Druginfo: 15th January 2002

Stuart has certainly given us food for thought - I'd really like to see responses from people other than the usual correspondents - whether on the literature presented so extensively, or on the policy issues (registerability of herbal preparations or the desirability of marketing something that is only just starting to be tested), or on the business processes at play.

Andy Gray

(Andy Gray, Senior Lecturer, Dept of Experimental and Clinical Pharmacology, Nelson R Mandela School of Medicine, University of Natal, Moderator of the Druginfo List)

Druginfo: 15 January 2002

I enjoyed reading Stuart's report on Sutherlandia. At face value, it should be taken seriously and studied. This is a good piece of consumer advocacy. We need more of these efforts.

Rene Doms

(Rene Doms, pharmacist and lawyer, MD of Pharma Natura)

Druginfo: 22 January 2002

HIV/AIDS is a new disease about which we learn new aspects daily. The physiological effects of this illness are, in many respects unknown to us. Long-term safety: "has enjoyed a long history of safe and widespread use in Southern Africa" founds no justification in immune compromised patients, as it previously could not have been exploited for this purpose. How do the imminent array of scientists justify testing the safety of a drug after marketing the substance?

The Bill of Rights under the Constitutions states; Freedom and security of the person 12 (2) Everyone has the right to bodily and psychological integrity, which includes the right

a.       to make decisions concerning reproduction;

b.       to security in and control over their body; and

c.       not to be subjected to medical or scientific experiments without their informed consent. 

Are we experimenting on an unsuspecting population and infringing their fundamental rights?

Rene Doms

Rene Doms, pharmacist and lawyer, MD of Pharma Natura)

Druginfo: 21st January 2002

Dear Andy and list members

Thanks for posting the Phyto Nova statement(s).

A few observations and comments are in order.

The statement relies heavily on "pseudo-credibility status by association" with the educational institutions from which some of the members are acting in their private capacity, and also State institutions and authorities with which Phyto Nova is now involved at this late stage (very much a matter of closing the stable door long after the horse has bolted), also under questionable allegiance connections to the Tramed group (very much a matter of the fox being in charge of the henhouse).

As I pointed out in my report, Gericke, Mayeng and Matsabisa (and also Albrecht) are colleagues from the bad old Tramed days, and Mayeng and Matsabisa now wield unacceptable influence within the MCC/DOH and MRC, allegiances which seriously compromise any outcome from the deliberations by these institutions. Prof Eagles, furthermore, now MCC Chair, was also part of the Tramed group and in fact all parties are still allied through the same project, now merely renamed the SA Traditional Medicines Research Unit, so as to break with the bad reputation carried by the Tramed Project following our earlier investigations and exposé of genocide and ethnopiracy.

I certainly find nothing reassuring in these associations/alliances/allegiances, indeed, the back-scratching and financially vested interests should give rise to concern rather than confidence. I am even more concerned than before, given the mere repetition of the assurance of safety by way of a single statement: "has enjoyed a long history of safe and widespread use in southern Africa". Compare this empty statement with my 10-page report to the contrary. Qualify his with the statement: "Phyto Nova (Pty) Ltd is awaiting the evaluation by the Medicines Control Council of a submitted clinical trial protocol designed to further research the safety and efficacy of this plant" and the criminality becomes clearly evident, considering the number of unsuspecting patients and consumers who have been already been subjected to the product as guinea pigs in an illegal experiment by Phyto Nova. I have shown beyond a reasonable doubt that 10-20 thousand South African's die unnecessarily every year due to traditional African medicines (Poppat A, et al, Clin Biochem, 34 (3) (2001))

http://www.gaiaresearch.co.za/trads2.html

The natural implication is that of this is that several hundred thousand, if not millions, of ignorant consumer's of these products, are spared death, but not untold protracted suffering as a result of using such products. Without any pharmacovigilance studies and adverse drug reaction monitoring, how can anyone claim a poisonous substance to be safe and effective. Quite simply, most drugs become unsafe at therapeutic doses, which is why these studies precede market entry and control post approval dosage (in theory at least). Should the illegal marketing of this toxic agent continue, I will consider initiating a class action suite to claim damages for each and every person harmed by the pre- and any post-approval damage to consumer's health, not only Phyto Nova and their distributors, but also the MRC and MCC for allowing these injuries to occur.

