-
What are stem cells?
-
What is the difference between embryonic and adult stem
cells?
-
Why do we hear more about embryonic stem cells than adult
stem cells in the media?
-
Can adult stem cells transform into any cell of the body?
-
Do StemTech or the StemEnhance product contain stem cells?
-
What do StemTech products and in particular StemEnhance
do?
-
What role do adult stem cells play in the body?
-
What is the adult stem cell theory of renewal?
-
How often are tissues renewed?
-
How do adult stem cells work in the renewal process?
-
What is the health benefit of taking StemEnhance®?
-
What is StemEnhance made from and how is it different than
just whole Aphanizomenon flos-aquae?
-
What is the key benefit of Mobilin™?
-
What are the key benefits of Phenylethylamine (PEA) and
Phycocyanin?
-
Is StemEnhance Vegetarian? Kosher? Halal? Organic?
-
Is StemEnhance genetically modified?
-
Is the Aphanizomenon flos-aquae (AFA) used in StemEnhance
farmed or wild crafted?
-
What is the recommended usage for StemEnhance?
-
What is the optimum way to take StemEnhance?
-
What is the science behind StemEnhance?
-
Will StemEnhance deplete my bone marrow’s supply of adult
stem cells?
-
What happens to circulating adult stem cells if they do not
reach tissue in need?
-
Does StemEnhance contain iodine?
-
Can adult stem cells lead to abnormal cells such as cancer?
-
Is StemEnhance approved by the US Food and Drug
Administration (FDA)?
-
Why does the StemEnhance label state “consult
your physician if you are pregnant or nursing”? What
if I get pregnant while I am taking StemEnhance?
-
Can StemEnhance be taken with other nutrients?
-
Can StemEnhance be taken with other Stemtech adult stem cell
nutrition products?
-
Why does the label say that people taking anticoagulants
should consult their physician prior to taking StemEnhance,
and what information does their physician need?
-
Can StemEnhance be taken with medications?
-
Can someone being treated by a health care practitioner with
health conditions take StemEnhance?
-
Can a person of any age take StemEnhance?
-
Does StemTech use vegetarian capsules?
-
Does the x-raying procedure performed by some shipping
services damage Stemtech products?
-
Is StemEnhance patented?
-
Why does the color and smell of StemEnhance seem to change?
Sometimes it is darker than other times, and has a different
odor.
-
Why has StemTech elected to use network marketing as its
distribution channel?
1. What are stem cells?
Stem cells are cells that have the ability to duplicate
themselves over and over and transform into cells of virtually
any tissue of the body. There are two categories of stem cells:
embryonic and adult.
Back to
FAQs
2. What is the difference between
embryonic and adult stem cells?
Embryonic stem cells are stem cells that are found in the embryo
and are responsible for becoming all the different cell lines
for the development of a baby. Adult stem cells are stem cells
found in the body after birth. Until recently, it was believed
that adult stem cells could only become blood cells, bone cells
and connective tissue. However, recent developments have shown
that adult stem cells can become virtually any cell in the body.
Back to
FAQs
3. Why do we hear more about
embryonic stem cells than adult stem cells in the media?
Firstly, there is controversy linked to the use of embryonic
stem cells and not to the use of adult stem cells. From a
research point of view embryonic stem cells were originally
thought to be more useful because they were easier to grow and
manipulate into other cells outside the body, ie, in a test
tube.
Back
to FAQs
4. Can adult stem cells transform
into any cell of the body?
Yes, recent scientific studies have shown that adult stem cells
can transform into virtually any type of cell in the body. For
example adult stem cells came become brain cells, kidney cells,
heart cells, muscle cells, etc.
Back to
FAQs
5. Do StemTech products or
StemEnhance contain
stem cells?
Our products DO NOT contain stem cells of any kind and are not
associated with embryonic stem cells or treatments involving any
kind of stem cells.
Back to FAQs
6. What do StemTech products do?
StemTech's products support the natural release and activity of
adult stem cells in the body.
Back to
FAQs
7. What role do adult stem cells
play in the body?
The US National Institutes of Health states that the role of
adult stem cells in the body is that of tissue maintenance and
repair.
Back to
FAQs
8. What is the adult stem cell
theory of renewal?
The Adult Stem Cell Theory of Renewal proposes that adult stem
cells are naturally released by the bone marrow and travel
through the bloodstream and into tissues to promote the body’s
natural process of tissue renewal.
Back to
FAQs
9. How often are tissues renewed?
Cells in the body are continually turning over, meaning cells
are expiring and new cells are taking their place, contributing
to tissue renewal. For example:
Your tissues completely renew themselves over the course of
time:
Intestinal lining – every 5 days
Red blood cells – every 90 days
Liver - every 3 years
Pancreas – every 4 years
Lung – every 4-5 years
Heart – every 20-25 years
Back to FAQs
10. How do adult stem cells work
in the renewal process?
When tissues have a need for renewal, adult stem cells work in
following manner:
-
Messengers are sent by tissues in need requesting the
release of adult stem cells from the bone marrow.
-
Adult stem cells circulate in the bloodstream.
-
New messengers attract adult stem cells to migrate into
tissues where the adult stem cells reproduce and become new
healthy cells of that tissue.
Back to
FAQs
11. What is the health benefit of
taking StemEnhance®?
StemEnhance supports the natural release of your own adult stem
cells from the bone marrow into the circulation. Many scientific
studies have shown that a greater number of circulating adult
stem cells equates to a greater quality of health and well being.
Back to
FAQs
12. What is StemEnhance made from
and how is it different than just whole Aphanizomenon
flos-aquae?
StemEnhance is a all natural, patented blend of proprietary
nutrient-dense concentrates of
Aphanizomenon
flos-aquae (AFA).
The Mobilin
™component
is rich in a naturally occurring molecule that has been
documented to support the release of adult stem cells. Whole AFA,
on the other hand, is not concentrated.
StemEnhance is specifically designed and developed to support
adult stem cell physiology, but it also concentrates other
beneficial naturally occurring nutrients which include
phenylethylamine (PEA), phycocyanin, polyunsaturated fatty
acids, chlorophyll, and others thereby providing unique support
for the whole body.
Back to FAQs
13. What is the key benefit of
Mobilin™?
The key benefit of Mobilin
™ is
that it contains a molecule known as an L-selectin ligand that
has been documented in a published scientific study (see FAQ 19)
to support the release of adult stem cells from the bone marrow.
Back to
FAQs
14. What are the key benefits of
Phenylethylamine (PEA) and Phycocyanin?
Phenylethylamine (PEA), a naturally occurring nutrient found in
some foods such as AFA, has been coined as “the molecule of
joy.” Phycocyanin is an antioxidant. PEA has been documented to
support a healthy mood. A key benefit of PEA is that it is a
natural compound made by the brain whenever one feels content
and happy. A key benefit of Phycocyanin is that it supports the
body in maintaining a healthy inflammatory balance.
Back to
FAQs
15. Is StemEnhance Vegetarian?
Kosher? Halal? Organic?
StemEnhance is a vegetarian/vegan product that contains no
sugar, artificial colors, artificial flavors, soy, dairy, yeast
or preservatives. It is certified
Kosher and
Halal –
please
click
the links to see
the certification letters. The StemEnhance AFA concentrate is
certified organic and is produced by a certified organic
facility.
Back to
FAQs
16. Is StemEnhance genetically
modified?
No, StemEnhance is not genetically modified.
Back to
FAQs
17. Is the Aphanizomenon
flos-aquae (AFA)
used in StemEnhance farmed or wild crafted?
The AFA used to produce StemEnhance is wild crafted. Wild
crafted means that it grows naturally.
Back to
FAQs
18. What is the recommended usage
for StemEnhance?
The suggested usage for StemEnhance is two capsules once or
twice a day.
Back to FAQs
19. What is the optimum way to
take StemEnhance?
StemEnhance can be taken any time of day with or without food.
Back to
FAQs
20. What is the science behind
StemEnhance?

StemEnhance
was tested in a double-blind, placebo controlled, crossover
study that was published in the peer reviewed journal,
Cardiovascular Revascularization Medicine, in September 2007.
The study documented that the consumption of one gram (two
capsules) of StemEnhance supported the natural release of adult
stem cells, significantly increasing the number of circulating
adult stem cells in the body approximately three million
additional adult stem cells in the circulation.
