What is a drug?

In the USA, the Food, Drug, and Cosmetic Act defines a drug as : (1) a substance recognized in an official pharmacopoeia or formulary (2) : a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (3) : a substance other than food intended to affect the structure or function of the body (4) : a substance intended for use as a component of a medicine but not a device or a component, part, or accessory of a device.

The FDA says: "The legal difference between a cosmetic and a drug is determined by a product's intended use."  


In Canada, the Food and Drug Act defines a drug as: 
“drug” includes any substance or mixture of substances manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
(b) restoring, correcting or modifying organic functions in human beings or animals


The European Union  DIRECTIVE 2001/83/E defines a 'medicinal product' as: 
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

What's wrong with this picture? 

It seems to say that the difference between a drug, and a non-drug depends on the use.  But if you read more carefully, that's not what it says.  It really says, in simple English:

"The difference between a drug, and a non-drug is defined by the way the product is marketed." (intended for use, sold or represented for use in, presented as having properties for). 

If it looks like a drug, and walks like a drug and talks like a drug - it makes no difference at all. It's not a drug until the paperwork is done.

But if the marketing paperwork to the government says: 

in the USA: "a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease"

in Canada: "substances manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms"

in the European Union: "presented as having properties for treating or preventing disease in human beings".


If the marketing department says it can be used to diagnose, cure, mitigate, treat or prevent disease, - it is a drug. That is the only requirement for a drug.  Thus, everything and anything can be a drug - if it is marketed as a drug.  Of course it must pass some significant paperwork hurdles - but these are easily managed by large corporations and their lawyers. 


Note: to create a drug in any of these countries, it is not necessary for the drug to be particularly effective, nor for the scientific or medical community to believe that the drug is effective.  Nor is it necessary for the drug to be safe in all situations.  It is only necessary to pass the paperwork tests. Government offices cannot and do not pass judgement on the efficacy of any drug application.  Governments pass judgement on the paperwork. Many new drugs cannot truly be tested for effectiveness, nor safety, on the general population until after they are in public use for many years, possibly even decades. 

It is easily seen that one of the problems with the USFDA, Health Canada, and European Unions definition of a drug is that there is little said about what is 'not a drug'. Almost everything can be defined as a drug.  

This has lead people to ask if water is a drug - because it can be marketed to prevent and cure dehydration (they failed due to the fact their the paperwork was not completed correctly). And it lead me to blog that the wind is my drug, because I claim it makes me feel better.


We need a different definition of a drug.  


Wikipedia says: "A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage."


Webster's Dictionary says: "a substance used as a medication or in the preparation of medication".  


We need a definition of DRUG, from a health viewpoint. 

Is there a simple way to delineate between drugs and non-drugs from a health viewpoint.  A definition not depending on a marketing department.  Rather a definition that depends on science and facts about our health and healthiness.

The first thing we should recognize about drugs is that they are almost all toxic by design. Drugs are designed to throw your health system off balance, to counter the imbalance of your illness, not to create health. You need a prescription for drugs because they are toxic.

If we want to define drugs, we need a way to separate the things we consume, through our mouth and other orifices, including our skin, into drugs - and not drugs. All three of the official government definitions make no such distinction.  Everything is a drug.  Everything should be regulated as a drug.  This is, frankly, a ridiculous situation.

Can we define drugs in a useful fashion?  Can we define non-drugs?

A healthicine is a substance that has a direct effect on the balances of healthiness. Healthicines are non-drugs. That effect might be positive, or if the healthicine is deficient or excessive - it will be a negative effect.


A drug is a substance that has an effect on illness.  Drugs have an indirect, usually negative effect on the balances of healthiness. This negative effect is designed to throw the illness off balance and allow your body to heal.  Or sometimes the illness is designed to simply trick your body into 'feeling healthy', by minimizing symptoms. 

Water is not a drug. If you are dehydrated, water still cannot be a drug.  Water cures dehydration, or it restores the balance of hydration - but it is not a drug. Water is necessary for healthiness.  A deficiency or an excess results in an illness and possibly death.

