Wednesday, August 29, 2007

The FDA - What's a disease?

The Health Jerk, Part Three

Health Jerk back again. As promised Part Two had a little more bite. In this part we will continue discussing the FDA as we still have some definitions to complete.
Disease:
-any departure from health
-a particular destructive process in an organism
-an evil or destructive tendency.
-As a verb, to cause disease in, infect, corrupt.

The reason the word disease is so important is that the FDA uses it in the definition of a drug.
Only a drug can be used to treat, diagnose, cure or prevent a DISEASE.
It also uses it to define who can treat, diagnose, cure or prevent a disease, that being licensed doctors and pharmacists and so on.
Hopefully some bells are going off...

Only drugs can prevent a disease? Does that mean I cannot eat unapproved nutritional foods and unapproved dietary supplements because they might make me healthy and resistant to (read prevent) disease. What if I ate some oranges with Vitamin C and prevented scurvy? You get the idea.

Here is a fictional story. It's fictional. Make believe. I do not have a miracle plant and I do not have cancer. Fiction.
Once upon a time…
What if:
I found a plant growing beside some rocks in my backyard.
What if:
I had lung cancer and the doctors gave me 6 months to live.
What if:
I ate one leaf from that plant every day for 3 months.
What if:
I was completely cured of lung cancer.
What if:
You knew me and my medical history.
What if:
You contracted lung cancer and the doctors gave you 6 months to live.
What if:
You asked me how I got better.
What if:
I told you that I ate a leaf a day for 3 months from this special plant.
What if:
You asked me if you could eat a leaf a day for 3 months.
What if:
You recovered from lung cancer.
What if:
Word spread about our recoveries from lung cancer.
What if:
100 people asked me if they could eat a leaf a day for 3 months.
What if:
I said yes.
Then the FDA would put me in jail.

As I have told this fictional story, the FDA would probably put me in jail during my self treatment if they found out about it. I would certainly be in jeopardy when I shared my treatment with you. With 100 patients, the FDA would call out the SWAT team.

I know it is a silly story, but it becomes really silly when you understand the purview of the FDA. I am not a licensed doctor or pharmacist therefore I cannot distribute anything which is intended to treat, diagnose, cure or prevent a disease. Certainly cancer is a disease. Therefore in my story I broke the law even during my self treatment.

Here's one that is non-fiction. What if I burned my hand. I wanted to treat it with aloe, a widely known natural remedy for burns. Under one interpretation of the FDA regulations, my treatment of the burn with aloe would break numerous rules: non licensed treating and diagnosing of the burn, non licensed curing of an injury, use of a non-FDA-approved natural substance to treat and cure an injury. This is getting silly but it gets even better.
OK, what’s a disease anyway?

Well no one would care if the FDA was not running around classifying and renaming every simple ache and pain as a disease. For example, simple indigestion, our parents called it heartburn, now it’s a disease – acid reflux disease. The pharmaceutical industry has over the counter and prescription drugs to address and cure that disease. Please save me from the TV ads. The point being made here is that indigestion is now a disease which means that per FDA regulations, it can only be treated, diagnosed, cured and prevented by an FDA approved drug. That is a drug which when taken at extreme doses will be toxic per Rule LD50.

How did we get caught in this catch 22? Stay tuned for the next part as we continue to discuss the government and our Health.
Later sheep.

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