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ALZA ANNOUNCES FDA APPROVAL
OF ONCE-DAILY CONCERTAT (CII), FOR ADHD
ATTENTION DEFICIT HYPERACTIVITY
DISORDER
First to Offer Full-Day ADHD
Symptom Control That "Lasts From Home to Homework"
MOUNTAIN VIEW, Calif., August 1, 2000 - ALZA Corporation (NYSE: AZA)
announced today that it has received approval from the U.S. Food &
Drug Administration (FDA) to market ConcertaT (methylphenidate HCl)
extended-release tablets (CII) for the treatment of attention deficit
hyperactivity disorder (ADHD) in patients age six and older. Developed
on behalf of Crescendo Pharmaceuticals Corporation (Nasdaq: CNDO),
ConcertaT is expected to be available by prescription before the start
of the 2000 school year.
Until ConcertaT, there was no once-daily methylphenidate medication
for ADHD that worked effectively throughout the day. Some other forms of
medication may require two or three doses per day to achieve the desired
improvement in symptoms. ConcertaT uses an advanced OROS®
patterned-release delivery system. The OROS® system has been used
safely for nearly 20 years in widely accepted prescription and
over-the-counter medications, including medications taken by children.
"For patients taking ConcertaT, the need for in-school and
after-school dosing will be eliminated," said Timothy E. Wilens,
M.D., Associate Professor of Psychiatry, Harvard Medical School,
Massachusetts General Hospital. "That's especially important for
kids with after-school activities and homework. Using this once-a-day
medication for ADHD can also help to eliminate the feelings of
embarrassment that children may have when taking medication in the
middle of the school day or during after-school activities."
"When Max was first diagnosed with ADHD and put on medication,
we noticed an immediate improvement in his symptoms," said Francine
Padrid, mother of a 13-year old boy enrolled in the clinical trial.
"The problem was he had to take the medication several times a day.
With ConcertaT, he only has to take it once in the morning. That's great
because he doesn't have to take his medication at school or hurry home
after school."
ConcertaT: Efficacy from "Home to Homework" "This is a
very exciting time for all the employees of ALZA, who have worked for
many years to fill an important need in the treatment of ADHD,"
said Dr. Ernest Mario, Chairman and C.E.O. of ALZA Corporation. "ALZA,
in partnership with McNeil Consumer Healthcare, is committed to
responsibly educating parents, physicians, and other health care
professionals about the importance of properly diagnosing and treating
ADHD and the role of ConcertaT as part of a total treatment
program."
The efficacy of ConcertaT was evaluated in three double-blind,
active- and placebo-controlled studies of 416 children from the ages of
six through 12. The product was evaluated in multiple settings --
including community schools, laboratory schools (specialized schools
used to monitor children with ADHD for treatment evaluation purposes),
and at home.
ConcertaT qd (18, 36, or 54 mg) was compared to methylphenidate given
tid (15, 30, or 45 mg total daily dose) over 12 hours and placebo in
three double-blind trials in patients aged 6 to 12 years old. In these
three studies, teachers and parents consistently reported a
statistically significant improvement in attention and reduction in
overactivity throughout the day among children taking once-daily
ConcertaT versus placebo.
Both teachers and parents used the IOWA Conners scale, one of the
most commonly used and recognized scales for evaluating children with
ADHD in clinical studies. The IOWA Conners scales rate inattention and
overactivity on a scale from one to 15, with lower numbers representing
improved behavior. In one of the three studies, a large-scale 13-center
trial including 282 children between the ages of six and 12, community
teachers using the IOWA Conners scale rated children an average of 5.98
for ConcertaT and 9.77 for placebo.
Background on OROS® Technology - ConcertaT employs an advanced form
of ALZA's OROS® technology, which uses osmotic pressure to deliver
medication at a controlled rate. This technology features a
semipermeable rate-controlling membrane surrounding an osmotic core,
which contains a push layer and a drug layer. Once in the body's
gastrointestinal tract, water enters the osmotic system and dissolves or
suspends the drug in the tablet's core. The drug is then released
through a laser-drilled hole in the membrane at a controlled rate. This
can be a significant benefit for patients by providing controlled
symptom relief and reducing the number of daily doses compared to
conventional therapies. "The advantage of ConcertaT is that the
outer layer of medication provides an immediate release of
methylphenidate within one hour, while the inner layers provide
medication to sustain effect through the school day and into the early
evening," said James M. Swanson, PhD., director of the Child
Development Center and professor of Pediatrics and Cognitive Sciences,
University of California, Irvine. "This system provides smooth drug
levels throughout the day that minimizes the peak and trough blood
fluctuations associated with repeated dosing of immediate release MPH
products." ConcertaT is available in 18 mg and 36 mg tablets. It
should be taken in the morning, with or without breakfast. ConcertaT
tablets must be swallowed whole with the aid of liquid and must not be
chewed, divided, or crushed. In the largest controlled clinical study
with patients using ConcertaT, the most common side effects reported
were headache (14%), upper respiratory tract infection (8%), stomach
ache (7%), vomiting (4%), loss of appetite (4%), sleeplessness (4%),
increased cough (4%), sore throat (4%), sinusitis (3%), and dizziness
(2%).
