Guest guest Posted April 22, 2006 Report Share Posted April 22, 2006 -NEWS FROM THE NATIONAL VACCINE INFORMATION CENTERVienna, Virginia http://www.nvic.org* * * * * * * * * * * * * * * * * * * * * * * UNITED WAY/COMBINED FEDERAL CAMPAIGN #8122* * * * * * * * * * * * * * * * * * * * * * *"Protecting the health and informed consent rights of children since 1982." ==========================================================================================BL Fisher Note:Vaccine induced autism is not just about mercury. It is about children whoare genetically vulnerable being unable to handle one or more vaccines,especially if given simultaneously. In 1985 in DPT: A Shot in the Dark,medical historian Harris Coulter and I first reported cases of pertussisvaccine induced brain inflammation that led to autistic behaviors. We warnedthat DPT vaccine was just the tip of the iceburg and that the vaccine injuryspectrum includes minimal brain damage, such as learning disabilities andADHD; more severe forms of vaccine injury such as autism, seizure disordersand mental retardation; as well as immune system disorders, such as asthma,diabetes, and severe allergies.In addition to lab altered viruses and bacteria, vaccines contain a numberof toxins and additives which have not been adequately studied that couldcause brain and immune sytem dysfunction in genetically vulnerableindividuals. For the past 24 years, the National Vaccine Information Centerhas been calling for large, prospective case controlled studies comparingthe long term health of highly vaccinated and unvaccinated children, as wellas biological mechanism studies to determine the genetic and otherbiological high risk factors for vaccine-induced brain and immune systemdysfunction.Until these studies are performed by unbiased researchers with no financialties to government or industry and the whole truth about vaccines isrevealed, parents will continue to witness the regression of their childrenafter vaccination. And they will be told by public health officials,pediatricians and drug company salesmen that what they are witnessing isjust a "coincidence" and not due to vaccination.Pediatricians are now instructed by the CDC to inject children with 48 dosesof 14 vaccnes by age 5, with the first dose given at 12 hours of age in thethe newborn nursery. More doses and more vaccines are coming. It is unknownhow many children will escape some form of vaccine injury that willnegatively affect their health in the future.http://news.monstersandcritics.com/lifestyle/consumerhealth/article_1156142.php/The_Age_of_Autism_Pox_--_Part_1Monsters and Critics.comThe Age of Autism: Pox -- Part 1By Dan Olmsted Apr 18, 2006, 2:21 GMTOLYMPIA, WA, United States (UPI) -- Children in families with problematicreactions to chickenpox virus may be at risk for developing autism if theyget that live-virus immunization too close to other live-virus vaccines, athree-month United Press International investigation of cases in onenorthwest U.S. city suggests.Several such families in the Washington state capital of Olympia watchedtheir children regress into full-syndrome autism -- losing language andsocial skills and adopting repetitive behaviors -- in the months followingthe shots. Two children had participated in small clinical trials in Olympiaof investigational Merck & Co. chickenpox vaccines in combination with thelive-virus mumps-measles-rubella vaccine -- the MMR.Federal health authorities consistently have rejected concerns about a linkbetween immunizations and autism. But a family background of problems copingwith viruses used in live-virus vaccines has not been considered a possiblerisk factor, experts said.One of the children in the clinical trials, Jimmy Flinton, now 4, got about10 times the standard dose of chickenpox vaccine in a shot that alsocontained the standard MMR.Called ProQuad, that combined immunization was approved by the U.S. Food andDrug Administration last September -- the first time four 'attenuated' orweakened live viruses have been mixed together in a single shot.The second child, Timothy Baltzley, now 6, got an investigational 'processupgrade' chickenpox shot and a separate MMR shot at the same office visit.Both children have a parent who had unusual reactions to chickenpox virus.Timothy`s Baltzley`s mother, Kimberly, had chickenpox three times, the lastat age 16, just three years before he was born. Jimmy Flinton`s father,Paul, had shingles as a teenager. Shingles is reactivated chickenpox virusthat painfully inflames nerves and mostly affects older people or those withweakened immune systems.Both children got the vaccines at 12 months, the age at which chickenpox andMMR immunizations are first recommended by the Centers for Disease Controland Prevention. They were among a total of 101 subjects in the two trials inOlympia, according to the Western Institutional Review Board, which approvedthe trial protocols.Half-a-dozen