Yourlawyer.com (Thimerosal News)

Hep B Vaccine With Thimerosal Linked to Developmental Delays in Animal Study

Fri, 09 Oct 2009 00:00:00 -0700

The vaccination debate has been a long and controversial one with claims of adverse effects as a result of the mercury-based preservative, thimerosal, at the root of the issue. Now, CBS News is writing that a new study conducted with rhesus macaque monkeys and thimerosal-containing hepatitis B vaccination points to some noteworthy physical delays.

The study indicates that those monkeys who were vaccinated demonstrated “significant delays in the acquisition of critical survival reflexes" versus the unvaccinated control group, said CBS News correspondent, Sharyl Attkisson. The study represents the first of its kind in which vaccinated and unvaccinated time controls were used, said CBS News, which explained13 newborn rhesus macaque monkeys received a vaccine with the hepatitis serum and that contain thimerosal in a dose equivalent to what was given to human babies up until the earlier part of this decade. Four baby monkeys received a saline placebo injection and three did not receive any shots.

Dr. Laura Hewitson of the University of Pittsburgh, a lead investigator in the study, said that baby monkeys who were not injected developed normally, while the monkeys who received vaccinations “demonstrated … survival reflex delays,” according to CBS. “Infants of lower birth weight and gestational age were at greater risk,” said Dr. Hewitson. The study was published last week in the scientific journal NeuroToxicology.

The study was not constructed to determine if thimerosal or any other element of the injection caused the delays, said CBS. “We undertook these experiments largely because we were unable to find any safety studies comparing vaccinated and unvaccinated animals,” said Dr. Andrew Wakefield of Thoughtful House, and another study author, quoted CBS. Thoughtful House, said CBS, offers resources for children diagnosed with developmental disorders.

In 1998, Wakefield and his team conducted research in Great Britain on a group of autistic children, said CBS. The results, which were published in the British Journal Lancet, opened a flood of controversy and called for additional studies to look at the safety of the three-in-one MMR—measles, mumps, rubella—vaccine, explained CBS. At the time, Wakefield suggested the vaccines be administered separately.

The earlier study actually began much of the arguments that went on between safety advocates and government and industry, with the U.S. Food and Drug Administration (FDA) and the American Academy of Pediatrics saying thimerosal is safe in vaccine doses, reported CBS. Although the toxin has been removed, for the most part, from vaccines, it is found in most flu shots, most notably in the recent H1N1 swine flu vaccines and is also present in other vaccines advertised as “preservative free.” To be thimerosal-free or –reduced, no preservative is permitted in the vaccine; however, trace amounts may be used during manufacturing and could be present in the final product, said CBS.

For years, many parents of autistic children argued that thimerosal used in vaccines had a connection to autism. No study was able to find a definitive connection, yet autism rates continued to rise despite the fact that the use of thimerosal was widely discontinued. According to the Boston Globe, the thimerosal theory became so highly controversial and polarizing within the autism community that for years, research into environmental triggers was looked upon with skepticism. But, as rates of autism reached epidemic numbers, scientists realized that genetic factors alone could not account for the upswing.

Thimerosal Vaccine Lawsuit Can Go Forward, Georgia Supreme Court Says

Wed, 08 Oct 2008 00:00:00 -0700

A Georgia couple with an autistic son will be allowed to sue the maker of the vaccine they claim is responsible for the child's disorder. In an unanimous ruling, the Georgia Supreme Court said that the National Childhood Vaccine Injury Compensation Act, the 1986 federal law that has been used to bar similar lawsuits, does not preempt state law. This case marks the first time a state appellate court has issued such a ruling in a vaccine injury case.

Marcelo and Carolyn Ferrari allege that a vaccine made by American Home Products Corp., now known as Wyeth, caused their son to develop autism. The vaccine contained the preservative thimerosal, a mercury-based chemical. The couples lawsuit claims that their son, Stefan, was a normal toddler before he was administered thimerosal-containing vaccines when he was 18 months old. The boy, now 10, hasn't spoken since.

According to the Department of Health and Human Services, the National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program (VICP). The VICP was established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines. The VICP is a no-fault alternative to the lawsuit for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccine

Wyeth had argued that the Ferrari's lawsuit was barred by the National Childhood Vaccine Injury Compensation Act, claiming that Congress wanted the federal law to pre-empt state rules. Other courts have ruled in favor of this argument in other vaccine injury cases.

But the Ferrari's lawsuit contended that the federal law was meant to supplement state law, not replace it.

The Georgia court agreed with the plaintiffs. In its ruling, written by Justice George Carley, the court held that federal law "clearly does not pre-empt all design defect claims against vaccine manufacturers." To be immune from state defective design claims, the court said that vaccine manufacturers must prove on a case-by-case basis that the side effects of a particular vaccine were unavoidable.

For years, autism advocates have claimed that vaccines containing thimerosal contributed to autism. Thimerosal contains mercury, a chemical known to cause brain damage. In July 1999, following a review of mercury-containing food and drugs, the Centers for Disease Control and the American Academy of Pediatrics asked vaccine makers to remove thimerosal from vaccines as quickly as possible.

Despite a rising prevalence of autism among US children, the government and vaccine industry have insisted that thimerosal has not played a role in the autism epidemic. However, thimerosal has been removed in recent years from standard childhood vaccines. The only exception are flu vaccines, which are not packaged in single doses.

What the CDC and FDA Don’t Want You to Know About Thimerosal and Autism/Part VII

Thu, 03 Jul 2008 00:00:00 -0700

In 2005, Robert F. Kennedy, Jr. published a lengthy examination of the history of Eli Lilly´s deadly mercury compound, thimerosal, in vaccines and its decades-long history of suppressed data about dangers to those receiving it. Following is the seventh in a series from that piece, describing the outcome the 2000 Simpsonwood Conference, in which a group of government scientists and health officials met for a secret, highly-secluded meeting convened by the Centers for Disease Control and Prevention (CDC). In the coming days, we will continue to provide more information from this important paper on this dangerous health issue.

Dr. Paul Offit, one of CDC´s top vaccine advisers and who shares a patent on one of the vaccines, admitted to Kennedy that he "would make money" if his vote eventually led to a marketable product, but brushed off Kennedy’s suggestion that a scientist’s direct financial investment in CDC approval might bias his judgment. Kennedy wrote that other vaccine scientists and regulators provided similar assurances, all seeing themselves as “enlightened guardians of children’s health, proud of their ‘partnerships’ with pharmaceutical companies, immune to the seductions of personal profit, besieged by irrational activists whose anti-vaccine campaigns are endangering children’s health.” Kennedy found that such experts were resentful of questioning. "Science," said Offit, "is best left to scientists."

Regardless, some government officials were alarmed by the “apparent conflicts of interest.” Paul Patriarca of the FDA—in a 1999 email to the CDC—harshly criticized federal regulators for “failing to adequately scrutinize the danger posed by the added baby vaccines,” saying, "I’m not sure there will be an easy way out of the potential perception that the FDA, CDC, and immunization-policy bodies may have been asleep at the switch re: thimerosal until now.” Speaking about the connection between regulatory officials and the pharmaceutical industry, Patriarca wrote that it “Will also raise questions about various advisory bodies regarding aggressive recommendations for use" of thimerosal in child vaccines.

Kennedy wrote, “If federal regulators and government scientists” did not understand the risks of thimerosal before, “no one could claim ignorance after the secret” Simpsonwood Meeting. Unfortunately, instead of conducting more studies, the CDC gave its database on childhood vaccines—a database mostly developed with taxpayer money—to the private agency, America´s Health Insurance Plans, which ensured the files could not be used for research. The CDC also instructed the Institute of Medicine—an advisory organization and part of the National Academy of Sciences—to produce a study disproving the link. The CDC "wants us to declare, well, that these things are pretty safe," Dr. Marie McCormick, who chaired the IOM´s Immunization Safety Review Committee, said adding that, "We are not ever going to come down that [autism] is a true side effect" of thimerosal exposure. According to that meeting’s transcripts, the committee’s chief staffer, Kathleen Stratton, predicted that the IOM would conclude that the evidence was "inadequate to accept or reject a causal relation" between thimerosal and autism because this is what "Walt wants," a reference to Dr. Walter Orenstein, director of the CDC’s National Immunization Program.

Experts Set to Discuss Autism, Vaccines

Mon, 30 Jun 2008 00:00:00 -0700

Recently, the parents of nine-year-old Hannah Poling won a government settlement out of a federal fund that compensates those injured by vaccines. In this case, US officials acknowledged that the immunizations worsened an underlying disorder that led to Hannah’s autism-like symptoms. The Polings said five simultaneous vaccinations administered in July 2000 led to Hannah's autistic behavior. Hannah was about 18 months at the time. Government officials won’t say why they conceded this case, but did say those with pre-existing injuries can obtain compensation under the program if they establish that their underlying condition was "significantly aggravated" by a vaccine.

Hannah has a disorder involving her mitochondria—the energy makers of cells—which can be present at birth from an inherited gene or acquired later in life and impairs cells' ability to use nutrients, often affecting brain functioning that can lead to delays in walking and talking. According to Hannah’s father, either she was born with the disorder and the vaccines caused a stress that worsened the condition or thimerosal caused the mitochondrial dysfunction. Since 2002, the preservative thimerosal has been removed from shots recommended for young children, except for some flu shots.

Meanwhile, federal health officials are convening some of the world’s leading experts to discuss this case this week; however, the government has kept quiet about a second case that some feel is even more disturbing than the Poling case and may be more relevant. This January, a six-year-old Colorado girl received the flu vaccine, FluMist. The following week, she “became weak with multiple episodes of falling to ground” and “difficulty walking,” according to a case report filed with federal health officials, which also stated that she grew increasingly weak and feverish and “became more limp, appears sleepy, acts as if drunk.” She was hospitalized and underwent surgery and was finally withdrawn from life support. She died on April. Hannah was 19 months old and developing normally in 2000 when she received five shots against nine infectious diseases. Two days later, she developed a fever, cried inconsolably, and refused to walk. In the next seven months, she spiraled downward; in 2001, doctors diagnosed autism. Both girls had mitochondrial disorders.

The Poling case points to vaccines causing or contributing to an underlying mitochondrial disorder, which, in turn, causes autism. Mitochondria act as the energy factories of cells and have their own genetic material that is passed directly from mother to child. Flaws are relatively common and, as flaws multiply, they interfere with mitochondrial function. Dr. De Vivo said as many as 700,000 people in the United States had flawed mitochondria, and in roughly 30,000 of them the genetic flaws were expansive enough to cause disease. No one has dismissed the notion that a vaccine could cause a decline in such children. A discussion about the possible links between mitochondrial disorders, autism, and vaccination is needed, said Dr. Insel of the mental health institute.

This week’s Indianapolis meeting is being sponsored by the mental health institute, the Food and Drug Administration (FDA), the CDC, the National Institutes of Health (NIH), the Department of Health and Human Services (HHS), and the National Institute of Neurological Disorders and Stroke.

Eli Lilly Knew of Thimerosal Dangers for Decades

Wed, 18 Jun 2008 00:00:00 -0700

In 2005, Robert F. Kennedy, Jr. published a lengthy examination of the history of Eli Lilly´s deadly mercury compound, Thimerosal, in vaccines and its decades-long history of suppressed data about dangers to those receiving it. The piece described the outcome of a secret, highly-secluded 2000 meeting—The Simpsonwood Conference—involving a group of government scientists and health officials convened by the Centers for Disease Control and Prevention (CDC).

Internal Eli Lilly documents revealed by the Kennedy paper show the company knew immediately that its product—Thimerosal—could cause damage, even death, in animals and humans. Lilly tested Thimerosal in 1930, giving it to 22 terminal meningitis patients; within weeks, all 22 patients died. This test was not included in Lilly’s report “declaring thimerosal safe.” In 1935, researchers at vaccine manufacturer, Pittman-Moore, warned Lilly that its claims about Thimerosal´s safety "did not check with ours." In a study Pittman conducted with dogs injected with thimerosal-based vaccines, half of the dogs fell ill prompting researchers to “declare the preservative ‘unsatisfactory as a serum intended for use on dogs.’”

The mounting case against Thimerosal did not stop in the 1930s. During WWII, the Department of Defense used Thimerosal in vaccines on soldiers but required Lilly to label it "poison." In 1967, a study in Applied Microbiology found Thimerosal killed mice when added to vaccines. In 1972, Lilly´s found Thimerosal to be "toxic to tissue cells" in concentrations as low as one part per million (PPM), 100 times weaker than the in a typical vaccine. Despite all of this ongoing and emerging data, Lilly “continued to promote Thimerosal as ‘nontoxic,’” even including Thimerosal in topical disinfectants. In 1977, ten babies at a Toronto hospital died when an antiseptic preserved with Thimerosal was dabbed on their umbilical cords. In 1982, the FDA proposed a ban on over-the-counter products containing Thimerosal. In 1991 the FDA considered banning Thimerosal from animal vaccines.

Horribly, in 1991, the CDC recommended “infants be injected with a series of mercury-laced vaccines: Newborns would be vaccinated for hepatitis B within 24 hours of birth; two-month-old infants would be immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.” The same year, Dr. Maurice Hilleman, a Merck vaccine program luminary, warned Merck that six-month-olds administered Thimerosal-laced shots would “suffer dangerous exposure to mercury” and recommended Thimerosal be discontinued, "especially when used on infants and children," noting the industry knew of nontoxic alternatives. "The best way to go," he added, "is to switch to dispensing the actual vaccines without adding preservatives."

Thimerosal enables big pharm to package vaccines in multi-dose vials costing half as much as smaller, single-dose vials, cutting costs for international agency distribution to impoverished areas. Money prompted Merck to ignore Hilleman. Government officials pushed Thimerosal-laced vaccines and by 1999, children received an unbelievable 22 immunizations by the time they reached first grade. Before 1989, American preschoolers received eleven vaccinations: polio, diphtheria-tetanus-pertussis and measles-mumps-rubella.

Thimerosal Risk Hidden by Feds, Big Pharma

Mon, 02 Jun 2008 00:00:00 -0700

In 2005, Robert F. Kennedy, Jr. published a lengthy examination of the history of Eli Lilly´s deadly mercury compound, thimerosal, in vaccines and its decades-long history of suppressed data about dangers to those receiving it. Following is the third in a series of information from that piece, which described the outcome of a 2000 meeting—The Simpsonwood Conference—in which a group of government scientists and health officials met for a secret, highly-secluded meeting convened by the Centers for Disease Control and Prevention (CDC). In the coming days, we will continue to provide more information from this important paper on this dangerous health issue.

According to Kennedy, “The story of how government health agencies colluded with Big Pharma to hide the risks of thimerosal from the public is a chilling case study of institutional arrogance, power, and greed.” Kennedy said he was “drawn into the controversy only reluctantly” but notes that as both a lawyer and environmentalist, he “spent years working on issues of mercury toxicity” and “frequently met mothers of autistic children who were absolutely convinced that their kids had been injured by vaccines.”

Kennedy said that he was skeptical and “doubted that autism could be blamed on a single source.” He also understood the government’s standing in reassuring parents that vaccinations are safe and necessary to rid society of deadly childhood diseases. Kennedy also added that he was often in agreement with known skeptics such as Representative Henry Waxman, a Democrat from California, who criticized his colleagues on the House Government Reform Committee for jumping to conclusions about autism and vaccinations saying, "Why should we scare people about immunization until we know the facts?"

Kennedy stated that he became convinced about the reality of the thimerosal link to the rising epidemic of childhood neurological disorders after reading the Simpsonwood Conference transcripts, studying the leading scientific research, and speaking with many of the nation´s pre-eminent mercury authorities on mercury. Kennedy notes that five of his children belong to what is often referred to as the “Thimerosal Generation,” the group of people born between 1989 and 2003 and who received heavy doses of mercury from vaccines.

At a House Government Reform Committee in 1999, Patti White, a school nurse, said, "The elementary grades are overwhelmed with children who have symptoms of neurological or immune-system damage. Vaccines are supposed to be making us healthier; however, in twenty-five years of nursing I have never seen so many damaged, sick kids. Something very, very wrong is happening to our children." As of the date of the Kennedy piece, written in 2005, over 500,000 kids were suffering from autism and pediatricians were diagnosing over 40,000 new cases annually. Until 1943, the disease was unknown. In 1943, autism was identified and diagnosed among eleven children born in the months after thimerosal was first added to baby vaccines in 1931.

Some dispute the rise in autism is caused by thimerosal-tainted vaccinations, arguing that the autism rise is a result of better diagnosis. Because most of the new cases seem to affect a single generation of children, this theory seems, at the very least, questionable.

Plan Sought to Dispose of Mercury-Laced Light Bulbs

Fri, 23 May 2008 00:00:00 -0700

Yesterday, a number of health advocates and a local politician asked lawmakers to develop a plan for the safe disposal of compact fluorescent light bulbs, those energy-efficient bulbs that contain small amounts of mercury. While traditional incandescent bulbs do not contain mercury, they are also not energy efficient.

Because federal and Suffolk county officials have introduced plans to phase out the incandescent, mercury-free bulbs in favor of the higher-efficiency, mercury-laced bulbs, state Senator Craig Johnson (Democrat-Port Washington) announced that now is the time to develop "safe, fiscally prudent" methods for disposing of these compact fluorescent light bulbs, also known as CFLs. Johnson added, "It's not just simply the light bulb burns out and you can throw it out."

Mercury remains a dangerously significant source of environmental contamination and a recent study published in the Journal of Industrial Ecology indicated that in 2000, mercury releases caused by mercury-containing products accounted for an estimated 32 percent of mercury releases to air, two percent to land, and four percent to water. “Mercury-containing products such as thermometers, switches, and dental products release mercury throughout the product life-cycle, including during production, use, and disposal,” sad Alexis Cain, lead author of the study and an EPA environmental scientist.

High mercury levels can harm the brain, heart, kidneys, lungs, and immune system; can harm a developing fetus if the mother is exposed to high levels; and accumulates in fish populations. Because many popular products release mercury throughout their lifecycles, there are significant uncertainties concerning the impact of mercury release into the environment. This includes CFLs, which each contain an average of five milligrams of mercury. And, while the EPA recommends the use of CFLs, it stresses safety in their handling, said spokesman Elias Rodriguez, suggesting placing the bulbs in two plastic bags before throwing them away or discarding them at recycling centers. On Long Island, Brookhaven and Huntington have permanent facilities for dropping off such items; other towns schedule special waste drop-off dates; and a CFL recycling program, with up to five drop-off facilities with regular hours may be running by year-end in Suffolk county, said Carrie Meek Gallagher, county commissioner of environment and energy.

Proper bulb disposal is not the only concern, said John Gilmore, executive director of Autism United, a Hicksville-based coalition of advocacy groups, who argues that use of CFLs could increase the environment's overall mercury level, leading to increased health problems. Some autism advocates blame thimerosal, a once common mercury-based vaccine preservative for the rise in autism rates. Barbara Kaplan, 42, of Roslyn Heights, an advocate for children's health, said lawmakers rushed into support of CFLs without examining the possible consequences. "Here we are taking mercury out of flu shots and bringing it into our homes," she said.

The disposal of mercury-containing products has been the subject of public debate in recent years and programs have been initiated to eliminate mercury in thermometers as well as to discontinue its use in CFLs. There is also controversy revolving around who should pay for the separate disposal of mercury-containing switches and headlights removed from cars before they are crushed and recycled.

How Safe Are Vaccines?

Fri, 23 May 2008 00:00:00 -0700

Under current regulations, state laws require vaccinations for all children enrolling in kindergarten. Today, the U.S. enjoys the highest immunization rate ever: 77% of children are completely up-to-date on their recommended doses and those remaining who are not fully up-to-date are missing just a few shots by the first day of school.

Meanwhile, since the 1980s, the number of vaccinations children receive has doubled, while autism diagnoses have tripled. And, last month the U.S. government—which has always stood by the safety of vaccines—acknowledged that a nine-year-old Georgia girl with a preexisting cellular disease experienced a worsening of her disease due to inoculations she received as an infant, which "significantly aggravated" the condition, resulting in a brain disorder with autism-like symptoms. Government officials won’t say why they conceded this case, but did say those with pre-existing injuries can obtain compensation under the program if they establish that their underlying condition was "significantly aggravated" by a vaccine.

Despite the rules requiring students to be vaccinated, doctors can issue waivers to children whose compromised immune systems might make vaccines risky. All but two states allow waivers for children whose parents object to vaccines on religious grounds; 20 allow parents to opt out on philosophical grounds.

Meanwhile, since the 1930s, a mercury compound known as thimerosal had been included in some vaccines—but not the measles inoculation—as a preservative to keep the vaccines free of fungi and bacteria. Thimerosal is now known to do serious damage to brain tissue, especially in the brain tissue of children, whose brains are still developing. And, in 2001, a U.S. Food and Drug Administration (FDA) study revealed that a six-month-old receiving the recommended complement of childhood vaccinations was exposed to total levels of vaccine-based mercury that were twice as high as the amount the Environmental Protection Agency (EPA) considers safe in a diet that includes fish. By year-end 2001, thimerosal-free formulations of the five inoculations that previously included thimerosal—hepatitis B, diphtheria, tetanus, pertussis, and some versions of Haemophilus influenzae type b (Hib)—replaced the older thimerosal-containing versions of the vaccines. A drop in mercury exposure in fully immunized six-month-old babies from 187.5 micrograms to just trace amounts still found in some flu vaccines was realized.

Many parents have raised concerns over the government’s handling of the vaccine controversy as well as the vaccine industry, which continued developing shots to the point where today’s children receive up to 28 injections for 14 diseases, more than double the number required in the 1970s. And, now, parents are also beginning to object to the mandatory nature of the shots—and that a child’s access to education is contingent on compliance with immunization regulations. Also, some parents question why children are being inoculated against rarely seen diseases, such as polio.

Most agree that there may be children with genetic predispositions or other underlying conditions that make them susceptible to being harmed by vaccines. The Georgia girl in the recent vaccine case is the first such documented child, but her story suggests there could be others.

What the CDC and FDA Dont Want You to Know About Thimerosal and Autism--Part II

Wed, 21 May 2008 00:00:00 -0700

In 2005, Robert F. Kennedy, Jr. published a lengthy examination of the history of Eli Lilly´s deadly mercury compound, thimerosal, in vaccines and its decades-long history of suppressed data about dangers to those receiving it. Following is the second in a series of information from that piece, which described the outcome of a 2000 meeting—The Simpsonwood Conference—in which a group of government scientists and health officials met for a secret, highly-secluded meeting convened by the Centers for Disease Control and Prevention (CDC). In the coming days, we will continue to provide more information from this important paper on this dangerous health issue.

The government ably handled the damage, with the CDC paying the Institute of Medicine to conduct a new study to minimize the risks of thimerosal, ordering researchers to "rule out" thimerosal’s link to autism. The study withheld Verstraeten´s findings, despite the fact that the findings were scheduled for immediate publication. The other scientists were told that the original data was “lost" and could not be replicated. In an effort to hinder the Freedom of Information Act, it gave its enormous database of vaccine records to a private company, declaring it off-limits to researchers. When Verstraeten finally published his study in 2003, he had gone to work for GlaxoSmithKline and edited his data to hide the thimerosal-autism link.

