Flu vaccines may not save lives of elderly

No solid proof that shots prevent seniors from dying of disease, expert says

Reuters

Updated: 8:19 p.m. ET Sept 24, 2007

WASHINGTON - Getting an annual flu vaccine may not save the lives of seniors, and health officials may want to look at other ways to protect the elderly, researchers said on Monday.

No studies have conclusively proven that influenza shots prevent flu-related deaths in people over the age of 65, and some of the arguments that have been used to support this idea are based on faulty data, the researchers argue in the Lancet medical journal.

"We need to find a way to better estimate what the true benefits are," said Dr. Lone Simonsen of George Washington University.

Simonsen stressed that the elderly should continue to get flu shots. But she said health officials should also be looking for other ways to prevent some of the 36,000 deaths that come each year from flu in the United States alone.

"We can probably do more to protect the seniors," Simonsen said in a telephone interview.

Every year, the U.S. Centers for Disease Control and Prevention launches a new flu vaccination campaign, citing the research that shows the deaths and the 200,000 hospitalizations every year from flu-related illness.

People over the age of 65 make up the majority of these cases, although some children also die every year from flu.

Less benefit
But Simonsen said that no one has actually ever shown that vaccination cuts deaths from flu among the elderly. She said there is plenty of evidence to show that, because older people have lower immune activity, they in fact get less benefit than younger people from vaccination.

"There is no question about the vaccine working in people under the age of 65," she said.

Simonsen said it may be possible to design vaccines that better protect the elderly — something the CDC is working on.

She said the CDC should also consider recommending more aggressive use of antiviral drugs that can treat and sometimes even prevent flu.

CDC flu expert Dr. Joe Bresee said his agency was considering these and other measures — including better vaccination of health care workers and recommending the widespread vaccination of schoolchildren.

"We know that school children are a big part of community transmission. They shed lots of virus. They shed it for long periods of time," Bresee said in a telephone interview.

Bresee and Simonsen said elderly people may get other benefits from the flu vaccine. Influenza shots do not always completely prevent infection, but they can make the illness less serious.

Simonsen noted that a vaccine now commonly used against several types of streptococcal bacteria, which cause pneumonia, meningitis and ear infections, did not show big effects across populations until it became a regular childhood vaccine.

Experts now agree that the vaccine not only protects children, but it protects the elderly people that the children may have been infecting before.

(c) Reuters 2007. All rights reserved. Republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

URL: http://www.msnbc.msn.com/id/20962720/

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Flu vaccines may not save lives of elderly - Cold & Flu - MSNBC.com

Report assails FDA oversight of clinical trials

Federal investigator says little done to ensure patient safety

By Gardiner Harris

The New York Times

Updated: 12:58 p.m. ET Sept 28, 2007

WASHINGTON - The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.

In a report released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.

The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

Animal research centers have to register with the federal government, keep track of subject numbers, have unannounced spot inspections and address problems speedily or risk closing, none of which is true in human research, Mr. Caplan said.

Enforcement needs more 'teeth'
Because no one collects the data systematically, there is no way to tell how safe the nation’s clinical research is or ever has been.

The drug agency oversees just the safety of trials by companies seeking approval to sell drugs or devices. Using an entirely different set of rules, the Office for Human Research Protections oversees trials financed by the federal government.

Privately financed noncommercial trials have no federal oversight.

“It’s crazy that we have all these different sets of rules,” said Dr. Ezekiel J. Emanuel, chairman of the bioethics department at the National Institutes of Health. “It would facilitate things a lot if we had one agency overseeing things.”

Dr. Janet Woodcock, chief medical officer at the drug agency, acknowledged that it needs to put more “teeth” in its enforcement. “We are working to address these problems very aggressively,” Dr. Woodcock said.

The case of Audine Graybill demonstrates the flaws in the system. According to the F.D.A., in the spring of 2005, she decided to try an experimental drug to treat mania associated with bipolar disorder. The consent form that she signed on May 29 stated that she could change her mind at any point in the study.