Back to
FAQs
21. Will StemEnhance deplete my
bone marrow’s supply of adult stem cells?
StemEnhance will not deplete the supply of adult stem cells in
your bone marrow. The bone marrow continually produces and
releases adult stem cells into the bloodstream over the course
of your life. In the bone marrow, adult stem cells reproduce
though a self preserving mechanism called asymmetrical
reproduction. Through this process, anytime an adult stem cell
is released from the bone marrow it leaves a sister cell in the
bone marrow, maintaining the bone marrow’s adult stem cell
population constant.
The increase in the number of circulating stem cells by an
average of approximately 3 million following consumption of one
gram (2 capsules) of StemEnhance is well within normal
physiological range and does not constitute stress on the bone
marrow environment.
Back to
FAQs
22. What happens to circulating
adult stem cells if they do not reach tissue in need?
Adult stem cells that are not used to renew tissue simply go
back into the bone marrow.
Back to FAQs
23. Does StemEnhance contain
iodine?
Unlike some seaweeds from the ocean, the
Aphanizomenon
flos-aquae(AFA) used to create StemEnhance is a freshwater
algae and contains a very small amount of iodine - only 0.39 mcg
per gram. The Recommended Daily Allowance of iodine is 150 mcg.
For further reference, one slice of bread contains roughly 6 mcg
of iodine; one medium egg has 14 mcg; and one gram of Kelp (a
type of seaweed from the ocean) contains approximately 5000 mcg.
Back to
FAQs
24. Can adult stem cells lead to
abnormal cells such as cancer?
Unlike embryonic stem cells, adult stem cells released from the
bone marrow have not been found to lead to abnormal cell growth.
A study using StemEnhance was published in a scientific journal,
Anticancer Research, in January 2009, and provides additional
information about this subject. Visit:
http://www.ncbi.nlm.nih.gov/pubmed/19331184
Back to
FAQs
25. Is StemEnhance approved by the
US Food and Drug Administration (FDA)?
StemEnhance is a dietary supplement, not a drug, and is not
intended to treat, cure or prevent illness or disease. Its
benefits have therefore not been evaluated by the US Food and
Drug Administration (FDA). However, the FDA does regulate the
labeling and safety of the dietary supplements, such as
StemEnhance. StemEnhance is manufactured in a licensed,
FDA-inspected facility in accordance with Good Manufacturing
Practices.
Back to FAQs
26. Why does the StemEnhance label
state “consult
your physician if you are pregnant or nursing”? What if I
get pregnant while I am taking StemEnhance?
Many products carry such warnings out of caution rather than any
known pregnancy risk. StemTech is not aware of any evidence that
consuming StemEnhance during pregnancy will create a health
risk.
Back to FAQs
27. Can StemEnhance be taken with
other nutrients?
Yes. There are no known nutrient–nutrient interactions with
StemEnhance
Back to FAQs
28. Can StemEnhance be taken with
other Stemtech adult stem cell nutrition products?
Yes, StemTech products are for complete adult stem cell support.
StemEnhance – supports the release of adult stem cells from
the bone marrow
StemFlo® –
supports the circulation of adult stem cells, nutrients and
oxygen in the bloodstream
ST-5 with MigraStem™ –
supports the ability of adult stem cells to get into
(migrate into) the tissues
Back to
FAQs
29. Why does the label say that
people taking anticoagulants should consult their physician
prior to taking StemEnhance, and what information does their
physician need?
The statement on the label pertains to the anticoagulant
medication called Coumadin
™ or
warfarin. People taking warfarin are typically advised by their
prescribing physician to pay attention to the amount of vitamin
K in their diet. Like many green foods, StemEnhance contains
naturally occurring vitamin K.
The US Recommended Daily Allowance (RDA) of vitamin K is 80 mcgs.
Two capsules of StemEnhance have approximately 40 mcgs of
vitamin K. For further reference, half a cup of raw chopped
broccoli has roughly 100 mcg of vitamin K and half a cup of
boiled spinach has about 540 mcg of vitamin K.
Back to
FAQs
30. Can StemEnhance be taken with
medications?
As for medications other than anticoagulants (
see
FAQ 29 for
information on anticoagulant medications), there are no known
contraindications associated with taking StemEnhance. However,
there is a theoretical possibility of an interaction with
anti-depressant medications.
This is because StemEnhance contains a naturally occurring
nutrient known as phenylethylamine (PEA) as do some other
naturally occurring foods like chocolate. PEA is a natural
compound made by the brain whenever one feels content and happy;
it has been described as “the molecule of love.” Consumption of
PEA has been documented to support mood. Interactions with
antidepressant medications have not been reported, but it is a
theoretical consideration and people should consult their
healthcare practitioner.
Back to
FAQs
31. Can someone being treated by a
health care practitioner with health conditions take
StemEnhance?
Due to the naturally occurring nutrient PEA (phenylethylamine)
in StemEnhance, there is a theoretical possibility that it may
be contraindicated in people with mania or bipolar disorder
though this is not based on any known ill effect (
see
FAQ 30 regarding
the benefits of PEA).
There is also a theoretical possibility that StemEnhance may be
contraindicated in people having a disease of the bone marrow,
though this is not based on any known ill effect. Although there
are no known ill effects, it is recommended that people with
these conditions consult their health care practitioner prior to
taking StemEnhance.
As with any dietary supplement, it is recommended that you
consult with your physician prior to using StemEnhance if you
are being treated by a health care practitioner or taking
medications of any kind. We suggest that you make information
like these FAQ’s available to your health care practitioner, so
they can make an educated decision. There are no known risks
resulting from the use of StemEnhance.
Back to
FAQs
32. Can a person of any age take
StemEnhance?
Yes, just follow the directions on the label and do so under
adult supervision.
Back to FAQs
33. Does Stemtech use vegetarian
capsules?
Yes. Stemtech uses vegetarian capsules that are commonly used in
the dietary supplement industry. They contain no gelatin or
animal by-product of any kind. They are essentially made of
cellulose, a polysaccharide fiber found in vegetables.
Back to
FAQs
34. Does the x-raying procedure
performed by some shipping services damage Stemtech products?
To the best of our knowledge, Stemtech’s products are not
affected by the levels of radiation used when shipping services
randomly x-ray packages for security reasons.
Back to FAQs
35. Is StemEnhance patented?
Yes, StemEnhance has two patents. One patent is a Use Patent
that pertains to the use of
Aphanizomenon
flos-aquae (AFA)
for supporting adult stem cell physiology. The second patent is
a Composition Patent that has been filed world-wide. The
Composition Patent pertains to the specific components in AFA
that are responsible for adult stem cell support.
Back to
FAQs
36. Why does the color and smell
of StemEnhance seem to change? Sometimes it is darker than other
times, and has a different odor.
StemEnhance is a natural product, and in nature color and odor
are not consistent. Depending on weather conditions and the time
of year, the color of the patented StemEnhance concentrate can
vary from dark green to a medium green and sometimes to what
some would call a slight brownish color. The odor may also vary.
No matter the color and odor, the nutrients that support your
adult stem cell physiology remain constant.
Back to
FAQs
37. Why has StemTech elected to
use network marketing as its distribution channel?
The Stem Cell Theory of Renewal constitutes a new paradigm in
wellness, and StemTech's products are the first in a new
category of nutrition products known as adult stem cell
nutrition. An educational process is therefore needed to help
consumers understand the benefits of this new technology.
Relationship-based network marketing has many advantages over
store shelves in this regard, offering an effective method to
generate awareness about adult stem cell nutrition and educate
people about the "Stem Cell Theory of Renewal" paradigm.
Likewise, network marketing provides satisfied consumers and
entrepreneurs with the opportunity to develop their own
home-based business, generate extra income and be their own
boss.
Back to
FAQs
OTHER FREQUENTLY ASKED QUESTIONS
-
Response to Mr. Stephen Barrett of MLM Watch.org and
the National Council Against Health Fraud
-
The Whole Story About Microcystin and AFA
-
Aphanizomenon flos-aquae Review of The Literature
Regarding Neurotoxicity
-
Quality and Safety of Klamath Lake Blue-Green Algae
Response to Mr. Stephen Barrett of MLM Watch.org
and the National Council Against Health Fraud
Recently, people conducting an Internet search on "adult stem
cell enhancer" were surprised to find an article by Stephen
Barrett already raising doubts about StemEnhance and adult stem
cell enhancers. We welcome this opportunity to provide you with
further information on StemEnhance.
