Skip to comments.The Status of Research Into Vaccine Safety and Autism
Posted on 06/22/2002 4:57:29 AM PDT by rubbertramp
Committee on Government Reform - The Status of Research into Vaccine Safety and Autism - Please read.
Committee on Government Reform - The Status of Research into Vaccine Safety and Autism
June 19, 2002 - 11:00 a.m.
2154 Rayburn House Office Building
In April the Committee conducted a hearing reviewing the epidemic of autism and the Department of Health and Human Services (HHS) response. Ten years ago, autism was thought to affect 1 in 10,000 individuals in the United States. When the Committee began its oversight investigation in 1999, autism was thought to affect 1 in 500 children. Today, the National Institutes of Health (NIH) estimates that autism affects 1 in 250 children.
In April we looked at the investment our Government has made into autism as compared to other epidemics. We showed in that hearing that the CDC and NIH have not provided adequate funding to address the issues in the manner that our Public Health Service agencies have used to address other epidemics.
(two charts comparing amount of funding for various diseases)
After our hearing, I joined with my colleagues on the Coalition on Autism Research and Education to request from our appropriators that at least 120 million dollars be made available in FY 2003 for autism research across the NIH and at that an additional $8 million be added to the CDCs budget for autism research.
Giving more money to research is not the only answer though. Oversight is needed to make sure that research that is funded will sufficiently answer the questions regarding the epidemic, how to treat autism, and how to prevent the next ten years from seeing the statistic of 1 in 250 from becoming 1 in 25 children.
High quality clinical and laboratory research is needed now, not five or ten years from now. Independent analysis of previous epidemiological and case control studies is needed as well.
We have learned that a majority of parents whose children have late-onset or acquired autism believe it is vaccine-related. They deserve answers. We have also learned that the parents have been our best investigators in looking for both causes of autism and for treatments.
It has been parents who have formed non-profit organizations to raise research dollars to conduct the research that the CDC, the FDA, and the NIH have neglected to do. We have heard from many of these parents in the past, Elizabeth Birt, Rick Rollens, Shelley Reynolds, and Jeanna Smith, to name just a few. Each of these parents had healthy babies who became autistic after vaccination.
I might have been like many of the officials within the public health community denying a connection - had I not witnessed this tragedy in my own family. I might not have believed the reports from parents like Scott and Laura Bono, Jeff Sell, Jeff and Shelly Segal, and Ginger Brown, who came to me with pictures, videos and medical records. I might have been like so many pediatricians who discounted the correlation between vaccination and the onset of fever, crying, and behavioral changes. Because both of my grandchildren suffered adverse reactions to vaccines, I could not ignore the parents plea for help. I could not ignore their evidence.
My only grandson became autistic right before my eyes shortly after receiving his federally recommended and state-mandated vaccines. Without a full explanation of what was in the shots being given, my talkative, playful, outgoing healthy grandson Christian was subjected to very high levels of mercury through his vaccines. He also received the MMR vaccine. Within a few days he was showing signs of autism.
As part of our investigation, the Committee has reviewed ongoing concerns about vaccine safety, vaccine adverse events tracking, the Vaccine Safety Datalink (VSD) Project, and the National Vaccine Injury Compensation Program. I have joined with Congressman Weldon, Congressman Waxman and 32 other members of Congress in introducing HR 3741, the National Vaccine Injury Compensation Program Improvement Act of 2002 to realign the compensation program with Congressional Intent.
In todays hearing, we will receive a research update from several previous witnesses as well as new research findings that further support a connection between autism and vaccine adverse events. We will learn more about both the possible link between the use of the mercury-containing preservative thimerosal in vaccines and autism, as well as autistic entercolitis resulting from the Measles-Mumps-Rubella (MMR) vaccine.
Through a Congressional mandate to review thimerosal content in medicines, the FDA learned that childhood vaccines, when given according to the CDCs recommendations exposed over 8,000 children a day in the United States to levels of mercury that exceeded Federal guidelines. Is there a connection between this toxic exposure to mercury and the autism epidemic? We will hear from Dr. James Bradstreet and Dr. Vera Stejskal on this issue.
