Naturopathic Product Classed as a Drug

Just last week I received a letter from Metagenics, one of the premier naturopathic supplement companies in Australia and the US, notifying me of a natural product which had been taken from being freely available for naturopath’s to prescribe, and had been classed as an S4 medication which is now only available on prescription.

For years we have been warned of the dangers of the Codex initiatives, to take our natural supplements out of the hands of well-trained natural practitioners and class them as drugs.  Foods, herbs and supplements fall into this category, where any substance which causes an effect on the body, can be classed as a drug.

There is no discretion between safe substances and dangerous medicines.  The warnings tell us that high dose, or therapeutic levels of supplements will be banned and all we will have left to work with is very small amounts of vitamins which will do very little therapeutically.  For example it has been bandied around that Vitamin C will only be available in 60mg tablets – which is completely ineffective.  For therapeutic levels, I have often prescribed up to 25,000mg per day in certain circumstances – so how many 60mg tablets would we have to use in this case?

The push for Big Pharma to regulate our natural products as drugs, stems from the fact that consumers are turning their backs on pharmaceutical medicine and turning to alternatives in droves.  A monopoly on the health market assures these companies of covering all bases, so they do not lose market share, wherever the dollars are being spent.

In this worst case scenario, taking natural medicines away and making them only accessible to doctors, (who are not trained in how to use natural medicine) means that essentially, this form of treatment will no longer be available to the public.  Doctors are not likely to prescribe anything natural over a drug, and we would therefore be in danger of losing a whole industry.  I hope it doesn’t come to that.

The product that has been taken away from naturopath’s is one called Red Yeast Rice extract which is (from the Metagenics Practitioners Manual) “the fermented product of rice (Oryza sativa) on which red yeast (Monascus prupureus) has been grown. It has been used in China for hundreds of years. The major active components in red yeast rice extract are a group of compounds known as monacolins. These compounds directly inhibit the enzyme HMG-CoA reductase to decrease cholesterol synthesis in hepatic cells, reducing LDL levels and supporting HDL levels.”

Essentially, we used this product as an alternative to statin medication as a successful adjunct to treatment to lower cholesterol levels in people who had been advised to go on medication to manage this marker.

When a patient is advised to go on statin (cholesterol lowering) medication, it is usually viewed as one that they will need for life to “manage” their cholesterol levels.  The medical profession appear to be confused as to the role of cholesterol in a healthy body, and like to see it as low as possible.  Most naturopath’s are aware, however, that cholesterol which has been stable and rises rapidly is just a marker of some type of underlying problem that may need to be addressed.

Liver congestion, poor bile production and fat breakdown, a change in diet, thyroid dysfunction, hormonal imbalances – there are many reasons why someone can present with a marker called “high cholesterol” and the idea is to treat the whole person and bring them back into balance with natural medicine, at which point their cholesterol levels return to normal.

During this process we may use a product such as Red Yeast Rice extract, to assist in managing the biochemistry until other methods of dietary changes, herbal support, exercise, etc are employed to correct any underlying causes.  Then the person is weaned off this supplement as their health improves.  Short term, as a part of a naturopathically managed program, I have no problem with using this product.

But now the TGA in Australia has deemed this product to be too dangerous for naturopath’s to use.

“At the June 2009 meeting, the Committee agreed to a new Schedule 4 class entry for HMG-CoA reductase inhibitors. The June 2009 minutes included the following:
• It was agreed that a patient generally could not self-diagnose hypercholesteraemia.
• Should a patient incorrectly self-diagnose (and take an HMG CoA reductase inhibitor), the patient would be unnecessarily exposed to the risk of side-effects (including the risk of rhabdomyolysis). Furthermore, given that this class of substances was used to lower blood cholesterol in order to decrease the risk of heart attack or stroke, oversight by a medical practitioner was appropriate to look at the entirety of the matter.”

What they are saying in this report, is that anyone taking natural red yeast rice extract for lowering cholesterol should be monitored by a medical practitioner. So instead of finding a way to integrate both our worlds and provide the best outcome for the patient – they have just taken away our ability to work with these patients effectively.

Any good naturopathwho is working with a patient with high cholesterol will also be working with the patient’s doctor as well.  We also like to see blood test results and gauge how our patient is traveling with the treatment.  So what the TGA have effectively said in their report, is that they don’t look at the option of holistic treatment for the patient, but dismiss it entirely.  They do not even mention that this product was “naturopath only” , the patient can not purchase it “off the shelf”, meaning they would need to be in the care of a well-trained natural medicine specialist.  In the report they use the terms “self-diagnosis” rather than giving credence to a valid profession.

This is where our health care system breaks down.  There is no integration between the worlds of natural and orthodox medicine – even if it is in the best interests of the patient.  This is a sad day for natural medicine, and I genuinely hope that this isn’t the tip of the iceberg.

Leisa