Barrett provides a relatively good background history of
StemEnhance and Stemtech HealthSciences (STHS). However he makes
an inaccurate rapprochement between STHS and Cell Tech. STHS nor
Desert Lake Technologies has NEVER been involved in any lawsuit
about false claims. The work done by STHS and DLT is based on
science, it is completely independent from Cell Tech, and all of
our claims are solidly backed by science.
Barrett also claims that blue-green algae based products might
contain dangerous toxins. (See below for reports on microcystin
and neurotoxicity) There is no excuse at this point in time,
nearly a decade after the industry has developed a stringent
quality control program, to still repeat such irrelevant
allegations. Whereas infection of beef by E.coli is still
responsible for more than 20,000 intoxications and nearly 500
deaths every year, whereas aflatoxin in corn, peanuts, milk
products, spices and other foodstuff have been responsible for
several deaths, and whereas shellfish toxins are still
responsible for several deaths every year, blue-green algae has
been linked to no ill effect. Like any other food ingredient, if
potential contaminants like heavy metals, pesticides, and
shellfish toxins are present in quantity below levels
established as safe, then the product is deemed safe. Stating
that blue-green algae may be dangerous is akin to stating that
eating a shrimp cocktail or a hamburger at your favorite
restaurant is dangerous. Such a statement reflects a lack of
scientific background and knowledge, or deceptive intent.
Barrett states that before taking any product, it is advisable
to know whether it has been proven safe and effective for its
intended purpose(s), and that with respect to StemEnhance, the
following questions would have to be answered.
Back to Top
Frequently Asked Questions
-
What evidence shows that taking StemEnhance will improve
anyone's health?
-
Has any study shown that people improved their health as a
result of taking it?
-
What evidence shows that StemEnhance is safe for long-term
use?
-
How can users be certain that long-term use will not cause
abnormal tissue growth?
-
For whom is the product advisable?
-
Who should not take it?
1. What evidence shows that taking StemEnhance
will improve anyone's health?
Numerous studies performed by various scientific teams
throughout the world, including the National Institute of
Health[1] have clearly established that the higher the
levels of circulating adult stem cells the better the
ability of the body to maintain optimal health. A recent
publication in the New England Journal of Medicine[2]
reported that the level of adult stem cells in the blood was
one of the best indicators of cardiovascular health.
Elevating the number of adult stem cells in the blood has
been shown to improve health in many ways. [3-6] StemEnhance
supports the natural release of adult stem cells from the
bone marrow and increases the number of circulating adult
stem cells, which is bound to assist the body in maintaining
optimal health.
As Mr. Barrett must know, given his claimed experience with
the FDA, that we cannot make any health claims linked to
StemEnhance since it is a dietary supplement and not a drug.
Our claims are limited to structure and function claims,
which is what we have solidly documented. StemEnhance
supports the natural release of adult stem cells from the
bone marrow, thereby assisting the body in maintaining
optimal health. We would be delighted to publish the single
patient outcomes we have documented, but they could be
construed as inferred health claims. Nevertheless, clinical
studies are currently in progress involving specific organs
and system to further document the mechanics of stem cell
physiology, and these studies will be eventually published.
2. Has any study shown that people improved
their health as a result of taking it?
Numerous empirical reports and testimonials testify to the
health benefits of taking StemEnhance. Many companies have
been shut down by the FDA because of inferred health claims
linked to documentation of improvements with various
diseases. We intend to maintain our message clearly within
the boundaries of the Dietary Supplement Health and
Education Act, and let StemEnhance speaks for itself. We
would be delighted to provide Mr. Barrett with a few bottles
of StemEnhance so he can see the benefits on his own health.
3. What evidence shows that StemEnhance is safe
for long-term use?
AFA, the raw ingredient from which StemEnhance is derived,
has been on the marketplace for more than two decades with a
very good track record of safety. A safety study in mice
determined that consumption of the equivalent of up to 2,000
AFA capsules daily led to no health problems at all. In
fact, the authors claimed that the mice receiving the
highest dose of AFA were less aggressive and looked
healthier. StemEnhance is a concentrate of AFA, and just
like concentrates of echinacea or grape seed or ginkgo or
wheat grass juice that are as safe as the whole plant they
are derived from, StemEnhance is as safe as whole AFA.
StemEnhance is to whole AFA what carrot juice is to a whole
carrot.
The question may also refer to the safety of increasing the
number of circulating adult stem cells everyday. Here also
the safety is unquestionable. The normal range for the
number of circulating stem cells is between 1.2 and 5.0adult
stem cells per L of blood. An increase of 3-4 million adult
stem cells in the circulation would at most mean an increase
of 1.5 cells per L, which is well within normal
physiological range. Looking at this from a different angle,
Krause et al. [7] reported that one adult single stem cell
was enough to reconstitute the entire hematopoietic (red
blood cell) and immune systems. If one single adult stem
cell can do this, then the billions of adult stem cells left
in the bone marrow after taking StemEnhance can maintain a
healthy and strong bone marrow.
4. How can users be certain that long-term use
will not cause abnormal tissue growth?
The release of adult stem cells from the bone marrow and
their migration to tissues is a natural process that happens
everyday. StemEnhance simply supports that natural process
and tips the balance toward health everyday. StemEnhance
does not do anything that the body does not already do
everyday. So far, no instances of cancer or any similar
problem have ever been observed when using in vivo natural
release of adult stem cells from the bone marrow. Abnormal
cellular growth has only been seen when manipulating adult
stem cells in test tubes.
5. For whom is the product advisable?
Since StemEnhance supports the natural release of adult stem
cells from the bone marrow, which is turn travel throughout
the body to maintain the health of various organs and
tissues. StemEnhance is the optimal daily support for the
maintenance of optimal health. It is for everyone interested
in giving their body an extra boost toward daily renewal of
cells throughout the body. It is for anyone interested in
supporting his or her bodys natural renewal system.
6. Who should not take it?
StemEnhance naturally contains a significant amount of
vitamin K. Therefore, anyone taking anticoagulant medication
should consult their doctor in order to adjust the
medication, if necessary. StemEnhance could also be
contraindicated for anyone having a disease of the bone
marrow, though this is solely speculative and is not based
on any observation of ill effect.
AFA contains phenylethylamine (PEA), known as the "molecule
of love" or the "molecule of joy". PEA is a natural compound
made by the brain whenever one feels content, happy.
Deficiency in PEA has been linked to problems of
concentration and low mood, and oral intake of PEA has been
shown to improve these conditions. StemEnhance concentrates
PEA at about 5mg/g. PEA is responsible for the immediate
feeling of well-being that one experiences after taking
StemEnhance. Because of the effect of PEA in the brain,
StemEnhance could be contraindicated for people suffering
from severe manic depression.
Finally, Barrett states that "A few studies most of them
done in laboratory animalshave shown that circulating stem
cells from bone marrow can develop into a few other types of
mature cells. As far as I know, however, no study has
demonstrated that increasing the number of circulating cells
is safe or makes people healthier." This is certainly the
most eloquent expression of Barretts lack of expertise in
this field.
Anyone interested to see if there are only "a few studies"
showing that circulating adult stem cells can develop into
"a few other cell types", can simply do a search on Medline
to see the thousands of article on that topic. Or simply
refer to the study of Krause[7] in which bone marrow
adult stem cells were seen to become functional cells of the
skin, liver, colon, intestine, stomach, esophagus, kidney
and lung. Bone marrow adult stem cells have also been
documented to become brain cells,[8] heart cells,[1] muscle
cells,[9] pancreatic cells[10] virtually any cell type in
the body. As to the second statement that to Barretts
knowledge "no study has demonstrated that increasing the
number of circulating cells makes people healthier," one
only needs to refer to the studies by Orlic at the NIH[1]
and that of Werner et al.[2] Barrett could have done a
simple search at the NIH library with the key words
circulating adult stem cells healing (PubMed) and he could
have avoided misleading people as he did.
I believe it is important for the sake of ethics and public
integrity to end this discussion by putting these comments
from Stephen Barrett, as well as all other comments by him,
into a bigger context. Barrett is a retired psychiatrist who
has not had many positive comments about dietary supplements
and over the years have waged a little vendetta against
anything that comes through an Network Marketing. He would
probably be against peanut butter if they were sold through
and MLM. His attacks against natural approaches such as
homeopathy and herbal medicine constituted a rather eloquent
display of his ignorance.