other parents of preschool-age autistic children from the sameneighborhood in Olympia recognized a common thread: unusual chickenpoxhistories in their families and simultaneous or closely timed chickenpox andMMR shots in their children.'It`s the proximity of the chickenpox and MMR vaccinations' and the familyhistories that stand out, said Denise Rohrbeck, mother of 3-year-old Grant.Rohrbeck has not been able to develop immunity to chickenpox despite beingtwice vaccinated as an adult, the last time just two years before her sonwas born. A couple of months before he got the standard chickenpox and MMRshots at the same office visit at age 1, Grant had a stubborn and severecase of roseola, which like chickenpox is a herpesvirus.Four days after the MMR and chickenpox injections he became ill with a feverand lay limp in his mother`s arms for the first time in his life.'He began having chronic diarrhea, and by his 15-month checkup he hadregressed so drastically that his pediatrician suggested he could beautistic,' Rohrback recalled. The doctor agreed to the parents` request foran immediate neurodevelopmental evaluation, which resulted in a diagnosis offull-syndrome autism.Rohbeck said she began looking for a possible connection between vaccinesand autism among neighborhood children after the Thurston County HealthDepartment did not follow up on parents` concerns raised at a meeting lastOctober. With the parents` continued involvement, she has now compiledvaccination records of 14 Olympia children diagnosed with autism, as well as16 who are not.The admittedly unscientific chickenpox-MMR association continues to bestriking, and the two cases following the clinical trials seemed tounderscore it, she said.A Merck spokeswoman said the company reported those two cases to the FDAthis March -- the same month UPI asked Merck about them.'We just received these reports in March 2006, six months after ProQuad wasapproved in the U.S., and they were sent to the FDA after we received them,'Merck`s Christine Fanelle said in a statement. She said Merck received 'thetwo reports of autism AEs from Olympia -- one from the parent of a child inthe ProQuad trial and one from the parent of a child in (the `processupgrade` chickenpox) study.'Parents Jennifer Flinton and Kimberly Baltzley say they never called Merckand wouldn`t know who to contact there; last summer, Jennifer Flintonreported Jimmy`s autism to the federal government`s Vaccine Adverse EventsReporting System, attributing it to the cumulative effects of vaccination.The federal health employee she spoke to on the phone said she would followup by gathering lot numbers and other information on the vaccines.The parents said their pediatrician, who conducted both of the Merck-fundedtrials in Olympia, knew about their children`s autism diagnoses withinmonths of their participation in January 2001 and October 2002.The Olympia trials were part of wider Merck studies conducted at severalsites in the United States and abroad. Fanelle said Merck would not discloseinformation about any other reports of autism.'We have confirmed your original inquiry on whether we received the tworeports out of Olympia,' she said. 'We are not going to comment on reportsbeyond this.'There were more than 7,000 children in our ProQuad trials, 5,800 of whomreceived ProQuad vaccine,' she added.Diana Sparby of the Western Institutional Review Board in Olympia said ithad not received reports of autism from the local ProQuad study, but shenoted the protocol 'was not designed to assess long-term safety, as itcalled for follow-up for only 42 days following vaccine administration.'The FDA, which approves drugs after determining they are safe and effectiveand monitors reports of side effects after they come on the market, did notrespond to repeated inquiries from UPI about the Olympia cases or parents`concerns about family chickenpox histories.Other unusual histories in neighborhood families with autistic children 6and under:-- Another child had roseola 12 weeks before getting his chickenpox and MMRshots;-- Another father had shingles as a teenager;-- Another mother had chickenpox as an adult two years before her pregnancy;-- A mother had chronic cold sores, also a herpesvirus, as a child that wereso severe they had to be treated medically;In addition, another mother had a case of measles as an adult.Merck, which manufactures the standard MMR shot and the standalone Varivaxchickenpox shot as well as the experimental vaccines used in the clinicaltrials, said repeated studies show no relation between vaccines and autism.'We don`t see an association,' spokeswoman Fanelle said, citing asconfirmation a 2004 report by the widely respected Institute of Medicine,part of the National Academies. That report rejected a link between autismand either the MMR vaccine or the mercury-based preservative thimerosal. Thereport also urged that research dollars be spent