Most prescription drugs kids take not approved for their use

Most prescription drugs kids take not approved for their use
Here's what you should know
BY HEATHER NEWMAN • FREE PRESS STAFF WRITER • September 21, 2008


All of the prescription drugs your kids are taking probably aren't approved for them.
If you didn't know that, you've got company.

The majority of parents surveyed in a recent poll think whatever their pediatrician prescribes is safe.

But according to doctors and researchers at the University of Michigan, 70% of available drugs -- including those being used to treat kids for everything from respiratory illnesses to weight issues -- have not been approved by the Food and Drug Administration for use by children.

The FDA is reviewing the use of cold medicines in children ages 2 to 11. The drugs were pulled off store shelves for kids under 2 earlier this year after several kids died from accidental overdoses.

The two FDA committees overseeing the review are to meet in October.

The statistics used to be worse. About a decade ago, 80% to 90% of drugs were not approved for kids.

And while the numbers are improving, pediatricians and researchers say they're not comfortable.

"It's business as usual, but it's not business the way you want it to be done," said Dr. Richard Gorman, a pediatrician and chairman of the American Academy of Pediatrics Section on Clinical Pharmacology and Therapeutics. The gap is a huge concern for doctors, who must use educated guesses about which medicines might be effective and what dosages to prescribe.

The academy's official position is that it's up to the pediatrician to prescribe off-label drugs to children if there's a scientific reason to expect they'll be helpful and when there is a lack of realistic alternatives -- the situation those doctors and parents are faced with every day, he said.

Finding child test subjects can be difficult.

For Mike and Connie Wall of Plymouth, the decision to put their 11-year-old daughter Christine into a study for a cancer vaccine last October was a hard one. She had a rare type of cancer -- a malignant peripheral nerve sheath tumor -- with a high return rate; the vaccine, if successful, would help.

"We prayed and agonized over it a lot," Mike Wall said. "We don't know if it could be a lifesaver or harmful. We may not know forever."

He said that if her condition hadn't been life-threatening, they wouldn't have participated in the research. Christine now appears to be in remission.

Researchers say traditionally there has not been much financial incentive for drug companies to test children, who may represent a tiny portion of the market for a particular drug, and finding parents willing to have drugs tested on their children can be difficult.

"That leaves parents and doctors in a tough situation," said Dr. Matthew Davis, U-M associate professor of pediatrics, a pediatrician at C.S. Mott Children's Hospital in Ann Arbor and coauthor of the National Poll on Children's Health that was released in May. The study surveyed more than 2,000 parents and found that 83% believe that their child's last prescription was FDA-approved.

Test subjects
While about 30% of medicines have been approved for kids, some drugs, like those to treat Alzheimer's, truly are useful only for adult conditions. The percentage of drugs that children are prescribed off-label hasn't been specifically nailed down.

But parents often end up effectively testing drugs on their children without knowing it.

Children are not just small adults, said Dr. Esther Yoon a lecturer in the U-M division of pediatrics, a practicing pediatrician in Canton and the poll's coauthor. "They metabolize substances differently."

Beth Hurley, 42, of Canton said she made the tough decision to turn down Elidel skin cream for her son Aiden's eczema after reading that it hadn't been approved for children. The condition left him with cracking and bleeding skin behind his knees as a toddler. Nothing helped. One doctor suggested the new cream.

"It had not been approved for children 2 years and younger," Hurley said. On a TV commercial, she noted that the side effects included possible cancer or death. "I said, 'Are you kidding me?' "

A few years later in 2005, the drug was given a "black box" warning, the most serious the FDA can add, because of its role as a possible cause of skin cancer.

"I really felt, thank God we made that decision," said Hurley, who was a paid discussion leader for the Free Press' former MotorCityMoms.com site. "We have always erred on the side of caution. Cracking, bleeding skin -- that's horrible, but I'm not willing to risk death for it."

That said, the family decided to allow their son, who has allergies, to use Zyrtec, which had not been approved for children his age. That was after reading up on potential side effects and quizzing their doctor. "It's been because we were desperate, and there were no dire warnings," Hurley said. "When your child can't breathe..."

If not this, what?
Because of legislation passed in the past 10 years, pediatric assessments -- how likely it is that a drug will be prescribed to kids -- are now required as part of the approval process. The FDA also has the power to require companies to conduct pediatric tests.

Dr. Lisa Mathis, associate director for maternal and pediatric health staff in the office for new drugs at the FDA, said much has been learned in recent years. But, she said, "We're still in a position that there are still more drugs that aren't labeled than are. But the whole environment has changed. We now have the opportunity to intervene. That said, we're not satisfied that we're where we need to be."In June, the American Academy of Pediatrics recommended that doctors use some statin cholesterol-lowering drugs in children as young as 8. Pravastatin, commonly sold as Pravachol or Selektine, was approved by the FDA for children after studies that included a two-year trial on 214 children. The drug had side effects including heartburn and muscle pain.

"That's the only one that is approved for children of that age," said Nicolas Stettler, assistant professor of pediatrics at the Children's Hospital of Philadelphia and a member of the committee that approved the new recommendations. The group had been waiting for something to help younger kids with cholesterol issues.

"The major benefit of having FDA approval is that approval indicates significant information about safety and dosing," U-M's Davis said.

Other, more common drugs for kids, such as Amoxicillin, are tested and approved for kids. But if the child has an allergy to penicillin, making amoxicillin an unsafe choice, doctors find themselves in a bind, especially for infants.

Most doctors would reach for azithromycin (sold under the brand name Zithromax), which is an excellent drug, said Yoon. The problem: It's only approved for babies over six months.

Another example is albuterol, a drug that increases air flow to the lungs, which is commonly prescribed to children with bronchiolitis, a common illness of the respiratory tract that makes it difficult for kids to breathe. Babies and toddlers are susceptible to the condition, especially in winter, Yoon said, but albuterol isn't approved for children under age 2.

"As a physician, would I use this medication? Of course. I have no other real alternatives that are FDA-approved," she said.

No one size fits all
The FDA approves about 95% of all adult medications. But getting drug approval for children involves hurdles:

• There isn't one blanket approval. A drug can be approved for children over 6 months, 2, 6 or even 12 years of age.

"There's a whole range of pediatric patients and they all present different issues in terms of drug development," said Alan Goldhammer, deputy vice president of regulatory affairs for Pharmaceutical Research and Manufacturers of America, the industry trade association for drug makers. "You can't do a study on teenagers and extrapolate it down to a baby."

• There often aren't many incentives for drug companies to get older medicines approved. If the drug is already off-patent (available in generic form), there's almost no financial advantage to do the tests.

• Finally, there's the problem of finding enough kids to do studies. About 60% of those parents polled say they would not let their children participate in tests.

Lipitor, a cholesterol-lowering medication approved for kids ages 10 and up, was tested on children ranging from 2 to 16 before it was approved, said Dr. Halit Bander, executive director, Pfizer's Cardiovascular Medical Team, Lipitor lead. There just weren't enough patients in the study younger than 10 to allow for that kind of labeling.

A followup test focused on children ages 10-17 and the drug was labeled for children that age in 2002, six years after it was approved for adults.

Testing incentives
The Food and Drug Administration has taken several steps over the past six years to encourage more manufacturers to test their drugs for children. A study released early this year by the FDA showed that drugs tested for kids at the FDA's request generally ended up getting critical changes in dosages as a result.

The Best Pharmaceuticals for Children Act, passed in 2002, gives drug companies an extra six months of exclusivity on the market if they test their medicine for children at the FDA's request. The Pediatric Research Equity Act went into effect in 2003, requiring drug companies to put new medicines through pediatric testing unless they successfully won a waiver for their products.

Potential grounds for waivers include drugs where the population of kids would be too small -- typically 50,000 or fewer nationwide -- to reasonably allow testing; or drugs that are unlikely to be used in children and offer no substantial benefit over existing drugs for them.

Since last year, 100 applications for waivers have been filed by drug companies. Another 50 requested a deferral to do pediatric research after the drug hit the market. And 50 new drugs were actually tested for kids.

"I think the best policy is for doctors to hold an open discussion with parents," Davis said. "I explain to parents the situation if I'm faced with an illness with a child where only non-FDA-approved drugs are available."

Contact HEATHER NEWMAN at 313-223-3336 or hnewman@freepress.com.

High Fructose Corn Syrup

An overweight America may be fixated on fat and obsessed with carbs, but nutritionists say the real problem is much sweeter -- we're awash in sugar.

Not just any sugar, but high fructose corn syrup.

The country eats more sweetener made from corn than from sugarcane or beets, gulping it down in drinks as well as in frozen food and baked goods. Even ketchup is laced with it.

Almost all nutritionists finger high fructose corn syrup consumption as a major culprit in the nation's obesity crisis. The inexpensive sweetener flooded the American food supply in the early 1980s, just about the time the nation's obesity rate started its unprecedented climb.

The question is why did it make us so fat. Is it simply the Big Gulp syndrome -- that we're eating too many empty calories in ever-increasing portion sizes? Or does the fructose in all that corn syrup do something more insidious -- literally short-wire our metabolism and force us to gain weight?

The debate can divide a group of nutritional researchers almost as fast as whether the low-carb craze is fact or fad.

