|
Rep.
Dave Weldon, M.D. Speaks on Autism and Thimerosol (Congressional
Record)
Special
Order on Flawed IOM Report by U.S. Rep. Dave Weldon, M.D. | Congressional
Record June 18, 2004
Autism
The SPEAKER
pro tempore. Under the Speaker's announced policy of January 7, 2003,
the gentleman from Florida (Mr. Weldon) is recognized for 60 minutes as
the designee of the majority leader.
Mr. WELDON of Florida. Mr. Speaker, I rise this afternoon to address the
House regarding the very important issue of autism and the epidemic of
autism that we are seeing in this country today, but before I begin my
prepared remarks on this subject, I want to extend my condolences to the
family of Paul Johnson.
His son lives in Merritt Island, an area in my congressional district,
and it is indeed a great tragedy for our Nation and very obviously a great
tragedy for his family. As I understand it, he was a great person, a great
American, a patriotic American, and it goes to show to all of us that
the war on terror continues and that there is a great peril to American
contractors, probably anywhere in the Middle East, but particularly in
Saudi Arabia and, obviously, as we know, in Iraq.
I do want to salute those contractors that do take the risk and go over
there. They perform vital functions. In many ways, they are as important
as our military people over there and we need to honor them and respect
them.
So my condolences go out to the Johnson family, and certainly I hope that
they will be comforted by the good Lord in their time of grief.
I would
like to take this time to address what I consider to be a very growing
problem, the epidemic of autism and neurodevelopmental disorders that
are plaguing our Nation.
In January of this year, the Department of Health and Human Services sent
out an autism alarm to the Nation's pediatricians. In this alarm, they
stated that one in every 167 children is being diagnosed with an autism
spectrum disorder. I will repeat that. One in every 167 children being
born in the United States today is being diagnosed with an autistic spectrum
disorder.
Furthermore, one in seven children is being diagnosed with either a learning
disability or a behavioral disability.
Mr. Speaker, something dreadful is happening to our youngest generation,
and we must sound the alarm and figure out what is going on with our children.
I had the pleasure of addressing an autism conference in Chicago last
month, and I would like to share today some of the thoughts I shared then
with about 1,000 researchers, doctors, nurses, educators and, most importantly,
parents who were there to seek answers to this growing problem.
I have said repeatedly that the autism community is the 900-pound gorilla
that has not had its voice properly heard on Capitol Hill. This is largely
due to the endless demands on the time, effort, emotions and financial
resources of the parents of these children who are struggling to meet
the unique needs of these kids with autism. There is little time, money,
energy left to engage in public debates, let alone engage the Congress
when one is trying to raise a child with a disability like autism.
However, I see that changing, and last month's Institute of Medicine report
I think has had one positive effect. It has united and reinvigorated parents
throughout the country in their efforts to get answers to why children
are being diagnosed with autism at such a high rate in the United States.
At the outset of my remarks, I want to make it extremely clear that I
support vaccinations. I have a six-year-old son, and he has received all
of his vaccinations. Someone in the media recently 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 the pattern, to vilify those who simply ask
if our vaccines could be made safer.
I support vaccinations, and indeed, I gave vaccinations to thousands of
my patients when I was practicing medicine full-time prior to coming to
the U.S. House. However, I believe it is appropriate to acknowledge that
like with any other medical intervention, different individuals respond
differently. We are all unique. We all have different genetic makeup,
and what may cause no harm to the vast majority of people can cause serious
side effects in some individuals.
Since we established the National Vaccine Compensation Program in the
late 1980s, several thousand individuals have been compensated for vaccine
injuries. We know that there are adverse reactions, and I believe it is
important that we dedicate resources to better understand why some children
have these reactions.
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 cases receive compensation,
and too many parents feel that the program is not worth the difficulty
of going through it.
The questions I raise are multiple. The number one question has been whether
neurologic problems were caused in some children by the high levels of
a mercury containing additive that was included in our vaccines in the
1990s. This mercury containing additive is called thimerosol, and in the
1990s, infants and unborn children were exposed to significant amounts
of mercury at a most critical point in their development.
Now, this recent Institute of Medicine report, what exactly is wrong with
it? What about it has so many people in the autism community upset?
