Alternative
Health & Healing Newsletter
September, 2002
CONTENT
Guide to a Good Night’s Sleep
Insomnia Blends
Check Your Digestive Health…
Alzheimer’s In America: The Aluminum-Phosphate Fertilizer
Connection
Meningitis Vaccine Proven
to Cause Diabetes
Malnourished…with fruit and veggies? This Will Shock You!
Alternative Drug War
Resolution Elusive 4 Years Into Breast Implant Inquiry…FDA
Keeping Lid on Case
Eat Those Bananas!
Eat Your Vaccines
Guide
to a Good Night's Sleep
By: Dr. J. Mercola
If you are having sleep problems, whether you are not able
to fall asleep, wake up too often, don't feel well-rested
when you wake up in the morning, or simply want to improve
the quality and quantity of your sleep, try as many of the
following techniques below as possible
· Avoid
before-bed snacks, particularly grains and sugars. This will raise blood sugar and
inhibit sleep. Later, when blood sugar drops too low (hypoglycemia),
you might wake up and not be able to fall back asleep.
· Sleep
in complete darkness or as close as possible. When light hits the eyes, it disrupts the circadian rhythm
of the pineal gland and production of melatonin and seratonin.
There also should be as little light in the bathroom as
possible if you get up in the middle of the night.
· No
TV right before bed.
Even better, get the TV out of the bedroom or even out of
the house, completely. It is too stimulating to the brain
and it will take longer to fall asleep. Also disruptive
of pineal gland function for the same reason as above.
· Wear
socks to bed.
Due to the fact that they have the poorest circulation,
the feet often feel cold before the rest of the body. A
study has shown that this reduces night wakings .
· Read
something spiritual or religious. This will help to relax. Don't read anything stimulating,
such as a mystery or suspense novel, as this may have the
opposite effect. In addition, if you are really enjoying
a suspenseful book, you might wind up unintentionally reading
for hours, instead of going to sleep.
· Avoid
using loud alarm clocks.
It is very stressful on the body to be awoken suddenly.
If you are regularly getting enough sleep, they should be
unnecessary. I gave up my alarm clock five years ago and
use a dawn simulator which works by with an alarm to a dimmer
switch that gradually turns the light on to full intensity
over 45 minutes. I just love it as it is so gentle and if
I need more sleep, I get it without being startled or disrupting
my adrenals. Almost like a real dawn.
· Journaling. If you often lay in bed with your
mind racing, it might be helpful keep a journal and write
down your thoughts before bed. Personally, I have been doing
this for 15 years, but prefer to do it in the morning when
my brain is functioning at its peak and my coritsol levels
are high.
· Melatonin
and its precursors.
If behavioral changes do not work, it may be possible to
improve sleep by supplementing with the hormone melatonin.
However, I would exercise extreme caution in using it, and
only as a last resort, as it is a powerful hormone. Ideally
it is best to increase levels naturally with exposure to
bright sunlight in the daytime (along with full spectrum
fluorescent bulbs in the winter) and absolute complete darkness
at night. One should get blackout drapes so no light is
coming in from the outside. One can also use one of melatonin's
precursors, L-tryptophan or 5-hydroxytryptophan (5-HTP).
L-tryptophan is the safest and my preference, but must be
obtained by prescription only. However, don't be afraid
or intimidated by its prescription status. It is just a
simple amino acid.
· Get
to bed as early as possible.
Our systems, particularly the adrenals, do a majority of
their recharging or recovering during the hours of 11PM
and 1AM. In addition, your gallbladder dumps toxins during
this same period. If you are awake, the toxins back up into
the liver which then secondarily back up into your entire
system and cause further disruption of your health. Prior
to the widespread use of electricity, people would go to
bed shortly after sundown, as most animals do, and which
nature intended for humans as well.
· Check
your bedroom for electro-magnetic fields (EMFs). These can disrupt the pineal gland and the production
of melatonin and seratonin, and may have other negative
effects as well. To purchase a gauss meter to measure EMFs
try Cutcat at 800-497-9516. They have a model for around
$40. One doctor even recommends that people pull their circuit
breaker before bed to kill all power in the house (Dr. Herbert
Ross, author of "Sleep Disorders").
· Keep
the temperature in the bedroom no higher than 70%. Many people keep their homes and particularly the
upstairs bedrooms too hot.
· Eat
a high-protein snack several hours before bed. This can provide the L-tryptophan need to produce
melatonin and serotonin.
· Also
eat a small piece of fruit.
This can help the tryptophan cross the blood-brain barrier.
· Reduce
or avoid as many drugs as possible. Many medications, both prescription and over-the-counter
may have effects on sleep. In most cases, the condition,
which caused the drugs to be taken in the first place, can
be addressed by following the guidelines elsewhere on this
web site.
· Avoid
caffeine.
A recent study showed that in some people, caffeine is not
metabolized efficiently and therefore they can feel the
effects long after consuming it. So an afternoon cup of
coffee (or even tea) will keep some people from falling
asleep. Also, some medications, particularly diet pills
contain caffeine.
· Alarm
clocks and other electrical devices. If these devices must be used, keep them as far away from
the bed as possible, preferably at least 3 feet.
· Avoid
alcohol. Although alcohol will make people
drowsy, the effect is short lived and people will often
wake up several hours later, unable to fall back asleep.
Alcohol will also keep you from falling into the deeper
stages of sleep, where the body does most of its healing.
· Lose
weight. Being overweight can increase the
risk of sleep apnea, which will prevent a restful nights
sleep.
· Avoid
foods that you may be sensitive to. This is particularly true for dairy and wheat products,
as they may have effect on sleep, such as causing apnea,
excess congestion, gastrointestinal upset, and gas, among
others.
· Don't
drink any fluids within 2 hours of going to bed. This will reduce the likelihood of needing to get
up and go to the bathroom or at least minimize the frequency.
