Chapter X: Part I: Council Reports (5)

2. No matter which published formula be accepted as correct, it is at best a weak antiseptic. The antiseptic ingredients present cannot act as germicides in the strength in which they are used, or in the alkaline solution on the unique virtues of which the circular lays so much stress (“the one antiseptic solution based on the alkalinity and saline strength of normal blood”). As shown by Verhoeff and Ellis,[52] undiluted Glyco-Thymoline does not kill _Staphylococcus aureus_ in four hours. It evidently, they say, “could have but little if any greater therapeutic value than sterile salt solution.”

[52] Verhoeff, F. H., and Ellis, Edward Keith: The Bactericidal Values of Some Widely Advertised Antiseptics, The Journal A. M. A., June 29, 1907, p. 2175.

DANGEROUS RECOMMENDATIONS

_In Diphtheria_: “Case-reports” in the advertising pamphlet describe the treatment of diphtheria with Glyco-Thymoline. It is surely unnecessary to point out that, whatever the possible merits of Glyco-Thymoline or its ingredients, they are utterly irrelevant here. But let a “case-report” be quoted:

“............., M.D., states: ‘I have many an interesting story of
Glyco-Thymoline. I just finished up a family in which I was
treating five cases of diphtheria--two of which presented
diphtheritic membrane in nasal cavity. I decided not to use
antitoxin in these cases. I used only the regular constitutional
treatment and Glyco-Thymoline as a local antiseptic. I believe
the Glyco-Thymoline worked wonders. My cases are all now in good
health, with no after troubles. I think it an ideal antiseptic for
every trouble in nose and throat.’”

Words of denunciation fall flat before the complacent self-revelation of the physician who “decided not to use antitoxin.” Surely if any other physicians have been misguided by this example, there must be many another “interesting story of Glyco-Thymoline” to tell--not to speak of other families that have been “finished up.”

_In Ophthalmia Neonatorum_: We gain from the same advertising pamphlet the following information on prophylaxis:

“The treatment in the past has consisted of instillation of silver
nitrate, boric acid, salts of mercury, nucleinated salts of silver
and mercury, etc. ..., but these agents have proved to be failures
as an absolute specific.... During the past few months experiments
have demonstrated the efficacy of a new mode of treatment that
is both rapid and thorough, and devoid of danger in its use.
This method consists of thorough irrigation of the eyes in fully
developed cases of the disease with a solution of Glyco-Thymoline.”

At the very best, Glyco-Thymoline is a weak, a very weak antiseptic--not a germicide. To assert, or even to imply, that it is superior to the well-tried and efficacious Credé method of treatment for ophthalmia in the new-born is cruelly wicked.

_In Consumption_: This from the same pamphlet:

“The indifference of phthisical patients toward the maintenance of
sanitary conditions is proverbial.

“That the environment of all such patients should be absolutely
aseptic both for the good of the patient and for the welfare of
those who are brought into contact with them is a well-established
fact.”

It is, instead, an ill-established fiction. To talk about maintaining an “absolutely aseptic” environment under any practical conditions of daily life is to talk nonsense; the thing is impossible, even were it desirable. But, not to be distracted from the main issue by subsidiary falsehoods:

“In Glyco-Thymoline we have an antiseptic which, while mild and
soothing ... is still a powerful agent for promoting asepsis, and
a potent factor in the maintenance of sanitary environment in the
sick room.

“Inhaled from a vaporizer or a fine spray atomizer, it will loosen
the mucus in a marvelous manner and in a wonderfully short time,
shorten the paroxysms of coughing to a marked degree, at the same
time reducing the danger of contagion to a minimum.”

And this is the preparation, it will be remembered--this “powerful agent for promoting asepsis”--which, when applied in undiluted strength, was unable to kill _Staphylococcus aureus_ in four hours!

It would be a waste of space to cite further evidence to show that the advertising of Glyco-Thymoline is in conflict with Rule 6 of the Council, which provides that no article shall be accepted “concerning which the manufacturer or his agents make unwarranted, exaggerated or misleading statements as to the therapeutic value.” It is further in conflict with Rule 4, against indirect advertising by means of the label, package or circular accompanying the package.

CLAIMS TO ORIGINALITY

Hatcher and Wilbert have pointed out that from a therapeutic point of view the composition of Glyco-Thymoline is based on the formula of the widely known “compound solution of sodium borate,” or Dobell’s solution. For the phenol in the original, a mixture of antiseptic acids and volatile oils has been substituted.

SUMMARY

Glyco-Thymoline is in conflict with Rules 1 and 4 of the Council on Pharmacy and Chemistry, because of its indefinite composition and the method of advertising it to the public. It is in conflict with Rules 10, 6 and 8, in that it is an unscientific, shot-gun mixture sold under unwarranted therapeutic claims and under a misleading name. Altogether it must be considered an unscientific heterogeneous mixture, in which a few valuable ingredients are hidden by the useless shrubbery which surrounds them.--(_From The Journal A. M. A., Oct. 10, 1914._)

GLYCOZONE

Report of the Council on Pharmacy and Chemistry, with Comments

A number of specimens of Glycozone purchased in the open market were examined by a subcommittee. The product was found to be a mixture of approximately 90 per cent. glycerin, 5 per cent. glyceric acid, a small amount of water and traces of undetermined matter. The absence of hydrogen peroxid or other peroxids was demonstrated.

In its report the subcommittee held that: (1) The name of the product is objectionable and misleading; (2) the statements made in regard to its composition also are misleading; (3) the claims for its therapeutic value are exaggerated and untrue. Since the objectionable statements have been given wide publicity among physicians as well as among the laity, the subcommittee recommended that attention should be called to the matter in The Journal.

The report of the subcommittee was adopted by the Council.

W. A. Puckner, Secretary.

Comment:--While the name gives the impression that ozone or some similar substance is an essential constituent of Glycozone, or else that the preparation is a compound or derivative of ozone, and while the earlier advertisements stated that Glycozone was “glycerine combined with ozone,” the examination made by the Council shows that there is no basis of fact for such inferences.

