| Vaccine Injury Compensation Court Award to Hannah Poling: Vaccines Caused Regressive Encephalopathy with Features of Autism |
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↓ Or skip Introduction to Dr. Bernadine Healy and go directly to Index of Articles on this page ↓
Dr. Bernadine Healy is a physician, educator, and health administrator who was the first woman to head the National Institutes of Health (NIH) as its Director from 1991 to 1993. Known for her outspoken, innovative policymaking, Dr. Healy has been particularly effective in addressing medical policy and research pertaining to women. Healy studied at Vassar College where she graduated summa cum laude, earned her M.D. at Harvard Medical School, and completed her training in internal medicine and cardiology at Johns Hopkins University School of Medicine, where she rose to the rank of Professor of Medicine.While she was at the National Institutes of Health, Dr. Healy undertook a number of initiatives. She established an award program to keep talented scientists working within the grant system during funding lapses, oversaw the development of a major intramural genetics laboratory and an Institute for Nursing Research, and launched the $625 million Women's Health Initiative (a long-term health study involving 150,000 women). In the interest of better understanding the different ways disease and treatment affect men and women, she also established a policy whereby the National Institutes of Health would fund only those clinical trials that included both men and women when the condition being studied affected both genders.
Currently, Dr. Bernadine Healy is Health Editor for U.S.News & World Report and writes the On Health column. She is a member of the President's Council of Advisors on Science and Technology and also served as president and CEO of the American Red Cross. In addition to her various administrative positions, Dr. Healy has continued to treat patients during much of her career. An author as well as a policymaker and manager, Dr. Healy has written or co-authored more than 220 peer-reviewed manuscripts on cardiovascular research and health and science policy. Dr. Healy also has been a Medical Contributor for CBS News, and published a book entitled, A New Prescription for Women's Health.
On May12, 2008, in an exclusive interview, former NIH Director Dr. Bernadine Healy told CBS News' Correspondent Sharyl Attkisson that the question of a link between vaccines and autism is still open for debate. She expressed dismay at the latest Institute of Medicine (IOM) Immunization Safety Review Committee's Report: Vaccines and Autism, that stated that the weight of the body of scientific evidence does not show a causal link between vaccines and autism, and that more research on the vaccine question is counterproductive. Healy also said public health officials have intentionally avoided researching whether subsets of children are "susceptible" to vaccine side effects—afraid of what they might find and afraid the answer will scare the public into not getting their children vaccinated, and have intentionally avoided the kinds of scientific research studies that might show causality.
In the sections below, we are posting the video and transcript excerpts of the CBS Interview with Dr. Healy, Dr. Healy's own article - Fighting the Autism-Vaccine War, additional information from CBS News' Correspondent Sharyl Attkisson, the transcript of the Don Imus interview with reporter Sharyl Attkisson on her story about Dr. Healy and vaccines, documents about the recent Vaccine Injury Compensation Program Trust Fund1 award to Hannah Poling, a case study of developmental regression and mitochondrial dysfunction in a child with autism by Jon Pauling, court medical papers on thimerosal exposure and the causation of regresive autism used in the Hannah Poling Case, the transcript of the 2008 meeting of the Vaccine Safety Working Group of the National Vaccine Advisory Committee (NVAC) and opinions by CNN's Dr. Sanjay Gupta and Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy author David Kirby.
Other information concerning a possible link between thimerosal-containing vaccines and the increase in autism spectrum disorders in children, including testimony from Congressional hearings, independent research studies, newly released transcripts of a secret meeting in 2001 between CDC and FDA officials that acknowledge the government's awareness of a thimerosal-vaccine-autism link from research studies, can be found on our website page: Is Thimerosal in Vaccines for Children Related to a Possible Causal Link Between Mercury Exposure and Autism Spectrum Disorders?
Autism - Vaccine - Thimerosal Controversy
| Posted May 12, 2008, by Shartyl Attkisson
Perhaps the most puzzling thing about autism and ADD is that more than a decade into this public health crisis, our best, smartest government scientists and public health officials still say they have no idea what's causing it. Scary stuff, when parents having a child today realize there's at least an estimated 1 in 150 chance their child will have an autism disorder (1 in 90 if it's a boy). While the government has been utterly unable to stop it, or even tell us what is causing it, they say they do know one thing: it's not vaccines. But today, in an exclusive interview with CBS News, Dr. Bernadine Healy becomes the most well-known medical voice yet to counter the government on that claim. Healy's credentials couldn't be more "mainstream." After all, she once was a top government health official as head of the National Institutes of Health. She founded the first school of public health in Ohio, and then headed both the school of public health and the school of medicine at Ohio State University. She's an internist and cardiologist. And she's a member of the Institute of Medicine, the government advisory board that tried to put the vaccine-autism controversy to rest in 20042 by saying a link was not likely. According to Healy, when she began researching autism and vaccines she found credible published, peer-reviewed scientific studies that support the idea of an association. That seemed to counter what many of her colleagues had been saying for years. She dug a little deeper and was surprised to find that the government has not embarked upon some of the most basic research that could help answer the question of a link. The more she dug, she says, the more she came to believe the government and medical establishment were intentionally avoiding the question because they were afraid of the answer. Why? Healy says some in the government make the mistake of treating vaccines as an all-or-nothing proposition. The argument goes something like this: everybody gets vaccinated at the same time with the same vaccines or nobody will get vaccinated and long-gone deadly diseases will re-emerge. (When I asked about cases of brain damage resulting in autism that have been quietly compensated by the government in vaccine court over the years3, one government official recently told me that "it's still better overall to get vaccinated than not to get vaccinated.") Healy says the argument need not be framed in those terms (vaccinate or don't vaccinate). Instead, she says, we should vaccinate, but work to do it in the safest manner possible based on what we know and what we can find out. That's what the parents of autistic children have told me as well. If we can screen children to see which ones might be more susceptible to vaccine side effects, and vaccinate them on a more personalized schedule that is safer for them, why wouldn't we? If it's safer for all children to have their vaccinations spread out, why wouldn't we? Healy says it's called "personalized medicine" and is being done in virtually all areas of medicine today with the exception of vaccines. Yet the government continues to frame the conversation in all-or-nothing, "one-size-fits-all" terms. Lastly, Healy says the government has a long way to go to even do basic research that could get at the heart of what she believes is an open question. For example: why in the past decade hasn't the government compared the autism/ADD rate of unvaccinated children with that of vaccinated children? If the rate is the same, it tends to point away from vaccines. If the rate is markedly lower in unvaccinated children, it tends to point toward vaccines. The government has a dataset of unvaccinated children available. It has published more than one survey of parents of undervaccinated and unvaccinated children (to find out why the parents are choosing not to vaccinate). It would seem simple to use those same families to measure their rate of autism/ADD. Also, why hasn't the government used vaccine court as a resource to ask the autism/vaccine question. There, nearly 5,000 families have self-selected as believing their children's autism was caused by vaccines. Many have expressed willingness to let their children's medical records be released and studied; but nobody in the government has been interested. As if that's not scary enough, look down the road a little. Millions of autistic children will - in the not-too-distant future - outgrow their parents, or their parents will no longer be able to care for them. Their only option in many cases is institutionalization. Who, but a parent or family member, can and would devote the moment-by-moment attention it takes to raise an autistic child? Our nation has not, to my knowledge, begun to build these institutions, or figure out how to pay for them. Back to the subject at hand. If the day comes that public health officials can finally tell us with reasonable certainty what is causing all the autism and ADD, and if the cause has nothing to do with vaccines, I think most people will just be relieved to know what it is and feel that we can, then, be closer to stopping it. Until then, in the minds of many, including Healy, it remains a sad, open question. |
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Dr. Bernadine Healy: "This is the time when we do have the opportunity to understand whether or not there are susceptible children, perhaps genetically, perhaps they have a metabolic issue, mitochondrial disorder, immunulogical issue, that makes them more susceptible to vaccines plural, or to one particular vaccine, or to a component of vaccine, like mercury. So we now, in these times, have to, I think, take another look at that hypothesis; not deny it. And I think we have the tools today that we didn't have ten years ago, that we didn't have twenty years ago, to try and tease that out and find out if indeed there is that susceptible group. Why is this important? A susceptible group does not mean that vaccins are not good. What a susceptible group will tell us is that maybe there is a group of individuals, or a group of children, that shouldn't have a particular vaccine or shouldn't have vaccine on the same schedule. I do not believe that if we identified a susceptibility group, if we identified a particular risk factor for vaccines, or if we found out that maybe they should be spread out a little longer, I do not believe the public would lose faith in vaccines. I think people undersatnd a polio epidemic. I think they understand a measles epidemic. I think they understand congenital rubella. I think they understand diptheria. Nobody's going to turn their back on vaccines. But, it is the job of the public health community, and of physicians, to be out there and to say, 'yes, we can make it safer', because we are able to say, 'This is a subset. We're going to deliver it in a way that we think is safer.' so I think that the public would respect that." Sharyl Attkisson: "But public health officials have been saying they know—they've been implying to the public they know, there's enough evidence, and it's not causal." Dr. Bernadine Healy: "I think you can't say that. And part of the... um... I think... You can't say that." Sharyl Attkisson: Do you think the government was too quick to dismiss, out of hand, that there was this possibility of a link between vaccines and autism?" Dr. Bernadine Healy: "I think the government, or certain health officials in the government, are - have been too quick to dismiss the concerns of these families without studying the population that got sick. I haven't seen major studies that focus on - three hundred kids, who got autistic symptoms within a period of a few weeks of a vaccine. I think that the public health officials have been too quick to dismiss the hypothesis as irrational, without sufficient studies of causation. I think that they often have been too quick to dismiss studies in the animal laboratory, either in mice, in primates, that do show some concerns with regard to certain vaccines and also to the mercury preservative in vaccines. The government has said, in a report by the Insitute of Medicine—and by the way, I'm a member of the Institute of Medicine. I love the Institute of Medicine—but a report in 2004 - it basically said, 'Do not pursue susceptibility groups. Don't look for those patients, those children, who may be vulnerable4. I really take issue with that conclusion. The reason why they didn't want to look for those susceptibility groups was because they're afraid if they found them—however big or small they were—that that would scare the public away. First of all, I think the public's smarter than that; the public values vaccines. But, more importantly, I don't think you should ever turn your back on any scientific hypothesis because you're afraid of what it might show!" Sharyl Attkisson: "You're saying, that public health officials have 'turned their back' on a viable area of research, largely because they're afraid of what might be found! Dr. Bernadine Healy: "If you read the 2004 report4, and converse with a few of my colleagues, um, who, um, who believe this still to be the case, there is a certain concern - um, I mean, there - Wait. - There is a completely expressed concern that they don't want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. I don't believe the truth ever scares people, and if it does have an edge to it, then that's the obligation of those who are delivering those facts, um, to do it in a responsible way, so you don't terrify the public. One never should shy away from science. One should never shy away from getting causality information - in a setting in which you can test it. Populations do not test causaulity, they test associations. You have to go into the laboratory, and you have to do designed research studies - in animals5. What we're seeing—in the bulk of the population—vaccines are safe. Vaccines are safe. But, there may be the susceptible group. The fact that there is concern, that you don't want to know that susceptible group, is a real disappointment to me. If you know that susceptible group you can save those children. If you turn your back on the notion that there's a susceptible group, that means that you are - um, what can I say!?" Sharyl Attkisson: "It sounds like you don't think the hypothesis—of a link between vaccines and autism—is completely irrational." Dr. Bernadine Healy: "When I first heard that there was a link between autism and vaccines, I thought: Well that's silly. Um, really - I mean I intended to dismiss it just on the, um, superficial kind of reading, or you know, just reading what was in the papers - no offense to the media - um, so when I first heard about it I thought: Well, that doesn't make sense to me. The more you delve into it - if you look at the basic science - if you look at the research that's been done, in animals5 - if you also look at some of these individual cases - and, if you look at the evidence that there is no link - what I come away with is: The question has not been answered. |
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| Posted May 13, 2008, by Dr. Sanjay Gupta, CNN Chief Medical Correspondent
Last week, I sat down with Dr. Bernadine Healy at CNN's Women's Health Summit in New York City. She is a remarkable person who has been the "first" at many things, including the first woman to head the National Institutes of Health. We talked about many things, including the persistent brain fog patients and their doctors have when it comes to heart disease and women. Everyone should know that heart disease is the biggest killer of women; in fact heart disease kills ten times as many women as breast cancer. What I wanted to blog about today, though, is her response to a question I asked about autism. She had written a column about the topic in U.S. News and World Report and told me she believes the link between vaccines and autism is "biologically plausible." Of course, that spurred several more questions from me. Healy went on to say that many in the scientific world have been quick to dismiss the concerns of parents and have not conducted the necessary studies of causation to definitively rule out a vaccine/autism link. Healy's comments have become a lightning rod in the medical community - with an infectious disease expert with the American Academy of Pediatrics calling CNN twice yesterday to express concern parents will misconstrue Healy's comments and stop get their kids vaccinated - and that vaccines save lives. Wow. We had to take a moment at the summit, where I reminded the doctor that her comments seemed to fly in the face of most of her former colleagues at the NIH, and the CDC, FDA, and AAP for that matter. She is sticking to her guns, as is the neurologist father of Hannah Poling, who believes when the vaccine court awarded his daughter Hannah compensation, it was a milestone in this debate. Neither are anti-vaccine, and both are arguably legitimate scientists. I have said over and over again that I was going to keep digging into this issue. What is happening here? For the record, I have had both my girls vaccinated on schedule, but I am curious - what do comments like Healy's say to parents and scientists? |
| The following is an unauthorized transcript of Don Imus' interview with CBS reporter Sharyl Attkisson.
Don Imus: Let's go to Sharyl Attkisson, CBS News, who had a report last night with Dr. Bernadine Healy about the possible link between thimerosal, a mercury based preservative, still in some vaccines, flu vaccines....and autism. Good morning Ms. Attkisson. Sharyl Attkisson: Good Morning. Don Imus: I had Dr. Healy on about an hour ago. The question I had for her is why did she want to get involved in this? Sharyl Attkisson: What did she say? Don Imus: Well, she thought it was important. She really didn't give me a good answer. She now writes for US News and World Report and the Vaccine Court cranked up...and she said she got motivated to get involved in this because of the Poling case, that child down in Atlanta. So, I guess she did give me an answer. Sharyl Attkisson: Well, that's what she told me as well. When she saw the Poling case, which had been quietly settled by the government but not announced last fall, it piqued her medical curiosity...and she started digging. When she dug, what she told me was, she was very surprised to find the state of things were not what had been presented for the past decade. Largely by public health officials. The more she dug, the more she found out and the more curious she got. She really had a sense of outrage, when she described for me, what she felt. What questions were and haven't been answered.....versus what we have been led to believe. Don Imus: As I observed to her, I don't have an autistic child myself, thank God, however, because of David Kirby's book, "Evidence of Harm", which was based upon a statement the CDC or IOM made....they said they found no evidence of harm, no casual link between thimerosal and autism....which as Mr. Kirby pointed out...and seemed to make common sense to me....saying they haven't found any casual link is one hundred and eighty degrees from saying it's safe. So, the people who think there is a link, and there is a wide body of evidence suggesting there is....they're characterized as being crazy So one of the things I asked Dr. Healy was, did she suspect she was going to be lumped in with those folks by all of her colleagues. She didn't seem to care. Sharyl Attkisson: That's why I felt the interview was very important. There are a lot of medical voices that have been saying the same thing, but, they are not well-known people. I guess its pretty easy to paint them with a broad brush and call them (unintelligble)...and, they don't know what they're talking about. I think its pretty important when someone with the stature of Bernadine Healy, the former head of the National Institute of Health, with a whole lot of credentials to her name....when she says something like this, that agrees with those people who have been labeled somewhat off center, I think you really do pay attention. And, it is newsworthy. Don Imus: I found it interesting she was also head of, as you obviously know, the Red Cross. Any resistance from the powers that be over there at CBS to put this story on the air? Apparently not, I guess. Sharyl Attkisson: No. And Dr. Healy is no longer head of the Red Cross. CBS News is very interested in pursuing any story that sounds like it has merit and value. People would be interested in that. So, that's where we went with this one. They're familiar with Dr. Healy's credentials as well. When you mentioned how the government will sometimes say there is no casual evidence found...one of the things Dr. Healy pointed out....that doesn't mean it doesn't exist. The point she tried to make in the story we aired last night was....she believes they haven't looked and they intentionally haven't looked because they know what they might find. They are afraid of the repercussions, people may not vaccinate their children at all. She takes issue with that "all or nothing" mentality. That people get all their vaccines on time...or get not vaccines....and diseases will come back. What she said was "There is something in-between". If you can identify there are susceptible children, you can handle them a little bit differently. Then you can still vaccinate the population properly...but a little bit more safely and differently. That was the point she was making in our piece last night. Don Imus: That was the point that David Kirby made. When the government says they haven't found any causal link, you're right, it doesn't mean it doesn't exist. It also doesn't mean these vaccines are safe. Not only is thimerosal, a more lethal form of mercury than the mercury found in fish, still remaining in vaccines. Aluminum, which is a neuro-toxin and formaldehyde....which is not only a neuro-toxin but a carcinogen as well. The people who support safe vaccines are not against, like for example my wife and others, are not against children getting vaccinated. They are simply demanding safe vaccines, which seems like a reasonable request. Sharyl Attkisson: Dr. Healy expressed herself as very pro-vaccine, over and over again, she's very supportive of vaccinations She was surprised about things like, studies that haven't been done that are very simple...and...she says would be obvious to do. Like study those kids who are selected for vaccine court.....to see if there is a common factor we could find that would make them susceptible, either genetic or biological, or some other way.....to side effects of vaccines Also, I told her CBS News has found a number of cases as far back as 1991, that we were tipped off to, where the government has been paying brain damaged cases in vaccine court, some of which resulted in autism or autism symptoms.6 At the same time, they've been saying publicly there is no reason to be worried about any association. She said why aren't they tracking those cases. So, I asked the government: "Are you tracking how many of your brain damaged cases you paid on for vaccines resulted in the specific kind of brain damage of autism? And they said "No, we're not tracking it". She said that's really unthinkable, that they're not even looking. |
| Posted April 10, 2008, by Bernadine Healy, M.D.
