Click on the questions below to display the corresponding answer.
- 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 products contain stem cells?
- What do Stemtech products 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?
Other Frequently Asked Topics
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.
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.
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.
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.
5. Do Stemtech products 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.
6. What do Stemtech products do?
Stemtech’s products support the natural release and activity of adult stem
cells in the body.
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.
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.
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
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.
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 amount
of circulating adult stem cells equates to a greater quality of health.
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.
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.
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.
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.
16. Is StemEnhance genetically modified?
No, StemEnhance is not genetically modified.
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.
18. What is the recommended usage for StemEnhance?
The suggested usage for StemEnhance is two capsules once or twice a day.
19. What is the optimum way to take StemEnhance?
StemEnhance can be taken any time of day with or without food.
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.
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.
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.
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.
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
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.
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.
27. Can StemEnhance be taken with other nutrients?
Yes. There are no known nutrient–nutrient interactions with StemEnhance
27. Can StemEnhance be taken with other nutrients?
Yes. There are no known nutrient–nutrient interactions with StemEnhance
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
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.
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.
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.
32. Can a person of any age take StemEnhance?
Yes, just follow the directions on the label and do so under adult supervision.
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.
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.
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.
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.
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.
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.
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
[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.
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The Whole Story About Microcystin and AFA
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.
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.
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
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
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. 3 Volumes.
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.
Q&A ON FDA’S DRAFT GUIDANCE
COMPLIMENTARY AND ALTERNATIVE MEDICINE PRODUCTS AND THEIR REGULATION BY THE
FOOD AND DRUG ADMINISTRATION
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf
Q: Does this Draft Guidance change how FDA regulates dietary supplements such
as StemEnhance?
A: No – The Draft Guidance provides FDA’s proposed definition of CAM
products (Complimentary and Alternative Medicine Products) and explains how these
products, depending on how they are labeled and marketed and for what specific intended
uses, will fall into existing FDA regulatory categories such as “drugs,”
“biologics,” “devices” or “foods” (which include
“dietary supplements”).
Q: Can dietary supplement products still be marketed with structure/function
claims such as “supports the natural release of adult stem cells”?
A: Yes – The Draft Guidance has no impact on legal structure/function claims
for foods or dietary supplements, and does not change how products making such claims
will be regulated.
Q: If individual distributors or the manufacturer make oral or written claims
for a dietary supplement that the product will help prevent or treat a disease,
how will the product be regulated according to the Draft Guidance?
A: As an illegal drug -- Disease prevention or treatment claims, such as curing
or preventing cancer, diabetes, arthritis or other disease, would cause FDA to regulate
the dietary supplement as an illegal drug, with the exception that if there is an
FDA-approved health claim, disease prevention claims might be legal. Disease treatment
claims for dietary supplements were illegal before the issuance of the Draft Guidance
and continue to be illegal. Claims to decrease risk or prevent disease should not
be made in the context of the sale of dietary supplements without first confirming
that such claims are legal as a result of an FDA-approved health claim.