Lance Rothschild, the PR person for Simply Slim, submitted this letter for publication in the Mail&Guardian essentially objecting to Prof. Roy Jobson’s blog, Simply Slim ‘defies’ the MCC, on the Mail & Guardian’s Thought Leader blog. Below Rothschild’s contribution is Prof. Jobson’s rejoinder. The Mail&Guardian have however not published either of the letters in the three weeks since submission, so it is unlikely that they will be published in the M&G. I have taken the liberty of publishing them here, with thanks to Prof Jobson for passing them on to me.
Simply Slim does not defy the MCC nor does it flout the provisions of the Medicines and Related Substances Act, 1965 (“the Medicines Act”), as alleged by Dr. Jobson in his article published in the Mail & Guardian Online Thought Leader article on 09 May 2010. Although Simply Slim accepts that Dr. Jobson is not legally trained, Dr. Jobson is prepared to publish unsubstantiated factual allegations, and draw unfounded legal conclusions which necessitates this response.
The starting point of the debate must be the fundamental rights entrenched in the Bill of Rights in the Constitution of South Africa, which –
Simply Slim agrees that the MCC is mandated and instructed in terms of the Medicines Act to ensure the safety, quality and efficacy of medicines made available to the public of South Africa – but it must do so in terms of the powers granted to it by Parliament in terms of the Medicines Act and it must follow the prescribed process in discharging its mandate, which it clearly did not do.
The MCC decisions taken on 27 January 2010 (“the impugned decisions”) were not taken in terms of any authorised or prescribed provision or process in terms of the Medicines Act, as a result of which Simply Slim was entitled, and did lodge an appeal against the impugned decisions, and also gave the required statutory notice that it intends to take the impugned decisions on review to the High Court – exercising its entrenched fundamental rights.
Simply Slim was advised that the impugned decisions are automatically suspended as a result of the filing of a notice of appeal in terms of the current judgments of our High Court on this subject, which meant that if the MCC wanted the decisions to remain operative, then it would have had to approach the High Court for such relief, which the MCC did not do, because Simply Slim gave its full co-operation to withdraw all its product, that had been imported from China, and could potentially have contained sibutramine, from the market. A full recall was done by Simply Slim out of its own accord with the assistance of reputable regulatory pharmacists – and not as Dr. Jobson alleges that the MCC forced Simply Slim to do so.
In addition Simply Slim did not take delivery of the stock in the bonded warehouse at O R Tambo International Airport from the original manufacturer – these products therefore never entered South Africa.
What Dr. Jobson also does not tell the public is that the MCC has since provided Simply Slim with a letter that the impugned decisions only apply to the so-called “old product” – i.e. the one imported from China, which was withdrawn from the market by Simply Slim – and not also to the “new product” manufactured in a cGMP compliant facility in South Africa after proper analysis and testing done on the raw materials prior to manufacturing, as well as the manufactured product, after manufacturing and prior to the final release thereof to the retail market. There is no decision by the MCC that the “new product” is being sold unlawfully.
The quality of the “new product” is therefore guaranteed by Simply Slim with the assistance of an independent manufacturer who is certified as being compliant with current good manufacturing processes, and does comply, and an independent SANAS accredited laboratory.
In addition Simply Slim has attached a special identification number to each pack of Simply Slim, which allows a Simply Slim customer to contact the Simply Slim call centre to establish whether it is a genuine Simply Slim product, or a counterfeit.
Because Simply Slim complies with the minimum requirements for a safe and quality product, there is no risk to the public in using the product, and the object of the Medicines Act has therefore been satisfied.
The MCC has since 1965, and more particularly since the Call Up Notice of 1972 referred to by Dr. Jobson, consistently treated herbal products which do not contain scheduled substances, as so-called complementary medicines. Dr. Jobson having been on the MCC will recall the various proposed amendments to the Medicines Act during his time in office, which includes the SAMDRA debacle, and the fact that the long title of the Medicines Act was not amended in 1997 to include the regulation of complementary medicines by the MCC, as originally intended and proposed to Parliament.