One of the most vitriolic debates in medical history is just beginning to have its day in court—vaccine court, that is. Without laying blame, the independent Office of Special Masters of the Court of Federal Claims—with a 20-year record of handling vaccine matters—recently conceded that the brain damage and autistic behavior of Hannah Poling stemmed from her exposure as a toddler to five vaccinations7 on one day in July 2000. Two days later, she was overtaken by a high fever and an encephalopathy that deteriorated into autistic behavior. Even though autism has a strong genetic basis, and she has a coexisting rare mitochondrial disorder, I would not be too quick to dismiss Hannah as an anomaly. At some level, the decision was a vindication for families who have been battling with the vaccine community, arguing that some poorly understood reaction to components of vaccines or their mercury-based preservative, thimerosal, could cause brain injury. Yes, vaccines are extraordinarily safe and bring huge public health benefit. (Remember the 1950s polio epidemics?) But vaccine experts tend to look at the population as a whole, not at individual patients. And population studies8 are not granular enough to detect individual metabolic, genetic, or immunological variation that might make some children under certain circumstances susceptible to neurological complications after vaccination. A trigger? Families are not alone in searching for a trigger that might explain why autism and autism spectrum disorders have skyrocketed; now they reportedly affect about 1 in 150 kids. No doubt some of the increase is soft, due to broader diagnostic criteria, greater awareness, and—now that the notion of a detached "refrigerator" mom as a cause has blessedly fallen by the wayside—greater openness. But the rise of this disorder, which shows up before age 3, happens to coincide with the increased number and type of vaccine shots in the first few years of life. So as a trigger, vaccines carry a ring of both historical and biological plausibility. Go back 40 or 50 years. The medical literature is replete with reports of neurological reactions to vaccines, such as mood changes, seizures, brain inflammation, and swelling. Several hundred cases of the paralytic illness Guillain-Barré after the swine flu vaccine were blamed on the government and gave Gerald Ford heartburn—but eventually led to the vaccine court. Pediatricians were concerned enough about mercury, which is known to cause neurological damage in developing infant and fetal brains, that they mobilized to have thimerosal removed from childhood vaccines by 20029. Their concern was not autism but the lunacy of injecting mercury into little kids through mandated vaccines that together exceeded mercury safety guidelines10 designed for adults. But as in all things vaccine, this move too was contentious. Both the Centers for Disease Control and Prevention and the World Health Organization remain unconvinced that thimerosal puts young children at risk. There is no evidence that removal of thimerosal from vaccines has lowered autism rates. But autism numbers are not precise, so I would say that considerably more research is still needed on some provocative findings. After all, thimerosal crosses the placenta, and pregnant women are advised to get flu shots, which often contain it. Studies in mice suggest that genetic variation influences brain sensitivity to the toxic effects of mercury. And a primate study designed to mimic vaccination in infants11 reported in 2005 that thimerosal may clear from the blood in a matter of days but leaves inorganic mercury behind in the brain. The debate roils on—even about research. The Institute of Medicine in its last report on vaccines and autism in 2004 said that more research on the vaccine question is counterproductive: Finding a susceptibility to this risk in some infants would call into question the universal vaccination strategy that is a bedrock of immunization programs and could lead to widespread rejection of vaccines. The IOM concluded that efforts to find a link between vaccines and autism "must be balanced against the broader benefit of the current vaccine program for all children." Wow. Medicine has moved ahead only because doctors, researchers, and yes, families, have openly challenged even the most sacred medical dogma. At the risk of incurring the wrath of some of my dearest colleagues, I say thank goodness for the vaccine court.
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Washington (AP) May 12, 2008
Parents claiming that childhood vaccines cause autism should not be awarded by the courts when the scientific community has already rejected any link, U.S. government lawyers argued Monday on the first day of a federal hearing. Overall, nearly 4,900 families have filed claims with the U.S. Court of Claims alleging that vaccines caused autism and other neurological problems in their children. Lawyers for the families are presenting three different theories of how vaccines caused autism. A hearing concerning one of those theories began Monday and is expected to last through the month. The theory at issue is whether vaccines containing the preservative thimerosal caused autism. Lynn Ricciardella, a Justice Department lawyer, said that the theory has not moved beyond the realm of pure speculation. She noted that such organizations as the Institute of Medicine and the Centers for Disease Control and Prevention have rejected any link between thimerosal and autism. "There is no scientific debate," Ricciardella said. "The debate is over." Thimerosal has been removed in recent years from standard childhood vaccines, except flu vaccines that are not packaged in single-doses. The CDC says single-dose flu shots currently are available only in limited quantities. Under a two-decades-old program, individuals claiming injury from a vaccine must file a petition for "no-fault" compensation with the United States Court of Federal Claims. The secretary of Health and Human Services replaces the vaccine manufacturer or vaccine administrator to defend the claim. Two 10-year-old boys from Portland, Oregon, will serve as test cases to determine whether thousands of families can be compensated. Attorneys for the boys will attempt to show they were happy, healthy and developing normally - but, after being exposed to vaccines with thimerosal, they began to regress. To win, the attorneys for the two boys, William Mead and Jordan King, will have to show that it is more likely than not that the vaccine actually caused the injury, which they described as regressive autism. Tom Powers, one of their attorneys, acknowledged that the evidence showing thimerosal led to regressive autism was indirect and circumstantial. Still, it is clear in the case of the two boys that they were normal and typical well after their first birthday. Only after the full round of vaccines had been administered, did they begin showing symptoms of autism. The attorneys for the families said that a study in monkeys showed that mercury could ignite "neuroinflammation" in the brain, and such inflammation is the hallmark of somebody with autism12. They also noted that previous studies of thimerosal were focused on autism, rather than on a more rare, specific form of the disorder that they described as regressive autism. The first witness for the families, Sander Greenland, a professor at the UCLA School of Public Health, said that published studies he reviewed failed to separate regressive autism from other types of autism when looking at thimerosal, thus they allow for a substantial association of the vaccines with clearly regressive autism. Under the vaccine compensation program, officials titled special masters serve as the trial judges. The hearing that began Monday involved three special masters who will hear the evidence and determine whether thimerosal belongs on the list of causes for regressive autism. The ruling are appealable to the Court of Federal Claims. Plaintiffs were instructed to designate three test cases for each of their theories - nine cases in all. The two cases beginning Monday are among the three that focus on the second theory of causation: that thimerosal-containing vaccines alone cause autism. If the families are successful, they could be entitled to damages that cover lost income after the person turns 18 and up to $250,000 for pain and suffering. Many members of the medical community are skeptical of the families' claims. They worry that the claims about the dangers of vaccines could cause some people to forego vaccines that prevent illness. Autism is a developmental disability that typically appears during the first three years of life and affects a person's ability to communicate and interact with others. Dr. Andrew Gerber, a psychiatrist, said that medical experts don't have a comprehensive understanding of what causes autism, but they do know there is a strong hereditary component. Toxins from the environment could play a role, but currently, data does not support that they do, Gerber said.
Copyright © 2008 The Associated Press. All Rights Reserved
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Katie Couric: "Every 20 minutes in this country, another child is diagnosed with autism, and in Washington today parents went to court to try to prove that some of those cases are linked to childhood vaccines. Tonight, in a CBS News Exclusive, one prominent doctor weighs in. Here's Sharyl Attkisson." Sharyl Attkisson: "Jordan King was a typical baby, [.His parents called him] vocal and vivacious. Then just before age 2, after a large battery of vaccinations, he [simply] withdrew from the world. Mylinda King: "The real scary thing was when I noticed he wasn't looking at us any more in the eyes" [, Mylinda King, Jordan's mother, said]. Sharyl Attkisson: "William Mead was a Pottery Barn baby model who [and] met all the typical milestones. Then, [also] at age 2, after a set of vaccinations, [William became very ill and] he, too, changed forever. "
[At first, both sets of parents suspected hearing problems. "The reason we had him tested for a hearing deficit was 'cause he wouldn't respond to us," (George) Mead (William's father) said. "He no longer used any of his language."
"We had him tested for deafness, it was that bad," King said. "I mean, you could slam a book on the floor and he wouldn't turn around to see what the sound was. It was like he was in this bubble of somewhere else, like he'd left the planet or something."
Doctors said it wasn't a hearing problem... It was the brain disorder autism.] Tests in both children [, batteries of tests] revealed dangerous levels of [the brain toxin] mercury [in their systems], which can cause permanent brain damage. Their only known exposure: Thimerosal—a [the] mercury preservative once widely used in childhood shots. ["Our doctor, Dr. Green, said 'you can stop looking for sources'," King said. "I know where it came from and it was... when he told us it was the vaccines, you just can't believe it."] Now William and Jordan—age ten—are [two] test cases among [nearly] 5,000 autism claims in a special federal [vaccine] court set up to compensaste vaccine injuries. The [Most] claims argue that mercury in vaccines, or the vaccines themselves [or MMR shots, or both], caused [resulted in] their children's autism. Government officials and many scientists insist there's no way [nothing about] vaccines [that] can lead to autism. Dr. Anne Schuchat: "I think it's important for the average parent to know that the government hasn't made a link between vaccines and autism" [, said Dr. Anne Schuchat of the Centers for Disease Control]. Sharyl Attkisson: "But now, a powerful medical voice is breaking ranks with her colleauges." Dr. Bernadine Healy: "I think that the public health officials have been too quick to dismiss the hypothesis as irrational," [Healy said]. Dr. Bernadine Healy is the former head of the National Institutes of Health [and the most well-known medical voice yet to break with her colleagues on the vaccine-autism question]. In an exclusive interview [ with CBS News], she [Healy] says [said] a link between vaccines and autism has not been ruled out [the question is still open]. Sharyl Attkisson:"But public health officials have been saying they know—[they've been implying to the public] there's enough evidence, and [they know] it's not causal" [, Attkisson said]. Dr. Bernadine Healy: ["I think you can't say that," Healy said.] "You can't say that." Sharyl Attkisson: "Dr. Healy accuses [goes on to say] public health officials of [have] deliberately [intentionally] avoiding [avoided] research[ing] into whether some [subsets of] children may be more [are] susceptible to vaccine side effects—afraid the answer will scare the public.
["You're saying that public health officials have turned their back on a viable area of research largely because they're afraid of what might be found?" Attkisson asked.
Healy said: "There is a completely expressed concern that they don't want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. "First of all," Healy said, "I think the public's smarter than that. The public values vaccines. But more importantly, I don't think you should ever turn your back on any scientific hypothesis because you're afraid of what it might show." ] And she's disturbed government researchers haven't bothered to study the cases in vaccine court [As an example, Healy points to the existing vaccine court claims]. CBS News has learned the government has paid more than 1,300 claims of brain injuries [brain injury claims] caused by vaccines [in vaccine court since 1988], but a government health official admits they've never even looked to see how many resulted in autism, telling CBS News they do not track cases on this basis." [but is not studying those cases or tracking how many of them resulted in autism. The branch of the government that handles vaccine court told CBS News: "Some children who have been compensated for vaccine injuries... may ultimately end up with autism or autistic symptoms, but we do not track cases on this basis." ] Dr. Bernadine Healy: "What we're seeing—in the bulk of the population—vaccines are safe. Vaccines are safe. But, there may be the [this] susceptible group. The fact that there is concern, that you don't want to know that susceptible group, is a real disappointment to me. If you know that susceptible group you can save those children. [If you turn your back on the notion that there is a susceptible group... what can I say?]" Sharyl Attkisson: Government officials would not respond directly to Dr. Healy's views [... but reiterated, vaccines are safe]. She, like the parents of Jordan and William [Like Healy, the Kings and the Meads support vaccination], support vaccines but believe [say] that the government should be working harder to make them [it can me made] safer. Sharyl Attkisson, CBS News, Washington. [At age 10, William's life is full of intensive therapy. "Horrifying is a good word," his father George said. "It was horrendous to watch your own child become, in effect, a zombie. It's something I wouldn't wish on my worst enemy. It was awful." Jordan, also 10, can't even communicate as well as he did as a toddler. "Oh yeah, he doesn't talk at all anymore" said Jordan's father, Fred. Public health officials insist there's no connection to their shots. Thousands of families are hoping for a different answer in vaccine court.] |
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Posted February 25, 2008 by David Kirby at The Huffington Post
Excerpt: After years of insisting there is no evidence to link vaccines with the onset of autism spectrum disorder (ASD), the US government has quietly conceded a vaccine-autism case in the Court of Federal Claims. The unprecedented concession was filed on November 9, and sealed to protect the plaintiff's identify. It was obtained through individuals unrelated to the case. The claim, one of 4,900 autism cases currently pending in Federal "Vaccine Court," was conceded by US Assistant Attorney General Peter Keisler and other Justice Department officials, on behalf of the Department of Health and Human Services, the "defendant" in all Vaccine Court cases. The child's claim against the government—that mercury-containing vaccines were the cause of her autism —was supposed to be one of three "test cases" for the thimerosal-autism theory currently under consideration by a three-member panel of Special Masters, the presiding justices in Federal Claims Court13. Keisler wrote that medical personnel at the HHS Division of Vaccine Injury Compensation (DVIC) had reviewed the case and "concluded that compensation is appropriate." The doctors conceded that the child was healthy and developing normally until her 18-month well-baby visit, when she received vaccinations against nine different diseases all at once (two contained thimerosal). Days later, the girl began spiraling downward into a cascade of illnesses and setbacks that, within months, presented as symptoms of autism, including: No response to verbal direction; loss of language skills; no eye contact; loss of "relatedness;" insomnia; incessant screaming; arching; and "watching the florescent lights repeatedly during examination." Seven months after vaccination, the patient was diagnosed by Dr. Andrew Zimmerman, a leading neurologist at the Kennedy Krieger Children's Hospital Neurology Clinic, with "regressive encephalopathy (brain disease) with features consistent with autistic spectrum disorder, following normal development." The girl also met the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) official criteria for autism. In its written concession, the government said the child had a pre-existing mitochondrial disorder that was "aggravated" by her shots, and which ultimately resulted in an ASD diagnosis. "The vaccinations received on July 19, 2000, significantly aggravated an underlying mitochondrial disorder," the concession says, "which predisposed her to deficits in cellular energy metabolism, and manifested as a regressive encephalopathy with features of ASD." This statement is good news for the girl and her family, who will now be compensated for the lifetime of care she will require. But its implications for the larger vaccine-autism debate, and for public health policy in general, are not as certain. Kirby continues in this post, expanding the discussion in analyzing the following questions:
In attempting to answer his own final question, David Kirby goes on to say: The significance of this concession will unfortunately be fought over in the usual, vitriolic way - and I fully expect to be slammed for even raising these questions. Despite that, the language of this concession cannot be changed, or swept away. Its key words are "aggravated" and "manifested." Without the aggravation of the vaccines, it is uncertain that the manifestation would have occurred at all. When a kid with peanut allergy eats a peanut and dies, we don't say "his underlying metabolic condition was significantly aggravated to the extent of manifesting as an anaphylactic shock with features of death." No, we say the peanut killed the poor boy. Remove the peanut from the equation, and he would still be with us today. Read more ....
