Medical journals are replete with reports of remarkable results obtained with the most varied forms of treatment instituted at the time that the “influenza epidemic” had been reached. In these cases it is more than probable that the lessened virulence of the causative factor of the disease, the gradually established resistance of those stricken with it in the latter period and the improved management resulting from experience deserve the credit for the successful outcome of the treatment, rather than the particular form of medication employed.
The report of the Tonopah Mines Hospital Association directly implies that Syrup Leptinol prevents the development of pneumonia in practically all cases of influenza in which it would develop and that it entirely abolishes the mortality of that disease. However, it is well known that innumerable remedies have been recommended as specifics in the treatment of pneumonia on the basis of the treatment of a limited number of cases which recovered, and that eventually these asserted specifics have been discarded as of little value. In the present instance, the recovery of twenty-two cases in succession afford prima facie evidence that those cases were not the virulent type of pneumonia in which the death rate is very high under any methods of treatment. While no effort appears to have been made to determine the nature of the infecting organism, the records show fairly conclusively that they belonged to those causing the milder type of pneumonia.
The Council finds Syrup Leptinol (formerly Syrup Balsamea) inadmissible to New and Nonofficial Remedies because: (1) the information in regard to composition does not state the amount of potent ingredient, nor permit the determination of its identity and uniformity; (2) the recommendation for its use in such infectious diseases as pneumonia and epidemic influenza is unwarranted and its claimed therapeutic efficacy in other diseases is without satisfactory supporting evidence; and (3) the recommendations for its use which appear on the label and the circular wrapped with the trade package constitute an indirect advertisement to the public.
The Council accepts the explanation of the manufacturer that he has been unable to obtain a satisfactory classification of the plant from which Syrup Leptinol is made. It would be undesirable to exclude from therapeutic use a valuable drug simply because its botanical character has not been determined or because an exhaustive chemical examination had so far not been made. However, in the absence of such information the manufacturer should give full information with regard to the preparation or standardization of his remedy and the therapeutic claims made for it should be accompanied by indisputable, thoroughly controlled clinical evidence. In the case of Syrup Leptinol, there is no satisfactory evidence available showing that the preparation has any value in the treatment of epidemic influenza, pneumonia, whooping cough, etc. While it is probable that a balsamic syrup, such as Syrup Leptinol, has palliative properties in coughs, such action does not at all justify the claim that it is useful in the contagious diseases for which it is proposed. The Council cannot recognize a syrup presenting an unknown plant in uncertain proportions which is recommended in a variety of dangerous contagious diseases in which it ultimately may be harmful, even though in early stages of these diseases it may serve to allay some of the milder symptoms.
Concerning the composition of the plant from which Syrup Leptinol is prepared, the Balsamea Company states that it contains “Alkaloids, acids, glucosides, volatile and fixed oils, gums and resins.” This information is valueless, since no information is given concerning the character, amounts or pharmacologic action of the ingredients. Further, it is unreliable as far as the presence of alkaloids is concerned since the A. M. A. Chemical Laboratory has been unable to find any alkaloids in the specimen of the crude drug furnished by the manufacturers.
In accordance with its regular procedure, the Council submitted the preceding statement to the manufacturer.
In reply the Balsamea Company stated that it is more than ever of the belief that Syrup Leptinol is deserving of recognition by the Council, basing this opinion on further clinical experience with it in the treatment of influenza.
The manufacturer stated that the use of the words “Leptinol” and “Syrup Leptinol” interchangeably was due to an oversight and promised to limit the use of the word “Leptinol” to an alcoholic extract of the plant.