She checked into High Pointe Healthcare in Oklahoma City, a psychiatric center owned by a psychiatrist, Dr. David Linden. On June 3, Ms. Graybill changed her mind and asked to leave.

Dr. Linden refused to let her go.

On June 6, she was given the experimental medicine. Ms. Graybill’s lawyer, Anthony Sykes, obtained a writ of habeas corpus for her to appear in court and took the writ to the hospital, where the staff refused to honor it and said it would not give it to Dr. Linden, Mr. Sykes said.

Mr. Sykes tracked Dr. Linden to another office and had him served with the writ, Mr. Sykes said. Within hours, Dr. Linden’s lawyer called Mr. Sykes and said Ms. Graybill was free to go. Mr. Sykes took her home on June 7.

Ms. Graybill could not be reached.

More than nine months later, an F.D.A. inspector appeared at Dr. Linden’s research center and uncovered myriad other problems.

The agency sent its warning letter more than two years after Ms. Graybill’s experience.

Last November, the Oklahoma Board of Medical Licensure and Supervision suspended Dr. Linden’s license for three months because he had sex with two patients and gave them genital herpes infections, according to board records. Dr. Linden, who also owns a psychiatric center in Las Vegas, did not return repeated telephone messages.

Dr. Linden has conducted clinical trials for most major pharmaceutical companies and continues to do research, according to his Web site.

The F.D.A. disqualified investigators from conducting further clinical trials 26 times from 2000 to 2005 and disqualified their data just twice even though the agency found serious problems at trial sites 348 times in that period, the inspector general found.

While some of the report’s findings surprised ethicists, its conclusion that the agency’s oversight of clinical trials is disorganized and underfinanced has long been known and is, in many ways, identical to criticisms leveled at other agency functions, including its oversight of imported food, foreign drug manufacturers, animal food and the safety of older medicines.

In each case, the size and complexity of the tasks facing the agency have grown enormously as the number of inspectors for those tasks has generally declined.

An inspector general’s report in 2000 criticized the oversight of clinical trials and noted that the inspections mostly focused on whether study information was accurate and not on whether human subjects were protected. That is still true.

In the present report, the inspector general recommended that the agency create a registry of all continuing clinical trials, an idea signed into law by President Bush on Thursday.

The report also recommended that the agency create a complete registry of research ethics boards, create a single comprehensive database to track its research inspections and obtain greater authority to regulate research assistants.

Senator Charles E. Grassley, Republican of Iowa, said the agency “needs to implement these recommendations to meet its duty.”

Representative Rosa DeLauro, Democrat of Connecticut, said it needed more money and guts.

“They’re passive, they’re reactive, and they often side with industry over public health,” Ms. DeLauro said.

The agency’s reserve is apparent in some of its warning letters.

On May 24, 2005, an inspector, Barbara Breithaupt, went to the office of Dr. Frank A. Wingrove of Ames, Iowa, and for weeks asked to see records of his study of an experimental topical treatment for periodontal disease. Dr. Wingrove refused. Dr. Wingrove did not return telephone messages seeking comment.

More than two years later, the agency sent Dr. Wingrove a warning letter. The inspector general’s report suggests that if Dr. Wingrove promised to reform, the agency was unlikely to show up again to see whether he had followed through.

Copyright © 2007 The New York Times

URL: http://www.msnbc.msn.com/id/21032902/

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Report assails FDA oversight of clinical trials - The New York Times - MSNBC.com

More info below, but here are the highlights: the CDC (and various former pharma employees) did a study with the intent of proving that thimerosal exposure from vaccinations does not pose a neurological risk. However, they

* eliminated children with low birth weight, prematurity, and other risk factors

* deliberately did not include any Autism Spectrum Disorders in the study (I guess they don't count as neurological disorders?)

* found that vaccinated boys had a greater incidence of tics (proving a causal link between vaccinations and at least one neurological disorder).

Just more misinformation brought to you by your government. Don't believe the hype.