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FULL TEXT: AUTISM VACCINE CASE
IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS CHILD, a minor, by her Parents and Natural Guardians, MOM & DAD, Petitioners, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent. RESPONDENT'S RULE 4(c) REPORT In accordance with RCFC, Appendix B, Vaccine Rule 4(c), the Secretary of Health and Human Services submits the following response to the petition for compensation filed in this case. FACTS CHILD ("CHILD") was born on December --, 1998, and weighed eight pounds, ten ounces. Petitioners' Exhibit ("Pet. Ex.") 54 at 13. The pregnancy was complicated by gestational diabetes. Id. at 13. CHILD received her first Hepatitis B immunization on December 27, 1998. Pet. Ex. 31 at 2. From January 26, 1999 through June 28, 1999, CHILD visited the Pediatric Center, in Catonsville, Maryland, for well-child examinations and minor complaints, including fever and eczema. Pet. Ex. 31 at 5-10, 19. During this time period, she received the following pediatric vaccinations, without incident:
Id. at 2. At seven months of age, CHILD was diagnosed with bilateral otitis media. Pet. Ex. 31 at 20. In the subsequent months between July 1999 and January 2000, she had frequent bouts of otitis media, which doctors treated with multiple antibiotics. Pet. Ex. 2 at 4. On December 3,1999, CHILD was seen by Karl Diehn, M.D., at Ear, Nose, and Throat Associates of the Greater Baltimore Medical Center ("ENT Associates"). Pet. Ex. 31 at 44. Dr. Diehn recommend that CHILD receive PE tubes for her "recurrent otitis media and serious otitis." Id. CHILD received PE tubes in January 2000. Pet. Ex. 24 at 7. Due to CHILD's otitis media, her mother did not allow CHILD to receive the standard 12 and 15 month childhood immunizations. Pet. Ex. 2 at 4. According to the medical records, CHILD consistently met her developmental milestones during the first eighteen months of her life. The record of an October 5, 1999 visit to the Pediatric Center notes that CHILD was mimicking sounds, crawling, and sitting. Pet. Ex. 31 at 9. The record of her 12-month pediatric examination notes that she was using the words "Mom" and "Dad," pulling herself up, and cruising. Id. at 10. At a July 19, 2000 pediatric visit, the pediatrician observed that CHILD "spoke well" and was "alert and active." Pet. Ex. 31 at 11. CHILD's mother reported that CHILD had regular bowel movements and slept through the night. Id. At the July 19, 2000 examination, CHILD received five vaccinations DTaP, Hib, MMR, Varivax, and IPV. Id. at 2, 11. According to her mother's affidavit, CHILD developed a fever of 102.3 degrees two days after her immunizations and was lethargic, irritable, and cried for long periods of time. Pet. Ex. 2 at 6. She exhibited intermittent, high-pitched screaming and a decreased response to stimuli. Id. MOM spoke with the pediatrician, who told her that CHILD was having a normal reaction to her immunizations. Id. According to CHILD's mother, this behavior continued over the next ten days, and CHILD also began to arch her back when she cried. Id. On July 31, 2000, CHILD presented to the Pediatric Center with a 101-102 degree temperature, a diminished appetite, and small red dots on her chest. Pet. Ex. 31 at 28. The nurse practitioner recorded that CHILD was extremely irritable and inconsolable. Id. She was diagnosed with a post-varicella vaccination rash. Id. at 29. Two months later, on September 26, 2000, CHILD returned to the Pediatric Center with a temperature of 102 degrees, diarrhea, nasal discharge, a reduced appetite, and pulling at her left ear. Id. at 29. Two days later, on September 28, 2000, CHILD was again seen at the Pediatric Center because her diarrhea continued, she was congested, and her mother reported that CHILD was crying during urination. Id. at 32. On November 1, 2000, CHILD received bilateral PE tubes. Id. at 38. On November 13, 2000, a physician at ENT Associates noted that CHILD was "obviously hearing better" and her audiogram was normal. Id. at 38. On November 27, 2000, CHILD was seen at the Pediatric Center with complaints of diarrhea, vomiting, diminished energy, fever, and a rash on her cheek. Id. at 33. At a follow-up visit, on December 14, 2000, the doctor noted that CHILD had a possible speech delay. Id. CHILD was evaluated at the Howard County Infants and Toddlers Program, on November 17, 2000, and November 28, 2000, due to concerns about her language development. Pet. Ex. 19 at 2, 7. The assessment team observed deficits in CHILD's communication and social development. Id. at 6. CHILD's mother reported that CHILD had become less responsive to verbal direction in the previous four months and had lost some language skills. Id. At 2. On December 21, 2000, CHILD returned to ENT Associates because of an obstruction in her right ear and fussiness. Pet. Ex. 31 at 39. Dr. Grace Matesic identified a middle ear effusion and recorded that CHILD was having some balance issues and not progressing with her speech. Id. On December 27, 2000, CHILD visited ENT Associates, where Dr. Grace Matesic observed that CHILD's left PE tube was obstructed with crust. Pet. Ex. 14 at 6. The tube was replaced on January 17, 2001. Id. Dr. Andrew Zimmerman, a pediatric neurologist, evaluated CHILD at the Kennedy Krieger Children's Hospital Neurology Clinic ("Krieger Institute"), on February 8, 2001. Pet. Ex. 25 at 1. Dr. Zimmerman reported that after CHILD's immunizations of July 19, 2000, an "encephalopathy progressed to persistent loss of previously acquired language, eye contact, and relatedness." Id. He noted a disruption in CHILD's sleep patterns, persistent screaming and arching, the development of pica to foreign objects, and loose stools. Id. Dr. Zimmerman observed that CHILD watched the fluorescent lights repeatedly during the examination and would not make eye contact. Id. He diagnosed CHILD with "regressive encephalopathy with features consistent with an autistic spectrum disorder, following normal development." Id. At 2. Dr. Zimmerman ordered genetic testing, a magnetic resonance imaging test ("MRI"), and an electroencephalogram ("EEG"). Id. Dr. Zimmerman referred CHILD to the Krieger Institute's Occupational Therapy Clinic and the Center for Autism and Related Disorders ("CARDS"). Pet. Ex. 25 at 40. She was evaluated at the Occupational Therapy Clinic by Stacey Merenstein, OTR/L, on February 23, 2001. Id. The evaluation report summarized that CHILD had deficits in "many areas of sensory processing which decrease[d] her ability to interpret sensory input and influence[d] her motor performance as a result." Id. at 45. CHILD was evaluated by Alice Kau and Kelley Duff, on May 16, 2001, at CARDS. Pet. Ex. 25 at 17. The clinicians concluded that CHILD was developmentally delayed and demonstrated features of autistic disorder. Id. at 22. CHILD returned to Dr. Zimmerman, on May 17, 2001, for a follow-up consultation. Pet. Ex. 25 at 4. An overnight EEG, performed on April 6, 2001, showed no seizure discharges. Id. at 16. An MRI, performed on March 14, 2001, was normal. Pet. Ex. 24 at 16. A G-band test revealed a normal karyotype. Pet. Ex. 25 at 16. Laboratory studies, however, strongly indicated an underlying mitochondrial disorder. Id. at 4. Dr. Zimmerman referred CHILD for a neurogenetics consultation to evaluate her abnormal metabolic test results. Pet. Ex. 25 at 8. CHILD met with Dr. Richard Kelley, a specialist in neurogenetics, on May 22, 2001, at the Krieger Institute. Id. In his assessment, Dr. Kelley affirmed that CHILD's history and lab results were consistent with "an etiologically unexplained metabolic disorder that appear[ed] to be a common cause of developmental regression." Id. at 7. He continued to note that children with biochemical profiles similar to CHILD's develop normally until sometime between the first and second year of life when their metabolic pattern becomes apparent, at which time they developmentally regress. Id. Dr. Kelley described this condition as "mitochondrial PPD." Id. On October 4, 2001, Dr. John Schoffner, at Horizon Molecular Medicine in Norcross, Georgia, examined CHILD to assess whether her clinical manifestations were related to a defect in cellular energetics. Pet. Ex. 16 at 26. After reviewing her history, Dr. Schoffner agreed that the previous metabolic testing was "suggestive of a defect in cellular energetics." Id. Dr. Schoffner recommended a muscle biopsy, genetic testing, metabolic testing, and cell culture based testing. Id. at 36. A CSF organic acids test, on January 8, 2002, displayed an increased lactate to pyruvate ratio of 28,1 which can be seen in disorders of mitochondrial oxidative phosphorylation. Id. at 22. A muscle biopsy test for oxidative phosphorylation disease revealed abnormal results for Type One and Three. Id. at 3. The most prominent findings were scattered atrophic myofibers that were mostly type one oxidative phosphorylation dependent myofibers, mild increase in lipid in selected myofibers, and occasional myofiber with reduced cytochrome c oxidase activity. Id. at 7. After reviewing these laboratory results, Dr. Schoffner diagnosed CHILD with oxidative phosphorylation disease. Id. at 3. In February 2004, a mitochondrial DNA ("mtDNA") point mutation analysis revealed a single nucleotide change in the 16S ribosomal RNA gene (T2387C). Id. at 11. CHILD returned to the Krieger Institute, on July 7, 2004, for a follow-up evaluation with Dr. Zimmerman. Pet. Ex. 57 at 9. He reported CHILD "had done very well" with treatment for a mitochondrial dysfunction. Dr. Zimmerman concluded that CHILD would continue to require services in speech, occupational, physical, and behavioral therapy. Id. On April 14, 2006, CHILD was brought by ambulance to Athens Regional Hospital and developed a tonic seizure en route. Pet. Ex. 10 at 38. An EEG showed diffuse slowing. Id. At 40. She was diagnosed with having experienced a prolonged complex partial seizure and transferred to Scottish Rite Hospital. Id. at 39, 44. She experienced no more seizures while at Scottish Rite Hospital and was discharged on the medications Trileptal and Diastal. Id. at 44. A follow-up MRI of the brain, on June 16, 2006, was normal with evidence of a left mastoiditis manifested by distortion of the air cells. Id. at 36. An EEG, performed on August 15, 2006, showed "rhythmic epileptiform discharges in the right temporal region and then focal slowing during a witnessed clinical seizure." Id. At 37. CHILD continues to suffer from a seizure disorder. ANALYSIS Medical personnel at the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC) have reviewed the facts of this case, as presented by the petition, medical records, and affidavits. After a thorough review, DVIC has concluded that compensation is appropriate in this case. In sum, DVIC has concluded that the facts of this case meet the statutory criteria for demonstrating that the vaccinations CHILD 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. Therefore, respondent recommends that compensation be awarded to petitioners in accordance with 42 U.S.C. § 300aa-11(c)(1)(C)(ii). DVIC has concluded that CHILD's complex partial seizure disorder, with an onset of almost six years after her July 19, 2000 vaccinations, is not related to a vaccine-injury14. Respectfully submitted,
PETER D. KEISLER
TIMOTHY P. GARREN
MARK W. ROGERS
VINCENT J. MATANOSKI
s/ Linda S. Renzi by s/ Lynn E. Ricciardella DATE: November 9, 2007 UPDATE: On February 22, 2008, HHS conceded that this child's complex partial seizure disorder was also caused by her vaccines14. |
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Developmental Regression and Mitochondrial Dysfunction in a Child With Autism
Journal of Child Neurology, 2006 Feb;21(2):170-2. Jon S. Poling, MD, PhD | Department of Neurology and Neurosurgery Johns Hopkins Hospital Baltimore, MD Richard E. Frye, MD, PhD | Department of Neurology Boston Children's Hospital Boston, MA John Shoffner, MD | Horizon Molecular Medicine Georgia State University Atlanta, GA Andrew W. Zimmerman, MD | Department of Neurology and Neurosurgery Johns Hopkins Hospital Kennedy Krieger Institute Baltimore, MD Abstract: Autistic spectrum disorders can be associated with mitochondrial dysfunction. We present a singleton case of developmental regression and oxidative phosphorylation disorder in a 19-month-old girl. Subtle abnormalities in the serum creatine kinase level, aspartate aminotransferase, and serum bicarbonate led us to perform a muscle biopsy, which showed type I myofiber atrophy, increased lipid content, and reduced cytochrome c oxidase activity. There were marked reductions in enzymatic activities for complex I and III. Complex IV (cytochrome c oxidase) activity was near the 5% confidence level. To determine the frequency of routine laboratory abnormalities in similar patients, we performed a retrospective study including 159 patients with autism (Diagnostic and Statistical Manual of Mental Disorders-IV and Childhood Autism Rating Scale) not previously diagnosed with metabolic disorders and 94 age-matched controls with other neurologic disorders. Aspartate aminotransferase was elevated in 38% of patients with autism compared with 15% of controls (P < .0001). The serum creatine kinase level also was abnormally elevated in 22 (47%) of 47 patients with autism. These data suggest that further metabolic evaluation is indicated in autistic patients and that defects of oxidative phosphorylation might be prevalent. (J Child Neurol 2006;21:170172; DOI 10.2310/7010.2006.00032). The autism spectrum disorders comprise a heterogeneous group of patients who exhibit similar behavioral phenotypes. The etiologies of autism remain idiopathic in most cases despite comprehensive investigations. Others have reported functional mitochondrial abnormalities in patients with autism and epilepsy,1 mitochondrial DNA G8363A transfer ribonucleic acid (Lys) mutation,2 chromosome 15q inverted duplication,3 and A3243G mitochondrial DNA mutation or mitochondrial DNA depletion.4 Patients with Rett syndrome are known to have mitochondrial ultrastructural abnormalities,5 as well as abnormalities in oxidative phosphorylation enzymes.6 We describe a female patient in whom developmental regres- sion and autism followed normal development and subtle laboratory abnormalities suggesting mitochondrial dysfunction led to a diagnostic muscle biopsy. Case Report: A 19-month-old girl was born after a normal full-term pregnancy. There was no family history of autism or affective, neuromuscular, or hearing disorders. Her development was progressing well, with normal receptive and expressive language and use of prelinguistic gestures, such as pointing for joint attention. Imaginary play and social reciprocity were typical for age. She used at least 20 words and could point to five body parts on command. Several immunizations were delayed owing to frequent bouts of otitis media with fever. Within 48 hours after immunizations to diphtheria, tetanus, and pertussis; Haemophilus influenzaeB; measles, mumps, and rubella; polio; and varicella (Varivax), the patient developed a fever to 38.9°C (102.02°F), inconsolable crying, irritability, and lethargy and refused to walk. Four days later, the patient was waking up multiple times in the night, having episodes of opisthotonus, and could no longer normally climb stairs. Instead, she crawled up and down the stairs. Low-grade intermittent fever was noted for the next 12 days. Ten days following immunization, the patient developed a generalized erythematous macular rash beginning in the abdomen. The patient's pediatrician diagnosed this as due to varicella vaccination. For 3 months, the patient was irritable and increasingly less responsive verbally, after which the patient's family noted clear autistic behaviors, such as spinning, gaze avoidance, disrupted sleep/wake cycle, and perseveration on specific television programs. All expressive language was lost by 22 months. The patient continued to have chronic yellow watery diarrhea intermittently for 6 months, which was evaluated with negative testing for Clostridium difficile, ova/parasites, and culture. Four months later, an evaluation with the Infant and Toddlers Early Intervention program for possible autism was initiated. Along with the regression, her appetite remained poor for 6 months and her body weight did not increase. This resulted in a decline on a standard growth chart for weight from the 97th to the 75th percentile. Evaluation at 23 months showed atopic dermatitis, slow hair growth, generalized mild hypotonia, toe walking, and normal tendon reflexes. The Childhood Autism Rating Scale (CARS) score was 33 (mild autism range), and she also met Diagnostic and Statistical Manual for Mental Disorders-IV criteria for autism. Laboratory findings included repeated measurements of aspartate aminotransferase 40 IU/L (normal < 31 IU/L), serum bicarbonate 20 mmol/L (normal 2131 mmol/L), serum creatine kinase level 203 IU/L (normal < 170 IU/L), and fasting lactic acid 3.3 mmol/L (normal 0.52.2 mmol/L). Quantitative urinary organic acid analyses showed trace amounts of dicarboxylic acids (adipic, suberic, octenedioic acids) and small amounts of ethylmalonic and methylsuccinic acids, consistent with a fatty acid oxidation dysfunction. Quantitative plasma amino acids were all within the normal range; however, the alanine to lysine ratio (a surrogate marker for pyruvate; Dr Richard Kelley, personal communication, 2001) was elevated at 3.2 (normal 1.52.5). Cranial magnetic resonance imaging, otoacoustic emission testing, overnight electroencephalography with slow-wave sleep, serum lead, chromosomes, and fragile X by DNA testing were all normal. The patient was referred for muscle biopsy (J.S.) because of persistent mild lactic acidosis, elevated serum creatine kinase level, and increased aspartate aminotransferase. A fresh vastus lateralis biopsy was performed and examined as described previously.7,8 The biopsy showed abnormal histology with type I myofiber atrophy, increased myofiber lipid content, and reduced cytochrome coxidase activity. Oxidative phosphorylation enzymology showed markedly reduced complex I, I + III, and III activity. Complex IV activity was near the 5% confidence limit of the control group (Table 1). Mitochondrial DNA sequencing of the skeletal muscle was normal. Now 6 years old, our patient has been treated with vitamin supplements since 2½ years of age. Even before starting supplementation, the patient began speaking again at 23 months old and had a four-word vocabulary of "bubbles," "ball," "drink," and "cracker." Levocarnitine 250 mg and thiamine 50 mg three times per day were initiated when the patient was 29 months old. Coenzyme Q 10 was added at age 33 months. Although she still exhibits mild autistic behaviors, our patient has continued to improve in language functions and sociability such that she now attends a regular kindergarten with an aide. There have been slow yet steady improvements in muscle tone, motor coordination, and gastrointestinal symptoms with occupational therapy, applied behavioral analysis interventions, and mitochondrial enzyme cofactor supplements. After the age of 2 years, growth trajectory has continued along the 75th percentile for both height and weight. Laboratory tests were repeated at ages 2 years and 10 months (aspartate aminotransferase 47 IU/L, normal < 38 IU/L; alanine transferase 20 IU/L, normal < 40 IU/L; serum creatine kinase level 105 IU/L, normal < 194 IU/L), 4 years old (aspartate aminotransferase 36 IU/L; alanine transferase 19 IU/L; serum creatine kinase level 169 IU/L), and 6 years old (aspartate aminotransferase 36 IU/L; alanine transferase 21 IU/L; alanine to lysine ratio 1.58, normal < 1.5 to 2.5). During an acute illness owing to C difficile, the aspartate aminotransferase was on one occasion elevated to 50 IU/L; however, the serum creatine kinase level remained normal at 169 IU/L. Urine organic acids and serum amino acids have been normal at ages 3 and 6 years. Childhood Autism Rating Scale scores since beginning kindergarten have been under 30.
