SIDS

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Saturday, September 5, 1998

Federal claims court seems to connect vaccine, SIDS

JOHN HANCHETTE and SUNNY KAPLAN

Gannett News Service

WASHINGTON -- For almost a decade, a federal claims court has been

drawing a significant association between mysterious child deaths and

a controversial vaccine in cases previously attributed by medical

examiners, hospitals and doctors to SIDS, or Sudden Infant Death

Syndrome.

The computer records from the National Vaccine Injury Compensation

Program, obtained by Gannett News Service using the Freedom of

Information Act as part of a four-month study of federal immunization

policy, reveal:

-- Of 253 infant death cases awarded more than $61 million by the

U.S. Court of Federal Claims in the 1990s under the compensation

program, 224, or 86 percent, were attributed to vaccination with DTP,

the diphtheria, tetanus and pertussis (whooping cough) shot. In

these cases, mortality was originally attributed to SIDS in 90, or 40

percent, of them.

-- Of 771 total claims filed by parents from 1990 through

mid-1998, 660, or 86 percent, contained assertions that DTP was the

cause of death. And 43 percent were classified by medical

authorities at time of death as SIDS cases.

A second federal database tends to draw a similar connection.

This one, for the 1990s from the Food and Drug Administration,

contains 460 reports of children who died within three days of

receiving shots containing DTP.

Of those 460 reports, 266 -- or 58 percent -- listed SIDS as a

" reaction. "

That database is called VAERS, for Vaccine Adverse Event Reporting

System. It was ordered by Congress to track dangerous reactions to

the shots all babies must receive as admission to our society. In

typical federalese, the FDA refers to death as an " adverse event "

or a " reaction. "

By law, reports of reactions to DTP and other vaccines are

supposed to be made religiously by doctors, pharmaceutical companies

and public health clinics. But former FDA commissioner A.

Kessler has estimated the reports " represent only a fraction of the

serious adverse events " -- perhaps as few as 10 percent. Dr. Marcel

Salive, chief of the FDA's epidemiology staff, says, " Any number you

get, take with a grain of salt. "

SIDS is defined under federal public health policy as the sudden

death of an infant or toddler that is unexpected, and in which an

autopsy fails to demonstrate an adequate cause. For parents, it is a

frequent source of fear and in cases of death, guilt.

Critics of vaccines, parental advocacy groups and some scientists

have labored for decades to make a connection between SIDS and the

DTP shot. One reason is markedly suspicious timing.

The three primary doses of DTP are usually given at 2,4 and 6

months of age. About 85 percent of SIDS cases occur during the first

six months of life, with the peak incidence at age 2-4 months. The

prestigious Institute of Medicine says only a small percent of SIDS

cases occur after 6 months of age.

The Centers for Disease Control monitoring system, between 1978

and 1990, picked up 350 cases of SIDS that occurred within four weeks

of DTP vaccination.

A mid-1980s study by University of Nevada-Reno neurologist Dr.

C. Torch decried by federal scientists found that in 103 SIDS

deaths in 12 different countries, more than two-thirds followed DTP

shots -- 26 percent within three days, 37 percent within a week and

70 percent within three weeks. He also found SIDS frequencies peaked

at 2 and 4 months, the same ages of the first two recommended

vaccinations of infants.

A 1992 paper published in the American Journal of Epidemiology

suggested SIDS deaths in the three-day period following DTP shots

occurred at a rate eight times greater than others in the study.

The GNS review of VAERS, the FDA's database on reported " adverse

events, " reveals that between 1979 and 1984, one unnamed military

family suffered three SIDS deaths, one son and two daughters, while

stationed in three separate states: Ohio, Texas and Nevada. All

three deaths followed the first DTP vaccination.

Many Americans remain unaware of SIDS, and it was practically

unheard of prior to the 1960s. But it has been a huge problem for

parents and public health officials in recent decades. About 61,900

baby deaths were classified as SIDS between 1983 and 1994 by the CDC.

SIDS deaths were increasing to between 6,000 and 7,000 a year

until 1992, when the American Academy of Pediatrics began educating

parents that placing infants in the prone, or face down, position in

the crib -- as about 70 percent of parents were doing -- was a

definite risk factor. SIDS deaths dropped dramatically to about

3,500 a year, where they remain. The academy estimates only 29

percent of infants now go to sleep on their stomachs.

