Posted on Mon, Jun. 11, 2007
Parents of autistic kids get their day in court
AT ISSUE IS WHETHER VACCINES CAUSE CONDITION
By Shankar Vedantam, THE WASHINGTON POST

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For more than a decade, families across the country have been warring with the medical establishment over their claims that routine childhood vaccines are responsible for the nation's apparent epidemic of autism. In an extraordinary proceeding that begins today, the battle will move from the ivory tower to the courts.

Nearly 5,000 families will seek to convince a special "vaccine court" in Washington that the vaccines can cause healthy and outgoing children to withdraw into uncommunicative, autistic shells, even though a large body of evidence and expert opinion has found no link. The court has never heard a case of such magnitude.

The family of severely autistic Michelle Cedillo arrived in Washington on Friday for the trial.

Michelle was a healthy 15 month old when she was given the measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so words she had been able to speak, including mommy, daddy, baby, kitty and juice, vanished. She developed a high fever one week after the shot and went rapidly downhill. Today, she does not speak and is totally dependent on caregivers. She suffers from seizures, arthritis and inflammatory bowel disease and is nearly blind.

Theresa Cedillo said she is "not anti-vaccine" and not very interested in playing the blame game or weighing in on matters of public policy.

"I am not a scientist. I am not a doctor," she said in an interview. "We want to focus on Michelle and find out what happened and get the help for her that she needs."

The shift from laboratory to courtroom means the outcome will hinge not on scientific standards of evidence but on a legal standard of plausibility, what one lawyer for the families called "50 percent and a feather." That may make it easier for the plaintiffs to sway the panel of three "special masters." The decision not only could change the lives of thousands of American families, it could have a profound effect on the decisions of parents around the world about whether to vaccinate their children.

A victory by the plaintiffs, public health officials say, could increase the number of children who are not given vaccines and later fall sick or die from the diseases they prevent.

In this case, economics and politics intersect with questions of health and the deepening mystery of soaring autism rates. Advocates of the vaccine theory have argued that the increase in cases was triggered by a mercury-based preservative in vaccines that, they say, is toxic to children's brains.

Under pressure from the advocates, and to keep the issue from disrupting vaccination programs, U.S. officials began phasing out the additive, thimerosal, in children's vaccines around 1999 while maintaining that there was no hard evidence that it was dangerous.

But thimerosal is still used in vaccines across much of the developing world. If the vaccine court decides that the preservative caused autism, parents of children in poor countries are likely to protest its inclusion. But removing it would make vaccines much more expensive and potentially put them out of reach for many.

Experts for the government will argue that a range of epidemiological studies found no link between vaccines and autism, as the Institute of Medicine concluded in a 2004 report. The institute, part of the National Academies that was chartered by Congress to advise the government and the public on matters of science, dismissed the vaccine-autism theory, which is based mostly on biochemistry studies on the toxic effects of mercury.

Large international studies, and preliminary evidence from the United States, suggest that after thimerosal was removed from children's vaccines, autism rates continued to soar.

The plaintiffs acknowledge that their case is far from airtight scientifically. But Kevin Conway, a Boston attorney representing one family, said that even if the science is equivocal, he has a good legal argument, which is all he needs.

Adventures in Autism & Autism Blogs

Vaccine Test Case Reaches Federal Court
Tony Mauro, Legal Times, 06-04-2007
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The family stories are remarkably, painfully, similar.

They begin begin with toddlers developing well, and happily. Then they are taken to the doctor’s office for routine vaccines which, in the early 1990s, often were bundled together.

A week after the shots, the devastation begins: loss of speech and eye contact, high fever, constant pain, screaming, bowel problems, no sleep. The children no longer respond to their names; later, they are diagnosed with autism or related disorders.

“Words alone cannot explain the trauma of watching your only child’s health deteriorate to such a degree before your eyes,” Theresa Cedillo of Arizona writes in an e-mail to Legal Times.