In my 10 years of service in the U.S. Congress, I have never seen a report
so badly miss the mark. I have heard some weak arguments here in Washington,
D.C., and I can tell my colleagues that the arguments put forward in this
IOM report are indeed very weak.
Let us examine this report in some detail. On January 15 of this year,
I wrote Dr. Julie Gerberding, the director of CDC, and I asked her to
postpone the February 9 Institute of Medicine meeting and this report
because of my concern that this was not an exercise in discovering the
truth, but was instead a meeting, and I will quote what I said in my letter,
``being driven by a desire to shortcircuit important research and draw
premature conclusions.''
I said, ``If the purpose of this meeting is to seriously consider and
address these concerns, then this will not be accomplished.''
Quoting further from my letter to Dr. Gerberding, I said, ``It appears
to me, not only as a member of Congress but also as a physician, that
some officials within the CDC's National Immunization Program, the NIP,
may be more interested in a public relations campaign than getting to
the truth about Thimerosal.'' I said, ``Pressing forward with this meeting
at this time I believe will further undermine the credibility of the Centers
for Disease Control on matters of vaccine safety and do damage to the
reputation of the Institute of Medicine. I believe the proposed date of
this meeting, which you have the ability to change, is in the best interest
of no one who is seeking the truth about a possible association between
vaccines and neurodevelopmental disorders, including autism.''
Now, I had a follow-up conversation on February 3 of this year with Dr.
Gerberding, and she assured me that the Institute of Medicine's February
meeting was not an attempt to ``draw conclusions,'' but merely to ``update
the science,'' of where we were, basically.
However, it is clear that this report draws conclusions; and what is perhaps
the greatest outrage, it goes further to call for the halt of further
research.
A public relations campaign, rather than sound science, seems to be the
modus operandi of officials at the CDC's National Immunization Program.
Why do I say this? Let us 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 decision.
The Institute of Medicine bases their decision almost entirely on five
epidemiologic studies. Epidemiology is essentially the statistical analysis
of disease in populations. All of these studies were conducted by researchers
with an interest in not finding an association. All of the studies had
significant shortcomings, all of which the IOM itself declares would miss
the association with autism in a genetically acceptable 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 the IOM placed just
on epidemiology.
In 2001 the Institute of Medicine concludes: ``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 scope to looking just at autism. Does that sound like an agency
interested in understanding whether or not Thimerosal is 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 the CDC to only consider
the possible relationship between Thimerosal and autism rather than neurodevelopmental
disorders as a whole. Anyone familiar with the Verstraeten study, a study
published looking at Thimerosal and autism, knows exactly why the IOM
scope was narrow, because the 2003 Verstraeten study found associations
between Thimerosal and neurodevelopmental disorders in 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
neurodevelopmental disorders in some children.
This latest IOM report is simply part of a PR 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 neurodevelopmental
disorders as a whole? In evaluating Thimerosal's relationship to autism,
the IOM relies almost exclusively on these five epidemiologic studies.
The principal authors of all five of these 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 the
NIH virtually ignored the Institute of Medicine'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 epidemiologic evidence to support causality,
the IOM was instructed to give biological evidence little consideration
and was prohibited from allowing biological evidence to lend evidence
towards causality.
Is it any wonder that the CDC has spent the past 2 years dedicating significant
funding to epidemiology while starving funding for clinical and biological
research? The IOM notes in their report that the epidemiologic studies
they examined were not designed to pick up a genetically susceptible population,
and this is the very theory of the link between Thimerosal and autism
and autism spectrum disorders. One in 167 become autistic. Why do the
other 166 not? It is because they do not have the impaired ability to
eliminate mercury from their system. We are looking at a genetically susceptible
subpopulation. Yet these studies that they base this report on, they admit,
were not capable of picking up these subsets in the populations.
Let us look at these studies. The only study done in the United States,
the Verstraeten study, was published in the Journal of Pediatrics in November
of last year. 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 what is called
a dose response gradient. Those who got less Thimerosal later in life
had less autism is the theory behind the study.
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 coauthor of the study was quick to declare to
the news media: ``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 Vaccine Containing Mercury,''
the 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 Thimerosal-containing
vaccines and neurodevelopmental outcomes. In the first phase of our study,
we found an association between exposure to mercury from Thimerosal-containing
vaccines 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
they changed the study and most of the associations disappeared.
