Kennedy's article on vaccines

[Guest guest]

_http://www.salon.com/news/feature/2005/06/16/thimerosal/index.html_

(http://www.salon.com/news/feature/2005/06/16/thimerosal/index.html)

 

 

 

 

Deadly immunity

When a study revealed that mercury in childhood vaccines may have caused

autism in thousands of kids, the government rushed to conceal the data -- and

to

prevent parents from suing drug companies for their role in the epidemic.

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By Robert F. Kennedy Jr.

(http://www.salon.com/news/feature/2005/06/16/thimerosal/email.html) June

16, 2005 | In June 2000, a group of top government scientists and health

officials gathered for a meeting at the isolated Simpsonwood conference center

in

Norcross, Ga. Convened by the Centers for Disease Control and Prevention,

the meeting was held at this Methodist retreat center, nestled in wooded

farmland next to the Chattahoochee River, to ensure complete secrecy. The

agency

had issued no public announcement of the session -- only private invitations to

52 attendees. There were high-level officials from the CDC and the Food and

Drug Administration, the top vaccine specialist from the World Health

Organization in Geneva, and representatives of every major vaccine

manufacturer,

including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the

scientific data under discussion, CDC officials repeatedly reminded the

participants,

was strictly " embargoed. " There would be no making photocopies of documents,

no taking papers with them when they left.

The federal officials and industry representatives had assembled to discuss a

disturbing new study that raised alarming questions about the safety of a

host of common childhood vaccines administered to infants and young children.

According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the

agency's massive database containing the medical records of 100,000 children,

a mercury-based preservative in the vaccines -- thimerosal -- appeared to be

responsible for a dramatic increase in autism and a host of other

neurological disorders among children. " I was actually stunned by what I saw, "

Verstraeten told those assembled at Simpsonwood, citing the staggering number

of

earlier studies that indicate a link between thimerosal and speech delays,

attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC

and

the FDA had recommended that three additional vaccines laced with the

preservative be given to extremely young infants -- in one case, within hours of

birth -- the estimated number of cases of autism had increased fifteenfold, from

one in every 2,500 children to one in 166 children.

Even for scientists and doctors accustomed to confronting issues of life and

death, the findings were frightening. " You can play with this all you want, "

Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the

group. The results " are statistically significant. " Dr. Richard Johnston, an

immunologist and pediatrician from the University of Colorado whose grandson

had been born early on the morning of the meeting's first day, was even more

alarmed. " My gut feeling? " he said. " Forgive this personal comment -- I do

not want my grandson to get a thimerosal-containing vaccine until we know

better what is going on. "

But instead of taking immediate steps to alert the public and rid the vaccine

supply of thimerosal, the officials and executives at Simpsonwood spent most

of the next two days discussing how to cover up the damaging data. According

to transcripts obtained under the Freedom of Information Act, many at the

meeting were concerned about how the damaging revelations about thimerosal

would affect the vaccine industry's bottom line.

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

said Dr. Robert Brent, a pediatrician at the Alfred I. duPont Hospital for

Children in Delaware. " This will be a resource to our very busy plaintiff

attorneys in this country. " Dr. Bob Chen, head of vaccine safety for the CDC,

expressed relief that " given the sensitivity of the information, we have been

able

to keep it out of the hands of, let's say, less responsible hands. " Dr. John

Clements, vaccines advisor at the World Health Organization, declared flatly

that the study " should not have been done at all " and warned that the results

" will be taken by others and will be used in ways beyond the control of this

group. The research results have to be handled. "

In fact, the government has proved to be far more adept at handling the

damage than at protecting children's health. The CDC paid the Institute of

Medicine to conduct a new study to whitewash the risks of thimerosal, ordering

researchers to " rule out " the chemical's link to autism. It withheld

Verstraeten's findings, even though they had been slated for immediate

publication, and

told other scientists that his original data had been " lost " and could not be

replicated. And to thwart the Freedom of Information Act, it handed its giant

database of vaccine records over to a private company, declaring it

off-limits to researchers. By the time Verstraeten finally published his study

in

2003, he had gone to work for GlaxoSmithKline and reworked his data to bury the

link between thimerosal and autism.

