To : THE PUBLIC PROTECTOR

15 November 1996

PRIVATE BAG X677

PRETORIA

0001

BY FAX AND REGISTERED MAIL

Dear Advocate Fourie

Herewith a brief report on my 1 November meeting with the MCC in Pretoria and on subsequent events having a bearing on this matter.

Appendix (1) is the agenda for the crisis meeting hosted by the Dept. Of Health and chaired by the Director General, Dr O. Shisana. Since over 40 delegates attended and the minutes are not available at time of writing, I shall restrict my coverage to the most pertinent developments and viewpoints of the most passionate spokespersons representing the various groupings. I trust that this perspective will also allow you to gain a more balanced overview of the issues likely to be omitted from the official minutes for various reasons, the most obvious being the historical bias of the Dept. of Health.

The most important insight which I can share with you is that of the philosophical dichotomy which serves to polarise the roleplayers into two opposing camps as follows:

POST -ACTIVE Remedial / Curative Medicinal Pharmacological Intervenient Reductionistic Synthetic Harsh / Toxic Restores Health Profits from disease

PRO-ACTIVE Protective / Preventative Supplemental Nutriutional Supportive Wholistic Natural Gentle / Non-Toxic Builds Health Profits from health

CORRESPONDING GROUPING OF DELEGATES

POST-ACTIVE

1) Prof. Folb, Chairman MCC

2) Prof. Schlebusch, Registrar MCC

3) Dr. Theo van der Venter, Director, Toxicology

4) René Doms, Managing Director, Pharma Natura

5) Brian Turner, Technical Director, Pharma Natura

6) Allison Vienings, Medicines Control Consultants

Professors Folb & Schlebusch would have had delegates believe that the Council and its secretariat, being entrusted with the safety of the public, are acting in accordance with that mandate when restricting natural health substances and that with additional staff, such action is set to intensify.

My comment was that the fact that the vast majority of registered products have documented likely or potential side-effects and risks in excess of the symptoms they are used to treat (Ref. 1), generally without regard to contributing lifestyle and nutritional factors and which products have created new causes of disease known as iatrogenic and nosocomical, depending on whether induced by doctors or hospitals respectively, makes mockery of current action against natural health substances, many of which are generally regarded as safe (GRAS), are adequately documented as safe, or have a sound epidemiological record based on traditional long term or recent widespread usage.

Dr van der Venter offered his services to bring foodstuffs, cosmetic and disinfectants similarly under increasing regulatory control, since these fall under his directorate in terms of Act 54 of 1972.

My comment is that the fact that the food chain, environment and most consumer products are riddled with toxic synthetic pesticide and veterinary drug residues and other synthetic chemicals, including disinfectants (Ref 2) of known toxicity or questionable safety in spite of this directorate and that of Act 36 of 1974 (agriculture and veterinary remedies), also makes a mockery of the recent urgency to more strictly regulate natural health substances similarly GRAS or documented or epidemiologically demonstrated to be safe.

René Doms smugly took credit for having precipitated the current crisis by having formally reported the entire industry for disregarding his interpretation of the law and for having convinced the MCC of their having prejudiced Pharma Natura and the establishment pharmaceutical industry by insisting on the registration of their medicines comprising European herbs of claimed documented safety (Anthroposophical) whilst ignoring the flood of exotic Chinese, Indian and South American herbs being marketed as food supplements but which in his opinion should be registered as medicines in order to protect the public.

Doms produced documentation relating to 40 cases of herbal poisonings, 2 of which were fatalities and 9 of which were deemed to have been critical. When I questioned him as to the time-span and geographical range, his reply was since 1987 (9 years) and internationally.

My comment was to question what the hell the storm in a teacup fuss was really all about when by comparison several million critical cases of iatrogenic and nosocomial toxicities are recorded annually; some 1,17 million hospital admissions in the UK being annually attributed to iatrogenic toxicities (Ref. 3) and in the US some 100,000 fatalities being annually attributed to adverse reactions from FDA approved drugs (Ref. 4).

Further comment was that approved over-the-counter drugs such as eg. Ibuprofen (Nurofen), widely used even for infants for non-critical symptoms such as pain, inflammation and fever, is increasingly implicated in the etiology of disproportionate benefit/risk immuno-suppressive infectious diseases such as the severely disfiguring necrotising fasciitis and often fatal toxic shock syndrome (Refs. 5 & 6) and even AIDS (Ref.7), without regulatory restrictions other than registration and hence making a mockery of claims to be acting in the interests of puclic safety, since registration per se, under the present system rarely serves that role, but rather serves as a source of revenue and as a disincentive to competing with the establishment industry who actually benefit from this and their financial monopolisation.

