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Saturday, 5 May 2012

The Clay Report: Autism an International Crisis.


Autism is National Crisis We Cannot Ignore by Beth Clay, The Clay Report
http://www.theclayreport.com/the-clay-report-blog.html 
 In August 1999, the House Committee on Government Reform and Oversight began looking at why autism spectrum disorders, which had once been considered a rare disease, had increased at epidemic rates.  At that time, autism was estimated to affect 1 in 500 American children.  On March 30, 2012, the Centers for Disease Control and Prevention (CDC) announced that the prevalence of autism was up 1 in 88 for children born in 2000.  For boys where the incidence is higher, 1 in 54 were found to be on the autism spectrum.  

If we continue to do nothing to change where things are going, by 2020, when children born this year are evaluated by the CDC, the rate is calculated to be 1 in 22.  

Vaccine Injury – the Discussion Just Won't Go Away: Government and most medical professionals will tell the public that the question of a possible relationship between the autism epidemic and vaccines and vaccine ingredients is 'settled science' – that there is no evidence of harm.  They want the whole thing to go away.  But just like the evidence that thimerosal in vaccines given to infants in the first six months of life causes harm, "it just won't go away".  As someone who led the Congressional inquiry, and who has remained informed, I bear witness that the issue is far from settled and that individuals in the public who have not been personally affected and thus investigated the matter are likely not accurately informed.  

Thousands of mothers and fathers contacted us and told similar stories –a child born healthy, developing normally, and within hours or days of receiving one or more vaccines (often we heard of 5 vaccines for 9 diseases at one office visit), the child became physically ill.  Among other injuries, some developed seizures, some showed signs of encephalopathy and some showed symptoms of mercury poisoning. Their ill health would lead to developmental delays, loss of speech, sleep disturbances, often the development of gastric symptoms to eventually receive a diagnosis of autism.   

I spoke personally with hundreds of the thousands of parents who contacted the Committee and shared their stories.  As a mother of four children born between 1981 and 1990, the same time frame so many of the children I was hearing about during this inquiry, I thought to myself on more than one occasion 'there but by the Grace of God go I" as my children like most American children had been immunized in compliance with Federal recommendations.   

Vaccine policies are sacred to the public health community.  To ask valid questions about safety meant we were vehemently attacked and labeled anti-vaccine. Even today, our investigation is attacked by those who feel no one should question vaccine policies even Congress. And contrary to what many say, herd immunity goals have not been threatened.  From the outset of the investigation that vaccines are the only medication mandated by a government for American children to receive as a condition of school and day care attendance, and as a condition for families to receive food stamps and most other federal assistance packages, our inquiry was focused on insuring that vaccines were as safe as possible, so that herd immunity could be preserved and as few children as possible would become collateral damage.  We were told that vaccine injury was rare, very rare.  In 20 years since the Vaccine Injury Compensation Program (VICP) was created more than 1300 children have been compensated for vaccine induced brain injury.    

We would learn during the investigation that many of the doctors put forward to the media for interviews actually had direct ties to vaccine manufacturers – through consulting relationships and patents, and they never seem to mention that during their interviews. We would also learn that most of those whom the US Government hired as consultants and advisors on vaccine policy and regulation also had close ties to vaccine manufacturers, financial conflicts of interest that were ignored by federal officials who were supposed to be protecting against such conflict.  

1 in 5000 sees Justice:  Hannah Poling, the little girl whose case the US Government conceded in the Vaccine Injury Compensation Program (VICP) received 5 vaccines for 9 diseases in July 2000, one month after the now infamous closed door meeting the CDC called at the Simpsonwood Retreat Center in Atlanta.   In this meeting, the CDC, FDA officials, their advisors many with ties to the vaccine industry and even vaccine company representatives admitted that the analysis of the CDC's Vaccine Safety Database (VSD) showed a concerning association with exposure to mercury in vaccines and (1) speech and language delays, (2) neurodevelopmental delays in general and (3) tics, all of which are known to occur in children with autism.  

Through information uncovered by SafeMinds through the Freedom of Information Act, we learned that the original findings were even worse than what was discussed at the Simpsonwood meeting.  The original analysis of the data by Dr. Thomas Verstraeten, now often referred to as Generation Zero data, compared the highest levels of exposure to mercury containing vaccines to those with zero exposure and found the elevated risk of autism for the highest exposure levels at one month ranged from 7.6 to 11.4 times the zero exposure level. This means that a child exposed to thimerosal in their vaccines is 7.6 to 11.4 times more likely to develop autism than one who was not exposed to thimerosal.  

