Re: (Fwd) Re: guidelines/ethics
Enigl@aol.com
Tue, 31 Dec 1996 20:01:13 -0500
In a message dated 96-12-30 19:54:04 EST, you (lcrocker@calweb.com (Lee
Daniel Crocker) wrote:
<< I am amazed that some seemingly rational minds are even persuaded by
something as thoroughly disproven as colloidial silver. >>
Colloidal silver is bacteriostatic in relatively low concentration and is
widely used for the treatment of disease of mucous membranes and eyes, ref.
_Nurses Drug Guide 1995_ by Wilson, Shannon and Strang. Argyrol S.S.
colloidal silver is an FDA NDA approved drug.
I think what you may be objecting to is the claims that it can be efficacious
for prophylaxis of upper respiratory diseases e.g., rhinoviruses such as the
common cold virus. What studies are you speaking of? . . . disprove it for
what? Can you give an example? What I would like to know is what is it
disproven _for_? i.e. What medical end point and in what clinical trial?
<< If it really
worked--if one single responsible peer-reviewed study proved that it
did something useful-->>
That's not 100% true. It _is_ used as a topical antiinfective and is active
against gram negative and gram positive bacteria. It is used for
preoperative eye surgery and mild inflammatory conditions. It is also use to
cover burns to reduce the probability of infection. This is well
established.
For instance, colloidal silver passes the FDA required USP 23 <51>
antimicrobial efficacy test for _Staphylococcus_ aureus_,
_Pseudomonas_aeruginosa_, _Escherichia_coli_, _Candida_albicans_, and
_Aspergillus_niger_.
In general silver compounds are widely used as antiinfectives. There are two
types of silvers: soluble silver salts (highly ionized) and colloidal silvers
(very low ionization).
<<it would be all over every paper in the nation,
and any doctor would be crazy not to take advantage of it. HMOs would
dump the expensive stuff from their formularies in a minute if it was
cheaper and as effective.>>
After the validation studies to get ANDA or NDA FDA approval, it may NOT be
less expensive.
<< But the plain facts are that it's a fraud.>>
Be careful here. A lot of things that _work_ may not be _proven_ because
companies can't invest the money to get NDA FDA approval. Colloidal silver
is probably not patentable as such, so the incentive is less for NDA approval
at this point in time. This may change because of an increase in antibiotic
drug resistance.
Still, the colloidal silver (trade named): Argyrol S.S _is_ an NDA FDA
approved drug. The FDA does _not_ think Argyrol S.S. is a fraud.
It's an over statement to say colloidal silver is good for absolutely nothing
or that it is a total fraud.
Probably what you (and I) object to are the claims that "by mouth"
_prophylactic_ use is efficacious. _Topical_ prophylaxis has been NDA FDA
approved.
BTW, conventional doctors use colloidal silver instead of the more common
silver nitrate (was used to kill gonococcus in eyes of babies
prophylactically), silver lactate, silver picrate and silver sulfadiazine
because colloidal silver is not as irritating to human tissues.
<<Spare me the personal story, I'm not interested. Show me proof. >>
Look up the NDA for Argyrol S.S. Also, look in _The Pharmaceutical Basis for
Therapeutics by Goodman and Gilman (send me your snail mail address and I
will send the pages 956, the systemic effects of silver and pages 1039-1041
the local medical uses of silver, to you).
Colloidal silver _was_ USP official also, but since the advent of
antibiotics, has fallen out of favor. That's why so many of the references
are old. But, that doesn't invalidate them simply because they are old.
With more and more antibiotic resistance organisms, I expect someone to pay
the money and try to validate to FDA's NDA satisfaction for some defined
clinical end point, probably some disease of the eyes, ears, nose, throat,
stomach or mucous membranes.
Prophylactic use may be more harmful than good and has not been proven to be
effective for say, the common cold. Argyria is caused by the indescriminant
use of silver.
Davin C. Enigl, MS-MEAS
President-Microbiologist
Hazard Analysis and Critical Control Point Validations
for the Food, Cosmetic and Pharmaceutical Industry
HACCP Validations (sm)
enigl@aol.com
http://members.aol.com/enigl/index.html
December 31, 1996
4:14 pm