Reusable plastic bottles leach BPA at room temperature
A lot of people have those reusable polycarbonate water bottles; you can’t go to a college campus these days without seeing students carrying these multi-hued bottles around as they make their way through classes.
Well, a couple weeks back researchers at the University of Cincinnati released a startling new study showing that many of these bottles leach bisphenol A (BPA), an endocrine disruptor, into water that is being stored within the container.
These researchers found that these plastic bottles leach BPA into room-temperature water. That’s bad enough, but if boiling water is put into these bottles, the rate of BPA leaching goes up by quite a bit.
All the evidence out there tells us that this stuff is not good for you; EWG tested canned foods recently, which are lined with the same BPA plastic as these water bottles are made from. As it turns out, foods from metal cans contain significantly more of the chemical than water from bottles.
We applaud the use of reusable water bottles to cut down on the environmental impact of bottled water, but with this new research, metal water bottles are looking better and better. Some have a plastic lining, but Klean Kanteen makes metal water bottles that are BPA free.
Parents who are concerned about baby’s plastic bottles should know that although this study didn’t look at baby bottles, it studied the same type of plastic. At this point, there’s enough research out there to justify the added expense of buying BPA-free or glass bottles. But an even more critical step would be to substitute powdered formula for liquid formula if your baby isn’t drinking breast milk. Babies don’t need to be getting extra endocrine disruptors in any form.
Just some of the many bad-for-you ingredients on the "what not to buy" list from the Environmental Working Group. Hard to imagine someone thinking that it's a good idea to put mercury or human placenta into cosmetics. Decide not to buy these products, and maybe Paula Dorf and Z Bigatti will change their minds.
... but no deaths in most recent study means it's a green light for Merck to promote this new toxic needleful. Wouldn't want to cut into the $16 BILLION annual profit by admitting a mistake and not promoting (or not selling at all) this latest debacle of a vaccine.
ATLANTA (AP) — Children suffered higher rates of fever-related convulsions when they got a Merck & Co. combination vaccine instead of two separate shots, according to a new study presented Wednesday.
The results prompted a federal advisory panel on vaccines to water down their preference for the combo vaccine ProQuad, which protects against measles, mumps and rubella as well as chickenpox.
In the study of children ages 12 months through 23 months, the rate of seizures was twice as high in toddlers who got ProQuad, compared with those who got one shot for chickenpox and one for the three other diseases.
The risk translates to about one extra case of convulsion for every 2,000 doses of ProQuad given said Dr. Nicola Klein, who lead the federally funded study. She presented the data at a meeting of the Advisory Committee on Immunization Practices.
The study focused on children who develop fevers and then go into convulsions — an occurrence that frightens parents but usually has no lingering consequences. There were no deaths in the new study.
ProQuad was licensed in 2005. It's been in extremely short supply since last year, when Merck suspended production because of manufacturing problems. The company expects to resume ProQuad production next year.
The panel had previously taken a position that they preferred doctors give children as few needlesticks as possible, and that ProQuad is preferable to giving separate shots.
It voted Wednesday to amend that, to say they're no longer voicing a preference for ProQuad over the separate shots.
"Safety, shortages, delivery issues — lots of reasons not to state such a strong preference," said member panel Patsy Stinchfield, an infectious disease expert at Children's Hospitals and Clinics of Minnesota.
Merck officials said their own research, though preliminary, also showed a doubling of the risk in children within five to 12 days of vaccination. However, the occurrence was low — about 5 cases in 10,000, Merck officials said.
They said there was five times more chickenpox antigen, the key ingredient, in the ProQuad shot than in the stand-alone chickenpox shot. But they said it's not clear that would explain the difference in seizure rates.
For some reason, the difference disappears when comparing rates for 30 days, Merck officials added.
Klein's research checked seizure rates only at seven to 10 days after vaccination, and looked at about 43,000 kids who got ProQuad and 315,000 who got the two other shots together. It found fever-related seizures occurred at a rate of 9 per 10,000 children vaccinated with ProQuad, compared with 4 per 10,000 for those who got separate shots.
Klein is co-director of Kaiser Permanente Vaccine Study Center in Oakland, Calif., one of seven sites in the study. Her work was funded by the U.S. Centers for Disease Control and Prevention.
ProQuad costs $124 per dose, about the same as the two other shots combined.
Rally at the CDC with Jenny McCarthy to get the government to step back from ordering parents to inject their kids with aluminum and other toxins. June 27, 28, or 29, TBA... Watch Jenny's video invitation!
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:
Vaccine Dates Administered Hep B 12/27/98; 1/26/99 IPV 3/12/99; 4/27/99 Hib 3/12/99; 4/27/99; 6/28/99 DTaP 3/12/99; 4/27/99; 6/28/99
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-injury.
Respectfully submitted,
PETER D. KEISLER Assistant Attorney General
TIMOTHY P. GARREN Director Torts Branch, Civil Division
MARK W. ROGERS Deputy Director Torts Branch, Civil Division
VINCENT J. MATANOSKI Assistant Director Torts Branch, Civil Division
s/ Linda S. Renzi by s/ Lynn E. Ricciardella LINDA S. RENZI Senior Trial Counsel Torts Branch, Civil Division U.S. Department of Justice P.O. Box 146 Benjamin Franklin Station Washington, D.C. 20044 (202) 616-4133 DATE: November 9, 2007
Geez, I'm sure glad they force us to vaccinate our kids against Hep B (a blood-borne disease, by the way) here in the US! That won't lead to any lawsuits! Oh, wait, maybe it will. Maybe kids don't need to be vaccinated against a disease that's primarily transmitted via IV drugs and sex.
