[Congressional Record Volume 150, Number 85 (Friday, June 18, 2004)]
[House]
[Pages H4564-H4568]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                                 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

[[Page H4565]]

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.

                              {time}  1715

  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

[[Page H4566]]

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.

                              {time}  1730

  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

[[Page H4567]]

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

[[Page H4568]]

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.

                              {time}  1745

  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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