He created the so-called National Council Against Health
Fraud, which ironically is itself rather fraudulent and
misleading, as it does not represent any objective and
expert council, it does not represent any official national
organization, and it provides rather biased information.
Barrett claims to have several links with the FDA and a
great expertise in FDA matter. We will let Judge Fromholz of
the California Superior Court Case shed some light on Mr.
Barrett. As stated by the Judge, Barretts motives appear to
be more linked to personal financial gain than generous
public education.
Below is an excerpt from Judges decision rendered against
NCAHF 12/17/01 by Judge Framholz in California Superior
Court. You can read the complete transcript, "A Judges View
of the Quackbusters"
"Dr. Barrett was offered on several issues by the Plaintiff, but
the Court found that there was substantial overlap on the issues
that he and Dr. Sampson were asked to address". Thus, in order
to avoid duplicative or cumulative evidence (see Cal. Evidence
Code 352, 411, 723), Dr. Barrett's testimony was limited by the
Court to the sole issue of FDA treatment of homeopathic drugs.
The relevancy of this issue was questionable at best, since the
Plaintiff had previously asserted that its case did not depend
on or seek to establish any violation of federal food and drug
laws or regulations. Nevertheless, Plaintiff elicited testimony
from Dr. Barrett on his experience with the FDA as it relates to
regulation of homeopathic drugs.
"Dr. Barrett was a psychiatrist who retired in or about 1993, at
which point he contends he allowed his medical license to lapse.
Like Dr. Sampson, he has no formal training in homeopathic
medicine or drugs, although he claims to have read and written
extensively on homeopathy and other forms of alternative
medicine. Dr. Barrett's claim to expertise on FDA issues arises
from his conversations with FDA agents, his review of
professional literature on the subject and certain continuing
education activities.
"As for his credential as an expert on FDA regulation of
homeopathic drugs, the Court finds that Dr. Barrett lacks
sufficient qualifications in this area. Expertise in FDA
regulation suggests a knowledge of how the agency enforces
federal statutes and the agency's own regulations. Dr. Barrett's
purported legal and regulatory knowledge is not apparent. He is
not a lawyer, although he claims he attended several semesters
of correspondence law school. While Dr. Barrett appears to have
had several past conversations with FDA representatives, these
appear to have been sporadic, mainly at his own instigation, and
principally for the purpose of gathering information for his
various articles and Internet web-sites. He has never testified
before any governmental panel or agency on issues relating to
FDA regulation of drugs. Presumably his professional continuing
education experiences are outdated given that he has not had a
current medical license in over seven years. For these reasons,
there is no sound basis on which to consider Dr. Barrett
qualified as an expert on the issues he was offered to address.
Moreover, there was no real focus to his testimony with respect
to any of the issues in this case associated with Defendants'
products.
"Furthermore, the Court finds that both Dr. Sampson and Dr.
Barrett are biased heavily in favor of the Plaintiff and thus
the weight to be accorded their testimony is slight in any
event. Both are long-time board members of the Plaintiff; Dr.
Barrett has served as its Chairman. Both participated in an
application to the U.S. FDA during the early 1990s designed to
restrict the sale of most homeopathic drugs. Dr. Sampson's
university course presents what is effectively a one-sided,
critical view of alternative medicine. Dr. Barrett's heavy
activities in lecturing and writing about alternative medicine
similarly are focused on the eradication of the practices about
which he opines. Both witnesses' fees, as Dr. Barrett testified,
are paid from a fund established by Plaintiff NCAHF from the
proceeds of suits such as the case at bar. Based on this fact
alone, the Court may infer that Dr. Barrett and Sampson are more
likely to receive fees for testifying on behalf of NCAHF in
future cases if the Plaintiff prevails in the instant action and
thereby wins funds to enrich the litigation fund described by
Dr. Barrett. It is apparent, therefore, that both men have a
direct, personal financial interest in the outcome of this
litigation. Based on all of these factors, Dr. Sampson and Dr.
Barrett can be described as zealous advocates of the Plaintiff's
position, and therefore not neutral or dispassionate witnesses
or experts. In light of these affiliations and their
orientation, it can fairly be said that Drs. Barrett and Sampson
are themselves the client, and therefore their testimony should
be accorded little, if any, credibility on that basis as well."
References
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[1] Orlic D, Kajstura J, Chimenti S, Limana F, Jakoniuk I,
Quaini F, Nadal-Ginard B, Bodine DM, Leri A. & Piero
Anversa. (2001) Mobilized bone marrow cells repair the
infracted heart, improving function and survival. PNAS
98(18):1034410349.
[2] Werner N, Kosiol S, Schiegl T, Ahlers P, Walenta K, Link
A, Bohm M, Nickenig G. (2005) Circulating endothelial
progenitor cells and cardiovascular outcomes. N Engl J Med.
8;353(10):999-1007.
[3] Bozlar M, Aslan B, Kalaci A, Baktiroglu L, Yanat AN,
Tasci A. (2005) Effects of human granulocyte-colony
stimulating factor on fracture healing in rats. Saudi Med J.
26(8):1250-4.
[4] Kong D, Melo LG, Gnecchi M, Zhang L, Mostoslavsky G,
Liew CC, Pratt RE, Dzau VJ. (2004) Cytokine-induced
mobilization of circulating endothelial progenitor cells
enhances repair of injured arteries. Circulation.
110(14):2039-46.
[5] Eroglu E, Agalar F, Altuntas I, Eroglu F. (2004) Effects
of granulocyte-colony stimulating factor on wound healing in
a mouse model of burn trauma. Tohoku J Exp Med. 204(1):11-6.
[6] Tomoda H, Aoki N. Bone marrow stimulation and left
ventricular function in acute myocardial infarction. Clin
Cardiol. 2003 Oct;26(10):455-7.
[7] Krause DS, Theise ND, Collector MI, Henegariu O, Hwang
S, Gardner R, Neutzel S, Sharkis SJ. (2001) Multi-organ,
multi-lineage engraftment by a single bone marrow-derived
stem cell. Cell 105:369-77.
[8] Eglitis MA and Mezey VA. (1997) Hematopoietic cells
differentiate into both microglia and macroglia in the
brains of adult mice. Proc. Natl. Acad. Sci. USA Vol. 94,
pp. 40804085.
[9] Camargo FD, Green R, Capetenaki Y, Jackson KA, and
Goodell MA. (2003) Single hematopoietic stem cells generate
skeletal muscle through myeloid intermediates. Nature
9(12):1520-27.
[10] Ianus A, Holz GG, Theise ND, and Hussain MA. (2003) In
vivo derivation of glucosecompetent cells from bone marrow
without evidence of cell fusion. J. Clin. Invest.
111:843-850.
The Whole Story About Microcystin and AFA
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Much has been said and written about microcystin as a possible
contaminant of the cyanophyta Aphanizomenon flos-aquae (AFA).
Everything seen on the media and read on the Internet spurred
from an event that took place in the summer of 1996, in which I
was one of the main protagonists. At the time, the magnitude of
the misinformation was such that we elected not to respond,
thinking that such misinformation could not last. I can tell now
that it was ill-advised, and I decided to tell the whole story.
AFA has been on the marketplace as an exceptional dietary
supplement for more than two decades. During this time, not one
incident remotely linked to microcystin has been reported or to
any other toxin as a matter of fact. But the media has
established another perceived reality for AFA, under a unique
set of circumstances.
In 1996, I was Director of Research and Development of a
marketing company centered around the sale of AFA. Soon after my
arrival in 1995, I implemented a testing procedure for a then
little-known toxin with the collaboration of Dr. Wayne
Carmichael of Wright State University. The toxin was
microcystin, which is produced by a type of blue-green algae
called Microcystis. Since Microcystis is seen at times in
Klamath Lake during some parts of the summer and since a new
assay had been developed to measure microcystin, we decided to
add this testing to our quality control program. In order to
have records as complete as possible we tested samples backing
as far as 1992. As expected, microcystin was present in small
amounts that presented no health concern.
However, in the summer of 1996 we observed a bloom of
Microcystis that was somewhat larger than the previous years.
