“Something
is Rotten, But Not Just In Denmark”
Remarks of Rep. Dave Weldon, M.D. (R-FL) Autism One Conference
Chicago, Illinois May 29, 2004
It is a pleasure to be here with you today. I am pleased to
see that the Autism community is more united today than they
have ever been. I have said repeatedly that the Autism Community
is the 900-pound gorilla that has not had its voice heard adequately
on Capitol Hill.
That is
largely due to the endless demands on your time, effort,
emotions,
and money in caring for the unique needs of your
children. There is little left to engage the public at large
and the Congress in particular. I see that changing. Certainly,
last week’s Institute of Medicine “report” has
had one positive effect, it has united and reinvigorated you
and the parents of autistic and vaccine injured children across
this nation.
I want
to make it clear that I support vaccinations. My 5-year-old
son has
had all of his vaccinations. Someone in the media last
week tried to portray me as a “vaccine skeptic.” After
reviewing my record on this issue and all of my statements
in the past, the newspaper printed a retraction. This however,
seems to be part of a pattern – to vilify those who simply
ask if our vaccines could be safer.
Friends, I practice what I preach. I support vaccinations
and gave them to thousands of my patients and my own son. However
I also believe it is appropriate to acknowledge that, like
with any medical intervention, different individuals respond
differently. We are all unique, we all have a different genetic
makeup, and what may cause no harm in one individual just might
cause harmful in another.
Since we established the vaccine compensation program in the
late 1980s several thousand individuals have been compensated
for vaccine injuries. We know there are adverse reactions,
and I believe it is important that we dedicate resources to
better understand why some children have them.
For too long, those who run our national vaccination program
have viewed those who have adverse reactions, including those
with severe adverse reactions, as the cost of doing business.
Furthermore, the vaccine compensation program which was designed
to be a no-fault compensation system has become so adversarial
that only the most obvious of cases receive compensation and
too many parents feel that the program is not worth the agony.
The questions
that I have raised and continue to raise about vaccines are
several.
The number one question has been whether
neurological problems were caused in some children by the high
levels of mercury contained in many vaccines in the 1990s.
Mercury is a neurotoxin. And, in the 1990s children – infants
and unborn children – were exposed to significant amounts
of mercury at the most critical point of their development.
Is the Autism community united now in their effort to see
that research into the possible association between vaccines
and neurodevelopmental disabilities is investigated? You bet!
Autism One, Defeat Autism Now, Cure Autism Now, Unlocking
Autism, The Autism Society of America, Unlocking Autism, Moms
Against Mercury, The National Autism Association, No Mercury,
and The National Alliance For Autism Research have all expressed
objections to the IOM report and have united behind the need
to ensure that the federal government commits the necessary
research to fund the biological and clinical research needed
to get at the facts.
Just what is so wrong with the IOM report? What has caused
all of the Autism groups to unite against the IOM?
In my 10
years of service in the US Congress, I have never seen a
report so
badly miss the mark. I have heard some weak
arguments around Washington and I can tell you that those in
the IOM’s recent report are very weak. Examine this report
in detail. It is plagued with serious flaws.
On January
15 of this year I wrote Dr. Julie Gerberding, the Director
of the
CDC, I asked her to post-pone the February
9, IOM meeting and this report because of my concern that this
was not an exercise in discovering the truth but was instead
a meeting “being driven by a desire to short-circuit
important research and draw premature conclusions. If the purpose
of this meeting is to seriously consider and address these
concerns” I wrote, “then this will not be accomplished.”
Allow me to quote further from my letter to Dr Gerberding:
“It appears to me not only as a Member of Congress but also as a physician
that some officials within the CDC’s NIP may be more interested in a public
relations campaign than getting to the truth about thimerosal.”