KYODO, Japan, Feb. 25 (UPI) -- The Japanese government is bracing for a flood of damage suits from hundreds of people who contracted hepatitis B through mandatory childhood vaccinations.
Lawyers for the victims say the first suits will be filed in late March by a group of some 20 people who are seeking compensation of between $139 million and $555 million each, Kyodo News reported Monday.
Other groups are expected to follow in April, filing their cases in 11 district courts across Japan, the lawyers say.
Last month the Diet enacted relief measures for people who contracted hepatitis C from tainted blood products after Japan's Supreme Court ordered compensation for five hepatitis B victims, Kyodo said.
Japan no longer mandates vaccinations against certain diseases due to side effects that prompted a number of lawsuits.
This is related to my prior post regarding the Journal of Child Neurology paper on the girl with mitochondrial disease and autism. This girl's lawsuit against the United States Department of Health & Human Services is one of the 4,900 cases in the Omnibus Autism Proceeding going on right now, and this girl won. The US government admitted that the mandatory vaccine that this girl received caused her to develop autism, and awarded her monetary damages.
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 Court.
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.
In fact, the government's concession seems to raise more questions than it answers.
1) Is there a connection between vaccines, mitochondrial disorders and a diagnosis of autism, at least in some cases?
Mitochondria, you may recall from biology class, are the little powerhouses within cells that convert food into electrical energy, partly through a complex process called "oxidative phosphorylation." If this process is impaired, mitochondrial disorder will ensue.
The child in this case had several markers for Mt disease, which was confirmed by muscle biopsy. Mt disease is often marked by lethargy, poor muscle tone, poor food digestion and bowel problems, something found in many children diagnosed with autism.
But mitochondrial disorders are rare in the general population, affecting some 2-per-10,000 people (or just 0.2%). So with 4,900 cases filed in Vaccine Court, this case should be the one and only, extremely rare instance of Mt disease in all the autism proceedings.
But it is not.
Mitochondrial disorders are now thought to be the most common disease associated with ASD. Some journal articles and other analyses have estimated that 10% to 20% of all autism cases may involve mitochondrial disorders, which would make them one thousand times more common among people with ASD than the general population.
Another article, published in the Journal of Child Neurology and co-authored by Dr. Zimmerman, showed that 38% of Kennedy Krieger Institute autism patients studied had one marker for impaired oxidative phosphorylation, and 47% had a second marker.
The authors -- who reported on a case-study of the same autism claim conceded in Vaccine Court -- noted that "children who have (mitochondrial-related) dysfunctional cellular energy metabolism 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."
An interesting aspect of Mt disease in autism is that, with ASD, the mitochondrial disease seems to be milder than in "classic" cases of Mt disorder. In fact, classic Mt disease is almost always inherited, either passed down by the mother through mitochondrial DNA, or by both parents through nuclear DNA.
In autism-related Mt disease, however, the disorder is not typically found in other family members, and instead appears to be largely of the sporadic variety, which may now account for 75% of all mitochondrial disorders.
Meanwhile, an informal survey of seven families of children with cases currently pending in Vaccine Court revealed that all seven showed markers for mitochondrial dysfunction, dating back to their earliest medical tests. The facts in all seven claims mirror the case just conceded by the government: Normal development followed by vaccination, immediate illness, and rapid decline culminating in an autism diagnosis.
2) With 4,900 cases pending, and more coming, will the government concede those with underlying Mt disease -- and if it not, will the Court award compensation?
The Court will soon begin processing the 4900 cases pending before it. What if 10% to 20% of them can demonstrate the same Mt disease and same set of facts as those in the conceded case? Would the government be obliged to concede 500, or even 1,000 cases? What impact would that have on public opinion? And is there enough money currently in the vaccine injury fund to cover so many settlements?
When asked for a comment last week about the court settlement, a spokesman for HHS furnished the following written statement:
"DVIC has reviewed the scientific information concerning the allegation that vaccines cause autism and has found no credible evidence to support the claim. Accordingly, in every case under the Vaccine Act, DVIC has maintained the position that vaccines do not cause autism, and has never concluded in any case that autism was caused by vaccination."
3) If the government is claiming that vaccines did not "cause" autism, but instead aggravated a condition to "manifest" as autism, isn't that a very fine distinction?
For most affected families, such linguistic gymnastics is not so important. And even if a vaccine injury "manifested" as autism in only one case, isn't that still a significant development worthy of informing the public?
On the other hand, perhaps what the government is claiming is that vaccination resulted in the symptoms of autism, but not in an actual, factually correct diagnosis of autism itself.
4) If the government is claiming that this child does NOT have autism, then how many other children might also have something else that merely "mimics" autism?
Is it possible that 10%-20% of the cases that we now label as "autism," are not autism at all, but rather some previously undefined "look-alike" syndrome that merely presents as "features" of autism?
This question gets to the heart of what autism actually is. The disorder is defined solely as a collection of features, nothing more. If you have the features (and the diagnosis), you have the disorder. The underlying biology is the great unknown.