· Take
a hot bath, shower or sauna before bed. When body temperature is raised in the late evening, it
will fall at bedtime, facilitating sleep,
· Remove
the clock from view.
It will only add to your worry when constantly staring at
it... 2 AM...3 AM... 4:30 AM...
- Keep Your Bed For Sleeping.
If you are used to watching TV or doing work in bed, you
may find it harder to relax and to think of the bed as a
place to sleep.
- Have your adrenals checked
by a good natural medicine clinician. Scientists have found that Insomnia may be caused by adrenal stress (Journal
of Clinical Endocrinology & Metabolism, August 2001;
86:3787-3794)?
- If you are menopausal
or perimenopausal, get checked out by a good natural medicine
physician. The hormonal changes at this time may cause problems
if not properly addressed.
Insomnia Blends
From “The Fragrant Mind by
Valerie Ann Worwood
Here are a few blends to try on those restless nights.
# 1 Insomnia - Nightmares
Wake You - Lavender 15 drops; Roman Chamomile 5 drops; Mandarin
10 drops
# 2 Insomnia - Noise Wakes You - Lavender 10 drops; Lemon 15 drops;
Vetiver 5 drops
# 3 Insomnia - Restlessness - Vetiver 10 drops; Clary Sage 10 drops;
Lemon 10 drops
# 4 Insomnia - Fitfulness - Marjoram 5 drops; Lavender 15 drops; Lemon
10 drops
# 5 Insomnia - Anxiety - Chamomile Roman 10 drops; Sandalwood 15 drops;
Lemon 5 drops
#6 Insomnia - Worry - Cistus 5 drops; Lavender 15 drops
# 7 Insomnia - Exhaustion - Valerian 5 drops; Lemon 10 drops; Mandarin
10 drops
Prepare blend.
How to use:
Add up to 10 drops of a blend
in a warm bath.
Use in a diffuser.
Add blend
to 1 oz. carrier oil and use for massage.
Place 1-2 drops on a cotton
ball and place under your pillow.
Check
Your Digestive Health…
Your stool can be an important
tool to help you assess your digestive health.
Few of us are comfortable talking about what goes on (or doesn't go on) in
our private moments in the bathroom - even with our own physician. That's
too bad because your stool can be surprisingly revealing about your health
status.
Elimination varies from person to person, but for optimum health, you should
eliminate 2-3 times a day (one time for each meal). Bowel transit time should
be about 12 hours. Healthy bowel movements should be brown to light brown,
light enough to float, bulky (not compacted), and easy to pass. Although
it is normal for stool to have some odor, it shouldn't be strong or pungent
(signs of increased bowl transit time and a diet too high in animal proteins
and saturated fat.) If you don't fit this model, you are not alone. Here
are a few things to watch for:
-Bloody or mucous-covered stools can be a sign of Crohn's disease, ulcerative
colitis or even colon cancer. It can also be a sign of hemorrhoidal inflammation
and irritation. Report symptoms like these to your physician right away.
-Thin, ribbon-like or flattened stools are usually the sign of an obstruction
like a polyp that narrows the elimination pathway. It can also be a sign
of Irritable Bowel Syndrome (I.B.S.) or spastic colon.
-Stools that are large, messy and leave a film in toilet water can be a sign
of malabsorption. If the problem is chronic, consider consulting with a qualified
health professional. Malabsorption problems can lead to nutritional deficiencies.
-Abnormally fatty stools may be a sign of pancreatitis, inflammation of the
pancreas that can lead to diabetes.
-Extremely foul-smelling stools may mean you have a deficiency of "friendly
bacteria" that inhabit your intestines, a diet too high in red meat
protein, or Candida yeast overgrowth.
-Greenish stools may mean you should cut down on sugar. If you are a vegetarian
who doesn't consume a lot of sugar, it may mean you need more whole grains
in your diet.
-Pale, greyish stools can be a sign of liver or gallbladder problems.
-Black, tar-like stools may mean you have bleeding in your upper digestive
tract. Report these symptoms to your physician right away.
-Dark brown stools can be the result of too much salt in the diet.
Do you need a colon cleanse? Decaying food ferments, forms gases as well
as 2nd, even 3rd generation toxins, and the colon becomes a breeding ground
for putrefactive bacteria, viruses, parasites, yeasts and more. Most naturopaths
believe that this old, infected material in bowel pockets (diverticulosis)
which often reabsorbs into the body and nearby organs, is a cause for up
to 90% of all disease.
Remember. Healthy intestines are our body's second immune system. To find
out the benefits of a digestive/colon cleanse, go to www.ghchealth.com and
check out our Oxy-Powder.
Alzheimer's
in America:
The Aluminum-Phosphate Fertilizer Connection
by Lynn Landes
Americans are losing their minds to Alzheimer's
disease. It's an epidemic. And it's not typical of what's going
on in the rest of the world.
The World
Health Organization (WHO) estimates that there are 18 million
people with Alzheimer's. Over 4 1/2 million Americans have
the disease. We account for 25% of all Alzheimer's cases,
even though we represent only 4.6% of the world's population.
Europe is experiencing half our rate of disease. For
Americans over 85 years of age, 50% are thought to have Alzheimer’s.
The question
is, "Why?"
Alzheimer's
was first discovered in 1906. It is not a part of normal aging,
says the National Institutes of Health (NIH). The NIH
contends that the cause of Alzheimer's is "not known." They
say, "Prior theories regarding the accumulation of aluminum,
lead, mercury, and other substances in the brain have been
disproved."
Don't believe
that. Federal agencies have a talent for not finding
environmental causes for many diseases. They live by the motto, "Do
not seek and thou shall not find." Genetic triggers
and lifestyle choices get the research dollars for pretty
obvious reasons - their findings don't hurt polluters’ profits.
