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Thursday, October 13, 2005

Safe From What?

Parents blame a vaccine additive for their autistic children

by Marnie Ko

It is not surprising that Dr. Michael Palmer's new medical thriller, Fatal, is flying off bookstore shelves across North America. The author is a nine-time New York Times best-selling author, medical doctor and former emergency-room physician, and the book is an engrossing novel about corrupt and dirty dealings by pharmaceutical companies that manufacture childhood vaccinations and sell them with little scientific study on their safety. But while the book may be fiction, the 59-year-old Massachusetts medic's concern about vaccinations is quite real.

When Dr. Palmer's son Luke was born in 1990, the boy received the standard vaccinations. "I didn't think about it. I'm a doctor. I vaccinated, no questions asked," says Dr. Palmer ruefully. By eight months of age, Luke began to suffer ear infections, which continued relentlessly until he was 19 months. He then needed an operation to have tubes put in. Then, by the time Luke was three, he was diagnosed with a form of autism, Asperger's syndrome, known as "right brain autism." Dr. Palmer took him to a variety of treatment centres and met dozens of other parents with developmentally delayed children.

"The similarities from case to case were striking," he recalls. Often, chronic ear infections developed soon after immunizations, and soon after that an onset of autistic symptoms. "Healthy, normal children suddenly developed autism after childhood shots."

For parents whose healthy child has received a vaccine and regressed in development or stopped responding altogether, there are too many "what-ifs." During research for his book, Dr. Palmer met parents across the U.S. who believed vaccines were directly responsible for their children's autism because the shots contained thimerosal, a mercury derivative used since the 1930s as a preservative and anti-biological agent. Mercury is one of the most toxic elements on earth, a heavy metal and neurotoxin known to have devastating effects on humans, including neurological damage, according to some medical experts.

The problems are not limited to American children, either. Vaccine-related lawsuits around the world have alleged mercury causes immune-system, sensory, neurological, motor and behavioural dysfunction, especially involving the central nervous system, in children and adults. Mercury has been linked to autism, learning disabilities, multiple sclerosis, lupus, arthritis and other diseases. The number of children affected by autism has skyrocketed in the last five years. According to a study released by the Ontario government earlier this year, almost 800 children aged six and under were diagnosed with autism in 1998--a 53% increase over two years.

On May 9, a group of Canadian parents launched a historic lawsuit against Aventis Pasteur, Merck Frosst Canada and GlaxoSmithKline Inc., all large Canadian pharmaceutical companies. The suit alleges that the drug manufacturers knowingly used mercury preservatives in childhood vaccines, causing neurological damage and resulting in autism in about 100 infants. (Aventis Pasteur, the main target of the suit, used thimerosal as a preservative in diphtheria-pertussis-tetanus [DPT] combination vaccine in the '80s, and up to about 1994 in some provinces, according to company officials. Company spokesman Nancy Simpson says the firm's infant vaccinations no longer contain thimerosal.)

The lawsuit, launched in the Ontario Supreme Court and representing families from Alberta, Saskatchewan, Manitoba and Ontario, is the first of its kind in this country, but similar suits have been filed in the United Kingdom, the U.S. and New Zealand. In the course of legal action, one U.S. law firm obtained a confidential report authored by the U.S. Centers for Disease Control. The report studied whether mercury in shots could result in autism or neurological injury. The official version of the report released to the public claimed the study was inconclusive. However, the confidential version of the study obtained by lawyers concluded that an infant exposed to more than 62.5 micrograms of mercury--an amount contained in some combinations of vaccines--within three months of birth would be two-and-a-half times more likely to develop autism. (U.S. courts have generally ruled that a relative increased risk of 2.0 or higher is sufficient to prove exposure to a substance causes the disease.)

That is not to say the Canadian parents will have an easy time winning. Aventis Pasteur manufactures one billion vaccine doses for about 400 million people worldwide each year. The firm also owns Connaught Laboratories, which manufactured most Canadian vaccines until the '90s and also produced the "hot lot" under scrutiny in Baby Alan Yurko's death in Florida (see story, page 49). Shortly after the class-action lawsuit was filed, company spokeswoman Shirley Ernstberger told reporters the company would "vigorously defend" against the lawsuit. "All products produced by the company and marketed in Canada were approved by Health Canada at all times," she said.

The suit demands $1 billion in compensation and $250 million in punitive damages on behalf of about 100 families, alleging the drug company "continued to sell the vaccines in Canada when it knew or ought to have known that the thimerosal in the vaccines is hazardous to the health of infants." It will be early next year before the court decides whether it will accept the class-action lawsuit. If it does not, David Klein of Vancouver, lawyer for the parents, plans to file individual suits across the country.