ConcertaT should not be taken by patients who: have significant
anxiety, tension, or agitation, since ConcertaT may make these
conditions worse; are allergic to methylphenidate or any of the other
ingredients in ConcertaT; have glaucoma, an eye disease; have tics or
Tourette's syndrome, or a family history of Tourette's syndrome; or who
are taking a prescription monoamine oxidase inhibitor (MAOI). ConcertaT
should be given cautiously to patients with a history of drug dependence
or alcoholism. Chronic abusive use can lead to marked tolerance and
psychological dependence. ConcertaT should not be used in children under
6 years, since safety and efficacy in this age group have not been
established. ConcertaT should not be administered to patients with
preexisting severe gastrointestinal narrowing.
The Facts About ADHD. ADHD is a medical condition characterized by
symptoms of inattention and/or hyperactivity- impulsivity that affects
millions of children and adults, often having a significant impact on a
person's life. According to the National Institutes of Health (NIH),
ADHD is one of the most common mental disorders among children. Today,
ADHD affects approximately three to five percent of the U.S. school-age
population, with boys diagnosed three to four times more often than
girls.
Establishing a diagnosis of ADHD (according to the Diagnostic and
Statistical Manual of the American Psychiatric Association) requires
that symptoms of inattention and/or hyperactivity-impulsivity have
persisted for at least 6 months and that they are more frequent and
severe than typically seen in individuals at a comparable level of
development.
Some symptoms of ADHD must have been present before age seven, with
some present in at least two settings (for instance, at school and at
home). There must also be impairment from the symptoms in two or more
settings (e.g. at school, work, and at home). While most people with
ADHD have symptoms of both inattention and hyperactivity-impulsivity,
one symptom pattern may predominate, resulting in three different
subtypes: predominately hyperactive-impulsive type, predominately
inattentive type, and combined type.
Under a previously announced agreement, ConcertaT will be co-promoted
in the United States by McNeil Consumer Healthcare, a Johnson &
Johnson (NYSE: JNJ) company.
ALZA Corporation, headquartered in Mountain View, Calif., is a
research-based pharmaceutical company with leading drug delivery
technologies. The company applies its delivery technologies to develop
pharmaceutical products with enhanced therapeutic value for its own
portfolio and for many of the world's leading pharmaceutical companies.
ALZA's sales and marketing efforts are focused on urology, oncology and
central nervous system products.
NOTE: Copies of ALZA's news releases, quarterly reports and corporate
fact sheets are available through ALZA's automated fax line at
800-859-5910. ALZA news releases also can be found on the World Wide Web
at http://www.alza.com. Full prescribing information for ConcertaT is
available upon request.
Attention Deficit Disorder and ADHD...A New, Non-Drug,
Natural Approach*
http://www.healthysource.com/add.html
U.S. Patent Awarded for Treating Attention
Deficit/Hyperactivity Disorder.
U.S. Patent Number: 5,719,178 Date: Feb. 17, 1998
"Finally, help and hope for ADD/ADHD sufferers ... a powerfully
effective and totally safe natural non-drug alternative for all
ages."
Attention Deficit Disorder and ADHD...
Scientifically Safe and Natural Non-Drug Alternative
Are you, your child, or a friend suffering from Attention Deficit
Disorder or ADHD? ADD (and ADHD) is a baffling and frustrating disorder
not only for those
who have the condition, but also for their loved ones and our nation's
dedicated doctors who attempt to treat it.
The frustration among physicians is due to the fact that science has
not yet identified the cause or causes of ADD. Thus, the subjects of
cause, and therefore a precisely appropriate treatment for the condition
are still two very large question marks.
A prominent neurologist states, "The more you study
hyperactivity or ADD, the less certain you are as to what it is, or
whether it is a thousand different situations all called by the same
name." (5) "No single cause has yet been identified for ADHD.
In fact, ADHD will probably one day prove to be an umbrella term for a
number of associated disorders." (3) "There is no identified
cause specific to ADD... We are left with the possibility that ADD may
be a catch-all condition." (13) "The cause of ADD and ADHD is
not known, but structural abnormalities have been ruled out. The leading
suspect appears to be problems with neurotransmitters, possibly
associated with decreased activity or stimulation in the upper brainstem
and frontal midbrain. There is also suspicion that toxins, environmental
problems, or neurologic immaturity could be causative factors." (8)
There are many theories as to ADD's cause, but as yet no facts. This
explains why practically all physicians in the U.S. currently attempt to
simply mask patients' symptoms of the disorder with powerful drugs, as
their only alternative. The problem with drug treatment of ADD, however,
are the frequent and dangerous side effects they produce. More on that
in a moment.
"The American Psychiatric Association lists fourteen signs, of
which at least eight must be present for a child to be officially
classified as ADD.
These fourteen signs are:
- Often fidgeting with hands or feet, or squirming while seated.
- Having Difficulty remaining seated when required to do so.
- Being easily distracted by extraneous stimuli.
- Having difficulty awaiting turn in games or group activities.
- Often blurting out answers before questions are completed.
- Having difficulty in following instructions.
- Having difficulty sustaining attention in tasks or play
activities.
- Often shifting from one uncompleted task to another.
- Having difficulty playing quietly.