The world's
scientists and government researchers have not taken aluminum
off the scientific table as a causal factor in Alzheimer's.
Research scientists with the International Aluminum Network
report, "Aluminum has been implicated ...as a potential
factor or cofactor in the Alzheimer's syndrome, as well as
in the etiopathogenesis of other neurodegenerative diseases,
Parkinsonism, Amyotrophic Lateral Sclerosis and other diseases." That's
a mouthful, but you get the picture.
Initially,
it was thought that aluminum might be the sole cause of Alzheimer's.
Persons with Alzheimer's have been found to experience increased
absorption of aluminum in the brain, as well as exhibit densities
of senile plaques and neurofibrillary tangles. However, there
are reports that suggest plaques and tangles do not always
signify Alzheimer's, and vice versa.
Further clouding
the issue are patients on kidney dialysis machines. They are
unable to excrete aluminum, plus they may also be treated
with medicines that include aluminum. However, reports say
that dialysis patients don't develop Alzheimer's, although
they can develop dialysis dementia if the equipment doesn't
filter out aluminum. And therein lies a clue.
The process
of kidney dialysis requires very purified, non-fluoridated
water. What does this mean? Perhaps fluoride is aluminum's
partner-in-crime.
In 1998 Julie
Varner and two colleagues published research on the effects
of aluminum-fluoride and sodium-fluoride on the nervous system
of rats. They concluded, "Chronic administration
of aluminum-fluoride and sodium-fluoride in the drinking water
of rats resulted in distinct morphological alterations of
the brain, including the effects on neurons and cerebrovasculature." In
layman's terms, it looked like fluoride and aluminum could
cause Alzheimer's.
That was not
a definitive study, but they may have been onto something.
Aluminum is in our drinking water, foods, and many consumer
products. Adding fluoride to drinking water in the U.S. started
in the 1950's. America's drinking water is now over 60% fluoridated.
Fluoride appears in many processed foods and beverages made
with fluoridated water. Keep in mind, Europe has half our
rate of Alzheimer’s. They don't fluoridate their water supplies,
but they do use fluoride supplements and dental products. Is
there a connection?
There are
other intriguing issues. Why do people with thyroid disease
have an increased risk for Alzheimer's? In the U.S.,
thyroid disease has reached even greater epidemic levels than
Alzheimer's, with as many as 20 million American victims.
Besides problems with iodine intake, a common cause of thyroid
disease is radiation.
There are
also striking similarities between Alzheimer's, Creutzfeldt-Jacob-Disease
(CJD), and mad cow disease. Mad cow has been linked to livestock
feed and fertilizer.
So, what do
radiation, livestock feed, fluoride, and fertilizer have in
common which may have led to the emergence of the Alzheimer’s
epidemic? The phosphate fertilizer industry.
"Fertilizer
use was not a common practice in the United States until after
1870, when phosphate and lime were applied to crops like cotton
and tobacco. By the end of World War II, an era of intensive
agriculture began…," says Cargill Fertilizer. "Of
the phosphate produced in Florida, about 95% is used in agriculture
(90% goes into fertilizer and 5% into livestock feed supplements)." The
remaining 5% is used in a variety of foods and beverages,
plus personal care, consumer and industrial products.
George Glasser
writes in the Earth Island Journal, "Radium wastes from
filtration systems at phosphate fertilizer facilities are
among the most radioactive types of naturally occurring radioactive
material wastes...Uranium and all of its decay-rate products
are found in phosphate rock, fluorosilicic acid (fluoride)
and phosphate fertilizer."
The Florida
Institute of Phosphate Research says, "Removal of uranium
as a product is no longer profitable and all of the extraction
facilities have been dismantled. The uranium that remains
in the phosphoric acid and fertilizer products is at a low
enough level that it is safe for use." That's not
reassuring. Chronic exposure to low levels of contamination
can be as dangerous, or more so, than chronic high levels
of exposure or acute occurrences.
Of particular
interest is calcium silicate, another byproduct of the phosphate
fertilizer industry. One of its uses is as an anti-caking
agent in iodized table salt. Is calcium silicate also radioactive?
Would that have a significant impact on the thyroid? Given
the relationship between Alzheimer's and thyroid disease,
Alzheimer's may be destined to increase exponentially.
The phosphate
fertilizer industry seems to be the common thread in Alzheimer's
- and maybe also in thyroid and mad cow type diseases. Aluminum
by itself may not cause Alzheimer's, but in combination with
the radioactive products of the phosphate fertilizer industry,
it could be wreaking havoc on our health.
Whatever the cause, we deserve
real answers to the Alzheimer's epidemic, not the red herrings
of research on genetics and lifestyle. The number of American
victims is totally out of proportion to the incidence of Alzheimer's worldwide. Something truly has
gone terribly wrong.
Meningitis Vaccine Proven to Cause Diabetes
The prestigious peer reviewed journal Autoimmunity published data this week
by Dr. J. Bart Classen, an immunologist at Classen Immunotherapies, and David
Carey Classen, an infectious disease specialist at the University of Utah,
proving a causal relationship between the hemophilus vaccine and the development
of insulin dependent diabetes. The data is particularly disturbing because
it indicates the risk of the vaccine exceeds the benefit. The findings are
expected to allow many diabetics to receive compensation for their injuries
and lead to safer immunization.
The study followed over 100,000 children which had been randomized in a large
clinical trial to receive 1 or 4 doses of the hemophilus vaccine and over
100,000 unvaccinated children. After 7 years the group receiving 4 doses
of the vaccine had a statistically significant 26% elevated rate of diabetes,
or an extra 54 cases/100,000 children, compared to children who did not receive
the vaccine.
By contrast immunization against hemophilus is expected to prevent only 7
deaths and 7 to 26 cases of permanent disability per 100,000 children immunized.
