According to the article:  Duke University's Katz said the whole-cell vaccine did produce short-term problems. But, referring to a 1991 report by the Institute of Medicine, he said, "There's no evidence that it produced any chronic brain damage."

 

Here is what the IOM actually said:  "In the course of its review, the committee encountered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines.  These include inadequate understanding of the biological mechanisms underlying adverse events

following natural infection or immunization, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiolgocal studies and limited capacity of existing surveillance systems of vaccine injury to provide persuasive evidence of causation.  The committee found few experimental studies published in relation to the number of epidemiologic studies published.  Clearly, if research capacity and accomplishment in these areas are not improved, future reviews of vaccine safety will be similarly HANDICAPPED (emphasis mine)."

 

And why are they allowing Dr. Katz, one of the developers of the measles vaccine, to be seriously used as its defender?

 

The absence of evidence is not proof of the absence of a relationship or causation.  And in the case of vaccines it is clearly the result of the absence of well-designed, meaningful studies.- SM

 

 

http://www.charlotte.com/partners/news/full/news_full_1_Oct15.htm

 

Published Monday, October 15, 2001

injecting controversy into health circles

Debate simmers over vaccinations

Parents, health officials weigh potential risks of child immunizations

By KAREN GARLOCH

The sign announced a meeting of PAVE - People Advocating Vaccine Education.

Inside, Lisa Jillani, who founded the Charlotte group sixyears ago, wore a T-shirt with the message: "Vaccination. Don't Be A Victim."

About 20 people came to the recent gathering to hear Jillani and other parents share worries about the multiple immunizations required by law before children can enter kindergarten or go to day care.

One mother described fevers and seizures her children suffered after they received vaccinations. She described the resistance she encountered when she tried to get medical exemptions from the law. Others shared what they'd read in books and on the Internet about possible links between vaccines and autism or lupus.

Jillani's group is one of many grass-roots organizations across the country, launched by parents convinced of the dangers of vaccines for some children. With access to the Internet, these small, but vocal groups are spreading their stories faster than ever.

Earlier this month, a coalition of law firms filed class-action suits, led by an Oregon woman who claims her son became autistic because of a mercury-containing preservative in vaccines.

The anti-vaccine campaign worries U.S. public health officials, who tout the success of vaccines at virtually wiping out once-dreaded diseases, such as polio and smallpox. If immunization levels are allowed to drop, they warn, the country could see a recurrence of diseases that young parents have never experienced.

But Jillani and parents like her are convinced: "There's a dark side to vaccination that people don't know about."

`In her own little world'

Like other dutiful mothers, Jillani took her newborn daughter, Samantha, to the doctor for required immunizations. As months passed, she began to notice "a gradual fading away" in her daughter. After the fourth of five sets of shots, Samantha "acted like she was in her own little world," Jillani said. " She acted like she was drunk sometimes."

Samantha, now 9, was 3 when she was diagnosed with sensory integration dysfunction, a milder-than-autism disorder. Doctors couldn't identify a cause.

After some research, Jillani and her husband, A.J., became convinced that her problems came from vaccines. They agreed that their second daughter, Madison, now 5, would get no vaccinations.

The Jillanis' pediatrician, who disagreed with their anti-vaccine stance, refused to see them any more. And when Madison was born, the couple felt hospital nurses and doctors tried to intimidate them into accepting shots.

"It was just a very hostile experience that I didn't think other people should have to go through," Lisa said.

A few months later, she started PAVE.

Vulnerability issue raised

Meanwhile, mainstream organizations, such as the federal Centers for Disease Control and Prevention, the American Academy of Pediatrics and state and local health departments, stress that a drop in vaccination levels could be devastating.

"Our very success is our worst enemy," said Dr. Samuel Katz, a Duke University pediatrician and co-chairman of the National Network for Immunization Information.

"Young parents today, and young physicians and nurses, have rarely seen measles, polio, meningitis, whooping cough, because we have been so successful at preventing them. But we are quite vulnerable. These occur everywhere throughout the world."