- Often talking excessively.
- Often interrupting or intruding on others.
- Often not listening to what is being said.
- Often forgetting things necessary for tasks or activities.
- Often engaging in physically dangerous activities without
considering possible consequences.
Here is another point to consider: "Official guidelines for
evaluating ADD symptoms are vague and open to interpretation - yet they
lead to an all-or-nothing diagnosis. In all the behaviors listed by the
DSM (Diagnostic and Statistical Manual of Mental Disorders, published by
the American Psychiatric Association) under ADD, the word often is used
to describe behavior that has become a problem. How useful is
this?" (13) Millions of parents across the United States are
virtually frantic over the fact that not only have their children been
diagnosed as having ADD, but that the prescribed treatment usually
consists of powerful stimulant
drugs such as Ritalin, Dexedrine, and Cylert. As a result, many such
parents have the constant, gnawing, and disturbing sense of feeling
trapped within a very bad situation: "If I don't avail my child of
these prescribed drugs...what else can I do that will help? If I keep my
child on the drugs, I'm forced to watch the frequent side effects taking
their toll...on my child's health, and on the peace within my
family!" What are some of these drugs' side effects? Several short
term effects could be the following: "Ritalin rebound", loss
of appetite and resulting weight loss, insomnia, headaches,
stomachaches, drowsiness, potential liver damage, facial tics, and a
"sense of sadness", to mention just a few.
The Downside of Ritalin Derived from the same family as cocaine Lasts
only four hours Treats only some of the symptoms of ADD Provides
superficial healing, does not treat the root of the problem can cause
side effects such as appetite loss, anxiety, insomnia, tics, headaches,
stomach aches Gets children into the habit of taking drugs May need to
be taken over entire life span (14) "Ritalin as a Recreational
Drug: A recently identified drawback of Ritalin is its popularity as an
illicit drug. The annual survey, 'Monitoring the Future' by the
University of Michigan warns of a trend concerning Ritalin abuse. From
1993 to 1994 the number of high school seniors admitting to having
abused Ritalin doubled, representing about 350,000 students nation-wide.
Kids call Ritalin "Vitamin-R," "R-ball," or
"the smart drug" and seek it out to study better and to get
high." (15) "A 1995 Newsweek article reported that students at
an upscale New York college crushed and snorted Ritalin tablets like
cocaine. They described an immediate rush, as if they felt
hyperactive." (16) "Ritalin consumption has risen nearly
sixfold during the past five
years. (16) One college student took Ritalin in order to help focus his
attention in his studies. Soon he was snorting it twice daily, needing
more and more to achievethe same results. The side effects of Ritalin
addiction include strokes, hyperthermia, hypertension, and seizures.
Several deaths have been attributed to Ritalin abuse, including that
of a high school senior in Roanoke, Virginia, who died from snorting
Ritalin after drinking beer. (16) According to DEA statistics, emergency
room admissions due to Ritalin abuse numbered 1,171 in 1994." (15)
Also, several authorities report that the long term consequences could
be devastating. Equally disturbing is that for many children and adults,
the common, prescribed drugs often do not work very well.
"Still there remains much we don't know about the benefits or
drawbacks of taking Ritalin, especially over many years... Nevertheless,
what published research does exist has found the long-term value of
Ritalin disappointing. Studies beginning in the 1960s showed that
children who took stimulants for hyperactivity (the name for ADD at the
time) over several years did just as poorly in later life as the group
of hyperactive children who took no medication. Compared to children
without hyperactivity, both groups were less likely to have finished
high school or to be employed, and more likely to have had trouble with
the law or to have drug or alcohol problems. A large percentage of the
hyperactive group, medicated or not, did relatively well, but overall
those in this category wound up struggling much more frequently than
their normal peers... My own experience with young patients has brought
these dry statistics to life for me and has sometimes contradicted the
studies." (13) All of this information may sound discouraging,
however, it needn't be.
The good news is this:
Every week from coast to coast (USA) many thousands of grateful parents,
and adult Attention Deficit Disorder (ADD and ADHD) sufferers, plus ADD
support group members are discovering dramatic relief from a new,
entirely non-drug approach. "Q. How was the benefit of Pycnogenol
to those with ADD discovered? A. I'll take credit for being the first to
report this at a scientific meeting, but the discovery has been made
unexpectedly by many individuals. A common example is that persons
taking Pycnogenol for their hay fever found that their ADD symptoms
decreased in a week or two. Through the years, because I was the author
of two other books on Pycnogenol, I have received hundreds of letters
reporting this. "I surveyed the case histories and recent
experience of several patients
and found that Pycnogenol had helped all of the patients who tried it. I
reported this small study at The Second International Pycnogenol
Symposium in May 1995 in Biarritz, France. In August 1995, I received a
letter from psychologist Julie Paull, Ph.D., who confirmed that
Pycnogenol had also helped her immensely. Dr. Paull and her colleague
Stephen Tenenbaum, Ph.D., are conducting a formal clinical study on
Pycnogenol and ADD. At this early stage, they can only report that it is
obvious that Pycnogenol helps to increase their attention and improve
their focus, and may be decreasing their emotional reactivity." (8)
It is an approach that is totally safe to use, employing a 100%
non-toxic and natural -- and powerfully effective -- nutritional method.