The study showed that almost all of the extra cases of diabetes caused by
the vaccine occurred between 3-4 years after vaccination. Furthermore the
paper provides new data proving the vaccine causes diabetes in mice and reviews
data from 3 smaller human studies, which all had similar results to the current
study, but were too small to reach statistical significance.
"Our results conclusively prove there is a causal relationship between immunization
schedules and diabetes. We believe immunization schedules can be made safer," stated
Dr. Bart Classen.
The Classens' research is already becoming widely accepted. An independent
group of researchers working at a prestigious Swedish medical center recently
published a paper (Ann. N.Y. Acad Sci. 958: 293-296, 2002) supporting their
findings. Last year doctors attending a conference of the American College
for Advancement in Medicine overwhelmingly agreed that vaccines can cause
chronic diseases such as diabetes. For the latest information on the effects
of vaccines on insulin dependent diabetes and other autoimmune diseases visit
the Vaccine Safety Web site.
Autoimmunity August
2002 Vol. 35 (4), pp. 247-253
People with complex
problems look for complex solutions. Wrong! That is one of the problems with medicine today -- looking
for more and more complex solutions. People look
for complexities so that they can have an excuse for failure. ---Karl Loren
Malnourished…with
fruit and veggies? This will shock you!
By: Warren Matthews
This is a concept that you may have difficulty in accepting.
Nonetheless it is one that I have been ‘preaching’ for years
and has now been confirmed by studies showing people in the
US, Canada and the UK are amongst the most malnourished in
the world. This is the case in spite of obesity reaching epidemic
proportions in the US. Malnourishment is without doubt a leading
factor in a wide variety of health problems including cancers.
Does this mean that overweight people are eating all the food
to the detriment of the rest of the population? Not at all!
In fact, obese people figure prominently amongst those people
who are malnourished.
I can sense you thinking... ”That’s a crazy statement”. After
all, when you think of someone being malnourished your mind
flashes to pictures which you have seen on TV of starving
children in Africa. How can an overweight person be malnourished?
Much easier than you think... please read on and I will explain.
The Problem is in the Food!
A recent analysis of a range of staple foods in Canada including
potatoes, tomatoes, bananas, apples, onion, broccoli etc,
etc was commissioned by The Globe and Mail and CTV news.
The results were predictable to some and a shock to others.
Let’s use potatoes as an example. This is what the analysis
found:
Over the last 50 years the potato has lost:
· 100%
of its Vitamin A
· 57%
of its Vitamin C and iron
· 28%
of its Calcium
· 50%
of its riboflavin
· 18%
of its thiamine
Of the seven nutrients analyzed only niacin levels had increased.
The results were similar for all the 25 fruits and vegetables
tested. One of the worst results was from broccoli in which
ALL nutrients had declined measurably including niacin with
Calcium down 63%.
The Globe and Mail and CTV used comparative figures from government
researchers for the years 1951, 1972 and 1999. These earlier
figures had been published in various scientific journals
in the UK including the British Food journal. Release of this
data in the US has been limited to a few alternative health
journals.
Tim Lang a professor at the centre for Food Policy in England
says as a further example of how our food has been degraded
is that you would now have to eat eight oranges today to get
the same amount of Vitamin A that your grandparents got from
eating just one orange.
What’s gone wrong?
That’s simple to explain. Consumer demand for cheaper and ‘good
looking’ food has over recent decades changed traditional
farming methods as well as distribution. A farmer used to
rotate his crops to suit his land and maximized his yields
through natural methods and then supplied his fresh produce
to his local market for distribution.
Regrettably that is largely the way of the past. Now, the
emphasis is on production, appearance, storability and transportability.
Nutritional value of fruits and vegetables is of virtually
no concern. As Dr Phil Warman, an agronomist and professor
of agricultural sciences at Nova Scotia Agricultural College
points out, “crops are bred to produce higher yields, to be
resistant to disease and to produce more visually attractive
fruits or vegetables, but little or no emphasis is placed
on their vitamin and mineral content.”
Unfortunately the situation is getting worse as more Corporations
become more vertically integrated and control the entire food
process from supplying the seeds through all the production
stages, and distribution. Because of these controls some farmers
have become little more than modern day serfs with almost
no options left to them other than contract to these major
conglomerates and conform to their ‘corporate’ farming methods.
Add to this the increasing foothold of GE engineered crops
where nutritional value is way down on the priority list and
this problem is going to become much, much more serious and
will I believe flow on to an elevation of health problems
such as cancer and brain disease which may well reach epidemic
proportions over the next couple of decades unless the public
wake up to what is happening.
Do foods that have low nutritional values play a part in obesity?
Absolutely! I believe this is a major factor in the current
epidemic of obesity. If you are lacking in essential nutrients
it will have a serious flow-on effect in your body. First
of all you will never really feel ‘well’, you will lack energy
which means you exercise less, and you will have a tendency
to seek out ‘comfort’ foods which generally contain sugars
and thus the cycle continues and it gets worse and worse and
ultimately ends up in obesity and ill health.
What can be done about this problem?
· Try
to eat organic fruit and vegetables wherever possible.
· Avoid
processed foods! If you think the loss of nutrient value in
fresh fruit and vegetables is bad enough, I can assure you
that it is nothing compared to the nutritional emptiness of
processed foods... and to add insult to injury they are full
of transfats due to the hydrogenated processing methods that
are used.
· Take
a QUALITY multi NUTRIENT supplement. A multi
vitamin/mineral tablet is not adequate for a number of reasons.
The prime one is that most ‘multi vitamin’ supplements use
synthetic ingredients with both questionable efficacy and
bio-availability and they lack other important nutrients.
Unfortunately this is an area in which many consumers are
being misled. It’s a complex subject and as such I may devote
a newsletter to this very important subject in the not to
distant future.
