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P.H.A.R.M.A.P.A.C.T

TRADITIONAL AFRICAN MEDICINE

GENOCIDE AND ETHNOPIRACY

AGAINST THE AFRICAN PEOPLE

PHARMAPACT

Whilst we have no desire to bring African traditional healers and medicinal vendors under any undue regulatory pressure, preferring education to suppression, the blatant traditional African medicine (TAM) regulatory double-standard exercised by the State, amounting to protracted genocidal negligence by the Medicines Regulatory Authority and ethnopiracy by the Department of Health, are unacceptable to us. It is ludicrous that these authorities, entrusted with public safety, intend that new regulations for complementary medicines, at tremendous burden to role-players and taxpayers alike, will only address marketed labelled medicines, and not those supplied by sangomas, nyangas and other informal vendors, when the latter are the sources of the very high rates of morbidity and mortality from traditional African medicines, eclipsing even the excessive allopathic iatrogenicity and thereby aiming at the wrong target while discriminating against the internationally established relatively innocuous herbals and nutritionals.

This report is structured in 5 parts: 1) Traditional African Medicines (TAM) Toxcicity Double-Standard, incorporating 2) Estimated TAM Mortality Burden; 3) TAM Ethno-piracy by the State and the Pharmaceutical Industry, incorporating 4) TAM Working Group (Nat Ref Centre ); and 5) Cultural Notes.

TRADITIONAL AFRICAN MEDICINES TOXICITY REGULATORY DOUBLE-STANDARD

"The SAMMDRA Bill makes provision for different procedures to be applied when registering orthodox (science-based, allopathic) medicines and complementary (herbal, traditional, or homeopathic) medicines. In the case of traditional medicines, issues of safety and quality will take precedence over demonstrations of efficacy. Thus, while the National Drug Policy might have been intended for application to all medicines, including traditional medicines, this Bill leaves many issues perhaps as muddy as before. Given the number of unresolved issues, the possibility of a court challenge after passage through Parliament cannot be ruled out." (Andy Gray, "Registration of traditional medicines- new bill", Healthlink, Issue No 37, October 1998)

We are impressed by how perceptively the public, regarding natural health suppression, often remark "but what about traditional African healers, herbs and muti-medicines?" In the past, the African tradition was "apparently" exempt from Act 101/65 regulation and now under Act 132/98, the MRA proposes that the Expedited Registration Procedure not extend to these medicines. We challenge constitutionally this double-standard. Section 9 of the Constitution (Equality), subsection (3), states "The State may not unfairly discriminate against anyone on one or more grounds…, including ethnic origin or culture".

Significantly subsection (5) moreover, specifically states that "Discrimination on one or more grounds listed in subsection (3) is unfair, unless it is established that the discrimination is fair". The onus is uniquely on the party wishing to discriminate, and hence to enforce compliance, the regulatory authority would have to, at their initiative, convince the Constitutional Court that the discrimination in these circumstances is fair, which is clearly impossible, given the facts presented hereunder. We note that recent MCCy /MRA propaganda statements indicate that the authorities are determined to avoid this dilemma by creating false divisional categories by strategically differentiating products to be regulated via the defining concept of "market", via the restrictive misapplication of the WHO criteria of "bulk", "finished" or "labelled" products, so as to attempt to exempt medicines used by African traditional healers and vendors from the SAMMDRA regulations, apparently due to a lack of heart or will to deal with this traditional medicine toxicity crisis.

Consider the political hot potato issues which the regulatory proposals fail to adequately address, if at all:

Medicines regulation, in the public interest, comprises of 3 integral aspects: quality, safety and efficacy. The first aspect is only meaningful to the extent that it relates to the latter aspects. There is no point in ensuring quality if it does not positively enhance safety and efficacy. The authorities however, appear to be prepared to allow the regressive erosion of the latter in a compromise for adherence to the former, which suits the pharmaceutical complementary medicines industry but will seriously fail all consumers. This is clearly exemplified by eg absurdities which will legitimise useless homoeopathic products with serious unsubstantiated indications and ignore a clear problem of deadly traditional African substances.

In terms of "quality", the hygienic and contamination situation relating to the pavement on which these wares are displayed in the urban setting are of legitimate concern, being as they are, often tainted with sputum, urine and faeces etc from human, animal and pedestrian traffic, plus a fair measure of vehicular combustion petrochemical deposits. We must however, be careful not to pursue purity to absurdity, as with the GMP pharmaceutical manufacturing standards insisted on for natural health substances, which we insist ought logically to be maximally set at those for food standards, which latter are consumed in far more significant quantities, ironically also responsible for thousands of equally preventable deaths annually.

Regarding "efficacy and safety" aspects, it is imperative to evaluate the relative risk from traditional African herbs and substances, since some 75% of the African population are estimated to use traditional substances, usually in combinations. According to the electronic database established by Noristan Laboratories, now with TramedF , of the 350 plant extracts assayed, some 79 % showed definite pharmacological activity, and 12 % definite toxic effects. (Hughson L, Pharmaceutical & Cosmetic Review, Jul / Aug 1995) How can these now ideologically escape the claimed need for urgent appropriate scheduling or safety regulations?

