Even M.D.’s Fail to Understand
We’re in more than one health crisis in the U.S. right now, but the one most important to many of us is keeping homeopathy alive and well and available to all concerned with natural health. The Food and Drug Administration is very close to imposing rules on it that can make every single remedy, from Arnica to Zincum, a “new drug.” Effectively, this makes every remedy illegal, and so costly and impossible to “prove efficacy” by conventional drug standards that homeopathy could vanish this year.
I’m moved to share with you a representative response reported to me by one signer of the petition to the FDA to stop their nonsense.
[Haven’t signed it yet? Here’s where you can, but only until March 23: Please CLICK HERE to Sign]
What’s become obvious from the Congress and Senate responses is that most do not know enough about homeopathy to vote responsibly or voice their opposition to the current FDA Draft Guidance.
A Bit of History is in Order
Homeopathy has its roots in the late 1700’s, founded by physician Samuel Hahnemann, who by pure observation discovered substances that could cause symptoms when taken in crude form, could also cure those same symptoms in highly diluted form in the sick.
The homeopathic drugs (remedies) were all thoroughly tested by willing physicians who volunteered to take various substances until symptoms appeared. Each substance’s symptoms were meticulously recorded in books called materia medicae, which are still widely available today.
The preparation of homeopathic remedies was standardized and involves ultra-dilution, to the point where none of the original substance can be measured. The manufacture of homeopathic remedies in the U.S. is regulated by the HPUS (Homeopathic Pharmacopeia of the United States).
While homeopathy works in small children and animals, precluding a placebo effect, we as yet do not fully understand how highly diluted remedies work to prompt the patient to heal his illness.
Ultra-dilution: Key to Safety
In the 200 years since Dr. Hahnemann invented homeopathy there has never been a single documented injury or death from the use of properly formulated homeopathic remedies. Because they are so dilute, homeopathic remedies are inherently safe and side effects are exceedingly rare.1
It is this ultra-dilution that is often missed when regulators seek to “protect the populace.” This response to one reader’s petition comments illustrates this ignorance well:
The guidance focuses on products with the greatest potential for patient risk. These include: products with reported safety concerns; products that contain or claim to contain dangerous ingredients such as belladonna and nux vomica — Michael C. Burgess, M.D.
Member of Congress
See where he’s gone wrong with these two remedies?
In the remedies he names, any potency (the number reflecting the amount of dilution) over 12C will have exactly this much physical herb in them:
0 (milligrams, micrograms, picograms, you name the measure).
A scientist looking for the original herb would find none present on analysis. And what’s the commonest potency in use and for sale today?
It’s a 30C. Many times more diluted.
How Diluted is That?
To give you a sense of the “ultra” we’re talking about here, homeopathic dilution means a drop of crude herbal tincture was mixed with 99 drops of water. The homeopathic pharmacy then agitated that dilution (a process called “potentization” or “succussion”) and a 1C dilution resulted (C stands for centesimal, or 1 part in 100).
One drop from that vial was added to a new vial and 99 more drops of water were added. That vial was succussed and the result was a 2C potency.
To make a 3C, the process was repeated: one drop of the 2C, 99 more drops of water, etc.
In total, this was repeated thirty times to get the remedy you’ll commonly find in Whole Foods or any other store that sells homeopathic medicines. That’s how a 30C potency is made.
Any physical evidence of either belladonna or nux vomica was long gone after twelve rounds of this dilution process. You don’t have to be a math whiz to see that 30C is way more diluted, by 18 additional 1:100 dilutions.
So, while both herbs could be toxic in crude form, they are far from unsafe at this common level of dilution.
And yet, they work.
One Tiny Dose, A Changed Cow
Here’s a small case to show nux vomica at work. I kept and milked a couple of cows for a very special guest to Austin in early Summer, 2007. They lived outside at pasture and came to a lean to I’d set up to milk them in.
One night, the weather changed radically as a cold front came through with a chilling rain. One of two cows had next to no milk the following morning. Her rumen (the first digestive vat/stomach) was at a standstill instead of doing its normal churning a few times a minute. She was dull eyed, much less “with it” than her normal kind of spooky nature, and after milking, she just laid on her right side with her left side looking a bit bloated.
I thought about her symptoms:
- complete indigestion, quiet instead of her usual noisy gut sounds
- no cud chewing like her mate (every normal cow burps up partially digested feed from her rumen, re-chews it several times and re-swallows it; this happens all day long unless she’s completely asleep)
- dull, withdrawn
And, I thought about what changed in her world: she had been unexpectedly chilled by a cold rain.
