Prof Roy Jobson, professor of pharmacology at Rhodes University, has posted an article on the Mail &Guardian ThoughtLeader blog expressing his views on the re-launch of Simply Slim. You know, the product without proof of efficacy that also contained a Scheduled and risky ingredient, sibutramine, that the MCC "banned".
"Simply Slim relaunched their new product, as spokesperson of the Department of Health (DOH) Fidel Hadebe stated on 15 April 2010, “in defiance of the MCC [Medicines Control Council] directive” — ie before it had been registered and a certificate of registration issued by the Registrar of the MCC as is required by the Medicines Act. If this is incorrect, my full apology will be made, and a link to a copy of the certificate of registration will be posted on this blog."
Read more . . .
Simply Slim ‘defies’ the MCC
Simply Slim relaunched their new product, as spokesperson of the Department of Health (DOH) Fidel Hadebe stated on 15 April 2010, “in defiance of the MCC [Medicines Control Council] directive” — ie before it had been registered and a certificate of registration issued by the Registrar of the MCC as is required by the Medicines Act. If this is incorrect, my full apology will be made, and a link to a copy of the certificate of registration will be posted on this blog.
The directive from the MCC, dated 2 February 2010 according to Simply Slim, but dated 27 January 2010 according to the Department of Health, was issued to the marketers of Simply Slim to recall the product. This was because samples of Simply Slim had been found to contain sibutramine — a Schedule 5 substance which can only be prescribed by doctors. As sibutramine is a registered medicine used in assisting weight loss, it is not surprising that Simply Slim’s apparent results up to that time seemed to be so spectacular. Simply Slim complied with part of the MCC’s directive and issued a recall of the product dated 5 February, 2010. This was a Class I, Type A recall — the most widespread form of recall the MCC can require for any product.
At that time Fidel Hadebe stated: ” … the Council concluded that the risks associated with the use of weight loss medicine Simply Slim are greater than the benefits and that the product needs to be registered as a medicine before it can continue to be sold” and
“[b]ased on these findings, the MCC resolved to suspend the sale of Simply Slim until more complete supportive data on the safety, quality and efficacy of the medicine has been submitted by the manufacturer and evaluated by the Council. Only if the MCC is completely satisfied that the medicine is safe, effective, of good quality and therefore in the public interest will it allow the product to be registered and sold in
South Africa.” (emphasis added)
This is really quite explicit.
- The risks associated with the tested Simply Slim product are not insignificant.
- The product must be registered as a medicine. (The MCC has obviously decided Simply Slim is not a complementary medicine.)
- Data on the safety, quality and efficacy of the medicine must be submitted.
- Only if the MCC is completely satisfied will it allow the product to be registered and sold.
The MCC are clearly still waiting for the required data. The relaunch of the product without the MCC being completely satisfied makes Simply Slim fully deserving of the description of defiance. They may possibly have been charged with contravention of the Medicines Act.
Of course Simply Slim could not have submitted the required data on safety and efficacy without doing clinical trials, and it’s highly unlikely a reliable and valid clinical trial would have been completed since the time of suspension of sales of the medicine.
The MCC is “simply” doing its job in line with the Constitution of the country and as mandated by parliament and the Medicines Act in order to protect the citizens and consumers of South Africa. After all the DOH has already stated in its strategic plan that unregistered complementary medicines pose a serious public health risk. The imported Simply Slim product was clearly — in the words of the DOH itself — a serious public health risk.
It is the prerogative, right, responsibility and statutory duty of the MCC to uphold the Medicines Act. This legislation defines what a medicine is. It is not up to marketers, sellers, distributors or even consumers to decide this. Presently there is no definition of complementary medicine in the Medicines Act or its regulations. Neither does the ill-conceived complementary medicines call up of 2002 define them but vaguely calls them “medicines frequently referred to as complementary medicines”.
