The air in the meeting room had grown stale as the afternoon
wore on, but Minnesota Attorney General Mike Hatch listened intently, puzzling
his way through the data. Leaning forward at the head of the oak table that
dominated the room, he asked, Are you saying there is still mercury in vaccines
today? After a quick glance at his attaché case, Dr. Mark Geier
replied, "In several of them - we have the bottles here to show you." "I
thought the Federal and Drug Administration required it to be removed," countered
Hatch. Mark Geier sighed. "They recommended it be removed. Many of our children
are still being injected with mercury at their well-baby checkups." Mercury
is the main component of thimerosal, an antibacterial preservative that until
recently was used in most vaccines. It has become a lightening rod
in an escalating debate over the cause of the nation's rising rates of autism.
It has entangled parents, health care providers, legislators, attorneys,
public health officials, and drug makers, prompting them to ask one central
question: Is thimerosal the mark of colossal government negligence or merely
a symbol of parental desperation? This debate became more than a theoretical
one for me the day I received a call from the office of Congressman David
Weldon (R-Florida), asking me if I was writing anything about thimerosal.
Stuart Burns, Weldon's deputy chief of staff, was calling in response to
an article I wrote in The Washington Post Magazine, detailing the government's
acknowledgment of my son's brain damage from a vaccine. Mr. Burns gave me
the name of Dr. Mark Geier and Dr. Geier's son David, saying, "They are the
only self-funded researchers publishing in peer reviewed journals on thimerosal
and autism, using CDC data. You should talk with them." Twenty-four hours
later, I was on the phone with the Geiers. I was doubtful about what
I'd hear as I dialed their number. We started speaking at 9:30 on a Saturday
night. We didn't finish until after midnight. In the course of that
call and a two day visit to their home a few weeks later I heard a story
that sounded more like a whodunit than a typical scientific investigation.
They detailed their evidence linking thimerosal with the autism epidemic,
and it was compelling.
I had to hear more and told them I'd come visit in order to fully understand
the issue. Almost everybody knows of someone with autism today but it wasn't
always like that. In the years between 1970 and the late '90s, the autism
rates in America rose from 1 in 10,000 children to 1 in 166. The Centers
for Disease Control and Prevention (CDC) and the American Academy of Pediatrics
(AAP) sent out an Autism A.L.A.R.M. to pediatricians across the country in
March 2004, warning them that the disorder is prevalent and must be treated
early and aggressively. A scan of the US Department of Education data on
autism in children makes the surge obvious: In the decade between 1992 and
2002, the rate of autism was up an average of 1,000 percent in all 50 states.
Recent articles in The Journal of the American Medical Association and Pediatrics
contend that the increase is real - that it is not an issue of increased
reporting or shifting demographics. The related
disorders of attention deficit hyperactivity and speech delays have spiked
as well. The question is, why? Since autism was first described by
Dr. Leo Kanner in 1943, numerous theories have emerged to explain its etiology,
ranging from bad mothering to microwave ovens to faulty genetics. At first
they talked about refrigerator mothers and then the Measles, Mumps, and Rubella
(MMR) vaccine, said Dr. Adrian Sandler, chairperson for the AAP. "The field
of autism is littered with the carcasses of false causes." Several recent
studies have linked autism to particular genes; however, the role of the
environment in the epidemic must be factored in, as genetics alone cannot
account for the rapid increase in the prevalence of the disease. Most scientists
agree that epigenetics -an interaction between genes and the environment
- will ultimately be identified as the cause.
In the mid '90s, concerned scientists, parents, and politicians began questioning
the link between the skyrocketing incidence of neurological problems in children
and thimerosal, a drug that is approximately 50 percent mercury by weight.
Thimerosal was first trademarked by Eli Lilly and Company in April 1930 and
was added to childhood vaccines a few years later. Due to the comparatively
lax safety standards of the time, it never underwent animal testing or long-term
safety trials. The growing interest in thimerosal sprang from multiple avenues:
biological plausibility (the effects of mercury toxicity have been studied
through a series of industrial accidents), the Environmental Protection Agency's
(EPA) classification of mercury as a potent neurotoxin, and research from
other medical disciplines demonstrating thimerosal's toxicity.
