September 27, 2007
Vaccine Compound Is Harmless, Study Says, as Autism Debate Rages
By GARDINER HARRIS
Yet another study has found that a controversial vaccine preservative appears to be harmless. But the study is unlikely to end the increasingly charged debate about vaccine safety. The study examined whether thimerosal — a mercury-containing vaccine preservative that was almost entirely eliminated from childhood vaccines by 2002 — is associated with neurological or certain psychological problems in children ages 7 to 10.
Some parents’ groups and prominent legislators contend that thimerosal has caused an epidemic of childhood autism. Several studies have examined this question and found no evidence that thimerosal is associated with autism. The most recent study did not assess thimerosal’s association with autism directly. The Centers for Disease Control and Prevention is conducting a separate autism and thimerosal study that is expected to be published next year.
In this study, published yesterday in The New England Journal of Medicine, researchers from the C.D.C. and several managed-care organizations subjected 1,047 children to 42 neurological and psychological exams, which included I.Q. tests, how well children recalled a list of names and whether they could repeat the names backward, their manual dexterity, and whether they stuttered or had tics.
The researchers also took detailed medical histories to determine whether the subjects’ mothers were exposed to thimerosal while pregnant, and how much thimerosal the children were exposed to in their first seven months of life. After subjecting the data to nearly 400 different statistical measures, researchers found 19 different possible associations between thimerosal and various mental outcomes — most of which suggested that thimerosal was actually beneficial.
Researchers largely dismissed these associations as statistical flukes.
“By chance alone, with that number of tests, we would estimate that 5 percent of the results would be significant,” said Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at the C.D.C. “And that’s what we found.” The lone worrisome result was that, among boys, the study found an association between thimerosal and tics, which are involuntary movements or sounds. At least one earlier study had found a similar association.
But Dr. Schuchat said that researchers had made no distinction between transitory tics — those that soon disappear and are not considered clinically important — and permanent, serious or disfiguring tics. “That particular finding is being evaluated further,” Dr. Schuchat said. Dr. Jeffrey Baker, a pediatrician and vaccine expert who is director of the history of medicine program at Duke University, said that the study’s findings should be reassuring for parents.
“This study will further strengthen a growing consensus among researchers that there is no real evidence that thimerosal in vaccines led to any actual harm,” Dr. Baker said. But Sallie Bernard, executive director of SafeMinds, a nonprofit parent organization whose members contend that thimerosal injured their children, said the study was inconclusive. Ms. Bernard served on a board of consultants that helped design and oversee the study, but she withdrew her
support for the published version of the study, saying its conclusions were not supported by the underlying data.
“There are some red flags here,” Ms. Bernard said.
Nearly 5,000 families have filed claims with the federal government contending that vaccines caused their children to become autistic. Even if the government dismisses their claims, many families have vowed to continue their fight in the courts. Since thimerosal’s removal from vaccines, there has been no evidence that autism is on the decline.
Arch Dis Child 2000;83:174-175 ( August ) http://adc.bmj.com/cgi/content/abstract/83/2/174?ck=nck
Mercury intoxication presenting with tics Albert M Lia, Michael H M Chanb, T F Leunga, Robert C K Cheungb, Christopher W K Lamb, T F Foka
a Department of Paediatrics, The Chinese University of Hong Kong, 6th Floor, Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China, b Department of Chemical Pathology, The Chinese University of Hong Kong
Correspondence to: Dr Li email: Albertm68mcli@yahoo.com
Accepted 22 March 2000
A 5 year old Chinese boy presented with recurrent oral ulceration followed by motor and vocal tics. The Chinese herbal spray he used for his mouth ulcers was found to have a high mercury content. His blood mercury concentration was raised. Isolated tics as the sole presentation of mercury intoxication has not previously been reported.
Renegade School Board Member Educates Parents On ADHD Alternatives
Monday, November 26, 2007
by: Gwen Olsen
Can you believe the audacity of some renegade school board member in Virginia who dared to send fliers home to parents informing them of nutritional alternatives to prescription ADHD medication? What is this world coming to when parents are allowed to receive fair, balanced information and make informed decisions for their children's health? Ms. Elizabeth Daniels has clearly takenher roll as a community educator too far! See story in The Virginian-Pilot (http://content.hamptonroads.com/story.cfm?story=135015&ran=160257&tref=po)
Well, not to worry. Big Pharma was having none of that and immediately sent in their paid-for-supporters and front groups such as CHADD (Children and Adults with Attention Deficit/Hyperactivity Disorder) to demand equal advertising time . . . or flier distribution rights, in order to counter this damning information and present their position that ADHD is a serious disease that requires treatment. Problem is CHADD's fliers will contain propaganda paid for by drug manufacturers and distributed strictly for corporate financial gain, but parents will be none the wiser. So, in the interest of fair balance let's examine the actual facts of this case:
ADHD has never been proven to be a neuro-developmental disease by any of the currently acceptable scientific standards. There is a lack of empirical evidence (meaning it cannot be repeated, tested, measured, or verified) that ADHD is a disease by definition. Therefore, to make such a claim is fraudulent.
Since there is no medical test of scientific validity with which to diagnose ADHD, it is a diagnosis made solely by a third-party's observation of maladaptive behaviors and is entirely subjective. On the other hand, nutritional deficiency testing, testing for heavy metal toxicity, food allergy tests, and other infectious disease tests can be scientifically and medically verified. There are a number of top-notch, FDA approved labs across the country currently performing tests of this nature. The problem presented here for Big Pharma is that these tests suggest there are therapies which can eliminate ADHD symptoms without drugs.