But let's say the government does determine that these kids don't have actual "autism" (something I speculated on HuffPost a year ago). Then shouldn't the Feds go back and test all people with ASD for impaired oxidative phosphorylation, perhaps reclassifying many of them?
If so, will we then see "autism" cases drop by tens, if not hundreds of thousands of people? Will there be a corresponding ascension of a newly described disorder, perhaps something like "Vaccine Aggravated Mitochondrial Disease with Features of ASD?"
And if this child was technically "misdiagnosed" with DSM-IV autism by Dr Zimmerman, how does he feel about HHS doctors issuing a second opinion re-diagnosis of his patient, whom they presumably had neither met nor examined? (Zimmerman declined an interview).
And along those lines, aren't Bush administration officials somewhat wary of making long-distance, retroactive diagnoses from Washington, given that the Terry Schiavo incident has not yet faded from national memory?
5) Was this child's Mt disease caused by a genetic mutation, as the government implies, and wouldn't that have manifested as "ASD features" anyway?
In the concession, the government notes that the patient had a "single nucleotide change" in the mitochondrial DNA gene T2387C, implying that this was the underlying cause of her manifested "features" of autism.
While it's true that some inherited forms of Mt disease can manifest as developmental delays, (and even ASD in the form of Rhett Syndrome) these forms are linked to identified genetic mutations, of which T2387C is not involved. In fact little, if anything, is known about the function of this particular gene.
What's more, there is no evidence that this girl, prior to vaccination, suffered from any kind of "disorder" at all- genetic, mitochondrial or otherwise. Some forms of Mt disease are so mild that the person is unaware of being affected. This perfectly developing girl may have had Mt disorder at the time of vaccination, but nobody detected, or even suspected it.
And, there is no evidence to suggest that this girl would have regressed into symptoms consistent with a DSM-IV autism diagnosis without her vaccinations. If there was such evidence, then why on earth would these extremely well-funded government attorneys compensate this alleged injury in Vaccine Court? Why wouldn't they move to dismiss, or at least fight the case at trial?
6) What are the implications for research?
The concession raises at least two critical research questions: What are the causes of Mt dysfunction; and how could vaccines aggravate that dysfunction to the point of "autistic features?"
While some Mt disorders are clearly inherited, the "sporadic" form is thought to account for 75% of all cases, according to the United Mitochondrial Disease Foundation. So what causes sporadic Mt disease? "Medicines or other toxins," says the Cleveland Clinic, a leading authority on the subject.
Use of the AIDS drug AZT, for example, can cause Mt disorders by deleting large segments of mitochondrial DNA. If that is the case, might other exposures to drugs or toxins (i.e., thimerosal, mercury in fish, air pollution, pesticides, live viruses) also cause sporadic Mt disease in certain subsets of children, through similar genotoxic mechanisms?
Among the prime cellular targets of mercury are mitochondria, and thimerosal-induced cell death has been associated with the depolarization of mitochondrial membrane, according to the International Journal of Molecular Medicine among several others. (Coincidently, the first case of Mt disease was diagnosed in 1959, just 15 years after the first autism case was named, and two decades after thimerosal's introduction as a vaccine preservative.)
Regardless of its cause, shouldn't HHS sponsor research into Mt disease and the biological mechanisms by which vaccines could aggravate the disorder? We still do not know what it was, exactly, about this girl's vaccines that aggravated her condition. Was it the thimerosal? The three live viruses? The two attenuated viruses? Other ingredients like aluminum? A combination of the above?
And of course, if vaccine injuries can aggravate Mt disease to the point of manifesting as autism features, then what other underlying disorders or conditions (genetic, autoimmune, allergic, etc.) might also be aggravated to the same extent?
7) What are the implications for medicine and public health?
Should the government develop and approve new treatments for "aggravated mitochondrial disease with ASD features?" Interestingly, many of the treatments currently deployed in Mt disease (i.e., coenzyme Q10, vitamin B-12, lipoic acid, biotin, dietary changes, etc.) are part of the alternative treatment regimen that many parents use on their children with ASD.
And, if a significant minority of autism cases can be linked to Mt disease and vaccines, shouldn't these products one day carry an FDA Black Box warning label, and shouldn't children with Mt disorders be exempt from mandatory immunization?
8) What are the implications for the vaccine-autism debate?
It's too early to tell. But this concession could conceivably make it more difficult for some officials to continue insisting there is "absolutely no link" between vaccines and autism.
It also puts the Federal Government's Vaccine Court defense strategy somewhat into jeopardy. DOJ lawyers and witnesses have argued that autism is genetic, with no evidence to support an environmental component. And, they insist, it's simply impossible to construct a chain of events linking immunizations to the disorder.
Government officials may need to rethink their legal strategy, as well as their public relations campaigns, given their own slightly contradictory concession in this case.
9) What is the bottom line here?
The public, (including world leaders) will demand to know what is going on inside the US Federal health establishment. Yes, as of now, n=1, a solitary vaccine-autism concession. But what if n=10% or 20%? Who will pay to clean up that mess?
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.
Many people look forward to hearing more from HHS officials about why they are settling this claim. But whatever their explanation, they cannot change the fundamental facts of this extraordinary case:
The United State government is compensating at least one child for vaccine injuries that resulted in a diagnosis of autism.
And that is big news, no matter how you want to say it.
David Kirby is the author of "Evidence of Harm - Mercury in Vaccines and the Autism Epidemic, A Medical Controversy" (St. Martins Press 2005.)
