Whether they read it or not will yet to be seen, but I suspect it will not be long before it makes its way to the MDH offices.

Rebuttal of Misleading Statements

From Minnesota Department of Health Parents and Patients Handout:
Thimerosal and Childhood Vaccines: What You Should Know

By Tim Kasemodel, Minnesota Natural Health Legal Reform Project

Is there thimerosal in childhood vaccines today?

MDH:  Since 2001, all routinely recommended vaccines (except for the flu vaccine) currently being made for administration to young children in the U.S. contain no thimerosal or only trace amounts.

MNHLRP:  This statement is misleading because it implies that “only trace amounts” of mercury in a vaccine, (which can mean as much as 2,000 parts per billion), is not a concern.  Studies on the mercury in thimerosal have shown it to be toxic at much lower concentrations, causing cell impairment, damage and death.  Using the terms “all” and “except” in the same sentence is not only misleading, it is simply bad grammar.

It is important to note from the beginning the interchangeable use of the terms child, childhood, children, and young children without any clarification of the ages involved.  The recommended childhood vaccine schedule is broken down into the birth to age 6 group, and the 7 to 17 group.  While most of this handout relates only to the younger age group, it is not clearly stated.  This could mislead a reader to believe reasonably enough that all of the information relates to children up thru age 17.

What is Thimerosal?

MDH:  Thimerosal is an organic mercury-based preservative used in some vaccines, including some influenza vaccines.  Thimerosal contains ethyl mercury.  This is not the same as the methyl mercury found in fish or emitted by power plants.  It has been used as a preservative since the 1930s to prevent contamination in vials containing multiple doses of a vaccine and other medical products. Federal agencies have guidelines to make sure no child will receive excessive mercury from childhood vaccines or other medical products.  Thimerosal is also found in other medical products such as some throat and nose sprays.

MNHLRP:  Stating that ethyl mercury and methyl mercury are different with no explanation seems intended to mislead the reader into believe that ethyl mercury is safe.  While federal agencies do have exposure guidelines, these are based on methyl mercury.  There are no exposure guidelines based on ethyl mercury.  The intentional separation of ethyl mercury from methyl mercury, yet at the same time using exposure guidelines for methyl mercury to assess the safety of ethyl mercury is misleading.

The FDA’s justification for safety of thimerosal exposure for infants under current recommendations is that the total possible exposure of 28 micrograms by 7 months of age is “significantly below the Environmental Protection Agency (EPA) calculated exposure guideline for methyl mercury of 65 micrograms during the first 6 months of life for a child in the fifth percentile body weight.”  The word “during” indicates the calculation was made based on the daily weight of this baby multiplied by the daily exposure limit, calculated each day, then totaled after 6 months.  However, the EPA exposure guidelines are 0.1 mcg per kilogram body weight per day.   For a 20 pound infant, the 65 micrograms calculated to be safe by the FDA would be 72 times more than allowed that day.  The 12.5 micrograms of mercury in each of the mandatory two flu shots is actually 14 times more than the EPA guidelines for the average 6 month old.

This is the same as the FDA accepting that giving 8400 mgs of Tylenol (three 1 oz. bottles) all at one time at 6 months and another 8400 mgs at 7 months of age is “SAFE” because the baby could have received 43,200 mgs now that he is 180 days old.

What is a trace amount?

MDH:  Thimerosal is still used in the early stages of manufacturing of a few vaccines to ensure the production line is sterile, but is removed through a purification process, with only a trace, or insignificant, amounts remaining. This is different than the few vaccines that contain thimerosal as a preservative.  The thimerosal in vaccines is left in after production to prevent contamination when multi-dose vaccines are used.

A few vaccines still contain a trace amount of thimerosal but manufacturers are working to remove this trace even though the FDA considers these vaccines to be thimerosal free.

MNHLRP:   Calling mercury concentrations of 600 to 2000 parts per billion “insignificant” is outright and patently false.  Liquids with 200 ppb mercury or higher is considered hazardous waste.  Mercury concentrations as low as one fifth of one part per billion have been shown to negatively affect enzymes necessary for the removal of mercury itself from the body.  A fetus or newborn infant does not even have the ability to detoxify heavy metal exposure, so it remains with yet unstudied consequences.  There is no evidence that shows that mercury exposure, of any kind or concentration, does not cause harm to living tissue.