Audra East and her son Keean, now nine, of Fort Fraser, Ont., are the representative claimants in the class-action lawsuit, which claims that all the victims were born healthy and developed normally until receiving DPT or hepatitis B (hep B) shots as part of routine vaccine programs, at which time they developed serious illnesses and neurological damage. For example, Keean was a healthy, well-adjusted two-year-old until he received his third DPT shot. Almost overnight, his parents allege, he became withdrawn and unresponsive. He stopped making eye contact and began hurting himself, banging his head and biting his hands--all classic symptoms of autism.

Cindy Stark, a Vancouver mother, also had a frightening experience after having her son vaccinated. He received his shots at the recommended times, including hep B and haemophilus influenzae type b (Hib), both of which contained thimerosal. After each shot, the baby was screaming and arching his back, and either could not sleep at all or slept excessively. Each time, doctors assured Mrs. Stark this was "a normal reaction."

By nine months, the baby had little comprehension and stopped making eye contact. By 20 months, he was diagnosed with autism. "He started spinning, and stopped looking and responding to us," says Mrs. Stark. She is still deciding whether to join the class-action lawsuit or launch her own against the vaccine manufacturer. Her son, now four, has severe allergies, especially to red dye, and has to wear gloves at preschool just to paint. He is still in diapers and uses a bottle. "In some ways, he's like a one-year-old," she says. He was tested by a U.S. doctor, who found abnormally high levels of mercury in his bloodstream. "We blame the vaccines. Where else is he going to get mercury at this level?"

The medical community has voiced concerns over the toxicity of mercury to humans for more than 50 years. By 1996, the U.S. Food and Drug Administration (FDA) took steps to stop the sale and use of over-the-counter mercurial topical ointments, including those that contained thimerosal. A 1998 FDA review concluded that children receiving the full set of recommended shots could be exposed to 30 to 50 times more mercury than recommended by the U.S. Environmental Protection Agency. But it was not until July 1999 that the American Academy of Pediatrics issued a warning that vaccines containing thimerosal should not be given to children. The same year, the FDA announced that an infant receiving just one combination vaccine (a vaccine for more than one disease) could be exposed to 100 times the safe level of mercury for humans. Even then, the agency requested only that vaccine manufacturers voluntarily phase out thimerosal from their products. However, many clinics are still believed to maintain older stocks of vaccines containing thimerosal that have not yet been used up.

So far, at least one vaccine lawsuit has been successful. In May 2001, a French court upheld an earlier, lower court ruling accepting the existence of a connection between the hepatitis B vaccine, made by GlaxoSmithKline, and multiple sclerosis. Two women launched the suit after developing MS following hep B shots. The court did not demand proof of a direct link, but ordered the firm to compensate the women financially. But Nancy Pekarek, spokeswoman for GlaxoSmithKline, told reporters, "There's no scientific evidence that there is any harm caused by thimerosal-containing vaccines. Vaccines have done an incredible job of preventing disease. It would just be terrible if people used something like this to stop vaccinating." Meanwhile in the U.S., about 10 law firms in 25 states are involved in a national thimerosal class-action lawsuit, with dozens of individual lawsuits also in progress.

Ever since 1986, when the U.S. Congress set up a national no-fault vaccine injury compensation fund, American doctors have been legally required to report suspected cases of vaccine damage to VAERS (Vaccine Adverse Event Reporting System). Still, FDA officials say 90% of doctors do not report reactions to the shots. Some doctors refuse to believe a child's injury is related to the vaccine, despite the parents' insistence that their child was healthy before being vaccinated. Still, 12,000 to 14,000 reactions to vaccines are reported to VAERS annually, and these include hospitalizations, irreversible brain damage and hundreds of deaths.

If only 10% of adverse reactions are reported, that would place the real number as high as 140,000 vaccine-induced injuries to infants each year. But David Kesler, former head of the FDA, told reporters a mere 1% of serious adverse drug reactions are reported. If he is correct, the number of infants damaged after a vaccination may be in the millions.

A surtax on each vaccine is earmarked for the compensation fund. If a child dies after a vaccination, the family is awarded $250,000 out of the fund. When a child is brain-damaged or otherwise seriously harmed, the awards are much more substantial, compensating for pain, suffering and lifelong medical bills. VAERS has already paid out more than $1 billion in compensation, with thousands of cases pending. Some cases have also led to private settlements with the drug companies. The VAERS system is fast, with most hearings completed within two days and claims adjudicated within a year. However, the program has a downside. Lawyers' fees may or may not be covered, and legal representation is recommended because procedures are complicated. All cases are heard in the U.S. Court of Federal Claims in Washington, and only lawyers admitted to practise in that court can appear. But if a child received a vaccine and subsequently developed a condition listed on the vaccine injury table (such as seizures, brain damage or paralysis), compensation is awarded and the family does not have to prove vaccines were the culprit.