Can we extend this distinction to other substances - it gets a bit more complicated. If you have a Vitamin C deficiency, taking Vitamin C to 'treat' the deficiency is not taking a drug - any more than eating oranges is taking a drug.

Vitamin C can also be used as an injection to treat a serious inflammation.  In that case the Vitamin C is not addressing a normal Vitamin C deficiency, it is being used to tackle a health problem that is best treated by an excess of Vitamin C. Vitamin C has a negative effect on the problem - the inflammation - note, inflammation is normally a healthy response to stress. Administering an excess of Vitamin C, or any substance, for a therapeutic effect separate from the Vitamin C health balance, is administering a drug.

Is this a clear dividing line?  Maybe, maybe not.  The government definition of drugs for sale needs to be a clear, black and white, legal definition.  But the definition of drugs for health, and for personal healthiness, has many shades of grey, ranging from black to white and every shade in-between, possibly even different colours.

A healthy definition of ''drug" needs to be open to dispute and discussion. The government definition is like a proclamation from God, there is not room for argument, not way to dispute the decision. This is not a healthy definition. It is not a democratic definition. It is not a 'freedom' definition.  I believe in Personal Health Freedom.  The freedom to differ.

All illness and disease are be caused by an imbalance, a deficiency or excess of genetics, nutrition, parasites, toxins, stress, growth (including healing and immune systems) - or a combination thereof.http://personalhealthfreedom.blogspot.com/2011/10/hierarchy-of-health-primary-and.html

A drug is always an excess. In most cases, if you are healthy, a drug is toxic to some aspect of your health. You need a prescription - a doctor must sign that you 'need the drug'. When you are ill, the drug may have a beneficial effect. By design. Drugs are not designed to fix health imbalances. Drugs are not nutrients. Drugs are not designed to cure - they are designed to create an 'opposing imbalance' so that your body can heal.

All drugs have 'side effects'.  Why is that?  Because all drugs are toxins - they have toxic effects.  If they didn't have toxic effects, they would have no effect at all.  In some cases, the toxic effects are intended.  That's the 'design' of drugs. But in many cases the toxic effects are unintended, or even unknown. Generally unknown until many people fall ill or die. Mercola tells us that drugs kill more people than car accidents in the USA. 

Are some drugs worthwhile?  Are some drugs the 'best treatment'?  Yes.  Of course. If you have a bacterial infection, the best treatment might be a toxin that kills the bacteria, but has minimal effect on your health and healthy cells.  An anti-biotic.  However,  most, possibly all antibiotics kill some healthy cells as well. 


We need to search for health, not illness. We need to search for 'heals', not 'cures'.  We need honesty and openness about treatments; to measure which treatments have the best effect on any illness, not which is the 'latest (untested on the public at large) drug'. 


New drugs have the most potential for danger. We need a health paradigm, not an illness paradigm. We need a healthicine paradigm, not a drug paradigm. 


Yours in health, tracy
www.personalhealthfreedom.com

Tracy is the author of two book about healthicine: 

Great New Drug Discovery, Prevents Cancer Too

A recent study reports that over 75 percent of advanced cancer patients have low levels of Vitamin D.  Read about it here. The lowest levels of Vitamin D are associated with the most advanced cancers.

Vitamin D has become the new wonder drug. Vitamin D deficiency is implicated in Multiple Sclerosis. Flu season is the season when our sunlight deficiency causes a drop in our Vitamin D levels and a corresponding drop in the health of our immune systems.  Moderate to high doses may reduce heart disease, and can slow the progress of congestive heart failure. Of course we have known for years that Vitamin D deficiency causes as loss of bone density progressing to rickets.  Vitamin D is a commonly recommended preventative for osteoporosis. Vitamin D is now being studied for diabetes because it decreases insulin resistance - a benefit for diabetics.

What's wrong with this picture?  It hi-lights some serious deficiencies in our medical paradigm.  We need a health paradigm. 

