Toxic Tipping Point

[Guest guest]

http://www.motherjones.com/news/feature/2004/03/02_354.html

 

Toxic Tipping Point

Are the CDC, the FDA, and other health agencies covering up evidence

that a mercury preservative in children's vaccines caused a rise in

autism?

 

Andrea Rock

March/April 2004 Issue

 

In August of 2001, Rita Shreffler of Nixa, Missouri, sent her son's

baby tooth to a lab. A year earlier, nine-year-old Andy had been

diagnosed with Asperger's syndrome, a form of autism, and Shreffler

had just read a report in the journal Medical Hypotheses suggesting

that such neurological disorders might be the result of mercury

poisoning associated with an additive in children's vaccines.

 

Wayne Middleton, of Middleton Microbiological & Environmental Testing

Laboratory, was so astonished at Andy's results that he even used his

own children's baby teeth as controls. Andy's tooth registered a

mercury level of 3,040 parts per billion. By comparison, the

Environmental Protection Agency's limit for mercury in drinking water

is 2 ppb, and the limit for mercury content in waste going into a

landfill is 200 ppb.

 

" Wayne asked me how on earth Andy could have been exposed to so much

mercury, " recalls Shreffler. " When I explained that a vaccine

preservative called thimerosal had exposed babies to excessive levels

of mercury, he said that couldn't be true because he used to work for

a lab that made animal vaccines, and thimerosal had been discontinued

in vaccines for cattle back in the early 1990s. He was sure it

wouldn't be allowed in children's vaccines. "

 

He was wrong.

 

The Battle Lines

 

Did the use of a mercury preservative in vaccines directly contribute

to the autism epidemic plaguing the country? And did federal health

officials—fearful of liability facing their agencies and vaccine

manufacturers, and loss of compliance with the federal vaccine

program—put such concerns above the health of millions of infants? Are

the recent studies discounting a link between thimerosal-containing

vaccines (TCVs) and autism really rife with conflicts of interest and

data manipulation? Or are the parents, researchers, and members of

Congress who make such claims seeing conspiracies where none exist?

 

The stakes in this debate are high indeed. In 2002, an estimated 1 in

250 American children was diagnosed with autism, up from 1 in 500 in

2000, and 1 in 5,000 in the 1980s. If vaccine manufacturers and

government agencies are found liable for neurological damage to

millions of infants, TCV litigation could rival that of tobacco or

asbestos. Currently, some 3,500 families of autistic children are

slated to go before a special federal vaccine court—a step that

Congress has required before they engage in any civil litigation, but

one that will probably be just the first in a long legal battle.

 

The controversy began back in July 1999, when the American Academy of

Pediatrics and federal health officials unexpectedly announced that

thimerosal would be phased out of children's vaccines—a change, they

insisted, that was purely precautionary. " The current levels of

thimerosal will not hurt children, " said then-AAP president Joel J.

Alpert. " Reducing those levels will make safe vaccines even safer. "

 

Prior to the AAP announcement, there had been no public outcry against

TCVs. But there had been increasing concern about mercury in fish and

other food, so much so that Rep. Frank Pallone (D-N.J.) authored a

bill requiring the Food and Drug Administration to evaluate mercury

levels in all food and drug products—including vaccines. This

accounting unearthed a disturbing fact: Throughout the 1990s, as new

TCVs were added to the list of a child's required shots, federal

health officials had inadvertently nearly tripled the amount of

mercury—a potent neurotoxin—being injected into some babies during a

critical period for brain development. Astonishingly, as each new

vaccine was added to the schedule, no one bothered to total up how

many micrograms of mercury children would receive as a result. By

1999, a baby who received all recommended vaccines at her two-month

checkup could be injected with up to 62.5 micrograms of mercury—118

times the EPA's limit for daily exposure. (These guidelines are based

on methylmercury, while thimerosal contains ethylmercury; the

difference regarding human toxicity is thus far unclear.) During the

1990s, when some 40 million children were vaccinated, the number of

TCVs given to children nearly tripled, while autism rates inexplicably

increased tenfold.