There was another reason thimerosal was suspect: the linear correlation between
increasing rates of autism and the amount of thimerosal children received
during the '90s. With the number of routine thimerosal-containing vaccines
rising from eight to nearly 40 in that decade, federal health officials realized
that some children were receiving many times the EPA's safe limit for mercury-
the daily limit of allowable mercury based on evaluation of documented human
mercury exposure - on given
days in the first six months of life. Essentially, it appeared that
the
more thimerosal given to a child in a year, the more likely he or she was
to develop autism or a related neurological disorder. Following
up on my promise to the Geiers, I flew to the East Coast last fall to meet
with them. The subway ride from Washington, D.C., was humid and long as the
train sped past a blur of high-rise buildings and emptied out in the Maryland
suburbs. I spotted Mark Geier on the platform - middle-aged with practical
glasses, slightly unruly hair, and an easy grin. No flash, I thought, but
exuding confidence. I'm Mark, he said, extending a hand before
climbing into the driver's seat of a car with Geier 4 spelled out on the
license plate. What happened to Geier 1, 2, and 3? I asked. My
wife and son have those, he replied. We traveled through a residential
neighborhood to his modest two-story home. He chatted amiably as we drove
and told me a story about his attempt to have thimerosal delivered to his
house so that he could study it in one of his labs. "A day after I ordered
it," he said, "I received a frantic call from the Fed- Ex office. The woman
on the other end said they would not be able to deliver thimerosal to my
home." He continued, "She said, 'It's too dangerous-it needs to be handled
in a secure lab with protective clothing.' She wasn't overreacting, though
there was an incident a few years ago when
a researcher from Dartmouth
spilled a drop of dimethyl mercury on her gloved hand. They did everything
they could to treat her. She died a few months later." He paused and
looked over at me.
"This is the same stuff we are injecting into our kids."
I didn't respond. Despite the severe reaction my son Porter had to the pertussis
(whooping cough) vaccine, I am a firm believer in immunizations. I've had
two children since Porter's injury, and both of them have been fully vaccinated.
The mercury-poisoning theory of autism reminded me too much of the preposterous
Mad Hatter in Alice in Wonderland. The training I did for my PhD in experimental
psychology taught me to be skeptical, and it was working well at the moment.
Mark must have seen the look on my face. "I know it's hard to believe," he
said. "Spend a few days with us, and we'll tell you about thimerosal. We'll
show you the research and studies and data. Decide for yourself when
we're done."
I spent the next two days with them. Here is what I learned. In 1999,
the American Academy of Pediatrics (AAP) and the US Public Health Service
took the unexpected step of recommending that thimerosal be removed from
childhood vaccines. In a recent interview, Dr. Thomas Saari, spokesperson
for the AAP, interpreted the decision this way: "I think everyone recognizes
that removing heavy metals like mercury or thallium from our environment
is a good thing.. We project over the next ten years that we'll add one to
two new vaccines a year, so you need to be concerned about the total amount
of thimerosal children would ultimately get if the newer vaccines use thimerosal
as a preservative as well." He continued, "While I could not say that there
is or is not a relationship to autism in some children, the AAP was on the
forefront of raising this issue and suggesting that we remove thimerosal
out of an abundance of caution." This move was not unfounded. It followed
the Food and Drug Administration's (FDA) Modernization Act of 1997, legislation
that, among other regulations and improvements, required the FDA to review
the amount of mercury that was added to products. In the mid '90s,
concerned scientists, parents, and politicians began questioning the link
between the skyrocketing incidence of neurological problems in children and
thimerosal, a drug that is 50 percent mercury by weight.
In 1999, the review was completed, and the FDA required the removal of thimerosal
from over-the-counter drugs. The same year, once the amount of thimerosal
in childhood vaccines was finally tallied, the FDA discovered that children
were receiving more than 100 times the EPA's safe limit for mercury by 18
months of age. The agency also acknowledged that long-term safety trials
for thimerosal had never been conducted. "The recognition caused a huge stir,"
Barbara Loe Fisher said. Fisher is the cofounder and president of the National
Vaccine Advisory Committee and served for four years on the FDA Vaccines
and Related Biological Products Advisory Committee, a group that advises
the CDC on vaccine issues. She also has a son she believes was harmed
by a vaccine. "I stood in the back of the room when they announced the amount
of mercury, and you could hear the sighs, people were obviously upset. They
worried that a crisis of public confidence would jeopardize the vaccine program."
In 2001, the Institute of Medicine (IOM), an impartial advisory board
to Congress, stated that a link between thimerosal and autism was "biologically
plausible" and reaffirmed the recommendation to remove it from vaccines.
Curtis Allen, of the CDC's National Immunization Program, said in a recent
e-mail that "at present, all routinely recommended vaccines manufactured
for administration to US infants are either thimerosal-free or contain only
trace amounts of thimerosal that are a byproduct of the manufacturing process."
In contrast, a review of FDA documents, acquired by Rep. Weldon, reveals
that some of the
Influenza, Meningitis, and Diptheria-Tetanus and Acellular
Pertussis (DTaP) vaccines given to children today still contain thimerosal.
For example, the DTaP multi-dose vaccine still contains "standard" levels
(25 micrograms per dose), although thimerosal has been removed from DTaP
single-dose vials. The agency also acknowledged that the final stock of many
thimerosal-containing immunization didn't expire until the end of 2002.
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The FDA did not respond to Seed's repeated requests for an interview.