In the advertisements the “chemical formula” C_{3}H_{6}O_{4} + C_{3}H_{8}O_{3} appears under the word Glycozone. From the Council’s report it is apparent that C_{3}H_{6}O_{4} stands for glyceric acid and the C_{3}H_{8}O_{3} for glycerin, and that these, therefore, indicate the chief constituents of Glycozone. Few, doubtless, would recognize the first formula as being that of a glyceric acid, a product practically unknown in medicine, nor would many associate glycerin with the second. The evident intent is that physicians should accept the formula as a badge of respectability.

According to the label on a trade package, Glycozone is “prepared only by Charles Marchand, chemist,” and is {“}an absolute cure for dyspepsia, catarrh of the stomach, ulcer of the stomach, heart-burn,” etc. The label further reads: “This remedy is positively harmless. By destroying the microbian element in the stomach it prevents the fermentation of food and stimulates digestion.” An examination of medical literature fails to reveal any basis for these claims. While glycerin possesses some antiseptic properties, it is evident that the glycerin which constitutes 90 per cent. of this remedy is not the agent that gives the glycozone such phenomenal virtues. General literature contains nothing that would indicate that glyceric acid in any quantity, with or without glycerin, possesses these miraculous properties. If by “microbian element” is meant microbic organisms, the statement is without foundation. There is nothing in this product which possesses these bactericidal powers.

The circular which accompanied a trade package envelops the preparation in an air of mystery. Derivation from, or close relation to, ozone and hydrogen peroxid is vaguely hinted at, without definite assertion. Thus, the chief therapeutic properties of glycozone and hydrozone are compared as follows:

“Hydrozone instantly destroys the microbian element, leaving the
tissues beneath in a healthy condition.”

“Glycozone acts more slowly, but not less certain as a stimulant to
healthy granulations.”

There is no similarity between the action of hydrozone, which is a hydrogen peroxid preparation, and glycozone, which consists of a mixture of glycerin and glyceric acid. The representation is false and misleading. The following statement, also, is an unwarranted exaggeration of the facts:

“As an internal medication in fermentation of food, catarrhal and
inflammatory conditions of the stomach, and intestinal disorders,
its action is prompt and effective, giving immediate relief to the
patient.”

The following is another illustration of the vague statements made: After asserting that Glycozone is hygroscopic and that it will deteriorate by absorption of water unless securely corked, it is stated that “Its healing properties increase with age.” Whatever mysterious ingredient there may be present in this mixture to justify the statement that the healing properties increase with age can only be conjectured. To humbug the patient further, the circular advises him to use only a “silver, glass or hard rubber spoon.”--(_From the Journal A. M. A., June 5, 1909._)

GARDNER’S SYRUP OF HYDRIODIC ACID

Report to the Council on Pharmacy and Chemistry

The following report on Gardner’s Syrup of Hydriodic Acid was
submitted to the Council by a subcommittee:

This product was first taken under consideration in February,
1906. Reference to several committees was necessary, on account
of the peculiar claims for the pharmaceutical, and especially the
therapeutic, superiority of this preparation. At this time, as the
Council did not have the necessary facilities for investigating
therapeutic claims, the product was approved by the Council.

Since this time, however, the manufacturers have laid especial
stress in their advertisements on some highly improbable claims,
stating, for instance, that this Syrup of Hydriodic Acid possesses
“all the advantages, with none of the objectionable symptoms caused
by potassium iodid, or other forms of iodin medication.” To one with
even an elementary knowledge of chemistry, the absurdity of this
statement should be evident. The alkaline reaction of the tissues
makes it impossible that hydriodic acid should persist as such in the
body. In fact, the iodin must circulate in precisely the same form,
whether administered originally as potassium iodid or as hydrogen
iodid. The qualitative identity of the therapeutic actions is further
proof of this fact, were such needed.

Since the most important objectionable symptoms of iodid medication
arise after the absorption of the drugs, and since hydrogen iodid is
conceded to be readily absorbed, it is evident that these symptoms
must be equally liable to occur with hydrogen iodid as with potassium
iodid, provided that equivalent doses of iodin are administered. An
apparent difference in clinical results would arise if one drug were
habitually given in smaller doses than the other. Since, however, the
iodin is present in the body in precisely the same form, whether it
is administered as a hydrogen iodid or potassium iodid, it is evident
that a given degree of therapeutic effect would correspond to an
identical tendency to iodism, whichever drug was used. If, as appears
to be the case, the use of hydriodic acid is commonly restricted to
those cases in which only minimal doses of iodin are required, the
relative infrequency, or even absence of symptoms with such doses
would not prove that the drug itself is less apt to cause them than
is the potassium salt.

These facts are in reality self-evident; but since the Council now
has proper facilities for obtaining the views and experiences of
clinicians, it voted to submit the statement in question to its staff
of clinical consultants, and to be guided by their advice.

OPINIONS OF THE CLINICAL STAFF

The following is an epitome of the replies of the eleven members of
this staff who had used the article or who expressed an opinion to
the questions sent out by the Council:

1. QUERY: “Do you think it possible that such a preparation could be
devoid of the usual effects of iodin preparations?”

Eight reply that they consider this, _a priori_, impossible; three
stamp the statement as highly improbable, but do not care to say
that it would be impossible. One of the correspondents remarks:
“While distinctly taking the position that under many conditions
we must accept clinical results which we find not explainable by
our theoretical knowledge, where the conditions are so simple as in
this case and where we know that the iodin, whether administered as
hydrogen iodid or potassium iodid, must behave in the same way, after
absorption, I believe that no properly educated and correct thinking
physician can or will, after due consideration, fail to reject the
claims of superiority made by the proprietors of this preparation.”

2. QUERY: “Would you consider it necessary to make clinical
experiments to settle this question?”

Seven of the correspondents consider this superfluous; four of these
have had some experience with the article. Four, who have not used
this product, consider a clinical test advisable. Under Query 3 we
discuss the results of such tests.

3. QUERY: “When using Gardner’s Syrup of Hydriodic Acid, have you
ever noticed from it any of the objectionable effects of iodin
preparations?”