“Pressing
forward with this meeting at this time, I believe, will further
undermine the credibility of the Centers
for Disease Control (CDC) on matters of vaccine safety and
do damage to the reputation of the IOM. I believe the proposed
date of this meeting, which you have the ability to change,
is in the best interests of no one who is seeking the truth
about a possible association between vaccines and neurodevelopmental
disorders, including autism.
In a follow-up
telephone conversation to me on February 3, 2004, Dr. Gerberding
assured
me that the IOM’s February
meeting was “not an attempted draw conclusions” but
merely to “update on the science” of where we are
at this point in time. However, it clearly draws conclusions
and in what is perhaps the greatest outrage it goes further
to call for a halt to all further research.
A public
relations campaign, rather than sound science, seems to be
the M.O.
of the officials at the CDC’s National
Immunization Program (NIP) office. Why do I say this? Let’s
look, not only at the timing of the IOM meeting in February,
the content of the IOM report, but also at studies the IOM
used as a basis for their decisions. The IOM bases their decision
almost entirely on five 3 epidemiology studies, all of which
were conducted by researchers with an interest in not finding
an association, all of which have short-comings, and all of
which the IOM declares would miss an association if it were
in a genetically susceptible subset of children.
Not only the timing of the IOM meeting raises suspicions,
but also the narrowing of the scope of inquiry, and the emphasis
IOM was to assign to epidemiology.
In 2001,
the Institute of Medicine concluded that “exposure
to thimerosal-containing vaccines could be associated with
neurodevelopmental disorders.” The IOM also recommended
that children not be given mercury-containing vaccines. What
was the response of the CDC? For this most recent report they
narrowed the IOM’s scope to looking just at Autism. Does
that sound like an agency interested in understanding whether
or not thimerosal might be harmful, to some children? Or, does
this response lead one to conclude that they are more interested
in designing something to reassure an increasingly skeptical
public?
Unlike
2001, this time the IOM was directed by CDC to only consider
the possible
relationship between thimerosal and Autism,
rather than NDDs as a whole. Anyone familiar with the Verstraeten
study knows exactly why the IOM’s scope was narrowed – because
the 2003 Verstraeten study found associations between thimerosal
and NDDs and some children with autism may have been misdiagnosed
as having speech or language delay.
By narrowing
the scope – which largely went unnoticed
by the media – the CDC has avoided acknowledging that
thimerosal very well may have caused NDDs in some children.
This latest IOM report is simply part of a P.R. campaign in
my view. Would we not have had a much more productive report
if the CDC had updated the research on possible associations
between thimerosal and NDDs as a whole.
In evaluating
thimerosal’s relationship to Autism, the
IOM relies almost exclusively on five epidemiology studies.
The principal authors of all five studies have serious conflicts
of interest. All five studies were published in 2003 leading
up to the IOM’s February 2004 meeting. All were conducted
while the CDC and NIH virtually ignored the IOM’s 2001
biological and clinical research recommendations.
It is critical to note the instructions that the IOM was given,
primarily by the CDC, which has been funding the IOM. Pages
5 and 6 of the IOM report make it clear that epidemiology was
to reign supreme. In the absence of epidemiological evidence
to support causality, IOM was instructed to give biological
evidence little consideration, and was prohibited from allowing
biological evidence to lend evidence toward causality.
Is it any
wonder that the CDC has spent the past two years dedicating
significant
funding to epidemiology while starving
funding for clinical and biological research? The IOM notes
in their report that the epidemiology studies they examined
were not designed to pick up a genetically susceptible population.
Yet, they attempt to use these five flawed and conflicted statistical
studies to quash further research into the possible association
between vaccines and autism. This report is extreme in its
findings and recommendations. The IOM process became little
more than an attempt to validate the CDC’s claims that
vaccines have caused no harm,
while quashing research to better understand whether or not
and how the MMR or thimerosal might contribute to the epidemic
of neurodevelopmental disorders, including autism.
I would like to turn now to the specifics of these five studies.