on 'more promising' autismresearch.'There will always be some people who say vaccines cause autism despite thelack of scientific evidence,' Fanelle said.In the United States, controversy over a possible link has centered onthimerosal. Beginning in the late 1980s children were exposed to increasingamounts of thimerosal, which is half ethyl mercury, as more vaccines weremandated.Thimerosal was phased out of routine childhood immunizations -- but not allflu shots given to children and pregnant women -- beginning in 1999.Although the Olympia children with autism were born after the phase-out wasrecommended, their vaccine records show more than half of them got at leastone shot containing thimerosal during the first year of life. It is possibleall of them did, but incomplete information from manufacturers makes thatuncertain.Chickenpox and MMR immunizations don`t contain thimerosal because themercury would inactivate the viruses, but some proponents of avaccine-autism link suspect thimerosal exposure from other immunizationscould have a potentiating effect, damaging a child`s defenses and paving theway for live viruses to wreck havoc.All live-virus vaccines are attenuated -- significantly weakened based onthe theory that this creates immunity without causing the actual disease orother adverse health consequences. Other vaccines on the U.S. childhoodimmunization schedule, including hepatitis B and the polio shot, containkilled or so-called inactivated viruses. Live polio virus was dropped in2000 after health authorities determined it was actually causing polio in asmall number of cases.Despite the Olympia parents` concern, none points an accusing finger atdoctors.'I worry about pediatricians being vilified,' said Rohrbeck. 'We vaccinatedour son because we shared their faith that vaccines were safe.'If it turns out that some vaccines are not safe for all children and thatthese hazards could have been found with more rigorous testing -- or worse,that the dangers were already known -- that`s the fault of the CDC, the FDAand the manufacturers,' she said.'I`ll defend doctors to the end on this point. They are a convenient frontline for those agencies to hide behind -- it`s just shameful.'The theory that live virus immunizations could trigger autism first arose in1998 in Britain, when gastroenterologist Dr. Andrew Wakefield published apaper suggesting a possible association between childhood MMR immunization,bowel disease and regressive autism.The premise: Interaction between viruses -- a well-known phenomenonscientifically known as immune interference -- could depress a susceptiblechild`s immune system, lead to persistent infection by the measles virus inthe GI tract and possibly the nervous system itself, and triggerautism-inducing brain damage. While the case has not been proven, it gainsplausibility from the fact that naturally occurring measles infection isknown to cause delayed brain damage in a small percentage of children,proponents of the theory say.Wakefield`s study, and his plea in Britain to separate the componentmeasles, mumps and rubella (German measles) vaccines and administer them ayear apart to reduce possible risk, caused an uproar. Co-authorssubsequently repudiated part of the paper, conflict-of-interest allegationsemerged, and the prestigious Lancet, which originally published the study,issued a statement calling it 'fatally flawed.'Wakefield was asked to leave his medical job in Britain and is now doingresearch in Austin, Texas.After the Olympia cases were described to him by UPI in March, Wakefield metwith several of those parents at an autism conference in Portland, Ore. Healso read studies Merck cites as central to the FDA approval of ProQuad.'It`s actually heartbreaking, listening to these parents, because you`restaring into an abyss,' Wakefield said afterwards. 'You`re listening tostories which reflect the fundamental misconception of vaccine manufacturersof what viruses are and what they do. The whole perception of these peopleis dangerously naïve.'In contrast to the United States, British health authorities have notrecommended chickenpox immunization. But an MMR-chickenpox shot was underdiscussion there at one point, and Wakefield said he warned its developersthat putting four live viruses in one shot was a bad idea.He says the Olympia cases show why.'As far as I`m concerned, you are further increasing the likelihood ofpersistent infection and delayed disease, which they are never looking forand therefore they will never find if it does occur, as it did clearly in arelatively short space of time with some of these children, and it`s neverascribed to an adverse reaction to the vaccine.'On its Web site, the CDC says such concerns -- and Wakefield`s studies inparticular -- are not based on good science.'Current scientific evidence does not support the hypothesis that MMRvaccine, or any combination of vaccines, causes the development of autism,including regressive forms of autism,' the CDC says.'The existing studies that suggest a causal relationship between MMR vaccineand autism have generated media attention. However, these studies havesignificant weaknesses and are far outweighed by epidemiological studies ...that have consistently failed to show a causal relationship between MMRvaccine and autism.'