Six of the correspondents have not used it, or are uncertain whether
or not they used the product made by Gardner. One correspondent
remarks: “Never used it. Repelled by claims of superiority which
exaggerate disadvantages of potassium iodid and overlook the small
amount of iodin used in the preparation advertised.” The five
clinicians who have prescribed the preparation report as follows:
1. Objectionable iodin effects in two cases, both patients being
intolerant of all iodin preparations. 2. Has only prescribed it once
or twice, but thinks he has seen iodism in one case, some years ago;
does not recall clearly. 3. No; but has used this make very little,
and then always in very small but continued doses. 4. No, always used
it in small doses. 5. Yes, several cases in children; typical coryza,
etc., with doses of three drams three times a day.

CONCLUSIONS: It appears that typical iodism occurred in several
cases, after doses corresponding to 10 grains or less of potassium
iodid per day, and this is a rather limited clinical material.
Objectionable iodin effects are, therefore, not uncommon. Several
correspondents remark that the relative infrequency of iodism is
easily explainable by the fact that syrup is rarely employed in
conditions which demand an active iodin medication and that it is,
therefore, always taken in small doses. In fact, the main if not the
only point of superiority of the syrup appears to be in its flavor.

These clinical opinions and experiences, therefore, are in complete
agreement with the judgment of the committee, namely, that the
therapeutic claims made by the manufacturers for this article are
exaggerated and misleading.

OTHER MISSTATEMENTS

The above is by no means the only misstatement in the printed matter
issued by this manufacturer. In the publication, “The Applications
of Iodin,” issued in 1907, there occur the following misleading
statements which, since they refer to plainly chemical facts, did not
require submission to the clinical staff:

That the administration of potassium iodid after meals greatly
impairs its physiologic action “by its chemical union with the
various food products” (page 19). So far as the committee knows,
potassium iodid does not combine with the food products in the
stomach.

“Iodid of potassium, having an alkaline reaction, neutralizes the
hydrochloric acid in the gastric secretions, causing indigestion,
loss of appetite and depression” (page 19). The United States
Pharmacopeia states, under Potassii Iodidum: “Its aqueous solution
is neutral or has a slightly alkaline reaction on litmus paper.” The
slight occasional alkalinity would be physiologically insignificant,
and it is absurd to claim that this alkalinity causes “indigestion,
loss of appetite and depression.”

“The dose of iodid of iron is so small that the amount of iodin
contained therein is of little advantage” (page 19). As a matter of
fact, the pharmacopeial average dose (1 c.c.) of the Syrup of Iodid
of Iron contains as much iodin (0.85 grains) as a teaspoonful of
Gardner’s Syrup of Hydriodic Acid (0.83 grains).

“In hydriodic Acid the iodin is in combination with hydrogen, one
of the elements of the natural secretions of the body, and is,
therefore, in physiologic harmony” (page 21). No comment is needed.

It is implied elsewhere (page 29) that potassium iodid decomposes
more readily, with the liberation of iodin, than does hydrogen
iodid. This is contrary to the prevailing opinion, and would require
definite evidence before it could be accepted. It is also stated the
large doses of potassium iodid in syphilis are necessary, because the
gastric decomposition prevents complete absorption. This is certainly
untrue, for potassium iodid is absorbed almost quantitatively.

These, and numerous other misstatements, constitute violations of
Rule 6; and it is, therefore, recommended that Gardner’s Syrup of
Hydriodic Acid be removed from the list of remedies approved by the
Council; it is further recommended that this report be published.

The Council postponed final action on the report, pending its submission to R. W. Gardner. This having been done, and the reply of Mr. Gardner submitted to the Council, the above report was adopted and ordered published.

W. A. Puckner, Secretary.

(_From The Journal A. M. A., Nov. 14, 1908._)

HYPEROL

Report of the Council on Pharmacy and Chemistry

The Purdue Frederick Company, exploiters of Gray’s Glycerine Tonic, have recently been advertising to the medical profession a nostrum called Hyperol. The following report to the Council, by the referee, was adopted and its publication authorized.

W. A. Puckner, Secretary.

According to the label, Hyperol is “A Utero-Ovarian Corrective and Tonic.” The circular accompanying the trade package states that it is:

“Indicated in all functional diseases of women such as: Amenorrhea,
Dysmenorrhea, Menorrhagia, Metrorrhagia, Subinvolution, and in all
conditions requiring a utero-ovarian corrective and tonic.”

From another circular we learn that:

“Hyperol is a combination of Hydrastine, Aloin, Iron, Apiol and
Ergotin. Its components to a certain extent will indicate its
action, but the therapeutic effects of each ingredient seem to
be augmented to an unusual degree by use in this particular
combination. The proportions of each have been determined by
extensive clinical experimentation, and the formula seems to be
exactly balanced to produce the best therapeutic effects in all
derangements of the utero-ovarian functions.”

This “formula” is not very enlightening and a physician who wrote for further details was told that Hyperol contained:

Hydrastin 1/40 gr.
Aloin 1/12 gr.
Iron salts 3 gr.
Apiol (Special) 3 ♏
Ergotin 1 gr.
And excipients.

If this is correct, then, so far as its active ingredients are concerned, Hyperol is but a mixture of well-known drugs, having contradictory properties. According to the claims in the circular quoted above, it is useful both in amenorrhea and in menorrhagia. The mixture is as unscientific as it is unnecessary. It cannot be adapted to any individual case; when ergot is indicated, apiol would naturally be contra-indicated; if aloes is appropriate, hydrastis may defeat the object sought. It is unnecessary because no intelligent physician would prescribe such a combination of drugs in any given case. The claims are exaggerated, improbable and foolish. Hyperol conflicts with the following rules of the Council:

_Rule 4_, in that statements on the label and in the circular enclosed with the trade package advertise it to the public in the treatment of diseases.

_Rule 6_, in that exaggerated and unwarranted claims are made for its therapeutic qualities.

_Rule 8_, in that the name of this pharmaceutical mixture fails to disclose the potent constituents.

_Rule 10_, in that it is unscientific.

It is recommended that publication of this report be authorized to call attention to the unscientific character of such complex mixtures.

[Editor’s Note: Hyperol is advertised in _American Medicine_ and the _St. Paul Medical Journal_.]--(_From The Journal A. M. A., April 18, 1914._)

INGLUVIN

Report of the Council on Pharmacy and Chemistry

A subcommittee of the Council reported that unwarranted claims and misrepresentation were made for Ingluvin by its manufacturers, William R. Warner & Co., recommended that the preparation be refused recognition and that the report be submitted to Warner & Co. for action.