* * *

New CDC Study Falsely Claims Thimerosal is Safe
Consumer Participant Dissents

Dear A-CHAMP subscribers:

On September 27, 2007 the New England Journal of Medicine will publish a
study entitled, "Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10
Years." For more than two years we at A-CHAMP have been hearing rumors of a new study
that "exonerates" thimerosal, despite the fact that the study results were supposed
to be kept strictly confidential.

Now the rumors have been turned into hype - another government funded study
that tries to spin data and clear thimerosal of any suspicion of causing
neurodevelopmental disorders. The study authors claim in their "Conclusions" that "[o]ur study does not support a causal association between early exposure to mercury from thimerosal-
containing vaccines and immune globulins and neuropsychological functioning at
the age of 7 to 10 years."

The statement is plainly false. The study's conclusions do not reflect the study's data or the limitations of the study,

Unfortunately we have come to expect misleading statements – some might say
fraudulent statements – from studies emanating from the CDC and their associates. It is
not merely the fact that the authors of the study are burdened by large conflicts of
interests - almost all of the 18 study authors have worked for vaccine manufacturers,
received money from them, or performed research on their behalf. What is truly shocking
about this study is that it does, indeed, find significant associations between thimerosal-
containing vaccines and tics, speech, executive functioning and attention, but
irresponsibly dismisses the associations. The study did not even look at children with
autism – that is the subject of another uncompleted study – and children who might be
more vulnerable to mercury, like low birth weight babies and children from families with
lower incomes, were excluded or under-represented in the study sample

Fortunately, an advocate from our own community was an external consultant to the
study, participated in its development from the outset, and is intimately familiar with the
data and methodology. She has dissented from the study's conclusions. In addition, our
colleagues and fellow parents at SafeMinds will be issuing a critique of the study in the
near future. We are also told that the study data will be made publicly available so that
independent researchers may examine it and draw their own conclusions.

Although detailed analysis of the study is beyond the scope of this letter, below are
some key points that cause us to distrust this study as another attempt to
manipulate the scientific and public debate on thimerosal to the detriment of the health and
safety of America's children:

1. The Study's Claim of No Causality is Contrary to the Study's Data

The study authors claim that the data disproves causality when in fact, several
findings show a negative effect on neuropsychological functioning warranting more study.
At least one such adverse association was also found to be associated with low dose
thimerosal exposure in other studies. As with earlier studies hyped by vaccine promoters,
the study is unable to prove or disprove causality. The blanket dismissal of the troubling
neuropsychological outcomes in this study is disingenuous and misleading.

2. Children with autism were excluded from this study

The early media contacts we have received suggest that this study shows no
association between thimerosal and autism. In fact, the study specifically did not look at
children with autism as the sample size was too small and the testing is impossible to
complete for the typical child with autism. The exclusion of children with autism from the study may have undermined the power of the study to draw any conclusions about thimerosal.

3. The Study's Authors Misrepresent Previous Toxicokinetic Studies of Thimerosal

The study authors falsely claim that research by Burbacher et al. at the University of
Washington (distribution of thimerosal as compared with methylmercury in infant
monkeys) shows that ethylmercury is safer than methylmercury. But the authors focus only
on the blood "half-life", ignoring data, showing twice as much inorganic mercury trapped
in the brains of monkeys than from same dose of methylmercury.

4. The Study's Methodology has Serious Limitations Negating Any Conclusions
Drawn

Major flaws that that causes a large underestimation of neurological adverse effects
burden the study: 70% of the families recruited for the study failed to participate. This kind of bias in epidemiological studies is well known to distort even large studies of health
effects. (See , for example, NY Times Magazine, "Do We Really Know What Makes Us
Healthy" by Gary Taubes 9/16/07). It is well established that people who choose
to participate in this kind of study are probably very different than those who
refuse to participate (the "healthy person" or "complier" effect); especially when the
ones who refused to participate said they were too busy.