 

Though the public didn't know it, this discovery alarmed health

officials. Consider a June 29, 1999, email sent by Peter Patriarca of

the FDA, which licenses vaccines, to Martin Meyers, head of the CDC

office that monitors vaccine safety and formulates immunization policy

in concert with the AAP. Facing pressure from AAP vaccine expert Neal

Halsey to assess and disclose the thimerosal problem, Patriarca said

he feared the FDA would 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. " Noting that calculating the cumulative

dose really involved nothing more complicated than ninth-grade math,

Patriarca posed the questions he feared would be asked: " What took the

FDA so long to do the calculations? Why didn't CDC and the advisory

bodies do these calculations when they rapidly expanded the childhood

immunization schedule? "

 

Transcripts of CDC meetings show that officials compounded this

remarkable lapse in oversight with concerted efforts to minimize both

the extent of the problem and any liability their agencies faced. " We

are in a bad position from the standpoint of defending any lawsuits, "

noted one CDC adviser, " and I am concerned. " Regulators chose not to

act aggressively to reduce infants' exposure to thimerosal, and as a

result TCVs mandated for infants remained on the U.S. market until

November 2002. (The CDC and FDA refused Mother Jones' requests for

interviews, as did vaccine makers, citing pending litigation.)

 

" You would think the CDC and FDA would be totally mobilized, " says

Rep. David Weldon (R-Fla.), " that they would be making rapid efforts

to get mercury out of all the vaccines, bringing in independent

scientists to study this, and really doing a very thorough

investigation. But their response has been totally inadequate. "

 

As a conservative and a physician, Weldon is an unlikely critic of

either the vaccine program or of pharmaceutical companies. But he sat

on the Committee on Government Reform, and when its then chairman,

Rep. Dan Burton (R-Ind.), was prompted by his grandson's autism

diagnosis to investigate the risks posed by mercury in vaccines,

Weldon found himself listening to three years of testimony on the

subject. Now, like many parents of autistic children and a growing

number of scientists, he believes that exposure to thimerosal among

infants born with a heightened sensitivity to mercury or an inability

to excrete it could have contributed to the autism epidemic.

 

Dr. Weldon is also troubled by what he described in a November 2003

letter to CDC director Julie Gerberding as a " disturbing pattern " of

collusion among vaccine-program officials, the pharmaceutical

industry, and others with a vested interest in minimizing liability.

Weldon specifically addressed a just-published and much-publicized

Pediatrics article that analyzed CDC vaccine data and claimed there

was no consistent link between TCVs and autism. Weldon's review of the

study revealed the " appearance of selective use of data to make the

associations…disappear. " He also noted that Pediatrics failed to

mention that the study's author now works for a vaccine maker facing

liability and instead identified him as still being a CDC employee,

which " undermines this study further. "

 

Weldon also asked that the CDC provide all its vaccine data to

independent researchers, which thus far it has been unwilling to do.

" If it is eventually determined that an entire generation of kids was

essentially poisoned, a class-action suit against the federal

government could be on the order of hundreds of billions of dollars,

and so there's very good reason for them to try to cover this up, "

says Weldon. " And then when they appear as though they are covering it

up, it makes you suspicious that it's all true. "

 

Between the Cracks

 

ANYONE WHO RECALLS the stinging sensation of having a skinned knee

painted with a reddish-orange antiseptic called Merthiolate has an

intimate acquaintance with thimerosal, simply another name for the

bacteria-killing compound developed by Eli Lilly in 1929. Early

internal safety data on injections containing thimerosal were not

encouraging. In 1935, for example, a researcher reported to Lilly that

adverse reactions indicated that thimerosal was " unsatisfactory as a

preservative for serum intended for use on dogs. "

 

Yet that same year, thimerosal began to be added to childhood

vaccines. Mostly it was used in large, multidose vials in which

contamination can arise from repeated needle re-entry. Individually

bottled vaccines don't require preservatives but are more expensive,

and a mercury-free preservative has been used by one pediatric vaccine

maker since 1997; but in 1999 most infant vaccines used in the United

States contained thimero-sal (as, indeed, some flu and booster

shots—and most infant vaccines used in the developing world—still do).

