Galantamine is a Safe, Effective, and Natural Plant Product
Galantamine Rescues Brain Cells

Now the news! Another drug has been found to be safe and effective. Big deal. That's not news. But why do we never hear this pronouncement applied to anything else? Such as . . .

  • A food is safe and effective
  • A nutrient supplement is safe and effective
  • A sexual practice is safe and effective

If studies were published finding that these statements were scientifically tenable, would you then believe that it's safe to eat or take a vitamin or have sex? Do we need the FDA to set recommended daily allowances for our dinner, our vitamins, and our acts of love? Do we want them in our kitchens, our bathrooms, and our bedrooms? Where do we draw the line? For certain, if the FDA had its way, everything would be a drug, and "everything not permitted would be forbidden."

IS LIFE SAFE AND EFFECTIVE?
Consider another headline: Life has been found to be safe and effective. We certainly know that this is not true. Life is conditional. It is not guaranteed. And until some undetermined time in the future, life will end for each and every one of us. So how can it be safe and effective? Can food - the staff of life - be safe and effective? Can nutrients - essential to life - be safe and effective? And again, what about sex? The safety of food or supplements or sex must be judged on its own merit. Also, who should be the judge?

Yet we are led to believe and not question that drugs, especially when approved by a federal agency, can be pronounced as "safe and effective." There are certainly things that are safe and certainly things that are effective, but there are a great many circumstances surrounding every issue, and a governmental body, subject as it is to political persuasion and consideration, is not an appropriate judge.

Obviously, drug standards are not the same as those we use to judge whether food, for example, is safe and effective. If we fail to distinguish the difference between the drug standard and the food standard, we are pulling the wool over our eyes, or giving others permission to do just that.

GALANTAMINE IS SAFE AND EFFECTIVE 
According to a recent paper in the British Medical Journal (BMJ) reporting on a study of 653 Alzheimer's disease patients, galantamine "appears to slow the progression of the neurodegenerative condition" and is "safe and effective."1 Now this isn't the FDA speaking, but the authors of the latest double-blind, placebo-controlled research on galantamine, including a British professor, a director of research at a pharmaceutical company, and a statistician (also with a pharmaceutical company), all in league with the Galantamine International-1 Study Group.

The BMJ study lasted for 6 months, at the end of which the patients receiving the phytonutrient (plant-derived nutrient) galantamine were found to be better off than those receiving placebo. Galantamine (taken at either 24 or 32 mg/day) resulted in significantly higher cognitive scores. There was little difference between the two doses in this regard. In the same study, an additional measure of the efficacy of galantamine was evaluated through interviews by clinicians who confirmed the perception of its effectiveness.

GALANTAMINE IS AN HERB, NOT A DRUG
There have been several other large-scale, multicenter studies of galantamine in the last few years that have found similar results.2 So the BMJ research is not the first study to arrive at the clear finding that galantamine is effective. However, to the study's discredit, its authors make the following statement:

Galantamine is a new drug that reversibly and competitively inhibits acetylcholinesterase and enhances the response of nicotinic receptors to acetylcholine.

While presumably valid as a conclusion about the mechanism of galantamine, this statement is misleading because galantamine is a plant extract and not a synthetic drug. The Merck Index indicates that galantamine is an unaltered extract from the Caucasian snowdrop plant, Galanthus wornorii. In the earliest reference to galantamine in Medline's Index Medicus, it is referred to as a "medical plant."3 Even further back in Old Medline, galantamine is referred to as an herb and a plant4,5 with many references to its sources as extracts from a wide variety of plants.6,7,8

The Bulgarian Pharmaceutical Industry, where the modern use of galantamine originated back in the 1950s, refers to it on its Web site as a "natural substance,"13 in a column that distinguishes it from pharmaceuticals and phytochemicals. If it's natural and it's not a chemical or a pharmaceutical, how can it be a drug?

MEDICAL ESTABLISHMENT TRYING TO PASS OFF GALANTAMINE AS A DRUG
Strangely, there is not one word in the text of the BMJ paper that gives a clue that the "drug" galantamine is extracted unchanged from plants and thus is a natural substance. Only a very studious reader can grasp that it is a plant extract and not a drug. That is, there are no clues in the titles of the references and only 3 out of 35 references have any keywords that suggest or mention plants, extracts, herbs, or indeed any origin or source for galantamine. Moreover, the text of the entire BMJ article does not mention the words extract, plant, herbs, herbal, phytonutrient, natural, or any of the common or Latin names of the plants from which galantamine has been extracted - not once. Yet the word drug is used again and again. Why?

DRUGS ARE MORE PROFITABLE THAN HERBS AND MORE EXPENSIVE TOO
A tool found valuable for understanding questions of motives is Cui bono (whose interest is served?). The projected estimate for galantamine sales in the United States for the first year - if made available and marketed as a drug rather than as a dietary supplement - could approach $1.5 billion. This doesn't suggest that there is a conspiracy to defraud the public or the doctors and other professionals who read the BMJ, but merely it provides drug companies with the opportunity to presell the idea of galantamine as a drug that can be obtained only by prescription. Thus, the establishment of an exclusive franchise on galantamine, in effect a monopoly, can dictate price structure.

The medical establishment recognizes the importance of establishing the effectiveness of galantamine. They want it so bad because it is so good. But they can't have it unless it is declared "safe and effective," a phrase necessary to assure successful marketing and use of a drug, and the phrase "safe and effective" has been coopted and monopolized by the FDA, an agency highly subject to political correctness.

If, on the other hand, galantamine is classified as a phytonutrient - and thus grandfathered in by the Dietary Supplement Health and Education Act (DSHEA) of 1994 because it was sold as a dietary supplement before that law's date of enactment - then its fate will be very different. Galantamine would be widely available and far less expensive.

