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http://www.house.gov/burton/pdf/Insight61003.doc
Insight on the News - National
Issue: 06/10/03

Vaccines May Fuel Autism Epidemic
By Kelly Patricia O Meara

The mother of an autistic child wonders aloud when health officials will wake up to the epidemic that has claimed not only her son but hundreds of thousands of other children in the United States, with no end in sight. She muses, "Maybe someday this will be as important as SARS and we'll get the same attention. God knows we need it."

Autism is a severely incapacitating developmental disability for which there is no known cure. According to a recently released report by the California Department of Developmental Services (DDS) entitled Autistic Spectrum Disorders, Changes in the California Caseload: 1999-2002, the rate of children diagnosed with full-syndrome autism in the Golden State between 1999 and 2002 nearly doubled from 10,360 to 20,377. The report further revealed that "between Dec. 31, 1987, and Dec. 31, 2002, the population of persons with full-syndrome autism has increased by 634 percent." That is a doubling of autism cases every four years, and the staggering increases are not limited to California.

According to data provided by the U.S. Department of Education, the increased autism rate in California is in line with the increases other states are experiencing. For example, in 1992 Ohio reported 22 cases. A decade later the number had increased by 13,895 percent to 3,057. In Illinois the rate of autism cases climbed from just five in 1992 to 3,802 - an increase of 76,040 percent. Mississippi, New Hampshire and the District of Columbia reported no cases of autism in 1992, but by 2002 the number of cases reported were 461, 404 and 144, respectively. Only Puerto Rico can claim to have an increase of less than 100 percent, with the remaining states reporting increases of at least 500 percent during the same period.

Although once considered rare, during the last two decades the chance of a child being diagnosed with autism has skyrocketed from one in 10,000 to one in 150. In California, full-syndrome autism now is the No. 1 disability among children and more prevalent than childhood cancer, diabetes and Down's syndrome. It is estimated that within the next four years autism cases in the Golden State will exceed the total number of cases of both cerebral palsy and epilepsy. To get a better idea of how quickly the epidemic is spreading one need only consider that in 1987 there were 2,778 persons with autism in California. By 2002 the number had increased to 20,377, and in 2002 3,575 new cases had been added to the rolls, far exceeding the total number of cases in the state 15 years earlier.

For years there has been a debate about the cause or causes of autism, but the vast majority of finger-pointing has been directed at childhood vaccines as the culprit. And considering what is put into the vaccines injected into hours-old infants, it is easy to understand why they are at the top of the list of suspects: formaldehyde (used in embalming), thimerosal (nearly 50 percent mercury), aluminum phosphate (toxic and carcinogenic), antibiotics, phenols (corrosive to skin and toxic), aluminum salts (corrosive to tissue and neurotoxic), methanol (toxic), isopropyl (toxic), 2-pheoxyethanol (toxic), live viruses and a host of unknown components considered off-limits as trade secrets. These are just part of the vaccine mixture.

For those who believe there are elements in vaccines that may be responsible for the increased number of autism cases and other neurological disorders, thimerosal currently is at the top of the list of possible culprits being investigated.

Despite official insistence that the evidence linking injected thimerosal to autism is inconclusive, the data suggest otherwise. In 1999 the National Academy of Sciences Institute of Medicine (IOM) must have thought there was something seriously wrong when it supported removal of thimerosal from vaccines, stating that it was "a prudent measure in support of the public goal to reduce mercury exposure of infants and children as much as possible." The IOM further urged that "full consideration be given to removing thimerosal from any biological product to which infants, children and pregnant women are exposed."

A recently published study in the Journal of American Physicians and Surgeons by Mark Geier, M.D., Ph.D., and president of the Genetic Centers of America and his son, David Geier, president of Medcon Inc. and a consultant on vaccine cases, was titled "Thimerosal in Childhood Vaccines, Neurodevelopment Disorders and Heart Disease in the United States." It presents strong epidemiological evidence for a link between neurodevelopmental disorders and mercury exposure from thimerosal-containing childhood vaccines.

Specifically, the authors evaluated the doses of mercury that children received as part of their immunization schedule, then compared these doses with federal safety guidelines. Furthermore, to compare the effects of thimerosal in vaccine recipients, the incident rates of neurodevelopmental disorders and heart disease reported to the government's Vaccine Adverse Events Reporting System were analyzed. The results were dramatic. The report revealed that "U.S. infants are exposed to mercury levels from their childhood-immunization schedule that far exceed the EPA [Environmental Protection Agency] and FDA [Food and Drug Administration]-established maximum permissible levels for the daily oral ingestion of methyl mercury."