After much discussion with several experts we elected to be
pro-active with the situation and to trigger an education
campaign. Similar to the story with aflatoxin in peanuts and
corn, we decided to educate the local authorities and to work
toward the development of safe limits to ensure quality and
safety. We invited officials at the Oregon Health Division (OHD)
to visit our facilities and to tell them about microcystin and
our Quality Control program. It was the first time they were
hearing about microcystin. We showed them the test, the
inventory of product on hold, caught by an efficient Quality
control program; we showed them everything.
We thought we had done our duty and acted responsibly; we were
expecting a response from OHD that would honor the approach we
had taken. To our surprise, soon after the officials at OHD
published an article mentioning that microcystin was a dangerous
toxin, that more than 60 people had died in Brazil from
microcystin toxicity. What they failed to mention was that this
incident was linked to intravenous exposure through dialysis to
about 25 gallons of water contaminated with microcystin. There
is a world of difference between intravenous and oral exposures.
Just think bout having a teaspoon of peanut butter injected in
your vein
In the same article they mentioned that product containing as
much as 20 ppm of microcystin had been harvested, though they
failed to mention that this product had been caught by an
effective Quality Control program and never reached any
consumer. We were appalled. The moment we tried to defend our
position we became the unconscionable corporate entity trying to
make money by intoxicating people. Nothing could have been
further from the truth. While a safe limit of 20 ppb had been
established for aflatoxin, levels as high as 300 ppb have been
tolerated at times, like in 1988, when a drought threatened
farmers in the Midwest. Salmonella is present in about 0.02% of
the eggs consumed by American, which amounts to a few thousand
real exposures everyday. Contamination of ground beef by E. coli
is responsible for an estimated 20,000 hospitalization and
nearly 500 deaths every year. While all of these are tolerated,
OHD triggered an unprecedented misleading bad press for a
product that had no history of ill effect.
Officials at OHD went as far as publishing an appalling paper in
the scientific literature reporting that in spite of a ruling
limiting the amount of microcystin in AFA at 1 ppm, 85 of the 87
samples taken from the marketplace contained a level of
microcystin superior to 1 ppm. As with their previous releases,
they failed to mention an important piece of information. The
ruling was passed on October 17, 1997. Between the summer of
1996 and the date of the ruling, the industry had adopted the
safe limit proposed by two prominent scientists, Dr. Wayne
Carmichael, expert in toxic cyanobacteria at Wright State
University, and Dr. Gary Flamm, former Head Toxicologist at the
FDA in Washington, who both proposed a safe level of 5 ppm.
These testimonials are on records at the Oregon Department of
Agriculture (ODA). The samples tested by OHD were taken from the
marketplace in the months following the ruling of 1 ppm.
However, all the samples came from product released on the
marketplace prior to the ruling, respecting the interim level of
5 ppm proposed by the experts. So while the industry was playing
by the rules and respecting experts opinion, OHD once again
acted deceptively concluding that the industry ignored the
ruling. The situation was like one day changing the speed limit
on a street and then accusing someone of having driven too fast
the day before. The intent to deceive was obvious for those
knowing the situation in details.
Supported by experts we proposed to have a moratorium at 5 ppm
for 2 years while we would pay for studies showing the safety of
low levels of microcystin in AFA. The study that OHD relied upon
for their safety assessment consisted of mice gavaged daily with
pure toxin dissolved in water. The very process of gavaging a
mouse leads to significant liver injury. In that study, at times
control groups showed greater toxicity than the group receiving
the highest level of toxin. The study was obviously flawed.
Beside, using pure toxin was inappropriate. For example, AFA
contains significant levels of silymarin, a bioflavanoid known
to provided 100% protection against microcystin. To establish
the safety of microcystin as a contaminant of AFA, we have to
test microcystin in AFA. OHD refused any suggestion.
Later on, someone close to the one person leading this whole
vendetta at OHD, Duncan Gilroy, told me that no reasonable
argument could change OHD's position because Duncan Gilroy did
not like blue-green algae and had the clear intention of
bringing down this industry. Even after the ruling of 1 ppm,
Gilroy kept telling consumer that no level of microcystin was
safe and people should avoid consuming from blue-green algae. In
any industry if a product is below the level considered safe,
the product is deemed pure and safe for consumption, like corn
and peanuts with aflatoxin, and beef with E. coli.
The facts
The blue-green algae harvested from Klamath lake and currently
sold on the market is more than 99% Aphanizomenon flos-aquae.
This blue-green alga from Klamath Lake is absolutely non-toxic,
as demonstrated by many years of extensive testing. During a few
weeks in the summer, Microsystis, a co-occurring blue-green alga
capable of producing the toxin microcystin, is found as a minor
constituent of the Klamath Lake phytoplankton community. This
phenomenon is not recent and Microcystis has always been present
in very small amounts in Klamath Lake. Despite its presence,
Microsystis is not a problem, since Desert Lake Technologies
(DLT) has developed a method to separate this alga from
Aphanizomenon flos-aquae.
In 1995, Dr. Wayne Carmichael from Wright State University and
Dr. Don Anderson from Woodshole Oceanographic Institute became
consultants for a member of the Klamath Lake Algae industry, on
the specific issue of algal toxicity. During the summer of 1996
a substantial bloom of Microcystis was unexpectedly observed
that started in early July and continued into the third week of
September. In collaboration with Dr. Jake Kann, Dr. Wayne
Carmichael and Dr. Don Anderson, the situation was brought to
the publics attention, because of the industrys commitment to
public safety and public education, which led to the Oregon
Health Division's awareness of the situation.
Because of the existence of only a few proposed guidelines based
on single studies and the uncertainties surrounding these
studies, an unrestricted grant was given to the University of
Illinois for the completion of a comprehensive risk assessment,
reviewing more than 300 scientific articles, aimed at accurately
evaluating the risk associated with microcystin as a possible
contaminant of blue-green algae products. This risk assessment
determined that 10 g/g was considered a safe level. A similar
safe level (5 g/g) was later confirmed by a risk assessment
performed by Dr. Gary Flamm, former head toxicologist at the FDA
in Washington, DC. This safe level of 5 g/g was also supported
by Dr. Wayne Carmichael in a written testimonial.
Despite the written opinions of many experts and the significant
amount of data indicating that levels of 5 g/g and even 10 g/g
were safe for human consumption, even children, the Oregon
Department of Agriculture decided to pass a regulation
establishing 1 g/g as the maximum acceptable concentration
(MAC). The actual safe level determined by animal studies was
between 2,500 and 6,000 g of microcystin per day. To add a
margin of safety, this safe level was further divided by a
factor of 1,000. The adopted safe level of 1 g/g is therefore
1,000 times lower than level established as safe in animal
studies, ensuring complete safety for children. Microcystin is
indeed a liver toxin, however, it is completely safe at the
levels currently found in blue-green algae products. Liver
damage only occurs at levels that exceeds 10,000 times the
adopted safe level of 1 g/g. One would have to eat more than
5,000 capsules per day to reach such levels.
The industry nonetheless welcomed the regulation and went
immediately into compliance. During the entire process and after
the adoption of the regulation the relationship between ODA and
the blue-green algae industry has been one of collaboration.
One of the unresolved elements of this regulatory process was
the development of a validated assay to quantify microcystin. It
was believed that such an assay could be developed in the year
following the adoption of the regulation. However, collaboration
between ODA and FDA in Washington State, as well as with
independent universities and institutions, has failed to produce
a validated test for the precise measurement of microcystin at
low levels. Nevertheless, the tests currently utilized that have
been developed and refined over the past 5 years, an enzyme
linked immunosorbent assay (ELISA) and a protein phosphatase
inhibition assay (PPIA), are precise enough to monitor
compliance, even though levels found in a same sample analyzed
on different occasions, or by different laboratories, can at
times show significant variations.
In conclusion, the blue-green algae industry has been extremely
pro-active with the problem of the presence of Microcystis in
Klamath Lake. Members of the Klamath Lake Algae industry have
worked with the Oregon Department of Agriculture to raise the
regulated level to 5 g/g. However, DLTs position has been to
fully integrate the regulatory level of 1 g/g, and to develop
ways to reduce microcystin content. As stated before, DLT has
developed and implemented a method to separate Microcystis for
Aphanizomenon flos-aquae. Lots of AFA harvested since 2000 all
tested at less than 1 g/g.
