In
January 02, I released a report titled: “Canavanine Toxicity:
Is Sutherlandia a Healthy Herb or Potential Poison”. What follows
is an attempted rebuttal (denial) by Phyto Nova’s Dr Carl Albrecht,
and my detailed response, point by point to each comment made
by Albrecht and to additional comments made by Phyto Nova on
their two websites.
CA: “Sutherlandia Passes
Safety Test! Earlier this year Information condemning the
indigenous medicinal plant Sutherlandia as a possible poisonous
plant because it contained the amino acid L-canavanine (appeared).
I believe this attack was based on unscientific reasoning.”
ST: Significantly, not just
an amino acid, but a “non-protein” amino acid and a potentially
highly toxic one at that! “Unscientific reasoning”’, let’s
take a closer look. Phyto Nova's website in layman's terms makes
incredible health claims for Sutherlandia, all toatlly unsubstantiated,
even by the "published literature" references provided,
which claims I showed via abstracts of subsequent research, rather
than mere references, are not sustained scientifically.
Phyto
Nova’s van Wyk and Gericke have published two books based mainly
on work poached from others. Regarding Sutherlandia, one
states: “a number of ‘highly active’ compounds (canavanine
& pinitol) occur in ‘high quantities’.” The other
states: “the plant is ‘rich’ in amino acids”
(and the formula of canavanine is illustrated). A
photographic advertisement states: “’Highly bioactive’ compounds
have been found in Phyto Nova Sutherlandia”. A press release
states: “Analysis of the plant showed two ‘particularly abundant’
elements”. The theme continues. Under "Chemistry and
Pharmacology", the website states: "Significent
levels" of L-canavanine are found in Sutherlandia leaves. L-Canavanine
is a "potent" L-arginine antagonist and a selective inhibitor
of inducible nitric oxide synthase." A high potency
/ concentration message is indisputable.
To a toxicologist, all of
this would indicate a very high potential for human toxicity under
certain common circumstances, especially in malnourishment and AIDS.
What my report attempted
was to balance, with some pertinent “scientific” toxicological facts,
the ridiculously broad and overly optimistic anecdotal safety and
efficacy sales propaganda, which might harm the gullible and desperate
by raising false hopes and also by the recommended, let alone reckless
higher doses. That the two faces of Sutherlandia cannot logically
be reconciled is exemplified by Phyto Nova’s about face on concentrations.
Following my report,
‘there is now an opposite trend - emphasizing how “low” the canavanine
content is’.
Albrecht, in response to a reporter emphasized the “very low
amounts of canavanine” (Shevlin,
Sunday Tribune, 21 April 2002) In
a response to my report, titled “Sutherlandia Safety and
Canavanine”, Phyto Nova
state: “There is no scientific
evidence that long term exposure to ‘the ‘very low amounts’ of
canavanine in Sutherlandia’ can have any adverse effects”.
In another response titled “Safety of Phyto Nova Sutherlandia”,
Phyto Nova state: “Alfalfa sprouts are widely sold as a health
food in South Africa and the USA. Despite the presence of canavanine
in alfalfa, the FDA has placed alfalfa in the category of food “generally
regarded as safe” (GRAS). If the accusation is correct that daily
ingestion of ‘small amounts’ of canavanine is harmful, this would
have become evident from the millions (millions?) of people all
over the world eating alfalfa sprouts (daily?), and alfalfa would
have been banned”.
This is not a valid argument.
Many harmful foods are in common usage, often encouraged by medical
authorities. By way of example, animal products cause millions of
cancer and cardiovascular disease deaths annually, yet are not banned.
I will explain shortly why alfalfa, in spite of containing more
canavanine, is rendered less toxic in some cases and more so
in others, sparing some, yet harming others, as applies also to
Sutherlandia, but with the important difference that Phyto Nova
are particularly targeting the ill, who are by far the most susceptible
to canavanine toxicity, whilst those using alfalfa sprouts tend
to be more well-nourished health conscious health food users, who
are further spared by the fact that alfalfa itself is rich in
the canavanine antagonist, L-arginine, a protein amino acid,
besides its weight increasing and its
canavanine decreasing at the leafing sprout stage.