Furthermore,
in January 2004, the lead coauthor 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 the media was that there is nothing
to be concerned about, but the study said something different. The news
media to a large degree took the CDC's spin hook, line and sinker. Largely
they chose not to read the study itself.
Five months after that study was published in the Journal of Pediatrics
and, I might add, after the IOM report was largely written, 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,'' is what Dr. Thomas Verstraeten said. Dr. Verstraeten,
the lead author of this study, says that an association between Thimerosal-containing
vaccines and neurodevelopmental disorders cannot be refuted based on his
study.
Yet the IOM in their assessment of that same study states that it is a
basis for concluding, ``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 no exposure.
I might also add, Mr. Speaker, that the Verstraeten study cannot be validated.
The earlier data sets have been destroyed, and the only data sets the
CDC will make available to outside researchers are the ones 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 the CDC researchers. Only one independent researcher has been
granted access to the CDC's VSD database, and the CDC has kicked that
researcher out based on ridiculous reasons. They claim their research
methods might infringe on privacy, yet they know the database contains
no names and it is impossible to locate the patients from this database.
I want to talk briefly about the other four studies that the Institute
of Medicine based its conclusions on. The IOM cited the 2003 Hviid study
of the Danish population as one of the key studies upon which it based
its conclusions. Let us first consider the conflict of interest of the
principal author. Dr. Hviid works for the Danish Epidemiology Science
Center, which is housed at the Staten Serum Institute, the government-owned
Danish vaccine manufacturer. Also, all of his coauthors either work with
him at the center or are employed by the SSI.
The SSI, the Staten Serum Institute, makes a considerable profit off the
sales of vaccine and vaccine components and the U.S. is a major market
for the SSI.
SSI has $120 million in annual revenue, and vaccines are the fastest-growing
business segment, accounting for 80 percent of its profits. Both the United
States and the United Kingdom 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 then face
significant lawsuits. These facts are important and are critical when
evaluating Dr. Hviid's work. Furthermore, this study looked at autism
and not at neurodevelopmental disorders.
The important thing in evaluating this study is that exposure in the Danish
population to Thimerosal varied considerably from that in the United States.
Danish children received 75 micrograms of mercury in their first 9 weeks
of life and then another 50 micrograms at 10 months. By comparison, children
in the United States received 187.5 micrograms of mercury by the age of
6 months, nearly 2 1/2 times as much mercury as the Danish population.
Dr. Boyd Haley has said that comparing the exposure of the U.S. children
to these children in Denmark 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's study were skewed in that they began to add outpatient
autism diagnoses 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 all these serious limitations, the IOM felt
that the study had ``strong internal validity.'' Like the Verstraten study,
Hviid would not be able to pick up a group of children who were genetically
susceptible to mercury toxicity, principally because they have impaired
ability to excrete mercury.
Case in point: Danish autism rates are six in 10,000, where in the United
States it is less than one in 200.
I do not believe how they can use a Danish study as a valid conclusion
to say that thimerosal did not cause the increase in autism and other
autism spectrum disorders and neurodevelopmental disorders in the United
States when children in the United States received significantly more
mercury exposure.
Another study that the Institute of Medicine relied on was the Madsen
study. Madsen et al., once again examined virtually the same population,
Danish children, Danish children who received significantly less than
they. Let us consider the conflicts of interest in the Madsen study. First
of all, two of Madsen's co-authors are employed by the same Staten Serum
Institute. The study, like Hviid, added outpatient cases into the number
of cases of autism after 1995, a methodological flaw. The authors acknowledged
that this addition might have exaggerated the incidence of autism after
the removal of autism. The IOM acknowledged this but yet used the data
anyway.
Another study that the IOM relied on, the Stehr-Green study, examined,
guess what, the Danish population again, along with the Swedish population.
I will not repeat the problems with the Danish data, but with regard to
Sweden it is important to note that the children there received even less
thimerosal than children in Denmark, receiving only 75 micrograms by 2
years of age versus children in the United States receiving 187.5 micrograms
by 6 months of age.
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 cite it anyway.
The Miller study also included in the IOM report examines the population
of children in the United Kingdom. This study is still unpublished, which
limits its ability to be examined critically. It is important to note,
however, that Dr. Miller has actively campaigned against those who have
raised questions about vaccine safety. We have a person here who is actively
campaigning, testifying in lawsuits, against the theory that thimerosal
is linked to neurodevelopmental disorders and autism, doing a study supposedly
showing there is no link.