 

Back in 1935, the FDA didn't yet regulate drugs and vaccines. But even

once it did, remarkably, thimerosal was never required to undergo

clinical testing. When FDA officials asked Lilly for safety data in

1973, shortly before reviewing thimerosal's use in over-the-counter

products, Lilly's director of regulatory affairs responded, " t

would be difficult to get recognized researchers to conduct new

studies for safety or efficacy. They believe that over 40 years of

wide usage has proven efficacy and safety beyond that which could be

done in special studies. " Nine years later, FDA officials recommended

pulling over-the-counter products containing thimero-sal from the

market, though 16 years passed before they were. And, still, its use

in vaccines went unexamined. Thimerosal also continued to bypass

toxicity testing, even after federal regulations for reviewing

vaccines required it. " The absence of appropriate preclinical testing

of thimerosal is a staggering oversight, " FDA drug reviewer Dr. Eric

Colman wrote in 2002, after his son was diagnosed with an autistic

spectrum disorder.

The Tipping Point?

WHEN AUTISM WAS FIRST RECOGNIZED as a neurological disorder in 1954,

the symptoms described were essentially the same as those currently

used for diagnosis of classic autism: severely limited speech,

impaired social interaction, and repetitive behaviors such as arm

flapping. Today, the broader autistic spectrum includes less severe

forms in which some children may speak but have unusual behaviors and

learning disabilities, or have high IQs but difficulty with social

interaction, a common characteristic of Asperger's syndrome.

Psychologist Bruno Bettelheim once convinced doctors that autism was

attributable to the bad parenting of " refrigerator moms. " After that

theory was scrapped, autism was assumed to be an unavoidable genetic

fate. But the exponential rate increases have led more and more

scientists to suspect that autism might result from an interplay

between genetic vulnerability and nongenetic causes, says Harvard

pediatric neuroscientist Dr. Martha Herbert. " This new line of

investigation calls for a knowledge of toxicology, genetic

individuality, and biochemistry much more detailed than most current

autism researchers possess. "

Those who believe in the thimerosal/autism theory suggest that the

precise form the disease takes simply reflects the degree of mercury

exposure. Vaccines are just one pathway for mercury to reach and

accumulate in the fetal or infant brain, but a high exposure at a key

time might—especially for children genetically ill- disposed to flush

the toxin—be the tipping point. For infants born to women with high

mercury consumption, AAP vaccine-policy expert Neal Halsey commented

back in 1999, " no one knows what dose of mercury, if any, from

vaccines is safe.… We can say there is no evidence of harm, but the

truth is no one has looked. "

After the AAP announcement, a group of parents founded Sensible Action

for Ending Mercury-Induced Neurological Disorders, or Safe Minds. Many

members of Safe Minds (and other groups) are doctors, nurses, and

researchers who stress that they are " anti-mercury, not anti-vaccine, "

says board member Mark Blaxill. " Virtually every step forward of any

consequence with respect to the scientific agenda has come from

parents. This is a new phenomenon: direct scientific activism by

parents using their own professional skills to aggressively take on

anyone who makes arguments based on sloppy science to try to make this

problem go away. "

In 2001, two Safe Minds board members, Lyn Redwood, a nurse, and

Sallie Bernard, a market researcher, published a study in the journal

Medical Hypotheses that detailed overlaps between symptoms of autism

and those of mercury toxicity. They noted, for example, that a brand

of teething powder containing mercury was popular until the 1950s,

when a doctor finally connected it to Pink's disease, which had

symptoms similar to autism. Once the teething powder was removed from

the market, Pink's disease disappeared.

Blaxill himself published a paper in the April 2003 Journal of Autism

and Developmental Disorders that outlined errors made in a study by

public-health experts who argued that the rise in autism rates could

be partly accounted for by diagnostic substitution, i.e., children

previously categorized as mentally retarded now diagnosed as autistic.