Vaccine manufacturers had already begun to phase thimerosal out of injections

given to American infants -- but they continued to sell off their

mercury-based supplies of vaccines until last year. The CDC and FDA gave them a

hand,

buying up the tainted vaccines for export to developing countries and allowing

drug companies to continue using the preservative in some American vaccines

-- including several pediatric flu shots as well as tetanus boosters

routinely given to 11-year-olds.

The drug companies are also getting help from powerful lawmakers in

Washington. Senate Majority Leader Bill Frist, who has received $873,000 in

contributions from the pharmaceutical industry, has been working to immunize

vaccine

makers from liability in 4,200 lawsuits that have been filed by the parents of

injured children. On five separate occasions, Frist has tried to seal all of

the government's vaccine-related documents -- including the Simpsonwood

transcripts -- and shield Eli Lilly, the developer of thimerosal, from

subpoenas.

In 2002, the day after Frist quietly slipped a rider known as the " Eli Lilly

Protection Act " into a homeland security bill, the company contributed

$10,000 to his campaign and bought 5,000 copies of his book on bioterrorism.

Congress repealed the measure in 2003 -- but earlier this year, Frist slipped

another provision into an anti-terrorism bill that would deny compensation to

children suffering from vaccine-related brain disorders. " The lawsuits are of

such magnitude that they could put vaccine producers out of business and limit

our capacity to deal with a biological attack by terrorists, " says Andy

Olsen, a legislative assistant to Frist.

Even many conservatives are shocked by the government's effort to cover up

the dangers of thimerosal. Rep. Dan Burton, a Republican from Indiana, oversaw

a three-year investigation of thimerosal after his grandson was diagnosed

with autism. " Thimerosal used as a preservative in vaccines is directly related

to the autism epidemic, " his House Government Reform Committee concluded in

its final report. " This epidemic in all probability may have been prevented or

curtailed had the FDA not been asleep at the switch regarding a lack of

safety data regarding injected thimerosal, a known neurotoxin. " The FDA and

other

public-health agencies failed to act, the committee added, out of

" institutional malfeasance for self protection " and " misplaced protectionism of

the

pharmaceutical industry. "

The story of how government health agencies colluded with Big Pharma to hide

the risks of thimerosal from the public is a chilling case study of

institutional arrogance, power and greed. I was drawn into the controversy only

reluctantly. As an attorney and environmentalist who has spent years working on

issues of mercury toxicity, I frequently met mothers of autistic children who

were absolutely convinced that their kids had been injured by vaccines.

Privately, I was skeptical. I doubted that autism could be blamed on a single

source, and I certainly understood the government's need to reassure parents

that

vaccinations are safe; the eradication of deadly childhood diseases depends

on it. I tended to agree with skeptics like Rep. Henry Waxman, a Democrat from

California, who criticized his colleagues on the House Government Reform

Committee for leaping to conclusions about autism and vaccinations. " Why should

we scare people about immunization, " Waxman pointed out at one hearing, " until

we know the facts? "

It was only after reading the Simpsonwood transcripts, studying the leading

scientific research and talking with many of the nation's preeminent

authorities on mercury that I became convinced that the link between thimerosal

and

the epidemic of childhood neurological disorders is real. Five of my own

children are members of the Thimerosal Generation -- those born between 1989

and

2003 -- who received heavy doses of mercury from vaccines. " The elementary

grades are overwhelmed with children who have symptoms of neurological or

immune-system damage, " Patti White, a school nurse, told the House Government

Reform

Committee in 1999. " Vaccines are supposed to be making us healthier;

however, in 25 years of nursing I have never seen so many damaged, sick kids.

Something very, very wrong is happening to our children. " More than 500,000

kids

currently suffer from autism, and pediatricians diagnose more than 40,000 new

cases every year. The disease was unknown until 1943, when it was identified

and diagnosed among 11 children born in the months after thimerosal was first

added to baby vaccines in 1931.