...and worst of all, there's no benefit to the injection in nearly every circumstance. If your baby is a girl, or a boy who will not be circumcised, or a boy who will be circumcised after seven days (when babies produce plenty of their own Vitamin K, and when orthodox Jewish families circumcise their boys), and if you had a delivery without forceps (which could cause intracranial bleeding), there is no need to give your baby an injection of a vitamin that prevents excess bleeding. Too bad the government forces it in every child born in a hospital in the US. This could be the next great class action suit.
Vitamin K and leukaemia: one study finds no link, but others don't completely exclude a risk
In the early 1990s two reports by Golding et al suggested thatthe risk of childhood cancer, particularly leukaemia, was doubledin children who had received prophylactic intramuscular vitaminK at birth. None of the subsequent research found any significantassociation, but these studies used different methods and werehampered by lack of power. This week's issue includes four morestudies: all provide further evidence against an effect of thevitamin K of the size suggested by Golding et al.
The first, by McKinney et al, failed to show any significantassociation between cancer and vitamin K (p 173). In a populationbased case-control study in Scotland designed to identify riskfactors for childhood cancer they investigated vitamin K byusing information in hospital records and found no significantlyraised risks for leukaemia or any other type of cancer. Accountingfor other factors that might explain an association, such astype of delivery or deprivation, did not alter their findings.
Two studies (case-control and ecological) by Passmore et al(p 178, 184) and another case-control study by Parker et al(p 189) do not, however, exclude a possible association withleukaemia. Passmore et al consider that this might be explainedby the association they found between type of delivery and riskof leukaemia. Parker et al found no association with non-leukaemiamalignant disease but were unable to rule out an associationwith acute lymphoblastic leukaemia, especially for that diagnosedin children aged 1-6 years. Passmore et al and Parker et alsuggest that their results support a policy of giving intramuscularvitamin K only to babies at high risk of vitamin K deficiencybleeding, with oral vitamin K being given to the others.
Perhaps you remember my previous post (http://theresma.spaces.live.com/blog/cns!80EE15D075B65A13!248.entry) about Dr. Robert Rust testifying in Hazlehurst v. HHS that there is "no reasonable biological explanation" for thimerosal-containing vaccines causing autism, despite the fact that the Journal of Child Neurology, of which he is one of the editors, published a paper stating EXACTLY THAT two weeks after his testimony. He must have seen the paper by the time he testified, given publication schedules.
Well, it turns out that Rust's lie is even bigger. The JCN publshed another paper about vaccines causing a 19-month-old girl's autism a year BEFORE his testimony. Details are below...
A 19-month-old girl … [with] … 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 influenzae B;
measles, mumps, and rubella; polio; and varicella (Varivax), the patient
developed a fever to 38.9°C, 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.
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.
Here it is: only 40% effective (down from the 52% that the CDC projected earlier this year), and still containing mercury (in the multi-dose vials)! What a great idea!
The flu season is getting worse, and U.S. health officials say it's partly because the flu vaccine doesn't protect against most of the spreading flu bugs. The flu shot is a good match for only about 40 percent of this year's flu viruses, officials at the U.S. Centers for Disease Control and Prevention said Friday.
The situation has even deteriorated since last week when the CDC said the vaccine was protective against roughly half the circulating strains. In good years, the vaccine can fend off 70 to 90 percent of flu bugs.
Infections from an unexpected strain have been booming, and now are the main agent behind most of the nation's lab-confirmed flu cases, said Dr. Joe Bresee, the CDC's chief of influenza epidemiology.
It's too soon to know whether this will prove to be a bad flu season overall, but it's fair to say a lot of people are suffering at the moment. "Every area of the country is experiencing lots of flu right now," Bresee said.
This week, 44 states reported widespread flu activity, up from 31 last week. The number children who have died from the flu has risen to 10 since the flu season's official Sept. 30 start.
Those numbers aren't considered alarming. Early February is the time of year when flu cases tend to peak. The 10 pediatric deaths, though tragic, are about the same number as was reported at this time in the last two flu seasons, Bresee said.
The biggest surprise has been how poorly the vaccine has performed.
Each winter, experts try to predict which strains of flu will circulate so they can develop an appropriate vaccine for the following season. They choose three strains_ two from the Type A family of influenza, and one from Type B.
Usually, the guesswork is pretty good: The vaccines have been a good match in 16 of the last 19 flu seasons, Bresee has said.
But the vaccine's Type B component turned out not to be a good match for the B virus that has been most common this winter. And one of the Type A components turned out to be poorly suited for the Type A H3N2/Brisbane-like strain that now accounts for the largest portion of lab-confirmed cases.
Over the years, the H3N2 flu has tended to cause more deaths, Bresee said.
This week, the World Health Organization took the unusual step of recommending that next season's flu vaccine have a completely different makeup from this year's. The U.S. Food and Drug Administration is expected to make its decision about the U.S. vaccine next week.
H3N2 strains are treatable by Tamiflu and other antiviral drugs, but the other, H1N1 Type A strains are more resistant. Of all flu samples tested this year, 4.6 percent have been resistant to antiviral medications. That's up from fewer than 1 percent last year.
"This represents a real increase in resistance," Bresee said.