Blaxill's analysis prompted the study's authors to concede that his

criticisms were valid. A partner in a leading business-strategy firm,

Blaxill says that he " learned to be skeptical of 'experts' " in his

business. " I'm not intimidated by numbers or science, " he says. " I

know how people can lie with numbers, and if there's one thing I'm

good at doing, it's taking those numbers apart to find the truth. The

CDC has been lying with numbers regularly. "

Blaxill also contributed to a study led by Louisiana physician Amy

Holmes, who is the mother of an autistic child, which analyzed mercury

levels in samples collected from baby hair. 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.

Because mercury crosses the placental barrier, the study also examined

maternal exposure to mercury via food, dental fillings, and the

thimerosal-containing Rho D immunoglobulin injections typically given

to Rh-negative women—16 percent of the population—during pregnancy.

Prior to the mid-1980s, an Rh-negative woman was given this injection

only after delivery to prevent complications that can occur if the

baby is Rh-positive. But Rh-negative women now receive Rho D

injections at 28 or 34 weeks, and any time there is a chance of a

mother's blood mixing with the baby's—after undergoing amniocentesis,

for instance. The study found that nearly half of the autistic

children's mothers had received Rho D injections, compared with only 9

percent in the control group. In addition, 37 percent of mothers in

the autistic group also had 10 or more fillings containing mercury,

compared with only 18 percent in the control group. The authors

suggest that the near absence of mercury in hair samples of autistic

infants despite higher exposure indicates that TCVs could be the last

straw for children whose ability to excrete mercury is impaired or who

are near a dangerous threshold due to maternal exposure.

But it's not just parents who are conducting important research about

thimerosal. Boyd Haley, a University of Kentucky biochemist who

researches heavy-metal neurotoxicology, explains that APO-E—a protein

crucial in carrying mercury out of the body—comes in three varieties,

ranging from one that can carry out two atoms of mercury for every

molecule of APO-E, to the least protective version, APO-E4, which

doesn't carry out any. Both autistics and Alzheimer's patients tend to

have APO-E4. " There is clearly a subpopulation of people who can't

excrete even low levels of mercury effectively, " says Haley. He also

found evidence that may explain why for every autistic girl, there are

four autistic boys. When he added estrogen to a petri dish of

thimerosal and brain cells, the hormone reduced the rate of brain

cells killed by thimerosal, whereas adding testosterone dramatically

increased the death rate. Based on his results, Haley says no level of

mercury can be considered a " safe dose " for infants.

Haley—whose thimerosal research was tangential to what he's best known

for, developing successful diagnostic tests for Alzheimer's—says that

once he published the risks of mercury in vaccines and dental

fillings, he found himself turned down for NIH grants, after being

consistently funded for decades. " People told me I would have funding

problems if I worked on mercury, and they were right, " Haley says.

Richard Deth, a Northeastern University pharmacologist, has found that

even low levels of thimerosal affect a critical neural pathway

regulating brain-cell growth. When Deth submitted his study to

Proceedings of the National Academy of Sciences, he said he was

rejected on the grounds that it hadn't met standards for " exceptional

importance and novelty. " Deth was dumbfounded: " I keep hearing from

public-health officials that there is no scientific basis to support a

connection between thimerosal exposure and autism. Yet here I am

bringing it to you and it's not considered important? "

" We are treated all too often, " says a researcher who insists that

anonymity equals continued funding, " to patronizing remarks by

researchers about 'hysterical parents' who 'can't accept their child's

genetic fate'; highly publicized but methodologically weak and

conflict-of-interest-ridden studies that claim to definitely refute

any role for various vaccines in the increased rates of autism but

raise no alarms about the increased rates themselves; and a press

blackout on subsequent critiques and refutations. "

Rep. Weldon has heard similar complaints from other researchers and is

examining whether the NIH peer-review system has become as politicized

as they contend. " I've heard that if you start wading into this, " he

says, " you can ruin your career. "

Protect the Herd

Why would there be a backlash against researchers who investigate the

interplay between TCVs and autism? Aside from liability issues and

conflicts of interest (more on that later), the medical establishment

is deeply protective of the national vaccine program, and " herd

immunity " —ensuring that the highest number of people are vaccinated—is

key to preventing diseases such as polio and rubella, which the

program has been so successful in stamping out. And the

anti-thimerosal lobby tends to get lumped in with the anti-vaccine

movement, which threatens the herd.

