TO : DR P. MAKHAMBENE
CHAIRMAN
COMPLEMENTARY MEDICINES COMMITTEE:
MEDICINES CONTROL COUNCIL
BY URGENT FAX 012-3262528
16 January 1997
I refer you to our recent telephone conversation and your undertaking to table this documentation as an urgent late motion at Council's meeting on Friday 17 January 1997.
PHARMAPACT, which was launched at the Dept. of Health's 1 November meeting on "Natural Health Substances & the Enforcement of Act 101/65" (appendix 1) and whose mission statement (THE TIME TO ACT IS NOW) is enclosed and whose introductory statement to that meeting is set out in Appendix 2, currently consists of 90+ principal and 1000+ associate subscribing members from all categories listed.
Arising out of subsequent developments and in particular the resurrection of the previously defunct Complementary Medicines Committee, are our objections as follows:
a) First and foremost is Council's abuse of the original legislative intent of Act 101 which was primarily public protection from highly potentially toxic allopathic drugs, but which is increasingly being abused to suppress safer alternatives via the imposition of inappropriate restrictive regulations on relatively non-toxic alternatives and natural health substances, we believe, in accord with an international conspiracy to protect the dominance and profitability of the pharmaceutically orientated medical model, as witnessed by a world-wide trend to this end and which local scenario is partly covered in my 10 December letter to the Press (appendix 3) in response to Prof. Folb's denial hereof.
One serious outcome of this is that already severely limited resources are wastefully diverted to storm in a herbal teacup and related natural health substance safety concern red herrings, whilst actual iatrogenic maimings and fatalities are criminally allowed to escalate due to resultant MCC neglect of their primary mandate, and with the result that the iatrogenic crisis shockingly far exceeds comparative war statistics, which situation one can only logically assume is tolerated by regulatory authorities largely for the extra medical profits, revenue and self-perpetuation that further accrues from the establishment from such a situation.
Please see marked sections of Appendix 4, pages 3, 4 & 6 and also Appendices 5 & 6 for my refutation of this herbal toxicity sham and for substantiation of the remarkable comparative herbal safety record, especially considering that 99% plus of plant toxicities in Appendix 5 are non-herbal and include all plant exposures over a decade, with just one (non-herbal) fatality, as opposed shockingly to 1 million-plus allopathic iatrogenic fatalities. US statistics are legitimately extrapolatable to our local situation especially considering the MCC's modeling itself on the US FDA's legislation.
In this regard it is highly significant that the US Congress, via the Dietary Supplement Health & Education Act of 1994 were obliged to step-in to enact legislation to halt the FDA's regulatory abuse with respect to natural health substances and thereby resolved four vexing issues as follows:
1) Natural health substances have a unique statutory definition within the umbrella of food in the legislation;
2) The FDA maintains the burden of proof to establish that a product is unsafe;
3) Natural health substances can have truthful, non-misleading statements as to how these substances affect human body functions and structures; and
4) Third party literature such as peer reviewed scientific articles can be used in connection with the sale of these products, provided the information is not false or misleading, so as to present a balanced view of the available scientific information.
If Council is unfamiliar or out of step with these regulatory developments, it can make no claim to international professionalism and in any event its formal response on the possibility of submitting voluntarily to implementation of similar arrangements is sought with interest.
b) Of second importance but even greater immediate urgency is our vehement rejection of the undemocratic structures put in place via the reconstituted Complementary Medicine Committee (CMC) and its sub-committees which are essentially a further subterfuge and an unacceptable further attempt to extend Council's jurisdiction to include natural health substances via shallow window-dressing of shockingly non-representative and ill-placed non-democratic structures.
A simple review of the scope and restricted circulation of the invitations list and the top-down appointment of the CMC hierarchy negates any legitimate use of the words "democratic" and "representativeness", which to be valid would have had to be far more widely announced and the top structure, namely the MCC itself, appointed by the majority of role-players, which clearly is not the case and hence the CMC and its sub-committees are relegated to the level of a cast of stooges, some of which have a pecuniary conflict of interest and others who are possibly oblivious to their being used to further Council's own aim of extended control by contributing pseudo-legitimacy to said structures.
