Rescues Brain Cells
by Will Block
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."
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
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
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
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
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
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
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
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.
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
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
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.
food for mind and
rescues brain cells
the old become young
- 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.
- A 5-month, randomized, placebo-controlled trial of galantamine in
Alzheimer's Disease. The
Galantamine USA-10 Study Group. Neurology 2000 Jun 27;54(12):2269-76.
- 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.
- 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.
- 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.
- Kawatani T, Ishihara K, Ono T. On a trial cultivation of Lycoris
squamigera Maxim. as a source of galanthamine. Eisei Shikenjo Hokoku
- Asoeva Ez, Dauksha Ad, Denisova Ek. Galanthamine from Amaryllis hybrida.
Galantamin Iz Amarillisa Sadovogo. Med Prom SSSR 1963 May;17:35-6.
- 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.
- Nastev G, et al. Nivalin treatment of patients with diseases of nervous
system. Cultura Med (Roma), 1960, 15, 87-97.
- Maarmo E. Nivaline. Riforma Med 1961 Mar 25;75:339-40
- 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.