Maybe people don't understand how viruses work, but this is not a surprise to me at all. See, viruses learn to fight different medications (just as bacteria learn to fight antibiotics), and then the medications (or antibiotics, in the case of bacteria) don't work anymore. Maybe it's not so smart to dope yourself up when the alternative is feeling a little crummy for a few days (and gaining a stronger immune system). Maybe it's not so smart to give Big Pharma your money when the result is a weaker immune system for you and a stronger set of flu viruses.
Resistance to Tamiflu Increases As seasonal influenza activity continues to increase, the CDC is monitoring a rise in resistance to Tamiflu (oseltamivir). But the increase in resistance is not worrisome enough that the agency is considering altering its recommendations about the use of antiviral medication. Of 350 influenza isolates tested this season, 16 (4.6%) were resistant to the antiviral medication, and all of the resistance is among H1NI influenza A virus, where it accounts for 8.1% of isolates tested -- up from 0.7% last flu season. The agency currently recommends Tamiflu or Relenza (zanamivir) as a second line of defense -- after vaccination -- against the seasonal flu, noting they can prevent infection or reduce the severity of disease. CDC surveillance shows that 84% of cases of flu are being caused by influenza A, with the remainder by influenza B.
I saw another article in The Morning Call that said this year's shot may only be 40% effective. Great! I'm sure glad the CDC encouraged everyone to get it--especially given that the 10-dose vial still has mercury in it!
Report Indicates Flu Vaccine Less Effective This Year This season's flu vaccine may not offer as much protection against infection as it has in years past, according to a Defense Department Study. The report indicates the vaccine, which is usually 70% to 90% effective in preventing infection, is only 52% effective this year. This year, after producing their vaccine, experts discovered two new strains of influenza not covered by the inoculation. These new strains, called "Brisbane" and "Yamagata" now account for almost half of all influenza infections this season. Experts at the CDC say that, while this season's vaccine may not prevent infection in a large number of people, it is not totally ineffective. Those who have received the vaccine and still contract the flu will likely have milder symptoms than non-vaccinated people. The CDC is urging people with a high risk of flu complications, especially the elderly and frail, and those who care for them, to get vaccinated because the flu season typically peaks in the weeks ahead.
As the parent of a child with autism and a writer on the subject for About.com, I enjoyed reading “A Spectrum of Disorders” (by Ashley Pettus, January-February, page 27). I would like to comment on one point. The author, in describing intensive behavioral therapy for very young children, says “Although ABA [applied behavioral analysis] strikes some parents as an unnatural and excessively regimented treatment, many researchers now agree that, for the most severely affected children, it is necessary to apply the most intensive strategy at the youngest possible age....The exposure of a young child who may not be autistic to intensive behavioral, speech, and language therapies will certainly not harm the child’s development.”
ABA is generally recommended for 40 hours a week. In addition, as the article notes, most parents don’t stop with ABA. They add in a range of additional therapies, some quite intensive and carrying significant risks for the child (chelation therapy, megavitamin supplements, hyperbaric oxygen therapy, and so forth). That means that a two-year-old could be experiencing 50 to 60 hours per week of intensive therapy—leaving no time for typical interaction with peers or with the world around him. It’s hard to believe that such intervention “will not harm the child’s development,” particularly if the autism diagnosis turns out to be incorrect.
There are other options for treatment, not discussed in this article, such as “Floortime” and Relationship Development Intervention (RDI), which are far more developmentally appropriate than ABA. For a child with a “borderline” diagnosis, these offer both the intensity of ABA and far broader, more naturalistic opportunities for engagement with parents, siblings, peers, and the world. They are not as intensively studied, but research so far shows very positive outcomes.
In addition, while researchers do recommend intensive early intervention, I have yet to find any research that compares that type of intervention with later treatment. It is, of course, easier for parents and teachers to work intensively with younger, smaller children—but I can find no evidence that it’s actually more effective. The push to early-as-possible intervention leads to panic—with parents rushing to provide every possible treatment prior to an imaginary “deadline” when the “window of opportunity” will slam shut. This phenomenon creates all the problems the author notes (financial and marital stress, to name a few)—and encourages parents to seek out and implement every possible treatment, no matter how unresearched or potentially dangerous, before it’s “too late.”
With so much emphasis on early diagnosis and intensive treatment, combined with a panicked rush to the finish line, it’s easy to forget some very basic truths.
A child with autism is still a child—and despite all mythology to the contrary, is almost certainly capable of love, joy, and engagement with other human beings.
There is no “window of opportunity.” Your child can benefit from therapy throughout his or her lifespan.
It may never be possible to “fix” your child with autism—even if you start early and work hard. But the truth is that many, many people with autism can and do live creative, fulfilled lives.
Lisa Jo Rudy Falmouth, Mass.
I was disappointed to read the article and to learn nothing new about autism spectrum disorders (ASDs). I found Pettus’s article both shallow and misleading. Pettus dismisses the possible thimerosal (ethylmercury) connection to autism, despite the fact that the latest research demonstrates a definitive link between higher levels of mercury in the blood and autism.
Pettus also misuses the term “recover” when she applies it to training such as Applied Behavioral Analysis, which is a therapy. “Recovery” is properly used to describe the process by which autistic children are healed by therapies such as chelation (removal of heavy metals from the body) and diet modifications. I was shocked not to see any mention of the gluten-free, casein-free diet that has helped many parents to recover their autistic children. For an article that claims to discuss the “biological basis of autism” to ignore basic body chemistry is unforgivable.