Simply put: if you have a kid with ADHD or mild ASD or other neurodevelopmental
disorders, you are likely to be busier, more stressed, and less available than the mother of
a healthy normal child. This phenomenon serves to amplify the effect of the
"complier", the "healthy families," - those who do cooperate with the study - confounding or
confusing the study's results. The cooperative parents included in the study were more
likely to be those with relatively trouble-free kids

5.Major Conflicts of Interest Burden Almost Every One of the 18 Study Authors

Many of the study authors have either worked for or received money from vaccine
manufacturers. Others are employed by the CDC, which has been criticized by an
IOM committee for its inherent conflict of interest in promoting vaccines while
simultaneously monitoring safety. Many of the remaining study authors have conducted studies
for vaccine manufacturers. The conflicts of interest cast doubt on the validity of
the study, especially of the clearly biased final conclusions.

6. The High & Low Thimerosal Exposure Groups Too Small to Draw Conclusions

In addition to the number of children of the study being too small to draw
statistically significant conclusions, the numbers of children in the high exposure group and
the low exposure group were far too small to draw conclusions. Yet the study ignored
this limitation and drew sweeping conclusions of no causality.

7.Vulnerable Children Were Excluded from the Study; Early Intervention Was
Ignored

Children with a birth weight under 5 lbs. 8 oz. were excluded from the study
further skewing the results, as these children are likely more vulnerable to thimerosal
than larger babies. In addition, the fact that early intervention may have reduced deficits
such as speech delay detected by neuropsychological testing of children aged 7-10 was
not accounted for in the study results. There also was no analysis of combined
prenatal and postnatal mercury exposures. Only 103 mothers who were exposed to mercury from prenatal immune globulins participated in the study, far too small a group for
researchers to draw conclusions regarding the safety of thimerosal in these products.

8. The Study Fails to Account for the Subset of Children with "Efflux Disorder"

Only approximately 1000 children participated in the study, out of more than
3000 that were recruited. In addition to the "complier" bias discussed above, the study
sample size is too small to accurately estimate the adverse effect of Thimerosal on the subset
of the population who have a problem in mobilizing and excreting mercury. While the
study's author's focus on the average time it takes for mercury to clear from the blood,
itself misrepresented, we know that in 15% of the population this average is greatly
exceeded. It is these children who are vulnerable to the effects of mercury from thimerosal.
This study fails to account for the effect of mercury from vaccines on this subset of children.

These are but a few of the serious problems with the study and the way the
data have been presented. We look forward to the forthcoming SAFEMINDS critique of the study and thank them for their continued close monitoring and analysis of the scientific research that affects our children.

In the meantime, if you see headlines stating that "Vaccines Cleared in New
Study" or "New Study Finds Thimerosal Safe" know that we are all again being played, and that those who we should be able to trust are compromising the truth and the health of our children.

Sincerely,


Bob Krakow, for A-CHAMP

Message Brought To You By A-CHAMP
Advocates for Children's Health Affected by Mercury Poisoning
See Our Action Alerts. Click the TAKE ACTION! button
http://capwiz.com/a-champ/home/



www.a-champ.org
BE A-CHAMP FOR CHILDREN!

* * *

http://www.msnbc.msn.com/id/20996847/

Vaccines not linked to kids’ neurological ills

Study: Mercury not connected to problems, but autism risk still unexamined

Updated: 7:34 p.m. ET Sept 26, 2007

LOS ANGELES - A mercury-based preservative once used in many vaccines does not raise the risk of neurological problems in children, concludes a large federal study that researchers say should reassure parents about the safety of shots their kids received a decade or more ago.

However, the study did not examine autism — the developmental disorder that some critics blame on vaccines. A separate study due out in a year will look at that issue, said scientists at the federal Centers for Disease Control and Prevention, who led the latest analysis and published results in Thursday’s New England Journal of Medicine.

They found no clear link between early exposure to the preservative thimerosal and problems with brain function and behavior in children age 7 to 10. The results are in line with past research that found no connection between vaccines and neurological problems or autism.

Thimerosal (pronounced thih-MEHR’-uh-sawl) has not been used in Error! Hyperlink reference not valid. since 2001, although it is still in some flu shots. The new findings apply to children immunized before then, or exposed to the preservative through shots their mothers received while pregnant. Thimerosal was put in vaccines to prevent contamination from bacteria.