In March 2003, a Pediatrics paper by Dr. Karin B. Nelson, a

neurological researcher at NIH, and Dr. Margaret Bauman, a Harvard

neuropathologist, challenged the thimero-sal/autism link first

publicized by Safe Minds' Bernard and Redwood. They pointed out that

there is no clear evidence that the ethylmercury in thimerosal has the

same ability as the methylmercury found in fish to cross from the

blood to the brain. (NIH researchers now studying thimerosal say it

does but is flushed from the body much quicker and thus might not be

as cumulatively toxic.) The Pediatrics paper also questioned whether

autism increases are indeed real: " There has clearly been a broadening

of the criteria for autism, better case-finding, increased awareness

by clinicians and by families, and an increase in referrals…. Whether

the sum of these is sufficient to account for the more frequent

diagnosis of autism is a matter of contention and is properly settled

by careful research. "

But careful epidemiological research is being done by the state of

California, where classic autism diagnoses nearly doubled between 1998

and 2002, and are 6.3 times higher than in 1987. The state

commissioned a study to see if the increases could be explained by

factors suggested in Pediatrics. Investigators, led by University of

California-Davis epidemiologist Dr. Robert S. Byrd, verified all

diagnoses and ruled out all alternative explanations except for better

case finding and increased public awareness, which they didn't study.

" That could be a contributing factor, " says Byrd, " but for

hyperawareness to explain the increases we've seen, we would have had

to be missing 2 out of 3 cases of autism, so I don't think that's a

plausible explanation....The increase we are seeing is real and

unexplained. "

An Interpretive Dance

As the court dates draw closer, a flurry of studies both to disprove

and support the thimerosal/autism link has been released. Typically

they have been criticized by one side or the other as conducted by

researchers with a bias or conflict of interest. And some rely on

small sample sizes that can be easily dismissed. Which is why the

latest flash point is over what could be a comprehensive source of

data. Several HMOs are paid by the federal government to provide

children's immunization and medical records for the CDC's Vaccine

Safety Datalink, a database used to track pos-sible adverse side

effects of vaccines. After the discovery that mercury levels had

exceeded EPA guidelines, the CDC's Thomas Verstraeten reviewed medical

records of 110,000 children. A confidential February 29, 2000, version

of his report obtained through the Freedom of Information Act showed

that the " relative risk " for autism in infants receiving 62.5

micrograms or more of mercury by the age of three months (as had most

children abiding by the vaccine schedule) was 2.48 times higher than

in infants who did not. In courts of law, a relative risk of 2.0 or

higher has been considered sufficient proof that a given exposure

causes disease. The figure was especially significant given that

autism is typically not diagnosed until after age three, and 40

percent of the children in the study were younger.

Yet these findings were never published or even disclosed to CDC

advisory-committee members. Prior to a meeting of the committee in

June 2000 to discuss the report, CDC officials apparently added to the

study's database children born with congenital disorders (who had

previously been excluded) and two groups of babies not yet one year

old. Such statistical adjustment reduced the relative risk for autism

to 1.69, comfortably below the legal threshold for causation. The

lower number was provided to the CDC's advisory-committee members.

Nevertheless, as a transcript of that meeting reveals, even the

adjusted results—which still showed statistically significant

relationships between thimerosal exposure and subsequent diagnoses of

attention deficit disorder, language and speech delays, and a host of

other neurodevelopmental problems—startled committee members.