Whilst Phyto Nova omit these
relevant facts, they do appear to acknowledge indirectly that diet
and health are key factors. Proclaiming safety and lack of “severe”
side effects, Gericke informed the press that: “the Phyto Nova
team tested the Sutherlandia tablets in high doses (?) on ourselves,
fellow doctors and family and friends” (all well-fed "fat
cats"). “Having determined (how?) that the product
was ‘safe when administered with a balanced food diet’ (how
many qualify?), the company (unlawfully) distributed Sutherlandia
to AIDS patients”. Even more specifically, the theme develops
further to read: “Remission is hoped for. This will require compliance
of appropriate dose in addition to meticulous attention to diet”.
The preponderance of data
at this point still clearly favours continued toxicological concern,
in spite of, if not because
of the bogus MRC tests, vindicating my charge of abuse of public
funds for a private enterprise, which study achieved nothing other
than to confirm that Phyto Nova has no intention of truly determining
whether or not their recommended use of Sutherlandia could likely
cause harm to ill and other susceptible people. It is my contention
that for many, even a monthly R35.00-R100.00 would be better spent
on good food, at least for the vast majority of poor and malnourished
persons whose resultant illness is often wrongly attributed to HIV-AIDS
and might need no more than some good food and medication typed
to their opportunistic infections, instead of their means to the
former being squandered on quackery.
(A)
Let me address Albrecht’s curt rebuttal of my ten-page report,
before I address the bogus MRC “safety” study.
“Sutherlandia contains
2.5 mg L-canavanine per gram (dry). L-canavanine can be toxic at
a very high dose.”
ST: L-canavanine is also
accumulatively toxic at much lower doses over time in several susceptible
individuals, particularly those who are malnourished or otherwise
deficient in protein / L-arginine and those who are ill (especially
with prolonged illness or infections), using medications and or
subjected to chemical exposures, under which circumstances,
so widely prevalent in South Africa and especially
in AIDS patients, even relatively low doses of L-canavanine
are readily substituted for arginine. Canavanine may have limited
possible short-term minor anti-inflammatory drug benefits, but these
are logically only likely at higher active doses, equally likely
to be followed by potentially catastrophic consequences for health,
as detailed in my report.
Arginine-rich protein, rather
than mere canavanine concentration, is the arbiter of toxicity in
this equation, having as it does, by its availability, the ability
to prevent canavanine from being erroneously incorporated in the
place of arginine. The degree to which arginine is deficient is
the degree to which canavanine is likely to exert both beneficial
drug effects, as well as toxic effects, the latter merely following
the former, insidiously at first, some time later, depending on
the other variables. In the absence of other susceptibility factors,
arginine is required in a ratio of 5:1 to canavanine to prevent
canavanine uptake and toxicity (Tschiersch
B, Pharmazie, 17, 621, 1962). Even
conservative clinical supplemental suggestions are as high as
25g L-arginine per day for immune function and host resistance
to infection (B Thomas, Manual of
Dietetic Science, Blackwell Science, 1994).
Deficiencies or imbalances
of essential amino acids result in increased urea production and
excretion and thus, any amino acid deficiency increases the demands
upon available arginine. Only high protein foods (a luxury in
sub-Saharan Africa) are rich in arginine, with very little available
in the staple cereals, grains and vegetables. A protein
/ arginine deficiency, and hence canavanine toxicity, is far more
likely to occur with poverty, malnutrition and poor protein especially
with excessive lysine, and in pregnancy, rapid growth and trauma.