Vaccine manufacturers began to phase thimerosal out of injections given to American infants at that time but continued to sell off their remaining thimerosal-based vaccines until 2004. The CDC and FDA also purchased the tainted vaccines for export to developing countries and allowed drug companies to continue using thimerosal in some American vaccines, including pediatric flu shots and tetanus boosters given to children.

Drug manufacturers also received significant assistance from some powerful Washington lawmakers such as Senate Majority Leader Bill Frist who received $873,000 in contributions from the pharmaceutical industry and worked to protect vaccine makers from liability in 4,200 lawsuits filed by the parents of injured children. On no less than five separate occasions, Frist attempted to seal all of the government´s vaccine-related documents—including the Simpsonwood Conference transcripts—and “shield Eli Lilly, the developer of thimerosal, from subpoenas.”

In 2002, the day after Frist slipped a rider known as the "Eli Lilly Protection Act" into a homeland security bill, Eli Lilly contributed $10,000 to Frist’s campaign and bought 5,000 copies of his book on bioterrorism. Although the measure was repealed by Congress in 2003, Frist slipped another provision into an anti-terrorism bill in 2005 that would deny compensation to children suffering from vaccine-related brain disorders. "The lawsuits are of such magnitude that they could put vaccine producers out of business and limit our capacity to deal with a biological attack by terrorists," said Dean Rosen, health policy adviser to Frist.

Representative Dan Burton (Republican-Indiana) oversaw a three-year investigation of thimerosal following his grandson’s diagnoses with autism. "Thimerosal used as a preservative in vaccines is directly related to the autism epidemic," his House Government Reform Committee concluded in its final report. "This epidemic, in all probability, may have been prevented or curtailed had the FDA not been asleep at the switch regarding a lack of safety data regarding injected thimerosal, a known neurotoxin."

Report Detailed Thimerosal Cover-up

Wed, 14 May 2008 00:00:00 -0700

In 2005, Robert F. Kennedy, Jr. published a lengthy examination of the history of Eli Lilly´s deadly mercury compound, thimerosal, in vaccines and its decades-long history of suppressed data about dangers to those receiving it, especially via injection. Following is some excerpted information from that paper. In the coming days, we will provide more information from this important paper on this dangerous health issue.

In June 2000, a group of government scientists and health officials met for a secret, highly-secluded meeting convened by the Centers for Disease Control and Prevention (CDC) to discuss issues over the safety of a variety of ubiquitous childhood vaccines routinely given to infants and young children. The CDC issued no public announcement of the session; 52 private invitations were sent to attendees including high-level CDC and Food and Drug Administration (FDA) officials, the top vaccine specialist from the World Health Organization (WHO) in Geneva, and representatives from every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth, and Aventis Pasteur. Meeting information was strictly "embargoed"; there would be no copying or removing documents.

According to CDC epidemiologist, Tom Verstraeten, who analyzed the CDC’s enormous cache of medical records of 100,000 children, thimerosal pointed to a dramatic increase in autism rates as well as many other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told the group, citing the staggering number of earlier studies indicating a link between thimerosal and speech delays, attention-deficit disorder (ADD), hyperactivity, and autism. Since 1991, when the CDC and the FDA recommended three additional vaccines laced with thimerosal be administered to extremely young infants—one within hour of birth—the estimated number of autism cases increased 15-fold, from one in every 2,500 children to one in 166 children.

Instead of alerting the public and removing thimerosal from the vaccine supply, the group worked on a cover up. According to transcripts obtained under the Freedom of Information Act, many attendees expressed concerned over how this would affect the vaccine industry’s. "We are in a bad position from the standpoint of defending any lawsuits," said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for Children in Delaware. "This will be a resource to our very busy plaintiff attorneys in this country." Dr. Bob Chen, head of vaccine safety for the CDC, expressed relief that "given the sensitivity of the information, we have been able to keep it out of the hands of, let’s say, less responsible hands." Dr. John Clements, vaccines advisor at the WHO, said, "perhaps this study should not have been done at all," adding "the research results have to be handled," and warning that the study "will be taken by others and will be used in other ways beyond the control of this group."

"You can play with this all you want," Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results "are statistically significant." Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado—whose grandson was born on the meeting’s first day—said, "My gut feeling? Forgive this personal comment: I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on.

Parents Testify in Autism Vaccine Case

Tue, 13 May 2008 00:00:00 -0700

Testimony resumed this week in the U.S. Court of Federal Claims in a long-running case that involves thousands of children with autism. The children’s parents claim regressive autism—in which normally developing children suddenly exhibit learning disorders and behavioral problems; age of onset is typically between ages one and two—was triggered by an early childhood vaccination containing thimerosal.

The thimerosal-autism issue has been hotly debated and vigorously studied in recent years. And, yes, autism diagnoses have increased exponentially in recent decades; however, there is ongoing disagreement regarding the link. Some parent groups and lawmakers feel the preservative, which contains mercury, has caused a rash of new autism cases.

Autism, also called “classical autism,” is the most common condition in a group of developmental disorders known as autism spectrum disorders (ASDs) and is characterized by impaired social interaction; problems with verbal and nonverbal communication; and unusual, repetitive, or severely limited activities and interests. Experts estimate three to six out of every 1,000 children will have autism, with males four times more likely to have autism than females.

Two families are serving as test cases in this second of a three-phase review of evidence being reviewed by a special federal court meant to compensate victims of injuries caused by vaccines. This phase is scheduled to run three weeks and each phase involves a review of representative cases of autistic children and their medical history to determine whether there is a link between autism and thimerosal-containing vaccines. Nearly 5,000 other autism claims are pending.

A plaintiff attorney disputed what he said is the government's focus on defending the nation's vaccination program. The government's defense rests largely on research done no later than 2004. Thimerosal was removed from infant vaccines in 1999.

Meanwhile, during his campaign in Texas, Republican hopeful Senator John McCain was quoted as saying, “It’s indisputable that autism is on the rise among children. The question is, what’s causing it?” Given that the US Department of Health and Human Services concluded that childhood vaccines contributed to the symptoms of one girl’s autism, McCain’s comments were timely, if nothing else. The family of Hannah Poling, nine, of Athens, Georgia is entitled to receive compensation from a federal vaccine injury fund. In a court document, the government said vaccines aggravated “a rare underlying metabolic condition that resulted in a brain disorder with features similar of autism spectrum disorder.” According to Centers for Disease Control (CDC) estimates, as many as one in 150 children in some communities have autism disorders.

Also, a new study of Texas school district and industrial mercury-release data, which was conducted by researchers at The University of Texas Health Science Center at San Antonio, reveals that there is a statistically significant link between the pounds of industrial release of mercury and an increase in autism rates. The study examined mercury-release data from 39 coal-fired power plants and 56 industrial facilities in Texas and autism rates from 1,040 Texas school districts and confirmed—for the first time in scientific literature—that there is a statistically significant link between autism risk and distance from the mercury source. The study revealed mounting evidence that children and other developing organisms are more susceptible to neurobiological effects of mercury.

Vaccines Caused Autism Symptoms in Girl, US Officials Say, But Regulators Still Deny Autism-Vaccine Link

Thu, 06 Mar 2008 00:00:00 -0800

Autism in a Georgia girl was brought about by a reaction to vaccines, federal health regulators said. They have decided that the girl is entitled to a payment from a federal vaccine injury fund, a stunning development considering that US health officials have long maintained that neither vaccines or the thimerosal once used in them have nothing to do with the onset of autism.

Autism is a brain development disorder that impairs social interaction and communication, and causes restricted and repetitive behavior, all starting before a child is three years old. In the 1990s, the definition of autism was expanded to take in a group of milder, related conditions, which are known as autism spectrum disorders.

For years, autism advocates have claimed that vaccines containing the preservative thimerosal contributes to autism. Thimerosal contains mercury, a chemical known to cause brain damage. In July 1999, following a review of mercury-containing food and drugs, the Centers for Disease Control and the American Academy of Pediatrics asked vaccine makers to remove thimerosal from vaccines as quickly as possible. Despite a rising prevalence of autism among US children, the government and vaccine industry have insisted that thimerosal has not played a role in the autism epidemic.

US regulators still maintain that vaccines do not cause autism, but they have conceded that vaccines the Georgia girl received aggravated a mitochondrial disorder the child had, leading to symptoms of autism. The disorder impairs cells' ability to use nutrients, and often causes problems in brain functioning, as well as delays in walking and talking. According to an article in the Associated Press, this disorder may be more common in children who develop autism.

According to the Associated Press, a document from the US Department of Health and Human Services said that five vaccines the girl received on one day in 2000 aggravated her mitochondrial condition, predisposing her to metabolic problems that manifested as worsening brain function "with features of autism spectrum disorder." The Associated Press said the document does not address whether it was the thimerosal that was at fault. Despite its own decision, the Health Resources and Services Administration (HRSA), which is in charge of the vaccine injury fund, said: "HRSA has maintained and continues to maintain the position that vaccines do not cause autism."

The Associate Press said that nearly 5,000 families are seeking compensation from the vaccine court for autism or other developmental disabilities they blame on vaccines and thimerosal. The vaccine court was established by Congress to compensate people injured by vaccines and to protect vaccine makers from damages.

This decision gives many of those autism families renewed hope, and will further ignite the debate over the vaccine-autism link. According to the Associated Press, a decision is expected this spring on the first test case for a larger group of autism-vaccine claims, which are being heard in the U.S. Court of Federal Claims.

New mercury limits denied

Wed, 25 Oct 2006 00:00:00 -0700

Federal health officials won’t put new restrictions on the use of a mercury-based preservative in vaccines and other medicines, denying a petition that sought the limits because of health concerns.

A group called the Coalition for Mercury-free Drugs petitioned the Food and Drug Administration in 2004 seeking the restrictions on thimerosal, citing concerns that the preservative is linked to autism. In a reply dated Sept. 26 but made public only Tuesday, the FDA rejected the petition.

“Only a small number of licensed and approved products still contain thimerosal, and the available evidence supports FDA’s conclusion that all currently licensed vaccines and other pharmaceutical drug products containing thimerosal are safe,” Jeffrey Shuren, the FDA’s assistant commissioner for policy, wrote in denying the petition.

“We’re not accepting that answer,” said Mark Geier, one of the petitioners.

The group now plans to seek a court order that would force the FDA to withdraw thimerosal from all vaccines and medicines unless the agency can show the preservative is safe, Geier said.

Thimerosal, about 50 percent mercury by weight, has been used since the 1930s to kill microbes in vaccines.

There have been suspicions that thimerosal causes autism. However, studies that tracked thousands of children have consistently found no association between the brain disorder and the mercury-based preservative.

Critics contend the studies are flawed.

Since 2001, all vaccines given to children 6 and younger have been either thimerosal-free or contained only trace amounts of the preservative. Thimerosal has been phased out of some, but not all, adult vaccines as well.

Most doses of the flu vaccine still contain thimerosal, though manufacturers produce versions free of the preservative for use in children. The FDA said it was in discussions with those manufacturers to increase the supply of thimerosal-free flu vaccine.

There also are minute amounts of mercury, as thimerosal or phenylmercuric acetate, in roughly 45 eye ointments, nasal sprays and nasal solutions, the FDA said. Various antivenoms for black widow and snake bites also contain thimerosal.

PARENTS GROUP MAINTAINS AUTISM IS PREVENTABLE AND REVERSIBLE WHEN MERCURY IS REMOVED FROM CHILDRENS BODIES

Thu, 26 May 2005 00:00:00 -0700

The battle lines could not be more clearly drawn. On one side are the experts who claim autism is not linked to mercury exposure (from childhood vaccines and other sources) and who agree with the position of the Centers for Disease Control (CDC) that autism is permanent and not treatable. On the other side are the experts, parents, and attorneys who maintain that autism is directly related to mercury exposure and can be prevented and even reversed by removing mercury from the bodies of autistic children.

A series of recent studies and investigations indicate that mercury is at the heart of the growing autism epidemic. This has lead a number of doctors to employ chelation therapy to remove the extremely toxic substance from affected children. Now, a group of parents of autistic children have founded a nonprofit organization known as Generation Rescue to get the message out that there are biomedical treatments that can effectively treat and reverse autism. The group and the doctors who advocate such treatments are confident that many, if not a majority, of autistic children can make a full recovery from the debilitating disorder. Generation Rescue can be reached at www.GenerationRescue.org.

A Child's Return From Autism

Wed, 25 May 2005 00:00:00 -0700

A Lafayette couple, certain that chelation therapy has helped their autistic son, stepped squarely into the controversy surrounding the causes of autism and its treatment Tuesday as they joined 150 other parents in launching an international support group that will aggressively promote the treatment.

Jamie Handley was a happy, healthy baby who reached all his developmental milestones until he turned 18 months, his parents said. Then, he started spinning in circles and standing on his toes and no longer responded to his name. They were eventually told he was autistic one of an increasing number of children over the last decade to be diagnosed with the disorder, which severely impairs a child's ability to interact with others.

The Handleys are now among a small minority of parents who, believing that the autism was caused by the mercury in thimerosal, a preservative that was routinely used in vaccines until recently are treating their children with chelation therapy, a lotion or pill that strips the body of heavy metals. It has been used for decades to detoxify people contaminated in industrial accidents, but no studies have proved whether it is an effective treatment for autism.

For Jamie's parents, the proof they need is in front of them: Jamie, now 3 years old and several months into treatment, is plump and playing baseball. His smile has returned.

"Every day brings small, steady gains," said Lisa Handley of Lafayette. "Our life is filled with hope and the conviction that Jamie won't just improve, but will completely recover."

The Handleys said the new support group, Generation Rescue, and its Web site, www.generationrescue.com, will offer information on chelation therapy and connect parents with those who can help. The chelation therapy includes not only the medicine, but dietary restrictions and vitamins and mineral supplements.

The medical community differs on the cause of autism, a developmental disorder marked by communication problems and restricted or repetitive behavior. Some say it's genetic, possibly exacerbated by other medical or environmental conditions. Others have noticed that the symptoms have often surfaced after a child got routine vaccinations containing thimerosal and believe that the skyrocketing numbers of autism in the last decade are the result of an increasing use of the vaccinations over the same period.

"Mercury is the second most neurotoxic substance on earth, after plutonium, and they were injecting it into newborns until 2003," said Lynn Mielke, Jamie's doctor. "An entire generation of children was basically poisoned."

In California, 1,605 children were diagnosed with autism in 1992-93, compared with nearly 20,000 a decade later, according to the U.S. Department of Education.

The national Institute of Medicine, a branch of the National Academies, has concluded that there is no link between thimerosal and autism and says that a number of other factors could explain the rise in autism diagnoses.

But the Handleys and other parents say they noticed symptoms in their children after they got booster shots.

"Our son Andy regressed immediately after his 15-month vaccinations," said Karen Schwing of Beach Haven, N.J., another member of Generation Rescue. "I was told nothing can be done. Our son is living proof that autism is treatable."

Treatment of autism is as hotly debated as the causes of the disease. Mielke, who has an autistic son, is a member of a group called Defeat Autism Now and attends an international research conference on autism twice a year. She insists that almost every child improves with the chelation therapy. Others say that it can be treated through changes in diet and with nutritional supplements. Nothing yet has been proved to cure autism, however.

If thimerosal is part of the problem, the numbers of cases should begin to drop. In 1999, the American Academy of Pediatrics and the U.S. Public Health Service said vaccine manufacturers should phase out thimerosal. While it may still be found in vaccines on the shelves of doctors' offices, said Bernard Rimland, founder of the Autism Research Institute of San Diego, new pediatric vaccines now contain trace amounts of the preservative or none at all.

Three states: Iowa, Missouri and California have banned the preservative, although the California law doesn't take effect until July 2006. Other states are considering following suit, but a U.S. Senate bill would prevent states from banning mercury in vaccines.

Government funding is needed to prove or disprove the mercury connection, said Dr. Boyd Haley, a mercury researcher and expert on toxicology at the University of Kentucky. "We need the NIH (National Institutes of Health) to put their money and expertise to determine the best possible treatment."

Infant Vaccine Is Dangerous, Researchers Say

Fri, 22 Apr 2005 00:00:00 -0700

A mercury-laced preservative once widely added to pediatric vaccines exposes infants' brains to twice the neurotoxin as previously suspected, offering evidence health guidelines may underestimate the risk newborns face, researchers say in a report published Thursday.

The additive, thimerosal, has been used in vaccines since the 1930s and is almost 50 percent mercury by weight. Since 2001, manufacturers gradually have phased it from almost all domestic pediatric vaccines, though it remains in use overseas in cheaper "multidose" vaccines.

The study, published in Environmental Health Perspectives, a peer-reviewed publication of the National Institutes of Health, also chides health officials for abandoning an earlier recommendation that the preservative be completely phased out and further studies conducted.

And it fuels the debate concerning the federal government's aggressive vaccination plan that subjects infants to a battery of shots some of which contain aluminum and other potentially harmful compounds in their first weeks of life.

"We're talking about a low-level delivery of a toxin given to a baby on the first day of its life," said mercury expert Boyd Haley, chairman of the chemistry department at the University of Kentucky but not involved in the study.

"What's needed is a total study of the sensibility of the vaccine program. Why would you want to vaccinate a baby on the first day of its life?"

The report is one of the first to look beyond mercury blood levels resulting from vaccines. Instead it examines both the amount and the type of mercury reaching the brain. It suggests health officials examined the wrong compound and
failed to look far enough when assessing the danger of mercury in thimerosal.

This is largely a past concern for the United States, given the predominance today of thimerosal-free vaccines. Both the study's lead author and the Centers for Disease Control and Prevention on Wednesday urged parents to have their children vaccinated.

"That's the first message," said Thomas Burbacher, lead author and associate professor in the Department of Environmental and Occupational Health Sciences at the University of Washington's School of Public Health.

"The bottom line is that trying to assess the effects of a compound with very little or no data is not a good thing to do. Unfortunately, we started doing studies on this compound way too late. Basic information like this should've been available decades ago."

However, the problem is very much alive for developing nations, where the additive is common. The World Health Organization has expressed interest in Burbacher's research.

The problem, Burbacher said, is that regulators trying to assess thimerosal's harm used as a benchmark methylmercury, a widely studied compound, rather than the little-known compound called ethylmercury in thimerosal.

Both compounds cross the blood-brain barrier. But methylmercury breaks down slowly, whereas ethylmercury dissipates fairly rapidly, suggesting to regulators that a standard based on methylmercury would adequately protect infants.

Burbacher and colleagues found ethylmercury's fast breakdown leaves higher levels of so-called "inorganic" mercury in the brain. Inorganic mercury lingers in the brain for a year or more, potentially altering certain cells. A previous study has shown such damaged cells are also found in children
with autism.

Using monkeys, Burbacher found the brains of thimerosal-exposed infants had twice as much inorganic mercury as methylmercury-exposed infants.

The Food and Drug Administration has never required testing of thimerosal's safety or of its safe exposure levels for newborns and children.

Although high mercury levels particularly as a result of vaccinations have long been suspected as a leading cause of skyrocketing autism levels, the CDC and Burbacher cautioned Wednesday against drawing any conclusion linking the two.

"To date, the vast majority of the science doesn't support an association between thimerosal and incidences of autism," said CDC spokesman Glen Nowak. But "at the end of the day, we still don't know what causes autism."

Others, however, expect such links to become apparent as thimerosal fades from use in the United States. Already, noted Haley, California's autism rates have decreased three of the past four quarters a first.

"There's something in the vaccines doing it. That something is thimerosal."

Thimerosal, Methylmercury React Differently in the Brains of Infants, Study Says

Thu, 21 Apr 2005 00:00:00 -0700

Researchers have uncovered greater detail about differences in how thimerosala preservative used in vaccines since the 1930s-and methylmercury are distributed in and eliminated from the brain and body, as reported in a study published online today by the peer-reviewed journal Environmental Health Perspectives. Among other effects, researchers found that brain concentrations of total mercury following thimerosal exposure were nearly threefold lower than those following methylmercury exposure.

These findings are important because they demonstrate that methylmercury is not a suitable reference for determining risk from exposure to thimerosal. The current debate over a potential link between thimerosal in vaccines and autism has led many families to question whether the risk of developing the disorder is greater than the benefit of vaccination.

Thimerosal breaks down in the body to ethylmercury and thiosalicylate. Because few health effects data exist for ethylmercury, methylmercury guidelines have been used to predict the toxicokinetics and neurodevelopmental effects of ethylmercury exposure. An earlier study calculated that children receive 187.5 micrograms of ethylmercury from thimerosal-containing vaccines given over the first 14 weeks of life, which can exceed EPA guidelines for methylmercury exposure during pregnancy.

In the present study, researchers exposed 41 infant Macaca fascicularis, or crab-eating monkeys, to thimerosal and methylmercury. These monkeys are among the best proxies for infant humans. Infants assigned to the thimerosal group received the typical schedule of injected vaccines for human infants, while infants assigned to the methylmercury group were exposed through a feeding tube.

Absorption and initial distribution of total mercury proved to be similar for both thimerosal and methylmercury. However, injected thimerosal reacted differently from methylmercury in that it cleared from the infant much more quickly. Also the peak blood mercury concentration in the methylmercury group rose to a level three times higher than the thimerosal infants after the fourth dose. Brain concentrations of total mercury were significantly lower for the thimerosal group compared to the methylmercury group.

These results suggest that ethylmercury is dealkylated much more extensively than methylmercury, producing higher levels of inorganic mercury in the brain. While dealkylation is thought to be a detoxification mechanism that helps protect the central nervous system, previous work by Burbacher and his group has shown that inorganic mercury can affect certain types of cells in the brain such as the microglia. Recent reports have indicated abnormal microglia in the brains of children with autism.

According to the researchers, more research is needed to accurately predict how immunization with thimerosal-containing vaccines may affect children. "Knowledge of the biotransformation of thimerosal is urgently needed to afford a meaningful interpretation of the potential developmental effects of immunization with thimerosal-containing vaccines in newborns and infants," the study authors write. "This information is critical if we are to respond to public concerns regarding the safety of childhood immunizations."

Dr. Jim Burkhart, science editor for EHP, says, "This study emphasizes that thimerosal and methylmercury behave differently in the body. Given that we routinely inject thimerosal into millions of infants, the study authors' call for more in-depth research on the subject is the right way to go."

Merck Misled on Vaccines, Some Say

Mon, 07 Mar 2005 00:00:00 -0800

Drug maker Merck & Co. continued to supply infant vaccine containing a mercury-based preservative for two years after declaring that it had eliminated the chemical.

In September 1999, amid rising concern about the risks of mercury in childhood vaccines, Merck announced that the Food and Drug Administration had approved a preservative-free version of its hepatitis B vaccine.

"Now, Merck's infant vaccine line," the company's press release said, "is free of all preservatives."