On June 11, the case of Michelle Cedillo, Theresa’s daughter, goes before an extraordinary tribunal assembled by the U.S. Court of Federal Claims. Its goal is to determine, for the first time in a judicial proceeding, whether the combination of certain vaccines and thimerosal, a mercury-based vaccine preservative, can cause autism — a set of disorders that is gaining attention as more and more children are diagnosed, as many as one in 150 children born in the United States. The government has long denied such a link exists.

In her first comments to the media since her case began in 1998, Theresa Cedillo tells Legal Times, “The profound downward change in Michelle’s health began seven days following the MMR (measles, mumps, and rubella vaccine).”

Of her daughter, now 12, she adds, “Her childhood has passed right before our eyes spent in hospitals and doctors’ offices, not in parks and with little friends. The trauma of the sheer human suffering she endures every day is beyond explanation and understanding, filling us with overwhelming anguish.”

Michelle, her mother says, “will require a very highly skilled and involved level of daily care as she continues to age . . . It is our hope that she can gain some type of communication skills in the future.”

Cedillo v. Secretary of Health and Human Services was picked as a test case from more than 4,800 autism claims that have been filed with the little-known court, which sits anonymously overlooking Lafayette Square near the White House. The outcome of the case, the court hopes, will guide the disposition of other claims and prevent the need for repetitive discovery and expert witness testimony.

The determination also could shake — or bolster — public confidence in the vaccine system and affect autism litigation worldwide.

During three weeks of testimony, the hotly contested issue of causation will be advanced and picked apart by expert witnesses. A sign of the emotions infused into the case: The court sealed the names of the witnesses, for fear they would be harassed.

The trial before three special masters will take place in a 400-seat courtroom that may be filled with parents and their lawyers, as well as lawyers and lobbyists for the pharmaceutical industry, which has a huge but indirect stake in the case. Special arrangements have been made to enable out-of-town parents to listen to the trial by phone, and transcripts and audio of the trial will be made available online.

“There’s never been another case like this,” says Kevin Conway of Boston’s Conway, Homer & Chin-Caplan, one of Cedillo’s lawyers.

TOO STRONG A CASE?

The proceeding is more than five years in the making. The plaintiffs’ lawyers and the government, with an occasional assist from pharmaceutical companies, have been jockeying over discovery issues for years. On May 25, the special masters denied a long-pending request by the plaintiffs for access to a massive vaccine database developed by the government’s Centers for Disease Control and Prevention and private managed-care organizations.

“It’s infuriating,” says Conway, asserting that the database would have been an important resource for Cedillo’s witnesses. Instead, he says, about 250,000 other documents have been released over the years, which Conway describes as “a haystack without a needle — useless.”

Some lawyers also question whether Cedillo’s was the right one to pick as a test case. Michelle’s extreme reaction, while not rare among claimants, may not result in a ruling that that will help children with a less severe or more delayed injury. “Her case may be too strong,” says Curtis Webb, a plaintiffs lawyer from Twin Falls, Idaho. “I wonder if a ruling in her favor will let other kids win.”

Rita Shreffler of Nixa, Mo., is one of the parents who hopes to be in the audience for at least some of the trial. Shreffler is the mother of Andrew, 15, and Mary, 13, both of whom have autism — both, she believes, the result of childhood vaccines.

“They were totally normal until about 18 months,” she says in a phone interview. After their routine vaccinations, “I saw them slip away. There were really drastic personality changes.” Andrew cried constantly, she recalls. “I swear he didn’t sleep for three years.”

Shreffler, now executive director of the National Autism Association, has joined the upcoming claims court litigation on behalf of her children. “If you look at the scientific evidence, it’s a no-brainer” that the mercury in the thimerosal preservative caused or contributed to their autism. “My son got a level of mercury injected into him, which, under (Environmental Protection Agency) guidelines, would be safe only if he weighed 1,100 pounds.”

That mercury was delivered in the form of thimerosal, a preservative that is nearly 50 percent mercury.

With the addition of more vaccines — for Haemophilus influenzae type B (Hib) and hepatitis among others — to the typical regimen in the 1990s, children were exposed to more and more mercury.