So what can we conclude about these five epidemiologic studies? We can
see clearly why the IOM is on very shaky ground in drawing the conclusion
that it did. They based their decision on these five studies, three of
them examining genetically homogenous children in Denmark. At least one
employee of the Staten Serum Institute serves as a co-author on three
of the studies. Only one study examines the U.S. population, and that
study did not compare children who had received mercury with those who
had not. Four of them are studies of children receiving less than half
the amount of mercury that U.S. children received. None of them with any
ascertainment of prenatal or postnatal background mercury exposures, none
of them considering prenatal exposure which may have been given to the
children, none of them have been able to detect a susceptible subgroup
in the population, three of them failing to address how the addition of
outpatient cases of autism in Denmark might have previously skewed their
results. Four of them examined populations with autism rates considerably
less than the United States, and one of these studies has never been published.
It is impossible to review the data.
Might I also add they are all statistical studies. There have been numerous
biological studies suggesting that thimerosal is linked, mercury is linked
to autism, specifically mercury studies that show after chelation therapy,
children with autism excrete a tremendous amount of mercury in their urine,
whereas normal children do not.
And it is important to note that there was a recent report published by
Dr. Emili Garcia-Berthou and Dr. Carlos Alcaraz examining statistical
errors in medical publications. They found five volumes of Nature and
11 volumes of the British Medical Journal. They found 11 percent of the
computations in Nature and the BMJ were incongruent and at least one statistical
error appeared in 38 percent of the papers, despite all the biological
evidence suggesting there may be a link with thimerosal and autism here
and the obvious knowledge that many of these statistical studies are flawed.
The Institute of Medicine concluded, and many people in the press believed
it, that there is no link.
Mr. Speaker, something needs to be done. The Institute of Medicine report
not only looked at the mercury issue. It as well looked at the issue of
the safety of the measles-mumps-rubella vaccine. Many years ago a researcher
in England, a Dr. Andrew Wakefield, published a report suggesting that
some children with autism have measles virus growing in their intestines
causing a condition called inflammatory bowel disease, and, indeed, there
have been recent reports in the medical literature that some of these
children have measles virus particles in their cerebral spinal fluid and
elevations of a protein called myelin basic protein in their cerebral
spinal fluid, suggesting they have an active low-grade encephalitis being
caused by measles virus.
The IOM was asked to look at this issue. How did they approach this issue?
Did they ask for research protocols that attempted to duplicate the Wakefield
study? No. What they did was again another epidemiologic study.
I believe that the CDC's conclusion and the Institute of Medicine's conclusion
on the MMR is well flawed. I am pleased that finally attempt is underway
to duplicate Dr. Wakefield's findings, and hopefully we can get some answers
to these questions regarding the safety of the measles-mumps-rubella vaccine.
For the reasons that I have outlined above and other reasons, the Institute
of Medicine report I believe is premature, perilously reliant on epidemiology,
based on preliminary and incomplete information, and I believe may ultimately
be repudiated perhaps in short order. This report will not deter me nor
the autism community from our commitment to see 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 are no problems with the
MMR, it may contribute further to an erosion of the doctor/patient relationship
in the United States.
This report has dragged the Institute of Medicine under a cloud of controversy
that has currently engulfed the CDC. Much like the infamous 1989 study
by the National Institute of Child and Human Development which missed
the link between folic acid deficiencies and neural tube defects like
spina bifida, the epidemiologic studies reviewed by the IOM in drawing
these findings could easily have missed an association in susceptible
populations.
Finally, let us remember that the IOM is not immune to error and has been
forced to reverse itself before. Most recently, the IOM reversed a longstanding
finding that chronic lymphocytic leukemia was not due to Agent Orange
exposure. A similar reversal is very real and possible here.
On April 2 of this year, I introduced, along with the gentlewoman from
New York (Mrs. Maloney), H.R. 4169, the Mercury Free Vaccines Act of 2004.
We currently have 22 co-sponsors from across the political spectrum. H.R.