But Merck continued to distribute vaccine containing the chemical known as thimerosal, along with the new product, until October 2001, according to an FDA letter sent in response to a congressional inquiry.

The thimerosal-containing supplies had expiration dates in 2002.

Merck executives confirmed the details in the FDA letter but defended the accuracy of Merck's announcement in 1999, saying the company had indeed begun to produce preservative-free vaccine.

Merck continued to supply the preservative-containing version "during the transition period to ensure an adequate supply of vaccine to help protect the nation's children," said spokeswoman Mary Elizabeth Blake. She said package labels disclosed which lots of vaccine were preservative-free.

Parent groups and a congressional critic of U.S. vaccine policy are crying foul.

"As far as the world knew, the product coming out of Merck had no thimerosal in it," said Sallie Bernard, executive director of Safe Minds, a group concerned about childhood exposure to mercury, a neurotoxin. Parents and doctors who wanted a thimerosal-free product "would be totally confused," she said.

Rep. Dave Weldon, a Florida Republican and a physician, said what Merck did was "misleading."

"You had people literally into 2002 getting shots with mercury, having been told it was all taken out in 1999," he said. "There should have been a much more cautious announcement that we're going to eliminate the mercury over time." The FDA letter was sent to Weldon in June 2003 in response to his questions about progress in removing mercury from vaccines.

Thimerosal, which is nearly 50% ethyl mercury, has largely been eliminated from most routine childhood vaccines, though it still is present in most flu shots. It had been widely used as a sterilizing agent to prevent bacterial contamination from repeated insertion of needles into multi-dose vials of vaccine.

More than 4,200 claims have been filed in the federal Vaccine Injury Compensation Program by parents alleging that their children suffered autism or other neurological disorders from mercury in their shots.

Last year California banned thimerosal in childhood vaccines as of 2006.

Vaccine makers and many health officials say there is no credible evidence of harm from the small doses of mercury once widely present in kids' shots. They cite a report last May by the prestigious Institute of Medicine of the National Academy of Sciences, which concluded that available evidence "favors rejection of a causal relationship" between vaccines and autism.

Parents have cited contrary findings and say the studies cited by the institute's panel were flawed.

Though they said there was no proof of harm, the U.S. Public Health Service and the American Academy of Pediatrics in July 1999 acknowledged that mercury exposures from a multitude of shots exceeded federal health guidelines, and they called on manufacturers to voluntarily eliminate thimerosal from kids' vaccines.

Last month The Times disclosed a leaked Merck memo from 1991 showing that the company was aware at that time of concerns about thimerosal. In the memo, a former Merck scientist calculated that 6-month-old children who received their shots on schedule could receive a mercury dose up to 87 times higher than the guideline for the maximum daily consumption of mercury from fish.

"When viewed in this way, the mercury load appears rather large," said the memo by Dr. Maurice R. Hilleman, an internationally renowned vaccinologist and a former senior vice president of Merck. "The key issue is whether thimerosal, in the amount given with the vaccine, does or does not constitute a safety hazard."

Hilleman and Merck executives have declined to discuss the memo.

Merck's announcement of the new thimerosal-free vaccine figured strongly in a shift in federal immunization policy.

In issuing their 1999 appeal, federal authorities also recommended that the first hepatitis B shot, typically given to newborns in their first 12 hours of life, be postponed except for at-risk infants those whose mothers had tested positive or whose hepatitis B status was unknown.

But that caveat was lost in confusion over the new policy, and some hospitals delayed the birth dose even for at-risk children. Fearing that these babies could contract the serious disease, the Centers for Disease Control and Prevention reinstated the birth dose for all newborn babies, citing the availability of the new Merck vaccine.

The Merck release was issued Sept. 9, 1999, and the CDC announced the revised policy the next day.

The CDC notice cited the introduction of the Merck vaccine and the expectation that a preservative-free version from a second manufacturer would be available soon. It called on hospitals and doctors to assure that they had enough of the new product for newborns before giving it to older babies.

"There was a belief there was enough thimerosal-free hepatitis vaccine, so they went back to the birth dose," said Glen Nowak, a spokesman for the CDC.

Dr. Eric Mast, chief of the prevention branch in the CDC's division of viral hepatitis, said the agency had not conducted surveys to determine the percentage of newborns who got mercury-free shots. But he said the CDC had not received reports "from state health departments or providers that there was a problem with access" to preservative-free vaccine.

Weldon, however, said that with the old product continuing to flow into the market, he was "fairly confident that newborns continued to get mercury-containing vaccines."

"It would have to be a very well-informed and diligent pediatrician to make sure all of the stock he supplied contained no mercury," he said.

91 Memo Warned of Mercury in Shots

Tue, 08 Feb 2005 00:00:00 -0800

A memo from Merck & Co. shows that, nearly a decade before the first public disclosure, senior executives were concerned that infants were getting an elevated dose of mercury in vaccinations containing a widely used sterilizing agent.

The March 1991 memo, obtained by The Times, said that 6-month-old children who received their shots on schedule would get a mercury dose up to 87 times higher than guidelines for the maximum daily consumption of mercury from fish.

"When viewed in this way, the mercury load appears rather large," said the memo from Dr. Maurice R. Hilleman, an internationally renowned vaccinologist. It was written to the president of Merck's vaccine division.

The memo was prepared at a time when U.S. health authorities were aggressively expanding their immunization schedule by adding five new shots for children in their first six months. Many of these shots, as well as some previously included on the vaccine schedule, contained thimerosal, an antibacterial compound that is nearly 50% ethyl mercury, a neurotoxin.

Federal health officials disclosed for the first time in 1999 that many infants were being exposed to mercury above health guidelines through routine vaccinations. The announcement followed a review by the U.S. Food and Drug Administration that was described at the time as a first effort to assess the cumulative mercury dose.

But the Merck memo shows that at least one major manufacturer was aware of the concern much earlier.

"The key issue is whether thimerosal, in the amount given with the vaccine, does or does not constitute a safety hazard," the memo said. "However, perception of hazard may be equally important."

Merck officials would not discuss the contents of the memo, citing pending litigation.

Separately, the drug giant is trying to fend off a legal onslaught over Vioxx, the popular painkiller it introduced in 1999. The company, based in Whitehouse Station, N.J., faces hundreds of lawsuits claiming that the drug caused heart problems and that Merck concealed the risks. Merck, which in September pulled Vioxx off the market, has denied the allegations.

The legacy of thimerosal, meanwhile, also is causing problems for Merck and other drug companies.

More than 4,200 claims have been filed in a special federal tribunal, the Vaccine Injury Compensation Program, by parents asserting that their children suffered autism or other neurodevelopmental disorders from mercury in vaccines. A handful of similar claims are awaiting trial in civil courts. The plaintiffs cite various scientific studies that they say prove the dangers of thimerosal, including at the levels found in vaccines.

Thimerosal has been largely removed from pediatric vaccines in recent years in what health officials have described as a precautionary measure. (This has been accomplished as drug makers have voluntarily switched from multi-dose vials of vaccine, which require a chemical preservative like thimerosal, to single-dose containers.)

In September, Gov. Arnold Schwarzenegger signed legislation prohibiting vaccines with more than trace amounts of thimerosal from being given to babies and pregnant women. Iowa has a similar ban.

For their part, Merck and other vaccine makers, along with many government health officials and scientists, say there is no credible evidence of harm from the amounts of mercury once widely present in kids' shots. They cite a report in May by a committee of the national Institute of Medicine concluding that the evidence "favors rejection of a causal relationship" between vaccines and autism.

The seven-page Merck memo was provided to The Times by a Washington lawyer who works with parent groups on vaccine safety issues. He said he obtained it from a whistle-blower whom he would not name.

The memo provides the "first hard evidence that the companies knew or at least Merck knew that the children were getting significantly more mercury" than the generally accepted dose, the lawyer said.

He also provided a copy to attorneys for Vera Easter, a Texas woman who blames thimerosal for the condition of her 7-year-old son, Jordan, who is autistic and mentally retarded. The Easter lawsuit is pending in U.S. District Court for the Eastern District of Texas. The defendants include Merck; rival vaccine makers GlaxoSmithKline, Aventis Pasteur Inc. and Wyeth; and thimerosal developer Eli Lilly & Co.

Easter's lawyer described the memo as "incredibly damning and incredibly significant." After receiving it in the fall, he confronted Merck lawyers about why he hadn't seen it earlier.

Merck attorneys said they had in fact made available 32 boxes of records, but that the copying service hired by the plaintiffs for some reason had failed to copy several of the boxes including the one with the Hilleman memo.

"The memo," said company spokeswoman Mary Elizabeth Blake, "was produced voluntarily by Merck in the ordinary course of discovery proceedings."

Hilleman is a former senior vice president of Merck who developed numerous vaccines for the company. A 1999 profile in the Philadelphia Inquirer said that "it is no exaggeration to assert, as many scientists do, that Maurice Hilleman has saved more lives than any other living scientist."

Hilleman, 85, currently director of the Merck Institute for Vaccinology, had officially retired and was a consultant to Merck when he wrote the '91 memo. He declined to be interviewed.

The memo was sent to Dr. Gordon Douglas, then head of Merck's vaccine division and now a consultant for the Vaccine Research Center at the National Institutes of Health. Douglas also declined to comment.

The memo stated that regulators in several countries had raised concerns about thimerosal, including in Sweden, where the chemical was being removed from vaccines.

"The public awareness has been raised by the sequential wave of experiences in Sweden including mercury exposure from additives, fish, contaminated air, bird deaths from eating mercury-treated seed grains, dental amalgam leakage, mercury allergy, etc.," the memo said.

It noted that Sweden had set a daily maximum allowance of mercury from fish of 30 micrograms for a 160-pound adult, roughly the same guideline used by the FDA. Adjusting for the body weight of infants, Hilleman calculated that babies who received their shots on schedule could get 87 times the mercury allowance.

The Swedish and FDA guidelines work out to about four-tenths of a microgram of mercury per kilogram of body weight. A stricter standard of one-tenth of a microgram per kilogram has been adopted by the Environmental Protection Agency and endorsed by the National Research Council.

These standards are based on methyl mercury, the type found in fish and airborne emissions from power plants. Though toxic, the ethyl mercury in thimerosal may be less hazardous than methyl mercury, some scientists say, because it is more quickly purged from the body.

"It appears essentially impossible, based on current information, to ascertain whether thimerosal in vaccines constitutes or does not constitute a significant addition to the normal daily input of mercury from diverse sources," the memo said.

"It is reasonable to conclude" that it should be eliminated where possible, he said, "especially where use in infants and young children is anticipated."

In the U.S., however, thimerosal continued to be added throughout the '90s to a number of widely used pediatric vaccines for hepatitis B, bacterial meningitis, diphtheria, whooping cough and tetanus.

It was added to multi-dose vials of vaccine to prevent contamination from repeated insertion of needles to extract the medicine. It was not needed in single-dose vials, but most doctors and clinics preferred to order vaccine in multi-dose containers because of the lower cost and easier storage.

The Hilleman memo said that unlike regulators in Sweden and some other countries, "the U.S. Food and Drug Administration does not have this concern for thimerosal."

A turning point came in 1997 when Congress passed a bill ordering an FDA review of mercury ingredients in food and drugs.

Completed in 1999, the review revealed the high level of mercury exposure from pediatric vaccines and raised a furor. In e-mails later released at a congressional hearing, an FDA official said health authorities could be criticized for "being 'asleep at the switch' for decades by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products."

It would not have taken "rocket science" to add up the amount of exposure as the prescribed number of shots was increasing, one of the e-mails said.

While asserting that there was no proof of harm, the U.S. Public Health Service in July 1999 called on manufacturers to go mercury-free by switching to single-dose vials. Soon after, Merck introduced a mercury-free version of its hepatitis B vaccine, replacing the only thimerosal-containing vaccine it was still marketing at the time, a company spokesman said.

By 2002, thimerosal had been eliminated or reduced to trace levels in nearly all childhood vaccines. One exception is the pediatric flu vaccine made by Aventis and still sold mainly in multi-dose vials.

Debate Grows On Vaccine-Autism Link

Sun, 08 Feb 2004 00:00:00 -0800

The new vaccines kept coming, each containing a tiny amount of mercury as a preservative. For nearly a decade, until regulators realized the problem in 1999, children who received all the recommended vaccinations could have absorbed an elevated amount of the toxin by the time they were 6 months old.

"I feel badly that I didn't pick it up," acknowledged an adviser to the National Immunization Program, Dr. Neal Halsey of Johns Hopkins University, at a hearing in Cambridge three years ago.

The preservative, called thimerosal, is used only in trace amounts or not at all in today's US vaccines, but the debate over the human cost of that public health miscalculation is growing. Tomorrow, a panel of the Institute of Medicine will hear new evidence on whether mercury-containing vaccines could explain the apparent increase in autism, a neurological disorder whose victims have difficulty interacting with others or even with talking, and often rely on ritual behavior to cope.

By some estimates, the number of US autism cases has risen tenfold in the past 30 years, although it is unclear how much of the increase reflects greater awareness of the disease rather than a true rise. Many public health officials say the amount of mercury was too small to do much harm, but parents of autistic children say their concerns are not getting a fair hearing because federal health agencies, along with vaccine manufacturers, manipulate studies to play down the role of vaccines in neurological problems.

"I just want to figure out what happened to my kid," said Mark Blaxill of Cambridge, whose 8-year-old daughter was diagnosed with autism shortly after she received childhood immunizations.

The anticipated hearing in Washington marks the second time that the institute, an independent science adviser to the government, has tackled the emotional and politically charged issue. In 2001, it concluded that it is "biologically plausible" that mercury, used since the 1930s to keep vaccines fresh, causes autism. The institute's Immunization Safety Review Committee found insufficient evidence to substantiate the claim but recommended that mercury be phased out of vaccines for children as a precaution.

Since then, advocacy groups have zeroed in on changes in the vaccine program beginning in the late 1980s as a possible cause of the apparent increase in autism cases. In that period, a broad effort to increase vaccination rates raised the number of children getting thimerosal-containing vaccines, and new vaccines for hepatitis B and a form of bacterial meningitis were added. The US Food and Drug Administration found that an infant would receive more mercury from the shots than the federal safety standard for mercury in the environment, although mercury in vaccines takes a different chemical form.

But studies in the past three years have reached conflicting conclusions about whether any harm was done. The federal Centers for Disease Control and Prevention has found no consistent link, but other specialists, such as Richard Deth of Northeastern University, have found in laboratory experiments that the form of mercury in vaccines can disrupt chemicals that are key to the developing brain.

The stakes in the vaccine review, expected to be made public by May, are enormous, both for the parents of autistic children and for the US childhood immunization program. Already, 3,500 families of autism patients have applied to the National Vaccine Injury Compensation Program, a federal fund that pays hundreds of thousands of dollars for proven vaccine injuries. Hundreds of other families of autism sufferers have sued the government and vaccine makers directly. But "no one has been compensated one penny yet alleging that mercury in vaccines causes autism," said Jack Hamilton, a lawyer in Melbourne, Fla., who represents more than 50 claims before the compensation program.

More broadly, researchers say the thimerosal controversy has contributed to growing anxieties about children's scheduled shots, and they fear a drop in immunization rates even though today's vaccines, collectively, contain 60 times less thimerosal than the 1990s vaccines. A new University of Michigan survey found that 93 percent of pediatricians had encountered at least one parent who refused vaccines for his or her child in the past year.

"We can do tremendously more harm if we in fact create an environment where children don't get vaccines and we begin to have outbreaks of vaccine-preventable illnesses," said Dr. Gary Freed, director of the Child Health Evaluation and Research Unit at the University of Michigan and author of the study.

Critics say the CDC itself may have undermined confidence in vaccine safety with a study published last November that found no consistent link between mercury in vaccines and autism. The study, based on a review of records from three health maintenance organizations, found only scattered evidence of an increased risk of tics and speech delays but not autism for children exposed to thimerosal. The study called for further investigation.

But SafeMinds, an advocacy group, obtained the transcript of a meeting in July 2000 in which study authors and advisers discussed preliminary findings that indicated the risk of autism was 2 1/2 times greater among children who received the highest levels of thimerosal compared with those who received none. "I do not want [my] grandson to get a thimerosal-containing vaccine until we know better what is going on," said Richard Johnston, a pediatrics professor at the University of Colorado, according to the transcript.

The version of the study published in the journal Pediatrics last year found no such link, in part because the researchers obtained new data on children from Harvard Pilgrim health plan that diluted the original findings.

US Representative Dave Weldon of Florida, one of the few doctors serving in Congress, is pressing the CDC to give outside researchers access to the study data and calling for an independent review. "There may have been a selective use of the data to make the associations in the earliest study disappear," he wrote to CDC director Julie Gerberding.

CDC spokesman Von Roebuck declined to respond publicly to Weldon's charge, although the researchers have said they collected the Harvard Pilgrim data to broaden their analysis. And Roebuck defended the CDC's objectivity in the vaccine debate: "We're really trying to take a look at the science and understand it."

A Link Between Thimerosal And The Brain: Can Vaccines Affect Central Nervous System Function?

Thu, 05 Feb 2004 00:00:00 -0800

According to new research from Northeastern University pharmacy professor Richard Deth and colleagues from the University of Nebraska, Tufts, and Johns Hopkins University, there is an apparent link between exposure to certain neurodevelopmental toxins and an increased possibility of developing neurological disorders including autism and attention-deficit hyperactivity disorder. The research the first to offer an explanation for possible causes of two increasingly common childhood neurological disorders will be published in the April 2004 issue of the journal Molecular Psychiatry, and earlier as advance online publication.

Though some speculation exists regarding this link, Deth and his colleagues found that exposure to toxins, such as ethanol and heavy metals (including lead, aluminum and the ethylmercury-containing preservative thimerosal) potently interrupt growth factor signaling, causing adverse effects on methylation reactions (i.e. the transfer of carbon atoms). Methylation, in turn, plays a significant role in regulating normal DNA function and gene expression, and is critical to proper neurological development in infants and children. Scientists and practitioners have identified an increase in diagnoses of autism and ADHD in particular, though the reasons why are largely unknown.

In their work, the scientists found that insulin-like growth factor-1 (IGF-1) and the neurotransmitter dopamine both stimulated folate-dependent methylation pathways in neuronal cells. At the same time they noted that compounds like thimerosal, ethanol and metals (like lead and mercury) effectively inhibited these same biochemical pathways at concentrations that are typically found following vaccination or other sources of exposure. By better understanding what happens when infants and children are exposed to these materials, the work of Deth and his colleagues helps to explain how environmental contact with metals and administration of certain vaccines may lead to serious disorders that manifest themselves during childhood, including autism and ADHD.

"Scientists certainly acknowledge that exposure to neurotoxins like ethanol and heavy metals can cause developmental disorders, but until now, the precise mechanisms underlying their toxicity have not been known." said Deth. "The recent increase in the incidence of autism led us to speculate that environmental exposures, including vaccine additives might contribute to the triggering of this disorder."

Thimerosal, which was largely phased out in the U.S. and in Europe starting in 2000,was often used for its preservative abilities in multi-dose units of vaccines for diseases like hepatitis, whooping cough, tetanus and diptheria. Today, most vaccines carry only trace amounts of it, according to the CDC. But in larger, multi-dose vials of these vaccines, often shipped to and used in third world countries, thimerosal is still very common. Multi-dose flu vaccines still contain thimerosal.

Additionally, the scientists recently obtained more insight into the mechanism by which thimerosal interferes with folate-dependent methylation. It acts by inhibiting the biosynthesis of the active form of vitamin B12 (methylcobalamin), which is of particular interest because doctors treating autistic kids are having good success with the administration of methycobalamin.

Child Vaccines Linked To Disorders

Thu, 05 Feb 2004 00:00:00 -0800

After assuring parents that additives in vaccines don't cause brain damage, scientists have found what they believe could be a "smoking gun" linking these additives to autism and attention-deficit hyperactivity disorder in children.

In a study published online today, two months ahead of its scheduled release in the journal Molecular Psychiatry, U.S. researchers have discovered an apparent link between thimerosal, a controversial mercury-based preservative once commonly used in childhood vaccines, to an increased risk of neurological disorders such as autism and ADHD.

While most vaccines used in Canada have been thimerosal-free since the early 1960s, the preservative was used in the annual flu shot doctors recommended this year for even healthy children.

In tests on human brain cells, researchers found two natural chemicals -- one compound that stimulates cell growth and dopamine, which transmits nerve signals -- are both key to a process in the brain called methylation. Methylation helps DNA work properly and is crucial to the normal development of the brain. The team found thimerosal, ethanol, and the metals lead and mercury, all interfere with methylation.

What's more, researchers found that thimerosal interfered with methylation even at doses 100 times lower than a child would receive after a shot with a vaccine containing the preservative.

"It was by far the most potent," says investigator Richard Deth, a professor of pharmacology at Northeastern University in Boston.

He said the study, which also involved researchers from Johns Hopkins University, the University of Nebraska and Tufts University in Boston, could account for the rising rates of autism since the early 1980s, when more thimerosal-containing shots were added to a child's vaccine schedule.

A recent review of vaccine-related "adverse events" in the U.S. found a "significant correlation" between shots containing thimerosal and autism, the researchers report.

In a press release, the journal said the new study is "the first to offer an explanation for possible causes of two increasingly common childhood neurological disorders."

But one of Canada's leading experts in vaccination says large studies have repeatedly failed to find any association between brain damage and vaccines that do, or don't, contain thimerosal.

"What (the researchers) are doing in the test tube may or may not have any relationship to what happens in the body," added Dr. Ronald Gold, professor emeritus of pediatrics at the University of Toronto and author of Your Child's Best Shot: A Parent's Guide to Vaccination. He says there's no evidence that the low doses of thimerosal researchers tested would even cross a child's blood-brain barrier.

But Deth thinks there may be a link, and he believes thimerosal may play a role for the one out of 200 children who will experience some kind of developmental disorder.

Before the early '90s, most causes of autism were believed to have a strong genetic component, and symptoms surfaced soon after the child was born.

But with a newer and more common form of the disease, known as regressive autism, children appear to be developing normally but then suddenly regress.

"They lose functions they had before, such as early speech," Deth says. "Parental anecdotes and clinical reports have suggested it happened during periods of high vaccine exposure.

"Up to now, people have said the cause, or causes, of autism, are unknown. Our work isn't final in any sense at all, but it seems to point to this biochemistry as a potential, or even primary, cause of autism."

Thimerosal had been used to prevent the growth of bacteria or fungi in multi-dose units of vaccines for diseases such as hepatitis and diphtheria, pertussis (whooping cough) and tetanus, or DPT. Ontario, Nova Scotia, Newfoundland and Prince Edward Island have not used childhood vaccines containing thimerosal since the early 1960s. All other provinces began to move to thimerosal-free vaccines starting in 1997. As of March 2001, vaccines for routine immunization of children in Canada have been available without thimerosal.

But the annual flu shot which Canadian doctors this year began pushing on even healthy children over six months of age contains the preservative. And thimerosal is still found in larger, multi-dose vaccines shipped to Third World countries.