Table 1. Skeletal Muscle Oxidative Phosphorylation Enzymology Results
* Units of enzyme activity are expressed as nanomoles of substrate/min/mg mitochondrial protein.
Additional Studies: The subtle laboratory abnormities identified in this case led us to retrospectively evaluate the laboratory records of other patients with autism. Records from the Kennedy Krieger Institute between January 1995 and September 2002 were selected. Available laboratory tests processed by the Johns Hopkins Hospital clinical laboratory were reviewed in 159 patients with autism and 94 patients of a similar age with other neurologic disorders. Patients with autism met both Diagnostic and Statistical Manual of Mental Disorders-IV and Childhood Autism Rating Scale criteria. Only a subset of laboratory values could be analyzed owing to sample size limitations. Liver function tests were available in a reasonable number of subjects. Serum levels of aspartate aminotransferase, but not alanine transferase, were significantly higher in autistic patients compared with control patients (autism vs control mean [standard error]: aspartate aminotransferase 36.3 [1.2] vs 29.7 [3.0]; alanine transferase 24.6 [3.0] vs 20.6 [2.5]; t-test: aspartate aminotransferase P = .00005; alanine transferase P = .22). Chi-square analysis also demonstrated that significantly more autistic patients demonstrated abnormal values for aspartate aminotransferase but not alanine transferase (autistic vs control: aspartate aminotransferase 46% vs 22%; alanine transaminase 6% vs 7%; chi-square: aspartate aminotransferase 20.8, P=.000005; alanine transaminase 0.1, P > .50). Too few laboratory values for the serume creatine kinase level were available from control subjects to directly compare this laboratory value between autistic and control patients. However, the number of abnormal serum creatine kinase level values was unusually high for the autistic group (22 of 46 [47%]; binomial probability: P < 1 × 10-14). Discussion: To our knowledge, this is the first description of an autistic child with mitochondrial dysfunction, growth failure, and abnormal muscle histopathology without seizures or a defined chromosomal abnormality. This patient exemplifies important questions about mitochondrial function in autism and developmental regression. It is unclear whether mitochondrial dysfunction results from a primary genetic abnormality, atypical development of essential metabolic pathways, or secondary inhibition of oxidative phosphorylation by other factors. If such dysfunction is present at the time of infections and immunizations in young children, the added oxidative stresses from immune activation on cellular energy metabolism are likely to be especially critical for the central nervous system, which is highly dependent on mitochondrial function. Young children who have dysfunctional cellular energy metabolism therefore might be more prone to undergo autistic regression between 18 and 30 months of age if they also have infections or immunizations at the same time. Although patterns of regression can be genetically and prenatally determined,9 it is possible that underlying mitochondrial dysfunction can either exacerbate or affect the severity of regression. Abnormalities of oxidative phosphorylation can be developmental and age related and can normalize with time.10 Our findings of mildly increased aspartate aminotransferase and serum creatine kinase level in children with autism might reflect abnormal mitochondrial function in skeletal muscle since alanine transaminase and other liver enzymes were normal. Without muscle biopsy data, it is not entirely possible for us to exclude that false-positive laboratory results contribute to our high rate of aspartate aminotransferase and serum creatine kinase level abnormalities. As pointed out by others, children who struggle during venipuncture can skew the results of blood analysis.11 However, our laboratory uses a hemolysis index that specifically avoids falsely elevated aspartate aminotransferase. Further prospective biochemical studies are needed to evaluate mitochondrial function in children within the autistic spectrum. There is a need for reliable laboratory markers to detect abnormalities of mitochondrial function, which will then facilitate further clinical investigations in this subgroup of children with autism.
Received February 7, 2005. Accepted for publication March 31, 2005. Address correspondence to Dr Andrew W. Zimmerman, Kennedy Krieger Institute, 707 N. Broadway, Baltimore, Md 21205.
References:
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UNITED STATES COURT OF FEDERAL CLAIMS, OFFICE OF SPECIAL MASTERS
IN RE: CLAIMS FOR VACCINE INJURIES RESULTING IN AUTISM SPECTRUM DISORDER OR A SIMILAR NEURODEVELOPMENTAL DISORDER VARIOUS PETITIONERS v. SECRETARY OF HEALT H AND HUMAN SERVICES, Respondent. General Information The National Vaccine Injury Compensation Program (VICP) is an innovative federal no-fault program enacted in 1986, (and since amended), which was designed to resolve a perceived crisis in vaccine tort liability claims that threatened the continued availability of childhood vaccines nationwide. In mandating that vaccine injury claims be considered first under VICP, the statute was intended to reduce lawsuits against physicians and manufacturers, while providing those claiming vaccine injuries a reduced burden of proof. Claimants under the VICP need not prove negligence, failure to warn, or other tort causes of action; they must only prove that a covered vaccine caused injury. Vaccines Covered Under the VICP The VICP originally covered vaccines against seven diseases - diphtheria, tetanus, pertussis, measles, mumps, rubella (German measles), and polio. Subsequently, coverage was extended to four additional vaccines - hepatitis B, hemophilus influenza type b (Hib), varicella (chicken pox), and rotavirus. In July 2005, the annual influenza (flu) vaccine became covered as well. An excise tax for each dose of vaccine sold funds a trust fund, which pays awards and administrative costs of the program. See www.hrsa.gov/vaccinecompensation for more information about the VICP. Litigation Process Under the VICP, rather than filing a lawsuit against the vaccine manufacturer or vaccine administrator in the civil tort system, individuals claiming injury from covered vaccines must first file a petition for "no-fault" compensation with the United States Court of Federal Claims The petition must also be served upon the Secretary of Health and Human Services, who replaces the vaccine manufacturer or vaccine administrator to defend the claim The Act creates the Office of Special Masters as an adjunct to the United States Court of Federal Claims. The Special Masters function in all respects as the trial judges in the vaccine cases, including having final decision making authority under the Act. The Special Master's rulings are appealable to the Court of Federal Claims on an "arbitrary and capricious" standard, with further review available before the Court of Appeals for the Federal Circuit and ultimately before the United States Supreme Court. Causation Under the VICP As in any product liability case, the initial question for decision is causation. There are two ways to prove causation under the Act. The VICP contains a Vaccine Injury Table, which is designed to minimize difficulties petitioners face in proving that their injury resulted from a vaccine. The Vaccine Injury Table lists certain injuries and conditions which, if found to occur within a prescribed period of time following vaccination, create a rebuttable presumption of causation In such "on-Table" cases, petitioners do not need to adduce proof of actual causation. For example, if a petitioner proves that her child received a DPT vaccine and that the child suffered an encephalopathy (brain injury) within three days thereafter, causation is presumed. The Act's Qualifications and Aids to Interpretation further define the compensable conditions. Assuming a petitioner is able to meet the Table's requirements, the respondent (the Secretary of HHS) may still defeat the compensation claim by establishing that the condition was more probably than not caused by a "factor unrelated" to the vaccine. If the petitioner can demonstrate the receipt of one of the listed vaccines but claims that some medical condition other than those listed in the statute resulted, or that a listed condition occurred outside the statutory time frame, the petitioner may still pursue a claim but must establish actual causation. This proof is akin to traditional standards applied in tort litigation. The Act's legislative history instructs that "[s]imple similarity to conditions or time periods listed in the Table is not sufficient evidence of causation; evidence in the form of scientific studies or expert medical testimony is necessary to demonstrate causation for such a petitioner." Types of Compensation The VICP provides compensation for past and future medical expenses, rehabilitation, therapies, special education expenses, equipment and placement. For pain and suffering, the VICP provides a maximum of $250,000. For lost earnings, if the injured prior to the age of 18, the VICP calculates lost earnings based upon "the average gross weekly earnings of workers in the private, non-farm sector, less appropriate taxes and the average cost of a health insurance policy." If the injury occurred after the age of 18, lost earnings are determined utilizing "generally recognized actuarial principles and projections." The VICP provides a $250,000 award for a vaccine-related death. Also, the VICP is a secondary payer; that is, compensation shall not be made to the extent payment is available from insurance, a state compensation program, or a Federal or State health benefits program, excluding Medicaid. Statistics As of May, 2008, over 12,500 cases have been filed, 5,365 representing autism cases. Of the total, 6,740 have been adjudicated, with 2,147 being compensated. Claims arising from vaccinations given prior to October 1, 1988, were paid from general fund appropriations. Petitioners filed 4,259 pre-1988 claims, with 1,187 being compensated. Over 890 million dollars of general revenue was paid for pre-October 1988 cases, including attorneys' fees at the statutorily capped level. Payments for post- October 1988 cases come from a trust fund supported by an excise tax on each dose of vaccine that is covered by the Program. Thus far, 8,313 post-1988claims have been filed, with 956 being compensated. Over 859 million dollars has been paid in compensation from the trust fund for the post- 1988 cases, including attorneys' fees and costs There is currently over 2.7 billion dollars in the trust fund. There is a wide range of awards depending on the severity of injury, with the highest award currently being $9.1 million in present dollars. OMNIBUS AUTISM PROCEEDING The adopted procedure for addressing the claims in the Omnibus Autism Proceeding (OAP) involves the conduct of a two phase proceeding. The first phase of the proceeding inquires into the general causation question of whether certain vaccinations can cause autism and, if so, under what circumstances. Three general causation theories advanced by petitioners are being evaluated in nine test cases. The conclusions reached in these test cases will inform the second phase of the OAP proceeding. The second phase of the proceeding involves applying the information acquired during the first phase of the proceeding to decide the specific causation question of whether the received vaccinations caused the autistic condition alleged in an individual case. At the request of petitioners' counsel, through a designated Petitioners' Steering Committee (PSC), petitioners were afforded a generous period of time to conduct discovery that would inform their theories concerning causation. After an extended discovery period, hearings were conducted in three test cases on the first general causation theory in the OAP The hearings were held in May 2007, October 2007, and November 2007, respectively. In begining these recent court (the "vaccine court") hearings, on behalf of the Petitioners, the Petitioners' Steering Committee (PSC) stated its desire to present three different theories of "general causation" in the Omnibus Autism Proceeding, and the undersigned Special Masters (Patricia Campbell-Smith, Denise Vowell, George L. Hastings, Jr.) instructed the PSC to designate three "test cases" for each of these three theories. Accordingly, during 2007 the court conducted hearings in three "test cases" with respect to the PSC's first "general causation" theory, i.e., the theory that MMR vaccines and thimerosal-containing vaccines can combine to cause autism. Specifically, in June the court conduced an evidentiary hearing concernung the first "test case", Cedillo v. HHS no. 98-916v, with special master hastings presiding. in the second case, Hazelhurst v. HHS, No. 03-654V, a hearing was held before Special Master Campbell-Smith in October, and in the third case, Snyder v. HHS, No. 010162V, a hearing was held in November before Special Master Vowell. As noted above, the PSC proposed to present three different theories of "general causation". The PSC's second stated theory is that thimerosal-containing vaccines alone can cause autism. As to that theory, the court conducted an evidentiary hearing on May 12 through ___, 2008. At that evidentiary hearing, the PSC and Respondent presented testimony concerning both that "general causation issue" and also the "specific causation" issue in two of the particular "test cases" for that theory selected by the PSC, which are the cases of King v. HHS, No. 03-584V, and Mead v. HHS, No. O3-215V. All three of the undersigned Special Masters (Patricia Campbell-Smith, Denise Vowell, George L. Hastings, Jr.) participated in that hearing. Special Master Hastings will decide the specific causation issue in the King case, and Special Master Campbell-Smith will decide the specific causation issue in the Mead case. Special Master Vowell will decide the specific causation issie in the third "test case", Dwyer v. Secretary of HHS, No. 03-1202V; evidence specific to that case will be presented in a hearing to be held on July 21-23, 2008. The above information comes from the lastest "Autism Update" of the Omnibus Autism Proceeding, as of August 1, 2008. "Autism Updates", Testimony and Documents from these hearings are currently available online at the U. S. Court of Federal Claims website page: "Docket of Omnibus Autism Proceeding". For example, in one of the documents listed here, Petitioners' Motion to Issue Third Party Subpoena (MERCK), the court decides to issue a subpeona to vaccine manufacturer Merck & Company, Inc. for documents related to thimerosal-containing vaccines and MMR vaccines in its possession that Merck has has refused to submit or release since the court's request nearly a year previous. The documents requested in these omnibus autism hearings are "Product License Applications" ("PLA's")—documents and materials that are generated and maintained by vaccine manufacturers as required under various federal statutes and regulations and that must be submitted to the FDA as part of the process by which the FDA approves and licenses the vaccines for use. Although these documents are in the possession of the FDA, "the FDA is limited, by statute and regulation, in its ability to disclose the contents of the documents, or to release the documents to third parties, including petitioners, without review and approval by the vaccine manufacturers". The court notes that "of the 400,000 pages of documents related to dozens of PLA's, petitioners have received only approximately 2,600 pages of a single PLA after nearly 11 months of discovery" and that "the documents produced so far are heavily redacted". The court goes on to say that there is good cause for the Special Master to issue said subpeona to Merck, and that "it is also likely that the vaccine manufacturers have information about the health and safety attributes of their products that the Respondent (the Secretary of Health and Human Services) does not have" and that "that imformation is critical in resolving the causation issues confronting the more than 3,000 seriously injured children (petitioners) in the autism proceeding" and that Merck's delay "imposes a huge burden on respondent and its client agencies, creates significant public costs, and causes delays that seriously jeopardize the Omnibus proceeding to complete the general causation inquiry in any reasonable amount of time".