(E Braverman, The Healing Nutrients
Within: Facts, Findings and New Research on Amino Acids, Keats,
1995)
CA: “Analysis of the literature
shows that the only well documented case of human toxicity involved
the consumption of 80-160 g of ground alfalfa seeds daily. Ingestion
of the seeds resulted in mild anaemia and leucopenia, which reversed
when consumption of the seeds stopped (The
Lancet, March 14, 1981, pg. 615)
ST: More thorough analysis
of the literature actually indicates that this was but the first
case of clear canavanine toxicity from acute overdose
due to the large quantity consumed in a short period of
time, rather than my concern of insidious smaller dose accumulative
chronic auto-immune toxicity, which latter became evident following
informed vigilance (Roberts J, et
al, (letter), N Engl J Med, 308, 1361, 1983); (Ames B, Science,
221(4617), 1983); (Malinow M, et al, Science, 216, 415, 1984); (Alcocer-Varela
J, et al, Arthritis Rheum, 28(1), 1985); (S Chan, Women’s
Health and the Environment, Environmental Care 86, China)
This condition, especially if chronic, may never resolve,
or may do so only with immunosuppressive drugs, since once an auto-immune
reaction is triggered, it may perpetuate itself
(Klein J, Horejsi V, Immunology, blackwell, 1997)
In the early eighties,
eating of alfalfa sprouts was popular amongst natural health faddists,
who because they were unlikely to be malnourished and because
alfalfa is relatively rich in arginine and low in its competitor,
lysine, toxicity from alfalfa, in spite of its high canavanine content,
was moderated and generally healthy consumers spared otherwise
more serious long-term canavanine auto-immunotoxicity, as witnessed
in those less fortunate, more susceptible cases extensively documented
above and hereunder. Much the same applies to today, health foods
being eaten mainly by the health conscious, affording them protection
from canavanine, so informed health professionals continue to advise
auto-immune patients to avoid alfalfa, surely not all because of
an allegedly single well-documented case of alfalfa overdose some
20 years ago, as Phyto Nova would have us naively believe.
Contrary to Albrecht’s
mischievous claim, a number of clinical reports and experimental
studies have shown that auto-immune responses and/or auto-immune
diseases and disorders are frequently induced in humans by xenobiotics,
including food sourced alfalfa derived canavanine. By the end of
the 80’s, Professor Varro Tyler, a pharmacognosy authority at Purdue
University, warned of reports of patients with clinically and
serologically quiescent systemic lupus erythematosus (SLE) had even
had the disease reactivated by merely ingesting canavanine-containing
alfalfa tablets (V Tyler, et al
(Eds), Pharmacognosy, Lea and Febiger, 1988). The cautionary
trend continues to this day. Quoting Belmont H, MD, director of
the lupus clinic at Bellevue Hospital and chief medical officer
at the Hospital for Joint Disease in New York City, "There
are foods that aggravate lupus and chief among them is alfalfa"
(Lupus Advocational Resource Centre,
January 30, 2001).
The following published
reports relate to subsequent toxic human canavanine exposures:
(Morimoto I, Kobe J Med Sci, 35(5-6), 1989); (Rosenthal G, et al,
J Biol Chem, 264(23), 1989); (Morimoto I, et al,
Clin Immunol Immunopathol, 55(1), 1990); (Ames B, et al, Proc. Natl.
Acad. Sci. USA, July 17, 1990); (D Metcalf, in: Food Allergy: adverse
reactions to foods, D Metcalf, et al (Eds), Blackwell Scientific
Publications, 1991); (Yoshida S, Gershwin M, Semin Arthritis Rheum,
22(6), 1993); (A Mongey & E Hess, in Dubois’ Lupus Erythematosus
and Associated Disorders, D Wallace & B Hahn (Eds), Lea and
Febiger, 1993); (Herbert V, et al, Amer J Clin Nutr, 60: 639, 1994);
(Leporatti
M, Fitoterapia, 67(6), 1996);
(Bigazzi P, Toxicology,
119(1), 1997);
(Brinker F, Herb Contraindications and Drug Interactions, Eclectic
Medical Publications, 1998); (Powell
J, et al, Environ Health Perspectives, 107(Suppl 5), 1999);
(Brown A, J
Renal Nutr, 10(4), 2000); (Capasso
R, et al, Fitoterapia, 71:1001, 2000); (Gebbers O, Schweiz Rundsch
Med Prax, 90(44), 2001); (Siddhuraju P, Becker K, Nahrung, 45(4),
2001); (E Hess, The Environment and Lupus,
Fourth Intl Lupus Patients' Conference Barcelona, Spain, Mar
2001); (Patavino T, Brady D, Altern Med Rev, 5(6), 2001).