Finally, Pettus succumbs to rhetoric popular with Big Pharma and shallowly researched mainstream press articles when she claims that “it is not possible to get an accurate count of real cases prior to the early 1990s.” Certainly, any diagnosis of a mental disorder is at some level a judgment call, and there has likely been some mislabeling of autism. However, to imply that the increase in autism diagnoses is purely a shift in semantics is to be intentionally ignorant. ASDs did not exist at all prior to the 1930s; environmental factors (possibly combined with a genetic predisposition) are the most likely explanation for the skyrocketing diagnoses of these devastating disorders. To focus only on possible genetic causes of ASDs is to ignore a whole universe of prevention and therapy. I expected more from Harvard.
Theresa V. (Makin) O’Brien ’00 New York City
Editor’s note: Other correspondents suggested as causes for autism exposure to plastics, ear infections that compromise language development, aggressive management of childbirth and resulting fetal distress, miscellaneous toxins, other ingredients in vaccines, and use of fetal ultrasound during pregnancy.
Ashley pettus’s thoughtful cover story does an excellent job of calling attention to “the urgent search to understand the biological basis of autism,” and the importance of early intervention and treatment in providing the best possible outcome for the 1 in 166 children who suffer from autistic spectrum disorders.
We are learning more than ever about the inner workings of the brain, yet that which we do not know is still painfully evident. Pettus’s comment that “solving the puzzle of autism will require close collaboration between those in the laboratory and those on the front lines of patient care” is right on the money, and is consistent with the National Institutes of Health’s recent focus on translating scientific discoveries into practical applications.
Similarly to autism, mood disorders such as bipolar disorder and depression are biologically based brain disorders, and there is growing evidence that these neuropsychiatric disorders may be clinically and genetically linked. As is the case with autism, there has been a dramatic increase in recent years in the number of children being diagnosed with bipolar disorder and related conditions. There remains, however, much disagreement among clinicians over the appropriate criteria for diagnosing, as well as treating, mood disorders in children. What is clear is that early and accurate diagnosis and treatment, for both autism and mood disorders, are paramount if we hope to achieve the best possible outcomes and quality of life for these children.
Jocelyn Scribano, M.B.A. ’86 Board of Directors Child and Adolescent Bipolar Foundation New Albany, Ohio
Media Contacts: Amy Carson 828-776-0082 or Angela Medlin 919-633-0200
PARENTS OF AUTISTIC CHILDREN PROTEST AT AMERICAN ACADEMY OF PEDIATRICS
-"Toxic Children, Toxic Lies" Rally Expresses Outrage Over AAP's Refusal to Demand Safer Vaccines, Highlights Dramatic Recovery Stories -
Elk Grove, IL (February 18, 2008)- Dozens of parents of vaccine-injured children from all over America will join a cadre of researchers and physicians Wednesday morning for "Toxic Children, Toxic Lies," a protest at the American Academy of Pediatrics Headquarters in Elk Grove Village, Illinois. The rally will express the outrage of thousands of parents of autistic children over the American Academy of Pediatrics' unethical maneuvers to protect the National Immunization Program, even if it means lying to the public about the safety of children's vaccines. Parents will also share dramatic recovery stories of vaccine-injured children who have undergone biomedical intervention therapies to reverse the damage caused by toxic metals and viral overload in vaccines.
Parents of vaccine-injured children were shocked at the recent censorship attempt of the AAP, which recently demanded that ABC cancel the series premiere of the new drama "Eli Stone." The episode portrayed an attorney who successfully sued a pharmaceutical giant after his client's child became autistic after receiving a mercury-containing vaccine.
On Wednesday, February 20th, 2008, parents of vaccine-injured children will gather at the American Academy of Pediatrics Headquarters at 141 NW Point Boulevard, Elk Grove Village, IL, beginning at 7:30 a.m., to confront AAP leadership as they arrive for work. A news conference will be held for the media at 9:30 a.m. featuring parents and physicians.
-more-
In 1999, the AAP recommended the removal of thimerosal, a mercury-based preservative, from all childhood vaccines. However, the AAP has recently reversed its position on thimerosal, and now inexplicably states that there is no health concern with injecting mercury, a known neurotoxin, into infants and children. Dozens of advocacy groups representing parents of autistic children believe the AAP leadership have become apologists for unsafe vaccines, and dangerous one-size-fits-all vaccination policies which have harmed a subset of genetically vulnerable children. Furthermore, autism advocacy groups are dismayed that the AAP continues to refuse to recognize the efficacy and growing popularity of biomedical intervention therapies for vaccine-injured children.
Parental concern over the safety of the vaccination schedule has risen as the number of recommended vaccines has risen. In 1983, when autism affected just 1 in 10,000 children, the Centers for Disease Control's mandatory vaccination schedule consisted of 10 shots. Today, when 1 in 150 children is affected with an autism spectrum disorder, the CDC now recommends 36 separate shots from birth to age six, a whopping increase of 260%. With that increase, the prevalence of neurological disorders like autism and ADHD has grown exponentially.
Thousands of parents believe their child's regression into autism was triggered, if not caused, by over-vaccination with toxic ingredients and live viruses found in vaccines, such as mercury, aluminum, formaldehyde, ether and antifreeze. The Centers for Disease Control and the AAP dispute this, but independent research and the first-hand accounts of parents tell a different story. Additionally, autistic children around the country have seen dramatic recoveries from vaccine injury when they begin to undergo biomedical intervention therapies to reverse the damage caused by toxic metals and viral overload.