Some skeptics dispute that the rise in autism is caused by thimerosal-tainted

vaccinations. They argue that the increase is a result of better diagnosis

-- a theory that seems questionable at best, given that most of the new cases

of autism are clustered within a single generation of children. " If the

epidemic is truly an artifact of poor diagnosis, " scoffs Dr. Boyd Haley, one of

the world's authorities on mercury toxicity, " then where are all the

20-year-old autistics? " Other researchers point out that Americans are exposed

to a

greater cumulative " load " of mercury than ever before, from contaminated fish

to

dental fillings, and suggest that thimerosal in vaccines may be only part of

a much larger problem. It's a concern that certainly deserves far more

attention than it has received -- but it overlooks the fact that the mercury

concentrations in vaccines dwarf other sources of exposure to our children.

What is most striking is the lengths to which many of the leading detectives

have gone to ignore -- and cover up -- the evidence against thimerosal. From

the very beginning, the scientific case against the mercury additive has been

overwhelming. The preservative, which is used to stem fungi and bacterial

growth in vaccines, contains ethylmercury, a potent neurotoxin. Truckloads of

studies have shown that mercury tends to accumulate in the brains of primates

and other animals after they are injected with vaccines -- and that the

developing brains of infants are particularly susceptible. In 1977, a Russian

study found that adults exposed to much lower concentrations of ethylmercury

than

those given to American children still suffered brain damage years later.

Russia banned thimerosal from children's vaccines 20 years ago, and Denmark,

Austria, Japan, Great Britain and all the Scandinavian countries have since

followed suit.

" You couldn't even construct a study that shows thimerosal is safe, " says

Haley, who heads the chemistry department at the University of Kentucky. " It's

just too darn toxic. If you inject thimerosal into an animal, its brain will

sicken. If you apply it to living tissue, the cells die. If you put it in a

petri dish, the culture dies. Knowing these things, it would be shocking if one

could inject it into an infant without causing damage. "

Internal documents reveal that Eli Lilly, which first developed thimerosal,

knew from the start that its product could cause damage -- and even death --

in both animals and humans. In 1930, the company tested thimerosal by

administering it to 22 patients with terminal meningitis, all of whom died

within

weeks of being injected -- a fact Lilly didn't bother to report in its study

declaring thimerosal safe. In 1935, researchers at another vaccine

manufacturer,

Pittman-Moore, warned Lilly that its claims about thimerosal's safety " did

not check with ours. " Half the dogs Pittman injected with thimerosal-based

vaccines became sick, leading researchers there to declare the preservative

" unsatisfactory as a serum intended for use on dogs. "

In the decades that followed, the evidence against thimerosal continued to

mount. During the Second World War, when the Department of Defense used the

preservative in vaccines on soldiers, it required Lilly to label it " poison. " In

1967, a study in Applied Microbiology found that thimerosal killed mice when

added to injected vaccines. Four years later, Lilly's own studies discerned

that thimerosal was " toxic to tissue cells " in concentrations as low as one

part per million -- 100 times weaker than the concentration in a typical

vaccine. Even so, the company continued to promote thimerosal as " nontoxic " and

also incorporated it into topical disinfectants. In 1977, 10 babies at a

Toronto hospital died when an antiseptic preserved with thimerosal was dabbed

onto

their umbilical cords.

In 1982, the FDA proposed a ban on over-the-counter products that contained

thimerosal, and in 1991 the agency considered banning it from animal vaccines.

But tragically, that same year, the CDC recommended that infants be injected

with a series of mercury-laced vaccines. Newborns would be vaccinated for

hepatitis B within 24 hours of birth, and 2-month-old infants would be

immunized for haemophilus influenzae B and diphtheria-tetanus-pertussis.

The drug industry knew the additional vaccines posed a danger. The same year

that the CDC approved the new vaccines, Dr. Maurice Hilleman, one of the

fathers of Merck's vaccine programs, warned the company that 6-month-olds who

were administered the shots would suffer dangerous exposure to mercury. He

recommended that thimerosal be discontinued, " especially when used on infants

and

children, " noting that the industry knew of nontoxic alternatives. " The best

way to go, " he added, " is to switch to dispensing the actual vaccines without

adding preservatives. "

For Merck and other drug companies, however, the obstacle was money.