It was interesting to see that even some mainstream physicians
are beginning to recognize this problem as evidenced by a
recent article in JAMA which advocated people take quality
supplements for preventative measures.
Let's look
at the stats on American Healthcare: $1.3B industry, 1
out of 3 people get cancer, 1 out of 2 get heart disease,
obesity is at epidemic levels, 70% of children are getting
hardening deposits in their arteries as early as 12 years
of age. And here is the best one of all, in 1999 over
120,000 people died from prescription drugs. So what does
that tell you about how well we are doing as a society?
Alternative Drug War
By: Robert Watson, Vitamin
Research News
First, it was St. John's wort. Then, ephedra. And now, Ginkgo
biloba. One by one, some of the most effective herbal remedies
in American are coming under attack, often accompanied by
calls for modifying — or overturning — the Dietary Supplement
and Health Education Act (DSHEA) of 1994.
The attacks on herbal alternatives to prescription drugs are
increasing as the pharmaceutical industry struggles to protect
its image — and profits. This past May, one of the nation's
largest lobbying groups for older Americans accused six pharmaceutical
companies of paying competitors to keep affordable generic
drugs off the market. In filing suit against the companies,
the drug companies were accused of violating antitrust laws
and committing patent abuse to prevent the release of affordable
generic drugs used to treat anxiety, high blood pressure and
cancer.
This comes on top of allegations that the top US drug companies
are spending twice as much on advertising, marketing and administration
as they are on research and development, while drug prices
are skyrocketing. Noting that drug companies get a tax break
for research and development costs, Michigan Sen. Deborah
Stabenow pointed out that they also get to use — for free — the
results of basic research done at taxpayer expense by the
National Institutes of Health. "They get the write-off.
Then we give them a 20-year patent," Stabenow said. "We
protect them from competition for 20 years. And what do we
(the American taxpayers) get in the end? The highest (drug)
prices in the world."
As calls for greater regulation of the supplement industry
are increasingly sandwiched in between advertisements for "the
little purple pill" and Viagra, keep in mind that what
is at stake here is the continued choice of American consumers
for safe, effective and affordable health options. For almost
every pharmaceutical drug on the market, there is a natural
equivalent that is safer and cheaper, with a therapeutic benefit
that often equals or exceeds the more expensive, more dangerous
synthetic drug. And under DSHEA, the American supplement industry
continues to function with a degree of safety and customer
support that the pharmaceutical industry can only dream of.
Resolution elusive
4 years into breast-implant inquiry
FDA keeping lid on case involving
Irving manufacturer
By
JIM MORRIS / The Dallas Morning News 09/03/2002
WASHINGTON – Four years ago, the Food and Drug
Administration began a criminal investigation of Mentor Corp.,
a breast-implant manufacturer whose factory in Irving had
fallen into disfavor with FDA inspectors. The inquiry, conducted
by the FDA's Office of Criminal Investigations, remains open.
But that's about all anyone outside of the agency knows about
it.
"We would
love to get a better indication of what the focus might be," said
Josh Levine, Mentor's senior vice president for sales and marketing. "We
have asked repeatedly." Mentor says that any deficiencies
at the plant were minor and long ago corrected. Others suspect
the problems are more serious. In January 2000, James Austin
Templer quit his job as a Dallas-based FDA compliance officer
because, he said, he came to believe that the Mentor investigation
was a "sham," intended to keep inquisitors at bay. "The
agency has gone out of its way to ensure that the public does
not know" about potential health hazards associated with
Mentor's products, Mr. Templer said.
Members of the
House Energy and Commerce Committee have been pressing the FDA
for information, to little avail. "I'm questioning just
how 'active' this 'active investigation' is," said Rep.
Roy Blunt, R-Mo. Another committee member, Rep. Gene Green,
D-Houston, said there could be hearings if answers aren't forthcoming.
What is going on at Mentor's
Texas plant, which supplies saline- and silicone gel-filled
implants to women throughout the United States and Canada?
Because the FDA is not talking, implant recipients and would-be
recipients are left to wonder whether the products are safe.
And Mentor is left operating under a cloud, which the company
would like lifted before it asks the FDA to remove restrictions
on silicone implants. The FDA would not discuss the investigation
with The Dallas Morning News. Interviews with Mentor
officials, Mr. Templer and others indicate that it involves
the company's manufacturing practices, its handling of an
FDA-required clinical study, or both. Headquartered in Santa
Barbara, Calif., Mentor completed the move of its U.S. manufacturing
operation from Goleta, Calif., to Skyway Circle North in Irving
in the summer of 1994.
In 1995, the FDA began inspecting
breast-implant factories to determine whether they were making
sterile, uniform products and keeping records of patient complaints.
(The agency was still smarting from charges that it had been
slow to respond to concerns about silicone implants, which
some patients and physicians had blamed for debilitating illnesses.)
Mentor fared
poorly in its inspection, said Mr. Templer, who worked in the
FDA's Dallas district office. "They found a whole lot of
problems," he said, and a warning letter was issued at
his urging. The letter stated that Mentor, among other things,
had not investigated implant failures or patient complaints
in a timely fashion. Because of the criminal investigation,
the FDA will not publicly release Mentor inspection reports
dating to 1995. Clarke Scherff, the company's vice president
for regulatory compliance, said that FDA inspectors made routine
observations about the Irving plant during each of the reviews
and that Mentor took appropriate action.
Mr. Scherff said he was told
the plant was in full compliance with FDA regulations after
the most recent inspection in February. Mr. Levine said the
agency had never expressed doubts about the safety of Mentor's
implants. "If there had been any question at all, even
a remote question, they would have shut us down," he
said.