Mayer Eisenstein, MD, JD, MPH, is Medical Director Homefirst® Health Services in Chicago, IL. Eisenstein works with parents who are concerned about the CDC's extreme vaccination schedule and helps them design a different schedule for their children that is gentler to an infant's developing immune system.
-more-
"As a physician and an attorney, I also hold a degree in public health. I am extremely proud of the thousands of parents, who in spite of their pediatricians' lack of concern for injecting mercury into their children, reject the idea of doing so," said Eisenstein.
Researcher and physician David Ayoub, MD, is the Director of the Prairie Collaborative for Immunization. "A growing number of experimental, epidemiological and biochemical research has unequivocally shown that mercury is directly linked to the development of autism spectrum disorders and is significantly toxic to the gastrointestinal, immunological, metabolic and neurobiological systems in children," said Ayoub. "The nation's one-size-fits-all vaccination policy has indisputably harmed some of our kids. It is time for the AAP and the CDC to stop the denial. We must demand answers and learn why the increase in the number and composition of so many vaccinations has led to an epidemic in neurological disorders in our nation's children."
Let's even ignore the studies on animal models showing that thimerosal injected into mice gives them autistic symptoms, and that thimerosal given to monkeys finds its way into their brains and stays there. Let's just look at, say, the piece published in Dr. Rust's own freaking journal, and ask ourselves how he can pretend that it doesn't exist.
Dr. Rust testified on behalf of the US Department of Health and Human Services (the respondent in the Hazlehurst v HHS lawsuit that is part of the Autism Omnibus proceeding). He testified on October 17, 2007. You can read his testimony by clicking the link below (ftp://autism.uscfc.uscourts.gov/autism/hazlehurst/transcripts/DAY03.pdf), but I'd like to draw your attention to the following two sections:
Page 7, beginning with line 22: The attorney (Renzi) for the HHS asks, "Is there any credible evidence that thimerosal-containing vaccines can cause autism?" Dr. Rust answers, "No, ma'am, not to my knowledge." He then goes on to cite "the lack of any kind of epidemiological correlation" and "no such reasonable biological explanation."
Page 10, beginning with line 16: Renzi asks, "Do you serve on editorial boards?" and Dr. Rust replies that he does, listing the Journal of Child Neurology as one of them.
Now you might want to click over to http://jcn.sagepub.com and read the November 2007 issues of the aforementioned Journal of Child Neurology, on whose editorial board Dr. Rust sits. You might want to read the piece entitled, "Blood Levels of Mercury Are Related to Diagnosis of Autism: A Reanalysis of an Important Data Set," by M. Catherine DeSoto and Robert T. Hitlan (http://jcn.sagepub.com/cgi/content/abstract/22/11/1308). These two researchers analyzed the oft-cited Ip data set and found that Ip et al GOT THEIR MATH WRONG. The researchers further state, "a significant relationship does exist between the blood levels of mercury and diagnosis of an autism spectrum disorder. Moreover, the hair sample analysis results offer some support for the idea that persons with autism may be less efficient and more variable at eliminating mercury from the blood."
This piece was published in the November 2007 issue of the Journal of Child Neurology. Dr. Rust testified on October 17, 2007. I find it inconceivable that he was unaware of DeSoto and Hitlan's work, given that (as a member of the editorial board) he was tasked with reviewing it. This leaves only one conclusion: that Dr. Rust lied. (Did you also notice that he went to four different schools for college? Weird.) This lie is unconscionable, in light of the importance of the Hazlehurst trial.
This is awesome. These two settlements together are one of the largest healthcare fraud settlements ever achieved by the Justice Department. Damn. You know, this just fills me with trust for Merck. I mean, these guys would definitely not push thimerosal or MMR on anyone in order to make a profit, right? They would definitely not dump toxins into the Delaware River, kill fish and risk people's lives, and not tell anyone for 10 days, right? Oh, wait ... um, yeah, they would.
If you read this article and were surprised by it, then you obviously need to read some of my previous posts:
Merck & Co. Inc. Resolves Federal and State Investigations Related to Past Pricing and Past Sales and Marketing Activities
02/7/2008
Merck & Co. Inc. announced that it has reached civil settlements with federal and state authorities to resolve longstanding investigations related to disputes over the proper calculation of Medicaid rebates as well as certain past sales and marketing activities that ended in 2001. This civil resolution encompasses two matters involving the federal government, the District of Columbia and all 49 states that participate in the Medicaid prescription drug program. In the first matter that was pending in the Eastern District of Louisiana, Merck has agreed to pay $250 million plus interest. In the second matter that was pending in the Eastern District of Pennsylvania, which includes a related Nevada action, Merck has agreed to pay $399 million plus interest. Merck announced in December that it would take a $670 million charge in the fourth quarter of 2007 in anticipation of these two settlements. As a result of the agreements, lawsuits against Merck will be dismissed by federal courts in Philadelphia, New Orleans and Nevada.
Your leader (February 5) appeals to Popper's hallmark of scientific validity, that a theory stands until overtaken by a new theory that better addresses the relevant facts. In Dr Andrew Wakefield's case the relevant facts were measles in the gut of autistic children, but rarely in control children. Recent epidemiological studies that failed to find a link between MMR and autism, when comparing for example the prevalence of autism among vaccinated and non-vaccinated populations, were not looking at biological data, but at a different set of facts to Wakefield.