What is clear to me, a fifteen-year-veteran of the pharmaceutical industry who can easily recognize their re-positioning and mis-information tactics, is that Pharma is scrambling to do damage control for their multi-billion dollar psycho-pharmacologics business that has been under scrutiny by Congress, the general public and, reluctantly, even FDA regulators of late. The Drug Enforcement Administration classified methylphenidate in 1971 as a Schedule II substance (indicating this drug has significant risk of abuse and addiction with limited medicinal value). The black box warnings were added only last year to methylphenidate products such as Ritalin and Concerta, as well as to the ADHD drugs Adderall and Strattera, for their potential to cause serious psychiatric and cardiovascular problems, including psychosis, heart attack, stroke, and sudden death. These label warnings had been fought by their manufacturers for years. In addition to the above, Strattera, an SNRI (select norepinephrine reuptake inhibitor) drug, also contains warnings for severe liver damage as well as suicidal ideation.
There is consistent clinical data showing that as many as 40% of children fail to tolerate or respond well to stimulant therapy. The prestigious MTA study conducted by the National Institute of Mental Health found that long- term outcomes for medicated children demonstrate diminishing returns over time and behavioral improvements dissipate when treatment is withdrawn. In addition, stimulant drugs are known to cause jitteriness, tremors, loss of appetite, suppression of growth, insomnia, nausea, abdominal pain, dizziness, headache, blood pressure and pulse changes, depression, sadness, over stimulation of the brain, aggression, anxiety, psychosis and tachycardia in children.
Even more distressing is the fact that much of the current psychotropic business for ADHD and depression is being funneled into the newer atypical antipsychotics and promoted "off label" for these indications. Dangerous drugs such as Zyprexa, Alibify, Geodon, and Seroquel are prescribed to children without any indication that these drugs are safe or effective for children with ADHD symptoms. However, these newer products have a longer shelf life as branded drugs - many of the SSRIs and ADHD stimulants are available in generics or about to go off patent -and represent a much more lucrative prescription long term for the industry.
The atypicals haven't gotten quite the amount of negative press yet that some of the other psychotropics have. Despite the fact that antipsychotic medications are known to cause permanent disfiguring tics and dyskinesias, akathisia, mania,neuroleptic malignant syndrome, weight gain, increased cholesterol, and diabetes.
None of these drugs are currently approved for use in children, although several manufacturers have submitted requests for bi-polar illness indications in children and adolescents. According to a report by CBS Evening News, there has been a 500% increase recently in the prescribing of antipsychotics for children! No good article about psychiatric drug controversy would be complete without stating the contributions made by the Church of Scientology. In this one,Daniels said she hadn't received any complaints from parents about the fliers, only concerns that the information was taken from the Citizens Commission on Human Rights Web site which has ties to Scientology. Wonder specifically who stated that concern? Was it the CHADD representative, perhaps, who has vested financial interests with the manufacturers of stimulants? Leave it to those pesky Scientologists to suggest some crazy notion that parents deserve to be informed about the dangerous effects stimulant drugs have on their children! Sorry, but this issue has nothing to do with religion or politics. This is definitely just another Pharma diversion tactic - and a lame one at that - in an attempt to divert attention away from the dangers of their
drugs and refocus the issue on political, Scientology propaganda.
Consider this fact, CHADD's annual report for 2004-2005 lists total pharmaceutical donation support through unrestricted educational grants as comprising 22% of their total revenue. That represents $1,019,448 of contributions in one year alone. I think the propaganda that parents should be most concerned about is the covert advertising information presented by someone who has this level of financial interest in promoting dangerous drug therapy to children. Of course, that conflict-of-interest information was not revealed in the Virginian-Pilot article. When will parents finally comprehend that our children are considered a human commodity by the pharmaceutical industry? Or, when will they understand the financial significance of the fact that the child psychiatric market is potentially the most lucrative expansion market that the industry has today, bar none? Or when will Americans realize that this is an industry where
human death and suffering is relegated to statistics and bar charts depicted in patient years, not body counts?
Perhaps it will be in the discovery process of one of the many lawsuits filed on behalf of a loved one lost to a psychotropic drug reaction. Or, maybe it will be
in the desperate search for answers in a crisis situation when they reach out to others on the World Wide Web. But there is one thing I do know from my extensive experience in the industry, to Pharma it's just another day at the office - just another cost of doing business!
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Thimerosal exposure in infants and neurodevelopmental disorders: an assessment of computerized medical records in the Vaccine Safety Datalink.
Summarized results: Consistent significantly increased rate ratios were observed for autism, autism spectrum disorders, tics, attention deficit disorder, and emotional disturbances with Hg exposure from TCVs.
Geier & Geier J Neurol Sci. 2008 Aug 15;271(1-2):110-8. Epub 2008 May
A two-phased population epidemiological study of the safety of thimerosal-containing vaccines: a follow-up analysis.
. . . significant associations between cumulative exposures to thimerosal and the following types of NDs: unspecified developmental delay, tics, attention deficit disorder (ADD), language delay, speech delay, and neurodevelopmental delays in general.
Geier & Geier Med Sci Monit. 2005 Apr;11(4):CR160-70. Epub 2005 Mar 24
Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United kingdom does not support a causal association.
With the possible exception of tics, there was no evidence that thimerosal exposure via DTP/DT vaccines causes neurodevelopmental disorders.
Andrews, Miller, Grant et al Pediatrics. 2004 Sep;114(3):584-91
Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases.
Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 micro g of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. RESULTS: In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics.
Verstraeten, Davis, DeStefano et al; Pediatrics. 2003 Nov;112(5):1039-48