We have twice received testimony from Dr. Andrew Wakefield regarding his clinical research into autistic entercolitis. We will learn today that not only has he continued to conduct clinical research, but that this research is confirming the presence of vaccine-related measles RNA in the biopsies from autistic children. Dr. Wakefield - like many scientists who blaze new trails - has been attacked by his own profession. He has been forced out of his position at the Royal Free Hospital in England. He and his colleagues have fought an uphill battle to continue the research that has been a lone ray of hope for parents whose children have autistic entercolitis. Dr. Arthur Krigsman is joining us as well today to discuss his clinical findings of inflammatory bowel disorder in autistic children. He will share with us his initial findings as well as discuss his research plans currently with his Institutional Review Board for approval.
Do the epidemiological and case control studies, which the CDC has attempted to use to refute Dr. Wakefields laboratory results, answer the autism-vaccine questions honestly? Epidemiologist Dr. Walter Spitzer is back today to answer this question. What else is needed to prove or disprove a connection?
Unfortunately, rather than considering the preliminary clinical findings of Dr. Wakefield as a newly documented adverse reaction to a vaccine, the CDC attempted to refute these clinical findings through an epidemiological review. While epidemiological research is very important, it cannot be used to disprove laboratory and clinical findings. Valuable time was lost in replicating this research and determining whether the hypothesis was accurate.
Officials at HHS have aggressively denied any possible connection between vaccines and autism. They have waged an information campaign endorsing one conclusion on an issue where the science is still out. This has significantly undermined public confidence in the career public service professionals who are charged with balancing the dual roles of assuring the safety of vaccines and increasing immunization rates. Increasingly, parents come to us with concerns that integrity and an honest public health response to a crisis have been left by the wayside in lieu of protecting the public health agenda to fully immunize children. Parents are increasingly concerned that the Department may be inherently conflicted in its multiple roles of promoting immunization, regulating manufacturers, looking for adverse events, managing the vaccine injury compensation program, and developing new vaccines. Families share my concern that vaccine manufacturers have too much influence as well. How will HHS restore the publics trust?
Access to the Vaccine Safety Datalink (VSD)
One of the primary topics to be discussed at this hearing is access to the Vaccine Safety Datalink. (VSD). To help fill scientific gaps, the CDC formed partnerships with eight large health maintenance organizations through an agreement with the American Association of Health Plans to continually evaluate vaccine safety. This project is known as the Vaccine Safety Datalink (VSD) and includes medical records on millions of children and adults. Up until this year, access to data from the VSD has been limited to researchers affiliated with the CDC and a few of their handpicked friends. This good old boys network practice has predictably led to questions about the objectivity of the research and the fairness of the results.
The VSD data should be made available to all legitimate scientific researchers so that independent studies can be conducted and results verified. This database contains a wealth of data involving millions of patients over a ten-year period. If properly utilized, it can help researchers study vitally important questions about the safety of vaccines, the effects of mercury-based preservatives in childhood vaccines, and many other questions.
The Committee first raised this issue with the CDC two years ago. For two years the CDC delayed. Six months ago, we were informed that the CDC was developing a plan to expand access to the database. Finally, in February of this year, after a great deal of prompting from the Committee, Dr. Robert Chen, Chief of Vaccine Safety and Development at the National Immunization Program, informed Committee staff that the CDC had finalized its plan and that it was poised to put it into effect. Under this plan, any legitimate scientist could submit a proposal to the CDC to conduct research using VSD data and access to the data would be provided along with some basic safeguards.
In preparation for todays hearing, Committee staff asked the CDC why the plan described to us in February had not yet been put into effect. The staff was informed that the plan had been put into effect. However, there had been no public announcement. How are researchers supposed to know about the availability of the data if there is no announcement? It took two years of prodding by this Committee to get the CDC to open up access to the database. For four months it appears that the CDC didnt inform anybody but this Committee of the datas availability.
That doesnt make it appear that the CDC is making a good faith effort to open up this database. It looks to me like the CDC is trying to do the bare minimum that they have to do to get us off their backs. Thats not acceptable. Thats why I insisted that Dr. Chen be here today. I just want to ask him why they didnt tell anyone about the database being available. Id like to know how he expects researchers to use this data if nobody tells them its available.
Dr. Roger Bernier is here from the CDC to testify about these issues. He is accompanied by both Dr. Chen, the creator of the VSD Project and Dr. Frank DeStefano, the CDC official who is also a co-author of the MMR IBD study. They are here to address our questions on the VSD project and the vaccine- autism research. The CDC employees are accompanied by Dr. Stephen Foote of the National Institutes of Health and Dr. William Egan of the Food and Drug Administration.