Dr. Laszlo Palkonyay, medical-scientific adviser for Quebec-based flu vaccine maker Shire Biologics, said a study published in the journal Pediatrics last September, which was based on a registry of all psychiatric admissions in Denmark between 1971 and 2000, found no trend toward an increase in autism rates during the period thimerosal was used in vaccines in that country. In fact, he said the incidence of autism increased after the preservative was removed from vaccines in 1990.

Deth believes it is more than coincidental that his team's work "falls directly in line" with some current treatments for autism. For example, his group found that thimerosal inhibits the body's ability to break down a form of vitamin B12, which doctors are now using, with some success, to treat autistic children.

Groups such as the B.C.-based Vaccination Risk Awareness Network have heard from parents convinced routine childhood vaccines sickened or killed their children, and class action lawsuits blaming vaccines for deaths and disorders such as autism have been filed in the U.S. and Canada.

Deth stressed that more work needs to be done, and that there are other risk factors for autism, such as genetic factors and other possible environmental exposures. "Some would consider (thimerosal) a smoking gun," Deth said. "I think it is."

Vaccine Preservative Linked To Brain Disorders

Thu, 05 Feb 2004 00:00:00 -0800

A new study is linking an additive used in the flu vaccine to an increased possibility of developing neurological disorders, such as autism and ADHD, attention deficit-hyperactivity disorder.

The flu vaccine contains an additive called thimerosal, a mercury-based preservative. The chemical has been shown to interfere with brain development.

Thimerosal was phased out of the vaccines generally given to children in Canada since the 1960s. Yet it is still in the flu vaccine, says CTV medical correspondent Avis Favaro.

"It's always been in the flu vaccine," she says. "But it's only lately that the flu vaccine has been recommended to children six months and older."

The American university researchers looked at how thimerosal affects brain growth in children. They found that exposure to heavy metals, including ethylmercury-containing thimerosal, interrupts growth factor signaling in cells, causing adverse effects in regulating DNA function and brain development.

"Scientists certainly acknowledge that exposure to neurotoxins like ethanol and heavy metals can cause developmental disorders," said lead researcher Dr. Richard Deth. "But until now, the precise mechanisms underlying their toxicity have not been known.

Deth says his study could account for the rising rates of autism in recent decades, when more thimerosal-containing shots were added to a child's vaccine schedule.

"The recent increase in the incidence of autism led us to speculate that environmental exposures, including vaccine additives might contribute to the triggering of this disorder."

Favaro says the study shouldn't cause parents to panic or to stop vaccinating their children.

"The dose of thimerasol is very small and would be much less than a child would ingest if they ate a couple of tuna sandwiches a month," she says.

She points out that this study has found only the mechanism by which mercury could enter the brain, but does not confirm whether it is actually happening to children and causing ill effects.

"Parents should realize that there have been five studies looking at the link between thimerosal and autism and none of these studies have found any sort of link," Favaro points out.

"Parents should really not be that concerned."

Deth says he doesn't want to parents to misunderstand how important vaccine programs are to children's health.

"It's not the vaccines that are the problem -- it's the additives," he says.

The study appears in this week's issue of the journal Molecular Psychiatry and was published two months ahead of schedule.

Mercury Risk To Newborns Alarming

Thu, 05 Feb 2004 00:00:00 -0800

About 630,000 children are born each year at risk for lowered intelligence and learning problems caused by exposure to high levels of mercury in the womb, according to a new analysis by the Environmental Protection Agency.

That's nearly double the previous EPA estimate of 320,000 babies a year.

The analysis prompted a call for government warnings about eating some kinds of fish with high levels of mercury and for a crackdown on mercury pollution.

The new estimate is based on data collected by the Centers for Diseases Control and Prevention and recent studies that show the level of mercury in the umbilical cord blood of newborns is 1.7 times higher than the mercury level in their mother's blood.

According to the new estimate, one in every six women of childbearing age has enough mercury in her blood to pose a risk to her child, compared with previous estimates of one in every 12 women.

Blood samples taken by the CDC from 1,709 women found that 8 percent of women of childbearing age had mercury levels at or above 5.8 parts per billion, which is the EPA's safety limit.

However, recent studies indicate that the developing fetus may have more difficulty excreting mercury than pregnant women, which would account for the higher mercury levels in cord blood versus maternal blood.

That means a mercury level of only 3.5 ppb in a mother's blood would be enough for her fetus' blood to cross the 5.8 ppb safety threshold, according to an analysis by Kathryn Mahaffey, a scientist with the EPA's Office of Prevention, Pesticides and Toxic Substances.

Nearly 16 percent of women have mercury blood levels of 3.5 ppb or higher, Mahaffey calculated.

Blood mercury levels also were seven times higher in women who told the CDC they had eaten fish two or more times a week over the previous month compared with women who said they had not eaten fish in the previous month, Mahaffey reported.

While adults can be harmed by long-term exposure to small amounts of mercury, a powerful neurotoxin, the risk is much greater for fetuses and young children because their nervous systems are still developing.

The main source of human exposure to mercury is through eating fish, particularly larger species at the top of the food chain, such as shark, swordfish, and some species of tuna.

The new estimate is likely to add more fuel to the already heated debate over whether the government should be doing more to warn consumers of the health risks of eating fish with high levels of mercury, including such frequently consumed fish as canned albacore tuna.

"Over 600,000 children are born each year overexposed to mercury in seafood," said Jane Houlihan, a scientist with the Environmental Working Group, an advocacy organization. "This increases the urgency for the Food and Drug Administration to correct the misinformation it is giving the public and for the Bush administration to crack down on mercury pollution from coal-fired power plants."

However, Linda Candler, a spokeswoman for the National Fisheries Institute, a trade association for the commercial seafood industry, said that the consumption of seafood in the United States is generally so low that children are not at risk.

"It's long been known that if you eat a lot of high-level mercury species, your mercury levels go up," Candler said. "However, fish is so important to the diet and the developing fetus that mothers should not let these things scare them away from eating fish during pregnancy. They should of course follow the FDA's advice to avoid those high-mercury species."

The Washington state Department of Health already urges women of childbearing age and children to skip fish known to be high in mercury.

"We're going to have a look at this (EPA) report, but it certainly wouldn't change (our) message," said Rob Duff, acting director of the Office of Environmental Health Assessment.

The department recommends limits on canned tuna consumption based on weight and age for women and children. Recent studies have found much higher levels of mercury in canned white albacore tuna up to three times more than in chunk or solid light tuna.

"Now we know there's a difference," said Duff. "You can reduce your amount of mercury exposure by choosing light over albacore white."

Family Suing To Aid Autistic Son

Sat, 31 Jan 2004 00:00:00 -0800

Timothy Wells begins this day as he does every other eyes to the sky, shouting, "Sun come up! Sun come up!"

The 9-year-old Baton Rouge boy's world is filled with requisite ritual. Words and phrases are repeated over and over again. Unfamiliar aisles at Wal-Mart are traumatic. Unexpected noises elicit screaming. And the sun absolutely must come up on time.

It's the way of life that comes with being autistic, and Timothy was diagnosed with the disorder at the age of 3.

Over the years, Richard and Lisa Wells have worked three jobs between them, mortgaged their Bramble Drive home twice and sold possessions to help their son.

Now they're trying another approach: taking the nation's largest pharmaceutical companies to court.

The Wells are among seven Baton Rouge area families and dozens more throughout south Louisiana with autistic children who are suing companies that manufactured and marketed childhood vaccines containing the mercury-based preservative thimerosal.

The cases, filed about a year ago, could very well be the first of their kind in the nation to make it to trial in federal court.

It won't be the first time Eli Lilly and Co., Wyeth Inc., Aventis Pasteur, Merck & Co. and SmithKline Beechum have been to court because of childhood vaccines.

In 1988, Congress established a National Vaccine Injury Compensation Program and a Vaccine Court in which all such claims first must be tried. Claims are subject to a three-year statute of limitations and a $250,000 cap for noneconomic damages.

The Wells and other families are trying the equivalent of a legal end-run around the special court. Rather than the child suing for an alleged injury, the parents are claiming "loss of consortium" the normal relationship they'll never have with the injured child. They also are taking the approach that thimerosal was an additive, not an actual vaccine, and therefore not covered by the Vaccine Court.

Timothy Wells works on math problems during a class at Westminster Elementary School.
Even so, the parents will have to prove a connection between thimerosal and autism exists a theory the U.S. Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration and several independent medical organizations say has never been proven.

U.S. District Judge James Brady in Baton Rouge twice has refused to throw out the cases, writing that they are "importantly different" from previous litigation.

Attorneys for both sides already have ruled out settlement conferences and alternative dispute resolution. No trial date has been set.

Mystery ailment

"Bus coming! Bus coming! Bus coming!"

There are still 30 minutes until the yellow-and-black vehicle pulls up in front of his house to take him on the hour-long ride to Westminster Elementary School, but Timothy is certain something is amiss.

He has already run through his roster of rituals. He's already gotten dressed. Eaten his instant grits. Pleaded with the sun to rise. Taken his medicine. Endured his mother brushing his teeth. Walked a bicycle up and down the street. Reminded his father to empty the trash compactor. And watched the Rev. Larry Stockstill's morning message on TV.

"Bus coming!" he says, nearly in tears. He grabs his father's hand and leads him outside to the curb.

"Tim," Richard says, stroking the boy's ginger hair. "You still have another 30 minutes. Seven o'clock."

"Seven o'clock! Seven o'clock!" Timothy says, looking frantically down the street. "Bus coming!"

Even on mornings like these, Lisa hasn't forgotten how badly she and Richard both Baton Rouge natives wanted their first child. It took them 51/2 years to have Timothy.

He was born healthy, his parents said, weighing in at 10 pounds, 12 ounces. He seemed to develop normally, eventually calling the couple "momma" and "daddy," smiling, giggling and playing.

But when Timothy was 18 months old, Lisa and Richard said, they began to notice he no longer made eye contact. He had fits of screaming and crying. He became a picky eater and refused utensils. He stopped talking and started humming.

"It was like he just entered his own little world," Lisa said. "We had no idea what happened."

Although Richard's mother told the couple she thought Timothy might have autism, the Wells had him tested for everything from deafness to allergies. At the age of 3, their son was diagnosed as moderately autistic.

The next four years were, according to Lisa, "a blur." The couple would wake up in the middle of the night to comfort him during screaming fits one so violent that Timothy put his head through a sheetrock wall. They got rid of the television set because the noise bothered him. And they began to realize their marriage was strained.

But when Timothy became aggressive at times toward his two younger sisters Hannah, now 7, and Sarah, 6 Richard and Lisa made a decision.

They sent him to St. Mary's Residential Training Facility, a live-in school for the developmentally disabled in Alexandria. Every weekend, the family traveled to Alexandria and slept in a camper at Indian Creek Recreational Area while visiting Timothy.

It took 10 days, but the school potty-trained their son. Through therapy and education, Timothy learned to care for himself like putting on his own clothes and eating with utensils again.

"It was like walking away from him," Richard said. "We'd go in there and look at his empty bed and we'd cry. We just missed him. But it saved our marriage, our family and our nervous system. Lisa and I got to be husband and wife instead of caretakers for 24 hours a day."

After two years, the Wells were ready to bring Timothy home, where he's been ever since.

"The affection we missed out on with this baby it's like a big hole in our hearts," Lisa said. "It's like somebody came into our house and stole our child's personality overnight. That's what autism is. That's what it feels like. It's like, where did he go?"

The bus arrives, and Timothy ambles up the steps and takes his seat always the same one, three rows back next to the window. The sun has come up. But if Timothy has noticed, he says nothing.

No numbers

No one knows how many children have autism.

Various government entities and other organizations conservatively estimate the incidence to be anywhere between one in 250 to one in 1,000 children in the United States. The Louisiana Department of Health and Hospitals does not statistically track autism cases, spokeswoman Kristen Meyer said.

Autism refers not to a specific ailment but to a collection of neurological disorders. Those with the condition generally experience impaired social interaction and communication skills, and show a tendency toward repetitive behaviors or interests. Some are able to live independently; others require constant care.

Boys are three to four times more likely to have autism than girls, the CDC contends, but the condition occurs in all racial, ethnic and social groups.

Although autism cannot be cured, the federal agency notes, its symptoms can be treated with medication and therapy.

Its cause, however, has proven elusive. The NIH is exploring a variety of theories, including the possibility that it may be caused by a viral infection, environmental triggers, genetic predisposition or a combination of factors.

One theory is that childhood vaccines are to blame.

Estimated autism rates have tripled during the past two decades, according to the Autism Society of America. During that same period, the suggested childhood immunizations did, too. That, those who point to vaccines as the culprit contend, may have increased the amount of mercury to which children were exposed.

Until a few years ago, vaccines against such diseases as influenza, hepatitis, tetanus and diphtheria often contained thimerosal a mercury-based preservative. At one point, infants as young as six months were being injected with up to 187.5 micrograms of mercury, according to the U.S. Centers for Disease Control. Today, the approved level is less than 3 micrograms. There are one million micrograms in a gram.

Thimerosal was developed by University of Maryland researcher Morris Kharasch in 1927. Eli Lilly purchased the patent. In 1930, Dr. K.C. Smithburn conducted a study at Lilly Laboratories for Clinical Research in which he injected people dying of meningitis with Merthiolate, the trade name for thimerosal.

Those who are suing the company contend the study did not disclose that some of the test subjects began dying of a severe neurological disease and that at least one had a severe toxic reaction to the thimerosal.

Lilly no longer produces or distributes thimerosal, though the reasons are not clear.

In 1999, the American Academy of Pediatrics and the U.S. Public Health Service issued a joint statement alerting clinicians and the public of "concern" about thimerosal. Other pharmaceutical companies agreed to stop manufacturing vaccines containing the preservative in March 2001.

Lilly denies any link between the preservative and autism, as do Wyeth Inc. and SmithKline Beechum, which used Lilly's thimerosal in their vaccines.

The drug makers deny the plaintiffs' claims that thimerosal is "extremely hazardous to human health" or that the companies "intentionally failed to reveal knowledge of risks associated with the vaccines," said, a attorney representing SmithKline Beechum. The companies also deny the contention that they "consciously and actively concealed and suppressed any information or knowledge or consciously disregarded the safety of children."

Studies on the link between thimerosal and autism have been mixed. Besides the CDC, NIH and other medical organizations, the Autism Society of America the nation's largest autism group hasn't publicly supported the new batch of lawsuits because "the evidence is still out," says its president, Lee Grossman.

A new approach

Since 1988, the federal Vaccine Act has mandated that injury claims against a vaccine manufacturer first go through the National Vaccine Injury Compensation Program.

A Vaccine Court then awards money to pay for the medical care of people injured by a vaccine. The awards are not paid by the pharmaceutical companies, but rather through a surcharge on inoculations.

Last year, more than 1,200 thimerosal cases were pending before the Vaccine Court. But even there, the link between thimerosal and autism remains undecided.

Chief Special Master Gary J. Golkiewicz has scheduled an evidentiary hearing March 22 to evaluate evidence from both sides on whether vaccines can cause autism symptoms. The decision will be issued July 3, and his conclusions will be applied to the thimerosal cases in the Vaccine Court.

Said Golkiewicz at the time he announced his plan: "So far the issue of thimerosal being a cause hasn't been litigated specifically."

His decision is expected to have significant bearing in the Louisiana cases as well.

"Causation is really going to be the battleground in this case," said , the attorney representing the Wells and other families. "The ultimate question becomes, 'Did the mercury in thimerosal that was shot into these children's bodies create the injury of mercury poisoning?'"

The three pharmaceutical companies have argued in court that the Louisiana autism cases should be dismissed and pursued in Vaccine Court.

"The goal of the Vaccine Act is to protect the nation's vaccine supply," argues Eli Lilly attorney Heather Valliant of New Orleans. "If runaway tort liability forces the manufacturers of ingredients in vaccines out of the market, the attempt to preserve the vaccine supply would be in vain."

But the court's guidelines set a three-year statute of limitations and other restrictions on claims, leaving families like the Wells who would have had to file a complaint by the time Timothy was 6 with no prospects for relief.

Hundreds of lawsuits have been filed in federal and state courts seeking to lay blame on pharmaceutical companies for creating a market for thimerosal, failing to adequately research the dangers or purposely covering them up. Bickford is part of a group of lawyers representing the Louisiana families and others across the nation.

Their strategy is to claim the mercury poisoning has resulted in a loss of consortium essentially, the normal relationship the families otherwise would have enjoyed with their child.

They also claim that Lilly either was negligent or purposely withheld information when it marketed thimerosal as a vaccine additive. The point is key: The plaintiffs maintain the case should be decided outside Vaccine Court because Lilly is not being sued as a manufacturer of a vaccine, but of an additive.

In his ruling against dismissing the cases, Brady cited that very issue.

"Lilly's arguments to the effect that it is entitled to protection under the Vaccine Act as a vaccine manufacturer are irrelevant to these consolidated cases," Brady wrote. "This is so because Lilly is not sued as a manufacturer."

An uncertain future

"Macaroni! Macaroni! Macaroni!"

It's dinnertime, and Timothy is hungry.

"OK," Richard says. "Get a pot."

There are three clean pots in the cabinet, but none of them is The Macaroni Pot. That one is in the sink, and Richard must wash it immediately.

With his father's help, Tim puts the water in the pot on the stove, and waits for it to heat up all the while crunching on the raw macaroni. Foods with casein and gluten give those with autism a morphine-like high.

"Tim, stop. Stop! Stop!" Richard says. "He eats it raw; I hope that's not hurting him."

"They recommend that he eat gluten and casein free foods, but it's expensive to stock a pantry with that stuff," Lisa says. "One thing that contributes to his behavior is that his biochemistry is so screwed up. He craves the stuff."

"Messed up," Richard says quickly.

"Screwed up!" Timothy says. "Screwed up!"

Though their son is only 9, they are already thinking ahead to his future. While he might be able to dress himself, ride a bus to school and cook a pot of macaroni, they know he'll never be able to care for himself.

And that's what worries them the most.

Richard and Lisa don't want him to be a burden on other family members, but also don't want him living in a state-run home. Their wish is for him to stay in their Bramble Drive home with round-the-clock care.

"The bottom line is, his care is all about money," Richard said. The more money you have, the better care he's going to get."

Big Rise In Autism Cases Prompts Debate Over Causes

Sun, 25 May 2003 00:00:00 -0700

An alarming rise in the number of children with autism in Virginia drew researchers, physicians and parents to a conference here, including a British doctor who claims that widely administered childhood vaccines may be responsible for the increase.

According to the Autism Program of Virginia, the number of autism cases in the United States jumped 173 percent over the past decade. In Virginia, the number of cases has climbed by about 78 percent over the past three years, and now 2,702 children have autism in the state.

Among the speakers at Saturday's conference, sponsored by the Central Virginia Autism Group, was Dr. Andrew Wakefield, a British gastroenterologist whose studies have prompted heated debate and helped prompt a congressional investigation.

Wakefield told the approximately 100 people attending the conference that his first encounter with an autistic child led him to question the conventional wisdom about the causes of autism. His subsequent research linked a mercury-containing preservative in the Measles-Mumps-Rubella, or MMR, vaccine with autism.

Wakefield described how the child's mother said her son was developmentally normal until he had his MMR vaccine at 15 months old. Then the autism appeared, and with it severe bowel problems.

In the five years since he saw that first patient, Wakefield has extensively studied bowel disease in children with autism. He has identified an inflammatory condition that seems to be linked to the MMR vaccine. MMR contains the preservative Thimerosal, which has the toxic element mercury among its ingredients.

Wakefield says that some children with the inflammatory disorder in the bowel also have other developmental disorders. He said he believes the damaged membrane of the intestine can't act as an efficient barrier to harmful molecules, which can then enter the blood stream and cause problems throughout the body.

His team's first findings on 12 children were published in The Lancet, a British medical journal. Wakefield said he lost his job after refusing to back down from the findings and now continues research with several other teams. His latest findings implicate the measles virus used in the vaccine, he said.

Dr. Elizabeth Mumper, a Lynchburg pediatrician, said she plans to work on repeating Wakefield's research. She will work with Michael H. Hart, a Roanoke pediatric gastroenterologist who will do the evaluations needed.

Mumper first became interested in autism after hearing Wakefield speak previously about his research.

"I thought it was very compelling," she said. "And I thought it was something that made it clear that other investigators should try to look into this issue, and either say, 'We're seeing the same thing the Wakefield team did' or 'In our laboratory we can't reproduce these findings."'

In general, Mumper said, she sees indications of a link to the vaccine.

"There does seem to be a change in the pattern of autism," she said. "For many years, most kids seemed to be affected very early on. And in the last 15 years or so, the numbers have shifted a bit. And what people are reporting is more and more kids who seem normal (at first) and were noted to regress between 15 months and two years."

Wakefield's allegations have drawn widespread attention and prompted hearings by U.S. Rep. Dan Burton of Indiana, chairman of the House Government Reform Committee. Burton's committee staff recently released a report that found that "there's no question that mercury does not belong in vaccines" and that the federal Centers for Disease Control should have acted at least three years ago to encourage the use of vaccines that do not contain the additive.

Part of the problem, according to critics, is that although the amount of mercury in each vaccine was within federal guidelines for mercury exposure, many children got several vaccines at once. As a result, some were getting up to 125 times the level considered safe.

The CDC currently is working with pharmaceutical companies to develop vaccines that do not contain mercury. In the meantime, the pharmaceutical makers continue to deny that their vaccines are responsible for the rise in autism cases.

Controversy over the claimed link to mercury is likely to continue for some time, in part because autism is very complex, said Dr. Mary Megson, a Richmond pediatrician who has more than 2,000 patients who have autism and other disabilities.

"I think autism is caused by having a genetic predisposition and then an environmental event which disconnects major metabolic pathways in the body," she said.

Megson said she is having some success treating autism with vitamin A, which she said is best absorbed as an oil molecule but is most often found in other forms in today's diet. By switching patients to an oil-based form of the vitamin, she said, she has seen dramatic improvements.

"The first child I treated was a fifth-grader with no language," she said. "I put him on just the RDA, the recommended dietary requirement of vitamin A in the form of oil molecules and cod liver oil. Three weeks later, when I walked into the room, he was telling his mother, 'Leave me alone, I can get up on the table by myself."'

Although much of the conference was highly technical, even the laymen in the audience said it was important to air the issues thoroughly.

"It is complicated," said Willmer Price, parent of a 3 year-old autistic child. "Autism itself is complicated. So there is no one answer to any of the problems."

State Autism Rate Doubled In 4 Years

Wed, 14 May 2003 00:00:00 -0700

The number of children with autism in California has nearly doubled in the last four years and continues to grow as researchers struggle to identify the cause of the incurable developmental disorder, a new report released Tuesday found.
The report by the California Department of Developmental Services found that 20,377 California children were receiving DDS services for autism as of December 2002 a 97 percent increase since 1998. The disorder is now more prevalent in California than childhood cancer, diabetes and Down syndrome.