Soon after, the Geiers began to investigate thimerosal - and grew increasingly
concerned. "Once we understood the data well enough, we were frightened,"
recalled David. Prompted by concerned parents they had met through
their work on vaccine safety, they examined the CDC and FDA's Vaccine Adverse
Reporting System (VAERS)-a database where doctors and parents report vaccine
side effects. Over the course of two years, the Geiers published six peer-reviewed
correlational studies based on the VAERS data, with startling results: The
more thimerosal children received, the higher the incidence of neurological
problems, including autism. Next they tackled the US Department of Education
data and conducted a statistical comparison of yearly autism rates with the
amount of thimerosal given to children. Again, a tight lockstep between the
two was revealed. But this data only took them so far. "Correlation
only means a relationship," explained David. "The autism epidemic of the
'90s also coincided with increased television-watching among children. But
none of us are arguing that TV is the cause." To resolve this issue,
the Geiers wanted to reanalyze the CDC's Vaccine Safety Datalink (VSD)-a
database of medical records purchased from seven Health Maintenance Organizations
(HMOs) for study purposes at a cost of more than $30 million. Analysis of
the VSD by CDC researchers began in 1999 and revealed a statistically significant
relationship between thimerosal and several neurological problems in approximately
110,000 children. CDC scientists continued analyzing the data, and e-mails
they exchanged, obtained through the Freedom of Information Act (FOIA), revealed
that despite "running, rethinking, rerunning and rethinking" their analyses,
the thimerosal effect did not disappear. As the subject line of lead researcher
Dr. Thomas Verstraeten's e-mail to colleagues read, "It just won't go away."
These early findings were kept from the public, though they were presented
to representatives from the CDC, the FDA, the AAP, and vaccine makers at
a private meeting at the Simpsonwood Conference Center in Georgia in 2000.
Copies of the data shared at the meeting, also obtained through the FOIA,
showed a linear correlation between thimerosal exposure and neurological
problems, including autism. The meeting transcript revealed that several
participants were concerned about thimerosal's alleged neurologically toxic
effects and the impact the information might have on America's immunization
program. Dr. Bill Weil, a consultant to the AAP and a conference participant,
commented on thimerosal, saying, "You can play with this all you want. [The
results] are statistically significant." Dr. Richard Johnston, an immunologist
and pediatrician, was concerned enough to consider his own family members.
"My gut feeling? It worries me enough," he said. "Forgive this
personal comment, but I got called out for an emergency, and my daughter-in-law
delivered a son by C-section. and I do not want that grandson to get a thimerosal-containing
vaccine until we know better what is going on."
The group's final discussion centered on how best to guard the incendiary
findings from the public. "Consider this embargoed information," said Dr.
Roger Bernier, the associate director for science at the National Immunization
Program, to the group. The participants took his caution seriously, and the
findings remained out of the public eye until they were released to Safe
Minds, a nonprofit group founded by parents concerned about the role of mercury
in disease, under the FOIA in July 2001.
Following the Simpsonwood conference, Dr. Thomas Verstraeten, the lead author
of the VSD study, was concerned about how refinement of the thimerosal data
might jeopardize scientific rigor. In an e-mail to Robert Chen, chief of
the Immunization Safety Branch of the CDC's National Immunization Program,
and others, he wrote, "I do not wish to be the advocate of the anti-vaccine
lobby and sound as if I am convinced that thimerosal is or was harmful; but
at least I feel that we should use sound scientific argumentation and not
let our standards be dictated by our desire to disprove an unpleasant theory."
Nonetheless, the thimerosal effect did go away. Three years later, when Dr.
Verstraeten and peers published the research in a November 2003 issue of
Pediatrics, the results no longer showed a link between thimerosal and autism.
The results took four years to publish, due to refinement of the VSD data,
including the addition of some children to the database and the removal of
others. Dr. Thomas Saari from the AAP defended the study's changing
data and said they were understandable if one looked more closely. "I've
talked to Dr. Verstraeten a number of times on this matter at different stages
of the maturation of the study," he said. "I believe he thought he did see
a weak signal with thimerosal concerning some neurodevelopmental conditions
in the beginning stages of the study." But once the CDC group reworked the
data in response to reviewers concerns, "the effect was less apparent and
seemingly restricted to a couple of conditions, like tics and language delays."
He explained that the changing data represented "attempts at more accurate
case ascertainment and improving the quality of the data to be analyzed."
Others felt this explanation didn't go far enough.
"Good case ascertainment had already been done before Simpsonwood- in fact,
they talk about it quite a bit in the transcript," David Geier said. "The
data shuffling was so extreme in the four years after the initial study that
they actually found in their article that thimerosal may be protective for
certain neurological problems. I find it hard to fathom that a scientist
could actually claim that a potent neurotoxic substance like mercury is good
for the developing brain." Dr. Verstaeten hasn't responded to a congressional
subpoena to be questioned about the VSD data, although he continues to publish
with the CDC. His current employer, GlaxoSmithKline, stated that he is not
granting interviews at this time. But Dr. Verstraeten responded to
criticisms of his work via a Letter to the Editor in the April 2004 issue
of Pediatrics, the journal in which the CDC study was first published.