If not for the VAERS chart, few families would be successful in obtaining compensation for their vaccine-damaged children. "No human studies have proved that mercury from amalgams or from the preservative causes autism in children," said Boyd Haley, chairman of the University of Kentucky chemistry department and a mercury toxicity expert. Nonetheless, he told U.S. reporters this comes down to "common sense." "Thimerosal is the best suspect for the huge increase in autism, and maybe other neurological disorders," he said.

In contrast, Dr. Liana Nolan, medical officer of health for Waterloo, Ont., told reporters recently thimerosal in vaccines has been linked to autism only by allegations, and there is "no satisfactory evidence of a link." The thimerosal in the Canadian hepatitis B vaccine, for example, "is a trace amount," she said.

Dr. Nolan's reassurances offer cold comfort to Christine Colebeck, a Kitchener, Ont., mother. She qualifies to join the Canadian vaccine lawsuit on behalf of her youngest son Carter, age six. He was vaccinated as a baby. The injection site became swollen and red, and he cried uncontrollably after the shots. Doctors assured the family his reaction was normal. But by age three, he was not behaving like a normal child. "He didn't play with toys. He lined them up and classified them." He had little short-term memory, and developed behaviour problems.

Carter was eventually diagnosed with Asperger's syndrome, obsessive-compulsive disorder and verbal tics. Despite his afflictions, he is brilliant with mathematical problems, and is considered an "autistic savant," meaning he has exceptional but narrow abilities. (At one time, individuals who had talents in one area with an overall cognitive impairment, or even mental retardation, were known as "idiot savants," from a French term referring to unlearned skill. Savant abilities can include mathematical calculations, amazing memory feats and artistic and musical aptitude.) But while Carter can perform complicated multiplication problems in his head and count higher than most adults, he is emotionally and socially inept. He licks people, hugs strangers and currently says the word "ass" more than his parents would like. He has trouble making friends and does not behave appropriately in social situations. Mrs. Colebeck, a nurse who left the profession to home-school her children, blames her son's neuro-immunological dysfunction on childhood shots. He received various vaccines, including diptheria and tetanus, polio and Hib. Since then, he has regressed gradually but continuously.

It is the second such tragedy for the Colebeck family. In 1986, the couple's daughter Laura died at three months, several hours after receiving her first vaccination. While doctors attributed her demise to SIDS (sudden infant death syndrome), Mrs. Colebeck now blames the pertussis vaccine, which contained live disease.

Mrs. Colebeck is working with other parents to force the Canadian government to start a federal injury-compensation program like the one in the U.S. "My daughter's life will not be lost for nothing," says the mother. The family has decided to hire a lawyer and pursue legal action on behalf of Carter.

Meanwhile, vaccine programs across the country are moving ahead at full throttle. In May, Alberta announced it would make the pneumococcal conjugate vaccine part of routine shots offered to infants. It will cost $14 million a year, beginning in this fall. Even though pneumococcal disease results in an average of just 15 deaths a year in Alberta children under five, out of about 40,000 infants born, health officials believe the vaccine is worthwhile.

But according to Dr. Palmer, there are far too many unanswered questions about vaccines. The medical profession, he says, is "not studying the long-range complications of vaccinations. Many researchers stop looking at these vaccines the moment they are approved. What if there is something wrong? What if vaccines do have a role in autism, MS, asthma or diabetes?

"What most struck me was how little people question, whether they are parents, scientists or doctors. Everyone is willing to discard science. Nobody has done carefully designed, double-blind studies when it comes to vaccines. The moment there is a new one, people want it in circulation. They don't want to spend 10 years evaluating its effectiveness and safety."

What is autism?
AUTISM is a neuro-developmental syndrome that usually develops before age two. It is characterized by impaired socialization, impaired language and communication skills, abnormal movement and sensory dysfunction. Vacant staring, failure to make eye contact, self-injury and headbanging are common symptoms. Thirty years ago, autism affected one in 2,000 children and was considered rare. Now, according to the U.S. Centers for Disease Control, about one in 150 children display autistic behaviours, and one in 250 children suffer developmental disorders. Vaccine reactions
This past spring, Dr. Robert Wolfe, a Chicago family doctor, visited various Web sites created by parents who say their children were injured by vaccines. For example, the Concerned Parents for Vaccine Safety Web site at http://home.sprynet.com/~gyrene/injured.htm has collected nearly two dozen stories of children who suffered catastrophic damage after receiving a routine childhood vaccination.

In an article published June 25 in the Journal of the American Medical Association, Dr. Wolfe complained the Web sites were filled with anecdotal stories and little scientific data. "Initially, I was kind of amused. I think my initial reaction was it was hard to believe that anyone would take this seriously," said Dr. Wolfe, who is also professor of medicine at Northwestern University. The medical community has repeatedly assured the public that vaccine reactions are rare.

