Resurrection? Or extinction? It's up to us.
On 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
https://www.federalregister.gov/.../homeopathic-products-eval... 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
"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.)."
[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 are NOT pharmaceutical drugs, and should not be treated
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.