When you look up nux vomica in any materia medica, you’ll see this state can be caused by nux vomica, taken in crude form. I raced home to get my 200C remedy kit (how much more diluted than that usual 30C at the store? You do the math.)
I mixed a few tiny granules into some water, shot it in the corner of this sick cow’s mouth and sat to observe if my hunch on nux was correct.
Within two minutes, Bossy let out a big burp. Within five, she’d roused her digestion into starting its normal churn, and she was up on her feet, once again lively and not wanting to be messed with. She passed a hard stool (another nux v symptom: constipation), and moved off to graze with her cow companion. That evening, her milk production was nearly back to normal and she never needed another dose.
Teething Tablets with Belladonna
The good doctor/congressman Burgess also wrote:
the FDA has seen an increase in the number of products containing inconsistent and sometimes dangerous levels of certain ingredients. homeopathic teething products have been a large concern for the FDA. Some of these products contained belladonna, which has unpredictable and possibly dangerous effects in children under age two, the primary users of these products. These effects can include hallucinations, convulsions, and coma.
The folks spear heading the drive to safe homeopathy, Paola Brown and helpers at Americans for Homeopathy Choice responded to this, directly to the FDA in a comment:
More on the actual amounts of the toxic ingredient found in the teething tablets:
The teething remedy over which the FDA was so concerned contained so little of the active ingredient scopolamine (from the Belladonna plant) that it would have been impossible for the remedy to cause the toxic reactions reported.
The results of the FDA’s own testing showed that the highest amount of scopolamine in the teething remedies it tested was only 0.00039 milligrams (mg) of scopolamine. This is like taking a drop of water (50 mg) and dividing it into 128 thousand equal parts. One of those parts (or about 1 /1000 of 1 percent) is the amount of scopolamine the FDA claims it is concerned about.
For comparison, the FDA has already approved scopolamine as safe and effective for treating motion sickness. The dose is 0.4 mg. That dose is 1,025 times higher than the amount found in the teething tablets.
A parent would have to administer seven entire bottles of teething tablets to a baby in a short space of time just to reach the dose which the FDA already considers safe and effective for the treatment of motion sickness. This is merely a therapeutic level, not a toxic level.2
That’s not to say there aren’t mislabeled products needing regulation, but the FDA already has the power to deal with them:
At our meeting last week, several safety issues were referenced relating to homeopathic products. After reviewing the cases you referenced, we do not see a single instance where a truly homeopathic product was factually cited as causing a problem.
We did see examples of products that may have caused a problem because they were mislabeled as homeopathic but they are not.
We believe all of the examples cited are already correctable by enforcement of the law under the current guidance (CPG 400.400) and do not justify the changes proposed. Furthermore, it is our position that the removal of CPG 400.400 would result in far greater confusion surrounding homeopathy and would be detrimental not only to homeopathy but also to public health and safety, as the draft guidance is less comprehensive than the CPG 400.400.3
Regulations That Worked for Years
It’s important to know that homeopathy and its remedies have been lawfully regulated for years, going back to the Food, Drug, and Cosmetic Act of 1938. The FDA’s own “Compliance Policy Guide (CPG) Sec. 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed” provides regulatory safeguards since 1988.
The FDA’s latest actions, if allowed, will remove their own policy guide and require homeopathic remedies to be classified as “new drugs,” as mentioned previously, effectively making all remedies illegal and forcing them to be removed from the U.S. market.
It’s Time to ACT
If you haven’t responded yet to the FDA, or even if you did before December 30, 2019 when we asked them for an extension, you are asked to respond now.
In fact, every member of your family can respond, as can every individual living anywhere in the world — U.S. citizenship is not a requirement to tell the FDA your thoughts on this citizens petition (<– yes, that’s a link to zip right to the place to make your comment, awaiting only your click).
Americans for Homeopathy Choice have a very well-worded response on the other side of that click and you have a choice to use that or craft your own. This can literally take all of 2-3 minutes to make your voice heard. What’s more, you’ll see a check box to also alert your U.S. Congress peeps and Senators, as well as the President and Vice President of the U.S.!
That’s a few minutes well spent, to save a system of natural medicine that’s been helping patients of all species for over 200 years.
Let us know in the comments when you’ve sent in your response and bonus points if you excerpt any responses you get that show a lack of understanding by those who govern you. We’ve got work to do when our governing people can vote homeopathy out of existence.