Some doctors say the CDC study should reassure parents worried about the safety of vaccines.

“It’s good news for families,” said Dr. Michael Goldstein, vice president of the American Academy of Neurology who works in private practice in Salt Lake City. “There’s no evidence that these vaccines have caused injury.”

The study involved 1,047 children who were exposed to varying levels of thimerosal while in the womb or after birth in the 1990s. The children belonged to four health maintenance organizations that are part of a federal project to study the side effects of vaccines. Their mercury exposure was determined through medical and immunization records and interviews with parents.

Each child was tested for speech and language skills, motor coordination and intelligence. Parents, teachers and trained specialists also rated stuttering, attention span and tic disorders such as head shaking, eye blinking and neck jerking. A total of 42 neurological problems were analyzed.

On balance, researchers did not find a consistent pattern between increasing thimerosal exposure and the risk of these problems. However, they said one finding merited further study: Boys exposed to higher mercury levels seemed to have more tic problems — a link seen in previous research.

“The doses of mercury that children were exposed to because of immunization doesn’t cause neuropsychological damage,” said Dr. Bruce H. Cohen, a Cleveland Clinic pediatric neurology specialist who had no role in the study.

The CDC study was reviewed by an independent panel of scientists and statisticians who oversaw its design, reviewed results and contributed to writing the report.

The panel included one vaccine opponent — Sallie Bernard, executive director of the consumer group SafeMinds. Although she had a role in planning the study, she asked to be listed as a “dissenting member” because she disagreed with the study’s conclusions.

The research was led by William Thompson, a CDC epidemiologist who once worked for vaccine maker Merck & Co. Four other researchers have received fees from drug companies and one has served as a consultant to a CDC committee on immunization.

The study was not designed to tease out the effects of mercury exposure on autism. Thompson is completing a separate study examining whether thimerosal exposure before or after birth causes autism. The study recruited 1,000 children including 250 with autism. Results are expected next year.

Autism is a major public health concern, with one in 150 American children diagnosed with the disorder characterized by repetitive behaviors and impaired social interaction.

Although past scientific studies have found no link between autism and thimerosal-containing vaccines, the highly charged issue went on trial this summer.

A court in Washington, D.C., heard from an Arizona mother who blamed vaccines on her 12-year-old daughter’s severe autism. The case is being followed by about 5,000 families who filed similar claims to receive compensation from a federal vaccine injury fund. The fund so far has not paid out an autism claim.

© 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Vaccines not linked to neurological ills - Kids & Parenting - MSNBC.com

Value of annual checkup questioned

WASHINGTON - The customary annual physical checkup at the doctor's office may not be worth the time or money, researchers said on Monday.

About 63 million U.S. adults visit a doctor annually for a routine medical or gynecological checkup at a total cost of $7.8 billion, according to a study intended to help answer questions about the value of this trip to the doctor's office.

More than 80 percent of preventive care provided by doctors does not take place during this annual checkup, the study showed. And more than $350 million worth of potentially unnecessary medical tests are performed, the researchers said.

"We need to question encouraging everybody to come in for an annual physical," Dr. Ateev Mehrotra of the University of Pittsburgh School of Medicine and the RAND Corp., who led the study, said in a telephone interview.

"There's a lot of money, a lot of visits, a lot of adults going to see their doctor for annual physical exams with a real unclear benefit. It's the No. 1 reason adults see their doctor, and yet we don't know whether it's helpful or not," he added.

The study appears in the Archives of Internal Medicine.

These checkups account for one in 12 adult outpatient visits to the doctor's office, the study found. On average, they lasted 23 minutes and cost $116, including laboratory and radiology services, the researchers said.

More in Northeast get annual checks
The study also documented differences across the country in routine annual physicals. People in the Northeast are far more likely to get them than those in the West. The kinds of care and testing provided by doctors also varies by locality.

Many patients were routinely given laboratory tests such as complete blood cell counts or urinalyses of uncertain medical value in the absence of a specific reason, the study found.

Mehrotra said no major North American clinical organization advises people to get an annual medical checkup, but most adults think they should get one and most doctors recommend them.