Professors Folb and Schlebusch, past chairman and registrar of the MCCy respectively, opinioned internationally a decade ago that "the issues of traditional medicines need to be addressed" (Folb P et al, J Clin Pharmacol 1988: 28), yet apparently a moratorium exists iro traditional medicines, in spite of Folb again writing, under the heading "Traditional drugs and indigenised pharmaceuticals", that "some give rise to serious adverse reactions, and others contain chemicals that have long term effects such as carcinogenicity and hepatoxicity." (Folb P, SA Jour Sci, Vol. 85. 1989 Aug) Why no urgent action here?

PHARMAPACT and its allies consider it ludicrous that these professors and now their successors, Dr Helen Rees (chair), Precious Matsoso (registrar) and especially Prof Eagles (vice-chair) claim jurisdiction over exotic herbal and other natural health substances as medicines when it is clear that these are impacting positively on health and negatively on medical profits, but not to have jurisdiction when some of the indigenised medicines are impacting negatively on health and positively on medical profits, whilst hypocritically using public safety as a red herring to suppress public access to those improving health. Tobacco and alcohol are relatively freely available, yet are both strongly pharmacologically active and are responsible for more deaths than any other substances, the most addictive, merely bearing a warning. Some serious reprioritisation is called for and the authorities are obliged to honestly face this dilemma. Toxicity is an adverse effect on health. In the final analysis, regulatory authorities deal not with toxicity, but with risk. Risk is the probability that the toxic properties of a substance will be produced in populations of individuals under their actual conditions of exposure. We can prove that there is no real risk from the natural substances about to be regulated, but exceptional risk from those which will not be.

Whilst there is little difference between an African medicinal and the exotics, all of which except for the former are currently the target of such vicious regulatory fervour by the regulatory authorities, the only difference we have identified, is that the latter have had their problematically toxic items excluded from international commerce for fear of litigation, whereas this process has not occurred with the indigenous substances, but for very few items. With current budget constraints, we cannot conceive of bureaucratic systems receiving the disproportionately high priority afforded it for relatively safe products, when an urgent traditional medicines Toxics List and educational programme are the only practical ways to truly act in the consumer's interest and save several thousand lives each year, not to mention untold suffering.

Whilst researching an earlier report, we assumed that the morbidity and mortality incidence for South Africans using indigenous medicines would be minuscule, but we were stunned to uncover the shocking scientifically recorded and published clinical observation that "in South Africa, the major cause of death (from acute poisoning) among black South Africans are traditional medicines."!!!!! To reassure the reader that this was not a typographical error, the editor, a Clinical Professor of Medical Toxicology, added in brackets "(about 50 % of deaths)". (Ellenhorn's Medical Toxicity: Diagnosis and Treatment of Human Poisoning, Williams & Wilkins, 2nd. Edn.1997) That this situation could have escaped the authorities and has not received swift remedial action, is not only unacceptable, it is clearly criminal.

Dr. P.H. Joubert, M.D., author of the internationally published article referenced in the above-mentioned textbook has, as Professor with the Dept. of Pharmacology & Therapeutics at the Medical University of South Africa (Medunsa)f been responsible for most of the epidemiological work in the shamefully neglected field of local indigenised medical toxicology. In spite of Joubert (and others) attempting for almost three decades to draw attention to this serious problem, practically nothing has been done to address this highly suspect apartheid oversight. Who needs a Third Force, when muti-medicine and a MCCy blind- eye to the problems, known to them for decades, will suffice as a silent tool for racist population control?

Joubert's successors and the medical press have played down this problem, eg. Dr. D.H Brand is mentioned in an article referring to follow-up work at Medunsaf , 1987-1993, but both the title of the article, "Accidental poisonings rare in herbals" and the theme, contrary to the facts, suggested a small percentage of overdose or poisoning from traditional medicine, whereas Dr Brand’s research had actually determined that "while only a small number of plant species were involved, these resulted in high mortality". (Medical Chronicle, Nov / Dec 1993); Brand also reported that "toxicity levels of Urginea sanguinea and some Drimia species are currently being investigated at Medunsaf , following the observation of toxic symptoms in patients who had taken herbal medicines". (Brand pers comm with Anne Hutchings); Dr E Osuch, Joubert’s current successor, in a recent thesis, confirmed that "The same traditional medicines (24 different plants) tended to recur as causes of hospital admissions…responsible for more than half of all acute poisoning deaths". (Thesis Summary)

Noteworthy is that this work continues at Medunsaf [Department of Pharmacology and Therapeutics], but now in determining the toxicity of traditional medicines in the "scientific marketplace". (S Afr J Sci 1997 Nov-Dec; 93(11/12)); The current department head, Prof W.J. du Plooy plays down the Medunsaf statistics by deliberately interpreting them in the most meaninglessly favourable light, in an effort to trivialise the problem. (pers comm 16 Feb 1998, & "Analysing the Epidemiology of Traditional Medicine Poisoning", delivered at the Complementary Health Care Summit, 25 August 1998, and advertised as "Determine how your organisation can capitalise from this unique opportunity in the market". Entrance fee: R2000+ per day for the 3-day event).