“We were set up for disaster,” says Cheryl Gaudino of Attleboro, Mass., another parent who believes there is a vaccine-autism connection. In 1997, when he was 13 months old, Gaudino’s son Ryan was given the Hib and MMR vaccines during a doctor’s visit for an ear infection. He’d had several rounds of antibiotics for earlier illnesses, so his immune system was already compromised, she says.

Within days, Ryan had an intense allergic reaction and developed vasculitis. “That means the valves in your veins leak,” Gaudino says. “There is pooled blood under the skin. He looked like a burn victim.” A photo from that time confirms her description.

Ryan recovered, but then lost language skills and continues with severe problems. “He can get out some of his wants,” says Gaudino. “He will screech; he can hit himself; he can hit you.”

‘NO EVIDENCE OF HARM’

The question of whether thimerosal leads to autism did not surface widely until the late 1990s. Parents and autism groups now point angrily to both government and drug company documents that show questions were being raised years earlier about the safety of the mercury preservative. Environmentalist Robert F. Kennedy Jr. wrote a controversial Rolling Stone article in 2005 accusing the government of “whitewashing” evidence of thimerosal’s effects.

But the government, while phasing out the use of mercury preservatives in most vaccines, still says there is “no evidence of harm” from thimerosal. A 2004 study released by the Institute of Medicine, founded as part of the National Academy of Sciences, said the accumulation of scientific evidence “favors rejection of a causal relationship.”

For many, that closed the debate, but for parents, bolstered by new studies that reach the opposite conclusion, as well as their own experiences, the connection is still apparent. Future test cases before the claims court will examine whether thimerosal alone, or the MMR vaccine alone, can also cause autism.

The Cedillo trial is a crucial moment not only for the causation issue but for the vaccine compensation system, devised by Congress in 1986 to limit the liability of vaccine makers.

Broad-based vaccination is one of the success stories of the 20th century, effectively killing off diseases ranging from smallpox to polio that used to afflict millions. The compensation system was meant to handle the rare but inevitable injuries that result from allergic and other reactions to vaccines. Under the 1986 law, instead of suing manufacturers, those injured by vaccines file claims against the government in the federal claims court — which some call the “Vaccine Court.”

Special masters acting as trial judges hear individual cases and award damages once a causal connection has been made. Pain and suffering damages are capped at $250,000, but lost wages, medical and educational costs, and lawyers’ fees can all be compensated. Awards can top $1 million, and more than $750 million has been paid out since the program began.

But nobody envisioned the torrent of autism claims.

“This is the biggest group of cases we’ve ever handled,” says Gary Golkiewicz, the court’s chief special master. Cedillo and future test cases, says Golkiewicz, “will be critical in presenting the issues so we can get these decisions out as quickly as possible.”

More than 5,100 autism-related claims have been filed since 1999 (some have been withdrawn) compared to 2,700 for all other vaccine claims since the program started operating in 1988.

If causation is shown, where will the money to compensate victims come from? Under the program, patients pay a 75 cent excise tax for each vaccine, which adds $200 million to a compensation fund each year, for a current total of $2.5 billion.

So the autism litigation, even if successful, won’t actually cost the pharmaceutical industry a dime. And no drug-company lawyer will have a formal role in the upcoming trial. Yet the drug companies will be watching.

A PRO-VACCINE CAMPAIGN

One concern the companies have is the effect the case might have on public confidence in vaccines generally, says Randolph Moss, a partner at WilmerHale who advises pharmaceutical industry clients on vaccine issues. “This trial is a big deal from a public health perspective,” Moss says. “There could be very dramatic public health consequences if the judges were to conclude, despite the strong scientific evidence to the contrary, that there is some connection between vaccines and autism or similar neurological disorders.”

The CDC has voiced similar concerns, and pro-vaccine groups are approaching the media in advance of the June 11 trial.

But Jared Hansen of Framingham, Mass., sees an inherent conflict of interest for the CDC. “The same agency that is responsible for promoting vaccines is also assessing their risk,” Hansen says. “It’s a real tangle.”

