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	a quiet place by peggy o'mara

Just In Case
Issue 115

Mothering has covered vaccinations as a freedom-of-conscience issue since 1979. Early on, our coverage raised questions about vaccines because we wanted parents to have true informed consent. In the last ten years, however, the stakes have changed. Parallel to the rise in the number and combinations of required infant vaccines has also been a rise not only in prescriptions for Ritalin but also in the number of cases of regressive autism. Between new and combination vaccines, an infant could receive nine vaccines at one visit.

Autism is part of a spectrum of disorders, of which it is the most severe. Other disorders of this spectrum include ADD, ADHD, dyslexia, Asperger's syndrome, hyperlaxia, and PDD. Speech and learning delays can be part of this spectrum and are often its first signal. Autism has exploded during the last ten years. Previously found in 1 out of every 10,000 children, it's now found in 1 in 250 children in the US and 1 in 86 in the UK. In California the autism rate has increased 273 percent since 1987. Many consider these rates to be epidemic. On June 19 of this year, Amy Morrison of our staff and I attended a congressional hearing on "The Status of Research into Vaccine Safety and Autism." Since 1999, the Government Reform Committee has held ten hearings on vaccine safety and vaccine policy. The June hearing took testimony from five scientists and five representatives of the Health and Human Services Centers for Disease Control and Prevention. The scientists have done research related to the toxicity of metals as well as the possible association between vaccines and autism. One theory holds that there is a relationship between the MMR vaccine, which does not contain thimerosal, and autistic enterocolitis. Another suggests a possible link between the use of mercury-containing thimerosal in multiple vaccines and late- onset autism.

Vera Stejskal, PhD, associate professor of immunology at the University of Stockholm, has worked with mercury toxicity for 20 years. Her research shows that thimerosal is a strong allergen. Worldwide, it is more allergenic than nickel. In fact, it is the number-one childhood allergen. About 10 to 30 percent of children are allergic to it.

Andrew Wakefield, MD, and three other physicians at the hearing presented evidence for a correlation between the MMR vaccine and autism. Wakefield's research has been confirmed by nearly a dozen controlled trials worldwide. In 1997 he and several other researchers published a paper, in the British medical journal The Lancet, on a possible link between Crohn's disease and the measles vaccine. After its publication, parents began asking Wakefield to examine their autistic children. To their surprise, he and his colleagues found measles in the guts of these autistic children, who had never had the disease and whose only known exposure to measles was through the MMR vaccine. Wakefield developed a hypothesis that certain susceptible children suffered from a new form of bowel disease, possibly triggered by the MMR vaccine and linked to autism. He recommended that parents should have the choice of single measles, mumps, and rubella vaccines. In Japan, after an outbreak of vaccine-related meningitis, MMR was completely withdrawn in favor of single shots. In Canada it is administered in a different form because of related concerns. In October 2001, the Institute of Medicine Immunization Safety Review Committee, commissioned by the CDC, concluded "that although the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders is not established...the hypothesis is biologically plausible." This conclusion was based on data from the Vaccine Safety Datalink (VSD) project, developed in 1990 by the CDC. At the June hearing, CDC officials admitted the existence of a previous, undisclosed CDC study that does, in fact, establish a connection between thimerosal and autism. The existence of this secret study was first revealed through a Freedom of Information request made to the CDC by the parent advocacy group SAFEMINDs.

The previously undisclosed CDC study was discussed at a two-day meeting, Scientific Review of the Vaccine Safety Datalink Information, that was held on June 7 and 8, 2000, at the Simsonwood Retreat Center in Georgia. At the meeting, the results of a study entitled "Risk of Neurologic and Renal Impairment Associated with Thimerosal-containing Vaccines," authored by Thomas Verstraeten, Robert Davis, Frank DeStefano, and the VSD team of the CDC, were presented and discussed. In this study, the automated data from two health maintenance organizations was prospectively collected for vaccine safety studies. The study concluded, "This analysis suggests that in our study population, the risks of tics, ADD, language and speech delays, and developmental delays in general may be increased by exposures to mercury from thimerosal containing vaccines during the first six months of life." The study showed 3,114 cases of neurological developmental disabilities out of 109,993 cases. The most prevalent disability was developmental speech and language delay, a precursor of autism. There were 127 cases of autism and 374 cases of ADD. The tragedy is that this study was kept secret, and vaccines with thimerosal continued to be administered to infants for at least a year after the study was published. Roger Bernier, PhD, MPH, associate director for science of the CDC's National Immunization Program, testified at the hearing that "In mid-1999, the United States Public Health Service agencies, including NIH, FDA, HRSA and CDC, took action, working collaboratively with the American Academy of Pediatrics, the American Academy of Family Physicians and the vaccine manufacturers, to begin removing thimerosal preservative from the vaccine supply.... As a result of this action, all manufacturers are now producing only vaccines that are free of thimerosal or contain only trace amounts, as a preservative for routine infant immunization." Congressman Dan Burton (R-IN), chair of the Committee on Government Reform, berated the CDC representatives for not moving more quickly to remove thimerosal from vaccines and asked if "the scientific community and health agencies delayed in taking it off the market because of undue influence being exerted on our agencies by pharmaceutical companies." He noted CDC internal memos from as far back as 1992 expressing concerns about thimerosal. Based on European studies, thimerosal was removed from childhood vaccines in Sweden as early as 1998. Burton further criticized the CDC for not making the VSD data available to independent researchers. Henry Waxman (D-CA), ranking Democrat on the House Reform Committee, claimed that there were issues of privacy in releasing the data, but researchers use only raw data without identifiable markers. CDC spokespeople testified at the hearing that the VSD data was now available for independent research and could be obtained by contacting the CDC.