Nevertheless, plenty of vaccine critics say the SIDS problem is

not entirely solved.

" By definition, SIDS is something that you don't know the cause

for, " says Dr. Mark Geier, a land geneticist and pediatric

specialist who testifies in many vaccine compensation hearings. " But

if you have a DTP shot and within 24 hours the baby dies, and you

have other proven DTP-related symptoms, then it was probably DTP. "

Geier thinks " the majority of SIDS deaths are not

vaccine-related, but there is no way of knowing for sure -- some are

related to the whole-cell DTP. "

Scientists say the culprit in DTP that causes reactions is the

pertussis portion of the inoculation, mainly because it is made from

the killed whole cells of the bacteria that causes whooping cough.

Curtis Webb, a Twin Falls, Idaho, lawyer who has represented

almost 200 families before the federal compensation program, thinks

doctors and medical examiners are prone to gloss over the official

cause of death when mortality occurs in close proximity to the DTP

vaccination:

" Sudden death within a few days of DTP is often characterized by

doctors as SIDS, " Webb said. " They think if a kid has a DTP

reaction, they should call it SIDS. I think DTP does cause some true

SIDS cases. I think, in some not trivial percentage, SIDS cases had

something to do with a DTP shot. "

Dr. J. , the former FDA research virologist who

first labeled the notorious swine flu vaccine dangerous in 1976, said

that " in some cases, there is a connection between DPT shots and

SIDS. " But he predicted public health officials " will say the

children would have been hurt anyway -- they ondition that also

occurs in children who have never been vaccinated, so these dead

children could have (died) in the absence of vaccines. "

They already have.

The Institute of Medicine, a non-government group associated with

the National Academy of Sciences, studied SIDS and the suspected

association with pertussis vaccines in 1991 and 1994 at the behest of

Congress.

Despite seven sophisticated epidemiological studies that show

large percentages of SIDS deaths closely following DTP shots, the

institute found they offered " limited insight into the possibility

of a causal connection between this immunization and the occurrence

of SIDS. "

More controlled epidemiological studies, including child

populations with SIDS deaths not immediately following the shots,

showed no biological evidence of a link, the institute said. " The

evidence favors rejection of a causal relation between DTP and Sudden

Infant Death Syndrome, " it said.

The CDC's National Immunization Program and the American Academy

of Pediatrics also have looked at the possible connection.

" Good scientific data shows that there is no correlation -- some

studies even show a decreased risk, " said Dr. Walter Orenstein,

director of the CDC program. " It can be one in a billion, but when

we review the scientific literature, the evidence tilts against a

relationship. "

Both the parent-group National SIDS Alliance in Baltimore and the

Department of Health and Human Services downplay any SIDS-DTP

connection. They point to the Institute of Medicine conclusions and

to a 1994 study by the National Institute of Child Health and

Development, which found only two of 145 SIDS infants had received a

DTP immunization within 24 hours of death.

The Institute of Medicine conclusions attribute the SIDS deaths

closely following DTP shots to sheer coincidence: " a temporal

relation between these events " that would have showed up anyway

because the kids have to get their shots during the period when all

these children are dying anyway.

As a recent Public Health Service pamphlet put it: " In other

words, the SIDS deaths would have occurred even if no vaccinations

had been given. "

Barbara Loe Fisher, president and co-founder of the parent

advocacy group National Vaccine Information Center of Vienna, Va., is

one of many critics of federal immunization policy who think these

" no causal relation " studies have turned logic completely on its

head.

" Most government health authorities and members of the medical

establishment hotly deny them, but there have been indications that a

number of deaths attributed to SIDS are misclassified, when they are

really caused by the pertussis vaccine, " Fisher said.

Fisher estimates more than 900 a year were misclassified back when

SIDS deaths approached 7,000 annually.

For the families of the children whose deaths were attributed to

SIDS, but whose deaths were suspected of being tied to a DTP shot,

the government's review of studies and the reassurances offered in

its pamphlets offer little solace. The case of Hislop is

typical.