Thimerosal enables the pharmaceutical industry to package vaccines in vials that

contain multiple doses, which require additional protection because they are

more easily contaminated by multiple needle entries. The larger vials cost half

as much to produce as smaller, single-dose vials, making it cheaper for

international agencies to distribute them to impoverished regions at risk of

epidemics. Faced with this " cost consideration, " Merck ignored Hilleman's

warnings, and government officials continued to push more and more

thimerosal-based

vaccines for children. Before 1989, American preschoolers received only three

vaccinations -- for polio, diphtheria-tetanus-pertussis and

measles-mumps-rubella. A decade later, thanks to federal recommendations,

children were

receiving a total of 22 immunizations by the time they reached first grade.

As the number of vaccines increased, the rate of autism among children

exploded. During the 1990s, 40 million children were injected with

thimerosal-based vaccines, receiving unprecedented levels of mercury during a

period

critical for brain development. Despite the well-documented dangers of

thimerosal,

it appears that no one bothered to add up the cumulative dose of mercury that

children would receive from the mandated vaccines. " What took the FDA so long

to do the calculations? " Peter Patriarca, director of viral products for the

agency, asked in an e-mail to the CDC in 1999. " Why didn't CDC and the

advisory bodies do these calculations when they rapidly expanded the childhood

immunization schedule? "

But by that time, the damage was done. Infants who received all their

vaccines, plus boosters, by the age of 6 months were being injected with levels

of

ethylmercury 187 times greater than the EPA's limit for daily exposure to

methylmercury, a related neurotoxin. Although the vaccine industry insists that

ethylmercury poses little danger because it breaks down rapidly and is removed

by the body, several studies -- including one published in April by the

National Institutes of Health -- suggest that ethylmercury is actually more

toxic

to developing brains and stays in the brain longer than methylmercury.

Officials responsible for childhood immunizations insist that the additional

vaccines were necessary to protect infants from disease and that thimerosal

is still essential in developing nations, which, they often claim, cannot

afford the single-dose vials that don't require a preservative. Dr. Paul Offit,

one of CDC's top vaccine advisors, told me, " I think if we really have an

influenza pandemic -- and certainly we will in the next 20 years, because we

always do -- there's no way on God's earth that we immunize 280 million people

with single-dose vials. There has to be multidose vials. "

But while public-health officials may have been well-intentioned, many of

those on the CDC advisory committee who backed the additional vaccines had close

ties to the industry. Dr. Sam Katz, the committee's chair, was a paid

consultant for most of the major vaccine makers and shares a patent on a

measles

vaccine with Merck, which also manufactures the hepatitis B vaccine. Dr. Neal

Halsey, another committee member, worked as a researcher for the vaccine

companies and received honoraria from Abbott Labs for his research on the

hepatitis B vaccine.

Indeed, in the tight circle of scientists who work on vaccines, such

conflicts of interest are common. Rep. Burton says that the CDC " routinely

allows

scientists with blatant conflicts of interest to serve on intellectual advisory

committees that make recommendations on new vaccines, " even though they have

" interests in the products and companies for which they are supposed to be

providing unbiased oversight. " The House Government Reform Committee discovered

that four of the eight CDC advisors who approved guidelines for a rotavirus

vaccine laced with thimerosal " had financial ties to the pharmaceutical

companies that were developing different versions of the vaccine. "

Offit, who shares a patent on the vaccine, acknowledged to me that he " would

make money " if his vote to approve it eventually leads to a marketable

product. But he dismissed my suggestion that a scientist's direct financial

stake

in CDC approval might bias his judgment. " It provides no conflict for me, " he

insists. " I have simply been informed by the process, not corrupted by it.

When I sat around that table, my sole intent was trying to make recommendations

that best benefited the children in this country. It's offensive to say that

physicians and public-health people are in the pocket of industry and thus

are making decisions that they know are unsafe for children. It's just not the

way it works. "

Other vaccine scientists and regulators gave me similar assurances. Like

Offit, they view themselves as enlightened guardians of children's health, proud

of their " partnerships " with pharmaceutical companies, immune to the

seductions of personal profit, besieged by irrational activists whose

anti-vaccine

campaigns are endangering children's health. They are often resentful of

questioning. " Science, " says Offit, " is best left to scientists. "

Still, some government officials were alarmed by the apparent conflicts of

interest. In his e-mail to CDC administrators in 1999, Paul Patriarca of the

FDA blasted federal regulators for failing to adequately scrutinize the danger

posed by the added baby vaccines. " I'm not sure there will be an easy way out

of the potential perception that the FDA, CDC and immunization-policy bodies

may have been asleep at the switch re: thimerosal until now, " Patriarca

wrote. The close ties between regulatory officials and the pharmaceutical

industry, he added, " will also raise questions about various advisory bodies

regarding aggressive recommendations for use " of thimerosal in child vaccines.