The authors concluded that "in light of voluminous literature supporting the biologic mechanisms for mercury-induced adverse reactions, the presence of amounts of mercury in thimerosal-containing childhood vaccines exceeding federal safety guidelines for the oral ingestion of mercury and previous epidemiological studies showing adverse reactions to such vaccines, a causal relationship between thimerosal-containing childhood vaccines and neurodevelopment disorders and heart disease appears to be confirmed."

It is no secret among government and health officials that mercury is toxic and causes serious adverse reactions. In July 1999 the American Academy of Pediatrics and the U.S. Public Health Service issued a joint statement calling for the removal of thimerosal from vaccines. Five years after the joint statement, however, it still is difficult for parents and physicians to be sure that the pharmaceutical companies have indeed removed the toxic substance from their vaccines.

According to Mark Geier, "The 2003 Physicians' Desk Reference [PDR] still shows childhood vaccines containing thimerosal, including diphtheria, tetanus and acellular pertussis. DTaP, manufactured by Aventis Pasteur, contains 25µg [25 micrograms] of mercury, Hemophilus influenzae b (Hib) vaccine manufactured by Wyeth contains 25µg of mercury and pediatric Hepatitis B vaccine, manufactured by Merck, contains 12.5µg of mercury."

Geier continues, "In addition, the influenza vaccine that is recommended for an increasing segment of the pediatric population in the U.S. also contains 25µg of mercury. Assuming that the labeling is correct, it is possible that children in the U.S. in 2003 may be exposed to levels of mercury from thimerosal contained in childhood vaccines that are at higher levels than at any time in the past. Possible total childhood mercury in 2003 is more than 300µg."

Whether the "labeling is correct" is the question du jour. According to Len Lavenda, a spokesman for Aventis Pasteur, the maker of DTaP, "Aventis only sells the DTaP vaccine in the preservative-free formulation. The PDR references both the single and multidose. However, when we received the license for the preservative-free we ceased sales of the multidose vial. For some reason, the package insert takes much longer to revise than one would expect. I believe it is at the FDA waiting for approval, but the fact is we do not sell or market that product. In March 2001 we stopped all sales of that product in the preservative formulation. We did not recall the product at that time because it was our belief that if we did children may go unimmunized. It's been two years since anyone has been able to purchase the preservative formulation from us."

Lavenda continues: "The package insert talks about both the single and multidose vials and it says that the single-dose vial is preservative-free, and that is all that is sold. The PDR is outdated, but parents don't have to worry about their children being administered 25µg of thimerosal. It just takes time to get the paperwork caught up. The current package insert does not accurately reflect what is being marketed."

Geier is astounded by Lavenda's admission. "If this is true, they should be in jail. They can't have an insert on a drug that is totally wrong. It is against all regulations. If I'm a doctor and I'm giving you a shot and the insert says such and such is in the shot, it had better be in it. If doctors can't rely on the instructions that come with what we're injecting then all bets are off. This is a far worse admission than admitting that thimerosal is still in the vaccine. There are at least 15 laws that say the insert has to match what is in the product. This is absolutely horrendous. In my entire career in medicine I have never heard of a drug company claiming that what's in the insert and the accompanying product don't match. This is total mislabeling and fraud by their own admission. Legally they should be forced to close down because our clinical decisions are based on their labeling."

Assuming that the package inserts are correct, Geier tells Insight, "The EPA limit is 0.1 micrograms of mercury per kilogram body weight per day. It doesn't take a genius to do the calculations when on their day of birth children are given the hepatitis B vaccine, which is 12.5 micrograms of mercury. The average newborn weighs between 6 and 7 pounds, so they would be allowed 0.3 micrograms of mercury - but in this one shot they are getting 12.5 micrograms. That's 39 times more than allowed by law. And it gets worse when you consider that children are getting multiple vaccinations at 2 months. And this limit is for oral ingestion and not injection, which is much worse."

Rhonda Smith, a spokeswoman for the federal Centers for Disease Control and Prevention (CDC), tells Insight that, except for mere traces, thimerosal has been removed. "All routinely recommended licensed vaccines," says Smith, "that are currently being manufactured for children in the U.S., except influenza, contain no thimerosal or only trace amounts - a concentration of less than 0.0002 percent." But according to the 2003 immunization schedule and the package inserts, there appear to be a number of childhood vaccines that still contain mercury, including those for tetanus and diphtheria.