The new study you report finds no link when comparing peripheral blood samples of 98 autistic and 142 non-autistic children. But how can Popper's test of validity apply if the study looks at blood and not bowel samples? All sides agree on the importance of settling the issue of an association between MMR and autism. But in the 10 years since Wakefield's first paper, new science has failed to address the facts found. Instead we have three conflicting types of theory: epidemiological, biological blood and biological bowel (not to mention genetics). There has been much talk of Wakefield's discredited research, but on Popper's test his findings stand until overthrown by studies that invalidate them, such as replication studies that negate or support the presence of measles virus in the gut of autistic children. It is too early to assert that fears about MMR safety are groundless. Attempts to foreclose further scientific research could not be further from the spirit of openness in scientific inquiry that Popper also encouraged.
This is the kind of bull that makes me see red. It's pretty clear that the aim of this "study" was to make the MMR vaccine look good, not to discover whether it causes any harm to vaccinated children.
I've learned that Dr. Wakefield and his colleagues are preparing a formal response, and that his initial concerns about the study are these:
"This paper contributes nothing to the issue of causation, one way or another. It tells us nothing about what actually happened to the children at the time of exposure. I am increasingly persuaded that measuring things in blood many years down the line tells us nothing about the initiating events in what is, in effect, a static (non-progressive) encephalopathy unlike, for example, subacute sclerosing panencephalitis which is a progressive measles encephalopathy. The gut is a different matter and analysis of mucosal tissues has been very informative since here we see, in the relevant children, active ongoing inflammation."
Dr. Wakefield's study in 1998 is not the only study linking MMR to autism, and not the only study showing gut disorders resulting from MMR vaccination. For example, check out the study done by Bradstreet (citation in a moment) that found measles-virus antigen in the cerebrospinal fluid of autistic children (68% of the 28 children tested) and only in one of the non-autistic children used as controls. (This child had leukemia and Burkett's lymphoma; he was obviously not typical from an immunological perspective.) It's pretty clear that the measles virus in the MMR vaccine does affect some children in a horribly negative way, harming their intestines and possibly contributing to their developing autism. Don't believe the propaganda put out by the CDC and the Health Protection Agency; they have a vested interest in coercing every child to be vaccinated.
Here are citations for two Bradstreet studies, so you can look them up for yourself. Note that we never receive actual study data from any of the "vaccines are wonderful" crowd. Also note that the “vaccines are wonderful” crowd always says, “We don’t need any more studies on this.” Now why would ANY scientist ever look at two conflicting studies and say, “Let’s not examine this topic anymore”???
Bradstreet J, El Dahr J, Anthony A, Kartzinel J, Wakefield A. Detection of Measles Virus Genomic RNA in Cerebrospinal Fluid of Children with Regressive Autism: a Report of Three Cases. J Am Phys Surg, Vol 9 No 2, 2004.
Bradstreet J, El Dahr J, Walker S, Montgomery S.M, Kartzinel J, Wakefield A, Sheils O, O'Leary J. TaqMan RT-PCR Detection of Measles Virus Genomic RNA in Cerebrospinal Fluid in Children with Regressive Autism. Presented IMFAR, MIND Institute May 2004.
LONDON (Feb. 4) - A vaccine for measles, mumps and rubella does not cause autism, according to the largest study yet showing there is no evidence linking the childhood shot to the development disorder.
The study, published on Tuesday in the Archives of Disease in Childhood, found no evidence of any abnormal biological response from the shot that could point to a link between the vaccine and autism.
“This study really supports the view these are safe vaccines," said David Brown, a researcher at Britain's Health Protection Agency who worked on the study. "The evidence is now so solid there really isn't a need for further studies here."
In 1998, Dr. Andrew Wakefield of Royal Free Hospital in London and colleagues sparked a fierce worldwide debate among scientists and a health scare by suggesting the MMR jab caused autism. Outbreaks of all three diseases followed.
Autism is marked by a variety of difficulties in social interaction and behavior, from the awkwardness of Asperger syndrome to severely debilitating repetitive behaviors and an inability to speak.
The British study looked at nearly 100 autistic children, a group of 52 with learning difficulties and 90 who were developing normally.
All the volunteers chosen from a sample of 57,000 children in southern England had received an MMR vaccination but not everybody got both doses, said Gillian Baird, a pediatrician at the Newcomen Centre for Child Development, who led the study.
The researchers took blood samples from the children and found no abnormal immune response in any of them marked by higher antibody levels or presence of a measles virus still left in the body from the shot, Baird added.
Wakefield, whose research has been widely discredited, had pointed to these two factors as a way to explain the link but the latest findings do not back up that case, Baird said. Wakefield said in a newspaper interview last year he believed it was biologically plausible the shot could cause autism.
"There was no difference across any of the groups no matter how you cut them up," Baird said in a telephone interview. "The response to the MMR vaccine was the same in every group."
Before Wakefield's study, more than 90 percent of British children received the vaccination, a figure that dropped to 80 percent before recovering to a current 85 percent, according to government figures.
Baird said she hoped the findings, along with a U.S. study last week showing that a mercury-based preservative called thimerosal did not cause autism, would bolster confidence in the MMR shot.
"It is a big study and we hope people can have confidence in the MMR shot again," Baird said in a telephone interview. "Measles has come back again because people have stopped immunizing their children."
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