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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:

  1. Often fidgeting with hands or feet, or squirming while seated.
  2. Having Difficulty remaining seated when required to do so.
  3. Being easily distracted by extraneous stimuli.
  4. Having difficulty awaiting turn in games or group activities.
  5. Often blurting out answers before questions are completed.
  6. Having difficulty in following instructions.
  7. Having difficulty sustaining attention in tasks or play activities.
  8. Often shifting from one uncompleted task to another.
  9. Having difficulty playing quietly.
  10. Often talking excessively.
  11. Often interrupting or intruding on others.
  12. Often not listening to what is being said.
  13. Often forgetting things necessary for tasks or activities.
  14. 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.

Other ADHD Links

www.caer.com - ADHD: A Path to Success

www.adhdhelp.org - Critical ADHD questions are answered


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