If federal regulators and government scientists failed to grasp the potential

risks of thimerosal over the years, no one could claim ignorance after the

secret meeting at Simpsonwood. But rather than conduct more studies to test

the link to autism and other forms of brain damage, the CDC placed politics

over science. The agency turned its database on childhood vaccines -- which had

been developed largely at taxpayer expense -- over to a private agency,

America's Health Insurance Plans, ensuring that it could not be used for

additional research. It also instructed the Institute of Medicine, an advisory

organization that is part of the National Academy of Sciences, to produce a

study

debunking the link between thimerosal and brain disorders. The CDC " wants us to

declare, well, that these things are pretty safe, " Dr. Marie McCormick, who

chaired the IOM's Immunization Safety Review Committee, told her fellow

researchers when they first met in January 2001. " We are not ever going to come

down that [autism] is a true side effect " of thimerosal exposure. According to

transcripts of the meeting, the committee's chief staffer, Kathleen Stratton,

predicted that the IOM would conclude that the evidence was " inadequate to

accept or reject a causal relation " between thimerosal and autism. That, she

added, was the result " Walt wants " -- a reference to Dr. Walter Orenstein,

director of the National Immunization Program for the CDC.

For those who had devoted their lives to promoting vaccination, the

revelations about thimerosal threatened to undermine everything they had worked

for.

" We've got a dragon by the tail here, " said Dr. Michael Kaback, another

committee member. " The more negative that [our] presentation is, the less likely

people are to use vaccination, immunization -- and we know what the results of

that will be. We are kind of caught in a trap. How we work our way out of the

trap, I think is the charge. "

Even in public, federal officials made it clear that their primary goal in

studying thimerosal was to dispel doubts about vaccines. " Four current studies

are taking place to rule out the proposed link between autism and

thimerosal, " Dr. Gordon Douglas, then-director of strategic planning for

vaccine

research at the National Institutes of Health, assured a Princeton University

gathering in May 2001. " In order to undo the harmful effects of research

claiming

to link the [measles] vaccine to an elevated risk of autism, we need to

conduct and publicize additional studies to assure parents of safety. " Douglas

formerly served as president of vaccinations for Merck, where he ignored

warnings

about thimerosal's risks.

In May of last year, the Institute of Medicine issued its final report. Its

conclusion: There is no proven link between autism and thimerosal in vaccines.

Rather than reviewing the large body of literature describing the toxicity

of thimerosal, the report relied on four disastrously flawed epidemiological

studies examining European countries, where children received much smaller

doses of thimerosal than American kids. It also cited a new version of the

Verstraeten study, published in the journal Pediatrics, that had been reworked

to

reduce the link between thimerosal and autism. The new study included

children too young to have been diagnosed with autism and overlooked others who

showed signs of the disease. The IOM declared the case closed and -- in a

startling position for a scientific body -- recommended that no further

research be

conducted.

The report may have satisfied the CDC, but it convinced no one. Rep. David

Weldon, a Republican physician from Florida who serves on the House Government

Reform Committee, attacked the Institute of Medicine, saying it relied on a

handful of studies that were " fatally flawed " by " poor design " and failed to

represent " all the available scientific and medical research. " CDC officials

are not interested in an honest search for the truth, Weldon told me, because

" an association between vaccines and autism would force them to admit that

their policies irreparably damaged thousands of children. Who would want to

make that conclusion about themselves? "

Under pressure from Congress, parents and a few of its own panel members, the

Institute of Medicine reluctantly convened a second panel to review the

findings of the first. In February, the new panel, composed of different

scientists, criticized the earlier panel for its lack of transparency and urged

the

CDC to make its vaccine database available to the public.