Stating that trace level mercury containing vaccines are “considered by the FDA to be preservative free” gives the impression that the FDA has rigorously tested thimerosal and proven it is safe at trace amounts, which they or the manufacturer have not done at all.  In fact, the FDA has no substantive proof that thimerosal is safe at any dosage or concentration.

Is thimerosal bad for you?

MDH:  The current body of scientific research reviewed by the Minnesota Department of Health and national health organizations shows no evidence of harm caused by small amounts of thimerosal in vaccines, except insofar as it might contribute to minor reactions like redness and swelling at the injection site.  In rare instances, people have had a severe allergic reaction to thimerosal.  There are studies that show mercury can cause brain and kidney damage; however, they are based on research of methyl mercury – the kind found in foods – not on ethyl mercury which is the kind found in medical products.  We are not able to predict adverse effects of ethyl mercury exposure based on studies of exposure to other forms of mercury, especially since ethyl mercury is excreted faster from the body than methyl mercury.

MNHLRP:  Contrary to the statement that the current body of research reviewed by MDH shows no evidence of harm, summaries of several recent studies were handed to the MDH on January 27th, 2007.  These peer reviewed and published studies showed clear evidence of harm from thimerosal at concentrations similar to or much lower than that found in infant vaccines.  The manufacturer’s material safety data sheet clearly states that thimerosal can cause kidney and brain damage, based on the simple fact that it contains mercury.  The study “Comparison of organic and inorganic mercury distribution in suckling rat” showed that thimerosal targeted the brain.  While research on methyl mercury was possible due to large spills or contamination of foods, no such research was conducted when food was contaminated with ethyl mercury.  Using this as evidence of safety is misleading.  Declaring that ethyl mercury is excreted faster from the “body” is absolutely false.  Although studies show it leaves the blood sooner than methyl mercury, they also show that thimerosal ended up in the brain and converted to inorganic mercury at 2 to 4 times the rate of methyl mercury.  Leaving the bloodstream is not the same as leaving the body.

If thimerosal isn’t bad for you, why did they take it out of vaccines?

MDH:  There is a broader goal legislated by Congress to remove as many sources of mercury exposure as possible. Unlike much of the environmental sources of mercury that are hard to remove, the thimerosal in vaccines is a small but controllable source that can be removed.

MNHLRP:  This question itself is misleading.  Thimerosal has not been completely taken out of vaccines.  Thimerosal use has continued uninterrupted through the use of trace level infant vaccines.  Infants and fetuses (during pregnancy) are frequently exposed to preservative level mercury from the flu shot, and adolescents are given preservative level meningococcal and tetanus vaccines.

Does thimerosal cause neurological disorders? 

MDH: Studies done to date show no association between developmental disorders such as autism and thimerosal.

A recent study (Dec. 2007) published in the Archives of General Psychiatry found autism cases in California continued to increase even after thimerosal was removed from routine childhood shots in 2001.

The New England Journal of Medicine (Sept. 2007) analyzed data on over 1000 children assessed 42 neuro-psychological outcomes did not support an association between early exposure to mercury from thimerosal and neuropsychological disorders.  The study consulted a wide variety of outside experts and advocates including experts in toxicology, epidemiology, biostatistics psychology vaccine safety and a representative fro the autism advocacy community (this study did not assess autism: the Centers for Disease Control and Prevention (CDC) is conducting a separate autism study.

A study (July 2006 out of Canada found that thimerosal exposure from vaccines was unrelated to the increasing trend in pervasive developmental disorder prevalence in Canada.

In a 2004 study, a panel of medical experts at the Institutes of Medicine examined dozens of studies and found no evidence that thimerosal in vaccines causes autism.  The CDC examined the incidence of autism and other neurological disorders in relation to the amount of thimerosal in vaccines. Their study (Nov. 2003)  found no change in autism rates relative to the amount of thimerosal a child received from vaccines in the first six months of life. In other words, a child who received more thimerosal was not more likely to be autistic.

MNHLRP:   It is patently false to say Thimerosal was “removed from routine childhood shots in 2001” as the MDH implies.  While a few vaccine manufacturers began to produce vaccines at trace level or mercury free versions, routine childhood vaccines at preservative level remained ion use and did not expire until 2003.  The fact that the population studied could not be positively confirmed not to be exposed to any level of mercury in vaccines, makes the study misleading.