Would the rates of 1 in 88 be lower if the CDC had gone public with the Generation Zero Data?   I am not one that likes to run through 'what if' scenarios, however, I can only think that so many of the families whose children, like Hannah, were vaccine injured after this June 2000 meeting might be living a different life if the CDC had immediately embraced the findings and aggressively moved to reduce exposure to thimerosal, do as Congressman Burton wanted and conduct a recall of all thimerosal containing vaccines.  How would that July 2000 medical visit have gone with Hannah if her parents had been informed of what Verstraeten found before her five injections some containing thimerosal?     

Sadly, instead of acting aggressively, the CDC would drag their feet, rework the data at least four times and wait years to publish a paper with data that was so watered down as to be almost inconsequential.  I was at the Boston meeting of the Institute of Medicine the morning that Dr. Verstraeten took the podium, took a deep breath and announced that he had just that morning accepted a job with vaccine manufacturer Glaxo Smith Kline in his home country of Belgium. (This can only mean he was negotiating his future employment through critical phases of this research project.) This IOM meeting was the first time his data was to be presented publicly and he had linked his financial future onto the industry wagon before uttering his first word to the IOM.  He would successfully extricate himself from the debate, return to Belgium away from the power of subpoena, and continue to collaborate with CDC during the multiple rewrites and efforts to publish. While he said he reluctantly accepted the thimerosal VSD project while on an epidemiology fellowship to the CDC, he has continued publishing papers on vaccine adverse reactions issues in his work with Glaxo. 

You may be telling yourself that Verstraeten study does not really matter because 'they got mercury out of vaccines'.  Sadly, that is not true.  The last of the heavy doses of thimerosal stayed in circulation until they expired in 2003. Since then some vaccines used in very young children continue to contain trace amounts, which according to mercury experts is still enough to cause harm.  Pregnant women continue to be given mercury containing flu vaccines.  Some vaccines use mercury in the production process and claim it is removed, but there is no real validation or testing to confirm exactly how much mercury remains. So we have never 'gotten the mercury out.' 

Vaccine Safety Datalink (VSD) Monitoring Medical Records:  As we would learn, the CDC had been monitoring about 5% of the American populations medical data for a decade, using the medical files from health maintenance organizations (HMOs) like Kaiser Permanente to study topics of interest, such as the thimerosal exposure questions.  I will leave my concerns about medical privacy and health freedom for another discussion, but if how the VSD has been used is any indication of what the future holds when everyone's medical records are available for review by the government, then we all have much to be concerned about.  

Replication is the hallmark of good science. The Verstraeten study should have been replicated by an independent team.  However, the government made it near impossible for years for anyone outside government to access the VSD data and in the interim managed to destroy the actual dataset Dr. Verstraeten used.   The inability to have independent verification calls into question the published research.

If the Verstraeten controversy is not enough to shake your confidence in the job the government has done to investigate these issues, the alleged criminal acts by Dr. Poul Thorsen will have you disgusted for sure.  Thorsen came to the CDC Division of Birth Defects and Developmental Disabilities in 2001 as a visiting scientist.  It would appear that he built a strong relationship with CDC staff, and began a relationship that has underwritten his entire career.  He successfully promoted the idea of awarding research funds to Denmark to study the relationship between autism and vaccines.  He "provided input and guidance for the research to be conducted." Once the funding was secured, Thorsen returned to Denmark to act as principal investigator of the study which our government emphasizes as the basis for denying vaccine induced autism.  A conversation just this week with the parent of one of the children whose case was rejected in the Autism Omnibus proceedings stated that the Danish studies (Thorsen) and the study at CDC by Verstraeten are the reasons the government listed in the letter notifying him his case was rejected.  

Poul Thorsen was indicted by a federal grand jury on April 13, 2011, on 13 counts of wire fraud and 9 counts of money laundering.  The indictment details that through an elaborate scheme of submitting false invoices and forging CDC employee signatures, that Poul Thorsen diverted more than $1 million from the $16 million in CDC grant funds.  Amazingly CDC did not uncover the scheme; rather someone in Denmark discovered the discrepancies that lead to the federal investigation.  Aarhus University would issue a public statement distancing them from Thorsen by stating that he was no longer as he had violated their dual employment regulations.  The Danish government would bring tax evasion charges against him for failing to report income.   At the time of the indictment, Derrick L. Jackson, Special Agent in Charge of the Atlanta Region for the Office of Inspector General of the Department of Health & Human Services stated, "Stealing research grant money to line his pockets, as Poul Thorsen stands accused of here today, cheats U.S. taxpayers and will simply not be tolerated...HHS/OIG will continue to work closely with our law enforcement partners to bring these criminals to justice."