Dr. Verstraeten wrote, "The CDC screening study of thimerosal-containing
vaccines was perceived at first as a positive study that found an association
between thimerosal and some neurodevelopmental outcomes. This was the perception
both independent scientists and anti-vaccine lobbyists had at the conclusion
of the first phase of the study. It was foreseen from the very start
that any positive outcome would lead to a second phase. "Because the
findings of the first phase were not replicated in the second phase, the
perception of the study changed from a positive to a neutral study. Surprisingly,
however, the study is being interpreted now as negative by many, including
anti-vaccine lobbyists. The article does not state that we found evidence
against an association, as a negative study would. It does state, on
the contrary, that additional study is recommended, which is the conclusion
to which a neutral study must come."
Further muddying the water for some, Pediatrics failed to reveal that Dr.
Verstraeten worked for GlaxoSmithKline, a vaccine maker that may be vulnerable
to lawsuits over thimerosal. He joined the pharmaceutical company in 2001,
on the day he presented his thimerosal findings to the IOM. In his Letter
to the Editor, Dr. Verstraeten also addressed this issue, stating, "I regard
myself as a professional scientist who puts ethical value before any person
or material gains. "I've studied thimerosal and talked to people on both
sides of the issue. There is enough evidence I've seen to make it clear to
me that we need to get thimerosal out of the products we give to our children."
I believe that I am currently employed by a company that has the same
high ethical standards as myself. Therefore, any suggestion that GlaxoSmithKline
intended to have me manipulate this data is nothing short of an insult to
both my and the company's intergrity." GlaxoSmithKline also did not
respond to Seed's requests for an interview.
Conflicts of interest, such as Dr.Verstraeten's, are all too common in vaccine
research.
Scientists armed with pharmaceutical or CDC grants conduct nearly
all vaccine research in this country, and independent corroboration is the
anomaly. This raises the question of whether such researchers can fairly
evaluate the safety of products, such as vaccines, and whether their affiliations
have played into the thimerosal debate. These tangled relationships provide
ample fodder for those who believe that the CDC is trying to cover its tracks
regarding thimerosal. They also undermine studies that point to the safety
of the preservative. A case in point is the large scale Danish study, published
in Journal of the American Medical Society (JAMA) in September 2003, which
found no link between thimerosal and autism.
The study is routinely cited as proof that the preservative is safe in vaccines.
Soon after its publication, however, it was revealed that JAMA failed to
disclose that the study's authors work for Denmark's largest maker and distributor
of childhood vaccines another company that could face lawsuits over thimerosal.
Given these conflicted reports and apparent conflicts of interest,
Mark and David Geier's work became more urgent, as they are the only self-funded
scientists who have examined the CDC's vaccine databases.
Mar
k Geier has a long history of forging into uncharted territory.
When he was 23, he corrected a genetic disorder in a tissue culture, gaining
distinction as one of the founders of the field of genetic engineering. The
discovery earned him front-page stories in The New York Times and The London
Times, and a call from President Nixon. Anything but a fringe player, he
holds an MD and a PhD in genetics which he earned while on a tennis scholarship
at George Washington University. He then spent ten years at the National
Institutes of Health and several more as a professor at Johns Hopkins University
before opening the genetic laboratory and clinical practice that he co-owns
today.
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In addition to tending to a full roster of patients, Mark has testified before
the IOM on five occasions, as well as the US House of Representatives Committee
on Government Reform; and he has been certified as an expert witness on vaccines
in federal, state, Canadian, and English courts. He was one of the original
architects of the National Childhood Vaccine Injury Act, which created the
national program that compensates children who have been injured by vaccines.
He works with his only child, David, 23, who is currently pursuing graduate
studies in biochemistry at George Washington University and is a ranked tennis
player himself. David is quiet and self deprecating, and routinely embarrassed
when Mark points out his accomplishments. He finishes his father's
sentences and jumps in to correct him when a detail is omitted during one
of the numerous presentations they make together. In the past five years
alone, they have published more than 30 peer reviewed research articles in
many top scientific journals; David has actually published more articles
than several of his professors in graduate school.
The Geiers live in the house where David grew up and work most nights and
weekends on side-by-side computers in the study. The entire basement has
been converted into a work area, Ping- Pong table in the family room is covered
with stacks of articles, binders of their research notes, and scholarly books.
Despite Mark's long track record of studying vaccine safety, he did
not see the thimerosal debate coming. In fact, when frantic parents originally
asked him to explore the possible link in 2001, he believed it was a case
of wishful thinking, as there was simply no good science to back it up.
