IODEOL AND IODAGOL
Report of the Council on Pharmacy and Chemistry
Iodeol and Iodagol (formerly called Iodargol) are products of Viel and Company, Rennes, France, widely advertised in this country by David B. Levy, Incorporated, New York. The claim made for both preparations is that they depend on “colloidal iodin” for their action. They are put up in a number of forms, for instance:
“Iodeol Ampoules each containing 1 c.c. (20 centigrammes colloidal iodin in an oily vehicle).”
“Iodeol External, containing 50 per cent. colloidal iodine.”
“Iodagol Ampoules, each containing 2 c.c. (50 centigrammes colloidal iodine in an oily vehicle).”
The claim is, that, the iodin being in the colloidal state, it has the properties of elementary iodin and thus the preparations may be used in concentrations and under conditions which would make the use of free iodin impossible. The products have been extensively and extravagantly advertised for use in a wide range of conditions. Thus Iodeol has been proposed in the treatment of:
“Pulmonary Tuberculosis”
“Laryngeal Tuberculosis,”
“Glandular Tuberculosis”
“Tuberculosis of the Bones”
“Pneumonia, Broncho-pneumonia, and Congestive Conditions”
“Whooping Cough, Influenza, Asthma”
“Typhoid Fever”
“Syphilis”
“Obesity.”
Iodagol, which is for external use, has been advised in the treatment of:
“Gonorrhea and its Sequelæ”
“Cystitis”
“Tetanus”
“Wounds complicated by gaseous gangrene”
“Burns”
“Old Suppurations, ulcers, abscesses, etc.”
“Articular rheumatism”
“Abscess Alveolar”
“Pyorrhea Alveolaris”
“Stomatitis (Canker-Sores).”
Nearly two years ago the American agents requested the Council to consider Iodeol and Iodagol for admission to New and Nonofficial Remedies. The information submitted in regard to their character and composition was vague and indefinite, the pharmacologic information practically nil and the clinical data as voluminous as it was unconvincing.
On the basis of chemical, pharmacologic, bacteriologic and clinical investigation carried out under the direction of the referee and a study of the submitted evidence, the referee reported:
1. Iodeol and Iodagol do not contain the amount of iodin claimed.
2. The iodin is not present as elementary iodin, but instead the preparations behave similarly to the well-known organic iodin compounds such as iodized fats.
3. The therapeutic claims made for the preparations are exaggerated and unwarranted.
In view of his findings he recommended that Iodeol and Iodagol be declared inadmissible to New and Nonofficial Remedies for conflict with Rules 1 and 2 (misleading statements regarding composition and identification) and Rule 6 (unwarranted therapeutic claims). The Council adopted the recommendation of the referee, directing inclusion of the full report in the annual Council reports after submission to the manufacturer, and recommending publication of an abstract of this report in The Journal.
This report was brought to the attention of the American agent, David B. Levy, Inc., and through them to the French manufacturers, E. Viel and Company. The manufacturers have intimated that they will not file a reply to the report. The firm of David B. Levy, Inc., has decided to sever its connection with these products and to discontinue their sale.
W. A. Puckner, Secretary.
Summary of Referee’s Report
Iodeol and Iodagol were submitted to the Council nearly two years ago as “electro-colloidal iodine” and with the claim that they produced all the antiseptic and other effects of ordinary iodin without any of its side actions. The referee has done much work on the subject, conducted a large amount of correspondence and has contended with long delays. He feels that the consideration of these products should be brought to a conclusion and accordingly he submits this report of their consideration. The following is a summary of the report, which is appended:
I. Discrepancy in Iodin Percentage.—The examination at the Chemical Laboratory of the American Medical Association, as well as that of the referee, shows that the various samples of Iodeol and Iodagol examined contained a little less than one-half of the total iodin claimed. These facts were reported to the American agent. After a lengthy delay a reply was received which presented a double excuse: (1) that the full amount of iodin had been added, whatever had become of it later; (2) that the claims were made for “colloidal iodin” and that this is not elementary iodin in the colloidal state, but a preparation of iodin containing only 50 per cent. of real iodin. Neither explanation can be taken seriously, as they are obvious quibblings. The referee concludes that the preparations are falsely labeled as to iodin content.
II. Nature of the Iodin Compound in Iodeol and Iodagol.—In the information sent the Council, Iodeol and Iodagol were defined as “A suspension of electro-chemical colloidal iodin in a vehicle of purified oil.” Numerous inquiries have failed to elicit more specific information from the manufacturer or his agent. The statement of composition can mean only that the preparations contain free iodin (but in colloidal form) suspended in oil. No evidence to substantiate this claim has been submitted. (There is evidence that the preparations contain colloidal particles, but it does not indicate if this colloidal material is iodin, or a combination of iodin or indeed whether the colloidal component contains any iodin.) The recent statements of the agent seem to concede that what they call “electro-colloidal iodin” contains only about 50 per cent. of real iodin, in other words that it is not “colloidal iodin” at all, but a mixture or combination of iodin with some other unnamed substance. This, of course, is something very different.