I was perhaps most affected that day by something that happened after the hearing, on the way to the Metro, when the mother of an autistic son, Hayden Louis Goetz, approached Amy and me. He was born perfectly normal nine years ago, with an Apgar score of 9/9, and was vaccinated with hep B (thimerosal-containing) 12 hours after birth. Four weeks later, he was vaccinated a second time with hep B (also thimerosal-containing). At two months, he was vaccinated with whole-cell DTPH and had his first vaccine reaction. He now has the mental capacity of an 18 month old and is nonverbal and not toilet- trained. It took 39 months and 72 doctors before Hayden's injury was diagnosed as vaccine related. Tough luck, however. The Federal Circuit Court of Appeals ruled in 2001 that the "36-month statute of limitations was absolute," referring to the statute of limitations of the Vaccine Injury Compensation Program (VICP). The Goetz family will get no compensation from their government.

Hayden's family faces $30,000 a year in expenses for physical, occupational, speech, and behavior therapy, as well as medical expenses for MRIs, EEGs, allergy testing, IV infusions, supplements, dietary interventions, and other treatments. Because of limitations and restrictions that were not the original intent of the National Vaccine Injury Act that created the VICP, Mr. and Mrs. Goetz must bear a lifetime cost of caring for their beloved son of well over 1 million dollars.

Barely a month after the June 19 Government Reform Committee hearing revealed the previously undisclosed CDC study establishing a causal relationship between thimerosal and neurologic developmental disorders, legislation was introduced to reduce vaccine liability. Senate Bill 2053, cosponsored by Hilary Clinton (D-NY) and William Frist (R-TN), makes it illegal to bring a civil action against a vaccine administrator or manufacturer unless a person proves physical injury and has filed a petition in accordance with the statute of limitations of the VICP. The law further prohibits civil action by a parent or third party unless "the action is joined with a civil action brought by the person whose vaccine-related injury is the basis for the action."

Critics of the bill say that the legislation is an attempt to deflect the class-action suit filed in April by the Texas firm Waters and Kraus. The suit is the first known civil case to allege that the mercury-based preservative thimerosal, used until recently in over 30 childhood vaccines, has caused mercury poisoning in children. Many of the families involved in the class-action suit did not make a claim with the VICP because their child's vaccine injury was not diagnosed until after the statute of limitations had run out.

According to the National Vaccine Information Center, SB 2053 "would amend the Vaccine Injury Compensation Program (VICP) in a way that would benefit drug companies and shield them from liability. There are many provisions in the bill but the most problematic one will stop the ability of a vaccine injury victim to bring a lawsuit in civil court."

Senate Bill 2053 further attempts to appropriate surplus funds in the Vaccine Trust Fund. This money is earmarked for compensation to parents. The bill reads, "Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall submit recommendations regarding how to address the growing surplus in the Vaccine Trust Fund." It's the taxpayers' money that funds the VICP, a total of $800 million since the bill was enacted in 1986.

In contrast to SB 2053, the National Vaccine Injury Compensation Program Improvement Act of 2002, HR 3741, introduced in the House by Dan Burton and Henry Waxman, extends the statute of limitations for vaccine injury claims and ensures payment to lawyers who defend vaccine-injured children.

Manufacturers and physicians are already protected from liability by the National Vaccine Injury Act. However, doctors can be found liable if a patient gets a "vaccine-preventable" disease. In some places, physicians are actually compensated for vaccine compliance. In the UK, for example, physicians are compensated £2,865 a year for 90 percent vaccine compliance and nearly £955 for 70 percent compliance. In New Zealand, general practitioners are compensated per vaccine. Only the most independent and courageous doctors can afford to question vaccine safety. Most who do lose hospital privileges, professional standing, and, in some cases, their jobs. Economics may be what this all boils down to. While the profits of the Fortune 500 companies declined this year by 53 percent, the second deepest dive in profits the Fortune 500 has taken in 47 years, the top-ten US drugmakers increased profits by 33 percent. Their profits were eight times higher than all other Fortune 500 industries combined. Public Citizen's Congress Watch reported that drug companies attained these profits by hiking prescription prices, advertising medicine to consumers in unprecedented amounts, and spending less than the industry has suggested on research and development.