Other scientists are even more directly in denial, eg Professor Drewes, ex Head of Chemistry, Natal University, clearly stated "What is certain, is that the nyangas are not going to poison their patients." Professor Laing, of the same department agreed, claiming that "no one dies from nyanga’s prescriptions. It doesn’t hurt them." (Muti: Myth, Magic or Medically Sound?, Peta Lee, Longevity, May 1996); Is it pure coincidence that Prof Drewes has done commercial drug investigative work on indigenous traditional medicinal plants, including the "African potato", Hypoxis rooperi, now on the commercial market in synthesied form, as have so many of his colleagues at universities throughout the country? It is our contention that most scientists and policy-makers/administrators so deeply in denial have seriously vested interests, financial and / or otherwise.

Urgent telephonic and e-mail requests made a year ago for specific research documents lodged in Du Plooy’s Dept at Medunsaf , to focus priority attention on this unacknowledged problem, have gone 90% unheeded. Du Plooy in his August presentation volunteers a grand total of one additional botanical name: Boophane disticha. Significantly, Du Plooy is a member of the NRC and a MRC funding recipient for "Traditional medicines as part of the national drug policy" and " Toxicology of traditional medicines", so neither he nor the authorities can claim ignorance or obscure research. Paradoxically, du Plooy hypocritically concludes: "The public should be protected against compounds that have harmful properties. How? It is impossible for medicines." Even more hypocritically: "AT LEAST THE PUBLIC SHOULD BE WARNED! ie awareness."

THE ESTIMATED MORTALITY BURDEN FROM TRADITIONAL AFRICAN MEDICINES

What then are the facts? "Information on cause of death among adults in sub-Saharan Africa is essentially non-existent." (Kaufman J, et al Bull World Health Organisation, 1997; 75(5)), yet we can definitely confirm that a phenomenal problem exists, beyond the worst-case scenario expectations of most scientists and policy-makers. The author of this report estimates that annually several thousand deaths from traditional African medicines occur, far in excess of those dying of AIDS and significantly Dr M Stewart, Department of Chemical Pathology, SA Institute for Medical Research, concurs with this assessment, having recently determined "70 traditonal African medicine deaths in 8 months at Coronation Hospital, Johannesburg, and this just the few that made it to the hospital alive, only to die there, not to mention those who were/are extremely close to death." (pers comm, 31 March, 1999) It is significant that the major poisoning symptoms and causes of death from traditional African medicines closely mirror the major symptoms and causes of death (besides infectious) among the black population: diarrhoea, fetal distress, hypoglycaemia, renal / hepatic failure, respiratory distress, and cardiac failure.

"In the developing world, medically certified information is available for less than 30% of all deaths that occur and 98% of deaths in children younger than 15 years and 83% and 59% of deaths at 15-59 and 70 years, respectively occur there. The probability of dying from a non-communicable disease is higher in sub-Saharan Africa (and other developing countries) than in other market economies. This is at odds with popular perception. The paradox of higher non-communicable death rates in the adults of the developing world must be attributable to other (non-communicable) major determinants of mortality that are more common in these regions. The estimates that are most uncertain are those for sub-Saharan Africa, particularly for the exact composition of non-communicable and injury mortality. As more regions undergo epidemiological transition, particularly premature death among adults will increasingly become a major public-health concern. Surveillance and research to measure and monitor mortality must anticipate this trend." (Murray C, Lopez A, Mortality by cause for 8 regions of the world: Global Burden of Disease Study, Lancet 1997; 349)

"Information on cause of death among adults in sub-Saharan Africa is essentially non-existent, mostly extrapolations and outright guesses. Non-communicable diseases account for a significant portion, yet the empirical bases for public health policies and interventions are essentially absent." (Kaufman J, et al, Bull World Health Organisation, 1997, 75(5)); "Data on mortality and morbidity in South Africa are inadequate. The absence of a comprehensive national health information system, poses problems for an analysis of mortality." (White Paper on Population Policy, RSA, March 1998); "Estimating specific causes of death in South Africa is difficult, the last detailed information being almost a decade old, with no chance of an update, since the law was changed at that time to exclude the necessity of recording the details of the actual cause of death. The data collection system makes no provision for gathering the type of data needed to determine how many deaths might be attributable to traditional medicines. The overall figures must all be considered to be vast underestimates. Not all deaths in rural areas are registered and many are in the ill-defined category where it was not specified on the certificate." (pers comm. Dr Debbie Bradshaw, Centre for Epidemiological Research in Southern Africa, MRC , 6 April 1999); "There is an urgent requirement for development of diagnostic methods in order to reduce the number of (cases, and) cases in which the death certificate refers only to the final pathology and not the causative agent." (Stewart M et al, Ther Drug Monit, 1998, Oct, 20(5))