There were other reasons to be hesitant: The Geiers are adamantly provaccine-and
have learned through experience that questioning the immunization program
can make scientists extremely unpopular with their peers. In the early '90s,
Mark was assailed for criticizing the whole-cell pertussis vaccine and arguing
that it should be taken off the market. The attacks only abated in 1995,
once the FDA recommended its removal and replacement with a safer version
of the vaccine. The pattern is repeating with thimerosal. The AAP took the
unusual step of posting a document on its Web site in 2003 that was highly
critical of the Geiers'' research; more recently, the Geiers have been faulted
for their use of VAERS, a database that some researchers feel is too subjective
(almost anyone can report a health problem, and they may incorrectly link
the problem to a vaccine), and for their vociferous objections against thimerosal.
A more material reason for proceeding with caution is the risk of mass declines
in vaccination rates due to heightened fears. Anyone interested in vaccine
safety is well aware of Britain's recent experience with this. As concerns
escalated about a potential link between autism and the MMR vaccine, the
country saw immunization rates fall by 10 percent and disease rates increase.
As I sat at the dining room table in the Geiers' house in Maryland during
my first visit with them, several clear themes emerged from their story:
Working with the US government is neither fast nor easy; it's tough to gain
trust as an outsider; and people don't appreciate you poking around something
as important to the national interest as vaccines. Roadblocks were to be
expected, but at some point they became nearly insurmountable. "It
started," said David, "when we asked the CDC for data on the net distribution
of all vaccines given to American adults by year, which is something we needed
to accurately calculate vaccine reactions. They told us it didn't exist.
However, a month later an anonymous CDC employee secretly faxed photocopies
of the data to us."
The Geiers believed it was crucial to reexamine the very data that Dr. Verstraeten
and his colleagues used to study thimerosal. Up to that point in time the
CDC had refused to allow independent researchers to view the data they used
to publish vaccine safety studies. Under intense lobbying by Congress, the
agency announced in August 2002 that outside researchers would be allowed
to analyze the VSD database. The Geiers immediately applied. Just
as quickly, their proposal was rejected.
At first, the CDC denied their application on the basis of the configuration
of their proposed studies. The Geiers rewrote their requests and applied
again, beginning a five month process of back-and-forth with the CDC comprised
of new proposals, new rejections, new requirements, and further rejections.
Ultimately, the logjam was broken only through weekly intervention by Rep.
David Weldon, who is a physician himself and an advocate of independent research.
Over the course of the reapplication process, the Geiers incurred thousands
of dollars worth of fees and their proposal grew to more than 200 pages as
they incorporated suggestions from the CDC's half dozen rejection letters.
The delays continued as the CDC proved incapable of tracking down some of
its own data. "First they said we couldn't have a particular data set because
an outside researcher did not want to share it," Mark said. "After Dr. Weldon
intervened, the CDC said we couldn't have it because it was on obsolete media
and after further pressure, they stated that it was lost"
In December 2002, the Geiers' proposals were finally accepted, though they
were still ten months from actually seeing the data. In the interim, the
CDC required them to correspond with HMO review boards and to take lessons
in patient confidentiality. "The course on confidentiality was the last straw,"
recounted Mark. "I've taught patient confidentiality at Johns Hopkins University,
the National Institutes of Health, and Sarah Lawrence College, but they still
required a 12-module course through the University of Miami. The bigger issue
was the fact that no patient names, addresses, or clinic locations are in
the database, so you couldn't identify patients even if you wanted to."
The CDC initially turned down Seed's interview requests regarding thimerosal
but eventually agreed to answer questions via e-mail. Curtis Allen, of the
CDC's National Immunization Program, passed over queries about the Simpsonwood
meeting and whether it violated the Sunshine Act (a law requiring that meetings
of government agencies be open to the public), the Geiers' difficulty gaining
access to the VSD, and Rep. Weldon's requisite lobbying on their behalf.
Instead, he commented that, "Replication of studies and findings is a fundamental
component of science and scientific research.. The staff who have developed
the data-sharing program have been working diligently to ensure that the
program is successful and to ensure that VSD data be made available, as appropriate,
to external scientific researchers, while maintaining confidentiality."
The agency's reluctance to discuss its thimerosal research comes as no surprise.
Much is on the line for the CDC. If a thimerosal-autism link is firmly established,
the revelation will shake public confidence in the agency and its vaccination
protocol and may prompt litigation aimed at the CDC and
individual researchers within its ranks.
As the Geiers got closer to viewing the actual VSD data, Rep. Weldon asked
the agency to release all data sets from the different phases of Dr. Verstraeten's
study in order for the Geiers to examine how refinement of the data over
the years may have affected results. Of particular interest was the study
discussed at the Simpsonwood meeting, which indicated a statistically significant
link between thimerosal and numerous neurological problems. The CDC agreed
to provide the information, though the Geiers still had not received the
data several months later. Rep. Weldon continued to intervene on the Geiers'
behalf. "To date, only those with a conflict of interest have had access
to the database," he explained before sending another letter to the CDC's
director, Dr. Julie Gerberding, and others, asking about the hold up. A month
later he heard back and was told that previous data sets no longer existed.