It involves the use of an antioxidant nutritional compound from France
that has produced stunning health results across Europe for over a
decade, and that many progressive doctors are now beginning to recommend
here in the United States and Canada. This compound is a natural
patented extract (U.S. Patent Number 4,698,360). In an easy to swallow
tablet form, has been hailed by researchers as the most potent, natural
antioxidant compound ever discovered.
Masquelier's invention is also patented for treating Attention
Deficit/Hyperactivity Disorder (U.S. Patent Number 5,719,178). This
patented compound is not a drug and is now readily available in the U.S.
without a prescription. Moreover, it is far less costly than traditional
drug therapy. Masquelier's Original OPCs is as safe to use as vitamin C.
However, as an antioxidant supplement, it is much more powerful than
vitamin E or C. "As an antioxidant, Pycnogenol, a blend of
special bioflavonoids, reduces free-radical-caused tissue damage many
times more effectively than vitamin E, potentiates the health-giving
effects of vitamin C, and protects brain and nerve tissue with its
nearly unique ability to penetrate the blood-brain barrier." (6)
Masquelier's Original OPCs is well documented with 50 years of
scientific research and human studies, conducted through universities,
scientific institutes, hospitals and clinics by medical practitioners,
dieticians and specialists of various professions. "A surprising
use of OPC has arisen among people suffering from that bewildering
disorder in concentration and attention known as attention deficit
disorder (ADD), or attention deficit hyperactivity disorder (ADHD). It
is said to have begun quite accidentally when people with ADD took OPC
for another purpose, such as allergies, and noticed an improvement in
concentration and mental focus, classic symptoms of attention deficit.
Others started using it. Word spread, and the ADD remedy has achieved
high visibility on the Internet and at natural products trade shows...
"Scientifically, how could this possibly be true? How could
mundane grape seed and pine bark chemicals have a profound influence on
the brain comparable to that of a powerful pharmaceutical drug?
According to Marcia Zimmerman, a California consultant who specializes
in research on OPCs, there is some underpinning in the scientific
literature, suggesting possible mechanisms of action. A fascinating way
OPCs might affect brain cells, as shown by studies in cell cultures, she
says, is
by regulating enzymes that help control two crucial neurotransmitters --
dopamine and norepinephrine, chemicals that carry messages among brain
cells and are involved in 'excitatory' responses. OPCs also help deliver
nutrients to the brain, such as zinc, manganese, selenium, and copper,
that are helpful in ADHD, according to recent research. Additionally,
OPCs' remarkable antioxidant activity may help stabilize brain cells and
improve their functioning by neutralizing damage from free
radicals." (2) "Pycnogenol is important to brain function, not
only because it protects blood vessels, but also because it is one of
the few dietary
antioxidants that readily crosses the blood-brain barrier to protect
brain cells. The blood-brain barrier protects the brain from compounds
that normally circulate in the blood. Brain cells are very sensitive to
some compounds, even though they may not damage other cells in the body
or even be needed by other cells... "In laboratory experiments in
which blood is rapidly injected into brain blood vessels, dramatically
increasing the blood pressure within those vessels for a brief time,
Pycnogenol shows a significant protective effect." (6) "a
patented peak performance nutrient. It is among the best new weapons I
use in my program to maintain overall good health for longer and longer
periods of time." (4) The Brain-Immune Connection "Top
research institutions worldwide ... now understand that there is a
two-way chemical dialog between the brain and the immune system. Each
can influence the other directly... the ongoing chemical dialog between
the brain and the immune system, a connection that depends on two
languages: the neurotransmitters of the brain, and the
immunotransmitters of the immune system... "Cytokines - the immune
system's own chemical messengers crafted to deliver warnings to speed up
or slow down the immune system's responses - may also play a complex
role in causing or promoting neurological illness... In recent years,
investigators have identified a large number of cytokines as the cause
of quite a few - and sometimes detrimental - effects on brain function.
For example, certain cytokines are capable of producing fatigue, slowed
thinking, and other depressive symptoms." (3) How does Masquelier's
Original OPCs help the immune system? "Natural killer cell
cytotoxicity was increased with Pycnogenol treatment... as a free
radical scavenger, lowers histamine levels, and protects against
vascular permeability... important in protecting and modulating immune
systems." (7) "As a dietary supplement, it acts both as an
antioxidant and an immune system booster... studies at the University of
Arizona showed that Pycnogenol has the power to maintain healthy immune
system function by restoring cytokine imbalances and increasing white
blood cell activity."
(3) More Nutritional Therapies to Consider Now:
"Keep up Zinc Levels to Improve ADHD Symptoms... Now, as
scientists continue to map out the various ways in which zinc is needed
by your body, a number of studies are pointing to an association between
zinc deficiency and ADHD. One such 1996 study, published in the Journal
of Child Psychology and Psychiatry, revealed a statistically significant
correlation between zinc and fatty acids, in that both were decreased in
children with ADHD. In another study, this one conducted at Ohio
State University, investigators found a relationship between zinc
deficiency and response to stimulant therapy among people with ADHD.