The report was submitted to the firm, and after waiting one month and no acknowledgement or reply having been received, the Council directed its publication. It is as follows:

REPORT ON INGLUVIN

Ingluvin is manufactured by W. R. Warner & Co., chemists, Philadelphia, Pa. The printed matter contains numerous claims and representations of which the following are specimens:

“A positive specific for indigestion, dyspepsia and the most
effective remedy in obstinate cases of vomiting of gestation....
A specific for vomiting in pregnancy in doses of from 10 to 20
grains, and a potent and reliable remedy for the cure of marasmus,
cholera infantum, indigestion, dyspepsia, and sick stomach
caused from debility of that organ. It is superior to the pepsin
preparations since it acts with more certainty, and effects cures
where they fail.... The natural glycocholic acid in Ingluvin is the
active principle and the most efficient agent in the treatment of
all stomachic and enteric disorders.”

Two samples were purchased at different times in the open market and on examination found to consist essentially of powdered meat fiber mixed with what appeared to {be} a membranous tissue resembling the lining of a gizzard. Both samples on being tested by the method prescribed by the U. S. Pharmacopeia for estimating the strength of pepsin were found to possess little, if any, proteolytic activity. In order to determine whether or not the lining of a fowl’s gizzard possesses proteolytic action, a fresh gizzard was secured, the lining washed slightly with water, then removed and on using one-half of same in place of pepsin as prescribed by the Pharmacopeial method, it was found to digest 10 grams of albumin within the time limit. Pepsin, when properly kept, does not lose its strength to any material extent.

A careful examination was made for the presence of glycocholic acid, claimed to be the active principle of Ingluvin, but its presence could not be established. Furthermore, the anatomic relations of the fowl are such as to preclude its presence.

The above shows that Ingluvin does not possess nearly as much proteolytic activity as ordinary saccharated pepsin recognized by the 1880 Pharmacopeia, which was prepared on the basis of digesting 300 times its weight of egg albumin. Inasmuch as no glycocholic acid is present in Ingluvin, it would seem that saccharated pepsin would be far more efficacious in treating the abnormal conditions for which Ingluvin is recommended in the advertising circulars. Furthermore, the claims made for the preparation are grossly extravagant.

A communication from Warner & Co. has been received since the above report was adopted, in which it is stated: “The reason that previous letter was not replied to was because we were desirous of securing all the information possible on the subject. Since that time we have made considerable research and also made laboratory investigation, and are enclosing the accumulated data with diagram of a part of the alimentary canal showing the esophagus, crop and gizzard.”

Much of the other matter submitted is immaterial. The following, so far as it means anything, seems to confirm the correctness of the report of the Council’s referee that Ingluvin is practically devoid of proteolytic activity: “... the therapeutic activity must be due to the bitter property, rather than any proteolytic activity, and it probably increases, thereby, the functional activity of the stomach, by which the normal digestive process is increased. Ingluvin in a 0.4 per cent. hydrochloric acid solution at 37 to 40 C. or if mixed with an aqueous solution of pepsin under the same conditions possesses an acrid, bitter taste and increases the secretion of the saliva and this is practically the same condition as when in the stomach, it no doubt stimulates the depressed mucosa peptic glands and increases gastric solution.”

W. A. Puckner, Secretary.

COMMENTS

The fallacies attending the use of digestive ferments in most stomach diseases have been previously noted in The Journal.[53] In most digestive disorders a deficiency of the digestive ferment has not been proved. In cases in which pepsin is lacking, its administration is valueless unless it is combined with large doses of hydrochloric acid, and it is doubtful whether this combination is either necessary or conspicuously useful. There is, however, something so alluring about medication by digestive ferments which are assumed to supply a physiologic need, that since their discovery they have formed a fertile field for the activity of the manufacturer of proprietaries. As by scientific laboratory tests, it is possible to determine whether a given preparation has digestive power, the manufacturers of Ingluvin avoid this point by claiming that the remedy acts, not on the food, but on the stomach itself. That remedies may exist which act as stimulants to the digestive secretions can not be denied, although at the present time this power has not been satisfactorily demonstrated. The proprietors of Ingluvin, finding that proteolytic activity is not to be attributed to this preparation of chickens’ gizzards, announce a new therapeutic fact in the claim that “the natural glycocholic acid in Ingluvin is the active principle and the most efficient agent in the treatment of all stomachic and enteric disorders. According to the report made to the Council there is no glycocholic acid in this preparation, nor is it possible, from the anatomic arrangements of the fowl’s digestive apparatus, for it to get there. By all the tests which can be applied to determine its value this preparation is of much less value in digestive disorders than saccharated pepsin, which was discontinued in the Pharmacopeia because of its inferiority to the other forms of the ferment.

[53] Feb. 2, 1907, p. 415, and Feb. 9, 1907, p. 521.

The repudiation, by the manufacturers, of the more absurd claims made for Ingluvin, shows the need of maintaining an attitude of healthy skepticism toward the advertised therapeutic virtues of proprietary preparations. If a physician is disposed to use digestive ferments, he should give preference to the official preparations, and ferments from other sources should be required to stand the exact tests which demonstrate the worthlessness of so many preparations on the market.--(_From The Journal A. M. A., July 11, 1908._)

INTESTINAL ANTISEPTIC W-A

Report of the Council on Pharmacy and Chemistry

The Council voted that Intestinal Antiseptic W-A be refused recognition, and that the publication of the following report be authorized.

W. A. Puckner, Secretary.

The Abbott Alkaloidal Company advertises “Intestinal Antiseptic W-A” as

“... A scientifically blended and physiologically adjusted mixture,
of the pure sulphocarbolates of calcium, sodium and zinc, grs. 5,
with bismuth subsalicylate, gr. 1-4 and aromatics.”

This formula is in conflict with Rule 1 in that it does not state in what proportion the sulphocarbolates are present.

The name “Intestinal Antiseptic W-A” is in conflict with Rules 4 and 8, since it is therapeutically suggestive.

The preparation is in conflict with Rules 6 and 10, in that exaggerated claims are made for it, no evidence being submitted to prove the superior value of the mixture.