"I'm not saying that preventive care itself is not helpful. It is clearly helpful — mammograms, pap smears, cholesterol screening, colon cancer screening, prostate cancer screening. And patients should get those. But does it need to happen at this special visit? Or can we get it some other way?" he said.

The institution of the annual medical checkup, intended to detect or prevent unseen health problems, dates back about a century in the United States, Mehrotra said.

No major medical benefits
But large studies in 1960s and 1970s failed to show these checkups provide a significant medical benefit to the patient, and there has been a debate about their value ever since.

The researchers examined government survey data from 2002 to 2004, and questioned doctors nationwide about what they did during the checkups.

Only 20 percent of eight preventive services tracked by the researchers were performed at these checkups as opposed to during other types of visits to doctors, the study showed.

Most patients visited the doctor for some other reason during a given year, it found.

But these checkups were the most likely time for some key preventive services like Pap smears and mammograms.

"Is a physical harmful at all? To the patient, there's likely little harm. The potential downsides of a physical are the money and people's time," as well eating up a doctor's time that might be better used elsewhere, Mehrotra said.

URL: http://www.msnbc.msn.com/id/20960175/wid/11915773?GT1=10412

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Value of annual checkup questioned - Health Care - MSNBC.com

Prenatal Aspartamate Exposure

Some parents suspect that prenatal aspartame (NutraSweet) can trigger the auto-immune response that leads eventually to autism. Controversy exists about the potential effects of this artificial sweetener, and about whether or not it has an effect on the developing brain. We agree that there is absolutely no reason for its use. Nancy Markle (1120197) lectured at the World Environmental Council in 1999 on Aspartame, also marketed as Equal and Spoonful.

When the temperature of Aspartame exceeds 86 degrees F, the wood alcohol in Aspartame coverts to formaldehyde and then to formic acid, which in turn causes metabolic acidosis. The methanol toxicity is thought to mimic the symptoms of multiple sclerosis.

Some believe that systemic lupus erythematosis may be triggered by Aspartame. Other practitioners report that lupus improves when diet soda consumption is stopped.

Symptoms of fibromyalgia, spasms, shooting pains, numbness in the legs, cramps, vertigo, dizziness, headaches, tinnitus, joint pain, depression, anxiety, slurred speech, blurred vision, or memory loss have been attributed to Aspartame.

It is thought that the methanol in the aspartame converts to formaldehyde in the retina of the eye, causing blindness.

Aspartame changes the dopamine level in the brain, affecting Parkinson's Disease.

This drug is thought by some to cause Birth Defects. In the Congressional record, Dr. Roberts stated, "It makes you crave carbohydrates, and will make you gain weight." He reported that when he got patients off aspartame, their average weight loss was 19 pounds per person. The formaldehyde stores in the fat cells, particularly in the hips and thighs.

Aspartame is thought to make diabetic control especially problematic.

Memory loss is thought to be due to aspartic acid and phenylalanine being neurotoxic without the other amino acids found in protein. They may go past the blood brain barrier and deteriorate the neurons of the brain. Dr. Russell Blaylock, neurosurgeon, said, "The ingredients stimulate the neurons of the brain excessively, causing ... damage of varying degrees.

Dr. Blaylock has written a book entitled Excitotoxins: The Taste That Kills (Or, Publisher: Health Press: 1-800-643-2665).

Dr. H.J. Roberts, diabetic specialist, has written a book entitled Defense Against Alzheimer's Disease : A Rational Blueprint for Prevention ( Or, 1-800-814-9800). Dr. Roberts believes that aspartame poisoning is escalating Alzheimer's Disease.

Dr. Roberts says, "consuming aspartame at the time of conception can cause birth defects."

"The phenylalanine concentrates in the placenta, causing mental retardation," according to Dr. Louis Elsas, Pediatrician Professor -Geneticist, at Emory University in testimony before Congress. In the original lab tests, animals developed brain tumors (phenylalanine breaks down into DXP, a brain tumor agent).