(Stimulants
such as Ritalin...) Basically, this study showed that children diagnosed
with ADHD may be zinc deficient, and that this deficiency may result in
their poor response to stimulant therapy." (3) "Omega-3 fatty
acids such as EPA (eicosapentaneoic acid) and DHA (docosahexanoic acid)
have the potential to support brain and immune function. EPA and DHA are
natural anti-inflammatory substances which are able to reduce the
potentially harmful effects of arachidonic acid through their ability to
inhibit the delta-5 desaturse enzyme... "DHA is the primary
structural fatty acid in the gray matter of the brain and promotes
communication between brain cells by allowing synapses to remain soft
and functional... "A naturally anti-inflammatory agent, DHA
protects cells membranes against oxidative damage and is being actively
examined for its potential in treating clinical conditions ranging from
Alzheimer's disease to multiple sclerosis and attention deficit disorder
(ADD)." (3)
And when it comes to antioxidants: "Consider this as very
important. The best course of action is to use as many sources of
antioxidants as you can and let them all work together. Every
antioxidant has specific functions and all of them are needed to fight
the variety of free radicals that we must confront." and let them
all work together. Every antioxidant has specific functions and all of
them are needed to fight the variety of free radicals that we must
confront." (11) Masquelier's Original OPCs and ADD/ADHD
Masquelier's Original OPCs is relatively new to physicians and consumers
in North America. However, due to overwhelmingly-positive anecdotal
clinical results individual physicians have obtained thus far, major
universities and institutions in the U.S. have already begun full-scale,
double blind research studies.
As a result, Masquelier's invention was recently awarded another
patent for the Treatment of ADD/ADHD:
Attention-Deficit/Hyperactivity Disorder United States Patent Number:
5,719,178; Date: Feb. 17, 1998. A "non-toxic, water soluble
nutrient. Pycnogenol holds promise as an
alternative to Ritalin... comes from grape seed extract or from the bark
of the French maritime pine tree. Most of the research was done on the
grape seed extract... Many children with ADD have found this substance
effective to decrease their symptoms by normalizing brain function. It
seems to improve memory by improving circulation to the brain. Free
radicals reprogram DNA and are implicated in more than sixty diseases.
It has been thought to help in inflammation of the joints and other
tissues, as well as improve functioning of the circulatory, nervous and
immune systems." (12) "Q. How does Pycnogenol help those with
ADD? A. One way is that the antioxidant effect of Pycnogenol keeps
neurotransmitters functioning longer. Pycnogenol also improves
circulation, including microcirculation in the brain. However, I suspect
that the effect of Pycnogenol is more complex than this. It will take
more research to uncover exactly how Pycnogenol functions to help those
with ADD and to improve cognitive function in general." (8) "A
remarkable prediction: The general consensus among many experts in the
health field is that Pycnogenol is destined to become the most vital of
all antioxidant compounds. As more scientific evidence presents itself,
Pycnogenol may eventually sweep 21st century dietary
supplementation." (9) Also especially gratifying is that adults and
children are finding this patented compound is literally providing them
with anon-drug, new lease on life:
"A preliminary study by Marion Sigurdson, Ph.D., a psychologist
in Tulsa, Oklahoma, who specializes in treating attention deficit
disorder, has found striking benefits from OPC. Using a blend of pine
bark and grape seed (Dr. Masquelier's OPC product), Dr. Sigurdson found
that it worked just as well as the commonly prescribed stimulant
medications, including Ritalin, on thirty children and adults diagnosed
with ADD. The subjects were given a battery of computerized and behavior
tests to judge their attention, concentration, and other important
factors in ADD under various circumstances: when they were either on or
off their usual
stimulant medications, or on the OPC alone. When they were off their
medications, their ADD deteriorated. On their medications, they were
much improved. But when they took daily doses of the OPC grape seed-pine
bark mixture, their scores and behavior were just as improved as when
they took stimulant drugs. In other words, the OPC equaled the drugs in
most subjects... (Many of the subjects also had other positive effects:
decreased heart beat, disappearance of tennis elbow, relief of acne,
improved sleep and mood.)...
"STEVEN'S MIRACLE 'I Can Now Finish What I Start.' Looking back,
clinical psychologist Steven Tenenbaum realizes he has always had
problems concentrating, paying attention, and focusing. He did poorly in
school, especially in math... He was hyperactive-impulsive and had
problems with attention. But not until 1984, at age twenty-five when he
was getting his doctorate at St. Louis's Washington University to become
a psychologist, did he understand he had a neurological condition called
attention deficit hyperactive disorder or ADHD, characterized by a short
attention span, impulsivity, and sometimes hyperactivity. The condition
is said to affect 4 to 7 percent of the population, both youngsters and
adults.
"Under ordinary circumstances, Dr. Tenenbaum would have relied
on stimulant drugs, such as Ritalin, Dexedrine, or Cylert, widely
prescribed for ADHD. But he had learned to fly recreationally, and if he
took such drugs he could not keep his pilot's license under Federal
Aviation Administration (FAA) regulations. So he toughed it out for many
years without medication. After getting his doctorate, he set up the
Attention Deficit Center in St. Louis, which specializes in counseling
and developing coping abilities in children with ADHD.