This scenario becomes even more bizarre when one further considers that thimerosal is not a necessary component in vaccines. It first was introduced by pharmaceutical giant Eli Lilly and Co. in the 1930s and is added to vaccines only as a preservative - the theory being that multiple doses are taken from the same bottle and that thimerosal will protect against contamination. However, according to Geier, "the solution to any such problem is to make vaccines available in a single dose, which will cost the pharmaceuticals about one penny more. What is interesting is that if you look up the mumps, measles, rubella [MMR] vaccines in the PDR you'll see that they do not contain thimerosal because it would kill the live virus. The MMR is available in multidose packaging and, yet, there is no preservative - nothing. What they did was put a label on it that says 'This product does not contain preservatives. Handle with care.' It's that simple."

Geier insists, "I'm pro-vaccines, but the bottom line is that our kids are getting massive amounts of mercury. Mercury has been withdrawn from everything, including animal vaccines, yet we keep injecting it into our children. Everyone should absolutely refuse to take a vaccine shot that has thimerosal in it, and they should insist on reading the vaccine package insert. Our data showed that the more mercury children received in their childhood vaccines the more neurodevelopment disorders there are. We've looked at this every possible way and every time there's massive evidence to support it."

So, if everyone acknowledges the toxicity of mercury and top U.S. health officials have called for its removal, why is thimerosal still in vaccines? "Maybe," concludes Geier, "the mercury isn't being taken out all at once because if the pharmaceutical companies did that you would see an unbelievable change in the rate of autism and there would be massive lawsuits. If you look at the graphs now they go up and up. If you stop the thimerosal all at once you'd see the numbers fall dramatically."

Rep. Dan Burton (R-Ind.), a longtime advocate for victims of autism, has a grandson who became autistic after receiving nine vaccines in one day. Burton recently sent his second request in as many years to the White House asking for a conference of scientists, researchers and parents to look into the causes of autism. The Indiana lawmaker tells Insight, "There is no doubt in my mind that the mercury in vaccines is a major contributing factor to a growing number of neurological disorders among children, but in particular autism."

Burton explains that "thimerosal is a toxic substance - mercury - and should not be put in close proximity of people, should not be injected into people, especially children who have a newly formed immune system that may not be able to handle it. To my knowledge there never have been long-term tests on thimerosal and we never should have used mercury in vaccines, period. Now what we've got is an epidemic that is absolutely out of control."

The Indiana congressman continues, "One reason this isn't getting the attention it needs is that the Food and Drug Administration has very close ties to the pharmaceutical companies, as does the Department of Health and Human Services [HHS] and the Centers for Disease Control. I've said in the past that in some cases it appears that it's a revolving door and people leave government health agencies and go to work for the pharmaceuticals, which I think have undue influence on our health agencies. Of course, they may not want to look at this because there's a possibility that large claims would be filed and the pharmaceutical companies would have to cough up the money to take care of these kids who have been damaged."

Burton means business. He insists, "The FDA, CDC and HHS should put out in a very public way the dangers of mercury, but as soon as they do it will amount to an admission that their mercury is causing these problems. So the reports that come out of the FDA, CDC and HHS use ambiguous terms. Well, if they're not sure, and there's the remotest possibility that mercury in vaccines could cause autism, they ought to get thimerosal off the market. Too many kids are being ruined for life because of this stuff."

Barbara Loe Fisher is founder of the National Vaccine Information Center, a charitable organization dedicated to the prevention of vaccine injuries and deaths through public education. Fisher tells Insight, "There are many things in vaccines that could be causing these disorders, and thimerosal is only part of the problem. In the last 20 years, we've gone from giving children 23 doses of seven vaccines to 38 doses of 12 vaccines. I think the mercury is part of it for some kids, though I'm not sure it's the answer for all." But this is a no-brainer, says Fisher. "Mercury shouldn't be in vaccines. They've taken it out of everything else so why not the vaccines? The one thing that people really need to look at is the dramatic rise in chronic disease and disabilities in our kids in just the last two decades. You have to admit that there is something occurring that a growing number of children cannot get through without being immune-system and brain-system damaged. And what is the one thing that we expose every child to? Those vaccines."

Fisher concludes, "I've always argued that public health is not measured only by an absence of infectious disease. It also is measured by the absence of chronic disease. By that score we get a big fat 'F.' So we don't have measles and mumps, but look what we have now. It's just really simple: Take the mercury out and let's see what happens."

Even so, based on the Aventis admission that the package insert does not reflect what is in the vaccine, it will be difficult to know when, if ever, the thimerosal actually has been removed. This skews the data about the relationship between thimerosal and autism. More important, it means parents cannot be sure the vaccinations their children receive are free of mercury.

Neither the Wyeth nor Merck pharmaceutical companies, nor HHS or FDA, returned Insight's calls about this matter.

Kelly Patricia O'Meara is an investigative reporter for Insight magazine.
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