The most serious of these conflicts consists in the exaggerated and misleading therapeutic claims. The advertisements say:

“This combination has no equal as an antiseptic and inhibitive
agent in typhoid fever, diarrhea, dysentery,” etc.

“Numerous cleverly devised and scientifically constructed
intestinal antiseptics have been introduced to the profession, but
not one of them has ever rivaled for one moment these salts in
popularity.”

“... we are convinced that no small share of the credit for the
reduction of the death rate in infantile diarrheas is due to
the widespread application of this general method of treatment,
associated of course with the calomel clean-out and the regulation
of diet, now known to be essential.”

“But the use of the sulphocarbolates is not restricted to diseases
of the alimentary canal, although in the summer diarrheas,
gastric fermentation, intestinal indigestion, typhoid fever,
dysentery--indeed in all alimentary disturbances--it is the
one essential remedy. It is also indicated in practically all
infectious diseases.”

“Typhoid Fever (in this disease the W-A Intestinal Antiseptic is of
great value; used early, with the proper synergistic cleanout, it
will often cut short the disease).”

These extreme claims exceed the limits of permissible optimism, unless they are supported by strong dependable evidence. They contrast sharply with the low esteem in which the phenolsulphonates (sulphocarbolates) are generally held. To accept these claims, and to justify encouraging physicians to rely on them, it would be necessary to establish:

First, that feasible concentrations have a distinct antiseptic action on cultures of intestinal bacteria. This experiment could be easily made, but the claims do not seem to be based on evidence of this kind.

Second, that the preparation actually checks putrefaction in the intestines. There are several methods by which this proof may be attempted; but the claims do not appear to be based on evidence of this kind.

Third, that the preparation actually has a favorable influence on the progress of diseases. This sort of evidence is exposed to so many fallacies that it would have to be gathered very carefully and critically, duly discounting the effect of other treatment; for instance, by comparison with similar cases which do not receive this preparation. This is especially important; and yet we find directions to use this preparation in conjunction with active cathartic treatment, which in itself has considerable influence on the conditions for which this preparation is recommended. No evidence of this kind is presented.

The testimonials contained in the advertisements cannot be considered as serious evidence. None present any indication of accurate record or proper control of conditions, or of the performance of control observations. They are superficial impressions, to which little or no weight can be attached.

It is recommended that Intestinal Antiseptic W-A be considered ineligible for New and Nonofficial Remedies.--(_From The Journal A. M. A., Dec. 19, 1914._)

BANNERMAN’S INTRAVENOUS SOLUTION

Report of the Council on Pharmacy and Chemistry

Bannerman’s Intravenous Solution (Wm. Bannerman and Co., Chicago) was refused recognition because vague, indefinite and misleading statements were made regarding its composition, because it was recommended for anemia, tuberculosis and syphilis under grossly exaggerated and unwarranted claims and because the intravenous injection of complex and indefinite mixtures is unscientific and dangerous. Notice of the action of the Council having been sent to the Bannerman Company, the firm submitted a revised statement of composition and also a revised advertising circular.

The claim is made that Bannerman’s Intravenous Solution “is a compound of only the purest and proven efficient U. S. P. drugs.” According to the latest statement:

Each 10 c.c. of Bannerman’s Solution contains:

Hydrargyri Albuminas
Mercury Content 1 1-9 Gr. or 0.075 Gm.
Ferri Albuminas
Iron Content 4 1-4 Grs. or 0.286 Gm.
Sodii Chloridum 6 1-5 Grs. or 0.412 Gm.
Calcii Salicylicum 4 Grs. or 0.26 Gm.
Guaiacol 4 Grs. or 0.26 Gm.
Creosote (Beechwood) 5 Grs. or 0.32 Gm.

The solvent is said to be distilled water.

The formula is unsatisfactory in several particulars. The stated amounts of some of the ingredients are in excess of their solubility in water; the nature and amount of albumin contained in the “Hydrargyri Albuminas” and “Ferri Albuminas” are not given; the claim that the solution contains only U. S. P. drugs is not true. But the main objection to the preparation is its unscientific character and the unwarranted therapeutic claims made for it.

Even though a patient had all three diseases, syphilis, tuberculosis and anemia, it would be most irrational to use a shotgun prescription, containing, in fixed unvarying proportions, mercury for the syphilis, iron for the anemia and germicides for the tuberculosis. In syphilis the mercury-content of Bannerman’s Solution is inadequate; in anemia the intravenous administration of iron is unwarranted, and in tuberculosis there is no evidence that the injection of bactericides is efficient.

Exception must be taken, moreover, to the statement that “its use is absolutely safe.” The danger of anaphylaxis from repeated injections of albuminates cannot be disregarded, and as J. F. Anderson, director of the Hygienic Laboratory, has pointed out[54] we know little of the secondary or remote effects of the intravenous injection of toxic substances; some of them probably do permanent harm.

[54] The Journal A. M. A., July 4, 1914, p. 1.

Such claims as the following require no comment:

“It builds up and increases the hemoglobin in the blood.
“It increases the number of red blood corpuscles.
“It regulates the white cells.
“It stimulates cell growth; therefore, it is reconstructive.
“It is a powerful antiseptic.
“It is useful in any septic condition.”

In view of the facts given, the Council again refused recognition to Bannerman’s Intravenous Solution.--(_From The Journal A. M. A., Jan. 2, 1915._)

IODALIA[O]

Abstract of Report of the Council on Pharmacy and Chemistry

[O] For the unabridged report of the Council’s action on Iodalia, see Reports Council Pharm. and Chem., 1914, p. 69.

Iodalia is sold by Geo. J. Wallau, Inc., with the claim that because of the peculiar combination in which it contains iodin it is a valuable and efficient substitute for iodids. The preparation was examined in the Chemical Laboratory of the American Medical Association, which reported to the Council that, contrary to claim, iodin in the form present in Iodalia would, when administered, act like an ordinary iodid. Further the proportion of iodin present was so small that to administer the equivalent of 20 grains of potassium iodid it would be necessary to give the contents of a one-dollar bottle of Iodalia. In view of this report it is evident that the claim that Iodalia is “always well tolerated” and that it cannot produce “symptoms of iodism” is true only because of the small percentage of iodin it contains. The claims made in the advertising matter, that Iodalia is an efficient iodin medication in the treatment of syphilis, that it is a suitable substitute for cod-liver oil and that it may be used in anemia, dysmenorrhea, dyspepsia, malaria and diseases of the heart, are entirely unwarranted.