( http://www.cdc.gov/nip/vacsafe/concerns/autism/autism-mmr.htm)Dr. Jeff Bradstreet, a family practitioner in Florida who treats 3,000autistic children and has worked with Wakefield, said he believes the riskof autism rises the earlier and closertogether that live-virus vaccines areadministered. He warned the Institute of Medicine in 2004 that it wasignoring the possibility that younger children are more vulnerable becausetheir immune and neurological systems are immature.'There`s definitely been an association of kids getting MMR at 12 months andcrashing (becoming autistic),' Bradstreet said.He said adding 10 times the standard dose of chickenpox virus, calledvaricella-zoster, to the MMR shot and administering it to 1-year-olds isplaying with fire.'We think putting varicella with MMR is just nuts.'British researcher Paul Shattock sees another reason to be concerned withcombining the four viruses: He suspects that children who get wild -- ornaturally occurring -- chickenpox too close in time to the MMR shot face ahigher risk for autism. That`s scenario parallels the one Olympia parentsnoticed with the chickenpox vaccination.Shattock, director of the Autism Research Unit in the School of Sciences atthe University of Sunderland, said he noticed that autistic British childrenwhose parents blame the MMR for triggering the disorder had a pattern of'undisclosed viral illness' around the time of the shot.He studied the records of 100 of those children, compared to 100 childrenwhose parents did not cite the MMR as the trigger, to see if there was ahigher incidence of chickenpox cases three months before or after the MMRimmunization.'Now, there was,' Shattock said in an interview while attending an autismconference this month in Washington, D.C. 'It wasn`t statisticallysignificant at the 95 percent level -- but enough to make you think that ifit was a huge study, it might be.'His concern about adding chickenpox to the MMR shot: 'I`m worried about itbecause of the interference of the vaccines, mainly because it depresses theimmune system by yet another mechanism.'A Merck scientist discussed that issue at a CDC meeting in 2004, the yearbefore ProQuad was approved, according to agency minutes. Dr. FlorianSchodel 'confirmed the possibility' that the chickenpox virus component ofProQuad was 'causing a local immune suppression and an increase in measlesvirus replication. ...'The current hypothesis is that the varicella and measles virus areco-infecting the same or proximate areas of the body and engaging in aspecific interaction, but how that works is as yet unknown.'He said the interference appeared to involve only the chickenpox and measlesviruses -- 'there is no such effect for the mumps or rubella vaccinesadministered locally at the same time.'At the same meeting, Merck`s Dr. Barbara Keller said the amount ofchickenpox virus in ProQuad is 'about a log' -- or 10 times -- higher thanMerck`s standalone chickenpox vaccine, Varivax, in order to overcome immuneinterference.Both Wakefield and Shattock said the Olympia families` unusual historieswith chickenpox are worrisome because their children might have inheritedproblems coping with the vaccine.'There`s no doubt the immune response to viruses is determined by ourgenetic constitution,' Wakefield said. 'It may well be there is agenetically determined predisposition to abnormal handling of chickenpoxvirus, at least in children.'This kind of phenomenon has been shown to (play a role in) measles. Theimmune response to measles is determined by your genetic profile. It`scertainly consistent with what is known about the immune response toviruses.'ProQuad is likely to be widely adopted by healthcare professionals whopreviously administered separate MMR and Varivax shots.'Use of licensed combination vaccines, such as (ProQuad), is preferred toseparate injection of their equivalent component vaccines,' says the newedition of the CDC`s authoritative 'Pink Book' on vaccine-preventablediseases.'When used, (the immunization) should be administered on or after the firstbirthday, preferably as soon as the child becomes eligible for vaccination.'This series of articles, based on reporting in Olympia in February andMarch, tells the families` stories, looks at the scientific controversy andexamines implications for the autism-vaccine debate.Next: 'He has gone backward mentally ...The Age of Autism: Pox -- Part 2By Dan Olmsted Apr 21, 2006, 4:55 GMTWASHINGTON, DC, United States (UPI) -- Call it the silence of the feds.This week, The Age of Autism began a series