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Background: This testimony was submitted at the Omnibus Autism Proceeding in the United States Court of Federal Claims on behalf of the Petitioners in Mead v. HHS, No. O3-215V, May, 2008, by Marcel Kinsbourne, MD. Dr. Marcel Kinsbourne is a pediatric neurologist and cognitive neuroscientist. He is currently Professor of Psychology at The New School for Social Research and Research Professor of Cognitive Studies at Tufts University. He researches brain-behavior relations, consciousness, imitation, psychology of attention, attention deficit disorder, and autism. Dr. Kinsbourne obtained his BM. BCh. degree, a British equivalent of the M.D. degree, at Oxford University. He then undertook medical specialty training in the United Kingdom (and New York University, Bellevue Hospital) in Pediatrics, Neurology and Pediatric Neurology. At the National Hospital, Queen Square, London, he was awarded the Queen Square Prize in Neurology and was also awarded Membership of the Royal College of Physicians of London (comparable to American Specialty Board Certifications in medical specialties). After holding an Oxford University Lectureship in Experimental Psychology, he moved to Duke University Medical Center where he was Associate Professor of Pediatrics and Neurology, Chief of the Division of Child Neurology and Director of the Developmental Evaluation Clinic. He also became Director of the Department of Behavioral Neurology at the Eunice Kennedy Shriver Center for Mental Retardation, Waltham, MA, and Clinical Associate at the Massachusetts General Hospital. At the Shriver Center he was awarded numerous NIH-funded grants for his research program on children with problems in attention, language and learning.
Scope of the Report: This report describes the biologically plausible mechanism by which exposure to mercury contained in the thimerosal added to many pediatric vaccines can be a substantial contributing cause of the symptoms of regressive autism observed in some of the affected children. It is offered in support of the petitioners' general theory of causation regarding the role of thimerosal-containing vaccines (TCVs) in the appearance of regressive autistic symptoms; that is, it supports the proposition that TCVs belong on the list of potential environmental factors to consider in evaluating the etiology of cases of regressive autism where other causes have been ruled out through differential diagnosis. The report does not offer any opinion as to whether any specific child's regressive autism is related to that child's thimerosal exposure. Specifically, this report examines the following issues:
Conclusions: The state of the science in autism has shifted radically in recent years. Long assumed to be the static aftermath of early brain damage or genetically induced dysgenesis, many investigators now regard autism as often caused by an active ongoing disease process. Gene-environment interaction, on account of which genetically predisposed individuals react to specific environmental factors, such as infections and toxins, by becoming autistic, is coming into favor as a mechanism of causation. The mechanism of injury offered in this report, of causation by a hyperglutamatergic state, is not specific to any one provocative agent, but can result from a range of virus and of heavy metal exposures (and is also found in neurodegenerative diseases, which however are not at issue in the causation of regressive autism). The proposed causation involving exposure to the mercury in TCVs is presented in the light of these advances in the science of autism. TVCs are sources of inorganic mercury, which is the breakdown product when TCVs are deposited and accumulate in the brain. Reacting to the presence of the mercury, the brain's innate immune system launches an ongoing neuroinflammatory process. (The autistic brain itself has been found to be the site of innate immune activation and neuroinflammation, and corresponding inflammatory markers have been found in the cerebrospinal fluid of autistic children). The neuroinflammation results in a hyperglutaminergic state. Mitochondria, which are neuroprotective in that they moderate glutamate excess, are themselves compromised by the oxidative stress generated by the inflammation. Furthermore, if for genetic reasons a particular child's mitochondria are abnormally vulnerable to stress, then the glutamate levels will be particularly apt to swing out of control. The overactivation of cerebral neuronal systems that results from the hyperglutamatergic state causes behavioral overarousal. Many, if not all, of the symptoms that collectively lead to the diagnosis of autistic spectrum disorder are explained by overarousal. For reasons summarized in this report, it is my opinion, to a reasonable degree of medical probability that a series of TCVs can result in or contribute to an accumulation of Hg++ in the brain. The mercury in the brain may trigger an inflammatory response in some children. The inflammation results in a hyperglutamatergic state. This state is characterized by overactivation (increased excitatory tone). Overactivation gives rise to behavioral arousal, which accounts for the child's regression into particular patterns of deficits and abnormal behaviors that characterizes autism. This process and the resulting symptoms may occur even if there is no clinical or pathological evidence of acute mercury poisoning or toxicity. It is therefore medically reasonable to consider the involvement of a TCV-induced encephalopathy when one engages in the differential diagnosis of a case of regressive autism, particularly when the other known medical causative factors in the differential diagnosis have been ruled out, or are not supported by reliable evidence. Rebuttal: After Dr. Kinsbourne's testimony at the hearing, counsel for the Respondent, Mr. Matanoski: "Are you going to look at and consider the fact that every reputable ... independent medical organization that has considered this issue, the Institute of Medicine, the American Academy of Pediatrics, the European Medicine Association, the World Health Organization, have all concluded that thimerosal containing vaccines do not cause autism? Are you also going to consider that every court that has had to consider this claim before it, before you have considered it, in fact, has found that the claim is so lacking in merit that it should not even be presented to a jury? Reliable scientific evidence at this point is all on one side of the ledger. Vaccines don't cause autism. Thank you."
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| On June 10, 2008, Gary J. Golkiewicz, Chief Special Master of the United States Court of Federal Claims, Office of Special Masters (also known as the "Vaccine Court", to some), sent a letter inviting journalist David Kirby (author of the book, Evidence of Harm), Dr. Bernadine Healy and others to "This year's United States Court of Federal Claims Judicial Conference", scheduled for November 19, 2008. In the letter, which began, "SAVE THE DATE.", Special Master Golkiewicz went on to say, "a significant portion of the Conference will focus on the Vaccine Program [aka National Vaccine Injury Compensation Program]." and that "This year's session will take a broader view of the policies underlying the Act [aka National Childhood Vaccine Injury Act of 1986] and the implications of vaccine decisions on families, public health, and vaccine litigation outside of the Vaccine Program."
Special Master Golkiewicz noted that these issues would br explored through two panels and that ther first panel "is tentatively titled 'Vaccines: Balancing Benefits with Parental Concerns (the autism issue?).'." Golkiewicz said that the panel "will be moderated by Sharyl Attkisson, a reporter with the CBS Evening News" and that "the panelists will be":
Noting that "There is no doubt that this discussion will be lively and informative", the Chief Special Master concludes: "I believe wholeheartedly that the Bench and the Bar must communicate periodically to improve the system of justice. I believe this Conference program - the panel discussions of general vaccine policy issues and the information underpinning vaccine compensation decisions - can provide that important dialogue. Dialogue requires participation. I am asking for your support."
David Kirby, in his Huffington Post Article: Federal Court Cancels Vaccine-Autism Panel, tells us, however, that this vaccine panel has been cancelled, as he was told on July 2, 2008 (approximately 22 days after the letter of invitation quoted above) by this letter from "His Honor":
Kirby goes on to say, "I publish both letters here in the public interest, and without further comment - though I still extend my thanks to Chief Special Master Golkiewicz for having invited the panel to speak in the first place. It would have been an interesting event, indeed." But we are still wondering, who was it who decided that this discussion about "general vaccine policy issues and the information underpinning vaccine compensation decisions"—that the Court's Chief Special Master originally said was an "important dialogue" ... " to improve the system of justice"—so abruptly, and so "apparently", became "simply a discussion not consistent with the Court's Conference".
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After 26 years, U.S. health officials are wrestling with how to prove to parents and doctors that current vaccine policies have adequately addressed evidence that more and more children are regressing after vaccination and suffering brain and immune dysfunction. On April 11, 2008, the National Vaccine Advisory Committee (NVAC) convened a meeting of the Vaccine Safety Working Group of the National Vaccine Advisory Committee. The process for this working group was predominantly to hear about the long term five year strategy that has been put together by CDC's Office of Immunization Safety. The first task is to undertake and coordinate a scientific review of the ISO's five year agenda. The second task for the working group was to undertake a larger and perhaps even more important review of the current status of the vaccine safety research efforts and to work on creating a report on the system and where it should be moving in the 21st century to get the best possible science and an effort to identify gaps and opportunities and the kinds of resources and the kinds of partners that need to be brought in going forward.
In his introduction to the meeting, Dr. Andrew Parvia, Professor of Pediatrics at the University of Utah School of Medicine, spoke more regarding this second task, saying: "But the second piece of what we're doing today is to try and begin what I hope is a long and much better process of improving transparency, improving communication, and public trust. There's been a lot of anger and a lot of distrust over issues of vaccine safety and what's needed in my opinion and I think we'll hear a great deal more is a very comprehensive and thoughtful way for different voices to be engaged and to do that we have asked a panel of people representing different voices and different expertise at 2 o' clock to speak to that specific issue. What are some of the mechanisms that can be used and that will work to make sure there is real public dialogue ___ engagement that people's voices are heard?
We then have about an hour for public comments. That's quite limited, I know. We have asked people to register in advance and to limit the comments to five minutes but there are going to be many other opportunities for comment here. I want to make that clear from the front. One is since we are in the modern era, one is electronically. Written comments that come to NVPO working group will be posted on the NVPO website so that we will all have a chance to review them but they will be there for the public to see. So, if you have material to submit please be aware that it is going to be in the public domain but we would appreciate that. This meeting is being transcribed and I hope that what comes out of the session this afternoon are some novel ideas for how to move forward and from that a commitment I think for ways in which this working group can hear from the public, but probably much more importantly since we are independent outside people that the government scientist and physicians who are responsible for vaccines and vaccine safety, have much better ways to interact with the public and have meaningful dialogues. Below, we are listing all the attendees to this meeting and their affiliations, followed by the excerpted public statement by Terry Poling, the mother of vaccine-injured Hannah Poling. The transcript of the entire meeting is also made available here.
The National Vaccine Advisory Committee (NVAC) Transcript of the Proceedings of the April 11, 2008
Meeting of the Vaccine Safety Working Group of the National Vaccine Advisory Committee LIST OF ATTENDEES:
Terry Poling's Statement to the Vaccine Safety Working Group of the National Vaccine Advisory Committee TERRY POLING: Hello everybody. I am Terry Poling, and I hope that you all know who that is. I'm the mother of Hannah Poling, and I am so happy to be here, and please forgive me if I go over five minutes, but I have been waiting for years to talk about this and I missed my day in court and I am not complaining, but I really have a couple of things to say and I hope they're helpful. I'm going to tell you little bit about my background. For 13 years I worked as a critical care nurse in both pediatric, neonatal, and adult ICU. I worked in the emergency room. I've seen kids come in with vaccine-induced seizures. I didn't know about VAERS [Vaccine Adverse Event Reporting System], didn't sing up with VAERS. I've worked in the post-anesthesia recovery room. I decided I don't know those. I think Aristotle said that those who do not study rhetoric are victims of it, so I decided to go to law school. So I picked up from California and moved across the country with my 8-year-old son and went to Boston University School of Law. At the same time I was working as a nurse in the ICU and attending School of Public Health. I graduated in 1993, came down to Washington, DC met with my husband or met up with my husband, Jon Poling and eventually married. I'm here and I am telling you all of this because I want you to understand the kind of person that I am. I love to read. I love to learn. I love to travel, and I love intense situations and getting things done intense situations. I had no idea that I was preparing myself to take care of a child with the special needs of a regressive autistic child with mitochondrial dysfunction. I had no idea that I was going to be preparing myself for the type of debate that has occurred between autism and vaccine. I find myself in the middle like a ping-pong net, in the middle of the two conflicting sides. I see both sides. I am here today because HHS agreed that Hannah's receipt nine vaccines in one day triggered her autism. You can now switch semantics, anyway you want but Hannah does have autism and the vaccines triggered it. She also has mitochondrial dysfunction. I am here to talk a few - about three things just to make you aware that I think are important for you as a group, and that is that we know now the autism is not rare, one out of every 150 kids has been diagnosed with autism and although the level of disability very significantly, children like my daughter and, I've have met many, are going to require life-long care.** Mitochondrial autism is not rare, and it can be triggered by vaccines. We know that the mitochondria act like little batteries in our cells to produce energy that is critical for normal function. We also know during the first two years of a child's life their brain development is also critical. They're developing language acquisition, sensory motor skills, and social adaptation. When a child has a mitochondrial dysfunction any trigger that requires a level of energy that the mitochondrial cannot produce, including vaccines, can put them at risk for brain injury and regression. In Hannah's case we know it' was the vaccines. There's also a problem here, and Hannah's case it not rare. There is a study out, and most of you know about it, from Portugal that shows that it could be up to 7.2 percent. There's other studies that have not been published yet that could be as high as 20 percent. Currently, autism researchers do not understand whether mitochondrial dysfunction is causative or whether it's just a biological marker, but the important point for you here today is that we now have a biological marker. In the 2004 IOM report [Institute of Medicine, Immunization Safety Review: Vaccines and Autism, May 2004] they said that they could not prove or there was no connection between vaccines and autism, but they couldn't disprove a connection in an individual because they have no biological markers. We are now telling you, you have your biological marker and it's called mitochondrial dysfunction and you need to research and you need to fund money into mitochondrial dysfunction. Therein lies major promise in trying to figure out what is happening with a lot of these children, and we know it's not necessarily just vaccines, but we still need to find out what that susceptible population is, and in light of this what the IOM can do is if they find out that this - the science determines, once the science checks this mitochondrial susceptibility and determines that number if they find out that the population is relatively uncommon, then every conclusion that you've had so far between vaccines and autism must be discarded and you must do another study with that subpopulation. If that turns out that it is common, you then have to go back and check to see if it was sufficiently powered for the predicted _______(INAUDIBLE). The body has very promising information. I - I think this is - this is great. We are making strides. We've got something to work with here. In the meantime, I think we've got a problem. I think we need to identify children at risk and we need to learn how to immunize them safely. We need to develop methods and criteria to screen for susceptible children. Maybe we need to wait to vaccinate until critical developmental milestones have been met so that we don't have our parent come in and saying, Well, they said a few words and then they got the MMR, and they're really just not talking, because that is the critical time of development. That is when they are starting to talk. Maybe we need to postpone that MMR until they're three. There's a lot of issues there because there childcare and there is daycare, but that's something that people can speak to. The other thing that I have a major problem with is VAERS. I read your agenda. I'm impressed with the agenda, but one of the problems I have with that is that you rely on VAERS for your safety and accessibility. I am a lawyer and a nurse, and I didn't know about VAERS, and I didn't learn it from anybody here. So that's really not a good assessment tool for determining whether or not the vaccines are safe, and the other problem is I interpret it as the Vaccine Injury Compensation Program. Again, a lawyer and a nurse, I didn't know about it for over year. I did not know that it existed. So you cannot use that as a measure for looking at the safety. I understand _______(INAUDIBLE). I didn't see anything or discussions that they are actually looking at the individual, but I read from your agenda that in fact they are and I am very, very happy that that is case. I think that's necessary, and at closing I want to say that our public health leaders are facing a new paradigm shift. While it has taken far too long to get here, the point is we are here. Instead of reading the same old stories, we don't know whether there is a real interest in autism. We don't know what causes autism. We have a lead, a very strong lead. We need to look at the mitochondria. We need highly specialized physicians that know how to do this, and we need to fund them and we need to get that research done. Thank you. (Clapping)
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FOOTNOTES:
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General Information
The National Vaccine Injury Compensation Program (VICP) is an innovative federal no-fault program enacted in 1986, (and since amended), which was designed to resolve a perceived crisis in vaccine tort liability claims that threatened the continued availability of childhood vaccines nationwide. In mandating that vaccine injury claims be considered first under VICP, the statute was intended to reduce lawsuits against physicians and manufacturers, while providing those claiming vaccine injuries a reduced burden of proof. Claimants under the VICP need not prove negligence, failure to warn, or other tort causes of action; they must only prove that a covered vaccine caused injury. Vaccines Covered Under the VICP The VICP originally covered vaccines against seven diseases - diphtheria, tetanus, pertussis, measles, mumps, rubella (German measles), and polio. Subsequently, coverage was extended to four additional vaccines - hepatitis B, hemophilus influenza type b (Hib), varicella (chicken pox), and rotavirus. In July 2005, the annual influenza (flu) vaccine became covered as well. An excise tax for each dose of vaccine sold funds a trust fund, which pays awards and administrative costs of the program. See www.hrsa.gov/vaccinecompensation for more information about the VICP. Litigation Process Under the VICP, rather than filing a lawsuit against the vaccine manufacturer or vaccine administrator in the civil tort system, individuals claiming injury from covered vaccines must first file a petition for "no-fault" compensation with the United States Court of Federal Claims. The petition must also be served upon the Secretary of Health and Human Services, who replaces the vaccine manufacturer or vaccine administrator to defend the claim. The Act creates the Office of Special Masters as an adjunct to the United States Court of Federal Claims. The Special Masters function in all respects as the trial judges in the vaccine cases, including having final decision making authority under the Act. The Special Master's rulings are appealable to the Court of Federal Claims on an "arbitrary and capricious" standard, with further review available before the Court of Appeals for the Federal Circuit and ultimately before the United States Supreme Court. [ Return to Text ]
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| The Immunization Safety Review Committee (ISR) was a project within the Institute of Medicine that addressed current and emerging vaccine-safety concerns. The committee was created to provide independent, non-biased advice to vaccine policy-makers, as well as practitioners and the public.