The son of and Hislop of Longmont, Colo., died

at 4 months of age, a day after he received his second dose of DTP in

October 1992. Mother was suspicious even before the

inoculations when the pediatrician handed her a pamphlet that said

" there is no evidence that the DTP shot causes SIDS deaths. " She

looked at that sheet and wondered, " Why are they addressing this if

it is not an issue? "

At the daycare center the next day, after much screaming and a

temperature of 102, turned blue and died. The mother recalled,

" I said to the doctor: it is the shots. She said, 'There is no

evidence, it is SIDS.' You have a healthy child Thursday, and then

he is dead on Friday. "

The Hislops filed a claim with the federal vaccine compensation

program.

" What we really needed was someone to say, 'Yes, this is what

happened. SIDS is bull ... Something killed my son, and I want you

to tell me what it was. "

On Feb. 8, 1996, the federal claims court did. Special master

F. , one of several appointed by the court to hear such

vaccine cases, awarded the Hislops $250,000 after finding their

medical expert's testimony that the DTP triggered death-causing

encephalopathy, or acquired brain damage, " thoroughly persuasive. "

" It makes me sick to my stomach to hear that babies are still

getting the whole-cell DTP, " Hislop told GNS. " I hold the

government mostly responsible for this because they allow the

pharmaceutical companies to play God. "

Leland and Ruegsegger of Thornton, Colo., had twin sons --

and -- on Oct. 14, 1985. The twins had their

four-months DTP shot on a Friday. By Sunday, was fussy and

crying. By Monday, he was lethargic and slept all day. By Tuesday,

he was dead.

" Everyone at the hospital said it was a SIDS death, "

recalled. " They wanted in the hospital because of past cases

of twins dying of SIDS within 24 hours.

" I thought in my heart that the vaccine is what he died from, not

the SIDS. You really want to know why your baby died. "

The Ruegseggers didn't read of a possible DTP connection until

four years later. They filed a claim in 1990 with the federal

compensation program. Three years later, they got a hearing. The

Justice Department lawyer defending against the claim, the mother

recalled, " made it into a trial, not a hearing -- she was trying to

accuse me of being a bad parent. "

In June 1994, the claims court special master verified the DTP

connection, awarding the Ruegseggers $250,000.

" I felt relieved that someone else believed me, " the mother

said. " Now, I can honestly say with conviction that he died from a

DTP shot, but there is still a lot of emptiness that he is not

here. "

While scientists, doctors and lawyers admit that SIDS by

definition is an admission no one knows what killed the child,

Justice Department lawyers defending the federal death claims have

used SIDS as an alternative cause of death so often in arguments that

the special masters frequently chastise them for it.

When Justice attorneys tried it in the 1990 case of Wynnie Lee of

Honolulu, Hawaii, the daughter of and Wayson Lee, who died a

few days after her six-months DTP shot, special master

slapped them down.

" A diagnosis of SIDS amounts to the absence of any identifiable

cause of death and is not in itself an alternative explanation of

death, " she wrote. The federal defense argument " that Wynnie died

of SIDS, " she continued, is " an argument which seemingly requires

more than a little sleight of hand. "

Many medical experts agree with her.

Dr. Enid Gilbert-s, a Tampa pediatric pathologist who

teaches at the University of South Florida and is an international

expert on SIDS, said, " I object to the term -- it's just a cop-out

when people can't find anything else. It does nothing but create

confusion. It's not a syndrome. They're inventing this. "

Gilbert-s thinks post-mortem medical exams need to be less

sloppy: " In most cases, the incidents are very low where you cannot

find a cause. "

The rush to rule puzzling child deaths as SIDS -- whether through

sloth, ignorance or ineptitude -- has caused some widely covered

horror stories. In upstate New York, Waneta Hoyt was widely pitied

for losing five children to SIDS over three decades. A Syracuse

physician published an accepted paper in a prestigious medical

journal blaming breathing problems. In 1995, Hoyt was convicted of

killing all five. Earlier this month in Philadelphia, Noe was

charged with smothering eight of her 10 children. Not one had

reached a second birthday. She and her husband had taken out

insurance polices on six of the victims. All eight had been

classified SIDS deaths.

Meanwhile, federal health officials insist that SIDS and DTP have

no connection. They tend to believe in the coincidental occurrence

of symptoms. That's true for those connected with the federal

program aimed at compensating those in vaccine-related deaths.

" The majority of the cases compensated are not vaccine-related

under current scientific information, " insisted Dr. Geoffrey ,

the federal compensation program's chief medical officer. " Every

time we compensate a SIDS case, I cringe. "

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Karin Schumacher

Vaccine Information & Awareness (VIA)

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