One year later, Thorsen has not been brought to justice.  The arrest warrant was issued a year ago and in November sources tell me that the US Government requested that Dr.Thorsen be extradited to the United States.   In the mean time, Thorsen remains a free man employed at the Department of Obstetrics and Gynecology, Lillebaelt Hospital, Kolding, Denmark.  He continues to collaborate with at least one CDC employee, Dr. Diana Schendel, as a co-author of several research papers published after the indictment.  His research team provided a poster session at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in early March 2012 in San Diego.  It is unclear whether Dr. Thorsen came to the United States himself since his passport is supposed to be flagged by Immigration. I hope that the Danish autism community will reach out to their government and demand that Thorsen be extradited to the United States so he can be prosecuted.  Only with that progressing will we learn if he had help in his alleged criminal acts by others in the US, and at the CDC.  I do have concerns at how aggressively and effectively those prosecuting Thorsen will be.  After all, the Department of Health and Human Services is the lead agency in funding research including Thorsen.  They are the parent organization of the CDC, HRSA, NIH, and FDA.  HHS Secretary Secretary Sebellius stated in an interview that her staff have reached out to media with a request to stop giving the autism/vaccine injury community air time.  It is the same Department of Justice that will prosecute Thorsen which used Thorsen's papers to deny compensation to families with vaccine injured children.  All of these issues will need to be addressed and handled with transparency.

All of the studies funded by the CDC in which Thorsen played even a minor role should be removed from any discussion because the data cannot be trusted.  If he was willing to falsify invoices, what would he do with the data to keep his client the CDC happy?  If one removes the studies in which Thorsen is a co-author from the VICP and IOM decisions, then the entire house of cards of their conclusions come tumbling down.  Sadly, government officials will likely not take the high road on this matter and protect the Thorsen studies at all costs.  

One of the MMR Doctors Exonerated:  While CDC was paying Thorsen, who is now under federal indictment, they vehemently attacked Dr. Andrew Wakefield and his colleagues in the United Kingdom for the study they conducted looking at autistic entercolitis subsequent to receiving the MMR vaccine.  Last year, the media widely reported that the General Medical Council (GMC) in the United Kingdom suspended the medical licenses of Dr. Andrew Wakefield and his colleague, Dr. John Walker Smith.  Brian Deer, the journalist whose behavior chasing Dr. Wakefield around the world which I personally observed could only be described as 'stalker-like' grew even more venomous in his published comments after the GMC ruling.  The facts seemed to matter less than the need to slaughter Dr. Wakefield's reputation world-wide to insure he could not work in the medical field anywhere in the world, including Texas where he had moved to continue his research. One can only wonder who has been funding Brian Deer these many years to engage so intensely on this issue.  Why also would the British Medical Journal, one of the most widely read medical journals in the world, and a journal that I used to hold in very high regard, would publish an article he wrote without subjecting it to peer review and join with him in an attack of Dr. Wakefield by publishing an editorial? 

In addition to his Congressional testimony, I heard Dr. Wakefield present at conferences on numerous occasions.  He detailed the scientific process he went through to study the issues presented to him by families with children suffering serious gastric conditions.  I found his process thorough and logical.  He followed the scientific method so exquisitely that if he had been investigating anything other than a vaccine, he likely would have been nominated for the Nobel Prize in Medicine by his colleagues at the GMC.     

GMC Case Overturned:  Sadly, far fewer in the main stream media who reported on the GMC ruling covered the ruling in March 2012, in which Dr. John Walker Smith was victorious in his appeal in the courts.  The judge in the appeal said that the ethical findings of the General Medical Council were unsupportable based on the evidence and added, "It would be a misfortune if this were to happen again."   Where in the world is Matt Lauer now?

Dr. Wakefield has brought a defamation of character case in the United States against individuals who have been most vitriolic in their public accusations that he committed fraud including Brian Deer.  What will happen in these legal matters remains to the courts.  It will be the first time in which discovery will occur and in which Deer and others will be cross-examined, and not simply allowed to issue statements.  

Is the Investment in Autism to Date a Good Use of Tax Payer Funds?  A recent news article put forward that $1 billion has been invested in autism research in the last decade.  Has it been well spent?  If this were a business investment, there would have been an ROI study (return on investment).  This has not happened with federal agencies that have been responsible for funding autism research. I believe Congress needs to ask the Government Accounting Office in coordination with autism community, to conduct an ROI study.  

