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Homeopathy in the USA - Under Fire


Resurrection? Or extinction? It's up to us.

homeopathyOn 03-19-15 the FDA published an advisory about homeopathic asthma OTC medications, recommending that patients be wary, and that health care practitioners be sure to report any adverse effects to the FDA.

 Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program."
 FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.

The FDA has also now scheduled public hearings on the safely and efficacy of homeopathic medications, on extraordinarily short notice: Here is the link – The actual document was not published until 03-27-15, and the date of the hearings is April 20 and 21, 2015, from 9 a.m. to 4 p.m. That is three weeks from the time of publication of the notice.

 Here, I think, is the real issue - with regards to FDA regulation of homeopathic "drugs". We always need to look at who benefits - cui bono. "The CPG noted that, at the time of original publication in 1988, the homeopathic drug market was a multimillion dollar industry in the United States. In 2007, the National Health Interview Survey, conducted by the Centers for Disease Control and Prevention's National Center for Health Statistics, estimated that adults spent about $2.9 billion on the purchase of homeopathic medicine. Today the homeopathic drug market has grown to become a multimillion dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products.”

On 03-26-15 it became clear that the FDA is moving rapidly in the direction of regulation of homeopathic remedies as drugs.

 "Negative health effects from drug products labeled as homeopathic have been reported through the FDA's Adverse Event Reporting System and the National Poison Data System (NPDS), which is maintained by the American Association of Poison Control Centers and tracks human poison exposure cases."
 "The 2012 American Association of Poison Control Center Annual Report indicated that there were 10,311 reported poison exposure cases related to "Homeopathic Agents," with 8,788 of those reported cases attributed to children 5
years of age and younger (Ref. 3). Of the 10,311 reported cases, 697 required treatment in a health care facility (Id.)."

homeopathy[In fact, Homeopathics are placed in a category called "Dietary supplement, herbal, and homeopathic". They are not tracked in their own category. Analysis of the 8,788 reported cases of pediatric adverse events related to herbal remedies and supplements, not to homeopathics. And one of the adult adverse events was related to a suspicion of yohimbine which turned out not to be present in the patient's body before his death, by blood analysis. This would NEVER be accepted in a court of law, nor should it be accepted in the scientific world, if we think that the scientific world is honest. None of the published events specified any homeopathic remedy.

So... is this just a blip on the radar? Or are we really planning to eliminate homeopathic remedies?

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.

We urge you to be aware of this controversy, to make public comment on the FDA website, or to show up in Washington.

Comments will be accepted through June 22, as best I can read from the verbiage.

We urge all those who are unable to attend the hearings in Washington to inform themselves of the agenda, and to spread the word as widely as possible.