Back to Top
Aphanizomenon flos-aquae
Review Of The Literature Regarding Neurotoxicity
Aphanizomenon flos-aquae (Aph. flos-aquae) is a filamentous
blue-green algal species harvested each summer from Upper
Klamath Lake in Klamath Falls, Oregon. Aph. flos-aquae has been
sold as a nutritional food supplement for nearly 20 years. It is
known to be rich in certain vitamins (B12, carotenoids, K) and
in trace minerals. The nutritional benefits of Aph. flos-aquae
have been appreciated by over a million consumers, many of whom
reported increased energy levels, heightened mental clarity,
improved memory and recall, and an overall feeling of
well-being.
Aph. flos-aquae from Upper Klamath Lake
To appreciate Aph. flos-aquae from Klamath Lake, it is important
to consider the unique ecosystem in which this alga "blooms."
Upper Klamath Lake, which covers approximately 325 km2, has the
greatest surface area of any natural water body in Oregon
(Gearheart et al. 1995). Numerous springs charged with water
filtered through miles of nutrient-rich volcanic soils on the
flanks of the Cascade mountains (Gearheart et al. 1995), and six
major tributaries, contribute 90% of the annual inflow to the
lake (1,527,600 mean acre-feet (1929-1993); Gearheart et al.
1995). Overall, Upper Klamath Lake is described as a very
productive eutrophic lake that is marked by high levels of
available nutrients and plant life. It is this wealth of
nutrients that allows Aph. flos-aquae to grow in such abundance
in the wild. Upper Klamath Lake is one of only a few ecosystems
which supports the recurrent growth of Aph. flos-aquae in such
abundance.
Upper Klamath Lake has sometimes been referred to as polluted
because of the lake's incredible bounty of Aph. flos-aquae. The
most observable influence of this blue green algae is the change
in the chemical properties of the water around the blooming
algal masses, namely dissolved oxygen, pH and ammonia. Given
summer conditions and a large algal bloom, water chemistry can
change drastically and these parameters can reach levels that
can directly impact fish species (Monda and Saiki, 1993). Fish
will congregate near inflow areas of better water quality, yet
their density and stressed condition renders them susceptible to
outbreaks of disease and die-offs. In Upper Klamath Lake such
fish kills (1971, 1986, 1995) are generally attributed to
outbreaks of "Columnaris" disease (Logan and Markle, 1993).
These outbreaks have been common in fish hatcheries under
crowded, high temperature conditions (Piper et al. 1982). Such
impact on the survival of fish has led people unaware of this
natural chemistry to state that Klamath Lake is polluted.
Various testing for pesticides, petro-chemicals and other
contaminants over the past 10 years failed to reveal the
presence of any such contaminants.
Aph. flos-aquae and the issue of neurotoxicity
A few reports of neurotoxicity in the scientific literature have
raised unwarranted concern. Aside from these reports, nearly ten
years of regular testing (more than 300 samples tested) has
failed to reveal the presence of any neurotoxins. In the late
1990s two lawsuits were filed against companies harvesting from
Klamath Lake for neurotoxicity. Both cases were dismissed after
considerable effort to detect neurotoxins proved unsuccessful.
Finally, a study recently published used genetic technologies to
determine that the previous reports of neurotoxicity associated
with Aph. flos aquae had misidentified the algal species and the
toxic algal samples were not Aph. flos aquae but a species of
Anabaena. Below is a brief and more detailed account of the
evolution of the scientific data regarding the neurotoxicity of
Aph. flos aquae.
Klamath Lake
The first article to report toxicity of Aph. flos aquae
summarized a 1960 US Department of Health, Education and Welfare
seminar in which authors Phinney and Peek (1961) refer to a
toxic algal bloom that occurred in Upper Klamath Lake in the
late 1950's. A sample of this algal bloom was sent to Dr. Paul
Gorham, then at the National Research Council, Ottawa, Canada,
for toxicological analysis. Although Phinney and Peek reported:
"no concrete evidence was obtained as to the effect of this
toxin on the biota of the Lake and River, but experiments
with mice proved that ingestion of the algal material was
quickly lethal and intraperitoneal injection of the aqueous
extract almost instantaneous in causing death"
Gorham determined that the sample was not pure Aph. flos-aquae,
but actually consisted of equal parts of Aph. flos-aquae and
Microcystis - an algae known to produce microcystins. Gorham
concluded that the toxicity came not from the Aph. flos-aquae,
but from the Microcystis (Gorham, 1964; Carmichael and Gorham,
1980; Gorham, personal communication to W.W.C., 1995).
The second article concerning Klamath Lake was a preliminary
summary of a toxicity test on Upper Klamath Lake Aph. flos-aquae
published by Gentile (1971) in a review article on blue-green
and green algal toxins. A mouse assay (n=1) was performed on a
colony isolate of Aph. flos-aquae cultured for a short period of
time in a laboratory. Signs of poisoning in the mouse were
reported as similar to that of a Kezar Lake, New Hampshire (see
below) Aph. flos-aquae sample later shown to produce a toxin
with similarities to saxitoxin and its derivatives.
In both articles, several elements did cast significant
uncertainty concerning this possible neurotoxicity of Upper
Klamath Lake Aph. flos-aquae. These include:
-
lack of taxonomic verification of Aph. flos-aquae as the
dominant alga in the tested culture;
-
lack of a complete mouse bioassay which would have
established the minimum lethal dose, LD50 and toxicity
compared to known saxitoxin standards; and
-
lack of a confirmation of toxicity by other laboratories
working with these neurotoxins.
For these reasons, it could not be concluded that Aph.
flos-aquae from Upper Klamath Lake produced a neurotoxin. As
quoted by Gentile (personal communication to W.W.C., March 27,
1996), "This anecdotal toxicity test on Upper Klamath Lake Aph.
flos-aquae should be rigorously restudied before it can be
concluded that the alga produces a toxin". Periodic toxicity
tests in the 1980s plus frequent regular testing since 1991 have
failed to reveal any neurotoxins in Upper Klamath Lake Aph.
flos-aquae (Carmichael et al., 2000).
Aph. flos-aquae samples from other locations
In spite of the complete absence of neurotoxicity as tested
numerous times using HPLC and mouse bioassay, doubts regarding
the possible neurotoxicity of Klamath Lake Aph. flos-aquae
persisted because of the discovery of three samples of Aph.
flos-aquae found elsewhere (USA and Finland) that contained
neurotoxicity.
Sawyer et al. (1968) and Gentile and Maloney (1969) reported
toxicity of an atypical non-colony forming Aph. flos-aquae that
killed fish and laboratory mice. This Aph. flos-aquae came from
Kezar Lake in New Hampshire. More recently, Rapala et al. (1993)
reported toxicity of Aph. flos-aquae isolated from water blooms
in Finland. These studies establish that Aph. flos-aquae is
toxic only in some geographical locations. This study also
demonstrated that it was not possible, under the experimental
conditions, to manipulate a non-toxic strain of Aph. flos-aquae
to become toxic.
At this point in time, the general consensus among scientists
was that some strains of Aph. flos-aquae were capable of
producing neurotoxins but most strains, include the Klamath Lake
strain, were non-toxic.
One aspect that caught the attention of several scientists was
the mention in the aforementioned articles that the toxic
samples of Aph. flos-aquae were atypical non-colony forming Aph.
flos-aquae. In other words, the toxic strains that were
originally identified and classified as Aph. flos-aquae were not
typical of Aph. flos-aquae and the original identification could
have been inaccurate. Indeed, the boundary between Aph.
flos-aquae and some Anabaena species is very unclear and
misidentification of the algal species can be problematic.
Anabaena spp. is known to produce various kinds of neurotoxins.
Recent developments in genetics have provided the tools to
determine, using genetic similarities, whether the toxic strains
of Aph. flos-aquae are the same species as the strain showed to
be non-toxic. Recently, Li et al. (2000) have shown that all the
toxic strains of Aph. flos-aquae are genetically dissimilar to
the non-toxic strains and most likely belong to the Anabaena
genera.
Court Cases
It is interesting to briefly discuss two instances in which
lawsuits were filed around the issue of neurotoxicity of Klamath
Lake Aph. flos-aquae.
In the first one a man, Mr. Fineman, claimed that consumption of
Aph. flos-aquae triggered neuropathy. The case revealed that Mr.