Loading high fructose corn syrup into increasingly larger portions of soda and processed food has packed more calories into us and more money into food processing companies, say nutritionists and food activists. But some health experts argue that the issue is bigger than mere calories. The theory goes like this: The body processes the fructose in high fructose corn syrup differently than it does old-fashioned cane or beet sugar, which in turn alters the way metabolic-regulating hormones function. It also forces the liver to kick more fat out into the bloodstream.

The end result is that our bodies are essentially tricked into wanting to eat more and at the same time, we are storing more fat.

"One of the issues is the ease with which you can consume this stuff," says Carol Porter, director of nutrition and food services at UC San Francisco. "It's not that fructose itself is so bad, but they put it in so much food that you consume so much of it without knowing it."

A single 12-ounce can of soda has as much as 13 teaspoons of sugar in the form of high fructose corn syrup. And because the amount of soda we drink has more than doubled since 1970 to about 56 gallons per person a year, so has the amount of high fructose corn syrup we take in. In 2001, we consumed almost 63 pounds of it, according to the U.S. Department of Agriculture.

The USDA suggests most of us limit our intake of added sugar -- that's everything from the high fructose corn syrup hidden in your breakfast cereal to the sugar cube you drop into your after-dinner espresso -- to about 10 to 12 teaspoons a day. But we're not doing so well. In 2000, we ate an average of 31 teaspoons a day, which was more than 15 percent of our caloric intake. And much of that was in sweetened drinks.

Beyond soda

So, the answer is to just avoid soda, right? Unfortunately, it's not that simple, because the inexpensive, versatile sweetener has crept into plenty of other places -- foods you might not expect to have any at all. A low-fat, fruit-flavored yogurt, for example, can have 10 teaspoons of fructose-based sweetener in one serving.

Because high fructose corn syrup mixes easily, extends shelf-life and is as much as 20 percent cheaper than other sources of sugar, large-scale food manufacturers love it. It can help prevent freezer burn, so you'll find it on the labels of many frozen foods. It helps breads brown and keeps them soft, which is why hot dog buns and even English muffins hold unexpected amounts.

The question remains just how much more dangerous high fructose corn syrup is than other sugars.

Fructose, as the name implies, is the sugar found naturally in fruit. It can be extracted, turned into granules and used like sugar in the kitchen. It used to be considered a healthier alternative to sucrose -- plain old table sugar. It's sweeter, so less is needed to achieve the same taste. Diabetics use it because fructose doesn't stimulate insulin production, so blood sugar levels remain stable.

The process of pulling sugar from cornstarch wasn't perfected until the early 1970s, when Japanese researchers developed a reliable way to turn cornstarch into syrup sweet enough to compete with liquid sugar. After some tinkering, they landed on a formula that was 55 percent fructose and 45 percent glucose -- sweet enough and cheap enough to make most soda companies jump from liquid sugar to high fructose corn syrup by the 1980s.

The results were dramatic. -- a whopping increase of 4,080 percent.

Journalist Greg Critser lays out a compelling case against high fructose corn syrup in his 2003 book, "Fat Land: How Americans Became the Fattest People in the World." He argues that federal policies that aimed to stabilize food prices and support corn production in the 1970s led to a glut of corn and then to high fructose corn syrup. With a cheaper way to sweeten food, producers pumped up the size and amount of sweet snacks and drinks on the market and increased profits.

It's not natural

Critser writes that despite the food industry's arguments that sugar is sugar, whether fructose or sucrose, no group "has yet refuted the growing scientific concern that, when all is said and done, fructose ... is about the furthest thing from natural that one can imagine, let alone eat."

Although some researchers have long been suspicious that too much fructose can cause problems, the latest case against high fructose corn syrup began in earnest a few years ago. Dr. George Bray, principal investigator of the Diabetes Prevention Program at Louisiana State University Medical Center told the International Congress on Obesity that in 1980, just after high fructose corn syrup was introduced in mass quantities, relatively stable obesity rates began to climb. By 2000, they had doubled.

Further, the American Journal of Clinical Nutrition in 2002 published research that showed that teenagers' milk consumption between 1965 and 1996 decreased by 36 percent, while soda consumption increased by more than 200 percent. Bray argues that without calcium, which nutritionists agree can help the body regulate weight, kids got fatter. He says that he could find no other single combination of environmental or food changes that were as significant to the rise in obesity.

Other studies by researchers at UC Davis and the University of Michigan have shown that consuming fructose, which is more readily converted to fat by the liver, increases the levels of fat in the bloodstream in the form of triglycerides.

And unlike other types of carbohydrate made up of glucose, fructose does not stimulate the pancreas to produce insulin. Peter Havel, a nutrition researcher at UC Davis who studies the metabolic effects of fructose, has also shown that fructose fails to increase the production of leptin, a hormone produced by the body's fat cells.

Both insulin and leptin act as signals to the brain to turn down the appetite and control body weight. And in another metabolic twist, Havel's research shows that fructose does not appear to suppress the production of ghrelin, a hormone that increases hunger and appetite.

"Because fructose in isolation doesn't activate the hormones that regulate body weight as do other types of carbohydrate composed of glucose, consuming a diet high in fructose could lead to taking in more calories and, over time, to weight gain," he says.

However, Havel isn't convinced high fructose corn syrup is by itself the problem. That's in part because it is composed of 55 percent fructose and 45 percent glucose, which is similar to the 50-50 combination of fructose and glucose found in table sugar. Havel's studies have focused on fructose by itself and not as part of a high fructose corn syrup mixture.

"Whether there is an important difference in the effects of consuming beverages sweetened with a mixture of 55 percent as opposed to 50 percent fructose would be hard to measure," he says. "Additional studies are needed to better understand the nutritional impact of consuming different types of sugars in humans."

Still, other researchers are finding new problems with high fructose corn syrup. A study in last month's Journal of the National Cancer Institute suggests that women whose diet was high in total carbohydrate and fructose intake had an increased risk of colorectal cancer. And Dr. Mel Heyman, chief of pediatric gastroenterology and nutrition at UCSF, is seeing sick children whose bodies have been overloaded with fructose from naturally occurring fructose in fruit juice combined with soda and processed food.

"The way the body handles glucose is different than fructose,'' he says. "It can overload the intestines' ability to absorb carbohydrate by giving it too much fructose. That can cause cramps, bloating and loose stools."

The jury's still out

Like others in the field, he says there is much to discover in how sugar works, but he disagrees that high fructose corn syrup is somehow reprogramming our bodies toward obesity. Rather, he says, we're just eating too much of it.

Nutrition theory holds that the basic make-up of fructose-laced corn syrup is not much different than table sugar. They react about the same in the body, says Dr. Walter Willett, a professor of epidemiology and nutrition at Harvard School of Public Health. "There are some modest differences in metabolism, but I don't think fructose per se is the culprit."

Neither do the food companies that use it in copious amounts.

Says Stephanie Childs, a spokesperson for the Grocery Manufacturers Association: "At the end of the day, how any sweetener affects your weight depends on how many calories you are taking in overall. Overemphasizing one nutrient at the detriment of others is not going to solve the problem."

Even some leading nutrition reformers aren't convinced that high fructose corn syrup is of itself the issue. The bigger battle, says Michael Jacobson, executive director of the Center for Science in the Public Interest, a consumer advocacy group, is to get added sugars listed on food labels with a percentage of daily value. That means a consumer could look at a package and see that, for example, one soda provides almost all the sugar a person should eat in a day.

"It simply comes down to this,'' he says. "We're eating too much refined sugars, be it sucrose or high fructose corn syrup or any other refined sugar."


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A sugar glossary
Here's a rundown of the various types of sugar you'll find on product labels.

Brown sugar. Sugar crystals contained in a molasses syrup, with natural flavor and color; 91 to 96 percent sucrose

Corn syrup. Made from cornstarch. Mostly glucose. Can have maltose

Dextrose. Commonly known as corn sugar and grape sugar. Naturally occurring form of glucose

Fructose. Sugar found in fruit and honey. Sweetest natural sugar

Galactose. Sugar found linked to glucose to form lactose, or milk sugar

Glucose. Also called dextrose. The human body's primary source of energy. Most of the carbohydrates you eat are converted to glucose in the body.

High fructose corn syrup. Derived from cornstarch, usually a combination of 55 percent fructose and 45 percent sucrose. Treated with an enzyme that converts glucose to fructose, which results in a sweeter product. Used in soft drinks, baked goods, jelly, syrups, fruits and desserts

Honey. Sweet syrupy fluid made by bees from the nectar collected from flowers and stored in nests or hives as food. Composed of fructose and glucose

Lactose. Sugar found in milk and milk products that is made of glucose and galactose

Maltose. Also called malt sugar. Used in the fermentation of alcohol by converting starch to sugar

Maple syrup. A concentrated sucrose solution made from mature sugar maple tree sap that flows in spring. Mostly replaced by pancake syrup, a mixture of sucrose and artificial maple flavorings

Molasses. Thick syrup left after making sugar from sugarcane. Brown in color with a high sugar concentration

Powdered or confectioner's sugar. Granulated sugar that has been pulverized. Available in several degrees of fineness

Sucrose. Commonly called cane sugar, table sugar or simply sugar

Sugar (granulated). Refined cane or beet sugar; 100 percent sucrose

Turbinado sugar. Raw sugar that has been partially refined and washed


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Awash in corn syrup
It should come as no shock to most consumers that a Pepsi or a Fig Newton has plenty of sugar - most of it from high fructose corn syrup. But what's surprising is the products where the sweetener hides out and how disguised it can be by the deceptively small serving size listed on the nutrition label. Although the numbers below show teaspoons of sugar per serving, people often eat more than one serving. The U.S. Department of Agriculture advises most people to limit themselves to 10 to 12 teaspoons of added sugars a day.