So far, though, only two scientists have managed to gain access. Dr. Mark

Geier, president of the Genetics Center of America, and his son, David, spent a

year battling to obtain the medical records from the CDC. Since August 2002,

when members of Congress pressured the agency to turn over the data, the

Geiers have completed six studies that demonstrate a powerful correlation

between

thimerosal and neurological damage in children. One study, which compares

the cumulative dose of mercury received by children born between 1981 and 1985

with those born between 1990 and 1996, found a " very significant

relationship " between autism and vaccines. Another study of educational

performance found

that kids who received higher doses of thimerosal in vaccines were nearly

three times as likely to be diagnosed with autism and more than three times as

likely to suffer from speech disorders and mental retardation. Another

soon-to-be-published study shows that autism rates are in decline following the

recent elimination of thimerosal from most vaccines.

As the federal government worked to prevent scientists from studying

vaccines, others have stepped in to study the link to autism. In April, reporter

Dan

Olmsted of UPI undertook one of the more interesting studies himself.

Searching for children who had not been exposed to mercury in vaccines -- the

kind

of population that scientists typically use as a " control " in experiments --

Olmsted scoured the Amish of Lancaster County, Penn., who refuse to immunize

their infants. Given the national rate of autism, Olmsted calculated that

there should be 130 autistics among the Amish. He found only four. One had been

exposed to high levels of mercury from a power plant. The other three --

including one child adopted from outside the Amish community -- had received

their vaccines.

At the state level, many officials have also conducted in-depth reviews of

thimerosal. While the Institute of Medicine was busy whitewashing the risks,

the Iowa Legislature was carefully combing through all of the available

scientific and biological data. " After three years of review, I became

convinced

there was sufficient credible research to show a link between mercury and the

increased incidences in autism, " says state Sen. Ken Veenstra, a Republican who

oversaw the investigation. " The fact that Iowa's 700 percent increase in

autism began in the 1990s, right after more and more vaccines were added to the

children's vaccine schedules, is solid evidence alone. " Last year, Iowa

became the first state to ban mercury in vaccines, followed by California.

Similar

bans are now under consideration in 32 other states.

But instead of following suit, the FDA continues to allow manufacturers to

include thimerosal in scores of over-the-counter medications as well as

steroids and injected collagen. Even more alarming, the government continues to

ship

vaccines preserved with thimerosal to developing countries -- some of which

are now experiencing a sudden explosion in autism rates. In China, where the

disease was virtually unknown prior to the introduction of thimerosal by U.S.

drug manufacturers in 1999, news reports indicate that there are now more

than 1.8 million autistics. Although reliable numbers are hard to come by,

autistic disorders also appear to be soaring in India, Argentina, Nicaragua and

other developing countries that are now using thimerosal-laced vaccines. The

World Health Organization continues to insist thimerosal is safe, but it

promises to keep the possibility that it is linked to neurological disorders

" under review. "

I devoted time to study this issue because I believe that this is a moral

crisis that must be addressed. If, as the evidence suggests, our public-health

authorities knowingly allowed the pharmaceutical industry to poison an entire

generation of American children, their actions arguably constitute one of the

biggest scandals in the annals of American medicine. " The CDC is guilty of

incompetence and gross negligence, " says Mark Blaxill, vice president of Safe

Minds, a nonprofit organization concerned about the role of mercury in

medicines. " The damage caused by vaccine exposure is massive. It's bigger than

asbestos, bigger than tobacco, bigger than anything you've ever seen. " It's hard

to calculate the damage to our country -- and to the international efforts to

eradicate epidemic diseases -- if Third World nations come to believe that

America's most heralded foreign-aid initiative is poisoning their children.

It's not difficult to predict how this scenario will be interpreted by

America's enemies abroad. The scientists and researchers -- many of them

sincere,

even idealistic -- who are participating in efforts to hide the science on

thimerosal claim that they are trying to advance the lofty goal of protecting

children in developing nations from disease pandemics. They are badly

misguided.

Their failure to come clean on thimerosal will come back horribly to haunt

our country and the world's poorest populations.

- - - - - - - - - - - -

About the writer

Robert F. Kennedy Jr. is senior attorney for the Natural Resources Defense

Council, chief prosecuting attorney for Riverkeeper and president of

Waterkeeper Alliance. He is the co-author of " The Riverkeepers. " Sound Off

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