms, up to 125 times the EPA "safe" level, if all of her vaccines contained thimerosal. In 1999 the FDA requested that vaccine manufacturers phase in a replacement for thimerosal, and they agreed to do so by 2001. However, no ban was enacted, and thimerosal remains in vaccines five years after the FDA recommendation.

The National Academy of Sciences confirmed the EPA mercury reference dose when it released its report "Toxicological Effects of Methylmercury" to Congress in July 2000. That same month, the Government Reform Committee of the US House of Representatives held the hearing "Mercury in Medicine: Are We Taking Unnecessary Risks?"

One of the risks that the Government Reform Committee has investigated in depth is autism. In August 2000, the committee held the hearing "Autism: Present Challenges, Future Needs-Why the Increase?" and in June 2002 it held "The Status of Research into Vaccine Safety and Autism." Alarming figures released by the committee claimed that autism rates have risen from 1 in 5,000 to 1 in 500 in less than 20 years. The committee called for independent research into the causes and directed the CDC to make its Vaccine Safety Datalink (VSD) available to independent researchers. The VSD is a large-linked database that contains information on more than six million people from seven large health maintenance organizations, such as Kaiser Permanente. It includes information on vaccine history as well as medical records that can be monitored for adverse effects.

Just the year before, in July 2001, the National Academy of Science's Institute of Medicine's Immunization Safety Review Committee recognized the need for diverse and extensive research into vaccines and autism and called a link between the two "biologically plausible." The committee also recommended the use of thimerosal-free vaccines.

By 2002, concern about spiraling autism rates was beginning to reach state legislatures. Dr. Robert Byrd's report to the California legislature, "Principal Findings from the Epidemiology of Autism in California," concluded that the 273 percent increase in autism in California since 1987 could not be explained by greater awareness and reporting of autism, looser criteria for diagnosis of autism, or immigration of families seeking services for autistic children-all reasons commonly given for the alarming increase.

Even as state legislators and the US Congress were trying to make sense of the rising rate of autism and its possible link to thimerosal, thimerosal manufacturer Eli Lilly sought protection from liability. Three attempts were made in 2003 to write limits on Eli Lilly's liability regarding thimerosal into the law. Finally, with the Homeland Security Act, the attempt succeeded, only to have the protection removed by the Omnibus Appropriation Bill of January 2003 amid public outrage.

After years of insistence by Congress, the CDC finally opened the VSD to independent researchers Mark R. Geier, PhD, MD, and David Geier in 2003. At the second National Academy of Science's Institute of Medicine's Immunization Safety Review Committee meeting on February 9, 2004, the Geiers presented their preliminary data, which compared the autism rates of 85,000 children who received thimerosal-containing vaccines with 70,000 children who received thimerosal-free vaccines. They testified that the rate of autism was 27 times higher in the group that received thimerosal-containing vaccines.

Less than a month after the hearing, on February 25, 2004, the Kaiser Permanente California Institutional Review Board suspended the Geiers' research project and forbade them to access the VSD data because of confidentiality breaches alleged by the CDC's acting associate director for science, Jeanne Santoli, MD. Mark Geier, commissioned by Congress to research the VSD, is a well-respected, independent vaccine expert who has been published in more than 30 different peer-reviewed publications and who has yet to finish his analysis of the CDC data.

With this almost-daily volley between Congress and the CDC on the issue of thimerosal, it came as a surprise when, in April of this year, the AAP and CDC released their recommendations for the flu vaccine without any mention of the mercury preservative. Many parents believe that mercury is out of vaccines and may not think to ask when they get flu vaccines for their families in the fall. And while health organizations may be more concerned about pandemics than about thimerosal, parents must think twice.

Take the two choices for flu vaccines for toddlers under two, for example. Aventis Pasteur licenses both under the name Fluzone. One choice has less than 0.3 microgram of thimerosal per dose, is considered to be "preservative free," and is well below the EPA reference dose. The other choice has 25 micrograms per dose and is 25 times what a 22-pound baby should have in a day, based on both the EPA and the NAS reference doses for ingested mercury. While it is fair to say that there is no reference dose for injected mercury, it is ludicrous to think that such a reference dose would actually be set higher than the one for ingested mercury.

This fall, parents who unknowingly or unwittingly choose the flu vaccine with thimerosal for their children under two will be exposing their children to mercury in excess of federal guidelines.

Just three days after the CDC and the AAP recommended universal flu vaccinations without mentioning thimerosal, Representatives Dave Weldon, MD (R-FL), and Carolyn Maloney (D-NY) introduced a bipartisan bill (HB 4169) that would remove vaccines that contain thimerosal from the market by January 2005. In May, the governor of Iowa, Thomas J. Vilsack, became the first to sign into law a state bill banning the use of thimerosal in vaccines. Some expect this law to start a national precedent. In fact, in her March-April 2004 Mother Jones article, "Toxic Tipping Point," author Andrea Rock likens the autism epidemic and its suspected link to thimerosal to the cigarette and asbestos settlements.

So what's a parent to do? Examine the evidence and decide whether or not you consider the flu a threat to your family. (See our article on the flu vaccine on page 40.) If you decide to vaccinate, choose thimerosal-free vaccines. (See the list and the link on page 45.) Be prudent, and do not combine the flu vaccine with other vaccines. If thimerosal-free flu vaccines are not available, reconsider.

While we would like to accept the reassurances of those health organizations that fear a pandemic more than they fear mercury, as parents we must err on the side of caution. On page 48, we present a compelling letter to the government written by the parents of mercury-injured children. It is their voices that make us insist on caution.