"In 1995 he began to hear about alternative treatments for ADHD
from patients, parents, and people on the Internet. The buzz on one such
substance, Pycnogenol (Masquelier's OPCs invention), was particularly
fascinating to Tenenbaum. He tried it and was thrilled. 'My
effectiveness has increased by about 40 or 50 percent in the year and a
half I've been on it. I can now finish what I start.' he raves. Without
his three-times-daily regimen of the pine bark extract, he becomes
mentally scattered and unable to focus... "it produces the increase
in attention, the increase in focus, the decrease in emotional
reactivity.' He also feels it elevated his mood. Tenenbaum notes that
like prescription stimulants, the OPC seems to work for some but not
others. It does not eliminate the problem, of course, but only helps
control it. 'It just dampens some of the intensity of the disorder,' he
asserts." (2) What is it? Masquelier's invention is NOT a drug and
is now readily available in the
U.S. without a prescription (more on that in a moment). Moreover, it is
far less costly than traditional drug therapy. It is as safe to use as
vitamin C. However, as an antioxidant supplement, Masquelier's Original
OPCs is actually 20 times more powerful than vitamin C, and 50 times
more powerful than vitamin E. This compound comes from a very highly
scientific process isolating living molecules from the French maritime
pine tree and grape seeds (U.S. Patent Number 4,698,360, click here to
view the patent). Masquelier's Original OPCs, in an easy to swallow
tablet form, has been hailed by researchers as the most potent, natural
antioxidant compound ever discovered. "In 1947 the renowned French
chemist Jack Masquelier, professor emeritus of medicine at the
University of Bordeaux, isolated the first OPC, a colorless substance,
from the red skin of the peanut. He tells how he gave it to the wife of
the dean of his faculty, who had severe edema from pregnancy; her
swollen legs got so tired she could barely walk. 'Well, the dean's wife
was cured in forty-eight hours,' says Dr. Masquelier. 'So there had to
be something special about my extract.' In 1950 the peanut-skin OPC
became the first vasculo-protective medicine, known as Resivit and sold
in France. About a quarter of a century later another drug based on Dr.
Masquelier's grape seed OPC, called Endotelon, made its debut in France.
By 1979 Masquelier had also christened his brainchild "pycnogenols,"
a generic word describing in Greek its multi-faceted chemistry... Dr.
Masquelier has also detected OPC in virtually all plants, red wine, and
the peanut kernel itself. The current concentrated commercial sources
are grape seeds and the bark of the French maritime pine tree. Dr.
Masquelier also says OPC primarily accounts for the antioxidant,
artery-protecting activity of red wine and tea." (b) Are
Masquelier's Original OPCs the same as
"grape seed extract" or "pine bark extract"? Not at
all. "Grape seed extract" and "pine bark extract"
are very NON-specific names and have no patents. Some manufacturers and
retailers try to confuse consumers by using the term "grape seed
extract" or "pine bark extract" on their products and
borrow the science of Masquelier's patented product to promote theirs...
Authentic vs. "Borrowed" Science The world is full of
imitations, offshoots and "generic" forms of scientifically
proven and patented natural products. Consumers who are looking for a
product that will produce the proven results and not just the
"claimed" or "implied" results, want the authentic
product that was used in the actual scientific research. This is
especially important when you buy a product in the "grape seed and
pine bark extract" product category. It is practically impossible
for retailers and for you to read between the lines of labels and
distinguish inferior products from quality ones. Click here for a
Comparative Analysis. Quite a few labels do not mention the actual
source of a grape seed or pine bark extract. In many cases, consumers
cannot be assured of the quality, bioavailability and safety of the
product. According to an independent test, no active OPC could be
detected in one leading American brand of grape seed extract. (c) Today,
Masquelier's products are the only products available on the market that
were consistently used throughout these decades of clinical and human
trials. These authentic Masquelier's Original OPCs products remain the
products, used in the original experiments by which Dr. Masquelier
invented OPCs' antioxidant properties. For the use of OPCs as an
antioxidant the US Government granted Dr. Masquelier a patent on October
6, 1987 (U.S. Patent 4,698,360). How can I identify the
Masquelier's Authentic FRENCH PYCNOGENOL®* and OPCs in the American
market? Masquelier named and trademarked his invention PYCNOGENOL® in
France, but now he cannot use his trade name within the United States
because of his former International broker, Horphag. According to Dr.
Masquelier
(who does not speak English): "Horphag plans coup and secretively
files for registration of the trademark in it's own name... This covert
attempt to grab control by means of plain theft of intellectual property
set the stage for the current trademark problems." (e) Now Horphag
who now sells a DIFFERENT and pine bark only based extract - NOT
manufactured or endorsed by Masquelier - may legally use the trademark
PYCNOGENOL® in the U.S. Of course most American's don't realize that
Masquelier's FRENCH Pycnogenol® and Horphag's U.S. Pycnogenol® are not
the same. Horphag's U.S. Pycnogenol® ONLY "borrows" from the
50 years of research for Masquelier's authentic FRENCH Pycnogenol - but
they are NOT the same! Click here for a Comparative Analysis. This is
why there is much confusion in the American marketplace. MASQUELIER's®
original and only industrial extraction factory, located in France.
"OPC 'tea' made at Berkem's, the OPC factory in Gardonne (France).