Employee
allegations
From
1995 through 1999, however, current and former Mentor employees
brought Mr. Templer a range of allegations. Saline implants
equipped with a certain type of valve tended to leak, they
said, and silicone implants may have been contaminated with
platinum and polyurethane. Some patients' complaints were
not being noted, the informants alleged, and manufacturing
processes were not being properly validated to ensure product
uniformity. "If a company
isn't manufacturing a product under a good state of control,
it's going to have a much higher rate of failure," said
Mr. Templer, who lives in Frisco.
Some of the same
informants were talking to Kim Hoffman, who received Mentor's
Siltex silicone implants in March 1995 and said she began suffering
from extreme fatigue, memory loss and a "burning, itchy
feeling" in her breasts. Ms. Hoffman, who lives in Niangua,
Mo., had the implants removed after eight months, and her health,
she said, gradually improved. But when she tried to report her
ailments to Mentor so they could be included in a clinical study,
she said, "they treated me like a litigation problem rather
than a patient and referred me to their lead counsel. They just
blew me off." Ms. Hoffman contacted the FDA and later
began talking to current and former Mentor workers, who told
her that her and other women's health problems had been excluded
from the study, upon which the agency depends to monitor complication
rates. "I was totally alarmed," Ms. Hoffman said.
Her fear, she said, is that "bad products are getting into
the market and there's a breakdown in the regulatory process
that allows them to stay on the market." She has sued Mentor,
alleging that it knowingly made a defective product and negligently
conducted the study.
Mr. Scherff said he could not
comment on Ms. Hoffman's allegations because of the lawsuit.
He did cite a 1999 FDA inspection report that concluded patient "complaints
received were handled [properly] and the appropriate records
maintained." Mentor also has been named in a class-action
lawsuit alleging that a valve on its saline implant, used
from 1984 to 1994, regularly failed. The company's response: "There
were no safety concerns with this product." The valve,
it said, was replaced with an even better device.
Throughout 1996 and 1997, Mr.
Templer continued to interview informants and pushed officials
at FDA headquarters to force Mentor into compliance. In May
1998, the company entered into a consent decree with the agency,
promising to subject itself to examination by outside experts
and improve its validation procedures. "It was purely
a documentation issue," Mr. Scherff said. Mentor used
the same validation techniques in Texas that it had in California,
where the district FDA office had no objection, he said.
"The Texas
FDA officials did not agree that the validations were adequate," Mr.
Scherff said, but found nothing that suggested an "increased
risk to women" and did not restrict or halt sales. Dr.
Harlan Pollock, a Dallas plastic surgeon, said he had used Mentor's
products for years and had "always found this company to
be very upfront and ethical. I've been very pleased." Currently,
only saline implants may be used for purely cosmetic breast
augmentation. After some patients and researchers contended
that silicone implants were prone to leakage and caused disease,
the FDA decreed in 1992 that the products would be available
only for breast reconstruction – following cancer surgery or
to fix a congenital deformity or a prior implant problem.
Results
of study
While
some studies have continued to raise questions about the
safety of silicone gel, others – notably, one published
by the Institute of Medicine two years ago – have found
no link between the substance and cancer or other serious
illnesses. Mentor
officials say they will ask the FDA, possibly next fall,
to allow silicone implants to be sold again for breast augmentation,
a larger market than reconstruction.
Mr. Levine,
of Mentor, said the company's implants are "unequivocally" safe.
But Ms. Hoffman and Mr. Templer, who began sharing information
in 1998, said problems at the plant went beyond the paperwork
issues that company officials described. According to a memorandum
written by Mr. Templer in December 1999, for example, one
former Mentor employee said in an affidavit that she and her
supervisor had been fired "after they prepared a series
of reports regarding very high field failure rates in Siltex
breast implants." She also alleged that Mentor destroyed
records that reflected negatively on its products.
Mentor sued
the woman for defamation after she made the allegations in
an unpublished letter to Forbes magazine in 1997. In
the suit, which was dismissed under confidential terms, the
company denied the charges and said the woman had been fired
for "deficient job performance" and violating company
policies. Neither Mentor nor the woman would comment. Mr.
Templer and Ms. Hoffman were instrumental in getting the FDA
to open a criminal inquiry of Mentor in the summer of 1998.
But by the end of 1999, Mr. Templer had become suspicious
and disheartened. He soon resigned.
Dr. Suzanne
Parisian, former chief medical officer in the FDA's Center
for Devices and Radiological Health, said the agency had been
reluctant to take harsh actions against breast-implant manufacturers. "A
whole culture has grown up dependent on these devices," said
Dr. Parisian, now a consultant in Front Royal, Va. "The
FDA is caught between a rock and a hard place."
COMMENT: Yes,
we have a culture that has grown up dependent
upon breast implants. And for those that truly have
a need, because of surgery or disease, there are certainly
other healthy avenues that can be explored for reconstruction. On
the other hand, we have a media who has made women feel
like if they are not "firm and large" that they
are somehow unattractive and can never hope to attract the
opposite sex. And, men have been made to believe,
through the same media, that if their wife/girlfriend doesn't
look like a super-model then somehow they have been cheated. So,
in the name of vanity (sorry, just a fact) thousands of
women have flocked into their doctor's office for this procedure
in hopes of becoming more attractive/desirable. Because
of this never-ending mass publicity through the media (magazines,
TV, movies, even Saturday morning cartoons and let's not
leave out Barbie) our society now associates large breasts
with sexiness and beauty. Too bad we have become so
superficial and peer dependant that women are willing to
put their health on-the-line in the name of "attractiveness." I
would assume that the many women that now suffer from debilitating
disease and pain wish they had been told the TRUTH! Ah..."truth"...another
topic all together! Unfortunately most can’t handle the
truth! Truth is that the immune system will attack anything that
is not supposed to be in the body…that is its job! It will
continually attack the implant causing, in time, leakage. Many
implants that have been removed have been encased with a
fungus growing on the outside. Again, we can thank
our FDA for remaining quiet. When will we actually
start to believe that "anything" that the FDA
deems as safe should be taken with a grain of salt? LL
Nothing in the
world can take the place of persistence. Talent will not;
nothing is more common than unsuccessful men with talent.
