Docket # 98N-0182
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
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
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.
Victim of Greed Passed Off As Science
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.
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.
In a 1995 misc.health.alternative email to Nancy McNabb, Steve Harris, M.D., said this about Argyrol: "There used to be a silver-containing tonic called Argyrol. People who drank it for years eventually developed silver crystals under their skin, of just the right size to absorb yellow light and give them a lovely purple-colored hide. Permanently. I once saw an Argyrol victim in 1984, and she was still a delicate violet color, decades after the fact. I wonder how your product compares."
Note: A very nice description of how Argyrol "gets under your skin" don't you think. However, it appears that Dr. Harris continues to argue the case against the use of ionic colloidal silver by referencing the effects that Argyrol -- a compound-containing silver -- had on a relatively few users of that product. Many thousands were treated with Argyrol, primarily as nose drops. In fact, Dr. Barnes, the developer of Argyrol amassed a fortune and created a foundation from the profits derived from Argyrol. I would like to see clinical evidence produced by Dr. Harris, or anyone else, that specifically proves argyria is caused by the use of silver ions suspended in pure water.