Berkem extracts vegetal materials such as pine bark and grape seeds
according to Masquelier's original extraction method. The factory has
been working with Masquelier since the earliest days of OPC production
on an industrial scale." (f)Horphag's extract does NOT carry
the trademark PYCNOGENOL in France. On the other hand, Masquelier's
extract does NOT carry the trademark PYCNOGENOL in America. This is
why there is much confusion in the American marketplace. Therefore,
while the legal issues of terminology are settled in the United States
courts, look for MASQUELIER's® name and patent on the bottle. These
products GUARANTEE Masquelier's genuine FRENCH PYCNOGENOL extract to
distinguish his original OPCs products from inactive bioflavonoids,
generic grape seed and pine bark extracts and other offshoot products,
passed off by unauthorized competitors. The Safety Factor Masquelier's
authentic FRENCH "Pycnogenol studies carried out at the Pasteur
Institute in Lyon, France, have shown it to be nontoxic to humans. In
one study, daily doses of up to 35,000 mg were given for six months,
with no adverse effects. Pycnogenol should be viewed as a
completely safe nutrient." (a) Analytical batch testing serves
consumers in an important but indirect way. It is the supplier's
guarantee to purchasers and authorities that the consumer gets the
product that was tested in research. MASQUELIER's Authentic FRENCH OPCs
routine and extensive analytical batch-to-batch consistency testing both
in France and in the USA serves as a guarantee of constancy and
uniqueness for this classic, authentic, researched and renowned product.
(d) Most especially gratifying is that so many are finding this patented
compound is literally providing a non-drug, new lease on life for many
thousands of people.
How to contact Healthy Source™: 1-800-200-1203 or (949) 498-3490 or
1-800-810-8696 or (505) 898-9594 · info@healthysource.com
*PYCNOGENOL® and PYCNOGENOLS® are registered trademarks of the
International Nutrition Company (France, Portugal, Austria, Germany,
Australia, New Zealand, Thailand, Japan, South Korea, and other
countries) and Horphag Overseas Ltd. (U.S. and other countries)
protected by U.S. Patent # 4,698,360 and international patents.
Professor Jack Masquelier is the inventor of both the patent and the
term, "PYCNOGENOL". And now Prof. Masquelier's French
companies, including Soci?t? Civile d'Investigations Pharmacologiques
d'Aquitaine (SCIPA), are members of the International Nutrition Company
(INC) group of companies.
Dr. Masquelier named and trademarked his invention PYCNOGENOL® in
France, but now he cannot use his trade name within the U.S. because of
his former International broker, Horphag. According to Dr. Masquelier:
"Horphag plans coup and secretively files for registration of the
trademark in it's own name... This covert attempt to grab control by
means of plain theft of intellectual property set the stage for the
current trademark problems." Therefore, Horphag changed extraction
manufacturing companies and now sells a DIFFERENT pine bark based
extract - NOT manufactured or endorsed by Masquelier. Horphag's extract
does NOT carry the trademark PYCNOGENOL in France. On the other hand,
Masquelier's extract does NOT carry the trademark PYCNOGENOL in America.
This is why there is much confusion in the American marketplace.
Therefore, while the legal issues of terminology are settled in the
United States courts, look for MASQUELIER's® name and patent on the
bottle. These products GUARANTEE Masquelier's genuine FRENCH PYCNOGENOL
extract to distinguish his original OPCs products from inactive
bioflavonoids, generic grape seed and pine bark extracts and other
offshoot products, passed off by unauthorized competitors. Prof.
Masquelier's authentic oligomeric proanthocyanidins (OPCs) from Maritime
Pine tree bark and grape seeds are the result of 50 years of scientific
research and development. The original MASQUELIER's products are
unsurpassed, well defined, safe and highly efficaceous patented
products. Look for the authentic MASQUELIER's®. You can feel the
difference!
*IF THERE ARE ANY QUESTIONS THAT COME TO MIND THAT MAY NOT BE EASILY
ANSWERED THROUGH YOUR RESEARCH AND THE HERE INCLUDED CITATIONS, PLEASE
CONSULT THE APPROPRIATE MEDICAL PROFESSIONAL.
The information presented here is done so under the benefit and
authority of the First Amendment to the Constitution of the United
States of America, ordained and preserved for the benefit of all.
(Authentic French PYCNOGENOL®*) U.S. Patent Awarded for Treating
Attention Deficit/Hyperactivity Disorder U.S. Patent #5,719,178 Date:
Feb. 17, 1998
"A surprising use of OPC has arisen among people suffering from
that bewildering disorder in concentration and attention known as
attention deficit disorder (ADD), or attention deficit hyperactivity
disorder (ADHD).
It is said to have begun quite accidentally when people with ADD took
OPC for another purpose, such as allergies, and noticed an improvement
in concentration and mental focus, classic symptoms of attention
deficit... a preliminary study by Marion Sigurdson, Ph.D., a
psychologist in Tulsa, Oklahoma, who specializes in
treating attention deficit disorder, has found striking benefits from
OPC.
Using a blend of pine bark and grape seed (Dr. Masquelier's product),
Dr. Sigurdson found that it worked just as well as the commonly
prescribed stimulant medications, including Ritalin, on thirty children
and adults diagnosed with ADD.