Meetings The committee met three times a year from 2001 - 2004. The topic of each meeting was a specific vaccine-safety question. For each vaccine-safety question, the committee read and discussed the relevant epidemiologic evidence for or against a causal relationship, as well as any case reports, and clinical evidence. The committee also heard presentations from the authors of key papers, as well as ongoing, unpublished research. Reports Committee reports, as well as their summaries and press releases, are available online in full-text format. Following each meeting, the committee wrote a report with three types of conclusions about:
Based on their conclusions, the committee made recommendations for future activities (i.e. surveillance, research, policy, communication) regarding the safety concern. The committee's reports are addressed to federal vaccine research policymakers, state and local vaccine program implementers, health care professionals, the public, and the media. Free Reports Each of the committee's eight full-text reports are available for free in PDF format (Email sign-in is required. Select "PDF Download", "Free", "Download"):
The committe also offers free Executive Summaries of the above eight reports (Email sign-in is not required) Who They Are The ISR committee was composed of 14 people with expertise in:
The IOM Immunization Safety Review Committee was chaired by Marie McCormick, M.D., Sc.D., Professor and Chair of the Department of Maternal and Child Health, Harvard School of Public Health. Other committee members included:
The committee was sponsored by the Centers for Disease Control and Prevention, and the National Institutes of Health. [ Return to Text ]
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As of May, 2008, over 12,500 [12,547] cases have been filed with the Vaccine Injury Compensation Program (VCIP), 5,365 representing autism cases. Of the total, 6,740 have been adjudicated, with 2,147 (32%) being compensated. Of the total claims, 982 represented vaccine injuries that resulted in deaths. The VCIP does not publicly release information about which specific cases were either compensated or dismisssed.
The Claims arising from vaccinations given prior to October 1, 1988, were paid from general fund appropriations. Petitioners filed 4,259 pre-1988 claims, with 1,187 being compensated. Over 890 million dollars [$902,519,103.37] of general revenue was paid for pre-October 1988 cases, including attorneys' fees at the statutorily capped level. Payments for post- October 1988 cases come from a trust fund supported by an excise tax on each dose of vaccine that is covered by the Program. Thus far, 8,313 post-1988 claims have been filed, with 956 being compensated. Over 859 million dollars [$895,929,130.70] has been paid in compensation from the trust fund for the post- 1988 cases, including attorneys' fees and costs. Thus, the total amount paid for vaccine injury claims to date has been roughly $1,798,000,000.00 (app 1.8 billion dollars). There is currently over 2.7 billion dollars in the trust fund. There has been a wide range of awards depending on the severity of injury, with the highest award currently being $9.1 million in present dollars.
Data source: U.S. Court of Federal Claims, Office of Special Masters, May 2008
The Table below shows claims filed and compensated or dismissed, listed by specific vaccine, as of May 5, 2008:
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| Thimerosal does not cause autism; nor does the MMR vaccine. This is the conclusion reached by The Institute of Medicine's Immunization Safety Review Committee in its report, Vaccines and Autism.1
The report states that "the body of epidemiological evidence favors rejection of a causal relationship between the MMR vaccine and autism" as well as a "rejection of a causal relationship between thimerosal-containing vaccines and autism." The hypothesis that the MMR vaccine was associated with autism was originally proposed in a highly publicized series of case reports published in The Lancet in 1998.2 The authors suggested that the onset of the symptoms of autism with gastrointestinal problems was temporally associated with the receipt of the MMR vaccine. The IOM committee confirmed that this study by Wakefield and colleagues did not provide evidence that the MMR vaccine could cause autism. Indeed, in 2004, ten of the thirteen authors of that study formally retracted their suggestion of a possible link between MMR vaccine and autism.3 In a previous report in 2001,4 the IOM's committee had rejected any causal relationship between the MMR vaccine and autism at the population level‹that means the MMR vaccine did not cause autism in the general population. However, the available evidence at that time was not sufficient to exclude the possibility that MMR could contribute to autism in a small number of children with a genetic predisposition to that disorder. More recent epidemiological studies, which are assessed in the new IOM report, have consistently shown no evidence that the MMR vaccine was associated with autism.5 The IOM report described two studies by Geier6 which had reported an association between MMR and autism as "characterized by serious methodological flaws and their analytic methods were nontransparent making their results uninterpretable, and therefore non-contributory with respect to causality." In other words, the studies by Geier could not establish a causal relation between MMR and autism because of their methods—such as using statistical measures incorrectly and omitting facts about their research approach. Similar problems were found in six other studies by Geier7 and one study by Blaxill8, which reported findings of an association between thimerosal-containing vaccines and autism. In addition, Geier's expertise in neurological disorders has been questioned.9 Five large studies in Sweden, Denmark, the United States and the United Kingdom consistently found no evidence of an association between thimerosal and autism.10 For that reason, the IOM's committee favored rejection of a causal relationship between thimerosal-containing vaccines and autism. This rejection differs from the conclusion of a 2001 report11 by the same committee on thimerosal-containing vaccines and neurodevelopmental disorders. The 2001 report stated that at that time the evidence was inadequate to accept or reject a causal relationship between thimerosal and the disorders of autism, attention deficit, and speech and language delay. The evidence now favors rejection of a relationship between thimerosal and autism. The current report did not evaluate the other disorders. The IOM committee recommended that immunization schedules remain unchanged. The IOM committee also recommended that research funding for autism be channeled towards more productive areas, such as the better understanding of the genetic causes of autism.12
References
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Routine Safety Study That Government Scientists Refused To Do Illustrates Vaccine Program And Mercury Health Risks Says SafeMinds
ATLANTA, May 19 /PRNewswire-USNewswire/ -- Findings released Friday showed that infant monkeys given vaccines officially recommended by the CDC and the American Academy of Pediatrics (AAP) exhibited autism-like symptoms. Lead investigator Laura Hewitson of the University of Pittsburgh and colleagues presented study results at the International Meeting for Autism Research (IMFAR) in London. Safety studies of medicines are typically conducted in monkeys prior to use in humans, yet such basic research on the current childhood vaccination regimen has never before been done. The abstracts presented at IMFAR, the world's top autism science conference, describe biological changes and altered behavior in vaccinated macaques that are similar to those observed in children with autism. Unvaccinated animals showed no such adverse outcomes. The vaccines given were those recommended for U.S. infants in the 1990s, including several with the mercury preservative thimerosal and the Measles-Mumps-Rubella vaccine. Rates of autism spectrum disorder among children born in the 1990s surged dramatically, from about 1 in 5,000 to 1 in 150 children. "This research underscores the critical need for more investigation into immunizations, mercury, and the alterations seen in autistic children," stated Lyn Redwood, director of SafeMinds. "SafeMinds calls for large scale, unbiased studies that look at medical conditions associated with autism and the effects of vaccines given as a regimen." The group's request for research echoes that of Dr. Bernadine Healy, Former NIH Director, in a CBS interview earlier this week. She asserted that public health officials have been too quick to dismiss an autism-vaccine connection when the research has been insufficient. The government recently conceded a federal vaccine court case which agreed that a child regressed into autism as a result of 9 vaccines given on one day. "The full implications of this primate study await publication of the research in a scientific journal," noted Theresa Wrangham, president of SafeMinds. "But we can say that it demonstrates how the CDC evaded their responsibility to investigate vaccine safety questions. Vaccine safety oversight should be removed from the CDC and given to an independent agency."
Read More [Research Study: "Pediatric Vaccines Influence Primate Behavior, and Amygdala Growth and Opioid Ligand Binding", Abstracts and Excerpts]
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The government does not normally release any details of specific cases in the Vaccine Injury Compensation Program adjudicated by the U.S. Court of Federal Claims, Office of Special Masters. The cases below, referred to by CBS News reporter Sharyl Attkisson—and most recently, the publication of some of the "test cases" in the Autism Omnibus Proceeding—are the exception.
In the cases published below, VICP decisions revealed nine instances in which compensation was awarded for the lifelong care of children and young adults who were diagnosed with autism or related conditions after they sustained documented, verifiable vaccine injuries. Of the 6,740 vaccine injury claims that have been adjudicated so far, 2,147 (32%) have resulted in compensation by the VICP. For non- case-specific information, see: Claims Filed and Compensated or Dismissed by Vaccine.
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When she was 19 months old, Hannah [Poling], the daughter of Jon and Terry Poling, received five vaccines — diphtheria-tetanus-acellular pertussis (DTaP), Haemophilus influenzae type b (Hib), measles-mumps-rubella (MMR), varicella, and inactivated polio (IPV). At the time, Hannah was interactive, playful, and communicative. Two days later, she was lethargic, irritable, and febrile. Ten days after vaccination, she developed a rash consistent with vaccine-induced varicella. Months later, with delays in neurologic and psychological development, Hannah was diagnosed with encephalopathy caused by a mitochondrial enzyme deficit. Hannah's signs included problems with language, communication, and behavior — all features of autism spectrum disorder. (Source: New England Journal of Medicine)
There has been some confusion in reporting the number of vaccines Hannah Poling received in one single day of vaccinations. Some sources have reported 5 vaccines while others have reported 9. The confusion arises because some of the "vaccinations" (or "shots") contained multiple "vaccines". The MMR vaccine is a actually a combination of three vaccines—Measles, Mumps and Rubella (German or "Three-Day" Measles)—in a single shot. Likewise the DTaP vaccine is also a combination of three vaccines—for Diptheria, Tetanus and Pertussis (whooping cough). So, 5 "vaccinations" were administered, which contained 9 "vaccines".
Note: The acellular DTaP (Diphtheria-Tetanus-acellular Pertussis) vaccine replaced the whole cell DPT (Combined Diptheria-Pertussis-Tetanus) Vaccine in the United States in 1996. DPT was a crude highly reactive vaccine that was available in the US (mostly in public health clinics) until about 2001. DPT was known to cause brain inflammation in one in 110,000 DPT shots and permanent brain damage in one in 310,000 DPT shots. One US study showed that one in 875 DPT shots was followed by a convulsion or collapse shock reaction. The purified DTaP vaccine now used by American children from two months through adolescence, causes fewer cases of brain inflammation, convulsions and permanent brain damage. However, if a child is genetically or otherwise biologically vulnerable to vaccine induced brain and immune system dysfunction, DTaP can cause brain inflammation and permanent injury. The same contraindications which apply to the old DPT vaccine also apply to the newer DTaP vaccine. It is very important for parents to be aware of the signs and symptoms of an acute reaction to DTaP (high fever, collapse/shock, high pitched screaming, inconsolable crying for hours, deep sleep/unconsciousness, convulsions) or subsequent mental regression, physical deterioration or emotional behavior changes in the days and weeks following vaccination. If your child has suffered vaccine reaction symptoms or health deterioration after receipt of DTaP or any other vaccine, it may be a warning sign that further vaccination could produce the same or a worse symptoms. The most tragic cases of vaccine-induced brain and immune system damage occur when parents and doctors ignore signs and symptoms that a child is not tolerating the process of vaccination and is becoming sicker after each round of vaccines. In the face of worsening health, it can be very risky to continue vaccinating with DTaP or any other vaccine which has been associated with illness after a previous vaccination.
Source: Mothering Magazine Ask The Experts Barbara Loe Fisher, National Vaccine Information Center (NVIC)
Vaccine Risks: What You Need to Know
What are the risks from DTaP vaccine? Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of DTaP vaccine causing serious harm, or death, is extremely small. Mild Problems (Common)
These problems occur more often after the 4th and 5th doses of the DTaP series than after earlier doses. Sometimes the 4th or 5th dose of DTaP vaccine is followed by swelling of the entire arm or leg in which the shot was given, lasting 1-7 days (up to about 1 child in 30). Other mild problems include:
These problems generally occur 1-3 days after the shot. Moderate Problems (Uncommon)
Severe Problems (Very Rare)
Controlling fever is especially important for children who have had seizures, for any reason. It is also important if another family member has had seizures. What if there is a moderate or severe reaction? What should I look for? Any unusual conditions, such as a serious allergic reaction, high fever or unusual behavior. Serious allergic reactions are extremely rare with any vaccine If one were to occur, it would most likely be within a few minutes to a few hours after the shot. Signs can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. If a high fever or seizure were to occur, it would usually be within a week after the shot. What should I do?
Some children should not get the DTaP vaccine or should wait
The National Vaccine Injury Compensation Program In the rare event that you or your child has a serious reaction to a vaccine, a federal program has been created to help pay for the care of those who have been harmed. For details about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit the program's website at www.hrsa.gov/vaccinecompensation.
Source: Centers for Disease Control and Prevention (CDC) | Diptheria, Tetanus & Pertussis Vaccines: What You Need To Know
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In 2004, the CDC asked the Institute of Medicine to review the available studies to determine if a link between Thimerosal and neurological disorders was plausible The IOM listened to many researchers explain how ethyl mercury could be causing an epidemic of autism and other disorders among children The review committee critiqued and discounted nearly all of those biological studies, saying none of them proved thimerosal caused autism or other developmental disorders The committee based the bulk of its conclusions on five epidemiological studies conducted by the CDC and European counterparts:
Epidemiological (or "population") studies cannot be used to prove or disprove a link, only to suggest plausibility. Regardless, the IOM made a bold statement that vaccines were not linked to the rise in autism, and stated that research into the link should be discontinued.
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On February 22, 2006, a bipartisan letter was sent by Congressional leaders in the House and Senate to David Schwartz, Director of the National Institute of Environmental Health Sciences (NIEHS). The letter from Senator Joseph Lieberman and others informed Mr. Schwartz of pending legislation that would order a new look at the connection between mercury containing vaccines and autism. Lieberman et al asked NIEHS to review the CDC's work on the vaccine database and report back with critiques and suggestions.