Iodalia is exploited in a way to suggest its use to the public for a host of diseases. Particularly reprehensible are the recommendations contained in a circular which accompanies the trade package that Iodalia:

“... offers the same protection against grippe, bronchitis,
pneumonia, tuberculosis, pleurisy and other infectious diseases
that vaccine does against small pox ...”

“It is also the best preventive against the slight infections and
ailments to which debilitated and delicate children are subject.”

The Council voted that Iodalia be refused recognition.--(_From The Journal A. M. A., Dec. 12, 1914._)

IODEX

Report of the Council on Pharmacy and Chemistry

Iodex is manufactured by Menley and James, Ltd., New York. It is advertised as

“... an embodiment of vaporized iodin in an organic base, reduced
and standardized at 5 per cent. by incorporation with a refined
petroleum product.”

The advertising conveys the impression that the effects of free iodin are to be obtained from the preparation; it is said to contain “5 per cent. Therapeutically Free Iodine,” and to do

“... everything the doctor expects of FREE iodin employed by
inunction, without one physical or therapeutic drawback.”

The statements are also made that the preparation “neither stains, irritates, blisters or cracks the skin,” and that “thirty minutes after inunction iodin can be found in the urine.”

The following report of an examination made by the Chemical Laboratory of the American Medical Association has been submitted to the Council:

“Iodex is dark green, practically black. The green color is apparent
when the ointment is rubbed on the skin, but disappears on continued
rubbing. This nonstaining property is explained by the results of a
test for free iodin, made on five specimens, four of which yielded
only minute traces of free iodin, while the fifth yielded none.
Of course, the statements that Iodex is an ‘Effective Free Iodin
Application Without Drawbacks’ and also a means of ‘Really Efficient
External Iodine Therapy Without Stain or Irritation’ contradict each
other. Free iodin cannot be present in a sufficient quantity to be
therapeutically efficient in any application which does not stain or
irritate the skin.

“The total iodin content of the five specimens was found to be 2.63
per cent.--a little over one-half of the content claimed.

“Absorption and excretion experiments were performed to test the
claim that ‘thirty minutes after inunction iodin can be found in the
urine.’ In several subjects, from 1 to 2 gm. of Iodex was rubbed on
the skin of the forearms, and the urine, for periods varying from
seven to seventy-two hours, was collected and tested for iodin. In
all of the tests the results were negative.”

Iodex is advertised as beneficial in muscular soreness, sprains, sciatica, neuritis, chronic rheumatism, enlarged glands, orchitis, epididymitis, gout, burns and dermatomycoses. It is also said to be “Indicated in Glandular Enlargements, Inflammatory Conditions, Various Joint Diseases, Rheumatism, Skin Diseases, Chilblains, etc., etc.”

To sum up:

1. As shown in the foregoing laboratory report, the composition is incorrectly stated, for the actual iodin content is only about half of that claimed.

2. It is not true that the action of Iodex is essentially that of free iodin, which is the impression conveyed by the advertising.

3. The assertion made in the advertising, that iodin may be found in the urine shortly after Iodex has been rubbed on the skin, has been experimentally disproved.

In view of these findings, the Council voted that Iodex be refused recognition for conflict with Rules 1, 4 and 6.--(_From The Journal A. M. A., June 19, 1915._)

IODIA

Report of the Council on Pharmacy and Chemistry

The following report on Iodia was adopted by the Council and its publication authorized.

W. A. Puckner, Secretary.

Iodia is put on the market by Battle and Company, under the claim that it contains potassium iodid in combination with iron phosphate and vegetable “principles.” It is extravagantly recommended for use in many and varied conditions. For instance, it is “an unexcelled altero-reconstructive,” “almost a specific” in eczema and rheumatism and “a highly efficient form of iodin,” which will not produce iodism!

The therapeutic effects of iodids result from a chemical transformation by which molecular iodin is set free in the tissues, thus producing a mild degree of iodism. It follows, then, that a preparation which cannot give rise to the symptoms of iodism cannot be expected to produce the therapeutic effects of the iodids. The claim that Iodia is therapeutically efficient without producing iodism therefore justifies suspicion, to put it mildly.

In view of the exaggerated tone of the advertising, together with the fact that a report from the Chemical Laboratory of the American Medical Association showed marked discrepancies between the formula and the composition of Iodia, it seemed desirable to investigate this product. The report of the laboratory, which is given below, shows conflict with Rule 1 (secrecy of composition) and with Rule 2 (false claims of standardization). A discussion of the claims made for Iodia follows the report.

LABORATORY REPORT

The composition of Iodia is given thus:

“Formula.--Iodia is a combination of active principles obtained
from the green roots of Stillingia, Helonias, Saxifraga,
Menispermum and aromatics. Each fluid drachm also contains two and
one-half grains Iod.-Potas. and one and one-half grains Phos.-Iron.”

We are told that:

“Its several ingredients are selected with scrupulous care, and the
most exacting methods are constantly employed to insure absolute
uniformity and maximum therapeutic potency.”

This “formula” is an absurdity: First, the amounts of the “active
principles” of the plants named are not given; second, these
“principles,” with the possible exception of menispermum alkaloids,
have not been isolated; and, third, ferric phosphate and potassium
iodid are incompatible! Incidentally, there are no methods whereby it
is possible to secure “absolute uniformity” of a mixture such as Iodia
is claimed to be.

Qualitative tests demonstrated the absence of iron and the absence
of all but traces of phosphorus compounds (0.015 gm. phosphorus per
100 c.c.). Minute traces of alkaloids, possibly from menispermum,
were found (that amount being about 0.004 gm. per hundred c.c. of the
preparation). Therapeutically this quantity is entirely negligible.
Determinations of iodid demonstrated the presence of only about 60 per
cent. of the amount of potassium iodid claimed. The “formula” for Iodia
is false and misleading.[55]

[55] It should be noted that the discrepancies here reported between the actual and the claimed composition of Iodia were pointed out more than thirty years ago by A. B. Lyons (Detroit _Lancet_, October, 1882, vi, 157–8), who found that Iodia was deficient in iodid content and practically free from iron.