Genius will not; unrewarded genius is almost a proverb. Education
alone will not; the world is full of educated derelicts. Persistence
and determination alone are omnipotent. The slogan "press
on" has solved and always will solve the problems of
the human race. --- John Calvin Coolidge
Eat Those Bananas!
Banana... If you want a quick fix for flagging energy levels
there's no better snack than a banana. Containing three
natural sugars - sucrose, fructose and glucose - combined
with fiber, a banana gives an instant, sustained and substantial
boost of energy. Research has proved that just two bananas
provide enough energy for a strenuous 90-minute workout. No
wonder the banana is the number one fruit with the world's
leading athletes. But energy isn't the only way a banana can
help us keep fit. It can also help overcome or prevent a substantial
number of illnesses and conditions making it a must to add
to your daily diet.
Anemia: High in iron, bananas can stimulate
the production of hemoglobin in the blood and so helps in
cases of anemia.
Blood Pressure: This unique tropical fruit is extremely
high in potassium yet low in salt, making it the perfect to
beat blood pressure. So much so, the US Food and Drug Administration
has just allowed the banana industry to make official claims
for the fruit's ability to reduce the risk of blood pressure
and stroke.
Brain Power: 200 students at a Twickenham
(Middlesex) school were helped through their exams this year
by eating bananas at breakfast, break and lunch in a bid to
boost their brain power. Research has shown that the potassium-packed
fruit can assist learning by making pupils more alert.
Constipation: High in fiber, including bananas
in the diet can help restore normal bowel action, helping
to overcome the problem without resorting to laxatives.
Depression: According to a recent survey undertaken
by MIND amongst people suffering from depression, many felt
much better after eating a banana. This is because bananas
contain trypotophan, a type of protein that the body converts
into serotonin known to make you relax, improve your mood
and generally make you feel happier.
Hangovers: One of the quickest ways of
curing a hangover is to make a banana milkshake, sweetened
with honey. The banana calms the stomach and, with the help
of the honey, builds up depleted blood sugar levels, while
the milk soothes and re-hydrates your system.
Heart-burn: Bananas have a natural antacid effect
in the body so if you suffer from heart-burn, try eating a
banana for soothing relief.
Morning
Sickness: Snacking on bananas between
meals helps to keep blood sugar levels up and avoid morning
sickness.
Mosquito
bites: Before reaching for the insect bite
cream, try rubbing the affected area with the inside of
a banana skin. Many people find it amazingly successful
at reducing swelling and irritation.
Nerves: Bananas are high in B vitamins that
help calm the nervous system. Overweight and at work? Studies
at the Institute of Psychology in Austria found pressure at
work leads to gorging on comfort food like chocolate and crisps.
Looking at 5,000 hospital patients, researchers found the
most obese were more likely to be in high-pressure jobs. The
report concluded that, to avoid panic-induced food cravings,
we need to control our blood sugar levels by snacking on high
carbohydrate foods every two hours to keep levels steady.
PMS: Forget the pills eat a banana. The
vitamin B6 it contains regulates blood glucose levels, which
can affect your mood.
Ulcers: The banana is used as the dietary
food against intestinal disorders because of its soft texture
and smoothness. It is the only raw fruit that can be eaten
without distress in over-chroniculcer cases. It also neutralizes
over-acidity and reduces irritation by coating the lining
of the stomach.
Temperature
Control: Many other cultures see bananas
as a 'cooling' fruit that can lower both the physical and
emotional temperature of expectant mothers. In Thailand,
for example, pregnant women eat bananas to ensure their
baby is born with a cool temperature.
Seasonal
Affective Disorder (SAD): Bananas
can help SAD sufferers because they contain the natural
mood enhancer, trypotophan.
Smoking: Bananas can also help people trying
to give up smoking The B6, B12 they contain, as well as the
potassium and magnesium found in them, help the body recover
from the effects of nicotine withdrawal.
Stress: Potassium is a vital mineral, which
helps normalize the heartbeat, sends oxygen to the brain and
regulates your body's water-balance. When we are stressed,
our metabolic rate rises, there by reducing our potassium
levels. These can be re-balanced with the help of a high-potassium
banana snack.
Strokes: According to research in 'The
New England Journal of Medicine' eating bananas as part of
a regular diet can cut the risk of death by strokes by as
much as 40%!
Warts: Those keen on natural alternatives swear that, if you
want to kill off a wart, take a piece of banana skin and place
it on the wart, with the yellow side out. Carefully hold the
skin in place with a plaster or surgical tape! So you
see a banana really is a natural remedy for many ills. When
you compare it to an apple, it has four times the protein,
twice the carbohydrate, three times the phosphorus, five times
the vitamin A and iron, and twice the other vitamins and minerals.
It is also rich in potassium and is one of the best value
foods around. So maybe its time to change that well-known
phrase so that we say, "A Banana a day keeps the doctor
away!"
Eat your Vaccines
Allan N. Spreen, MD
Recently there was an article
published in "Nature Science Update" describing
experiments to incorporate vaccines within plant life, so
that immunizations could be administered orally in the form
of vegetables instead of needles.
For those not predisposed to the joys of having needles stuck in their bodies,
this has the ring of amazing convenience. We're talking one of those incredible
advances in modern medicine here, a technological quantum leap.
I guess I'm weird (probably not much doubt about that) but I had a slightly
different reaction/horror.
The venerable Dr. Joseph Mercola said it best; "This is one genie that
should be left in its bottle." How right I believe he is.