Hansen is another claimant in the upcoming autism litigation. His sons Jacob and William both have autism. Their problems began soon after they received standard vaccinations as toddlers. Jacob was not diagnosed with autism until after William was born and had received vaccinations.

Hansen says his main hope for the trial, which he will follow on the Internet, is that “the science finally gets a hearing.” He has an open mind about it and says more research is needed.

“There is science to be done, yes,” he says. “But with children involved, shouldn’t we err on the side of safety?”

Tony Mauro can be contacted at tmauro@alm.com.


Health

Thimerosal and autism: David Kirby's 'Evidence of Harm'
By Evelyn Pringle, Online Journal Contributing Writer
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June 29, 2005—David Kirby's new book, "Evidence of Harm" is a must read for anyone seeking to understand the connection between autism and childhood vaccines containing the mercury-based preservative thimerosal. The book examines the political and legal side of this travesty and presents information that cannot be disputed.

The book is a result of a thorough investigation and is by no means an anti-vaccine campaign. But most importantly, it's obvious that Kirby has no ax to grind.

"I was 100 percent unfamiliar with this story right up until November of 2002," Kirby says, "I had never met a person with autism in my life and I had never heard of thimerosal,"

"And I had certainly never heard of any connection between any form of mercury and autism," he adds, "although I did know mercury was not good for you. But I don’t think I realized the extent to which it could do damage in your body."

"Growing up in school," Kirby said, "I have tried . . . I have searched my brain going back class by class, trying to think, 'Could that kid have been autistic?'”

"But, I have seen autistic kids and no," he said, "I don’t believe I had ever met anybody—certainly no one who was diagnosed."

For people who insist that there is no epidemic and that it is just better reporting and better diagnostics, "I really would like to pose the question to them that Mark Blaxill, from Safe Minds, asks," Kirby said, "Where are all those people? Where are the one in 166 autistic adults? We can’t find them."

The epidemic is real and politicians know it. On June 18, 2004, Representative Dave Weldon, MD, (R-FL) took to the floor of Congress and told the members, "I would like to take this time to address what I consider to be a very growing problem, the epidemic of autism and neurodevelopmental disorders that are plaguing our nation.

"In January of this year, the Department of Health and Human Services sent out an autism alarm to the nation's pediatricians. In this alarm, they stated that one in every 167 children is being diagnosed with an autism spectrum disorder. I will repeat that. One in every 167 children being born in the United States today is being diagnosed with an autistic spectrum disorder. Furthermore, one in seven children is being diagnosed with either a learning disability or a behavioral disability.

"Mr. Speaker, something dreadful is happening to our youngest generation, and we must sound the alarm and figure out what is going on with our children," Weldon said.

According to Weldon, "autism was once in America a rare and infrequently seen condition. I went through four years of medical school, internship, residency, and years of private practice and practice within the military and had not seen one single case. I have seen case after case in my congressional district over the last seven years, a disease that I had never seen before."

Weldon told the committee, "The number one question has been whether neurologic problems were caused in some children by the high levels of a mercury containing additive that was included in our vaccines in the 1990s. This mercury containing additive is called thimerosol, and in the 1990s, infants and unborn children were exposed to significant amounts of mercury at a most critical point in their development."

Ironically, Republican lawmakers are openly blaming thimerosal and seeking to have it banned. In addition to Weldon, Senator Roy Holand (R-Missouri), also a physician by training, identified thimerosal as the culprit and got Missouri legislators to prohibit its use in childhood vaccines in his state.

“As a physician, I’ve been concerned about the rising levels of autism, and the more I’ve learned about thimerosal, the more convinced I am that it causes neurological damage,” said Holand. “Mercury has no place being injected into children.”

Evidence of Harm examines the politics involved and reads like a mystery. Kirby weaves together the determined efforts by parents to force attention upon autism; the conflicting scientific evidence regarding thimerosal; and the behind-the-scenes maneuverings that led to an investigation by the Department of Health and Human Services into allegations of malfeasance on the part of employees at the CDC and the FDA.