DANGEROUS RECOMMENDATIONS

One of the Iodia labels reads:

“INDICATIONS.--Syphilitic, scrofulous and cutaneous diseases,
dysmenorrhea, menorrhagia, leucorrhea, amenorrhea, impaired
vitality, habitual abortion and general uterine debility.”

Such recommendations are likely to lead to self-drugging in conditions that are not only dangerous to the individual but also a menace to the community. The preparation thus conflicts with Rule 4 of the Council. After admitting the need of efficient iodid medication in certain stages of syphilis and after exaggerating the frequence and severity of symptoms of iodism, an advertising circular entitled “Practical Therapeutics” asserts:

“Iodia then is the preparation of iodid of potassium to be
preferred whenever it requires to be administered in large doses or
for prolonged periods of time...

“Not only does the association of the iodid of potassium with the
vegetable alteratives offer a measure of protection against iodism
but the latter exert depurative effects on their own account ...”

It is generally accepted that in certain stages of syphilis the only hope of success lies in efficient iodin medication. The exploiters of Iodia state that a dose of the nostrum contains 2-1/2 grains of potassium iodid; actually it contains only 1-1/2 grains. To urge physicians and the public to depend on this product for efficient iodid medication constitutes an unwarranted therapeutic exaggeration (Rule 6) which approaches criminality. The reason Iodia does not produce iodism is that, in the doses recommended, the iodin action is extremely feeble.

Likening the human body to a factory and discussing the “break downs” which are likely to occur, a circular entitled “Always Trustworthy” says:

“When administered in proper dosage, Iodia stimulates organic
functions, promotes the elimination of waste products, and
re-establishes metabolic activity. It increases the solvent
properties of the blood, and arrests abnormal tissue metamorphosis.
In other words, it lends material assistance to weakened
cells and curbs those unduly active. Iodia, obviously, has
a wide range of indications. It has been most generally and
successfully employed, however, in Syphilitic, Scrofulous and
Cutaneous Diseases, Rheumatic and Gouty Ailments, Dysmenorrhea,
Menorrhagia, Leucorrhea, Amenorrhea, Impaired Vitality, Habitual
Abortion and General Uterine Debility, and wherever a reliable
altero-reconstructive is required.”

These recommendations show that in addition to the objections already given, this nostrum is an unscientific shot-gun mixture. This brings it in conflict with Rule 10 (unscientific articles inimical to the medical profession and the public).

It is recommended that Iodia be refused recognition.--(_From The Journal A. M. A., Nov. 21, 1914._)

BURNHAM’S SOLUBLE IODINE[P]

Report of the Council on Pharmacy and Chemistry

[P] See also Burnham’s Soluble Iodine, p. 233.

The Council has authorized publication of the following report on Burnham’s Soluble Iodine.

W. A. Puckner, Secretary.

Burnham’s Soluble Iodine is offered to the medical profession by the Burnham Soluble Iodine Company, Auburndale, Mass., under the claim that by

“... a new process hitherto unknown to chemistry, ... Iodine is
converted into a soluble article--soluble in water and soluble in
gastric secretions and in the tissues.”

Beyond this no statement as to the qualitative or quantitative chemical identity of Burnham’s Soluble Iodine is furnished; this secrecy, of course, has given the preparation a certain mysterious prestige among unthinking physicians.

Burnham’s Soluble Iodine was examined in the Chemical Laboratory of the American Medical Association some six years ago and was found to be an alcoholic solution of free iodin (approximately 3 gm. per hundred c.c.) and combined iodin in the form of iodid (equivalent to about 2 gm. of potassium iodid per hundred c.c.). Thus the total iodin content was somewhat less than half of that of the official Tincture of Iodin (Tr. Iodi), which contains 7 gm. of free iodin and 5 gm. of potassium iodid to each 100 c.c. The official tincture, diluted one-half, therefore, would be essentially equivalent to the Burnham preparation, both being miscible with water. The Burnham Soluble Iodine Company objected to the conclusions drawn, from this analysis, but admitted the correctness of the analysis itself.

Any one who gathered his first knowledge of the subject from the Burnham advertising might readily infer that no soluble iodin had been known prior to Burnham’s Soluble Iodine. This, of course, is not the case; the method of producing a solution of iodin by the use of an iodid has long been known.

The following statement is not only obviously untrue but also nonsensical:

“In all the history of iodin medication, covering a period of
laboratory research of many years duration, every effort to produce
a free iodin, _prior_ to the evolution of Burnham’s Soluble Iodine,
was attended by failure.”

The company lays stress on the assumed superiority over the iodids of a preparation containing free iodin. This assumption is based on a fallacy. Those who regard free iodin as superior to combined iodin forget that free iodin taken by the mouth is converted in the intestines, by the action of the alkaline intestinal secretions, into an iodid with a small amount of iodate, while administered intravenously (a procedure that, while advocated by the Burnham concern, is therapeutically indefensible), it enters into combination with the alkaline salts and proteins of the blood. The free iodin in Burnham’s Soluble Iodine must act in the system as an iodid, and the whole iodin content, to furnish a correct estimate of the value of the preparation, should be reckoned as an iodid.

Bearing this in mind, then, it is evident that the doses of Burnham’s Soluble Iodine recommended by the manufacturers are extremely small. They range from 20 minims (equivalent to 1 grain of potassium iodid) to 1/2 minim (equivalent to 1/40 grain of potassium iodid). From 5 to 20 minims (equivalent to about 1/4 to 1 grain of potassium iodid) is the dosage recommended for syphilis; from “1 to 3 minims [equivalent to from 1/20 to 3/20 grain of potassium iodid] three to six times daily” for typhoid and other intestinal diseases. No wonder the exploiters can say that this nostrum does not irritate the intestines, that it is “non-irritating to the weakest stomach” and that there is an “entire absence of toxic action from maximum doses”! Its alleged freedom from the irritating and untoward effects of ordinary iodids is due, not to any inherent superiority of the preparation, but to the insignificant amount of iodid present.