All of these reports consider canavanine to
be undesirable.
CA: “The dose of alfalfa seeds contained 1200-2400 mg
L-canavanine per day, about 500-1000 times the amount in two Sutherlandia
tablets, the recommended daily-dose. On the basis of this Sutherlandia
was condemned.”
ST: In this instance
more than 1 kg of seeds ground dry seeds, not canavanine-reduced
sprouts, were consumed in a short period of time rendering it
an acute, rather than chronic poisoning case. In view of
the foregoing reports, I have to reject Phyto Nova’s blatantly mischievous
choice of this one extreme case as their basis for comparative and
extrapolative purposes. Furthermore,
Phyto Nova on their website advocate not just 2, but 6 (2X3)
tablets daily, thereby tripling the possible toxicity stakes.
A photographic advertisement gives as the suggested dosage, that:
“AIDS and cancer patients should take Phyto Nova Sutherlandia
on an ongoing basis under supervision of a health care professional”,
leaving determination of the dose to the discretion of one of several
class of possible quacks considered to be health care professionals.
We have no indication of how much arginine the Sutherlandia contains,
but it is certain that it is nowhere near the abovementioned
5:1 protective ratio, nor the established safe supplemental dose
of 25g of arginine for preserved immune function.
CA: “I believe the
lesson to be learnt here was expressed by Paracelsus centuries ago
- "No substance is a poison by itself, it is the dose that
makes the substance a poison”.
ST: Yes, but not only
the dose. Several variables are being totally ignored in
this over-simplistic equation. As I have already pointed out, health
food eaters using alfalfa sprouts tend to be more well-nourished
and are further spared from canavanine poisoning by the fact that
alfalfa itself is rich in the L-canavanine antagonist, L-arginine,
besides the bulk/weight of sprouts increasing and the canavanine
content decreasing at the leafing sprout stage. The essential
points to bear in mind is that with Phyto Nova’s target
users (cancer and especially AIDS), we are not dealing with
healthy consumers, but with those more likely to be suffering protein/arginine
deficiency and exposed to chemicals, rendering them more
susceptible to adverse auto-immune outcomes from Sutherlandia,
especially considering that bacterial and viral agents are
also likely to be triggering factors for auto-immune diseases, rendering
such persons far more vulnerable to canavanine toxicity.
Several chemicals increase
auto-immune susceptibility, including herbicides, preservatives,
dyes, plastics, rubber products, hydrazine, silicone, gold, mercury,
cadmium, tobacco smoke and paraffin (in many sub-economic
households), (A-B Mongey & E Hess,
The Role of Environmental Agents in Systemic Lupus Erythematosus
and Associated Disorders, in Dubois’ Lupus Erythematosus, D Wallace
& B Hahn (Eds), Academic Press, 1996), factors
to which many workers suffering from cancer and especially AIDS
might be chronically exposed. There are also more
than 70 medications with a likely or definite association
with auto-antibody production and lupus-like syndromes, some
in high likely usage within Phyto Nova’s target group for Sutherlandia,
eg Isoniazid (anti-tuberculosis) and Quinidine (anti-malaria) (A-B
Mongey & E Hess, Drug and Environmental Lupus: Clinical Manifestations
And Differences, in Systemic Lupus Erythematosus, R Lahita (Ed),
Academic Press, 1998).
Medical treatment
for SLE-like conditions is in itself complicated and includes immunosuppressive
corticosteroids and non-steroidal anti-inflammatory drugs,
as well as cytotoxic drugs to reduce steroid dosage. Treatment
results are variable, with debilitating side effects. Prednisone
causes musculoskeletal complications like avascular necrosis and
the NSAIDS cause gastrointestinal damage. The cytotoxic drugs often
fail to achieve remission and cause side effects such as cytopenia,
hepatitis, nausea, vomiting, stomatitis, and central nervous system
disturbances. Although SLE occurs in all age groups and gender,
the target population is women and in addition, certain ethnic
groups including Africans, have a higher susceptibility and incidence
than Caucasians. (Patavino T,
Brady D, Altern Med Rev, 6(5), 2001) It is no coincidence
that I subtitled my report “HIV Positives and AIDS Sufferers Beware:
The Remedy May be Worse than the Alleged Disease”.
