Your natural medicines under threat

JEANNE VIALL

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)

 

 
Welcome

Welcome to Creating Health

Explore the heart and spirit of the healing process in a creative way with us.

This website will help you make informed decisions about health maintenance and managing ill health. You'll be exposed to cutting edge news about what's emerging in the natural and integrative health field and share many ideas and viewpoints on healing.

Your body wants to, and can, heal, but it needs an approach that includes the physical, mental, emotional and spiritual aspects of our lives.

This requires you to be creative, make informed lifestyle choices, and continually be in touch with that spark inside which makes you feel alive.

Managing lifestyle is a key to health and to ill-health and we'll offer you a whole new world of great ideas to help you along the way. You'll find them all here, along with our thoughts, opinions and musings about life.

You'll find inspirational stories, more serious articles about health written by a leader in the field of integrative medicine, interesting articles we've come across and the latest news emerging as medicine recreates itself to be more humane, people-centred and conscious.

And some playful ways to remind you not to take life too seriously.

Find many ways to create the health you want. It's in your hands.

Warm wishes,
Bernard and Jeanne.
 

 
September 2014

Hi

Last week draft amendments to the 2013 natural medicine regulations were published - that’s admitting there were problems with the first set, in my opinion, and a response to public and industry pressure. Well done!

However, in the last eight months hundreds of hours have been spent by hundreds of people trying to work out what’s going on, how to fill in seemingly impossible forms, deciphering (often through guesswork) which natural medicines will be able to be registered, which not, and not least, at a huge cost all around. Seems such a waste of resources.

There’s a three-month response period but until we have guidelines to the amendments, they remain vague. It does give us time to regroup, and build a more vocal support base. We are the only voice of the consumer  out there (apart from the Avaaz petition), so please go to the natural health alliance www.naturalhealthalliance.co.za website, or our Facebook page https://www.facebook.com/naturalhealthalliance and click LIKE  - if we have thousands of followers we’re that much stronger. Spread the word to all your networks – I know there are thousands of like-minded people out there, and let’s keep a conversation going.

This month’s newsletter is full of interesting info – Dr Brom’s take on the Banting diet, what inflammation is all about, and making choices.

Enjoy!

Jeanne

From the Desk of Dr Bernard Brom

I am frequently asked what I think about the Banting high fat diet as described by Professor Tim Noakes. I must firstly admit that there I have only heard praise by family, friends and others who have tried it. One colleague in the health industry was very skeptical because right through his life he had been told that ‘fat’ is dangerous to heart health and there were serious problems in his family around heart issues. So he started the diet really carefully after much contemplation and study. Within two months his blood cholesterol levels had returned to normal and he felt better than he had felt in a very long time - more energy and he could run at a level that had only been possible 10 years previously. His body fat fell dramatically, but muscle weight went up and his average weight remained the same.

Others have told me similar stories. Recently a young man who has been on the Banting diet for three years told me how his autoimmune disease had disappeared.

So the big question is: why am I not advocating the diet and using it myself?

I guess I have an inherent suspicion of any approach that tends to be too narrow minded in its approach, and that may not be quite natural. I recognize that many specialists say this diet is the way people probably ate in an earlier age, and point to the eskimos and some African tribes whose diet is mainly fat.  But the truth is that while these groups may eat a high-fat diet, their lifespan is not particularly long and no longer than other groups, who eat more protein, mixed vegetables and sea food.

The Mediterranean diet and vegetarian diets have performed extremely well in reversing diabetes, and even worked in people with serious narrowing of their coronary blood vessels. I therefore feel more comfortable with a diet that is balanced, includes all food groups, but excludes junk foods and processed food and uses instead organic foods, free-range eggs and meat from pasture fed animals. I would perhaps decrease the amount of grains, especially wheat products. Wheat particularly is so hybridized that it is now almost unnatural, and when refined becomes over-processed. Sugar is also processed and refined, and should be reduced as much as possible. A glass of red wine every now and again is probably okay, but alcohol is a liver poison.

My concern is the long-term effects of chronic ketosis. This is an experiment that I don’t choose to be part of. Short term use - and here I mean even over many months - is quite safe.  I have noticed that many people on a ketogenic type diet tend to reduce carbohydrates as if it is an enemy, and forget that the body requires carbohydrates for normal function. Glycoproteins for example are a mixture of carbs and protein and an essential component of mucous. The mucous is secreted by all mucous-secreting glands in the nose and all the way down the intestinal track. One of the reasons for constipation on the Banting/ketogenic diet may not only be the lack of fibre, but also decreased secretions of mucous.  Mucous, apart from protecting the lining of the gastrointestinal track, also has powerful immune properties protecting the body from microbes. This is part of the reason that with a cold the nose runs abundantly, and why it is not such a good idea to dry up those secretions with antihistamines. That mucous is important to help clear the body of the virus.

Thought of the month

Systems are no longer systems when broken apart to examine their parts. Life then slips through the gaps, and we are left with dead aggregates and no life.

Something similar happens with thinking, which breaks so called reality into bits and pieces and then thinks it understands what is going on. Reality is much bigger than the bits and pieces of thinking mind’s play.

Journeywork

I am concerned at how many people feel really negative and pessimistic about life today. It may seem justified when one looks around and sees the amount of corruption, evil intent of groups of people, killings, rapes and other insanities.

Despite all this a true, unconditional optimist remains optimistic because it helps him feel optimistic, and that feeling is better than feeling pessimistic.