Verstraeten
Study – Pediatrics,
November 2003
The Verstraeten
study has been the subject of considerable criticism. This
study, published in November 2003 in Pediatrics
the journal of the American Academy of Pediatrics was released
with much fanfare and public relations “spin.” Much
has been written exposing the study’s methodological
problems, findings, and conclusions. Most importantly however,
is that this study did not compare children who got thimerosal
to those who did not. Instead, its CDC-employed authors focused
primarily on a dose response gradient.
In addition
to the study itself, it is important to note the public relations “spin” surrounding
this study.
On the
day the Verstraeten study was released, a top CDC researcher
and a coauthor of
the study was quick to declare to the news
media that, “The final results of the study show no statistical
association between thimerosal vaccines and harmful health
outcomes in children, in particular autism and attention-deficit
disorder.” Let me repeat that, “The final results
of the study show no statistical association between thimerosal
vaccines and harmful health outcomes in children, in particular
autism and attention-deficit disorder.”
The newspaper headlines of the day read:
•
“Study Clears Vaccines Containing Mercury” Associated
Press and USA Today,
•
“CDC Says Vaccines are Safe...” The Seattle Times
While that
was the spin of the day, allow me to quote from the study. “... we found no consistent
significant associations between TCVs [thimerosal containing vaccines] and neurodevelopmental
outcomes. In the first phase of our study, we found an association
between exposure to Hg from TCV and some of the neurodevelopmental
outcomes screened. In the second phase, these associations
were not replicated for the most common disorders in an independent
population.” They did find associations, but as they
changed the study most of the associations, but not all, disappeared.
Furthermore, in a January 2004 article this lead co-author
was forced to admit that many children in the study were too
young to have received an autism diagnosis. He went on to admit
that the study also likely mislabeled young autistic children
as having other disabilities thus masking the number of children
with autism.
The message
from the CDC to media was that there is nothing to be concerned
about, but the study said something somewhat
different. The news media too a large degree took the CDC’s
spin hook, line, and sinker, and largely chose not to read
the study itself.
Five months
after the article was published, and largely after the IOM
report
had been written, the lead author of the study,
Dr. Thomas Verstraeten broke his silence in a letter to Pediatrics
stating: “The bottom line is and has always been the
same: an association between thimerosal and neurological outcomes
could neither be confirmed nor refuted, and therefore, more
study is required.”
Dr Verstraeten
the lead author of the study says that an association between
TCVs and NDDs cannot be refuted based on his study,
yet the IOM in their assessment of the same study state that
it is a basis for concluding that “there is no association
between thimerosal-containing vaccines and autism."
The IOM
acknowledges that Verstraeten would not have picked up an
association
in a genetically susceptible population.
The IOM also noted that the study was limited in its “ability
to answer whether thimerosal in vaccines causes autism because
the study tests a dose-response gradient, not exposure versus
non-exposure.”
It is also
critical to note that the Verstraeten study cannot be validated.
The
earlier datasets have been destroyed and
the only datasets the CDC will make available to outside researchers
are the ones that they have already manipulated. The raw, unaltered
data is not available. Additionally, outside researchers are
held to a much more restrictive access to information than
are CDC researchers. Only one independent researcher has been
granted access to the CDC’s VSD database and the CDC
has kicked those researchers out based on ridiculous reasons.
They claimed their research methods might infringe on privacy.
Yet the database contains no names. The researchers do not
even know what HMO the patient is enrolled in. Nor do they
know what state the subjects live in. There is no way for an
individual to be identified through their research.
Hviid Study
The IOM sited the 2003 study by Hviid of the Danish Population
as one the key studies upon which it bases its conclusions.
Let’s consider first the conflict of interest of the
principal author. Hviid works for the Danish Epidemiology Science
Center which is housed at the Staten Serum Institute (SSI)
the government owned Danish vaccine manufacturer. Also, all
of his coauthors either work with him at the Center or are
employed by SSI. Staten Serum Institute (SSI) makes a considerable
profit off the sale of vaccines and vaccine components and
the U.S. is a major market for SSI.SSI has $120 million in
annual revenues and vaccines are the fastest growing business
segment accounting for 80% of its profits. Both the U.S. and
U.K. are important export markets for SSI’s vaccines
and vaccine components.