[NOTE: The data
repeated hereunder from the main report, in this response, is reduced
to a different colour font should you wish to skip the repetition]
Canavanine is a potentially deleterious arginine antimetabolite
whose toxicity is expressed in canavanine-sensitive organisms including
humans (Rosenthal G, et al, J Biol Chem, 264(23), 1989). Canavanine
bears strong structural analogy to its protein amino acid counterpart,
arginine. As a subtle structural mimic of L-arginine, L-canavanine
can function in all enzymic reactions for which arginine is a substrate.
Therefore, canavanine potentially can inhibit any enzyme-directed
reaction employing arginine as the preferred substrate. Canavanine
assimilation can alter protein conformation and adversely affect
normal biological function and biochemical activities. It is reasonable
to propose that ‘administration of L-canavanine to a human
would result in the formation of L-canaline, a highly toxic nonprotein
amino acid’ that is a powerful inhibitor of pyridoxal phosphate-dependent
enzymes via a direct reaction between canaline and the vitamin B6
moiety of an enzyme. (Rosenthal G, L-canavanine: A Novel Chemotherapeutic
Agent for Human Pancreatic Cancer, 2001)
Why anyone would promote
canavanine with its potential to form anomalous, structurally aberrant
protein with such health damaging, even life threatening toxic potential,
in a natural health idiom, and in particular for AIDS, is beyond
me. Immunocompetent cells rely on amino acids as energy substrates.
Arginine in particular is a modulator of immunity and greater availability
improves the nonspecific immune response. (Walrand S, et al, Am
J Clin Nutr, 72(3), 2000) Nitric oxide synthases (NOS) catalyze
the oxidation of L-arginine to nitric oxide (NO), which plays a
key role in neurotransmission, control of blood pressure and cellular
defense mechanisms (Boucher J, et al, Cell Molec Life Sci, 55(8/9),
1999). Host defense epithelia with their antimicrobial armament,
including T-cells and natural killer cells, are incapable of ensuring
survival of the host against commensal organisms in the combined
absence of phox and NOS. Sustained production of NO requires extracellular
arginine uptake and endows macrophages with cytotoxic activity against
viruses, bacteria, fungi, protozoa, helminths, and tumor cells (MacMicking
J, et al, Annu Rev Immunol, 15: 323, 1997); (Nathan C, Shiloh M,
Proc Natl Acad Sci, 97(16), 2000).
The cytotoxic and pro-inflammatory
potential of NOS advances the case for its therapeutic inhibition
only in diseases that are not infectious in etiology, or in those
infectious diseases where the inflammatory effect of NOS outweighs
its antimicrobial effect, emphasizing the possibility of adverse
consequences attendant on its inhibition. Expression of NOS sometimes
makes a profound difference to the course of infection or inflammation,
acting both as a direct effector and as a regulator of other effectors.
These complexities do not preclude experimental therapeutic intervention,
but demand caution when trials are with nitric oxide synthase inhibitors.
(Nathan C, J Clin Invest, 100(10), 1997) Inhibitors of NOS (agents
that prevent binding of substrate L-arginine) are potentially beneficial
only in the treatment of conditions associated with overproduction
of NO, eg septic shock, neurodegenerative disorders, and inflammation.