Galantamine may still become a blockbuster, but instead of one pharmaceutical company having a monopoly on it, it is highly probable that it will be sold by many nutrient companies. Furthermore, through broad-spectrum marketing, galantamine is likely to be not only less expensive, but more accessible, better explained, and of higher potential standards - believe it or not. Who loses by restricting availability and driving prices higher for a naturally safe and effective product? Many of those who need it most.

GALANTAMINE TARGETS ACETYLCHOLINE DEFICIENCY
Alzheimer's disease is a devastating disorder with progressive dementia as its hallmark. The disease is characterized by protein plaques and nerve tangles that gradually distort the architecture of the brain. A naturally occurring protein, amyloid, has been implicated as a key player in the destructive process, but the primary dysfunctionality is attributed to the loss of availability and activity of the neurotransmitter acetylcholine (ACh).

If the studies about galantamine are what they appear to be, galantamine is one of the best - if not the best - treatments yet discovered for age-related memory impairment, decline, and dementia progressing to Alzheimer's disease. But the connection is not new, and its effect as a acetylcholinesterase (AChE) inhibitor and for treatment of the central nervous system was suggested at least as far back as 1960,10-11 and for memory loss back in 1972.12

Galantamine takes the ACh deficiency head-on by inhibiting the production of AChE that breaks down ACh. It also enhances the brain's response to ACh, which is directly linked to memory maintenance. In the study, out of 653 patients diagnosed with mild to moderate Alzheimer's disease, approximately half received galantamine while the other half received a placebo. Galantamine was found to be well tolerated and effective, slowing the decline of functional ability as well as cognition.

According to the study's lead author, Dr. Wilcock, "To halt the disease, you have to stop the brain cells from being killed." What galantamine does to improve the symptoms is the functional equivalent of that, making up for the loss of brain cells in other ways. In other words, galantamine rescues brain cells from death.

ALZHEIMER'S THREATENS TO DOMINATE COGNITIVE DEGENERATION
One in ten people over the age of 65, and nearly half of those over 85, have Alzheimer's disease, according to the Alzheimer's Association in Chicago - and the situation is getting worse as people live longer. Over 4 million Americans have Alzheimer's disease, and, unless a cure or prevention is found, that number will leap to 14 million by the year 2050. On a global scale, it is estimated that by the year 2025, 22 million individuals will develop this debilitating disease.

TO AGE OR NOT TO AGE
As serious as Alzheimer's is, it is not the only reason to consider the use of galantamine. As we age, a slow but sure mental degeneration takes place. Ultimately, aging is the thief that steals our memory, consciousness, and personality away. But that thief, specifically, is the age-related decline of the cholinergic system.

Galantamine offers a means to do something about age-related memory impairment right now, a syndrome now viewed as a precursor to advanced degenerative diseases such as Alzheimer's. It can help to prevent the decline and deterioration of our vital mental functions by enhancing our supply of the essential neurotransmitter acetylcholine. There is probably no better way to ensure the preservation of memory and its myriad of precious functions than through a well-designed cognitive supplement program, in which galantamine plays a fundamental role.

Galantamine is a natural plant-derived product that has been used throughout Eastern Europe for more than 40 years. It is reassuring to know that galantamine is currently available and affordable, not because it has achieved "drug status," but because of its track record for the treatment of a wide variety of age-related deficiencies and age-related decline.

References

  1. Wilcock GK, Lilienfeld S, Gaens E. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. BMJ 2000 Dec 9;321(7274):1445-9.
  2. A 5-month, randomized, placebo-controlled trial of galantamine in AD. The Galantamine USA-10 Study Group. Neurology 2000 Jun 27;54(12):2269-76.
  3. Venturi VM, Piccinin GL, Taddei I. Pharmacognostic study of self-sown Galanthus nivalis (var. gracilis) in Italy. Boll Soc Ital Biol Sper 1965 Jun 15;41(11):593-7.
  4. Miyazaki Y, Godaishi K. Experimental cultivation of plants containing galanthamine at Izu. (2) Relation of light intensity to the growth and yield of shokiran (Lycoris aurea Herb.) in green-houses. Eisei Shikenjo Hokoku 1963 Oct;81:176-9.
  5. Miyazaki Y, Godaishi K. Experimental cultivation of the plants containing galanthamine at Izu. (1) General growth of shokiran (Lycoris aurea Herb.), natsuzuisen (L. squamigera Maxim.), snowflake (Leucojum aestivum L.), and snowdrop (Galanthus nivalis L.), 1961 to 1962. Eisei Shikenjo Hokoku 1963 Oct;81:172-6.
  6. Kawatani T, Ishihara K, Ono T. On a trial cultivation of Lycoris squamigera Maxim. as a source of galanthamine. Eisei Shikenjo Hokoku 1963 Oct;81:159-63.
  7. Asoeva Ez, Dauksha Ad, Denisova Ek. Galanthamine from Amaryllis hybrida. Galantamin Iz Amarillisa Sadovogo. Med Prom SSSR 1963 May;17:35-6.
  8. Gheorghiu A, Ionescu-Matiue. Presence of lycorine and galanthamine in Leucojum aestivum L. Anatomical study of the aerial parts of the plant and the corresponding powders. Ann Pharm Franc 1962 Jun;20:531-8.
  9. Nastev G, et al. Nivalin treatment of patients with diseases of nervous system. Cultura Med (Roma), 1960, 15, 87-97.
  10. Maarmo E. Nivaline. Riforma Med 1961 Mar 25;75:339-40
  11. Borodkin IuS, Krauz VA. The role of intracentral and interneuronal relations in the mechanism of short-term memory control. Farmakol Toksikol 1972 Sep-Oct;35(5):533-7.
  12. http://www.bulgpharmgroup.com

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