of articles entitled 'Pox,'laying out the compelling observations of a group of parents in Olympia,Wash., who are concerned live-virus vaccines are triggering autism.These parents spotted a possibly troublesome trio of factors in theirchildren`s cases: Chickenpox and measles-mumps-rubella (MMR) vaccinationsclustered together at the earliest recommended ages; a family history ofproblematic reactions to naturally occurring chickenpox and otherherpesviruses; and the onset of autism in their children, often following abrief but notable physical illness.Two of the children had been in clinical trials in Olympia of vaccines notyet approved by the U.S. Food and Drug Administration, vaccines withinvestigational chickenpox formulas. The FDA subsequently approved one ofthose drugs, called ProQuad, last September.What does the FDA say to these concerns, and in particular to a case ofregressive full-syndrome autism after a clinical trial of a drug it justapproved?Nothing.In Part 1, we reported: 'The Food and Drug Administration, which approvesdrugs after determining they are safe and effective and monitors reports ofside effects after they come on the market, did not respond to repeatedinquiries from UPI about the Olympia cases or parents` concerns about familychickenpox histories.'On Monday, March 20 -- a month ago -- I sent an e-mail to FDA spokesmanStephen King asking about the autistic Olympia children from the clinicaltrials. King had already told me that there were no minutes available for anFDA advisory committee hearing prior to ProQuad`s approval, because nomeeting had been held.Such meetings sometimes are called if there are concerns about safety orother issues surrounding proposed or already-approved medicines.ProQuad combines the existing MMR and the standalone chickenpox vaccine,Varivax, but with a major difference: It contains about 10 times morechickenpox vaccine, apparently in order to overcome immune interference fromthe other weakened live viruses in the shot.My e-mail:'Hi Stephen,I left you a voice mail last week and wanted to follow up with this writtenquery. ...Questions:-- Was the FDA aware of these or any other reports of autism following(clinical trials)? If not, would they have been of concern and are they ofconcern now?-- Why was it necessary to put significantly more varicella (chickenpox)virus in ProQuad than in the standalone Varivax shot? ...-- Has the FDA ever considered immune status of parents re live virusvaccines as a possible factor in the child`s ability to handle them? Themother of one of the children had a severe case of chickenpox just threeyears before her child was born; the father of the other had shingles as ateenager, which is unusual.Thanks for considering these questions. I would appreciate hearing from youthis week.Sincerely,Dan OlmstedUnited Press International'There was no response.I also learned that one of the Olympia parents, Jennifer Flinton, lastsummer called the federal government`s Vaccine Adverse Events ReportingSystem, jointly monitored by the FDA and the Centers for Disease Control andPrevention, to report her son Jimmy`s autism. She attributed his regressionto cumulative exposure to vaccinations; the worker who took the report saidshe would follow up by collecting all the information about the vaccines hewas given.Jimmy Flinton had been in the ProQuad clinical trial in 2002 and developedautism four months afterwards. He was one of 33 children in the Olympia armof the trial.Merck & Co., which funded the trials and manufactures the vaccines involvedincluding ProQuad, said it reported the two autism cases from Olympia to theFDA this March, which is when Age of Autism first asked about them. Mercksaid that is also when the parents made the reports, but the parents saidthey don`t know what Merck is talking about.Maybe federal health officials have just plain had it with these concerns,which they clearly consider preposterous. Study after study, they say, hasshown no evidence that vaccines are linked to autism, and in 2004 the widelyrespected Institute of Medicine said the case was closed and it was time tolook elsewhere for the cause or causes of autism. Dr. Marie McCormick, thedistinguished Harvard professor who headed that review, famously derided as'really terrifying, the scientific illiteracy that supports thesesuspicions.'A single case several months after a child receives an investigationalchickenpox vaccine in a trial with 33 other children certainly wouldn`tthreaten that view.Nor would another case at the same pediatrician`s office in the same cityusing the same live viruses in another small clinical trial, this one with68 kids.Nor would problematic chickenpox histories in those families, nor would thesame pattern among other families with autistic children in the sameneighborhood. ...Still, at some point, wouldn`t you expect someone somewhere in the nation`spublic health hierarchy to raise an