Complementary medicines cannot be regulated under the same requirements as pharmaceutical drugs. It is inappropriate, and it is irrational. Complementary medicines are not drugs. They are not used in the same way as drugs are, and they do not carry the same risks.
That is one of the main objections to the new regulations, and the debate around them. The regulations are being challenged in court.
Some background: In November last year regulations for natural medicines, or complementary and alternative medicines (CAMS) as they are referred to, were passed that could effectively remove 60 to 85% of CAMS from the shelves, depending on whose estimate you go on. There was no broad consultation and they came as a surprise to the industry, and the public, even today, know little about them.
This industry is worth around R7-billion, with more than 30 000 products on the market. The regulations define a new category of medicines under the law, Category D Complementary Medicines. Anything that doesn’t fit into that definition moves to Category A, general medicines, which are pharmaceutical drugs.
Probiotics, now a Category A medicine, will need to be registered under the same stringent requirements as, for example, Prozac. So too high dose Vitamin C (which has excellent research behind it); doses higher than 500iU of Vitamin D3 (the Vitamin D Council in the United States recommends a dose of 5000iU). Around 65% of products now on the market will fall into the “general drugs” category.
The reasons given are that this in the interests of public safety.
No one is against regulation. There are some dodgy products on the market – especially in the slimming, body building and sexual enhancement sector. There may even be some CAMS which could need to be used on prescription only. Some may need to carry warnings.
No one, again, is against good manufacturing practices: as a consumer I want to know that what the label says is what I get, that it is not adulterated with anything else, and that it has been manufactured in hygienic conditions.
Category D medicines include herbal medicine, Chinese medicine, other traditional medicines and homeopathy. This category will not be seriously affected.
It’s the Category A medicines which will be hit hard (about 65% of the market). Because the new regulations are so stringent, companies will need to spend millions of rand to comply with toxicological and clinical studies required, with no way to recoup costs, as there is no proprietary protection for them. Natural medicines cannot be patented.
No one is suggesting that we allow unsafe medicines on the market. But consider: Complementary medicines are not drugs. Drugs are toxic, have patent laws which apply to them and require research required to make sure they are safe. Natural medicines cannot be patented and are generally safe, with hundreds of years of safety record behind them. There is also extensive research on many of the products on the market.
How risky are CAMS? The United States is one of the countries where complementary medicines are least regulated, and it is estimated that around half the population uses them. In 2010 the peer-reviewed scientific journal Clinical Toxicology published the annual report by the American Association of Poison Control Centres which concluded: “In 2009, there were no deaths from multiple vitamins or any single vitamin, no deaths from herbal medicine, no deaths from any amino acids or dietary mineral supplement and no documented deaths from homeopathic medicines.” There are also comparative risk studies from Australia, the UK and Europe showing the miniscule risk of using complementary medicines.
“In South Africa,” says Anthony Rees, of the Natural Health Alliance, “no one can tell me of single death or adverse reaction having being reported as a result of the use of commercially available complementary medicines since the inception of the Medicines and Related Substances Act in 1965.” Compare this to some 1681 acute poisonings in 2012 as a result of common analgesics, benzodiazepines, antihistamines, SSRIs and other multiple drug ingestions at The Poison Information Centre at Tygerberg Hospital. These are regulated medicines. There are around 20 000 documented deaths from traditional African medicines, a sector still to be regulated.
The Medicines Control Council already has the power to take any product it deems dangerous off the market. It does not need the new regulations to do so.
Dr Rene Doms, who has been closely involved in the medicine regulatory environment for almost 20 years, uses the concept of the “bio-burden” of our population as a reason for the stringent regulations. With a large proportion of South Africans being immune compromised (more than 20%), he says, care must be taken. While low-dose multi-vitamins won’t do any harm, in higher doses they may, he says. “With any medicine we work with the exception, not the rule. We have to be careful.” Really? Most medicines, particularly drugs, are used knowing that there are risks, sometimes very serious ones. Anti-inflammatories, and that includes aspirin, have a high-risk of causing stomach ulcers and bleeding, (aspirin is obtainable over the counter, and cheaply).
The majority of complementary medicines, on the other hand, have a very low-risk profile.
After speaking to Doms, I look at Health Canada’s monographs (a system he favours), which includes dosage, uses and risks for some of the CAMS I regularly take. Not one of them has a warning, few have contraindications. I particularly look at probiotics, which he warns are problematic in immune-compromised people. There are reported cases of probiotic sepsis, but they are extremely rare, weighed against their health benefits and usage by millions of people.
For those at risk, a simple warning on the label would be sufficient.
The argument of the “bio-burden” of disease in South Africa, I would argue, is all the more reason for CAMS to be available. CAMS are not used in the same way as drugs; they are used to support the body’s innate ability to heal itself
But that’s a different approach to health and disease, and one missed or misunderstood by the regulators.
(The Canadian system, incidentally, resulted in about 60% of products being removed form the shelves, and there’s a high court action challenging them.)
Some CAMS do carry risks, and these can quite easily be placed in a category for use under the care of a doctor or other qualified health practitioner. This category of CAMS has been completely left out of the regulations, potentially leaving many doctors without the medicines they require. One example is bio-identical hormones, used by some medical specialists concerned with the side-effect profile of artificial hormones.
Dr Bernard Brom, Chairman of chairman of the SA Society for Integrative Medicine, is concerned that innovative natural products used by Integrative Medical doctors around the world will require regulation under the new system which would make it almost impossible for them to be registered. “I think we need a significant change in the way natural medicines are regulated that comes with the understanding that the practitioner and public should be able to have free choice around the management of ill health, just as we have in choosing to smoke, drink alcohol and buy junk foods,” says Dr Brom.
Some products’ claims of treating specific diseases have come under fire, and this speaks to the issue of efficacy, another reason put forward as a reason for regulation. Does the product that claims to boost my immune system actually do that? Do probiotics promote gut health?
Efficacy may be difficult to measure in some cases, especially when using the criteria of allopathic drugs, which are single chemical substances. Many CAMS are combination products, based on extensive research by well-qualified people. Many Chinese medicines, for example, are never used as single herbs as they work synergistically with others.
“The people regulating these medicines do not have the knowledge to assess them,” says the owner of a company, whose has experienced this. That, along with the high cost of completing dossiers, may mean his products will not be registered, and he will go out of business. (Although a product may only cost around R1 500.00 to be registered, the dossier is so complicated that consultants are required, who charge around R35000 per product).
After much research, I still have questions unanswered. Who drew up the regulations, who advised the health department? Will the people who assess CAMS be qualified to do so? Who will benefit from the regulations? I know pharmaceutical companies are increasingly entering the natural medicine market, no doubt with similar products. But surely no one intended to decimate the R7-billion industry, with its loss of import duties, VAT, jobs?
In conclusion: I have the right to choose the health system that works for me. Yes, I want safe products, and I will soon stop using a product if it doesn’t work (allopathic or otherwise). If I use products based on my doctor’s recommendation, or my own research, that is my choice. If they are withdrawn from the market, I have no choice.
(Jeanne Viall is a freelance journalist specialising in health)