Furthermore, if Hviid were to find an association between
thimerosal and autism, SSI with which he and his Center are
affiliated would face significant lawsuits. These facts are
important and are critical when evaluating this study.
Furthermore,
this study only looked at Autism and not neurodevelopmental
disorders
as a whole. Mercury exposures in the Danish population
varied considerably from those in the U.S. Danish children
received 75 micrograms of mercury by 9 weeks and another 50mcgs
at 10 months. By comparison, children in the U.S. received
187.5 mcgs of mercury by age 6 months – nearly 2 1/2times
as much mercury as Danish children in just the first 6 months
of life.
Dr. Boyd Haley has said that comparing the exposures in the
US to those in other countries is like comparing apples and
cows. I think there is a lot of truth to that.
Hviid states that the rate of autism went up after they began
removing thimerosal from vaccines in 1992. The numbers in Hviid
study are skewed in that they added outpatient Autism diagnosis
to the number after 1992. The IOM notes other limitations of
the study including the differences in the dosing schedule
and the relative genetic homogeneity of the Danish population.
Yet even
with these serious limitations, the committee concludes that
this study
has a “strong internal validity,” finding
an increase in autism after removal of thimerosal.
Like the Verstraeten study, Hviid would not be able to pick
up a group of children who were genetically susceptible to
mercury toxicity.
Danish
autism rate is about 6 in 10,000 vs. 30 in 10,000 in the
U.S. – once
again we are comparing apples and cows. Indeed, I believe
it can legitimately be argued that the lower
rate of Autism in Denmark is attributable to the lower exposure
to mercury in their population
Madsen Study
Next the IOM relies on the study by Madsen et al., once again
examining virtually the same population that Hviid examined.
Again, the relevance of the Danish experience to the U.S. experience
is limited in that the Danish population is genetically homogenous
and had significantly lower thimerosal exposures than children
in the U.S.
Let’s consider the conflicts of interest with this study.
First of all, two of Madsen’s coauthors are employed
by the Staten Serum Institute. Additionally, like Hviid, two
of Madsen’s coauthors work directly for the Staten Serum
Institute (SSI) – the Danish vaccine manufacturer which
exports vaccines and vaccine components to the U.S. and which
faces liability if an association is found. Madsen works for
the Danish Epidemiology Science Center – which is affiliated
with SSI.
This study, like Hviid, added outpatient cases into the number
of cases of autism after 1995. The authors acknowledged that
this addition might have exaggerated the incidence of autism
after the removal of thimerosal.
The IOM acknowledged that this limits the study’s contribution
to causality
Stehr-Green Study
The IOM relied on the Stehr-Green study which examined the
Danish population (do you see a pattern yet?) and Swedish populations
and attempted to compare that to the U.S. population. Furthermore,
a key coauthor if this study is employed by the Danish vaccine
manufacturer Staten Serum Institute.
I will
not repeat the problems with the Danish data again, but with
regard
to Sweden it is important to note the children
there received even less thimerosal than children in Denmark –receiving
only 75 mcgs by age 2. Furthermore, the authors included only
inpatient autism diagnoses in the Swedish population. The IOM
notes that the ecological nature of this data “limits
the study’s contribution to causality.” But they
site it anyway.
Miller et al..
The Miller study examines the population of children in the
United Kingdom. This study is still unpublished which limits
a critical and public evaluation of its findings.
Dr. Miller has actively campaigned against those who have
raised questions about vaccine safety. She and her department
receive funding from vaccine manufacturers, and she reportedly
serves as an expert witness on behalf of vaccine manufacturers
who are being sued.
This study, like the Verstraeten study is a dose response
study which is limited in that it does not compare children
who received thimerosal to those who did not.