We recommend avoiding aspartame, since it has no nutritional value and appears to contribute to weight gain overall, rather than weight loss. While its effects on the developing brain are largely speculative, it clearly has no benefits, is not a food, and should be avoided. Apparently, the term "diet drink," is a misnomer.

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Autism: An Overview and Theories on its Causes

 Autism: An Overview

Written and Maintained by Lewis Mehl-Madrona, M.D., Ph.D.

What is autism?

Autism is a developmental delay that includes symptoms such as speech difficulties, lack of eye contact, isolation and no fear of danger.

Autistic children act and sound like much younger children. What causes autism specifically is not known. Some experts believe there are bio-chemical reasons for autism; others suspect that it is a psychiatric disorder. Some believe that a combination of the wrong foods and too many antibiotics and environmental toxins can damage the colon and lead to physical and behavioral problems, including autism.

The behavioral syndrome of autism includes abnormalities of language and thinking skills; repetitive behavior such as rocking; abnormal responses to sensations, people, events and objects; and self-injurious behavior.

Website designed, created and hosted by The Healing Center On-Line © 2000

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Autism: An Overview and Theories on its Causes

Growth Attenuation by Commission and Omission May Be Ethically Justifiable in Children With Profound Disabilities

Arch Pediatr Adolesc Med. 2007;161:418.

Gunther and Diekema present a unique case report of a child with profound disabilities whose parents requested an active intervention to arrest growth to facilitate caregiving at home...

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Arch Pediatr Adolesc Med -- Growth Attenuation by Commission and Omission May Be Ethically Justifiab

The following news release appeared in the popular media in 1998, and was a major television news item:

Cleveland, Ohio, Posted 4:00 P.M. November 20, 1998:

"Studies Suggest the Measles-Mumps-Rubella Vaccine Is a Possible Cause of Autism"

News Channel 5 reports hundreds of thousands of children receive the MMR vaccine every year, but now studies show a tiny percentage of cases may cause autism. Since the MMR vaccine was introduced about 35 years ago,the incidents of autism in children have increased by 1,000 percent - from two or three in 10,000 - to one in 500.

Evidence of a possible link between the MMR vaccination and autism came from the finding of children from villages, within two miles of each other in Scotland, being diagnosed with autism after MMR inoculation.¹ The three children from different families in Ayrshire were given MMR vaccine at the same health center within four months of each other. Child neuro-psychologist, Ken Aitken, said that the cluster of cases in Ayrshire indicated the need for further research before the MMR vaccine can be declared safe beyond doubt.

"More children are being diagnosed with autism and clusters like these are deeply worrying", he said. "There is strong circumstantial evidence to point to the MMR ä as the reason, but there has to be much more coordinated research to look into this issue in detail. Research so far hasn't been adequate to address the questions that are being raised about the possible links and there have been a lot of queries about the validity of the conclusions which were drawn."

In the 1980s, one in 2500 children in Britain and America were diagnosed as autistic. Latest figures compiled by researchers revealed a dramatic leap - to one in 146.

The MMR immunisation was introduced in the UK in 1988 with the first dose aimed at children of 12-15 months, a the second dose at 3-5 years. It is designed to protect against measles, mumps and rubella (German Measles) and works by stimulating the immune system to produce antibodies against the viruses without causing harm. It was so well received by both parents and doctors that over 90 per cent of children were being immunised by 1992.

Most children received the vaccine with no obvious serious side-effects, but some became seriously ill within a few weeks. These children began behaving strangely, stopped talking and became socially withdrawn, staring into space for hours on end. Many developed a raging thirst, bizarre eating habits, multiple food allergies, hyperactivity and sleep problems. This was usually accompanied by abdominal pain, bloating and bowel disturbances. Some children became incontinent of urine or feces. Their development deteriorated. Thousands of children now fall into this category of abnormal development only after receiving the vaccine.

Professor John O'Leary, Director of Pathology at the Coombe Women's Hospital in Dublin, told the US Congress in April, 2000, that he had produced compelling evidence of an association between autism and the MMR vaccine. Professor O'Leary found the measles virus in the guts of 24 out of 25 children who had developed autism, after an apparently previously healthy infancy... 