The crude death rate in South Africa is 8.9 per 1 000 (1995 United Nations estimates, & RSA Stats in Brief, Aug 1996; 9.4/1000 according to DoH), meaning that approximately 400,000 of 40 million South African’s die each year. In the RSA 20% of all deaths are of unknown causes, (according to Stats South Africa: 13.71 ill-defined (15.2, DoH), 4.24 undetermined, and 1.61 other external). (Bradshaw D, Estimated Cause of Death Profiles SA, Based on 1990 Data, CERSA, MRC, 1991); Deaths from traditional African medicines could constitute a large portion of this 80,000 and it is not unrealistic to assume that traditional medicine poisoning deaths are responsible for at least 10% of the 80,000 annual deaths from unnatural causes, (excluding homicide, violence, accidents and self-inflicted), ie 8,000 traditional medicine mortalities would be conservative, confidently doubled to 15,000 and taking into account a percentage of deaths attributed to natural causes such as cardiac failure, 5000 additional of which may be traditional medicine induced, 20,000 is a conservative estimate for annual preventable deaths from traditional medicine.

Prof Pieter Joubert, ex Medunsaf , whose work is widely respected, published and cited internationally, has determined that "in developing countries, besides infectious conditions, acute poisonings with pesticides, paraffin (kerosene) and traditional medicines are the main causes of morbidity, whilst acute poisonings with traditional medicines is the main cause of mortality." (Joubert P, Mathibe L, Acute poisoning in developing countries, Adverse Drug React Acute Poisoning Rev 1989;8(3)); This assessment accurately pertains to local circumstances where "amongst black South Africans, the poisoning category is the second in order of importance in the five main causes of death (second only to contagious and parasitic diseases), whereas it is only the third and fourth category amongst the other groups." (Van Rensburg H, Mans A, Profiles of Disease and Health Care in South Africa, R&H Academica, 1982) This is confirmed by the 1990 MRC CERSA 91 data.

Joubert, the internationally recognised authority on South African indigenous medical toxicity, in his earliest published work on the subject of traditional medicine poisonings, undertook a retrospective comparative epidemiological study of acute poisonings at teaching hospitals of the University of the Orange Free State, Bloemfontein, 1970-1976, which revealed that "among whites, medical drug poisonings predominated", but "among the black developing community, was responsible for few poisonings, priorities being prevention of pesticide, paraffin, carbon monoxide (indoor fires) and traditional medicine poisonings." (Joubert P, "Toxicology units in developing countries: different priorities?" J Toxicol Clin Toxicol 1982 Jul;19(5))

In a subsequent project covering 1981-1982 at Ga-Rankuwa Hospital, Pretoria, Joubert determined that "whilst 18 % of all acute poisonings were due to traditional medicines, most (86.58 %) of all deaths from acute poisoning were as a result of poisoning with traditional medicines" and concluded that (First World) "toxicology services, primarily geared towards the management of cases of drug poisoning, are inappropriate to the needs of developing communities." (Joubert P, Sebata B, "The role of prospective epidemiology in the establishment of a toxicology service for a developing community." S Afr Med J 1982 Nov 27; 62(23))

In a continuing project covering 1981-1985, also at Ga-Rankuwa Hospital, Joubert once again determined that "the main poisoning causes were paraffin (59 %), but with low mortality (2.1 %), whilst poisoning with traditional medicine resulted in a high mortality of 15.2 % and accounted for 51.7% of all deaths, always accidental". Furthermore, "Vomiting, diarrhoea, and abdominal pains were the most frequently encountered symptoms, while lungs, liver and central nervous system were commonly affected. The traditional healer was the main source, 83.4 %, while 11.3 % was bought from African medicine shops. Questioning patients and traditional healers facilitated the identification of a number of etiological agents". (Venter C, Joubert P, "Aspects of poisoning with traditional medicines in southern Africa". Biomed Environ Sci 1988 Dec;1(4))

The main paper referenced in the above-mentioned textbook is Prof. Joubert's "Poisoning admissions of black South Africans" (Joubert P, J Toxicol Clin Toxicol 1990; 28(1)), also dealing with acute poisoning admissions to Ga-Rankuwa Hospital, 1981-1985. This study determined that "Overall, the major causes of mortality were traditional medicines, responsible for 51.7 % of the deaths that occurred, followed by pesticides (23%). Of the patients who died, 62 % were poisoning by traditional medicines of which none were deliberate self-poisoning". Joubert concluded: "the main issues were the extremely high mortality" and "prevention of poisoning by traditional medicines merits high priority in the health care of the indigenous population of South Africa". Are labelled, finished, "marketed" medicines to blame here? Absolutely not.