Child abuse or vaccine reaction?

ALAN Yurko, two months old, had been ill since birth. Born in September 1997 weighing five pounds eight ounces, he spent the first seven days of his life on oxygen in intensive care after respiratory distress at birth. He suffered from pneumonia, severe jaundice and diarrhea. But doctors advised the Yurkos, of Orlando, Florida, to vaccinate baby Alan despite his illness.

The shot he received was a combination of six vaccines, including DPaT (acellular diptheria-pertussis-tetanus). Within 24 hours, he was irritable and feverish. Within 10 days, he had a high-pitched cry and his skin was hot to the touch. He stopped breast-feeding and became lethargic. On the morning of November 24, he began vomiting and wheezing, and then stopped breathing.

Baby Alan's father, also named Alan, was home with the baby. Mom Cindy was out with the car. "I checked for something obstructing his air passages," Mr. Yurko recalls. "Nothing. I gave CPR. Nothing!" Frantic, the father rushed the baby to the hospital after borrowing a neighbour's car.

It was 20 minutes before doctors were able to resuscitate baby Alan. He spent the next 75 hours on life support. Eventually, massive bleeding led to brain damage, and doctors convinced Mrs. Yurko to disconnect him from life support.

Soon after, Mr. Yurko was arrested. Police were convinced the baby was a victim of shaken baby syndrome (SBS). SBS is suspected when the infant has bleeding in the brain or the eye, or fractures of the rib cage, all of which were true of baby Alan.

In February 1999, a jury convicted Mr. Yurko of first-degree murder and aggravated child abuse. He maintained his innocence throughout trial and refused to accept a plea bargain. He was sentenced to life in prison plus 10 years.

At the trial, four witnesses testified for the state. None of them had obtained baby Alan's previous medical records. Under oath, one prosecution medical expert admitted he had never even read the hospital records; he never knew the infant had serious illnesses from birth. None of the witnesses mentioned how long the infant had stopped breathing before being revived. The lone medical expert for the defence, a university professor and neuropathologist who specializes in infant deaths and holds two doctorates, testified baby Alan had been suffering from meningitis.

The professor reviewed the tissue slides and baby Alan's medical records and testified that the infant died due to natural causes, not trauma. He noted all the bleeding in the baby's brain was fresh, only eight to 24 hours old, and could not possibly have been caused by Mr. Yurko, as the infant had spent 75 hours hospitalized before dying. But in the end, the jury believed the local doctors who testified for the prosecution. Mr. Yurko is serving his sentence in a Florida prison.

To this day, the father maintains his innocence, and, with the help of his wife, is fighting to have his conviction overturned. Almost 200 doctors, scientists and experts support him. Numerous medical doctors have reviewed baby Alan's medical records and concluded that he died of a reaction to the DPaT vaccine. In fact, a growing number of medical experts say some suspected SBS cases are really vaccine reactions.

After reviewing Mrs. Yurko's pregnancy records and baby Alan's medical records, two American physicians, Harold Buttram and Edward Yazvak, conclude that Mr. Yurko was wrongly convicted of murder based on a mistaken diagnosis. They are convinced baby Alan died after a vaccine reaction. "Shaken baby syndrome has never caused pneumonia and meningitis," they insist.

They also suggest baby Alan's rib fractures are likely from a bone disease due to severe vitamin and mineral deficiencies, not from rough handling. "One of the biggest pieces of misinformation is that a baby has to be violently shaken to cause the syndrome," says Dr. Buttram.

"The baby had been given intravenous heparin, which may have caused or contributed to the massive bleeding," Dr. Buttram adds. Also, Mrs. Yurko was unhealthy during pregnancy, and by birth had a net weight gain of only two pounds.

Given the circumstances, Dr. Buttram concludes, "a serious, possibly catastrophic, reaction to vaccination would have been predictable." The baby was premature and extremely ill, both conditions that should have delayed the DPaT vaccination.

The DPaT vaccine given to baby Alan was from the "hottest" lot on record, out of more than 800 vaccine lots. The U.S. government-run VAERS (Vaccine Adverse Events Reporting System) program collects all reports of injury or death resulting after vaccination. A "hot-lot" is a specific batch of vaccines with 10 or more reports of damage to infants, or two seizures or two deaths. The vaccine given to baby Alan was from the most lethal lot in VAERS history--64 adverse reactions were reported from this vaccine, with the average reaction time 11.45 days. Baby Alan died 12 days after having his shot.

2005 Case Update: Alan Yurko is a free man having served the majority of his sentence. He chose to accept parole when it was offered versus continued imprisonment (and continued separation from his wife and child) while he continued his legal battle to overturn his conviction. He maintains his innocence and his wife Francine and other supporters continue to stand behind him.

Posted by Becca

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