Autism a lifelong neurological condition found mostly among males severely impairs a person's ability to speak, communicate and interact with others. The report addresses only those with "classic" autism, the disorder's most severe form characterized by severely limited speech, impaired social interaction, and repetitive behaviors such as finger tapping. Children under three years of age, and those with lesser forms of the disorder such as Asberger's syndrome, were not included.

The report is the continuation of a study published by DDS in 1999, which showed a 237 percent spike in autism cases from 1987 to 1998.

Ron Huff, a psychologist who conducted both studies for DDS, said the latest numbers reflect an actual increase in autism in the state, not just improved diagnosis of existing cases.

"After we did the first report, we anticipated the numbers would go down," Huff said. "Instead, they were actually increasing. It's not just a matter of better diagnosis."

Indeed, despite a broader awareness of autism and stepped up research in recent years, the DDS report said scientists have not yet pinpointed a cause for the disorder. A once-dominant theory, now discounted, that placed blame on cold and distant mothers for causing autism has given way to a more thorough investigation of the potential genetic and environmental factors that may increase a child's vulnerability to the condition.

"We know that it's a very complicated genetic disorder, but it's also probably true that genes are not the entire answer," said Dr. David Amaral, research director for the MIND Institute at University of California, Davis, which studies autism. "It's most likely a combination of genetic susceptibility and an environmental disorder."

DDS researchers are looking at range of environmental toxins that could make children more vulnerable, including PCBs, pesticides, and heavy metals such as mercury and lead. They are also exploring the debated theory that childhood vaccines may be at the root of the problem.

While at least one large study has discounted the connection between autism and the MMR (measles, mumps and rubella) vaccine, Huff pointed to other research indicating that the mercury contained in thimerosal, used as preservative for many vaccines, has caused neurological problems in animals.

Advocacy groups and many parents have pressed for a closer examination of the autism/vaccine connection. Rick Rollens said his 12-year-old autistic son Russell was a normal baby until he suffered a violent reaction to a series of vaccines he received when he was seven months old.

"Getting researchers to look at vaccines has been like attacking the sacred cow," said Rollens, who helped found the MIND Institute. "We're dealing with a paradox of all the good vaccines do to control and often eliminate infectious disease, but may also add a burden to kids who may be genetically susceptible to autism."

The DDS has released guidelines to promote effective treatment of autism throughout the state. "We have to look for ways to reduce stress on families and make access to services more palatable," Huff said.

FDA & CDC Bumbling at the Expense of Mercury-Poisoned Children

Mon, 12 May 2003 00:00:00 -0700

The Federal Drug and Food Administration and Centers for Disease Control both get a big "F" in protecting children from the hazards of mercury poisoning. The House Government Reform Committee released a report this week that concluded the FDA and CDC failed in their duty to be vigilant as new vaccines containing the mercury-based preservative Thimerosal were approved and added to the immunization schedule.

When the Hepatitis B and Haemophilus Influenzae Type b (Hib) vaccines were added to the recommended schedule of childhood immunizations in the early 1990's, the cumulative amount of ethylmercury to which children were exposed nearly tripled. Meanwhile during the last decade, autism (symptoms of which are markedly similar to mercury poisoning) in the U.S. has grown to epidemic proportions-some estimates are between 10% and 17% per year.

"This breaks my heart," says Laura Bono, parent of a child originally misdiagnosed with autism and now diagnosed with mercury poisoning. "I followed the law and vaccinated my child thinking the government vaccination program had done all their homework. I found out that my son received 125 micrograms of ethylmercury during his first 16 months. That is 144 times the EPA allowable limit for his average weight during that time. In my opinion, this is criminal."

The Government report states, "The CDC's failure to state a preference for Thimerosal-free vaccines in 2000 and again in 2001 was an abdication of their responsibility. As a result, many children received vaccines containing Thimerosal when Thimerosal-free alternatives were available."

The Committee also found that, "The actions taken by the HHS to remove Thimerosal from vaccines in 1999 were not sufficiently aggressive. As a result, Thimerosal remained in some vaccines for an additional two years." Lori McIlwain parent of a three-year-old with heavy metal toxicity and numerous neurodevelopmental problems said, "This means that my child and thousands of other children continued to be poisoned even after the government knew the risks and the consequences."

Despite the reputation that mercury is an extremely toxic substance, the report states that, "The FDA has never required manufacturers to conduct adequate safety testing on Thimerosal and ethylmercury compounds." A coalition of parents and advocacy groups are outraged that the government could have prevented additional exposure many wonder why lawmakers haven't taken notice. Ironically, FDA has repeatedly warned pregnant women not to eat large amounts of fish so as to avoid toxic mercury, yet it continued to approve vaccines containing increasingly large doses of mercury.

The committee report also suggests there is inadequate research regarding ethylmercury neurotoxicity and nephrotoxicity, and the relationship between autism and the use of mercury-containing vaccines. It states that to-date, "Studies conducted or funded by the CDC that purportedly dispute any correlation between autism and vaccine injury have been of poor design, under- powered, and fatally flawed. The CDC's rush to support and promote such research is reflective of a philosophical conflict in looking fairly at emerging theories and clinical data related to adverse reactions from vaccinations."

Although the report is clearly shocking to the general public, parents with autistic children that were exposed to hazardous levels of mercury through their childhood vaccines aren't surprised at all. "We have followed this controversy for a long time," said Bono. "We knew we had a normal child before vaccinations and now we have a mercury-poisoned child showing all the behavioral signs of autism. At bigger issue now is, 'What is the government going to do about it?'"

Thousands of families like the Bonos were not aware mercury was in the vaccines and missed the three-year statute of limitations to file a claim in the National Vaccine Injury Compensation Program. These families will not receive any compensation to help with their children's medical needs and are prevented under the NVICP law to file a civil claim against the pharmaceutical companies. The parents are angry that their children have been poisoned and now have no civil rights under the current NVICP.

Proposals put forth in the Senate now by Senator Judd Gregg and Senator Bill Frist will further protect vaccine manufacturers and bar recovery for many of these injured children.

Autism, Vaccine Link Considered

Mon, 05 May 2003 00:00:00 -0700

An epidemic of autism and other brain problems in American children is linked to vaccines, say doctors, activists and one member of Congress who met in Chicago over the weekend to discuss the disease.

At a three-day meeting at Loyola University, researchers said growing evidence indicates that vaccines are linked to increasing rates of brain problems and that government health agencies have done little to recognize it. Autism One, a non-profit group dedicated to learning more about autism, sponsored the meeting.

"There are some bureaucrats in these agencies who have really dropped the ball and are doing things that are malicious and may be criminal," said Dr. Boyd Haley, chairman of the Department of Chemistry at the University of Chicago.

Boyd believes a mercury-based preservative added to vaccines during the 1990s may be a cause of autism. He said the Food and Drug Administration and the Centers for Disease Control and Prevention have failed to address the issue.

Autism rates have increased 10 times since the late 1980s. The CDC says that one in 300 American children may suffer from autism.

The leading theories about autism discussed in Chicago:

A mercury-based preservative called thimerosal used during the 1990s plays a role. Mercury has known toxic effects and during that decade, the CDC drastically increased the recommended number of vaccines. Some children may have been exposed to 125 times the federal limit for mercury exposure.

An intestinal disorder may eventually impact the brain. That disorder might start with vaccinations for measles, mumps and rubella, the first multi-dose vaccine for children to contain three live viruses. Some researchers said mercury poisoning might make the body unable to fight off the infection.

Debate over a possible connection between brain problems and vaccines is hotly contested. Critics of the government blame a revolving door between pharmaceutical companies and government regulators for complicating the debate. Researchers who say there is a link claim they have been blackballed.

"I hope somebody will ask the question, 'Is there collusion between the pharmaceutical companies and our health agencies?'" asked Rep. Dan Burton, R-Ind., chairman of the House Human Rights and Wellness Subcommittee. "The appearance in many cases is that there is."

Vaccine manufacturers say the science does not favor a link between thimerosal in vaccines and autism. The Pharmaceutical Research and Manufacturers of America did not return calls seeking comment. But Len Lavenda, a spokesman for vaccine manufacturer Aventis Pasteur, told United Press International this spring that scientists have not proven a link between the additive and brain problems.

"We think we are experiencing opposition to thimerosal for emotional reasons," Lavenda said. "This is not based on research and not based on testing."

Burton has been investigating vaccines for more than four years. In Chicago he released a report on thimerosal criticizing government health agencies and vaccine manufacturers for their roles.

Doctors and activists in Chicago also discussed a new study that claims to show an association between thimerosal and brain problems. The study claims to show "strong epidemiological evidence for a link between increasing mercury from thimerosal-containing childhood vaccines and neurodevelopmental disorders and heart disease."

The study compares reports of speech disorders, autism and heart arrest for one vaccine that contained thimersosal to one that did not, over a 10-year period. It also uses information from manufacturers to determine how much mercury was in shots during different points during that decade.

The study found reports of brain problems for vaccines that contained the additive and that the relative risk went up as more mercury was in vaccines in general.

Two Silver Spring, Md., researchers performed the study, Dr. Mark Geier and his son David Geier.

The study shows that "the relative risk of each of those disorders correlated with increasing doses of mercury contained in childhood vaccines."

The CDC sets the national immunization schedule for children. The CDC says about thimerosal: "There are no data or evidence of any harm caused by the level of exposure that some children may have encountered in following the existing immunization schedule."

The Institute of Medicine the government's adviser on medical issues said in October 2001 that the link between the preservative and autism is "biologically plausible" but that "current scientific evidence neither proves nor disproves a link." This March, the institute found "no association" between the measles, mumps and rubella vaccine and autism.

In 1999, the American Academy of Pediatrics, followed by the CDC, called for the removal of thimerosal from vaccines but said there was no evidence showing it had harmed children. The CDC continues to recommend the measles, mumps and rubella vaccine.

Autism, referred to by parents as a disease, usually showing up before age 2. Sometimes children who had previously appeared to interact normally will suddenly regress, become withdrawn and stop responding to their parents and the outside world. They may perform repetitive motions, like spinning or flapping their arms, scream uncontrollably and resist physical touch.

Parents of children with autism at the Chicago conference said the disease has a way of isolating parents because of the time-consuming task of raising a child with autism.

"I did not leave my son's side for four years," said Edmund Arranga, with Autism International Association. "It keeps people from connecting."

Arranga said he estimates that 40 percent of parents of children with autism believe vaccines cause the disease.

Many parents described previously normal children who appear to digress suddenly with signs of autism within days of receiving vaccinations. Those vaccinations often include measles, mumps and rubella vaccines and large doses of thimerosal.

Liz Birt, an attorney with Burton's Subcommittee on Human Rights and Wellness, said that during the 1990s, the U.S. childhood vaccination schedule exposed some children to 125 times the federal limit on mercury exposure set by the Environmental Protection Agency. Birt said the CDC and the FDA have been slow to admit the damage the vaccines may have caused because key officials want to keep their jobs and vaccine manufacturers do not want the liability.

"It all comes down to money," Birt said.

Vaccine Prompts Class-Action Lawsuit

Wed, 26 Feb 2003 00:00:00 -0800

Niko Soursos of Richmond was born a perfectly healthy boy almost three years ago. He achieved every developmental milestone expected of normally developing children physically, neurologically and socially, says his father, Elias Soursos.

But after receiving three mandatory shots of the hepatitis B vaccine by the time he was eight months old, Niko began displaying signs of neurological damage, becoming more distant, and losing language skills.

Niko was diagnosed with autism last year after his second birthday. His father, a 35-year-old investment adviser with Canaccord Capital, began researching the possible causes of autism a few weeks after his son was diagnosed.

"Doctors used to say this is genetic," the Soursos said Tuesday. He now believes his son's neurological damage was caused by Thimerosal, an organic mercury compound used as a preservative in child vaccines. Two years ago, it was phased out for infant vaccines in Canada. It has also been phased out in the U.S. for infant vaccines.

Soursos says Thimerosal was used in hepatitis B vaccines his son received as part of Richmond's mandatory inoculation program for children.

This week, Soursos was one of two parents who filed separate class-action lawsuits against several drug companies, claiming their sons suffered neurological damage after receiving vaccinations containing Thimerosal.

Soursos is suing drug companies Merck Frosst Canada and GlaxoSmithKline Inc., which made and distributed the vaccines.

He is seeking damages for his son's autism therapy that costs $3,500 a month, part of which is covered by a $1,600-a-month government grant.

His lawsuit claims the drug companies failed to warn of the risks associated with Thimerosal in vaccines.

"The defendants failed to communicate the dangerous nature of the vaccines to the public and must be held accountable for their negligence," Vancouver lawyer David Klein said Tuesday.

Klein is representing the Soursos and the plaintiff in the other class-action lawsuit, Jaqueline Chamberlain of Sooke, whose 10-year-old son Aaron also suffers from autism.

"It may be too late for Aaron and Niko but Thimerosal has been taken out of all routine vaccines for infants in Canada," Klein said.

The lawsuits claim the drug companies should have known of the neurotoxic effects of the mercury contained in Thimerosal, which had been used as a preservative and anti-biological agent since the 1930s.

"Mercury is one of the most toxic elements on earth," the lawsuits claim. "Mercury poisoning is well documented in medical literature."

Infants are more susceptible than adults to the toxic effects of mercury because mercury interferes with infants' developing neurological systems, the lawsuits say.

The lawsuits allege that the drug companies developed, tested, manufactured, licensed, distributed, marketed, supplied and/or sold the vaccines with the knowledge that they would be injected into infants.

Chamberlain's lawsuit claims her infant son Aaron suffered neurological damage after receiving two doses of the DPT vaccine containing Thimerosal, which is manufactured by Aventis Pasteur Limited.

The DPT vaccine, which was phased out in 1994, was used against diphtheria, whole cell Pertussis (whooping cough) and tetanus.

Like Niko, Aaron was born perfectly healthy and demonstrated social, language, cognitive, behavioural and physical skills appropriate for his age, the lawsuit says.

But before his second birthday, after receiving the DPT vaccine, he became unresponsive, withdrawn, slow in speech development, developed repetitive behaviours and an obsessive-compulsive disorder.

Aaron was diagnosed with autism at age five. He still has limited language and social skills, the legal action claims.

Parents of Autistic Children Continue Fight Against Homeland Security Act Provision

Wed, 15 Jan 2003 00:00:00 -0800

Parents of children with autism are continuing their fight to eliminate a provision in the Homeland Security Act, which they feel takes away the rights of children injured by vaccines.

This provision is called the "thimerosal liability shield."
Some parents believe that thimerosal in vaccines, manufactured by the pharmaceutical giant Eli Lilly, caused their children to develop autism, a neurological disorder that affects brain functioning.

George Shadie, president of SAFE (Supporting Autism & Families Everywhere) and father of a 13-year-old autistic son, stressed that SAFE is not an anti-vaccination group.
Yet, he noted that putting mercury in shots "has no basis in science, but only enhanced the bottom line" of corporations that manufactured these vaccines.

"What did the drug companies save? What did this mindless act cost?" Shadie asked. "How long have we, as a society, as families, been paying the terrible price?"

Many parents are pursuing litigation against Eli Lilly. They feel that the "thimerosal liability shield" in the Homeland Security Act would exempt drug manufacturers from liability for the manufacturing, sale and use of defective vaccines and pharmaceutical products.

These parents have questioned what relation childhood vaccines have to homeland security.

U.S. Senators Susan Collins and Olympia Snowe of Maine and Lincoln Chafee of Rhode Island recently announced that they are pursuing an agreement with the Senate leadership to eliminate the thimerosal liability shield from the Homeland Security Act.

This was welcome news to parents and non-profit organizations like the Safe Minds and the Mercury Policy Project, which have the mission of re-establishing justice and legal recourse for vaccine-injured children.

These groups are also dedicated to reducing and eliminating mercury exposure and improving children's health.

"We applaud Senators Chafee, Snow and Collins in their continuing efforts to right a terrible wrongdoing taking away the legal rights of autistic children," Michael Bender of the Mercury Policy Project said in a prepared statement. "We look forward to seeing the vaccine compensation act amended within the next six months so that it is more family-friendly."

Lyn Redwood, president of Safe Minds, hopes an agreement will be reached "for families of autistic children whose right to go to court was taken away in the Homeland Security Bill by a corporate special-interest provision for pharmaceutical giant Eli Lilly."

The Homeland Security Act was approved by a 90-9 vote in November of last year, but some provisions of the act are being debated this month.

U.S. Senators Rick Santorum and Arlen Specter of Pennsylvania voted in favor of the legislation.

In a letter obtained by The Citizens' Voice, Santorum said the Homeland Security Act provision is actually intended to make it easier for families affected by the rare side effects of government-recommended vaccines to receive compensation.

Since 1986, the federal government has awarded $1.3 billion in compensation to more than 1,700 families through the Vaccine Injury Compensation Program, Santorum said.

Recently, Santorum said a number of lawsuits have claimed that an individual vaccine component is a contaminant and thus not covered by the VICP.

"These claims ignore that the component is listed on the product's label and was part of the product composition that won Food and Drug Administration approval," Santorum said.

"If allowed to continue unchecked, these lawsuits could produce serious vaccine shortages if the companies that manufacture components used in vaccines decide to stop providing their products to vaccine manufacturers due to liability exposure," he added.

"In fact, the establishment of the VICP was a response to a similar liability crisis in the mid-1980s, where a rash of lawsuits caused the number of companies worldwide that produce vaccines to dwindle from 12 to only four."

Santorum concluded that nothing in the provision's language "takes away anyone's right to sue if they are not satisfied with the arbitration provided by the VICP."

Parents Rally Against Vaccine Provision

Mon, 13 Jan 2003 00:00:00 -0800

Parents rallied at the Capitol on Wednesday against a law that protects vaccine makers, and Democrats promised to fight to repeal the measure.

The vaccine provision was attached to a bill creating a new Homeland Security Department, which President Bush signed into law in November.

The Republican-backed provision essentially shields vaccine makers from lawsuits concerning the use of the compound Thimerosal by requiring that claims go through a special federal program that pays limited damages for vaccine-related injuries, rather than through courts.

Thimerosal is a mercury-containing preservative once added to some childhood vaccines. Indianapolis, Ind.-based Eli Lilly, a major Republican Party contributor, was the biggest manufacturer of Thimerosal.

A spokesman for Eli Lilly, Ed Sagebiel, said the company had lobbied for the measure earlier but had no role in its placement in the homeland security bill. But Sagebiel added, "It's something we support now. We think it's good public policy."

Medical research has not established a link between autism and Thimerosal, but many parents believe the ingredient may be to blame. Scores of parents have filed lawsuits that claim that Thimerosal caused their children to develop autism or related nerve diseases.

Many of those parents on Wednesday held signs that said "Homeland Security Took Our Rights" and "Vaccine Injured." They accused Congress of stripping them of their rights.

"It's injustice at its worst," said Teri Small of Wilmington, Del., whose 4-year-old son was diagnosed with severe autism. "These are vulnerable, defenseless children who have been harmed irreparably."

Trish Desgroseilliers of Landenberg, Pa., said when she heard of the new law, "I was sad to think that our government is not protecting these children and that there are things going on behind closed doors that us as Americans are not privy to."

Several Democrats have already introduced legislation to repeal the measure.

Sen. Debbie Stabenow, D-Mich., called the measure "government and politics at its worst."

"Shame on the Congress and the administration for allowing it to happen," Stabenow said.

Mercury In Baby Vaccines Is Linked To Autism

Mon, 13 Jan 2003 00:00:00 -0800

MERCURY, one of the most dangerous substances known to man, is being used in a series of infant vaccines in spite of a warning from NHS advisers that its use as a cheap preservative "may be toxic" to babies aged under six months.

Thimerosal, a compound 50 per cent composed of ethyl mercury, which is banned in the United States amid fears of its links to autism, is being used in the DTwP vaccines given to infants aged eight weeks.

A report from NHS scientists has indicated that thimerosal is not only dangerous to infants, but also to the unborn child if contained in products used by pregnant women.

The UK Medicines Information (UKMI) service, run under the NHS banner to provide advice to doctors, has compiled a report naming the 13 UK vaccines which contain thimerosal referred to as "thiomersal" by some scientists.

The list includes four out of the seven flu vaccines issued this year by the government, a pneumonia vaccine and four of the 11 child vaccines. The main source is the triple DTwP jab, for whole-cell diphtheria, tetanus and pertussis.

There is no mercury in vaccines for MMR, polio, meningitis C or the DTaP injection, which also protects against diphtheria and tetanus. But UK infants are always given the DTwP vaccine, which does contain mercury.

"The very low thiomersal concentrations present in the pharmacological and biological products are relatively non-toxic in adults," the UKMI report says. "But it may be toxic in utero [in the foetus] and during the first six months of life."

It is the first time any UK health official has admitted to the danger posed by mercury in vaccines.

Pressure groups described the UKMI advice as a "bombshell" which should "make Britain wake up to what the Americans have known for years" and force ministers to take mercury out of all medicine.

Action Against Autism, a pressure group, said this tallied with the boom in autism since vaccination ages were lowered in 1990.

"If the Department of Health is aware that thimerosal is unsafe for childhood vaccines, than we may be looking a criminal medical negligence on a massive scale," said Bill Welsh, the groups chairman.

The Department of Health last night confirmed to The Scotsman that the UK vaccination schedule will have exposed infants to thimerosal, and therefore mercury, three times by the age of 17 weeks.

"The level of thiomersal present is 50 micrograms per injection," a spokesman said. "UK childhood exposure to thiomersal is via DTP-containing vaccine only and, as such, up to four months of age-cumulative exposure to thiomersal is 150 micrograms from three injections."

Although it did not refute that this substance is toxic, it said the UK Committee on Safety of Medicines "has advised that there is no evidence of harm caused by doses of thiomersal in vaccines, except for hypersensitivity reactions".

It is hypersensitive reactions to thiomersal, however, which are now being linked to autism by research. The UKMI advice says as many as 18 per cent of children almost one in five can experience side-effects.

It added that a memo warning about the toxic risk in thiomersal was provided by the Wessex Drug and Medicines Information Centre in Southampton University Hospitals Trust, dated October 2002.

The Department of Health said it was "independent advice from independent doctors" and that it is not necessarily endorsed by ministers.

Thimerosal has been used in vaccines since 1939. The first case of autism was diagnosed four years after - a condition never before recorded in medical science.

The US Institute of Medicine has warned that thiomersal has a "biologically plausible" link to autism, an admission which has fuelled 30 billion class action in the US against Eli Lilly, the main thiomersal producer.

The Scottish Parliament has the power to ban mercury in vaccines. In spite of pressure from the SNP and the Tories, ministers have decided to stay within the UK vaccination programme.

Buncombe Woman: Rider Repeal Wonderful, But Doesn't End Fight For Day In Court With Vaccine Makers

Mon, 13 Jan 2003 00:00:00 -0800

Amy Carson went to Washington last week on a mission. She joined hundreds of parents who believe their children were injured by thimerosal, a mercury-based preservative used in childhood vaccines until 1999, to protest a rider in the Homeland Security Bill.