Children in the U.K were exposed to up to 75 mcg of mercury
by 4 months of age. This represents about one-half of what
children in the US would have been exposed to by this age,
plus children in the U.S. got another 50 mcg two months later
at age 6 months for a total exposure in the first six months
of life of nearly 2 1/2 times what children received in the
U.K.
The author concludes that the study found no association between
increasing exposures to thimerosal and Autism.
Conclusion on Epi studies.
You can see clearly why the IOM is on very shaky ground in
drawing the conclusions they did. They based their decision
on five epidemiology studies:
• Three
of them examining the genetically homogenous population of
Denmark
• At least one employee of the Staten Serum Institute serves
a coauthor of at least 3 of the studies.
•
Only one study examining the U.S. population – and that
study did not compare those with no mercury exposure to those
with exposures.
• Four of them with populations receiving less than half of the
mercury exposure that children in the U.S. received
• None of them with any ascertainment of prenatal or postnatal
background mercury exposures.
• None of them considering prenatal exposures which may have
given children
• None of them able to detect a susceptible subgroup that many
have had a genetic susceptibility to mercury toxicity.
• Three of them failing to address how the addition of outpatient
cases of Autism in Denmark might have perilously skewed the
results.
• Four of them examined populations with autism rates considerably
below that in the U.S.
• One of the studies has not been published and not subjected
to public review.
Bio/Clinical Research - Thimerosal
Since the release of the IOM’s report in 2001, public
health officials in the US virtually ignored the biological
and clinical research recommendations. While the CDC had no
trouble funding epidemiology studies – all with their
flaws and inadequacies – several critical biological
and clinical research recommendations were starved of funding:
The IOM recommended that the following studies be done, but
the CDC and the NIH failed to dedicate the resources to fund
these studies:
• Identify primary sources and levels of prenatal and
postnatal background exposures to thimerosal, including Rho
(D) Immune Globulin in pregnant women and other forms of mercury
(fish) in infants, children and pregnant women – NOT
DONE;
• Compare
the incidence and prevalence of NDDs before and after removal
of thimerosal from vaccines. NOT DONE and
the CDC tells me they will not begin such studies until2006.
• Research how children, including those with NDDs,
metabolize and excrete metals –particularly mercury-
NOT DONE
• Conduct research on theoretical modeling of ethylmercury
exposures, including the incremental burden of thimerosal with
background mercury exposures from other sources– NOT
DONE
• Conduct careful, rigorous and scientific investigations
of chelation when used in children with NDDs, especially Autism.
NOT DONE though in their latest report they urge that this
be highly restricted. • Conduct comparative animal studies
of the toxicity of ethylmercury and methylmercury to better
understand the NDD effects of thimerosal – ONLY PARTIALLY
DONE – but with very little federal support.
In 2001
the IOM stated that it is “unclear whether ethylmercury
[from vaccines] passes readily through the blood-brain barrier...” The
IOM recommended several biological and clinical studies to
answer this question and whether this mercury could cause developmental
problems. These studies were in large part never done. Yet
IOM chose to ignore the need for this research and instead
has focused its analysis on the data available today, most
of which is statistical data.
There is much more research that needs to be done before it
can definitively be said that thimerosal does not contribute
to NDDs. Even today, the IOM cannot tell you with any degree
of certainty what happens to ethylmercury once injected into
an infant. Does it go to the brain? Does is cause developmental
problems? Who knows?
MMR – Autism
Association
Allow me to touch briefly on the IOM’s analysis of
the MMR-Autism issue. They devoted only one hour of discussion
to this topic at the February meeting and failed to invite
those who were most intimately involved in this research to
present to the IOM.
As with
thimerosal, the IOM relied almost exclusively on epidemiology.
They made
their decision about whether or not measles may be
related to Autism in children, by reviewing 13 statistical
studies in which many of the authors have conflicts of interest.