Vaccine revenues in the US are estimated at more than $1 billion a year, twice what they were in 1990. The cost to fully vaccinate a child has risen from $107 in 1986 to $367 in 1996, a 243 percent increase in just ten years. Merck is the second most profitable pharmaceutical company, netting $7.3 billion last year, which is more than the profits of all the Fortune 500 companies in the semiconductor, pipeline, food production, crude oil production, and hotel, casino, and resort industries combined. Merck is one of only four companies that manufacture childhood vaccines and is the only one that produces MMR and Varivax. The other three are Wyeth-Ayerst, GlaxoSmithKline, and Aventis Pasteur, the sole manufacturer of IPV. On the day of the hearing, the following headline appeared on the front page of the Washington Post, "Drug Firms among Big Donors at GOP Event." The chief corporate fund-raiser for the gala event was Robert Ingram of GlaxoSmithKline. The company gave at least $250,000. Pharmaceutical Research and Manufacturers of America, a trade group funded by the drug companies, also gave $250,000. Merck paid up to $50,000 to "sponsor" a table. The event was expected to net over $30 million. Every company that donated money to the GOP had business currently before Congress.

I can't help but contrast the $30 million paid in one day to influence public policy with the $30,000 the parents of Hayden Louis Goetz must pay every year out of their own pocket for damage caused to their son by a public policy that had risks the US medical establishment did not warn them about and does not take responsibility for.

Since 1940, the number of required childhood vaccines has risen from three doses of DPT to 40 doses of 12 different vaccines. No vaccine on the market has ever been evaluated by a prolonged double-blind study. It is considered unethical in the scientific community to deprive the citizens of a lifesaving vaccine, but ethical to experiment on them through its use. The CDC and FDA rely on a post-marketing evaluation system of physician reporting to monitor adverse vaccine reactions. Physicians are encouraged to report any adverse reactions to the Vaccine Adverse Events Reporting System (VAERS), but only a small percentage of them do so. In addition, many reactions are not recognized as vaccine-related until years after the initial insult.

One of the few tools available to the scientific community to evaluate vaccines is the Vaccine Safety Datalink project that Congressman Burton and the Committee on Government Reform are so upset about. The Government Reform Committee has been trying to obtain this data for independent analyses for over two years. They want the database open to the public immediately so that independent researchers can evaluate the data regarding vaccines and adverse effects. Many in the vaccine safety community have for years called for independent research to compare the acute and chronic health outcomes of children who have been vaccinated with those of children who have not. Dr. Bernier of the CDC admitted that there were trace amounts of thimerosal still in vaccines. I have downloaded a list of available vaccines and their thimerosal content (www.vaccine safety.edu/ thi-table.htm), and it shows that there is a thimerosal-free version available for every childhood vaccine, but tragically, parents are reporting difficulty getting them. While one doctor told me that she used only thimerosal-free vaccines in her practice and assumed that all other doctors did the same, another physician called to tell me that he had been unable to obtain thimerosal-free hep B vaccines for his own school-age children. In addition, parents are finding it nearly impossible to find monovalent vaccines-single doses of vaccines that are usually given in combination, such as the MMR.

The majority of parents of children with regressive autism believe that vaccines are responsible. They often do not question the importance of vaccines, but they do feel betrayed by their government. Five to eight times more boys than girls are autistic. In fact, 1 percent of boys are autistic-420,000 in the US. Their lifetime care will cost 3 to 4 trillion dollars. There are well over half a million autistic children in the US, yet the CDC budget for autism research is a little over $10,000,000. About twice as many Americans have AIDS, but the CDC budget for this research cash cow is $932,000,000, nearly ten times as much as the autism research budget. In 1997, the National Institutes of Health (NIH) spent $2.9 billion in AIDS research and less than a million on autism.

As Congressman Burton said, "The actions taken by HHS officials in the past-aggressively denying any possible connection between vaccines and autism, and waging an information campaign endorsing one conclusion on an issue where the science is still out-have significantly undermined public confidence in the career public service professionals who are charged with balancing the dual roles of assuring the safety of vaccines and increasing immunization rates." It is not anti-vaccine to be pro-vaccine safety. I encourage you to write to your representatives to ask them to support the Committee on Government Reform's efforts to secure access by independent researchers to the VSD and to ask their assurance that, as a parent, you will have access to thimerosal-free and monovalent vaccines. Demand that double-blind studies, the gold standard of drug testing, be required prior to vaccine licensure. The issues at stake here are infant safety, public trust, and freedom of conscience. In a democracy, we want our public agencies to protect us. Most often they do, but sometimes they are wrong. Sometimes overzealousness, greed, avarice, or fear of reprisal can affect human judgment. Sometimes people just make mistakes. I want to live in a society that admits its mistakes, makes reparation, and moves on. I object to a society in which I must be wary of public agencies I finance as a taxpayer. Join me in taking responsibility for our own health and that of our children, in requiring public officials and public institutions to be accountable for public policy, and in remembering that people in authority are not always right. For more information on the hearing, see www.house.gov/reform. For more information on the thimerosal class-action suit, call the Texas law firm Waters and Kraus at 800-226-9880.