How much is too much?

The list below shows how much sugar, mostly in the form of high fructose corn syrup, is in each of these single servings.

Sunkist soda: 10 1/2 teaspoons of sugar

Berkeley Farms low-fat yogurt with fruit: 10 teaspoons of sugar

Mott's applesauce: 5 teaspoons of sugar

Slim-Fast chocolate cookie dough meal bar: 5 teaspoons of sugar

1 tablespoon ketchup: 1 teaspoon of sugar

Hansen's Super Vita orange-carrot Smoothie: 10 teaspoons of sugar

E-mail Kim Severson at kseverson@sfchronicle.com.
Article on the Web

Aspartame

Wednesday, September 17, 2008 by: Leigh Erin Connealy, M.D.

NaturalNews) Aspartame, more commonly known as NutraSweet or Equal, is one of the most toxic substances being consumed today. The artificial sweetener, currently used in over 4,000 products worldwide, entertains a sordid past and has been one of the most tested and debated food additives in the history of the FDA. While the manufacturer maintains that aspartame is not a danger to your health, the scientific studies don’t necessarily agree. The FDA has approved the product for mass consumption, in spite of overwhelming evidence that aspartame can have neurotoxic, metabolic, allergenic, fetal and carcinogenic effects. When you question how such a substance has not been banned, one simply needs to look at the billions of dollars generated by the sale of aspartame each year. In light of the staggering number of dollar signs involved, it’s easy to see that the artificial sweetener industry has reached Big Tobacco status. With so much money at stake, the truth suffers almost as much as the health of the consumers, while the shareholders' wealth continues to grow exponentially.

The Ingredients

In 1965, James Schlatter, a chemist for G.D. Searle, was developing an anti-ulcer drug when he accidentally stumbled upon aspartame. Made up of aspartic acid (40%), phenylalanine (50%) and methanol (10%), aspartame is 200 times sweeter than natural sugar.

* Aspartic Acid

Aspartate is a neurotransmitter in the brain, facilitating information from one neuron to another. Too much aspartate allows an influx of calcium into the brain cells, triggering an excessive amount of free radicals which kill the cells. Aspartate is referred to as an “excitotoxin” because of the nerve cell damage that it causes. Many chronic illnesses have been attributed to long term excitotoxin exposure, including multiple sclerosis, ALS, memory loss, hormonal problems, hearing loss, epilepsy, Alzheimer’s disease, Parkinson’s disease, hypoglycemia, dementia, brain lesions and neuroendocrine disorders.

In 1971, Dr. John Olney, neuroscientist and one of the world’s foremost experts on excitotoxins, informed G.D. Searle that his research had revealed that aspartic acid caused holes in the brains of mice. Searle did not inform the FDA of these findings until after aspartame's approval in 1981. This would prove to be one event in a startling pattern of lies and deception.

* Phenylalanine

Phenylalanine is an amino acid normally found in the brain. Human testing has shown phenylalanine levels in the blood are increased significantly in those who chronically use aspartame. Excessive levels of phenylalanine in the brain can cause the levels of serotonin to decrease, which can lead to depression, schizophrenia and make one more susceptible to seizures.

Studies conducted on rats by G.D. Searle found phenylalanine to be safe for humans. However, Louis J. Elsas, II, M.D., Director of Medical Genetics and Professor of Pediatrics at Emory University School of Medicine told the U.S. Senate in 1987 that, “Normal humans do not metabolize phenylalanine as efficiently as do lower species such as rodents and thus most of the previous studies on aspartame effects on rodents are irrelevant.” Unfortunately, this fell on deaf ears and failed to garner additional testing.

* Methanol

By far, the most controversial ingredient in aspartame is methanol (aka wood alcohol). An EPA assessment of methanol states that it is “considered a cumulative poison due to the low rate of excretion once it is absorbed. In the body, methanol is oxidated to formaldehyde and formic acid; both of these metabolites are toxic.” This oxidation occurs when methanol reaches 86 degrees F (30 degrees C).

* Formaldehyde

A product broken down from aspartate is a known carcinogen and causes retinal damage, birth defects and interferes with DNA replications.

The EPA recommends a consumption limit of 7.8 mg/day. A 1 Liter aspartame sweetened beverage contains about 56 mg of methanol, seven times the EPA limit.

The most common maladies related to methanol poisoning are vision problems including misty vision, progressive contraction of visual fields, blurring of vision, obscuration of vision, retinal damage and blindness.

The History of Aspartame

In 1973, G.D. Searle submitted aspartame to the FDA for approval as a sweetening agent. Approval was granted in July of 1974 but pulled in December after objections to its safety were filed by neuroscience researcher, John Olney, and consumer attorney, James Turner. Questions regarding G.D. Searle’s research practices were subsequently raised and an FDA investigation was launched.

It is important to note that of the 164 studies that were conducted, 74 of them had industry related sponsorship and 90 were funded without any industry money. Of the 90 non-industry sponsored studies, 83 (92%) identified one of more problems with aspartame.

In 1976, an FDA task force investigation revealed numerous faults in G.D. Searle’s studies. FDA Toxicologist and Task Force member, Dr. Adrian Gross stated, “They [G.D. Searle] lied and they didn’t submit the real nature of their observations because, had they done that, it is more likely that a great number of these studies would have been rejected for adequacy. What Searle did, they took great pains to camouflage these shortcomings of the study... For instance, animals would develop tumors while they were under study. Well, they would remove these tumors from the animals.” In July 1976 the FDA created another task force, headed by Jerome Bressler, to investigate the discrepancies in three studies in particular.

In 1977, a Grand Jury investigation into Searle’s violation of the law was launched, headed by U.S. Attorney William Conlon. Conlon failed to follow through and the statute of limitations ran out. 15 months later, Conlon accepted a job with the law firm representing G.D. Searle in the investigation.

In August of 1977, the Bressler Report was released, citing a myriad of lies and inconsistencies with Searle’s studies. Senior Scientist on the FDA's task force, Jacqueline Verrett, testified in front of the U.S. Senate, “It would appear that the safety of aspartame and its breakdown products has still not been satisfactorily determines, since the flaws cited in these three studies were also present in all of the other studies submitted by Searle.” Due to these findings, a Public Board of Inquiry (PBOI) was launched.

In 1980, the PBOI voted unanimously to reject the use of aspartame until additional studies on its potential to cause brain tumors could be done.

In January of 1981, G.D. Searle reapplied for approval, submitting new studies with its application. In March, a 5 member FDA panel of scientists reviewed the PBOI’s findings. The panel referred to the brain tumor data as “worrisome” and could not recommend approval. In July of 1981, FDA Commissioner Arthur Hull Hayes, Jr. overruled the PBOI and approved aspartame for dry foods use, ignoring the Food, Drug and Cosmetic Act (21 U.S.C. 348) which states that a food additive should not be approved if tests are inconclusive.

In October 1982, Searle petitioned the FDA for approval to use aspartame in soft drinks and children’s vitamins. The FDA approved the use in soft drinks in 1983. Shortly after approval, Commissioner Hayes left the FDA under charges of improprieties and was hired as a consultant for G.D. Searle’s PR Firm, Burson Marstellar.

In July of 1983, both Woodrow Monte, Director of the Science and Nutrition Laboratory at Arizona State University and James Turner, Esq. filed petitions objecting to the approval of aspartame based on possible serious adverse side effects from chronic intake of aspartame. In November, the FDA denied the petitions “because public interest did not require it.”

In 1984, 6,900,000 lbs of aspartame were consumed in the U.S.

In 1985, G.D. Searle was bought out by Monsanto, creating the NutraSweet Company as a separate subsidiary from G.D. Searle. 14,400,000 lbs. of aspartame were consumed in the U.S. that same year.

15,700,000 lbs of aspartame were consumed in the U.S. in 1986. 17,100,000 lbs were consumed in 1987. NutraSweet stopped providing consumption data to the USDA after 1987.

In 1996, the FDA removed all restrictions on aspartame and authorized its use in all products, including heated and baked goods. This was done in spite of the fact that aspartame breaks down into formaldehyde above 86 degrees F.

Today, aspartame accounts for over 75% of the adverse reactions to food additives reported to the FDA. How sweet it is? A few of the 90 different documented symptoms include: headaches/migraines, dizziness, seizures, nausea, numbness, muscle spasms, weight gain, rashes, depression, fatigue, irritability, tachycardia, insomnia, vision problems, hearing loss, heart palpitations, breathing difficulties, anxiety attacks, slurred speech, loss of taste, tinnitus, vertigo, memory loss and joint pain. Which one are you ready for?Natural News Aspartme Article

An Autism Mom's Open Letter to Dr. Paul Offit

http://www.ageofaut ism.com/2008/ 09/an-autism- moms.html

September 15, 2008

An Autism Mom's Open Letter to Dr. Paul Offit

By Julie Obradovic

Dear Dr. Offit,

I am writing in regard to your new book, Autism’s
False Prophets: Bad Science, Risky Medicine and Finding a Cure.