Sincerely

Stuart Thomson,
Director, Gaia Research Institute

Sutherlandia Status: Stuart Thomson Responds to Carl Albrecht

Druginfo: 9th June 2003

Let me dissect and reply to Albrecht’s piece titled “Sutherlandia Status” (Druginfo: 8 June 2003).

CA: "It is remarkable that there is not a single publication concerning the South African medicinal plant Sutherlandia on Pubmed."

ST: Remarkable indeed. This means that Sutherlandia has never been the subject of an original paper published in a peer-reviewed scientific journal, and so it should be. No science, no paper, no publication, period! For an example of hits on Pubmed for a true "hot plant", which is what Albrecht would have us believe Sutherlandia is, try a real wonder herb such as the green tea (which incidentally, I pioneered educationally as a healthy beverage in this country).

CA: "Nevertheless, the MRC safety study with vervet monkeys was published on the Internet last year at http://www.sahealthinfo.org/tradionalmeds/firststudy.htm"

ST: I dealt more than successfully with this bogus science in my piece: "Sutherlandia Fails the Safety Test" which was posted on Druginfo and published on the Internet at: http://www.gaiaresearch.co.za/sutherlandia.html A summary is appended below this current dissection.

CA: "This is an ‘official’ 35-page document of the MRC".

ST: And hence an ‘official’ fraud perpetrated by the MRC!

CA:"................ showing clearly that up to 9-times the daily dose of dried Sutherlandia leaves consumption for 3 months was not associated with toxic or other side effects in a cohort of vervet monkeys. Indeed Sutherlandia appeared to stabilise 6 of the 50 parameters studied, i.e. haematocrit, haemoglobin, mean corpuscular volume, creatine kinase, alkaline phosphatase and urea."

ST: Let me make a point clearly one more time, exposing the fraud inherent in this bogus "safety" study.

L-canavanine is 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, with resultant canavanine toxicity. A high arginine content is found only in high protein foods, with little in cereals and grains.

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).

Albrecht conceded this when pinned down previously, stating that: "The giving of any drug or tonic to malnourished AIDS patients is a big problem. Most AIDS drugs were tested in developed countries where malnutrition is not rife. I agree that the nutritional status of AIDS patients, especially in South Africa, is of cardinal importance in terms of drug side-effects and efficacy. Nevertheless, the appropriate circumstances to measure safety and efficacy in malnourished AIDS patients is indeed with AIDS patients and not with vervet monkeys. The mere conceptualisation of the experimental details of creating a cohort of malnourished vervet monkeys representative of malnourished AIDS patients is exceedingly problematical." No animals in the MRC study were malnourished and 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. How then can this study be claimed to prove the safety of Sutherlandia? It's a farce.

CA: "There are now at least 4 companies selling Sutherlandia in South Africa and abroad and I estimate that at least 400 000 monthly units (600 mg dried leaf powder per day) have been sold over the past 3 years."

ST: That's nothing on MacDonald's and we all know how unhealthy their products are.

CA: "Surely if this plant were poisonous, someone, somewhere would have complained by now. Surely there should have been at least one proven case of lupus erythematosus if Stuart Thomson et al's theories of L-canavanine-induced toxicity are correct?"

ST: If they were ill, why would they suspect, let alone why would they know that it was the wonderful natural remedy Sutherlandia that was responsible for their deterioration? If not ill and were merely using it prophylactically, why would they suspect, let alone how would they know that the Sutherlandia was responsible for their subtle insidiously developing symptoms. I notice that I have independent support for my position.

CA: "The plant has now been used as a tonic at least since 1895 (108 years) as reported by Andrew Smith at the time."

ST: So has tobacco, and a host of other inappropriate substances, in spite of killing millions annually.

CA: "I know that the plant is being studied intensively at RAU, UWC, UP, UPE, MEDUNSA, UV, UND and the MRC with collaborators in Korea, India, UK and US".

ST: So what? So has the mating-habits of dung beetles and even child pornography. It is not the studies, but the results and their ultimate application that count. Even then, science requires independent review and replication.

CA: "I also know that certain manuscripts and clinical studies are in the pipeline".

ST: If and when these were finalised and gave Sutherlandia a clean bill of health, would be the appropriate time to test the substance on innocent unsuspecting human guinea pigs, so that the real problems, as attendant to all medicines, rear their ugly heads epidemiologically, if indeed anyone is watching, rather than counting profits.

CA: "I therefore wish to suggest that the current lack of peer-reviewed publications on Sutherlandia should not be seen as any indication that it is either unsafe or lacking efficacy but rather a legacy of decades of neglect"

ST: Oh please. What melodramatic nonsense obscuring the scientific fraud at hand here!