eyebrow? Yet getting anyone`s attentionis just about impossible -- in Washington state no less than Washington,D.C.Dr. Diana Yu of the Thurston County Health Department in Olympia insisted tome over a period of several weeks that no clinical trials whatsoever hadbeen conducted by any pediatricians there. This, despite my faxing herconsent forms signed by the parents.One seven-page documents begins: 'Research Subject Consent Form: VaccineStudy -- Children. Your child is invited to be in a research study ... Thestudy is being done for Merck & Co. ... (B)oth investigational drugs ...have not been licensed by the U.S. Food and Drug Administration.'Yu told me: 'None of the practices were in any `clinical trials` as part ofany vaccine study. Some practices may have been `trying things out` but havenot made it a policy for their clinic yet. With all due respect, thesedoctors are not on trial and should not be painted with such a broadstroke.'Nobody`s indicting pediatricians. It`s public health officials and drugcompanies they`re wondering about.'I worry about pediatricians being vilified,' said Denise Rohrbeck, one ofthe Olympia parents quoted in Pox -- Part 1. 'We vaccinated our son becausewe shared their faith that vaccines were safe.'If it turns out that some vaccines are not safe for all children and thatthese hazards could have been found with more rigorous testing -- or worse,that the dangers were already known -- that`s the fault of the CDC, the FDAand the manufacturers,' she said.Meanwhile, another potentially significant issue in Olympia remainsunanswered weeks after I raised it with the health department there. Thefirst thing that caught the parents` attention was a seeming absence ofautism cases at one of the two big medical practices in town, PediatricAssociates.The parents, who know each other through a countywide support group, haven`tbeen able to find a single case of full-syndrome autism among preschoolerswho were vaccinated from birth at PA, as the parents call it.Anecdotal, yes -- but intriguing: Autism cases are not hard to find at theother pediatric practices in town, no surprise given a rate of autisticdisorders of 1 in 166 American children.So what`s up at PA?Parents say they learned at least half the doctors there delay thechickenpox and MMR shots until 18 months, and the other half tend to breakthem up -- giving one at 12 or 15 months and the other about six monthslater. Records parents gathered suggest this trend at PA started sometimeafter 2000 -- records collected from 1999 show the two shots given togetheras early as 12 months.Interestingly, parents found full-syndrome kids from PA born before 2000.The CDC recommends that the MMR and chickenpox shots be given as soon aspossible beginning at 12 months and no later than 15 months for the MMR and18 months for chickenpox. That`s when the autistic kids the parents inOlympia are talking about got them -- sooner rather than later and usuallyat the same time, not widely spaced or starting at 18 months as appears tobe the case at Pediatric Associates.Thus the PA kids and their shot patterns might be an informal 'controlgroup' right in the middle of this state capital of just over 50,000 on theSouth Puget Sound.Pediatric Associates did not respond to questions about its immunizationpolicies. Neither did the county health department, although Yu acknowledgedit would be 'simple' for the department to check its records and determinewhether there really is a difference in immunization schedules.As this series on the Olympia kids unfolds over the next several weeks, theparents are hopeful that more information -- maybe even some sort ofresponse from the nation`s drug regulators -- will be forthcoming.Stay tuned. Don`t hold breath.Next: Ryan reacts at the doctor`s office.E-mail: dolmsted=============================================News is a free service of the National Vaccine InformationCenter and is supported through membership donations. Learn more about vaccines, diseases and how to protect your informed consent rights http://www.nvic.orgBecome a member and support NVIC's work https://www.nvic.org/making%20cash%20donations.htmTo sign up for a free e-mail subscription http://www.nvic.org/emaillist.htmTo from this list, please go to http://nvic.org/emaillistunsub.htm or send an email to news-request and type UNSUBSCRIBE in the body of the email.NVIC is funded through individual membership donations and does not receive government funding. Barbara Loe Fisher, President and Co-founder.NOTE: This is not an interactive e-mail list. Please do not respond to messages. "Our ideal is not the spirituality that withdraws from life but the conquest of life by the power of the spirit." - Aurobindo. Blab-away for as little as 1¢/min. Make PC-to-Phone Calls using Messenger with Voice. Quote Link to comment Share on other sites More sharing options...
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