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Vaccines: The MMR Vaccine (Measles, Mumps, Rubella)

On February 17, 2000, The FDA cleared a new pneumococcal pneumonia vaccine with questionable safety, and a US government advisory panel is reported a plan to selectively target African-American and Native American children for immunization. This plan was criticized for making children of racial minorities "human guinea pigs". It is possible that 1% or more of the children who receive the vaccine may develop insulin dependent diabetes or another autoimmune disease from the vaccine.²

The CDC's Advisory Committee on Immunization Practices recommended that children under 2 receive the new pneumococcal vaccine, asking that black and Native American children age 2-5 be selectively targeted for immunization. This policy came under criticism because the vaccine had not been properly tested for safety and the FDA had been told by an expert that the vaccine might cause autoimmune disease.

The controversial vaccine was the conjugated 7-valent pneumococcal vaccine, which is a combination of 7 different vaccines, each to a separate strain of pneumococcal pneumonia bacteria. The vaccine is similar in structure to the already marketed hemophilus meningitis vaccine, which has been linked to insulin dependent diabetes.³

Dr. Classen told the FDA that the 7 valent pneumococcal vaccine could be 7 times as toxic as the hemophilus vaccine, possibly causing an estimated 400 to 700 children to develop insulin dependent diabetes per100,000 children immunized. These cases of diabetes may not occur until 3.5 to 10 years following immunization.

Hemophilus Meningitis Vaccine

Dr. J. Bart Classen, an immunologist at Classen Immunotherapies published data in the British Medical Journal (BMJ 1999; 319:1133 supporting a causal relationship between the hemophilus vaccine and the development of insulin dependent diabetes. The vaccine was incriminated in causing over 58 cases of insulin dependent diabetes per 100,000 children immunized in Finland.^4,5

Classen also presented data at the International Public Conference on Vaccination which showed that vaccines are the largest cause of insulin dependent diabetes in children. His data indicated that vaccines cause approximately 80% of cases of insulin dependent diabetes in children who have received multiple vaccines starting after 2 month of life.

Dr. Classen presented data supporting a causal relationship between many different vaccines and the development of insulin diabetes. His data included the pertussis, mumps, rubella, hepatitis B, hemophilus influenza and others. The data indicated people with vaccine induced diabetes may not develop the disease until 4 or more years after receiving a vaccine.

Dr. Classen's research has been published in numerous journals and featured in national news reports. For the latest information on the effects of vaccines on insulin dependent diabetes and other autoimmune diseases, see the Vaccine Safety Website.

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Vaccines: Information on Other Vaccines

Quick Index to this Paper

• Introduction
  
  
• Epidurals and pain relief
  
  
• Overall complication rates for epidural anesthesia
  
  
  • Effects of epidurals on cesarian rate
  • Significant low blood pressure (hypotension)
  • Fetal distress
  • IV cannulation
  • Trauma to blood vessels
  • Punctured dura
  • Infection
  • Backache
  • Broken catheters
  • Abnormal uterine contractions
  • Second stage labor effects
  • Inadequate pain relief
  • Accidental spinal anesthesia
  • Maternal heart attack or spinal cord ischemia
  • Asthmatics
  • Medication interactions
  • Interactions with other illnesses
  • Malignant hyperthermia
  • Respiratory arrest
  • Other neurological disabilities
  • Nausea and vomiting
  • Allergic conditions
  • Heart problems
  • Headache
  • Motor blockade
  • Use in VBAC (Vaginal Birth After Cesarian)
  • Technical considerations
  • Herpes simplex
    
    
• Case examples: mild problems
  
  
• Permanent disability from epidural anesthesia
  
  
• Deaths from epidural anesthenia
  
  
• Critique of 3 other studies
  
  
  • Does epidural analgesia protect against cesarian section in nulliparous patients?
  • Epidural anesthesia and uterine function
  • The relationship of ambulation in labor to operative delivery
    
    
• References
  
  
• Related Childbirth Risk Resources 

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