"The ‘traditional healer’ was the main source, 83.4 %, while 11.3 % was bought from African medicine shops. In only 0.6% of cases were medicines collected by the patients themselves and in 4.4% the substances were obtained from other sources. The traditional healer is an integral part of African culture and many South Africans make use of traditional African medicines, mostly of plant origin, but also minerals or animal. In most instances these medicines are "crude watery extracts". Most towns and cities have "African medicine shops" where traditional medicines can be bought over the counter. There is currently no legislation controlling traditional African medicines. The traditional African medicine mortality is extremely high. If poisoning due to these substances can be eliminated, the overall mortality will decrease by about 50%". Most frequently implicated were Jatropha curcas, Ricinus communis and Datura strammoniun. (Joubert, J Tox Clin Tox 1990;28(1))

This study described "traditional medicines" as "a particularly important and interesting aspect of the local poisoning pattern" and pointed out that "the major cause of fatal poisoning pattern at Ga-Rankuwa appears to be very similar to that reported from Bloemfontein", and also "is similar to mortality reported from Zimbabwe" (ref above) & (Nyazema NZ, Trans R Soc Trop Med Hyg 1986;80) & (Chitsike I, Cent Afr J Med 1994 Nov;40(11)) Researchers at the University of Zimbabwe have reported that "poisoning by traditional medicines are the biggest single group of all cases." (Kasilo O, Nhachi C, S Afr Med J 1992 Sep;82(3)); "The main agents associated with acute poisoning were traditional medicines." (Nhachi C, Kasilo O, J Appl Toxicol 1992 Dec;12(6); and "Zimbabwe has a big poisoning problem, especially with regard to treatments recommended by the traditional healer." The conclusion:"Education and information dissemination on toxic agents are vital and much remains to be done. The report confirms the importance of toxicology information to the Southern African (SADCC) region as a whole". (Kasilo O, Froese E, A 10-year review of the Teaching Hospital-Based National Drug and Toxicology Information Service. Clin Pharm Ther 1989 Oct; 14(5))

Further vindicating Prof. Joubert's concerns, in spite of attempted down-playing propaganda, are the summary conclusions of Joubert's current successor, Dr. E Osuch, who extended his work as a thesis covering the subsequent period 1987-1992. Dr Osuch concluded that "Traditional medicine ingestion was responsible for more than half of all acute poisoning deaths." Also of interest is that "Eight remedies have been identified which were associated with haematuria and renal failure. One of the most common causes of acute poisoning admission to the Ga-Rankua hospital was ingestion of the watery extract of Urginea sanguinea." Even more recently Osuch et al stated: "A large percentage of acute poisonings in black South Africans is due to traditional medicines." (Foukardis G, Munting G, Osuch E, Toxicological aspects of some traditional medicines used by patients admitted to Ga-Rankuwa Hospital. J Ethnopharmacol 1994 Feb;41(3)); "Used as a blood purifier, clinical symptoms affect the, gastro-intestinal & urinary tract, central nervous system, or the splanchnic system." (Foukaridis G, Osuch E, Mathibe L, Tsipa P, J Ethnopharmacol 1995 Dec; 49(2))

Du Plooy confirms our position by clinically summarising the work of Joubert, Brand, Osuch and Foukaridis: "A solid is less harmful. Extractions are more harmful. It could be life saving if the material is identified, which may take too long. Clinically, longer than 6-24 hours after poisoning is too long. (Activated charcoal must be given within 1-hour of ingestion.) Typical clinical features include kidney failure (haemolytic anaemia), heart failure, arrhythmia and a variety of infections. In children the most common problem is dehydration and eventual kidney failure. The incidence of poisoning is high in patients who are old and go for blood purification; patients with fertility problems (male and female); for abortion; and for male STDs". ("Analysing the Epidemiology of Traditional Medicine Poisoning", Compl Health Care Summit. 25 Aug 1998)

We have also identified and independently profiled what is probably the major traditional African medicine "killer plant", again from a lead originating from Joubert, namely Callilepsis laureola, known as Impila, which ironically means "health" in Zulu. (Hutchings A, Terblanche S. S Afr Med J 1998;75.); "Toxic plants are used for medicinal purposes by the Zulu population." (Foukardis G, Joubert P, Forte M, Clin Toxicol 1992;30); "With approximately 50% of the population using Impila in Natal, it is the second most widely used and has been reported on extensively."(Ellis M. Medicinal Plant Use-A Survey, Veld and Flora 1986 Sept), eg:

IMPILA: Byrant A, Zulu Medicine and Medicine Men, Centaur, 1966 – "without doubt a virulent poison"; Seedat Y, Hitchcock P, S Afr Med J Jul 31;45(30) – "acute renal failure"; Wainwright J, Schonland M, Candy H, S Afr J Med 1977 Aug 13;52(8) – "found to cause fatal liver necrosis, widely used as a herbal medicine, nephrotoxic, hypoglycaemic, hepatoxic"; Watson A, Coovadia H, Bhoola K, S Afr Med J 1979 Feb 24;55(8) – "administration of Impila is common, the practice can and does cause poisoning, hepatic and renal tubular necrosis, hypoglycaemia, alteration of consciousness, hepatic and renal dysfunction"; Veale D, S Afr Pharm J 1987;(54) "rootstock is toxic and can be fatal if ingested in small quantities; confusion, vomiting, diarrhoea, convulsions, hypoglycaemia and liver and kidney failure"; Savage A, Hutchings A, "Poisoned by herbs". Br Med J 1987;295 – "clinical symptoms of Impila intoxication are abdominal pain, jaundice, hypoglycaemia, disturbed hepatic and renal function"; Dehrmann F et al, J Ethnopharmacol 1991 Sep; 34(2-3) – "used extensively as a medicament, nephrotoxic"; Bye S, Dutton M, In: Oliver J, ed. Forensic Toxicology. Scottish Academic Press,1992 – "hepatoxic, nephrotoxic, hypoglycaemic".