"I ran the program several times, and each time it turned out the same the
kids in group five
receiving 100 micrograms of thimerosal were over ten
times more likely to have autism than the kids in group one [with no
mercury]." -David Geier
"Aside from the fact that they promised to maintain the data, it is standard
practice to do it so that others can analyze what you leave in and what you
take out," Mark Geier said."Unfortunately, that can never be done in this
case." David Geier's frustration with the situation was palpable: "The CDC
only allowed outside researchers into the VSD because Congress demanded it,
though it was obvious by the endless hurdles that they don't want us
looking at their data." But Dr. Robert Davis, who along with Dr.Verstraeten
and several other researchers co-authored the VSD study, insisted that interpreting
the changing and lost data as a cover-up is silly. "Of course the data changed
from one phase of the VSD study to another," he said. "It evolved. If
Congressmen Weldon questions that, then he doesn't fully understand the proper
approach to scientific research." He continued, "Science is best left to
scientists."
After 14 months of petitioning, the Geiers got their chance to review the
VSD. They drove to an address a few miles from their house. The building
they arrived at was nondescript from the outside and tucked behind a strip
mall. After taking the elevator up to the fourth floor, they stepped
into a long hallway dotted with offices on either side. Each door had a padlock
but was propped open with books or cups. "The building seemed deserted,"
David remembered. The Geiers followed the hall to a windowless room in the
building's interior, in which a single computer sat on a card table. Behind
it was a second small table, where a woman from the CDC was sitting quietly
waiting for them. The rules for viewing the data were laid out: no
phones, no tapes, no copies, no cell phones. Every keystroke the Geiers made
would be recorded. Their data would be printed in a locked room and examined
by the CDC observer and some pieces of it would be deleted with Liquid Paper
before they were allowed to see it. The CDC promised not to analyze the Geiers'
data but would keep a copy of it to ensure patient confidentiality.
On the computer were specific data sets corresponding to the Geiers' proposed
studies.
They got to work, spending their first day at the site
organizing the
information so they could compare children who had received different amounts
of thimerosal. The key lay in examining recipients of two kinds of DTaP vaccines-one
containing 25 micrograms of thimerosal per dose and one containing none.
From medical records, they were able to identify which type of vaccine each
child had received. They knew that fully vaccinated children had received
four DTaP shots by the age of 18 months, making it possible to segregate
the children into five groups from those who received virtually no thimerosal
(the control) to those who were given four doses of it.
Next, they programmed the computer to search for the International Code of
Disease for autism in the children's files and to count up the number of
children with the diagnosis of autism in each of the five groups.
The value of this design was that it did not require case ascertainment,
as there would be equal accuracy in labeling autistic children in all groups.
Interpreting the results from the control group was easy. The children
who received no thimerosal had no autism. Things began to change as they
viewed data from the higher-dose groups.
"At first I didn't think
it was right," David said. "I ran the program several times, and each time
it turned out the same, the kids in group five [receiving 100 micrograms
of thimerosal] were over ten times more likely to have autism than the kids
in group one [with no mercury]."Return to
Top
The results of the Geiers' VSD study were accepted for publication in Expert
Review of Vaccines, a peer-reviewed journal in which the CDC frequently
publishes. An October 22, 2003 e-mail from the journal's editor, Elisa Manzotti,
thanked the Geiers for an "excellent revision" in response to the peer-review
and outlined information on obtaining reprints of the published article.
But on November 11, 2003, Manzotti e-mailed them again. All bets were off.
The editors had abruptly reversed themselves, stating that they could not
publish the Geiers' work due to the concerns voiced by a new, anonymous reviewer.
"When we called the editor, she was very apologetic and said that after 20
years in the field, it was a first for her," said Mark, who has published
more than 70 peer-reviewed articles in the course of his career and has never
had an article withdrawn. Expert Review of Vaccines did not reply to
repeated requests for comment. Rep. Weldon is currently working with the
Geiers to get the study published in another leading journal. Meanwhile,
the results remain in limbo.
While scientists debated the thimerosal issue, the topic surfaced in the
political realm as well. In mid 2003, the Geiers were invited to present
their research to multiple state attorneys general, and I accompanied them.
Interest on the part of the attorneys general is just one indication
of how high the stakes have become. The National Vaccine Injury Compensation
Program in Washington, D.C., the vaccine court through which my son won his
claim, has been besieged by nearly 4,000 thimerosal cases, with more filed
daily. It was established in 1986 to shield vaccine makers from liability
while providing legal recourse and compensation for vaccine-injured children.
Parents are required to start there but may opt out after 240 days to pursue
civil litigation.
At present, thimerosal suits are on hold while the court determines causation
for all cases, which have been lumped together as the "Omnibus Autism Case."
