The request for information regarding the animal experiments said to have determined the toxicity was ignored, nor were references supplied to clinical reports demonstrating the value of the product.
The Council declared Tri-Arsenole inadmissible to New and Nonofficial Remedies because of conflict with the rules as follows:
In the absence of details of the method used, the claim that the preparation has been tested biologically is in conflict with Rule 2, which requires that for preparations claimed to be physiologically standardized the method of testing must be published so as to permit of control by independent investigators.
The claims that “Merco-Arseno-Benzo-Chloride” is “the result of many years research,” that its “toxicity has been fully tested upon animals before using clinically” and that clinical use has “proven such complete success” have not been substantiated by evidence and must be held as unwarranted.
The name is in conflict with Rule 8, which requires that pharmaceutical mixtures shall bear names descriptive of their composition. Further, the name “Tri-Arsenole” by its similarity to Diarsenol, the Canadian brand of arseno-phenolamin hydrochlorid, suggests that this pharmaceutical mixture is a chemical compound similar to salvarsan. Moreover, the danger of confusion is increased by the addition of the hydrastis preparation which imparts a yellow color like that of salvarsan to the solution obtained when the colorless mercury and arsenic compounds of the mixture are dissolved. Again, the synonym “Merco-Arseno-Benzo-Chloride” conveys the false impression that Tri-Arsenole is a definite chemical compound.
The label does not declare the poisonous constituents claimed to be contained in the mixture; namely, “arsenous acid” and corrosive mercuric chlorid (Rule 7).
There is no evidence that arsenous acid (arsenic trioxid) used intravenously is efficient and safe as a spirocheticide, and the administration of this drug in conjunction with mercuric chlorid in fixed proportion is irrational and dangerous—particularly so because of the implied similarity of Tri-Arsenole to arsenphenolamin hydrochlorid (Salvarsan, Diarsenol) (Rule 10).
L. O. Compound No. 1 and L. O. Compound No. 2.—In submitting these preparations to the Council, the Medical Supply Company stated that “No. 1” was “composed of the following ingredients; chloral, camphor, menthol, iodin, and oil of gaultheria, incorporated in a fatty base. Each ounce contains fifteen grains of chloral hydrate, nine grains of resublimed iodine.” “No. 2” was said to have the same composition as “No. 1” except that the oil of gaultheria had been omitted. The Medical Supply Company was informed that the rules of the Council required declaration of the amounts of each therapeutic constituent of pharmaceutical mixtures and that, therefore, in addition to the information furnished the amounts of camphor, menthol and oil of gaultheria should be given for “No. 1” and the amount of camphor and menthol for “No. 2.” The following reply was received:
| “L. O. Compound No. 1 equals to each Tube, | |
Chloral hydrate | gr. 15 |
Camphor | gr. 22 |
Menthol | gr. 71⁄2 |
Iodin (resublime) | gr. 32⁄3 |
Oil of gaultheria | m. 3 |
Petrolatum, q. s. | oz. 1 |
| L. O. Compound No. 2, |