The rider protected vaccine makers from litigation over thimerosal, which Carson and others believe caused an autism- like condition in their children. Two days after the Wednesday rally, Congress voted to remove the rider.

"I can't tell you how wonderful it feels," said Carson. "We still have a long road of fighting ahead of us, but we made history."

After the rider was repealed, Senate Majority Leader Bill Frist (R-Tenn.) said he'll visit the issue again in more comprehensive legislation later this year.

Parents of children with autism have filed lawsuits claiming that thimerosal caused their children to develop the disease, and they strongly protested the limitations on their legal options.

The Institute of Medicine has released a report saying studies done so far have neither confirmed nor disproved their theory and the theory is biologically possible.

"All we're asking for is our day in court and this rider would have prevented that," said Carson. "I'm sure that's what Frist's legislation will do, too, so we have to keep up the fight for our children."

Carson and others met with a number of legislators, including Sen. Debbie Stabenow (D-Mich.), who promised to help.

"I promised those parents I would fight to remove this provision, and I will fight to ensure the legislation announced today does that job," Stabenow said before the agreement was reached to remove the rider.

Lilly, the maker of thimerosal, released a statement saying it was "disappointed" with the deal to repeal the vaccine provision. "However, Lilly agrees that the process by which this legislation was enacted was not desirable," the statement read.

Families who pressed for the change were pleased with the repeal of the rider, Lori McIlwain, the mother of an autistic child and the head the North Carolina chapter of the Autism Autoimmunity Project, told Reuters News Service.

"We're just being really leery about all of this," she said. "We're not likely to have a whole lot of trust here."

Medical Industry Gives To Sen. Frist

Sun, 12 Jan 2003 00:00:00 -0800

Shortly after Sen. Bill Frist introduced legislation limiting suits against vaccine makers, the drug industry's trade group gave $10,000 to the surgeon-turned-politician's political action committee.

Throughout his political career, the new Senate majority leader has supported the health-care industry and the industry has supported him.

Frist, R-Tenn., has raised more than $2 million from doctors, health insurers, drug companies and others in the health-care industry. That's roughly 20 percent of all the contributions to his two Senate campaigns.

Spokesman Nick Smith said the senator's votes have nothing to do with his contributions.

"Health care is a priority of Sen. Frist," Smith said. "He works on legislation that improves the quality of health care and the affordability of health care for all Americans. Sen. Frist votes his conscience. His votes take into account his understanding of the medical field."

Industries often give to lawmakers who sit on the committees overseeing their interests, and Frist is a member of the Senate Health Committee.

But Frist's relationship with the health industry is deeper. Besides being the Senate's only medical doctor, his father founded what is now HCA Inc., the nation's largest for-profit hospital chain.

"It's not at all surprising that the industry is one of the big givers to him," said Larry Noble, executive director of the Center for Responsive Politics, a research group that tracks money and campaigns.

"He is one of their people in terms of where he comes from, in terms of the committees he's on. He's from the industry, he supports the industry and he understands their problems and needs."

HCA is Frist's largest lifetime financial patron; the company and its officers and employees have contributed $172,250 to the senator's campaign committee and his leadership political action committee, which raises funds under federal contribution limits as well as unlimited soft money donations.

The company recently agreed to pay the Justice Department $631 million to settle allegations of health-care fraud that occurred when the company was headed by Rick Scott.

Frist's next four largest contributors also have Tennessee connections: FedEx, which gave $140,225; AutoZone, $115,000; Vanderbilt University, $74,950; and the law firm of Bass, Berry and Sims, whose clients include HCA and which gave $59,875. The figures include donations from employees, officials, the companies and PACs.

The president of the American Medical Association said doctors appreciate having one of their own on Capitol Hill.

"You don't have to give a lot of background and explanation," said Dr. Yank D. Coble, an endocrinologist in Jacksonville, Fla. "This is a person you can communicate with and has some experiences you can relate to."

Frist has supported the drug industry and the medical community on several key issues. In March, he introduced legislation to limit suits against companies that used Thimerosal, a mercury-based ingredient in certain childhood vaccines that some parents believe have caused autism in their children. The bill would have required the parents to file claims through a federal vaccine compensation program that caps damages at $250,000.

The Pharmaceutical Research and Manufacturers of America, the drug industry trade group, supported the measure. After Frist introduced the bill, the drug trade group gave $10,000 to Frist's political action committee.

House Republicans, who received $1 million in campaign contributions from the drug industry's trade group, eventually added the provision to the homeland security bill. The contributions came in the two months leading up to the measure's passage. House and Senate leaders said Friday they would pass legislation removing the provision.

Smith said the senator's bill was based on recommendations from a federal advisory committee on vaccines and the American Academy of Pediatrics. "He, like many Americans, is very concerned about a stable and affordable vaccine supply," Smith said.

The senator also sided with the drug industry on other votes. In the last session of Congress, Frist was one of 21 senators to vote against legislation to speed generic drugs to market, allow importers to buy U.S.-made drugs in Canada, and allow states to force drug companies to give Medicaid discounts. And he voted against the industry-opposed Democratic plan for a Medicare prescription drug benefit.

Frist also joined with his fellow doctors to support an unsuccessful effort to limit punitive damages and curtail lawyers' fees in medical malpractice cases.

Family Blames Vaccine Additive For Son's Autism

Sat, 04 Jan 2003 00:00:00 -0800

Until he was about 15 months old, Jevyn Neves was hitting all his developmental milestones. Then he began to regress. His speech vanished.

After perplexing doctors for more than a year, he was diagnosed with autism.

"He did not play with me like other kids did with their mom," said his 25-year-old mother, Nicole Bernier, a New Bedford native.

Ms. Bernier believes that her 6-year-old son's condition was caused by a series of DTP (diphtheria, tetanus and pertussis) and MMR (measles, mumps and rubella) vaccinations Jevyn received during that critical early period of his life.

She and her husband, Antonio Neves, are plaintiffs in a class action lawsuit against Eli Lilly and other pharmaceutical companies who manufactured the mercury-based additive called Thimerosal, used to give these vaccines a longer shelf life.

With Republican Sen. Bill Frist succeeding Trent Lott as Senate majority leader and a recently passed Homeland Security bill inoculating vaccine manufacturers from paying hefty damages, the prospects are dimming for the class action.

"(Sen. Frist) is our public enemy number one," said Mark Blaxill of Safeminds, a parent advocacy group in the thick of the Thimerosal controversy. "It's frightening. He is in the forefront of the movement to deprive families of their due process, the prime mover behind complete immunity provisions for Eli Lilly."

Sen. Frist defended the amendment to the Homeland Security bill on the floor of the Senate last November. He said he fears that without the added legal protections, there will be a chilling effect on vaccine manufacturer's incentive to fight bioterrorism. "The threat of lawsuits mustn't be a barrier to protecting the American people," said Frist before the bill was passed.

Frist said the vaccine injury compensation program, a special vaccine court that caps the payout to families harmed by vaccines, provides adequate recompense.

The families in the class action suit are fighting a statute of limitations specification, which bars compensation three years from the onset of signs and symptoms. "You have a class of individuals who will go uncompensated," said attorney John Kim of Gallagaher, Lewis, Downey and Kim, of Houston, Texas, one of the two law firms appointed to handle the case.

Drug manufacturing giant Eli Lilly developed Thimerosal in the 1930s and sold it for 40 years. It was used as a preservative in a number of applications other than with vaccines, such as in cosmetics and eye drops.

"It had been considered a medically safe project," said Dr. Ann Bajart at the Ophthalmic Consultants of Boston, "until we realized that over time, it caused inflammatory conjunctivitis, a reddening of the eyes. The preservative was causing an allergic response." Mercury-based products would be taken off the market for topical applications in 1985.

Pharmaceutical companies continued to manufacture childhood vaccines with Thimerosal up until a few years ago, when a 1997 report on mercury was submitted to Congress. In 1999, the American Academy of Pediatrics demanded that childhood vaccines stop being produced with the chemical preservative. Three years later, many of these vaccines are still on the shelves.

The amount of Thimerosal in any given vaccine shot was too small to be of any significance 30 years ago when a child received only a few vaccines. Today, the federally mandated vaccine program will have a child injected with anywhere between 25 and 30 shots.

And as autism rates skyrocket, parents are raising concerns of possible links between autism and vaccinations. Republican congressman Dan Burton from Indiana has an autistic grandson.

"I am personally convinced that there is a link," he said on C-SPAN last month. "Christian received nine shots in one day. Seven of them contained mercury. And two days later he became autistic, he started running around and banging his head against the wall. Severe constipation and diarrhea. Lost his ability to speak well."

Scientists are confounded. "It appears to be a dramatic increase (in autism)," said Harvard pediatric neurologist Dr. Martha Herbert. Studies indicate a spike of anywhere between 283 and 400 percent in the past 10 to 15 years.

Dr. Herbert is on the forefront of research on autism. She believes that certain children are more vulnerable to "environmental insults," or changes to their brains and bodies. These children are more susceptible to becoming autistic through environmental agents.

But the question of a connection between Thimerosal and autism has not yet been solved definitively. "We just don't really know," she said from her lab at Massachusetts General Hospital. "There is a lot of data suggesting that it does cause problems. And there are a lot of studies that should be done that have trouble being funded."

Pam Ferro, a registered nurse at Hopewell Associates in Mattapoisett, tests and treats children for autism. "Some parents can tell you to the day. It was like a switch."

She is convinced that there is a link between Thimerosal and autism. She explained that there is no good test for mercury. Unlike lead, it does not stay in the blood stream. "But one of the tests is a hair analysis. Some of the autistic children were found to have lower levels of mercury (in their hair) than normal children."

She believes this suggests that some kids do not have the ability to expel the toxic substance from their bodies. "Some kids are able to detox mercury and others cannot," she claims.

Dr. Herbert is not surprised that the Food and Drug Administration, the Center for Disease Control and the drug companies have chosen not to recall the vaccines. "It would be an admission of guilt more than anything else."

Eli Lilly spokesman Edward Sagebiel insists that there is "no scientifically credible causal link between Thimerosal and autism."

Mr. Sagebiel fears that trial lawyers attempting to cash in on the families of autistic children ultimately harm science. "We are seeing our vaccine industry reduced to absolutely nothing," he lamented. "It is important that (pharmaceutical companies) are not weighing potential liabilities as they undergo the development to find new vaccines."

And while Dr. Herbert might agree with him, she believes that the reason for this is more a function of inadequate study than hard proof.

A lot of the recent studies on the subject were either "poorly designed" or had "a long list of conflicts of interest." These are the symptoms of a tragic and disturbing trend that she calls "Epidemic Denial," the title of her recently published paper.

"Why is it that we don't fully entertain the (autism-Thimerosal) hypothesis?" she asks. "Because it is too painful. They don't want to believe that we could make mistakes like this."

The scientists, government officials and businessmen involved are very proud of the young lives they save through the vaccine program. "These people really want vaccines to be a good thing for children," said Dr. Herbert.

She is suggesting an endemic intellectual dishonesty in the scientific studies and public relations spheres pertaining to vaccines. "This casts a pall over all of science," she said. "It puts a bias on what you are allowed and not allowed to think about."

"I want to protect the pharmaceutical companies as much as possible," Rep. Burton said last month on C-SPAN.

"We need that research. We need to fight the war on terrorism. But what do you do about these thousands and thousands of children who have been damaged for life?"

Meanwhile, Nicole Bernier acknowledges how onerous the liabilities might be if companies such as Eli Lilly were held liable. "But it will cost our government a whole lot more to educate (these autistic children)," she says. "Taxpayers are paying to support corporate America."

Debate Over Vaccine Amendment

Fri, 03 Jan 2003 00:00:00 -0800

Many parents across the nation are still fuming over four small paragraphs at the end of 475 pages designed to protect America. Despite the lack of evidence, these parents are certain their kids were harmed by childhood vaccinations. But now, theyve been stripped of their right to sue the vaccine makers. Why, and who did it?

KATHY KILPATRICK has to watch her daughter very closely. Six-year-old Mary-Kate is autistic and needs constant supervision.

Shes different and shes isolated, says Kilpatrick. She knows that shes different.

Mary-Kate is one of about 90,000 children in America diagnosed with this neurological disorder that impairs her mental and social development. Her parents believe her vaccinations are to blame, specifically a preservative added to them.

I never once questioned the shots, says Kilpatrick. There was never any discussion of any risks involved.

At issue is a vaccine preservative called thimerosal. It contains mercury and was used in child vaccines until 1999. Although a scientific link to autism has never been proven, thousands of parents believe thimerosal is the cause and filed suit against its maker, Eli Lilly.

But just days before the homeland security bill was passed this fall, an amendment was slipped in. It was part of a bill written by incoming Senate majority leader Bill Frist, and it closed off the major avenue by which people could sue a vaccine maker for illness.

What it did to the families is it took away their last option, literally or figuratively closed the door on their last access to the courts of justice, says Prof. Lawrence Gostin of Georgetown University School of Law.

One of the most powerful members of Congress, outgoing House majority leader Rep. Dick Armey, R-Texas, was behind the amendment and argues that if drug companies werent protected, they might refuse to make vaccines, a big worry amid fears of bioterrorism.

Im proud that I put it in there and I know that its going to make America more secure, and thats why its there, says Armey.

But congressman Dan Burton is among those who are furious.

For anybody to say theyre proud for putting that kind of an amendment in there is just beyond me, says Rep. Burton, R-Ind.

Burtons grandson is autistic. He also chairs the committee that oversaw the bill and says he was blindsided by Dick Armeys last-minute addition.

Now, he can take sole responsibility for it, thats his prerogative if he wants to, but that amendment is criminal in my opinion, says Burton.

Some critics of the amendment point out that drug companies give generously to the Republican party and that some top officials at Eli Lilly have close ties to the White House. Lillys chairman, Sidney Taurel, served on the White House advisory council on homeland security. Mitch Daniels, a former top Lilly executive, is now director of the White House office of management and budget.

The White House denies any influence.

Eli Lilly released a statement reading, at no point did anyone at Lilly... past or present, ask for this language to be inserted in the homeland security act.

Some members of Congress from both parties say theyre already trying to undo the effects of the recent legislation to once again give parents the right to sue in court despite the absence of conclusive evidence to back up the families claims.

Theres been no scientific connection made between thimerosal and autism, not in the medical community, not in the scientific community, says Armey.

And for families like the Kilpatricks?

Every night when I go to bed, says Kathy Kilpatrick, I think, my God, whats going to happen to this poor baby when Im gone? Shes going to outlive me by 40 years.

For now, this family and others wait to find out how the next move in vaccine politics might affect the quality of their lives.

New Senate Leader Backs Drug Makers

Tue, 24 Dec 2002 00:00:00 -0800

Tennessee Sen. Bill Frist's ascension Monday to Senate majority leader could end up helping drug companies.

Frist is author of a bill to protect vaccine makers from lawsuits over vaccine preservatives.

Frist maintains he is not the lawmaker who slipped that provision in a homeland security bill that passed in November.

But as the new Senate leader he will be responsible for renegotiating it as several Republican lawmakers unhappy with its inclusion in the bill have requested.

Two senators who objected to the provision said Monday that they expect Frist to honor the promise of outgoing Majority Leader Trent Lott, R-Miss., to modify the liability protection as soon as Congress returns.

"I don't expect any change with respect to this commitment, and I will be working to ensure it is carried out when Congress reconvenes in January," said Sen. Olympia Snowe, R-Maine.

A spokeswoman for Sen. Susan Collins, R-Maine, said Frist "has not given us any indication to think otherwise."

Frist's spokesman said the senator has already begun talking with Snowe, Collins and others about changes.

But Frist still is hoping to pass separately his original bill, which included the liability protection and other measures aimed at securing a sufficient supply of vaccines.

The provision would stop pending and future lawsuits against vaccine makers from families who believe their children were harmed by the mercury-based preservative thimerosal.

Some people believe thimerosal can cause the debilitating neurological condition of autism.

To be on the safe side, the Food and Drug Administration asked manufacturers in 1999 to take thimerosal out of their vaccines. Research has not proven thimerosal causes autism.

Eli Lilly and Co., the Indianapolis-based pharmaceutical giant, created thimerosal and is viewed as the primary beneficiary of the legislation.

Although Frist consulted Lilly and other interested parties when writing his bill, his spokesman said the provisions came from an advisory commission that makes recommendations on federal vaccine policy.

Besides the vaccine legislation, Lilly has other ties to Frist, the Senate's only physician.

Lilly boosted the sales of Frist's book on bioterrorism published after Sept. 11, 2001, by buying 5,000 copies and distributing them to doctors around the country.

Frist's spokesman said Lilly's promotion of the book did not affect the company's relationship with the senator.

THE NEEDLE AND THE DAMAGE DONE

Thu, 19 Dec 2002 00:00:00 -0800

Debbie Greco's son was a normal 3-year-old when, after finishing a round of childhood immunizations, he became withdrawn, aggressive, and slow to speak all symptoms of autism.

"I didn't know what was causing them," says Greco, a San Antonio native. "Friends have the same problem, but their children's doctor told them there was no need to question the use of vaccines. We didn't know about Thimerosal."

The coziness between the pharmaceutical companies and the Bush administration has harmed families but helped drug manufacturers, including Eli Lilly, producer of Thimerosal. The drug company's cause was recently buttressed after Majority Leader and Texas Republican Dick Armey(who didn't cop to the deed until last week) stealthily tacked on a protective clause to the Department of Homeland Security bill that prohibits families from suing Eli Lilly for faulty vaccinations including those containing Thimerosal, which could have caused autism in thousands of children.

Nineteen-month-old Kristian Gallegos grimaces as he receives a vaccination by Nurse Dina Guillen at the Metropolitan Health District's downtown immunization center. The Health District no longer uses vaccines containing the controversial preservative Thimerosal.Photo by Mark Greenberg

"That clause should have gone through this committee and it didn't," said U.S. Representative Dan Burton (R-Indiana), a member of the House's Government Reform Committee. He has an autistic grandchild and is a harsh critic of Thimerosal.

Thimerosal prevents bacteria from forming in vaccines; it was used widely in in the 1980s and '90s. The mercury-based chemical also boosted drug companies' profits because they could sell multiple doses in one vial without fear of contamination.

Although in 1999 the Federal Drug Administration required pharmaceutical companies to remove Thimerosal from their vaccines, it didn't recall batches already sitting in doctors' offices, public health clinics, or hospitals.

As many as 30 vaccines have contained Thimerosal, including the Diptheria, Tetanus, and Pertussis combination; during the 1990s, health officials required children to receive additional Thimerosal-containing vaccines, including Hepatitis B.

The FDA knew the risks of Thimerosal years before it forced drug companies to quit using it in vaccines. In the 1980s, the FDA required companies to remove the chemical from all over-the-counter products, but not vaccines. By 1999, the FDA announced that infants who receive several thimerosal-containing vaccines might be overexposed to mercury, which prompted a ban on Thimerosal but not a recall.

Some parents of once-healthy children, such as Debbie Greco, believe that the chemical has caused autism in their kids. Other parents don't know about the possible connection between Thimerosal and autism because there is an average of a 44-month gap between the initial vaccinations and the onset of symptoms. Autism was once a rare disorder. In 1970, about one in 2,000 children suffered from it; over the next 30 years during the time children were being exposed to more mercury-containing vaccines that number has increased to one in 150, according to the Centers for Disease Control.

A neurological disorder, autism causes developmental delays, abnormal language and thinking skills, and other erratic behavior. Expensive therapy and medicine out of financial reach for most working families can lessen the symptoms and allow autistic children to learn basic skills, but do not cure the disease.

The Grecos spend about $25,000 a year in additional medical and therapy expenses for her son. "My son's illness impacts our whole family for life," Greco says. "It's not something that is going away."

The federal government initially covered up the serious risk of Thimerosal-based vaccines. But a non-profit advocacy group, SAFEMINDS (Sensible Action for Ending Mercury-Induced Neurological Disorders), filed a Freedom of Information Act to obtain a confidential Thimerosal study conducted by the CDC. That study showed that children exposed to mercury from vaccines were more than twice as likely to develop autism than kids who were unexposed.

In July 2001, the CDC released a revised version of the study that downplayed the role Thimerosal had in causing autism stating the data was inconclusive.

Many scientists, such as Dr. Boyd Haley, chairman of the chemistry department at the University of Kentucky, believe Thimerosal is toxic for children. With smaller kidneys and livers, children can't process the mercury in their bodies as adults can. "Giving a 10-pound infant a single vaccine in a day is the equivalent of giving a 100-pound adult 40 vaccines in a day. We're talking about causing death; we're talking about causing autism."

U.S. Representative Burton has also taken the Bush administration to task for protecting drug manufacturers from litigation. He held hearings on the damage caused by vaccines containing Thimerosal and said there was "clear evidence on the relationship between the vaccines and autism." He has demanded that all vaccines containing Thimerosal be destroyed. "Every day that mercury-containing vaccines remain on the market is another day of putting 8,000 children at risk."

Dallas-based law firm Walter & Kraus is representing several parents in lawsuits against Eli Lilly and other pharmaceutical companies. Attorney Andy Waters accused Lilly of hiding the truth about Thimerosal and using its own biased study to promote it. "Lilly used an unethical study to help them sell their product."

Drug companies such as Lilly are also using their political muscle to protect their financial interests. According to the Center for Responsive Politics, in the 2001-2002 election cycle, Lilly contributed more than $6 million to various Republican committees.

Lilly has other connections to the White House: George Bush the First served on its board in the 1970s; Dubya hired Mitch Daniels, director of Office and Management and Budget, from Lilly, where Daniels worked as president of the company's North American operations.

Unlike the drug companies, the parents, families, and autistic children have no one to represent their concerns on Capitol Hill. "The problem is we have no lobbyists," Greco explains.

Without the political or financial power, Greco and thousands of families like hers have little recourse to hold drug companies accountable, especially when the pharmaceutical industry has so many friends in government to protect them.

The Man Behind The Vaccine Mystery

Thu, 12 Dec 2002 00:00:00 -0800

It's been a mystery in Washington for weeks. Just before President Bush signed the homeland security bill into law an unknown member of Congress inserted a provision into the legislation that blocks lawsuits against the maker of a controversial vaccine preservative called "thimerosal," used in vaccines that are given to children.

Drug giant Eli Lilly and Company makes thimerosal. It's the mercury in the preservative that many parents say causes autism in thousands of children like Mary Kate Kilpatrick.

Asked if she thinks her daughter is a victim of thimerosal, Mary Kate's mother, Kathy Kilpatrick, says, "I think autism is mercury poisoning."

But nobody in Congress would admit to adding the provision, reports CBS News Correspondent Jim Acosta until now.

House Majority Leader Dick Armey tells CBS News he did it to keep vaccine-makers from going out of business under the weight of mounting lawsuits.

"I did it and I'm proud of it," says Armey, R-Texas.