It would be premature to say for sure, but I am
willing to bet I would be considered a “False
Prophet” in your eyes. I am a mother who
witnessed her daughter regress into Autism, and I
am a mother who believes it was because of her
vaccines. I dedicate much of my time to helping
other parents who experienced the same thing with their own children.

I also make it a point to encourage parents to
research vaccine safety carefully before blindly
subjecting their children to it. In fact, I can
count at least 10 children under the age of 3
right now who have been spared the
one-size-fits- all approach to administering
vaccines because of my advice. They are
undoubtedly part of any decrease in vaccination rates.

Some critics call me an irresponsible
anti-vaccine zealot for this. Frankly, I am
baffled by that; I am simply advocating for more
independent and relevant research into their
safety and administration. I am also simply
telling parents to do their homework; any
decision they make not to vaccinate is theirs.

I have serious, unanswered questions about the
current state of vaccination, and the bullying,
fear-mongering, and hateful discourse spewed
towards someone like myself does nothing to
squelch my concerns, or more important, the
concerns my family, friends and neighbors having children right now.

These people know that I am a rational, logical,
courageous, highly educated, intelligent mother
who pulled her own child out of the depths of
Autism. They saw with their own eyes the descent
of my perfectly healthy baby girl at birth until
6 months of age into the lost, sick state of
Autism by age 2. It’s not me telling them a
version of what happened; they saw it for themselves.

They also saw us claw our way out of that
hell-hole. They witnessed our family do what-ever
it took for however long to get our little girl
back. Despite the terrible odds against us, we
got her. My daughter no longer qualifies as having Autism.

With 1 in 20 families now being affected by
Autism, and thousands of those families
recovering their children as we did, you can only
imagine this trend (of parents not trusting you)
growing. You continue to tell these family
members, friends and neighbors that what they
witnessed wasn’t real. That doesn’t sit well with
most people I know, including you. If I’m not
mistaken, the real reason for your book is
because you don’t like it when people call you a liar. It goes both ways.

*****

Instead of critics thanking me for preventing one
more person from being dependent on the state for
the rest of her life, thus saving them thousands
of tax dollars in lifetime care, I am portrayed
as an irresponsible parent who just couldn’t
accept that she is genetically flawed. Worse, I
am now using my denial to hurt other children and
society as a whole by scaring parents away from vaccinations.

For starters, I find it interesting that
encouraging parents to research and question
vaccines, including their ingredients and
administrative protocol, is threatening. If there
truly is nothing for parents to be afraid of,
then what is the problem with telling them to
look into it for themselves? The idea that
overwhelmingly the medical community would rather
parents not question anything in this area,
thereby “just trusting us”, gives them reason to pause.

I trust my financial adviser, but I certainly
won’t let him do whatever he wants with my money
before researching it first. And I trust my
child’s teacher, but that doesn’t mean I don’t
participate in obtaining the learning outcomes
desired for my child. Certainly you can
understand that when it comes to a parent’s baby,
they are going to be involved in the decision
making process of the most important thing that baby has…her health.

Perhaps your resentment of educated parents stems
from the fact that there are legitimate
unanswered questions about vaccines that research
fosters….like what is the safe amount of aluminum
that can be injected into a tiny baby and how do
you know that? (A biological study that has never
been performed and a question that has never been answered.)

When a parent objects that you would subject
their child to such an experiment, you are
frustrated. Why? Because it appears to be safe
for the general public, and that should be a good enough answer?

It would be a blatant lie to say these concerns
are only fostered by desperate parents giving bad
information and promoting bad science on the
internet, but you perpetuate that myth
none-the-less. It’s easier to paint us as silly
fools than to admit that you don’t have all the
answers. You probably find it shocking that of
those 10 children I mentioned, 3 of them have
parents who are physicians trained in
evidence-based medicine. These are not stupid people.

As such, they can’t help but be suspicious of
someone like you who claims “I don’t get paid to
talk about vaccines” and “vaccines are the safest
thing you can put in your body” knowing you just
sold a patent for one worth $182 million dollars
(a vaccine that as one version had to be pulled
because it actually killed some children).

They can’t help but question you when they learn
that millions of dollars have been paid out to
people hurt by vaccines in a special “vaccine
court” designed to protect vaccine manufacturers.

They can’t help but wonder what you are talking
about when they read the list of ingredients in a
vaccine for themselves, or when they realize
those ingredients have never been independently tested for safety.

They also can’t help but wonder about your sanity
when you crazily suggest a child could get
100,000 vaccines in one day, no problem. (Would
100,000 traces of thimerosal still be considered a trace?)

And they certainly can’t help but wonder why
someone so confident about his knowledge about
what does not cause Autism has actually never treated someone with it.

Coupled with the fact that you refuse to debate
any Autism specialists, journalists, parents or
scientists in person, you end up being as credible as a used car salesman.

*****

In light of their research, and not just with
regard to Autism, more and more parents are
growing skeptical of vaccines for other reasons
as well. Much of it is due to the current state
of children’s health in our country.

You don’t have to have a child with Autism to
know something is wrong: We have the most
vaccinated children in the world, and the
sickest. That may or may not be related, but it
certainly warrants investigation. An epidemic of
immune system dysfunction taking place in kids
who are given more vaccines to provoke their
immune systems at an earlier age than ever is disturbing, isn’t it?

Right now, 1 in 5 children is in Special
Education; allergies and asthma plague millions;
diabetes and other chronic diseases are at an all
time high; speech delay, learning disabilities,
ADHD, and occupational needs continue to soar;
and certainly 1 in 64 boys being diagnosed with Autism is beyond comprehension.

In spite of these shameful statistics, medical
authorities are doing their best to pretend this
is all normal. They just can’t figure out whether
or not this is a problem (is it better diagnosis
or not?), thereby continuing to deny calling this what it is: An epidemic.

We all know, however, that epidemics can never be
genetic; something environmentally must be
triggering the problem. This is becoming obvious
enough that even the CDC is claiming to look for
that trigger (which begs the question, why look
for a trigger of an epidemic you claim doesn’t
exist?). It will add to the others that have also been conducted.

In one study, they found it could be the television causing Autism.

In another, they suggested dog shampoo could be doing it.

And now, as Dr. Harvey Karp mentioned on Larry
King Live!, they are even looking into the flame
retardant used in children’s pajamas and their mattresses.

The sad thing about these studies is how truly
insulting and wasteful they are. I have yet to
meet or read about one parent of a child with
Autism who says, “You know, I turned on the
television one day, and wouldn’t you know it, my
baby got non-stop diarrhea everywhere!”

Or, “By golly, we washed the dog, and the next
day, she stopped looking me in the eye!”

Or my favorite, “I put my child in new pajamas,
and I swear he regressed right into Autism!”

Yet thousands upon thousands of parents all have
the same story: They vaccinated their babies, and
something happened….chronic illnesses began,
gastro-intestinal stress started, tantrums
ensued, seizures took place and their sensory
perception changed (among many other problems).

Still, the authorities refuse to make it a
priority to look first and foremost at the
chemicals INJECTED INTO THEIR BODIES as being the
probable cause. No, instead, we’re looking at their pajamas.

Could these stupid studies be necessary because
actually finding the real trigger may be too
frightening? As Dr. Bernadine Healy eloquently
stated on the CBS Evening News, there is an
expressed concern that finding that answer would
jeopardize the vaccination program.

This means there are people in great positions of
power who could investigate this issue thoroughly
and instead have clearly stated, “We don’t want
to know if vaccines are causing Autism because
the ramifications of that answer are too huge.”

*****

I assume your response would be two-fold: One,
that you think Dr. Healy is misinformed as you
stated at the AAP Press Conference (it’s
interesting how everyone who disagrees with you
is misinformed) ; and Two, that this question has
been answered and re-answered: Vaccines have nothing do with it.

You will probably support this belief by
referencing studies that supposedly exonerate not
only vaccines, but their ingredients as well, from playing any part.

Unfortunately, I know from years of being
involved in this debate that the average person
doesn’t have a clue about any of these studies.
Instead, they hear a prominent physician like you
referring to them on the nightly news or NPR and believe they must be true.

What they don’t realize is that these studies in
fact do very little to determine the role
vaccines or their ingredients play in the Autism epidemic.

*****

To “prove” that vaccines don’t cause Autism,
physicians like you have compiled studies they
believe put the issue to rest. Most of these studies are population in nature.

The paradigm supported by their compilation is
that epidemiological studies would confirm if
vaccines were indeed implicated in Autism; the
fact that they repeatedly do not allows them to
close the book on the subject. In other words,
because they haven’t found the association in the
general population, the debate is over.

There are 4 major flaws with this.

1. Study Bias

These studies are done by the people who have the
most to lose if the outcome is a bad one.

Your paradigm assumes that these compiled studies
are independent studies that are not trying to generate a desired outcome.

I do not believe there is a conspiracy in the
vaccines-causing- Autism controversy (a common
tactic used to discredit my character). That
would mean I believe from the very beginning,
someone purposely set out to hurt my child. I do not.