On 29 March 2010 Simply Slim made a submission to the MCC in accordance with the 2002 Complementary Medicines call-up. I wonder if an ethical pharmacist or medical doctor assisted in completing the forms. The submission was received and stamped with a registry number as are all communications with the MCC. In all likelihood the person receiving and stamping the submission was a clerk whose job is to sort the voluminous correspondence received by the Department of Health. Simply Slim seems to have interpreted the allocation of a registry number as permission for their now “made in South Africa” new product to be (re-)launched. This is highly misleading and dishonest. (The previous product found to contain sibutramine was imported from China as explained in a radio interview with the CEO of Simply Slim.) The Simply Slim website continues to quote testimonials from satisfied users of the previous product and not the new one. This surely compounds the dishonesty.
It should be noted that the test result on Simply Slim’s website showing no sibutramine in its “new” product is dated 31 March — two days AFTER the submission to the MCC. In other words the submission was seemingly made without even evidence of the absence of sibutramine. One cannot extrapolate safety and efficacy from a certificate of analysis — which only measures the concentrations of the ingredients. (The converse, however, is that without the certificate of analysis any statements about safety and efficacy are meaningless because the ingredients and their concentrations are not known.)
The MCC’s statement that the product was still suspended was responded to by Simply Slim with a statement to its distributors indicating that they need not worry because the original decision of the MCC had been taken on appeal to the high court because the MCC decision had not been fair, and that this meant the original decision of the MCC no longer applied. Excuse me, but since when does administrative justice override public safety? Surely it would have been better for this organisation’s management to have simply apologised to the public of South Africa for exposing them to an illegal medicine, and have gone ahead in setting up the clinical trials needed to meet the Medicines Act’s requirements for any product to be registered.
In a nutshell the information that would be needed by the MCC to register the product would include:
- Testing and proving the quality of the product — what’s in Simply Slim is actually there, in the stated concentrations, and nothing else is present; (The test result on the website only shows the absence of sibutramine and not what’s present in the medicine.)
- Ensuring a quality-controlled manufacturing system so that every batch meets required standards. (This seems to be being met for the new product.)
- Testing for the safety of the medicine on human cells in a laboratory; on animals if necessary; then varying concentrations of single doses in human beings.
- Testing for the efficacy (and safety) of the medicine in human beings through an appropriately designed clinical trial.
- Creating systems for ongoing pharmacovigilance and recording of adverse effects once the product is released onto the market (also referred to as post-marketing surveillance).
This is the minimum required for conventional medicines and should be the norm for all medicines whether they are labelled complementary, alternative, holistic, traditional, allopathic etc. The MCC would then decide whether or not the applicant (eg Simply Slim) has correctly categorised the product in terms of any call-up notices and whether any of the substances contained in the product are, or should be Scheduled substances.
Simply Slim is a medicine because it is used for a purpose which meets the definition of a medicine. This was made explicit in the Dr Rath high court judgment. Just because a product happens to contain a few herbs does not make it a complementary medicine. All slimming products are classified as medicines and they were called up for registration in 1972. [Government Gazette 3389, Notice 118 of 1972, 25 February 1972]. This call-up notice was not exempted by the Complementary Medicines call-up notice of 2002. In my understanding of the Medicines Act, this means that any product containing pharmacological substances claiming to assist with weight loss must be registered with the MCC and if it has not been, it is in contravention of the Act.
This would mean that along with Simply Slim the following products (some of which are no longer available) are/were probably also not really legal: BioSlim and BioSlim Fat Attack (Glomail); Herbex; Slimming Solution; Supreme Slim; Super Slim; Herbalife; Peel Away the Pounds (Homemark); Weight Loss Facilitator (Solal Technologies); Simplex and Sportrim (Sportron); O2 Lean and O2 Lean Plus (Verimark); My Weigh (Verimark); EcoSlim (Feel Good Health); Appestop (BioHarmony Patrick Holford); Vital Apple Cider Diet Complex, Vital Vita-Slim, Vital Fat Burner (Vital Health Foods); Slim Coffee (Homemark) and many more.
In addition, the claims made for Simply Slim and most of these products contravene Appendix A Clause 4.1 of the Advertising Standard Authority’s (ASA) Code of Advertising Practice which states that: “[a]ll advertisements for products subject to licensing under the Medicines and Related Substances Control (sic) Act 101 of 1965 should comply with the requirements of the Act and any conditions contained in the product registration.” It seems that to date the ASA has not applied this aspect of their own code when complaints about advertisements for weight-loss products and other unregistered medicines “subject to licensing” have been received.