Fineman had been suffering from diabetes since early childhood
and had had many episodes of developing neuropathy. After two
years of contracting with various laboratories throughout the
world to detect and identify a neurotoxin in Aph. flos-aquae,
Mr. Fineman had to withdraw the suit because of lack of
evidence. The court obliged Mr. Fineman to published the
following statement:
"I, Samuel Fineman, brought a lawsuit against Cell Tech and
the Kollmans because I thought I had been harmed by some
substance in Cell Tech's products. Testing and investigation
(including testing for neurotoxins) did not confirm the
presence of any such substance. Accordingly, I have
withdrawn my lawsuit in its entirety."
In a second case, the aforementioned company Cell Tech filed a
lawsuit against an individual, Mark Thorson, who had
relentlessly published over the Internet that Aph. flos-aquae
from Klamath Lake contained a neurotoxin similar to cocaine and
dangerous to consumers. Once again, after considerable effort to
prove his allegations, Mr. Thorson lost his case. He was also
asked to published the following statement over the Internet:
"During the last several years, I have from time to time
posted to this and other newsgroups a file of information
called "An Anatoxin-a Primer." I now retract the statements
made in the Anatoxin-a Primer.
The Anatoxin-a Primer implied that Super Blue Green Algae
from Klamath Lake, produced by Cell Tech, contains
anatoxin-a (a neurotoxin I characterized as addictive), and
that Cell Tech deliberately avoids testing for this toxin
because anatoxin-a is responsible for the effects reported
by SBGA users. I have since been advised that Cell Tech
conducts regular tests that would disclose anatoxin-a, and
that this toxin has never been found in Super Blue Green
Algae. I had no basis for the suggestions I made in the
Anatoxin-a Primer, and I hereby retract it in full."
These two cases are interesting as they both relied on the
explicit demonstration that Aph. flos-aquae from Klamath Lake
contained a neurotoxin. In both cases, many laboratories
throughout the world with the capability and the expertise to
detect and quantify neurotoxins were contracted to find
neurotoxins in Aph. flos-aquae from Klamath Lake, with no
success.
Summary
In summary, the few instances of reports of neurotoxicity of
Aph. flos-aquae pertained not to Aph. flos-aquae but to species
believed to be Anabaena spp. All samples shown to be Aph.
flos-aquae by PCR technology (genetics) were all reported to be
non-toxic. In addition, two significant legal suits failed to
detect the presence of any neurotoxin in Aph. flos-aquae from
Upper Klamath Lake.
Taken altogether, the available data demonstrate the
non-toxicity of Aph. flos-aquae from Upper Klamath Lake.
Back to Top
References
Carmichael, W.W., Drapeau, C., and Anderson, D.M. (2000)
Harvesting of Aphanizomenon flos-aquae Ralfs ex Born. &
Flah. Var. flos-aquae (Cyanobacteria) from Klamath Lake for
human dietary use, J. App. Phyco., vol. 12, pp. 585-595.
Carmichael, W.W., and P.R. Gorham. (1980) Freshwater
cyanophyte toxins, In: Algae Biomass, Elsevier, New York,
pp. 437-448.
Gearheart, R.A., J.K Anderson, M.G. Forbes, M. Osburn, and
D. Oros. (1995) Watershed strategies for improving water
quality in Upper Klamath Lake, Oregon. Humboldt State
University, Environmental Resources Engineering Department.
3 Volumes.
Gentile, J.H., and T.E. Maloney. (1969) Toxicity and
environmental requirements of a strain of Aphanizomenon flos
aquae (L.) Ralfs, Can. J. Microbiol., vol. 15 (2), pp.
165-173.
Gentile, J.H. (1971) Blue green and green algal toxins. In:
Microbial Toxins, Vol. 7, Academic Press, New York, pp.
27-67.
Gorham, P.R. (1964) Toxic Algae. In: Algae and Man, Plenum
Press, New York, pp. 307-306.
Logan, D.J., and D.F. Markle (1993) Fish faunal survey of
Agency Lake and northern Upper Klamath Lake, Oregon. In
Environmental research in the Klamath Basin, Oregon - 1992
Annual Report. S.G. Campbell (ed.) p. 341.
Monda, D.P. and M.K. Saiki. (1993) Tolerance of Juvenile
Lost River and Shortnose suckers to high pH, ammonia
concentration, and temperature, and to low dissolved oxygen
concentration. In Environmental research in the Klamath
Basin, Oregon - 1992 Annual Report. S.G. Campbell (ed.) p.
341.
Piper, R.G, I.B. McElwain, L.E. Orme, J.P. McCraren, L.G.
Fowler, and J.R. Leonard. (1982) Fish Hatchery Management.
U.S. Department of the Interior, Fish and Wildlife Service.
Washington D.C. p. 517.
Phinney, H.K. and Peek, C.A. (1961) Klamath Lake, an
instance of natural enrichment. In Transactions of the
seminar on Algae and Metropolitan Wastes. U.S. Public Health
Service, pp. 22-27.
Rapala, J., Sivonen, K., Luukkainen, R., and S.I. Niemela.
(1993) Anatoxin-a concentration in Anabaena and
Aphanizomenon under different environmental conditions and
comparison of growth by toxic and non-toxic Anabaena strains
- a laboratory study, J. Applied Phycol., vol. 5, pp.
581-591.
Li, R., Carmichael, W.W., Liu, Y., and Watanabe, M.M. (2000)
Taxonomic re-evaluation of Aphanizomenon flos-aquae NH-5
based on morphological and 16 rRNA gene sequences,
Hydrobiologica, vol. 438, pp. 99-105.
Sawyer, P.J., Gentile J.H., and J.J. Sasner. (1968)
Demonstration of a toxin from Aphanizomenon flos-aquae (L.)
Ralfs, Can. J. Microbiol., vol. 14, pp. 1199-1204.
Quality And Safety Of
Klamath Lake Blue-Green Algae
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Overview
Klamath Lake Algae is a nutritional food supplement which is
harvested each summer from Upper Klamath Lake in Klamath Falls,
Oregon and consists almost exclusively of the filamentous
blue-green algal species Aphanizomenon flos-aquae. Aph.
flos-aquae is a nutrient dense food rich in vitamins, minerals,
essential amino acids, and proteins. The nutritional benefits of
Klamath Lake Algae mostly reported are increased energy levels
and an overall feeling of well-being.
Klamath Lake Algae from Upper Klamath Lake is absolutely
non-toxic. However, like many other agricultural products,
Klamath Lake Algae may contain naturally occurring compounds,
microorganisms or by-products of human activity that need to be
monitored and controlled. Each batch (lot) of Klamath Lake Algae
is subjected to a battery of scientific tests to ensure that the
algae consistently meets the highest standards of safety and
purity. As a result of these tests, Klamath Lake Algae is one of
the purest and safest foods available.
Klamath Lake Algae in Upper Klamath Lake
To appreciate Klamath Lake Algae, one first should consider the
unique ecosystem in which the algae "blooms." Upper Klamath
Lake, which covers approximately 125 square miles, has the
greatest surface area of any natural water body in Oregon (Gearheart
et al. 1995). Numerous springs charged with water filtered
through miles of nutrient-rich volcanic soils on the flanks of
the Cascade mountains (Gearheart et al. 1995), and six major
tributaries, contribute 90% of the annual inflow to the lake
(1,527,600 mean acre-feet (1929-1993); Gearheart et al. 1995).
Overall, Upper Klamath Lake is described as a very productive
eutrophic lake that is marked by high levels of available
nutrients and plant life. It is this wealth of nutrients that
allows Aph. flos-aquae to grow in such abundance in the wild.
Upper Klamath Lake is one of only a few ecosystems which
supports the recurrent growth of Aph. flos-aquae in such
abundance.
Historically, Upper Klamath Lake was a highly productive (eutrophic)
and diverse ecosystem due to a naturally high inflow of
nutrients (Gearheart et al. 1995). Though the term eutrophic is
often associated with adverse water quality conditions, in
reality, a body of water may be ecologically healthy and
eutrophic. In their 1967 report, Miller and Tash described a
nutrient-rich sediment layer many feet deep in Upper Klamath
Lake. They reported that the principal nutrients in Upper
Klamath Lake were supplied through natural geological processes
in quantities sufficient to maintain dense algal blooms, however
they did not include nutrient loading which resulted from either
local or upper watershed non-point sources (mostly poor forestry
and agricultural land management; Gearheart et al. 1995).
Current information indicates that human activities have
increased nutrient loading to the lake over historical
background levels (Bortleson and Fretwell 1993; Gearheart et al.
1995). However, much of the current debate centers on the effect
of additional nutrients on an already productive environment.