Too often I hear from the community experts who monitor what has been funded that too much of the funding is going towards genetics research and too little to environmental factors.  And when we look at the handling of the vaccine/autism question through the VSD, the Verstraeten study, the Thorsen/Danish studies and see so much emphasis on epidemiology while ignoring the studies that show through laboratory analysis and through animal studies with mice, rats, and monkeys that injury does occur, one can only ask at what length public health officials in the government will go to protect their policy?  The promised chelation study at the NIH never materialized.  At what point will the medical community take a stand to protect children from policies in which common sense has been thrown out the window? If these medical personnel would be held liable for their vaccine practices would their actions be different?

Is Hannah's Injury Really Different than the other 5,000?  With almost 5,000 cases of vaccine injury linked to the onset of autism filed in the National Vaccine Injury Compensation Program (VICP), an Omnibus Proceedings was organized within the program, eventually ruling 

against all of the cases except for one - Hannah Poling.  As mentioned above, the government conceded that Hannah Poling's vaccine injury was real and that she should be compensated in the VICP.  

What the media often miss is that Hannah's case was scheduled to be one of the three test cases in the Omnibus proceedings arguing a link between thimerosal, the mercury preservative, in vaccines and autism.  By plucking Hannah's case out of the Omnibus proceeding, the hundreds of other families whose children's injuries are identical or almost identical to Hannah's have been denied justice.  The official concession provides that the five vaccinations for nine diseases she received on July 19, 2000, "significantly aggravated an underlying mitochondrial disorder, which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of autism spectrum disorder."  Since that time, the government has stated that her mitochondrial disorder is 'rare'.  Again, what the government is stating to the public is not entirely accurate.  While her mitochondrial disorder may be rare in the general population, there is increasing evidence that between 10 and 20 percent of children who regress into autism may have this same 'rare' mitochondrial disorder.   The description of Hannah's health status before and after vaccination mirrored the story of most families.

How Could They Not Know?  Keeping in mind that key management staff at the VICP program today have been involved since the program's inception and have personally been required to sign off on cases that the government concedes or where the Special Master rules that compensation is warranted.  These same government managers have signed off on the 1300 cases over 20 years in which vaccine induced brain injury was conceded.  These same government staff would have signed off on the 21 cases discovered by investigators who published a paper in May 2011 in the Pace Environmental Law Review in which terms "autism or autism-like symptoms" in the court records.  These same staff would have been involved in the first series of IOM investigations in which autism originally was brought up in the early 1990s, would testify before Congress, and be involved in the subsequent IOM inquiry.  These same government officials involved in the VICP told the world the Hannah Poling concession was the first time the VICP had compensated an individual whose vaccine injury led to the onset of autism.  So, we are left asking whether they have been truthful in their statements to the public (and to Congress) and simply do not remember the 21 times autism cases were settled; or whether they have consciously chosen to exclude this admission.  If as they claim they have never tracked autism, questioning competence in management is certainly warranted.  More than one parent of a vaccine injured child who developed autism has said to me, "They are either lying about what they knew or they are incompetent!"  

In addition to the 21 cases mentioned above, when the investigators reached out to 150 of the 1300 families, of the ones that would participate in the study, another 62 cases of confirmed autism in individuals whose vaccine induced brain injury was financially compensated by the government were found.  I have a hard time believing today that when these individuals came before the Congress 12 years ago they did not know already that there were cases in the VICP that had been compensated in which the child developed autism as a result of the vaccine induced brain injury. Now that this study has been published, Congress needs to bring these individuals back in and under oath ask them to explain.

VICP is not working as Congress intended:  Congress created the VICP to be a compensation program that would be easy to traverse, swift, fair, non adversarial and when there was a close call, to rule in favor of the vaccine injured petitioner.  While the immunity given to drug companies and health professionals in the 1986 National Childhood Vaccine Injury Act has resulted in a massive expansion of our vaccine schedule that parallels the rise in autism; the VICP has become increasingly difficult for families to be compensated when a vaccine injury occurs.    Few realize that because the program is 'informal' that the typical rules of the court are not enforced, and this almost always hurts families who have cases in the program.  There are many inefficiencies such being unable to refer back to previous cases in which evidence of benefit has been presented.  The court remains a David Versus Goliath process that too often David is unsuccessful no matter how solid the case because the government has deep pockets and the upper hand with the court.  While we focus on the children injured, in today's VICP, half of those who file cases are adults who have been injured.