Katz recently returned from Africa, where he saw children with measles and polio.

"There is no U.S. strain of measles any more, but we haven't eliminated it from Japan, the Congo and India," he said. "If we stop immunizing our kids, we can't just sit back and say, `We don't have it here. We don't have to worry.' This is just a jet plane away."

Ground-breaking book

Concerns about vaccines got attention in 1985 with the publication of a book called "A Shot in the Dark" by Barbara Loe Fisher and Harris L. Coulter. Fisher founded the National Vaccine Information Center, the most prominent of the groups questioning vaccine safety.

Fisher wrote the book after her son developed neurological and cognitive disorders following a pertussis, or whooping cough, vaccination.

At the time, the pertussis vaccine was made with whole-cell pertussis bacteria and combined in one injection, called DTP, with vaccines for diphtheria and tetanus. Subsequently, health officials acknowledged that the whole-cell vaccine caused adverse reactions, such as fever, soreness, prolonged crying and seizures. The whole-cell vaccine is still available, but in 1996, the FDA licensed DTaP, which doesn't use the whole-cell pertussis bacteria and produces fewer, milder reactions.

Duke University's Katz said the whole-cell vaccine did produce short-term problems. But, referring to a 1991 report by the Institute of Medicine, he said, "There's no evidence that it produced any chronic brain damage."

When the pertussis controversy surfaced, vaccine manufacturers threatened to get out of the business rather than risk lawsuits. In 1988, the government created the Vaccine Injury Compensation Program as a way to resolve claims from adverse reactions to childhood vaccines. Those who seek compensation agree not to sue manufacturers or doctors.

A total of 6,043 claims had been filed through June30, according to the program's Web site. Of those, 1,663 were granted, for a total of $1.26billion.

Charlotte family affected

It took 15years for Dee Williams of Charlotte to get money from the compensation program on behalf of her daughter, Teri, who suffered brain damage after getting a DTP shot when she was 3months old.

"The day she received her shot, I had taken her to my friend's, who baby-sat her, and, you know, she wasn't acting right," Williams said. "She kind of stiffened up after I left and her eyes rolled back. From that day forward, she never, ever acted like she had. She developed like a blank stare."

At age 3, Teri was diagnosed with severe mental retardation. She began suffering seizures and acting violently. Doctors ruled out many causes. A vaccine reaction "was the only thing that couldn't be ruled out," Williams said. "It couldn't be proven, but couldn't be ruled out either."

Today, Teri, 42, has an IQ of 27. She attends an adult day-care center and lives with her mother.

Fifteenyears ago, when Williams heard about the compensation fund, she applied. "They said you didn't even need an attorney, which didn't turn out to be true."

Williams hired Virginia lawyers who specialize in vaccine compensation cases. This spring, she got a settlement. She declined to make the amount public.

"We agreed to a settlement only because I'm 61. I'm not in good health," Williams said. "I knew that if it went to trial, I might prevail, but I didn't know if I'd live long enough to see it."

Vaccine safety issues

Parents question vaccine safety for a variety of reasons. But three issues get much of the attention:

Measles and autism: When the Jillanis began looking into vaccine safety for their children, one of the studies they found most interesting was by Dr. Andrew Wakefield. The British gastroenterologist studied 12 children who had developed behavior problems, including autism, shortly after receiving the measles, mumps, rubella (MMR) vaccine. Published in The Lancet in 1998, Wakefield's study suggested - but did not prove - a link between the vaccine and autism.

Duke University's Katz said Wakefield's research has been discredited. He said Wakefield claimed to have found measles vaccine in the digestive tracts of some children he studied. But said scientists in the United States and other countries examined the same material and concluded that Wakefield misidentified a normal intestinal protein, Katz said.

U.S. public health officials say there is no connection proven between MMR and autism. An Institute of Medicine report released last spring did not rule out the possibility that MMR could contribute to autism in rare instances, but it said it "can find no proven biological mechanisms that would explain such a relationship."