What would the relative risk/benefit ratios be for Impila? (which would have to be comparatively higher for the latter than for the former for such a toxic drug to be tolerated by any self-respecting regulatory authority) Since there are no approved uses, we have to assess the popular uses against the above-mentioned risks, and clearly this plant would never be acceptable for and on the basis of these: a) "Roots are taken as tonics by young girls in the early stages of menstruation." (Doke C, Vilakazi B, Zulu-English Dictionary, 2nd edn. Witwatersrand Univ Press 1972); b) "Ground roots taken for snakebite and administered as enemas and in baths to protect the children of parents who have already lost many children." (Valley Trust [HST W ], pers comm Hutchings); c) "Roots also used as protective charms placed under the pillow to stop bad dreams." (Cunningham 2669 NU, in Hutchings A, et al, Zulu Medicinal Plants: An Inventory. Univ Natal Press 1996)

Even more dangerous is Impila’s traditional use during pregnancy and childbirth, likely the biggest killer of all, eg: "Roots are sometimes an ingredient in "inembe", taken regularly during pregnancy to ensure an easy childbirth, and to make an infusion for fertility." (Gerstner J , Bantu Stud 15 (3) (4), 1941); "They are sometimes included in medicines known as "isihlambezo", which are used by traditional birth attendants to ensure the health of both mother and baby during pregnancy." (Gumede M, Traditional Healers, Skotaville Publishers 1990); Dr Mike Stewart, Dept Chemical Pathology, SAIMR, has focused on Impila, yet his annual budget for all his analytical work is a mere R50,000 with not a cent from the MRC (Pers comm, 31 Mar 99).

"Many black South African women use traditional African herbal remedies as antenatal medications or to induce or augment labour. Very little is known about the pharmacology and potential toxicity of plants used in these herbal remedies. Several of these plants are poisonous." (Veale, et al, J Ethnopharmacol 1992 Jun; 36(3)); "Some of the herbs are toxic in large doses. According to Joy Veale, a lecturer in pharmacology at the University of Witwatersrand, there are about 36 plants in South Africa used to induce labour, of which 15 are toxic." (Pantanowitz D, Alternative Medicine: A Doctor’s, Perspective. Southern Book Publishers, 1994) "African traditional herbal medication is commonly used in pregnancy by women attending King Edward VIII Hospital, Durban. Its use may lead to fetal distress effecting pregnancy outcome." (Mabina M, Pitsoe S, Moodley J [MRC , Univ Natal, Dept Obstetrics and Gynaecology] S Afr Med J 1997; 87(8)); "Though some evidence exists suggesting negative effects of its ingestion, the maternal-fetal health impact and toxicity of isihlambezo have not been adequately studied. Pharmacological analysis suggested both therapeutic and harmful consequences of isihlambezo." (Varga C, Veale D, Soc Sci Med, 1997 Apr, 44(7))

Paediatric use is also seriously problematic. (Bodenstein J, S Afr Med J 1977 Nov 5;5;52(20)); More specifically eg at Habisa Hospital, Kwazulu Natal: "We have observed a distinct clinical syndrome amongst acutely unwell children frequently associated with the administration of a traditional medicine enema. Admission was frequently prompted by sudden, marked clinical deterioration following enema administration (68% within 24 h). Clinico-pathological features of this enema syndrome:- respiratory distress/insufficiency with tachypnoea, abdominal distension, hypotonia and loss of consciousness occurred frequently. In-hospital mortality was 28% and higher in those receiving herbal (43%) rather than chemical (21%) enemas. Hyperkalaemia, leucocytosis (> 15,000 mm3) and respiratory distress/insufficiency occurred more frequently in those who died." (Moore D, Moore N, Ann Trop Paediatr, 1998 Jun, 18(2)); Pediatric enemata are a problem in other provinces, eg: "herbal intoxication regularly occurs, with high mortality in infants, especially under 1 year of age." (pers comm, Dr Baker, ICU, Livingstone Hospital, PE, 26 Mar 1999)