The subjects were given a battery of computerized and behavior tests
to judge their attention, concentration, and other important factors in
ADD under various circumstances: when they were either on or off their
usual stimulant medications, or on the OPC alone.
When they were off their medications, their ADD deteriorated.
On their medications, they were much improved. But when they took
daily doses of the OPC grape seed-pine bark mixture, their scores and
behavior were just as improved as when they took stimulant drugs.
In other words, the OPC equaled the drugs in most subjects. Generally
children fared better on a lower dose (20 milligrams of OPC per 20
pounds of body weight daily), and adults did better with a higher
(double) dose of 40 milligrams per 20 pounds of body weight daily. (Many
of the subjects also had other positive effects: decreased heart beat,
disappearance of tennis elbow, relief of acne, improved sleep and mood.)
TIP DOSAGE: MASQUELIER's® U.S. Patent is based upon approx. 1.4mg
per pound of body weight per day. 3 "Scientifically, how could this
possibly be true? How could mundane grape seed and pine bark chemicals
have a profound influence on the brain comparable to that of a powerful
pharmaceutical drug? According to Marcia Zimmerman, a California
consultant who specializes in research on OPCs, there is some
underpinning in the scientific literature, suggesting possible
mechanisms of action.
A fascinating way OPCs might affect brain cells, as shown by studies
in cell cultures, she says, is by regulating enzymes that help control
two crucial neurotransmitters -- dopamine and norepinephrine, chemicals
that carry messages among brain cells and are involved in 'excitatory'
responses.
OPCs also help deliver nutrients to the brain, such as zinc,
manganese, selenium, and copper, that are helpful in ADHD, according to
recent research.
Additionally, OPCs' remarkable antioxidant activity may help
stabilize brain cells and improve their functioning by neutralizing
damage from free radicals."
1 "Brain Function[:] Pycnogenol is important to brain function,
not only because it protects blood vessels, but also because some of its
bioflavonoids readily cross the blood-brain barrier to directly protect
brain cells.
Brain cells need a lot of oxygen. (It is amazing how much oxygen this
organ consumes!)
Blood supplies the brain with oxygen, but since brain cells are very
sensitive to some compounds that normally circulate in the blood -- even
though those compounds may not damage other cells in the body or may
even be needed by other cells -- the brain filters out as many
nonessential compounds as it can. This is accomplished by the so-called
blood-brain-barrier."
2 OMEGA
3 FATTY ACIDS (EPA & DHA)
Docosahexaenoic Acid (DHA), a major component of the human brain
tissues and the retinal tissues of the eyes.
It also serves the other important function of the transmission of
nerve impulses in the nervous system.
EPA PLUS supplies the important EPA and DHA fatty acids in the
highest concentrations found and, in addition, it does not contain
potentially harmful levels of Vitamins A and D, such as that found in
equivalent amounts of many other fish liver and fish body oils.
"Omega-3 fatty acids such as EPA (eicosapentaneoic acid) and DHA
(docosahexanoic acid) have the potential to support brain and immune
function.
EPA and DHA are natural anti-inflammatory substances which are able
to reduce the potentially harmful effects of arachidonic acid through
their ability to inhibit the delta-5 desaturse enzyme...
"DHA is the primary structural fatty acid in the gray matter of
the brain and promotes communication between brain cells by allowing
synapses to remain soft and functional... "A naturally
anti-inflammatory agent, DHA protects cells membranes against oxidative
damage and is being actively examined for its potential in treating
clinical conditions ranging from Alzheimer's disease to multiple
sclerosis and attention deficit disorder (ADD).
"Independent investigators around the world have reached the
conclusion that a deficiency in [omega-3] fatty acids may therefore
adversely affect behavior, as a result of lowered prostaglandin
production and poor communication between brain cells.
With respect to ADHD, a number of studies confirm the importance of
[omega-3] fatty acids, in improving the brain metabolism in children.
"4 ZINC
CHILDREN NOT GETTING ENOUGH IRON, ZINC AND VITAMIN E
NEW YORK, Jul 07 2000 (Reuters Health) - Many children in the US do
not consume enough iron, zinc and vitamin E between the first and second
year of life, putting them at increased risk for delayed growth and
development as well as a host of illnesses.
Children came from middle- to upper-middle class families and 89% of
children were white.
SOURCE: Pediatrics 2000; 106:109-114; © 2000 Reuters Limited
"Keep up Zinc Levels to Improve ADHD Symptoms... Now, as
scientists continue to map out the various ways in which zinc is needed
by your body, a number of studies are pointing to an association between
zinc deficiency and ADHD.
One such 1996 study, published in the Journal of Child Psychology and
Psychiatry, revealed a statistically significant correlation between
zinc and fatty acids, in that both were decreased in children with ADHD.
In another study, this one conducted at Ohio State University,
investigators found a relationship between zinc deficiency and response
to stimulant therapy among people with ADHD.
(Stimulants such as Ritalin...)
Basically, this study showed that children diagnosed with ADHD may be
zinc deficient, and that this deficiency may result in their poor
response to stimulant therapy."
4 The Serenity Prayer God grant me the serenity to accept the things
I cannot change; courage to change the things I can; and wisdom to know
the difference.
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