What follows is written testimony that I submitted to an
FDA advisory committee considering adding MSP to the list
of bulk drugs that pharmacists are allowed to compound.
Docket # 98N-0182
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
rm. 1061
Rockville, MD 20852
March 8, 1999
Subject: Mild Silver Protein (MSP)
While MSP is well characterized chemically and has
a long history of medicinal use, there is also a whole
body of evidence indicating that it was neither safe
nor effective in any of its historical uses, including
as a treatment for conjunctivitis or as a means of sterilizing
the eye before surgery.
The best known brand of MSP, Argyrol, was marketed
in the US at least until 19961 .
It had been developed and introduced to commerce by Dr.
Alfred C. Barnes around 19022. Many silver drugs were fraudulently advertised for
decades3. Argyrol
in particular has been singled out as one of the most
fraudulently advertised4,5. The ingestion of silver causes argyria,
gray skin6. Look
at my photos. I have argyria which I developed about
40 years ago from taking nose drops that contained silver
that a doctor in N.Y. prescribed for me. I am not certain,
but I believe that the pharmacist compounded the drops
since the only label that they ever had was one that
he typed out and pasted on. It never showed a brand name.
We always referred to them as "the drops".
Every form of silver used therapeutically has caused
argyria7. Many cases were caused by Argyrol8 although
that never stopped the company from advertising it as "nontoxic"9.
It is well known that MSP put in the eye caused many
cases of argyrosis10, the deposition
of silver salts in the conjunctiva, lacrimal sac and
cornea. Referring to argyrosis, Hill and Pillsbury state
that, "...in severe cases
the degree of cosmetic disfigurement may be marked. The
color varies from light bluish-gray to a brownish-black."11
There is one case report in the literature that is
unusual because just one use of Argyrol drops (1% solution
MSP) resulted in argyrosis12.
In 1928 the Council on Pharmacy
and Chemistry refused to readmit Argyrol onto the list
of New and Nonofficial Remedies. The principle reason
given was the fraudulent adds the company persisted in
making. The Council stated that, "Notwithstanding the clinical popularity of
Argyrol, its antiseptic efficiency has been seriously
questioned. Bacterial culture tests have given variable
results, and in the clinical results it has been impossible
to distinguish definitely whether improvement is due
to the antiseptic or merely to the protective action." Contrary
to the manufacturer's claims ophthalmologists did not
find that a 25% solution of Argyrol prevented ophthalmia
neonatorium although many thought it useful in the treatment
of established ophthalmia.13
In 1983 an article reported a study in which the effectiveness
of MSP as a chemical preparation of the eye before surgery
was studied. Thirty-two patients had one eye treated
with it. Bacteriologic analysis found that MSP was ineffective
in reducing the number of species and colonies of bacteria
found in the eye. It was reported that many surgeons
used it merely because it acted as a stain enabling them
to see debris and mucus that had not been already washed
out. When this happened, the eye was irrigated again.
The authors pointed out that that had to be weighted
against the finding that irrigation itself caused an
increase in the bacterial flora of the conjunctiva.14
Summary:
Based on the evidence that MSP has been shown to be
unsafe and ineffective as an ophthalmologic drug and
on the potential of its being abused and used to treat
systemic illnesses for which it is equally ineffective
and far more dangerous, I request that it not be added
to the list of bulk drugs.
Rosemary Jacobs,
Private Citizen
Victim of Greed Passed Off As Science
http://homepages.together.net/~rjstan/
1. Fung, MC, Bowen, DL
Silver Products for Medical Indications: Risk-Benefit
Assessment CLINICAL TOXICOLOGY, 34(1), 119-26 (1996).
2. Schack, W. ART AND
ARGYROL THE LIFE AND CAREER OF DR. ALBERT C. BARNES
Sagamore Press, Inc. NY, 1960 p.51.
3. http://homepages.together.net/~rjstan/
4. Puckner, WA Council
on Pharmacy and Chemistry JAMA March 17, 1928 p.849-51.
5. Gaul, LE, Staud, AH
Clinical spectroscopy JAMA April 20, 1935 p.1387-90.
6. Mack, RB Return with
Us Now to Those Thrilling Days of Yesteryear Argyrol
and Argyria NCMJ Sept. 1988, Vol 49 #9 p. 451-2.
7. Hill, WR, Pillsbury,
DM ARGYRIA THE PHARMACOLOGY OF SILVER The Williams & Wilkins
Company 1939 p. 130.
8. Hill & Pillsbury
p.28.
9. THE EYE, EAR,
NOSE & THROAT
MONTHLY Vol. XXXI #1 Jan. 1952 p. 24.
10. Hill & Pillsbury
p. 112-5.
11. Hill & Pillsbury
p. 116.
12. Karcioglu, ZA,,
Caldwell, DR Corneal argyrosis: histologic, ultrastructural
and microanalytic study CAN J OPHTHALMOL vol. 29 #7
1985 p. 257-60.
13. Puckner, WA Council
on Pharmacy and Chemistry JAMA March 17, 1928 p.849-51.
14. Isenberg, S, et..
al. Chemical Preparation of the Eye in Ophthalmic Surgery
ARCH OPHTHALMOL Vol. 101, May 1983.