Besides the above-mentioned subsets, the following represent further confirmation of this enormous problem. "In the treatment of measles, a variety of indigenous medications are used, some of which are potentially dangerous." (Ijsselmuiden C, S Afr Med J 1983 Mar 5;63(10)); "Although widely recognised by physicians, the acute renal failure resulting from the use of herbal preparations obtained from witch-doctors has not been fully described." (Gold C. Clin Nephrol 1980 Sep;14(3)); "In cancer of the oesophagus, traditional medicines are a significant risk factor." (Sammon A, Cancer 1992 Feb 15;69(4)) "The potent effects of their herbal medicines can result in damage to any part of the gastro-intestinal tract, and may be fatal. Diseases caused by witch-doctors constitute an important facet of the disease spectrum of blacks." (Segal I, Tim L, S Afr Med J 1979 Aug 25;56(8)); "The inappropriate use of traditional medicines results in numerous fatalities, invariably in children." (Bye S, Dutton M, J Ethnopharmacol 1991 Sep; 34(2-3))

Traditional African medicines also have psychiatric usage. Dr Thomas Lambo, a champion of traditional African medicine, a Nigerian psychiatrist, dean of the Medical School, vice chancellor of the University of Idadan, and Deputy Director-General of the WHO for many years, in response to a question as to whether the traditional African healers sometimes harm their patients, answered "They have an extensive pharmacopoeia of herbal psychotropic drugs. A lot of damage has been done, there is no doubt". (Bass T, Reinventing the Future: "Conversations with the World’s Leading Scientists". Addison-Wesley Publishers, 1994) Prof D Oberholzer, Department of Psychiatry, Pretoria University, had traditional healer’s psychiatric herbs analysed at the university laboratories and determined that "many potentially harmful agents were discovered in the therapeutic plant material". (Oberholzer D, J S Afr Institute of Psycotherapy, 1985, Mar, Issue 36)

"Traditional medicines can be beneficial, dangerous or useless in a pharmacological or psychological capacity, their dangers being mainly as direct irritants or as hepatic or renal toxins. Mild to moderate toxicity from short or long term use is difficult to separate from the original illness. Greater absorption from enemas coupled with irritant proctitis and perforation indicate that enemata have a high mortality". (Ellis G, Medicinal Plant Use, Veld & Flora, Sept 1986) "Traditional medicines (or mutis) are usually administered orally or as an enema by a traditional healer . Gastro-intestinal irritation was the most common syndrome (54%) experienced after traditional medicine administration. Cardiac glycosides are often found (44%) in autopsies [Jhb Forensic Chem Lab] where death was presumed to be caused by herbal medicine. It is concluded that in patients with gastro-intestinal symptoms, traditional medicine cardiac glycosides should be suspected." (Mc Vann A, Havlik I, Joubert P, Monteagudo F, S Afr Med J 1992 Feb 1;81(3))

"Herbal medicine may be directly responsible for harmful or fatal results, and frequently cause especially gastro-intestinal disorders, which may certainly be ascribed to the witch-doctor and his medication." (Van Rensburg H, Mans A, Profiles of Disease and Health Care in South Africa, Academica 1982); Dr Desmond Pantanowitz, Professor of Surgery, University of Witwatersrand writes: "Many dangerous substances have been isolated from nyanga concoctions, including the orange crystals of potassium dichromate, which can cause liver failure. Cantharides (Spanish fly) is often used to treat impotence; the side-effects of this poison are irritation of the gut and urethral mucosa, as well as kidney failure. Some nyangas even add battery acid to their concoctions to give them some ‘body’. The concoctions are administered via various routes: oral, anal, and through the skin. Damage may occur along the entire gut, from the oesophagus all the way through to the anus. Ritual enemas are a favourite method used. Infants receive up to 100 enemas before age two. Enemas may be prescribed for ritual purposes and for the treatment of complaints as diverse as impotence, dysmenorrhoea, fever, diarrhoea, constipation, abdominal pain and headache. The traditional healer can be a danger to society". (Pantanowitz D, Alternative Medicine: A Doctor’s Perspective. Southern Book Publ 1994)

"In the rural setting, a truncated cow horn is often used to dispense the enema; this may mechanically damage the rectum, causing anorectal laceration or rectal perforation. Complications are seen regularly at academic hospitals, particularly Baragwanath. Conditions that are repeatedly diagnosed are gut necrosis with perforation, peritonitis, gram negative endotoxic shock, disseminated intravascular coagulation, adult respiratory distress syndrone and hepatorenal failure, which can all result in the death of the patient. While the rural individual is given mainly herbal enemas, such as the poisonous milkweed species Aesclepsias physocarpa, the sophisticated urban dweller is given additional exotics such as Dettol, vinegar, copper sulphate, potassium permanganate, hydrochloric acid, sodium hydroxide, and the favourite, battery acid. To my knowledge patient’s families have never charged murder against a traditional healer in this country. No evidence can be obtained in a court of law. There is a code of secrecy and silence governed by a fear of retribution." (Pantanowitz D, Alternative Medicine: A Doctor’s, Perspective. Southern Book Publishers, 1994)