1. Vitamin D is a nutrient. Not a drug. It is studied as it if was a drug.

2. The main natural source of Vitamin D is sunshine. But people who sell sunscreen have built a huge propaganda message against sunshine - so many doctors are reluctant to prescribe sunshine to prevent disease.  Fewer are likely to recommend sunshine for health. I have read - but not seen specific studies - that melanomas do NOT develop on areas of our skin that receive the most sun - the face and hands. Research published in the British Journal of Dermatology concluded that the perceived statistical increase in melanomas is most likely due to a shift in diagnoses which classify non-malignant lesions as cancerous. And countries near the equator,where the sun is strongest - tend to have lowest incidences of skin cancer. What's up with that? Here's Mercola's post on this item - the comments are interesting as well.

The wind is my drug - and now the sun as well. 


3. We have clearly documented measurements of 'the amount of Vitamin D required to prevent illness'.  Of course these numbers are being revised in light of new findings.  But we have no recommendations, and no studies, of the amount of Vitamin D consumption (or creation via exposure to sunlight) that will optimize health. We only research for the 'minimum to prevent disease' and then we measure drug like effects when Vitamin D is used to treat disease.

4. You can be deficient in Vitamin D.  Deficiency in Vitamin D means that you are consuming, or producing through exposure to sunlight, less than the RDA of Vitamin D.  You can be preficient in Vitamin D.  Preficiency exists when your Vitamin D levels are below the 'optimal' level of Vitamin D. But we do not know the optimal levels of Vitamin D.  There are no studies to measure the optimal intake, or even optimal range, of any nutrient. So, we don't know what amount of Vitamin D is most healthy. And we don't know what amount of sunshine is most healthy.

5. Vitamin D affects your health. But we don't study health, we only study illness. How Vitamin D affects your health is poorly studied - and recent studies of Vitamin D are all focused on illness, not on health.

This might explain why the information about Vitamin D has remained hidden from view for so long. We are now starting to study Vitamin D deficiency more often, but we do not yet study Vitamin D preficiency, nor Vitamin D health. It also makes me wonder what other nutrient imbalances hold keys to illness - that we don't understand because we don't study health.

6. Vitamin D is studied in isolation. All nutrients tend to be studied, as if  they are drugs, in isolation. When we learn to measure health, and to determine the correct amounts of nutrients for optimal health - we will learn about combinations of nutrients and how they affect health.  Studies to date on multi-vitamin supplements, for example, treat each multi-vitamin recipe as a drug, and measure results as if they were drugs.  Effects on health are not measured, because we don't measure health effectively. Only effects on illness are measured.

In theory, we should be able to:

a) Measure the health level of a person and the changes over a span of time, along many of the dimensions in the hierarchy of health.  At present there are no established techniques to effectively measure and compare the health of so called 'healthy' individuals.

b) Measure the nutrient intake and changes in nutrient intake of the same person over the same span of time.  It is very easy for our intake of nutrients to drift over time, without us being aware.  We seldom evaluate diets - and are less likely to evaluate diets for overall nutrient content.  Instead, diets are evaluated for factors that do not contribute directly to health - but might contribute to illness - calories, unhealthy fats, etc.

c) Analyze the relationships between nutrient intake, changes in nutrient intake, and health.

Instead, we measure when illness is found. We deliberately wait until something breaks, and then try to fix it, or try to figure out how to prevent it from breaking, without understanding

Your body is always growing, healing, repairing, working to improve your health.  Working to restore health imbalances. Every person has a different level of health, different health strengths and weaknesses. But none of us have a clear idea what our individual strengths and weaknesses are.  Which of the over 100 essential nutrients are in your diet in healthy amounts?  What types of exercise are most healthy for your personal body?

Frankly, we don't know much about health. Hopefully we can start learning. You have a right to life, liberty and the pursuit of healthiness.

Yours in health, tracy

Tracy is the author of two book about healthicine: 

Personal Health Freedom