Traditional African remedies are furthermore currently totally unregulated, in spite of a well-known recent Noristan Laboratories research project having indicated that at least 12% of these plants investigated for their reputed healing properties showed definite toxic effects (Ref. 8) and in the light of which unconstitutional double-standards, current regulatory action is clearly a charade covering a hidden agenda with ominous financial motivations for the various champions of this extreme miscontextual interpretation of the provisions of Act 101.

Brian Turner predictably echoed Dom's claim that establishment pharmaceutical companies were being prejudiced by under-regulated competition.

My comment is that Turner, who is also vice-chairman of the Health Products Association, along with Doms and other big influencials on the executive, have recently hi-jacked the HPA from and against the will of its broader membership as part of their stategy to herd unsuspecting members into participating in a Pharma Natura / MCC regulatory initiative. This trend is confirmed by all of the foregoing roleplayers actively sharing a commercial platform at a symposium on electronic regulatory submissions.

Allison Vienings who benefits financially from increased regulatory action expressed frustration at MCC inconsistency towards natural health substances since she and her associates find themselves unable to reliably advise clients, in spite of MCC referrals for just such assistance.

Nearly 20 years of dialogue between the HPA and MCC has served only to indemnify its executive from accountability for Act 101 violations and has prejudiced both non-executive members, non-members and consumers by tacitly condoning sporadic and inconsistent regulatory action for fear of risking the cosy privileged insulation procured by "gatkruiping".

Patricia Tsotetsi raised a pertinent objection to the established companies (still mostly on the HPA executive) having reached that status on the basis of having registered their products via a grandfather clause to the Act whereby those companies not withdrawing from South Africa during the sanctions period were offered budget mass registrations without the necessary safety and efficacy data now requisite for registration and during which era only privileged white conservative business interests were in a position to benefit from these developments and the disenfranchised were either totally ignorant of or lacked the infrastructure necessary to take advantage of the situation and hence Tsotetsi's call for the same privileges to be extended to those previously denied same.

My comment is that logically all these grandfather registrations fail to satisfy the strict requirements of the Act and that if MCC is to enforce the Act to the literal extreme, then all these special registrations need to be revisited and full current criteria applied.

Stuart Thomson. PHARMAPACT wishes to unite both organised groupings and grassroots opposition to authoritarian intererence in the people's rights to build natural health and is prepared to be more openly militant in defending said rights and which threat is an international phenomenon being fought locally. The current conflict is not at this stage with the government itself, but rather with biased medico-pharmaceutical vested interests historically entrenched within it and the abuse of original legislative intent by the MCC and its secretariat in particular.

An update on the previous MSI legal history is also included to put into perpsective a misleading cliam by Prof. Schlebusch at the 1 November meeting to the effect that the MCC had received a final judicial ruling against MSI, which is clearly not the case and which claim was intended to mislead all of those present and in particular the Director General to whom the Registrar would have to answer for my revelations in this regard at the meeting and in respect of which the DG significantly had no knowledge.

I trust that the foregoing will serve to put current events in a more realistic perspective. I will deal with subsequent developments regarding my own conflict with the MCC under separate cover as soon as time permits.

Yours sincerely

STUART THOMSON - DIRECTOR

GAIA RESEARCH INSTITUTE

References:

1) Physicians Desk Reference, 50th edition, 1996. Medical Economics Co. NJ. USA.

2) Casarett & Doull's Toxicology: The Basic Science of Poisons,

  5th Edition 1996. Health Professions Div., McGraw Hill. NY. USA.

3) European Medical Journal, editorial, Dr Vernon Coleman, The Betrayal of Trust, 1994.

4) Journal of The American Medical Association, Nov. 27, 1991.

5) New Zealand Medical Journal, March 1995.

6) Clinical Infectious Diseases, October 1995.

7) P. Duesberg & J. Yiamouyiannis, AIDS, 1995. Health Action Press, Ohio, USA.

8) Pharmaceutical & Cosmetic Review, editorial, Lindy Hughson.

  Traditional Remedies and Self-Medication, July/August 1995.