When one member asked Verstraeten why risks of neurodevelopmental

problems were higher in children with greater exposure to thimerosal,

he replied, " Personally, I have three hypotheses: My first hypothesis

is it is parental bias: The children that are more likely to be

vaccinated are more likely to be picked up and diagnosed. Second

hypothesis: I don't know—there is a bias that I have not recognized,

and nobody has yet told me about it. Third hypothesis: It's true—it's

thimerosal. "

Asked by another member whether that third hypothesis was clearly

biologically plausible, Verstraeten responded, " When I saw this, and I

went back through the literature, I was actually stunned by what I

saw, because I thought it was plausible. "

Bill Weil, a pediatrician representing the AAP's environmental-health

committee, noted, " There are just a host of neurodevelopmental data

that would suggest that we've got a serious problem.… The number of

kids getting help in special education is growing nationally and state

by state at a rate we have not seen before. "

" Forgive this personal comment, " added Dr. Richard Johnston, a

Colorado immunologist, " but I got called out for an emergency call and

my daughter-in-law delivered a son by C-section. Our first male in the

next generation, and I do not want that grandson to get a

thimerosal-containing vaccine until we know better what is going on. "

Verstraeten's results also worried committee member Robert Brent, a

developmental biologist and pediatrician from Thomas Jefferson

University. " The medical/legal find- ings in this study, causal or

not, are horrendous, and therefore, it is important that the suggested

epidemiological, pharmacokinetic, and animal studies be performed, "

Brent said. " If an allegation was made that a child's neurobehavioral

findings were caused by thimerosal-containing vaccines, you could

readily find a junk scientist who would support the claim with 'a

reasonable degree of certainty.' But you will not find a scientist

with any integrity who would say the reverse with the data that is

available…. So we are in a bad position from the standpoint of

defending any lawsuits if they were initiated, and I am concerned. "

Perhaps because of such concerns, the committee decided to go along

with the CDC's view that it should refrain from stating a preference

for thimerosal-free vaccines. The fear was that such a statement would

discourage physicians and clinics from using existing inventories, and

immunization rates might fall if thimerosal-free versions weren't

available everywhere. But the financial impact to manufacturers was

mentioned three times by the CDC's Roger Bernier. " It could entail

financial losses of inventory if current vaccine inventory is wasted, "

he said. " It could harm one or more manufacturers and may then

decrease the number of suppliers. "

Transcripts also reveal that some members of the committee went on to

discuss various ways to " push " and " pull " the data further. Weldon and

other critics allege that's just what happened. When the final version

of the study was published in the November 2003 Pediatrics,

Verstraeten—who'd since left the CDC to work for vaccine maker

GlaxoSmithKline—claimed he had found " no consistent significant

associations between TCVs and neurodevelopmental outcomes. "

Writing to the CDC director, Rep. Weldon says that given the

appearance of data ma-nipulation and conflict of interest, the CDC

should open up its entire vaccine database to independent scientists.

He notes that geneticist Dr. Mark Geier paid the CDC for data sets,

only to be given many with no usable data—treatment Weldon

characterizes as " abysmal and embarrassing. " Overall, he later wrote,

" I have lost confidence in the ability of the CDC officials to give an

honest evaluation of the matters at hand. "

Thanks to Weldon's intervention, Geier has now been able to use the

CDC database to compare autism rates among more than 85,000 children

who received a TCV for diphtheria/tetanus/acellular pertussis (DTaP)

with rates among nearly 70,000 children who got the thimerosal-free

version. In the TCV group, the risk of autism was 27 times higher.

Geier's analysis is before two journals. Meanwhile, Dr. Walter

Spitzer, a highly respected epidemiologist, has reviewed it and says,

" This is important and needs to get out immediately. I see no major

flaws. It is sound epidemiologically. "

" Denying the existence of the tragic, massive autism epidemic will

neither cure the problem nor restore confidence in our much-needed

vaccine program, " says Geier. " Rather, we must admit our past mistakes

openly and honestly and then work to improve current and future

vaccines. The first step is the removal of thimerosal from all

vaccines, which we predict will result in the end of the autism epidemic. "

Full-Court Press

And that's the true test of the thimerosal theory: Will rates of

autism and related disorders decline in the years ahead? In May 2003

the AAP stated, " All routinely recommended infant vaccines currently

sold in the U.S. are free of thimerosal as a preservative and have

been for more than two years. " Yet because the FDA maintained it did

not have the scientific evidence to justify a recall of thimerosal,

vials distributed prior to the introduction of thimerosal-free

versions were allowed to remain on the market until they became

outdated. That means that regularly mandated TCVS were still available

until November 2002. And injections of Rho D containing 10.5

micrograms of mercury per dose were on the shelves until April 2003,

even though Rho D was produced in single-dose vials that don't require

a preservative. " Because the FDA chose not to recall

thimerosal-containing vaccines in 1999, " the House Committee on

Government Reform April 2003 report concludes, " in addition to all of

those already injured, 8,000 children a day continued to be placed at

risk for overdose for at least an additional two years. "