The preparation is advertised for use in an extremely wide range of diseases, in some of which iodid therapy is recognized as of value, while in others it is generally regarded as either worthless or harmful. Given orally or intravenously (the recklessness of the latter method should again be emphasized) Burnham’s Soluble Iodine is claimed to be of:

“... great utility as an internal antiseptic in tubercular
affections ...”

Since, as previously explained, free iodin, when introduced into the body, enters into chemical combination before it has a chance to permeate the tissues, and since the alkali iodids possess very slight (in fact, for this purpose, negligible) antiseptic powers, it is evident that this claim is unfounded. So, for the same reason, is the claim that “as an intestinal antiseptic,” Burnham’s Soluble Iodine is:

“... efficient in Typhoid Fever, Enteritis and other intestinal
diseases.”

It is recommended in exophthalmic goiter, notwithstanding that this condition is generally recognized as contraindicating the administration of iodids, which excite the action of the thyroid gland, and which therefore must be used with great circumspection. An especially indefensible recommendation is that 1/2 minim of Burnham’s Soluble Iodine (equivalent to 1/40 grain of potassium iodid) be administered every five minutes in “membranous croup”--diphtheria--until relief from dyspnea is obtained. But, of all the extravagant claims made for this preparation, perhaps the following is the most reprehensible:

“In the treatment of Phthisis, in its various forms, clinical
evidence clearly indicates that the use of SOLUBLE IODINE affords
the most potent method of treatment available. Dose--2 minims,
increasing to 5 minims in four ounces water before meals.”

Remove the mystery and tell physicians that a dose of 1/10 or 1/4 of a grain of potassium iodid is “the most potent method of treatment available” in tuberculosis and the absurdity becomes self-evident. Nor is this the worst feature of the advice here offered. Iodin, by combining with the fatty acids of tuberculous tissues, promotes their autolysis and consequently their softening and breaking down. The products of this autolysis are carried by the lymphatics to healthy tissues and thus may spread the infection. Therefore the use of iodids in tuberculosis, even in small dosage, should not be undertaken lightly.

It is recommended that Burnham’s Soluble Iodine, a semi-secret preparation, exploited by means of extravagant and dangerous therapeutic claims, be held ineligible for admission to New and Nonofficial Remedies, and that this report be published.--(_From The Journal A. M. A., May 15, 1915._)

IODOTONE[Q]

Abstract of Report of the Council on Pharmacy and Chemistry

[Q] For the unabridged report of the Council’s action on Iodotone, see Reports Council Pharm. and Chem., 1914, p. 72.

Eimer and Amend, New York, who market Iodotone, state that it is a solution of hydrogen iodid (hydriodic acid) in glycerin, containing 1 grain of iodin to each fluid dram. The unwarranted assertion is made that Iodotone

“... will produce the constitutional effect of iodine in a shorter
time than other preparations ...”

This cannot be true, for it is certain that, because of the alkaline reactions of the tissues, iodids, whether administered as hydrogen iodid or as alkali iodids, must circulate in precisely the same form and therefore exert the same therapeutic effects in precisely the same way.

Eimer and Amend further assert that the ordinary iodids may to advantage be replaced by Iodotone. The absurdity of this claim is apparent when it is considered that it will be necessary to administer nearly one fluidounce of glycerin to obtain an amount of Iodotone equivalent to a 10-grain dose of potassium iodid. The additional claim that Iodotone will not disturb the stomach or produce the usual disagreeable symptoms of iodism is evidently unwarranted, for it is generally conceded that symptoms of iodism can be avoided only at the risk of insufficient iodin medication. Because of these unwarranted and misleading claims and because the name Iodotone would tend toward the uncritical use of the preparation as a general tonic, the Council voted that Iodotone be refused recognition.--(_From The Journal A. M. A., Dec. 12, 1914._)

IOSALINE

Report of the Council on Pharmacy and Chemistry

Iosaline is a rheumatism remedy for external application. In view of the misleading and unwarranted claims which are made for it, the Council voted that Iosaline be refused recognition and recommended publication of the Committee’s report which appears below.

W. A. Puckner, Secretary.

COMMITTEE’S REPORT

The following sweeping but rather indefinite claims are made for Iosaline.

“Iosaline is a penetrator and overcomes the objectionable
escharotic properties of Iodine; it is readily absorbed and may be
used without discomfort or discoloration.”

“The strong analgesic properties of Iosaline make it especially
useful in controlling pain in cases of Neuralgia, Rheumatism, Gout,
and Arthritis Deformans.”

As there are few, if any, known iodin compounds which are “readily absorbed” through the skin and which will not at the same time produce discoloration or discomfort, it was thought worth while to take up the examination of Iosaline. The results of this examination are reported by the Chemical Laboratory of the Association as follows:

_Laboratory Report_:--Iosaline is advertised by the Iosaline Company
of New York, as a remedy for the treatment by external application,
of rheumatism, gout, neuralgia, pneumonia and numerous other
diseases. Concerning its composition the following statements are
made:

“A transparent, non-staining gelatinoid of combined iodine with
menthol and methyl salicylate.

“Alcohol 070. per cent.

“Chemical tests demonstrate the preparation to contain 5 per cent.
of iodine.”

The placing of a cipher before the percentage figure for alcohol,
though perhaps accidental and not meant to mislead, might cause a
hasty or careless reader to understand 7 per cent. or .07 per cent.,
instead of 70 per cent., as the proportion of alcohol present.

The preparation examined was a very pale yellowish, translucent solid
having a strong odor of methyl salicylate and a fainter odor of
menthol. A package sold for 2 ounces contained 51.7 gm. Qualitative
tests indicated the presence of alcohol, an iodid, menthol, methyl
salicylate, potassium, sodium, combined fatty acids and a trace of
glycerin. Thyroid extract was not found. Quantitative examination
indicated the following approximate composition for Iosaline:

Alcohol (by weight) 48.05 per cent.
Menthol 2.07 per cent.
Methyl salicylate 10.25 per cent.
Potassium iodid (4.25 per cent. iodin) 5.55 per cent.
Soap 12.68 per cent.
Glycerin a trace
Water and undetermined matter to make 100 per cent.