CA: "The jury on this plant has not even left the room and I believe that a number of peer-reviewed publications are on the way."

ST: Yes the jury is out and when it comes in, it may be a number of medical malpractice suits and assault charges on the way for all concerned.

CA: "From a research and development point of view, this would seem to me to be one of the "hottest" plant in South Africa."

ST: History has shown that most of the hottest plants have turned out to be total flops when the hype wears off. (For an example of validating hits on Pubmed, try the keyword "green tea" (1220 papers). For hits on Medline, "green tea" will yield 11,000 papers. Even a simple cup of Ceylon tea will put Sutherlandia to shame. Hot without the hype.)

Here ends my commentary, followed by a summary of my critique of Albrecht's "safety" study:

APPENDIX

ST: A PERFECT BOGUS STUDY, DESIGNED AND INTERPRETED TO WHITEWASH ANY TOXICITY ISSUES.

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). Clearly a case of "profit before people".

Regards

Stuart Thomson
Director, Gaia Research

Mon, 9 June 2003

Dear Andy and List Members

Reading Albrecht's second missive in this series compels me to comment further as follows and I trust that you will bear with me, since it ought to put the debate to rest:

CA: "Stuart Thompson's numerous attacks on Sutherlandia and those associated with it, on this website, are not standing up very well to the test of time."

ST: What test of time? Phyto Nova have never embarked on a formal pharmaco-vigilance program to net an indication of possible toxicities and hence are unlikely to record any. I believe that at least a package-insert reporting-form listing possible / likely symptoms would have generated some useful data in the absence of side-effects / contra-indication package insert listing same and in the absence of said program. I cannot believe the sloppiness with which these guys have launched into this purely commercial venture.

CA: "I hypothesize that it is most likely the very low concentration of L-canavanine in the daily dose of Sutherlandia (+- 2.5mg) is safe and 'inconsequential'".

ST: There you have it. The previously "high" concentrations of canavanine have now become "very low" concentrations. Isn't it remarkable how my critique served to miraculously invert the relative concentrations of canavanine in Sutherlandia? Furthermore, as Albrecht has stated, the concentrations are 'safe' and "inconsequential". This has been my point all along. As I said in my main argument, a dose of Sutherlandia is likely to be either too high for safety, or too low for sustained beneficial effect, either too risky or useless. The concentrations are likely to be either consequential or inconsequential in terms of both safety/toxicity and uselessness/efficacy. They cannot have it both ways. Eventually however, even at minimal therapeutic doses, cumulative delayed immunotoxicity will predominate over any early (extremely limited) antimicrobial and anti-inflammatory effects, potentially leading to serious disease states, as the arginine analog increasingly enfolds into the victims protein and their immune systems eventually turn on themselves.

If the user and prescriber cannot distinguish between the symptoms of their illness and that of the side-effects, they might not stop, but rather increase the doage, with disastrous consequences likely to be attributed to an underlying progressive illness, whereas they might actually be suffering from Sutherlandia induced iatrogenesis. I am unaware of any cautionary information being distributed to doctors, patients and consumers by the distributors of Sutherlandia. Rather "safety" and lack of side-effects are repeatedly claimed. How are doctors patients and consumers, let alone Phyto Nova, to guage the existence or likely extent of any toxicity outcomes. My work on the subject, the most comprehensive on the subject of canavanine toxicity to date, has been deliberately avoided, smeared, suppressed, even censored, to what end?

CA: "The anti-cachexia pharmacological properties suggest a role for this plant in those afflicted with HIV .................... Surely this possibility should be receiving high priority attention?"

ST: I have previously shown in a massively referenced document circulated to this, that the use of Sutherlandia or any other canavanine-containing substance at pharmacological doses would lead to a situation where two conditions with diametrically opposite treatment rationales would be superimposed, one upon the other, with the treatment of one or both leading tragically to the exacerbation of the other, a catch-20 situation rendering the patient essentially untreatable. Again I ask, to what end?

If Albrecht cuts the crap, we can leave it at that.

Regards

Stuart Thomson
Director, Gaia Research

Druginfo: 10th June 2003

Dear Andy

I respond (further) briefly to Albrecht's repetition of his empty arguments.