The final NIEHS report was a serious and thoughtful critique of where the CDC went wrong in its design, conduct and analysis of the study. The NIEHS panel "identified several serious problems," with the CDC's effort, criticism to which the agency had not responded—until now. In her letter to the House Appropriations Committee, the CDC Director responded directly to many—though not all—of the most important criticisms and recommendations contained in the NIEHS panel report. For example, the NIEHS had criticized CDC for failing to account for other mercury exposures, including maternal sources from flu shots and immune globulin, as well as mercury in food and the environment. "CDC acknowledges this concern and recognizes this limitation," the Gerberding reply says. The NIEHS also took CDC to task for eliminating 25% of the study population for a variety of reasons, even though this represented, "a susceptible population whose removal from the analysis might unintentionally reduce the ability to detect an effect of thimerosal." This strict entry criteria likely led to an "under-ascertainment" of autism cases, the NIEHS reported. "CDC concurs," Gerberding wrote, again noting that its study design was "not appropriate for studying this vaccine safety topic. The data are intended for administrative purposes and may not be predictive of the outcomes studied." Another serious problem was that the HMOs changed the way they tracked and recorded autism diagnoses over time, including during the period when vaccine mercury levels were in decline. Such changes could "affect the observed rate of autism and could confound or distort trends in autism rates," the NIEHS warned. "CDC concurs," Dr. Gerberding wrote again, "that conducting an ecologic analysis using VSD administrative data to address potential associations between thimerosal exposure and risk of ASD is not useful." |
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The letter was also signed by Sen. Debbie Stabenow (D-Mich.), Rep. Dave Weldon, M.D. (R-Fla.), Rep. Chris Smith (R-N.J.), Rep. Carolyn Maloney (D-N.Y.), Rep. Dan Burton (R-Ind.), Rep. Joseph Crowley (D-N.Y,) and Rep. Maurice Hinchey (D-N.Y.).
According to Dr. Weldon, in a prepared statement, "Federal agencies charged with overseeing vaccine safety research have failed. They have failed to provide sufficient resources for vaccine safety research. They have failed to fund extramural research and they have failed to free themselves from conflicts of interest that serve to undermine public confidence in the safety of vaccines". "The American public deserves better," Dr. Weldon stated, "and increasingly parents and the public at large are demanding better. There's an enormous inherent conflict of interest within the CDC, and if we fail to move vaccine safety to a separate independent office, safety issues will remain a low priority and public confidence in vaccines will continue to erode."
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On May 18, 2004, the Institute of Medicine, a branch of the prestigious National Academies, delivered its eighth and final report on vaccine safety, seeking to end a scientific controversy that had built to a slow boil over the previous five years: whether a mercury-containing vaccine
preservative called thimerosal was to blame for an alarming spike in autism cases among a generation of children. After three years of reviewing this and other immunization safety questions on behalf of the Centers for Disease Control and Prevention, the Institute's fourteen-member panel rejected the thimerosal link, and, in a powerful policy statement, recommended that research funding in this area be shifted toward other, more promising lines of inquiry.
What is known is this: Since the late 1980s the number of children diagnosed with autism has increased sixty-fold, from one in every 10,000 in 1987 to one in every 166 in 2003. Much of this spike overlaps with a period when, due to recommendations by the CDC and the Food and Drug Administration, the number of suggested immunizations on the childhood vaccination schedule more than doubled, raising the doses of mercury that some children received to levels that far surpassed federal standards for mercury exposure. (The standards were based on methylmercury, the type emitted by coal-burning power plants. Ethylmercury, which makes up nearly half of thimerosal by weight, is a closely related compound. To date, ethylmercury has received far less study, and scientists disagree on whether it's as harmful as methylmercury, though both are considered neurotoxins.) Until the late 1990s, health officials were unaware of the total amount of mercury children were receiving in their vaccinations. It's not unreasonable to ask how this went unnoticed, and unreported, for so long. The answer is simple: no one had ever done the arithmetic. When scientists did, the U.S. Public Health Service recommended that vaccine manufacturers phase out thimerosal from children's vaccines in 1999 as a precaution. It was careful to note, however, that "there are no data or evidence of any harm." As it stands, the preservative, which allowed drug manufacturers to supply vaccines in multidose vials (the thimerosal-free, single-dose versions are costlier), has been eliminated from most immunizations, excluding some flu and tetanus shots. During 1999 and 2000, the thimerosal link was quietly under study by the CDC, and, as shown in internal memos and meeting minutes, health officials were deeply concerned about what they might find. In June 2000, the CDC convened a closed meeting at the Simpsonwood Convention Center in Norcross, Georgia, to discuss, among other things, preliminary findings on thimerosal. In addition to the health officials, researchers, and vaccine experts in attendance were representatives from GlaxoSmithKline, Merck, Wyeth, and Aventis Pasteur, the vaccine manufacturers who had the most to lose if an autism link were proven. During one session of the two-day meeting, the CDC epidemiologist Thomas Verstraeten presented the results of an analysis of the CDC's Vaccine Safety Datalink, a database that contains the vaccination histories of more than seven million Americans. His study, at least at that stage, appeared to support a connection between thimerosal and neurodevelopmental disorders, showing what Verstraeten described as "statistically significant relationships between exposures and outcomes." The presentation caused one physician in attendance to remark, "the medical legal findings in this study, causal or not, are horrendous." Attendees were instructed that what they'd heard that day was to be considered "embargoed." Known as the Simpsonwood transcripts, the minutes of this meeting are widely available on the Internet thanks to a Freedom of Information Act request by the autism advocacy group SafeMinds. But Simpsonwood is not a smoking gun. Nor are other documents that purport to be, including the transcript of a private session of the Institute of Medicine's Immunization Safety Review Committee from 2001, in which the committee's chairwoman, Dr. Marie McCormick, referring to the vaccine-thimerosal issue, says that the CDC "wants us to declare, well, these things are pretty safe on a population basis." It is a statement that indicates to some that the IOM had already decided where it was going to come down on thimerosal. If transcripts of both meetings are not damning, the comments of some attendees are striking, particularly when they are quick to note the legal ramifications should a connection be established. As McCormick makes plain during the 2001 meeting, attendees were aware of the conclusion that the CDC wanted them to reach, but that isn't proof that the institute manipulated data to reach that end, as some allege. When the IOM panel released its final report in 2004, it had analyzed more than 200 studies and based its conclusions largely on five recent epidemiological papers that appeared to debunk the autism connection, including Verstraeten's and one from Denmark that shows autism cases rising after thimerosal was removed from that country's vaccine supply. Excluded was much of the biological research that supports a link, which the IOM deemed speculative. Those are the facts, though they are interpreted in radically different ways by each side. Even the question of whether the nation is currently experiencing an autism epidemic is subject to debate. Detractors posit that the increase in cases is a red herring, that the numbers reflect changes in how autism is diagnosed and reported. As for the IOM report — the nail in the coffin for the autism link as far as many scientists are concerned — believers hold that the studies that the panel relied on were flawed. For example, as David Kirby reports in Evidence of Harm, the researchers on the Danish study examined autism cases both before and after 1992, when thimerosal was removed, but used two different data sets in doing so, tallying inpatient cases through 1994 and adding outpatient cases to their count thereafter, a factor that could explain the increase they observed. According to Kirby, even the study's authors conceded, in their own words, that they "may have spuriously increased the apparent number of autism cases." Verstraeten, for his part, seemed to grow tired of how his findings were being interpreted by both sides. In an April 2004 letter to Pediatrics, he wrote that his study "does not state that we found evidence against an association, as a negative study would. It does state, on the contrary, that additional study is recommended, which is the conclusion to which a neutral study must come."
Source: Drug Test, by Daniel Schulman, Columbia Journalism Review, November/December 2005
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Representative Dave Weldon, M.D. (R-FL): 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 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. (June, 2004)
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1. General Background: The compound, ethyl(2-mercaptobenzoato-S)mercury sodium salt or, more commonly named, sodium ethylmecurithiosalicylate, patented as a topical anti-infective in 1928 and known by many trade names, including Thimerosal, has been used since the 1930's. Subsequently, Thimerosal came to be widely accepted as a "preservative" component in some of the vaccines and other drugs intended for use in humans. Moreover, though not labeled as such, Thimerosal (at levels from 0.01 % [100 ppm] down to "0.0002 % [2 ppm]" in vaccine formulations) seems to function as an "adjuvant."
From the 1980's to present, the Centers for Disease Control and Prevention (CDC) and the FDA have allowed:
Today, a range of multi-dose vaccines and related biological products that contain levels of Thimerosal above 0.001 % (10 ppm) are still produced, licensed or approved, and available for unrestricted use in humans. 2. Removal Of Thimerosal And Other Mercury-based Compounds From OTC Drugs: In 1982, a scientific panel, convened by the FDA to review the over-the-counter (OTC) use of Thimerosal, concluded,11 "that thimerosal is not safe for [over-the-counter] topical use because of its potential for cell damage if applied to broken skin and its allergy potential." [Note: This FDA-sponsored panel only addressed the epidermal and dermal effects of Thimerosal.] Based on the results of their review, that scientific panel recommended the removal of Thimerosal from over-the-counter products. Sixteen years later, in 1998, the FDA finally banned12 the use of:
What is most interesting about this OTC product is not the fact that it contains thimerosal ("not more than 0.002% as a preservative"), but that its label clearly states, "This product contains thimerosal as a preservative. Do not use this product if you are sensitive to mercury". It's too bad the FDA didn't (and still doesn't) plainly state such a warning for vaccines. Perhaps they thought that infants are not "sensitive to mercury" — a know, potent neurotoxin. The CDC currently states, on the CDC's website page, Vaccine Safety - Concerns - Mercury and Vaccines (Thimerosal): |
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The statement above seems to conflict with the vaccine/thimerosal tables currently (as of August 10, 2008) posted on the FDA website.
For information on the current status of vaccines that still contain thimerosal and which vaccines are purpotedly "thimerosal free", please see our section, What Are The Vaccines That Still Contain Thimerosal? It displays three tables from the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER):
Also, The Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health has a slightly different and more recent Vaccine Table updated June, 24, 2008, Thimerosal Content in Some U.S. Licensed Vaccines Referring to the terms "Thimerosal-free" and "trace amounts", it notes with asterisks six vaccines (DTaP, DTaP-Hib, DT, Td, Td-Tetanus and Diphtheria Toxoids Adsorbed, and Hib) that, according to JAMA 1999;282(18) and JAMA 2000;283(16), "should be considered equivalent to thimerosal-free products." In the same notation is the disclaimer for these vaccines: "This vaccine may contain trace amounts (< 0.3 mcg) of mercury left after post-production thimerosal removal; these amounts have no biological effect." It also lists 10 vaccines (DTwP, DT, Tetanus Toxoid-Tetanus Toxoid Adsorbed USP, Tetanus Toxoid-Tetanus Toxoid Adsorbed Adult Use, Tetanus Toxoid-Booster, Influenza 2007/8 Formula-multi-dose-CSL Limited, Influenza 2007/8 Formula-multi-dose-FluLaval-GlaxoSmithKline, Influenza 2007/8 Formula-multi-dose-Fluvirin-Novartis, Influenza 2007/8 Formula-multi-dose-Fluzone-sanofi-pasteur, and Meningococcal-multi-dose) that still have .01% Thimerosal (25 micrograms Mercury/0.5 ml) in them.
In addition to Thimerosal, there are also other chemicals and ingredients in vaccines. In the vaccine industry, these are known as "excipients" and "media". Excipients are (purportedly) "inactive" ingredients of a drug product necessary for production of a finished pharmaceutical formulation. Media includes growth media and culture materials (such as chicken embryos, bovine protein, monkey kidney tissue, mouse brain, etc.) used to produce mass quantities of a microorganism antibody, or other immunilogical agent, suitable for further processing into a finished pharmaceutical product. Below are two tables from the CDC that list the excipients and media included in licensed vaccines in the United States:
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Most vaccines today also contain "adjuvants". Adjuvants are added to vaccines to help stimulate the production of immunity against the vaccine ingredients, making the vaccine more effective. Aluminum salts have frequently been incorporated as adjuvants in vaccines licensed for use in the United States and elsewhere. There are other adjuvants incorporated in vaccines licensed in other countries and there are other adjuvants used in other medications (which are not vaccines) that have been licensed in the United States. It is likely that other adjuvants will be incorporated in a number of new vaccines currently being tested for use in the United States. Adjuvants purportedly serve to:
Studies have shown that many aluminum-containing vaccines cause higher and more prolonged antibody responses than comparable vaccines without the adjuvant. The benefit of adjuvants has usually been observed during the initial immunization series rather than with booster doses. There are three general types of aluminum-containing adjuvants:
Regarding vaccine adjuvants, Dr. Lewis Mehl-Madrona writes,
"Until recently, most vaccines presented antigens according to the same principals as they were 200 years ago - when vaccines consisted of the whole microorganism, alive or killed. The new generation of vaccines contains other defined antigens, called "subunit vaccines". Newly developed genetic technology gives us the means to produce the defined antigen in large enough amounts to generate a low price. |
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The mercury in Thimerosal is ethylmercury (sometimes written ethyl mercury) or what is known as "organic mercury". The only usual way it enters the human body is by bolus injection, as in childhood vaccinations. Essentially all safety guidelines for mercury exposure refer to methylmercury. Methylmercury, also known as "inorganic mercury", usually enters the body by the consumption of fish, other seafood or animals—such as birds—that eat fish and other aquatic species.
Other important environmental sources of methylmercury include the burning of fossil fuels, especially coal. There have been several episodes in which large numbers of people were severely poisoned by food contaminated with high levels of methylmercury, notably the dumping of industrial waste that resulted in the pollution and subsequent mass poisoning in Minamata and Niigata, Japan, and the situation in Iraq in the 1960s and 1970s in which wheat treated with methylmercury as a preservative and intended as seed grain was fed to animals and directly consumed by people. These episodes resulted in neurologic symptoms including paresthesias, loss of physical coordination, difficulty in speech, narrowing of the visual field, hearing impairment, blindness, and death. Children who had been exposed in-utero through their mothers' ingestion were also affected with a range of symptoms including motor difficulties, sensory problems and mental retardation.
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Additional information on mercury in vaccines and others sources of mercury can be found on our Vaccinations and Mercury page, which contains the following sections:
See also: Thimerosal and Animal Brains: New Data for Assessing Human Ethylmercury Risk [ Return to Text ] |
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Comparison of Blood and Brain Mercury Levels in Infant Monkeys Exposed to Methylmercury or Vaccines Containing Thimerosal
Thomas M. Burbacher, Danny D. Shen, Noelle Liberato, Kimberly S. Grant, Elsa Cernichiari, and Thomas Clarkson Abstract: Thimerosal is a preservative that has been used in manufacturing vaccines since the 1930s. Reports have indicated that infants can receive ethylmercury (in the form of thimerosal) at or above the U.S. Environmental Protection Agency guidelines for methylmercury exposure, depending on the exact vaccinations, schedule, and size of the infant. In this study we compared the systemic disposition and brain distribution of total and inorganic mercury in infant monkeys after thimerosal exposure with those exposed to MeHg. Monkeys were exposed to MeHg (via oral gavage) or vaccines containing thimerosal (via intramuscular injection) at birth and 1, 2, and 3 weeks of age. Total blood Hg levels were determined 2, 4, and 7 days after each exposure. Total and inorganic brain Hg levels were assessed 2, 4, 7, or 28 days after the last exposure. The initial and terminal half-life of Hg in blood after thimerosal exposure was 2.1 and 8.6 days, respectively, which are significantly shorter than the elimination half-life of Hg after MeHg exposure at 21.5 days. Brain concentrations of total Hg were signiÞcantly lower by approximately 3-fold for the thimerosal-exposed monkeys when compared with the MeHg infants, whereas the average brain-to-blood concentration ratio was slightly higher for the thimerosal-exposed monkeys (3.5 ± 0.5 vs. 2.5 ±0.3). A higher percentage of the total Hg in the brain was in the form of inorganic Hg for the thimerosal-exposed monkeys (34% vs. 7%). The results indicate that MeHg is not a suitable reference for risk assessment from exposure to thimerosal-derived Hg. Knowledge of the toxicokinetics and developmental toxicity of thimerosal is needed to afford a meaningful assessment of the developmental effects of thimerosal-containing vaccines.