Kirby is no stranger to investigative journalism. He has been writing extensively for The New York Times for the past seven years and was a foreign correspondent in Mexico and Central America from 1986 -1990, where he covered the wars in El Salvador and Nicaragua, and the politics, corruption and natural disasters in Mexico. From Latin America, he reported for UPI, the San Francisco Examiner, Newsday, Arizona Republic, Houston Chronicle and the NBC Radio Network.

Kirby keeps up with all the studies by independent scientists. "The most important ones among them are the work of Jeff Bradstreet, Jill James, and Dr. Richard Deth, and others looking into this: Boyd Haley, of course, from the University of Kentucky. Mark and David Geier have looked more into the epidemiology than the biology of this," he adds.

"The bottom line of what their studies are showing," Kirby says, "is that autistic kids retain heavy metals at a much greater rate than normal kids; that they seem unable, in fact, to actually excrete it."

There is a treatment known as "chelation" that is showing some success when used to draw mercury out of the bodies of autistic children.

"Following chelation," Kirby reports, "autistic children excrete far higher levels of mercury than normal kids. And yet, in their baby haircuts, we’re finding that normal kids have much higher levels of mercury in their hair," he said, "And that would then make sense, because they were excreting it properly; the autistic kids were holding onto it."

This theory is supported by research conducted by Dr. Mady Hornig which took different strains of mice—one strain which was genetically predisposed to have auto-immune disorders—and exposed them all to the same level of vaccines that children would have received.

In the sensitive group of mice, Hornig noticed autistic-like behavior and physiological development such as increased brain size that you see in autistic children. Of course as always happens to scientists who connect the dots on this issue, she has been attacked for the study.

According to Kirby, people said, "How can you tell if a mouse has autism or not?"

But he explains, "I’m not quite sure that was the point of the study. I think the point of the study was to show that certain members of the same species, with a genetic difference, will react differently to the same level of mercury exposure due to a genetic variance."

Which makes perfect sense. Those children whose bodies cannot rid themselves of mercury become autistic. The August 2003 International Journal of Toxicology study revealed that healthy children excreted eight times more mercury via their hair than did autistic children. In fact, the more severe a child's autistic symptoms, the less mercury was excreted in her hair, indicating that mercury also could be retained in the child's tissue, including her brain.

Thimerosal began to be slowly removed from vaccines in late 1999. "That means new vaccines started to be produced without mercury in them," Kirby said, "But as we know, all the vaccines on the shelf with mercury stayed on the shelves—there was never a recall."

According to Kirby, "We have no idea how long it took to use up all that mercury-containing vaccine, or even if it has all been used up," he said, "The OSC has said that there may be vaccine out there with an expiration date of 2005 that still contains the full amount of mercury."

"We don’t know when those lots were released; we don’t know where they were released; we don’t know what kids in what part of the country were getting mercury and what kids were not post 2000," he warns.

The truth is there are still some vaccines out there that contain full doses of the thimerosal with expiration dates in the fall of 2005. They include:

Meningococcal Polysaccharide Vaccine (Aventis Pasteur) 10-dose Vial, lot UB505AA, expires 17 Jun 05, 25 micrograms of mercury per dose from thimerosal; Td Vaccine (Aventis Pasteur) 10-dose Vial, lot U1014AA, expires 2 Sept 05; 25 micrograms of mercury per dose from thimerosal; Tetanus Toxoid Absorbed Vaccine (Aventis Pasteur) 10-dose Vial, lot U1048BA, expires 8 Sept 05, 25 micrograms of mercury per dose from thimerosal; Tetanus Toxoid Vaccine (Aventis Pasteur) 15-dose Vial, lot U0775AA, expires 10 Mar 05, 25 micrograms of mercury per dose from thimerosal; Japanese Encephalitis Vaccine (Je-Vax - Aventis Pasteur) 3 x 1 mL Vials, lot EJN*196B, 35.7 micrograms of mercury per dose from thimerosal; Td Vaccine Mass. Department of Health, 7.5 mL Vial, lot Td-102, expires 21 May 2005, 8.3 micrograms of mercury per dose from thimerosal; Influenza Virus Vaccine (Fluzone - Aventis Pasteur) 5 mL Vial, 25 micrograms of mercury per dose from thimerosal; Pediatric DT Vaccine (Aventis Pasteur) 5 mL Vial, 25 micrograms of mercury per dose from thimerosal.