Certain results reported from the American Medical Association’s Chemical Laboratory suggest that the so-called “colloidal iodin” of Iodeol may be a combination of iodin with a volatile oil. The investigations of the referee indicate that the iodin exists in a rather resistant form or combination behaving altogether differently from ordinary free iodin, and rather resembling the behavior of iodin substitution products, such as iodized fats or phenols. Briefly then the recent admissions of the agents indicate that Iodeol does not contain “colloidal iodin” in a chemical sense, and there are indications that it does contain its iodin in a rather firm (chemical) combination.
III. Chemical Properties of Iodeol.—From a study of different specimens of Iodeol, the referee concludes that fresh specimens contain no free iodin and that old ones contain small amounts as a result of decomposition. Iodeol has the solubility characteristics of fats and fat-like compounds. The examination, as a whole, shows that Iodeol contains a peculiar and rather resistant form or combination of iodin. There is nothing in the chemical data that suggests that it could act differently from ordinary iodin compounds, such as iodized fats. It would not act as ordinary iodin.
IV. Pharmacologic Data.—The pharmacologic statements which were submitted were loose and apparently meaningless or misleading. In reply to questions submitted by the referee, the manufacturer finally had some work done and submitted a report by Jean Laumonnier. The referee was unable to confirm some of this work, and as a whole it does not appear materially to elucidate the action of Iodeol. From a consideration of the submitted evidence, and as a result of his own work, the referee concludes that Iodeol does not behave like elementary iodin; it does not coagulate proteins and therefore is not irritant. It is presumably absorbed, but quite probably after chemical change; it is changed into iodid and, like organic iodids, is excreted somewhat more slowly than when inorganic iodids are administered, but the difference does not appear important.
V. Antiseptic and Bactericidal Action.—Elementary iodin is considered a fairly powerful agent in these respects. The activity is presumably due to changes in the proteins, etc., of the bacteria, analogous to the effects which produce pain, irritation and necrosis of the tissue cells. Since the latter effect is not produced by Iodeol, it seems highly improbable, if not impossible, that it should act on bacteria like elementary iodin. It is entirely unjustifiable to credit the known antibacterial qualities of ordinary iodin to “colloid” iodin. This misrepresentation is especially prominent in the circular “Notable New Therapeutic Agents,” as will be seen, for instance, from the following citations:
“Iodine has long been universally recognized as an antiseptic of extraordinary potency. Not only is it rapid and certain in its germ-destroying action, but it also possesses an attribute denied many other antiseptic agents, namely, the power to penetrate and impregnate the tissues. Other antiseptics, as is well known, act on the surface epithelium only.”
“According to Kinnaman (J. A. M. A., Aug. 26, 1905), iodine is far superior to bichloride of mercury, a two per cent. solution killing streptococcus pyogenes in two minutes. Iodine does not coagulate albumin, and is very penetrating.”
The citations imply that this “colloidal iodin” of Iodeol and Iodagol acts as an antiseptic like ordinary iodin, except that it is claimed to be more efficient by “diffusing” more readily. This is entirely unjustified and misleading. If Iodeol and Iodagol are really antiseptic, they must act by some other mechanism than that through which elementary iodin acts, and such antiseptic action would have to be demonstrated by direct observation and not assumed from the known action of free iodin.
Antiseptic and bactericidal effects are easily estimated by laboratory methods. Yet no evidence on this point appeared to have been available until the Council called for this. Laumonnier then carried out some experiments which were in turn submitted to bacteriologic control. The bacteriologist failed to obtain any results with some of the tests, and considered the other data of little value.
The claim that Iodeol and Iodagol have the antiseptic and bactericidal action of free iodin lacks proof and must be considered unwarranted and misleading in the extreme.
VI. Clinical Trials.—The manufacturers and agents of Iodeol presented many letters from physicians; but few, if any, of these gave evidence of careful, critical, controlled observations. They could not, therefore, be considered as acceptable evidence. The more important claims, letters and published papers, however, were submitted to clinical specialists collaborating with the Council, with the request that they examine these and conduct some clinical trials, if they considered it advisable. The results obtained in these preliminary trials did not appear sufficient to warrant further experimentation.
From a consideration of the evidence presented, the referee concludes that the claims made for Iodeol and Iodagol are unwarranted, exaggerated and misleading. He recommends that Iodeol and Iodagol be declared ineligible for New and Nonofficial Remedies for conflict with Rules 1 and 2 (misleading statements as to composition and identification) and with Rule 6 (unwarranted and misleading therapeutic claims). He further recommends that the Council authorize publication of the preceding summary of the consideration of Iodeol and Iodagol in The Journal and inclusion of the full report in the annual Council reports after submission to the manufacturer.—(From The Journal A. M. A., Nov. 17, 1917.)