Some of these authors have been openly hostile in their assessments,
which calls into question their objectivity. Also, remember
it is epidemiology that reigns supreme in this review – even
if the studies are flawed in their design.
The IOM
still cannot answer the question as to why measles is in
the intestines
of some Autistic children. Why is it there?
What is it doing? How did it get there? Is it contributing
to Autism? The IOM attempts to explain this issue away by saying
it’s likely that the presence of measles could just be
a co morbidity to Autism. This cavalier attitude of the IOM,
the CDC, and others in the public health community is unacceptable.
We have a moral obligation to fully support research to understand
why vaccine strain measles is the intestines and CSF of these
children. The government mandated vaccination, the least we
should do is fund research to understand why measles is persisting
in these children, what harm it might be causing, and how we
might best treat these children.
The NIH
is only now attempting to duplicate the work of Dr. Andrew
Wakefield.
Despite being vilified for the last 6 years
half of Dr. Wakefield’s work has been demonstrated to
be correct. Practitioners across the U.S. and in many other
parts of the world are finding the same inflammatory bowel
disease he first described in Lancet in 1998. Drawing “conclusions” at
this time is counterproductive. Statistical studies are of
little benefit, only a clinical pathological study will lay
this issue to rest.
A Few Final Remarks Regarding The IOM Report
For the
reasons outlined above and other reasons, this report is
premature,
perilously reliant on epidemiology, based on
preliminary incomplete information, and I believe may be ultimately
repudiated – perhaps in short order.
This report will not deter me nor the Autism community from
our commitment to seeing that thimerosal and MMR research is
properly done. This report will do nothing to put to rest the
concerns of parents who believe their children were harmed
by mercury-containing vaccines or the MMR vaccine.
While this report will lead many clinicians to believe that
thimerosal is safe and there is no problem with the MMR, it
may contribute further to an erosion in the doctor-patient
relationship.
This report has dragged the IOM under the cloud of controversy
that has currently engulfed CDC.
Much like the infamous 1989 study by The National Institute
of Child and Human Development(NICHD) which missed the link
between folic acid deficiencies and neural tube defects like
spina bifida, the epidemiology studies reviewed by the IOM
in drawing these findings, could easily have missed associations
in susceptible populations.
Finally, let’s remember that the IOM is not immune to
error and has been forced to reverse itself before. Most recently
the IOM reversed a long-standing finding that chronic lymphocyticleukemia
(CLL) was not due to Agent Orange exposures. A similar reversal
is a very real possibility here.
H.R.
4169 – The
Mercury Free Vaccines Act of 2004
On April
2, I introduced along with Rep. Carolyn Maloney, H.R. 4169 – The
Mercury Free Vaccines Act of 2004. We currently have 15 cosponsors
from across the political spectrum.
H.R. 4169 will phase-out the use of mercury in vaccines over
the next 3 years, giving particular attention to completely
eliminating mercury from childhood vaccines on an expedited
schedule.
This bill is in response to the fact that:
• The
safety of thimerosal in vaccines is not proven
• Mercury is well-established as a neurotoxin.
• According to the EPA 1 in 6 newborns is born with a blood mercury
level considered unsafe.
• The FDA and the EPA recently warned pregnant women, nursing
mothers, and young children to limit their consumption of certain
fish that are high in mercury.
•
No one at the NIH or CDC can tell you what happens to the mercury
once injected into an infant – Where does it go? How
much goes to critical organs? How much to the brain? Can it
cause damage to the developing central nervous system? No one
can answer these question and they should before infants are
exposed to more mercury.
•
The CDC is has adopted a policy reintroducing mercury into
childhood vaccines by recommending the flu vaccine for infants
at 6, 7, and 23 months of age – most of which contain
mercury. If we are going to move this legislation forward,
I am going to need each and everyone of you to go back and
get your member of Congress to cosponsor this bill. You need
to call them and ask them to cosponsor H.R. 4169. And be persistent,
but not rude.