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4.8 MB Thomas M. Burbacher, PhD | Thimrerosal Neurotoxicity and Neuroinflammation in Autism
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Thimerosal in Vaccines: Some Recent Research Presentation by Thomas M. Burbacher, PhD Associate Professor Department of Environmental and Occupational Health Sciences School of Public Health and Community Medicine University of Washington Note: When this presentation was being made, the NIEHS (National Institute of Environmental Health Sciences) was working with CDC to convene an expert panel in May 2006 to review the use of the CDC-supported Vaccine Safety Data Link (VSDL)—now known as the Vaccine Safety Datalink (VSD) Project—to address questions about changes in autism rates and their potential association with thimerosal exposure through childhood vaccination. Also included below are some not-often published tables about mercury exposure limits and the levels of mercury that infants and children were exposed to—from thimerosal—that were contained in the full text of the Institute of Medicine's Vaccine Safety Review 2004 Report, "Vacines and Autism":
Citing Burbacher's previous study above regarding brain inflammation in monkeys, Comparison of Blood and Brain Mercury Levels in Infant Monkeys Exposed to Methylmercury or Vaccines Containing Thimerosal, for background to the many studies and tables of mercury exposure from vaccines below, the author stated that: "The American Academy of Pediatrics and the U.S. Public Health Service (1999) published a joint statement that urged "all government agencies to work rapidly toward reducing children's exposure to mercury from all sources." The statement recommended that thimerosal be removed from vaccines as soon as possible as part of this overall process. Between 1999 and 2001, vaccines currently recommended for children ≤ 6 years of age were made available in thimerosal-free formulations in the United States (Centers for Disease Control and Prevention 2001). Exposures to thimerosal through pediatric vaccines, however, still occur in other countries where multiple-dose vials are used to maintain childhood immunization programs and the control of preventable disease (Knezevic et al. 2004). Recent publications have proposed a direct link between the use of thimerosal-containing vaccines and the significant rise in the number of children being diagnosed with autism, a serious and prevalent developmental disorder (for review, see IOM 2001). Results from an initial IOM review of the safety of vaccines found that there was not sufficient evidence to render an opinion on the relationship between ethylmercury exposure and developmental disorders in children (IOM 2001). The IOM review did, however, note the possibility of such a relationship and recommended further studies be conducted. A recently published second review (IOM 2004) appears to have abandoned the earlier recommendation as well as backed away from the American Academy of Pediatrics goal. This approach is difficult to understand, given our current limited knowledge of the toxicokinetics and developmental neurotoxicity of thimerosal, a compound that has been (and will continue to be) injected in millions of newborns and infants." Excerpts from the presentation: In a 2006 study by Geier & Geier, Early Downward Trends in Neurodevelopmental Disorders Following Removal of Thimerosal-Containing Vaccines, published the Journal of American Physicians and Surgeons, the authors noted that: "Contemporaneously with the epidemic rise in neurodevelopmental disorders (NDs), first observed in the United States during the 1990s, the childhood immunization schedule was expanded by the U.S. Centers for Disease Control and Prevention (CDC) to include several additional thimerosal-containing vaccines (TCVs). On July 7, 1999, a joint recommendation was made by the American Academy of Pediatrics (AAP) and the U.S. Public Health Service (PHS) to remove thimerosal from vaccines. A two-phase study was undertaken to evaluate trends in diagnosis of new NDs entered into the Vaccine Adverse Event Reporting System (VAERS) and the California Department ofDevelopmental Services (CDDS) databases on a reporting quarter basis, from 1994 through 2005. Significant increasing trends in newly diagnosed NDs were observed in both databases 1994 through mid-2002. Significant decreasing trends in newly diagnosed NDs were observed in both databases from mid-2002 through 2005. The results indicate that the trends in newly diagnosed NDs correspond directly to the expansion and subsequent contraction of the cumulative mercury dose to which children were exposed from TCVs through the U.S. immunization schedule." In conclusion, Geier & Geier state "The present controlled assessment of VAERS and CDDS databases shows that very specific NDs are associated with TCVs. This conflicts with the 2004 conclusions of the IOM, largely based upon examination of vaccine safety data from the National Immunization Program (NIP) of the CDC. The IOM stated that the evidence favored rejection of a causal relationship between thimerosal and autism, that such a relationship was not biologically plausible, and that no further studies should be conducted to evaluate it. From data presented here and other emerging data, it appears clear that additional research should be undertaken concerning the effects of mercury exposure, particularly from TCVs. This is especially true in light of the fact that the handling of vaccine safety data by the NIP has recently been called into question by the IOM. In a 2003 study by Bradstreet, et al., A Case-Control Study of Mercury Burden in Children with Autistic Spectrum Disorders, , published the Journal of American Physicians and Surgeons, the authors stated that: "Large autism epidemics have recently been reported in the United States and the United Kingdom. Emerging epidemiologic evidence and biologic plausibility suggest an association between autistic spectrum disorders and mercury exposure. This study compares mercury excretion after a three-day treatment with an oral chelating agent, meso-2,3-dimercaptosuccinic acid (DMSA), in children with autistic spectrum disorders and a matched control population. Overall, urinary mercury concentrations were significantly higher in 221 children with autistic spectrum disorders than in 18 normal controls (Relative Increase (RI)=3.15; P < 0.0002). Additionally, vaccinated cases showed a significantly higher urinary mercury concentration than did vaccinated controls (RI=5.94; P < 0.005). Similar urinary mercury concentrations were observed among matched vaccinated and unvaccinated controls, and no association was found between urinary cadmium or lead concentrations and autistic spectrum disorders. The observed urinary concentrations of mercury could plausibly have resulted from thimerosal in childhood vaccines, although other environmental sources and thimerosal in Rho(D) immune globulin administered to mothers may be contributory. Regardless of the mechanism by which children with autistic spectrum disorders have high urinary mercury concentrations, the DMSA treatment described in this study might be useful to diagnose their present burden of mercury."
TABLE 1: Calculated Exposure Limits for Mercury, Using Various Agency Guidelines for Exposure to Methylmercury, in Infants Less Than 6 Months of Age by Percentile Body Weight
TABLE 2: Estimated Exposure to Mercury from Vaccines in United States in 1999 and in 2004 (Less Than 6 Months of Age)
TABLE 3: Estimated Exposure to Mercury from Vaccines in United States in 1999 and in 2004 (Less Than 2 Years of age)
† A trace amount of mercury is present in Tripedia thus, the maximum mercury dose following three doses of Tripedia is <0.9 µg, the maximum mercury dose following four doses of Tripedia is <1.2 µg. †† A trace amount of mercury is present in EngerixB; thus, the maximum mercury dose following three doses of EngerixB is <1.5 µg. ††† Children less than 9 years of age receiving the influenza vaccine for the first time are recommended to receive two doses of the vaccine, at least one month apart (CDC, 1999b). A child less than 2 years of age may receive three doses of the influenza vaccine. This could occur if the child turned 6 months of age in October, during the beginning of the influenza season, receives one dose of influenza vaccine then, and subsequently at age 7 months. The child could receive the third dose of influenza vaccine during the following October, at age 18 months.
†††† CIP recommended recently that all children 6 to 23 months of age receive the influenza vaccine (CDC, 2004). Previously, the ACIP encouraged influenza vaccination in this age group and recommended vaccination in children with certain risk factors (CDC, 2003a,b). The number in brackets in the 1999 column reflects the amount of mercury if children received the influenza vaccine. SOURCE: Joint statement of the American Academy of Pediatrics (AAP) and the United States
Public Health Service (USPHS), 1999; FDA 2001, 2004e.
Source of tables above: Immunization Safety Review: Vaccines and Autism, 2004
For current FDA information on thimerosal in vaccines, see our section, Answers from the FDA: What Vaccines Still Contain Thimerosal?
For additional information on mercury in vaccines see the FDA Lists of Mercury in Vaccines and Other Products.
Review of Burbacher Study Results and Recommendations
Additional Notesand References: Immunity, Neuroglia and Neuroinflammation in Autism
Carlos A. Pardo, Diana L. Vargas & Andrew W. Zimmerman Abstract Autism is a neurodevelopmental disorder characterized by impaired communication and social interaction and may be accompanied by mental retardation and epilepsy. Its cause remains unknown, despite evidence that genetic, environmental, and immunological factors may play a role in its pathogenesis. To investigate whether immune-mediated mechanisms are involved in the pathogenesis of autism, we used immunocytochemistry, cytokine protein arrays, and enzyme-linked immunosorbent assays to study brain tissues and cerebrospinal fluid (CSF) from autistic patients and determined the magnitude of neuroglial and inflammatory reactions and their cytokine expression profiles. Brain tissues from cerebellum, midfrontal, and cingulate gyrus obtained at autopsy from 11 patients with autism were used for morphological studies. Fresh-frozen tissues available from seven patients and CSF from six living autistic patients were used for cytokine protein profiling. We demonstrate an active neuroinflammatory process in the cerebral cortex, white matter, and notably in cerebellum of autistic patients. Immunocytochemical studies showed marked activation of microglia and astroglia, and cytokine profiling indicated that macrophage chemoattractant protein (MCP)-1 and tumor growth factor-beta1, derived from neuroglia, were the most prevalent cytokines in brain tissues. CSF showed a unique proinflammatory profile of cytokines, including a marked increase in MCP-1. Our findings indicate that innate neuroimmune reactions play a pathogenic role in an undefined proportion of autistic patients, suggesting that future therapies might involve modifying neuroglial responses in the brain. Conclusions Autism is a complex neurobehavioral disorder of early life onset influenced by the interaction of different risk factors. We hypothesize that environmental factors (e.g., neurotoxins, infections, maternal infections) in presence of genetic susceptibility and the immunogenetic background of the host influence the development of abnormalities in cortical organization and neuronal circuitry and neuroinflammatory changes responsible for the generation of the autistic symptoms. Our neuroimmunopathological studies strongly suggests that innate rather than adaptive neuroimmune responses are part of the immunopathogenic mechanisms associated with autism, but we cannot exclude the possibility that specific immune reactions, cellular or humoral, may occur at early stages of the disease, during prenatal or postnatal stages of brain development. The roles of neuroglial activation and neuroinflammation in the pathogenesis of autism are still uncertain but could be critical in maintaining, if not also in initiating, some of the CNS abnormalities present in this neurodevelopmental disorder. Neuroglial and neuroinflammatory responses likely have polygenic and environmental bases and may have important clinical and therapeutic implications in autism. Large Brains in Autism: The Challenge of Pervasive Abnormality
Martha Herbert, MD, PhD [Harvard University] Excerpts Neuroinflammation and microgliosis are complex in both cause and function and have adaptive as well as maladaptive features (Wyss-Coray and Mucke 2002). In degenerative disorders, they can arise as a response to cellular debris related to progressive failure in a component of cell metabolism disrupted by the genetic error that underlies the disorder. But aside from distinct genetic variants such as Rett syndrome, we are not seeing compelling evidence of cumulative progress of an inborn genetically based metabolic error in autism. Although the decrease in relative volume and the decrease in cell size in certain regions with increasing age suggests a process that involves some losses in cell volume and/or number over time, these changes are mild compared with those in degenerative disorders, so that other mechanisms need to be considered. Various classes of environmental factors are candidate contributors to this picture. Oxidative stress, brain inflammation, and microgliosis have been much documented in association with toxic exposures including various heavy metals, pesticides, and air pollution (Kim and others 2002; Zurich and others 2002; Campbell 2004; Ling and others 2004; Shanker and others 2004; Filipov and others 2005). The burgeoning research domain of low-dose persistent toxic exposures may well prove relevant here (Welshons and others 2003). A number of investigators are studying how autism and other developmental disorders could also be mediated by immune or infectious factors, either chronic subclinical infection or the sequelae of infection in the past (Hornig and Lipkin 2001; Patterson 2002; Dalton and others 2003; Shi and others 2003). Both the newly appreciated chronicity of some of the underlying pathophysiology and the pervasiveness of the connectivity abnormalities open new horizons for seeking potential treatment targets. Inflammation, oxidative stress, excitotoxicity, and other neurochemical changes and their triggers open a range of possibilities for research into potential treatment targets. Characterizing the connectivity abnormalities underlying behavioral manifestations may allow a sharpening of behavioral therapies. More fundamentally, the awareness that the brain as well as medical conditions of children with autism may be conditioned by chronic biomedical abnormalities such as inflammation opens the possibility that meaningful biomedical interventions may be possible well past the window of maximal neuroplasticity in early childhood because the basis for assuming that all deficits can be attributed to fixed early developmental alterations in neural architecture has now been undermined. Citations Herbert also cites four other studies of inflammation in neurodegenerative diseases:
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What is the Proceeding
Beginning in 2001, parents began filing petitions for compensation with the Secretary of Health and Human Services (HHS) under the Vaccine Injury Compensation Program (VICP or Program), alleging that certain childhood vaccinations might be causing or contributing to a neurodevelopmental disorder known as "autism spectrum disorder," or "autism" for short. Specifically, it has been alleged that cases of autism, or neurodevelopmental disorders similar to autism, may be caused by
The Office of Special Masters (OSM) held a series of meetings in mid-2002 with an informal advisory committee to address the task of dealing with these claims. The OSM issued Autism General Order #1 in July 2002, in which it established the procedure for addressing the Omnibus Autism Proceeding (OAP). Petitioners' attorneys then initiated an extensive discovery process, a phase which is now concluded. What Has Happened So Far To date, the Secretary has produced over 218,000 pages of discovery, and has offered several officials for depositions. As of May 2, 2008,
2007 Test Cases: MMR and Thimerosal-Containing Vaccines The first evidentiary hearing for a test case was held June 11-26, 2007. The Petitioners' Steering Committee (PSC) and the Secretary presented expert testimony concerning the "general causation issue" for the combined theory (both MMR vaccine and thimerosal-containing vaccines caused autism), and also the specific causation issue in the first of three test cases for the combined theory. Hearings in the other two test cases for the combined theory were held in October and November of 2007. The special master's decisions in the first theory and three test cases are not expected before the summer of 2008. 2008 Test Cases: Thimerosol-Containing Vaccines On May 12, 2008, the Court will hold a 3-week hearing on the general causation issues for the thimerosal theory. Evidence in two test cases for the second theory will also be presented. As was true in 2007 for the first theory's general causation hearing and test cases, the public can listen to the hearing by registering on the Court's web site. Final decisions on the general causation theory and test cases are not expected until sometime in 2009. Further proceedings on the third theory of causation (i.e., MMR vaccine alone) await rulings by the court.
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On November 9, 2007, respondent filed a Rule 4 Report conceding that petitioner should be awarded compensation in accordance with 42 U.S.C. § 300aa-11(c)(1)(C)(ii). Respondent stated that, based on a review of the petition, medical records and affidavits, the "facts of this case meet the statutory criteria for demonstrating that the vaccination Hannah 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." (Rule 4 Report at 7). Respondent further stated in the Rule 4 Report that the onset of Hannah's complex partial seizure disorder, nearly six years after her July 19, 2000 vaccinations, was not related to her vaccinations. (Rule 4 Report at 7).
The filing of respondent's Rule 4 Report prompted the Petitioners' Steering Committee to search for another potential test case for the second theory of general causation to be heard in May 2008. The Petitioners' Steering Committee stated that respondent's "concession" places the case in [a] procedural posture that makes it inappropriate as a test case for hearing in May 2008. The undersigned (Patricia E. Campbell-Smith, Special Master) conducted a status conference with the parties to address the filed Rule 4 Report. During the status conference, petitioners stated that they intended to file an expert report from Andrew Zimmerman, M.D., Hannah's treating neurologist, in support of their claim that Hannah's complex partial seizure disorder was a sequela of her vaccine-related injury. The undersigned directed respondent to file a status report after reviewing Dr. Zimmerman's expert report that addressed respondent's position regarding petitioners' claim that Hannah's seizure disorder was vaccine-related. Petitioners filed the expert report from Dr. Zimmerman after the status conference. On February 21, 2008, respondent filed a Supplemental Rule 4 Report addressing respondent's review of Dr. Zimmerman's expert report. (See Supplemental Rule 4 Report at 1-2). Respondent stated that "[h]aving reviewed this additional evidence, [medical personnel at the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC)] now recommend [ ] compensation for Hannah's seizure disorder as sequela of her vaccine-injury in accordance with 42 U.S.C. § 300aa-11(c)(1)(C)(ii)." Based on respondent's concession, a damages determination is now underway in this case.
Read more: [ PETITIONERS' MOTION FOR COMPLETE TRANSPARENCY OF PROCEEDINGS ] ....
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