This timetable is crucial to the coming legal battle. If federal

health officials had ordered the removal of thimerosal by a specific

date, there would be a clear line in the sand to definitively indicate

whether exposure promoted neurological damage. As it is, the beginning

of a trend may be detectable in 2004, but due to the typical age of

diagnosis, a full assessment won't be possible until late 2008 or

early 2009.

Meanwhile, though, the federal vaccine injury court is seeking to

determine whether sufficient evidence exists that thimerosal caused

harm to the children in the 3,500 cases before it. The court was

created in 1988 to prevent drug companies from abandoning

manufacturing vaccines due to rising liability costs. Before suing

manufacturers, families must file claims through the federal Vaccine

Injury Compensation Program, which awards damages from a fund financed

by a fee tacked on to each vaccine's price. A team of special masters

hears claims; the federal government is represented by the Justice

Department. Regardless of the outcome, families can then move to civil

court. In November 2002, the Justice Department asked the vaccine

court to seal all documents in the autism cases; only days earlier,

congressional Republicans had sneaked a provision into the homeland

security bill that would shield Eli Lilly and other pharmaceutical

companies from civil suits over thimerosal. Both moves were thwarted

by public outcry from parents' groups. Still, because government

agencies and industry have been recalcitrant about handing over

documents, the discovery process has stalled and families are starting

to be allowed to move to civil court.

If the thimerosal theory starts to gain traction in court, the cost to

the $8 billion-a-year industry could be gigantic. Approximately 40

million American children were immunized in the 1990s. If current

rates hold true, roughly 160,000 will be diagnosed with classic

autism, another 270,000 with autistic spectrum disorders, and as many

as 2 million with pervasive developmental disorders.

But whether or not thimerosal is found to be instrumental in the

problems facing any of these children, the systemic flaws that allowed

mercury levels in vaccines to exceed federal guidelines must be fixed.

In a move observers consider highly significant, former AAP official

Neal Halsey also wrote a letter to Pediatrics criticizing

Verstraeten's study. In it, he suggests that an independent scientific

body should review the data and take charge of evaluating vaccine

safety. Having the CDC recommending vaccines and assessing their

safety, Halsey has said, " is a problem. "

And while the immunization program is laudable, zeal for full

compliance sometimes backfires. In an email sent to AAP officials back

in 1999, Ruth Etzel of the Department of Agriculture made that point

eloquently: " As you know, the Public Health Service informed us

yesterday that they were planning to conduct business as usual and

would probably indicate no preference for either product. While the

Public Health Service may think that their 'product' is immunizations,

I think their 'product' is their recommendations. If the public loses

faith in the PHS recommendations, then the immunization battle will

falter. To keep faith, we must be open and honest now and move forward

quickly to replace these products. "

The jury is still out as to whether thimero-sal injections caused the

autism epidemic or whether the concern over ethylmercury will expose

methylmercury or another compound to be the true culprit. But what is

certain—as evidenced by a 10-year interagency push to study all

possible causes of autism announced last November—is that researchers

and policymakers are no longer dismissive of environmental factors.

" 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. "

Soon, however, jurors will be joining the ranks of those who've been

forced to give the matter some very serious thought.

Andrea Rock received the National Magazine Award for journalism in the

public interest for her article documenting the failure of both the

blood-bank industry and public-health officials to cope with the

spread of HIV via blood transfusions and products. Her new book, The

Mind at Night, explores recent scientific research about how and why

we dream and what that reveals about the brain in waking consciousness.

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This article has been made possible by the Foundation for National

Progress, the Investigative Fund of Mother Jones, and gifts from

generous readers like you.

© 2004 The Foundation for National Progress

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