But I am not naïve either. It is appropriate to
be skeptical of certain scientists’ objectivity,
especially when one considers the consequences of
what their oversight may have caused (a foreign
policy nightmare, lowered vaccination rates and a
possible collapse of the vaccination program, law
suits, billions in lost revenue, criminal
charges). One needs only look at the tobacco
industry as an example of the lengths people will
go to protect themselves. This issue dwarfs tobacco.

Not only is there is high level conflict of
interest on part of many of the authors, but in
most instances, they are employees of vaccine
manufacturers and/or work for the CDC (an
organization responsible for keeping vaccination
rates high). This clearly makes them biased.

As an example, consider the Taylor article
published in the Lancet (1999). As a response to
the Wakefield study (1998), this article attempts
to exonerate the MMR from being involved with
regressive Autism. The study was performed by
several members of the UK Immunization Division
of the Public Health Department. In the discussion of their study, they state:

“We hope that our results will reassure parents
and others who have been concerned about the
possibility that MMR is likely to cause Autism
and that they will help to restore confidence in the MMR vaccine.”

A good scientist doesn’t set out to “reassure”
anybody of anything with his or her hypothesis.
They simply want to find the truth.

Only scientists who are truly independent can be
trusted with this important research, which is
why there is federal legislation currently pending for such action.

2. Poor Study Design

The methodology employed in these studies is not
properly structured to test the hypothesis it is trying to.

You mention bad science as being a part of the
problem in this debate; you even mention it in
your book title. In this regard, we couldn’t
agree more. Over and over and over, studies that
set out to test one hypothesis actually end up
being irrelevant or inconclusive for finding it
out if it’s true, but get reported as conclusive none-the-less.

Consider these examples.

In 2002, Pinichero et al. performed a study to
test for thimerosal safety. He reasoned that
exposing children to typical thimerosal
containing vaccinations and then collecting
blood, stool and urine samples would verify its
rapid excretion, thus proving its safety.

For starters, the study is limited it to only 40
children; provided Autism affects 1 in 150
children, it is highly probable his sample size
was too small. Regardless, the author could still
only account for a small percentage of the
mercury injected into the children. To explain
this, he assumes the rest of it was excreted when
he didn’t catch it. However, thimerosal is now
documented as entering tissue quickly, including
the brain. Without a biopsy of these children’s
organs, it is impossible to know where all the mercury went.

Even more, he fails to explain why the two month
old baby who received half the amount of
thimerosal as the others had the highest
percentage blood concentration of mercury. This
would seem to fit the theory that not all
children have the same detoxification abilities, but this fact is ignored.

None-the-less, this study is widely quoted as proving thimerosal is safe.

Another example of this problem, and perhaps the
most important of them all, is the CDC population
study conducted in the United States on the role
of thimerosal exposure in the development of
Autism and other developmental disorders.

Of primary concern, the CDC should have never
been allowed to conduct this study in the first
place. In perhaps the first instance of its kind,
the CDC was investigating a health outcome that they may have caused.

People accused of a crime do not have the luxury
of investigating themselves to find out if indeed
they are guilty. From the get-go, ethical and
responsible researchers should have identified
this conflict and given the task to someone on the outside. They did not.

Even after being redone 4 times before
publication, noting the correlation “just won’t
go away”, the study could still only report
finding a “neutral” association between the two.

This neutral association was present in spite of
the fact that a child’s cumulative exposure to
thimerosal was not accurately tabulated. Flu
shots, Rhogam shots given to their mothers while
pregnant, and other thimerosal containing
vaccines were eliminated from being used to
tabulate their total exposure. (Which is odd,
isn’t it? If you want to see if it’s having an
effect, why not include all of it?)

And now, the original data sets have been lost,
destroyed (both punishable as a Federal crime) or
stored in off-shore accounts where they cannot be accessed for replication.

Interestingly, Dr. Julie Gerberding, Head of the
CDC, recently declared the study “useless” and
not helpful in ruling out an association between the two.

Provided this study was a large part of the
Institute of Medicine’s 2004 ruling that
thimerosal did not play a causal role in the
development of Autism, and no longer warranted
further study, it is fair to say that their
ruling no longer stands. A “useless” study can
certainly not support such a position.

The list of examples I could site with this kind
of methodology flaw used to exonerate vaccines or
their components goes on and on. In fact, there
is not one study in your compilation that isn’t
subject to this scrutiny, including the recently released study on the MMR.

Because of this, I’m thinking about writing a
book too. I’m going to call it, Autism’s False
Offits: Biased Science, An absence of Medicine, and No Attempt to Find a Cure.

3. Irrelevant Findings

The studies used to exonerate vaccines from
causing Autism are extremely focused, although
the question is a broad based one that hasn’t been sufficiently addressed.

Once again, the theory behind vaccines triggering
Autism is that there is a genetically susceptible
group of individuals who upon exposure to vaccination regress into Autism.

To properly test this theory, multiple studies
have yet to be conducted. A study of the never
vaccinated versus the vaccinated would help
determine if vaccines were indeed implicated, but
not necessarily explain why. Additional study of
the children with these health impairments is
prudent. They need to be tested for vaccine
strain viruses that may have not properly cleared
the body and/or left behind damage (immediately
following regression preferably); they need to be
tested for heavy metal toxicity, which may have
sparked the problem to begin with; and they need
to be tested for any and all evidence that may
demonstrate how all of these issues are related.

But we don’t have these studies yet. Instead,
what we have are studies that have suggested, not
proved, that thimerosal ALONE does not cause
Autism in the general population (no longer
admissible) and current studies that suggest the MMR ALONE does not either.

Claiming the debate over whether or not vaccines
are involved in Autism based on this is
irresponsible. We don’t have a study on the
effect of the combination of the two, or on all
of the other vaccines given in combination.
Considering there are now dozens of routine
childhood vaccines, the causal possibilities are numerous.

*****

None-the-less, let’s assume that all of that
science is actually perfect. Let’s assume that
none of the authors, whether or not they are
vaccine patent holders like you, or employees of
vaccination companies, or members of the CDC are
unethical in any capacity. Let’s say that each
and every individual conducting these studies has
the highest professional standards and would not
compromise something so important in any
capacity. And let’s assume that all of the
studies were designed and methodically carried out to the tee.

They still don’t prove Autism isn’t caused by vaccines.

4. Epidemiology can never prove causation.

While population studies are useful for
identifying large-scale problems, they are not
useful in identifying genetic susceptibilities,
and again, can never stand alone in proving
something did or did not happen in an individual.

Suppose I have a grove of multiple kinds of fruit
trees, and every time I spray the grove with
pesticide, my orange trees get sick but none of
the other trees do. If I study the entire grove
over and over again and don’t come up with an
association between the pesticide and the sick
orange trees, I still can’t rule out that it was
the pesticide that did it to them.

That doesn’t mean my study of the fruit trees was
wrong, and it doesn’t mean the pesticide is bad
for all the trees; it just means my study was
irrelevant to the question at hand. At best I
know most of my fruit trees are fine when exposed
to this chemical. It doesn’t change the fact
something’s still wrong when my oranges are, or that I still don’t know why.

Provided none of the Autism studies touted
exclusively studies the children who did regress
after their vaccines, it is baffling that medical
professionals are so willing to claim the issue is closed for debate.

Ethical and compassionate physicians would make
it a priority to say, “Although I don’t
understand why this is happening to these
children, and although some studies are telling
me it didn’t happen to the general population of
children (Thank God!), I have an obligation to
find out why it did to this child. Why did this
child regress after his vaccines, and what
evidence does he show me that it was or wasn’t causal?”

This is a substantially different take from
saying “Population studies told me it didn’t
happen, therefore it didn’t. Case closed.”

*****

Those physicians who do feel obligated to look
beyond epidemiology are conducting such research.
Together they and scientists from prestigious
universities like Harvard and Colombia have
compiled significant scientific evidence
demonstrating that indeed vaccines may be involved.

Evidence

1. Anecdotal

Hundreds of thousands of parents globally all
have the same story: They vaccinated their
children and something happened. In some
instances, the something happened immediately. In
others, it happened slowly over time and got
worse with each series of vaccines. Regardless,
they all subscribe to the same story. They
witnessed their children’s health deteriorate
after vaccines, and subsequently their children were diagnosed with Autism.

While this is not conclusive as being causal, it
certainly is valid. Anecdotal evidence is revered
as being scientific and the fact that so many
parents are telling the same story should raise
red flags everywhere. Instead, parents are
irresponsibly dismissed as imagining it or remembering things inaccurately.

Furthermore, the timing of the onset of Autism
and vaccines is identical. This too makes it
highly plausible they are involved.

2. Epidemiological

Multiple studies done, including those sponsored
by the CDC, prove that there has been a
substantial increase in Autism and other
developmental disorders in the last 2 decades.
This increase starts precisely when the Hepatitis
B shot was administered at birth, beginning in the late 1980’s.

Many doctors have written this increase off as an
indication of better diagnosis. However, the
better diagnosis belief would mean that about 97%
of cases of Autism in 1985 and prior were missed.
In other words, 1 in 64 40 year old males is
walking around right now with Autism and doesn’t know it.