(Hobbs A, et al, Annu Rev Pharmacol Toxicol, 39; 191, 1999)
The production of NO represents
an important component of the host immune response against viral
infections, including retroviruses. Antiviral effects occur through
its microbiostatic and microbicidal activity and through its pro-inflammatory
and immunoregulatory properties. Macrophages are suspected to play
a major role in human immunodeficiency virus infection. AIDS viruses
stimulate NO production by human macrophages and thus NO concentration
is increased in the sera of patients with AIDS, especially in those
with neurological disorders and pulmonary disease caused by intracellular
opportunistic pathogens. (Blond D, et al, J Virol, 74(19), 2000)
Increased expression of NOS might be expected in AIDS infections,
yet elevated NO levels in serum are related only to active AIDS-related
bacterial, protozoan, and fungal infections, rather than chronic
viral infection alone. NO plays a role in the local control of chronic
viral infections at tissue level. (Lake-Bakaar G, et al, Dig Dis
Sci, 46(5), 2001)
Not only is there no rationale
for promoting canavanine-containing Sutherlandia for persons with
AIDS (wasting would also be addressed by feeding arginine rich protein),
but on the strength of the scientific information summarised here,
canavanine would be clearly contraindicated. Canavanine or a deficiency
of dietary protein or of arginine impairs constitutive and inducible
NO synthesis (Wu G, et al, J Nutr 129: 1347, 1999). A recent review
of the literature indicates that NOS inhibitors (of which Sutherlandia
canavanine is one) exacerbate infection by 80 species of viruses,
bacteria, fungi, and protozoa (M De Groote & F Fang, in: Nitric
Oxide and Infection, F Fang (Ed), Kluwer/Plenum, pp. 231-264, 1999);
(Nathan C, Shiloh M, Proc Natl Acad Sci, USA, 97(16), 2000).
Since the tuberculosis-exacerbating
effect of corticosteroids is quantitatively indistinguishable from
the effect of NOS deficiency, and corticosteroids suppress NOS,
this may be an important mechanism for the tuberculosis-promoting
effects of corticosteroids (Nathan C, J Clin Invest, 100(10), 1997).
Tuberculosis, the leading cause of death from infectious disease
and AIDS, poses an even greater threat as immunodeficiency spreads
among the host population and drug resistance rises. NOS is necessary
to control primary tuberculosis. The absence of NOS leads to rapid
bacterial growth, necrotic granulomatous pneumonitis, and death.
The sterile eradication of Mtb is rarely achieved. Long-term CD4+
memory T-cells must continually enlist the aid of macrophages to
maintain bacterial dormancy The fact that NOS is necessary to control
mycobacterial growth, has implications for the global incidence
of AIDS and human tuberculosis. (MacMicking J, et al, Proc Natl
Acad Sci, USA, 94 (5243), 1997)
Besides canavanine,
further concern is the suggestion of prolonged use of pinitol-containing
Sutherlandia, especially for AIDS, due to the fact that Enterobacteria,
including Klebsielleae, Yersinia, Erwinia and Salmonella, are capable
of metabolizing pinitol and using it as a source of energy (Talbot
H, Seilder R, Appl Environ Microbiol, 37(5), 1979); (Talbot H, Seilder
R, Appl Environ Microbiol, 38(4), 1979). Of particular concern is
Klebsiella, especially K pneumoniae, which causes primary pneumonia,
one of the main causes of death in AIDS, and also meningitis, and
in infants, septicaemia. Many strains are now antibiotic resistant
and cause serious infections, especially nosocomial and community-acquired,
particularly in infants and AIDS patients. (Feldman C, et al, J
Infect, 20(1), 1990); (Feldman C, et al, Respiration, 58(5-6), 1991);
(Cotton M, et al, S Afr Med J, 91(2), 2001)
(B) Finally, let me
expose the April 2002 MRC/NRF “Toxicity Study Of Sutherlandia” report
for the cheap sham that it is.
CA: Sutherlandia dried leaf powder was recently tested, independently,
for toxicity/safety.
ST: In my report I outlined
the links between the members of Phyto Nova and Dr M Mtsabisa, project
co-ordinator, which negates any possibility of this fraudulent exercise
even remotely qualifying as being “independent”.
CA: AFTER THOROUGH STATISTICAL
ANALYSIS OF THE DATA, NOT A SINGLE VARIABLE COULD BE FOUND THAT
INDICATED TOXICITY.