To date, approximately 25 suits have been filed against five drug
makers outside the vaccine court. The claims begin at $1 million and increase
from there, depending on the seriousness of the injury. Although the number
is small, primarily because litigants are required to start with the National
Vaccine Injury Compensation Program,
potential liability for the pharmaceutical
industry is astronomical. "When you multiply the number of autistic children
in the Department of Education data by the typical cost over a lifetime,
you quickly exceed a trillion dollars," said Mark. "Others have told
us these estimates are conservative since we don't factor in children with
related neurological disorders." But it is likely that the states
themselves have the most skin in the game, as the cost of educating and caring
for an autistic child throughout his or her lifetime is estimated to be $5
million to $10 million, an expense carried largely by taxpayers.
"One in eighty males is diagnosed with autism today," said Mark in
one of his recent presentations. "Many of them will not be able to work.
How are we going to pay for their care?" The Geiers' trip to
Minnesota Attorney General Mike Hatch's office took place in September and
was of particular interest due to Hatch's prominent role in tobacco litigation.
We arrived at the domed state capitol building early and waited for Hatch
in a high ceilinged meeting room. A woman with a fixed smile popped
her head out from the office and led us past the flags and official portraits
to a room with a long oak table. A few minutes later, Hatch bustled in with
coffee in hand, making apologies for being late.
The Geiers launched into their presentation. It was scheduled for 45 minutes,
but the conversation became intense and the meeting stretched to more than
three hours. Hatch's press secretary looked anxious and repeatedly tapped
his watch and raised his eyebrows at his boss, but the Attorney General only
nodded back. The Geiers fielded numerous questions from Hatch and his staff:
"Are there other studies besides your research that show thimerosal is a
problem?" Before answering, David tapped a foot-high pile of papers on the
table next to him. "Do your own Medline search, they're easy to find. We've
turned p 5,000 peer-reviewed articles so far that discuss thimerosal's toxicity,
which come out of all lines of medicine, agriculture, and other areas from
scientists across the globe. A dozen of these are written by scientists within
the CDC and FDA." Another question: "I've heard thimerosal is safe because
it doesn't cross, the blood-brain barrier." "That's not true," said Mark.
"And you don't have to take my word for it. Dr. William Slikker from the
FDA wrote a recent Neurotoxicology article and said that it does cross, and
accumulates in the brain." But the questioner wasn't satisfied. "I
read that ethyl and methyl mercury are different - the kind of mercury kids
get is safe." "That's not what Dr. Leslie Ball from the FDA wrote in 2001-and
she's just one of many stating it," Mark replied. (Thimerosal contains ethyl
mercury. The difference between ethyl and methyl mercury in terms of toxicity
to humans is still unclear.) More questions, more answers - each with complete
references to specific articles, authors, and journals.
This was actually the Geiers' second meeting with Hatch, and the Attorney
General had done his homework. Between their visits, he'd invited pharmaceutical
representatives to Minnesota to present their side of the thimerosal debate.
Similarly, when we met with Nebraska Attorney General Jon Bruning two months
later, he had met with representatives from pharmaceutical giants Wyeth and
Eli Lilly and Company. Ed Sagebiel, spokesperson for Eli Lilly and Company,
which first patented thimerosal and continues to receive money from licensing
agreements with other drug makers, stated that legal action over thimerosal
is misguided - although he was unwilling to answer questions about long-term
safety studies and was unfamiliar with recent molecular, DNA, and animal
studies of the chemical. Still, he continued, "There is no scientifically
credible evidence that links thimerosal to autism." He preferred not to comment
on the Geiers' research but forwarded a two-page document, created by the
company, that outlined why Mark Geier should be discredited. In a six-week
period around the beginning of this year, the Geiers traveled to Kansas,
Nebraska, New York, South Carolina, North Carolina, Virginia, and California
in rapid succession. In early December, I met them in Lincoln, Nebraska.
A local doctor and businessman were instrumental in getting the meeting arranged,
and they drove us through the countryside to the Attorney General Bruning's
office. Bruning, who at age 34 could easily pass for Tom Hanks in Big, strode
into the room smiling and sat directly across from the Geiers at a crowded
table. We were scheduled for 45 minutes, and again the meeting lasted three
or more hours.
"I've studied thimerosal and talked to people on both sides of the issue.
There is enough evidence I've seen to make it clear to me that we need to
get thimerosal out of the products we give to our children." - Ken Veenstra
(R-Iowa) The Iowa senate committee voted in favor of the ban on March
1.
Afterwards, the Geiers' day proceeded apace - a presentation to the University
of Nebraska medical school and a public talk, followed by more presentations
and a radio interview the next morning. A meeting in New York took
place three weeks later. I followed the Geiers through the Empire State
Building's security check, past a group of arguing teens, and up a creaking
elevator to Attorney General Eliot Spitzer's office. As usual, the
presentation ran long. "I was intrigued by the Geiers," Joseph Baker, deputy
health bureau chief, told me a month later. "We are pursuing it." The
visit to the California attorney general's office was different than the
others, as the state already has a law requiring that products containing
harmful substances have warning labels - and thimerosal is on the chemical
hit list. However, the state recently lost a lawsuit that would have required
thimerosal-containing vaccines to have such warnings-because federal law
is considered adequate for prescription drug warnings, explained Ed Weil,
supervising deputy attorney general in California. "The court ruled that
FDA standards are sufficient. If they say thimerosal doesn't need a warning,
we can't add one to vaccines.
