By the way — do you, as suggested, have a vested interest in any of these kinds of products?

John: Whether or not your particular arnica product’s powers are in your mind or not, the point of my original piece was that no one would have independently checked whether the product even has any arnica in it.

Gavin: Indeed. The industry is estimated at about R7billion a year in SA, so the old excuse of not being able to afford to do adequate research is no longer valid.

Johnny come lately: You’ve summarised the issues very clearly, thank you.

The six month call up of complementary medicine -and its de facto open ended extention – whether you can justify in law or not – is still a fraud with a capital F.

Allopathic meds are required to submit around 15000 pages of A4 paper background for every new drug registered in SA – regardless of the fact that they are more than often already fully registered in USA and Europe.
The MCC then can take up to 5 years before registration is granted

Complementary medicine manufacturers use their 2 page application as “proof of registration” and flaunt this in pharmacies and health shops. They are then granted a nappi code which entitles members to claim from medical aid. NO proof of safety, toxicity or efficacy needs to be submitted and to the best of my knowledge: none of the estimated 60000 complementary meds submited under the call up have been registered by the MCC

No one knows how many are killed by complementary meds as there is no system of reporting such morbidity. There is even less scientific evidence regarding the sometimes extravagant claims of such products

Allopathic meds are closely scrutinised on a benefit vs risk and toxicity basis

It’s such a pity that a huge double blind study on all the curative aspects of Arnica in 1998 found that it had none. The study covered such conditions as muscular pain, bruising, general aches and pains and so on. When the results on muscular pain were analysed, it was found that Arnica didn’t work nearly as well as the denatured oil and alcohol mix that was supposed to have no active ingredients.

I’ve always been concerned about Spirulina.

Spirulina is one of those ALTERNATIVE supplements that that regularly appears on the shelves with heavy metals. It is in the nature of Spirulina algae to absorb mercury and other heavy metals and because in South Africa, no testing takes place between harvesting and the consumer. Even the leading brand has recalled some products when an independent laboratory bought some and found concentrations of (I think it was) zinc.

I think the alternative health loonies miss just two points.

1 – Test the product using recognised scientific procedures that one’s peers can check up on. (many alternatives products like Spirulina pass this test)

2 – Continue to test each batch of the product for all the important criteria and keep the records for a reasonable period.

By the way, I still use Arnica but now I know that its amazing curative powers are all in my mind.

Let me also clarify for you…… The call up was for registration purposes. The call up states that a submission shall “be considered a primary step in the registration process”. It is not an audit, although the information will enable the MCC to compile an audit. You must not read the call up to suit your argument but rather as it states in English. This will allow a proper debate on the issues.

Roy your major gripe seems to be that products do not meet label claims. The are existing laws in South Africa that can deal with this. It is a common law offence called FRAUD. If firms wish the defraud the public, the mere registration of a product as a medicine will not protect the public from this.

Your whole argument misses out one vital point and that is new invented molecules as opposed to those molecules found in nature and used for hundreds of years without regulation have very different safety profiles. To equate the two is disingeneous. The third leading cause of Death in the USA are adverse drug reactions. This is not incorrectly prescribed medicines but correctly prescribed medicines that cause an adverse drug reaction. As you well know any product registered as a medicine does not have long term safety data. That is why registration and control over these invented and patented molecules is necessary. Your only positive comment is they may not contain heavy metals. This is a joke considering how many people pharmaceutical drugs kill annually.Consider prescription medication: in April of 1998, the Journal of the American Medical Association (JAMA) reported that properly prescribed pharmaceutical medicines killed over 106 000 hospital patients in the preceding year due to toxic reactions.Incidents resulting in death from complementary medicines are extremely small: about 50 deaths from all causes over the past 10 years can be attributed to complementary medicines worldwide.Only two contaminations of a complementary medicine have occurred in the USA over the past 15 years. This is statistically insignificant when compared with food contamination, which kills thousands of people every year.

I agree that legislation and laws should be written in such a way as to allow lay people like yourselves to understand it, but this is not the debate here.

The Truth Hurts

“The Medicines Control Council . . . has determined that, with effect from the date of publication of this notice all preparations or mixtures of substances that fall under the definition of a medicine [description of these] shall be subject to a call-up process . . . and shall be submitted to the MCC within six (6) months of the date of publication this notice.”

The problem is that in the next paragraph there’s a statement that [the call-up] “shall relate also to medicines that become available after the said date” but without a specified cut-off date.