For the full report http://www.sahealthinfo.org/traditionalmeds/firststudy.htm
ST: A PERFECT BOGUS STUDY,
DESIGNED AND INTERPRETED TO WHITEWASH ANY TOXICITY ISSUES.
-
No animals were reportedly
ill, in fact all were characterised as healthy, so in no way
resembled target users.
-
No animals were reportedly
receiving medication, in particular, auto-immunity disease risk-increasing
drugs. The MRC report in fact acknowledges that: “The
results in a study such as this do not preclude response to
the consumption of herbal medicines or any other medicinal compound”.
-
No animals were reportedly
exposed to chemicals, in particular to auto-immunity disease
risk-increasing ones.
-
No animals were females,
so in no way resembled the most frequently susceptible target
users. The report fails to note this, but acknowledges that:
“Sutherlandia was not tested in pregnant and young animals and
the results cannot be extrapolated to these groups”.
-
No animals were malnourished,
so in no way resembled most likely malnourished AIDS target
users. In fact, unspecified micro- and macronutrients were supplemented,
most likely negating any likelihood of acute toxicity.
-
No animals were monitored
beyond 12 weeks, whereas 24 weeks is the point at which well-fed
healthy animals on high doses significantly (10%) develop auto-antibodies
(Prete P, Can J Physiol Pharmacol, 63(7),
1985).
-
No animals received
3X and 9X the recommended human dose as claimed, since the doses
were adjusted to body-weight (30kg monkey = 60kg human) and
as shown previously, X2 and X6 tablets daily are commonly recommended
doses, with no maximum dose set anywhere, but left to the discretion
(supervision) of a health care professional, particularly in
cancer and AIDS patients (those most likely to be on higher
risk medications).
-
Besides the
time frame, the number of animals and frequency of monitoring
variables were grossly inadequate. Previous criticisms aside,
on this basis alone the study is rejected, since the information
generated is for all intents and purposes, useless. Assessing
the results of the variables, as well as the subsequent meaningless
interpretations and conclusions, amply validates this position.
The report admits as much, stating: “Results and observations
are reported mainly in terms of possible treatment effects and
not biological variation”. Treatment effects in healthy
animals? Statistically significant fluctuations only in the
control? What curious nonsense!
This position is confirmed
by assessing the report’s appendiced charts, where in virtually
every variable, the baseline values reflect greater significant
differences than both quarter and the end-points and where the control
group, which should reflect the greatest consistency over time from
the start, is the most erratic of all. In fact, the control group
appears to have received constant dietary manipulation, so that
even were no other criticisms valid, this fact alone would serve
to invalidate the entire study. Note eg the charts for Calcium,
Magnesium and Total Protein (figs 15, 16 & 22). Clearly, no
real comfort at all is provided by this MRC report.
Whilst
no toxicity indications were apparent, none would be expected under
current conditions so suited to the bland result planned for, but
then again, with no apparent assimilation of canavanine, nor would
any beneficial effects be possible either, so what is the point,
other than pretence at safety via a pseudo toxicological study?
Phyto Nova’s Dr Carl Albrecht, in
a recent newspaper article cited the MRC report, but when pressed
for a response to my report, “Canavanine Toxicity: Is Sutherlandia
a Healthy Herb or Potential Poison”, admitted to the reporter that:
“long term trials are essential to establish safety beyond doubt,
but that, well, took time. In the meantime they were free to market
the product”. (Ingrid
Shevlin, Sunday Tribune, Sunday Magazine, 21 April 2002)
Concluding remarks
Finally,
a word of caution when evaluating information of this nature, in
particular when human lives are at stake. Abstracts from accredited
journals are generally true reflections of the contents of the papers
cited, though these conclusions themselves may be argued with competing
hypothesis and data, as per the successful Gaia reports. As with
the original report titled “Canavanine
Toxicity: Is Sutherlandia a Healthy Herb or Potential Poison”, and
this rebuttal to the above critiqued toxicity study, titled “Sutherlandia
‘Fails’ Safety Test”, it is important to evaluate information purporting
to represent points and conclusions made, especially the context
and the original source.
