Homeopathy in the USA
Update: report from the hearing
The National Center for Homeopathy reports:
“The consistent message reinforced across these groups was that current FDA regulations of homeopathic remedies are sufficient and have served the public well for the last 25 years.
FDA panelists had the opportunity to ask follow-up or clarifying questions after each presentation. The questions showed a significant interest in homeopathic medicines and indicated that panelists were listening carefully to the speakers’ presentations and that they wanted to accurately understand the viewpoints and research that were presented in each.”
Please send your support
“to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic.”
Dr. Martha Grout summarizes the situation:
“On 03-26-15 we learned that the Federal Drug Administration – FDA – is beginning to (a) take homeopathy seriously and (b) taking steps to regulate it more closely. On March 19th a document was published raising questions about the safety of over-the-counter homeopathic remedies for asthma.
For the last 25 years, the FDA has had a relatively benign policy toward homeopathy, basically “hands-off” with the understanding that those remedies already in common use would be grandfathered in to common use, both medically and over-the-counter. No mention was made of the newer combination remedies.
On March 26th, 2015 it became clear that the FDA is moving rapidly in the direction of regulation of homeopathic remedies as drugs.”
“The FDA has published two documents recently, which clearly demonstrate how it is possible to “spin” a statement to take advantage of unconscious assumptions which may not be applicable in any given situation.”
“So… is this just a blip on the radar? Or are we really planning to eliminate homeopathic remedies?
Why suddenly try to fix a system that has worked very well for the past hundred years? The system is NOT broken, homeopathic remedies have NEVER resulted in death because of the remedy (unlike pharmaceutical drugs) and millions of people use them to good effect.
Homeopathic remedies are not appropriate for every circumstance. Neither are pharmaceutical drugs. Neither is surgery, or radiation, or acupuncture, or chelation therapy, or Ayurvedic medicine. Each has its place in the armamentarium of the practitioners of healing arts.
Homeopathic remedies are NOT pharmaceutical drugs, and should not be treated like drugs.
Should they be subject to rules and standards of Good Manufacturing Practices? Of course. They need to contain what they say they contain, without any unlisted additives, and be manufactured in a clean facility.
Proof of efficacy? In the field of homeopathy, the remedies are used for multiple symptoms, depending on the individual patient. Someone with headache might be prescribed any one of 40 or 50 remedies, depending on the constellation of symptoms with which they present. It’s a very different way of prescribing, using remedies which are so dilute that they may contain at the most one part per trillion of substance. The rest of the remedy is simply an energetic signature in water. Some call it “expensive water”. Those who have been helped by it may call it a miracle.
If this “expensive water” is able to create an effect in the brain which leads to improvement in the health of the organism, and if this “expensive water” is NOT a drug, why then are we trying to regulate it like a drug? It’s like trying to apply the rules for manufacture of an automobile to the growth of a field of tomatoes. Somehow there is a logical step missing.”
Read her whole article here.
My Puzzling Experience
On January 31, I ordered blank homeopathic pellets from the FDA-registered facility Rx Homeo, Inc. I had done this before, and was delighted when that previous shipment arrived within a week.
After a few weeks, I checked the tracking of the package of my January order, and found that it was in customs. It continued to be in customs for a while.
Then I received a letter from the FDA stating that the package of blank pellets had been detained because they had determined that
“the article appears to be a new drug without a new drug application.” FD&CA Section 505(a), 801(a)(3); UNAPPROVED NEW DRUG
Cane sugar pellets which were HPUS manufactured, and not medicated! Sugar pellets!
I notified the supplier of the situation, and after attempting to rectify it, instead sent me a new shipment. It came through on March 13! Thank you!
The shipment in question was returned to the supplier since they could not provide a new drug application. (for sugar)
Is this a sign of things to come?
A request from Dr. Bruce Shelton:
“As you may be reading the FDA has decided to hold public hearings in late April on how Homeopathic remedies are produced and labeled.
This COULD reverse a 75 year history that has helped make homeopathy as respected and popular as it has become.
Slight changes in regulations demanding hard science could create an environment where manufacturers won’t be able to supply even the simplest of homeopathics for our patients.
Folks THIS IS THE REAL DEAL. We need to act and act now.
It was decided on a group phone call on Saturday that I should make a presentation tied to my own experience as a physician patient.
Here I was 30 years ago, a graduate MD of NY medical college Board Certified in Family Medicine coming down with pneumonia that after antibiotic healing a week later became a florid case of life threatening asthma that in the matter of a month made me a pulmonary cripple.
I was placed on
- Aminophylline
- Ventolin inhalers
- Steroid inhalers
- Oral steroids
- Other blockers of all types
ALL TO NO AVAIL. I couldn’t breathe while lying down or with the slightest exertion.
I was headed for a horrible end when Homeopathy intervened under the direction of several very bright homeopaths.
Within 20 minutes of these little drops of “water” placed under my tongue my nightmare ended. It was such a life changing experience that I went back to school to learn what I know today and my second career began.
I have graduate degrees in homeopathy, have been medical director for two major homeopathic companies – Heel and Desbio and am now the past president of AHIMA and current head of the Arizona Homeopathic licensing Board.
Homeopathy filled a huge hole in the Allopathic paradigm that would have let me die. Not only did this work for me, but it has worked for thousands of patients that I’ve treated in my medical practice in Phoenix and for patients treated by other doctors I’ve helped train.
I’m requesting that each person reading this document tell their own story in a one page document that I can put in a book to bring with me to the Washington hearing.
Homeopathy hasn’t put all of the scientific pieces of the puzzle together as of yet but that is coming, and some day will earn the Nobel prize for someone who finally figures it out.
BUT IN THE MEANTIME I NEED YOUR STORIES
Please simply write me an email and we will see that it is typed properly for presentation.
I’m also sending this to my patients and asking you to do the same.
Please respect HIPAA rules and just ask for the story without privacy breaking identifiers.
The future of homeopathy is on the line.
PLEASE HELP!”
Warmly
Dr Bruce H Shelton MD, MD (H), DiHom, FBIH
shelton@drbruceshelton.com