Fisher and other parents won't be satisfied until researchers specifically rule out a connection. "Why would one assume that vaccines are not implicated, rather than biting the bullet and finding out?" she said.

Mercury levels: Since the 1930s, vaccines have contained mercury in a preservative called thimerosal. In 1999, Congress mandated a review by the FDA, which found that mercury levels in some vaccines were more than twice what the Environmental Protection Agency deems safe for very young children.

Public health agencies phased out mercury-containing vaccines earlier this year, although some may still be in use. Just this month, another in a series of Institute of Medicine reports on vaccines concluded that children and pregnant women should avoid thimerosal. The report said there is an unproved but "biologically plausible" risk that the substance could cause neurological problems.

Some parents complain that health officials didn't work faster to remove the mercury-containing vaccines from the market, but Duke's Katz praised the agencies for taking action even though there was no evidence that vaccines were harming children.

Oral polio vaccine: In use since 1960, the so-called Sabin vaccine contains live, weakened virus that can spread from person to person, immunizing many who were not vaccinated themselves. But in some cases, the ingested virus mutates into a virulent form capable of causing disease.

Since 1979, the only U.S. cases of polio have been caused by the oral vaccine, according to the Consumer Reports analysis. But not until 1999 did public health officials begin the switch to the injectable, inactivated vaccine that does not cause polio. In that 20-year period, eight or nine cases of vaccine-related polio were reported each year, Consumer Reports said.

"I agree that they were slow to make the change," Katz said. When the country was reporting 50,000 cases of polio a year, "that was a risk-benefit we could accept. When we weren't having any more natural polio, that was a price we could no longer pay."

What the laws say

Children must be immunized to start kindergarten or go to day-care centers unless they have an exemption from the law. The Carolinas allow exemptions for medical or religious reasons.

The Jillanis, for example, have religious exemptions for both of their daughters, and Lisa Jillani advised parents at the PAVE meeting that a religious exemption is easier to get than one for medical reasons. "You can be an atheist and claim a religious exemption," she said.

Beth Rowe-West, head of immunizations for the N.C. Division of Public Health, said medical exemptions are given only when doctors confirm that the child has a condition listed by the CDC. Religious exemptions are not so strict, but they must be more than a philosophical opposition to vaccines. Only 16 states permit philosophical exemptions. All but two, Mississippi and West Virginia, allow religious exemptions.

In North Carolina, 293 medical exemptions and 342 religious exemptions were granted for the 2000-01 school year. Charlotte-Mecklenburg Schools reported 14 medical exemptions and 16 religious exemptions last year. Other school systems in the region each reported only a few.

South Carolina uses a broader definition of medical exemption, including not only those who object to vaccinations, but those who are not yet updated on immunizations. Religious exemptions are not monitored. South Carolina reported a larger number of exemptions - 14,122 medical and 1,141 religious - last year.

Criticism questioned

Most doctors believe the criticism of vaccines is overblown.

"Some of this stuff has gotten a lot of hype," said Dr. Amina Ahmed, a pediatric infectious disease specialist with Carolinas Medical Center in Charlotte.

"When we had the old pertussis vaccine, we saw a lot of side effects with that. It's given at 2, 4 and 6months of age. That's when most kids are diagnosed with some sort of developmental delay, it's in the first year of life. That's also when vaccines are given. Because they are temporally related, they have assumed there is a cause-and-effect relationship.

"I was born in an underdeveloped country," said Ahmed, of Pakistan. "Because of what I've seen, I would advocate strongly against not immunizing."

But parents such as Fisher don't believe it's fair to risk even one child in pursuit of mass vaccination. "We've got to chart a middle course," she said. "Clearly, some children are not able to handle the vaccines. What we need to do is to find out who those children are. It's time to stop denying and start studying."

HealthSCOUT content:© 2000 Rx Remedy, Inc. All rights reserved.
The Charlotte Observer content: © 2000. All rights reserved.

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