Both internal and external nutrient loading can influence
nutrient concentrations in the lake (Bortleson and Fretwell
1993) and probably the composition of the planktonic community,
however the paucity of long-term scientific data makes it
difficult to determine actual causes. Kaffka et al. (1995)
remarked that phosphorous concentrations in available studies
were above levels that many limnologists think are limiting to
algal growth, and concluded that anthropogenic (human)
influences in the Basin were of little consequence compared to
natural enrichment processes. However, during periods of intense
algal blooms in Upper Klamath Lake, dissolved phosphorus
concentrations are reduced to levels which are known to be
limiting (Gearheart et al. 1995). Other biologists (Gearheart et
al. 1995; Bortleson and Fretwell 1993; Kann and Smith 1993;
Miller and Tash 1967) have documented increases in productivity
and algal growth over the past century. Bortleson and Fretwell
(1993) noted that these increases in productivity were
detrimental to fish populations and that such productive systems
have the potential to increase the magnitude of algal blooms,
furthering the detriments to fish. To counteract these potential
changes, most Klamath Basin biologists have expressed support
for efforts to restore natural conditions through wetland
restoration and initiation of appropriate land management
practices in the watershed.
Since agricultural and forestry managed land border the Upper
Klamath Lake watershed (although more than 70% of the watershed
is in federal ownership), runoff from these activities does
enter Upper Klamath Lake. Though questions about the effect of
nutrient loading (sometimes technically referred to as
"non-point" source pollution) on lake water quality and lake
productivity exist, this does not affect the safety and purity
of Aph. flos aquae for human consumption. Although highly
charged emotionally and politically, the word "polluted," in the
Upper Klamath Lake ecosystem, describes a condition in which
concentrations of dissolved nutrients (phosphorus and nitrogen)
have increased to higher than historic levels. These nutrients
have subsequently impacted the aquatic community of the lake by
enhancing algal growth and by affecting related chemical
properties (dissolved oxygen, pH, ammonia, etc.) of the lake
water. When Upper Klamath Lake is said to be polluted, the term
usually refers to the amount of nutrients present, their
influence on algal growth, and the impact of this algal growth
on lakes aquatic life. Upper Klamath Lake water is practically
free of contaminants and man made toxicological pollutants. The
nutrients which enter Upper Klamath Lake are the same materials
which are referred to as fertilizer when found in topsoil
(nitrogen and phosphorus compounds). While not recommended for
direct human consumption, they are absolutely necessary
components of a growing medium for all plant matter, including
algae in Upper Klamath Lake. Upper Klamath Lake is for the algae
what a rich soil is for any vegetable.
One of the reasons Upper Klamath Lake is sometimes referred to
as polluted or believed to be polluted, regardless of its
nutrient source, is because of the lakes incredible bounty of
Aph. flos-aquae. Such abundant algal growth is customarily
associated with pollution. The most observable influence of
abundant algal growth is the change in the chemical properties
of the water around the blooming algal masses. In the presence
of sunlight, algae utilize carbon dioxide and produce oxygen as
a by-product of photosynthesis (the conversion of light energy
to chemical energy). Due to the limited solubility of oxygen in
water at high temperatures, relatively little oxygen dissolves
in the water and the remainder is released into the atmosphere.
During the night, however, algae do not photosynthesize but
instead consume oxygen and decrease the amount of dissolved
oxygen in the water. When the algal bloom declines and cells
begin to die, nightly oxygen demand of the remaining algae,
combined with oxygen demand of decaying material in the water,
can reduce oxygen levels in Upper Klamath Lake to levels which
affect the health of aquatic animals. The fluctuation in carbon
dioxide in turn drives changes in lake pH which may directly or
indirectly influence the health of fish in the area. Given
summer conditions and a large algal bloom, water chemistry can
change drastically and dissolved oxygen, pH and ammonia may
reach levels which can directly impact fish species (Monda and
Saiki, 1993). If fish are not directly affected, they may be
stressed by environmental conditions and their resistance to
commonly rejected parasites and diseases reduced. These fish
will then congregate in and/or near inflow areas of better water
quality, yet their density and stressed condition renders them
susceptible to outbreaks of disease and die-offs. In Upper
Klamath Lake such fish kills (1971, 1986, 1995) are generally
attributed to outbreaks of "Columnaris" disease (Logan and
Markle, 1993). These outbreaks have been common in fish
hatcheries under crowded, high temperature conditions (Piper et
al. 1982), and are caused by a common bacteria which
specifically affects fish. Under given circumstances,
Columnaris, which is normally under control, may take an
explosive course and cause catastrophic losses in one or two
days after first appearing (Piper et al. 1982).
While the algal species that is now indirectly associated with
these fish kills in Upper Klamath Lake is Aph. flos-aquae, this
type of reaction to high temperatures and photosynthetically
changed water conditions is not restricted to this time or
location or to this species. The first reported fish kill in
Upper Klamath Lake was reported by Gilbert in June of 1894
(Logan and Markle 1993). While this mortality may have been
partly a result of post spawning stress, it is also likely that
hot calm conditions and the resulting algal blooms could have
degraded water conditions and contributed to this occurrence.
While this implies that algal blooms in Upper Klamath Lake are
natural and occurred before any large-scale anthropogenic
activity around the lake, reported fish kills seem to have
increased in frequency through time. Summer fish kills have also
occurred in numerous nutrient rich lakes in Canada (Barica
1975). In an effort to assist recovery of diminished native
Upper Klamath Lake fish stocks, extensive cooperative work
between local environmental agencies has been initiated to
explore and enact actions which will ultimately ameliorate
conditions which result in these fish kills.
References
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Barica, J. 1975. Summerkill risk in prairie ponds and
possibilities of its prediction. Journal Fisheries Research
Board of Canada. Vol 32, pp. 1283-1288.
Bortleson G.C., and M.O. Fretwell. 1993. A review of
possible causes of nutrient enrichment and decline of
endangered sucker populations in the Upper Klamath Lake,
Oregon. U.S.G.S. Water-Resources Investigations Report
93-4087, p. 24.
Gearheart, R.A., J.K Anderson, M.G. Forbes, M. Osburn, and
D. Oros. 1995. Watershed strategies for improving water
quality in Upper Klamath Lake, Oregon. Humboldt State
University, Environmental Resources Engineering Department.
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Kaffka, S.R., Lu, T.X., and H.L. Carlson. 1995. An
assessment of the effects of agriculture on water quality in
the Tule lake Region of California. Research Progress Report
108. Univ. Of California. p. 85.
Kann, J. and V.H. Smith. 1993. Chlorophyll as a predictor of
elevated pH in a hypertrophic Lake: Estimating the
probability of exceeding critical values for fish success.
Klamath Tribes Research Report: KT-93-02. The Klamath
Tribes, Chiloquin, Oregon. p. 22.
Logan, D.J., and D.F. Markle 1993. Fish faunal survey of
Agency Lake and northern Upper Klamath Lake, Oregon. In
Environmental research in the Klamath Basin, Oregon - 1992
Annual Report. S.G. Campbell (ed.) p. 341.
Matsunaga, S., Moore, R.E., Niernezura, W.P., and W.W.
Carmichael. 1989. Anatoxin-a(s) a potent anticholinesterase
from Anabaena flos-aquae, J. Amer. Chem. Soc., vol. 111, pp.
8021-8023.
Miller, W.F, and J.C. Tash. 1967. Interim report: Upper
Klamath Lake Studies, Oregon, Federal Water Pollution
Control Administration. p. 37.
Monda, D.P. and M.K. Saiki. 1993. Tolerance of Juvenile Lost
River and Shortnose suckers to high pH, ammonia
concentration, and temperature, and to low dissolved oxygen
concentration. In Environmental research in the Klamath
Basin, Oregon - 1992 Annual Report. S.G. Campbell (ed.) p.
341.
Oshima, Y., Sugino, K., and T. Yasumoto. 1989. Latest
advances in HPLC analysis of paralytic shellfish toxins. In:
Mycotoxins and phycotoxins, Natoris, S., Hashimoto, K., and
Ueno, T. [Eds], Elsevier, New York, pp. 319-326.
Piper, R.G, I.B. McElwain, L.E. Orme, J.P. McCraren, L.G.
Fowler, and J.R. Leonard. 1982. Fish Hatchery Management.
U.S. Department of the Interior, Fish and Wildlife Service.
Washington D.C. p. 517.