New Legislation to Monitor Adverse Reactions to Vaccines
It is critical that we make improvements in how we monitor
for and respond to adverse reactions to vaccines. Today there
are three government agencies that have responsibilities
related to monitoring the safety of vaccines – the
FDA, the CDC, and the NIH.
The Food and Drug Administration (FDA) has a responsibility
to monitor vaccine safety. However, their role is largely limited
to ensuring that vaccine lots that are released meet FDA standards
and collecting information to be entered into the Vaccine Adverse
Events Reporting System (VAERS).
The NIH does not have a concerted effort to fund vaccine safety
research. They provide funding for research in a haphazard
manner - if you happen to submit a proposal and it passes peer
review they may fund it. The NIH has funded only a handful
of studies over the past two years investigating vaccine safety
issues. The CDC has the greatest responsibility in this area.
Unfortunately, they also have the greatest conflict of interest.
The CDC’s
vaccine safety program amounts to about $30 Million a year,
and half of this goes to pay HMOs for access
to the Vaccine Safety Database.
The biggest
conflict within the CDC is that they are also responsible
for a running
$1 Billion vaccine promotion program.
The CDC largely measures it success by how high vaccination
rates are. Here lies the largest conflict. Any study raising
concerns that there might be adverse reactions is likely to
result in safety concerns leading to lower vaccination rates.
Lower vaccination rates are in direct conflict with the CDC’s
top measurement of success. Clearly, due to its overwhelming
size and the manner in which the agency measures its success,
the vaccine promotion program overshadows and influences the
CDC’s vaccine safety program.
In fact, rightly or wrongly, the vaccine safety office within
the CDC is largely viewed by outside observers as nothing more
than another arm of the vaccine promotion program, giving support
to vaccine promotion policies and doing very little to investigate
and better understand acute and chronic adverse reactions.
Further
complicating the CDC’s role and undermining
their research is the fact that the vaccine safety studies
produced by the CDC are impossible to reproduce. External researchers
are not granted the same level of access to the raw datasets
that the CDC’s internal researchers are granted. The
bottom line is that the CDC’s studies related to vaccine
safety cannot be validated by external researchers – a
critical component in demonstrating the validity of scientific
findings.
The CDC
recently announced that a Blue Ribbon Panel will meet to
examine how
the CDC might better review vaccine safety.
I do not hold out much hope for this panel, however, because
the panel is limited in their scope. Much like the IOM was
limited in the outcome they were allowed to draw, this panel
is limited to deciding where within CDC, vaccine safety monitoring
should be housed. The NIH recently recognized the importance
of moving patient safety monitoring outside of NIH – I
believe the same should be done with vaccine monitoring. It
should be completely removed from the CDC’s jurisdiction.
The CDC is too conflicted to oversee this function.
In order to ensure that there is a concerted and independent
effort within the federal government to monitor for adverse
reactions to vaccines, I have prepared legislation which I
will soon introduce that will ensure that vaccine safety monitoring
is completely independent. It has become clear to me that the
federal government has failed miserably and has not given this
issue the attention that is needed. Clearly, greater oversight
and complete independence is needed.
My legislation will ensure that those responsible for vaccine
safety research are free from all conflicts of interest and
have as their sole focus the following:
• Determining what these adverse reactions are
• Understanding why some individuals have adverse reactions,
and
• How we might best ensure that such reactions are avoided.
Brighton Collaboration
Finally, I want to turn my attention to something known as
the Brighton Collaboration.
I am very concerned about the development of the Brighton
Collaboration which began in 2000.This is an international
group comprised of public health officials from the CDC, Europe,
and world health agencies like WHO, and vaccine manufacturers.