"It's a matter of national security," Armey says. "We need their vaccines if the country is attacked with germ weapons."

Rep. Dan Burton, R-Ind., isn't buying it. The grandfather of an autistic child, Burton says Armey slipped the provision in at the last minute, too late for debate.

"And I said, 'Who told you to put it in?'" He said, 'No, they asked me to do it at the White House.'"

Critics say the Bush family and the administration have too many ties to Eli Lilly. There's President Bush's father, who sat on the company's board in the 1970's; White House budget director Mitch Daniels, once an Eli Lilly executive; and Eli Lilly CEO Sidney Taurel, who serves on the president's homeland security advisory council.

Officials at the drug giant insist they did nothing wrong. "No one, not our CEO, not myself, not anyone who works with me asked the White House to insert this legislation," said Eli Lilly spokeswoman Debra Steelman.

But Kathy Kilpatrick and her husband Michael argue that the thimerosal provision is not designed to protect the nation, but rather to protect Eli Lilly.

Asked what he'd say to a congressman who came forward and admitted he was responsible for inserting the provision, Michael Kilpatrick says, "I would ask him if he knew he was protecting mercury being shot into our kids."

Kathy Kilpatrick asks, "Why would anyone want to save Eli Lilly on our children's backs?"

Because Armey is retiring at the end of the year, some say the outgoing majority leader is the perfect fall guy to take the heat and shield the White House from embarrassment.

It's a claim both the White house and Armey deny.

New Vaccine Clause Angers Parents of Autistic

Mon, 09 Dec 2002 00:00:00 -0800

Thomas Brinker loves to sing and play with string. He watches ABC News anchor Peter Jennings on television every night and shouts: "Tickle Peter Jennings." He's 8 now, but his attention span is short and his temper flares easily.

Thomas has autism, a condition his parents believe was caused by a simple childhood immunization. "We're waiting for his first normal moment," said his mother, Donna Brinker of Glen Mills, Pa.

It was Donna Brinker's temper that flared when she learned that Congress had quietly restricted her right to sue Eli Lilly and Co. and other manufacturers of Thimerosal, the mercury-based vaccine preservative she believes caused her son's condition. The change came in two paragraphs tacked onto the massive Homeland Security Act just days before Congress approved the legislation in November.

The Brinkers are among 800 families in more than a dozen states that have filed similar cases seeking compensation for the costs of their children's autism. Under the new law, signed by President Bush Nov. 25, the parents are required to file claims with a special administrative court under the National Vaccine Injury Compensation Program before they can take their cases to civil court.

The changes could sharply reduce parents' chances of prevailing in civil courts, where damage awards normally could be much higher than those in the "vaccine court." The federal program covers claims for medical and education expenses, but damages for pain, suffering and death are limited to $250,000. Lawyers for the plaintiffs say their awards would likely be higher if they could first take their cases to state courts, where civil juries are known to award millions of dollars in medical injury cases.

Meanwhile, the Department of Justice has filed a request to restrict the use of information gathered in vaccine court proceedings in subsequent civil court cases, another potential obstacle for the plaintiffs.

"I felt betrayed," Brinker said of the new legislation. "I believe in protecting our homeland, but it petrifies me to think that our nation would protect any industry at the expense of our children."

Penny Starr-Ashton, of Drexel Hill, Pa., whose autistic 6-year-old daughter, Maddie, is another plaintiff in a class-action lawsuit filed in Pennsylvania in July, said it is particularly painful to have the provision wrapped in the flag.

"Who doesn't want a safer country?" she asked. "But who's going to protect me? Who's going to protect my child?"

The National Institute of Child Health and Human Development estimates that between 1 in 500 and 1 in 1,000 children is diagnosed with autism in the United States each year. Initial studies in the 1960s found four to five cases of autism in every 10,000 people, although the institute cautions that some of the increase could be due to changes in reporting and diagnosing the disease.

A study by the University of California at Davis found that a third of California parents of autistic children diagnosed in the mid-1990s blame vaccines for their children's illnesses.

Congress created the National Vaccine Injury Compensation Program in 1986 to address growing concerns about vaccine safety. Claims are filed with the Department of Health and Human Services through the U.S. Court of Federal Claims. The program has paid out 1,775 claims totaling $1.4 billion and is funded by a 75-cent surcharge on every child vaccination.

Brinker said parents of children with signs of mercury poisoning can spend up to $20,000 a year out of pocket. Thomas is undergoing chelation therapy to draw metals out of his body and is on a strict diet. His parents take him to a specialist in Louisiana for treatment, and his mother travels to Mexico to get drugs that are not approved in the United States.

Beyond today's expenses, Brinker worries about supporting Thomas in the long term. "The mercury preservative has deprived Thomas of having a normal life," she said. "That our nation would protect such a killer is beyond comprehension."

Aside from potentially lower awards, Thomas Brinker and Maddie Ashton will have another problem in vaccine court, said their lawyer, Tobi Millrood. Like many children, they were diagnosed with autism more than three years after their vaccinations, beyond the time permitted to file under the program's rules.

Some states, including Oregon, Florida, Louisiana, Illinois and California, had ruled that they had jurisdiction over Thimerosal cases, said John Kim, a Houston lawyer who argued against the government's request to close vaccine court records. "Now I guess this new provision in the Homeland Security Act trumps that," Kim said.

Meanwhile, all Thimerosal cases have been put on hold at vaccine court while the court grapples with the scientific debate over the possible causes of autism. The Office of the Special Master, which oversees procedural issues at vaccine court, expects 3,000 to 5,000 filings.

Parents outraged about the last-minute change point to Eli Lilly, the Indianapolis drug maker, as its biggest beneficiary. Lilly invented Thimerosal and manufactured it until the 1980s. The preservative is 50 percent mercury by weight, and had been used in vaccines since the 1930s. Lilly is a defendant in 200 Thimerosal-related lawsuits.

"It's turned into being about money," Brinker said. "Parents with kids with autism don't have the money to give to congressmen. It turns out whoever has the most money wins."

The provision in the Homeland Security bill was originally written by Sen. Bill Frist (R-Tenn.), a physician, as part of broader legislation aimed at helping drug companies produce vaccines after post-Sept. 11, 2001, concerns about smallpox and anthrax. The number of U.S. vaccine manufacturers has dropped to four, with companies complaining of low profit margins, manufacturing problems and fear of liability for injury.

Edward G. Sagebiel, a spokesman for Lilly, said his company had no role in pushing the last-minute legislative changes. "We express sympathy for the parents and the children who have suffered adverse reactions," he said. "However, the lawsuits that have been filed against Lilly and other manufacturers are not supported by science."

The House Government Reform Committee has scheduled a hearing on vaccine safety for Tuesday.

In 1999, the Food and Drug Administration conducted a review of Thimerosal and found no evidence of harm beyond limited cases of hypersensitivity to the vaccine. But the same year, the Academy of Pediatrics and the U.S. Public Health Service recommended that Thimerosal be removed from vaccines, partly out of fear that parents would stop immunizing their children and create a bigger public health problem.

In October 2001, the Institute of Medicine, a branch of the National Academy of Sciences, said there was no evidence that Thimerosal caused autism, but it did say the theory was "biologically plausible."

Most recently, on Nov. 30, the British medical journal the Lancet published a study showing that infants who received vaccines containing Thimerosal had levels of mercury in their blood that are within federal limits.

Starr-Ashton remains unconvinced. "I don't believe anything that is 50 percent mercury by weight is safe," she said. She noted reports of health damage caused by mercury in fish, thermometers and dental fillings. "I'm not that dumb."

The debate over science has become a furor over the democratic process in the tight-knit community of parents of children with autism that is linked by the Internet and community support groups.

"Nobody is owning up to it," Brinker said. "It is so underhanded. I just can't believe our government would do this. We're not going to back down on this issue. We will not be silent."

Starr-Ashton said she is not against vaccines, especially because she taught in a school for the deaf for many years: "I saw first-hand the damage done by rubella."

But now she does not know who to trust. "Here I was, a dutiful parent taking my child to do what the government and the Academy of Pediatrics said I should do to protect my child against disease," Starr-Ashton said. "Something went terribly wrong. I need answers."

Huge Rise In Autism

Mon, 09 Dec 2002 00:00:00 -0800

In less than two years, 4,000 suits have been filed against pharmaceutical companies over a mercury-laden preservative in childhood vaccines alleged to cause autism and other ailments.

Billions of dollars were at stake in what was shaping up to be one of the biggest litigation issues in history.

Then, without explanation, the suits were jeopardized because of a provision added to the domestic security bill signed Nov. 25 by President George W. Bush.

It protects Eli Lilly & Co. and other drug makers from suits, past and future, over the preservative thimerosal used widely in vaccines in the 1990s.

The White House has said it did not ask Congress to add the provision. No member of Congress will acknowledge proposing it. Lilly has denied asking for favors.

Parents here, like Michelle Mahnke, are fuming over the provision, which puts suits over thimerosal in a special "vaccine court."

Mahnke, 30, of Belleville, has a 5-year-old son, Jack, who has been diagnosed with autism. The child lives in a residential care facility where he is treated for the disorder.

Mahnke contends that thimerosal poisoned Jack, who was developing normally until around age 2 1/2, when his behavior turned dangerously violent.

Mahnke filed suit last week against a host of pharmaceutical companies, including Lilly.

"I was very angry that someone without a face was able to stop me from being able to recoup money from the responsible party," Mahnke said. "Someone needs to be held accountable."

She estimates that she has spent about $60,000 on her child's care.

"If my son can't get the treatment he needs, then this will end up being a burden on taxpayers," she said.

Rob Smith, a spokesman for Lilly, said his company contacted no one at the White House and had no direct involvement in the language of the bill.

"However, we have worked with members of Congress prior to that to get this clarification language inserted in the original homeland defense bill."

According to the provision, it affects "any vaccine set forth in the Vaccine Injury table, including any component or ingredient of any such vaccine." Smith contends that thimerosal is safe and that no study has ever shown a causal linkage between it and autism.

In Madison County, one law firm Wise & Julian has filed 17 thimerosal suits since April. A few have been filed in St. Louis in recent months, and more had been expected.

Wise & Julian, based in Alton, deals exclusively in mercury and asbestos cases. The company's Web site boasts that the firm has won $100 million in settlements in the last four years.

If such suits go to vaccine court, which awards payments from a consumer tax added to vaccinations, the damages for pain and suffering are limited to $250,000.

The new law had attorneys scrambling for countermoves last week.

"We are going to fight it," said Wise & Julian attorney Richard Saville, 38, of west St. Louis County. "We just haven't figured out how to do it yet."

Whether thimerosal, developed by Lilly in 1929, harmed children has been the subject of sharp debate.

Families coping with an explosion in autism that saw rates of the neurological disorder climb from 1 in 10,000 in the 1950s to current estimates of 1 in 500 viewed the preservative as the likeliest suspect.

While mercury is a known poison, scientific studies consistently concluded that there wasn't enough of it in vaccines to be harmful.

However, after conducting a review in 1999 of products containing mercury, the Food and Drug Administration issued a statement that infants who got thimerosal-laced vaccines might have been exposed to more mercury than recommended. The mercury has now been removed from most vaccines.

The most recent study, published last week in the British journal The Lancet, found that mercury levels in the blood of 33 children who got vaccines containing thimerosal were within federal safety limits.

Saville countered that the study did not test enough children and that its conclusions were flawed because they were based on how much mercury the subjects had excreted.

"The problem, at least in part for children who have been poisoned with mercury, is that they can't excrete it," Saville said.

The head of a consortium of personal injury law firms that have filed most of the thimerosal suits around the country said it was no mystery to him how the thimerosal provision got into the homeland security legislation.

Charles Siegel works for the Dallas firm of Waters & Kraus, which filed the first thimerosal suit in a state court in March 2001. His firm leads a national consortium, which includes Wise & Julian, that has filed similar cases in every major city, including St. Louis.

Siegel said the new law represents part of a concerted effort at national tort overhaul on the part of Republicans eager to reward corporations that donated heavily to the party in this year's elections.

"Thimerosal was the biggest (tort issue) to come along in a long time. It was right up there with asbestos and (the appetite suppressant) fen-phen," Siegel said, alluding to litigation that cost corporations hundreds of millions of dollars in settlements.

He noted that Lilly donated $1.6 million to candidates in the last election, 80 percent of it to Republicans.

He also discussed the close ties that Lilly has to the Bush administration: The elder George Bush was a Lilly board member in the 1970s, White House budget director Mitchell E. Daniels Jr. is a former Lilly executive, and the company's chief executive officer, Sidney Taurel, is on a council that advises Bush on homeland security.

"The Republicans are using their majority to curry favor with corporate interests," Siegel said. "It was payback time."

The White House declined to comment, referring questions to the Department for Homeland Security, which did not return phone calls last week and Monday.

Lilly is still a target

Wise & Julian filed mercury suits in Madison County on behalf of two children days after Bush signed the legislation.

The firm represented Michael and Kimberly Curia, who filed suit on behalf of their son, Christopher, as well as the Mahnkes.

The Mahnkes live in Belleville, and the Curias in Naperville, Ill., near Chicago.

Asked why the families declined to file in their home counties in favor of Madison County, which has a national reputation for being plaintiff-friendly, Saville would only say: "Venue statutes allow them to file here."

Siegel, the Dallas lawyer, said that barring a reversal of the law or a change in its language, most of the actual manufacturers of thimerosal named in the suits will, indeed, be off the hook. He said they included Bioport Corp., G.D.L. International, Parkdale Pharmaceuticals, Celltech Pharmaceuticals, Sigma-Aldrich Co., and Spectrum Chemical Manufacturing Corp.

But the lawyers still have Lilly in their sights.

"We are not suing Eli Lilly for manufacturing or adulterating. What we claim is that Eli Lilly was the original patenter, designer, defrauder and perverter of science," Siegel said. "That's a theory of liability not covered by the legislative amendments."

Public Confidence At Risk In Vaccine Plan

Mon, 02 Dec 2002 00:00:00 -0800

The government's plan to immunize hospital workers and others against smallpox could result in hundreds of side effects from the vaccine, including high fevers and raging rashes and that could have an adverse effect on public confidence in all other vaccines, some experts fear.

"It's a real possibility," says Joseph Bellanti, professor of pediatrics and microbiology-immunology at Georgetown University Medical Center in Washington, D.C. "We have to guard against that by education, informed consent and better screening, so we can identify people at risk," he says.

A core group of American parents is convinced that the vaccines given to babies Monday play a role in the development of autism and a host of other ills. Mainstream medical experts, backed by reams of scientific studies, say that vaccines are generally safe and that they protect children from deadly diseases with few, if any, negative side effects.

At its heart, the debate is about risk is it more dangerous to be vaccinated or to run the risk of contracting and spreading a contagious disease?

Most parents and many doctors have never seen the diseases vaccines prevent, such as measles, polio or diphtheria. Mary-Clayton Enderlein of Mill Creek, Wash., is an exception.

Twelve years ago, a week before she delivered son Colin, another mother, who didn't believe in vaccinating her children, stopped by with her little boy. He had a bad cough, which turned out to be pertussis (whooping cough). And even though Enderlein had been vaccinated as a child, she caught it, because her immune system was weakened by pregnancy.

Shortly after his birth, Colin got it, too. He was hospitalized for a week, and it's only because Enderlein is a nurse that she was able to bring him home that soon.

"He would cough and cough until he turned blue," she says. Babies with pertussis cough "30 or 40 times in a row, so they can't get enough oxygen. It's more than their little bodies can deal with," she says.

The infection made Colin susceptible to all sorts of illnesses in the first six months of his life, but today he's the picture of health, his mom says.

"I'm a big believer in the idea that you give people information and support their choices," Enderlein says. But people who choose not to vaccinate their children put their own families and others at risk, she says.

One potential danger is the use of live-virus vaccines, such as the oral polio vaccine. It is no longer used in the USA, because polio had been eradicated from the Western Hemisphere, and the only cases, about eight a year, were caused by the vaccine. They occurred mainly in infants with impaired immune systems or adults not fully immunized.

The smallpox vaccine also contains a live virus called vaccinia, which is similar to smallpox but not as dangerous. Still, it can cause problems, especially in people with weakened immune systems or a history of eczema. Experts estimate that if it's widely used, there could be thousands of illnesses and hundreds of deaths.

That's a dramatic contrast with vaccines routinely used today, says Walter Orenstein, director of the National Immunization Program at the Centers for Disease Control and Prevention in Atlanta. "With none of the current vaccines is there any risk of death," he says.

But some parents, doctors and others say routine childhood vaccines may carry risks of their own. "There has been a dramatic increase in chronic diseases as we've increased the number of vaccines," says Barbara Loe Fisher, president of the National Vaccine Information Center, a consumer group focused on vaccine safety.

Parents who believe their children have been harmed by vaccines have voiced their concerns from doctors' offices to Congress. Rep. Dan Burton of Indiana, whose grandson developed autism symptoms shortly after receiving a series of vaccines, has held public hearings on vaccine safety, and last week wrote to President Bush to urge him to host a White House conference on autism.

So far, vaccine rates remain high (about 77% of children receive the basic vaccines, say federal surveys), but health experts worry that public confidence is fragile.

Several studies have failed to find a link between vaccines and chronic health or developmental problems. The Immunization Safety Review committee of the Institute of Medicine (IOM), an expert body that advises federal policymakers, has produced reports on a myriad of vaccine safety questions: Does the measles-mumps-rubella vaccine cause autism? Does exposing babies to multiple immunizations harm their young immune systems? Is there a connection between multiple sclerosis and the hepatitis B vaccine?

In each case, the committee found no evidence of a link, but some parents remain unconvinced, believing that, at least for some children, vaccines may do more harm than good.

Sally Bernard of the advocacy group Safe Minds says thimerosal, a vaccine preservative that contains mercury, may be responsible for developmental disorders in children. The IOM, which looked at the issue, said there wasn't enough evidence to prove or disprove the theory. As of last year, thimerosal has been removed from most childhood vaccines, but Bernard says it shouldn't have been there in the first place. She says autism rates rose as the number of vaccines given to babies increased.

On Saturday, a study in the medical journal Lancet reported that mercury levels in infants who received vaccines containing thimerosal appear safely below health limits. Researchers in the Lancet study tested the blood levels of 40 infants for mercury following standard inoculations with vaccines containing the phased-out preservatives. All appear well below Environmental Protection Agency limits, the researchers say.

While no vaccine is perfectly safe or 100% effective, vaccines don't cause all the ills their critics say they do, says pediatric infectious disease specialist Paul Offit of the Children's Hospital in Philadelphia.

Known reactions to the pertussis vaccine, for example, are pain, redness and tenderness at the injection site, Offit says. In about one child per 10,000, it can lead to persistent, inconsolable crying, fever and seizures. But "none of those things cause permanent harm," he says, and the danger of being unprotected is significant. Pertussis still causes about 7,000 illnesses and 10 deaths annually.

In general, "the risks (of childhood vaccines) are trivial compared to the benefits," he says. "The vaccines don't cause death. It's the diseases that do that."

Parents' Struggle Over Children's Autism Frustrated By Bill Signed By Bush

Sun, 01 Dec 2002 00:00:00 -0800

The monster turned by the time Adam Reed was 2.

He stopped talking. He would not eat. He simply rocked and stared. In time, doctors diagnosed the Manteca boy as autistic.

Now, though Adam shows improvement, his parents are in court.

They are among at least 40 Californians suing makers of the vaccines that the plaintiffs consider responsible for their children's autism. It is a tough legal case, which just got more difficult.

In a vivid flexing of pharmaceutical industry muscle, the homeland security bill newly signed by President Bush squelches or, at the least, bumps off course the vaccination lawsuits. This means the end of approximately 100 lawsuits, and a half-dozen or so class-action lawsuits, filed nationwide.

"It makes me very angry," Adam's mother, Genett Reed, said.

She is not alone in her convictions, or her frustrations.

Mary Wyrick's 6-year-old daughter, Annie, does not talk. A Clovis resident, Wyrick is convinced that Annie was particularly susceptible to harm from mercury-laden vaccines. Annie showed a severe reaction to her first set of shots and showed as well high levels of mercury inside her body.

Wyrick said last week that she had been preparing for a lawsuit against the drug manufacturers that she holds responsible for Annie's autism.

Advised that such a lawsuit could not proceed under the bill signed by Bush, Wyrick gasped.

"I'm really disappointed that he would take that right away from us," Wyrick said.

One-third of California parents of autistic children diagnosed in the mid-1990s blame vaccines, a University of California at Davis survey issued last month found. The study, completed by the university's Medical Investigation of Neurodevelopmental Disorders Institute, did not pinpoint a cause for the state's stunning rise in autism cases.

Skepticism can't stop questions

But parental questions about vaccines persist, despite official skepticism about any link to autism.

California's 273 percent increase in reported autism between 1987 and 1998 is forcing parents and lawmakers alike to dig into root causes.

"We're angry that nobody was willing to listen to us," Reed said, adding that her lawsuit was designed "primarily to let people know that this can happen to their child."

Drug companies, in turn, complain that constant litigation threatens their ability to supply the public. Slipped at the last minute into the bill establishing the Department of Homeland Security, the provision protects drug companies not just against future lawsuits, but also against those already filed.

"A number of lawsuits that are without merit have been filed," Ed Sagebiel, spokesman for drug manufacturer Eli Lilly, told the San Francisco Chronicle. "That's why this legislation is a good idea. It prevents groundless lawsuits."

A handful of moderate Republicans joined with Democratic lawmakers in vowing an uphill fight next year to restore the vaccination lawsuit option. Republican leaders consented to consider revising the lawsuit provision next year but did not commit themselves to eliminating it.

The companies now can cite the law in asking judges to dismiss the lawsuits in state and federal courts. Texas attorney Andy Waters, who represents Reed and half a dozen other Central Valley parents, said he hopes he can maneuver to keep at least part of the lawsuits alive.

Parents, however, still can go to the U.S. Court of Federal Claims. This is the same court already used by parents who claim that their children suffered other vaccine injuries.

Conceivably, parents can win hundreds of thousands of dollars to help pay for their children's treatment.

Dollar awards in the claims court come from the government and widespread industry fees rather than from individual companies.

And this is where politics might enter the picture: The pharmaceutical industry gave at least $14.5 million to federal candidates since last year, according to an analysis by the Center for Responsive Politics. And Eli Lilly's former senior vice president, Mitch Daniels, is now Bush's budget chief.

In San Joaquin Valley homes, though, these legislative and litigation details seem a bit removed from the day-to-day challenge of raising autistic children.

Vaccinations caused withdrawal

Reed is the 30-year-old owner of a dog grooming business.

Her husband, Nathan, installs alarms. Adam is their only child. He was thoroughly happy and developing well, Genett Reed said, until he started getting shots designed to protect him from diseases such as measles, mumps and rubella.

"After every vaccination, he would withdraw more and more," she said. Until, "after his last set of shots, he just withdrew completely."

Research through the Internet and library convinced Reed that her son might have been harmed by Thimerosal, a preservative containing mercury, formerly used in childhood vaccines. Tests of Adam's urine showed mercury present at nearly five times expected levels.