Following the attorneys general meetings, the Geiers met with bipartisan
senate offices, including staff members for senators Stabinow, Cantwell,
Kennedy, Clinton, and Kerry, and with Senator Edwards himself. Concurrently,
lawmakers in Iowa, Missouri, Nebraska, and Kansas presented legislation to
ban thimerosal in childhood vaccines. Interestingly, while the thimerosal
issue is often painted as the terrain of liberal trial lawyers, Republican
lawmakers are actually leading the charge to ban the preservative's use.
A case in point is Senator Roy Holand (R-Missouri), a physician by training
who presented a bill to Missouri's legislators to prohibit thimerosal in
childhood vaccines in his state. On March 10, the bill passed the Missouri
state House of Representatives by 152 to four, the biggest landslide victory
in recent state history. Those who testified against the bill included
the Department of Health and Human Services and the Pharmaceutical Research
Manufacturers of America, among others.
"As a physician, I've been concerned about the rising levels of autism, and
the more I've learned about thimerosal, the more convinced I am that it causes
neurological damage," said Holand. "Mercury has no place being injected into
children."
Senator Ken Veenstra (R-Iowa), who introduced a similar
bill to Iowa's Senate Human Resources Committee, put it just as simply: "I've
studied thimerosal and talked to people on both sides of the issue. There
is enough evidence I've seen to make it clear to me that we need to get thimerosal
out of the products we give to our children." The Iowa senate committee
voted in favor of the ban on March 1.
A month later, on April 5, Rep. Weldon and Rep. Carolyn Murphy (D New York)
introduced legislation to ban mercury from vaccines at the federal level.
HR 4169 requires that by January 1, 2005, no childhood vaccine have more
than one microgram of mercury and that by January 1, 2006, mercury be removed
from all childhood and adolescent vaccines. In a statement, Rep. Weldon
said, "We can eliminate this exposure now, and it is inexcusable not to."
As I followed the Geiers around the country, I tracked down one of the participants
from the Simpsonwood meeting in Georgia, and he agreed to speak with me on
the condition of anonymity. Before I could ask my first question, he
cut in: "Just tell me first - are you one of those anti-vaccine militants?"
"No," I responded. "Are you one of those pro-pharmaceutical extremists?"
He laughed, and it broke the ice. I told him about my son Porter's brain
damage and about my other vaccinated children. I am not anti-vaccine,
I said, but what about Simpsonwood and the data you saw there that showed
a link with neurological problems? "Thimerosal is a potent neurotoxin -
no one would dispute that," he told me. "The question is whether the
amount children receive has any clinical significance." "Does it? " I asked.
"In all honesty, we may not know for a while," he said. "Medicine works that
way. Here's an example: We used to give oxygen to newborns. We thought that
was a good thing to do. Ten thousand children went blind from it. We may
not know about thimerosal for five to ten years." Dr. Thomas Saari
of the American Academy of Pediatrics agreed that time will tell: "I am keeping
an open mind [about thimerosal]. I am glad a lot of research is going on,
and we'll see in five years where things shake out." In Februrary, the Institute
of Medicine (IOM) convened a meeting to review thimerosal's safety, and numerous
scientists on both sides of the debate presented data, including the Geiers.
The IOM is expected to render its opinion sometime this month. Within
two weeks of sharing their VSD findings at the IOM meeting, however,
the Geiers received a letter from the CDC stating that due to "potential
issues of patient confidentiality," they would no longer be granted access
to the data. "I am very concerned about this action and find that it fits
the pattern," said Rep. Weldon. "It took me over a year of working with the
CDC to get Mark Geier access in the first place. I am committed to working
to see that access is restored." Rep. Weldon, with the backing of a
bipartisan contingent of Congressional members, is currently looking into
the matter. "These roadblocks won't stop progress," said Mark, seemingly
undeterred.
"Due to the epidemic of neurological problems, even the government has
officially put autism research on the national agenda. We're moving past
database studies anyway - fascinating new research is being done by scientists
from Tufts, Johns Hopkins, University of Kentucky, the United States' Department
of Agriculture, and other places,
showing through double-blind clinical
trials that autistic children have very little ability to eliminate mercury.
Others at
Northeastern and Baylor University have shown how thimerosal
damages DNA. This adds more potential evidence to the theory that
children cannot get rid of it when given large doses. Dr. Mady Hornig [a
professor of epidemiology] from Columbia University also just announced her
findings that she can make mice act like they have a disorder like autism
by treating them with thimerosal in a regiment similar to that used in infants.
If VSD studies are no longer possible, we will continue to pursue the other
avenues of research.
We, and many of the children, don't have five years
to wait."
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