Finally, no wide-scale study has been done on the
vaccinated versus never vaccinated children of
this country (a study that also has legislation
behind it). It is absolutely impossible to know
the true differences in health outcomes between
them. In this case, it is a lack of epidemiology that is hurting our kids.

3. Biological

Incredibly, the symptoms of mercury poisoning and
Autism are identical. They aren’t kind of
similar, or sort of the same, they are identical.
The idea that we are actually debating whether or
not injecting kids with mercury can cause the
symptoms of mercury is ridiculous.

I’ve included a table in case you are one of
those ignorant physicians often quoted who only
know mercury toxicity in the form of Acrodynia or
Minimata Disease and fail to understand the other
ways it may manifest. There is no doubt the
comparison of mercury toxicity to Autism is stunning.

*Borrowed from Changing the Course of Autism (Jepsen)

Mercury Toxicity Autism
Biochemistry Biochemistry
• Binds SH groups; blocks sulfate transporter in intestines and kidneys
• Reduces glutathione availability, inhibits
enzymes of glutathione metabolism; glutathione
needed in neurons, cells, and liver to detoxify
heavy metals; reduces glutathione peroxidase and reductase
• Disrupts purine and pyrimidine metabolism
• Disrupts mitochondrial activities, especially
in the brain • Low sulfate levels
• Low levels of glutathione; decreased ability of
liver to detoxify xenobiotics; abnormal
glutathione peroxidase activity in erythrocytes
• Purine and pyrimidine metabolism errors lead to autistic features
• Mitochondrial dysfunction, especially in the brain
Immune System Immune System
• Sensitive individuals more likely to have
allergies, asthma, autoimmune-like symptoms, especially rheumatoid-like ones
• Can produce an immune response in CNS, causes brain/MBP autoantibodies
• Causes overproduction of Th2 subset;
kills/inhibits lymphocytes, T-cells, and
monocytes; decreases NK T-cell activity; induces
or suppresses IGNg & IL-2 • More likely to have
allergies and asthma; familial presence of
autoimmune diseases, especially rheumatoid arthritis; IgA deficiencies
• On-going immune response in CNS; brain/MBP autoantibodies present
• Skewed immune-cell subset in the Th2 direction;
decreased response to T-cells mitogens; reduced
NK T0cell function; increased IFNg & IL-12
CNS (Central Nervous System) structure CNS Structure
• Selectively targets brain areas unable to
detoxify or reduce Hg-induced oxidative stress
• Accummulates in amygdale, hippocampus, basal
ganglia, cerebral cortex; damages Purkinje and
granule cells in cerebellum; brain stem defects in some cases
• Causes abnormal neuroanoal cytoarchitecture;
disrupts neuronal migration, microtubules, and cell division; reduces NCAMs
• Progressive microcephaly • Specific areas of
brain pathology; many functions spared (area 36)
• Pathology in amygdale, hippocampus, basal
ganglia, cerebral brain stem defects in some cases
• Nauronal disorganization; increased neuronal
cell replication, increased glial cells; depressed expression of NCAMs
• Progressive microephaly and macroephaly
Neuro-chemistry Neuro-chemistry
• Prevents presynaptic serotonin release and
inhibits serotonin transport; causes calcium disruptions
• Alters dopamine systems; peroxidine deficiency
in rats resembles mercurialism in humans
• Elevates epinephrine and norepinephrine levels
by blocking enzyme that degrades epinephrine
• Elevates glutamate
• Leads to cortical acetylcholine deficiency;
increases muscarinic receptor density in hippocampus and cerebellum
• Causes demyelinating neuropathy • Decreased
serotonin synthesis in children; abnormal calcium metabolisjm
• Either high or low dopamine levels; positive
response to peroxidine, which lowers dopamine levels
• Elevated norepinephrine and epinephrine
• Elevated glutamate and aspirate
• Cortical acetylcholine deficiency; reduced
muscarinic receptor binding in hippocampus
• Demylelination in brain
Neurophysiology Neurophysiology
• Causes abnormal EEGs, epileptiform activity,
variable patterns, e.g., subtle, low amplitude seizure activities
• Causes abnormal vestibular nystagums responses;
loss of sense of position in space
• Results in autonomic disturbance: excessive
sweating, poor circulation, elevated heart rate •
Abnormal EEGs, epileptiform activity, variable
patterns, including subtle, low amplitude seizure activities
• Abnormal vestibular nystagmus responses; loss of sense of position in space
• Autonomic disturbance: unusual sweating, poor
circulation, elevated heart rate
Psychiatric Disturbances Psychiatric Disturbances
• Social deficits, shyness social withdrawal
• Repetitive, preservative, stereotypic
behaviors; obsessive-compulsiv e tendencies
• Depression/depressi ve traits, mood swings, flat
affect; impaired face recognition
• Anxiety; schizoid tendencies; irrational fears
• Irritability, aggression, temper-tantrums
• Lacks eye contact; impaired visual fixation,
problems in joint attention • Social deficits, shyness social withdrawal
• Repetitive, preservative, stereotypic
behaviors; obsessive-compulsiv e tendencies
• Depression/depressi ve traits, mood swings, flat
affect; impaired face recognition
• Anxiety; schizoid tendencies; irrational fears
• Irritability, aggression, temper-tantrums
• Lacks eye contact; impaired visual fixation, problems in joint attention
Speech and Language Deficits Speech and Language Deficits
• Loss of speech, delayed language, failure to develop speech
• Dysarthria; articulation problems
• Speech comprehension deficits
• Verbalizing and word retrieval problems;
echolalia, word use and pragmatic errors • Loss
of speech, delayed language, failure to develop speech
• Dysarthria; articulation problems
• Speech comprehension deficits
• Verbalizing and word retrieval problems;
echolalia, word use and pragmatic errors
Sensory Abnormalities Sensory Abnormalities
• Abnormal sensation in mouth and extremities
• Sound sensitivity; mild to profound hearing loss
• Abnormal touch sensations; touch aversion
• Over-sensitivity to light; blurred vision, loss of color perception
• Under-sensitive or over-sensitive to pain •
Abnormal sensation in mouth and extremities
• Sound sensitivity; mild to profound hearing loss
• Abnormal touch sensations; touch aversion
• Over-sensitivity to light; blurred vision
• Under-sensitive or over-sensitive to pain
Motor Disorders Motor Disorders
• Flapping, myoclonal jerks, choreiform
movements, circling, rocking, toe walking, unusual postures
• Deficits in eye-hand coordination; limb
apraxia; intention tremors, problems with intentional movement or imitation
• Abnormal gait and posture, clumsiness and
incoordination; difficulties sitting, lying,
crawling, and walking; problem on one side of
body • Flapping, myoclonal jerks, choreiform
movements, circling, rocking, toe walking, unusual postures
• Deficits in eye-hand coordination; limb
apraxia; intention tremors, problems with intentional movement or imitation
• Abnormal gait and posture, clumsiness and
incoordination; difficulties sitting, lying,
crawling, and walking; problem on one side of body
Cognitive Impairments Cognitive Impairments
• Borderline intelligence, mental retardation- some cases reversible
• Poor concentration, attention, response inhibition
• Poor visual and perceptual motor skills; impairment in simple reaction time
• Deficits in understanding abstract ideas &
symbolism; degeneration of higher mental powers,
sequencing, planning and organization •
Borderline intelligence, mental retardation- some cases reversible
• Poor concentration, shifting attention
• Poor visual and perceptual motor skills;
impairment in simple reaction time lower performance on timed tests
• Difficulty in carrying out complex commands
• Deficits in understanding abstract ideas &
symbolism; degeneration of higher mental powers,
sequencing planning and organizing
Unusual Behaviors Unusual Behaviors
• Self-injurious behavior, head banging
• Inability to focus or concentrate; hyperactivity
• Agitation, unprovoked crying, grimacing and staring spells
• Sleep disturbances and impairments
• Self-stimulatory behaviors
• Obsessive compulsive behaviors • Self-injurious behavior, head banging
• ADHD traits
• Agitation, unprovoked crying, grimacing and staring spells
• Sleep disturbances and impairments
• Self-stimulatory behaviors
• Obsessive compulsive behaviors
Physical Disturbances Physical Disturbances
• Hyper or hypotonia; abnormal reflexes;
decreased muscle strength; especially upper body;
incontinence; problems chewing and swallowing
• Rashes, dermatitis, eczema, itching
• Peeling skin (hands and feet)
• Diarrhea; abdominal pain/discomfort, constipation, colitis
• Anorexia, nausea, vomiting; poor appetite, restricted diet
• Lesions of ileum and colon; increased gut
permeability • Hyper or hypotonia; abnormal
reflexes; decreased muscle strength; especially
upper body; incontinence; problems chewing and swallowing
• Rashes, dermatitis, eczema, itching
• Diarrhea; abdominal pain/discomfort, constipation, colitis
• Anorexia, nausea, vomiting; poor appetite, restricted diet
• Lesions of ileum and colon; increased gut permeability

It is impossible for a parent like myself, who
witnessed her daughter regress into Autism more
and more with each set of vaccines she received,
to believe that it is a coincidence that she was
repeatedly injected with mercury (including at
birth), and then developed the symptoms of mercury poisoning.