Perhaps “Truth Hurts” and I are both right about this? I certainly don’t fancy myself as a lawyer — but I do strongly believe that all legislation and its accompanying bits and pieces should be understandable to the lay person.

My understanding of the call up was that it was primarily for audit purposes so that the MCC could get a handle on what was happening in the complementary medicines market. It’s nearly 6 years down the line and we still have confusion and chaos. And only the sellers of the products have benefited. As I’ve already pointed out, consumers cannot even be sure that what’s said to be in a product, is actually in it.

In part (a) of the “call up” it states: “The data compiled from this call up will enable Council to compile an audit of all products currently available in the market place. Council will review the claims of safety, quality and efficacy for all identified products and will determine whether any such claims constitute a public, health hazard and act accordingly.”

This is where the whole system has seemingly fallen apart — in fact this “review” (re-labelled an “assessment” by the DoH spokesperson), if, as I have been led to believe, is simply entering products into a database, it is not adequate for determining safety, quality and efficacy and whether or not any of the claims made constitute a public health hazard. The only “natural” substance that has been declared undesirable by the MCC subsequent to this notice was Kava kava, and this based mainly on overseas experiences of deaths, liver toxicity, and the need for liver transplantation. It was not based on an assessment/review of products submitted as part of the “call up”. [See Government Notice No 25367, 29 August 2003.]

One of the major advantages of synthesised (as opposed to “natural”) medicines is that toxic heavy metals are excluded. One possibly toxic product I am aware of, frequently advertised on TV at one time, was a calcium product obtained from natural “coral”. The United States version (probably the one imported into SA) was found to be heavily contaminated with lead.

The list of products I submitted to the MCC earlier this year contained the banned substances “yohimbine” and “damiana”. According to the Health Products Association of SA (HPA) website, they have submitted a letter to the MCC urging it to reconsider “damiana” because they consider it “safe”. Why don’t the manufacturers represented by the HPA submit all their damiana-containing products for full registration with the MCC? All they would have to do is prove the quality and the efficacy (for all its different and various uses as claimed), if they already have evidence for the safety.

DHEA was removed from the USA market in 1985 because of false claims about health benefits. It reappeared with the Dietary Supplement Health and Education Act of 1994, but, support for the health claims, particularly as tested on people, is lacking. Given that DHEA products are sold as dietary supplements, there is no control over their contents or the manufacturing practices of the companies that make the supplements. One independent evaluation found that the amount of DHEA in over the counter products ranged from 0% to 150% of what the content stated on the label. Paraphrased from: http://www.umm.edu/altmed/articles/dehydroepiandrosterone-dhea-000299.htm

Far better that an attempt is made to control DHEA as a Scheduled drug than for it to masquerade as a “dietary supplement”. I do not know if “Truth Hurts” is a man or a woman, but if a man, may I recommend against taking the contraceptive pill. The contraceptive pill in South Africa is also a Scheduled medicine.

As for asthma inhalers being sold without active ingredient — the point is that they were discovered to be ineffective and the manufacturers were fined. In South Africa, it’s highly unlikely that anyone would even report an ineffective complementary medicine, and no fine would be imposed. We do not yet have a system whereby companies are fined for selling ineffective medicines, and are required to compensate the consumers who bought them.

Londoner — all medicines have side effects. With ARVs most side effects can be controlled, and must be weighed up against the “side effects” of AIDS itself. The Minister of Health’s unfortunate statement that ARVs are “poison” was particularly ill-advised without the rider that AIDS is even more poisonous in the long term. I know of no ARV containing benzine. The scam product “Virodene”, however, contained a toxic industrial solvent.

Johnnie call the chemist. Thanks. I do hope, if you’re a community pharmacist, that you’re not selling any of these scam products.

Johhnie call the chemist or is it Johhnie come lately………..you like to weave fact and opinion together. You say Roys article was well researched and trutefull article. O really……..Roys makes his opinions seem fact but they are not. For example he says “Even though the call-up was for six months only”. This is nonsense.
Roy must read the wording of the call up. It is certainly not limited to 6 months as he suggests. (For those wanting to know it was No. 23128 of 22 Feb 2002. No. R204) This is the problem when lay people like you and Roy start fancying yourselves as lawyers.

By the way the contraceptive pill is also a steroid….finished and klaar. What is your point about DHEA? Just beacause its scheduled here in SA does not mean it should be. In the USA its not.