The usual argument to this is that the person just does not have his feet on the ground and is not a “realist”. I have learnt over time that living in a world of exceeding complexity, where despite all the operating electronic machines we have at our 

disposal, weather prediction still remains a prediction, sometimes right and often completely wrong. There is no way therefore of knowing the absolute truth or predicting where this moment will move. We are constantly creating our own story from the bits and pieces at hand, stirring up our own emotions to support that viewpoint, and then feeling optimistic or pessimistic depending on the prevailing winds.

So, choose your story wisely, keeping in mind that your story not only influences you but also rubs off on everyone around you. Enlarge the influence of love by being loving. Increase the effects of optimism by being optimistic and share in fellowship by supporting the good in others and showing all that is good in you.

Interesting facts

There is the idea that like the liver, the kidney is also a detox organ required to get rid of poisons. This is not actually true. The liver is very much a detox organ, acting as a filter for the blood and removing toxins from the blood. Everything eaten, for example, must pass through the liver. But the kidneys have a different function.  While there is also a filtering system in the kidneys, this system has more to do with balancing the chemicals in the body than removing toxins. Excess of any chemical is removed not because it is a toxin, but to maintain the right balance of minerals and keep the pH of the blood constant.

This is why many folk drink their urine, firstly because it is not full of poisons but good quality minerals and other nutrients. Urine is also sterile and can therefore even be injected directly into the tissues of the body stimulating a range of responses, which may be helpful.

News and Views

Why is autoimmune disease so common today?

Autoimmune disease occurs when the body’s immune system becomes confused and fights against itself, very often even destroying its own tissues. This group of diseases has increased tremendously in frequency and may, as a group, be the most common cause of ill-health today, even conditions as diverse as Parkinson’s disease, Multiple Sclerosis, Crohn’s disease, Ulcerative colitis, diabetes.

I always like to ask the question: “What is it in you that is self destructive?” because very often the body is manifesting the same dysfunction that is happening on another level. With cancer the question would be: “What emotion is eating you up inside?”

Good remedies to take include large doses of EPA/DHA, even up to 6 grams/day plus Magnesium, Curcumin, Quercetin and Vitamin D in high doses (5000IU/day).

Inflammation

Everyone should be aware that injuries cause inflammation, and that the inflammation is part of the healing process. There is however a process involved, and usually inflammation is followed by healing.  So why do doctors give “anti-inflammatories” if inflammation is part of healing. Now, that is a good question. Let’s examine that question a bit more deeply.

Inflammation has many components, which include redness and swelling, but below the surface is a range of chemicals that sweep into the area and then sweep out. So the body has its own inflammatory chemicals and anti-inflammatory chemicals, and the process is clearly extremely precise and well co-ordinated, following an evolutionary intelligence that has been around for a very long time.

Using anti-inflammatory drugs in the blind way usually prescribed makes no sense to me, and probably accounts for the problem sometimes becoming chronic. Chronic inflammation is a more serious and even sinister event. Here we see the chronic production of chemicals, which are useful and important for the acute repair of tissue, but not helpful if chronic and prolonged. The chronic production of these chemicals is thought to be one of the underlying causes of many diseases, including cardiovascular disease, diabetes and even cancer.

Inflammation can be local or more generalized. Generalized inflammation, which is clearly more serious, is often caused by the foods we eat. Sugar in particular is an inflammatory promoter. Excess red meat generates lots of free radicals, which are also inflammatory promoters, and excessive exercise is also an inflammatory promoter. Stress is another cause of generalized inflammation.

What about natural anti-inflammatories like curcumin and omega 3?

These do not have the power of drugs to interfere with the inflammatory process in the same way. I generally don’t like to call them anti-inflammatories, but rather natural medicines that  ‘complement’ the inflammatory process. They support, promote and strengthen the inflammatory process to complete the healing. Now that is very different to what drugs do.

And Finally

We continue together with our lawyers to battle the new regulations, which will no doubt force the large majority of health shops to close down, prevent the public from buying natural medicines of their choice, necessitate a prescription for many of the natural medicines you can buy freely over the counter and thereby increase the cost of natural medicines in South Africa. The department of health has just published draft amendments, but no accompanying guidleines as yet which would give us a better idea of  whether they are helpful. However we are not convinced that these amendments will come close to what we have requested, and we continue to seek clarity and raise funds for the Natural Health Alliance.

 
Open to your feelings

In Chinese medicine the heart is not just an organ but an ‘orb’ which includes the heart organ but also a field of ‘energy-information’.

Try standing in front of someone and find out your comfort zone with them. With some people you can stand much closer than others. There is some science to this now. The electrocardiogram (ECG) which doctors use to record the electromagnetic field of the heart can now be detected with supersensitive machines ¾ metre extending from the body.

When we stand close together then our heart energy fields are linked and communicating. What does that say about heart to heart conversations? In Chinese Medicine the heart is also the place where the spirit rests. Our feelings, which we experience in the heart area, are the sensory apparatus of the spirit/soul. These feed into the head area and are responsible for the intuition that the thinking mind relies on for inspiration and great ideas.

Try connecting more often with your feelings rather than the thoughts only. Your feelings open you to the Great Mystery. That is were the awe and magic of life can be found.

 
Causes of ill health

Is it  true that we don't know the cause of cancer or Parkinson's disease?
Why there is such a gap between the conventional medical model and view, and what patients seem to know intuitively?

Most patients will hear their doctor tell them that cancer, Parkinson’s disease, multiple sclerosis, hypertension and numerous other diseases do not have a cause known to science.

I saw a patient recently with hypertension, diabetes, high cholesterol and depression who had been given four different drugs at the clinic. The clinic consultation lasted less than 15 minutes and she was asked to report back in one month. And that was that. When I asked the woman what she thought the cause of her ill health was she was able to give me some pretty good answers.

Read more...
 
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