As I said before, canavanine poisoning from alfalfa is rare, simply because it is rich in arginine, which reduces the assimilation and incorporation of canavanine into the host's proteins. I am amazed that the eminent professor cannot put forward even one good point in Sutherlandia's defence that will stand up to critique.

I believe that it is criminal to sell poison to sick persons based on such a weak hypothesis. At least in the case of registered drugs, some data has been established in meaningful animal studies and later, with informed consent from human subjects, properly monitored. Phyto Nova have put the cart before the horse at the expense of the innocent gullible public, which is criminal. Had we had an ethical and efficient regulatory authority in place, Phyto Nova would never get away with such flaunting of several laws currently on the statute books, including doctors promoting medicines, and in particular poisons as safe. Russell Coote is on this list and one can only speculate as to the reasons for not having acted against this open disregard for the law. Fraud and corruption are the order of the day. I pity the innocent seeking health and healing.

Regards

Stuart

Druginfo: 1st August 2003

Further to Coen van Wyk's recent probing of Carl Albrecht's follow up of Rene Doms' reference to at least one physician observed side-effect from Sutherlandia, I wish to know of Albrecht, who claims "lack of any reported evidence of serious human toxicity after commercialisation", precisely what the only non-serious reported human toxicity side effects are, that he has become aware of. Considering Albrecht's confidence in the safety of Sutherlandia, the list ought to be short enough to post here in sufficient detail to enable public scrutiny and independent evaluation of the claimed non-serious nature of the side-effects and whether or not they in fact relate to auto-immune reactions. I would also enquire as to what internationally acceptable measures have been instituted to collect the relevant data and when instituted. I cannot help but think of the three monkeys, hear, speak and see no evil, when thinking of the three main Sutherlandia apologists.

I would furthermore enquire as to how Albrecht anticipates distinguishing between the progressive symptoms of AIDS and the symptoms of canavanine toxicity, given the unprecedented diversity and complexity of the AIDS defining conditions and the equally diverse and complex mimicking and overlapping symptoms of canavanine related auto-immuno toxicity. I, for one, do not believe that it is within the means, let alone the will of Albrecht, Phyto Nova and their associates and agents to make the necessary distinctions. If it were relatively affordable and simple, I would long ago have recruited the necessary medical and legal expertise to take Phyto Nova to task by way of a class action for civil damages and criminal prosecution. This is not to say that it is not still my intention to do so. This very line of public questioning is preliminary consumer activist testing of Phyto Nova's sense of public responsibility or lack of same. The MCC are to be co-defendants.

Back to the crossover of symptoms attributable to both AIDS and canavanine and the question as to how Albrecht proposes to distinguish between the two. Given that NOS inhibitors, of which canavanine is one, have exacerbated infection by (at least) 80 species of viruses, bacteria, fungi, and protozoa (M DeGroote & F Fang, in: Nitric Oxide and Infection, F Fang (Ed), Kluwer/Plenum, pp. 231-264, 1999), Albrecht logically is compelled at the outset, to include all new and worsening infection cases into the data net as possible serious side effects, irrespective of whether the subjects are defined as having AIDS or not. This would, for starters, have to include all cases of tuberculosis and pneumonia, which are both directly impacted by canavanine induced auto-immuno toxicity. Clearly the pharmaco-vigilant surveillance needs to be extended far beyond the phenomenon of SLE, which Albrecht seems to wish to believe might be the only concern.

I would volunteer to compile a list of possible / likely side-effects and complications, were Albrecht man enough to undertake to incorporate the effort into a package insert to accompany the product along with an adverse drug-reaction reporting form, which would be the only means of merely starting to study the issue, let alone declaring the product to be safe. The lack of any precautionaries, combined with constant statements claiming safety, is hardly conducive to the honest collection of objective data. The vast majority of role-players, health care professionals? included, have no idea of what they are dealing with, so how are they to participate meaningfully in any process necessary to decide either way, the safety / toxicity and risk/benefit ratio attributable to Sutherlandia. Given the immediate out-of-hand rejection of my hypothesis (actually a thesis) by those responsible, how can we trust them to get anywhere near the truth in this matter.

I await Albrecht's carefully considered response and I thank Druginfo for their sense of public responsibility in continuing to facilitate this debate.

I dedicate the above effort to Coen van Wyk, whose own recent considerable effort was banned from this forum.