The Sept. 2007 study in the NEJM excluded susceptible populations such as babies less than 5.5 pounds, whose dose per kilogram would be substantially higher – double the mercury exposure of an 11 pound baby.  This exclusion is especially ironic because it also did not assess thimerosal exposure after 7 months because they “hypothesized the effects of such exposure would be small” and that later the mercury “dose per kilogram would be substantially lower”.  This assumption on the part of the researchers specifically also excludes an identifiable subset of children who are not able to detoxify the mercury at the same rate as the general population.  Those children would retain mercury making later exposure absolutely relevant.

The small sample size and few children in the highest and lowest exposure groups reduced the study's precision and ability to establish statistical significance. The study only obtained a 30% participation rate, well below the commonly accepted scientific standard of 70%.  Unlike gold-standard randomized clinical trials, an observational study such as this cannot address causation.

The July 2006 study out of Canada by Dr. Eric Fombonne of the McGill University Health Center also has serious flaws.  For instance, only a tiny fraction of the autism students were born when thimerosal-free DTP and Hib vaccines were given.  These students may have been exposed to thimerosal from the Hepatitis B vaccine newly recommended for infants of foreign born parents, which made up over one fourth of the greater Montreal population.  The vast majority of students in the study (more than 90%) were born in years in which thimerosal vaccines were widely used.

It is simply not true that the 2004 IOM study “found no evidence that thimerosal in vaccines causes autism.”  Rather, they concluded that “the body of epidemiological evidence favors rejection of a causal relationship.”  More importantly, they noted that “epidemiological studies can not rule out the possibility that vaccines cause autism in some small subset.”

Due to the controversy over the CDC study cited in the MDH handout, and Congressional pressure for investigation, last summer the National Institutes of Environmental Health Sciences reviewed the CDC study.  They found that it was unreliable and weak, and the other epidemiological studies reviewed by the 2004 IOM committee were even less reliable.  The VSD data showed that the children with the highest exposure to thimerosal had 7 to 11 times the rate of autism as the children with no exposure. However, the analysis published had been stripped of the children with the lowest and highest thimerosal exposure in order to come to its “conclusion” of no causation.  Finding no difference in lung cancer rates of two packs a day smokers versus two and a half packs a day smokers is not proof cigarettes are safe.  There are many studies done to date that show association between thimerosal and developmental disorders.  Disagreeing with an author or researcher does not make their studies irrelevant.

Is there thimerosal in flu vaccines?

MDH:  Yes. The majority of influenza vaccines distributed in the United States contain thimerosal as a preservative. However, some contain no thimerosal or only trace amounts of thimerosal and are considered by the Food and Drug Administration to be preservative-free.

MNHLRP:  Using the words “some contain no thimerosal” would mislead someone into think they are readily available, yet 94% of the 2007-08 flu shot supply contains 25 micrograms of ethyl mercury.  As mentioned earlier, stating that trace level mercury containing vaccines are “considered by the FDA to be preservative free” gives the impression that the FDA has rigorously tested thimerosal and proven it is safe at trace amounts, which they or the manufacturer have not done at all.  In fact, the FDA has no substantive proof that thimerosal is safe at any dosage or concentration.

Can I get flu vaccine that does not contain thimerosal?

MDH:  Sanofi Pasteur has a flu shot for children age 6 months to 3 years that is thimerosal - free. They also make limited amounts of thimerosal-free flu vaccine for older ages.  Novartis produces a limited amount of thimerosal-free flu shots for persons 4 and older.  The new nasal-spray flu vaccine, made from a weakened live virus, does not contain thimerosal. Healthy persons 2 through 49 years of age can receive this vaccine.

MNHLRP:  Of course you can get mercury flu free vaccines.  You can also get nearly every other vaccine in a thimerosal free version.  As stated by MDH earlier in the handout, thimerosal is a controllable source of mercury and can be removed.  However there are still trace level and preservative level vaccines available for sale and administration to children and adults in Minnesota.  There has to be more incentive created for manufacturers to produce mercury free vaccines.  Minnesota has the only pending thimerosal legislation in the nation that creates a fair incentive for manufacturers without a mandate.  The language of the Bill can be found HERE

If I can’t find a thimerosal free flu shot for my baby, just how much mercury am I exposing my baby to?

MDH:  There is 12.5 micrograms of mercury in a dose of thimerosal-containing flu vaccine that is given to infants. A can of tuna typically has about 11 micrograms. Breast milk contains between 1.4 to 1.7 micrograms of methyl mercury per liter. If a baby is fed exclusively up to six months, the baby will consume about 360 micrograms of mercury. Vaccines with trace amounts of thimerosal have 1 microgram or less of mercury.