This is the equivalent of someone saying that
they went into the sun for 2 hours on a sunny day
and got the symptoms of a sun burn, but the sun
didn’t do it because everybody else they know
always gets a tan, (and they better not treat
themselves or tell anyone what happened because
the sun is good). It is completely and totally
illogical to believe such a thing.

Further evidence to support a toxicological base
in Autism comes from studies that demonstrate
higher rates of Autism among children who live
near coal-burning plants; a study that
demonstrates glutathione levels (a substance
necessary for detoxification) being 68% lower in
children with Autism than their nuerotypical
peers; and a study on mice with a predisposition
for auto-immune conditions that shows a markedly
different response to thimerosal exposure than the mice who did not.

Then there are the studies that show thimerosal
causes mitochondrial dysfunction, the exact same
condition the Dept. of Health and Human Services
(in a medical decision, not a legal one) just
said caused Hannah Poling’s symptoms of Autism
after receiving 9 vaccines at once.

Not to mention, the very first cases of Autism
ever diagnosed in the world or anywhere in
medical literature were done shortly after
thimerosal was introduced on the market. Among
those cases, many of them had parents who worked
with or lived near ethyl mercury, the same kind of mercury used in thimerosal.

In fact, there is so much evidence against
thimerosal that an entire book was written on it
by an award-winning journalist in 2005: Evidence of Harm, by David Kirby.

At a minimum, this evidence substantiates ruling
out mercury toxicity in all children with Autism.
That was my purpose when finding a qualified specialist to test my daughter.

Why wouldn’t I rule it out as a possibility?
Because one flawed epidemiological study done by
those who would be held accountable told me maybe
it happened, maybe it didn’t? Because vaccines
save lives and questioning them is wrong? How
irrelevant! How irresponsible! My daughter was
injected with mercury and subsequently developed
the symptoms of what it causes! How could I not test her?

Naturally, when it was confirmed she was mercury
toxic, I was outraged. Well first, I actually vomited.

I don’t believe anyone tried to poison my
daughter, but they did. As a result, her entire
life and what she will be able to do with it has been permanently altered.

More urgent, she needed to be treated. Under a
doctor’s care, using only medication approved for mercury poisoning, she was.

Today, I’m thrilled to report; she no longer has mercury poisoning….or Autism.

*****

Dr. Offit, time limits my ability in this letter
to list each and every study that supports
evidence that children with Autism have
substantial health problems, including but not
limited to their immune system, their central
nervous system, and their gastro-intestinal
system. They have severe nutritional
deficiencies; tolerate horrific yeast overgrowth
in their guts coupled with leaky gut syndrome and
dysbiosis; are in a constant state of battling
viruses and infection; have lowered
detoxification capabilities and suffer from heavy
metal toxicity; and live daily with intense pain,
inflammation, and sensory issues.

All of these health issues are well-documented in
the medical literature. All a responsible physician has to do is look.

But instead, they are told not to because
according to physicians like you, all of it is
garbage. Somehow only the studies done by those
who have the most to lose, the CDC, the AAP, and
the vaccine manufacturing companies, are actually quality.

According to your (and their) logic:

It’s a coincidence that Autism didn’t appear in
the medical literature until right after
thimerosal came on the market. (It’s been around
for centuries, we just never bothered to document it.)

It’s a coincidence the symptoms of Autism and
mercury poisoning are the same. (Sometimes these things happen.)

It’s a coincidence that as children are being
treated for their medical problems they are
losing their diagnosis. (It’s both a lifelong
genetic condition and something people spontaneously recover from.)

It’s a coincidence that these children are
regressing into Autism at the same time they are
getting their vaccines. (Unfortunate timing.)

It’s a coincidence that four times as many boys
have Autism than girls, even though we know
mercury is synergistic with testosterone.
(Mercury has nothing to do with Autism.)

It’s a coincidence that the rate of Autism and
other developmental disorders has sky-rocketed as
we added more vaccines to the schedule. (We have
gotten better at diagnosing, that’s all.)

It’s a coincidence parent after parent has the
same story. They vaccinated and their child
shortly developed Autism thereafter. (It’s the internet’s fault.)

At the same time, you perpetuate the myth that
thimerosal is a safe substance and that it is no
longer in vaccines; you even state that in trace
amounts it is the equivalent of being exposed to
the mercury that we breathe or eat. I certainly
hope I am misunderstanding that you believe
breathing or eating a substance is the same as
having it injected into your body. They most certainly are not.

We both know that if you ever tried to convince a
parent that injecting their child with just a
little bit of lead, simply because lead is in a
pencil they use or in the food they eat, the
parent would run fast and far away from you. Yet
mercury is 500 times more toxic.

Additionally, you know that thimerosal has never
been tested for safety. It is labeled as poison
and the bottle clearly states that exposure may
result in neurological harm. It is so toxic that
it was banned from over-the-counter products in
1982 and form animal vaccines in 1991. It’s so
toxic that when put on the umbilical cords of 7
babies in a hospital in 1977, they all died.

Still, it inexplicably remains in human vaccines
to this day. Despite claims to the contrary, it
was never “removed”. To date, no one has verified
that indeed it is no longer on the shelves of
doctor’s everywhere. At best, it is only in
smaller amounts, not zero amounts. Even worse, it
is now recommended that all pregnant women and
children get a flu shot, which has the full dose
of 25 micrograms in it (unless they know to ask otherwise).

Considering the argument has always been there is
a genetic susceptibility to this substance, it is
irresponsible to claim that less of it would
automatically be less dangerous to such a
person. A person with a peanut allergy only
needs 1 peanut to go into anaphylactic shock, not
a bowl full, and sometimes less than that.

*****

By continuing to promote to this coincidental and
toxicological non-sense, you are denying the
right to medical care for millions across the
globe, a human right’s violation.

Our children are perhaps the sickest children on
the planet, and yet they are shamefully not given
medical care. Instead, they are told to go home
with their parents where they should get
behavioral therapy alone, and worse, look into an
institution. They are written off from society as
being hopeless causes and a burden to their families.

This is the equivalent of a parent whose child
has cancer being told to just forget about
treating them and go buy a burial plot.

In an even crueler twist of fate, our children
can’t tell us what is wrong or where it hurts
because their ability to speak has been taken
from them. To communicate sometimes, they scream
and hurt themselves and throw tantrums. They have
chronic gastro-intestinal distress and
unimaginable pain; are overly sensitive to
everything; often can’t ever get a good night’s
sleep; and sometimes can’t even tolerate being
touched as their parents try to comfort them. All
the while they are expected to learn or behave
properly. Can you imagine their hell?

And now parents are being told by ignorant
members of society that their precious kids are
simply brats who don’t know how to behave in
public. Supposedly they are just putting on act
because their fathers have disappeared or their
mom doesn’t know how to discipline. I suppose if
I weren’t an insider I would tell myself that
too; the idea that this is real is enough to
scare anyone into rationalizing it away.

Make no mistake, the torture of watching your
child succumb to this disease and being told that
there’s nothing you can or should do; well
frankly, it is enough to drive some people over
the edge. It should not be surprising parents of
children with Autism are killing themselves and
their children, jumping with them off bridges,
drowning them, and suffocating them.

It doesn’t get any more real than that.

*****

Dr. Offit, there is a generation of children who
are on fire right now. Their health is in flames,
and rather than doing everything in your power to
put them out, you have chosen to debate about
whether or not there really is a fire; if and how
it started; and whether or not there is any real reason to put them out.

Worse, you have taken it upon yourself to
ridicule and criticize those of us parents who
have decided to douse our children in water,
despite your inaction. You criticize the kind of
water we are using, where we are getting it from,
how much we are using, who is helping us get
it, and have the audacity to suggest that us
attempting to put out the flames is more irresponsible than letting them burn.

In an even more despicable twist, you go so far
as to accuse us of actually wanting and causing
other children to get hurt because we warn
parents about how our fire started; it’s easier
to blame us rather than acknowledge your pitiful
display of incompetence as being the real reason for the spark. How dare you.

I love my children more than anything in the
world. I also love the children of my family
members, my neighbors, and my friends. I would
lie down in traffic for any one of them if that’s
what it took to save their life. For anyone to
suggest that I would recklessly put their lives
or other people’s children at risk because I
encourage them to research vaccine safety is pouring salt on a gaping wound.

The pain I feel about what happened to my middle
child is often times intolerable, and I’m one of
the lucky ones. I got her back. There isn’t a day
that goes by that I don’t wish I didn’t believe
vaccines hurt her. I’ve lost faith in my
government, my media, and my medical institution
(but am hopeful it can be restored). To top it
off, I am subjected to the vile of anonymous
bullies and threatened physicians who are angry
that my experience differs from what they think it should have.

The saddest thing is we’re both on the same side.
We both want children to be protected, except I
believe we can and have to do better. To be sure
though, I would not wish what happened to my
daughter on my worst enemy, even them.

Can you imagine what it feels like to hold your
child down to be poisoned at the hands of people
you trusted; to watch her suffer in silence
unable to communicate her pain and fear; to
confirm she was poisoned after wasting years of
time; and to live with the never-ending pain of
not knowing what irreparable damage was caused or
who she was meant to be…Only to be told that what
you lived wasn’t real; that trying to help her is
irresponsible; and that by speaking out about it
and trying to prevent it from happening to
another child you are recklessly putting society at risk?