Yours sincerely

Stuart Thomson
Director, Gaia Research

Andy Gray, Senior Lecturer, Dept of Experimental and Clinical Pharmacology, Nelson R Mandela School of Medicine, University of Natal, Moderator of the Druginfo List, constructively (destructively?) joined (closed?) the Sutherlandia debate as follows:)

Druginfo: 15 August 2003

Hi all

I was reluctant to allow the "Sutherlandia" debate to re-open on this list, for reasons I've already stated. However, having allowed a question, and elicited a reply (and then an attempt to re-post a re-worked version of the initial mails rejected), nothing has happening - until this morning. It is clear that substantive exchange of details is not happening on this list - I am therefore posting Stuart's mail from this morning (see below), but as the final word on this specific topic. As Stuart notes, this might be viewed as "the debate .... declared closed in favour of Thomson et al". This list cannot substitute for the Medicines Control Council - as I see it, the ball is in their court, if they wish to remain true to the claim on their web site: "All medicines for human use are subject to this law, including complementary and complementary biological medicines".

Regards

Andy

Druginfo: Thursday, 14th August 2003

Dear Andy, Carl, Coen and list members

I recently enquired of Phyto Nova's Carl Albrecht on this forum precisely what the only non-serious reported human toxicity side effects from Sutherlandia are, that he has become aware of, seeing as he claims lack of any reported evidence of serious human toxicity after commercialisation.

I further enquired of Albrecht how he anticipates distinguishing between the the progressive symptoms of AIDS and the symptoms of canavanine toxicity, given the unprecedented diversity and complexity of the AIDS defining conditions and the equally diverse and complex mimicking and overlapping symptoms of canavanine related auto-immuno toxicity.

I notice in Albrecht's reply to van Wyk that (following the latters probing of Albrecht's follow up of Rene Doms' reference to at least one physician observed side-effect from Sutherlandia and Albrecht's admittal that he had not followed up on the report - the implication is that he has in fact technically lied to this forum in claiming not a single serious toxicity, if in reality he and Phyto Nova are so apathetic with follow-ups of reported toxicities.

Albrecht furthermore seizes my vexing question to him, repeated immediately hereabove, and cowardly attempts to hide behind the mentioned complexity in a futile effort to disassociate Sutherlandia from any possible serious toxicity. If any aspect of Albrecht's replies to date (including simply ignoring the questions) is illustrative of Phyto Nova being intellectually and morally out on a limb, then this is surely it.

It is however, my contention that Albrecht cannot legitimately use my complexity challenge to in one breath claim lack of serious side effects from Sutherlandia and in the next, to question how these aspects were differentiated from the effects of HIV-infection in the possible incrimination of Sutherlandia. If the matter of toxicity cannot be answered by a firm set of acceptable criteria and circumstances, then logically, neither can the matter of safety be answered by that same criteria and circumstances. What curious nonsense! This is assuredly our indigenous version of "Alice in Wonderland", which I will aptly retitle as "Albrecht in Sutherland".

The onus of the burden of proof of the safety of Sutherlandia is furthermore legally clearly the responsibility of Albrecht and Phyto Nova. We are talking here about a registerable marketed drug illegally offered for open sale, without any of a host of necessary contra-indication precautionaries, in spite of it containing a potentially highly toxic substance, using their on description, of two "particular abundant elements" at "significant levels".

As things currently stand, there is no reasonable and realistic safety status for Sutherlandia, just a highly likely toxicity status, based on the preponderance of available scientific facts and corroborative data and the negative probabilities accruing from these against Albrecht's relative lack of meaningful data, not to mention my substantial concerns against Albrecht's empty assurances, nor my lack of vested interest vs Albrecht's considerable vested interests in ignoring anything but the substantial profits to be made at another's risk of injury and probably, premature death.

Albrecht claims to be not adverse (sic) to the truth. This is easy enough to test. Can he concede the truths raised above? I think not.

A new and not unreasonable question to Albrecht is: "given that he claims to recommend Sutherlandia for use for cachexia in AIDS" with a view to "possibly help to maintain health longer", would he kindly provide a reasonably detailed scientific description as to exactly how he envisages Sutherlandia achieving such outcome?

I for one, await a reply with deep interest. In closing, might I just point out that Albrecht and Phyto Nova are falling so far behind in their replies to pertinent questions made by Coen van Wyk and I in the public interest, that the debate could be declared closed in favour of Thomson et al, but for our desire to pursue a socially just solution outside of the courts as first option, failing which, the fall from grace will be very hard indeed, including charges of murder or genocide.

Sincerely

Stuart Thomson
Director, Gaia Research Institute