Few realize that the package insert explaining the adverse events possible, which the FDA mandates be included with each vaccine, is not accepted as evidence in the VICP.  Why, since this is official information approved by the FDA?  Few realize that the promise to have full discovery in the autism omnibus proceedings did not occur from either the government or the industry.  The industry has never been subjected to full discovery under the VICP. And if we learned anything from VIOXX, we learned that Merck (and likely other companies) do not always tell the FDA everything. A decade later, justice has not been served and Congress has given no attention to VICP in a decade.  

It Likely is Not Just Vaccines:  Vaccine injury is not the only reason we have an epidemic rise in the rates of autism. However, I have seen plenty of evidence to suggest it is one of the causes.  Obesity during pregnancy and older fathers are much less likely to be main reasons for the rise as the government is now touting as the result of recent studies they funded.  Sadly, we do not know how prevalent vaccine induced autism is because the government has not done the type of research that is truly needed to answer the questions with scientific rigor. The tens of millions wasted on the denial campaign could have been used to answer the question and help develop evaluation tools to determine who is at risk for vaccine injury.

Few issues have as many implications for society as autism. Families face enormous financial strain in addition to the emotional strains.  Communities need to act now to meet the housing, services and educational needs of the 1 in 88.  Government does not have endless resources, so working together with the community, agencies and policy makers need to find ways to do more and be better with the resources that are and will be available.  Churches and the philanthropic community need to more fully engaged.  These 1in 88 born in 2000 will grow up to be adults, and as the families I have come to know whose children are now in their 20s are learning, adult services in this country are woefully inadequate.  Even for higher functioning individuals who can live independently, underemployment is a widespread issue.  

While the community is gearing up to develop solutions, others simply want to change the definition of autism so the epidemic will go away.  The DSM-V working group which includes government officials as well as Poul Thorsen have been busy trying to change the definition of autism in the DSM-V.  (DSM is the manual used to define mental health related conditions, the Diagnostic and Statistical Manual – V for fifth edition.) The suggested changes will not reduce the number of children affected; it will only restrict families from receiving early intervention and educational services and muddle future CDC study outcomes.

Whether or not your family is directly affected by autism, you are needed in the autism community.  In the first 40 years I was on the planet, I met exactly 1 individual diagnosed with autism, a little boy at church whom my daughter occasionally babysat as a teenager.  My life is truly enriched by coming to know the thousands of families I have met in the last dozen years and their children.  While I have and continue to consult with the autism community, I also feel I have a moral obligation to be engaged in looking for ways to improve the lives of families living with autism and to help reduce the incidence of a child developing an autism spectrum disorder through a vaccine induced brain injury, or other environmental factor.  

There is much research that is needed to look at these issues and organizations that are both open minded to the outcomes and capable of crafting well written grant applications and following through with credible research are urgently needed to enter into this field.  Government agencies with research dollars cannot fund what is not submitted.  

More work is needed to develop and evaluate currently used treatments to determine if/how/when they are effective and to assure safety, especially when used in combination with other therapies. This includes new drugs as well as drugs being used off label. It also includes nutritional supplements, hyperbaric oxygen therapy, and alternative therapies such as acupuncture, massage, energy therapies and homeopathy as well as behavioral therapies and biofeedback assistive devices such as the BAUD.  Much work is needed on the simplest things such as food tolerances and sensory issues.

In the 2008 Presidential election cycle both Senator John McCain and President Barrack Obama stated their belief that there was a connection between vaccine injury and autism.  Both have been essentially silent in these last four years.  Senator McCain could be calling hearings and investigating, but he has chosen not to. We have no evidence that President Obama has taken any direct action on that issues, but those who work in his Administration have been part of the problem, not part of the solution.

I have no doubt that history will not look kindly at how the government has handled this issue.  They will include this decades long vaccine experiment in the same discussion as the Post Nuremberg medical research atrocities such as the syphilis research in Tuskegee, the STD research in Guatemala, the high oxygen experiments on newborns which led to blindness and the Cincinnati radiation experiments.  A century from now the medical community will be appalled that toxic ingredients such as mercury and aluminum were injected into babies within hours of birth and that it would be the medical establishment that would fight to keep mercury in medicines injected to infants and pregnant women.  Future generations of doctors will rail in medical journals against the government authorities that protected policy at the detriment to so many children.  At the end of the day, whether the epidemic rise in autism rates is not related to vaccine injury, there is still an national and international crisis.  And what are we going to do to help stem the rising tide of the epidemic?  Will you be part of the solution?  

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An International Network of Eminent Scientists Questioning 
                                  the Science Behind "Science"
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