Let’s get something straight: my daughter is the
victim here, not the medical community. And as
for society, our debt has been paid a thousand fold.

When I followed the rules….When I listened to the
advice of my doctors and showed up at their
doorstep exactly on the day my baby was scheduled
to receive her shots, something horrible happened.

I don’t know why it happened to my daughter and
not my son. I don’t know why it happens to some
children and not others. I don’t have those
answers, Dr. Offit, but I do know this: It happened.

I’m sorry that makes you defensive. I’m sorry you
have chosen to take it personally rather than
admit you don’t have all the answers. I’m sorry
you cannot acknowledge the existing studies have
their limitations and that you, being a vaccine
patent holder are probably not the best person to
be promoting or dictating your version of vaccine safety.

But I am not sorry that I have chosen to speak
out about it. I am not sorry that those 10
children I mentioned earlier, including my own,
will no longer be subjected to blindly following
along a path that so many have for so long. I am
not sorry that parents everywhere are beginning
to think for themselves and are demanding answers.

And I absolutely will not apologize that I have
the courage to stand up and ask you if in the
name of good we have inadvertently swapped
infectious disease for chronic disease. No
responsible person wants a resurgence of vaccine
preventable diseases, but no responsible person
wants chronic disease to be the cost of
preventing them, especially if it is our children who are making that payment.

We have been vaccinating human beings for decades
now, and we have yet to take a step back and look
at any unintended consequences we may have
caused. We have a responsibility to humanity to
study that possibility, no matter how unpleasant the answer may be.

And no, despite your claim to the contrary, we haven’t.

Sincerely,
Julie Obradovic

Julie Obradovic is the mom of a recovered child.
http://www.ageofaut ism.com/2008/ 09/an-autism- moms.html

Overall Health

The condition of the physical body can affect the spirit. That’s why the Lord gave us the Word of Wisdom. He also said that we should retire to our beds early and arise early (see D&C 88:124), that we should not run faster than we have strength (see D&C 10:4), and that we should use moderation in all good things.

In general, the more food we eat in its natural state—the less it is refined, and the fewer additives it contains—the healthier it will be for us. Food can affect the mind, and deficiencies in certain elements in the body can promote mental depression.

A good physical examination periodically is a safeguard and may spot problems that can be remedied. Rest and physical exercise are essential, and a walk in the fresh air can refresh the spirit. Wholesome recreation is part of our religion and is a necessary change of pace; even its anticipation can lift the spirit.
By President Ezra Taft Benson
Do Not Despair

I have spent the last few weeks preparing for a class I am teaching to the women at my church tomorrow. The topic is Family Nutrition and the Word of Wisdom. For those not familiar with the LDS church, or the Word of Wisdom it is a revelation given to Joseph Smith Jr. What is so wonderful about it is that at the time there was no science surrounding the counsel, it was from the Lord. However over the years science has come to prove that it is not only good counsel but sound scientific advice.
Those who are familiar with the Word of Wisdom know that it is filled with many do's and don'ts but isn't a definitive list. Many ask "you can't drink coffee, but you can drink coke?" Upon searching further church documents, and counsel from subsequent prophets and leaders the information is there to help us pray and receive our own answers as to whether or not we should be drinking Coke, and other things that fall into the grey category. I like to point out at the time the revelation was given Coke wasn't around, I imagine it would have done more harm than good to have the Lord reference Coke. Just a few of the things that I have further found on this is the advice given that anything addictive in nature should be avoided, if you can't get through the day without X, Y, or Z, you should take some time to think further into it. Life is better when we can live it without vices.
Danny and I were discussing this the other day and came to our own, but I think very good conclusion. If you are having to justify why you are doing something, you have already received your answer from the Lord as to whether or not you should be doing it. When we don't have explain why we are doing something, this includes explaining to ourselves, it is because we are at peace with the decision to do it.
I personally have a testimony of living the word of wisdom and know that the harder I try to live it more fully the more blessed my life has become. There are several promises given to us if we follow the Word of Wisdom, one being that we will discover untold treasures, I know this is true in my life. Here is the Word of Wisdom directly from the Doctrine and Covenants from The Church of Jesus Christ of Latter Day Saints. I have also posted a list of link (they are not active you will have to cut and paste) to other talks that further explain, edify the do's from the Word of Wisdom. As we begin to live the do's more fully the don'ts become less and less of an issue. I would like to reiterate that the Word of Wisdom is something personal, to be read, prayed over and personal decisions to be made between you and the Lord.
THE
DOCTRINE AND COVENANTS
OF THE CHURCH OF JESUS CHRIST OF LATTER-DAY SAINTS
SECTION 89
Revelation given through Joseph Smith the Prophet, at Kirtland, Ohio, February 27, 1833. HC 1: 327–329. As a consequence of the early brethren using tobacco in their meetings, the Prophet was led to ponder upon the matter; consequently he inquired of the Lord concerning it. This revelation, known as the Word of Wisdom, was the result. The first three verses were originally written as an inspired introduction and description by the Prophet.
1–9, Use of wine, strong drinks, tobacco, and hot drinks proscribed; 10–17, Herbs, fruits, flesh, and grain are ordained for the use of man and of animals; 18–21, Obedience to gospel law, including the Word of Wisdom, brings temporal and spiritual blessings.
1 A Word OF Wisdom, for the benefit of the council of high priests, assembled in Kirtland, and the church, and also the saints in Zion—
2 To be sent greeting; not by commandment or constraint, but by revelation and the word of wisdom, showing forth the order and will of God in the temporal salvation of all saints in the last days—
3 Given for a principle with promise, adapted to the capacity of the weak and the weakest of all saints, who are or can be called saints.
4 Behold, verily, thus saith the Lord unto you: In consequence of evils and designs which do and will exist in the hearts of conspiring men in the last days, I have warned you, and forewarn you, by giving unto you this word of wisdom by revelation—
5 That inasmuch as any man drinketh wine or strong drink among you, behold it is not good, neither meet in the sight of your Father, only in assembling yourselves together to offer up your sacraments before him.
6 And, behold, this should be wine, yea, pure wine of the grape of the vine, of your own make.
7 And, again, strong drinks are not for the belly, but for the washing of your bodies.
8 And again, tobacco is not for the body, neither for the belly, and is not good for man, but is an herb for bruises and all sick cattle, to be used with judgment and skill.
9 And again, hot drinks are not for the body or belly.
10 And again, verily I say unto you, all wholesome herbs God hath ordained for the constitution, nature, and use of man—
11 Every herb in the season thereof, and every fruit in the season thereof; all these to be used with prudence and thanksgiving.
12 Yea, flesh also of beasts and of the fowls of the air, I, the Lord, have ordained for the use of man with thanksgiving; nevertheless they are to be used sparingly;
13 And it is pleasing unto me that they should not be used, only in times of winter, or of cold, or famine.
14 All grain is ordained for the use of man and of beasts, to be the staff of life, not only for man but for the beasts of the field, and the fowls of heaven, and all wild animals that run or creep on the earth;
15 And these hath God made for the use of man only in times of famine and excess of hunger.
16 All grain is good for the food of man; as also the fruit of the vine; that which yieldeth fruit, whether in the ground or above the ground—
17 Nevertheless, wheat for man, and corn for the ox, and oats for the horse, and rye for the fowls and for swine, and for all beasts of the field, and barley for all useful animals, and for mild drinks, as also other grain.
18 And all saints who remember to keep and do these sayings, walking in obedience to the commandments, shall receive health in their navel and marrow to their bones;
19 And shall find wisdom and great treasures of knowledge, even hidden treasures;
20 And shall run and not be weary, and shall walk and not faint.
21 And I, the Lord, give unto them a promise, that the destroying angel shall pass by them, as the children of Israel, and not slay them. Amen.
Word of Wisdom
LDS.org


My Obsession with Food
By Aleta Goodman Breakwell
http://lds.org/ldsorg/v/index.jsp?vgnextoid=2354fccf2b7db010VgnVCM1000004d82620aRCRD&locale=0&sourceId=c77c76e6ffe0c010VgnVCM1000004d82620a____&hideNav=1

A Principle with a Promise
President Ezra Taft Benson
Of the Quorum of the Twelve Apostles
http://lds.org/ldsorg/v/index.jsp?vgnextoid=2354fccf2b7db010VgnVCM1000004d82620aRCRD&locale=0&sourceId=da609c84f5d6b010VgnVCM1000004d82620a____

Cancer, Nutrition, and the Word of Wisdom
By William T. Stephenson, MD
Dr. Stephenson is a physician at Kansas City Cancer Center, Kansas City, Missouri.
http://www.lds.org/ldsorg/v/index.jsp?vgnextoid=2354fccf2b7db010VgnVCM1000004d82620aRCRD&locale=0&sourceId=86c33645a2cba110VgnVCM100000176f620a____&hideNav=1

The Do’s in the Word of Wisdom
By Lora Beth Larson
http://www.lds.org/ldsorg/v/index.jsp?vgnextoid=2354fccf2b7db010VgnVCM1000004d82620aRCRD&locale=0&sourceId=728c1f26d596b010VgnVCM1000004d82620a____&hideNav=1