A case in point here is
the rather impressive sounding “international” reference: “Trends
in Plant Science”, claiming that: “Sutherlandia frutescens microphylla
is gaining international attention as a cheap, readily grown herbal
medicine that can improve the health of AIDS patients through weight
gain and energy boosts.” (Note the sobering limited extent of the
reported claims, albeit still inaccurate, since weight gain and
energy boosts, even if eventually established as fact, do not necessarily
equate to improved health - ST) “The plant is native to South Africa
where indigenous people refer to the plant as insisa: the one that
dispels darkness. Insisa contains canavanine, pinitol and gaba,
chemicals already patented by drug companies. A team of traditional
healers, scientists and general practitioners have joined together
to try to ensure that insisa remains in the public domain. The medicine
will enter drug trials later this year .” (Chaffey
N, Stokes T, Trends in Plant Science, 7(2), 2002).
A very impressive claim
and reference, but for the fact that when one evaluates the source,
one finds that this information is sourced from a totally non-scientific
source: (Duval Smith, A. The Independent
(Lond), p. 18, 30 November, 2001) and as I have
shown in my first report, the media are often as much a part of
the misinformation problem as the marketers and vendors, not to
mention the institutions responsible for the pseudo-scientific reports
so eagerly seized upon by the aforementioned parties. Even the claims
to try to ensure that Sutherlandia remains in the public domain,
is a sham, since Phyto Nova have contracted widely to control the
majority of raw material.
The currently hyped phenomenon
around Sutherlandia for AIDS and other serious conditions is almost
entirely a non-factual fabrication by the members of Phyto Nova,
using their allopathic Tramed Project connections with the Departments
of Pharmacology and Pharmacy at the Universities of Cape Town and
Western Cape, the Medical Research Council and the Medicines Control
Council [Gericke (UCT), Matsabisa (UCT & MRC), Eagles (UWC &
MCC) and Mayeng (UCT & MCC)], which personalities and affiliated
institutions contribute to the fraud by allowing Phyto Nova members
to abuse the facilities, personnel and auspices of these institutions
in a private profit-making venture widely promoted without restraint
over the internet in order to create a global market for a product
steeped in hype and pseudo-science and yet to prove its safety and
worth. Sadly this potentially life-threatening health fraud is partly
perpetuated at the taxpayer’s expense and additionally many of our
already severely traumatised and/or ill citizens are either recklessly
used as guinea pigs in unregulated amateur trials or are persuaded
to part with their often extremely limited health-sustaining resources
(money for food) in their desperation for a miracle, all for the
financial benefit of a privileged well-connected few and whilst
the very authorities mandated to regulate such activities and protect
our citizens, not only turn a blind eye, but even double-standardly
participate in, authorise or endorse same.
Saddest of all is the official
blind eye turned to Phyto Nova’s illegal activities by the Medicines
Control Council, who frequently harass truly efficacious herbal
interests, but due to one Dr Mayeng, a member of Phyto Nova, in
their ranks, have done nothing to regulate the outrageous activities
of Phyto Nova, who have conducted illegal trials, made illegal claims
for their product, mass-manufactured and mass-marketed medicines
illegally and generally subjected thousands of ill people to unknown
risks to their health and lives. In fact, the abuse extends to the
MCC, in spite of these transgressions, actually inappropriately
approving clinical trials and effectively, through an apparent loophole
in legislation, exempting indigenous substances from regulation,
based on a recommendation by a MCC committee influenced, if not
led by Mayeng. Recall the "shock" reportedly expressed
by Peter Eagles, MCC Chairman, when informed by a major newspaper
investigator of Phyto Nova's illegal trials, his "plans to
investigate", and his statement that: "By law, all substances
which are claimed to alter or change a function of the body are
considered to be a medicine and should be registered" (Jessica
Bezuidenhout, Sunday Times, 16 December, 2001).
Folb, Eagles, Matsabisa, Mayeng, Gericke and even Albrecht all have
a long professional and personal association through the ethnopiracy
Traditional Medicines Project (Tramed) and they and this entire
debacle begs a judicial investigation.
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