As representatives of the people, we have a responsibility to ensure that our public health officials are adequately and honestly addressing this epidemic and its possible links to vaccine injury.
I look forward to hearing from our witnesses today. Our hearing record will remain open until July 3.
I now recognize the ranking minority member, Mr. Waxman for his opening statement.
Nowadays, when I see kids called "autistic" in my office, usually they are merely retarded, and don't really meet the criteria for autism. I suspect it's like a lot of epidemics we see: we lower the criteria for diagnosis, and voila an epidemic.
Too bad a congressman has to be directly affected by an issue like this before light gets shined on it.
I know of several cases of autism where the mothers involved were heavy drug users. Of course, this has never been disclosed to their doctors. Anecdotal information, but, still, it makes me wonder. If the medical establishment is willing to insist HIV causes AIDS, why should we expect them to get anything else straight.
Having these bozos tell me I can't have a smallpox shot when I *know* for a fact there are tons of poorly guarded smallpox stockpiles in Russia is infuriating.
The classical description of autism is a normal child who at the age of 8 months to two years develops a high fever. After the fever, he or she deteriorates and develops social problems, ritualistic behavior, speech abnormalities etc.
No one knows why. We do know that rubella can cause it, which is why they are so worried about MMR. Also, measles used to be associated with a lot of encephalitis, that left people brain damaged. That's why a lot of people are worried about MMR vaccine. There is also a question if the problem was the mercury preservative in the vaccine, since heavy metal poisoning like lead poisoning can cause retardation with social abnormal behavior.
Unlike a lot of the paranoia about medicine etc. this one is believed by a lot of doctors. However, most of us feel that the risk/benefit ration is worth it (kids die of measles, and one in ten thousand get encephalitis).
On line book about autism: AUTISM
For parents and relatives of autistic kids: Autism organization
Can we all say it...
Special "Double DUHDUH" to the Clinton Administration officials in FDA and CDC who didn't realize that EPA mercury exposure limits were being violated by the initial ACIP recommendations.
I'm still waiting to see if anyone in organized medicine has enough truth and honesty to request funding for the retrospective analysis on the kids who got Hepatitis B vaccine at birth and one month.
Dr. Thomas Verstraten., an epidemiologist hired by CDC to review data from the Vaccine Safety Datalink, which consisted of approximately 500,000 children from the North California Kaiser cohort. Dr. Verstraten found a "statistically significant connection" between thimerosal and tics, verbal delays and ADHD/ADD and autism.
Autism of the past looks different from the autism of today. There are actual changes in the mitochondria of many children diagnosed with autism today.
By Lorraine Fraser (Filed: 16/06/2002) http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2002/06/16/nmmr16.xml&sSheet=/news/2002/06/16/ixnewstop.html
Scientists have found new evidence to support fears that the MMR vaccine is causing children to develop autism and bowel disease, The Telegraph can reveal today.
Specialists from Trinity College, Dublin, have detected the strain of measles virus used in the MMR jab in tissue samples from the inflamed intestines of 12 children, who each developed autism after receiving the injection.
The results will add further weight to claims that MMR may be responsible for a rapid rise in autism in children over the past decade.
The Department of Health has repeatedly dismissed concerns about its safety, saying epidemiological studies have failed to find a link to autism. It has infuriated worried parents by refusing to allow the alternative of single vaccines to be prescribed on the NHS.
The work was carried out by Prof John O'Leary, a pathologist with a record of important discoveries in the field of virology. Although the finding does not prove that the MRR jab caused autism and bowel disease in the children, it raises urgent questions about the vaccine's role in their condition.
None of the children concerned had shown any sign of disease beforehand. The discovery comes days after the Government seized on a new study to bolster its claims that the MMR vaccine is safe.
The review, from a commercial company which lists the Department of Health as one of its clients, did not, however, consider work published since 1998 by scientists concerned about MMR.
Prof. O'Leary's results have been made public in a précis of a scientific presentation released ahead of a meeting of the Pathological Society of Great Britain and Ireland next month. It was greeted with alarm by parents last night.
Jackie Fletcher, of the parents' group JABS, said the findings had profound implications and must be taken seriously. "We have parents shouting that these problems are occurring and what do the Government and health chiefs do - they keep their heads buried in old reports not designed to identify these problems," she said. "No one is listening. Why?"