MNHLRP:  An accurate comparison between the effects of ingested methyl mercury to injected ethyl mercury can not be made.  The body has built in mechanisms in the digestive tract that aids in the excretion of ingested mercury, so much of the mercury eaten in tuna fish is never absorbed.  Injected mercury bypasses this natural defense.  Although infants do not eat tuna, a 200 lb man would need to eat 11 ½ cans (34 servings) of tuna to receive a comparable amount of mercury, proportional to body size, that which a 20 lb. six month old received from his flu shot, and absorb 100% of the mercury.  Breast milk at 1.7 micrograms per liter is also ingested orally, with protection in the GI tract from incremental amounts, as opposed to thimerosal at 25,000 micrograms per liter (infant version – toddlers and older get 50,000 mcg/l) injected intramuscularly. Toxicologists emphasize that any poison’s harm will differ markedly depending on how the exposure is delivered, i.e. inhalation, oral ingestion, or injection.  Ironically, material safety data sheets for thimerosal make no mention of exposure through injection.

What other vaccines contain thimerosal?

MDH: Other than the flu vaccine, there are a few vaccines that are NOT routinely recommended for young children, such as meningococcal and Japanese encephalitis vaccines.

MNHLRP:  This is misleading because it is not clearly stated that this is referring only to the birth to six recommendation schedule.  Many people may consider a seven year old or even an eleven year old a young child.  Preservative level meningococcal and tetanus vaccines are on the market, available for use in older children and commonly suggested by pediatricians.

Is it safe for children to get flu vaccine?

MDH:  Yes. There is no convincing evidence of harm caused by the small doses of thimerosal in vaccines.  On the other hand, there is the very real risk of influenza disease in children. Very young children often end up in the hospital when they get influenza. During the 2006-2007 flu season, six children eight and under died from complications of the flu.

MNHLRP:  It is absolutely false to say there is no convincing evidence of harm cased by thimerosal in vaccines.  As stated earlier, the MDH was given a summary of studies showing harmful effects from thimerosal at vaccine relevant doses and concentrations.  While these studies may not convince the MDH that thimerosal is harmful, it is incorrect to say it is not convincing evidence.  While any child’s death is tragic, it is important to note that most young children who have “died from complications of the flu” are often reported to have life threatening underlying conditions to begin with.  Implying that healthy children are at high risk for death from influenza or that vaccinating them all would absolutely protect those who are at high risk is not supported by science or epidemiology.

Is it safe for pregnant women to receive an influenza vaccine that contains thimerosal?

MDH:  Reports and studies indicate that pregnancy can increase the risk for serious medical complications of the flu. One study found that healthy women in the third trimester of pregnancy are hospitalized with flu at rates similar to those individuals with a high-risk condition

Two studies have looked at the safety of the flu vaccine during pregnancy and found that there was no negative effect from vaccination   Review of VAERS data also support these findings.  Additionally, a recent study (2007) looked at the potential impact of thimerosal exposure on the fetus and did not find an association between vaccination and neurological defects.

MNHLRP:  This question leads with “Is it safe” yet nowhere does MDH state a clear answer. The MDH curiously avoids the question of clinical safety, instead focusing on the concerns of influenza and epidemiological evidence, which by definition can not rule out association or assess clinical safety.

One of the two studies the MDH refers to showing no negative effect from vaccination did not even study thimerosal, the developing immune system or developmental disorders.  The study of “over 2000 pregnant women” (referred to in previous versions of this handout) actually primarily looked at whether the polio vaccine, given to 58,000 women in 1958 thru 1966, caused malignancies in offspring. There was only one sentence that provided any data on influenza vaccination outcome:   “Among 2,291 mothers immunized with killed influenza vaccine during pregnancy, one child developed an astrocytoma of the spinal medulla.”  The study did not attempt to examine any other adverse effects on the offspring, other than malignancies. 

The MSDS from thimerosal manufacturer Gihon states clearly that pregnant women should not be exposed to thimerosal.  The package insert from Sanofi Pasteur states that the safety of the flu vaccine on pregnant women has not been established.  Lastly, and this can not be repeated enough, any epidemiological study declaring it “did not find an association between vaccination and neurological defects” is, by definition, not able to completely rule out that an association does exist..

Tim Kasemodel is a stay at home dad of two boys affected by mercury from vaccines, and a member of the Minnesota Natural Health Legal Reform Project, a group dedicated to the pursuit of health freedom for all.