This first task of the Brighton Collaborations, created several
years ago, is to define what constitutes and adverse reaction
to a vaccine. They have established committees to work on various
adverse reactions to vaccines. Particularly troubling is the
fact that serving on the panels defining what constitutes an
adverse reaction to a vaccine, are vaccine manufacturers. What
is even worse is the fact that some of these committees are
chaired by vaccine manufacturers. It is totally inappropriate
for a manufacturer of vaccines to be put in the position of
determining what is and is not an adverse reaction to their
product.
Do we allow GM, Ford and Chrysler to define the safety of
their automobiles?
Do we let airlines set the safety standards for their airlines
and determine the cause of an airline accident?
Do we allow food processors to determine whether or not their
food is contaminated or caused harm?
Then, why I ask, are we allowing vaccine manufactures to define
what constitutes an adverse reaction to a vaccine?
This collaboration is fraught with pitfalls and merges regulators
and the regulated into an indistinguishable group.
It is critical that the American public look at what is going
on here and how this entity may further erode their ability
to fully understand the true relationships between various
vaccines and adverse reactions.
I plan to devote additional attention to this effort.
Concluding Remarks
Finally, Autism is a difficult challenge facing our nation.
We have made considerable progress through groups like Autism
One and the other autism organizations represented here.
The work you are doing is work that must continue. I commend
each of you.
I commend the researchers who are engaged to develop a deeper
understanding of what is going on with these children and how
we might improve their treatments. I am hopeful that the folks
down at the NIH, the CDC, and the IOM will be more supportive
of your work. I will do all that I can to see that critical
research in all areas of autism research continue to receive
increased funding. I commend the parents who have failed to
give up on their children.
I commend you for your dedication to want the best for your
children and for the sacrifices you have made for them.
I urge each of you to take your story to your Member of Congress
and your Senator. Share your struggles with them. If I, along
with the few others who have made defeating autism a top priority
are to be successful, it is critical that every Member of Congress
know what Autism is and that they have constituents who are
watching them and asking for their help.
I urge you to tell your local television reporters and newspaper
reporters your story and your struggles. Tell everyone who
are willing to listen. It is through your testimony that others
will know of this devastating epidemic plaguing our children.
I also urge you to share with others what is working in the
treatment of your children. You are blessed with the resources
that are available to you at this conference. Listen and learn
from the providers here who have a lot to offer.
Finally, let me know what I can do to help. I stand in partnership
with each of you.
Thank you for inviting me to join you today. It has been a
great honor.
(Special thanks to www.unlockingautism.org Nan for the note!)
Editors Comments:
I was quite impressed by this conference. The AutismOne Team
did an excellent job offering a wide variety of speakers
including topics from – government, traditional therapies,
alternative therapies and biomedical interventions. They
have four simultaneous speakers going from 8:00am to 5:00pm
with 1 hour (at best) for lunch. Each speaker started at
the top of the hour and had to finish by 50 past. That left
only 10 minutes for question and answer. The conference organizers
prepared a side room for key speakers for answering questions
that often lingered for hours.
All the sessions had good content but nothing was more interesting
than watching the IOM (Institutes of Medicine) and the CDC
address the audience mostly containing parents of autistic
children. Like a great movie (with the exception that this
movie is my life,) I laughed, I cried, I was angry, but found
hope. Parents and professionals asked good questions and left
them with the impression we are untied and ready to move this
cause faster and further than every before. I am interested
to see what message is received by these organizations who
are chartered to help find the cause and cure for our kids.
Now to the conference sessions: What I found was access to
speakers was great. And so was the content of their presentations.
I was able to pull them over, ask questions and get to know
them quite easily (without them being afraid!) Due to limited
time, speakers had to get to the point quick!
The most impressive part of the conference was an overwhelming
camaraderie. It felt like the attendees there (both parents
and professionals) were completely united on the “autism
cause.” For me I found the feeling exhilarating and as
if we could accomplish anything. The events of this week demonstrated
that with some amazing new studies released by some incredibly
smart folks.
To see the presentation handouts go to www.autismone.org
To acquire conference tapes go to http://www.fltwood.com/onsite/autism/