Ann Hewitt, whose son Thomas, eight, has severe autism and bowel problems, learned earlier this year that Dr O'Leary had found measles virus in the boy's gut. She and scores of others who received the same news now want to know what is going on.
The new results follow a study by Prof O'Leary and his colleagues, reported in February, in which they found measles virus of unknown origin in gut biopsies from 75 of 91 autistic children with bowel problems.
Measles virus was found in only five of 70 normal youngsters. The team now claims that the new study corroborates their earlier work linking measles virus with the condition and "indicates the origins of the virus to be vaccine strain".
Last night Visceral, a charity set up to fund research into autism and bowel disease, called for MMR to be suspended until studies establish just what the vaccine-strain virus is doing. MMR, which contains live measles mumps and rubella virus, was launched in the UK in 1988 and is given to infants at 12-15 months and four years.
The samples tested in Dublin were from some of nearly 200 youngsters diagnosed with developmental disorder and "new variant inflammatory bowel disease" by doctors at the Royal Free Hospital, in London, where Dr Andrew Wakefield worked until he was ousted last December.
The controversy over MMR and autism began four years ago when Dr Wakefield and his colleagues reported in The Lancet on 12 children with autistic problems and bowel disease and revealed that the parents of eight of them had said their children regressed developmentally after receiving the MMR jab.
While the genetic code of the strain of measles virus used in MMR differs only minutely from that of the virus responsible for natural infections, Prof. O'Leary and his colleagues were able to use a commercially produced molecular probe to distinguish the two.
The probe was designed to detect a single difference in the genetic code of the viruses and to give off a fluorescent signal when it does so. The MMR row became so heated this year that Tony Blair, the Prime Minister - who has refused to say whether his two-year-old son Leo has had the MMR jab - accused Dr Wakefield and the media of "scaremongering" on the issue.
The chief medical officer, Professor Liam Donaldson, has indicated he would rather resign than abandon official policy on the three-in-one vaccine.
Dr Wakefield said last night: "Prof. O'Leary and colleagues have now provided what may prove to be the most important piece of evidence to date in the case against the MMR vaccine. Parents must at the very least be given a choice of single vaccines.
"Not to do so in the face of these data and all the other evidence we have now published would be negligent in the extreme. It is not acceptable to assume that this vaccine virus is an innocent bystander if your concern is for the safety of the children."
The Department of Health said that it had no plans to review the use of MMR. "This study, if true, does not prove that MMR causes the condition of autism just because the virus is present in the gut. Critical will be independent testing of the teams' samples, which has long been awaited," said a spokesman.
Autism is rising at an epidemic rate in this country. Remember all that "for the children" stuff with the Clintons. Remember Rob Reiner talking about the wonders of a baby's brain. Meanwhile, early intervention...0-3 programs in this country have been savaged. Many parents who seek answers about their child's disability are shut down by managed care gatekeepers.
Recently talking to a young mother, she was informed by her doc that mercury had been taken out of the vaccines.....yeah...I doubt it. But that is probably what the doc had been told...and everyone trusts the doctor.
Most parents that I see that have autistic children are pillars of the community who follow doctor's regimen to the letter.
You would think so. But when it comes to potentially neurotoxic agents as a by-product of something that is perceived as "good," people take a "see no evil" approach to the issue.
This is especially true of LEGAL psychiatric drugs. The profession only looks into neurotoxicity questions when forced into it, and long after much damage has been done. Even then, they acknowledge the problems and do nothing about it.
A perfect example is neuroleptics (antipsychotics). It took them 2 decades to begin to acknowledge the neurological wreckage these drugs cause. But even then, they simply put the appropriate warnings in the PDR and kept on truckin'. Now in the last few years, we're beginning to hear the first whiffs of potential neurotoxicity problems with SSRIs.
Thanks for continuing to highlight this issue. We need to know a lot more on this as well as progress on related issues such as the role of neurotoxic agents in Parkinsons and Alzheimer's. When the U.S., with 5% of the world's population, produces 25% of the Alzheimer's patients, something is wrong.
The increase in reported Autism isn't due to increased screening...If anything. There is less screening going on. Teachers are tripping over these kids in schools. The only ones not recognizing this increase in autism stats are you bone-headed doctors.