As late as 2003, a review of the Physician's Desk Reference showed that three childhood vaccines were still being made with full doses of thimerosal. Diphtheria-Tetanus-acellular-Pertussis (DTaP) manufactured by Aventis-Pasteur in multi-dose vials contained 25 micrograms of mercury, Haemophilus-influenza-Type b (HibTITTER) in multi-dose vials manufactured by Wyeth contained 25 micrograms of mercury, and pediatric hepatitis B vaccine manufactured by Merck contained 12.5 micrograms of mercury. These vaccines represented about half of the childhood vaccines available for use in the US that year.

So we know that children may have been exposed to high levels of mercury in 2003. The total childhood mercury intake could have been more than 300 µg, according to the report in the Journal of American Physicians and Surgeons Spring 2003 issue.

The bottom line Kirby says, "We do know that kids were getting mercury right up through 2002, and perhaps later. We also know that it is in the flu shots," he adds.

On January 19, 2004, Mark Geier, the internationally renowned genetic researcher, discussed the flu vaccines with Kelley Omeara of Insight News, "There is something called the blood/brain barrier, which prevents some toxins from entering the brain. But ethyl mercury, which is what is in the influenza vaccine, crosses that barrier," he explained, "The influenza vaccine has 25 micrograms of mercury, which means that to be at the recommended level of safety, and assuming that you get no mercury from any other source, you'd have to weigh 550 pounds to be safe."

The independent scientific research behind this public health crisis is mounting and the public is beginning to sit up and take notice of the media stories coming out that discuss the information contained in Evidence of Harm.

For instance, an article titled "Deadly Immunity," written by Robert Kennedy, Jr., was co-published this month in Rolling Stone and Salon. It mentions Evidence of Harm and discusses many of the issues detailed in the book.

Kennedy's article, tells how in June 2000, the CDC held a conference at the Simpsonwood Conference Center in Norcross, Ga., where doctors and scientists gathered to discuss a preliminary study that indeed found a statistically significant link between thimerosal and autism. From material obtained via the Freedom of Information Act, Kennedy cites quotes that leave no doubt that the meeting's purpose, ultimately, was to "whitewash the risks of thimerosal, ordering researchers to 'rule out' the chemical's link to autism."

The American Prospect hailed the article as a "blockbuster piece," and on June 21, while discussing the article with Kennedy, Joe Scarborough, on his MSNBC TV show, said that "there's no doubt in my mind that thimerosal causes, in my opinion, autism."

According to Dr. Geier, "the current epidemic of autism may well be the greatest iatrogenic epidemic in history. The damage already done to our society is already in the trillions of dollars. The damage of the 9/11 terrorist attacks, and that of the AIDS epidemic pale when compared to the current epidemic of autism."

Or put another way, "To cling to a purely genetic explanation for autism is a desperate attempt to maintain the illusion that one lives in a comfortable and rational world where new chemicals and technologies always mean progress; experts are always objective and thorough; corporations are honest; and authorities can be trusted," says Harvard's Martha Herbert, "That human actions, rather than genes, might be responsible for compromising the health of a significant proportion of a whole generation is so painful as to be, for many, unthinkable."

The vaccine makers, along with their complicit government scientists and policy makers, have a lot to lose. If they don't find a way to keep the public from finding out that they knowingly allowed an entire generation of children to be damaged, the ensuing litigation will spread through the nation's court system like wild-fire and push tobacco and asbestos law suits down into small claims court.

The evidence presented in Kirby's book forces readers to face the unthinkable and leads to one conclusion: a generation of innocent and defenseless children were poisoned for profits by a greedy segment of society mistakenly entrusted to protect the common good of children all over the world.

Evelyn Pringle is a columnist for Independent Media TV and an investigative journalist focused on exposing corruption.

The views expressed herein are the writers' own and do not necessarily reflect those of Online Journal. Email editor@onlinejournal.com
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