Adam's original doctor was doubtful about linking the vaccines and autism. So are the federal Institute of Medicine scientists who have completed their own review.

"Preliminary data from a few studies have suggested that Thimerosal-containing vaccines could possibly very minimally affect some measures of normal child development," said Dr. Marie McCormick, chairwoman of the Institute of Medicine's study panel. "But the data are inconclusive."

McCormick added in her report that the evidence was "inadequate to either accept or reject a causal relationship between exposure to Thimerosal from vaccines" and autism.

This ambiguity will complicate any case filed in claims court.

The court has an established no-fault system for handling vaccine injuries, though it does not always work quickly. But autism, unlike shock or encephalitis, is not listed among the conditions presumed to be caused by vaccines. That means parents still must prove the vaccine caused the condition.

Adam, meanwhile, has been showing improvement after undergoing some controversial therapy designed to rid his body of toxins. Reed said her son is making eye contact, showing affection and once more using the words more precious than gold: Mommy and Daddy.

A Loss For Parents Of Autistic Kids

Sun, 24 Nov 2002 00:00:00 -0800

Kathy Kilpatrick knows her 6-year-old daughter, Mary Kate, will never experience a normal life, because autism makes her almost unable to express feelings and needs.

The privation has long saddened Kilpatrick. But last week the Jericho woman grew irate when Republicans in Congress denied her one more thing, the chance to hold someone immediately accountable.

Republicans put a last-minute provision in the homeland-security bill that blocks efforts by Kilpatrick and thousands of parents of autistic children to sue manufacturers of a children's vaccine additive that may cause autism.

The provision diverts a potential tidal wave of claims - none of them proven - that experts say could rival lawsuits filed over asbestos. Republicans say lawsuits might ruin companies whose capacity to produce vaccines is essential to fight the heightened threat of a biochemical terrorist attack.

But experts and critics call the provision a back-door gift to politically influential drug companies, particularly Eli Lilly and Co., whose chairman, Sidney Taurel, is on the White House Advisory Council on Homeland Security. The provision would extend the liability protection now given for vaccines to vaccine additives.

One additive faces serious medical questions and legal claims: thimerosal, invented by Lilly and used until recently in many common children's vaccines. An estimated 150 individual autism lawsuits and thousands more under preparation target Lilly.

But now families like the Kilpatricks must file claims with a federal compensation fund that pays medical costs and up to $250,000 more for pain and suffering, but makes no finding of fault. Plaintiffs can reject settlement offers and sue in court, but face tougher legal standards for winning punitive damages.

It's the corporate protection - not the cash limit - that enrages Kilpatrick.

"They need to be held accountable. The thought that my daughter could be living a normal life - she could be on a soccer team, she could be going to birthday parties, she could fall in love some day - none of those things are going to happen. Ever," she said.

Experts were stunned at how the liability provision was rammed through Congress with little deliberation, circumventing the usual committee process.

Lawrence Gostin, director of the Center for Law and the Public's Health at Georgetown and Johns Hopkins universities, agreed the liability protection should help assure vaccine supplies. But, he added, "We could have also done it by just giving a trillion dollars to the vaccine industry."

"Liability is there for important and complex reasons," Gostin said, citing negligence prevention and victim compensation.

The real problem with the U.S. vaccine supply is not that lawsuits threaten manufacturers, Gostin said, but that there is no national strategy to ensure that important vaccines are produced.

"If the sole concern was the national interest, there would have been a full and open debate about the best way to ensure stable investment and procurement of vaccines," Gostin said. But that wasn't done when Republicans took the one-page liability provision out of a stalled bill on vaccines and added it to the 484-page homeland-security bill charging toward approval.

"It's one small item plucked out in the most crude possible way," Gostin said.

Democrats called it payback to the pharmaceutical industry, which has given Republicans $14 million since January 2001, and $5.2 million to Democrats, according to the nonpartisan Center for Responsive Politics. They also questioned the influence of Mitch Daniels, Eli Lilly's former director of North American operations who is director of the White House Office of Management and Budget.

Management and budget office spokesman Trent Duffy dismissed the charge, noting Daniels had divested himself of all Lilly holdings. And Republicans said Democrats were beholden to lawyers, who opposed the provision and have given Democrats $45 million since January 2001 versus $17.5 million to Republicans.

Still, Republican leaders have backed off their late additions to the homeland security bill. "Some provisions went beyond what we needed to do," Senate Minority Leader Trent Lott (R-Miss.) conceded.

"The speaker agreed to work on these issues," said an aide to House Speaker Dennis Hastert (R-Ill.). "I don't know that there was really any specific agreement made." That comment seems to undermine moderate Republican senators, who said party leaders promised to modify the liability protection so it doesn't nullify pending lawsuits.

The liability protection was added as many people have blamed thimerosal for the tripling of autism cases in the last decade. The Food and Drug Administration advanced speculation in 1999 when it said infants who get recommended immunizations receive excessive mercury. It asked vaccine makers to stop using mercury-based thimerosal, which was used to prevent contamination when doctors jabbed a needle into the same vial to vaccinate child after child.

Last year, the Institute of Medicine said evidence was inadequate to find or deny a link between thimerosal and autism, a developmental disability that usually appears within the first three years of life, but "the hypothesis is biologically plausible."

The possible connection opened new avenues for lawsuits over thimerosal. Since 1988, vaccine manufacturers had been protected from liability when Congress started the federal compensation fund to compensate people claiming vaccine-related injuries.

But the fund, financed with a vaccine-sales tax, proved slow and difficult. A 1999 government audit found that claims typically took more than two years, and that the government was fighting them with unexpected vigor: 68 percent of the 5,566 resolved claims have been rejected to date, leaving the fund with a $1.8 billion balance.

Thimerosal seemed to provide a way to sue its manufacturers and vaccine makers who used it directly because as an additive, it was not protected by the fund.

Mike Hugo, a Boston lawyer working on 1,000 thimerosal cases, said vaccine manufacturers knew of risks in the 1970s but "continued to use thimerosal, even though scientists were telling them other things may be safer."

Industry officials denied the charge.

Republicans also noted that the liability protections were recommended by the American Academy of Pediatrics and the compensation fund's advisory commission to help stabilize the vaccine industry.

Other advocates had sought to make the fund more friendly to victims and had competing legislation. "But," said Rep. Henry Waxman (D-Calif.), who helped create the vaccine fund, "the administration and the Republican leadership have chosen to ignore those and move only on some industry protections."

Flu Bug Beginning to Bite

Fri, 22 Nov 2002 00:00:00 -0800

The flu bug is starting to bite in the tri-state. It's prime time for flu shots and it's a lot easier to find the vaccine this year.

Last year, when one major manufacturer stopped production, other companies scrambled to meet the huge demand. And they're finally caught up now. So there's no excuse not to get a flu shot this year.

Brent Ellard's having no trouble getting a flu shot now. Last year, that wasn't the case. "I usually get one every year since they've had the flu shot and I don't get the flu, and so I wanted it. But last year they were in short supply, so I never did get one. That was the only year I didn't get one."

In the last five weeks, the Visiting Nurse Association has given 12,000 flu shots at grocery stores, workplaces and even a golf course. The reason they can be everywhere? "It's available, where in the past few years we've had some trouble with the distribution of the vaccine. This year, it is very available, so we've been able to be at more public sites", explains registered nurse Cindy Meeks.

The CDC recommends children as young as six months get a shot, although the VNA is only giving them to people over the age 18.

Seniors or anyone with a chronic illness are most at risk for flu complications, which kill some 20,000 people every year.

And yet, some people still won't get one, says Meeks. "Some people still think you can the flu from the flu shot and you cannot. It's a dead virus. You cannot get the flu from the flu shot."

The flu knocked down Don Kipp for nearly two weeks last year. "I really didn't eat for five days and I lost 20 pounds. I was down to 140 pounds. It took me about a month to get it all back, so after that, I decided I'm going to do the flu shot every year."

The VNA is also offering pneumonia vaccines. Starting this year, the recommendation is for seniors and people with lung problems to get one every five years instead of ten. One company is making the vaccine without a chemical called thimerosal which contains mercury. Although it's never been proven, many people believe mercury based vaccines are linked to autism. But you have to ask for the special vaccine, it's not mainstream.

Homeland Bill's Surprise Side Effect

Fri, 22 Nov 2002 00:00:00 -0800

Jill Martinez of San Rafael saw this week's passage of a bill creating a huge new federal Homeland Security Department as a cruel joke.

Three sections tacked on at the last minute to the 484-page legislation directly affect Martinez, her husband, Gonzalo, and their 4-year-old autistic son by limiting their right to sue the makers of a mercury-based vaccine preservative they believe could be responsible for the young boy's condition.

Critics say the protection given to Eli Lilly and Co. and other firms was a brazen example of a favor White House and Republican congressional leaders granted to a huge GOP campaign donor that short-circuits the usual hearings and debate on legislation.

But defenders of the legal protection for the pharmaceutical-makers say the families of autistic children might be able to get payments through the existing National Vaccine Injury Compensation Program. They also say the new limits on lawsuits are part of the battle against greedy trial lawyers in search of big damage awards from juries.

No definite link has been made between the preservative, called Thimerosal, and the rising tide of autism among young children.

But hundreds of families, including the Martinezes, have joined in class- action lawsuits against Lilly, seeking damages and answers. None has gone to trial, and all the existing lawsuits will be thrown out after President Bush soon signs the bill.

After Congress voted, Martinez was left wondering what her son's autism has to do with the war against terrorism.

"It sounds suspicious, to be frank. I try not to be jaded, but I feel real disappointed," said Martinez, whose son started displaying symptoms of autism about 18 months ago, after he had received a host of the normal early childhood vaccinations given to all youngsters.

PROMISE TO 'REVISIT' ISSUE

The provision involving Thimerosal, which is no longer used in vaccines, was one of several that made for a dramatic last day of Senate debate on the bill that created the new Homeland Security Department, which was one of Bush's top legislative priorities for 2002.

Senate Democrats tried unsuccessfully to wipe out the provision, and three moderate Republicans who were thinking of voting with them exacted a pledge from Senate Minority Leader Sen. Trent Lott, R-Miss., that the issue will be "revisited" in the new GOP-controlled Congress.

"It is extremely unfortunate that the Republican leadership took advantage of the public desire for security to slip these outrageous provisions in the bill," said Rep. Nancy Pelosi, D-San Francisco, who will be House minority leader in the new Congress.

Michael Bender of the Mercury Policy Project, a small group based in Vermont that was created by the Tides Center of San Francisco, said some Republicans are talking about changing the statute of limitations for filing claims under the vaccine compensation program from three years to six years.

"But some parents of autistic children don't understand their children are affected for many years. Those parents now may have no other legal recourse because the Congress has cut their legs out from under them," Bender said.

"The Congress has allowed Eli Lilly to use a national threat to America to forward their own agenda," he charged.

Before passage of the Homeland Security bill, if the vaccine compensation program had rejected the Thimerosal claims, families could then file lawsuits.

Lilly, a multinational corporation based in Indianapolis, with annual sales of about $11 billion, made $1.6 million in campaign contributions during the 2002 election cycle, with about 75 percent going to Republicans.

Mitch Daniels, Bush's budget director, worked for Lilly for a decade before the president took office in 2001, and Lilly Chairman and CEO Sidney Taurel serves on the president's Homeland Security Advisory Council.

LILLY 'SURPRISED' AT PROVISION

Still, Lilly spokesman Ed Sagebiel said, the new legislation was unexpected.

"We're as surprised as anyone that the provision was inserted into the bill.

Once it was there, however, we supported it," he said.

Lilly supported similar legislation introduced early this year by Sen. Bill Frist, R-Tenn., the only physician in the Senate.

Frist defended the Thimerosal provision on Tuesday and was particularly scornful of lawyers who are telling families that childhood vaccinations are responsible for their children's autism -- and of senators who indicated sympathy for that idea.

"It's grandstanding that crosses the line. It's a false premise, not based on medical science, and it scares parents, telling them their children will be harmed by getting vaccinated," he said.

It's estimated that by the time American children enter kindergarten, they get 26 vaccinations.

PRESERVATIVE PHASED OUT

Sagebiel said Lilly stopped making the preservative about two decades ago, and the substance's use has been phased out over the past several years.

In 1999, federal authorities, medical associations and vaccine-makers agreed that as a precaution Thimerosal should no longer be used in vaccines.

Lilly and other pharmaceutical firms say trial lawyers are going after the companies because of their deep pockets. In the compensation program, damages are capped at $850,000 for children harmed by vaccines.

"A number of lawsuits that are without merit have been filed. That's why this legislation is a good idea. It prevents groundless lawsuits," Sagebiel said.

But Martinez thinks her family deserves its day in court.

"When I was pregnant, I ate organic food, and I did everything I could to have a healthy baby. I think what Congress did is very irresponsible, and now I'm very worried about the quality of my son's life for the rest of his life," she said.

Eleventh-Hour Add To Security Bill Limits Suits Over Vaccines

Thu, 21 Nov 2002 00:00:00 -0800

Last-minute additions to a bill creating the federal Department of Homeland Security will limit the legal rights of several Oregon families who have sued the makers of Thimerosal, a mercury-containing preservative once added to some childhood vaccines, an attorney for the families said Wednesday.

The lawsuits claim that Thimerosal caused some children to develop autism or related nerve diseases.

A member of the U.S. House just who remains a mystery added three brief sections to the homeland security bill just before the House passed it last week. The Senate approved the bill Tuesday. The added text, less than a page long, affects more than 100 lawsuits over Thimerosal.

The language added to the bill says such claims must go through a special federal program that pays limited damages for vaccine-related injuries, rather than through the court system. Because some of the lawsuits seek billion-dollar damages, the legal change could substantially alter the fortunes of suing families and companies that made Thimerosal, especially its biggest manufacturer, Indianapolis-based Eli Lilly & Co.

One of the first suits making such a claim was filed by George and Tory Mead of Beaverton, whose 41/2-year-old son, William, is autistic. Portland lawyer Michael Williams is leading a coalition of 35 law firms that last year filed class-action suits on behalf of more than 1,000 U.S. families.

On Wednesday, Tory Mead and Williams condemned the congressional action.

"We were furious," said Mead, who says she mailed every member of the House asking them to oppose that part of the security bill. "As parents, we were just appalled that the interests of a pharmaceutical company were put above the interests of children who might have been injured by a product."

Williams acknowledged that the language would have limited impact on the cases he has filed. Judges have sent most of those suits to the federal Vaccine Injury Compensation Program, which involves the U.S. Court of Federal Claims. The court is a "no-fault" system with some limits on liability, paid for through a surcharge on vaccines.

Although trial courts were sending Williams' suits to the "vaccine court" anyway, he said he had been planning to appeal that decision to higher courts -- until the security act passed. "Now we can't" appeal, he said.

Awards in vaccine-related deaths are capped at $250,000, plus attorney's fees and costs, according to the federal government. Awards to injured children have averaged nearly $825,000. If the vaccine program rejects claims, petitioners can file a lawsuit.

The vaccine program does not cover injuries attributed to "contaminants" in vaccinations. Williams and other lawyers have sued in court, claiming Thimerosal is a contaminant.

Drug companies have said it is part of the vaccine, not a contaminant, and judges have agreed. The language in the security bill states that all preservatives and other components of vaccines are included in the definition of vaccine and must go through the no-fault program.

Williams and Mead wondered who added the language to the bill -- a question several Congress members contacted Wednesday could not answer. Williams and Mead noted that drug companies have donated heavily to many congressional candidates in recent elections and that the Bush administration has several close ties to Eli Lilly.

For instance, Mitch Daniels was a senior vice president of Eli Lilly when President Bush nominated him to become director of the Office of Management and Budget, his current post. The president appointed Sidney Taurel, Lilly's chairman, president and chief executive, to the Homeland Security Advisory Council. The president's father, former President George Bush, once served on Lilly's board of directors.

"This is a give-away to Eli Lilly, primarily, and some other foreign manufacturers of Thimerosal," Williams said. "It's the buzz in Washington that it's the lobbying coup of the year."

But it's unclear how long these provisions of the new law will be in force. Sen. Debbie Stabenow, D-Mich., plans to introduce a bill to strike the Thimerosal-related language when the next Congress convenes in January, said her spokesman, Dave Lemmon. Several other legislators questioned the addition of the Thimerosal text, which was nearly blocked by an amendment, and could back that bill, he said.

Some Parents of Children With Autism Upset With Provision In Security Act

Thu, 21 Nov 2002 00:00:00 -0800

The act was approved by the U.S. Senate Wednesday by an overwhelming 90-9 vote, but some provisions of the act will be debated in January.

Allentown resident James McGuire, who is formerly from the Wyoming Valley and whose 2-year-old son has autism, is opposed to language in the act that exempts drug manufacturers from any liability for the manufacturing, sale and use of defective vaccines and pharmaceutical products.

McGuire noted that "compelling clinical evidence" shows a link between vaccines and autism, a neurological disorder that affects brain functioning.

While he supports the creation of a Department Homeland Security, McGuire believes this provision in the act would "severely abridge the legal rights of millions of Americans."

By passing this bill with the vaccine exemptions intact, McGuire believes, "The Senate is unjustly removing legal remedies for families that have been injured as a result of defective vaccines and pharmaceutical products."

Attorney Gerald Hanchulak, who is representing more than 30 families of children with autism, believes parents' claims - that thimerosal in vaccines may have a link to autism - have merit.

He is pursuing litigation against the drug manufacturer Eli Lilly and other drug companies that manufactured vaccines, which contained 49.6-percent ethyl mercury.

He also believes the provision in the Homeland Security Act "may affect the right of people to their current claims."

"Claims have been be made by families of autistic children all over the country, particularly about the measles-mumps-rubella vaccine," Hanchulak said. "We've known that heavy metal causes neurological injuries for 400 years. Some don't support the theory, but there are plenty of people who do."

George Shadie, president of SAFE (Supporting Autism & Families Everywhere) and father of a 13-year-old son with autism, said he also was disappointed with the provision attached to the Homeland Security Act dealing with childhood vaccines.

"We would like meaningful dialogue," Shadie said. "This was a coward's way to protect their special interests. There should be a national debate about it."
Parents of children with autism also questioned what relations vaccines have to homeland security.

Both U.S. Sens. Rick Santorum and Arlen Specter voted in favor of the Homeland Security Act.
Erica Clayton Wright, Santorum spokeswoman, pointed out that seven provisions of the act, including the provision on childhood vaccines, would be debated during the next Congressional session. That debate is expected to be held in January.

"We feel this is a great first step to protect our homeland," she said. "But with any bill, there may or may not be things in bill that we agree with."

Specter said he believed it was "vitally important" that the act be passed so "we move ahead to put all the so-called dots on the screen."
"Had all the dots been on the screen, I think 9/11 may have been prevented," Specter said.

Specter added that all provisions, including the provision about childhood vaccines, "require very extensive consideration and analysis."

"I am very distressed to see them added on the bill, with no hearings and no chance for consideration," Specter said, "This is really a case where it is a matter of take it or leave it on a bill which is undesirable in many aspects, but the importance of protecting America from terrorist attacks outweighs so many of these provisions which are highly undesirable."

The Homeland Security Act is a voluminous bill, which is hundreds of pages of long. Under this act, one government agency now will be responsible for coordinating protection of the nation's borders, coastlines, airports, landmarks, utilities and other public and private facilities.

The new agency, which is expected to have more than 170,000 employees, also will help lead the nation's defense against potential chemical, biological or nuclear attacks.

"It is so important to have a secretary with authority on homeland security to act to protect against terrorism," Specter said. "The bill is very weighty and has undesirable aspects, and there are amendments which would have improved the bill tremendously."

Specter concluded that the bill was presented as "legislative blackmail, with the House having gone home, a take-it-or-leave-it proposition" which put him in a "very difficult position."

Parents of Autistic Boy In fight For MMR Damages

Mon, 18 Nov 2002 00:00:00 -0800

The parents of a boy who developed autism after being given the MMR vaccination are suing its producers for thousands of pounds.

Nurse Karen Goodall and her husband Peter are part of a legal action involving parents from all over the country.

They are claiming unspecified damages of more than 50,000 from Merck and Co, based in Hertfordshire, for their son, Michael.

The couple, who live in Appletree Grove, Burwell, have joined other parents in the High Court action over the vaccination for mumps, measles and rubella.

Mrs Goodall, 41, said that Michael, now aged 10, seemed a normal baby until he was given the vaccine at 17 months when the family was living in Plymouth.

"As a nurse I believe in vaccination. My daughter Natalie, who is three years older than Michael, had it and was fine," she said.

"Michael was walking before he was a year old and was chattering away as most little ones do. But after he had the MMR it all stopped. He wouldn't respond and he wouldn't look at us."

Michael, who was diagnosed as having autistic tendencies in February, 1995, now attends a special school, Green Hedges at Stapleford. But when he is not at school he requires 24-hour attention.

"He does not speak and he gets very frustrated and agitated when he can't make himself understood," said Mrs Goodall.

"He is 5ft tall and weighs eight and a half stone and has smashed four doors in the house as well as no end of videos. He has no sense of danger so we have to watch him all the time.

"I can only work part-time because of the need to look after him.

"I understand why the Government wants people to give their children the vaccine. But the incidence of autism is so high now that I want 100 per cent proof that it isn't caused by the vaccination."

She said that she and her husband hoped to win damages to pay for Michael's future care.

Thimerosal Lawyer Injury MMR Autism Attorney Vaccine Mercury Lawsuit

Mon, 18 Nov 2002 00:00:00 -0800

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Thimerosal is the most common preservative that is used in vaccines and biologics that are marketed in the United States. Thimerosal is used to help prevent a vaccine from spoiling, for inactivating bacteria used to formulate several vaccines, and in preventing bacterial contamination of the final product. Several of the vaccines recommended routinely for children in the United States contain Thimerosal. However, reports have surfaced linking Thimerosal to mercury poisoning in infants often causing autism.

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On July 7, 1999, the American Academy of Pediatrics (AAP) issued with the US Public Health Service (USPHS) a joint statement alerting clinicians and the public of concern about Thimerosal, a mercury-containing preservative used in some vaccines. The reason for the warning is that Thimerosal contains related mercury compound called ethyl mercury. Mercury is a toxic metal that can cause immune, sensory, neurological, motor, and behavioral dysfunctions.

The Food and Drug Administration suggested that some infants, depending on which vaccines they receive and the timing of those vaccines, may be exposed to levels of ethyl mercury that could build up to exceed one of the federal guidelines established for the intake of methyl mercury. Symptoms of mercury toxicity in young children are extremely similar to those of autism.

This can explain the recent increase in the numbers of children diagnosed with autism since the early 1990's. The numerous amount of children diagnosed with autism seems to directly correlate with the recommendation of both the hepatitis B and HIB vaccine to infants in the early 1990s. Autism is a neurological disorder that is characterized by impairments in language, cognitive and social development.

If you or a loved one took Thimerosal and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.