4169 will phase out the use of mercury vaccines over the next 3 years,
giving particular attention to completely eliminating mercury from childhood
vaccines on an expedited schedule. This bill is a response to the fact
that the safety of thimerosal in vaccines is not proven. Mercury is a
well established neurotoxin. According to the EPA, one in six 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. No one at the NIH or CDC can
tell us what happens to mercury once injected into an infant. Where does
it go? How much goes to the critical organs, how much to the brain? Can
it cause damage to the developing central nervous system? No one has good
answers to these questions, and they should have answers to these questions
before more infants are exposed to mercury.
The CDC has adopted a policy to reintroduce mercury-containing vaccines
to children in the form of the flu vaccine which will be given at 6 months,
7 months, and 23 months of age. Most of the flu vaccine on the market
today contains mercury.
I believe we need new legislation. It is critical that we pass the Mercury
Free Vaccines Act of 2004. It is also critical, I believe, 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 has responsibility primarily to
make sure that the vaccines are prepared according to specifications.
They do operate the Vaccine Adverse Events Reporting System.
The NIH does not have a concerted effort to fund vaccine safety research.
They provide funding for research in a haphazard manner. If one happens
to submit a proposal and it passes peer review, the study may get funded.
The NIH has funded only a handful of studies over the past 2 years investigating
vaccine safety issues. The CDC has the greatest responsibility in this
area. Unfortunately, they have the greatest conflict of interest. The
CDC's vaccine safety program amounts to a $30 million, million, a year
program, and half of it 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 $1 billion, $1 billion, vaccine promotion program. The CDC largely
measures its success by high vaccination rates, and here lies the conflict.
Any study raising concerns that there might be adverse reactions to some
vaccines in some children has the ability to lower vaccine rates, and
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 in undermining the 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 data sets that the CDC's internal researchers are granted.
The bottom line is that the CDC studies related to vaccine safety cannot
be validated by external researchers, a critical component in demonstrating
the validity of scientific findings. The CDC's recently convened Blue
Ribbon Panel to examine how the CDC might better review vaccine safety
is a step in the right direction. However, I do not hold out much hope
because the panel is limited in its 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 out of the
NIH. I believe the same should be done with vaccine monitoring. It should
be completely removed from CDC's jurisdiction. The CDC is too conflicted
to oversee this function.
Mr. Speaker, I want to touch on one more additional issue, and that is
something called the Brighton Collaboration. I am very concerned about
the development of the Brighton Collaboration, which began in the year
2000. This is an international group comprised of public health officials
from the CDC, Europe, and world health agencies like WHO and vaccine manufacturers.
The first task of the Brighton Collaboration, created several years ago,
was to define what constitutes an adverse reaction to a vaccine. They
have established committees to work on various adverse reactions to vaccines.
Particularly troubling to me is the fact that serving on these panels
defining what constitutes an adverse reaction to a vaccine are the vaccine
manufacturers. What is even worse is the fact that some of these committees
are chaired by vaccine manufacturers.
It is inappropriate for a manufacturer of vaccines to be put in the position
of determining what is and what is not an adverse reaction to its 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 causing harm? Then, I ask,
why are we allowing vaccine manufacturers 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 the ability for us to fully understand the true relationship
between various vaccines and some adverse reactions in some subsets of
our population. I plan to devote additional attention to this effort in
the future.
Mr. Speaker, I look forward to working with you and others in this body
to address the problem that we face today.
As I stated at the outset of my comments this afternoon, autism was once
in America a rare and infrequently seen condition. I went through 4 years
of medical school, internship, residency, and years of private practice
and practice within the military and had not seen one single case. I have
seen case after case in my congressional district over the last 7 years,
a disease that I had never seen before.
The disease incidence was previously thought to be one in 10,000. It is
now thought to be as high as possibly one in 167, an almost 100-fold increase
in the incidence.
We need to get answers to these questions. We need to restore public confidence
and safety in our vaccine program. Our vaccine program saves millions
of lives, it saves millions of kids from a life of disability, and the
best way for us to ensure public confidence and make sure that all the
kids get vaccinated properly is to get answers to these questions. The
way the CDC and the Institute of Medicine and the industry is going about
trying to answer these questions is highly flawed.
Mr. Speaker, I encourage my colleagues to begin to look at this issue.
I know that many of them are coming to me saying they have parents coming
in their offices now with autistic kids, saying something needs to be
done. Something needs to be done.
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