Besides poisonous plants, other toxic agents controversially used by traditional healers are: battery acid, chloroxylenol, potassium permanganate / dichromate, and copper sulfate. (Ellenhorn's Medical Toxicity: Diagnosis and Treatment of Human Poisoning, Williams & Wilkins, 2nd Edn.1997). "Renal failure may occur with potassium dichromate". (Wood et al, S Afr Med J, 1990 Jun 16;77(12), (Michie et al, Hum Exp Toxicol, 1991;10) Potassium dichromate is used primarily for its colouring rather than disinfection action. (Bye S, Dutton M. Proc Int Assoc Forensic Toxicol, Scottish Academic Press, 1992); Du Plooy: neon colourants. (Analysing the Epidemiology of Traditional Medicine Poisoning, Compl Health Care Summit. 25 Aug 1998)

Dr Steven Toovey, Director of Medinfo, says: "We know, from experience, that some traditional medicines are toxic". The reporter continues: "Dr Toovey ran independent tests in two laboratories on a traditional mud remedy to "strengthen the blood, eaten mainly by pregnant women with anaemia. Both laboratories found arsenic and mercury in the samples. Among the test tubes filled with indigenous roots and herbs at Groote Schuur Hospital’s department of pharmacology (Folb-Ed), researchers have encountered problems that move beyond the diseases and ailments they set out to cure. Toxic chemicals in muti remedies have raised alarm in the scientific community." The photo caption: "TRADITIONAL WEAPON: a researcher (African-Ed.) runs a test on local muti" (Emily Osinoff, " Indigenous plants could provide real muti", Sunday Argus, May 30 1999)

A very recent report is further confirmatory: "Toxicity related to traditional African medicines is becoming more widely recognised. Accidental herbal toxicity occurs not only as a result of a lack of pharmaceutic quality in harvesting and preparation, but also because these remedies are believed to be harmless. Treatment in most cases of plant poisoning remains symptomatic, with few antidotes available. The recent commercialisation of the traditional medicine scene is leading to the depletion of many species as their dispensing moves from the traditional village setting to the more lucrative markets in the cities and towns." (Stewart M et al, "The toxicology of African herbal medicines." Ther Drug Monit, 1998, Oct, 20(5)); The further significance of this latter statement is that the expertise and responsibility towards the patient of the healer in dealing with the potentially toxic among these substances is being eroded by this type of commercialisation, and whilst this raises the likelihood of far more accidental mortalities, it also presents a golden opportunity for more efficient centralised preventive educational programmes to be instituted.

The Department of Health initiated a project on the safe handling and storage of pesticides with the aim of increasing community awareness towards potentially hazardous pesticides. (Health - Government Yearbook Government Communications GCIS 1998) Why no corresponding programme for more widely used traditional medicines? Additional problems not being adequately addressed for awkward political considerations are eg, "traditional healer’s may cause dangerous delays." (Smyth A, et al, South Africa’s Health, Letter, BMJ 1995;47(3)); "a potential route (incisions) for viral disease transmission." (Hepatitis, HIV) (Jolles S&F, Letter, African Traditional Medicine, Lancet, 1998 Jul 4, 352(9121)); Forensic medicine: "Ritual or muti murders by a traditional healer are a form of human sacrifice. The murder is carried out after body parts are removed while the victim is still alive." (Scholtz H, et al, Forensic Sci Int, 1997 Jun 6, 87(2)) Education now!

We have mentioned the openly identified poisonous species implicated in the Ga-Rankuwa sub-sets, but these are only 5 out of 24, and neither du Plooy, as custodian of Joubert, Brand, and Osuch’s Medunsaf toxicological data, nor Folb, as custodian of the UCT TramedF data, have complied with our repeated requests for information access to compile and release an urgent educational African botanical toxics list.

PHARMAPACT are singly campaigning for the necessary reform, via this and earlier efforts. We are trying to prepare an urgent toxics short-list, but are not receiving any co-operation from the authorities nor the data custodians in this regard. PHARMAPACT will refrain from publishing a compromise list, insisting on rightful access to the Tramed database, which was again denied us on 24 May 1999 by professor Folb, claiming that this aspect still had to be developed, yet declined our offer to undertake this work. (Pers comm, T/Dr A Rees)

In the meantime, besides this document, the following remain the only detailed but very limited sources of such information, but none in a form readily accessible or meaningful to the traditional healer / medicine fraternity: a) Watt J, Breyer-Brandwijk M, The Medicinal and Poisonous Plants of Southern and Eastern Africa, 2nd Edition, E & S Livingstone Ltd, 1962; b) Hutchings A, Zulu Medicinal Plants, Univ of Natal Press, 1996. It is interesting to note that Watt, like Folb, was a Professor of Pharmacology (Univ of Witwatersrand), but unlike the latter, cared enough about the African people to use the institution at his disposal to laboriously collate the existing toxicological information and make it widely available, including to all hospitals for the treatment of herbal poisonings. On the other hand, Folb, leader of the Traditional Medicines ProgrammeF and handed public custodianship of an electronic database 20 years under development, cannot 5 years later provide a toxics list, nor is he willing to grant access to those volunteering to undertake this priority work. Folb, as Chair of the MCC for 18 years, had a mandate to ensure the protection of the public from toxic medicines, yet instead of using the database to identify and alert healers to the risks, only lucrative new drug leads were sought. We will press charges of genocide, and complicity thereto against all perpetuating officials.