Simply Slim does not suggest that complementary medicines should not be regulated, but rather that all complementary medicines should be regulated in the same way, in terms of properly enacted legislation.
The selective treatment of the product Simply Slim by the MCC, in the circumstances also results in competitors having an unfair advantage, which amounts to unfair and unjustified discriminatory administrative action in circumstances where Simply Slim has demonstrated, and guarantees the quality and safety of its product.
Maybe Dr. Jobson can disclose whether his facility at Rhodes University is being sponsored in any way by manufacturers of prescription medicine registered in the Republic of South Africa, which have to compete with Simply Slim.
We trust that both Dr. Jobson and the public will be correctly informed as a result of this response, and we await his public apology.
Prof Jobson’s response:
I am flattered that Mr Rothschild/Simply Slim have chosen to respond in the Mail&Guardian’s letters column to my Thoughtleader blog: ht tp://www.thoughtleader.co.za/royjobson/2010/05/09/simply-slim-defies-the-mcc/ .
The presumptive allegation of ‘defiance of the Medicines Control Council (MCC)’ came directly from Mr Fidel Hadebe’s media release on the re-launch of Simply Slim. Mr Hadebe is the spokesperson of the Department of Health.
The Constitution of South Africa states that everyone has the right to bodily and psychological integrity. These human rights surely trump the business and other rights of unregistered medicines’ peddlars. The protection of consumers from organisations unscrupulously selling unproven remedies must take precedence over any other legality. And it is the sellers’ obligation to provide the evidence to the MCC.
Mr Rothschild states in his letter that ‘[b]ecause Simply Slim complies with the minimum requirements for a safe and quality product, there is no risk to the public in using the product, and the object of the Medicines Act has therefore been satisfied.’
The Medicines Act however does not exclude efficacy as Mr Rothschild has, in this conveniently disingenuous statement. Efficacy and safety are determined through conducting clinical trials in human beings, not through quality control of manufacture of a medicine. There is no evidence that clinical trials have been carried out and therefore there is no objective ‘proof’ that Simply Slim works (is efficacious) or is safe for human use. Without rigorous evidence of efficacy and safety in humans the object of the Medicines Act has clearly not been satisfied, not even minimally.
As stated in the blog, I will apologise if Simply Slim as the ‘holder of the certificate of registration’ of the product can provide me with a copy of their certificate of registration. This certificate is issued to all legitimate medicines available on the market.
Any insinuation about my being motivated to blog about Simply Slim because of any possible competitors’ sponsorships received by the Division of Pharmacology in the Faculty of Pharmacy at Rhodes University is insulting and contemptuous. I have written about Simply Slim because in my view it is a product which makes misleading claims, and those claims are misleading because the clinical trials have not been done. I included other weight-loss products in the blog which in my view also make unproven and therefore misleading claims.
Perhaps it would be appropriate for Mr Rothschild/Simply Slim to apologise to the public for marketing a medicine which has neither undergone clinical trials nor been registered by the MCC — the only authorised independent body in South Africa to evaluate quality, safety and particularly important in this case — efficacy.
I remind readers that the Constitution of South Africa states that everyone has the right to bodily and psychological integrity, and the Bill of Rights in the Constitution of South Africa guarantees among other:
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.
Considering that Simply Slim (or the specific mix of ingredients in the product) has NEVER been tested in humans, nor even in laboratory animals, one can conclude that selling this product directly to consumers without the products safety or efficacy having been adequately tested, is subjecting consumers to a medical or scientific experiment without their informed consent. Although consumers may have consented to buy the product, they were not fully informed that there was no adequate evidence to support the claims for the product.
One further and significant point: I pointed out to Lance Rothchild that Simply Slim has not apologised to consumers for having exposed them to sibutramine. They still have not – indeed, reading his posting, he is being disingenuous in trying to shift blame yet again.