Apart from full allopathic dominance of Council itself and further compromise on the CMC by way of Drs Makhambene & Moloi who are councillors and allopathic general practitioners and Professor Folb as MCC Chairman, Head of Dept. of Pharmacology at UCT and Chairman of the WHO Committee on Drug Policy, what hope can there be for a bottom-up approach against such a loaded allopathic bias and domination from the top-down?
This leads to the need to question the appropriateness of Michael O'Brien's qualifications and position, especially since he no longer represents the whole community but only one faction blind to Council's plot and the new direction and ramifications of which few of his diminished constituents even have knowledge of, let alone have approved. Appendix 7 covers my challenge in this regard, with no response to date, but iro which I am prepared to extend a benefit of the doubt in that has been away and may yet realign.
As for the rest of the CMC, Dr Brom also an allopathic, albeit wholistic practitioner, was apparently not even aware of his nomination and appointment. (Dr.Brom has a significant stake in the Chinese herbal sector. Ed.) Consider also Dr Stofberg's direct pecuniary conflict of interest via Natura and a Health Products Association Executive /Pharmaceutical Listings Proposal orientated faction within the industry; Dr Cooppan's pecuniary interest as a Sportron agent and occasional formulator and lecturer for Natura (also an allopath) and hence also his alliance to the former faction; Dr Gerieke's pecuniary interests with S.A. Druggists, possibly also Pharma Natura and also allied to the former faction. Drs Tsotetsi *& Webber* on the other hand are aware of the questionable credibility of the CMC (as are we of their questionable expertise/qualifications. Ed.), have expressed discomfort at events, including O'Brien's lack of consultation and are awaiting urgent clarity on the CMC's autonomy as originally proposed by O'Brien. (*Reference, personal communication).
O'Brien's original position, fully supported by us and others and serving as his mandate to serve as a single spokesman on behalf of all is set out in a 6 December letter to Prof. Folb as Chairperson of the MCC and I quote as follows: (page 2) "the present debate can be resolved by taking natural health products out of the ambit of the present definition of a medicine and of the procedures of the MCC"; (page 3) "it should be autonymous and have appropriate power to create and administer policy with regard to natural health products and be acountable to its constituents and the Dept. of Health" and further "Ultimately, control of the process by the MCC is not acceptable".
The present course, arising from a meeting on 10 December between Drs Makhambene, Moloi and Mateme (Chair of MCC Policy Committee) and O'Brien, hardly representative from the bottom-up, but rather exclusively at the top and which is set out in O'Brien's 18 December letter to the DG, Dr Shisana and challenged in my 20 December letter to O'Brien, (Appendix 7) is not a widely understood nor widely accepted position. All of the foregoing, even without further focus on the pecuniary interests, let alone the standards of expertise and qualifications of the CMC and its sub-committee's members and also the unrepresentative omissions thereon, in my estimation seriously throws this whole process into question and hence I am calling for the non-ratification by Council of the pseudo-structures currently in place.
I also request, indeed demand, as per my constitutional rights, that all the issues raised heretofore be satisfactorily addressed, that any related agenda documentation, and the minutes and resolutions be conveyed to me in writing and by registered post immediately on completion of the minutes of the 17 January meeting so as to enable this matter to be suitably clarified, if not actually settled in the very near future.
This communication represents but phase one of PHARMAPACT'S campaign on behalf of all prejudiced role-players and in no way relates to my personal business conflict with the MCC, its secretariat and inspectorate, other than to muzzle said tyrannical forces for the benefit of said role-players and which personal affairs will be taken up separately when time permits attention thereto.
Yours sincerely
STUART THOMSON
National Co-ordinator, PHARMAPACT
cc Dr N C Zuma, Hon. Minister of Health
Prof R Vuyiswa Gumbi, Chief Directorate: Health Resource Planning, Dept. Health
Dr O Shisana, Director General, Dept. of Health
Dr A Nkomo, Chairman, Parliamentary Portfolio Committee on Health
Adv S A M Baqua, Public Protector
Dr S Hendricks, Dept. Health
Michael O'Brien
PHARMAPACT Principal Members