There is more than one issue here. I'd certainly prefer to eat my vaccine,
like the old sugar cube deal for polio when I was a kid, rather than have
somebody shove a nail in me. Whatever your beliefs concerning immunizations
and their side effects, this route of delivery sounds pretty desirable.
However, three small issues come to mind (though I'll bet there are lots
more): first, wouldn't you like to know when you're getting a drug that someone
else has decided you need? Since spinach leaves with or without the
drug would presumably look the same you could have a problem there. What
if the drug adversely affects a developing fetus, or reacts against certain
drugs, or causes side effects in certain types of people? We've already
had our wake-up call with StarLink corn, a genetic variant that was 'supposed'
to be only for farm animals, and never meant to reach human consumption.
Too late. It's now everywhere, whatever the long-term affects of this mutant
strain, and it can't be stopped.
Before you assume I'm over-reacting, there are a couple of other issues.
Second, wouldn't you like to know just who has decided what new drug should
be administered to your body? With this neat new route of delivery it's no
longer your family doc, nor is it anyone else you can readily identify. You
won't know for sure how many drugs are being administered, or their purpose,
so you can't look into what testing was done, what a drug company did to
get approval, or why someone wants a certain medication inside you.
But say you're a trusting soul (not recommended for those with only one body
to inhabit). There's still that third little issue. This one's already an
issue today, with the use of fluoride in our water supplies. Whether you
are pro or con in the fluoride controversy, there is one simple problem that
nobody can dispute: You can't control the dose.
In the case of water delivery, there are sumo wrestlers who don't drink much
water, and there are little old ladies who drink lots of water, constantly.
Few (and no rational) individuals argue that either fluoride or any vaccine
is harmless at any dose level. These agents have toxicities, some of them
are unknown, and some are unquestionably dose-related.
In the case of vaccines in your salad, spinach lovers like Popeye could have
a real problem, while your veggie-phobic, junk food junkie teenager ends
up getting no "protection" at all.
Yeah, I know, we could all force down the veggie that we KNOW contains the
vaccine. But then you're still back to the StarLink corn situation (which
is now unstoppable and no longer a theoretical problem): How do you keep
the drug veggie away from the organic farm next door...or ANYBODY'S farm?
This is one horse that doesn't seem to be quite out of the barn yet. I'm
going to continue studying this issue and will let you know how you can get
involved to keep our vegetable supply drug free.
COMMENT: While I agree
with what Dr. Spreen is saying, I guess that I would be
much more bold in getting across that vaccines are not conducive
to health. I don’t know about you, but I don’t want any
kind or form of vaccine in my body…no matter what the delivery
system is! The remote possibility of this happening should
make the American public “scream” in horror! Chances are
we will not hear much screaming and people will willingly
line up at the supermarket cash register to purchase their
vaccines in vegetable form. Does this sound way-out to
you? Unless we get serious about our health and how the
government is trying to control it…veggies with vaccines
may be just around the corner. LL
SPEAKING SCHEDULE:
“The Cause, Prevention & Elimination
of Degenerative Disease”
An Evening
with
Dr. Edward F. Group III, D.C., Ph.D,
N.D.
September 26, 2002 (Thursday from 7:00 – 10:00 p.m.)
Leisure Learning
Greenway Plaza: Richmond/Kirby
Houston, TX 713.529.4414 (reserve your place early
as seating is limited)
www.llu.com
(If you live in or near Houston you will not want to miss
this exciting information about how to get and keep the
body healthy. We encourage people that are experiencing
disease and those who want to get/stay healthy to attend
this all-informative seminar. You will be amazed with the
information presented in this 3-hour seminar!)
“Cellular Consciousness
and Disease: Has Science Been Wrong?”
Workshop/Seminar with
Dr. Edward F. Group III, D.C., Ph.D,
N.D.
October 11-13, 2002 (Dr. Group will speak Friday and Sunday)
Florida Chiropractic Association
Orlando, Florida
Contact: Logan @ 407.740.8801 (CE hours available)
“Cellular Consciousness: Has
Science Been Wrong?”
By:
Dr. Edward F. Group III, D.C., Ph.D,
N.D.
October 19-20, 2002 (Dr. Group will speak Saturday)
Wellness Expo & Clean Air Festival
Addison Conference Centre
15650 Addison Road
Dallas, Texas
Info: 972.378.3770
“Cellular Consciousness & Disease: Has
Science Been Wrong?”
Global Healing Center,
Inc.
Presents
A “Cutting-Edge – Total Health” Seminar & Workshop
Featuring
Dr. Edward F. Group III, D.C., Ph.D, N.D.
November 2,
2002 (Saturday, 8:30 a.m. – 5:30 p.m.)
Mission Valley Hilton
901 Camino del Rio South
San Diego, California
Registration Fee: $99/postmarked
by Sept. 30; $125/postmarked by Oct. 15; $145 after Oct.15
Info: 619.303.6904 or 281.383.0038
Certificates will be presented to all participants
for 6 hours in Advanced, Alternative Medicine.
If you would like to have Dr. Group speak at your church,
organization or civic group or know of an organization
that would benefit from this seminar, please contact us
at 281.383.0038.
DISCLAIMER: It is your constitutional right to educate yourself in health and medical
knowledge, to seek helpful information and make use of it
for your own benefit, and for that of your family. You
are the one responsible for your health. In order
to make decisions in all health matters, you must educate
yourself. The views and nutritional advice expressed by
Global Healing Center are not intended to be a substitute
for conventional medical service. If you have a severe medical
condition, see your physician of choice. We do not claim
to "cure" disease, but simply help you make physical
and mental changes in your own body in order to help your
body heal itself.
PLEASE PASS THIS NEWSLETTER ON TO OTHER POTENTIAL SUBSCRIBERS.
“He who does not use
his endeavors to heal himself is a brother to him who
commits suicide.”
Proverbs 18:9 (Amplified)
